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Sample records for routine clinical laboratory

  1. Taking a new biomarker into routine use – A perspective from the routine clinical biochemistry laboratory

    Science.gov (United States)

    Sturgeon, Catharine; Hill, Robert; Hortin, Glen L; Thompson, Douglas

    2010-01-01

    There is increasing pressure to provide cost-effective healthcare based on “best practice.” Consequently, new biomarkers are only likely to be introduced into routine clinical biochemistry departments if they are supported by a strong evidence base and if the results will improve patient management and outcome. This requires convincing evidence of the benefits of introducing the new test, ideally reflected in fewer hospital admissions, fewer additional investigations and/or fewer clinic visits. Carefully designed audit and cost-benefit studies in relevant patient groups must demonstrate that introducing the biomarker delivers an improved and more effective clinical pathway. From the laboratory perspective, pre-analytical requirements must be thoroughly investigated at an early stage. Good stability of the biomarker in relevant physiological matrices is essential to avoid the need for special processing. Absence of specific timing requirements for sampling and knowledge of the effect of medications that might be used to treat the patients in whom the biomarker will be measured is also highly desirable. Analytically, automation is essential in modern high-throughput clinical laboratories. Assays must therefore be robust, fulfilling standard requirements for linearity on dilution, precision and reproducibility, both within- and between-run. Provision of measurements by a limited number of specialized reference laboratories may be most appropriate, especially when a new biomarker is first introduced into routine practice. PMID:21137030

  2. Yeast identification in routine clinical microbiology laboratory and its clinical relevance

    Directory of Open Access Journals (Sweden)

    S Agarwal

    2011-01-01

    Full Text Available Rapid identification of yeast infections is helpful in prompt appropriate antifungal therapy. In the present study, the usefulness of chromogenic medium, slide culture technique and Vitek2 Compact (V2C has been analysed. A total of 173 clinical isolates of yeast species were included in the study. An algorithm to identify such isolates in routine clinical microbiology laboratory was prepared and followed. Chromogenic medium was able to identify Candida albicans, C. tropicalis, C. krusei, C. parapsilosis and Trichosporon asahii. Chromogenic medium was also helpful in identifying "multi-species" yeast infections. The medium was unable to provide presumptive identification of C. pelliculosa, C. utilis, C. rugosa, C. glabrata and C. hemulonii. Vitek 2 compact (V2C differentiated all pseudohypae non-producing yeast species. The algorithm followed was helpful in timely presumptive identification and final diagnosis of yeast infections, including multi-species yeast infections.

  3. Routine operation of an Elliott 903 computer in a clinical chemistry laboratory

    Science.gov (United States)

    Whitby, L. G.; Simpson, D.

    1973-01-01

    Experience gained in the last four years concerning the capabilities and limitations of an 8K Elliott 903 (18-bit word) computer with magnetic tape backing store in the routine operation of a clinical chemistry laboratory is described. Designed as a total system, routine operation has latterly had to be confined to data acquisition and process control functions, due primarily to limitations imposed by the choice of hardware early in the project. In this final report of a partially successful experiment the opportunity is taken to review mistakes made, especially at the start of the project, to warn potential computer users of pitfalls to be avoided. PMID:4580240

  4. A simple method for plasma total vitamin C analysis suitable for routine clinical laboratory use

    OpenAIRE

    Robitaille, Line; Hoffer, L. John

    2016-01-01

    Background In-hospital hypovitaminosis C is highly prevalent but almost completely unrecognized. Medical awareness of this potentially important disorder is hindered by the inability of most hospital laboratories to determine plasma vitamin C concentrations. The availability of a simple, reliable method for analyzing plasma vitamin C could increase opportunities for routine plasma vitamin C analysis in clinical medicine. Methods Plasma vitamin C can be analyzed by high performance liquid chro...

  5. A simple method for plasma total vitamin C analysis suitable for routine clinical laboratory use.

    Science.gov (United States)

    Robitaille, Line; Hoffer, L John

    2016-04-21

    In-hospital hypovitaminosis C is highly prevalent but almost completely unrecognized. Medical awareness of this potentially important disorder is hindered by the inability of most hospital laboratories to determine plasma vitamin C concentrations. The availability of a simple, reliable method for analyzing plasma vitamin C could increase opportunities for routine plasma vitamin C analysis in clinical medicine. Plasma vitamin C can be analyzed by high performance liquid chromatography (HPLC) with electrochemical (EC) or ultraviolet (UV) light detection. We modified existing UV-HPLC methods for plasma total vitamin C analysis (the sum of ascorbic and dehydroascorbic acid) to develop a simple, constant-low-pH sample reduction procedure followed by isocratic reverse-phase HPLC separation using a purely aqueous low-pH non-buffered mobile phase. Although EC-HPLC is widely recommended over UV-HPLC for plasma total vitamin C analysis, the two methods have never been directly compared. We formally compared the simplified UV-HPLC method with EC-HPLC in 80 consecutive clinical samples. The simplified UV-HPLC method was less expensive, easier to set up, required fewer reagents and no pH adjustments, and demonstrated greater sample stability than many existing methods for plasma vitamin C analysis. When compared with the gold-standard EC-HPLC method in 80 consecutive clinical samples exhibiting a wide range of plasma vitamin C concentrations, it performed equivalently. The easy set up, simplicity and sensitivity of the plasma vitamin C analysis method described here could make it practical in a normally equipped hospital laboratory. Unlike any prior UV-HPLC method for plasma total vitamin C analysis, it was rigorously compared with the gold-standard EC-HPLC method and performed equivalently. Adoption of this method could increase the availability of plasma vitamin C analysis in clinical medicine.

  6. Real-Time PCR in Clinical Microbiology: Applications for Routine Laboratory Testing

    Science.gov (United States)

    Espy, M. J.; Uhl, J. R.; Sloan, L. M.; Buckwalter, S. P.; Jones, M. F.; Vetter, E. A.; Yao, J. D. C.; Wengenack, N. L.; Rosenblatt, J. E.; Cockerill, F. R.; Smith, T. F.

    2006-01-01

    Real-time PCR has revolutionized the way clinical microbiology laboratories diagnose many human microbial infections. This testing method combines PCR chemistry with fluorescent probe detection of amplified product in the same reaction vessel. In general, both PCR and amplified product detection are completed in an hour or less, which is considerably faster than conventional PCR detection methods. Real-time PCR assays provide sensitivity and specificity equivalent to that of conventional PCR combined with Southern blot analysis, and since amplification and detection steps are performed in the same closed vessel, the risk of releasing amplified nucleic acids into the environment is negligible. The combination of excellent sensitivity and specificity, low contamination risk, and speed has made real-time PCR technology an appealing alternative to culture- or immunoassay-based testing methods for diagnosing many infectious diseases. This review focuses on the application of real-time PCR in the clinical microbiology laboratory. PMID:16418529

  7. Mould routine identification in the clinical laboratory by matrix-assisted laser desorption ionization time-of-flight mass spectrometry.

    Directory of Open Access Journals (Sweden)

    Carole Cassagne

    Full Text Available BACKGROUND: MALDI-TOF MS recently emerged as a valuable identification tool for bacteria and yeasts and revolutionized the daily clinical laboratory routine. But it has not been established for routine mould identification. This study aimed to validate a standardized procedure for MALDI-TOF MS-based mould identification in clinical laboratory. MATERIALS AND METHODS: First, pre-extraction and extraction procedures were optimized. With this standardized procedure, a 143 mould strains reference spectra library was built. Then, the mould isolates cultured from sequential clinical samples were prospectively subjected to this MALDI-TOF MS based-identification assay. MALDI-TOF MS-based identification was considered correct if it was concordant with the phenotypic identification; otherwise, the gold standard was DNA sequence comparison-based identification. RESULTS: The optimized procedure comprised a culture on sabouraud-gentamicin-chloramphenicol agar followed by a chemical extraction of the fungal colonies with formic acid and acetonitril. The identification was done using a reference database built with references from at least four culture replicates. For five months, 197 clinical isolates were analyzed; 20 were excluded because they were not identified at the species level. MALDI-TOF MS-based approach correctly identified 87% (154/177 of the isolates analyzed in a routine clinical laboratory activity. It failed in 12% (21/177, whose species were not represented in the reference library. MALDI-TOF MS-based identification was correct in 154 out of the remaining 156 isolates. One Beauveria bassiana was not identified and one Rhizopus oryzae was misidentified as Mucor circinelloides. CONCLUSIONS: This work's seminal finding is that a standardized procedure can also be used for MALDI-TOF MS-based identification of a wide array of clinically relevant mould species. It thus makes it possible to identify moulds in the routine clinical laboratory setting

  8. Cost effectiveness analysis of clinically driven versus routine laboratory monitoring of antiretroviral therapy in Uganda and Zimbabwe.

    Directory of Open Access Journals (Sweden)

    Antonieta Medina Lara

    Full Text Available Despite funding constraints for treatment programmes in Africa, the costs and economic consequences of routine laboratory monitoring for efficacy and toxicity of antiretroviral therapy (ART have rarely been evaluated.Cost-effectiveness analysis was conducted in the DART trial (ISRCTN13968779. Adults in Uganda/Zimbabwe starting ART were randomised to clinically-driven monitoring (CDM or laboratory and clinical monitoring (LCM; individual patient data on healthcare resource utilisation and outcomes were valued with primary economic costs and utilities. Total costs of first/second-line ART, routine 12-weekly CD4 and biochemistry/haematology tests, additional diagnostic investigations, clinic visits, concomitant medications and hospitalisations were considered from the public healthcare sector perspective. A Markov model was used to extrapolate costs and benefits 20 years beyond the trial.3316 (1660LCM;1656CDM symptomatic, immunosuppressed ART-naive adults (median (IQR age 37 (32,42; CD4 86 (31,139 cells/mm(3 were followed for median 4.9 years. LCM had a mean 0.112 year (41 days survival benefit at an additional mean cost of $765 [95%CI:685,845], translating into an adjusted incremental cost of $7386 [3277,dominated] per life-year gained and $7793 [4442,39179] per quality-adjusted life year gained. Routine toxicity tests were prominent cost-drivers and had no benefit. With 12-weekly CD4 monitoring from year 2 on ART, low-cost second-line ART, but without toxicity monitoring, CD4 test costs need to fall below $3.78 to become cost-effective (<3xper-capita GDP, following WHO benchmarks. CD4 monitoring at current costs as undertaken in DART was not cost-effective in the long-term.There is no rationale for routine toxicity monitoring, which did not affect outcomes and was costly. Even though beneficial, there is little justification for routine 12-weekly CD4 monitoring of ART at current test costs in low-income African countries. CD4 monitoring

  9. Extrapulmonary involvement in patients with sarcoidosis and comparison of routine laboratory and clinical data to pulmonary involvement.

    Science.gov (United States)

    Zurkova, Monika; Kolek, Vitezslav; Tomankova, Tereza; Kriegova, Eva

    2014-12-01

    Patients with pulmonary and pulmonary plus extrapulmonary sarcoidosis differ in symptom severity and health status impairment. To date there is no information on differences in clinical and laboratory parameters between these phenotypes and limited information on extrapulmonary involvement in Czech sarcoidosis patients exists. We therefore compared clinical data (age, gender, organ involvement, lung function tests) and laboratory data (blood counts, bronchoalveolar fluid (BAL) cellular profile, serum levels of CRP, SACE, sIL-2R, neopterin) between patients with newly diagnosed pulmonary sarcoidosis (n=107) and those with pulmonary plus extrapulmonary sarcoidosis (n=54). Extrapulmonary sarcoidosis was diagnosed in 33% of patients, mostly affecting lymph nodes and skin and having hypercalciuria. There was no difference in the prevalence of extrapulmonary sarcoidosis between genders. Patients with extrapulmonary sarcoidosis were older and mostly non-smokers when compared to those with limited pulmonary form. X-ray Stage I and erythema nodosum were less frequent in extrapulmonary disease. Serum levels of CRP, SACE, sIL-2R and neopterin and BAL cellular profile did not differ between both phenotypes. We observed lower platelets, FEV1, VC, and BAL CD19+ in females with extrapulmonary involvement than in those with pulmonary disease. Affected lymph nodes, skin and hypercalciuria were the most common in sarcoidosis patients with extrapulmonary involvement. Pulmonary sarcoidosis did not differ in clinical and routine laboratory parameters from pulmonary plus extrapulmonary sarcoidosis. Observation of low platelets, VC, FEV1 and BAL CD19+ in females with extrapulmonary sarcoidosis needs further verification in larger cohort.

  10. Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data--The Influence of Different Parameters in a Routine Clinical Microbiology Laboratory.

    Science.gov (United States)

    Kohlmann, Rebekka; Gatermann, Sören G

    2016-01-01

    Many clinical microbiology laboratories report on cumulative antimicrobial susceptibility testing (cAST) data on a regular basis. Criteria for generation of cAST reports, however, are often obscure and inconsistent. Whereas the CLSI has published a guideline for analysis and presentation of cAST data, national guidelines directed at clinical microbiology laboratories are not available in Europe. Thus, we sought to describe the influence of different parameters in the process of cAST data analysis in the setting of a German routine clinical microbiology laboratory during 2 consecutive years. We developed various program scripts to assess the consequences ensuing from different algorithms for calculation of cumulative antibiograms from the data collected in our clinical microbiology laboratory in 2013 and 2014. One of the most pronounced effects was caused by exclusion of screening cultures for multi-drug resistant organisms which decreased the MRSA rate in some cases to one third. Dependent on the handling of duplicate isolates, i.e. isolates of the same species recovered from successive cultures on the same patient during the time period analyzed, we recorded differences in resistance rates of up to 5 percentage points for S. aureus, E. coli and K. pneumoniae and up to 10 percentage points for P. aeruginosa. Stratification by site of care and specimen type, testing of antimicrobials selectively on resistant isolates, change of interpretation rules and analysis at genus level instead of species level resulted in further changes of calculated antimicrobial resistance rates. The choice of parameters for cAST data analysis may have a substantial influence on calculated antimicrobial resistance rates. Consequently, comparability of cAST reports from different clinical microbiology laboratories may be limited. We suggest that laboratories communicate the strategy used for cAST data analysis as long as national guidelines for standardized cAST data analysis and reporting

  11. Routine internal- and external-quality control data in clinical laboratories for estimating measurement and diagnostic uncertainty using GUM principles.

    Science.gov (United States)

    Magnusson, Bertil; Ossowicki, Haakan; Rienitz, Olaf; Theodorsson, Elvar

    2012-05-01

    Healthcare laboratories are increasingly joining into larger laboratory organizations encompassing several physical laboratories. This caters for important new opportunities for re-defining the concept of a 'laboratory' to encompass all laboratories and measurement methods measuring the same measurand for a population of patients. In order to make measurement results, comparable bias should be minimized or eliminated and measurement uncertainty properly evaluated for all methods used for a particular patient population. The measurement as well as diagnostic uncertainty can be evaluated from internal and external quality control results using GUM principles. In this paper the uncertainty evaluations are described in detail using only two main components, within-laboratory reproducibility and uncertainty of the bias component according to a Nordtest guideline. The evaluation is exemplified for the determination of creatinine in serum for a conglomerate of laboratories both expressed in absolute units (μmol/L) and relative (%). An expanded measurement uncertainty of 12 μmol/L associated with concentrations of creatinine below 120 μmol/L and of 10% associated with concentrations above 120 μmol/L was estimated. The diagnostic uncertainty encompasses both measurement uncertainty and biological variation, and can be estimated for a single value and for a difference. This diagnostic uncertainty for the difference for two samples from the same patient was determined to be 14 μmol/L associated with concentrations of creatinine below 100 μmol/L and 14 % associated with concentrations above 100 μmol/L.

  12. Routine reporting of estimated glomerular filtration rate (eGFR) in African laboratories and the need for its increased utilisation in clinical practice.

    Science.gov (United States)

    Adebisi, Simeon A

    2013-03-01

    Chronic Kidney Disease (CKD) is defined as the presence of markers of kidney damage or of estimated glomerular filtration rate (eGFR)clinical practice. Current guidelines advocate the use of prediction equations, such as the Cockcroft-Gault (CG) formula and the Modification of Diet in Renal Disease (MDRD) study-derived equations. Laboratories in African should commence routine reporting of eGFR for a number of reasons; 1. The sensitivity of serum creatinine (Scr) in identifying CKD is low.2. In Nigeria, a representative country; screening for Chronic Kidney Disease (CKD) is hardly considered in the routine practice of the primary and secondary care medical officers.3 Studies have shown that routine reporting of eGFR improved the documentation and identification of CKD by almost 50%.4 There is the possibility of reversing CKD if picked earlier.5. The high cost of treating CKD patients in advanced stages and the low per capital income status of the populace in Sub-Saharan Africa.6. Poor health infrastructure to manage advanced CKD patients in the continent.7. Several studies, now show lack of awareness of CKD among non-nephrologists that is related, at least in part, to difficulty in interpreting serum creatinine concentrations (the reciprocal, non-linear relationship between GFR and serum creatinine).8 Mathematical estimates of GFR [ as in eGFR] that incorporate creatinine concentration, as well as factors affecting creatinine production rates, such as size, gender, age and ethnic background, are more sensitive to changes in renal function than serum creatinine value alone.9 Recent guidelines define "action plans" for CKD according to the GFR, including referral to nephrologists at GFRs<30 mL.min(-1).(1.73 m2).

  13. [Big data from clinical routine].

    Science.gov (United States)

    Mansmann, U

    2018-04-01

    Over the past 100 years, evidence-based medicine has undergone several fundamental changes. Through the field of physiology, medical doctors were introduced to the natural sciences. Since the late 1940s, randomized and epidemiological studies have come to provide the evidence for medical practice, which led to the emergence of clinical epidemiology as a new field in the medical sciences. Within the past few years, big data has become the driving force behind the vision for having a comprehensive set of health-related data which tracks individual healthcare histories and consequently that of large populations. The aim of this article is to discuss the implications of data-driven medicine, and to examine how it can find a place within clinical care. The EU-wide discussion on the development of data-driven medicine is presented. The following features and suggested actions were identified: harmonizing data formats, data processing and analysis, data exchange, related legal frameworks and ethical challenges. For the effective development of data-driven medicine, pilot projects need to be conducted to allow for open and transparent discussion on the advantages and challenges. The Federal Ministry of Education and Research ("Bundesministerium für Bildung und Forschung," BMBF) Arthromark project is an important example. Another example is the Medical Informatics Initiative of the BMBF. The digital revolution affects clinic practice. Data can be generated and stored in quantities that are almost unimaginable. It is possible to take advantage of this for development of a learning healthcare system if the principles of medical evidence generation are integrated into innovative IT-infrastructures and processes.

  14. Alpha-fetoprotein in the routine clinical laboratory: evaluation of a simple radioimmunoassay and review of current concepts in its clinical application

    International Nuclear Information System (INIS)

    Brummund, W.; Mennuti, M.T.; Arvan, D.A.; Starkovsky, N.A.

    1980-01-01

    The authors have assessed the clinical utility of a radioimmunoassay for alpha-fetoprotein (AFP). The method, which relies on ammonium sulfate precipitation for the separation of 'bound' and 'free' radiolabeled antigen, can be completed in one working day. The assay is specific for AFP, has a sensitivity of <10 ng/ml, and has intra- and inter-assay precision of 5-8% and 9-11%, respectively. They have conducted a three-year study of 472 pregnancies in which physicians wished to detect neural tube defects, and of 400 non-pregnant patients to assess the value of serum AFP as a marker for certain benign and malignant diseases. Six of 6 fetal open neural-tube defects (NTD'S) and 3 of 3 intrauterine fetal deaths were correctly identified by their association with marked AFP elevations in both maternal serum and amniotic fluid. Thirty non-pregnant patients were found to have AFP elevations greater than 20 ng/ml. Malignancies associated with these elevations were hepatoma, germ cell tumors, Wilms' tumor, and carcinoma of unknown origin. Carcinoma metastatic to the liver was not associated with AFP elevations. In AFP-associated tumors they found serial measurements of serum AFP to be of value in assessing therapeutic response. (Auth.)

  15. Clinical Laboratory Fee Schedule

    Data.gov (United States)

    U.S. Department of Health & Human Services — Outpatient clinical laboratory services are paid based on a fee schedule in accordance with Section 1833(h) of the Social Security Act. The clinical laboratory fee...

  16. How does preclinical laboratory training impact physical examination skills during the first clinical year? A retrospective analysis of routinely collected objective structured clinical examination scores among the first two matriculating classes of a reformed curriculum in one Polish medical school.

    Science.gov (United States)

    Świerszcz, Jolanta; Stalmach-Przygoda, Agata; Kuźma, Marcin; Jabłoński, Konrad; Cegielny, Tomasz; Skrzypek, Agnieszka; Wieczorek-Surdacka, Ewa; Kruszelnicka, Olga; Chmura, Kaja; Chyrchel, Bernadeta; Surdacki, Andrzej; Nowakowski, Michał

    2017-09-01

    As a result of a curriculum reform launched in 2012 at our institution, preclinical training was shortened to 2 years instead of the traditional 3 years, creating additional incentives to optimise teaching methods. In accordance with the new curriculum, a semester-long preclinical module of clinical skills (CS) laboratory training takes place in the second year of study, while an introductory clinical course (ie, brief introductory clerkships) is scheduled for the Fall semester of the third year. Objective structured clinical examinations (OSCEs) are carried out at the conclusion of both the preclinical module and the introductory clinical course. Our aim was to compare the scores at physical examination stations between the first and second matriculating classes of a newly reformed curriculum on preclinical second-year OSCEs and early clinical third-year OSCEs. Analysis of routinely collected data. One Polish medical school. Complete OSCE records for 462 second-year students and 445 third-year students. OSCE scores by matriculation year. In comparison to the first class of the newly reformed curriculum, significantly higher (ie, better) OSCE scores were observed for those students who matriculated in 2013, a year after implementing the reformed curriculum. This finding was consistent for both second-year and third-year cohorts. Additionally, the magnitude of the improvement in median third-year OSCE scores was proportional to the corresponding advancement in preceding second-year preclinical OSCE scores for each of two different sets of physical examination tasks. In contrast, no significant difference was noted between the academic years in the ability to interpret laboratory data or ECG - tasks which had not been included in the second-year preclinical training. Our results suggest the importance of preclinical training in a CS laboratory to improve students' competence in physical examination at the completion of introductory clinical clerkships during

  17. Routine environmental audit of Ames Laboratory, Ames, Iowa

    International Nuclear Information System (INIS)

    1994-09-01

    This document contains the findings identified during the routine environmental audit of Ames Laboratory, Ames, Iowa, conducted September 12--23, 1994. The audit included a review of all Ames Laboratory operations and facilities supporting DOE-sponsored activities. The audit's objective is to advise the Secretary of Energy, through the Assistant Secretary for Environment, Safety and Health, as to the adequacy of the environmental protection programs established at Ames Laboratory to ensure the protection of the environment, and compliance with Federal, state, and DOE requirements

  18. Adiponectin as a routine clinical biomarker.

    Science.gov (United States)

    Kishida, Ken; Funahashi, Tohru; Shimomura, Iichiro

    2014-01-01

    Adiponectin is a protein synthesized and secreted predominantly by adipocytes into the peripheral blood. However, circulating adiponectin level is inversely related with body weight, especially visceral fat accumulation. The mechanism of this paradoxical relation remains obscure. Low circulating adiponectin concentrations (hypoadiponectinemia; osteoporosis, and cancer (endometrial cancer, postmenopausal breast cancer, leukemia, colon cancer, gastric cancer, prostate cancer). On the other hand, hyperadiponectinemia is associated with cardiac, renal and pulmonary diseases. This review article focuses on the significance of adiponectin as a clinical biomarker of obesity-related diseases. Routine measurement of adiponectin in patients with lifestyle-related diseases is highly recommended. Copyright © 2013 Elsevier Ltd. All rights reserved.

  19. Radiation dose monitoring in the clinical routine

    Energy Technology Data Exchange (ETDEWEB)

    Guberina, Nika [UK Essen (Germany). Radiology

    2017-04-15

    Here we describe the first clinical experiences regarding the use of an automated radiation dose management software to monitor the radiation dose of patients during routine examinations. Many software solutions for monitoring radiation dose have emerged in the last decade. The continuous progress in radiological techniques, new scan features, scanner generations and protocols are the primary challenge for radiation dose monitoring software systems. To simulate valid dose calculations, radiation dose monitoring systems have to follow current trends and stay constantly up-to-date. The dose management software is connected to all devices at our institute and conducts automatic data acquisition and radiation dose calculation. The system incorporates 18 virtual phantoms based on the Cristy phantom family, estimating doses in newborns to adults. Dose calculation relies on a Monte Carlo simulation engine. Our first practical experiences demonstrate that the software is capable of dose estimation in the clinical routine. Its implementation and use have some limitations that can be overcome. The software is promising and allows assessment of radiation doses, like organ and effective doses according to ICRP 60 and ICRP 103, patient radiation dose history and cumulative radiation doses. Furthermore, we are able to determine local diagnostic reference doses. The radiation dose monitoring software systems can facilitate networking between hospitals and radiological departments, thus refining radiation doses and implementing reference doses at substantially lower levels.

  20. ORIGINAL ARTICLES Assessment of routine laboratory screening of ...

    African Journals Online (AJOL)

    clinical examination rather than failing to perform blanket laboratory and radiological ... additional information to that obtained from a thorough history and clinical ... reviewed to determine the patient's diagnosis and management plan. ... system were considered not to have had laboratory investigations performed.

  1. Consolidated clinical microbiology laboratories.

    Science.gov (United States)

    Sautter, Robert L; Thomson, Richard B

    2015-05-01

    The manner in which medical care is reimbursed in the United States has resulted in significant consolidation in the U.S. health care system. One of the consequences of this has been the development of centralized clinical microbiology laboratories that provide services to patients receiving care in multiple off-site, often remote, locations. Microbiology specimens are unique among clinical specimens in that optimal analysis may require the maintenance of viable organisms. Centralized laboratories may be located hours from patient care settings, and transport conditions need to be such that organism viability can be maintained under a variety of transport conditions. Further, since the provision of rapid results has been shown to enhance patient care, effective and timely means for generating and then reporting the results of clinical microbiology analyses must be in place. In addition, today, increasing numbers of patients are found to have infection caused by pathogens that were either very uncommon in the past or even completely unrecognized. As a result, infectious disease specialists, in particular, are more dependent than ever on access to high-quality diagnostic information from clinical microbiology laboratories. In this point-counterpoint discussion, Robert Sautter, who directs a Charlotte, NC, clinical microbiology laboratory that provides services for a 40-hospital system spread over 3 states in the southeastern United States explains how an integrated clinical microbiology laboratory service has been established in a multihospital system. Richard (Tom) Thomson of the NorthShore University HealthSystem in Evanston, IL, discusses some of the problems and pitfalls associated with large-scale laboratory consolidation. Copyright © 2015, American Society for Microbiology. All Rights Reserved.

  2. Sequim Marine Research Laboratory routine environmental measurements during CY-1977

    International Nuclear Information System (INIS)

    Fix, J.J.; Blumer, P.J.

    1978-06-01

    Beginning in 1976, a routine environmental program was established at the Marine Research Laboratory (MRL) at Sequim, Washington. The program is intended to demonstrate the negligible impact of current MRL operations on the surrounding environs and to provide baseline data through which any cumulative impact could be detected. The sampling frequency is greater during the first 2 years of the program to provide sufficient initial information to allow reliable estimates of observed radionuclide concentrations and to construct a long-term sampling program. The program is designed, primarily, to determine levels of radioactivity present in selected biota in Sequim Bay. The biota were selected because of their presence near the laboratory and their capacity to concentrate trace elements. Other samples were obtained to determine the radionuclides in Sequim Bay and laboratory drinking water, as well as the ambient radiation exposure levels and surface deposition of fallout radionuclides for the laboratory area. Appendix A provides a summary of the analytical methods used. The present document includes data obtained during CY 1977 in addition to CY-1976 data published previously

  3. [Unnecessary routine laboratory tests in patients referred for surgical services].

    Science.gov (United States)

    Mata-Miranda, María del Pilar; Cano-Matus, Norberto; Rodriguez-Murrieta, Margarita; Guarneros-Zapata, Idalia; Ortiz, Mario

    2016-01-01

    To question the usefulness of the lab analysis considered routine testing for the identification of abnormalities in the surgical care. To determine the percentage of unnecessary laboratory tests in the preoperative assessment as well as to estimate the unnecessary expenses. A descriptive, cross-sectional study of patients referred for surgical evaluation between January 1st and March 31st 2013. The database of laboratory testing and electronic files were reviewed. Reference criteria from surgical services were compared with the tests requested by the family doctor. In 65% of the patients (n=175) unnecessary examinations were requested, 25% (n=68) were not requested the tests that they required, and only 10% of the patients were requested laboratory tests in accordance with the reference criteria (n=27). The estimated cost in unnecessary examinations was $1,129,552 in a year. The results were similar to others related to this theme, however, they had not been revised from the perspective of the first level of attention regarding the importance of adherence to the reference criteria which could prevent major expenditures. It is a priority for leaders and operational consultants in medical units to establish strategies and lines of action that ensure compliance with institutional policies so as to contain spending on comprehensive services, and which in turn can improve the medical care. Copyright © 2015 Academia Mexicana de Cirugía A.C. Published by Masson Doyma México S.A. All rights reserved.

  4. Routine environmental reaudit of the Argonne National Laboratory - West

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1996-04-01

    This report documents the results of the Routine Environmental Reaudit of the Argonne National Laboratory - West (ANL-W), Idaho Falls, Idaho. During this audit, the activities conducted by the audit team included reviews of internal documents and reports from previous audits and assessments; interviews with U.S. Department of Energy (DOE), U.S. Environmental Protection Agency (EPA), State of Idaho Department of Health and Welfare (IDHW), and DOE contractor personnel; and inspections and observations of selected facilities and operations. The onsite portion of the audit was conducted from October 11 to October 22, 1993, by the DOE Office of Environmental Audit (EH-24), located within the Office of Environment, Safety and Health (EH). DOE 5482.113, {open_quotes}Environment, Safety, and Health Appraisal Program,{close_quotes} established the mission of EH-24 to provide comprehensive, independent oversight of Department-wide environmental programs on behalf of the Secretary of Energy. The ultimate goal of EH-24 is enhancement of environmental protection and minimization of risk to public health and the environment. EH-24 accomplishes its mission by conducting systematic and periodic evaluations of the Department`s environmental programs within line organizations, and by utilizing supplemental activities that serve to strengthen self-assessment and oversight functions within program, field, and contractor organizations.

  5. Routine environmental reaudit of the Argonne National Laboratory - West

    International Nuclear Information System (INIS)

    1996-01-01

    This report documents the results of the Routine Environmental Reaudit of the Argonne National Laboratory - West (ANL-W), Idaho Falls, Idaho. During this audit, the activities conducted by the audit team included reviews of internal documents and reports from previous audits and assessments; interviews with U.S. Department of Energy (DOE), U.S. Environmental Protection Agency (EPA), State of Idaho Department of Health and Welfare (IDHW), and DOE contractor personnel; and inspections and observations of selected facilities and operations. The onsite portion of the audit was conducted from October 11 to October 22, 1993, by the DOE Office of Environmental Audit (EH-24), located within the Office of Environment, Safety and Health (EH). DOE 5482.113, open-quotes Environment, Safety, and Health Appraisal Program,close quotes established the mission of EH-24 to provide comprehensive, independent oversight of Department-wide environmental programs on behalf of the Secretary of Energy. The ultimate goal of EH-24 is enhancement of environmental protection and minimization of risk to public health and the environment. EH-24 accomplishes its mission by conducting systematic and periodic evaluations of the Department's environmental programs within line organizations, and by utilizing supplemental activities that serve to strengthen self-assessment and oversight functions within program, field, and contractor organizations

  6. Modern clinical laboratory diagnostics

    International Nuclear Information System (INIS)

    Balakhovskij, I.S.

    1986-01-01

    Laboratory diagnosis is auxillary medical discipline studying specific laboratory symptoms of diseases, revealed by investigations of materials taken from patients. The structure of laboratory servie in our country and abroad, items of laboratory investigations, organizational principles are described. Attention is being given to the cost of analyses, the amount of conducted investigations, methods of result presentation, problems of accuracy, quality control and information content

  7. Diagnosis of antiphospholipid syndrome in routine clinical practice

    Science.gov (United States)

    Hills, J; Machin, SJ; Cohen, H

    2013-01-01

    The updated international consensus criteria for definite antiphospholipid syndrome (APS) are useful for scientific clinical studies. However, there remains a need for diagnostic criteria for routine clinical use. We audited the results of routine antiphospholipid antibodies (aPLs) in a cohort of 193 consecutive patients with aPL positivity-based testing for lupus anticoagulant (LA), IgG and IgM anticardiolipin (aCL) and anti-ß2glycoprotein-1 antibodies (aß2GPI). Medium/high-titre aCL/aβ2GPI was defined as >99th percentile. Low-titre aCL/aβ2GPI positivity (>95th < 99th percentile) was considered positive for obstetric but not for thrombotic APS. One hundred of the 145 patients fulfilled both clinical and laboratory criteria for definite APS. Twenty-six women with purely obstetric APS had persistent low-titre aCL and/or aβ2GPI. With the inclusion of these patients, 126 of the 145 patients were considered to have APS. Sixty-seven out of 126 patients were LA-negative, of whom 12 had aCL only, 37 had aβ2GPI only and 18 positive were for both. The omission of aCL or aβ2GPI testing from investigation of APS would have led to a failure to diagnose APS in 9.5% and 29.4% of patients, respectively. Our data suggest that LA, aCL and aβ2GPI testing are all required for the accurate diagnosis of APS and that low-titre antibodies should be included in the diagnosis of obstetric APS. PMID:22988029

  8. Fasting is not routinely required for determination of a lipid profile: clinical and laboratory implications including flagging at desirable concentration cut-points—a joint consensus statement from the European Atherosclerosis Society and European Federation of Clinical Chemistry and Laboratory Medicine

    Science.gov (United States)

    Nordestgaard, Børge G.; Langsted, Anne; Mora, Samia; Kolovou, Genovefa; Baum, Hannsjörg; Bruckert, Eric; Watts, Gerald F.; Sypniewska, Grazyna; Wiklund, Olov; Borén, Jan; Chapman, M. John; Cobbaert, Christa; Descamps, Olivier S.; von Eckardstein, Arnold; Kamstrup, Pia R.; Pulkki, Kari; Kronenberg, Florian; Remaley, Alan T.; Rifai, Nader; Ros, Emilio; Langlois, Michel

    2016-01-01

    Abstract Aims To critically evaluate the clinical implications of the use of non-fasting rather than fasting lipid profiles and to provide guidance for the laboratory reporting of abnormal non-fasting or fasting lipid profiles. Methods and results Extensive observational data, in which random non-fasting lipid profiles have been compared with those determined under fasting conditions, indicate that the maximal mean changes at 1–6 h after habitual meals are not clinically significant [+0.3 mmol/L (26 mg/dL) for triglycerides; −0.2 mmol/L (8 mg/dL) for total cholesterol; −0.2 mmol/L (8 mg/dL) for LDL cholesterol; +0.2 mmol/L (8 mg/dL) for calculated remnant cholesterol; −0.2 mmol/L (8 mg/dL) for calculated non-HDL cholesterol]; concentrations of HDL cholesterol, apolipoprotein A1, apolipoprotein B, and lipoprotein(a) are not affected by fasting/non-fasting status. In addition, non-fasting and fasting concentrations vary similarly over time and are comparable in the prediction of cardiovascular disease. To improve patient compliance with lipid testing, we therefore recommend the routine use of non-fasting lipid profiles, while fasting sampling may be considered when non-fasting triglycerides >5 mmol/L (440 mg/dL). For non-fasting samples, laboratory reports should flag abnormal concentrations as triglycerides ≥2 mmol/L (175 mg/dL), total cholesterol ≥5 mmol/L (190 mg/dL), LDL cholesterol ≥3 mmol/L (115 mg/dL), calculated remnant cholesterol ≥0.9 mmol/L (35 mg/dL), calculated non-HDL cholesterol ≥3.9 mmol/L (150 mg/dL), HDL cholesterol ≤1 mmol/L (40 mg/dL), apolipoprotein A1 ≤1.25 g/L (125 mg/dL), apolipoprotein B ≥1.0 g/L (100 mg/dL), and lipoprotein(a) ≥50 mg/dL (80th percentile); for fasting samples, abnormal concentrations correspond to triglycerides ≥1.7 mmol/L (150 mg/dL). Life-threatening concentrations require separate referral when triglycerides >10 mmol/L (880 mg/dL) for the risk of pancreatitis, LDL cholesterol >13 mmol/L (500 mg

  9. COMMERCIALLY ORIENTED CLINICAL LABORATORIES

    Science.gov (United States)

    Chapman, W. Max

    1964-01-01

    Out-of-state flat-rate mail order contract laboratories operating from states which have little or no legal control over them can do business in California without obedience to regulations that govern laboratories located within the state. The flat-rate contract principle under which some out-of-state laboratories operate is illegal in California. The use of such laboratories increases physician liability. Legislation for the control of these laboratories is difficult to construct, and laws which might result would be awkward to administer. The best remedy is for California physicians not to use an out-of-state laboratory offering contracts or conditions that it could not legally offer if it were located in California. PMID:14165875

  10. National survey on intra-laboratory turnaround time for some most common routine and stat laboratory analyses in 479 laboratories in China.

    Science.gov (United States)

    Fei, Yang; Zeng, Rong; Wang, Wei; He, Falin; Zhong, Kun; Wang, Zhiguo

    2015-01-01

    To investigate the state of the art of intra-laboratory turnaround time (intra-TAT), provide suggestions and find out whether laboratories accredited by International Organization for Standardization (ISO) 15189 or College of American Pathologists (CAP) will show better performance on intra-TAT than non-accredited ones. 479 Chinese clinical laboratories participating in the external quality assessment programs of chemistry, blood gas, and haematology tests organized by the National Centre for Clinical Laboratories in China were included in our study. General information and the median of intra-TAT of routine and stat tests in last one week were asked in the questionnaires. The response rate of clinical biochemistry, blood gas, and haematology testing were 36% (479/1307), 38% (228/598), and 36% (449/1250), respectively. More than 50% of laboratories indicated that they had set up intra-TAT median goals and almost 60% of laboratories declared they had monitored intra-TAT generally for every analyte they performed. Among all analytes we investigated, the intra-TAT of haematology analytes was shorter than biochemistry while the intra-TAT of blood gas analytes was the shortest. There were significant differences between median intra-TAT on different days of the week for routine tests. However, there were no significant differences in median intra-TAT reported by accredited laboratories and non-accredited laboratories. Many laboratories in China are aware of intra-TAT control and are making effort to reach the target. There is still space for improvement. Accredited laboratories have better status on intra-TAT monitoring and target setting than the non-accredited, but there are no significant differences in median intra-TAT reported by them.

  11. Prevalence of estimated GFR reporting among US clinical laboratories.

    Science.gov (United States)

    Accetta, Nancy A; Gladstone, Elisa H; DiSogra, Charles; Wright, Elizabeth C; Briggs, Michael; Narva, Andrew S

    2008-10-01

    Routine laboratory reporting of estimated glomerular filtration rate (eGFR) may help clinicians detect kidney disease. The current national prevalence of eGFR reporting in clinical laboratories is unknown; thus, the extent of the situation of laboratories not routinely reporting eGFR with serum creatinine results is not quantified. Observational analysis. National Kidney Disease Education Program survey of clinical laboratories conducted in 2006 to 2007 by mail, web, and telephone follow-up. A national random sample, 6,350 clinical laboratories, drawn from the Federal Clinical Laboratory Improvement Amendments database and stratified by 6 major laboratory types/groupings. Laboratory reports serum creatinine results. Reporting eGFR values with serum creatinine results. Percentage of laboratories reporting eGFR along with reporting serum creatinine values, reporting protocol, eGFR formula used, and style of reporting cutoff values. Of laboratories reporting serum creatinine values, 38.4% report eGFR (physician offices, 25.8%; hospitals, 43.6%; independents, 38.9%; community clinics, 47.2%; health fair/insurance/public health, 45.5%; and others, 43.2%). Physician office laboratories have a reporting prevalence lower than other laboratory types (P laboratories reporting eGFR, 66.7% do so routinely with all adult serum creatinine determinations; 71.6% use the 4-variable Modification of Diet in Renal Disease Study equation; and 45.3% use the ">60 mL/min/1.73 m(2)" reporting convention. Independent laboratories are least likely to routinely report eGFR (50.6%; P laboratories across all strata are more likely to report eGFR (P laboratories, federal database did not have names of laboratory directors/managers (intended respondents), assumed accuracy of federal database for sample purposes. Routine eGFR reporting with serum creatinine values is not yet universal, and laboratories vary in their reporting practices.

  12. Circulating tumor cell isolation and diagnostics: toward routine clinical use

    NARCIS (Netherlands)

    Stolpe, van de A.; Pantel, K.; Sleijfer, S.; Terstappen, L.W.; Toonder, den J.M.J.

    2011-01-01

    From February 7–11, 2011, the multidisciplinary Lorentz Workshop Circulating Tumor Cell (CTC) Isolation and Diagnostics: Toward Routine Clinical Use was held in Leiden (The Netherlands) to discuss progress and define challenges and potential solutions for development of clinically useful circulating

  13. How to isolate, identify and determine antimicrobial susceptibility of anaerobic bacteria in routine laboratories?

    Science.gov (United States)

    Nagy, E; Boyanova, L; Justesen, U S

    2018-02-17

    There has been increased interest in the study of anaerobic bacteria that cause human infection during the past decade. Many new genera and species have been described using 16S rRNA gene sequencing of clinical isolates obtained from different infection sites with commercially available special culture media to support the growth of anaerobes. Several systems, such as anaerobic pouches, boxes, jars and chambers provide suitable anaerobic culture conditions to isolate even strict anaerobic bacteria successfully from clinical specimens. Beside the classical, time-consuming identification methods and automated biochemical tests, the use of matrix-assisted laser desorption/ionization time-of-flight mass spectrometry has revolutionized identification of even unusual and slow-growing anaerobes directly from culture plates, providing the possibility of providing timely information about anaerobic infections. The aim of this review article is to present methods for routine laboratories, which carry out anaerobic diagnostics on different levels. Relevant data from the literature mostly published during the last 7 years are encompassed and discussed. The review involves topics on the anaerobes that are members of the commensal microbiota and their role causing infection, the key requirements for collection and transport of specimens, processing of specimens in the laboratory, incubation techniques, identification and antimicrobial susceptibility testing of anaerobic bacteria. Advantages, drawbacks and specific benefits of the methods are highlighted. The present review aims to update and improve anaerobic microbiology in laboratories with optimal conditions as well as encourage its routine implementation in laboratories with restricted resources. Copyright © 2018 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

  14. Sequim Marine Research Laboratory routine environmental measurements during CY-1978

    International Nuclear Information System (INIS)

    Houston, J.R.; Blumer, P.J.

    1979-03-01

    Environmental data collected during 1978 in the vicinity of the Marine Research Laboratory show continued compliance with all applicable state and federal regulations and furthermore show no detectable change from conditions that existed in previous years. Samples collected for radiological analysis included soil, drinking water, bay water, clams, and seaweed. Radiation dose rates at 1 meter aboveground were also measured

  15. Radiographic demonstration of small intestinal villi on routine clinical studies

    International Nuclear Information System (INIS)

    Gelfand, D.W.; Ott, D.J.

    1981-01-01

    The radiographic demonstration of the small intestinal villi is reported. The villi were demonstrable with both single- and double-contrast methods on routine clinical studies. The primary requirement for their delineation appears to be employment of a high-resolution radiographic system. (orig.) [de

  16. A new generation videokymography for routine clinical vocal fold examination

    NARCIS (Netherlands)

    Qiu, Qingjun; Schutte, Harm K.

    2006-01-01

    Objective. This study aims to introduce a new-generation videokymographic system, which provides simultaneous laryngoscopic and kymographic image, for routine clinical vocal fold examination. Study Design: The authors explored a new imaging method for diagnosis and evaluation of voice disorders.

  17. Stratification of type 2 diabetes based on routine clinical markers

    DEFF Research Database (Denmark)

    Safai, Narges; Ali, Ashfaq; Rossing, Peter

    2018-01-01

    AIMS: We hypothesized that patients with dysregulated type 2 diabetes may be stratified based on routine clinical markers. METHODS: In this retrospective cohort study, diabetes related clinical measures including age at onset, diabetes duration, HbA1c, BMI, HOMA2-β, HOMA2-IR and GAD65...... autoantibodies, were used for sub-grouping patients by K-means clustering and for adjusting. Probability of diabetes complications (95% confidence interval), were calculated using logistic regression. RESULTS: Based on baseline data from patients with type 2 diabetes (n=2,290), the cluster analysis suggested up....... CONCLUSIONS: Patients with type 2 diabetes cluster into clinically relevant sub-groups based on routine clinical markers. The prevalence of diabetes complications seems to be sub-group specific. Our data suggests the need for a tailored strategy for the treatment of type 2 diabetes....

  18. Routine pharmacogenetic testing in clinical practice: dream or reality?

    Science.gov (United States)

    Grossman, Iris

    2007-10-01

    Pharmacogenetics (PGx) has become progressively popular in recent years, thanks to growing anticipation among scientists, healthcare providers and the general public for the incorporation of genetic tests into the diagnostic arsenal at the physician's disposal. Indeed, much research has been dedicated to elucidation of genetic determinants underlying interindividual variability in pharmacokinetic parameters, as well as drug safety and efficacy. However, few PGx applications have thus far been realized in healthcare management. This review uses examples from PGx research of psychiatric drugs to illustrate why the current published findings are inadequate and insufficient for utilization as routine clinical predictors of treatment safety, efficacy or dosing. I therefore suggest the necessary steps to demonstrate the validity, utility and cost-effectiveness of PGx. These recommendations include a whole range of aspects, starting from standardization of criteria and assessment of the technical quality of genotyping assays, up to design of prospective PGx studies, providing the basis for reimbursement programs to be recognized in routine clinical practice.

  19. [Outsourcing of clinical laboratory department].

    Science.gov (United States)

    Murai, T

    2000-03-01

    Recently, to improve financial difficulties at various hospitals, outsourcing of the laboratory department is be coming more wide spread. At the department of clinical pathology of St. Luke's International Hospital, the system, so called, "Branch labo" which is one of the outsourcing laboratory conditions, was adopted in March 1999. In this reports. We described the decision procedure for accepting the situation and the circumstances of operation.

  20. Clinical laboratory accreditation in India.

    Science.gov (United States)

    Handoo, Anil; Sood, Swaroop Krishan

    2012-06-01

    Test results from clinical laboratories must ensure accuracy, as these are crucial in several areas of health care. It is necessary that the laboratory implements quality assurance to achieve this goal. The implementation of quality should be audited by independent bodies,referred to as accreditation bodies. Accreditation is a third-party attestation by an authoritative body, which certifies that the applicant laboratory meets quality requirements of accreditation body and has demonstrated its competence to carry out specific tasks. Although in most of the countries,accreditation is mandatory, in India it is voluntary. The quality requirements are described in standards developed by many accreditation organizations. The internationally acceptable standard for clinical laboratories is ISO15189, which is based on ISO/IEC standard 17025. The accreditation body in India is the National Accreditation Board for Testing and Calibration Laboratories, which has signed Mutual Recognition Agreement with the regional cooperation the Asia Pacific Laboratory Accreditation Cooperation and with the apex cooperation the International Laboratory Accreditation Cooperation.

  1. Routine clinical application of virtual reality in abdominal surgery.

    Science.gov (United States)

    Sampogna, Gianluca; Pugliese, Raffaele; Elli, Marco; Vanzulli, Angelo; Forgione, Antonello

    2017-06-01

    The advantages of 3D reconstruction, immersive virtual reality (VR) and 3D printing in abdominal surgery have been enunciated for many years, but still today their application in routine clinical practice is almost nil. We investigate their feasibility, user appreciation and clinical impact. Fifteen patients undergoing pancreatic, hepatic or renal surgery were studied realizing a 3D reconstruction of target anatomy. Then, an immersive VR environment was developed to import 3D models, and some details of the 3D scene were printed. All the phases of our workflow employed open-source software and low-cost hardware, easily implementable by other surgical services. A qualitative evaluation of the three approaches was performed by 20 surgeons, who filled in a specific questionnaire regarding a clinical case for each organ considered. Preoperative surgical planning and intraoperative guidance was feasible for all patients included in the study. The vast majority of surgeons interviewed scored their quality and usefulness as very good. Despite extra time, costs and efforts necessary to implement these systems, the benefits shown by the analysis of questionnaires recommend to invest more resources to train physicians to adopt these technologies routinely, even if further and larger studies are still mandatory.

  2. The prevalence of adrenal incidentaloma in routine clinical practice.

    LENUS (Irish Health Repository)

    Davenport, Colin

    2011-03-10

    The prevalence of adrenal incidentaloma (AI) on computed tomography (CT) in the general population has been reported to be as high as 4.2%. However, many of the previous studies in this field utilised a prospective approach with analysis of CT scans performed by one or more radiologists with a specialist interest in adrenal tumours and a specific focus on identifying the presence of an adrenal mass. A typical radiology department, with a focus on the patient\\'s presenting complaint as opposed to the adrenal gland, may not be expected to diagnose as many adrenal incidentalomas as would be identified in a dedicated research protocol. We hypothesised that the number of AI reported in routine clinical practice is significantly lower than the published figures would suggest. We retrospectively reviewed the reports of all CT thorax and abdomen scans performed in our hospital over a 2 year period. 3,099 patients underwent imaging, with 3,705 scans performed. The median age was 63 years (range 18-98). Thirty-seven true AI were diagnosed during the time period studied. Twenty-two were diagnosed by CT abdomen (22\\/2,227) and 12 by CT thorax (12\\/1,478), a prevalence of 0.98 and 0.81% with CT abdomen and thorax, respectively, for AI in routine clinical practice.

  3. The prevalence of adrenal incidentaloma in routine clinical practice.

    LENUS (Irish Health Repository)

    Davenport, Colin

    2012-02-01

    The prevalence of adrenal incidentaloma (AI) on computed tomography (CT) in the general population has been reported to be as high as 4.2%. However, many of the previous studies in this field utilised a prospective approach with analysis of CT scans performed by one or more radiologists with a specialist interest in adrenal tumours and a specific focus on identifying the presence of an adrenal mass. A typical radiology department, with a focus on the patient\\'s presenting complaint as opposed to the adrenal gland, may not be expected to diagnose as many adrenal incidentalomas as would be identified in a dedicated research protocol. We hypothesised that the number of AI reported in routine clinical practice is significantly lower than the published figures would suggest. We retrospectively reviewed the reports of all CT thorax and abdomen scans performed in our hospital over a 2 year period. 3,099 patients underwent imaging, with 3,705 scans performed. The median age was 63 years (range 18-98). Thirty-seven true AI were diagnosed during the time period studied. Twenty-two were diagnosed by CT abdomen (22\\/2,227) and 12 by CT thorax (12\\/1,478), a prevalence of 0.98 and 0.81% with CT abdomen and thorax, respectively, for AI in routine clinical practice.

  4. COPD management: role of symptom assessment in routine clinical practice

    Science.gov (United States)

    van der Molen, Thys; Miravitlles, Marc; Kocks, Janwillem WH

    2013-01-01

    Patients with chronic obstructive pulmonary disease (COPD) present with a variety of symptoms that significantly impair health-related quality of life. Despite this, COPD treatment and its management are mainly based on lung function assessments. There is increasing evidence that conventional lung function measures alone do not correlate well with COPD symptoms and their associated impact on patients’ everyday lives. Instead, symptoms should be assessed routinely, preferably by using patient-centered questionnaires that provide a more accurate guide to the actual burden of COPD. Numerous questionnaires have been developed in an attempt to find a simple and reliable tool to use in everyday clinical practice. In this paper, we review three such patient-reported questionnaires recommended by the latest Global Initiative for Chronic Obstructive Lung Disease guidelines, ie, the modified Medical Research Council questionnaire, the clinical COPD questionnaire, and the COPD Assessment Test, as well as other symptom-specific questionnaires that are currently being developed. PMID:24143085

  5. Preanalytical quality in clinical chemistry laboratory.

    Science.gov (United States)

    Ahmad, M Imteyaz; Ramesh, K L; Kumar, Ravi

    2014-01-01

    Haemolysis is usually caused by inadequate specimen collection or preanalytical handling and is suggested to be a suitable indicator of preanalytical quality. We investigated the prevalence of detectable haemolysis in all routine venous blood samples in OPDs and IPDs to identify differences in preanalytical quality. Haemolysis index (HI) values were obtained from a Vitros 5,1 in the routine clinical chemistry laboratory for samples collected in the outpatient department (OPD) collection centres, a hospital, and inpatient departments (IPD). Haemolysis was defined as a HI > or = 15 (detection limit). Samples from the OPD with the highest prevalence of haemolysis were 6.1 times (95% confidence interval (CI) 4.0 - 9.2) more often haemolysed compared to the center with the lowest prevalence. Of the samples collected in primary health care, 10.4% were haemolysed compared to 31.1% in the IPDs (p = 0.001). A notable difference in haemolysed samples was found between the IPDs section staffed by emergency medicine physicians and the section staffed by primary health care physicians (34.8% vs. 11.3%, p = 0.001). The significant variation in haemolysis indices among the investigated units is likely to reflect varying preanalytical conditions. The HI is a valuable tool for estimation and follow-up of preanalytical quality in the health care laboratory.

  6. Are we overlooking infections owing to non-tuberculous mycobacteria during routine conventional laboratory investigations?

    Directory of Open Access Journals (Sweden)

    Kushal Garima

    2012-01-01

    Full Text Available A large number of potentially pathogenic non-tuberculous mycobacteria (NTM encountered in the clinical laboratory makes it necessary to identify their species to ensure appropriate treatment. However, labor-intensive conventional methods of speciation are not used in every laboratory, and hence NTM infections are often ignored. Polymerase chain reaction (PCR restriction analysis (PRA was applied in this study for early identification and speciation of mycobacterial species on 306 cultures of acid-fast bacilli isolated from patients suspected of suffering from tuberculosis. Mycobacterium tuberculosis was identified in 85.6% of the isolates. The NTM isolated most commonly was Mycobacterium kansasii/gastri group (3.5%, followed by Mycobacterium fortuitum (3.2%. Four of the M. fortuitum were grown from cultures obtained on the same day, but from samples from different patients and were probably laboratory contaminants. Mycobacterium intracellulare and Mycobacterium avium were identified in 2.94% and 2.28% of the isolates, respectively. Three isolates of M. avium and two isolates of M. intracellulare were obtained in repeated cultures from sputum samples of the same patients and were thus pathogenic. A single isolate of Mycobacterium abscessus was obtained from a breast abscess. A rare pathogen Mycobacterium phocaicum was isolated from one patient with epididymitis. However, whether it was the causative agent of epididymitis in this patient remains doubtful. The results of this study highlight the importance of speciation of mycobacteria for appropriate diagnosis and the importance of including molecular assays to augment conventional methods of diagnosis of mycobacterial diseases for rapid identification of NTM so that these potential pathogens are not overlooked in routine diagnostic procedures.

  7. Influence of a prolonged fasting and mild activity on routine laboratory tests.

    Science.gov (United States)

    Šupak-Smolčić, Vesna; Antončić, Dragana; Ožanić, Doris; Vladilo, Ivana; Bilić-Zulle, Lidija

    2015-01-01

    Despite the standardization of the phlebotomy procedure, blood analysis is occasionally requested after recommended hours with the excuse that the patient is still fasting. We aimed to examine the influence of prolonged fasting and mild physical activity on routine laboratory tests. The study was conducted on 30 volunteers (27 female) median age 40y (20-59). Blood samples were taken in the morning (7:00-8:00a.m.) and early afternoon (1:00-2:00p.m.) after prolonged fasting and usual daily activities. Serum glucose (GLU), urea, creatinine, triglyceride, uric acid (UA), iron and electrolytes were analyzed on Roche cobas 6000 c501 and complete blood count on Siemens ADVIA 2120i. Statistical significance between the two measurements was tested using paired t-test or Wilcoxon test according to data distribution. Clinical significance was judged against calculated reference change values (RCV). A statistically significant decrease was found for red blood cell count, hemoglobin, hematocrit, mean corpuscular volume (MCV), GLU, urea, creatinine, triglycerides and electrolytes, whereas white blood cell count and iron were significantly increased. Judging against desirable bias derived from biological variation, a significant change was found for all the analytes except MCV, platelet count, UA and triglycerides. A clinically significant change was not found for any of the tested analytes when compared to RCV. Prolonged fasting and mild activity will not influence the medical decision for healthy subjects with normal results. Despite the present statistically significant change, the clinically significant change was not shown. However, the study did not include pathological results which have to be interpreted more carefully. Copyright © 2014 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

  8. Gamification of Clinical Routine: The Dr. Fill Approach.

    Science.gov (United States)

    Bukowski, Mark; Kühn, Martin; Zhao, Xiaoqing; Bettermann, Ralf; Jonas, Stephan

    2016-01-01

    Gamification is used in clinical context in the health care education. Furthermore, it has shown great promises to improve the performance of the health care staff in their daily routine. In this work we focus on the medication sorting task, which is performed manually in hospitals. This task is very error prone and needs to be performed daily. Nevertheless, errors in the medication are crucial and lead to serious complications. In this work we present a real world gamification approach of the medication sorting task in a patient's daily pill organizer. The player of the game needs to sort the correct medication into the correct dispenser slots and is rewarded or punished in real time. At the end of the game, a score is given and the user can register in a leaderboard.

  9. Toshiba General Hospital PACS for routine in- and outpatient clinics

    Science.gov (United States)

    Toshimitsu, Akihiro; Okazaki, Nobuo; Kura, Hiroyuki; Nishihara, Eitaro; Tsubura, Shinichi

    1996-05-01

    The Toshiba General Hospital introduced a departmental RIS/PACS (Radiology Information System/Picture Archiving and Communication System) in the radiology department in May, 1993. It has been used routinely since that time. In order to provide efficient means for clinicians to find and read many images, the system has been expanded to the neurosurgery and urology clinics and wards since May, 1995, and five image referring workstations now provide digital images to clinicians. In this paper we discuss an algorithm for image migration, one of the key issues to accomplish the expansion to outpatient clinics successfully, and propose the WYWIWYG (what you want is what you get) image transfer logic. This is the logic used to transfer images that physicians require refer without increasing the traffic between the image server and referring workstations. We accomplish the WYWIWYG logic by prioritizing exams the physicians have not yet viewed and by finding historical exams according to the modality, anatomy, and marking. Clinicians gave us comments from their first use of the system and suggested that the PACS enables clinicians to review images more efficiently compared to a film-based system. Our experience suggests that it is a key to the effective application of PACS in outpatient clinics to incorporate consideration patterns of clinicians on the migration algorithm.

  10. Clinical Laboratory Tests in Some Acute Exogenous Poisonings.

    Science.gov (United States)

    Tufkova, Stoilka G; Yankov, Ivan V; Paskaleva, Diana A

    2017-09-01

    There is no specific toxicological screening of clinical laboratory parameters in clinical toxicology when it comes to acute exogenous poisoning. To determine routine clinical laboratory parameters and indicators for assessment of vital functions in patients with acute intoxications. One hundred and fifty-three patients were included in the present study. They were hospitalized in the Department of Clinical Toxicology at St. George University Hospital, Plovdiv for cerebral toxicity inducing medication (n = 45), alcohol (n = 40), heroin abuse (n = 33). The controls were 35. The laboratory tests were conducted in compliance with the standards of the clinical laboratory. We used the following statistical analyses: analysis of variance (the ucriterion of normal distribution, the Student's t-test, dispersion analysis based on ANOVA) and non-parametric analysis. Based on the routine hematological parameters with statistically significant changes in three groups of poisoning are: red blood cells, hematocrit, hemoglobin (except alcohol intoxication) and leukocytes. We found statistically significant changes in serum total protein, sodium and bilirubin. The highest statistical significance is the increased activity of AST and ALT. We present a model for selection of clinical laboratory tests for severe acute poisoning with modern equipment under standardized conditions. The results of the study suggest that the clinical laboratory constellation we used can be used as a mandatory element in the diagnosis of moderate and severe intoxication with the mentioned toxic substances.

  11. Outsourcing of Academic Clinical Laboratories

    Science.gov (United States)

    Mrak, Robert E.; Parslow, Tristram G.; Tomaszewski, John E.

    2018-01-01

    American hospitals are increasingly turning to service outsourcing to reduce costs, including laboratory services. Studies of this practice have largely focused on nonacademic medical centers. In contrast, academic medical centers have unique practice environments and unique mission considerations. We sought to elucidate and analyze clinical laboratory outsourcing experiences in US academic medical centers. Seventeen chairs of pathology with relevant experience were willing to participate in in-depth interviews about their experiences. Anticipated financial benefits from joint venture arrangements often eroded after the initial years of the agreement, due to increased test pricing, management fees, duplication of services in support of inpatients, and lack of incentive for utilization control on the part of the for-profit partner. Outsourcing can preclude development of lucrative outreach programs; such programs were successfully launched in several cases after joint ventures were either avoided or terminated. Common complaints included poor test turnaround time and problems with test quality (especially in molecular pathology, microbiology, and flow cytometry), leading to clinician dissatisfaction. Joint ventures adversely affected retention of academically oriented clinical pathology faculty, with adverse effects on research and education, which further exacerbated clinician dissatisfaction due to lack of available consultative expertise. Resident education in pathology and in other disciplines (especially infectious disease) suffered both from lack of on-site laboratory capabilities and from lack of teaching faculty. Most joint ventures were initiated with little or no input from pathology leadership, and input from pathology leadership was seen to have been critical in those cases where such arrangements were declined or terminated. PMID:29637086

  12. Authentication scheme for routine verification of genetically similar laboratory colonies: a trial with Anopheles gambiae

    Directory of Open Access Journals (Sweden)

    Sutcliffe Alice C

    2009-10-01

    Full Text Available Abstract Background When rearing morphologically indistinguishable laboratory strains concurrently, the threat of unintentional genetic contamination is constant. Avoidance of accidental mixing of strains is difficult due to the use of common equipment, technician error, or the possibility of self relocation by adult mosquitoes ("free fliers". In many cases, laboratory strains are difficult to distinguish because of morphological and genetic similarity, especially when laboratory colonies are isolates of certain traits from the same parental strain, such as eye color mutants, individuals with certain chromosomal arrangements or high levels of insecticide resistance. Thus, proving genetic integrity could seem incredibly time-consuming or impossible. On the other hand, lacking proof of genetically isolated laboratory strains could question the validity of research results. Results We present a method for establishing authentication matrices to routinely distinguish and confirm that laboratory strains have not become physically or genetically mixed through contamination events in the laboratory. We show a specific example with application to Anopheles gambiae sensu stricto strains at the Malaria Research and Reference Reagent Resource Center. This authentication matrix is essentially a series of tests yielding a strain-specific combination of results. Conclusion These matrix-based methodologies are useful for several mosquito and insect populations but must be specifically tailored and altered for each laboratory based on the potential contaminants available at any given time. The desired resulting authentication plan would utilize the least amount of routine effort possible while ensuring the integrity of the strains.

  13. COPD management: role of symptom assessment in routine clinical practice

    Directory of Open Access Journals (Sweden)

    van der Molen T

    2013-10-01

    Full Text Available Thys van der Molen,1,2 Marc Miravitlles,3 Janwillem WH Kocks1,21Department of General Practice, 2GRIAC (Groningen Research Institute for Asthma and COPD, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands; 3Pneumology Department, Hospital Universitari Vall d'Hebron, Biomedical Research Networking Centre in Respiratory Diseases (CIBERES, Barcelona, SpainAbstract: Patients with chronic obstructive pulmonary disease (COPD present with a variety of symptoms that significantly impair health-related quality of life. Despite this, COPD treatment and its management are mainly based on lung function assessments. There is increasing evidence that conventional lung function measures alone do not correlate well with COPD symptoms and their associated impact on patients' everyday lives. Instead, symptoms should be assessed routinely, preferably by using patient-centered questionnaires that provide a more accurate guide to the actual burden of COPD. Numerous questionnaires have been developed in an attempt to find a simple and reliable tool to use in everyday clinical practice. In this paper, we review three such patient-reported questionnaires recommended by the latest Global Initiative for Chronic Obstructive Lung Disease guidelines, ie, the modified Medical Research Council questionnaire, the clinical COPD questionnaire, and the COPD Assessment Test, as well as other symptom-specific questionnaires that are currently being developed.Keywords: chronic obstructive pulmonary disease, symptoms, questionnaires

  14. Site study plan for routine laboratory rock mechanics, Deaf Smith County Site, Texas: Revision 1

    International Nuclear Information System (INIS)

    1987-12-01

    This Site Study Plan for Routine Laboratory Rock Mechanics describes routine laboratory testing to be conducted on rock samples collected as part of the characterization of the Deaf Smith County site, Texas. This study plan describes the early laboratory testing. Additional testing may be required and the type and scope of testing will be dependent upon the results of the early testing. This study provides for measurements of index, hydrological, mechanical, and chemical properties with tests which are standardized and used widely in geotechnical investigations. Another Site Study Plan for Nonroutine Laboratory Rock Mechanics describes laboratory testing of samples from the site to determine mechanical, thermomechanical, and thermal properties by less widely used methods, many of which have been developed specifically for characterization of the site. Data from laboratory tests will be used for characterization of rock strata, design of shafts and underground facilities, and modeling of repository behavior in support of resolution of both preclosure and postclosure issues. A tentative testing schedule and milestone log are given. A quality assurance program will be utilized to assure that activities affecting quality are performed correctly and that appropriate documentation is maintained. 18 refs., 8 figs., 3 tabs

  15. Routine clinical use of radiopharmaceuticals in Latin American developing countries

    International Nuclear Information System (INIS)

    Mitta, A.E.

    1985-01-01

    The paper describes the routine clinical use of radiopharmaceuticals in the developing countries of Latin America made possible by: (1) the International Atomic Energy Agency (IAEA), which sent experts and equipment to many countries and made a substantial bibliographic contribution on the subject; (2) the Latin American Association of Societies of Nuclear Biology and Medicine (ALASBIMN), which fostered the exchange of data on techniques of radiopharmaceutical preparation and quality control by providing materials for tests, etc., and by publishing quality control manuals in some countries, finally in 1982 producing the Manual of Radiopharmaceutical Quality Control, in collaboration with the Inter-American Nuclear Energy Commission (CIEN) and published by the Organization of American States (OAS); (3) the countries themselves under agreements between their atomic energy commissions; (4) radiopharmacy courses organized by universities, either alone or in collaboration with the IAEA, WHO, etc.; (5) professional workers who established radiopharmaceutical services at private centres. Finally, the societies of nuclear medicine and biology in each country, the World Federation of Nuclear Medicine and Biology, the ALASBIMN, the IAEA, etc. organized symposia and meetings which afforded opportunities to professionals of these countries to receive and exchange information, since in Latin America, given its language and human characteristics, the problems are similar. The countries referred to are Argentina, Brazil, Mexico, Uruguay, Bolivia, Paraguay, Chile, Peru, Ecuador, Colombia, Venezuela, Costa Rica, Guatemala, Puerto Rico, El Salvador and Panama; little is known about Honduras, Nicaragua, the Dominican Republic and Cuba. (author)

  16. Detecting Mycobacterium tuberculosis in Bactec MGIT 960 Cultures by Inhouse IS6110-based PCR Assay in Routine Clinical Practice

    Directory of Open Access Journals (Sweden)

    Jun-Ren Sun

    2009-02-01

    Conclusion: The combined use of the automated Bactec MGIT 960 system and the IS6110-based PCR assay is sensitive and rapid for the detection of M. tuberculosis complex, and we recommend that this method be used routinely for identification of mycobacteria in clinical laboratories.

  17. Variation in interoperability across clinical laboratories nationwide.

    Science.gov (United States)

    Patel, Vaishali; McNamara, Lauren; Dullabh, Prashila; Sawchuk, Megan E; Swain, Matthew

    2017-12-01

    To characterize nationwide variation and factors associated with clinical laboratories': (1) capabilities to send structured test results electronically to ordering practitioners' EHR systems; and (2) their levels of exchange activity, as measured by whether they sent more than three-quarters of their test results as structured data to ordering practitioners' EHR systems. A national survey of all independent and hospital laboratories was conducted in 2013. Using an analytic weighted sample of 9382 clinical laboratories, a series of logistic regression analyses were conducted to identify organizational and area characteristics associated with clinical laboratories' exchange capability and activity. Hospital-based clinical laboratories (71%) and larger clinical laboratories (80%) had significantly higher levels of capability compared to independent (58%) and smaller laboratories (48%), respectively; though all had similar levels of exchange activity, with 30% of clinical laboratories sending 75% or more of their test results electronically. In multivariate analyses, hospital and the largest laboratories had 1.87 and 4.40 higher odds, respectively, of possessing the capability to send results electronically compared to independent laboratories (pLaboratories located in areas with a higher share of potential exchange partners had a small but significantly greater capability to send results electronically and higher levels of exchange activity(pClinical laboratories' capability to exchange varied by size and type; however, all clinical laboratories had relatively low levels of exchange activity. The role of exchange partners potentially played a small but significant role in driving exchange capability and activity. Published by Elsevier B.V.

  18. Rapid targeted somatic mutation analysis of solid tumors in routine clinical diagnostics.

    Science.gov (United States)

    Magliacane, Gilda; Grassini, Greta; Bartocci, Paola; Francaviglia, Ilaria; Dal Cin, Elena; Barbieri, Gianluca; Arrigoni, Gianluigi; Pecciarini, Lorenza; Doglioni, Claudio; Cangi, Maria Giulia

    2015-10-13

    Tumor genotyping is an essential step in routine clinical practice and pathology laboratories face a major challenge in being able to provide rapid, sensitive and updated molecular tests. We developed a novel mass spectrometry multiplexed genotyping platform named PentaPanel to concurrently assess single nucleotide polymorphisms in 56 hotspots of the 5 most clinically relevant cancer genes, KRAS, NRAS, BRAF, EGFR and PIK3CA for a total of 221 detectable mutations. To both evaluate and validate the PentaPanel performance, we investigated 1025 tumor specimens of 6 different cancer types (carcinomas of colon, lung, breast, pancreas, and biliary tract, and melanomas), systematically addressing sensitivity, specificity, and reproducibility of our platform. Sanger sequencing was also performed for all the study samples. Our data showed that PentaPanel is a high throughput and robust tool, allowing genotyping for targeted therapy selection of 10 patients in the same run, with a practical turnaround time of 2 working days. Importantly, it was successfully used to interrogate different DNAs isolated from routinely processed specimens (formalin-fixed paraffin embedded, frozen, and cytological samples), covering all the requirements of clinical tests. In conclusion, the PentaPanel platform can provide an immediate, accurate and cost effective multiplex approach for clinically relevant gene mutation analysis in many solid tumors and its utility across many diseases can be particularly relevant in multiple clinical trials, including the new basket trial approach, aiming to identify appropriate targeted drug combination strategies.

  19. Can Unmanned Aerial Systems (Drones Be Used for the Routine Transport of Chemistry, Hematology, and Coagulation Laboratory Specimens?

    Directory of Open Access Journals (Sweden)

    Timothy K Amukele

    Full Text Available Unmanned Aerial Systems (UAS or drones could potentially be used for the routine transport of small goods such as diagnostic clinical laboratory specimens. To the best of our knowledge, there is no published study of the impact of UAS transportation on laboratory tests.Three paired samples were obtained from each one of 56 adult volunteers in a single phlebotomy event (336 samples total: two tubes each for chemistry, hematology, and coagulation testing respectively. 168 samples were driven to the flight field and held stationary. The other 168 samples were flown in the UAS for a range of times, from 6 to 38 minutes. After the flight, 33 of the most common chemistry, hematology, and coagulation tests were performed. Statistical methods as well as performance criteria from four distinct clinical, academic, and regulatory bodies were used to evaluate the results.Results from flown and stationary sample pairs were similar for all 33 analytes. Bias and intercepts were <10% and <13% respectively for all analytes. Bland-Altman comparisons showed a mean difference of 3.2% for Glucose and <1% for other analytes. Only bicarbonate did not meet the strictest (Royal College of Pathologists of Australasia Quality Assurance Program performance criteria. This was due to poor precision rather than bias. There were no systematic differences between laboratory-derived (analytic CV's and the CV's of our flown versus terrestrial sample pairs however CV's from the sample pairs tended to be slightly higher than analytic CV's. The overall concordance, based on clinical stratification (normal versus abnormal, was 97%. Length of flight had no impact on the results.Transportation of laboratory specimens via small UASs does not affect the accuracy of routine chemistry, hematology, and coagulation tests results from selfsame samples. However it results in slightly poorer precision for some analytes.

  20. Can Unmanned Aerial Systems (Drones) Be Used for the Routine Transport of Chemistry, Hematology, and Coagulation Laboratory Specimens?

    Science.gov (United States)

    Amukele, Timothy K; Sokoll, Lori J; Pepper, Daniel; Howard, Dana P; Street, Jeff

    2015-01-01

    Unmanned Aerial Systems (UAS or drones) could potentially be used for the routine transport of small goods such as diagnostic clinical laboratory specimens. To the best of our knowledge, there is no published study of the impact of UAS transportation on laboratory tests. Three paired samples were obtained from each one of 56 adult volunteers in a single phlebotomy event (336 samples total): two tubes each for chemistry, hematology, and coagulation testing respectively. 168 samples were driven to the flight field and held stationary. The other 168 samples were flown in the UAS for a range of times, from 6 to 38 minutes. After the flight, 33 of the most common chemistry, hematology, and coagulation tests were performed. Statistical methods as well as performance criteria from four distinct clinical, academic, and regulatory bodies were used to evaluate the results. Results from flown and stationary sample pairs were similar for all 33 analytes. Bias and intercepts were <10% and <13% respectively for all analytes. Bland-Altman comparisons showed a mean difference of 3.2% for Glucose and <1% for other analytes. Only bicarbonate did not meet the strictest (Royal College of Pathologists of Australasia Quality Assurance Program) performance criteria. This was due to poor precision rather than bias. There were no systematic differences between laboratory-derived (analytic) CV's and the CV's of our flown versus terrestrial sample pairs however CV's from the sample pairs tended to be slightly higher than analytic CV's. The overall concordance, based on clinical stratification (normal versus abnormal), was 97%. Length of flight had no impact on the results. Transportation of laboratory specimens via small UASs does not affect the accuracy of routine chemistry, hematology, and coagulation tests results from selfsame samples. However it results in slightly poorer precision for some analytes.

  1. Post-standardization of routine creatinine assays: are they suitable for clinical applications.

    Science.gov (United States)

    Jassam, Nuthar; Weykamp, Cas; Thomas, Annette; Secchiero, Sandra; Sciacovelli, Laura; Plebani, Mario; Thelen, Marc; Cobbaert, Christa; Perich, Carmen; Ricós, Carmen; Paula, Faria A; Barth, Julian H

    2017-05-01

    Introduction Reliable serum creatinine measurements are of vital importance for the correct classification of chronic kidney disease and early identification of kidney injury. The National Kidney Disease Education Programme working group and other groups have defined clinically acceptable analytical limits for creatinine methods. The aim of this study was to re-evaluate the performance of routine creatinine methods in the light of these defined limits so as to assess their suitability for clinical practice. Method In collaboration with the Dutch External Quality Assurance scheme, six frozen commutable samples, with a creatinine concentration ranging from 80 to 239  μmol/L and traceable to isotope dilution mass spectrometry, were circulated to 91 laboratories in four European countries for creatinine measurement and estimated glomerular filtration rate calculation. Two out of the six samples were spiked with glucose to give high and low final concentrations of glucose. Results Results from 89 laboratories were analysed for bias, imprecision (%CV) for each creatinine assay and total error for estimated glomerular filtration rate. The participating laboratories used analytical instruments from four manufacturers; Abbott, Beckman, Roche and Siemens. All enzymatic methods in this study complied with the National Kidney Disease Education Programme working group recommended limits of bias of 5% above a creatinine concentration of 100  μmol/L. They also did not show any evidence of interference from glucose. In addition, they also showed compliance with the clinically recommended %CV of ≤4% across the analytical range. In contrast, the Jaffe methods showed variable performance with regard to the interference of glucose and unsatisfactory bias and precision. Conclusion Jaffe-based creatinine methods still exhibit considerable analytical variability in terms of bias, imprecision and lack of specificity, and this variability brings into question their clinical utility

  2. Neither Single nor a Combination of Routine Laboratory Parameters can Discriminate between Gram-positive and Gram-negative Bacteremia

    Science.gov (United States)

    Ratzinger, Franz; Dedeyan, Michel; Rammerstorfer, Matthias; Perkmann, Thomas; Burgmann, Heinz; Makristathis, Athanasios; Dorffner, Georg; Loetsch, Felix; Blacky, Alexander; Ramharter, Michael

    2015-01-01

    Adequate early empiric antibiotic therapy is pivotal for the outcome of patients with bloodstream infections. In clinical practice the use of surrogate laboratory parameters is frequently proposed to predict underlying bacterial pathogens; however there is no clear evidence for this assumption. In this study, we investigated the discriminatory capacity of predictive models consisting of routinely available laboratory parameters to predict the presence of Gram-positive or Gram-negative bacteremia. Major machine learning algorithms were screened for their capacity to maximize the area under the receiver operating characteristic curve (ROC-AUC) for discriminating between Gram-positive and Gram-negative cases. Data from 23,765 patients with clinically suspected bacteremia were screened and 1,180 bacteremic patients were included in the study. A relative predominance of Gram-negative bacteremia (54.0%), which was more pronounced in females (59.1%), was observed. The final model achieved 0.675 ROC-AUC resulting in 44.57% sensitivity and 79.75% specificity. Various parameters presented a significant difference between both genders. In gender-specific models, the discriminatory potency was slightly improved. The results of this study do not support the use of surrogate laboratory parameters for predicting classes of causative pathogens. In this patient cohort, gender-specific differences in various laboratory parameters were observed, indicating differences in the host response between genders. PMID:26522966

  3. Clinical experience with routine diode dosimetry for electron beam radiotherapy

    International Nuclear Information System (INIS)

    Yaparpalvi, Ravindra; Fontenla, Doracy P.; Vikram, Bhadrasain

    2000-01-01

    Purpose: Electron beam radiotherapy is frequently administered based on clinical setups without formal treatment planning. We felt, therefore, that it was important to monitor electron beam treatments by in vivo dosimetry to prevent errors in treatment delivery. In this study, we present our clinical experience with patient dose verification using electron diodes and quantitatively assess the dose perturbations caused by the diodes during electron beam radiotherapy. Methods and Materials: A commercial diode dosimeter was used for the in vivo dose measurements. During patient dosimetry, the patients were set up as usual by the therapists. Before treatment, a diode was placed on the patient's skin surface and secured with hypoallergenic tape. The patient was then treated and the diode response registered and stored in the patient radiotherapy system database via our in-house software. A customized patient in vivo dosimetry report showing patient details, expected and measured dose, and percent difference was then generated and printed for analysis and record keeping. We studied the perturbation of electron beams by diodes using film dosimetry. Beam profiles at the 90% prescription isodose depths were obtained with and without the diode on the beam central axis, for 6-20 MeV electron beams and applicator/insert sizes ranging from a 3-cm diameter circular field to a 25 x 25 cm open field. Results: In vivo dose measurements on 360 patients resulted in the following ranges of deviations from the expected dose at the various anatomic sites: Breast (222 patients) -20.3 to +23.5% (median deviation 0%); Head and Neck (63 patients) -21.5 to +14.8% (median -0.7%); Other sites (75 patients) -17.6 to +18.8% (median +0.5%). Routine diode dosimetry during the first treatment on 360 patients (460 treatment sites) resulted in 11.5% of the measurements outside our acceptable ±6% dose deviation window. Only 3.7% of the total measurements were outside ±10% dose deviation. Detailed

  4. Lack of clinical relevance in routine final subcultures of radiometrically negative BACTEC blood culture vials

    International Nuclear Information System (INIS)

    Plorde, J.J.; Carlson, L.G.; Dau, M.E.

    1982-01-01

    During a 38-month period, 10,106 blood specimens were received in the laboratory for culture. These were inoculated into 26,424 vials and processed using the BACTEC radiometric detection system. Of these vials, 1,914 were eventually found to be microbiologically positive. Isolates from 836 vials were judged to be contaminants. In the remaining 1,078 vials, growth was first detected visually or radiometrically in 1,062 and by final subculture in 16. Growth from these sixteen bottles represented 12 clinically significant bacteremic episodes in as many patients. In nine of these episodes, other culture vials from the same patient were positive radiometrically. Therefore, 358 of 361 (99.2%) bacteremic episodes were detected without the benefit of routine final subcultures. The three patients whose bacteremia was missed were diagnosed clinically and placed on appropriate therapy prior to the detection of the bacteremias by final subculture

  5. Routine chest X-ray in the allergy clinic

    International Nuclear Information System (INIS)

    Garcia-Barredo, M.R.; Usamentiaga, E.; Fidalgo, I.

    1997-01-01

    To determine whether routine chest X-ray is indicated in allergy patients when there is no evidence of cardiopulmonary involvement. A retrospective study to analyze the indications and radiologic findings in 515 consecutive patients who underwent chest X-ray: Positive findings were considered to be any radiological sing that led to the performance of additional diagnostic measures or a change in the therapeutic management of the patient. Positive radiologic findings were observed in 39 cases (7.59%). Only two patients (0.38%) were diagnosed as having diseases that were susceptible to proper treatment. In one of them (0.19%), the failure to perform chest X-ray would have impeded the introduction of proper treatment. We do not recommend carrying out routine chest X-ray in this patient population. (Author) 7 refs

  6. Automation in the clinical microbiology laboratory.

    Science.gov (United States)

    Novak, Susan M; Marlowe, Elizabeth M

    2013-09-01

    Imagine a clinical microbiology laboratory where a patient's specimens are placed on a conveyor belt and sent on an automation line for processing and plating. Technologists need only log onto a computer to visualize the images of a culture and send to a mass spectrometer for identification. Once a pathogen is identified, the system knows to send the colony for susceptibility testing. This is the future of the clinical microbiology laboratory. This article outlines the operational and staffing challenges facing clinical microbiology laboratories and the evolution of automation that is shaping the way laboratory medicine will be practiced in the future. Copyright © 2013 Elsevier Inc. All rights reserved.

  7. How characteristic routines of clinical departments influence students' self-regulated learning : A grounded theory study

    NARCIS (Netherlands)

    Berkhout, J J; Slootweg, I. A.; Helmich, Esther; Teunissen, P W; van der Vleuten, C. P. M.; Jaarsma, A. D. C.

    2017-01-01

    Background: In clerkships, students are expected to self-regulate their learning. How clinical departments and their routine approach on clerkships influences students' self-regulated learning (SRL) is unknown.Aim: This study explores how characteristic routines of clinical departments influence

  8. Errors in clinical laboratories or errors in laboratory medicine?

    Science.gov (United States)

    Plebani, Mario

    2006-01-01

    Laboratory testing is a highly complex process and, although laboratory services are relatively safe, they are not as safe as they could or should be. Clinical laboratories have long focused their attention on quality control methods and quality assessment programs dealing with analytical aspects of testing. However, a growing body of evidence accumulated in recent decades demonstrates that quality in clinical laboratories cannot be assured by merely focusing on purely analytical aspects. The more recent surveys on errors in laboratory medicine conclude that in the delivery of laboratory testing, mistakes occur more frequently before (pre-analytical) and after (post-analytical) the test has been performed. Most errors are due to pre-analytical factors (46-68.2% of total errors), while a high error rate (18.5-47% of total errors) has also been found in the post-analytical phase. Errors due to analytical problems have been significantly reduced over time, but there is evidence that, particularly for immunoassays, interference may have a serious impact on patients. A description of the most frequent and risky pre-, intra- and post-analytical errors and advice on practical steps for measuring and reducing the risk of errors is therefore given in the present paper. Many mistakes in the Total Testing Process are called "laboratory errors", although these may be due to poor communication, action taken by others involved in the testing process (e.g., physicians, nurses and phlebotomists), or poorly designed processes, all of which are beyond the laboratory's control. Likewise, there is evidence that laboratory information is only partially utilized. A recent document from the International Organization for Standardization (ISO) recommends a new, broader definition of the term "laboratory error" and a classification of errors according to different criteria. In a modern approach to total quality, centered on patients' needs and satisfaction, the risk of errors and mistakes

  9. Selecting automation for the clinical chemistry laboratory.

    Science.gov (United States)

    Melanson, Stacy E F; Lindeman, Neal I; Jarolim, Petr

    2007-07-01

    Laboratory automation proposes to improve the quality and efficiency of laboratory operations, and may provide a solution to the quality demands and staff shortages faced by today's clinical laboratories. Several vendors offer automation systems in the United States, with both subtle and obvious differences. Arriving at a decision to automate, and the ensuing evaluation of available products, can be time-consuming and challenging. Although considerable discussion concerning the decision to automate has been published, relatively little attention has been paid to the process of evaluating and selecting automation systems. To outline a process for evaluating and selecting automation systems as a reference for laboratories contemplating laboratory automation. Our Clinical Chemistry Laboratory staff recently evaluated all major laboratory automation systems in the United States, with their respective chemistry and immunochemistry analyzers. Our experience is described and organized according to the selection process, the important considerations in clinical chemistry automation, decisions and implementation, and we give conclusions pertaining to this experience. Including the formation of a committee, workflow analysis, submitting a request for proposal, site visits, and making a final decision, the process of selecting chemistry automation took approximately 14 months. We outline important considerations in automation design, preanalytical processing, analyzer selection, postanalytical storage, and data management. Selecting clinical chemistry laboratory automation is a complex, time-consuming process. Laboratories considering laboratory automation may benefit from the concise overview and narrative and tabular suggestions provided.

  10. Burkholderia pseudomallei: Challenges for the Clinical Microbiology Laboratory.

    Science.gov (United States)

    Hemarajata, Peera; Baghdadi, Jonathan D; Hoffman, Risa; Humphries, Romney M

    2016-12-01

    Melioidosis is a potentially fatal infection caused by the bacterium Burkholderia pseudomallei Clinical diagnosis of melioidosis can be challenging since there is no pathognomonic clinical syndrome, and the organism is often misidentified by methods used routinely in clinical laboratories. Although the disease is more prevalent in Thailand and northern Australia, sporadic cases may be encountered in areas where it is not endemic, including the United States. Since the organism is considered a tier 1 select agent according to the Centers for Disease Control and Prevention and the U.S. Department of Agriculture Animal and Plant Health Inspection Service, clinical laboratories must be proficient at rapidly recognizing isolates suspicious for B. pseudomallei, be able to safely perform necessary rule-out tests, and to refer suspect isolates to Laboratory Response Network reference laboratories. In this minireview, we report a case of melioidosis encountered at our institution and discuss the laboratory challenges encountered when dealing with clinical isolates suspicious for B. pseudomallei or clinical specimens from suspected melioidosis cases. Copyright © 2016, American Society for Microbiology. All Rights Reserved.

  11. Laboratory hemostasis: milestones in Clinical Chemistry and Laboratory Medicine.

    Science.gov (United States)

    Lippi, Giuseppe; Favaloro, Emmanuel J

    2013-01-01

    Hemostasis is a delicate, dynamic and intricate system, in which pro- and anti-coagulant forces cooperate for either maintaining blood fluidity under normal conditions, or else will prompt blood clot generation to limit the bleeding when the integrity of blood vessels is jeopardized. Excessive prevalence of anticoagulant forces leads to hemorrhage, whereas excessive activation of procoagulant forces triggers excessive coagulation and thrombosis. The hemostasis laboratory performs a variety of first, second and third line tests, and plays a pivotal role in diagnostic and monitoring of most hemostasis disturbances. Since the leading targets of Clinical Chemistry and Laboratory Medicine include promotion of progress in fundamental and applied research, along with publication of guidelines and recommendations in laboratory diagnostics, this journal is an ideal source of information on current developments in the laboratory technology of hemostasis, and this article is aimed to celebrate some of the most important and popular articles ever published by the journal in the filed of laboratory hemostasis.

  12. Quality-assurance results for routine water analysis in US Geological Survey laboratories, water year 1991

    Science.gov (United States)

    Maloney, T.J.; Ludtke, A.S.; Krizman, T.L.

    1994-01-01

    The US. Geological Survey operates a quality- assurance program based on the analyses of reference samples for the National Water Quality Laboratory in Arvada, Colorado, and the Quality of Water Service Unit in Ocala, Florida. Reference samples containing selected inorganic, nutrient, and low ionic-strength constituents are prepared and disguised as routine samples. The program goal is to determine precision and bias for as many analytical methods offered by the participating laboratories as possible. The samples typically are submitted at a rate of approximately 5 percent of the annual environmental sample load for each constituent. The samples are distributed to the laboratories throughout the year. Analytical data for these reference samples reflect the quality of environmental sample data produced by the laboratories because the samples are processed in the same manner for all steps from sample login through data release. The results are stored permanently in the National Water Data Storage and Retrieval System. During water year 1991, 86 analytical procedures were evaluated at the National Water Quality Laboratory and 37 analytical procedures were evaluated at the Quality of Water Service Unit. An overall evaluation of the inorganic (major ion and trace metal) constituent data for water year 1991 indicated analytical imprecision in the National Water Quality Laboratory for 5 of 67 analytical procedures: aluminum (whole-water recoverable, atomic emission spectrometric, direct-current plasma); calcium (atomic emission spectrometric, direct); fluoride (ion-exchange chromatographic); iron (whole-water recoverable, atomic absorption spectrometric, direct); and sulfate (ion-exchange chromatographic). The results for 11 of 67 analytical procedures had positive or negative bias during water year 1991. Analytical imprecision was indicated in the determination of two of the five National Water Quality Laboratory nutrient constituents: orthophosphate as phosphorus and

  13. 77 FR 41188 - Clinical Laboratory Improvement Advisory Committee (CLIAC)

    Science.gov (United States)

    2012-07-12

    ... to general issues related to improvement in clinical laboratory quality and laboratory medicine... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Clinical... patient-centeredness of laboratory services; revisions to the standards under which clinical laboratories...

  14. Service quality framework for clinical laboratories.

    Science.gov (United States)

    Ramessur, Vinaysing; Hurreeram, Dinesh Kumar; Maistry, Kaylasson

    2015-01-01

    The purpose of this paper is to illustrate a service quality framework that enhances service delivery in clinical laboratories by gauging medical practitioner satisfaction and by providing avenues for continuous improvement. The case study method has been used for conducting the exploratory study, with focus on the Mauritian public clinical laboratory. A structured questionnaire based on the SERVQUAL service quality model was used for data collection, analysis and for the development of the service quality framework. The study confirms the pertinence of the following service quality dimensions within the context of clinical laboratories: tangibility, reliability, responsiveness, turnaround time, technology, test reports, communication and laboratory staff attitude and behaviour. The service quality framework developed, termed LabSERV, is vital for clinical laboratories in the search for improving service delivery to medical practitioners. This is a pioneering work carried out in the clinical laboratory sector in Mauritius. Medical practitioner expectations and perceptions have been simultaneously considered to generate a novel service quality framework for clinical laboratories.

  15. Incidence of hepatitis C infection among prisoners by routine laboratory values during a 20-year period.

    Directory of Open Access Journals (Sweden)

    Andrés Marco

    Full Text Available To estimate the incidence of Hepatitis C virus (HCV and the predictive factors through repeated routine laboratory analyses.An observational cohort study was carried out in Quatre Camins Prison, Barcelona. The study included subjects with an initial negative HCV result and routine laboratory analyses containing HCV serology from 1992 to 2011. The incidence of infection was calculated for the study population and for sub-groups by 100 person-years of follow-up (100 py. The predictive factors were determined through Kaplan-Meier curves and a Cox regression. Hazard ratios (HR and 95% confidence intervals (CI were calculated.A total of 2,377 prisoners were included with a median follow-up time of 1,540.9 days per patient. Among the total population, 117 HCV seroconversions were detected (incidence of 1.17/100 py. The incidence was higher between 1992 and 1995 (2.57/100 py, among cases with HIV co-infection (8.34/100 py and among intravenous drug users (IDU without methadone treatment (MT during follow-up (6.66/100 py. The incidence rate of HCV seroconversion among cases with a history of IDU and current MT was 1.35/100 py, which is close to that of the total study population. The following variables had a positive predictive value for HCV infection: IDU (p<0.001; HR = 7,30; CI: 4.83-11.04, Spanish ethnicity (p = 0.009; HR = 2,03; CI: 1.93-3.44 and HIV infection (p = 0.015; HR = 1.97; CI: 1.14-3.39.The incidence of HCV infection among prisoners was higher during the first part of the study and among IDU during the entire study period. Preventative programs should be directed toward this sub-group of the prison population.

  16. Value of routine admission laboratory tests to predict thirty-day mortality in patients with acute myocardial infarction

    NARCIS (Netherlands)

    Sjauw, KD; Van der Horst, ICC; Nijsten, MWN; Nieuwland, W; Zijlstra, F

    2006-01-01

    Most risk-stratification instruments that have been developed to predict outcome after myocardial infarction do not make use of laboratory parameters, although several laboratory parameters have, been shown to be predictors of adverse outcome. To assess the prognostic value of routine admission

  17. Error tracking in a clinical biochemistry laboratory

    DEFF Research Database (Denmark)

    Szecsi, Pal Bela; Ødum, Lars

    2009-01-01

    BACKGROUND: We report our results for the systematic recording of all errors in a standard clinical laboratory over a 1-year period. METHODS: Recording was performed using a commercial database program. All individuals in the laboratory were allowed to report errors. The testing processes were cl...

  18. Is routine antenatal venereal disease research laboratory test still justified? Nigerian experience

    Directory of Open Access Journals (Sweden)

    Nwosu BO

    2015-01-01

    Full Text Available Betrand O Nwosu,1 George U Eleje,1 Amaka L Obi-Nwosu,2 Ita F Ahiarakwem,3 Comfort N Akujobi,4 Chukwudi C Egwuatu,4 Chukwudumebi O Onyiuke5 1Department of Obstetrics and Gynecology, Nnamdi Azikiwe University, Nnewi Campus, Nnewi, Anambra State, Nigeria; 2Department of Family Medicine, Nnamdi Azikiwe University Teaching Hospital, Nnewi, Nigeria; 3Department of Medical Microbiology, Imo State University Teaching Hospital, Orlu, Imo State, Nigeria; 4Department of Medical Microbiology, Nnamdi Azikiwe University, Nnewi Campus, Nnewi, Anambra State, Nigeria; 5Department of Medical Microbiology, Nnamdi Azikiwe University Teaching Hospital, Nnewi, Anambra State, NigeriaObjective: To determine the seroreactivity of pregnant women to syphilis in order to justify the need for routine antenatal syphilis screening.Methods: A multicenter retrospective analysis of routine antenatal venereal disease research laboratory (VDRL test results between 1 September 2010 and 31 August 2012 at three specialist care hospitals in south-east Nigeria was done. A reactive VDRL result is subjected for confirmation using Treponema pallidum hemagglutination assay test. Analysis was by Epi Info 2008 version 3.5.1 and Stata/IC version 10.Results: Adequate records were available regarding 2,156 patients and were thus reviewed. The mean age of the women was 27.4 years (±3.34, and mean gestational age was 26.4 weeks (±6.36. Only 15 cases (0.70% were seropositive to VDRL. Confirmatory T. pallidum hemagglutination assay was positive in 4 of the 15 cases, giving an overall prevalence of 0.19% and a false-positive rate of 73.3%. There was no significant difference in the prevalence of syphilis in relation to maternal age and parity (P>0.05.Conclusion: While the prevalence of syphilis is extremely low in the antenatal care population at the three specialist care hospitals in south-east Nigeria, false-positive rate is high and prevalence did not significantly vary with maternal age or

  19. IT Infrastructure to Support the Secondary Use of Routinely Acquired Clinical Imaging Data for Research

    NARCIS (Netherlands)

    K.Y.E. Leung (Esther); F. van der Lijn (Fedde); H.A. Vrooman (Henri); M.C.J.M. Sturkenboom (Miriam); W.J. Niessen (Wiro)

    2014-01-01

    textabstractWe propose an infrastructure for the automated anonymization, extraction and processing of image data stored in clinical data repositories to make routinely acquired imaging data available for research purposes. The automated system, which was tested in the context of analyzing routinely

  20. Clinical relevance of routinely measured vital signs in hospitalized patients: a systematic review

    NARCIS (Netherlands)

    Storm-Versloot, Marja N.; Verweij, Lotte; Lucas, Cees; Ludikhuize, Jeroen; Goslings, J. Carel; Legemate, Dink A.; Vermeulen, Hester

    2014-01-01

    Conflicting evidence exists on the effectiveness of routinely measured vital signs on the early detection of increased probability of adverse events. To assess the clinical relevance of routinely measured vital signs in medically and surgically hospitalized patients through a systematic review.

  1. Clinical chemistry in higher dimensions: Machine-learning and enhanced prediction from routine clinical chemistry data.

    Science.gov (United States)

    Richardson, Alice; Signor, Ben M; Lidbury, Brett A; Badrick, Tony

    2016-11-01

    Big Data is having an impact on many areas of research, not the least of which is biomedical science. In this review paper, big data and machine learning are defined in terms accessible to the clinical chemistry community. Seven myths associated with machine learning and big data are then presented, with the aim of managing expectation of machine learning amongst clinical chemists. The myths are illustrated with four examples investigating the relationship between biomarkers in liver function tests, enhanced laboratory prediction of hepatitis virus infection, the relationship between bilirubin and white cell count, and the relationship between red cell distribution width and laboratory prediction of anaemia. Copyright © 2016 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

  2. [Future roles of clinical laboratories and clinical laboratory technologists in university hospitals].

    Science.gov (United States)

    Yokota, Hiromitsu; Yatomi, Yutaka

    2013-08-01

    Clinical laboratories in university hospitals should be operated with a good balance of medical practice, education, research, and management. The role of a clinical laboratory is to promptly provide highly reliable laboratory data to satisfy the needs of clinicians involved in medical practice and health maintenance of patients. Improvement and maintenance of the quality of the laboratory staff and environment are essential to achieve this goal. In order to implement these requirements efficiently, an appropriate quality management system should be introduced and established, and evaluated objectively by a third party (e.g. by obtaining ISO 15189 certification). ISO 15189 is an international standard regarding the quality and competence of clinical laboratories, and specifies a review of the efficient operational system and technical requirements such as competence in implementing practical tests and calibration. This means the results of laboratory tests reported by accredited laboratories withstand any international evaluation, which is very important to assure the future importance of the existence and management of clinical laboratories as well as internationalization of medical practice. "Education" and "research" have important implications in addition to "medical practice" and "management", as the roles that clinical laboratories should play in university hospitals. University hospital laboratories should be operated by keeping these four factors in good balance. Why are "education" and "research" required in addition to "medical practice" services? If individual clinical laboratory technologists can provide an appropriate response to this question, the importance of the existence of clinical laboratories would be reinforced, without being compromised.

  3. Clinical laboratory billing: superfluous requirements without justification?

    Science.gov (United States)

    Stadler, Stephen

    2004-01-01

    Congress occasionally passes new laws that affect how clinical laboratories handle test orders from physicians and, subsequently, process the billing for tests. Once a bill is signed into law, it is forwarded to administrative agencies, which draft regulations and administrative procedures, under which the intentions of Congress are carried out. In the case of laboratory test ordering and billing, the Centers for Medicare and Medicaid Services (CMS) has the greatest influence over how these regulations and procedures are defined. Unfortunately, in many cases, billing rules have been promulgated in ways that create the need for hospitals and commercial laboratories to expend huge sums of money to bill within the confines of the administrative rules; cause clinical laboratories to suffer from omissions and mistakes of other parties who are part of the patient care process but are not accountable for the billing information they provide to laboratories; and, frankly, in some respects, simply defy common sense.

  4. The effectiveness of online cognitive behavioral treatment in routine clinical practice

    NARCIS (Netherlands)

    Ruwaard, J.; Lange, A.; Schrieken, B.; Dolan, C.V.; Emmelkamp, P.

    2012-01-01

    Context Randomized controlled trails have identified online cognitive behavioral therapy as an efficacious intervention in the management of common mental health disorders. Objective To assess the effectiveness of online CBT for different mental disorders in routine clinical practice. Design An

  5. The effectiveness of online cognitive behavioral treatment in routine clinical practice

    NARCIS (Netherlands)

    Ruwaard, Jeroen; Lange, Alfred; Schrieken, Bart; Dolan, Conor V; Emmelkamp, Paul

    2012-01-01

    CONTEXT: Randomized controlled trails have identified online cognitive behavioral therapy as an efficacious intervention in the management of common mental health disorders. OBJECTIVE: To assess the effectiveness of online CBT for different mental disorders in routine clinical practice. DESIGN: An

  6. Face Transplantation: On the Verge of Becoming Clinical Routine?

    Directory of Open Access Journals (Sweden)

    Ralf Smeets

    2014-01-01

    Full Text Available Introduction. Face transplantation (FT is an innovative achievement of modern reconstructive surgery and is on the verge of becoming a common surgical opportunity. This review article was compiled to provide an update on this surgical field, especially regarding clinical outcomes, benefits, and complications implied. Methods. We performed an extensive research on all English-language Medline articles, case reports, and reviews published online until September 15, 2013. Used search terms were “face transplantation,” “face transplant,” “facial transplantation,” “facial transplant,” “face allograft,” and “facial allograft.” Results. To date 27 FTs have been performed worldwide. 19 of these cases have been published in the Medline database. Long-term follow-up reports of FT cases are rare. Three deaths associated with the procedure have occurred to date. The clinical outcomes of FT are satisfying. Reinnervation of sensation has been faster than motor recovery. Extensive functional improvements have been observed. Due to strict immunosuppression protocols, no case of hyperacute or chronic rejection and no graft-versus-host disease have occurred to date. Conclusions. As studies on long-term outcomes are missing, particularly regarding immunosuppression-related complications, FT will stay experimental for the next years. Nevertheless, for a small group of patients, FT already is a feasible reconstructive option.

  7. Clinical laboratory waste management in Shiraz, Iran.

    Science.gov (United States)

    Askarian, Mehrdad; Motazedian, Nasrin; Palenik, Charles John

    2012-06-01

    Clinical laboratories are significant generators of infectious waste, including microbiological materials, contaminated sharps, and pathologic wastes such as blood specimens and blood products. Most waste produced in laboratories can be disposed of in the general solid waste stream. However, improper management of infectious waste, including mixing general wastes with infectious wastes and improper handling or storage, could lead to disease transmission. The aim of this study was to assess waste management processes used at clinical laboratories in Shiraz, Iran. One hundred and nine clinical laboratories participated In this cross sectional study, Data collection was by questionnaire and direct observation. Of the total amount of waste generated, 52% (by weight) was noninfectious domestic waste, 43% was non-sharps infectious waste and 5% consisted of sharps. There was no significant relationship between laboratory staff or manager education and the score for quality of waste collection and disposal at clinical laboratories. Improvements in infectious waste management processes should involve clearer, more uniformly accepted definitions of infectious waste and increased staff training.

  8. Miniaturization and globalization of clinical laboratory activities.

    Science.gov (United States)

    Melo, Murilo R; Clark, Samantha; Barrio, Daniel

    2011-04-01

    Clinical laboratories provide an invaluable service to millions of people around the world in the form of quality diagnostic care. Within the clinical laboratory industry the impetus for change has come from technological development (miniaturization, nanotechnology, and their collective effect on point-of-care testing; POCT) and the increasingly global nature of laboratory services. Potential technological gains in POCT include: the development of bio-sensors, microarrays, genetics and proteomics testing, and enhanced web connectivity. In globalization, prospective opportunities lie in: medical tourism, the migration of healthcare workers, cross-border delivery of testing, and the establishment of accredited laboratories in previously unexplored markets. Accompanying these impressive opportunities are equally imposing challenges. Difficulty transitioning from research to clinical use, poor infrastructure in developing countries, cultural differences and national barriers to global trade are only a few examples. Dealing with the issues presented by globalization and the impact of developing technology on POCT, and on the clinical laboratory services industry in general, will be a daunting task. Despite such concerns, with appropriate countermeasures it will be possible to address the challenges posed. Future laboratory success will be largely dependent on one's ability to adapt in this perpetually shifting landscape.

  9. Selecting clinical quality indicators for laboratory medicine.

    Science.gov (United States)

    Barth, Julian H

    2012-05-01

    Quality in laboratory medicine is often described as doing the right test at the right time for the right person. Laboratory processes currently operate under the oversight of an accreditation body which gives confidence that the process is good. However, there are aspects of quality that are not measured by these processes. These are largely focused on ensuring that the most clinically appropriate test is performed and interpreted correctly. Clinical quality indicators were selected through a two-phase process. Firstly, a series of focus groups of clinical scientists were held with the aim of developing a list of quality indicators. These were subsequently ranked in order by an expert panel of primary and secondary care physicians. The 10 top indicators included the communication of critical results, comprehensive education to all users and adequate quality assurance for point-of-care testing. Laboratories should ensure their tests are used to national standards, that they have clinical utility, are calibrated to national standards and have long-term stability for chronic disease management. Laboratories should have error logs and demonstrate evidence of measures introduced to reduce chances of similar future errors. Laboratories should make a formal scientific evaluation of analytical quality. This paper describes the process of selection of quality indicators for laboratory medicine that have been validated sequentially by deliverers and users of the service. They now need to be converted into measureable variables related to outcome and validated in practice.

  10. The changing face of clinical laboratories.

    Science.gov (United States)

    Plebani, M

    1999-07-01

    Laboratory medicine has undergone a sea change, and medical laboratories must now adapt to, and meet new, customer-supplier needs springing from shifts in the patterns of disease prevalence, medical practice, and demographics. Managed care and other cost-containment processes have forced those involved in health care to cooperate to develop a full picture of patient care, and this has affected clinical laboratory objectives, the main focus now being on improvement in medical outcomes. More recently, the resource shortages in health care and results of cost/effectiveness analysis have demonstrated that the value of a laboratory test must be ascertained not only on the basis of its chemical or clinical performance characteristics, but also by its impact on patient management, the only true assessment of the quality of testing being quality of patient outcomes. The time is ripe for changing the vision of laboratory medicine, and some of the reasons for this are the availability of results in real-time, the introduction of more specific tests, and the trend to prevent diseases rather than cure them. The information from laboratory tests designed to evaluate biochemical or genetic risk and/or prognostic factors cannot be replaced either by physical examination and/or the assessment of symptoms. Today, the importance of laboratory scientists must be proven in three broad areas: a) guaranteeing the quality of tests, irrespective of where they are performed; b) improving the quality of the service; c) maximizing the impact of laboratory information on patient management.

  11. Clinical laboratory: bigger is not always better.

    Science.gov (United States)

    Plebani, Mario

    2018-06-27

    Laboratory services around the world are undergoing substantial consolidation and changes through mechanisms ranging from mergers, acquisitions and outsourcing, primarily based on expectations to improve efficiency, increasing volumes and reducing the cost per test. However, the relationship between volume and costs is not linear and numerous variables influence the end cost per test. In particular, the relationship between volumes and costs does not span the entire platter of clinical laboratories: high costs are associated with low volumes up to a threshold of 1 million test per year. Over this threshold, there is no linear association between volumes and costs, as laboratory organization rather than test volume more significantly affects the final costs. Currently, data on laboratory errors and associated diagnostic errors and risk for patient harm emphasize the need for a paradigmatic shift: from a focus on volumes and efficiency to a patient-centered vision restoring the nature of laboratory services as an integral part of the diagnostic and therapy process. Process and outcome quality indicators are effective tools to measure and improve laboratory services, by stimulating a competition based on intra- and extra-analytical performance specifications, intermediate outcomes and customer satisfaction. Rather than competing with economic value, clinical laboratories should adopt a strategy based on a set of harmonized quality indicators and performance specifications, active laboratory stewardship, and improved patient safety.

  12. Implementation of a companion diagnostic in the clinical laboratory

    DEFF Research Database (Denmark)

    Mancini, Irene; Pinzani, Pamela; Simi, Lisa

    2015-01-01

    A companion diagnostic test provides information that is essential for the safe and effective use of a corresponding therapeutic product as indicated in the drug instructions. The implementation of a companion diagnostic follows the rules of a molecular test for somatic mutations in a routine...... clinical laboratory environment and needs guidance on practical aspects, including the choice of the proper analytical method and the procedures for internal and external quality controls. Selection of the appropriate assay for detection of genetic alterations depends on several factors: the type...... on restrictions of the method used. In relation to these aspects herein we report an opinion paper of the Working Group Personalized Laboratory Medicine jointly constituted by the European Federation of Laboratory Medicine (EFLM) and by the European Society of Pharmacogenomics and Theranostics (ESPT) using...

  13. Point of care testing of fecal calprotectin as a substitute for routine laboratory analysis

    DEFF Research Database (Denmark)

    Hejl, Julie; Theede, Klaus; Møllgren, Brian

    2018-01-01

    Objectives Fecal calprotectin (FC) is widely used to monitor the activity of inflammatory bowel disease (IBD) and to tailor medical treatment to disease activity. Laboratory testing of fecal samples may have a turnaround time of 1–2 weeks, whereas FC home testing allows results within hours...... and thus enables a rapid response to clinical deterioration. Design and methods Fifty-five stool samples were analyzed by the IBDoc® Calprotectin Home Testing kit and the BÜHLMANN fCAL® turbo assay on a Roche Cobas 6000 c501. The correlation between the assays was assessed using Spearman's Rho correlation...... coefficient and the intermediate imprecision of both assays was calculated. Results We found a strong correlation coefficient of 0.887 between FC measured on IBDoc® and the laboratory assay BÜHLMANN fCAL® turbo. The coefficients of variation (CVs) at three different FC levels were in the range 2...

  14. Determination of contamination operational value by routine monitoring in research laboratories

    International Nuclear Information System (INIS)

    Salomao, Edeilson; Medeiros, Regina Bitelli; Mattos, Maria Fernanda S.S.; Daros, Kellen Adriana Curci

    2008-01-01

    The radioisotopes have a large spectrum of applicability in many areas of science, as in medicine, agriculture and industry in general. In the biological area, the radioisotopes have brought many benefits to study physiological processes in living organisms and in vitro. The most radioisotopes used in biological research are emitters of radiation of low energy, mainly β, and are used as unsealed sources. The manipulation of these radioisotopes generates radioactive wastes and eventually can cause contamination in the areas of handling or even occasionally in areas to which access is not controlled. According to CNEN-NE-3.02 standard is necessary and mandatory the exposure and contamination levels control in the areas of handling of unsealed sources. The goal of the work is to establish how often the monitoring should be done through the survey of the contamination and exposure levels, in areas designed to manipulate 32 P and how this monitoring can contribute to the improvement the conditions of radiological protection. From the twenty eight research laboratories registered by 'Nucleo de Protecao Radiologica' (NPR) were selected four where the activities are not restrict to 32 P biological assays. The levels of contamination and exposure were evaluated using monitors GM and the layout of laboratories containing the points to be tracker defined based on the researchers' routine. At each point three values were obtained to measure the rate of contamination on the surface and exposure rate. The measures were made twice a week before and after the radioisotope manipulation. Based on these data was possible to establish the range from 0,306 to 0,678 Bq.cm -2 as operational average level to the superficial contamination. The average exposure rate measured was 5.16 n C/Kg.h. The results were important to demonstrating to researchers how they can contribute to the improvement of radiological protection conditions. (author)

  15. PCR identification of bacteria in blood culture does not fit the daily workflow of a routine microbiology laboratory.

    Science.gov (United States)

    Karumaa, Santra; Kärpänoja, Pauliina; Sarkkinen, Hannu

    2012-03-01

    We have evaluated the GenoType blood culture assay (Hain Lifescience, Nehren, Germany) for the identification of bacteria in 233 positive blood cultures and assessed its suitability in the workflow of a routine microbiology laboratory. In 68/233 (29.2%) samples, the culture result could not be confirmed by the GenoType assay due to a lack of primers in the test, multiple organisms in the sample, or inconsistency with respect to the identification by culture. Although the GenoType blood culture assay gives satisfactory results for bacteria for which primers are available, there are difficulties in applying the test in the routine microbiology laboratory.

  16. A system for tumor heterogeneity evaluation and diagnosis based on tumor markers measured routinely in the laboratory.

    Science.gov (United States)

    Hui, Liu; Rixv, Liu; Xiuying, Zhou

    2015-12-01

    To develop an efficient and reliable approach to estimate tumor heterogeneity and improve tumor diagnosis using multiple tumor markers measured routinely in the clinical laboratory. A total of 161 patients with different cancers were recruited as the cancer group, and 91 patients with non-oncological conditions were required as the non-oncological disease group. The control group comprised 90 randomly selected healthy subjects. AFP, CEA, CYFRA, CA125, CA153, CA199, CA724, and NSE levels were measured in all these subjects with a chemiluminescent microparticle immunoassay. The tumor marker with the maximum S/CO value (sample test value:cutoff value for discriminating individuals with and without tumors) was considered as a specific tumor marker (STM) for an individual. Tumor heterogeneity index (THI)=N/P (N: number of STMs; P: percentage of individuals with STMs in a certain tumor population) was used to quantify tumor heterogeneity: high THI indicated high tumor heterogeneity. The tumor marker index (TMI), TMI = STM×(number of positive tumor markers+1), was used for diagnosis. The THIs of lung, gastric, and liver cancers were 8.33, 9.63, and 5.2, respectively, while the ROC-areas under the curve for TMI were 0.862, 0.809, and 0.966. In this study, we developed a novel index for tumor heterogeneity based on the expression of various routinely evaluated serum tumor markers. Development of an evaluation system for tumor heterogeneity on the basis of this index could provide an effective diagnostic tool for some cancers. Copyright © 2015 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

  17. XML Syntax for Clinical Laboratory Procedure Manuals

    OpenAIRE

    Saadawi, Gilan; Harrison, James H.

    2003-01-01

    We have developed a document type description (DTD) in Extensable Markup Language (XML)1 for clinical laboratory procedures. Our XML syntax can adequately structure a variety of procedure types across different laboratories and is compatible with current procedure standards. The combination of this format with an XML content management system and appropriate style sheets will allow efficient procedure maintenance, distributed access, customized display and effective searching across a large b...

  18. Updating the immunology curriculum in clinical laboratory science.

    Science.gov (United States)

    Stevens, C D

    2000-01-01

    To determine essential content areas of immunology/serology courses at the clinical laboratory technician (CLT) and clinical laboratory scientist (CLS) levels. A questionnaire was designed which listed all major topics in immunology and serology. Participants were asked to place a check beside each topic covered. For an additional list of serological and immunological laboratory testing, participants were asked to indicate if each test was performed in either the didactic or clinical setting, or not performed at all. A national survey of 593 NAACLS approved CLT and CLS programs was conducted by mail under the auspices of ASCLS. Responses were obtained from 158 programs. Respondents from all across the United States included 60 CLT programs, 48 hospital-based CLS programs, 45 university-based CLS programs, and 5 university-based combined CLT and CLS programs. The survey was designed to enumerate major topics included in immunology and serology courses by a majority of participants at two distinct educational levels, CLT and CLS. Laboratory testing routinely performed in student laboratories as well as in the clinical setting was also determined for these two levels of practitioners. Certain key topics were common to most immunology and serology courses. There were some notable differences in the depth of courses at the CLT and CLS levels. Laboratory testing associated with these courses also differed at the two levels. Testing requiring more detailed interpretation, such as antinuclear antibody patterns (ANAs), was mainly performed by CLS students only. There are certain key topics as well as specific laboratory tests that should be included in immunology/serology courses at each of the two different educational levels to best prepare students for the workplace. Educators can use this information as a guide to plan a curriculum for such courses.

  19. Routine environmental audit of the Sandia National Laboratories, California, Livermore, California

    International Nuclear Information System (INIS)

    1994-03-01

    This report documents the results of the Routine Environmental Audit of the Sandia National Laboratories, Livermore, California (SNL/CA). During this audit the activities the Audit Team conducted included reviews of internal documents and reports from preview audits and assessments; interviews with US Department of Energy (DOE), State of California regulators, and contractor personnel; and inspections and observations of selected facilities and operations. The onsite portion of the audit was conducted from February 22 through March 4, 1994, by the DOE Office of Environmental Audit (EH-24), located within the Office of Environment, Safety, and Health (EH). The audit evaluated the status of programs to ensure compliance with Federal, state, and local environmental laws and regulations; compliance with DOE Orders, guidance, and directives; and conformance with accepted industry practices and standards of performance. The audit also evaluated the status and adequacy of the management systems developed to address environmental requirements. The audit's functional scope was comprehensive and included all areas of environmental management and a programmatic evaluation of NEPA and inactive waste sites

  20. Routine environmental audit of the Sandia National Laboratories, California, Livermore, California

    Energy Technology Data Exchange (ETDEWEB)

    1994-03-01

    This report documents the results of the Routine Environmental Audit of the Sandia National Laboratories, Livermore, California (SNL/CA). During this audit the activities the Audit Team conducted included reviews of internal documents and reports from preview audits and assessments; interviews with US Department of Energy (DOE), State of California regulators, and contractor personnel; and inspections and observations of selected facilities and operations. The onsite portion of the audit was conducted from February 22 through March 4, 1994, by the DOE Office of Environmental Audit (EH-24), located within the Office of Environment, Safety, and Health (EH). The audit evaluated the status of programs to ensure compliance with Federal, state, and local environmental laws and regulations; compliance with DOE Orders, guidance, and directives; and conformance with accepted industry practices and standards of performance. The audit also evaluated the status and adequacy of the management systems developed to address environmental requirements. The audit`s functional scope was comprehensive and included all areas of environmental management and a programmatic evaluation of NEPA and inactive waste sites.

  1. Clinical laboratory detection of carbapenem-resistant and carbapenemase-producing Enterobacteriaceae.

    Science.gov (United States)

    Miller, Shelley; Humphries, Romney M

    2016-08-01

    Carbapenemases, enzymes that hydrolyze carbapenem-class antimicrobials, pose serious clinical and diagnostic challenges, including their recent rapid spread among members of the Enterobacteriaceae, a family with no inherent carbapenem resistance. Currently there is no one-size-fits-all method for detecting carbapenem-resistant Enterobacteriaceae (CRE) in the laboratory, nor how to differentiate carbapenemase-producers (CP) from isolates that are carbapenem-resistant via other or combined mechanisms. This article reviews definitions for CRE and CP-CRE, and discusses current phenotypic and molecular methods available to the clinical laboratory for the detection of both CP and non-CP CRE. Expert commentary: Routine evaluation of carbapenem resistance mechanism by the routine clinical laboratory are not necessary for patient care, as clinical breakpoints best predict response. However, evaluation for carbapenemase is integral to infection control efforts, and laboratories should have the capacity to do such testing, either in house or by submitting isolates to a reference laboratory.

  2. Can complex health interventions be evaluated using routine clinical and administrative data? - a realist evaluation approach.

    Science.gov (United States)

    Riippa, Iiris; Kahilakoski, Olli-Pekka; Linna, Miika; Hietala, Minni

    2014-12-01

    Interventions aimed at improving chronic care typically consist of multiple interconnected parts, all of which are essential to the effect of the intervention. Limited attention has been paid to the use of routine clinical and administrative data in the evolution of these complex interventions. The purpose of this study is to examine the feasibility of routinely collected data when evaluating complex interventions and to demonstrate how a theory-based, realist approach to evaluation may increase the feasibility of routine data. We present a case study of evaluating a complex intervention, namely, the chronic care model (CCM), in Finnish primary health care. Issues typically faced when evaluating the effects of a complex intervention on health outcomes and resource use are identified by using routine data in a natural setting, and we apply context-mechanism-outcome (CMO) approach from the realist evaluation paradigm to improve the feasibility of using routine data in evaluating complex interventions. From an experimentalist approach that dominates the medical literature, routine data collected from a single centre offered a poor starting point for evaluating complex interventions. However, the CMO approach offered tools for identifying indicators needed to evaluate complex interventions. Applying the CMO approach can aid in a typical evaluation setting encountered by primary care managers: one in which the intervention is complex, the primary data source is routinely collected clinical and administrative data from a single centre, and in which randomization of patients into two research arms is too resource consuming to arrange. © 2014 John Wiley & Sons, Ltd.

  3. Clinical Outcome of Degenerative Mitral Regurgitation: Critical Importance of Echocardiographic Quantitative Assessment in Routine Practice.

    Science.gov (United States)

    Antoine, Clemence; Benfari, Giovanni; Michelena, Hector I; Malouf, Joseph F; Nkomo, Vuyisile T; Thapa, Prabin; Enriquez-Sarano, Maurice

    2018-05-31

    Background -Echocardiographic quantitation of degenerative mitral regurgitation (DMR) is recommended whenever possible in clinical guidelines but is criticized and its scalability to routine clinical practice doubted. We hypothesized that echocardiographic DMR quantitation, performed in routine clinical practice by multiple practitioners predicts independently long-term survival, and thus is essential to DMR management. Methods -We included patients diagnosed with isolated mitral-valve-prolapse 2003-2011 and any degree of MR quantified by any physician/sonographer in routine clinical practice. Clinical/echocardiographic data acquired at diagnosis were retrieved electronically. Endpoint was mortality under medical treatment analyzed by Kaplan-Meir method and Proportional-Hazard models. Results -The cohort included 3914 patients (55% male) aged 62±17 years, with left ventricular ejection fraction (LVEF) 63±8% and routinely measured effective regurgitant orifice area (EROA) 19[0-40] mm 2 During follow-up (6.7±3.1 years) 696 patients died under medical management and 1263 underwent mitral surgery. In multivariate analysis, routinely measured EROA was associated with mortality (adjusted-hazard-ratio 1.19[1.13-1.24] p 40 mm 2 threshold. Conclusions -Echocardiographic DMR quantitation is scalable to routine practice and is independently associated with clinical outcome. Routinely measured EROA is strongly associated with long-term survival under medical treatment. Excess mortality vs. the general population appears in the "moderate" DMR range and steadily increases with higher EROA. Hence, individual EROA values should be integrated into therapeutic considerations, additionally to categorical DMR grading.

  4. Emerging Technologies for the Clinical Microbiology Laboratory

    Science.gov (United States)

    Buchan, Blake W.

    2014-01-01

    SUMMARY In this review we examine the literature related to emerging technologies that will help to reshape the clinical microbiology laboratory. These topics include nucleic acid amplification tests such as isothermal and point-of-care molecular diagnostics, multiplexed panels for syndromic diagnosis, digital PCR, next-generation sequencing, and automation of molecular tests. We also review matrix-assisted laser desorption ionization–time of flight (MALDI-TOF) and electrospray ionization (ESI) mass spectrometry methods and their role in identification of microorganisms. Lastly, we review the shift to liquid-based microbiology and the integration of partial and full laboratory automation that are beginning to impact the clinical microbiology laboratory. PMID:25278575

  5. What Clinical and Laboratory Parameters Distinguish Between ...

    African Journals Online (AJOL)

    Introduction: In developing countries, a large number of patients presenting acutely in renal failure are indeed cases of advanced chronic renal failure. In this study, we compared clinical and laboratory parameters between patients with acute renal failure (ARF) and chronic renal failure (CRF), to identify discriminatory ...

  6. Comparison of microbiological diagnosis of urinary tract infection in young children by routine health service laboratories and a research laboratory: Diagnostic cohort study

    Science.gov (United States)

    Birnie, Kate; Hay, Alastair D.; Wootton, Mandy; Howe, Robin; MacGowan, Alasdair; Whiting, Penny; Lawton, Michael; Delaney, Brendan; Downing, Harriet; Dudley, Jan; Hollingworth, William; Lisles, Catherine; Little, Paul; O’Brien, Kathryn; Pickles, Timothy; Rumsby, Kate; Thomas-Jones, Emma; Van der Voort, Judith; Waldron, Cherry-Ann; Harman, Kim; Hood, Kerenza; Butler, Christopher C.; Sterne, Jonathan A. C.

    2017-01-01

    Objectives To compare the validity of diagnosis of urinary tract infection (UTI) through urine culture between samples processed in routine health service laboratories and those processed in a research laboratory. Population and methods We conducted a prospective diagnostic cohort study in 4808 acutely ill children aged <5 years attending UK primary health care. UTI, defined as pure/predominant growth ≥105 CFU/mL of a uropathogen (the reference standard), was diagnosed at routine health service laboratories and a central research laboratory by culture of urine samples. We calculated areas under the receiver-operator curve (AUC) for UTI predicted by pre-specified symptoms, signs and dipstick test results (the “index test”), separately according to whether samples were obtained by clean catch or nappy (diaper) pads. Results 251 (5.2%) and 88 (1.8%) children were classified as UTI positive by health service and research laboratories respectively. Agreement between laboratories was moderate (kappa = 0.36; 95% confidence interval [CI] 0.29, 0.43), and better for clean catch (0.54; 0.45, 0.63) than nappy pad samples (0.20; 0.12, 0.28). In clean catch samples, the AUC was lower for health service laboratories (AUC = 0.75; 95% CI 0.69, 0.80) than the research laboratory (0.86; 0.79, 0.92). Values of AUC were lower in nappy pad samples (0.65 [0.61, 0.70] and 0.79 [0.70, 0.88] for health service and research laboratory positivity, respectively) than clean catch samples. Conclusions The agreement of microbiological diagnosis of UTI comparing routine health service laboratories with a research laboratory was moderate for clean catch samples and poor for nappy pad samples and reliability is lower for nappy pad than for clean catch samples. Positive results from the research laboratory appear more likely to reflect real UTIs than those from routine health service laboratories, many of which (particularly from nappy pad samples) could be due to contamination. Health service

  7. Comparison of microbiological diagnosis of urinary tract infection in young children by routine health service laboratories and a research laboratory: Diagnostic cohort study.

    Directory of Open Access Journals (Sweden)

    Kate Birnie

    Full Text Available To compare the validity of diagnosis of urinary tract infection (UTI through urine culture between samples processed in routine health service laboratories and those processed in a research laboratory.We conducted a prospective diagnostic cohort study in 4808 acutely ill children aged <5 years attending UK primary health care. UTI, defined as pure/predominant growth ≥105 CFU/mL of a uropathogen (the reference standard, was diagnosed at routine health service laboratories and a central research laboratory by culture of urine samples. We calculated areas under the receiver-operator curve (AUC for UTI predicted by pre-specified symptoms, signs and dipstick test results (the "index test", separately according to whether samples were obtained by clean catch or nappy (diaper pads.251 (5.2% and 88 (1.8% children were classified as UTI positive by health service and research laboratories respectively. Agreement between laboratories was moderate (kappa = 0.36; 95% confidence interval [CI] 0.29, 0.43, and better for clean catch (0.54; 0.45, 0.63 than nappy pad samples (0.20; 0.12, 0.28. In clean catch samples, the AUC was lower for health service laboratories (AUC = 0.75; 95% CI 0.69, 0.80 than the research laboratory (0.86; 0.79, 0.92. Values of AUC were lower in nappy pad samples (0.65 [0.61, 0.70] and 0.79 [0.70, 0.88] for health service and research laboratory positivity, respectively than clean catch samples.The agreement of microbiological diagnosis of UTI comparing routine health service laboratories with a research laboratory was moderate for clean catch samples and poor for nappy pad samples and reliability is lower for nappy pad than for clean catch samples. Positive results from the research laboratory appear more likely to reflect real UTIs than those from routine health service laboratories, many of which (particularly from nappy pad samples could be due to contamination. Health service laboratories should consider adopting procedures used

  8. Candida bloodstream infection: a clinical microbiology laboratory perspective.

    Science.gov (United States)

    Pongrácz, Júlia; Kristóf, Katalin

    2014-09-01

    The incidence of Candida bloodstream infection (BSI) has been on the rise in several countries worldwide. Species distribution is changing; an increase in the percentage of non-albicans species, mainly fluconazole non-susceptible C. glabrata was reported. Existing microbiology diagnostic methods lack sensitivity, and new methods need to be developed or further evaluation for routine application is necessary. Although reliable, standardized methods for antifungal susceptibility testing are available, the determination of clinical breakpoints remains challenging. Correct species identification is important and provides information on the intrinsic susceptibility profile of the isolate. Currently, acquired resistance in clinical Candida isolates is rare, but reports indicate that it could be an issue in the future. The role of the clinical microbiology laboratory is to isolate and correctly identify the infective agent and provide relevant and reliable susceptibility data as soon as possible to guide antifungal therapy.

  9. The quality of clinical maternal and neonatal healthcare - a strategy for identifying 'routine care signal functions'.

    Directory of Open Access Journals (Sweden)

    Stephan Brenner

    Full Text Available A variety of clinical process indicators exists to measure the quality of care provided by maternal and neonatal health (MNH programs. To allow comparison across MNH programs in low- and middle-income countries (LMICs, a core set of essential process indicators is needed. Although such a core set is available for emergency obstetric care (EmOC, the 'EmOC signal functions', a similar approach is currently missing for MNH routine care evaluation. We describe a strategy for identifying core process indicators for routine care and illustrate their usefulness in a field example.We first developed an indicator selection strategy by combining epidemiological and programmatic aspects relevant to MNH in LMICs. We then identified routine care process indicators meeting our selection criteria by reviewing existing quality of care assessment protocols. We grouped these indicators into three categories based on their main function in addressing risk factors of maternal or neonatal complications. We then tested this indicator set in a study assessing MNH quality of clinical care in 33 health facilities in Malawi.Our strategy identified 51 routine care processes: 23 related to initial patient risk assessment, 17 to risk monitoring, 11 to risk prevention. During the clinical performance assessment a total of 82 cases were observed. Birth attendants' adherence to clinical standards was lowest in relation to risk monitoring processes. In relation to major complications, routine care processes addressing fetal and newborn distress were performed relatively consistently, but there were major gaps in the performance of routine care processes addressing bleeding, infection, and pre-eclampsia risks.The identified set of process indicators could identify major gaps in the quality of obstetric and neonatal care provided during the intra- and immediate postpartum period. We hope our suggested indicators for essential routine care processes will contribute to streamlining

  10. The quality of clinical maternal and neonatal healthcare - a strategy for identifying 'routine care signal functions'.

    Science.gov (United States)

    Brenner, Stephan; De Allegri, Manuela; Gabrysch, Sabine; Chinkhumba, Jobiba; Sarker, Malabika; Muula, Adamson S

    2015-01-01

    A variety of clinical process indicators exists to measure the quality of care provided by maternal and neonatal health (MNH) programs. To allow comparison across MNH programs in low- and middle-income countries (LMICs), a core set of essential process indicators is needed. Although such a core set is available for emergency obstetric care (EmOC), the 'EmOC signal functions', a similar approach is currently missing for MNH routine care evaluation. We describe a strategy for identifying core process indicators for routine care and illustrate their usefulness in a field example. We first developed an indicator selection strategy by combining epidemiological and programmatic aspects relevant to MNH in LMICs. We then identified routine care process indicators meeting our selection criteria by reviewing existing quality of care assessment protocols. We grouped these indicators into three categories based on their main function in addressing risk factors of maternal or neonatal complications. We then tested this indicator set in a study assessing MNH quality of clinical care in 33 health facilities in Malawi. Our strategy identified 51 routine care processes: 23 related to initial patient risk assessment, 17 to risk monitoring, 11 to risk prevention. During the clinical performance assessment a total of 82 cases were observed. Birth attendants' adherence to clinical standards was lowest in relation to risk monitoring processes. In relation to major complications, routine care processes addressing fetal and newborn distress were performed relatively consistently, but there were major gaps in the performance of routine care processes addressing bleeding, infection, and pre-eclampsia risks. The identified set of process indicators could identify major gaps in the quality of obstetric and neonatal care provided during the intra- and immediate postpartum period. We hope our suggested indicators for essential routine care processes will contribute to streamlining MNH program

  11. Very poor agreement between routine outpatient clinic office and ambulatory blood pressure: time to improve an old hospital outpatient clinic routine?

    Science.gov (United States)

    Reinhard, Mark; Poulsen, Per L; Christensen, Kent L

    2016-12-01

    We investigated the agreement between elevated outpatient clinic office blood pressure (OC-OBP) as measured in the daily routine in our University Hospital Cardiology Outpatient Clinic and subsequent awake ambulatory blood pressure (AABP). In all patients referred for ambulatory blood pressure monitoring from our Cardiology Outpatient Clinic, we identified OC-OBP and changes in medication in the period from 1 January 2014 to 15 September 2015. The AABP was used as a reference measurement for the OC-OBP. A total of 183 patients were included in the study. Their mean age was 62.1±14.0 years and 49% were women. The mean systolic OC-OBP was 166.8±17.9 mmHg and the difference between the mean systolic OC-OBP and AABP was 28.0±19.5 mmHg (Pclinic agrees poorly with AABP and may lead to unnecessary treatment and pharmacologically induced symptomatic hypotension, particularly in elderly patients. The results of this study urgently call for alternative solutions to routine OC-OBP in hospital outpatient clinics.

  12. How characteristic routines of clinical departments influence students' self-regulated learning: A grounded theory study.

    Science.gov (United States)

    Berkhout, J J; Slootweg, I A; Helmich, E; Teunissen, P W; van der Vleuten, C P M; Jaarsma, A D C

    2017-11-01

    In clerkships, students are expected to self-regulate their learning. How clinical departments and their routine approach on clerkships influences students' self-regulated learning (SRL) is unknown. This study explores how characteristic routines of clinical departments influence medical students' SRL. Six focus groups including 39 purposively sampled participants from one Dutch university were organized to study how characteristic routines of clinical departments influenced medical students' SRL from a constructivist paradigm, using grounded theory methodology. The focus groups were audio recorded, transcribed verbatim and were analyzed iteratively using constant comparison and open, axial and interpretive coding. Students described that clinical departments influenced their SRL through routines which affected the professional relationships they could engage in and affected their perception of a department's invested effort in them. Students' SRL in a clerkship can be supported by enabling them to engage others in their SRL and by having them feel that effort is invested in their learning. Our study gives a practical insight in how clinical departments influenced students' SRL. Clinical departments can affect students' motivation to engage in SRL, influence the variety of SRL strategies that students can use and how meaningful students perceive their SRL experiences to be.

  13. The impact of pneumatic tube system on routine laboratory parameters: a systematic review and meta-analysis.

    Science.gov (United States)

    Kapoula, Georgia V; Kontou, Panagiota I; Bagos, Pantelis G

    2017-10-26

    Pneumatic tube system (PTS) is a widely used method of transporting blood samples in hospitals. The aim of this study was to evaluate the effects of the PTS transport in certain routine laboratory parameters as it has been implicated with hemolysis. A systematic review and a meta-analysis were conducted. PubMed and Scopus databases were searched (up until November 2016) to identify prospective studies evaluating the impact of PTS transport in hematological, biochemical and coagulation measurements. The random-effects model was used in the meta-analysis utilizing the mean difference (MD). Heterogeneity was quantitatively assessed using the Cohran's Q and the I2 index. Subgroup analysis, meta-regression analysis, sensitivity analysis, cumulative meta-analysis and assessment of publication bias were performed for all outcomes. From a total of 282 studies identified by the searching procedure, 24 were finally included in the meta-analysis. The meta-analysis yielded statistically significant results for potassium (K) [MD=0.04 mmol/L; 95% confidence interval (CI)=0.015-0.065; p=0.002], lactate dehydrogenase (LDH) (MD=10.343 U/L; 95% CI=6.132-14.554; panalysis and random-effects meta-regression analysis according to the speed and distance of the samples traveled via the PTS revealed that there is relation between the rate and the distance of PTS with the measurements of K, LDH, white blood cells and red blood cells. This meta-analysis suggests that PTS may be associated with alterations in K, LDH and AST measurements. Although these findings may not have any significant clinical effect on laboratory results, it is wise that each hospital validates their PTS.

  14. Implementation aspects of image management, archiving, and communication systems in routine clinical use

    NARCIS (Netherlands)

    Haar Romenij, ter B.M.

    1991-01-01

    Implementation of a digital imaging network in routine clinical use is a difficult task. Not only the high technical requirements, but especially the complexity of the organization of the diagnostic information flow in a hospital makes commitment essential in PACS implementation. The application of

  15. Implementing self sustained quality control procedures in a clinical laboratory.

    Science.gov (United States)

    Khatri, Roshan; K C, Sanjay; Shrestha, Prabodh; Sinha, J N

    2013-01-01

    Quality control is an essential component in every clinical laboratory which maintains the excellence of laboratory standards, supplementing to proper disease diagnosis, patient care and resulting in overall strengthening of health care system. Numerous quality control schemes are available, with combinations of procedures, most of which are tedious, time consuming and can be "too technical" whereas commercially available quality control materials can be expensive especially for laboratories in developing nations like Nepal. Here, we present a procedure performed at our centre with self prepared control serum and use of simple statistical tools for quality assurance. The pooled serum was prepared as per guidelines for preparation of stabilized liquid quality control serum from human sera. Internal Quality Assessment was performed on this sample, on a daily basis which included measurement of 12 routine biochemical parameters. The results were plotted on Levey-Jennings charts and analysed with quality control rules, for a period of one month. The mean levels of biochemical analytes in self prepared control serum were within normal physiological range. This serum was evaluated every day along with patients' samples. The results obtained were plotted on control charts and analysed using common quality control rules to identify possible systematic and random errors. Immediate mitigation measures were taken and the dispatch of erroneous reports was avoided. In this study we try to highlight on a simple internal quality control procedure which can be performed by laboratories, with minimum technology, expenditure, and expertise and improve reliability and validity of the test reports.

  16. A first step towards miniaturized HPLC systems in analytical routine laboratories

    NARCIS (Netherlands)

    Straten, van M.A.; Vermeer, E.A.; Claessens, H.A.

    1996-01-01

    This article shows that the first step towards the miniaturization of HPLC systems can be made without any, or only slight, modification to conventional equipment. Minor (less expensive) equipment modifications, particularly the use of micro-detector cells, allow the routine use of 3.2- and 2.1-mm

  17. Development of an algorithm for phenotypic screening of carbapenemase-producing Enterobacteriaceae in the routine laboratory.

    Science.gov (United States)

    Robert, Jérôme; Pantel, Alix; Merens, Audrey; Meiller, Elodie; Lavigne, Jean-Philippe; Nicolas-Chanoine, Marie-Hélène

    2017-01-17

    Carbapenemase-producing Enterobacteriaceae (CPE) are difficult to identify among carbapenem non-susceptible Enterobacteriaceae (NSE). We designed phenotypic strategies giving priority to high sensitivity for screening putative CPE before further testing. Presence of carbapenemase-encoding genes in ertapenem NSE (MIC > 0.5 mg/l) consecutively isolated in 80 French laboratories between November 2011 and April 2012 was determined by the Check-MDR-CT103 array method. Using the Mueller-Hinton (MH) disk diffusion method, clinical diameter breakpoints of carbapenems other than ertapenem, piperazicillin+tazobactam, ticarcillin+clavulanate and cefepime as well as diameter cut-offs for these antibiotics and temocillin were evaluated alone or combined to determine their performances (sensitivity, specificity, positive and negative likelihood ratios) for identifying putative CPE among these ertapenem-NSE isolates. To increase the screening specificity, these antibiotics were also tested on cloxacillin-containing MH when carbapenem NSE isolates belonged to species producing chromosomal cephalosporinase (AmpC) but Escherichia coli. Out of the 349 ertapenem NSE, 52 (14.9%) were CPE, including 39 producing OXA-48 group carbapenemase, eight KPC and five MBL. A screening strategy based on the following diameter cut offs, ticarcillin+clavulanate <15 mm, temocillin <15 mm, meropenem or imipenem <22 mm, and cefepime <26 mm, showed 100% sensitivity and 68.1% specificity with the better likelihood ratios combination. The specificity increased when a diameter cut-off <32 mm for imipenem (76.1%) or meropenem (78.8%) further tested on cloxacillin-containing MH was added to the previous strategy for AmpC-producing isolates. The proposed strategies that allowed for increasing the likelihood of CPE among ertapenem-NSE isolates should be considered as a surrogate for carbapenemase production before further CPE confirmatory testing.

  18. Contamination of the Clinical Microbiology Laboratory with Vancomycin-Resistant Enterococci and Multidrug- Resistant Enterobacteriaceae: Implications for Hospital and Laboratory Workers

    Science.gov (United States)

    Collins, Susan M.; Hacek, Donna M.; Degen, Lisa A.; Wright, Marc O.; Noskin, Gary A.; Peterson, Lance R.

    2001-01-01

    We surveyed environmental surfaces in our clinical microbiology laboratory to determine the prevalence of vancomycin-resistant enterococci (VRE) and multidrug-resistant Enterobacteriaceae (MDRE) during a routine working day. From a total of 193 surfaces, VRE were present on 20 (10%) and MDRE were present on 4 (2%) of the surfaces tested. In a subsequent survey after routine cleaning, all of the 24 prior positive surfaces were found to be negative. Thus, those in the laboratory should recognize that many surfaces may be contaminated by resistant organisms during routine processing of patient specimens. PMID:11574615

  19. Evaluation of the Roche prototype 454 HIV-1 ultradeep sequencing drug resistance assay in a routine diagnostic laboratory.

    Science.gov (United States)

    Garcia-Diaz, A; Guerrero-Ramos, A; McCormick, A L; Macartney, M; Conibear, T; Johnson, M A; Haque, T; Webster, D P

    2013-10-01

    Studies have shown that low-frequency resistance mutations can influence treatment outcome. However, the lack of a standardized high-throughput assay has precluded their detection in clinical settings. To evaluate the performance of the Roche prototype 454 UDS HIV-1 drug resistance assay (UDS assay) in a routine diagnostic laboratory. 50 plasma samples, previously characterized by population sequencing and that had shown ≥1 resistance associated mutation (RAM), were retrospectively tested by the UDS assay, including 18 B and 32 non-B subtypes; viral loads between 114-1,806,407 cp/ml; drug-naive (n=27) and drug-experienced (n=23) individuals. The UDS assay was successful for 37/50 (74%) samples. It detected all RAMs found by population sequencing at frequencies above 20%. In addition, 39 low-frequency RAMs were exclusively detected by the UDS assay at frequencies below 20% in both drug-naïve (19/26, 73%) and drug-experienced (9/18, 50%) individuals. UDS results would lead to changes from susceptible to resistant to efavirenz (EFV) in one drug-naive individual with suboptimal response to an EFV-containing regimen and from susceptible to resistance to lamivudine (3TC) in one drug naïve subject who subsequently failed a 3TC-containing regimen and in a treatment experienced subject who had failed a 3TC-containing regimen. The UDS assay performed well across a wide range of subtypes and viral loads; it showed perfect agreement with population sequencing for all RAMs analyzed. In addition, the UDS assay detected additional mutations at frequencies below 20% which correlate with patients' treatment history and had in some cases important prognostic implications. Copyright © 2013 Elsevier B.V. All rights reserved.

  20. Clinical and laboratory evaluation of adrenal dysfunction

    International Nuclear Information System (INIS)

    Ashkar, F.S.; Fishman, L.M.

    1983-01-01

    Because of their special physical and chemical properties, the adrenal secretory products were among the first hormonal substances to be measured by methods other than bioassay. Over the past several years, the development of sensitive and specific methods of hormone assay dependent on the use of radionuclides has revolutionized investigative and clinical endocrinology. While the capacity of defining most abnormalities of adrenal function antedates hormone measurement and adrenal imaging utilizing radioisotopes, the availability of such methods has greatly facilitated and made more precise the diagnostic approach to patients with suspected adrenal dysfunction. As an example of how clinical and laboratory considerations can be integrated into a rational approach to the diagnosis of adrenal disease, the problem of suspected adrenal hyperfunction is analyzed in light of current understanding of its pathophysiology. Reflection demonstrates that suspected primary aldosteronism and adrenal insufficiency are equally amenable to such an approach

  1. Hidden sources of mercury in clinical laboratories.

    Science.gov (United States)

    Alvarez-Chavez, C R; Federico-Perez, R A; Gomez-Alvarez, A; Velazquez-Contreras, L E; Perez-Rios, R

    2014-09-01

    The healthcare sector is an important contributor to mercury (Hg) pollution because of the potential presence of mercury in thermometers, blood pressure cuffs, amalgams, etc. There are also other potential sources of mercury in this sector which are used frequently and in high volumes where the presence of the metal is not obvious and which might be collectively contributing to pollution. For instance, some chemicals used for the clinical diagnosis of illness may contain mercury. The goal of this study was to investigate potential sources of mercury pollution, which originate from clinical laboratory discharges, using an exploratory approach. The focus was on the residue generated during automatic analysis of patients' bodily fluids at a medical center in Hermosillo, Sonora, Mexico. This study shows an overview of what might be happening in the region or the country related to non-obvious sources of mercury in the healthcare sector. The results showed measurable levels of mercury in the residues coming from urine sediment analysis. These amounts do not exceed the maximum allowed by Mexican environmental regulations; nevertheless, the frequency and cumulative volume of residues generated, combined with the potential for persistence and the bioaccumulation of mercury in the environment, warrant attention. The work carried out in this study is being taken as a model for future studies for pollution prevention in the healthcare sector with the goal of measuring mercury emissions to the environment from clinical laboratory wastewater, including identifying sources which--while not obvious--could be important given the frequency and volume of their use in the clinical diagnosis.

  2. Experience of domestic violence routine screening in Family Planning NSW clinics.

    Science.gov (United States)

    Hunter, Tara; Botfield, Jessica R; Estoesta, Jane; Markham, Pippa; Robertson, Sarah; McGeechan, Kevin

    2017-04-01

    This study reviewed implementation of the Domestic Violence Routine Screening (DVRS) program at Family Planning NSW and outcomes of screening to determine the feasibility of routine screening in a family planning setting and the suitability of this program in the context of women's reproductive and sexual health. A retrospective review of medical records was undertaken of eligible women attending Family Planning NSW clinics between 1 January and 31 December 2015. Modified Poisson regression was used to estimate prevalence ratios and assess association between binary outcomes and client characteristics. Of 13440 eligible women, 5491 were screened (41%). Number of visits, clinic attended, age, employment status and disability were associated with completion of screening. In all, 220 women (4.0%) disclosed domestic violence. Factors associated with disclosure were clinic attended, age group, region of birth, employment status, education and disability. Women who disclosed domestic violence were more likely to have discussed issues related to sexually transmissible infections in their consultation. All women who disclosed were assessed for any safety concerns and offered a range of suitable referral options. Although routine screening may not be appropriate in all health settings, given associations between domestic violence and sexual and reproductive health, a DVRS program is considered appropriate in sexual and reproductive health clinics and appears to be feasible in a service such as Family Planning NSW. Consistent implementation of the program should continue at Family Planning NSW and be expanded to other family planning services in Australia to support identification and early intervention for women affected by domestic violence.

  3. Polycystic ovary syndrome: clinical and laboratory evaluation

    Directory of Open Access Journals (Sweden)

    Marcos Yorghi Khoury

    Full Text Available OBJECTIVE: To evaluate clinically, and with laboratory, tests, women with polycystic ovary syndrome (PCO. PATIENTS: One hundred and twelve women with PCO were studied. METHODS: The following data was recorded: Current age; age at menarche; menstrual irregularity, occurrence of similar cases in the family; fertility, obstetric history; body mass index (BMI; and presence of hirsutism. Serum measurements of follicle stimulating hormone (FSH, luteinizing hormone (LH, prolactin, free testosterone, and dehydroepiandrosterone sulfate were taken. RESULTS: All patients presented either oligomenorrhea (31 percent, periods of secondary amenorrhea (9 percent, or both alterations (60 percent. The majority of the patients were infertile (75.6 percent. The LH/FSH ratio was higher than 2:1 in 55 percent of the patients and higher than 3:1 in 26.2 percent. The ultrasonographic aspect of the ovaries was considered to be normal in 31 percent. CONCLUSION: The main clinical feature of the PCO is the irregularity of menses since menarche, and that the laboratory tests would be important to exclude other disorders such as hyperprolactinemia or hyperandrogenemia caused by late-onset congenital adrenal hyperplasia.

  4. Autovalidation and automation of the postanalytical phase of routine hematology and coagulation analyses in a university hospital laboratory.

    Science.gov (United States)

    Mlinaric, Ana; Milos, Marija; Coen Herak, Désirée; Fucek, Mirjana; Rimac, Vladimira; Zadro, Renata; Rogic, Dunja

    2018-02-23

    The need to satisfy high-throughput demands for laboratory tests continues to be a challenge. Therefore, we aimed to automate postanalytical phase in hematology and coagulation laboratory by autovalidation of complete blood count (CBC) and routine coagulation test results (prothrombin time [PT], international normalized ratio [PT-INR], activated partial thromboplastin time [APTT], fibrinogen, antithrombin activity [AT] and thrombin time [TT]). Work efficacy and turnaround time (TAT) before and after implementation of automated solutions will be compared. Ordering panels tailored to specific patient populations were implemented. Rerun and reflex testing rules were set in the respective analyzers' software (Coulter DxH Connectivity 1601, Beckman Coulter, FL, USA; AutoAssistant, Siemens Healthcare Diagnostics, Germany), and sample status information was transferred into the laboratory information system. To evaluate if the automation improved TAT and efficacy, data from manually verified results in September and October of 2015 were compared with the corresponding period in 2016 when autovalidation was implemented. Autovalidation rates of 63% for CBC and 65% for routine coagulation test results were achieved. At the TAT of 120 min, the percentage of reported results increased substantially for all analyzed tests, being above 90% for CBC, PT, PT-INR and fibrinogen and 89% for APTT. This output was achieved with three laboratory technicians less compared with the period when the postanalytical phase was not automated. Automation allowed optimized laboratory workflow for specific patient populations, thereby ensuring standardized results reporting. Autovalidation of test results proved to be an efficient tool for improvement of laboratory work efficacy and TAT.

  5. Mass Spectrometry in Clinical Laboratory: Applications in Therapeutic Drug Monitoring and Toxicology.

    Science.gov (United States)

    Garg, Uttam; Zhang, Yan Victoria

    2016-01-01

    Mass spectrometry (MS) has been used in research and specialized clinical laboratories for decades as a very powerful technology to identify and quantify compounds. In recent years, application of MS in routine clinical laboratories has increased significantly. This is mainly due to the ability of MS to provide very specific identification, high sensitivity, and simultaneous analysis of multiple analytes (>100). The coupling of tandem mass spectrometry with gas chromatography (GC) or liquid chromatography (LC) has enabled the rapid expansion of this technology. While applications of MS are used in many clinical areas, therapeutic drug monitoring, drugs of abuse, and clinical toxicology are still the primary focuses of the field. It is not uncommon to see mass spectrometry being used in routine clinical practices for those applications.

  6. Laboratory research at the clinical trials of Veterinary medicinal Products

    OpenAIRE

    ZHYLA M.I.

    2011-01-01

    The article analyses the importance of laboratory test methods, namely pathomorfological at conduct of clinical trials. The article focuses on complex laboratory diagnostics at determination of clinical condition of animals, safety and efficacy of tested medicinal product.

  7. Prevalence and clinical significance of neutropenia discovered in routine complete blood cell counts: a longitudinal study

    DEFF Research Database (Denmark)

    Andersen, Christen Bertel L; Tesfa, D.; Siersma, Volkert Dirk

    2016-01-01

    BACKGROUND: Neutropenia, defined as an absolute blood neutrophil count (ANC) neutropenia detected in a routine complete blood cell count is poorly understood. METHODS: Using a primary care resource, comprising...... more than 370 000 individuals, we assessed the association with a number of previously recognized conditions as well as all-cause mortality in the 4 years following the identification of neutropenia. By matching laboratory data with Danish nationwide health registers, risk estimates were assessed....... RESULTS: Neutropenia was observed in approximately 1% of all individuals and was associated dose dependently with viral infections, haematological malignancies (but not autoimmune disorders or solid cancers) and mortality. Neutropenia was particularly associated with HIV, acute leukaemias...

  8. Clinical laboratory analytics: Challenges and promise for an emerging discipline

    Directory of Open Access Journals (Sweden)

    Brian H Shirts

    2015-01-01

    Full Text Available The clinical laboratory is a major source of health care data. Increasingly these data are being integrated with other data to inform health system-wide actions meant to improve diagnostic test utilization, service efficiency, and "meaningful use." The Academy of Clinical Laboratory Physicians and Scientists hosted a satellite meeting on clinical laboratory analytics in conjunction with their annual meeting on May 29, 2014 in San Francisco. There were 80 registrants for the clinical laboratory analytics meeting. The meeting featured short presentations on current trends in clinical laboratory analytics and several panel discussions on data science in laboratory medicine, laboratory data and its role in the larger healthcare system, integrating laboratory analytics, and data sharing for collaborative analytics. One main goal of meeting was to have an open forum of leaders that work with the "big data" clinical laboratories produce. This article summarizes the proceedings of the meeting and content discussed.

  9. Radiation protection in clinical chemical laboratories

    International Nuclear Information System (INIS)

    Jacob, K.

    1980-01-01

    In the clinical-chemical laboratory, the problems of the personal radiation protection can be handled relatively simply. Important conditions are certain requirements as far as the building is concerned and the keeping to protection measures to invoid ingestion, inhalation, and resorption of open radioactive substances. Very intensive attention must be paid to a clean working technique in order to be able to exclude the danger of contamination which is very disturbing during the extremely sensitive measurements. The higgest problem in the handling of open radioactive substances, however, is in our opinion the waste management because it requires which space and personnel this causing high costs. Furthermore, since 1 January 1979, the permission for the final storage of radioactive waste in the shut down mine ASSE was taken back from the county collection places and it cannot be said yet if and when this permission will be given again. (orig./HP) [de

  10. Near-drowning and clinical laboratory changes.

    Science.gov (United States)

    Oehmichen, Manfred; Hennig, Renate; Meissner, Christoph

    2008-01-01

    Opposite to clinical laboratory findings in experimental drowning of animals (erythrocytic lysis, hyperkalemia, and final cardial fibrillation) are the observations in drowned humans (increase of pCO2, hypoxic encephalopathy), which leads to a different pathophysiological interpretation of the drowning process. This process, however, is recently discussed again, therefore an additional study seemed to be recommended. In a retrospective study, 31 cases of near-drowning (23 cases: fresh water; 8 cases: brackish water) clinical laboratory data were analysed. While 21 of the cases were fatal with a delay of up to 180 days, 10 individuals survived the accident, four cases with severe neurological deficits. Data of pH, potassium, sodium, chloride, hemoglobin and total protein were collected during the very early post-drowning period. Nearly all cases (96%) revealed a reduction of pH due to hypoxic acidosis, and only two cases (6.5%) exhibited a slight hyperkalemia. The hemoglobin level was normal in most of the cases (83%) and slightly reduced in the others (17%) while the protein level was slightly reduced in most of the fatalities (80%). As a result of our investigation we have to state the lack of hyperkalemia as well as of an increase of the hemoglobin level indicate that there is no distinct intravascular red cell lysis due to influx of water into the vascular compartment. Therefore the death by drowning in humans in most cases is the result of a hypoxic cerebral process. A comparison with animal experiments obviously is not helpful because the drowning process in humans leads to an aspiration of only 2-4 ml water/kg, while in animal experiments more than 10 ml water/kg will be artificially aspirated leading to red cell lysis as well as to electrolyte disturbances and cardial fibrillation.

  11. Use of standard laboratory methods to obviate routine dithiothreitol treatment of blood samples with daratumumab interference.

    Science.gov (United States)

    Lintel, Nicholas J; Brown, Debra K; Schafer, Diane T; Tsimba-Chitsva, Farai M; Koepsell, Scott A; Shunkwiler, Sara M

    2017-01-01

    Daratumumab is an antibody currently used in the treatment of patients with refractory multiple myeloma. Blood samples from patients being treated with daratumumab may show panreactivity during pre-transfusion testing. To facilitate the provision of blood components for such patients, it is recommended that a baseline phenotype or genotype be established prior to starting treatment with daratumumab. If patient red blood cells (RBCs) require phenotyping after the start of daratumumab treatment, dithiothreitol (DTT) treatment of the patient's RBCs should be performed. The medical charts of four patients treated with daratumumab were reviewed. The individual number of doses ranged from 1 to 14; patient age ranged from 55 to 78 years; two men and two women were included in the review. Type and screen data were obtained from samples collected over 33 encounters with a range of 1 to 13 encounters per patient. All samples were tested initially by automated solid-phase testing. Any reactivity with solid phase led to tube testing with either low-ionic-strength saline, polyethylene glycol, or both. If incubation failed to eliminate the reactivity, the sample was sent to a reference laboratory for DTT treatment and phenotyping. Of the 33 samples tested, 23 (69.7%) samples had reactivity in solid-phase testing. In 8 of the 10 samples that did not react in solid-phase, testing was conducted more than four half-lives after the last dose of daratumumab. Of the 23 that had reactivity in solid-phase, 16 (69.6%) samples demonstrated loss of reactivity using common laboratory methods. For the seven patients whose sample reactivity was not initially eliminated, six were provided with phenotypically matched blood based on prior molecular testing. Only one sample was sent out for DTT treatment. These results suggest that daratumumab interference with pre-transfusion testing can be addressed using common laboratory methods. This finding could save time and money for laboratories that do

  12. Bringing ayahuasca to the clinical research laboratory.

    Science.gov (United States)

    Riba, Jordi; Barbanoj, Manel J

    2005-06-01

    Since the winter of 1999, the authors and their research team have been conducting clinical studies involving the administration of ayahuasca to healthy volunteers. The rationale for conducting this kind of research is twofold. First, the growing interest of many individuals for traditional indigenous practices involving the ingestion of natural psychotropic drugs such as ayahuasca demands the systematic study of their pharmacological profiles in the target species, i.e., human beings. The complex nature of ayahuasca brews combining a large number of pharmacologically active compounds requires that research be carried out to establish the safety and overall pharmacological profile of these products. Second, the authors believe that the study of psychedelics in general calls for renewed attention. Although the molecular and electrophysiological level effects of these drugs are relatively well characterized, current knowledge of the mechanisms by which these compounds modify the higher order cognitive processes in the way they do is still incomplete, to say the least. The present article describes the development of the research effort carried out at the Autonomous University of Barcelona, commenting on several methodological aspects and reviewing the basic clinical findings. It also describes the research currently underway in our laboratory, and briefly comments on two new studies we plan to undertake in order to further our knowledge of the pharmacology of ayahuasca.

  13. Routine clinical heart examinations using SQUID magnetocardiography at University of Tsukuba Hospital

    Science.gov (United States)

    Inaba, T.; Nakazawa, Y.; Yoshida, K.; Kato, Y.; Hattori, A.; Kimura, T.; Hoshi, T.; Ishizu, T.; Seo, Y.; Sato, A.; Sekiguchi, Y.; Nogami, A.; Watanabe, S.; Horigome, H.; Kawakami, Y.; Aonuma, K.

    2017-11-01

    A 64-channel Nb-based DC-SQUID magnetocardiography (MCG) system was installed at the University of Tsukuba Hospital (UTH) in March 2007 after obtaining Japanese pharmaceutical approval and insurance reimbursement approval. In the period between 2008 and 2016, the total number of patients was 10 085. The heart diseases diagnosed in fetuses as well as adults are mainly atrial arrhythmia, abnormal repolarization, ventricular arrhythmia, and fetal arrhythmia. In most cases of insufficient diagnostic accuracy with electrocardiography, SQUID MCG precisely revealed these heart diseases as an abnormal electrical current distribution. Based on success in routine examinations, SQUID MCG is now an indispensable clinical instrument with diagnostic software tuned up during routine use at UTH.

  14. Real-time patient survey data during routine clinical activities for rapid-cycle quality improvement.

    Science.gov (United States)

    Wofford, James Lucius; Campos, Claudia L; Jones, Robert E; Stevens, Sheila F

    2015-03-12

    Surveying patients is increasingly important for evaluating and improving health care delivery, but practical survey strategies during routine care activities have not been available. We examined the feasibility of conducting routine patient surveys in a primary care clinic using commercially available technology (Web-based survey creation, deployment on tablet computers, cloud-based management of survey data) to expedite and enhance several steps in data collection and management for rapid quality improvement cycles. We used a Web-based data management tool (survey creation, deployment on tablet computers, real-time data accumulation and display of survey results) to conduct four patient surveys during routine clinic sessions over a one-month period. Each survey consisted of three questions and focused on a specific patient care domain (dental care, waiting room experience, care access/continuity, Internet connectivity). Of the 727 available patients during clinic survey days, 316 patients (43.4%) attempted the survey, and 293 (40.3%) completed the survey. For the four 3-question surveys, the average time per survey was overall 40.4 seconds, with a range of 5.4 to 20.3 seconds for individual questions. Yes/No questions took less time than multiple choice questions (average 9.6 seconds versus 14.0). Average response time showed no clear pattern by order of questions or by proctor strategy, but monotonically increased with number of words in the question (30 words)-8.0, 11.8, 16.8, seconds, respectively. This technology-enabled data management system helped capture patient opinions, accelerate turnaround of survey data, with minimal impact on a busy primary care clinic. This new model of patient survey data management is feasible and sustainable in a busy office setting, supports and engages clinicians in the quality improvement process, and harmonizes with the vision of a learning health care system.

  15. Routine habitat change: a source of unrecognized transient alteration of intestinal microbiota in laboratory mice.

    Science.gov (United States)

    Ma, Betty W; Bokulich, Nicholas A; Castillo, Patricia A; Kananurak, Anchasa; Underwood, Mark A; Mills, David A; Bevins, Charles L

    2012-01-01

    The mammalian intestine harbors a vast, complex and dynamic microbial population, which has profound effects on host nutrition, intestinal function and immune response, as well as influence on physiology outside of the alimentary tract. Imbalance in the composition of the dense colonizing bacterial population can increase susceptibility to various acute and chronic diseases. Valuable insights on the association of the microbiota with disease critically depend on investigation of mouse models. Like in humans, the microbial community in the mouse intestine is relatively stable and resilient, yet can be influenced by environmental factors. An often-overlooked variable in research is basic animal husbandry, which can potentially alter mouse physiology and experimental outcomes. This study examined the effects of common husbandry practices, including food and bedding alterations, as well as facility and cage changes, on the gut microbiota over a short time course of five days using three culture-independent techniques, quantitative PCR, terminal restriction fragment length polymorphism (TRFLP) and next generation sequencing (NGS). This study detected a substantial transient alteration in microbiota after the common practice of a short cross-campus facility transfer, but found no comparable alterations in microbiota within 5 days of switches in common laboratory food or bedding, or following an isolated cage change in mice acclimated to their housing facility. Our results highlight the importance of an acclimation period following even simple transfer of mice between campus facilities, and highlights that occult changes in microbiota should be considered when imposing husbandry variables on laboratory animals.

  16. Clinical and para-clinical tests in the routine examination of headache patients

    DEFF Research Database (Denmark)

    Friberg, L; Sandrini, G; Jänig, W

    2000-01-01

    Para-clinical examinations in the diagnosis and treatment control of headache patients vary considerably between clinics and headache centers. Among the neurological societies in Europe there has been a consensus that some common procedures and recommendations should be created. In the Fall of 19...

  17. Nontyphoidal Salmonella: An Occupational Hazard for Clinical Laboratory Workers

    OpenAIRE

    Barker, Anna; Duster, Megan; Van Hoof, Sarah; Safdar, Nasia

    2015-01-01

    Laboratory-acquired infections due to nontyphoidal Salmonella are rare. Yet, recent outbreaks in microbiology teaching laboratories show that these species are still an appreciable occupational hazard for laboratory employees. This article presents two cases of nontyphoidal Salmonella that occurred at the authors' institution—an infected patient and a clinical laboratory worker who acquired the infection by handling this patient's specimens.

  18. Comparison of different references for brain perfusion SPECT quantification in clinical routine

    International Nuclear Information System (INIS)

    Olivera J, P.; Acton, P.; Costa, D.

    1997-01-01

    Full text: We used 40 brain perfusion SPECT studies from the INM, UCL database to investigate the performance of several references (denominators) in the calculation of perfusion ratios with single photon emission tomography (S PET) within a routine clinical service. According to clinical diagnosis and previous SPECT findings 4 groups were identified composed of: 10 controls (C, 23 to 84 y old); 10 myalgic-encephalomyelitis / chronic fatigue syndrome (ME/CFS, 22 to 61 y old); 10 major depression (MD, 24 to 68 y old); and 10 temporal lobe epilepsy (TLE, 19 to 39 y old). Routine protocols for processing were used and the analysis was blind to group classification. Brain perfusion ratios were calculated using 7 different references: hemi cerebellum with higher counts (Cer), total counts in a 4 pixel slice through the basal ganglia slice (BG), average counts per pixel in the visual cortex (VC), average counts per pixel in the white matter (WM), total acquired counts (TAC), total reconstructed counts (TRC) and maximum counts per pixel in the entire study (MAXX). Unpaired test to compare different diagnostic groups, coefficient of variation (CV) to assess the reliability to each references followed by ANOVA were the statistical test used. The lowest mean CV's were found with VC (4.8%) and TRC (5.1%), with all the others significantly higher (p<0.0001). The range of CV's for Cer was the lowest (3.7% to 5.9%). Consistent differentiation between diagnostic groups and controls was only obtained with Cer. In conclusion, it appears that for clinical routine services Cer is the most reliable reference, exception made for all diseases affecting the cerebellum. In these cases TRC or VC should be preferred. (authors)

  19. Rivaroxaban for venous thromboembolism prevention after major orthopedic surgery: translating trial data into routine clinical practice

    Directory of Open Access Journals (Sweden)

    Beyer-Westendorf J

    2017-01-01

    Full Text Available Jan Beyer-Westendorf,1 Patrick Mouret,2 Alexander GG Turpie3 1Thrombosis Research and Angiology, Dresden University Clinic, Dresden, Germany; 2Orthopedic Clinic, Klinikum Frankfurt Höchst GmbH, Frankfurt, Germany; 3Department of Medicine, General Division, Hamilton Health Sciences, Hamilton, ON, Canada Abstract: An established standard of care for the prevention of venous thromboembolism after major orthopedic surgery has been subcutaneous low-molecular-weight heparin. The non-vitamin K antagonist oral anticoagulant rivaroxaban has demonstrated superior efficacy and similar safety to all tested regimens of enoxaparin in large Phase III clinical studies of venous thromboembolism prevention after elective hip and knee arthroplasty. Despite regulatory approval of rivaroxaban for this indication, concerns remain among physicians regarding its optimal and effective use in routine clinical practice. Real-life studies, such as XAMOS and ORTHO-TEP, are providing physicians with more information on the routine use of rivaroxaban for venous thromboembolism prevention after orthopedic surgery, helping to establish its safety and effectiveness in everyday clinical care. Among the most important issues are the risk of bleeding complications, wound healing, timing of first dose, impact of type of anesthesia on thromboprophylaxis effectiveness, patient comorbidities and comedication use, periprocedural management, associated costs, and clinical outcomes in trauma-related fractures. Many of these issues are difficult to study in randomized, double-blind, Phase III trials, and can be assessed more readily using real-life data. In particular, real-life or noninterventional studies lack many of the strict inclusion and exclusion criteria associated with Phase III trials and involve unselected patients who often present with significant comorbidities or comedication use. Keywords: anticoagulants, arthroplasty, orthopedics, rivaroxaban, thrombosis

  20. SPIRIT: Systematic Planning of Intelligent Reuse of Integrated Clinical Routine Data. A Conceptual Best-practice Framework and Procedure Model.

    Science.gov (United States)

    Hackl, W O; Ammenwerth, E

    2016-01-01

    Secondary use of clinical routine data is receiving an increasing amount of attention in biomedicine and healthcare. However, building and analysing integrated clinical routine data repositories are nontrivial, challenging tasks. As in most evolving fields, recognized standards, well-proven methodological frameworks, or accurately described best-practice approaches for the systematic planning of solutions for secondary use of routine medical record data are missing. We propose a conceptual best-practice framework and procedure model for the systematic planning of intelligent reuse of integrated clinical routine data (SPIRIT). SPIRIT was developed based on a broad literature overview and further refined in two case studies with different kinds of clinical routine data, including process-oriented nursing data from a large hospital group and high-volume multimodal clinical data from a neurologic intensive care unit. SPIRIT aims at tailoring secondary use solutions to specific needs of single departments without losing sight of the institution as a whole. It provides a general conceptual best-practice framework consisting of three parts: First, a secondary use strategy for the whole organization is determined. Second, comprehensive analyses are conducted from two different viewpoints to define the requirements regarding a clinical routine data reuse solution at the system level from the data perspective (BOTTOM UP) and at the strategic level from the future users perspective (TOP DOWN). An obligatory clinical context analysis (IN BETWEEN) facilitates refinement, combination, and integration of the different requirements. The third part of SPIRIT is dedicated to implementation, which comprises design and realization of clinical data integration and management as well as data analysis solutions. The SPIRIT framework is intended to be used to systematically plan the intelligent reuse of clinical routine data for multiple purposes, which often was not intended when the

  1. Artificial neural networks to predict presence of significant pathology in patients presenting to routine colorectal clinics.

    Science.gov (United States)

    Maslekar, S; Gardiner, A B; Monson, J R T; Duthie, G S

    2010-12-01

    Artificial neural networks (ANNs) are computer programs used to identify complex relations within data. Routine predictions of presence of colorectal pathology based on population statistics have little meaning for individual patient. This results in large number of unnecessary lower gastrointestinal endoscopies (LGEs - colonoscopies and flexible sigmoidoscopies). We aimed to develop a neural network algorithm that can accurately predict presence of significant pathology in patients attending routine outpatient clinics for gastrointestinal symptoms. Ethics approval was obtained and the study was monitored according to International Committee on Harmonisation - Good Clinical Practice (ICH-GCP) standards. Three-hundred patients undergoing LGE prospectively completed a specifically developed questionnaire, which included 40 variables based on clinical symptoms, signs, past- and family history. Complete data sets of 100 patients were used to train the ANN; the remaining data was used for internal validation. The primary output used was positive finding on LGE, including polyps, cancer, diverticular disease or colitis. For external validation, the ANN was applied to data from 50 patients in primary care and also compared with the predictions of four clinicians. Clear correlation between actual data value and ANN predictions were found (r = 0.931; P = 0.0001). The predictive accuracy of ANN was 95% in training group and 90% (95% CI 84-96) in the internal validation set and this was significantly higher than the clinical accuracy (75%). ANN also showed high accuracy in the external validation group (89%). Artificial neural networks offer the possibility of personal prediction of outcome for individual patients presenting in clinics with colorectal symptoms, making it possible to make more appropriate requests for lower gastrointestinal endoscopy. © 2010 The Authors. Colorectal Disease © 2010 The Association of Coloproctology of Great Britain and Ireland.

  2. The clinical value of daily routine chest radiographs in a mixed medical-surgical intensive care unit is low

    NARCIS (Netherlands)

    Graat, Marleen E.; Choi, Goda; Wolthuis, Esther K.; Korevaar, Johanna C.; Spronk, Peter E.; Stoker, Jaap; Vroom, Margreeth B.; Schultz, Marcus J.

    2006-01-01

    INTRODUCTION: The clinical value of daily routine chest radiographs (CXRs) in critically ill patients is unknown. We conducted this study to evaluate how frequently unexpected predefined major abnormalities are identified with daily routine CXRs, and how often these findings lead to a change in care

  3. Pyelonephritis in Pregnancy: Clinical and Laboratorial Aspects and Perinatal Results.

    Science.gov (United States)

    Zanatta, Djulie Anne de Lemos; Rossini, Mariane de Mello; Trapani Júnior, Alberto

    2017-12-01

    Objective  To identify the prevalence of pyelonephritis during pregnancy and to analyze the clinical and laboratorial aspects, perinatal results and complications. Methods  A transversal study of 203 pregnant women who had pyelonephritis during pregnancy and whose labor took place between 2010 and 2016 at a hospital in the state of Santa Catarina, Brazil. The analysis was based on medical records as well as on the hospital's database. Clinical and laboratory conditions, antibiotics, bacterial resistance, perinatal outcomes and complications were all taken into account. The data was compared using the Mann-Whitney test and the Chi-square test. Results  A prevalence of 1.97% with pyelonephritis was evidenced, with most patients having it during the second trimester of gestation. The bacteria most commonly found in the urine cultures was Escherichia coli , in 76.6% of cases, followed by Klebsiella pneumoniae (8.7%). Ceftriaxone had the lowest bacterial resistance (only 3.5% of the cases). On the other hand, ampicillin and cephalothin presented higher bacterial resistance, 52% and 36.2%, respectively. The risk of very premature delivery was more than 50% higher in patients with pyelonephritis. Conclusion  Ampicillin and first-generation cephalosporins are associated with a higher bacterial resistance while ceftriaxone proved to have a high efficacy for the treatment of pyelonephritis due to low bacterial resistance. Patients with pyelonephritis showed a higher risk for very premature delivery (< 32 weeks). In this casuistry, there were no others significant differences in the overall perinatal outcomes when compared with the routine service series. Thieme Revinter Publicações Ltda Rio de Janeiro, Brazil.

  4. [The future of clinical laboratory database management system].

    Science.gov (United States)

    Kambe, M; Imidy, D; Matsubara, A; Sugimoto, Y

    1999-09-01

    To assess the present status of the clinical laboratory database management system, the difference between the Clinical Laboratory Information System and Clinical Laboratory System was explained in this study. Although three kinds of database management systems (DBMS) were shown including the relational model, tree model and network model, the relational model was found to be the best DBMS for the clinical laboratory database based on our experience and developments of some clinical laboratory expert systems. As a future clinical laboratory database management system, the IC card system connected to an automatic chemical analyzer was proposed for personal health data management and a microscope/video system was proposed for dynamic data management of leukocytes or bacteria.

  5. Frequency of vaginal candidiasis in pregnant women attending routine antenatal clinic

    International Nuclear Information System (INIS)

    Parveen, N.; Munir, A.A.; Majeed, R.

    2008-01-01

    To determine the frequency of vaginal candidiasis in clinically symptomatic and asymptomatic cases of pregnant women attending routine antenatal clinic. A total of 110 pregnant women were nonrandomly recruited by convenient sampling. The studied variables included the demographic data information on parity, trimester of pregnancy, presence of vaginal discharge and the presence or absence of diabetes. Vulva and vagina were inspected for signs of inflammation and discharge with sterile speculum and vaginal specimens were collected with sterile cotton tipped swabs. Swabs were subjected to Gram staining and examined microscopically for the diagnosis of candidiasis. The frequency of vaginal candidiasis during pregnancy was found to be 38%, in which 27% were symptomatic and 11% were asymptomatic group. Increased ratio of infection was observed in multigravida and diabetic women. There was no marked differences in results with respect to age and trimester of pregnancy. Although there is generally a high frequency of vaginal candidiasis, an increased ratio of vaginal candidiasis in multigravida and diabetic pregnant women requires these women to be routinely screened for vaginal candidiasis regardless of symptomatic status. (author)

  6. Immediate bromodeoxyuridine labelling of unseparated human bone marrow cells ex vivo is superior to labelling after routine laboratory processing

    DEFF Research Database (Denmark)

    Jensen, P O; Mortensen, B T; Christensen, I J

    1998-01-01

    It is important to evaluate the proliferation of bone marrow cells in several disease conditions and during treatment of patients with for example cytokines. Labelling with bromodeoxyuridine (BrdUrd), immunocytochemical staining with anti-BrdUrd antibody and analysis by flow cytometry provides...... a reliable and reproducible technique for estimation of the fraction of cells that incorporated BrdUrd into DNA during S-phase. We have compared immediate BrdUrd labelling of unseparated bone marrow cells with the previously used labelling in the laboratory after routine separation of the mononuclear cells....... Bone marrow aspirates from seven lymphoma patients without bone marrow involvement were studied with these two methods. We found higher BrdUrd labelling indices (LI) in the mononuclear cells, when cells were labelled immediately. A large variation in LI was found between patients. Our results suggest...

  7. Medical Service Clinical Laboratory Procedure--Hematology.

    Science.gov (United States)

    Department of the Army, Washington, DC.

    Presented are laboratory studies focusing on blood cells and the complete scheme of blood coagulation. Formed is the basis for the following types of laboratory operations: (1) distinguishing the morphology of normal and abnormal blood cells; (2) measuring the concentrations or number of blood cells; (3) measuring concentration and detecting…

  8. Lactate point-of-care testing for acidosis: Cross-comparison of two devices with routine laboratory results

    Directory of Open Access Journals (Sweden)

    Remco van Horssen

    2016-04-01

    Full Text Available Objectives: Lactate is a major parameter in medical decision making. During labor, it is an indicator for fetal acidosis and immediate intervention. In the Emergency Department (ED, rapid analysis of lactate/blood gas is crucial for optimal patient care. Our objectives were to cross-compare-for the first time-two point-of-care testing (POCT lactate devices with routine laboratory results using novel tight precision targets and evaluate different lactate cut-off concentrations to predict metabolic acidosis. Design and methods: Blood samples from the delivery room (n=66 and from the ED (n=85 were analyzed on two POCT devices, the StatStrip-Lactate (Nova Biomedical and the iSTAT-1 (CG4+ cassettes, Abbott, and compared to the routine laboratory analyzer (ABL-735, Radiometer. Lactate concentrations were cross-compared between these analyzers. Results: The StatStrip correlated well with the ABL-735 (R=0.9737 and with the iSTAT-1 (R=0.9774 for lactate in umbilical cord blood. Lactate concentrations in ED samples measured on the iSTAT-1 and ABL-735 showed a correlation coefficient of R=0.9953. Analytical imprecision was excellent for lactate and pH, while for pO2 and pCO2 the coefficient of variation was relatively high using the iSTAT-1. Conclusion: Both POCT devices showed adequate analytical performance to measure lactate. The StatStrip can indicate metabolic acidosis in 1 μl blood and will be implemented at the delivery room. Keywords: Lactate, Point-of-care testing, Blood gas, Fetal acidosis

  9. Review of clinical and laboratory features of human Brucellosis

    Directory of Open Access Journals (Sweden)

    Mantur B

    2007-01-01

    Full Text Available Infection with Brucella spp. continues to pose a human health risk globally despite strides in eradicating the disease from domestic animals. Brucellosis has been an emerging disease since the discovery of Brucella melitensis by Sir David Bruce in 1887. Although many countries have eradicated B. abortus from cattle, in some areas B. melitensis and B. suis have emerged as causes of this infection in cattle, leading to human infections. Currently B. melitensis remains the principal cause of human brucellosis worldwide including India. The recent isolation of distinct strains of Brucella from marine mammals as well as humans is an indicator of an emerging zoonotic disease. Brucellosis in endemic and non-endemic regions remains a diagnostic puzzle due to misleading non-specific manifestations and increasing unusual presentations. Fewer than 10% of human cases of brucellosis may be clinically recognized and treated or reported. Routine serological surveillance is not practiced even in Brucella - endemic countries and we suggest that this should be a part of laboratory testing coupled with a high index of clinical suspicion to improve the level of case detection. The screening of family members of index cases of acute brucellosis in an endemic area should be undertaken to pick up additional unrecognised cases. Rapid and reliable, sensitive and specific, easy to perform and automated detection systems for Brucella spp. are urgently needed to allow early diagnosis and adequate antibiotic therapy in time to decrease morbidity / mortality. The history of travel to endemic countries along with exposure to animals and exotic foods are usually critical to making the clinical diagnosis. Laboratory testing is indispensable for diagnosis. Therefore alertness of clinician and close collaboration with microbiologist are essential even in endemic areas to correctly diagnose and treat this protean human infection. Existing treatment options, largely based on

  10. Clinical and laboratory features of hepatocellular carcinoma

    Directory of Open Access Journals (Sweden)

    Andrés Cárdenas

    2007-02-01

    Full Text Available

    The clinical presentation of hepatocellular carcinoma (HCC differs between patients in developing countries (African and Chinese populations from those in industrialized countries. In industrialized countries, HCC co-exists with symptomatic cirrhosis in 80% of cases and clinical manifestations are usually related to those of the underlying disease. On the other hand, patients from developing countries have HCC and cirrhosis in approximately 40% of cases. Underlying cirrhosis in many cases is not advanced and does not produce any symptoms or associated symptoms are masked by those of the tumor (right upper quadrant pain, mass in the upper abdomen, weight loss and weakness. In a subset of patients, there are no clinical manifestations as HCC may occur in the context of hepatitis B infection without cirrhosis.

    Clinical Manifestations

    In Western countries, nearly 35% percent of patients with HCC are asymptomatic. Some of the most common clinical manifestations include: abdominal pain (53-58% of patients, especially in epigastrium or right upper quadrant, abdominal mass (30%, weight loss, malaise, anorexia, cachexia, jaundice or fever.

    Physical Exam

    Physical findings vary with the stage of disease. The patient may exhibit slight or moderate wasting when first seen. In patients with cirrhosis, typical stigmata of chronic liver disease may be present. In advanced stages of HCC the liver may be enlarged and there is significant tenderness. An arterial bruit may be heard over the liver

  11. Utility of repeat testing of critical values: a Q-probes analysis of 86 clinical laboratories.

    Science.gov (United States)

    Lehman, Christopher M; Howanitz, Peter J; Souers, Rhona; Karcher, Donald S

    2014-06-01

    A common laboratory practice is to repeat critical values before reporting the test results to the clinical care provider. This may be an unnecessary step that delays the reporting of critical test results without adding value to the accuracy of the test result. To determine the proportions of repeated chemistry and hematology critical values that differ significantly from the original value as defined by the participating laboratory, to determine the threshold differences defined by the laboratory as clinically significant, and to determine the additional time required to analyze the repeat test. Participants prospectively reviewed critical test results for 4 laboratory tests: glucose, potassium, white blood cell count, and platelet count. Participants reported the following information: initial and repeated test result; time initial and repeat results were first known to laboratory staff; critical result notification time; if the repeat result was still a critical result; if the repeat result was significantly different from the initial result, as judged by the laboratory professional or policy; significant difference threshold, as defined by the laboratory; the make and model of the instrument used for primary and repeat testing. Routine, repeat analysis of critical values is a common practice. Most laboratories did not formally define a significant difference between repeat results. Repeated results were rarely considered significantly different. Median repeated times were at least 17 to 21 minutes for 10% of laboratories. Twenty percent of laboratories reported at least 1 incident in the last calendar year of delayed result reporting that clinicians indicated had adversely affected patient care. Routine repeat analysis of automated chemistry and hematology critical values is unlikely to be clinically useful and may adversely affect patient care.

  12. [How do hospital clinical laboratories and laboratory testing companies cooperate and build reciprocal relations?].

    Science.gov (United States)

    Kawano, Seiji

    2014-12-01

    As the 2nd Joint Symposium of the Japanese Society of Laboratory Medicine and the Japanese Association of Laboratory Pathologists, the symposium on clinical test out-sourcing and branch laboratories was held at the 60th General Meeting of the Japanese Society of Laboratory Medicine on November 2nd, 2013 in Kobe. For the symposium, we conducted a questionnaire survey on the usage of clinical test out-sourcing and the introduction of branch laboratories to clinical laboratories of Japanese university hospitals, both private and public, between July 25th and August 20th, 2013. Seventy-two hospitals responded to the questionnaire survey, consisting of 41 public medical school hospitals and 31 private ones. According to the survey, the selection of each clinical test for out-sourcing was mainly determined by the capacities of hospital clinical laboratories and their equipment, as well as the profitability of each test. The main concerns of clinical laboratory members of university hospitals involved the continuity of measurement principles, traceability, and standardization of reference values for each test. They strongly requested the interchangeability and computerization of test data between laboratory testing companies. A branch laboratory was introduced to six hospitals, all of which were private medical college hospitals, out of 72 university hospitals, and eight of the other hospitals were open to its introduction. The merits and demerits of introducing a branch laboratory were also discussed. (Review).

  13. Implementing Functional Preoperative Mapping in the Clinical Routine of a Neurosurgical Department: Technical Note.

    Science.gov (United States)

    Sollmann, Nico; Meyer, Bernhard; Krieg, Sandro M

    2017-07-01

    Navigated transcranial magnetic stimulation (nTMS) is increasingly being used for mapping of various brain functions and in nTMS-based tractography in neurosurgical departments worldwide. When a department begins using nTMS data in the clinical workflow, smooth integration into the hospital's existing infrastructure is mandatory. Standardized approaches for this beyond the mapping or tractography procedures themselves have not yet been described. To create an effective workflow for neurosurgical nTMS mapping, we present the findings of our 7 years of experience and progressive integration into the clinical routine. After indication for mapping is made, the workflow starts with patient admission and includes all preoperative steps until tumor resection. Importantly, only standard software and devices were used, enabling new centers to easily integrate data derived from nTMS mapping and nTMS-based tractography into their hospital's infrastructure. Registration of the patient, appointment planning, and documentation of results of the nTMS procedures within the hospital information system (HIS) can be achieved by a novel tailored software mask. As another important part of the workflow, nTMS data are imported into the picture archiving and communication system (PACS) via PACS integrator software. In addition, for surgical planning including nTMS-based tractography, nTMS data can be effectively included in surgical neuronavigation software. Optimized integration of nTMS data can be achieved using a standardized workflow. The seamless integration and availability of nTMS data are crucial to the acceptance of these data in the clinical routine. This optimized workflow can serve as a guide for centers beginning to use nTMS data in patient care. Copyright © 2017 Elsevier Inc. All rights reserved.

  14. Adherence to fesoterodine in women with overactive bladder in routine clinical practice.

    Science.gov (United States)

    Simó, M; Porta, O; Pubill, J; Castillo, M T; Mora, I; Huguet, E; Ortega, J A; Martínez, E

    2015-05-01

    To assess the short-term compliance with fesoterodine treatment and to identify the reasons for lack of adherence and discontinuation in routine clinical practice. The secondary aim was to estimate the patient-reported outcomes. This was an observational retrospective, multicenter study conducted in a sample of women with overactive bladder on fesoterodine treatment for at least three months. Adherence to medication was assessed using the Morisky-Green test. Patient-reported outcomes were assessed using the Incontinence Questionnaire Short Form (ICIQ-SF), Overactive Bladder Questionnaire Short Form (OAB-qSF), and Treatment Benefit Scale (TBS). One hundred and twenty women with a mean age [standard deviation (SD)] of 62.2 (12.0) years with severe OAB [mean (SD) ICIQ-SF score 13.2 (4.0)] were included. 42.1% of the patients were considered compliant with fesoterodine treatment. The main causes for non-compliance/discontinuation stated by the remaining 57.9% of the patients were adverse events (62.2%) and lack of clinical benefits (20.0%). The illness status as well as the patient-perceived bother occasioned by the OAB symptoms and their impact on the quality of life improved significantly after three months on fesoterodine treatment (p<0.0001). Most of the patients stated that the current state of their urinary problems had greatly improved/ improved. In routine clinical practice, a high percentage of patients were adherent to fesoterodine and perceived the benefit that the treatment provided them three months after starting treatment. However, more than half of the study population failed to comply or discontinued the treatment mainly due to intolerance or lack of efficacy. Copyright © 2014 AEU. Publicado por Elsevier España, S.L.U. All rights reserved.

  15. Arterial Destiffening in Previously Untreated Mild Hypertensives After 1 Year of Routine Clinical Management.

    Science.gov (United States)

    Rodilla, Enrique; Millasseau, Sandrine; Costa, Jose Antonio; Pascual, Jose Maria

    2017-05-01

    Arterial stiffness, measured with pulse wave velocity (PWV), is now classified as a marker of target organ damage (TOD) alongside left ventricular hypertrophy and moderately increased albuminuria. Interventional studies on treated hypertensive patients have shown that PWV could be improved. Our aim was to assess changes in arterial stiffness after 1 year of routine clinical practice in never-treated hypertensive patients. We studied 356 never-treated patients with suspected hypertension. After standard clinical assessment during which presence of TOD was evaluated, hypertension diagnosis was confirmed in 231 subjects who subsequently received standard routine care. Both hypertensive and the 125 controls came back for a follow-up visit after 1 year. Hypertensive patients were slightly older (46 ± 12 vs. 50 ± 12 years, P < 0.001), with higher mean arterial pressure (MAP)-adjusted PWV compared to controls (8.6 ± 2.0 vs. 8.0 ± 1.7 m/s, P < 0.001) and 47% of them presented 1 or more TOD. After 1 year of treatment, MAP was similar in both groups (94.9 vs. 96.2 mm Hg; P = ns), but adjusted PWV remained significantly higher in the hypertensive patients (7.8 ± 1.4 vs. 8.3 ± 1.7 m/s, P = 0.004). The prevalence of elevated PWV was reduced from 20% to 12%. All antihypertensive drugs achieved the same blood pressure (BP) and PWV reduction with the exception of vasodilating beta-blockers which gave slightly better results probably due to heart rate reduction. BP reduction in newly diagnosed hypertensive patients improves arterial stiffness within a year of real-life clinical practice. Patients with the highest PWV and the largest reduction of BP "destiffened" the most whatever antihypertensive class was used. © American Journal of Hypertension, Ltd 2016. All rights reserved. For Permissions, please email: journals.permissions@oup.com

  16. [Why medical consultation is needed in the clinical laboratory].

    Science.gov (United States)

    Kawai, T

    1998-10-01

    During the 20th century, at least until the 1980s, clinical laboratory practice had been rapidly expanded, mainly because of a significant advancement in medicine as a whole and also in laboratory technology. However, recent economic changes in health care environment worldwide have been influencing greatly future trends in clinical laboratory practice. Four major macroeconomic forces drive change in clinical laboratory practice as follows; (1) Increasing cost of health care, (2) Implications of an aging population, (3) Social change in the patient population, and (4) Explosion of new technologies. Obviously, the increasing cost of health care is the primary driver. Considering a rapid change in the health care environment, clearly there are two separate pathways to be considered with regard to future modes of delivering patient care services through the clinical laboratory: commercial independent laboratories and hospital laboratories. In most hospital laboratories, in addition to high-quality, accurate and precise laboratory data being delivered through automated informatics in a timely fashion, laboratory physicians and other laboratorians should be available 24 hours a day and 7 days a week. The primary purpose of this approach is to develop a system in which the physician can order the most efficient number of tests, which will provide the maximum amount of clinically relevant informations most rapidly and most accurately at the least cost to the patient. Laboratory physicians must play a key role particularly in hospital laboratories. Their most important roles include those of a professional supplier of laboratory results being useful for health care and clinically relevant, and that of a consultative role for primary care physicians and other co-medical staffs to make important medical decision, based on laboratory results obtained. Therefore, the Japan Society of Clinical Pathology started in 1990 in publishing a series of proposed guidelines for adequate

  17. Incidental copy-number variants identified by routine genome testing in a clinical population

    Science.gov (United States)

    Boone, Philip M.; Soens, Zachry T.; Campbell, Ian M.; Stankiewicz, Pawel; Cheung, Sau Wai; Patel, Ankita; Beaudet, Arthur L.; Plon, Sharon E.; Shaw, Chad A.; McGuire, Amy L.; Lupski, James R.

    2013-01-01

    Purpose Mutational load of susceptibility variants has not been studied on a genomic scale in a clinical population, nor has the potential to identify these mutations as incidental findings during clinical testing been systematically ascertained. Methods Array comparative genomic hybridization, a method for genome-wide detection of DNA copy-number variants, was performed clinically on DNA from 9,005 individuals. Copy-number variants encompassing or disrupting single genes were identified and analyzed for their potential to confer predisposition to dominant, adult-onset disease. Multigene copy-number variants affecting dominant, adult-onset cancer syndrome genes were also assessed. Results In our cohort, 83 single-gene copy-number variants affected 40 unique genes associated with dominant, adult-onset disorders and unrelated to the patients’ referring diagnoses (i.e., incidental) were found. Fourteen of these copy-number variants are likely disease-predisposing, 25 are likely benign, and 44 are of unknown clinical consequence. When incidental copy-number variants spanning up to 20 genes were considered, 27 copy-number variants affected 17 unique genes associated with dominant, adult-onset cancer predisposition. Conclusion Copy-number variants potentially conferring susceptibility to adult-onset disease can be identified as incidental findings during routine genome-wide testing. Some of these mutations may be medically actionable, enabling disease surveillance or prevention; however, most incidentally observed single-gene copy-number variants are currently of unclear significance to the patient. PMID:22878507

  18. Assessing barriers to adherence in routine clinical care for pediatric kidney transplant patients.

    Science.gov (United States)

    Varnell, Charles D; Rich, Kristin L; Nichols, Melissa; Dahale, Devesh; Goebel, Jens W; Pai, Ahna L H; Hooper, David K; Modi, Avani C

    2017-11-01

    Patient-identified barriers to immunosuppressive medications are associated with poor adherence and negative clinical outcomes in transplant patients. Assessment of adherence barriers is not part of routine post-transplant care, and studies regarding implementing such a process in a reliable way are lacking. Using the Model for Improvement and PDSA cycles, we implemented a system to identify adherence barriers, including patient-centered design of a barriers assessment tool, identification of eligible patients, clear roles for clinic staff, and creating a culture of non-judgmental discussion around adherence. We performed time-series analysis of our process measure. Secondary analyses examined the endorsement and concordance of adherence barriers between patient-caregiver dyads. After three methods of testing, the most reliable delivery system was an EHR-integrated tablet that alerted staff of patient eligibility for assessment. Barriers were endorsed by 35% of caregivers (n=85) and 43% of patients (n=60). The most frequently patient-endorsed barriers were forgetting, poor taste, and side effects. Caregivers endorsed forgetting and side effects. Concordance between patient-caregiver dyads was fair (k=0.299). Standardized adherence barriers assessment is feasible in the clinical care of pediatric kidney transplant patients. Features necessary for success included automation, redundant systems with designated staff to identify and mitigate failures, aligned reporting structures, and reliable measurement approaches. Future studies will examine whether barriers predict clinical outcomes (eg, organ rejection, graft loss). © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  19. Diagnostic outcome following routine genetics clinic referral for the assessment of global developmental delay.

    LENUS (Irish Health Repository)

    Shahdadpuri, R

    2012-02-01

    The aim of this study was to ascertain the diagnostic yield following a routine genetics clinic referral for the assessment of global developmental delay. Detailed retrospective review of 119 complete consecutive case notes of patients referred to one single clinical geneticist over a 14 month time period was undertaken (n = 119; 54 males, 65 females). The age at initial review ranged from 2 months to 37 years 3 months (mean 8 y 3 mo [SD 7 y 10 mo]). We made a diagnosis in 36\\/119 (30%); 21\\/36 were new diagnoses and 15\\/36 were confirmations of diagnoses. We removed a wrong diagnostic label in 8\\/119 (7%). In 3\\/8 we were able to achieve a diagnosis but in 5\\/8 no alternative diagnosis was reached. We had a better diagnostic rate where the patients were dysmorphic (odds ratio [OR] 1.825; 95% confidence interval [CI] 1.065 to 3.128, p = 0.044). In the majority, the diagnosis was made by clinical examination only. Molecular diagnosis was reached in seven cases. Five cases were confirmed by cytogenetic analysis. Brain magnetic resonance imaging (MRI) revealed a diagnosis in three cases. This study confirms the importance of a clinical genetics assessment in the investigation of global developmental delay.

  20. A clinical perspective on the 2016 WHO brain tumor classification and routine molecular diagnostics.

    Science.gov (United States)

    van den Bent, Martin J; Weller, Michael; Wen, Patrick Y; Kros, Johan M; Aldape, Ken; Chang, Susan

    2017-05-01

    The 2007 World Health Organization (WHO) classification of brain tumors did not use molecular abnormalities as diagnostic criteria. Studies have shown that genotyping allows a better prognostic classification of diffuse glioma with improved treatment selection. This has resulted in a major revision of the WHO classification, which is now for adult diffuse glioma centered around isocitrate dehydrogenase (IDH) and 1p/19q diagnostics. This revised classification is reviewed with a focus on adult brain tumors, and includes a recommendation of genes of which routine testing is clinically useful. Apart from assessment of IDH mutational status including sequencing of R132H-immunohistochemistry negative cases and testing for 1p/19q, several other markers can be considered for routine testing, including assessment of copy number alterations of chromosome 7 and 10 and of TERT promoter, BRAF, and H3F3A mutations. For "glioblastoma, IDH mutated" the term "astrocytoma grade IV" could be considered. It should be considered to treat IDH wild-type grades II and III diffuse glioma with polysomy of chromosome 7 and loss of 10q as glioblastoma. New developments must be more quickly translated into further revised diagnostic categories. Quality control and rapid integration of molecular findings into the final diagnosis and the communication of the final diagnosis to clinicians require systematic attention. © The Author(s) 2017. Published by Oxford University Press on behalf of the Society for Neuro-Oncology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  1. Objections to routine clinical outcomes measurement in mental health services: any evidence so far?

    Science.gov (United States)

    MacDonald, Alastair J D; Trauer, Tom

    2010-12-01

    Routine clinical outcomes measurement (RCOM) is gaining importance in mental health services. To examine whether criticisms published in advance of the development of RCOM have been borne out by data now available from such a programme. This was an observational study of routine ratings using HoNOS65+ at inception/admission and again at discharge in an old age psychiatry service from 1997 to 2008. Testable hypotheses were generated from each criticism amenable to empirical examination. Inter-rater reliability estimates were applied to observed differences between scores between community and ward patients using resampling. Five thousand one hundred eighty community inceptions and 862 admissions had HoNOS65+ ratings at referral/admission and discharge. We could find no evidence of gaming (artificially worse scores at inception and better at discharge), selection, attrition or detection bias, and ratings were consistent with diagnosis and level of service. Anticipated low levels of inter-rater reliability did not vitiate differences between levels of service. Although only hypotheses testable from within RCOM data were examined, and only 46% of eligible episodes had complete outcomes data, no evidence of the alleged biases were found. RCOM seems valid and practical in mental health services.

  2. Point of Care Cardiac Troponin Assay Analytical Performances for their Use in Clinical Routine.

    Science.gov (United States)

    Dupuy, Anne M; Baillet, Solenne; Dumont, Richard; Giraud, Isabelle; Badiou, Stephanie; Bargnoux, Anne S; Kuster, Nils; Roubille, Francois; Cristol, Jean Paul

    2017-04-01

    We report the analytical and clinical performances of the Alere Triage Cardiac3© Panel on the Triage MeterPro© instrument, comparing concordance with hs-cTnT results from central laboratory above the respective 99th percentiles and determining the clinical sensitivity within the framework of AMI. The concordance was obtained with these two methods among unselected patients admitted to both the emergency and cardiology departments. The LoD of the assay is 0.010 µg/L. At 99th percentile (0.02 µg/L) the CV was found to be 18%, below the clinically acceptable cutoff of 20%. In the overall population, ROC AUC was not significantly different between the central laboratory assay and POC assay, with 0.952 (95% CI, 0.918 - 0.952) for hs-cTnT concentrations at presentation and 0.953 (95% CI, 0.912 - 0.953) for cTnI. Sensitivity and specificity of hs-cTnT vs. cTnI for AMI (n = 32) were 97% and 78% vs. 91% and 86%, respectively. Our results indicated 90.4% concordance between the two methods using the 99th percentile specific for each assay. The Kappa coefficient was higher than 0.75, and the strength of agreement could be considered to be good. The results of cTnI Alere assays provide similar clinical classification of patients, particularly for the AMI group as compared to the central laboratory hs-cTnT assay and could be suitable for clinical in accordance with the recommendations of Global Task Force guidelines.

  3. Condutas usuais entre os reumatologistas brasileiros: levantamento nacional Routine clinical practices of Brazilian rheumatologists: national overview

    Directory of Open Access Journals (Sweden)

    Marta M. C. Medeiros

    2006-04-01

    ão-hormonais (AINHs (89,3%, relaxante muscular (72,9%, fisioterapia (33,3%. O repouso no leito foi orientado por 31,6% dos especialistas. Num caso de lombalgia crônica com raio X recente mostrando espondilolistese grau 1 e discoartrose, 39,6% dos reumatologistas não solicitavam nenhum exame adicional, enquanto 26,2% e 24,4% solicitavam tomografia computadorizada (TC e ressonância nuclear magnética (RNM, respectivamente. As condutas mais indicadas nesse caso foram: fisioterapia (75,1%, relaxante muscular (48,5%, RPG (45,6%, exercícios físicos (41%, AINH seletivo da Cox-2 (40,5%, amitriptilina (35,3%, analgésicos opióides (34,7%. Outros cenários de artrose de joelho e ombro doloroso foram apresentados. CONCLUSÕES: a baixa taxa de devolução dos questionários pode refletir uma prática ainda não-incorporada na nossa cultura. O perfil dos reumatologistas respondedores é muito semelhante entre as regiões. A maioria das condutas escolhidas está de acordo com as melhores evidências disponíveis, refletindo uma homogeneidade de abordagem terapêutica entre os reumatologistas. Embora este estudo traga importantes dados sobre a prática reumatológica, pode não ser representativo da população de reumatologistas brasileiros, tendo em vista o baixo percentual de respondedores.OBJECTIVE: Evaluate routine clinical practices of Brazilian rheumatologists. METHOD: Virtual clinical scenarios representing a range of rheumatological practical situations were sent by mail to 831 specialists certified by the Brazilian Society of Rheumatology (SBR with postage-paid envelopes for reply. RESULTS: Only 21.4% of the questionnaires were returned. The average age of responding rheumatologists was 42.7 years (SD=11.7, with an average time since graduation from medical school of 19.8 years (SD=10.1. In a clinical scenario describing early active rheumatoid arthritis most respondents (84.7% chose to initiate treatment with prednisone or prednisolone. The most chosen disease modifying

  4. Advance Care Planning: Understanding Clinical Routines and Experiences of Interprofessional Team Members in Diverse Health Care Settings.

    Science.gov (United States)

    Arnett, Kelly; Sudore, Rebecca L; Nowels, David; Feng, Cindy X; Levy, Cari R; Lum, Hillary D

    2017-12-01

    Interprofessional health care team members consider advance care planning (ACP) to be important, yet gaps remain in systematic clinical routines to support ACP. A clearer understanding of the interprofessional team members' perspectives on ACP clinical routines in diverse settings is needed. One hundred eighteen health care team members from community-based clinics, long-term care facilities, academic clinics, federally qualified health centers, and hospitals participated in a 35-question, cross-sectional online survey to assess clinical routines, workflow processes, and policies relating to ACP. Respondents were 53% physicians, 18% advanced practice nurses, 11% nurses, and 18% other interprofessional team members including administrators, chaplains, social workers, and others. Regarding clinical routines, respondents reported that several interprofessional team members play a role in facilitating ACP (ie, physician, social worker, nurse, others). Most (62%) settings did not have, or did not know of, policies related to ACP documentation. Only 14% of settings had a patient education program. Two-thirds of the respondents said that addressing ACP is a high priority and 85% felt that nonphysicians could have ACP conversations with appropriate training. The clinical resources needed to improve clinical routines included training for providers and staff, dedicated staff to facilitate ACP, and availability of patient/family educational materials. Although interprofessional health care team members consider ACP a priority and several team members may be involved, clinical settings lack systematic clinical routines to support ACP. Patient educational materials, interprofessional team training, and policies to support ACP clinical workflows that do not rely solely on physicians could improve ACP across diverse clinical settings.

  5. Is daily routine important for sleep? An investigation of social rhythms in a clinical insomnia population.

    Science.gov (United States)

    Moss, Taryn G; Carney, Colleen E; Haynes, Patricia; Harris, Andrea L

    2015-02-01

    Social rhythms, also known as daily routines (e.g. exercise, of school or work, recreation, social activities), have been identified as potential time cues to help to regulate the biological clock. Past research has shown links between regularity and healthy sleep. This study examined the regularity and frequency of daytime activities in a clinical insomnia population and a good sleeper comparison group. Participants (N = 69) prospectively monitored their sleep and daily activities for a 2-week period. Although participants with insomnia and good sleepers had similar levels of activity, relative to good sleepers, those with insomnia were less regular in their activities. Findings from this study add to the growing number of studies that highlight the relative importance of the regularity of daytime activities on sleep. Accordingly, future research should test treatment components that focus on regulating daytime activities, which would likely improve treatment outcomes.

  6. Figure 1. Associations between pre-ART clinical and laboratory ...

    Indian Academy of Sciences (India)

    First page Back Continue Last page Graphics. Figure 1. Associations between pre-ART clinical and laboratory characteristics with subsequent TB-IRIS events. Figure 1. Associations between pre-ART clinical and laboratory characteristics with subsequent TB-IRIS events.

  7. Investigation of Factors Affecting Body Temperature Changes During Routine Clinical Head Magnetic Resonance Imaging

    Science.gov (United States)

    Kim, Myeong Seong

    2016-01-01

    Background Pulsed radiofrequency (RF) magnetic fields, required to produce magnetic resonance imaging (MRI) signals from tissue during the MRI procedure have been shown to heat tissues. Objectives To investigate the relationship between body temperature rise and the RF power deposited during routine clinical MRI procedures, and to determine the correlation between this effect and the body’s physiological response. Patients and Methods We investigated 69 patients from the Korean national cancer center to identify the main factors that contribute to an increase in body temperature (external factors and the body’s response) during a clinical brain MRI. A routine protocol sequence of MRI scans (1.5 T and 3.0 T) was performed. The patient’s tympanic temperature was recorded before and immediately after the MRI procedure and compared with changes in variables related to the body’s physiological response to heat. Results Our investigation of the physiological response to RF heating indicated a link between increasing age and body temperature. A higher increase in body temperature was observed in older patients after a 3.0-T MRI (r = 0.07, P = 0.29 for 1.5-T MRI; r = 0.45, P = 0.002 for 3.0-T MRI). The relationship between age and body heat was related to the heart rate (HR) and changes in HR during the MRI procedure; a higher RF power combined with a reduction in HR resulted in an increase in body temperature. Conclusion A higher magnetic field strength and a decrease in the HR resulted in an increase in body temperature during the MRI procedure. PMID:27895872

  8. Laboratory automation in clinical bacteriology: what system to choose?

    Science.gov (United States)

    Croxatto, A; Prod'hom, G; Faverjon, F; Rochais, Y; Greub, G

    2016-03-01

    Automation was introduced many years ago in several diagnostic disciplines such as chemistry, haematology and molecular biology. The first laboratory automation system for clinical bacteriology was released in 2006, and it rapidly proved its value by increasing productivity, allowing a continuous increase in sample volumes despite limited budgets and personnel shortages. Today, two major manufacturers, BD Kiestra and Copan, are commercializing partial or complete laboratory automation systems for bacteriology. The laboratory automation systems are rapidly evolving to provide improved hardware and software solutions to optimize laboratory efficiency. However, the complex parameters of the laboratory and automation systems must be considered to determine the best system for each given laboratory. We address several topics on laboratory automation that may help clinical bacteriologists to understand the particularities and operative modalities of the different systems. We present (a) a comparison of the engineering and technical features of the various elements composing the two different automated systems currently available, (b) the system workflows of partial and complete laboratory automation, which define the basis for laboratory reorganization required to optimize system efficiency, (c) the concept of digital imaging and telebacteriology, (d) the connectivity of laboratory automation to the laboratory information system, (e) the general advantages and disadvantages as well as the expected impacts provided by laboratory automation and (f) the laboratory data required to conduct a workflow assessment to determine the best configuration of an automated system for the laboratory activities and specificities. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

  9. Viral Contamination Source in Clinical Microbiology Laboratory.

    Science.gov (United States)

    Wang, Xin Ling; Song, Juan; Song, Qin Qin; Yu, Jie; Luo, Xiao Nuan; Wu, Gui Zhen; Han, Jun

    2016-08-01

    To understand the potential causes of laboratory-acquired infections and to provide possible solutions that would protect laboratory personnel, samples from a viral laboratory were screened to determine the main sources of contamination with six subtypes of Rhinovirus. Rhinovirus contamination was found in the gloves, cuffs of protective wear, inner surface of biological safety cabinet (BSC) windows, and trash handles. Remarkably, high contamination was found on the inner walls of the centrifuge and the inner surface of centrifuge tube casing in the rotor. Spilling infectious medium on the surface of centrifuge tubes was found to contribute to contamination of centrifuge surfaces. Exposure to sodium hypochlorite containing no less than 0.2 g/L available chlorine decontaminated the surface of the centrifuge tubes from Rhinovirus after 2 min. Copyright © 2016 The Editorial Board of Biomedical and Environmental Sciences. Published by China CDC. All rights reserved.

  10. Has compliance with CLIA requirements really improved quality in US clinical laboratories?

    Science.gov (United States)

    Ehrmeyer, Sharon S; Laessig, Ronald H

    2004-08-02

    The Clinical Laboratory Improvement Amendments of 1988 (CLIA'88) mandate universal requirements for all U.S. clinical laboratory-testing sites. The intent of CLIA'88 is to ensure quality testing through a combination of minimum quality practices that incorporate total quality management concepts. These regulations do not contain established, objective indicators or measures to assess quality. However, there is an implicit assumption that compliance with traditionally accepted good laboratory practices--following manufacturers' directions, routinely analysing quality control materials, applying quality assurance principles, employing and assessing competent testing personnel, and participating in external quality assessment or proficiency testing (PT)--will result in improved test quality. The CLIA'88 regulations do include PT performance standards, which intentionally or unintentionally, define intra-laboratory performance. Passing PT has become a prime motivation for improving laboratory performance; it can also be used as an objective indicator to assess whether compliance to CLIA has improved intra-laboratory quality. Data from 1994 through 2002 indicate that the percentage of laboratories passing PT has increased. In addition to PT performance, subjective indicators of improved quality--frequency of inspection deficiencies, the number of government sanctions for non-compliance, and customer satisfaction--were evaluated. The results from these subjective indicators are more difficult to interpret but also seem to show improved quality in US clinical laboratories eleven years post-CLIA'88.

  11. Time lapse imaging: is it time to incorporate this technology into routine clinical practice?

    Science.gov (United States)

    Bhide, Priya; Maheshwari, Abha; Cutting, Rachel; Seenan, Susan; Patel, Anita; Khan, Khalid; Homburg, Roy

    2017-06-01

    Time-lapse imaging (TLI) systems for embryo incubation, assessment and selection are a novel technology available to in vitro fertilization (IVF) clinics. However, there is uncertainty about their clinical and cost-effectiveness and insufficient good quality evidence to warrant their routine use. Despite this, enthusiastic commercial marketing and slipping clinical equipoise have led to the widespread hasty introduction of this technology into practice, often at a considerable expense to the patient. We have reviewed the published literature and aim to summarize the strengths, weaknesses, opportunities and threats of these systems. These specialized incubators provide undisturbed embryo culture conditions and, by almost continuous monitoring of embryo development, generate morphokinetic parameters to aid embryo selection. They are thus hypothesized to improve outcomes following IVF. Although literature reports improved reproductive outcomes, these outcomes are largely surrogate and there is a paucity of studies reporting live births. The use of time lapse systems may reduce early pregnancy loss, increase elective single embryo transfers and limit multiple pregnancies through better embryo selection. However, the quality of the studies and hence the evidence so far, is low to moderate quality. We recommend further research producing robust high-quality evidence for and against the use of these systems.

  12. Subsolid pulmonary nodule morphology and associated patient characteristics in a routine clinical population

    International Nuclear Information System (INIS)

    Mets, Onno M.; Jong, Pim A. de; Scholten, Ernst T.; Chung, Kaman; Ginneken, Bram van; Schaefer-Prokop, Cornelia M.

    2017-01-01

    To determine the presence and morphology of subsolid pulmonary nodules (SSNs) in a non-screening setting and relate them to clinical and patient characteristics. A total of 16,890 reports of clinically obtained chest CT (06/2011 to 11/2014, single-centre) were searched describing an SSN. Subjects with a visually confirmed SSN and at least two thin-slice CTs were included. Nodule volumes were measured. Progression was defined as volume increase exceeding the software interscan variation. Nodule morphology, location, and patient characteristics were evaluated. Fifteen transient and 74 persistent SSNs were included (median follow-up 19.6 [8.3-36.8] months). Subjects with an SSN were slightly older than those without (62 vs. 58 years; p = 0.01), but no gender predilection was found. SSNs were mostly located in the upper lobes. Women showed significantly more often persistent lesions than men (94 % vs. 69 %; p = 0.002). Part-solid lesions were larger (1638 vs. 383 mm"3; p < 0.001) and more often progressive (68 % vs. 38 %; p = 0.02), compared to pure ground-glass nodules. Progressive SSNs were rare under the age of 50 years. Logistic regression analysis did not identify additional nodule parameters of future progression, apart from part-solid nature. This study confirms previously reported characteristics of SSNs and associated factors in a European, routine clinical population. (orig.)

  13. Subsolid pulmonary nodule morphology and associated patient characteristics in a routine clinical population

    Energy Technology Data Exchange (ETDEWEB)

    Mets, Onno M.; Jong, Pim A. de [University Medical Center Utrecht, Radiology, Utrecht (Netherlands); Scholten, Ernst T.; Chung, Kaman; Ginneken, Bram van [Radboud University Nijmegen Medical Centre, Diagnostic Imaging Analysis Group, Nijmegen (Netherlands); Schaefer-Prokop, Cornelia M. [Radboud University Nijmegen Medical Centre, Diagnostic Imaging Analysis Group, Nijmegen (Netherlands); Meander Medical Center, Radiology, Amersfoort (Netherlands)

    2017-02-15

    To determine the presence and morphology of subsolid pulmonary nodules (SSNs) in a non-screening setting and relate them to clinical and patient characteristics. A total of 16,890 reports of clinically obtained chest CT (06/2011 to 11/2014, single-centre) were searched describing an SSN. Subjects with a visually confirmed SSN and at least two thin-slice CTs were included. Nodule volumes were measured. Progression was defined as volume increase exceeding the software interscan variation. Nodule morphology, location, and patient characteristics were evaluated. Fifteen transient and 74 persistent SSNs were included (median follow-up 19.6 [8.3-36.8] months). Subjects with an SSN were slightly older than those without (62 vs. 58 years; p = 0.01), but no gender predilection was found. SSNs were mostly located in the upper lobes. Women showed significantly more often persistent lesions than men (94 % vs. 69 %; p = 0.002). Part-solid lesions were larger (1638 vs. 383 mm{sup 3}; p < 0.001) and more often progressive (68 % vs. 38 %; p = 0.02), compared to pure ground-glass nodules. Progressive SSNs were rare under the age of 50 years. Logistic regression analysis did not identify additional nodule parameters of future progression, apart from part-solid nature. This study confirms previously reported characteristics of SSNs and associated factors in a European, routine clinical population. (orig.)

  14. Health status in routine clinical practice: validity of the clinical COPD questionnaire at the individual patient level

    Directory of Open Access Journals (Sweden)

    de Vos Barbara

    2010-11-01

    Full Text Available Abstract Background There is a growing interest to use health status or disease control questionnaires in routine clinical practice. However, the validity of most questionnaires is established using techniques developed for group level validation. This study examines a new method, using patient interviews, to validate a short health status questionnaire, the Clinical COPD Questionnaire (CCQ, at the individual patient level. Methods Patients with COPD who visited an outpatient clinic completed the CCQ before the consultation, and the specialist physician completed it after the consultation. After the consultation all patients had a semi-structured in-depth interview. The patients' CCQ scores were compared with those of the treating clinician, and with mean scores from 5 clinicians from a pool of 20 who scored the CCQ after reading the transcript of the in-depth interviews only. Agreement was assessed using Lin's concordance correlation coefficient (CCC, and Blant and Altman plots. Interviews with patients with low agreement were reviewed for possible explanations. Results A total of 44 COPD patients (32 male, mean age 66 years, FEV1 45% of predicted participated. Agreement between the patients' CCQ scores and those of the treating clinicians (CCC = 0.87 and the mean score of the reviewing clinicians (CCC = 0.86 was very high. No systematic error was detected. No explanation for individuals with low agreement was found. Conclusion The validity of the CCQ on the individual patient level, as assessed by these methods, is good. Individual health status assessment with the CCQ is therefore sufficiently accurate to be used in routine clinical practice.

  15. 42 CFR 414.510 - Laboratory date of service for clinical laboratory and pathology specimens.

    Science.gov (United States)

    2010-10-01

    ... and pathology specimens. 414.510 Section 414.510 Public Health CENTERS FOR MEDICARE & MEDICAID... date of service for clinical laboratory and pathology specimens. The date of service for either a clinical laboratory test or the technical component of physician pathology service is as follows: (a...

  16. Assessment of three frequently used blood glucose monitoring devices in clinical routine.

    Science.gov (United States)

    Zueger, Thomas; Schuler, Vanessa; Stettler, Christoph; Diem, Peter; Christ, Emanuel R

    2012-07-12

    Self-monitoring of blood glucose plays an important role in the management of diabetes and has been shown to improve metabolic control. The use of blood glucose meters in clinical practice requires sufficient reliability to allow adequate treatment. Direct comparison of different blood glucose meters in clinical practice, independent of the manufactures is scarce. We, therefore, aimed to evaluate three frequently used blood glucose meters in daily clinical practice. Capillary blood glucose was measured simultaneous using the following glucose meters: Contour® (Bayer Diabetes Care, Zürich, Switzerland), Accu-Chek® aviva (Roche Diagnostics, Rotkreuz, Switzerland), Free-Style® lite (Abbott Diabetes Care, Baar, Switzerland). The reference method consisted of the HemoCue® Glucose 201+ System (HemoCue® AB, Ängelholm, Sweden) with plasma conversion. The devices were assessed by comparison of the Mean Absolute Relative Differences (MARD), the Clarke Error Grid Analysis (EGA) and the compliance with the International Organization of Standardization criteria (ISO 15197:2003). Capillary blood samples were obtained from 150 patients. MARD was 10.1 ± 0.65%, 7.0 ± 0.62% and 7.8 ± 0.48% for Contour®, Accu-Chek® and Free-Style®, respectively. EGA showed 99.3% (Contour®), 98.7% (Accu-Chek®) and 100% (Free-Style®) of all measurements in zone A and B (clinically acceptable). The ISO criteria were fulfilled by Accu-Chek® (95.3%) and Free-Style® (96%), but not by Contour® (92%). In the present study the three glucose meters provided good agreement with the reference and reliable results in daily clinical routine. Overall, the Free-Style® and Accu-Chek® device slightly outperformed the Contour® device.

  17. U.S. Ebola Treatment Center Clinical Laboratory Support.

    Science.gov (United States)

    Jelden, Katelyn C; Iwen, Peter C; Herstein, Jocelyn J; Biddinger, Paul D; Kraft, Colleen S; Saiman, Lisa; Smith, Philip W; Hewlett, Angela L; Gibbs, Shawn G; Lowe, John J

    2016-04-01

    Fifty-five hospitals in the United States have been designated Ebola treatment centers (ETCs) by their state and local health authorities. Designated ETCs must have appropriate plans to manage a patient with confirmed Ebola virus disease (EVD) for the full duration of illness and must have these plans assessed through a CDC site visit conducted by an interdisciplinary team of subject matter experts. This study determined the clinical laboratory capabilities of these ETCs. ETCs were electronically surveyed on clinical laboratory characteristics. Survey responses were returned from 47 ETCs (85%). Forty-one (87%) of the ETCs planned to provide some laboratory support (e.g., point-of-care [POC] testing) within the room of the isolated patient. Forty-four (94%) ETCs indicated that their hospital would also provide clinical laboratory support for patient care. Twenty-two (50%) of these ETC clinical laboratories had biosafety level 3 (BSL-3) containment. Of all respondents, 34 (72%) were supported by their jurisdictional public health laboratory (PHL), all of which had available BSL-3 laboratories. Overall, 40 of 44 (91%) ETCs reported BSL-3 laboratory support via their clinical laboratory and/or PHL. This survey provided a snapshot of the laboratory support for designated U.S. ETCs. ETCs have approached high-level isolation critical care with laboratory support in close proximity to the patient room and by distributing laboratory support among laboratory resources. Experts might review safety considerations for these laboratory testing/diagnostic activities that are novel in the context of biocontainment care. Copyright © 2016, American Society for Microbiology. All Rights Reserved.

  18. [Knowledge management system for laboratory work and clinical decision support].

    Science.gov (United States)

    Inada, Masanori; Sato, Mayumi; Yoneyama, Akiko

    2011-05-01

    This paper discusses a knowledge management system for clinical laboratories. In the clinical laboratory of Toranomon Hospital, we receive about 20 questions relevant to laboratory tests per day from medical doctors or co-medical staff. These questions mostly involve the essence to appropriately accomplish laboratory tests. We have to answer them carefully and suitably because an incorrect answer may cause a medical accident. Up to now, no method has been in place to achieve a rapid response and standardized answers. For this reason, the laboratory staff have responded to various questions based on their individual knowledge. We began to develop a knowledge management system to promote the knowledge of staff working for the laboratory. This system is a type of knowledge base for assisting the work, such as inquiry management, laboratory consultation, process management, and clinical support. It consists of several functions: guiding laboratory test information, managing inquiries from medical staff, reporting results of patient consultation, distributing laboratory staffs notes, and recording guidelines for laboratory medicine. The laboratory test information guide has 2,000 records of medical test information registered in the database with flexible retrieval. The inquiry management tool provides a methos to record all questions, answer easily, and retrieve cases. It helps staff to respond appropriately in a short period of time. The consulting report system treats patients' claims regarding medical tests. The laboratory staffs notes enter a file management system so they can be accessed to aid in clinical support. Knowledge sharing using this function can achieve the transition from individual to organizational learning. Storing guidelines for laboratory medicine will support EBM. Finally, it is expected that this system will support intellectual activity concerning laboratory work and contribute to the practice of knowledge management for clinical work support.

  19. Utility of routine evaluation of sterility of cellular therapy products with or without extensive manipulation: Best practices and clinical significance.

    Science.gov (United States)

    Golay, Josee; Pedrini, Olga; Capelli, Chiara; Gotti, Elisa; Borleri, Gianmaria; Magri, Mara; Vailati, Francesca; Passera, Marco; Farina, Claudio; Rambaldi, Alessandro; Introna, Martino

    2018-02-01

    We analyzed the results of routine sterility testing performed in our center over the last 10 years, in the context both hematopoietic stem cell transplantation (HSCT) and Advanced Therapeutic Medicinal Products (ATMPs). For sterility tests 14-day cultures were performed in culture media detecting aerobic and anaerobic microorganisms. In this study, 22/1643 (1.3%) of apheretic products for autologous or allogeneic HSCT were contaminated, whereas 14/73 bone marrow (BM) harvests (17.8%) were positive. In 22 cases, the contaminated HSCs were infused to patients, but there was no evidence of any adverse impact of contamination on the hematologic engraftment or on infections. Indeed none of the five positive hemocultures detected in patients following infusion could be linked to the contaminated stem cell product. Our Cell Factory also generated 286 ATMPs in good manufacturing practice (GMP) conditions since 2007 and all final products were sterile. In three cases of mesenchymal stromal cell expansions, the starting BM harvests were contaminated, but the cell products at the end of expansion were sterile, presumably thanks to the presence of an antibiotic in the culture medium. The decreased rate of contamination of cell harvests observed with time suggests that routine sterility testing and communication of the results to the collecting centers may improve clinical practices. Furthermore, we recommend the use of antibiotics in the medium for ATMP expansion, to decrease the likelihood of expanding microorganisms within clean rooms. Finally we discuss the costs of sterility testing of ATMPs by GMP-approved external laboratories. Copyright © 2017 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

  20. [Accreditation of clinical laboratories based on ISO standards].

    Science.gov (United States)

    Kawai, Tadashi

    2004-11-01

    International Organization for Standardization (ISO) have published two international standards (IS) to be used for accreditation of clinical laboratories; ISO/IEC 17025:1999 and ISO 15189:2003. Any laboratory accreditation body must satisfy the requirements stated in ISO/IEC Guide 58. In order to maintain the quality of the laboratory accreditation bodies worldwide, the International Laboratory Accreditation Cooperation (ILAC) has established the mutual recognition arrangement (MRA). In Japan, the International Accreditation Japan (IAJapan) and the Japan Accreditation Board for Conformity Assessment (JAB) are the members of the ILAC/MRA group. In 2003, the Japanese Committee for Clinical Laboratory Standards (JCCLS) and the JAB have established the Development Committee of Clinical Laboratory Accreditation Program (CLAP), in order to establish the CLAP, probably starting in 2005.

  1. The effectiveness of online cognitive behavioral treatment in routine clinical practice.

    Directory of Open Access Journals (Sweden)

    Jeroen Ruwaard

    Full Text Available Randomized controlled trails have identified online cognitive behavioral therapy as an efficacious intervention in the management of common mental health disorders.To assess the effectiveness of online CBT for different mental disorders in routine clinical practice.An uncontrolled before-after study, with measurements at baseline, posttest, 6-week follow-up, and 1-year follow-up.1500 adult patients (female: 67%; mean age: 40 years with a GP referral for psychotherapy were treated at a Dutch online mental health clinic for symptoms of depression (n = 413, panic disorder (n = 139, posttraumatic stress (n = 478, or burnout (n = 470.Manualized, web-based, therapist-assisted CBT, of which the efficacy was previously demonstrated in a series of controlled trials. Standardized duration of treatment varied from 5 weeks (online CBT for Posttraumatic stress to 16 weeks (online CBT for Depression.Validated self-report questionnaires of specific and general psychopathology, including the Beck Depression Inventory, the Impact of Event Scale, the Panic Disorder Severity Scale-Self Report, the Oldenburg Burnout Inventory, and the Depression Anxiety Stress Scales.Treatment adherence was 71% (n = 1071. Study attrition was 21% at posttest, 33% at 6-week FU and 65% at 1-year FU. Mixed-model repeated measures regression identified large short-term reductions in all measures of primary symptoms (d = 1.9±0.2 to d = 1.2±0.2; P<.001, which sustained up to one year after treatment. At posttest, rates of reliable improvement and recovery were 71% and 52% in the completer sample (full sample: 55%/40%. Patient satisfaction was high.Results suggest that online therapist-assisted CBT may be as effective in routine practice as it is in clinical trials. Although pre-treatment withdrawal and long-term outcomes require further study, results warrant continued implementation of online CBT.

  2. Process mining routinely collected electronic health records to define real-life clinical pathways during chemotherapy.

    Science.gov (United States)

    Baker, Karl; Dunwoodie, Elaine; Jones, Richard G; Newsham, Alex; Johnson, Owen; Price, Christopher P; Wolstenholme, Jane; Leal, Jose; McGinley, Patrick; Twelves, Chris; Hall, Geoff

    2017-07-01

    There is growing interest in the use of routinely collected electronic health records to enhance service delivery and facilitate clinical research. It should be possible to detect and measure patterns of care and use the data to monitor improvements but there are methodological and data quality challenges. Driven by the desire to model the impact of a patient self-test blood count monitoring service in patients on chemotherapy, we aimed to (i) establish reproducible methods of process-mining electronic health records, (ii) use the outputs derived to define and quantify patient pathways during chemotherapy, and (iii) to gather robust data which is structured to be able to inform a cost-effectiveness decision model of home monitoring of neutropenic status during chemotherapy. Electronic Health Records at a UK oncology centre were included if they had (i) a diagnosis of metastatic breast cancer and received adjuvant epirubicin and cyclosphosphamide chemotherapy or (ii) colorectal cancer and received palliative oxaliplatin and infusional 5-fluorouracil chemotherapy, and (iii) were first diagnosed with cancer between January 2004 and February 2013. Software and a Markov model were developed, producing a schematic of patient pathways during chemotherapy. Significant variance from the assumed care pathway was evident from the data. Of the 535 patients with breast cancer and 420 with colorectal cancer there were 474 and 329 pathway variants respectively. Only 27 (5%) and 26 (6%) completed the planned six cycles of chemotherapy without having unplanned hospital contact. Over the six cycles, 169 (31.6%) patients with breast cancer and 190 (45.2%) patients with colorectal cancer were admitted to hospital. The pathways of patients on chemotherapy are complex. An iterative approach to addressing semantic and data quality issues enabled the effective use of routinely collected patient records to produce accurate models of the real-life experiences of chemotherapy patients and

  3. Reducing the Environmental Impact of Clinical Laboratories.

    Science.gov (United States)

    Lopez, Joseph B; Jackson, David; Gammie, Alistair; Badrick, Tony

    2017-02-01

    Healthcare is a significant contributor to environmental impact but this has received little attention. The typical laboratory uses far more energy and water per unit area than the typical office building. There is a need to sensitise laboratories to the importance of adopting good environmental practices. Since this comes at an initial cost, it is vital to obtain senior management support. Convincing management of the various tangible and intangible benefits that can accrue in the long run should help achieve this support. Many good environmental practices do not have a cost but will require a change in the culture and mind-set of the organisation. Continuing education and training are important keys to successful implementation of good practices. There is a need to undertake a rigorous cost-benefit analysis of every change that is introduced in going green. The adoption of good practices can eventually lead to ISO certification if this is desired. This paper provides suggestions that will allow a laboratory to start going green. It will allow the industry to enhance its corporate citizenship whilst improving its competitive advantage for long-term.

  4. Clinical value analysis of routine ultrasound combined with endoscopic ultrasonography in judging ulcerative colitis

    Directory of Open Access Journals (Sweden)

    Jing-Mei Tuo

    2016-01-01

    Full Text Available Objective: To study the clinical value of routine ultrasound combined with endoscopic ultrasonography in judging ulcerative colitis. Methods: A total of 60 cases of patients with ulcerative colitis were collected as observation group of research and 60 cases of healthy volunteers were collected as control group of research. Intestinal wall thickness was detected by white light endoscopy, abdominal intestinal ultrasound and endoscopic ultrasonography; TNF-α, IL-1β, IL-4 and IL-10 contents were detected by Elisa kit; Th1, Th2, Th17 and Treg ratios were detected by flow cytometry. Results: (1 intestinal wall thickness: intestinal wall thickness of both active UC patients and quiescent UC patients was significantly higher than that of control group, intestinal wall thickness of active UC patients was significantly higher than that of quiescent UC patients and the higher the degree of activity, the higher the intestinal wall thickness; (2 inflammatory mediators: TNF-α and IL-1β contents in intestinal mucosa of active UC patients were higher than those of quiescent UC patients and positively correlated with intestinal wall thickness; IL-4 and IL-10 contents were lower than those of quiescent UC patients and negatively correlated with intestinal wall thickness; (3 T cell contents: Th1 and Th17 cell contents in intestinal mucosa of active UC patients were higher than those of quiescent UC patients and positively correlated with intestinal wall thickness; Th2 and Treg cell contents in intestinal mucosa of active UC patients were lower than those of quiescent UC patients and negatively correlated with intestinal wall thickness. Conclusion: Routine ultrasound combined with endoscopic ultrasonography can accurately determine the severity of ulcerative colitis; measured intestinal wall thickness is closely correlated with the degree of inflammation and abnormal immune response.

  5. Localized single voxel 1H MR spectroscopy toward routine clinical use

    International Nuclear Information System (INIS)

    Lee, Jung Hee; Choi, Choong Gon; Kim, Sang Tae; Kim, Jin Suh; Mun, Chi Woong; Suh, Dae Chul; Lim, Tae Hwan; Auh, Young Ho

    1996-01-01

    To evaluate the automated 1 H magnetic resonance spectroscopy ( 1 H-MRS) method for a routine clinical use, various regions of the normal human brain were examined for regional variations, the reproducibility, and the quality control of the spectral data. Localized 1 H-MRS was performed in a GE 1.5T SIGNA MRI/MRS system using the automated method (PROton Brain Exam:PROBE). Six regions of the human brain from normal volunteers (N=25, age=23-65) were examined: Occipital gray matter, parietal white matter, frontal white matter, pons, cerebellum, and basal ganglia region. STEAM was used as the localization method with the following parameters : TE=30 msec, TR=3.0 sec, AVG=48 AVG, NEX=2, Spectral Width (SW)=2500 Hz, Size (SI)=2048 points (2K), and the size of voxel=7-9 ml. The reproducibility and the quality control of the spectral data were evaluated. For the 6 regions, the regional variation by the spectral patterns and the metabolites ratios relative to creatine was well demonstrated. Rates of the auto prescan success and the percentages of obtaining the acceptable quality spectral were high in the parietal white matter, occipital gray matter, and basal ganglia regions, and low in the frontal white matter and pons regions. PROBE is a highly practical as well as reliable method to produce reproducible quality spectra that represent the regional metabolic exam or as an additional series to a routine brain MRI exam, which takes less than 10 minutes for acquisition of one spectrum. In order to obtain good quality spectra, a good quality control scheme of the MR instrument is mandatory

  6. Non-adherence in seniors with dementia - a serious problem of routine clinical practice.

    Science.gov (United States)

    Lužný, Jan; Ivanová, Kateřina; Juríčková, Lubica

    2014-01-01

    Non-adherence to treatment in seniors with dementia is a frequent and potentially dangerous phenomenon in routine clinical practice which might lead to the inappropriate treatment of a patient, including the risk of intoxication. There might be different causes of non-adherence in patients with dementia: memory impairment, sensory disturbances, limitations in mobility, economical reasons limiting access to health care and medication. Non-adherence leads to serious clinical consequences as well as being a challenge for public health. to estimate prevalence of non-adherence in seniors with dementia and to study correlation between cognitive decline and non-adherence. Prospective study, analyzing medical records of seniors with dementia admitted to the inpatient psychogeriatric ward in the Kromeriz mental hospital from January 2010 to January 2011. Cognitive decline measured by MMSE, prevalence of Non-adherence to treatment and reasons for patient Non-adherence were studied. Non-adherence to any treatment was detected in 31.3% of seniors; memory impairment was the most common cause of non-adherence to treatment. In conclusion, non-adherence to treatment in the studied group of seniors with dementia correlates with the severity of cognitive impairment - a higher cognitive decline correlates with a higher risk of non-adherence to treatment.

  7. Chemical restraint in routine clinical practice: a report from a general hospital psychiatric ward in Greece

    Directory of Open Access Journals (Sweden)

    Papamichael Georgios

    2011-02-01

    Full Text Available Abstract Background There is a dearth of studies regarding chemical restraint in routine clinical psychiatric practice. There may be wide variations between different settings and countries. Methods A retrospective study on chemical restraint was performed in the 11-bed psychiatric ward of the General Hospital of Arta, in northwestern Greece. All admissions over a 2-year-period (from March 2008 to March 2010 were examined. Results Chemical restraint was applied in 33 cases (10.5% of total admissions. From a total of 82 injections, 22 involved a benzodiazepine and/or levomepromazine, whereas 60 injections involved an antipsychotic agent, almost exclusively haloperidol (96.7% of cases, usually in combination with a benzodiazepine (61.7% of cases. In 36.4% of cases the patient was further subjected to restraint or seclusion. Conclusions In our unit, clinicians prefer the combined antipsychotic/benzodiazepine regimen for the management of patients' acute agitation and violent behaviour. Conventional antipsychotics are administrated almost exclusively and in a significant proportion of cases further coercive measures are applied. Studies on the practice of chemical restraint should be regularly performed in clinical settings.

  8. NON-ADHERENCE IN SENIORS WITH DEMENTIA – A SERIOUS PROBLEM OF ROUTINE CLINICAL PRACTICE

    Directory of Open Access Journals (Sweden)

    Jan Lužný

    2014-01-01

    Full Text Available Background: Non-adherence to treatment in seniors with dementia is a frequent and potentially dangerous phenomenon in routine clinical practice which might lead to the inappropriate treatment of a patient, including the risk of intoxication. There might be different causes of non-adherence in patients with dementia: memory impairment, sensory disturbances, limitations in mobility, economical reasons limiting access to health care and medication. Non-adherence leads to serious clinical consequences as well as being a challenge for public health. Aim: to estimate prevalence of non-adherence in seniors with dementia and to study correlation between cognitive decline and non-adherence. Subjects and Methods: Prospective study, analyzing medical records of seniors with dementia admitted to the inpatient psychogeriatric ward in the Kromeriz mental hospital from January 2010 to January 2011. Cognitive decline measured by MMSE, prevalence of Non-adherence to treatment and reasons for patient Non-adherence were studied. Results: Non-adherence to any treatment was detected in 31.3% of seniors; memory impairment was the most common cause of non-adherence to treatment. Conclusion: In conclusion, non-adherence to treatment in the studied group of seniors with dementia correlates with the severity of cognitive impairment – a higher cognitive decline correlates with a higher risk of non-adherence to treatment.

  9. Training clinicians in how to use patient-reported outcome measures in routine clinical practice.

    Science.gov (United States)

    Santana, Maria J; Haverman, Lotte; Absolom, Kate; Takeuchi, Elena; Feeny, David; Grootenhuis, Martha; Velikova, Galina

    2015-07-01

    Patient-reported outcome measures (PROs) were originally developed for comparing groups of people in clinical trials and population studies, and the results were used to support treatment recommendations or inform health policy, but there was not direct benefit for the participants providing PROs data. However, as the experience in using those measures increased, it became obvious the clinical value in using individual patient PROs profiles in daily practice to identify/monitor symptoms, evaluate treatment outcomes and support shared decision-making. A key issue limiting successful implementation is clinicians' lack of knowledge on how to effectively utilize PROs data in their clinical encounters. Using a change management theoretical framework, this paper describes the development and implementation of three programs for training clinicians to effectively use PRO data in routine practice. The training programs are in three diverse clinical areas (adult oncology, lung transplant and paediatrics), in three countries with different healthcare systems, thus providing a rare opportunity to pull out common approaches whilst recognizing specific settings. For each program, we describe the clinical and organizational setting, the program planning and development, the content of the training session with supporting material, subsequent monitoring of PROs use and evidence of adoption. The common successful components and practical steps are identified, leading to discussion and future recommendations. The results of the three training programs are described as the implementation. In the oncology program, PRO data have been developed and are currently evaluated; in the lung transplant program, PRO data are used in daily practice and the integration with electronic patient records is under development; and in the paediatric program, PRO data are fully implemented with around 7,600 consultations since the start of the implementation. Adult learning programs teaching clinicians

  10. [ISO 15189 accreditation in clinical microbiology laboratory: general concepts and the status in our laboratory].

    Science.gov (United States)

    Akyar, Işin

    2009-10-01

    One important trend in the laboratory profession and quality management is the global convergence of laboratory operations. The goal of an accredited medical laboratory is to continue "offering useful laboratory service for diagnosis and treatment of the patients and also aid to the health of the nation". An accredited clinical laboratory is managed by a quality control system, it is competent technically and the laboratory service meets the needs of all its patients and physicians by taking the responsibility of all the medical tests and therapies. For this purpose, ISO 15189 international standard has been prepared by 2003. ISO 15189 standard is originated from the arrangement of ISO 17025 and ISO 9001:2000 standards. Many countries such as England, Germany, France, Canada and Australia have preferred ISO 15189 as their own laboratory accreditation programme, meeting all the requirements of their medical laboratories. The accreditation performance of a clinical microbiology laboratory is mainly based on five essential points; preanalytical, analytical, postanalytical, quality control programmes (internal, external, interlaboratory) and audits (internal, external). In this review article, general concepts on ISO 15189 accreditation standards for the clinical microbiology laboratories have been summarized and the status of a private laboratory (Acibadem LabMed, Istanbul) in Turkey has been discussed.

  11. Effectiveness of behavioral parent training for children with ADHD in routine clinical practice : A randomized controlled study

    NARCIS (Netherlands)

    van den Hoofdakker, Barbara J.; Van der Veen-Mulders, Lianne; Sytema, Sjoerd; Emmelkamp, Paul M. G.; Minderaa, Ruud B.; Nauta, Maaike H.

    2007-01-01

    Objective: To investigate the effectiveness of behavioral parent training (BPT) as adjunct to routine clinical care (RCC). Method: After a first phase of RCC, 94 children with attention-deficit/hyperactivity disorder (ADHD) ages 4-12, all referred to a Dutch outpatient mental health clinic, were

  12. Molecular diagnosis of microbial aetiologies using SepsiTest™ in the daily routine of a diagnostic laboratory.

    Science.gov (United States)

    Haag, Heike; Locher, Franziska; Nolte, Oliver

    2013-08-01

    A universal PCR and sequencing test, SepsiTest™ (Molzym, Germany) was evaluated for its applicability during daily diagnostic routine in a privately operated laboratory. In total, 96 specimens originating from 66 patients under suspect of infectious endocarditis, infections of joints, encephalitis/meningitis, systemic infections and infections of unknown genesis were PCR analysed and compared to culture results. Samples comprised cultured and non-cultured blood, synovial fluid, synovial tissue, heart valves, pacemakers, spinal tissue, cerebrospinal fluid, and swabs. PCR and culture were concordant in 26 negative and 8 positive cases (51.5%). A group of 25 patients was culture-negative but PCR-positive (37.9%). In at least 14 of these, common and/or rare aetiologies were identified, while for 4 patients the results of 16S PCR could not be unequivocally linked with the underlying disease. Benefits and limitations of the molecular test are discussed with special emphasis on technical and economic issues. In conclusion, SepsiTest™ proved to be a valuable tool for the diagnosis of aetiologies, particularly in cases of culture-negative patients who are under strong suspicion for an infection. Copyright © 2013 Elsevier Inc. All rights reserved.

  13. Site study plan for non-routine laboratory rock mechanics, Deaf Smith County Site, Texas: Revision 1

    International Nuclear Information System (INIS)

    1987-12-01

    This Site Study Plan describes the non-routine rock mechanics and thermal properties laboratory testing program planned for the characterization of site-specific geologic materials for the Deaf Smith County site, Texas. The study design provides for measurements of index, mechanical, thermomechanical, thermal and special properties for the host salt, and where appropriate, for nonhost lithologies. The types of tests which will be conducted are constant stress (creep) tests, constant strain (stress relaxation) tests, constant strain-rate tests, constant stress-rate tests, cyclic loading tests, hollow cylinder tests, uniaxial and triaxial compression tests, direct tension tests, indirect (triaxial) shear tests, thermal property determinations (conductivity, specific heat, expansivity, and diffusivity), fracture healing tests, thermal decrepitation tests, moisture content determinations, and petrographic and micromechanics analyses. Tests will be conducted at confining pressures up to 30 MPa and temperatures up to 300/degree/C. These data are used to construct mathematical models for the phenomenology of salt deformation. The models are then used in finite-element codes to predict repository response. A tentative testing schedule and milestone log are given. The duration of the testing program is expected to be approximately 5 years. 44 refs., 13 figs., 13 tabs

  14. Clinical Neuropathology practice news 1-2014: Pyrosequencing meets clinical and analytical performance criteria for routine testing of MGMT promoter methylation status in glioblastoma

    Science.gov (United States)

    Preusser, Matthias; Berghoff, Anna S.; Manzl, Claudia; Filipits, Martin; Weinhäusel, Andreas; Pulverer, Walter; Dieckmann, Karin; Widhalm, Georg; Wöhrer, Adelheid; Knosp, Engelbert; Marosi, Christine; Hainfellner, Johannes A.

    2014-01-01

    Testing of the MGMT promoter methylation status in glioblastoma is relevant for clinical decision making and research applications. Two recent and independent phase III therapy trials confirmed a prognostic and predictive value of the MGMT promoter methylation status in elderly glioblastoma patients. Several methods for MGMT promoter methylation testing have been proposed, but seem to be of limited test reliability. Therefore, and also due to feasibility reasons, translation of MGMT methylation testing into routine use has been protracted so far. Pyrosequencing after prior DNA bisulfite modification has emerged as a reliable, accurate, fast and easy-to-use method for MGMT promoter methylation testing in tumor tissues (including formalin-fixed and paraffin-embedded samples). We performed an intra- and inter-laboratory ring trial which demonstrates a high analytical performance of this technique. Thus, pyrosequencing-based assessment of MGMT promoter methylation status in glioblastoma meets the criteria of high analytical test performance and can be recommended for clinical application, provided that strict quality control is performed. Our article summarizes clinical indications, practical instructions and open issues for MGMT promoter methylation testing in glioblastoma using pyrosequencing. PMID:24359605

  15. Highly accurate prediction of food challenge outcome using routinely available clinical data.

    Science.gov (United States)

    DunnGalvin, Audrey; Daly, Deirdre; Cullinane, Claire; Stenke, Emily; Keeton, Diane; Erlewyn-Lajeunesse, Mich; Roberts, Graham C; Lucas, Jane; Hourihane, Jonathan O'B

    2011-03-01

    Serum specific IgE or skin prick tests are less useful at levels below accepted decision points. We sought to develop and validate a model to predict food challenge outcome by using routinely collected data in a diverse sample of children considered suitable for food challenge. The proto-algorithm was generated by using a limited data set from 1 service (phase 1). We retrospectively applied, evaluated, and modified the initial model by using an extended data set in another center (phase 2). Finally, we prospectively validated the model in a blind study in a further group of children undergoing food challenge for peanut, milk, or egg in the second center (phase 3). Allergen-specific models were developed for peanut, egg, and milk. Phase 1 (N = 429) identified 5 clinical factors associated with diagnosis of food allergy by food challenge. In phase 2 (N = 289), we examined the predictive ability of 6 clinical factors: skin prick test, serum specific IgE, total IgE minus serum specific IgE, symptoms, sex, and age. In phase 3 (N = 70), 97% of cases were accurately predicted as positive and 94% as negative. Our model showed an advantage in clinical prediction compared with serum specific IgE only, skin prick test only, and serum specific IgE and skin prick test (92% accuracy vs 57%, and 81%, respectively). Our findings have implications for the improved delivery of food allergy-related health care, enhanced food allergy-related quality of life, and economized use of health service resources by decreasing the number of food challenges performed. Copyright © 2011 American Academy of Allergy, Asthma & Immunology. Published by Mosby, Inc. All rights reserved.

  16. Performance Evaluation of an Automated ELISA System for Alzheimer's Disease Detection in Clinical Routine.

    Science.gov (United States)

    Chiasserini, Davide; Biscetti, Leonardo; Farotti, Lucia; Eusebi, Paolo; Salvadori, Nicola; Lisetti, Viviana; Baschieri, Francesca; Chipi, Elena; Frattini, Giulia; Stoops, Erik; Vanderstichele, Hugo; Calabresi, Paolo; Parnetti, Lucilla

    2016-07-22

    The variability of Alzheimer's disease (AD) cerebrospinal fluid (CSF) biomarkers undermines their full-fledged introduction into routine diagnostics and clinical trials. Automation may help to increase precision and decrease operator errors, eventually improving the diagnostic performance. Here we evaluated three new CSF immunoassays, EUROIMMUNtrademark amyloid-β 1-40 (Aβ1-40), amyloid-β 1-42 (Aβ1-42), and total tau (t-tau), in combination with automated analysis of the samples. The CSF biomarkers were measured in a cohort consisting of AD patients (n = 28), mild cognitive impairment (MCI, n = 77), and neurological controls (OND, n = 35). MCI patients were evaluated yearly and cognitive functions were assessed by Mini-Mental State Examination. The patients clinically diagnosed with AD and MCI were classified according to the CSF biomarkers profile following NIA-AA criteria and the Erlangen score. Technical evaluation of the immunoassays was performed together with the calculation of their diagnostic performance. Furthermore, the results for EUROIMMUN Aβ1-42 and t-tau were compared to standard immunoassay methods (INNOTESTtrademark). EUROIMMUN assays for Aβ1-42 and t-tau correlated with INNOTEST (r = 0.83, p ratio measured with EUROIMMUN was the best parameter for AD detection and improved the diagnostic accuracy of Aβ1-42 (area under the curve = 0.93). In MCI patients, the Aβ1-42/Aβ1-40 ratio was associated with cognitive decline and clinical progression to AD.The diagnostic performance of the EUROIMMUN assays with automation is comparable to other currently used methods. The variability of the method and the value of the Aβ1-42/Aβ1-40 ratio in AD diagnosis need to be validated in large multi-center studies.

  17. A national survey on pediatric critical values used in clinical laboratories across Canada.

    Science.gov (United States)

    Gong, Yanping; Adeli, Khosrow

    2009-11-01

    Notification of critical values to clinical staff is an important post-analytical process in all acute care clinical laboratories. No data are available however on how laboratories obtain or establish critical values, particularly in pediatric settings. This study was designed to examine and compare critical values used for pediatric patients in biochemistry laboratories in Canada and assess potential interlaboratory variability. Fourteen clinical laboratories, including two in pediatric hospitals and twelve in hospitals caring for both children and adults, participated in a survey that included 14 pre-selected STAT chemistry tests and 19 pre-selected therapeutic drug monitoring (TDM) tests. Among fourteen chemistry tests, good agreement was observed for critical values used for sodium and pH at both low and high levels within 14 participant laboratories. Significant interlaboratory variability existed for glucose critical values at the high end, magnesium at high end, and PO2 at the low end. For 19 TDM tests, the majority of laboratories did not have alert values to report values over the therapeutic level but not toxic. For critical values greater than the toxic range, significant variability existed at both trough and peak levels among laboratories surveyed. When asked to provide the source for critical values established at each site, only a limited number of laboratories identified their sources as either internal decision or published references. Although all laboratories have established and routinely use critical values to alert clinical staff, considerable variability exists in both the critical limits reported as well as the source of such values. There is a clear need for new national efforts to standardize pediatric critical value reporting and establish evidence-based critical limits for all medical laboratories across Canada.

  18. Usefulness of component resolved analysis of cat allergy in routine clinical practice.

    Science.gov (United States)

    Eder, Katharina; Becker, Sven; San Nicoló, Marion; Berghaus, Alexander; Gröger, Moritz

    2016-01-01

    Cat allergy is of great importance, and its prevalence is increasing worldwide. Cat allergens and house dust mite allergens represent the major indoor allergens; however, they are ubiquitous. Cat sensitization and allergy are known risk factors for rhinitis, bronchial hyperreactivity and asthma. Thus, the diagnosis of sensitization to cats is important for any allergist. 70 patients with positive skin prick tests for cats were retrospectively compared regarding their skin prick test results, as well as their specific immunoglobulin E antibody profiles with regard to their responses to the native cat extract, rFel d 1, nFel d 2 and rFel d 4. 35 patients were allergic to cats, as determined by positive anamnesis and/or nasal provocation with cat allergens, and 35 patients exhibited clinically non-relevant sensitization, as indicated by negative anamnesis and/or a negative nasal allergen challenge. Native cat extract serology testing detected 100% of patients who were allergic to cats but missed eight patients who showed sensitization in the skin prick test and did not have allergic symptoms. The median values of the skin prick test, as well as those of the specific immunoglobulin E antibodies against the native cat extract, were significantly higher for allergic patients than for patients with clinically non-relevant sensitization. Component based diagnostic testing to rFel d 1 was not as reliable. Sensitization to nFel d 2 and rFel d 4 was seen only in individual patients. Extract based diagnostic methods for identifying cat allergy and sensitization, such as the skin prick test and native cat extract serology, remain crucial in routine clinical practice. In our study, component based diagnostic testing could not replace these methods with regard to the detection of sensitization to cats and differentiation between allergy and sensitization without clinical relevance. However, component resolved allergy diagnostic tools have individual implications, and future

  19. The Quality of Clinical Maternal and Neonatal Healthcare – A Strategy for Identifying ‘Routine Care Signal Functions’

    Science.gov (United States)

    Brenner, Stephan; De Allegri, Manuela; Gabrysch, Sabine; Chinkhumba, Jobiba; Sarker, Malabika; Muula, Adamson S.

    2015-01-01

    Background A variety of clinical process indicators exists to measure the quality of care provided by maternal and neonatal health (MNH) programs. To allow comparison across MNH programs in low- and middle-income countries (LMICs), a core set of essential process indicators is needed. Although such a core set is available for emergency obstetric care (EmOC), the ‘EmOC signal functions’, a similar approach is currently missing for MNH routine care evaluation. We describe a strategy for identifying core process indicators for routine care and illustrate their usefulness in a field example. Methods We first developed an indicator selection strategy by combining epidemiological and programmatic aspects relevant to MNH in LMICs. We then identified routine care process indicators meeting our selection criteria by reviewing existing quality of care assessment protocols. We grouped these indicators into three categories based on their main function in addressing risk factors of maternal or neonatal complications. We then tested this indicator set in a study assessing MNH quality of clinical care in 33 health facilities in Malawi. Results Our strategy identified 51 routine care processes: 23 related to initial patient risk assessment, 17 to risk monitoring, 11 to risk prevention. During the clinical performance assessment a total of 82 cases were observed. Birth attendants’ adherence to clinical standards was lowest in relation to risk monitoring processes. In relation to major complications, routine care processes addressing fetal and newborn distress were performed relatively consistently, but there were major gaps in the performance of routine care processes addressing bleeding, infection, and pre-eclampsia risks. Conclusion The identified set of process indicators could identify major gaps in the quality of obstetric and neonatal care provided during the intra- and immediate postpartum period. We hope our suggested indicators for essential routine care processes

  20. Screening of intraocular pressure before routine pupil dilation for retinal photography: Clinical case report

    Directory of Open Access Journals (Sweden)

    Lap-kin Chiang

    2016-12-01

    Full Text Available Introduction: Pharmacologic dilation of the pupil results in twice the sensitivity of detection of diabetic retinopathy compared with undilated retinal examination. The potential risk of acute angle-closure glaucoma after pupil dilation has been hypothesized to be higher in Asian patients with diabetes mellitus. Clinical case: A 61-year-old man with diabetes mellitus and hypertension was incidentally found to have elevated intraocular pressure (IOP before routine retinal photography. He was asymptomatic and the visual acuity was 0.67 for both eyes. An ophthalmologist later found he had anatomical narrow-angle borderline glaucoma. Topical administration of pilocarpine and oral administration of acetazolamide were initiated, and laser iridotomy was later performed. IOP screening: Among 1736 diabetic and/or hypertensive patients who underwent IOP screening, 31 patients (1.8% had IOP of any eye persistently higher than 21 mm Hg on at least two occasions. The mean (standard deviation IOP of the right eye was 24.1 (2.1 mm Hg, while that of the left eye was 24.6 (2.5 mm Hg. Four patients (12.9% were found to have glaucoma, and treatment was initiated by an ophthalmologist. Therefore further study should be conducted to evaluate the cost-effectiveness of IOP screening among this group of patients.

  1. Routine conventional karyotyping of lymphoma staging bone marrow samples does not contribute clinically relevant information.

    Science.gov (United States)

    Nardi, Valentina; Pulluqi, Olja; Abramson, Jeremy S; Dal Cin, Paola; Hasserjian, Robert P

    2015-06-01

    Bone marrow (BM) evaluation is an important part of lymphoma staging, which guides patient management. Although positive staging marrow is defined as morphologically identifiable disease, such samples often also include flow cytometric analysis and conventional karyotyping. Cytogenetic analysis is a labor-intensive and costly procedure and its utility in this setting is uncertain. We retrospectively reviewed pathological reports of 526 staging marrow specimens in which conventional karyotyping had been performed. All samples originated from a single institution from patients with previously untreated Hodgkin and non-Hodgkin lymphomas presenting in an extramedullary site. Cytogenetic analysis revealed clonal abnormalities in only eight marrow samples (1.5%), all of which were positive for lymphoma by morphologic evaluation. Flow cytometry showed a small clonal lymphoid population in three of the 443 morphologically negative marrow samples (0.7%). Conventional karyotyping is rarely positive in lymphoma staging marrow samples and, in our cohort, the BM karyotype did not contribute clinically relevant information in the vast majority of cases. Our findings suggest that karyotyping should not be performed routinely on BM samples taken to stage previously diagnosed extramedullary lymphomas unless there is pathological evidence of BM involvement by lymphoma. © 2015 Wiley Periodicals, Inc.

  2. Synthesis of [{sup 123}I]IBZM: a reliable procedure for routine clinical studies

    Energy Technology Data Exchange (ETDEWEB)

    Zea-Ponce, Yolanda E-mail: yolanda@neuron.cpmc.columbia.edu; Laruelle, Marc

    1999-08-01

    The single photon emission computed tomography (SPECT) D{sub 2}/D{sub 3} receptor radiotracer [{sup 123}I]IBZM, is prepared by electrophilic radioiodination of the precursor BZM with high-purity sodium [{sup 123}I]iodide in the presence of diluted peracetic acid. However, in our hands, the most commonly used procedure for this radiosynthesis produced variable and inconsistent labeling yields, to such extent that it became inappropriate for routine clinical studies. Our goal was to modify the labeling procedure, to obtain consistently better labeling and radiochemical yields. The best conditions found for the radioiodination were as follows: 50 {mu}g precursor in 50 {mu}L EtOH mixed with buffer pH 2; Na[{sup 123}I]I in 0.1 M NaOH (<180 {mu}L), 50 {mu}L peracetic acid diluted solution, heating at 65 deg. C for 14 min. Purification was achieved by solid phase extraction (SPE) and reverse-phase high performance liquid chromatography (HPLC). Under these conditions, labeling yield average was 76{+-}4% (n=31); radiochemical yield was 69{+-}4% and radiochemical purity was 98{+-}1%. With larger volumes of the Na[{sup 123}I]I solution the yields were consistent but lower. For example, for volumes between 417 and 523 {mu}L the labeling yield was 61{+-}5% (n=21), radiochemical yield was 56{+-} 5% and radiochemical purity was 98{+-}1%.

  3. Synthesis of [123I]IBZM: a reliable procedure for routine clinical studies

    International Nuclear Information System (INIS)

    Zea-Ponce, Yolanda; Laruelle, Marc

    1999-01-01

    The single photon emission computed tomography (SPECT) D 2 /D 3 receptor radiotracer [ 123 I]IBZM, is prepared by electrophilic radioiodination of the precursor BZM with high-purity sodium [ 123 I]iodide in the presence of diluted peracetic acid. However, in our hands, the most commonly used procedure for this radiosynthesis produced variable and inconsistent labeling yields, to such extent that it became inappropriate for routine clinical studies. Our goal was to modify the labeling procedure, to obtain consistently better labeling and radiochemical yields. The best conditions found for the radioiodination were as follows: 50 μg precursor in 50 μL EtOH mixed with buffer pH 2; Na[ 123 I]I in 0.1 M NaOH ( 123 I]I solution the yields were consistent but lower. For example, for volumes between 417 and 523 μL the labeling yield was 61±5% (n=21), radiochemical yield was 56± 5% and radiochemical purity was 98±1%

  4. Genetic alterations in lung cancer: Assessing limitations in routine clinical use

    Directory of Open Access Journals (Sweden)

    Joana Espiga Macedo

    2007-01-01

    Full Text Available Lung cancer is the most frequent cause of cancer mortality worldwide, responsible for approximately 1.1 million deaths per year. Median survival is short, both as most tumours are diagnosed at an advanced stage and because of the limited efficacy of available treatments. The development of tumour molecular genetics carries the promise of altering this state of affairs, as it should lead to a more precise classification of tumours, identify specific molecular targets for therapy and, above all, allow the development of new methods for early diagnosis. Despite numerous studies demonstrating the usefulness of molecular genetic techniques in the study of lung cancer, its routine clinical use in Portugal has, however, been limited.In this study, we used a p53 mutation screen in multiple clinical samples from a series of lung cancer patients to attempt to identify the main practical limitations to the integration of molecular genetics in routine clinical practice. Our results suggest that the main limiting factor is the availability of samples with good quality DNA; a problem that could be overcome by alterations in common sample collection and storage procedures. Resumo: O cancro do pulmão é a causa mais frequente de mortalidade por cancro no mundo, sendo responsável por cerca de 1,1 milhões de mortes por ano. A sobrevivência média dos doentes é geralmente curta, por a doença se encontrar em estádios avançados na altura do diagnóstico, mas também devido à falta de eficácia dos tratamentos disponíveis. O advento da genética molecular dos tumores trouxe consigo a possibilidade de modificar esta situação, quer através do refinamento do diagnóstico, quer da identificação de alvos terapêuticos específicos, quer sobretudo por – pelo menos em teoria – permitir o diagnóstico precoce da doença. No entanto, e apesar de numerosos trabalhos terem já demonstrado a utilidade

  5. Outcome of small cell lung cancer (SCLC) patients with brain metastases in a routine clinical setting

    International Nuclear Information System (INIS)

    Lekic, Mirko; Kovac, Viljem; Triller, Nadja; Knez, Lea; Sadikov, Aleksander; Cufer, Tanja

    2012-01-01

    Small cell lung cancer (SCLC) represents approximately 13 to 18% of all lung cancers. It is the most aggressive among lung cancers, mostly presented at an advanced stage, with median survival rates of 10 to12 months in patients treated with standard chemotherapy and radiotherapy. In approximately 15-20% of patients brain metastases are present already at the time of primary diagnosis; however, it is unclear how much it influences the outcome of disease according the other metastatic localisation. The objective of this analysis was to evaluate the median survival of SCLC patients treated by specific therapy (chemotherapy and/or radiotherapy) with regard to the presence or absence of brain metastases at the time of diagnosis. All SCLC patients have been treated in a routine clinical practice and followed up at the University Clinic Golnik in Slovenia. In the retrospective study the medical files from 2002 to 2007 were review. All patients with cytological or histological confirmed disease and eligible for specific oncological treatment were included in the study. They have been treated according to the guidelines valid at the time. Chemotherapy and regular followed-up were carried out at the University Clinic Golnik and radiotherapy at the Institute of Oncology Ljubljana. We found 251 patients eligible for the study. The median age of them was 65 years, majority were male (67%), smokers or ex-smokers (98%), with performance status 0 to 1 (83%). At the time of diagnosis no metastases were found in 64 patients (25.5%) and metastases outside the brain were presented in 153 (61.0%). Brain metastases, confirmed by a CT scan, were present in 34 patients (13.5%), most of them had also metastases at other localisations. All patients received chemotherapy and all patients with confirmed brain metastases received whole brain irradiation (WBRT). The radiotherapy with radical dose at primary tumour was delivered to 27 patients with limited disease and they got 4–6 cycles of

  6. [Clinical laboratory approaches to parodontitis treatment optimization].

    Science.gov (United States)

    Soboleva, L A; Shul'diakov, A A; Oseeva, A O; Aleksandrova, E A

    2010-01-01

    In order to determine cycloferon liniment clinical-pathogenetic efficacy in comprehensive parodontitis therapy examination and treatment of 80 patients was done. It was determined that the cycloferon liniment use in comprehensive treatment of patients with parodontitis let to reduce infectious load in parodontal pockets and local inflammation intensity, to normalize the secretory immunoglobulin level and immune status indices that provided speed up of healing process and reduction relapse frequency.

  7. A Laboratory Course in Clinical Biochemistry Emphasizing Interest and Relevance

    Science.gov (United States)

    Schwartz, Peter L.

    1975-01-01

    Ten laboratory experiments are described which are used in a successful clinical biochemistry laboratory course (e.g. blood alcohol, glucose tolerance, plasma triglycerides, coronary risk index, gastric analysis, vitamin C and E). Most of the experiments are performed on the students themselves using simple equipment with emphasis on useful…

  8. Clinical and laboratory experience of chorionic villous sampling in ...

    African Journals Online (AJOL)

    2013-12-14

    Dec 14, 2013 ... clinical and laboratory procedures, including general characteristics of women, indications and outcome, .... quality assurance, accuracy and reliability of results. ... controls for confirmation of results, while negative control.

  9. Clinical Laboratory Data Management: A Distributed Data Processing Solution

    OpenAIRE

    Levin, Martin; Morgner, Raymond; Packer, Bernice

    1980-01-01

    Two turn-key systems, one for patient registration and the other for the clinical laboratory have been installed and linked together at the Hospital of the University of Pennsylvania, forming the nucleus of an evolving distributed Hospital Information System.

  10. 76 FR 5379 - Clinical Laboratory Improvement Advisory Committee (CLIAC)

    Science.gov (United States)

    2011-01-31

    ... modification of the standards to accommodate technological advances. Matters To Be Discussed: The agenda will... Coordinating Council on the Clinical Laboratory Workforce; the National Institutes of Health Genetic Test...

  11. [CAP quality management system in clinical laboratory and its issue].

    Science.gov (United States)

    Tazawa, Hiromitsu

    2004-03-01

    The CAP (College of American Pathologists) was established in 1962 and, at present, CAP-accredited laboratories include about 6000 institutions all over the world, mainly in the U.S. The essential purpose of CAP accreditation is high quality reservation and improvement of clinical laboratory services for patient care, and is based on seven points, listed below. (1) Establishment of a laboratory management program and laboratory techniques to assure accuracy and improve overall quality of laboratory services. (2) Maintenance and improvement of accuracy objectively by centering on a CAP survey. (3) Thoroughness in safety and health administration. (4) Reservation of the performance of laboratory services by personnel and proficiency management. (5) Provision of appropriate information to physicians, and contribution to improved quality of patient care by close communication with physicians (improvement in patient care). (6) Reduction of running costs and personnel costs based on evidence by employing the above-mentioned criteria. (7) Reduction of laboratory error. In the future, accreditation and/or certification by organizations such as CAP, ISO, etc., may become a requirement for providing any clinical laboratory services in Japan. Taking the essence of the CAP and the characteristics of the new international standard, ISO151589, into consideration, it is important to choose the best suited accreditation and/or certification depending of the purpose of clinical laboratory.

  12. Quality control of parasitology stool examination in Tabriz clinical laboratories

    Directory of Open Access Journals (Sweden)

    shahram Khademvatan

    2011-06-01

    Full Text Available The purpose of quality control program was to make doctors and laboratory personnel trust in laboratory results and consequently increasing confidence in laboratory achievements. The quality assurance means raising the level of quality in all tests that lead to raising the level of work efficiency and laboratories including minimum expense for society and minimum time for lab personnel. This study aimed to assess and determine the accuracy and precision of results in Tabriz medical diagnostic laboratories. Materials and Methods: In this retrospective study, 790 stool samples were selected randomly and tested by standard methods.Student t- test, SPSS software and sensitivity and accuracy formulas were used for data analysis. Results: The sensitivity was 62%, 22% and 8% with 95% confidence intervals for worm's eggs, protozoan cysts and trophozoite detection respectively. Conclusion: To elevate quality assurance in clinical diagnostic laboratory, monitoring and check of the laboratories by standard methods continually should be done.

  13. Estimation of the effects of multipoint pacing on battery longevity in routine clinical practice.

    Science.gov (United States)

    Akerström, Finn; Narváez, Irene; Puchol, Alberto; Pachón, Marta; Martín-Sierra, Cristina; Rodríguez-Mañero, Moisés; Rodríguez-Padial, Luis; Arias, Miguel A

    2017-09-23

    Multipoint pacing (MPP) permits simultaneous multisite pacing of the left ventricle (LV); initial studies suggest haemodynamic and clinical benefits over conventional (single LV site) cardiac resynchronization therapy (CRT). The aim of this study was to estimate the impact of MPP activation on battery longevity in routine clinical practice. Patient (n = 46) and device data were collected from two centres at least 3 months after MPP-CRT device implantation. Multipoint pacing programming was based on the maximal possible anatomical LV1/LV2 separation according to three predefined LV pacing capture threshold (PCT) cut-offs (≤1.5 V; ≤4.0 V; and ≤6.5 V). Estimated battery longevity was calculated using the programmed lower rate limit, lead impedances, outputs, and pacing percentages. Relative to the longevity for conventional CRT using the lowest PCT (8.9 ± 1.2 years), MPP activation significantly shortened battery longevity for all three PCT cut-offs (≤1.5 V, -5.6%; ≤4.0 V, -16.9%; ≤6.5 V, -21.3%; P's battery longevity was significantly shortened for the MPP ≤ 4.0 V and ≤6.5 V cut-offs (-10.8 and -15.7%, respectively; P's battery longevity compared with that for conventional CRT configuration. When reasonable MPP LV vector PCTs (≤4.0 V) are achieved, the decrease in battery longevity is relatively small which may prompt the clinician to activate MPP. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2017. For permissions, please email: journals.permissions@oup.com.

  14. The impact of introducing intensity modulated radiotherapy into routine clinical practice

    International Nuclear Information System (INIS)

    Miles, Elizabeth A.; Clark, Catharine H.; Urbano, M. Teresa Guerrero; Bidmead, Margaret; Dearnaley, David P.; Harrington, Kevin J.; A'Hern, Roger; Nutting, Christopher M.

    2005-01-01

    Background and purpose: Intensity modulated radiotherapy (IMRT) at Royal Marsden Hospital London was introduced in July 2001. Treatment delivery was dynamic using a single-phase technique. Concerns were raised regarding increased clinical workload due to introduction of new technology. The potential increased use of resources was assessed. Patients and methods: IMRT patient selection was within guidelines of clinical trials and included patients undergoing prostate plus pelvic lymph node (PPN) irradiation and head and neck cancer (HNC) treatment. Patient planning, quality assurance and treatment times were collected for an initial IMRT patient group. A comparative group of patients with advanced HNC undergoing two- or three-phase conventional radiotherapy, requiring matched photon and electron fields, were also timed. Results: The median overall total planning time for IMRT was greater for HNC patients compared to the PPN cohort. For HNC the overall IMRT planning time was significantly longer than for conventional. The median treatment time for conventional two- or three-phase HNC treatments, encompassing similar volumes to those treated with IMRT, was greater than that for the IMRT HNC patient cohort. A reduction in radiographer man hours per patient of 4.8 h was recorded whereas physics time was increased by 4.9 h per patient. Conclusions: IMRT currently increases overall planning time. Additional clinician input is required for target volume localisation. Physics time is increased, a significant component of this being patient specific QA. Radiographer time is decreased. For HNC a single phase IMRT treatment has proven to be more efficient than a multiple phase conventional treatment. IMRT has been integrated smoothly and efficiently into the existing treatment working day. This preliminary study suggests that IMRT could be a routine treatment with efficient use of current radiotherapy resources

  15. The impact of introducing intensity modulated radiotherapy into routine clinical practice.

    Science.gov (United States)

    Miles, Elizabeth A; Clark, Catharine H; Urbano, M Teresa Guerrero; Bidmead, Margaret; Dearnaley, David P; Harrington, Kevin J; A'Hern, Roger; Nutting, Christopher M

    2005-12-01

    Intensity modulated radiotherapy (IMRT) at the Royal Marsden Hospital London was introduced in July 2001. Treatment delivery was dynamic using a single-phase technique. Concerns were raised regarding increased clinical workload due to introduction of new technology. The potential increased use of resources was assessed. IMRT patient selection was within guidelines of clinical trials and included patients undergoing prostate plus pelvic lymph node (PPN) irradiation and head and neck cancer (HNC) treatment. Patient planning, quality assurance and treatment times were collected for an initial IMRT patient group. A comparative group of patients with advanced HNC undergoing two- or three-phase conventional radiotherapy, requiring matched photon and electron fields, were also timed. The median overall total planning time for IMRT was greater for HNC patients compared to the PPN cohort. For HNC the overall IMRT planning time was significantly longer than for conventional. The median treatment time for conventional two- or three-phase HNC treatments, encompassing similar volumes to those treated with IMRT, was greater than that for the IMRT HNC patient cohort. A reduction in radiographer man hours per patient of 4.8h was recorded whereas physics time was increased by 4.9h per patient. IMRT currently increases overall planning time. Additional clinician input is required for target volume localisation. Physics time is increased, a significant component of this being patient specific QA. Radiographer time is decreased. For HNC a single phase IMRT treatment has proven to be more efficient than a multiple phase conventional treatment. IMRT has been integrated smoothly and efficiently into the existing treatment working day. This preliminary study suggests that IMRT could be a routine treatment with efficient use of current radiotherapy resources.

  16. Quantitative CT characterization of pediatric lung development using routine clinical imaging

    Energy Technology Data Exchange (ETDEWEB)

    Stein, Jill M.; Brody, Alan S.; Fleck, Robert J. [Cincinnati Children' s Hospital Medical Center, Department of Radiology, Cincinnati, OH (United States); Walkup, Laura L. [Cincinnati Children' s Hospital Medical Center, Center for Pulmonary Imaging Research, Pulmonary Medicine and Radiology, Cincinnati, OH (United States); Woods, Jason C. [Cincinnati Children' s Hospital Medical Center, Department of Radiology, Cincinnati, OH (United States); Cincinnati Children' s Hospital Medical Center, Center for Pulmonary Imaging Research, Pulmonary Medicine and Radiology, Cincinnati, OH (United States)

    2016-12-15

    The use of quantitative CT analysis in children is limited by lack of normal values of lung parenchymal attenuation. These characteristics are important because normal lung development yields significant parenchymal attenuation changes as children age. To perform quantitative characterization of normal pediatric lung parenchymal X-ray CT attenuation under routine clinical conditions in order to establish a baseline comparison to that seen in pathological lung conditions. We conducted a retrospective query of normal CT chest examinations in children ages 0-7 years from 2004 to 2014 using standard clinical protocol. During these examinations semi-automated lung parenchymal segmentation was performed to measure lung volume and mean lung attenuation. We analyzed 42 CT examinations in 39 children, ages 3 days to 83 months (mean ± standard deviation [SD] = 42 ± 27 months). Lung volume ranged 0.10-1.72 liters (L). Mean lung attenuation was much higher in children younger than 12 months, with values as high as -380 Hounsfield units (HU) in neonates (lung volume 0.10 L). Lung volume decreased to approximately -650 HU by age 2 years (lung volume 0.47 L), with subsequently slower exponential decrease toward a relatively constant value of -860 HU as age and lung volume increased. Normal lung parenchymal X-ray CT attenuation decreases with increasing lung volume and age; lung attenuation decreases rapidly in the first 2 years of age and more slowly thereafter. This change in normal lung attenuation should be taken into account as quantitative CT methods are translated to pediatric pulmonary imaging. (orig.)

  17. Quantitative CT characterization of pediatric lung development using routine clinical imaging

    International Nuclear Information System (INIS)

    Stein, Jill M.; Brody, Alan S.; Fleck, Robert J.; Walkup, Laura L.; Woods, Jason C.

    2016-01-01

    The use of quantitative CT analysis in children is limited by lack of normal values of lung parenchymal attenuation. These characteristics are important because normal lung development yields significant parenchymal attenuation changes as children age. To perform quantitative characterization of normal pediatric lung parenchymal X-ray CT attenuation under routine clinical conditions in order to establish a baseline comparison to that seen in pathological lung conditions. We conducted a retrospective query of normal CT chest examinations in children ages 0-7 years from 2004 to 2014 using standard clinical protocol. During these examinations semi-automated lung parenchymal segmentation was performed to measure lung volume and mean lung attenuation. We analyzed 42 CT examinations in 39 children, ages 3 days to 83 months (mean ± standard deviation [SD] = 42 ± 27 months). Lung volume ranged 0.10-1.72 liters (L). Mean lung attenuation was much higher in children younger than 12 months, with values as high as -380 Hounsfield units (HU) in neonates (lung volume 0.10 L). Lung volume decreased to approximately -650 HU by age 2 years (lung volume 0.47 L), with subsequently slower exponential decrease toward a relatively constant value of -860 HU as age and lung volume increased. Normal lung parenchymal X-ray CT attenuation decreases with increasing lung volume and age; lung attenuation decreases rapidly in the first 2 years of age and more slowly thereafter. This change in normal lung attenuation should be taken into account as quantitative CT methods are translated to pediatric pulmonary imaging. (orig.)

  18. Sensitivity and Specificity of Clinical and Laboratory Otolith Function Tests.

    Science.gov (United States)

    Kumar, Lokesh; Thakar, Alok; Thakur, Bhaskar; Sikka, Kapil

    2017-10-01

    To evaluate clinic based and laboratory tests of otolith function for their sensitivity and specificity in demarcating unilateral compensated complete vestibular deficit from normal. Prospective cross-sectional study. Tertiary care hospital vestibular physiology laboratory. Control group-30 healthy adults, 20-45 years age; Case group-15 subjects post vestibular shwannoma excision or post-labyrinthectomy with compensated unilateral complete audio-vestibular loss. Otolith function evaluation by precise clinical testing (head tilt test-HTT; subjective visual vertical-SVV) and laboratory testing (headroll-eye counterroll-HR-ECR; vesibular evoked myogenic potentials-cVEMP). Sensitivity and specificity of clinical and laboratory tests in differentiating case and control subjects. Measurable test results were universally obtained with clinical otolith tests (SVV; HTT) but not with laboratory tests. The HR-ECR test did not indicate any definitive wave forms in 10% controls and 26% cases. cVEMP responses were absent in 10% controls.HTT test with normative cutoff at 2 degrees deviations from vertical noted as 93.33% sensitive and 100% specific. SVV test with normative cutoff at 1.3 degrees noted as 100% sensitive and 100% specific. Laboratory tests demonstrated poorer specificities owing primarily to significant unresponsiveness in normal controls. Clinical otolith function tests, if conducted with precision, demonstrate greater ability than laboratory testing in discriminating normal controls from cases with unilateral complete compensated vestibular dysfunction.

  19. Brand-to-generic levetiracetam switch in patients with epilepsy in a routine clinical setting.

    Science.gov (United States)

    Markoula, Sofia; Chatzistefanidis, Dimitrios; Gatzonis, Stylianos; Siatouni, Anna; Siarava, Eleftheria; Verentzioti, Anastasia; Kyritsis, Athanassios P; Patsalos, Philip N

    2017-05-01

    The therapeutic equivalence of generic and brand antiepileptic drugs, based on studies performed on healthy volunteers, has been questioned. We compare, in a routine clinical setting, brand versus generic levetiracetam (LEV) bioequivalence in patients with epilepsy and also the clinical efficacy and tolerability of the substitution. A prospective, open-label, non-randomized, steady-state, multiple-dose, bioequivalence study was conducted in 12 patients with epilepsy (5 females), with a mean age of 38.4±16.2 years. Patients treated with the brand LEV (Keppra; UCB Pharma) were closely followed for a four-week period and subsequently switched to a generic LEV (Pharmaten) and followed for another four-week period. Blood samples were collected at the end of each 4-week period, during a dose interval for each formulation, for LEV concentration measurements by liquid chromatography mass spectrometry. Steady-state area under the curve (AUC) and peak plasma concentration (Cmax) data were subjected to conventional average bioequivalence analysis. Secondary clinical outcomes, including seizure frequency and adverse events, were recorded. Patients had epilepsy for a mean period of 14.1±10.6years and the mean daily LEV dose was 2583.3±763.7mg. The mean AUC±SD and Cmax±SD was 288.4±86.3(mg/L)h and 37.8±10.4mg/L respectively for brand LEV and 319.2±104.7(mg/L)h and 41.6±12.3mg/L respectively for the generic LEV. Statistic analysis showed no statistical significant difference in bioequivalence. Also, no change in seizures frequency and/or adverse events was recorded. In our clinical setting, generic LEV was determined to be bioequivalent to brand LEV. Furthermore, seizures frequency or/and adverse events were not affected upon switching from brand to generic LEV. Copyright © 2017 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.

  20. [Clinical microbiology laboratory and imported parasitic diseases].

    Science.gov (United States)

    Martín-Rabadán, Pablo; Martínez-Ruiz, Rocío; Cuadros, Juan; Cañavate, Carmen

    2010-12-01

    Imported parasitosis represents an increasingly frequent diagnostic challenge for microbiology laboratories. A surge in immigration and international travel has led to a rise in the number of imported cases of parasitosis, and this trend is expected to continue in the future. The present article addresses this challenge by reviewing recommended diagnostic approaches and tests. Currently, microscopy is always recommended when analysing blood samples for parasites. If malaria is suspected, rapid antigen testing (including at least HRP2 antigen) should also be performed. The work-up for suspected leishmaniasis should include serology, culture, and in selected cases detection of antigen in urine. In suspected Chagas disease, two different serological tests should be performed. PCR for blood protozoa is highly sensitive, although it cannot be used to rule out Chagas disease, since this condition may be present without parasitemia. Accurate diagnosis of intestinal amebiasis usually requires PCR or antigen detection tests. In helminthiasis, traditional microscopy may need to be complemented with other tests, such as agar plate culture for strongyloidiasis, Og4C3 antigen detection for bancroftian filariasis, and antibody detection test for filariasis and schistosomiasis. Copyright © 2010 Elsevier España, S.L. All rights reserved.

  1. Promoting Good Clinical Laboratory Practices and Laboratory Accreditation to Support Clinical Trials in Sub-Saharan Africa

    Science.gov (United States)

    Shott, Joseph P.; Saye, Renion; Diakité, Moussa L.; Sanogo, Sintry; Dembele, Moussa B.; Keita, Sekouba; Nagel, Mary C.; Ellis, Ruth D.; Aebig, Joan A.; Diallo, Dapa A.; Doumbo, Ogobara K.

    2012-01-01

    Laboratory capacity in the developing world frequently lacks quality management systems (QMS) such as good clinical laboratory practices, proper safety precautions, and adequate facilities; impacting the ability to conduct biomedical research where it is needed most. As the regulatory climate changes globally, higher quality laboratory support is needed to protect study volunteers and to accurately assess biological parameters. The University of Bamako and its partners have undertaken a comprehensive QMS plan to improve quality and productivity using the Clinical and Laboratory Standards Institute standards and guidelines. The clinical laboratory passed the College of American Pathologists inspection in April 2010, and received full accreditation in June 2010. Our efforts to implement high-quality standards have been valuable for evaluating safety and immunogenicity of malaria vaccine candidates in Mali. Other disease-specific research groups in resource-limited settings may benefit by incorporating similar training initiatives, QMS methods, and continual improvement practices to ensure best practices. PMID:22492138

  2. The clinical value of daily routine chest radiographs in a mixed medical-surgical intensive care unit is low.

    Science.gov (United States)

    Graat, Marleen E; Choi, Goda; Wolthuis, Esther K; Korevaar, Johanna C; Spronk, Peter E; Stoker, Jaap; Vroom, Margreeth B; Schultz, Marcus J

    2006-02-01

    The clinical value of daily routine chest radiographs (CXRs) in critically ill patients is unknown. We conducted this study to evaluate how frequently unexpected predefined major abnormalities are identified with daily routine CXRs, and how often these findings lead to a change in care for intensive care unit (ICU) patients. This was a prospective observational study conducted in a 28-bed, mixed medical-surgical ICU of a university hospital. Over a 5-month period, 2,457 daily routine CXRs were done in 754 consecutive ICU patients. The majority of these CXRs did not reveal any new predefined major finding. In only 5.8% of daily routine CXRs (14.3% of patients) was one or more new and unexpected abnormality encountered, including large atelectases (24 times in 20 patients), large infiltrates (23 in 22), severe pulmonary congestion (29 in 25), severe pleural effusion (13 in 13), pneumothorax/pneumomediastinum (14 in 13), and malposition of the orotracheal tube (32 in 26). Fewer than half of the CXRs with a new and unexpected finding were ultimately clinically relevant; in only 2.2% of all daily routine CXRs (6.4% of patients) did these radiologic abnormalities result in a change to therapy. Subgroup analysis revealed no differences between medical and surgical patients with regard to the incidence of new and unexpected findings on daily routine CXRs and the effect of new and unexpected CXR findings on daily care. In the ICU, daily routine CXRs seldom reveal unexpected, clinically relevant abnormalities, and they rarely prompt action. We propose that this diagnostic examination be abandoned in ICU patients.

  3. Antiphospholipid antibody: laboratory, pathogenesis and clinical manifestations

    Directory of Open Access Journals (Sweden)

    T. Ziglioli

    2011-06-01

    Full Text Available Antiphospholipid antibodies (aPL represent a heterogeneous group of antibodies that recognize various antigenic targets including beta2 glycoprotein I (β2GPI, prothrombin (PT, activated protein C, tissue plasminogen activator, plasmin and annexin A2. The most commonly used tests to detect aPL are: lupus anticoagulant (LAC, a functional coagulation assay, anticardiolipin antibody (aCL and anti-β2GPI antibody (anti-β2GPI, which are enzyme-linked immunoassay (ELISA. Clinically aPL are associated with thrombosis and/or with pregnancy morbidity. Apparently aPL alone are unable to induce thrombotic manifestations, but they increase the risk of vascular events that can occur in the presence of another thrombophilic condition; on the other hand obstetrical manifestations were shown to be associated not only to thrombosis but mainly to a direct antibody effect on the trophoblast.

  4. Clinical laboratory technologist professional development in Camagüey

    Directory of Open Access Journals (Sweden)

    Mercedes Caridad García González

    2015-05-01

    Full Text Available The paper describes the results of research aimed at assessing the current conditions related to clinical laboratory technologist professional development. A descriptive cross study covering the period between November 2013 and January 2014 is presented. Several techniques for identifying and hierarchically arranging professional developmental related problems were used to study a sample at the Faculty of Health Technology of the Medical University “Carlos Juan Finlay”. The study involved heads of teaching departments and methodologists of health care technology specialties; moreover a survey and a content test were given graduate clinical laboratory technicians. The authors reached at the conclusion that clinical laboratory technologist professional development is limited and usually underestimate the necessities and interests of these graduates. Likewise, a lack of systematization and integration of the biomedical basic sciences contents and the laboratory diagnosis is noticeable.

  5. [Mass spectrometry in the clinical microbiology laboratory].

    Science.gov (United States)

    Jordana-Lluch, Elena; Martró Català, Elisa; Ausina Ruiz, Vicente

    2012-12-01

    Infectious diseases are still a cause of high mortality and morbidity rates. Current microbiological diagnostic methods are based on culture and phenotypic identification of isolated microorganisms, which can be obtained in about 24-48 h. Given that the microbiological identification is of major importance for patient management, new diagnostic methods are needed in order to detect and identify microorganisms in a timely and accurate manner. Over the last few years, several molecular techniques based on the amplification of microbial nucleic acids have been developed with the aim of reducing the time needed for the identification of the microorganisms involved in different infectious processes. On the other hand, mass spectrometry has emerged as a rapid and consistent alternative to conventional methods for microorganism identification. This review describes the most widely used mass spectrometry technologies -matrix-assisted laser desorption/ionization time-of-flight (MALDI-TOF) and electrospray ionization time-of-flight (ESI-TOF)-, both for protein and nucleic acid analysis, as well as the commercial platforms available. Related publications of most interest in clinical microbiology are also reviewed. Copyright © 2011 Elsevier España, S.L. All rights reserved.

  6. Laboratory and software applications for clinical trials: the global laboratory environment.

    Science.gov (United States)

    Briscoe, Chad

    2011-11-01

    The Applied Pharmaceutical Software Meeting is held annually. It is sponsored by The Boston Society, a not-for-profit organization that coordinates a series of meetings within the global pharmaceutical industry. The meeting generally focuses on laboratory applications, but in recent years has expanded to include some software applications for clinical trials. The 2011 meeting emphasized the global laboratory environment. Global clinical trials generate massive amounts of data in many locations that must be centralized and processed for efficient analysis. Thus, the meeting had a strong focus on establishing networks and systems for dealing with the computer infrastructure to support such environments. In addition to the globally installed laboratory information management system, electronic laboratory notebook and other traditional laboratory applications, cloud computing is quickly becoming the answer to provide efficient, inexpensive options for managing the large volumes of data and computing power, and thus it served as a central theme for the meeting.

  7. Clinical laboratory as an economic model for business performance analysis.

    Science.gov (United States)

    Buljanović, Vikica; Patajac, Hrvoje; Petrovecki, Mladen

    2011-08-15

    To perform SWOT (strengths, weaknesses, opportunities, and threats) analysis of a clinical laboratory as an economic model that may be used to improve business performance of laboratories by removing weaknesses, minimizing threats, and using external opportunities and internal strengths. Impact of possible threats to and weaknesses of the Clinical Laboratory at Našice General County Hospital business performance and use of strengths and opportunities to improve operating profit were simulated using models created on the basis of SWOT analysis results. The operating profit as a measure of profitability of the clinical laboratory was defined as total revenue minus total expenses and presented using a profit and loss account. Changes in the input parameters in the profit and loss account for 2008 were determined using opportunities and potential threats, and economic sensitivity analysis was made by using changes in the key parameters. The profit and loss account and economic sensitivity analysis were tools for quantifying the impact of changes in the revenues and expenses on the business operations of clinical laboratory. Results of simulation models showed that operational profit of €470 723 in 2008 could be reduced to only €21 542 if all possible threats became a reality and current weaknesses remained the same. Also, operational gain could be increased to €535 804 if laboratory strengths and opportunities were utilized. If both the opportunities and threats became a reality, the operational profit would decrease by €384 465. The operational profit of the clinical laboratory could be significantly reduced if all threats became a reality and the current weaknesses remained the same. The operational profit could be increased by utilizing strengths and opportunities as much as possible. This type of modeling may be used to monitor business operations of any clinical laboratory and improve its financial situation by implementing changes in the next fiscal

  8. Clinical laboratory as an economic model for business performance analysis

    Science.gov (United States)

    Buljanović, Vikica; Patajac, Hrvoje; Petrovečki, Mladen

    2011-01-01

    Aim To perform SWOT (strengths, weaknesses, opportunities, and threats) analysis of a clinical laboratory as an economic model that may be used to improve business performance of laboratories by removing weaknesses, minimizing threats, and using external opportunities and internal strengths. Methods Impact of possible threats to and weaknesses of the Clinical Laboratory at Našice General County Hospital business performance and use of strengths and opportunities to improve operating profit were simulated using models created on the basis of SWOT analysis results. The operating profit as a measure of profitability of the clinical laboratory was defined as total revenue minus total expenses and presented using a profit and loss account. Changes in the input parameters in the profit and loss account for 2008 were determined using opportunities and potential threats, and economic sensitivity analysis was made by using changes in the key parameters. The profit and loss account and economic sensitivity analysis were tools for quantifying the impact of changes in the revenues and expenses on the business operations of clinical laboratory. Results Results of simulation models showed that operational profit of €470 723 in 2008 could be reduced to only €21 542 if all possible threats became a reality and current weaknesses remained the same. Also, operational gain could be increased to €535 804 if laboratory strengths and opportunities were utilized. If both the opportunities and threats became a reality, the operational profit would decrease by €384 465. Conclusion The operational profit of the clinical laboratory could be significantly reduced if all threats became a reality and the current weaknesses remained the same. The operational profit could be increased by utilizing strengths and opportunities as much as possible. This type of modeling may be used to monitor business operations of any clinical laboratory and improve its financial situation by

  9. [View of a Laboratory Physician on the Present and Future of Clinical Laboratories].

    Science.gov (United States)

    Matsuo, Shuji

    2014-10-01

    It is meaningful to discuss the "present and future of laboratories" for the development of laboratories and education of medical technologists. Laboratory staff must be able to perform urgent high-quality tests and take part in so-called team-based medicine and should be proud of devising systems that efficiently provide laboratory data for all medical staff. On the other hand, there may be staff with a poor sense of professionalism who work no more than is expected and too readily ask firms and commercial laboratories to solve problems. Overwork caused by providing team-based medicine and a decrease in numbers of clinical chemists are concerns. The following are hoped for in the future. Firstly, laboratory staff will become conscious of their own high-level abilities and expand their areas of work, for example, bioscience, proteomics, and reproductive medicine. Secondly, a consultation system for medical staff and patients will be established. Thirdly, clinical research will be advanced, such as investigating unknown pathophysiologies using laboratory data and samples, and developing new methods of measurement. Lastly, it is of overriding importance that staff of laboratory and educational facilities will cooperate with each other to train the next generation. In conclusion, each laboratory should be appreciated, attractive, positive regarding its contribution to society, and show individuality.

  10. CLINICAL AND LABORATORY PROFILE OF DENGUE FEVER

    Directory of Open Access Journals (Sweden)

    Farhan Fazal

    2015-02-01

    Full Text Available AIM: Dengue is a major health problem in many parts of India and Gulbarga (North Karnataka was previously not a known endemic area f or dengue. Infection with dengue virus can cause a spectrum of three clinical syndromes , classic dengue fever (DF , dengue hemorrhagic fever (DHF and dengue shock syndrome (DSS. The present study was undertaken to determine the disease profile of dengue virus infection in hospitalized patients. METHODS AND MATERIAL: One hundred patients admitted in Basaveshwar Teaching and General hospital with fever more than 38.5 degree Celsius and IgM dengue positive were selected. They were followed from the onset of fever to twelve days or till they are recovered according to WHO discharge criteria whichever is earlier. They underwent relevant investigations to identify specific organ dysfunction and categorize them into the spectrum of Dengue fever in accordance to W HO criteria . RESULTS: Out of 100 cases in this study 70 cases belongs to DF , 23 cases to DHF and 7 cases to DSS based on WHO criteria. All the cases had fever (100%. Other common symptoms noted were myalgia (61% , joint pain (54% , headache (66% , vomitin g (55% , pain abdomen (48% , rash (41% , hepatomegaly (20% , bleeding (21% and shock (8%. Hess test was positive in 24% patients. Low platelet count of less than 100 , 000/cu mm according to WHO criteria was present in 73% patients. Deranged liver functio n test and renal parameters were seen in 26 and 8 patients respectively . Mortality documented was 7 patients due to delayed presentation. The average duration of hospital stay was 4.65 days. CONCLUSION: Dengue fever was a more common manifestation than DHF or DSS. During aepidemic , dengue should be strongly considered on the differential diagnosis of any patient with fever. The treatment of dengue is mainly fluid management and supportive. Early recognition and management of alarm symptoms is the key to bet ter outcome

  11. Fission reactor based epithermal neutron irradiation facilities for routine clinical application in BNCT-Hatanaka memorial lecture

    International Nuclear Information System (INIS)

    Harling, Otto K.

    2009-01-01

    Based on experience gained in the recent clinical studies at MIT/Harvard, the desirable characteristics of epithermal neutron irradiation facilities for eventual routine clinical BNCT are suggested. A discussion of two approaches to using fission reactors for epithermal neutron BNCT is provided. This is followed by specific suggestions for the performance and features needed for high throughput clinical BNCT. An example of a current state-of-the-art, reactor based facility, suited for routine clinical use is discussed. Some comments are provided on the current status of reactor versus accelerator based epithermal neutron sources for BNCT. This paper concludes with a summary and a few personal observations on BNCT by the author.

  12. Is Transducer Hygiene sufficient when Vaginal Probes are used in the Clinical Routine?

    Science.gov (United States)

    Merz, E

    2016-04-01

    Vaginal ultrasound probes are semi-critical Group A medical products which must be disinfected following the manufacturer's instructions after every patient examination. According to the "Essential Requirements for Medical Devices (Directive 93/42/EEC, Annex I, paragraph 13)" the manufacturer's instructions for use for reusable products must contain suitable instructions for preparation processes. This presumes both an effective and material-compatible method. Evidence of effectiveness must be validated.In the Editorial in issue 1 Ultraschall in der Medizin/European Journal of Ultrasound 2005 we discussed the topic of transducer hygiene and stated that proper handling and cleaning as well as disinfection of probes in daily use are indispensable. This applies particularly to vaginal ultrasound probes routinely used in gynecological and obstetrical clinics, gynecological practices as well as IVF centers Normally the probe used in a transvaginal ultrasound examination is covered with a latex protective cover (with CE marking) which contains a certain amount of ultrasound gel. After the examination, the cover is removed and disposed of, and the gel is removed from the transducer. Since handling of the probe, ultrasound gel and cover can result in smear infections and cross-contamination with various pathogens (e. g. MRSA, HBV, HCV, HIV, herpes papilloma and cytomegalic viruses), after the protective cover is removed, the probe must be cleaned and subjected to disinfection with a bactericidal, fungicidal and virucidal effect. This is especially important in the event the cover ruptures during the vaginal examination, and the probe comes into direct contact with vaginal secretions or blood. The same likewise applies if the sterile protective cover is perforated during a follicular puncture. Usually special bactericidal, levurocidal and virucidal wipes or special submersion disinfection methods are available for disinfecting the vaginal ultrasound probes 11. Using

  13. Clinical and laboratorial correlation of postoperative hypocalcemia after extensive thyroidectomy

    Directory of Open Access Journals (Sweden)

    Antonio José Gonçalves

    Full Text Available The medical records of 84 patients submitted to extensive thyroidectomy from January 1991 to April 1995 were reviewed and the data was analyzed in order to verify a correlation between postoperative laboratories results and physical findings suggestive of hypocalcemia. It was verified that there was hypocalcemia in 51.2 percent of the patients, of which only 18.6 percent presented symptoms. It was concluded that asymptomatic hypocalcemia is frequent in extensive thyroidectomy and a routine screening for serum calcium in the postoperative period following thyroidectomy and calcium reposition must be systematic.

  14. [Strategy Development for International Cooperation in the Clinical Laboratory Field].

    Science.gov (United States)

    Kudo, Yoshiko; Osawa, Susumu

    2015-10-01

    The strategy of international cooperation in the clinical laboratory field was analyzed to improve the quality of intervention by reviewing documents from international organizations and the Japanese government. Based on the world development agenda, the target of action for health has shifted from communicable diseases to non-communicable diseases (NCD). This emphasizes the importance of comprehensive clinical laboratories instead of disease-specific examinations in developing countries. To achieve this goal, the World Health Organization (WHO) has disseminated to the African and Asian regions the Laboratory Quality Management System (LQMS), which is based on the same principles of the International Organization of Standardization (ISO) 15189. To execute this strategy, international experts must have competence in project management, analyze information regarding the target country, and develop a strategy for management of the LQMS with an understanding of the technical aspects of laboratory work. However, there is no appropriate pre- and post-educational system of international health for Japanese international workers. Universities and academic organizations should cooperate with the government to establish a system of education for international workers. Objectives of this education system must include: (1) training for the organization and understanding of global health issues, (2) education of the principles regarding comprehensive management of clinical laboratories, and (3) understanding the LQMS which was employed based on WHO's initiative. Achievement of these objectives will help improve the quality of international cooperation in the clinical laboratory field.

  15. Routine Laboratory Blood Tests May Diagnose Significant Fibrosis in Liver Transplant Recipients with Chronic Hepatitis C: A 10 Year Experience.

    Science.gov (United States)

    Sheen, Victoria; Nguyen, Heajung; Jimenez, Melissa; Agopian, Vatche; Vangala, Sitaram; Elashoff, David; Saab, Sammy

    2016-03-28

    The aims of our study were to determine whether routine blood tests, the aspartate aminotransferase (AST) to Platelet Ratio Index (APRI) and Fibrosis 4 (Fib-4) scores, were associated with advanced fibrosis and to create a novel model in liver transplant recipients with chronic hepatitis C virus (HCV). We performed a cross sectional study of patients at The University of California at Los Angeles (UCLA) Medical Center who underwent liver transplantation for HCV. We used linear mixed effects models to analyze association between fibrosis severity and individual biochemical markers and mixed effects logistic regression to construct diagnostic models for advanced fibrosis (METAVIR F3-4). Cross-validation was used to estimate a receiving operator characteristic (ROC) curve for the prediction models and to estimate the area under the curve (AUC). The mean (± standard deviation [SD]) age of our cohort was 55 (±7.7) years, and almost three quarter were male. The mean (±SD) time from transplant to liver biopsy was 19.9 (±17.1) months. The mean (±SD) APRI and Fib-4 scores were 3 (±12) and 7 (±14), respectively. Increased fibrosis was associated with lower platelet count and alanine aminotransferase (ALT) values and higher total bilirubin and Fib-4 scores. We developed a model that takes into account age, gender, platelet count, ALT, and total bilirubin, and this model outperformed APRI and Fib-4 with an AUC of 0.68 (p fibrosis more reliably than APRI and Fib-4 scores. This noninvasive calculation may be used clinically to identify liver transplant recipients with HCV with significant liver damage.

  16. Hyperthermia: from the clinic to the laboratory and back again

    International Nuclear Information System (INIS)

    Maher, E.J.

    1989-01-01

    Murine tumours have been used extensively to investigate the effects of heat and radiation, but there are significant differences between controlled laboratory studies and relatively uncontrolled clinical experience. From 1983 to 1986 a simple clinical system was developed in order to investigate biological questions in the clinic. This involved identifying a suitable patient population, reliable heating and thermometry, and methods of evaluating response of human tumours and their vasculature. (author)

  17. Building bridges between clinical and forensic toxicology laboratories.

    Science.gov (United States)

    Martin, Bernardino Barcelo; Gomila, Isabel; Noce, Valeria

    2018-05-09

    Clinical and forensic toxicology can be defined as the two disciplines involved the detection, identification and measurement of xenobiotics in biological and non-biological specimens to help in the diagnosis, treatment, prognosis, prevention of poisonings and to disclose causes and contributory causes of fatal intoxications, respectively. This article explores the close connections between clinical and forensic toxicology in overlapping areas of interest. An update has been carried out of the following seven areas of interest in analytical toxicology: doping control, sudden cardiac death (SCD), brain death, sudden infant death syndrome (SIDS) and Munchausen syndrome by proxy (MSBP), prenatal exposure to drugs and fetal alcohol syndrome (FAS), drug-facilitated crimes (DFC) and intoxications by new psychoactive substances (NPS). While issues such as SCD, SIDS or doping control are investigated mainly in forensic laboratories, other as prenatal exposure to drugs or FAS are mainly treated in clinical laboratories. On the other hand, areas such MSBP, DFC or the intoxications by NPS are of interest in both laboratories. Some of these topics are initially treated in hospital emergency departments, involving clinical laboratories and sometimes lately derived to forensic laboratories. Conversely, cases with initial medical-legal implications and fatalities are directly handled by forensic toxicology, but may trigger further studies in the clinical setting. Many areas of common interest between clinical and forensic laboratories are building bridges between them. The increasing relationships are improving the growth, the reliability and the robustness of both kind of laboratories. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  18. A Required Rotation in Clinical Laboratory Management for Pathology Residents

    OpenAIRE

    Arvind Rishi MD; Syed T. Hoda MD; James M. Crawford MD, PhD

    2016-01-01

    Leadership and management training during pathology residency have been identified repeatedly by employers as insufficient. A 1-month rotation in clinical laboratory management (CLM) was created for third-year pathology residents. We report on our experience and assess the value of this rotation. The rotation was one-half observational and one-half active. The observational component involved being a member of department and laboratory service line leadership, both at the departmental and ins...

  19. Can machine-learning improve cardiovascular risk prediction using routine clinical data?

    Science.gov (United States)

    Kai, Joe; Garibaldi, Jonathan M.; Qureshi, Nadeem

    2017-01-01

    Background Current approaches to predict cardiovascular risk fail to identify many people who would benefit from preventive treatment, while others receive unnecessary intervention. Machine-learning offers opportunity to improve accuracy by exploiting complex interactions between risk factors. We assessed whether machine-learning can improve cardiovascular risk prediction. Methods Prospective cohort study using routine clinical data of 378,256 patients from UK family practices, free from cardiovascular disease at outset. Four machine-learning algorithms (random forest, logistic regression, gradient boosting machines, neural networks) were compared to an established algorithm (American College of Cardiology guidelines) to predict first cardiovascular event over 10-years. Predictive accuracy was assessed by area under the ‘receiver operating curve’ (AUC); and sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) to predict 7.5% cardiovascular risk (threshold for initiating statins). Findings 24,970 incident cardiovascular events (6.6%) occurred. Compared to the established risk prediction algorithm (AUC 0.728, 95% CI 0.723–0.735), machine-learning algorithms improved prediction: random forest +1.7% (AUC 0.745, 95% CI 0.739–0.750), logistic regression +3.2% (AUC 0.760, 95% CI 0.755–0.766), gradient boosting +3.3% (AUC 0.761, 95% CI 0.755–0.766), neural networks +3.6% (AUC 0.764, 95% CI 0.759–0.769). The highest achieving (neural networks) algorithm predicted 4,998/7,404 cases (sensitivity 67.5%, PPV 18.4%) and 53,458/75,585 non-cases (specificity 70.7%, NPV 95.7%), correctly predicting 355 (+7.6%) more patients who developed cardiovascular disease compared to the established algorithm. Conclusions Machine-learning significantly improves accuracy of cardiovascular risk prediction, increasing the number of patients identified who could benefit from preventive treatment, while avoiding unnecessary treatment of others

  20. [Quality use of commercial laboratory for clinical testing services - considering laboratory's role].

    Science.gov (United States)

    Ogawa, Shinji

    2014-12-01

    The number of commercial laboratories for clinical testing in Japan run privately has decreased to about 30 companies, and their business is getting tougher. Branch Lab. and FMS businesses have not expanded recently due to the new reimbursement system which adds an additional sample management fee, becoming effective in 2010. This presentation gives an outline of each role for hospital and commercial laboratories, and their pros & cons considering the current medical situation. Commercial laboratories have investigated how to utilize ICT systems for sharing test information between hospitals and our facilities. It would be very helpful to clarify issues for each hospital. We will develop and create new values for clinical laboratory testing services and forge mutually beneficial relationships with medical institutions. (Review).

  1. Pharmacology Portal: An Open Database for Clinical Pharmacologic Laboratory Services.

    Science.gov (United States)

    Karlsen Bjånes, Tormod; Mjåset Hjertø, Espen; Lønne, Lars; Aronsen, Lena; Andsnes Berg, Jon; Bergan, Stein; Otto Berg-Hansen, Grim; Bernard, Jean-Paul; Larsen Burns, Margrete; Toralf Fosen, Jan; Frost, Joachim; Hilberg, Thor; Krabseth, Hege-Merete; Kvan, Elena; Narum, Sigrid; Austgulen Westin, Andreas

    2016-01-01

    More than 50 Norwegian public and private laboratories provide one or more analyses for therapeutic drug monitoring or testing for drugs of abuse. Practices differ among laboratories, and analytical repertoires can change rapidly as new substances become available for analysis. The Pharmacology Portal was developed to provide an overview of these activities and to standardize the practices and terminology among laboratories. The Pharmacology Portal is a modern dynamic web database comprising all available analyses within therapeutic drug monitoring and testing for drugs of abuse in Norway. Content can be retrieved by using the search engine or by scrolling through substance lists. The core content is a substance registry updated by a national editorial board of experts within the field of clinical pharmacology. This ensures quality and consistency regarding substance terminologies and classification. All laboratories publish their own repertoires in a user-friendly workflow, adding laboratory-specific details to the core information in the substance registry. The user management system ensures that laboratories are restricted from editing content in the database core or in repertoires within other laboratory subpages. The portal is for nonprofit use, and has been fully funded by the Norwegian Medical Association, the Norwegian Society of Clinical Pharmacology, and the 8 largest pharmacologic institutions in Norway. The database server runs an open-source content management system that ensures flexibility with respect to further development projects, including the potential expansion of the Pharmacology Portal to other countries. Copyright © 2016 Elsevier HS Journals, Inc. All rights reserved.

  2. Rules for the certification of good practices in clinical laboratories. No regulation. 3-2009. Good Laboratory Practice

    International Nuclear Information System (INIS)

    2015-01-01

    Regulation for Certification of Good Practices in clinical laboratories, hereinafter Regulation establishes the methodology and procedures for clinical laboratories to demonstrate their state of compliance with good practices, according to Regulation 3-2009, and that the CECMED can verify.

  3. Clinical Chemistry Laboratory Automation in the 21st Century - Amat Victoria curam (Victory loves careful preparation)

    Science.gov (United States)

    Armbruster, David A; Overcash, David R; Reyes, Jaime

    2014-01-01

    The era of automation arrived with the introduction of the AutoAnalyzer using continuous flow analysis and the Robot Chemist that automated the traditional manual analytical steps. Successive generations of stand-alone analysers increased analytical speed, offered the ability to test high volumes of patient specimens, and provided large assay menus. A dichotomy developed, with a group of analysers devoted to performing routine clinical chemistry tests and another group dedicated to performing immunoassays using a variety of methodologies. Development of integrated systems greatly improved the analytical phase of clinical laboratory testing and further automation was developed for pre-analytical procedures, such as sample identification, sorting, and centrifugation, and post-analytical procedures, such as specimen storage and archiving. All phases of testing were ultimately combined in total laboratory automation (TLA) through which all modules involved are physically linked by some kind of track system, moving samples through the process from beginning-to-end. A newer and very powerful, analytical methodology is liquid chromatography-mass spectrometry/mass spectrometry (LC-MS/MS). LC-MS/MS has been automated but a future automation challenge will be to incorporate LC-MS/MS into TLA configurations. Another important facet of automation is informatics, including middleware, which interfaces the analyser software to a laboratory information systems (LIS) and/or hospital information systems (HIS). This software includes control of the overall operation of a TLA configuration and combines analytical results with patient demographic information to provide additional clinically useful information. This review describes automation relevant to clinical chemistry, but it must be recognised that automation applies to other specialties in the laboratory, e.g. haematology, urinalysis, microbiology. It is a given that automation will continue to evolve in the clinical laboratory

  4. Prometheus: the implementation of clinical coding schemes in French routine general practice

    Directory of Open Access Journals (Sweden)

    Laurent Letrilliart

    2006-09-01

    Conclusions Coding health problems on a routine basis proved to be feasible. However, this process can be used on a more widespread basis and linked to other management data only if physicians are specially trained and rewarded, and the software incorporates large terminologies mapped with classifications.

  5. A virtual asthma clinic for children: fewer routine outpatient visits, same asthma control

    NARCIS (Netherlands)

    Wijngaart, L.S. van den; Roukema, J.; Boehmer, A.L.M.; Brouwer, M.L.; Hugen, C.A.C.; Niers, L.E.M.; Sprij, A.J.; Rikkers-Mutsaerts, E.; Rottier, B.L.; Donders, A.R.T.; Verhaak, C.M.; Pijnenburg, M.W.; Merkus, P.J.

    2017-01-01

    eHealth is an appealing medium to improve healthcare and its value (in addition to standard care) has been assessed in previous studies. We aimed to assess whether an eHealth intervention could improve asthma control while reducing 50% of routine outpatient visits.In a multicentre, randomised

  6. A prospective study on the use of rivastigmine transdermal patch in Alzheimer's dementia in a routine clinical setting

    Directory of Open Access Journals (Sweden)

    Ejaz Nazir

    Full Text Available Abstract There is not much published literature on the use of rivastigmine patch in a "routine" clinical setting. Objectives: In this naturalistic longitudinal observational study we sought to evaluate the safety, tolerability and efficacy of the rivastigmine patch in patients with early and late onset moderate Alzheimer's disease in a routine clinical setting. Methods: Out of all routine clinical referrals, the first 30 patients with diagnosis of moderate Alzheimer's dementia who were started on rivastigmine patch were included in the study. Rivastigmine patch dose was titrated from 4.6 to 9.5 mg/ 24 hours as appropriate. The primary outcome measure was safety and tolerability, measured by the incidence of adverse events and discontinuation due to any reason. The secondary outcome measure was to examine improvement on global, functional and behavioral domains as demonstrated by the MMSE (Mini Mental State Examination score, BADLS (Bristol Activities of Daily Living Skills score, patient and carer feedback and clinical judgment. Results: Adverse events were reported in 20% of patients and 10% of total patients needed discontinuation of treatment. Improvement on global, functional and behavioral domains was observed in two thirds of patients whereas one third showed a relative decline. The most common side effect was skin irritation or erythema. Conclusions: The rivastigmine transdermal patch may provide a treatment option for those patients who require a change in their current oral cholinesterase inhibitor therapy due to safety or tolerability concerns.

  7. Use of structured musculoskeletal examination routines in undergraduate medical education and postgraduate clinical practice - a UK survey.

    Science.gov (United States)

    Baker, Kenneth F; Jandial, Sharmila; Thompson, Ben; Walker, David; Taylor, Ken; Foster, Helen E

    2016-10-21

    Structured examination routines have been developed as educational resources for musculoskeletal clinical skills teaching, including Gait-Arms-Legs-Spine (GALS), Regional Examination of the Musculoskeletal System (REMS) and paediatric GALS (pGALS). In this study, we aimed to assess the awareness and use of these examination routines in undergraduate medical teaching in UK medical schools and UK postgraduate clinical practice. Electronic questionnaires were distributed to adult and paediatric musculoskeletal teaching leads at UK medical schools and current UK doctors in training. Responses were received from 67 tutors representing teaching at 22/33 [67 %] of all UK medical schools, and 70 trainee doctors across a range of postgraduate training specialities. There was widespread adoption, at responding medical schools, of the adult examination routines within musculoskeletal teaching (GALS: 14/16 [88 %]; REMS: 12/16 [75 %]) and assessment (GALS: 13/16 [81 %]; REMS: 12/16 [75 %]). More trainees were aware of GALS (64/70 [91 %]) than REMS (14/67 [21 %]). Of the 39 trainees who used GALS in their clinical practice, 35/39 [90 %] reported that it had improved their confidence in musculoskeletal examination. Of the 17/22 responding medical schools that included paediatric musculoskeletal examination within their curricula, 15/17 [88 %] used the pGALS approach and this was included within student assessment at 4 medical schools. We demonstrate the widespread adoption of these examination routines in undergraduate education and significant uptake in postgraduate clinical practice. Further study is required to understand their impact upon clinical performance.

  8. Laboratory exercises to teach clinically relevant chemistry of antibiotics.

    Science.gov (United States)

    El Sayed, Khalid A; Chelette, Candace T

    2014-03-12

    To design, implement, and evaluate student performance on clinically relevant chemical and spectral laboratory exercises on antibiotics. In the first of 2 exercises, second-year pharmacy students enrolled in an integrated laboratory sequence course studied the aqueous stability of ß-lactam antibiotics using a spectral visual approach. In a second exercise, students studied the tendency of tetracycline, rifamycins, and fluoroquinolones to form insoluble chelate complexes (turbidity) with polyvalent metals. On a survey to assess achievement of class learning objectives, students agreed the laboratory activities helped them better retain important information concerning antibiotic stability and interactions. A significant improvement was observed in performance on examination questions related to the laboratory topics for 2012 and 2013 students compared to 2011 students who did not complete the laboratory. A 1-year follow-up examination question administered in a separate course showed >75% of the students were able to identify rifamycins-food interactions compared with laboratory exercises. The use of spectral visual approaches allowed students to investigate antibiotic stability and interactions, thus reinforcing the clinical relevance of medicinal chemistry. Students' performance on questions at the 1-year follow-up suggested increased retention of the concepts learned as a result of completing the exercises.

  9. Identifying complications of interventional procedures from UK routine healthcare databases: a systematic search for methods using clinical codes.

    Science.gov (United States)

    Keltie, Kim; Cole, Helen; Arber, Mick; Patrick, Hannah; Powell, John; Campbell, Bruce; Sims, Andrew

    2014-11-28

    Several authors have developed and applied methods to routine data sets to identify the nature and rate of complications following interventional procedures. But, to date, there has been no systematic search for such methods. The objective of this article was to find, classify and appraise published methods, based on analysis of clinical codes, which used routine healthcare databases in a United Kingdom setting to identify complications resulting from interventional procedures. A literature search strategy was developed to identify published studies that referred, in the title or abstract, to the name or acronym of a known routine healthcare database and to complications from procedures or devices. The following data sources were searched in February and March 2013: Cochrane Methods Register, Conference Proceedings Citation Index - Science, Econlit, EMBASE, Health Management Information Consortium, Health Technology Assessment database, MathSciNet, MEDLINE, MEDLINE in-process, OAIster, OpenGrey, Science Citation Index Expanded and ScienceDirect. Of the eligible papers, those which reported methods using clinical coding were classified and summarised in tabular form using the following headings: routine healthcare database; medical speciality; method for identifying complications; length of follow-up; method of recording comorbidity. The benefits and limitations of each approach were assessed. From 3688 papers identified from the literature search, 44 reported the use of clinical codes to identify complications, from which four distinct methods were identified: 1) searching the index admission for specified clinical codes, 2) searching a sequence of admissions for specified clinical codes, 3) searching for specified clinical codes for complications from procedures and devices within the International Classification of Diseases 10th revision (ICD-10) coding scheme which is the methodology recommended by NHS Classification Service, and 4) conducting manual clinical

  10. Information systems as a quality management tool in clinical laboratories

    Science.gov (United States)

    Schmitz, Vanessa; Rosecler Bez el Boukhari, Marta

    2007-11-01

    This article describes information systems as a quality management tool in clinical laboratories. The quality of laboratory analyses is of fundamental importance for health professionals in aiding appropriate diagnosis and treatment. Information systems allow the automation of internal quality management processes, using standard sample tests, Levey-Jennings charts and Westgard multirule analysis. This simplifies evaluation and interpretation of quality tests and reduces the possibility of human error. This study proposes the development of an information system with appropriate functions and costs for the automation of internal quality control in small and medium-sized clinical laboratories. To this end, it evaluates the functions and usability of two commercial software products designed for this purpose, identifying the positive features of each, so that these can be taken into account during the development of the proposed system.

  11. Information systems as a quality management tool in clinical laboratories

    International Nuclear Information System (INIS)

    Schmitz, Vanessa; Boukhari, Marta Rosecler Bez el

    2007-01-01

    This article describes information systems as a quality management tool in clinical laboratories. The quality of laboratory analyses is of fundamental importance for health professionals in aiding appropriate diagnosis and treatment. Information systems allow the automation of internal quality management processes, using standard sample tests, Levey-Jennings charts and Westgard multirule analysis. This simplifies evaluation and interpretation of quality tests and reduces the possibility of human error. This study proposes the development of an information system with appropriate functions and costs for the automation of internal quality control in small and medium-sized clinical laboratories. To this end, it evaluates the functions and usability of two commercial software products designed for this purpose, identifying the positive features of each, so that these can be taken into account during the development of the proposed system

  12. Routine calcium measurement is not necessary after most thyroid surgeries: a prospective clinical study.

    LENUS (Irish Health Repository)

    Quinn, E M

    2010-12-01

    Calcium levels are often measured to diagnose postoperative hypocalcaemia following thyroidectomy. The aims of this study were to (i) prospectively determine the incidence of symptomatic and biochemical hypocalcaemia following thyroidectomy, (ii) to identify if any associations exist between hypocalcaemia, type of surgery, histological diagnosis, specimen size\\/weight and the presence of histological parathyroid tissue and (iii) to evaluate the necessity of routine measurement of calcium levels following all thyroidectomies.

  13. Barium swallow study in routine clinical practice: a prospective study in patients with chronic cough

    OpenAIRE

    Nin, Carlos Shuler; Marchiori, Edson; Irion, Klaus Loureiro; Paludo, Artur de Oliveira; Alves, Giordano Rafael Tronco; Hochhegger, Daniela Reis; Hochhegger, Bruno

    2013-01-01

    OBJECTIVE: To assess the routine use of barium swallow study in patients with chronic cough.METHODS: Between October of 2011 and March of 2012, 95 consecutive patients submitted to chest X-ray due to chronic cough (duration > 8 weeks) were included in the study. For study purposes, additional images were obtained immediately after the oral administration of 5 mL of a 5% barium sulfate suspension. Two radiologists systematically evaluated all of the images in order to identify any pathological...

  14. Biomedical mass spectrometry in today's and tomorrow's clinical microbiology laboratories

    NARCIS (Netherlands)

    A.F. van Belkum (Alex); M. Welker (Martin); M. Erhard (Marcel); S. Chatellier (Sonia)

    2012-01-01

    textabstractClinical microbiology is a conservative laboratory exercise where base technologies introduced in the 19th century remained essentially unaltered. High-tech mass spectrometry (MS) has changed that. Within a few years following its adaptation to microbiological diagnostics, MS has been

  15. Clinical and Laboratory Predictors of Articular Disorders Among HIV ...

    African Journals Online (AJOL)

    radiologist for features of avascular necrosis (AVN) and sacroiliitis, respectively. Synovial fluid was obtained, for analysis and microscopy, culture/sensitivity testing and acid fast bacilli detection in those with demonstrable joint effusion. The clinically evident articular features, laboratory, and radiographic findings were used ...

  16. Symptomatic HIV infection in infancy - clinical and laboratory ...

    African Journals Online (AJOL)

    in infancy - clinical and laboratory markers of infection. M P Meyer, Z Latief, C Haworlh, 5 Salie,. A van Dyk. Objective. To investigate the usefulness of immunological tests in the diagnosis of HIV infection in young symptomatic children « 15 months of age). Design. Tests were evaluated in HIV-infected (HIV antibody- and ...

  17. Multiple myeloma in Nigeria: An insight to the clinical, laboratory ...

    African Journals Online (AJOL)

    ... the clinician to investigate along the lines of MM. Majority of patients have osteolytic lesions on X‑ray and pathological fractures, and benefit from melphalan based combinations in situations where facilities for transplant are not available. Key words: Clinical features, chemotherapy, laboratory features, multiple myeloma, ...

  18. Clinical and laboratory experience of chorionic villous sampling in ...

    African Journals Online (AJOL)

    Background: Chorionic villous sampling is a first trimester invasive diagnosis procedure that was introduced in Nigeria <2 decades ago. Objective: The objective of the following study is to review experience with chorionic villous sampling in relation to clinical and laboratory procedures, including general characteristics of ...

  19. A Computerized Clinical Support System and Psychological Laboratory.

    Science.gov (United States)

    Cassel, Russell N.

    1978-01-01

    Advocating "holistic" medicine, this article details the benefits to be derived from using a computerized clinical support system in a psychological laboratory focusing on internal healing where the client/patient becomes a committed partner utilizing biofeedback equipment, gaming, and simulation to achieve self-understanding and…

  20. Bariatric Surgery in the United Kingdom: A Cohort Study of Weight Loss and Clinical Outcomes in Routine Clinical Care

    Science.gov (United States)

    Douglas, Ian J.; Bhaskaran, Krishnan; Batterham, Rachel L.; Smeeth, Liam

    2015-01-01

    Background Bariatric surgery is becoming a more widespread treatment for obesity. Comprehensive evidence of the long-term effects of contemporary surgery on a broad range of clinical outcomes in large populations treated in routine clinical practice is lacking. The objective of this study was to measure the association between bariatric surgery, weight, body mass index, and obesity-related co-morbidities. Methods and Findings This was an observational retrospective cohort study using data from the United Kingdom Clinical Practice Research Datalink. All 3,882 patients registered in the database and with bariatric surgery on or before 31 December 2014 were included and matched by propensity score to 3,882 obese patients without surgery. The main outcome measures were change in weight and body mass index over 4 y; incident diagnoses of type 2 diabetes mellitus (T2DM), hypertension, angina, myocardial infarction (MI), stroke, fractures, obstructive sleep apnoea, and cancer; mortality; and resolution of hypertension and T2DM. Weight measures were available for 3,847 patients between 1 and 4 mo, 2,884 patients between 5 and 12 mo, and 2,258 patients between 13 and 48 mo post-procedure. Bariatric surgery patients exhibited rapid weight loss for the first four postoperative months, at a rate of 4.98 kg/mo (95% CI 4.88–5.08). Slower weight loss was sustained to the end of 4 y. Gastric bypass (6.56 kg/mo) and sleeve gastrectomy (6.29 kg/mo) were associated with greater initial weight reduction than gastric banding (2.77 kg/mo). Protective hazard ratios (HRs) were detected for bariatric surgery for incident T2DM, 0.68 (95% CI 0.55–0.83); hypertension, 0.35 (95% CI 0.27–0.45); angina, 0.59 (95% CI 0.40–0.87);MI, 0.28 (95% CI 0.10–0.74); and obstructive sleep apnoea, 0.55 (95% CI 0.40–0.87). Strong associations were found between bariatric surgery and the resolution of T2DM, with a HR of 9.29 (95% CI 6.84–12.62), and between bariatric surgery and the resolution of

  1. A mixed methods approach to adapting health-related quality of life measures for use in routine oncology clinical practice.

    Science.gov (United States)

    Harley, Clare; Takeuchi, Elena; Taylor, Sally; Keding, Ada; Absolom, Kate; Brown, Julia; Velikova, Galina

    2012-04-01

    The current study reviewed and adapted existing health-related quality of life (HRQoL) instruments for use in routine clinical practice delivering outpatient chemotherapy for colorectal, breast and gynaecological cancers. 564 (288 gynaecological, 208 breast and 68 colorectal) outpatient consultations of 141 patients were audio-recorded and analysed to identify discussed issues. Issues were ranked from most to least commonly discussed within each disease group. Existing HRQoL instruments were evaluated against these lists and best fitting items entered into cancer-specific item banks. Item banks were evaluated during semi-structured interviews by twenty-one oncologists (13 consultants and 8 specialist registrars), four clinical nurse specialists and thirty patients, from breast, gynaecological and colorectal cancer practices. Pilot questionnaires were completed by 448 (145 breast, 148 gynaecological and 155 colorectal) patients attending outpatient clinics. Item selection and scale reliability was explored using descriptive data and psychometric methods alongside qualitative patient and clinician ratings. Each questionnaire includes five physical and three psychosocial function scales each with good internal consistency reliability (α > 0.70) plus disease-specific individual-symptom items identified as useful in clinical practice. Three cancer-specific health-related quality of life measures were developed for use in routine clinical practice. Initial analyses suggest good clinical utility and acceptable psychometric properties for the new instruments.

  2. Interference by pralidoxime (PAM) salts in clinical laboratory tests.

    Science.gov (United States)

    Nagase, Sumika; Kohguchi, Katsunori; Tohyama, Kaoru; Watanabe, Mikio; Iwatani, Yoshinori

    2013-02-01

    Drugs sometimes alter the results of clinical laboratory tests. We examined the effects of pralidoxime (PAM) salts, a medicine used to treat organophosphorus poisoning, on clinical laboratory test results for the first time. The effects of PAM salts on glucose (GLU) measurements were examined using a point-of-care testing (POCT) meter, four self-monitoring of blood glucose (SMBG) meters, and two biochemical autoanalyzers. The effects of PAM salts on other clinical tests were also evaluated. The addition of PAM iodide or potassium iodide, but not of PAM chloride or potassium chloride, to blood samples increased the GLU values measured by one POCT meter and 4 SMBG meters using the enzyme electrode (hydrogen peroxidase or oxygen electrode) method. On the other hand, PAM iodide or PAM chloride, but not KI or KCl, affected the values measured at 340 nm by an autoanalyzer using absorption spectrophotometry in 8 of 14 clinical laboratory tests. The absorption spectrum of PAM changed from 294 to 338 nm due to the reaction between PAM and the alkaline buffer, a component of the measuring reagents. PAM iodide increases the GLU values measured by the enzyme electrode method, and PAM salts affected the values measured at 340 nm by absorption spectrophotometry in many other clinical test items. Copyright © 2012 Elsevier B.V. All rights reserved.

  3. Simulation-based medical education in clinical skills laboratory.

    Science.gov (United States)

    Akaike, Masashi; Fukutomi, Miki; Nagamune, Masami; Fujimoto, Akiko; Tsuji, Akiko; Ishida, Kazuko; Iwata, Takashi

    2012-01-01

    Clinical skills laboratories have been established in medical institutions as facilities for simulation-based medical education (SBME). SBME is believed to be superior to the traditional style of medical education from the viewpoint of the active and adult learning theories. SBME can provide a learning cycle of debriefing and feedback for learners as well as evaluation of procedures and competency. SBME offers both learners and patients a safe environment for practice and error. In a full-environment simulation, learners can obtain not only technical skills but also non-technical skills, such as leadership, team work, communication, situation awareness, decision-making, and awareness of personal limitations. SBME is also effective for integration of clinical medicine and basic medicine. In addition, technology-enhanced simulation training is associated with beneficial effects for outcomes of knowledge, skills, behaviors, and patient-related outcomes. To perform SBME, effectively, not only simulators including high-fidelity mannequin-type simulators or virtual-reality simulators but also full-time faculties and instructors as professionals of SBME are essential in a clinical skills laboratory for SBME. Clinical skills laboratory is expected to become an integrated medical education center to achieve continuing professional development, integrated learning of basic and clinical medicine, and citizens' participation and cooperation in medical education.

  4. Clinical Mass Spectrometry: Achieving Prominence in Laboratory Medicine

    Energy Technology Data Exchange (ETDEWEB)

    Annesley, Thomas M.; Cooks, Robert G.; Herold, David A.; Hoofnagle, Andrew N.

    2016-01-04

    Each year the journal Clinical Chemistry publishes a January special issue on a topic that is relevant to the laboratory medicine community. In January 2016 the topic is mass spectrometry, and the issue is entitled “Clinical Mass Spectrometry: Achieving Prominence in Laboratory Medicine”. One popular feature in our issues is a Q&A on a topic, clearly in this case mass spectrometry. The journal is assembling a panel of 5-6 experts from various areas of mass spectrometry ranging from instrument manufacturing to practicing clinical chemists. Dick Smith is one of the scientist requested to participate in this special issue Q&A on Mass Spectrometry. The Q&A Transcript is attached

  5. Routine Laboratory Blood Tests May Diagnose Significant Fibrosis in Liver Transplant Recipients with Chronic Hepatitis C: A 10 Year Experience

    OpenAIRE

    Sheen, Victoria; Nguyen, Heajung; Jimenez, Melissa; Agopian, Vatche; Vangala, Sitaram; Elashoff, David; Saab, Sammy

    2016-01-01

    Background and Aims: The aims of our study were to determine whether routine blood tests, the aspartate aminotransferase (AST) to Platelet Ratio Index (APRI) and Fibrosis 4 (Fib-4) scores, were associated with advanced fibrosis and to create a novel model in liver transplant recipients with chronic hepatitis C virus (HCV). Methods: We performed a cross sectional study of patients at The University of California at Los Angeles (UCLA) Medical Center who underwent liver transplantation for HCV. ...

  6. Understanding the interface between clinical and laboratory staff

    Directory of Open Access Journals (Sweden)

    Ankie van den Broek

    2014-07-01

    Objectives: To propose a new conceptual model to gain insight and analyse factors that influence the laboratory–clinical staff interface. Methods: To develop the conceptual model, a literature study was performed, regulatory guidelines and standards for laboratories were analysed and discussions were held with experts on the topic. Result: A conceptual model and analytical framework provided good guidance in understanding and assessing the organisational and personal factors shaping the interface. The model was based on three elements: (1 the three phases of communication (pre-analytical, analytical and post-analytical; (2 the organisational and personal factors of interaction; and (3 the socio-political, economic and cultural context in which clinicians and laboratory staff operate. Conclusion: Assessment of the interface between clinicians and laboratory workers can be performed in a systematic way. Applying this model will provide information to managers of health institutions and heads of laboratories and clinical departments about what happens when clinicians and laboratory staff interact, thus aiding them in designing strategies to improve this interface.

  7. Quality documentation challenges for veterinary clinical pathology laboratories.

    Science.gov (United States)

    Sacchini, Federico; Freeman, Kathleen P

    2008-05-01

    An increasing number of veterinary laboratories worldwide have obtained or are seeking certification based on international standards, such as the International Organization for Standardization/International Electrotechnical Commission 17025. Compliance with any certification standard or quality management system requires quality documentation, an activity that may present several unique challenges in the case of veterinary laboratories. Research specifically addressing quality documentation is conspicuously absent in the veterinary literature. This article provides an overview of the quality system documentation needed to comply with a quality management system with an emphasis on preparing written standard operating procedures specific for veterinary laboratories. In addition, the quality documentation challenges that are unique to veterinary clinical pathology laboratories are critically evaluated against the existing quality standards and discussed with respect to possible solutions and/or recommended courses of action. Documentation challenges include the establishment of quality requirements for veterinary tests, the use or modification of human analytic methods for animal samples, the limited availability of quality control materials satisfactory for veterinary clinical pathology laboratories, the limited availability of veterinary proficiency programs, and the complications in establishing species-specific reference intervals.

  8. MALDI-TOF mass spectrometry in the clinical mycology laboratory: identification of fungi and beyond.

    Science.gov (United States)

    Posteraro, Brunella; De Carolis, Elena; Vella, Antonietta; Sanguinetti, Maurizio

    2013-04-01

    MALDI-TOF mass spectrometry (MS) is becoming essential in most clinical microbiology laboratories throughout the world. Its successful use is mainly attributable to the low operational costs, the universality and flexibility of detection, as well as the specificity and speed of analysis. Based on characteristic protein spectra obtained from intact cells - by means of simple, rapid and reproducible preanalytical and analytical protocols - MALDI-TOF MS allows a highly discriminatory identification of yeasts and filamentous fungi starting from colonies. Whenever used early, direct identification of yeasts from positive blood cultures has the potential to greatly shorten turnaround times and to improve laboratory diagnosis of fungemia. More recently, but still at an infancy stage, MALDI-TOF MS is used to perform strain typing and to determine antifungal drug susceptibility. In this article, the authors discuss how the MALDI-TOF MS technology is destined to become a powerful tool for routine mycological diagnostics.

  9. Are routine visits to oncology clinics the most appropriate way to follow-up breast cancer patients?

    International Nuclear Information System (INIS)

    Kirkbride, Peter; Vallis, Katherine

    1997-01-01

    Purpose The routine follow-up at oncology clinics, of patients treated for breast cancer is believed to serve two purposes: to facilitate early detection of loco-regional recurrences and new primary tumors, and to provide psychological support for patients. Since it does not translate into improved survival, early detection of distant metastatic disease is not a priority. The purpose of this study was to determine the efficacy of routine clinic review in detecting loco-regional relapse following treatment for breast cancer. Materials and Methods The charts of all 579 patients with stage I, II and III breast cancer seen for the first time at our institution in 1982 were reviewed. Treatment consisted of mastectomy (367 cases), lumpectomy alone (53), or lumpectomy plus radiotherapy (159). Follow-up policy stipulated that patients were seen every 3 months for the first 2 years after primary treatment, every 6 months for the next 3 years and annually thereafter. Annual mammograms were performed. Results Thirteen patients were lost to follow-up during the 14 year study period. Loco-regional recurrence was diagnosed in 184 patients. Recurrent disease were detected by the patient (79 cases, 45%), at routine mammography (13 cases, 7%), at visits to physicians other than oncologists(40 cases, 22%). In 18 cases, the method of detection was unknown and only 34 (18%) loco-regional recurrences were detected at routine visits to oncology clinics. It is calculated that this group of patients attended approximately 11,000 follow-up clinic appointments over the period in question. Even if we assume that the 18 cases in which the method of detection was unknown were in fact detected at a visit to an oncology clinic, then the rate of detection is only 1 local recurrence per 212 visits. Conclusion Given the apparent limitations of routine follow-up, other methods of surveillance such as open access to a Breast Cancer Resource Centre merit investigation. It is imperative that non

  10. Bonding to oxide ceramics—laboratory testing versus clinical outcome.

    Science.gov (United States)

    Kern, Matthias

    2015-01-01

    Despite a huge number of published laboratory bonding studies on dental oxide ceramics clinical long-term studies on resin bonded oxide ceramic restorations are rare. The purpose of this review is to present the best available clinical evidence for successful bonding of dental oxide ceramic restorations. Clinical trials with resin-bonded restorations that had no or only limited mechanical retention and were made from alumina or zirconia ceramic were identified using an electronic search in PubMed database. Overall 10 publications with clinical trials could be identified. Their clinical outcome was compared with that laboratory bond strength studies. Clinical data provide strong evidence that air-abrasion at a moderate pressure in combination with using phosphate monomer containing primers and/or luting resins provide long-term durable bonding to glass-infiltrated alumina and zirconia ceramic under the humid and stressful oral conditions. As simple and clinically reliable bonding methods to oxide ceramics exist, the rationale for development of alternative bonding methods might be reconsidered especially when these methods are more time consuming or require rather complicated and/or technique sensitive procedures. Copyright © 2014 Academy of Dental Materials. Published by Elsevier Ltd. All rights reserved.

  11. Walking the bridge: Nursing students' learning in clinical skill laboratories.

    Science.gov (United States)

    Ewertsson, Mona; Allvin, Renée; Holmström, Inger K; Blomberg, Karin

    2015-07-01

    Despite an increasing focus on simulation as a learning strategy in nursing education, there is limited evidence on the transfer of simulated skills into clinical practice. Therefore it's important to increase knowledge of how clinical skills laboratories (CSL) can optimize students' learning for development of professional knowledge and skills, necessary for quality nursing practice and for patient safety. Thus, the aim was to describe nursing students' experiences of learning in the CSL as a preparation for their clinical practice. Interviews with 16 students were analysed with content analysis. An overall theme was identified - walking the bridge - in which the CSL formed a bridge between the university and clinical settings, allowing students to integrate theory and practice and develop a reflective stance. The theme was based on categories: conditions for learning, strategies for learning, tension between learning in the skills laboratory and clinical settings, and development of professional and personal competence. The CSL prepared the students for clinical practice, but a negative tension between learning in CSL and clinical settings was experienced. However, this tension may create reflection. This provides a new perspective that can be used as a pedagogical approach to create opportunities for students to develop their critical thinking. Copyright © 2015 Elsevier Ltd. All rights reserved.

  12. A Multidisciplinary Delphi Consensus-Based Checklist to Define Clinical Documentation Tools for Both Routine and Research Purposes

    Directory of Open Access Journals (Sweden)

    Cecilia Veraar

    2018-01-01

    Full Text Available Background: To the best of our knowledge, a strategic approach to define the contents of structured clinical documentation tools for both clinical routine patient care and research purposes has not been reported so far, although electronic health record will become more and more structured and detailed in the future. Objective: To achieve an interdisciplinary consensus on a checklist to be considered for the preparation of disease- and situation-specific clinical documentation tools. Methods: A 2-round Delphi consensus-based process was conducted both with 19 physicians of different disciplines and 14 students from Austria, Switzerland, and Germany. Agreement was defined as 80% or more positive votes of the participants. Results: The participants agreed that a working group should be set up for the development of structured disease- or situation-specific documentation tools (97% agreement. The final checklist included 4 recommendations concerning the setup of the working group, 12 content-related recommendations, and 3 general and technical recommendations (mean agreement [standard deviation] = 97.4% [4.0%], ranging from 84.2% to 100.0%. Discussion and Conclusion: In the future, disease- and situation-specific structured documentation tools will provide an important bridge between registries and electronic health records. Clinical documentation tools defined according to this Delphi consensus-based checklist will provide data for registries while serving as high-quality data acquisition tools in routine clinical care.

  13. Developing Medicare Competitive Bidding: A Study of Clinical Laboratories

    Science.gov (United States)

    Hoerger, Thomas J.; Meadow, Ann

    1997-01-01

    Competitive bidding to derive Medicare fees promises several advantages over administered fee systems. The authors show how incentives for cost savings, quality, and access can be incorporated into bidding schemes, and they report on a study of the clinical laboratory industry conducted in preparation for a bidding demonstration. The laboratory industry is marked by variable concentration across geographic markets and, among firms themselves, by social and economic heterogeneity. The authors conclude that these conditions can be accommodated by available bidding design options and by careful selection of bidding markets. PMID:10180003

  14. Utility of multispectral imaging for nuclear classification of routine clinical histopathology imagery

    Directory of Open Access Journals (Sweden)

    Harvey Neal R

    2007-07-01

    Full Text Available Abstract Background We present an analysis of the utility of multispectral versus standard RGB imagery for routine H&E stained histopathology images, in particular for pixel-level classification of nuclei. Our multispectral imagery has 29 spectral bands, spaced 10 nm within the visual range of 420–700 nm. It has been hypothesized that the additional spectral bands contain further information useful for classification as compared to the 3 standard bands of RGB imagery. We present analyses of our data designed to test this hypothesis. Results For classification using all available image bands, we find the best performance (equal tradeoff between detection rate and false alarm rate is obtained from either the multispectral or our "ccd" RGB imagery, with an overall increase in performance of 0.79% compared to the next best performing image type. For classification using single image bands, the single best multispectral band (in the red portion of the spectrum gave a performance increase of 0.57%, compared to performance of the single best RGB band (red. Additionally, red bands had the highest coefficients/preference in our classifiers. Principal components analysis of the multispectral imagery indicates only two significant image bands, which is not surprising given the presence of two stains. Conclusion Our results indicate that multispectral imagery for routine H&E stained histopathology provides minimal additional spectral information for a pixel-level nuclear classification task than would standard RGB imagery.

  15. Barium swallow study in routine clinical practice: a prospective study in patients with chronic cough

    Directory of Open Access Journals (Sweden)

    Carlos Shuler Nin

    2013-12-01

    Full Text Available OBJECTIVE: To assess the routine use of barium swallow study in patients with chronic cough.METHODS: Between October of 2011 and March of 2012, 95 consecutive patients submitted to chest X-ray due to chronic cough (duration > 8 weeks were included in the study. For study purposes, additional images were obtained immediately after the oral administration of 5 mL of a 5% barium sulfate suspension. Two radiologists systematically evaluated all of the images in order to identify any pathological changes. Fisher's exact test and the chi-square test for categorical data were used in the comparisons.RESULTS: The images taken immediately after barium swallow revealed significant pathological conditions that were potentially related to chronic cough in 12 (12.6% of the 95 patients. These conditions, which included diaphragmatic hiatal hernia, esophageal neoplasm, achalasia, esophageal diverticulum, and abnormal esophageal dilatation, were not detected on the images taken without contrast. After appropriate treatment, the symptoms disappeared in 11 (91.6% of the patients, whereas the treatment was ineffective in 1 (8.4%. We observed no complications related to barium swallow, such as contrast aspiration.CONCLUSIONS: Barium swallow improved the detection of significant radiographic findings related to chronic cough in 11.5% of patients. These initial findings suggest that the routine use of barium swallow can significantly increase the sensitivity of chest X-rays in the detection of chronic cough-related etiologies.

  16. Barium swallow study in routine clinical practice: a prospective study in patients with chronic cough.

    Science.gov (United States)

    Nin, Carlos Shuler; Marchiori, Edson; Irion, Klaus Loureiro; Paludo, Artur de Oliveira; Alves, Giordano Rafael Tronco; Hochhegger, Daniela Reis; Hochhegger, Bruno

    2013-01-01

    To assess the routine use of barium swallow study in patients with chronic cough. Between October of 2011 and March of 2012, 95 consecutive patients submitted to chest X-ray due to chronic cough (duration > 8 weeks) were included in the study. For study purposes, additional images were obtained immediately after the oral administration of 5 mL of a 5% barium sulfate suspension. Two radiologists systematically evaluated all of the images in order to identify any pathological changes. Fisher's exact test and the chi-square test for categorical data were used in the comparisons. The images taken immediately after barium swallow revealed significant pathological conditions that were potentially related to chronic cough in 12 (12.6%) of the 95 patients. These conditions, which included diaphragmatic hiatal hernia, esophageal neoplasm, achalasia, esophageal diverticulum, and abnormal esophageal dilatation, were not detected on the images taken without contrast. After appropriate treatment, the symptoms disappeared in 11 (91.6%) of the patients, whereas the treatment was ineffective in 1 (8.4%). We observed no complications related to barium swallow, such as contrast aspiration. Barium swallow improved the detection of significant radiographic findings related to chronic cough in 11.5% of patients. These initial findings suggest that the routine use of barium swallow can significantly increase the sensitivity of chest X-rays in the detection of chronic cough-related etiologies.

  17. Clinical and laboratory profile of patients with sickle cell anemia

    Directory of Open Access Journals (Sweden)

    Phelipe Gabriel dos Santos Sant'Ana

    Full Text Available Abstract Objective: This study aimed to describe and analyze clinical and laboratory characteristics of patients with sickle cell anemia treated at the Hemominas Foundation, in Divinópolis, Brazil. Furthermore, this study aimed to compare the clinical and laboratory outcomes of the group of patients treated with hydroxyurea with those patients that were not treated with hydroxyurea. Methods: Clinical and laboratorial data were obtained by analyzing medical records of patients with sickle cell anemia. Results: Data from the medical records of 50 patients were analyzed. Most of the patients were female (56%, aged between 20 and 29 years old. Infections, transfusions, cholecystectomy, splenectomy and systemic arterial hypertension were the most common clinical adverse events of the patients. The most frequent cause of hospitalization was painful crisis. The majority of patients had reduced values of hemoglobin and hematocrit (8.55 ± 1.33 g/dL and 25.7 ± 4.4%, respectively and increased fetal hemoglobin levels (12 ± 7%. None of the clinical variables was statistically significant on comparing the two groups of patients. Among hematological variables only hemoglobin and hematocrit levels were statistically different between patients treated with hydroxyurea and untreated patients (p-value = 0.005 and p-value = 0.001, respectively. Conclusion: Sickle cell anemia requires treatment and follow-up by a multiprofessional team. A current therapeutic option is hydroxyurea. This drug reduces complications and improves laboratorial parameters of patients. In this study, the use of the drug increased the hemoglobin and hematocrit levels of patients.

  18. Duplicate laboratory test reduction using a clinical decision support tool.

    Science.gov (United States)

    Procop, Gary W; Yerian, Lisa M; Wyllie, Robert; Harrison, A Marc; Kottke-Marchant, Kandice

    2014-05-01

    Duplicate laboratory tests that are unwarranted increase unnecessary phlebotomy, which contributes to iatrogenic anemia, decreased patient satisfaction, and increased health care costs. We employed a clinical decision support tool (CDST) to block unnecessary duplicate test orders during the computerized physician order entry (CPOE) process. We assessed laboratory cost savings after 2 years and searched for untoward patient events associated with this intervention. This CDST blocked 11,790 unnecessary duplicate test orders in these 2 years, which resulted in a cost savings of $183,586. There were no untoward effects reported associated with this intervention. The movement to CPOE affords real-time interaction between the laboratory and the physician through CDSTs that signal duplicate orders. These interactions save health care dollars and should also increase patient satisfaction and well-being.

  19. Routine administration of standardized questionnaires that assess aspects of patients quality of life in medical oncology clinics: A systematic review

    International Nuclear Information System (INIS)

    Alsaleh, Kh.

    2013-01-01

    Purpose: Increasing interest in the Quality of Life outcomes in cancer patients led to increase implementation of their use in routine clinical practice. The aim of this systemic review is to review the scientific evidence behind recommending the use of quality of life (QoL) scales routinely in outpatient evaluation. Methods: Systematic review for all published randomized controlled trials in English language between January 1, 1990 till December 31, 2012. Out of 487 articles (476 identified by electronic search + 11 articles identified by manual search), six trials satisfied the eligibility criteria: (1) the study was a randomized controlled trial (RCT) with randomization of patients or health care providers; (2) the findings of the administered questionnaire or scale (the intervention) were given to health care provider, and compared to standard care with no questionnaire administered (the control); (3) study was conducted in outpatient oncology clinics; and (4) an outcome was measured that related to (i) QoL improvement, (ii) reduction in morbidity, (iii) reduction in stress for the patients, (iv) improvement in communication between patients and health care provider, or (v) improved patient satisfaction. Assessment for the quality of the study was done using the GRADE methodology. Results: Serious methodological issues were affecting most of the trials. Overall the evaluation of the quality of the evidence from these identified trials suggests that there is a weak recommendation to use QoL scales in routine oncology practice to improve communication between physicians and patients. Conclusion: The routine use of such tools in the outpatient settings at improving the patient outcome or satisfaction cannot be recommended based on the available evidence. The potential harm with the excess use of resources needed to implement, collect, store, analyse, and present such data to health care providers should be also considered. Further research and better designed

  20. "There are too many, but never enough": qualitative case study investigating routine coding of clinical information in depression.

    Science.gov (United States)

    Cresswell, Kathrin; Morrison, Zoe; Kalra, Dipak; Sheikh, Aziz

    2012-01-01

    We sought to understand how clinical information relating to the management of depression is routinely coded in different clinical settings and the perspectives of and implications for different stakeholders with a view to understanding how these may be aligned. Qualitative investigation exploring the views of a purposefully selected range of healthcare professionals, managers, and clinical coders spanning primary and secondary care. Our dataset comprised 28 semi-structured interviews, a focus group, documents relating to clinical coding standards and participant observation of clinical coding activities. We identified a range of approaches to coding clinical information including templates and order entry systems. The challenges inherent in clearly establishing a diagnosis, identifying appropriate clinical codes and possible implications of diagnoses for patients were particularly prominent in primary care. Although a range of managerial and research benefits were identified, there were no direct benefits from coded clinical data for patients or professionals. Secondary care staff emphasized the role of clinical coders in ensuring data quality, which was at odds with the policy drive to increase real-time clinical coding. There was overall no evidence of clear-cut direct patient care benefits to inform immediate care decisions, even in primary care where data on patients with depression were more extensively coded. A number of important secondary uses were recognized by healthcare staff, but the coding of clinical data to serve these ends was often poorly aligned with clinical practice and patient-centered considerations. The current international drive to encourage clinical coding by healthcare professionals during the clinical encounter may need to be critically examined.

  1. “There Are Too Many, but Never Enough": Qualitative Case Study Investigating Routine Coding of Clinical Information in Depression

    Science.gov (United States)

    Cresswell, Kathrin; Morrison, Zoe; Sheikh, Aziz; Kalra, Dipak

    2012-01-01

    Background We sought to understand how clinical information relating to the management of depression is routinely coded in different clinical settings and the perspectives of and implications for different stakeholders with a view to understanding how these may be aligned. Materials and Methods Qualitative investigation exploring the views of a purposefully selected range of healthcare professionals, managers, and clinical coders spanning primary and secondary care. Results Our dataset comprised 28 semi-structured interviews, a focus group, documents relating to clinical coding standards and participant observation of clinical coding activities. We identified a range of approaches to coding clinical information including templates and order entry systems. The challenges inherent in clearly establishing a diagnosis, identifying appropriate clinical codes and possible implications of diagnoses for patients were particularly prominent in primary care. Although a range of managerial and research benefits were identified, there were no direct benefits from coded clinical data for patients or professionals. Secondary care staff emphasized the role of clinical coders in ensuring data quality, which was at odds with the policy drive to increase real-time clinical coding. Conclusions There was overall no evidence of clear-cut direct patient care benefits to inform immediate care decisions, even in primary care where data on patients with depression were more extensively coded. A number of important secondary uses were recognized by healthcare staff, but the coding of clinical data to serve these ends was often poorly aligned with clinical practice and patient-centered considerations. The current international drive to encourage clinical coding by healthcare professionals during the clinical encounter may need to be critically examined. PMID:22937106

  2. Developing the public health role of a front line clinical service: integrating stop smoking advice into routine podiatry services.

    Science.gov (United States)

    Gray, Jackie; Eden, Gary; Williams, Maria

    2007-06-01

    Although smoking is a major public health problem, many clinicians do not routinely provide evidence-based health improvement advice to smokers to help them to quit. Plan, Do, Study, Act (PDSA) cycle methodology was used to design and implement a service development so that health improvement advice for smokers featured in all podiatry consultations provided by a Primary Care Trust in North East England. IT systems were developed to record the number and proportion of patients for whom smoking status was assessed, and the number and proportion of smokers who were given advice to quit and referred for specialist support. A questionnaire to staff explored their perceptions of the development on their clinics and consultations. During a 6-month period, smoking status was recorded for all 8831 (100%) patients attending podiatry clinics; 83% of smokers were given brief advice to quit; 7% of smokers were given help to access specialist stop smoking support services. Improvements were introduced within existing budgets and did not prolong clinics. It is straightforward and inexpensive to develop clinical services so that public health guidance is routinely implemented. More widespread implementation of similar service developments could lead to national improvements in public health.

  3. Routine Sub-hepatic Drainage versus No Drainage after Laparoscopic Cholecystectomy: Open, Randomized, Clinical Trial.

    Science.gov (United States)

    Shamim, Muhammad

    2013-02-01

    Surgeons are still following the old habit of routine subhepatic drainage following laparoscopic cholecystectomy (LC). This study aims to compare the outcome of subhepatic drainage with no drainage after LC. This prospective study was conducted in two phases. Phase I was open, randomized controlled trial (RCT), conducted in Civil Hospital Karachi, from August 2004 to June 2005. Phase II was descriptive case series, conducted in author's practice hospitals of Karachi, from July 2005 to December 2009. In phase I, 170 patients with chronic calculous cholecystitis underwent LC. Patients were divided into two groups, subhepatic drainage (group A: 79 patients) or no drainage (group B: 76 patients). The rest 15 patients were excluded either due to conversion or elective subhepatic drainage. In phase II, 218 consecutive patients were enrolled, who underwent LC with no subhepatic drainage. Duration of operation, character, and amount of drain fluid (if placed), postoperative ultrasound for subhepatic collection, postoperative chest X-ray for the measurement of subdiaphragmatic air, postoperative pain, postoperative nausea/vomiting, duration of hospital stay, and preoperative or postoperative complications were noted and analyzed. Duration of operation and hospital stay was slightly longer in group A patients (P values 0.002 and 0.029, respectively); postoperative pain perception, nausea/vomiting, and postoperative complications were nearly same in both groups (P value 0.064, 0.078, and 0.003, respectively). Subhepatic fluid collection was more in group A (P = 0.002), whereas subdiaphragmatic air collection was more in group B (P = 0.003). Phase II results were nearly similar to group B patients in phase I. Routine subhepatic drainage after LC is not necessary in uncomplicated cases.

  4. CT colonography: accuracy of initial interpretation by radiographers in routine clinical practice

    International Nuclear Information System (INIS)

    Burling, D.; Wylie, P.; Gupta, A.; Illangovan, R.; Muckian, J.; Ahmad, R.; Marshall, M.; Taylor, S.A.

    2010-01-01

    Aim: To investigate performance of computed-assisted detection (CAD)-assisted radiographers interpreting computed tomography colonography (CTC) in routine practice. Materials and methods: Three hundred and three consecutive symptomatic patients underwent CTC. Examinations were double-read by trained radiographers using primary two-dimensional/three-dimensional (2D/3D) analysis supplemented by 'second reader' CAD. Radiographers recorded colonic neoplasia, interpretation times, and patient management strategy code (S0, inadequate; S1, normal; S2, 6-9 mm polyp; S3, ≥10 mm polyp; S4, cancer; S5, diverticular stricture) for each examination. Strategies were compared to the reference standard using kappa statistic, interpretation times using paired t-test, learning curves using logistic regression and Pearson's correlation coefficient. Results: Of 303 examinations, 69 (23%) were abnormal. CAD-assisted radiographers detected 17/17 (100%) cancers, 21/28 (72%) polyps ≥10 mm and 42/60 (70%) 6-9 mm polyps. The overall agreement between radiographers and the reference management strategy was good (kappa 0.72; CI: 0.65, 0.78) with agreement for S1 strategy in 189/211 (90%) exams; S2 in 19/27 (70%); S3 in 12/19 (63%); S4 in 17/17 (100%); S5 in 5/6 (83%). The mean interpretation time was 17 min (SD = 11) compared with 8 min (SD = 3.5) for radiologists. There was no learning curve for recording correct strategies (OR 0.88; p = 0.12) but a significant reduction in interpretation times, mean 14 and 31 min (last/first 50 exams; -0.46; p < 0.001). Conclusion: Routine CTC interpretation by radiographers is effective for initial triage of patients with cancer, but independent reporting is currently not recommended.

  5. A 50-year research journey. From laboratory to clinic.

    Science.gov (United States)

    Ross, John

    2009-01-01

    Prior important research is not always cited, exemplified by Oswald Avery's pioneering discovery that DNA is the genetic transforming factor; it was not cited by Watson and Crick 10 years later. My first laboratory research (National Institutes of Health 1950s) resulted in the clinical development of transseptal left heart catheterization. Laboratory studies on cardiac muscle mechanics in normal and failing hearts led to the concept of afterload mismatch with limited preload reserve. At the University of California, San Diego in La Jolla (1968) laboratory experiments on coronary artery reperfusion after sustained coronary occlusion showed salvage of myocardial tissue, a potential treatment for acute myocardial infarction proven in clinical trials of thrombolysis 14 years later. Among 60 trainees who worked with me in La Jolla, one-third were Japanese and some of their important laboratory experiments are briefly recounted, beginning with Sasayama, Tomoike and Shirato in the 1970 s. Recently, we developed a method for cardiac gene transfer, and subsequently we showed that gene therapy for the defect in cardiomyopathic hamsters halted the progression of advanced disease. Cardiovascular research and medicine are producing continuing advances in technologies for gene transfer and embryonic stem cell transplantation, targeting of small molecules, and tissue and organ engineering.

  6. U.S. Ebola Treatment Center Clinical Laboratory Support

    OpenAIRE

    Jelden, Katelyn C.; Iwen, Peter C.; Herstein, Jocelyn J.; Biddinger, Paul D.; Kraft, Colleen S.; Saiman, Lisa; Smith, Philip W.; Hewlett, Angela L.; Gibbs, Shawn G.; Lowe, John J.

    2016-01-01

    Fifty-five hospitals in the United States have been designated Ebola treatment centers (ETCs) by their state and local health authorities. Designated ETCs must have appropriate plans to manage a patient with confirmed Ebola virus disease (EVD) for the full duration of illness and must have these plans assessed through a CDC site visit conducted by an interdisciplinary team of subject matter experts. This study determined the clinical laboratory capabilities of these ETCs. ETCs were electronic...

  7. MODULAR ANALYTICS: A New Approach to Automation in the Clinical Laboratory.

    Science.gov (United States)

    Horowitz, Gary L; Zaman, Zahur; Blanckaert, Norbert J C; Chan, Daniel W; Dubois, Jeffrey A; Golaz, Olivier; Mensi, Noury; Keller, Franz; Stolz, Herbert; Klingler, Karl; Marocchi, Alessandro; Prencipe, Lorenzo; McLawhon, Ronald W; Nilsen, Olaug L; Oellerich, Michael; Luthe, Hilmar; Orsonneau, Jean-Luc; Richeux, Gérard; Recio, Fernando; Roldan, Esther; Rymo, Lars; Wicktorsson, Anne-Charlotte; Welch, Shirley L; Wieland, Heinrich; Grawitz, Andrea Busse; Mitsumaki, Hiroshi; McGovern, Margaret; Ng, Katherine; Stockmann, Wolfgang

    2005-01-01

    MODULAR ANALYTICS (Roche Diagnostics) (MODULAR ANALYTICS, Elecsys and Cobas Integra are trademarks of a member of the Roche Group) represents a new approach to automation for the clinical chemistry laboratory. It consists of a control unit, a core unit with a bidirectional multitrack rack transportation system, and three distinct kinds of analytical modules: an ISE module, a P800 module (44 photometric tests, throughput of up to 800 tests/h), and a D2400 module (16 photometric tests, throughput up to 2400 tests/h). MODULAR ANALYTICS allows customised configurations for various laboratory workloads. The performance and practicability of MODULAR ANALYTICS were evaluated in an international multicentre study at 16 sites. Studies included precision, accuracy, analytical range, carry-over, and workflow assessment. More than 700 000 results were obtained during the course of the study. Median between-day CVs were typically less than 3% for clinical chemistries and less than 6% for homogeneous immunoassays. Median recoveries for nearly all standardised reference materials were within 5% of assigned values. Method comparisons versus current existing routine instrumentation were clinically acceptable in all cases. During the workflow studies, the work from three to four single workstations was transferred to MODULAR ANALYTICS, which offered over 100 possible methods, with reduction in sample splitting, handling errors, and turnaround time. Typical sample processing time on MODULAR ANALYTICS was less than 30 minutes, an improvement from the current laboratory systems. By combining multiple analytic units in flexible ways, MODULAR ANALYTICS met diverse laboratory needs and offered improvement in workflow over current laboratory situations. It increased overall efficiency while maintaining (or improving) quality.

  8. Student perceptions of the clinical laboratory science profession.

    Science.gov (United States)

    McClure, Karen

    2009-01-01

    The purpose of this paper is to describe the attitudes and perceptions among college biology and CLS/CLT students. These students were on selected college campuses at Texas universities in Houston, Dallas and the Austin/San Antonio areas for the Spring 2007 semester. Specifically, students were questioned on factors that influence their choice of field of study, career expectations, legislative measures which might be used to attract individuals to the career, and factors that will be required to keep them in the field of practice. This study was part of a larger qualitative study which included exploratory discovery and inductive logic regarding the attitudes of four focus groups in Texas. Focus groups took place on college campuses or in hotel conference rooms. (1) junior/senior-level college biology students and (2) junior/senior-level students currently enrolled in CLS/CLT programs. Focus group discussions using a standard set of questions; group sessions lasted about 45 minutes. This study was a qualitative study which included exploratory discovery and inductive logic regarding the attitudes of two groups in Texas. College biology and CLS/CLT students find the clinical laboratory science profession to be interesting and exciting as a career prospect, however, many do not see themselves remaining in the profession and perceive it does not have good prospects for career advancement. The majority of students must work to support themselves through their college education and would welcome additional grants, scholarships and loan forgiveness programs as incentives to study the clinical laboratory sciences. Students believe that additional recruitment on high school and college campuses is needed to increase the visibility of the field as career choice. The majority of students who are entering the clinical laboratory science profession do not see the profession as their final career choice, but rather a stepping stone to another career field in healthcare or a

  9. Adult Hematology and Clinical Chemistry Laboratory Reference Ranges in a Zimbabwean Population.

    Science.gov (United States)

    Samaneka, Wadzanai P; Mandozana, Gibson; Tinago, Willard; Nhando, Nehemiah; Mgodi, Nyaradzo M; Bwakura-Dangarembizi, Mutsawashe F; Munjoma, Marshall W; Gomo, Zvenyika A R; Chirenje, Zvavahera M; Hakim, James G

    2016-01-01

    Laboratory reference ranges used for clinical care and clinical trials in various laboratories in Zimbabwe were derived from textbooks and research studies conducted more than ten years ago. Periodic verification of these ranges is essential to track changes over time. The purpose of this study was to establish hematology and chemistry laboratory reference ranges using more rigorous methods. A community-based cross-sectional study was carried out in Harare, Chitungwiza, and Mutoko. A multistage sampling technique was used. Samples were transported from the field for analysis at the ISO15189 certified University of Zimbabwe-University of California San Francisco Central Research Laboratory. Hematology and clinical chemistry reference ranges lower and upper reference limits were estimated at the 2.5th and 97.5th percentiles respectively. A total of 769 adults (54% males) aged 18 to 55 years were included in the analysis. Median age was 28 [IQR: 23-35] years. Males had significantly higher red cell counts, hemoglobin, hematocrit, and mean corpuscular hemoglobin compared to females. Females had higher white cell counts, platelets, absolute neutrophil counts, and absolute lymphocyte counts compared to males. There were no gender differences in eosinophils, monocytes, and absolute basophil count. Males had significantly higher levels of urea, sodium, potassium, calcium, creatinine, amylase, total protein, albumin and liver enzymes levels compared to females. Females had higher cholesterol and lipase compared with males. There are notable differences in the white cell counts, neutrophils, cholesterol, and creatinine kinase when compared with the currently used reference ranges. Data from this study provides new country specific reference ranges which should be immediately adopted for routine clinical care and accurate monitoring of adverse events in research studies.

  10. Adult Hematology and Clinical Chemistry Laboratory Reference Ranges in a Zimbabwean Population.

    Directory of Open Access Journals (Sweden)

    Wadzanai P Samaneka

    Full Text Available Laboratory reference ranges used for clinical care and clinical trials in various laboratories in Zimbabwe were derived from textbooks and research studies conducted more than ten years ago. Periodic verification of these ranges is essential to track changes over time. The purpose of this study was to establish hematology and chemistry laboratory reference ranges using more rigorous methods.A community-based cross-sectional study was carried out in Harare, Chitungwiza, and Mutoko. A multistage sampling technique was used. Samples were transported from the field for analysis at the ISO15189 certified University of Zimbabwe-University of California San Francisco Central Research Laboratory. Hematology and clinical chemistry reference ranges lower and upper reference limits were estimated at the 2.5th and 97.5th percentiles respectively.A total of 769 adults (54% males aged 18 to 55 years were included in the analysis. Median age was 28 [IQR: 23-35] years. Males had significantly higher red cell counts, hemoglobin, hematocrit, and mean corpuscular hemoglobin compared to females. Females had higher white cell counts, platelets, absolute neutrophil counts, and absolute lymphocyte counts compared to males. There were no gender differences in eosinophils, monocytes, and absolute basophil count. Males had significantly higher levels of urea, sodium, potassium, calcium, creatinine, amylase, total protein, albumin and liver enzymes levels compared to females. Females had higher cholesterol and lipase compared with males. There are notable differences in the white cell counts, neutrophils, cholesterol, and creatinine kinase when compared with the currently used reference ranges.Data from this study provides new country specific reference ranges which should be immediately adopted for routine clinical care and accurate monitoring of adverse events in research studies.

  11. Preschool children's response to behavioural parent training and parental predictors of outcome in routine clinical care.

    Science.gov (United States)

    van der Veen-Mulders, Lianne; Hoekstra, Pieter J; Nauta, Maaike H; van den Hoofdakker, Barbara J

    2018-01-01

    To investigate the effectiveness of behavioral parent training (BPT) for preschool children with disruptive behaviours and to explore parental predictors of response. Parents of 68 preschool children, aged between 2.7 and 5.9 years, participated in BPT. We evaluated the changes in children's behaviour after BPT with a one group pretest-posttest design, using a waiting period for a double pretest. Outcome was based on parents' reports of the intensity and number of behaviour problems on the Eyberg Child Behavior Inventory. Predictor variables included parents' attention-deficit/hyperactivity disorder symptoms, antisocial behaviours, and alcohol use, and maternal parenting self-efficacy and disciplining. Mother-reported child behaviour problems did not change in the waiting period but improved significantly after BPT (d = 0.63). High levels of alcohol use by fathers and low levels of maternal ineffective disciplining were each associated with somewhat worse outcome. BPT under routine care conditions clearly improves disruptive behaviours in preschool children. Mothers who consider themselves as inadequate in disciplining and mothers whose partners do not consume high levels of alcohol report the largest improvements. Copyright © 2017 John Wiley & Sons, Ltd.

  12. Transformation From a Conventional Clinical Microbiology Laboratory to Full Automation.

    Science.gov (United States)

    Moreno-Camacho, José L; Calva-Espinosa, Diana Y; Leal-Leyva, Yoseli Y; Elizalde-Olivas, Dolores C; Campos-Romero, Abraham; Alcántar-Fernández, Jonathan

    2017-12-22

    To validate the performance, reproducibility, and reliability of BD automated instruments in order to establish a fully automated clinical microbiology laboratory. We used control strains and clinical samples to assess the accuracy, reproducibility, and reliability of the BD Kiestra WCA, the BD Phoenix, and BD Bruker MALDI-Biotyper instruments and compared them to previously established conventional methods. The following processes were evaluated: sample inoculation and spreading, colony counts, sorting of cultures, antibiotic susceptibility test, and microbial identification. The BD Kiestra recovered single colonies in less time than conventional methods (e.g. E. coli, 7h vs 10h, respectively) and agreement between both methodologies was excellent for colony counts (κ=0.824) and sorting cultures (κ=0.821). Antibiotic susceptibility tests performed with BD Phoenix and disk diffusion demonstrated 96.3% agreement with both methods. Finally, we compared microbial identification in BD Phoenix and Bruker MALDI-Biotyper and observed perfect agreement (κ=1) and identification at a species level for control strains. Together these instruments allow us to process clinical urine samples in 36h (effective time). The BD automated technologies have improved performance compared with conventional methods, and are suitable for its implementation in very busy microbiology laboratories. © American Society for Clinical Pathology 2017. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

  13. SSPM based radiation sensing: Preliminary laboratory and clinical results

    International Nuclear Information System (INIS)

    Konnoff, Daniel C.; Plant, Thomas K.; Shiner, Elizabeth

    2011-01-01

    Recent Solid State Photomultiplier (SSPM) technology has matured, reaching a performance level that is suitable for replacement of the ubiquitous photomultiplier tube in selected applications for environmental radiation monitoring, clinical dosimetry, and medical imaging purposes. The objective of this work is low signal level laboratory and high signal level clinical testing of the Hamamatsu MPPC (S10362-11-050C), Photonique SSPM (0810G1), and Voxtel SiPM (SQBF-EKAA/SQBF-EIOA) SSPMs coupled to different inorganic scintillator crystals (Prelude 420, BGO), inorganic doped glass scintillator material SiO 2 :Cu 2+ and organic BCF-12 plastic scintillating fibers, used as detector elements. Plastic Optical Fibers (POFs) and Glass Optical Fibers (GOFs) are used as signal conduits for laboratory and clinical testing. Further, reduction of electron-beam-generated Cerenkov light in optical fibers is facilitated by the inclusion of metalized air-core capillary tubing between the BCF-12 plastic scintillating fiber and the POF. In a clinical setting dose linearity, percent depth dose, and angular measurements for 6 MV/18 MV photon beams and 9 MeV electron beams are compared with and without the use of the air-core capillary tubing for BCF-12 plastic scintillating fiber. These same measurements are repeated for SiO 2 :Cu 2+ scintillator material without air-core capillary tubing.

  14. [Applications of MALDI-TOF-MS in clinical microbiology laboratory].

    Science.gov (United States)

    Carbonnelle, Etienne; Nassif, Xavier

    2011-10-01

    For twenty years, mass spectrometry (MS) has emerged as a particularly powerful tool for analysis and characterization of proteins in research. It is only recently that this technology, especially MALDI-TOF-MS (Matrix Assisted Laser Desorption Ionization Time-Of-Flight) has entered the field of routine microbiology. This method has proven to be reliable and safe for the identification of bacteria, yeasts, filamentous fungi and dermatophytes. MALDI-TOF-MS is a rapid, precise and cost-effective method for identification, compared to conventional phenotypic techniques or molecular biology. Its ability to analyse whole microorganisms with few sample preparation has greatly reduced the time to identification (1-2 min). Furthermore, this technology can be used to identify bacteria directly from clinical samples as blood culture bottles or urines. Future applications will be developed in order to provide direct information concerning virulence or resistance protein markers. © 2011 médecine/sciences – Inserm / SRMS.

  15. Use of routinely available clinical, nutritional, and functional criteria to classify cachexia in advanced cancer patients.

    Science.gov (United States)

    Vigano, Antonio A L; Morais, José A; Ciutto, Lorella; Rosenthall, Leonard; di Tomasso, Jonathan; Khan, Sarah; Olders, Henry; Borod, Manuel; Kilgour, Robert D

    2017-10-01

    Cachexia is a highly prevalent syndrome in cancer and chronic diseases. However, due to the heterogeneous features of cancer cachexia, its identification and classification challenge clinical practitioners. To determine the clinical relevance of a cancer cachexia classification system in advanced cancer patients. Beginning with the four-stage classification system proposed for cachexia [non-cachexia (NCa), pre-cachexia (PCa), cachexia (Ca) and refractory cachexia (RCa)], we assigned patients to these cachexia stages according to five classification criteria available in clinical practice: 1) biochemistry (high C-reactive protein or leukocytes, or hypoalbuminemia, or anemia), 2) food intake (normal/decreased), weight loss: 3) moderate (≤5%) or 4) significant (>5%/past six months) and 5) performance status (Eastern Cooperative Oncology Group Performance Status ≥ 3). We then determined if symptom severity, body composition changes, functional levels, hospitalizations and survival rates varied significantly across cachexia stages. Two-hundred and ninety-seven advanced cancer patients with primary gastrointestinal and lung tumors were included. Patients were classified into Ca (36%), PCa and RCa (21%, respectively) and NCa (15%). Significant (p cachexia stages for most of the outcome measures (symptoms, body composition, handgrip strength, emergency room visits and length of hospital stays) according to cachexia severity. Survival also differed between cachexia stages (except between PCa and Ca). Five clinical criteria can be used to stage cancer cachexia patients and predict important clinical, nutritional and functional outcomes. The lack of statistical difference between PCa and Ca in almost all clinical outcomes examined suggests either that the PCa group includes patients already affected by early cachexia or that more precise criteria are needed to differentiate PCa from Ca patients. More studies are required to validate these findings. Copyright © 2016

  16. Preparing clinical laboratory science students with teaching skills.

    Science.gov (United States)

    Isabel, Jeanne M

    2010-01-01

    Training clinical laboratory science (CLS) students in techniques of preparation and delivery of an instructional unit is an important component of all CLS education programs and required by the national accrediting agency. Participants of this study included students admitted to the CLS program at Northern Illinois University and enrolled in the teaching course offered once a year between the years of 1997 and 2009. Courses on the topic of "teaching" may be regarded by CLS students as unnecessary. However, entry level practitioners are being recruited to serve as clinical instructors soon after entering the workforce. Evaluation of the data collected indicates that students are better prepared to complete tasks related to instruction of a topic after having an opportunity to study and practice skills of teaching. Mentoring CLS students toward the career role of clinical instructor or professor is important to maintaining the workforce.

  17. A new generation of cancer genome diagnostics for routine clinical use: overcoming the roadblocks to personalized cancer medicine.

    Science.gov (United States)

    Heuckmann, J M; Thomas, R K

    2015-09-01

    The identification of 'druggable' kinase gene alterations has revolutionized cancer treatment in the last decade by providing new and successfully targetable drug targets. Thus, genotyping tumors for matching the right patients with the right drugs have become a clinical routine. Today, advances in sequencing technology and computational genome analyses enable the discovery of a constantly growing number of genome alterations relevant for clinical decision making. As a consequence, several technological approaches have emerged in order to deal with these rapidly increasing demands for clinical cancer genome analyses. Here, we describe challenges on the path to the broad introduction of diagnostic cancer genome analyses and the technologies that can be applied to overcome them. We define three generations of molecular diagnostics that are in clinical use. The latest generation of these approaches involves deep and thus, highly sensitive sequencing of all therapeutically relevant types of genome alterations-mutations, copy number alterations and rearrangements/fusions-in a single assay. Such approaches therefore have substantial advantages (less time and less tissue required) over PCR-based methods that typically have to be combined with fluorescence in situ hybridization for detection of gene amplifications and fusions. Since these new technologies work reliably on routine diagnostic formalin-fixed, paraffin-embedded specimens, they can help expedite the broad introduction of personalized cancer therapy into the clinic by providing comprehensive, sensitive and accurate cancer genome diagnoses in 'real-time'. © The Author 2015. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

  18. Atomic spectrometry and trends in clinical laboratory medicine

    Science.gov (United States)

    Parsons, Patrick J.; Barbosa, Fernando

    2007-09-01

    Increasing numbers of clinical laboratories are transitioning away from flame and electrothermal AAS methods to those based on ICP-MS. Still, for many laboratories, the choice of instrumentation is based upon (a) the element(s) to be determined, (b) the matrix/matrices to be analyzed, and (c) the expected concentration(s) of the analytes in the matrix. Most clinical laboratories specialize in measuring Se, Zn, Cu, and Al in serum, and/or Pb, Cd, Hg, As, and Cr in blood and/or urine, while other trace elements (e.g., Pt, Au etc.) are measured for therapeutic purposes. Quantitative measurement of elemental species is becoming more widely accepted for nutritional and/or toxicological screening purposes, and ICP-MS interfaced with separation techniques, such as liquid chromatography or capillary electrophoresis, offers the advantage of on-line species determination coupled with very low detection limits. Polyatomic interferences for some key elements such as Se, As, and Cr require instrumentation equipped with dynamic reaction cell or collision cell technologies, or might even necessitate the use of sector field ICP-MS, to assure accurate results. Nonetheless, whatever analytical method is selected for the task, careful consideration must be given both to specimen collection procedures and to the control of pre-analytical variables. Finally, all methods benefit from access to reliable certified reference materials (CRMs). While a variety of reference materials (RMs) are available for trace element measurements in clinical matrices, not all can be classified as CRMs. The major metrological organizations (e.g., NIST, IRMM, NIES) provide a limited number of clinical CRMs, however, secondary reference materials are readily available from commercial organizations and organizers of external quality assessment schemes.

  19. Atomic spectrometry and trends in clinical laboratory medicine

    International Nuclear Information System (INIS)

    Parsons, Patrick J.; Barbosa, Fernando

    2007-01-01

    Increasing numbers of clinical laboratories are transitioning away from flame and electrothermal AAS methods to those based on ICP-MS. Still, for many laboratories, the choice of instrumentation is based upon (a) the element(s) to be determined, (b) the matrix/matrices to be analyzed, and (c) the expected concentration(s) of the analytes in the matrix. Most clinical laboratories specialize in measuring Se, Zn, Cu, and Al in serum, and/or Pb, Cd, Hg, As, and Cr in blood and/or urine, while other trace elements (e.g., Pt, Au etc.) are measured for therapeutic purposes. Quantitative measurement of elemental species is becoming more widely accepted for nutritional and/or toxicological screening purposes, and ICP-MS interfaced with separation techniques, such as liquid chromatography or capillary electrophoresis, offers the advantage of on-line species determination coupled with very low detection limits. Polyatomic interferences for some key elements such as Se, As, and Cr require instrumentation equipped with dynamic reaction cell or collision cell technologies, or might even necessitate the use of sector field ICP-MS, to assure accurate results. Nonetheless, whatever analytical method is selected for the task, careful consideration must be given both to specimen collection procedures and to the control of pre-analytical variables. Finally, all methods benefit from access to reliable certified reference materials (CRMs). While a variety of reference materials (RMs) are available for trace element measurements in clinical matrices, not all can be classified as CRMs. The major metrological organizations (e.g., NIST, IRMM, NIES) provide a limited number of clinical CRMs, however, secondary reference materials are readily available from commercial organizations and organizers of external quality assessment schemes

  20. Accuracy of some routine method used in clinical chemistry as judged by isotope dilution-mass spectrometry

    International Nuclear Information System (INIS)

    Bjoerkhem, I.; Bergman, A.; Falk, O.; Kallner, A.; Lantto, O.; Svensson, L.; Akerloef, E.; Blomstrand, R.

    1981-01-01

    Serum from patients was pooled, filtered, dispensed, and frozen. This pooled specimen was used for accuracy control in 64 participating laboratories in Sweden. Mean values (state-of-the-art values) were obtained for creatinine, cholesterol, glucose, urea, uric acid, and cortisol. These values were compared with values obtained with highly accurate reference methods based on isotope dilution-mass spectrometry. Differences were marked in the case of determination of creatinine and cortisol. Concerning the other components, the differences between the state-of-the-art value and the values obtained with the reference methods were negligible. Moreover, the glucose oxidase and the oxime methods for determination of glucose and urea were found to give significantly lower values than the hexokinase and urease methods, respectively. Researchers conclude that methods with a higher degree of accuracy are required for routine determination of creatinine and cortisol

  1. Kikuchi-Fujimoto disease: Clinical and laboratory characteristics and outcome

    Directory of Open Access Journals (Sweden)

    P S Rakesh

    2014-01-01

    Full Text Available Introduction: Kikuchi-Fujimoto disease is an uncommon disorder with worldwide distribution, characterized by fever and benign enlargement of the lymph nodes, primarily affecting young adults. Awareness about this disorder may help prevent misdiagnosis and inappropriate investigations and treatment. The objective of the study was to evaluate the clinical and laboratory characteristics of histopathologically confirmed cases of Kikuchi′s disease from a tertiary care center in southern India. Materials and Methods: Retrospective analysis of all adult patients with histopathologically confirmed Kikuchi′s disease from January 2007 to December 2011 in a 2700-bed teaching hospital in South India was done. The clinical and laboratory characteristics and outcome were analyzed. Results: There were 22 histopathologically confirmed cases of Kikuchi′s disease over the 5-year period of this study. The mean age of the subjects′ was 29.7 years (SD 8.11 and majority were women (Male: female- 1:3.4. Apart from enlarged cervical lymph nodes, prolonged fever was the most common presenting complaint (77.3%. The major laboratory features included anemia (54.5%, increased erythrocyte sedimentation rate (31.8%, elevated alanine aminotransferase (27.2% and elevated lactate dehydrogenase (LDH (31.8%. Conclusion: Even though rare, Kikuchi′s disease should be considered in the differential diagnosis of young individuals, especially women, presenting with lymphadenopathy and prolonged fever. Establishing the diagnosis histopathologically is essential to avoid inappropriate investigations and therapy.

  2. Effect of Omega-3 Fatty Acid Supplementation on Oxylipins in a Routine Clinical Setting

    Directory of Open Access Journals (Sweden)

    Christoph Schmöcker

    2018-01-01

    Full Text Available Omega-6 polyunsaturated fatty acid (n-6 PUFA is the predominant polyunsaturated fatty acid (PUFA, especially in Western diet. A high omega-6/omega-3 ratio in Western diets is implicated in the development of cardiovascular diseases and inflammatory processes. Studies in animal models and in humans have demonstrated beneficial effects of omega-3 PUFA (n-3 PUFA in a variety of diseases, including cardiac arrhythmias and inflammatory diseases, as well as breast and colon cancer. The molecular mechanisms underlying the effects of n-3 PUFA are still not well understood. Possible mechanisms include competition between n-3 and n-6 PUFAs at the cyclooxygenase (COX and lipoxygenase (LOX and cytochrome P450 levels, and subsequent formation of oxylipins with specific anti-inflammatory or anti-arrhythmic effects. In this study, we report the impact of routine long-term treatment with prescription-grade n-3 PUFA (either 840 mg or 1680 mg per day on blood cell membrane fatty acid composition, as well as plasma oxylipin patterns, in a patient population with severe hyperlipidemia and cardiovascular disease who are on standard lipid-lowering and cardioprotective medications. Lipidomics analyses were performed by LC/ESI-MS/MS. Supplementation led to a dose-dependent increase in n-3 PUFA eicosapentaenoic acid (EPA and docosahexaenoic acid (DHA in the blood cell fraction. We also observed a dose-dependent increase in EPA- and DHA-derived epoxy metabolites, whereas the effect of n-3 PUFA supplementation on LOX-dependent EPA- and DHA-derived hydroxy metabolites was less pronounced, with a tendency towards lower metabolites in subjects with higher n-3 PUFA levels. These data thus generally confirm effects of n-3 PUFA supplementation observed previously in healthy individuals. Additionally, they indicate a suppressive effect of high n-3 PUFA supplementation on the formation of LOX metabolites in the context of concomitant aspirin medication.

  3. An assessment of the clinical utility of routine antenatal screening of ...

    African Journals Online (AJOL)

    This prospective study was designed to provide the frequencies of the haemoglobin genotypes, ABO and Rh blood groups and their effects on the haematocrit values among pregnant women in Port Harcourt. One hundred and eighty (180) pregnant women at their first clinic attendance and in their first pregnancy (parity - 0) ...

  4. Training clinicians in how to use patient-reported outcome measures in routine clinical practice

    NARCIS (Netherlands)

    Santana, Maria J.; Haverman, Lotte; Absolom, Kate; Takeuchi, Elena; Feeny, David; Grootenhuis, Martha; Velikova, Galina

    2015-01-01

    Patient-reported outcome measures (PROs) were originally developed for comparing groups of people in clinical trials and population studies, and the results were used to support treatment recommendations or inform health policy, but there was not direct benefit for the participants providing PROs

  5. Customized laboratory information management system for a clinical and research leukemia cytogenetics laboratory.

    Science.gov (United States)

    Bakshi, Sonal R; Shukla, Shilin N; Shah, Pankaj M

    2009-01-01

    We developed a Microsoft Access-based laboratory management system to facilitate database management of leukemia patients referred for cytogenetic tests in regards to karyotyping and fluorescence in situ hybridization (FISH). The database is custom-made for entry of patient data, clinical details, sample details, cytogenetics test results, and data mining for various ongoing research areas. A number of clinical research laboratoryrelated tasks are carried out faster using specific "queries." The tasks include tracking clinical progression of a particular patient for multiple visits, treatment response, morphological and cytogenetics response, survival time, automatic grouping of patient inclusion criteria in a research project, tracking various processing steps of samples, turn-around time, and revenue generated. Since 2005 we have collected of over 5,000 samples. The database is easily updated and is being adapted for various data maintenance and mining needs.

  6. An analysis of the relationship between serum cortisol and serum sodium in routine clinical patients

    Directory of Open Access Journals (Sweden)

    Eleanor McLaughlan

    2017-08-01

    Full Text Available Objectives: Adrenal insufficiency is an uncommon cause of hyponatraemia that should not be overlooked due to the severe consequences of an Addisonian crisis. Using the laboratory database of a large teaching hospital, we have explored the relationship between serum sodium and serum cortisol, and have estimated the frequency of hypoadrenalism in severely hyponatraemic patients. Design and methods: Data were gathered over a 23 month period from the Laboratory Information Management System at the Leeds Teaching Hospitals NHS Trust for instances where serum sodium and cortisol had been measured on a single sample. Data were also gathered over the same time period for all patients with severe hyponatraemia (serum sodium ≤120 mmol/L in order to determine the frequency of cortisol requesting and the incidence of adrenal insufficiency. Results: Analysis of the data (n=3268 patients revealed a trend showing higher cortisol concentrations in patients who were severely hypo- or hypernatraemic. The median cortisol concentration for patients with sodium ≤110 mmol/L was 856 nmol/L, and there was a gradual decrease in cortisol over the sodium range ≤110–150 mmol/L (Rs =−0.323, p<0.0001. Patients with sodium ≥151 mmol/L had a median cortisol of 725 nmol/L. 42% of the 978 patients with serum sodium ≤120 mmol/L had serum cortisol measured within two weeks, of whom 1.7% were diagnosed with adrenal insufficiency. Conclusions: This dataset shows rising cortisol in response to hypo- or hypernatraemia, in keeping with the stress response to illness. The data show that adrenal insufficiency is a rare cause of hyponatraemia which may be overlooked. Keywords: Serum, Sodium, Cortisol, Adrenal insufficiency

  7. Evaluating laboratory key performance using quality indicators in Alexandria University Hospital Clinical Chemistry Laboratories.

    Science.gov (United States)

    Rizk, Mostafa M; Zaki, Adel; Hossam, Nermine; Aboul-Ela, Yasmin

    2014-12-01

    The performance of clinical laboratories plays a fundamental role in the quality and effectiveness of healthcare. To evaluate the laboratory performance in Alexandria University Hospital Clinical Laboratories using key quality indicators and to compare the performance before and after an improvement plan based on ISO 15189 standards. The study was carried out on inpatient samples for a period of 7 months that was divided into three phases: phase I included data collection for evaluation of the existing process before improvement (March-May 2012); an intermediate phase, which included corrective, preventive action, quality initiative and steps for improvement (June 2012); and phase II, which included data collection for evaluation of the process after improvement (July 2012-September 2012). In terms of the preanalytical indicators, incomplete request forms in phase I showed that the total number of received requests were 31 944, with a percentage of defected request of 33.66%; whereas in phase II, there was a significant reduction in all defected request items (Plaboratories.

  8. Laboratory hematology in the history of Clinical Chemistry and Laboratory Medicine.

    Science.gov (United States)

    Hoffmann, Johannes J M L

    2013-01-01

    For the occasion of the 50th anniversary of the journal Clinical Chemistry and Laboratory Medicine (CCLM), an historic overview of papers that the journal has published in the field of laboratory hematology (LH) is presented. All past volumes of CCLM were screened for papers on LH and these were categorized. Bibliographic data of these papers were also analyzed. CCLM published in total 387 LH papers. The absolute number of LH papers published annually showed a significant increase over the years since 1985. Also the share of LH papers demonstrated a steady increase (overall mean 5%, but mean 8% over the past 4 years). The most frequent category was coagulation and fibrinolysis (23.5%). Authors from Germany contributed the most LH papers to the journal (22.7%), followed by the Netherlands and Italy (16.3 and 13.2%, respectively). Recent citation data indicated that other publications cited LH review papers much more frequently than other types of papers. The history of the journal reflects the emergence and development of laboratory hematology as a separate discipline of laboratory medicine.

  9. Physician satisfaction with clinical laboratory services: a College of American Pathologists Q-probes study of 138 institutions.

    Science.gov (United States)

    Jones, Bruce A; Bekeris, Leonas G; Nakhleh, Raouf E; Walsh, Molly K; Valenstein, Paul N

    2009-01-01

    Monitoring customer satisfaction is a valuable component of a laboratory quality improvement program. To survey the level of physician satisfaction with hospital clinical laboratory services. Participating institutions provided demographic and practice information and survey results of physician satisfaction with defined aspects of clinical laboratory services, rated on a scale of 1 (poor) to 5 (excellent). One hundred thirty-eight institutions participated in this study and submitted a total of 4329 physician surveys. The overall satisfaction score for all institutions ranged from 2.9 to 5.0. The median overall score for all participants was 4.1 (10th percentile, 3.6; 90th percentile, 4.5). Physicians were most satisfied with the quality/reliability of results and staff courtesy, with median values of excellent or good ratings of 89.9%. Of the 5 service categories that received the lowest percentage values of excellent/good ratings (combined scores of 4 and 5), 4 were related to turnaround time for inpatient stat, outpatient stat, routine, and esoteric tests. Surveys from half of the participating laboratories reported that 96% to 100% of physicians would recommend the laboratory to other physicians. The category most frequently selected as the most important category of laboratory services was quality/reliability of results (31.7%). There continues to be a high level of physician satisfaction and loyalty with clinical laboratory services. Test turnaround times are persistent categories of dissatisfaction and present opportunities for improvement.

  10. Narrative meaning making is associated with sudden gains in psychotherapy clients' mental health under routine clinical conditions.

    Science.gov (United States)

    Adler, Jonathan M; Harmeling, Luke H; Walder-Biesanz, Ilana

    2013-10-01

    The present study had two aims: (a) to replicate previous findings regarding the characteristics of sudden gains (SGs) in psychotherapy under routine clinical conditions and (b) to examine whether clients' narrative meaning-making processes were associated with SGs in mental health. 54 psychotherapy clients completed the Systemic Therapy Inventory of Change (Pinsof et al., 2009) and wrote private narratives prior to beginning treatment and between every session for 12 assessment points over the course of psychotherapy for a variety of presenting problems. Clients' narratives were coded using existing systems (Adler, 2012; A. M. Hayes, Feldman, & Goldfried, 2006) to assess their content in eight themes: processing, avoidance, coherence, positive self, negative self, agency, hope, and hopelessness. The prevalence, magnitude, and timing of SGs in mental health observed in the present study were similar to those observed in prior research. Two narrative meaning-making processes-processing and coherence-were significantly associated with SGs in mental health. The present study significantly extends prior research on SGs, replicating the characteristics of these gains in routine clinical conditions with a measure of general functioning and identifying two narrative meaning-making processes that are associated with SGs in mental health.

  11. Patients' perceptions of sharing in decisions: a systematic review of interventions to enhance shared decision making in routine clinical practice.

    Science.gov (United States)

    Légaré, France; Turcotte, Stéphane; Stacey, Dawn; Ratté, Stéphane; Kryworuchko, Jennifer; Graham, Ian D

    2012-01-01

    Shared decision making is the process in which a healthcare choice is made jointly by the health professional and the patient. Little is known about what patients view as effective or ineffective strategies to implement shared decision making in routine clinical practice. This systematic review evaluates the effectiveness of interventions to improve health professionals' adoption of shared decision making in routine clinical practice, as seen by patients. We searched electronic databases (PubMed, the Cochrane Library, EMBASE, CINAHL, and PsycINFO) from their inception to mid-March 2009. We found additional material by reviewing the reference lists of the studies found in the databases; systematic reviews of studies on shared decision making; the proceedings of various editions of the International Shared Decision Making Conference; and the transcripts of the Society for Medical Decision Making's meetings. In our study selection, we included randomized controlled trials, controlled clinical trials, controlled before-and-after studies, and interrupted time series analyses in which patients evaluated interventions to improve health professionals' adoption of shared decision making. The interventions in question consisted of the distribution of printed educational material; educational meetings; audit and feedback; reminders; and patient-mediated initiatives (e.g. patient decision aids). Two reviewers independently screened the studies and extracted data. Statistical analyses considered categorical and continuous process measures. We computed the standardized effect size for each outcome at the 95% confidence interval. The primary outcome of interest was health professionals' adoption of shared decision making as reported by patients in a self-administered questionnaire. Of the 6764 search results, 21 studies reported 35 relevant comparisons. Overall, the quality of the studies ranged from 0% to 83%. Only three of the 21 studies reported a clinically significant effect

  12. [Children of mentally ill parents. A study of problem awareness in clinical routine practice].

    Science.gov (United States)

    Bohus, M; Schehr, K; Berger-Sallawitz, F; Novelli-Fischer, U; Stieglitz, R D; Berger, M

    1998-05-01

    The risk of developing clinically relevant psychiatric disorders in the lifetime course is significantly greater among children of mentally ill parents. A child-adapted programme of information concerning the nature and symptomatology of parental illness is considered to be an important preventive factor, and lies within the domain of the psychiatrist's or therapist's responsibilities. During the developmental phase of a prevention project at Freiburg University's Department of Psychiatry and Psychotherapy, both clinical practice and the level of problem awareness among patients and the therapists were evaluated. Over a period of one year, consecutive interviews involving 114 patients with children under 18 years of age, as well as their respective therapists, were conducted. The results showed that: scarcely any exchanges between children and therapists took place; the extent to which children are informed about parental illness must be considered as small; a high percentage of such children are already evaluated by their parents as disturbed, and the pressing need for support exists.

  13. Routine use of point-of-care tests: usefulness and application in clinical microbiology.

    Science.gov (United States)

    Clerc, O; Greub, G

    2010-08-01

    Point-of-care (POC) tests offer potentially substantial benefits for the management of infectious diseases, mainly by shortening the time to result and by making the test available at the bedside or at remote care centres. Commercial POC tests are already widely available for the diagnosis of bacterial and viral infections and for parasitic diseases, including malaria. Infectious diseases specialists and clinical microbiologists should be aware of the indications and limitations of each rapid test, so that they can use them appropriately and correctly interpret their results. The clinical applications and performance of the most relevant and commonly used POC tests are reviewed. Some of these tests exhibit insufficient sensitivity, and should therefore be coupled to confirmatory tests when the results are negative (e.g. Streptococcus pyogenes rapid antigen detection test), whereas the results of others need to be confirmed when positive (e.g. malaria). New molecular-based tests exhibit better sensitivity and specificity than former immunochromatographic assays (e.g. Streptococcus agalactiae detection). In the coming years, further evolution of POC tests may lead to new diagnostic approaches, such as panel testing, targeting not just a single pathogen, but all possible agents suspected in a specific clinical setting. To reach this goal, the development of serology-based and/or molecular-based microarrays/multiplexed tests will be needed. The availability of modern technology and new microfluidic devices will provide clinical microbiologists with the opportunity to be back at the bedside, proposing a large variety of POC tests that will allow quicker diagnosis and improved patient care.

  14. Should we reconsider the routine use of placebo controls in clinical research?

    Directory of Open Access Journals (Sweden)

    Avins Andrew L

    2012-04-01

    Full Text Available Abstract Background Modern clinical-research practice favors placebo controls over usual-care controls whenever a credible placebo exists. An unrecognized consequence of this preference is that clinicians are more limited in their ability to provide the benefits of the non-specific healing effects of placebos in clinical practice. Methods We examined the issues in choosing between placebo and usual-care controls. We considered why placebo controls place constraints on clinicians and the trade-offs involved in the choice of control groups. Results We find that, for certain studies, investigators should consider usual-care controls, even if an adequate placebo is available. Employing usual-care controls would be of greatest value for pragmatic trials evaluating treatments to improve clinical care and for which threats to internal validity can be adequately managed without a placebo-control condition. Conclusions Intentionally choosing usual-care controls, even when a satisfactory placebo exists, would allow clinicians to capture the value of non-specific therapeutic benefits that are common to all interventions. The result could be more effective, patient-centered care that makes the best use of both specific and non-specific benefits of medical interventions.

  15. Should we reconsider the routine use of placebo controls in clinical research?

    Science.gov (United States)

    Avins, Andrew L; Cherkin, Daniel C; Sherman, Karen J; Goldberg, Harley; Pressman, Alice

    2012-04-27

    Modern clinical-research practice favors placebo controls over usual-care controls whenever a credible placebo exists. An unrecognized consequence of this preference is that clinicians are more limited in their ability to provide the benefits of the non-specific healing effects of placebos in clinical practice. We examined the issues in choosing between placebo and usual-care controls. We considered why placebo controls place constraints on clinicians and the trade-offs involved in the choice of control groups. We find that, for certain studies, investigators should consider usual-care controls, even if an adequate placebo is available. Employing usual-care controls would be of greatest value for pragmatic trials evaluating treatments to improve clinical care and for which threats to internal validity can be adequately managed without a placebo-control condition. Intentionally choosing usual-care controls, even when a satisfactory placebo exists, would allow clinicians to capture the value of non-specific therapeutic benefits that are common to all interventions. The result could be more effective, patient-centered care that makes the best use of both specific and non-specific benefits of medical interventions.

  16. [Critical role of clinical laboratories in hospital infection control].

    Science.gov (United States)

    Yagi, Tetsuya

    2010-11-01

    The hospital infection control and prevention is recognized to be more and more important according to the advances in modern medical treatment and care. Clinical microbiology laboratory play critical roles in the hospital infection control as a member of infection control team (ICT). They are the first in a hospital to identify outbreak of MRSA in NICU and molecular epidemiological analysis of the isolates lead proper intervention of ICT to the concerned ward. From a viewpoint of infectious disease specialist, rapid and precise microbiological information is essential for the appropriate diagnosis and treatment of infectious diseases. Each medical technologist need to make efforts to understand the characteristics of the examinations for infectious diseases and send out information useful for clinical practices. In our hospital, with the participation of all members of medical technologists, rapid reporting system was developed for blood culture examinations, which greatly contribute to the appropriate treatment of bloodstream infections. Collaborations of clinical microbiology laboratory with other members of ICT realize high quality hospital infection control. They also need to be aware of themselves as good practitioners of infection control measures to prevent hospital infections.

  17. On the improvement of blood sample collection at clinical laboratories.

    Science.gov (United States)

    Grasas, Alex; Ramalhinho, Helena; Pessoa, Luciana S; Resende, Mauricio G C; Caballé, Imma; Barba, Nuria

    2014-01-09

    Blood samples are usually collected daily from different collection points, such hospitals and health centers, and transported to a core laboratory for testing. This paper presents a project to improve the collection routes of two of the largest clinical laboratories in Spain. These routes must be designed in a cost-efficient manner while satisfying two important constraints: (i) two-hour time windows between collection and delivery, and (ii) vehicle capacity. A heuristic method based on a genetic algorithm has been designed to solve the problem of blood sample collection. The user enters the following information for each collection point: postal address, average collecting time, and average demand (in thermal containers). After implementing the algorithm using C programming, this is run and, in few seconds, it obtains optimal (or near-optimal) collection routes that specify the collection sequence for each vehicle. Different scenarios using various types of vehicles have been considered. Unless new collection points are added or problem parameters are changed substantially, routes need to be designed only once. The two laboratories in this study previously planned routes manually for 43 and 74 collection points, respectively. These routes were covered by an external carrier company. With the implementation of this algorithm, the number of routes could be reduced from ten to seven in one laboratory and from twelve to nine in the other, which represents significant annual savings in transportation costs. The algorithm presented can be easily implemented in other laboratories that face this type of problem, and it is particularly interesting and useful as the number of collection points increases. The method designs blood collection routes with reduced costs that meet the time and capacity constraints of the problem.

  18. Are self-report scales as effective as clinician rating scales in measuring treatment response in routine clinical practice?

    Science.gov (United States)

    Zimmerman, Mark; Walsh, Emily; Friedman, Michael; Boerescu, Daniela A; Attiullah, Naureen

    2018-01-01

    Recent treatment guidelines have suggested that outcome should be measured in routine clinical practice. In the present report from the Rhode Island Methods to Improve Diagnostic Assessment and Services (MIDAS) project, we compared three self-report scales of depressive symptoms and the two most widely used clinician administered scales in treatment studies in their sensitivity to change and evaluation of treatment response in depressed patients treated in routine practice. At baseline and 4-month follow-up 153 depressed outpatients with DSM-IV MDD completed the Clinically Useful Depression Outcome Scale (CUDOS), Quick Inventory of Depressive Symptomatology-Self-report version (QIDS-SR), and Patient Health Questionnaire (PHQ-9). The patients were rated on the 17-item Hamilton Depression Rating Scale (HAMD) and the Montgomery-Asberg Depression Rating Scale (MADRS). On each scale treatment response was defined as a 50% or greater reduction in scores from baseline. While there were some differences in the percentage of patients considered to be responders on the different scales, a large effect size was found for each scale, with little variability amongst the scales. The level of agreement between the three self-report scales and the clinician rating scales was approximately the same LIMITATIONS: The present study was conducted in a single clinical practice in which the majority of the patients were white, female, and had health insurance. When measuring outcome in clinical practice the magnitude of change in depressive symptoms is as great on self-report scales as on clinician rating scales. Copyright © 2017 Elsevier B.V. All rights reserved.

  19. Routine sputum culture

    Science.gov (United States)

    Sputum culture ... There, it is placed in a special dish (culture). It is then watched to see if bacteria ... Elsevier; 2018:chap 36. Chernecky CC, Berger BJ. Culture, routine. In: Chernecky CC, Berger BJ, eds. Laboratory ...

  20. Systematic Reviews Published in Emergency Medicine Journals Do Not Routinely Search Clinical Trials Registries: A Cross-Sectional Analysis.

    Science.gov (United States)

    Keil, Lukas G; Platts-Mills, Timothy F; Jones, Christopher W

    2015-10-01

    Publication bias compromises the validity of systematic reviews. This problem can be addressed in part through searching clinical trials registries to identify unpublished studies. This study aims to determine how often systematic reviews published in emergency medicine journals include clinical trials registry searches. We identified all systematic reviews published in the 6 highest-impact emergency medicine journals between January 1 and December 31, 2013. Systematic reviews that assessed the effects of an intervention were further examined to determine whether the authors described searching a clinical trials registry and whether this search identified relevant unpublished studies. Of 191 articles identified through PubMed search, 80 were confirmed to be systematic reviews. Our sample consisted of 41 systematic reviews that assessed a specific intervention. Eight of these 41 (20%) searched a clinical trials registry. For 4 of these 8 reviews, the registry search identified at least 1 relevant unpublished study. Systematic reviews published in emergency medicine journals do not routinely include searches of clinical trials registries. By helping authors identify unpublished trial data, the addition of registry searches may improve the validity of systematic reviews. Copyright © 2014 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.

  1. Epidemiological, clinical and sleep laboratory evaluations of insomnia

    Science.gov (United States)

    Bixler, E. O.; Kales, A.; Kales, J. D.

    1975-01-01

    Epidemiological studies have contributed to the understanding of the total scope of the insomnia problem, both in terms of the incidence of sleep difficulties, and the extent and frequency of hypnotic drug use. Clinical studies - at the Sleep Research and Treatment Center - have been used to evaluate the medical, psychological, pharmacological and situational factors contributing to insomnia, and to evaluate the psychotherapy and chemotherapy best suited to treatment of insomnia. The sleep laboratory studies were of two types: (1) the study of sleep induction, sleep maintenance, and sleep stages, and (2) the use of hypnotic drugs, emphasizing their effectiveness in inducing and maintaining sleep, and the duration of this effectiveness.

  2. Quality Management Systems in the Clinical Laboratories in Latin America

    Science.gov (United States)

    2015-01-01

    The implementation of management systems in accordance with standards like ISO 9001:2008 (1,2) in the clinical laboratories has conferred and added value of reliability and therefore a very significant input to patient safety. As we know the ISO 9001:2008 (1) a certification standard, and ISO 15189:2012 (2) an accreditation standard, both, at the time have generated institutional memory where they have been implemented, the transformation of culture focused on correct execution, control and following, evidence needed and the importance of register. PMID:27683495

  3. Use of routine clinical multimodality imaging in a rabbit model of osteoarthritis--part I.

    Science.gov (United States)

    Bouchgua, M; Alexander, K; d'Anjou, M André; Girard, C A; Carmel, E Norman; Beauchamp, G; Richard, H; Laverty, S

    2009-02-01

    To evaluate in vivo the evolution of osteoarthritis (OA) lesions temporally in a rabbit model of OA with clinically available imaging modalities: computed radiography (CR), helical single-slice computed tomography (CT), and 1.5 tesla (T) magnetic resonance imaging (MRI). Imaging was performed on knees of anesthetized rabbits [10 anterior cruciate ligament transection (ACLT) and contralateral sham joints and six control rabbits] at baseline and at intervals up to 12 weeks post-surgery. Osteophytosis, subchondral bone sclerosis, bone marrow lesions (BMLs), femoropatellar effusion and articular cartilage were assessed. CT had the highest sensitivity (90%) and specificity (91%) to detect osteophytes. A significant increase in total joint osteophyte score occurred at all time-points post-operatively in the ACLT group alone. BMLs were identified and occurred most commonly in the lateral femoral condyle of the ACLT joints and were not identified in the tibia. A significant increase in joint effusion was present in the ACLT joints until 8 weeks after surgery. Bone sclerosis or cartilage defects were not reliably assessed with the selected imaging modalities. Combined, clinically available CT and 1.5 T MRI allowed the assessment of most of the characteristic lesions of OA and at early time-points in the development of the disease. However, the selected 1.5 T MRI sequences and acquisition times did not permit the detection of cartilage lesions in this rabbit OA model.

  4. The clinical value of routine whole-body magnetic resonance imaging (MRI) in palliative care

    Energy Technology Data Exchange (ETDEWEB)

    Geitung, Jonn Terje (Department of Radiology, Haraldspass Deaconess (University) Hospital (Norway); Department of Surgical Sciences, University of Bergen (Norway)), Email: jtgeit@online.no; Eikeland, Joakim (Department of Public Health and Primary Health Care, University of Bergen (Norway)); Rosland, Jan Henrik (Department of Public Health and Primary Health Care, University of Bergen (Norway); Sunniva Clinic for Palliative Care, Haraldsplass Deaconess (University) Hospital (Norway))

    2012-03-15

    Background. Whole-body MRI (WBMRI) has become an accessible method for detecting different types of pathologies both in the skeleton and the viscera, which may explain painful conditions, for example tumors and inflammation. Purpose. To assess a possible value of using WBMRI in order to improve palliative care. Material and Methods. Twenty patients (all eligible patients) admitted to the Department for Palliative Care were consecutively included in this study. They underwent a modified WBMRI, with fewer and shorter pulse sequences than in a standard WBMRI, to reduce patient stress. However, the patients' physicians were to exclude patients where little might be obtained and discomfort, distress, and pain could be induced. The treating physicians registered clinical utility directly after receiving the MRI report in a questionnaire. The registration was repeated after ended treatment. Results. Eighty percent had new findings detected, and 40% of the patients had a change in treatment due to the MRI result, mainly changes in analgesics and/or radiation therapy. Conclusion. The WBMRI helped the clinicians to improve treatment and a majority of the patients benefited from this. In eight patients the treatment was changed due to the results. The clinical value (utility) was indicated to be high

  5. Clinical and Laboratory Characteristics of Leishmaniasis in Armenia

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    A.L. Kazinian

    2014-11-01

    Full Text Available This work presents the clinical and laboratory characteristics of visceral leishmaniasis according to the data from Clinical hospital of infectious diseases «Nork» in Yerevan for 2013. It is shown that Armenia is a country endemic for visceral leishmaniasis. Most patients (81 % were males. About half of the patients were young children (up to 2 years. It was found that the majority of patients had acute onset of the disease with fever up to 40 °C, severe symptoms of intoxication and single hemorrhages on the skin. Enlargement of the liver and spleen was noted in all patients. The enlargement of the spleen was more pronounced, and it reached the level of the pelvis. One of the cardinal symptoms of visceral leishmaniasis — anemia — developed in all patients admitted to the hospital, and a significant change in the hemogram was observed in young children.

  6. Current status of matrix-assisted laser desorption ionisation-time of flight mass spectrometry in the clinical microbiology laboratory.

    Science.gov (United States)

    Kok, Jen; Chen, Sharon C A; Dwyer, Dominic E; Iredell, Jonathan R

    2013-01-01

    The integration of matrix-assisted laser desorption ionisation-time of flight mass spectrometry (MALDI-TOF MS) into many clinical microbiology laboratories has revolutionised routine pathogen identification. MALDI-TOF MS complements and has good potential to replace existing phenotypic identification methods. Results are available in a more clinically relevant timeframe, particularly in bacteraemic septic shock. Novel applications include strain typing and the detection of antimicrobial resistance, but these are not widely used. This review discusses the technical aspects, current applications, and limitations of MALDI-TOF MS.

  7. Initiation of conformal radiotherapy with a multileaf-collimator - An approach to clinical routine

    International Nuclear Information System (INIS)

    Bannach, B.; Doll, Th.; Pape, H.; Schmitt, G.

    1995-01-01

    The implementation of a three-dimensional conformal radiotherapy facility in the radiotherapy department of the Heinrich Heine University is described. Complex radiotherapy techniques with commercially available networked systems are introduced to improve clinical work. Over 18 month we have gained clinical experience with a PHILIPS Multileaf Collimator (MLC) mounted on a SL 25 linear accelerator. For a limited period the MLC was used as a conventional blocking device. The standard MLC-shapes are controlled with a stand-alone computer system. In addition, a three-dimensional treatment planning system (3-D-TPS / TMS-Radix, Helax AB) based on convolution/superposition algorithms was recently installed. Treatment optimization is achieved using static field arrangements with complete volumetric computerized tomographic patient data for 3-D-TPS. Conformal adaptation of the 95%-isodose to the Planning Target Volume (PTV, ICRU 50) results in MLC-field-shaping concerning size, position and contour to PTV-projection in beams-eye-view (BEV). Field prescription with defined leaf positions of the MLC-setting for geometrical beam shaping is transferred from TPS via TCP/IP. Patient treatment with complex coplanar and non-coplanar field arrangements is performed with an automatic set-up for gantry and collimator angle position contolled by a verification system. Quality assurance for treatment set-up is gained with a mega-voltage imaging device (MVI / PHILIPS SRI 100). Actual treatment outcome and accurate dose delivery for conformal therapy is verified by intercomparison of geometrical field matching of MVI and digitally reconstructed radiographs (DRR) for each delivered beam in BEV

  8. A Required Rotation in Clinical Laboratory Management for Pathology Residents

    Science.gov (United States)

    Hoda, Syed T.; Crawford, James M.

    2016-01-01

    Leadership and management training during pathology residency have been identified repeatedly by employers as insufficient. A 1-month rotation in clinical laboratory management (CLM) was created for third-year pathology residents. We report on our experience and assess the value of this rotation. The rotation was one-half observational and one-half active. The observational component involved being a member of department and laboratory service line leadership, both at the departmental and institutional level. Observational participation enabled learning of both the content and principles of leadership and management activities. The active half of the rotation was performance of a project intended to advance the strategic trajectory of the department and laboratory service line. In our program that matriculates 4 residents per year, 20 residents participated from April 2010 through December 2015. Their projects either activated a new priority area or helped propel an existing strategic priority forward. Of the 16 resident graduates who had obtained their first employment or a fellowship position, 9 responded to an assessment survey. The majority of respondents (5/9) felt that the rotation significantly contributed to their ability to compete for a fellowship or their first employment position. The top reported benefits of the rotation included people management; communication with staff, departmental, and institutional leadership; and involvement in department and institutional meetings and task groups. Our 5-year experience demonstrates both the successful principles by which the CLM rotation can be established and the high value of this rotation to residency graduates. PMID:28725766

  9. A Required Rotation in Clinical Laboratory Management for Pathology Residents

    Directory of Open Access Journals (Sweden)

    Arvind Rishi MD

    2016-05-01

    Full Text Available Leadership and management training during pathology residency have been identified repeatedly by employers as insufficient. A 1-month rotation in clinical laboratory management (CLM was created for third-year pathology residents. We report on our experience and assess the value of this rotation. The rotation was one-half observational and one-half active. The observational component involved being a member of department and laboratory service line leadership, both at the departmental and institutional level. Observational participation enabled learning of both the content and principles of leadership and management activities. The active half of the rotation was performance of a project intended to advance the strategic trajectory of the department and laboratory service line. In our program that matriculates 4 residents per year, 20 residents participated from April 2010 through December 2015. Their projects either activated a new priority area or helped propel an existing strategic priority forward. Of the 16 resident graduates who had obtained their first employment or a fellowship position, 9 responded to an assessment survey. The majority of respondents (5/9 felt that the rotation significantly contributed to their ability to compete for a fellowship or their first employment position. The top reported benefits of the rotation included people management; communication with staff, departmental, and institutional leadership; and involvement in department and institutional meetings and task groups. Our 5-year experience demonstrates both the successful principles by which the CLM rotation can be established and the high value of this rotation to residency graduates.

  10. [Laboratory unification: advantages and disadvantages for clinical microbiology].

    Science.gov (United States)

    Andreu, Antonia; Matas, Lurdes

    2010-10-01

    This article aims to reflect on which areas or tasks of microbiology laboratories could be unified with those of clinical biochemistry, hematology, immunology or pathology laboratories to benefit patients and the health system, as well as the areas that should remain independent since their amalgamation would not only fail to provide a benefit but could even jeopardize the quality of microbiological diagnosis, and consequently patient care. To do this, the distinct analytic phases of diagnosis are analyzed, and the advantages and disadvantages of amalgamation are evaluated in each phase. The pros and cons of the unification of certain areas such as the computer system, occupational risk units, customer service, purchasing logistics, and materials storage, etc, are also discussed. Lastly, the effect of unification on urgent microbiology diagnosis is analyzed. Microbiological diagnosis should be unique. The microbiologist should perform an overall evaluation of the distinct techniques used for a particular patient, both those that involve direct diagnosis (staining, culture, antigen detection techniques or molecular techniques) and indirect diagnosis (antibody detection). Moreover, the microbiology laboratory should be independent, with highly trained technicians and specialists in microbiology that provide added value as experts in infection and as key figures in the process of establishing a correct etiological diagnosis. Copyright © 2010 Elsevier España S.L. All rights reserved.

  11. Psychometric characteristics of Clinical Reasoning Problems (CRPs) and its correlation with routine multiple choice question (MCQ) in Cardiology department.

    Science.gov (United States)

    Derakhshandeh, Zahra; Amini, Mitra; Kojuri, Javad; Dehbozorgian, Marziyeh

    2018-01-01

    Clinical reasoning is one of the most important skills in the process of training a medical student to become an efficient physician. Assessment of the reasoning skills in a medical school program is important to direct students' learning. One of the tests for measuring the clinical reasoning ability is Clinical Reasoning Problems (CRPs). The major aim of this study is to measure psychometric qualities of CRPs and define correlation between this test and routine MCQ in cardiology department of Shiraz medical school. This study was a descriptive study conducted on total cardiology residents of Shiraz Medical School. The study population consists of 40 residents in 2014. The routine CRPs and the MCQ tests was designed based on similar objectives and were carried out simultaneously. Reliability, item difficulty, item discrimination, and correlation between each item and the total score of CRPs were all measured by Excel and SPSS software for checking psycometeric CRPs test. Furthermore, we calculated the correlation between CRPs test and MCQ test. The mean differences of CRPs test score between residents' academic year [second, third and fourth year] were also evaluated by Analysis of variances test (One Way ANOVA) using SPSS software (version 20)(α=0.05). The mean and standard deviation of score in CRPs was 10.19 ±3.39 out of 20; in MCQ, it was 13.15±3.81 out of 20. Item difficulty was in the range of 0.27-0.72; item discrimination was 0.30-0.75 with question No.3 being the exception (that was 0.24). The correlation between each item and the total score of CRP was 0.26-0.87; the correlation between CRPs test and MCQ test was 0.68 (preasoning in residents. It can be included in cardiology residency assessment programs.

  12. The use of reference change values in clinical laboratories.

    Science.gov (United States)

    Bugdayci, Guler; Oguzman, Hamdi; Arattan, Havva Yasemin; Sasmaz, Guler

    2015-01-01

    The use of Reference Change Values (RCV) has been advocated as very useful for monitoring individuals. Most of these are performed for monitoring individuals in acute situations and for following up the improvement or deterioration of chronic diseases. In our study, we aimed at evaluating the RCV calculation for 24 clinical chemistry analytes widely used in clinical laboratories and the utilization of this data. Twenty-four serum samples were analyzed with Abbott kits (Abbott Laboratories, Abbott Park, IL, USA), manufactured for use with the Architect c8000 (Abbott Laboratories, Abbott Park, IL, USA) auto-analyzer. We calculated RCV using the following formula: RCV = Z x 2 1/2x (CVA2 + CVw2)1/2. Four reference change values (RCV) were calculated for each analyte using four statistical probabilities (0.95, and 0.99, unidirectional and bidirectional). Moreover, by providing an interval after identifying upper and lower limits with the Reference Change Factor (RCF), serially measured tests were calculated by using two formulas: exp (Z x 2 1/2 x (CV(A)2 + CVw2)½/100) for RCF(UP) and (1/RCF(UP)) for RCF(DOWN). RCVs of these analytes were calculated as 14.63% for glucose, 29.88% for urea, 17.75% for ALP, 53.39% for CK, 46.98% for CK-MB, 21.00% amylase, 8.00% for total protein, 8.70% for albumin, 51.08% for total bilirubin, 86.34% for direct bilirubin, 6.40% for calcium, 15.03% for creatinine, 21.47% for urate, 14.19% for total cholesterol, 46.62% for triglyceride, 20.51% for HDL-cholesterol, 29.59% for AST, 46.31% for ALT, 31.54% for GGT, 20.92% for LDH, 19.75% for inorganic phosphate, 3.05% for sodium, 11.75% for potassium, 4.44% for chloride (RCV, p laboratories. RCV could be available as a tool for making clinical decision, especially when monitoring individuals.

  13. Clinical and laboratory characteristics of women with uterine leiomiyoma

    Directory of Open Access Journals (Sweden)

    Özgür ÖZKUL

    2009-06-01

    Full Text Available The aim of this study was to compare clinical and laboratory findings of women with or without uterine leiomyoma.Study group consisted of 82 women with uterine leiomyoma and the control group comprised 42 healthy women. Women’s age, gravity, parity, blood groups, pattern of menstrual cycles, complaints at presentation, fertility, ultrasonographical findings, surgical operations and thyroid function tests were evaluated.There were no significant differences in blood group distribution, gravity, parity and thyroid function test results between the patients and the control subjects (P>0.05. A significant difference was found in the complaints at presentation between two groups (P<0.001. Mentrual cycles irregularity was more frequently found in the patients compared with the controls (57.3% vs. 42.9%, respectively, P=0.009. Although no infertile woman was found in the control group, 8.5% of patients were found to have infertility. The sensitivity of ultrasonography was found to be 97.6%. Except for the existence of higher infertility rate and the menstrual cycles irregularities, no significant difference was found in the clinical and laboratory findings between women with or without uterine leiomyoma. Therefore, physical examination and imaging methods are remained as the most important diagnostic tools for uterine leiomyoma.

  14. Transmission of hepatitis B virus in clinical laboratory areas.

    Science.gov (United States)

    Lauer, J L; VanDrunen, N A; Washburn, J W; Balfour, H H

    1979-10-01

    The transmission of hepatitis B virus (HBV) in clinical laboratory areas was delineated by the use of hepatitis B surface antigen (HBsAg) as presumptive evidence for the presence of the infective agent. Twenty-six (34%) of 76 environmental surfaces sampled were positive for HBsAg. The outer surfaces of blood- and serum-specimen containers had HBsAg contamination rates of 55% (six of 11) and 44% (four of nine), respectively. Subsequent handling of pipetting aids, marking devices, and other items led to their contamination and further dissemination of HBsAg. An assay instrument for complete determinations of blood cell counts was observed to splatter and drip blood during its operation. The contamination rate for environmental surfaces associated with this instrument was 15%. The data indicate that transmission of HBV in the clinical laboratory is subtle and mainly via hand contact with contaminated items during the various steps of blood processing. These data support the concept that the portal of entry of HBV is through inapparent breaks in skin and mucous membranes.

  15. Control of muscle relaxation during anesthesia: a novel approach for clinical routine.

    Science.gov (United States)

    Stadler, Konrad S; Schumacher, Peter M; Hirter, Sibylle; Leibundgut, Daniel; Bouillon, Thomas W; Glattfelder, Adolf H; Zbinden, Alex M

    2006-03-01

    During general anesthesia drugs are administered to provide hypnosis, ensure analgesia, and skeletal muscle relaxation. In this paper, the main components of a newly developed controller for skeletal muscle relaxation are described. Muscle relaxation is controlled by administration of neuromuscular blocking agents. The degree of relaxation is assessed by supramaximal train-of-four stimulation of the ulnar nerve and measuring the electromyogram response of the adductor pollicis muscle. For closed-loop control purposes, a physiologically based pharmacokinetic and pharmacodynamic model of the neuromuscular blocking agent mivacurium is derived. The model is used to design an observer-based state feedback controller. Contrary to similar automatic systems described in the literature this controller makes use of two different measures obtained in the train-of-four measurement to maintain the desired level of relaxation. The controller is validated in a clinical study comparing the performance of the controller to the performance of the anesthesiologist. As presented, the controller was able to maintain a preselected degree of muscle relaxation with excellent precision while minimizing drug administration. The controller performed at least equally well as the anesthesiologist.

  16. BED-Volume histograms calculation for routine clinical dosimetry in brachytherapy

    International Nuclear Information System (INIS)

    Galelli, M.; Feroldi, P.

    1995-01-01

    The consideration of volumes is essential in Brachytherapy clinical dosimetry (I.C.R.U). Indeed, several indices, all based on dose-volume histograms (DVHs), have been designed in order to evaluate: before the therapy the volumetric quality of different possible implant geometries; during the therapy the consistency of the real and the previsional implants. Radiobiological evaluations, considering the dose deposition temporal pattern of treatment, can be usefully added to dosimetric calculations, to compare different treatment schedules. The Linear-Quadratic model is the most used: radiobiological modelisation and Biologically Effective Dose (BED) is principal related dosimetric quantity. Therefore, the consideration of BED-volume histogram (BED-VHs) is a straightforward extension of DVHs. In practice, BED-VHs can help relative comparisons and optimisations in treatment planning when combined to dose-volume histograms. Since 1994 the dosimetric calculations for all the gynecological brachytherapy treatments are performed considering also DVHs and BED-VHs. In this presentation we show the methods of BEDVHs calculation, together with some typical results

  17. Clinical and Laboratory Findings in Various Reasons of Thrombocytopenia

    Directory of Open Access Journals (Sweden)

    Serkan Akin

    2017-12-01

    Full Text Available Background: Thrombocytopenia is an important cause of bleeding. Different clinical conditions associated with thrombocytopenia and their reflections to the hemostatic table will be examined in this study. Methods: A total of 100 patients with thrombocytopenia who were treated in Hacettepe University between 1993 and 2013, 29 with thrombotic thrombocytopenic purpura (TTP, 36 with immune thrombocytopenic purpura (ITP, and 35 with aplastic anemia (AA, were included in the study. Clinical features and laboratory values were reviewed. Results: Thrombosis, fever, and sepsis were more frequently seen in TTP. The most common bleeding type was subcutaneous bleeding in all patient groups. Among patients with TTP, twenty-five patients (86, 2% had fever, 26 patients (89, 7% had a neurologic disorder, and 16 patients (55, 1% had renal dysfunction. Regarding the diagnostic criteria of TTP, 13 patients (44, 8% met five, 12 (41, 4% patients met four and 4 (13, 8% patients met three criteria. The median session of plasmapheresis was 17 (range; 2-127. There was no relation between session count and remission (p=0.28. Conclusion: The severity of clinical presentation and underlying disorders are the most important points with which to approach patients with thrombocytopenia. Clinical reflections may help to identify the cause of thrombocytopenia but not sufficiently demonstrative for diagnosis. [J Contemp Med 2017; 7(4.000: 316-322

  18. Quality of the clinical laboratory department in a specialized hospital in Alexandria, Egypt.

    Science.gov (United States)

    Elhoseeny, T A; Mohammad, E K

    2013-01-01

    Assessment and improvement of turnaround times (TAT) as well as customer satisfaction is essential for laboratory quality management. This study in a specialized hospital in Alexandria, Egypt measured the current TAT for outpatient department bilirubin samples and evaluated the satisfaction of physicians with aspects of clinical laboratory services. While the mean TAT for 110 bilirubin tests [58.1 (SD 31.8) min] was within the College of American Pathologists' benchmark, the 90th percentile was long (96.7 min); 62.7% of tests were reported within 60 min. The mean overall satisfaction score of physicians (range 1-5) was 3.46 (SD 0.49). The highest satisfaction rating was for staff courtesy while the lowest ratings were for laboratory management responsiveness, outpatient stat TAT and critical value notification. Quality or reliability of results was judged by physicians as the most important factor (32.3%), followed by routine test TAT (18.5%). Further analysis of the different steps of the TAT would be helpful and follow-up through examining outliers is recommended

  19. 78 FR 28292 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and...

    Science.gov (United States)

    2013-05-14

    ... DEPARTMENT OF VETERANS AFFAIRS Joint Biomedical Laboratory Research and Development and Clinical Science Research and Development Services Scientific Merit Review Board; Notice of Meetings; Amendment The... Joint Biomedical Laboratory Research and Development and Clinical Science Research and Development...

  20. Routine clinical application of the FRAXA Pfu PCR assay: limits and utility.

    Science.gov (United States)

    Condorelli, D F; Milana, G; Dell'Albani, P; Roccazzello, A M; Insirello, E; Pavone, L; Mollica, F

    1996-11-01

    Fragile X genotype is characterized by the excessive amplification of an unstable region of DNA: a trinucleotide repeat CGG of variable copy number present in the FRAXA locus. Methods based on polymerase chain reaction (PCR) amplification of the CGG repeat region could facilitate the development of a rapid screening assay. Unfortunately, amplification across CGG repeats can be inefficient and unreliable due to their 100% G + C base composition. The utility of the exonuclease-deficient Pfu polymerase for amplification and detection of the CGG repeats at the FRAXA locus has been reported. In the present study we analysed the utility of a Pfu PCR assay as a rapid initial screening method to rule out a diagnosis of fragile X syndrome in males with mental retardation. Affected males did not show any amplification products or a smear of amplification products between 350 and 550 bp. Only 10% of affected male samples did not show any amplification products, while the vast majority showed the amplification smear. The amplification smears represent a serious drawback of the method, since they cannot be distinguished from the amplification products of normal samples after separation in 1% agarose gel. Several modifications of the PCR conditions were attempted to eliminate this problem, but none was appropriate for clinical applications. However, the problem was easily solved by using a higher resolution electrophoretic system that allows a clear distinction of normal bands from pathological smears. We tested the specificity of the Pfu PCR assay, followed by an improved MetaPhor gel electrophoretic separation of PCR products, on 50 samples from normal males and 24 samples form affected males. The results showed that this method is a rapid, sensitive and specific assay for the exclusion of fragile X syndrome diagnosis in mentally retarded males.

  1. BIOTIN INTERFERENCE WITH ROUTINE CLINICAL IMMUNOASSAYS: UNDERSTAND THE CAUSES AND MITIGATE THE RISKS.

    Science.gov (United States)

    Samarasinghe, Shanika; Meah, Farah; Singh, Vinita; Basit, Arshi; Emanuele, Nicholas; Emanuele, Mary Ann; Mazhari, Alaleh; Holmes, Earle W

    2017-08-01

    The objectives of this report are to review the mechanisms of biotin interference with streptavidin/biotin-based immunoassays, identify automated immunoassay systems vulnerable to biotin interference, describe how to estimate and minimize the risk of biotin interference in vulnerable assays, and review the literature pertaining to biotin interference in endocrine function tests. The data in the manufacturer's "Instructions for Use" for each of the methods utilized by seven immunoassay system were evaluated. We also conducted a systematic search of PubMed/MEDLINE for articles containing terms associated with biotin interference. Available original reports and case series were reviewed. Abstracts from recent scientific meetings were also identified and reviewed. The recent, marked, increase in the use of over-the-counter, high-dose biotin supplements has been accompanied by a steady increase in the number of reports of analytical interference by exogenous biotin in the immunoassays used to evaluate endocrine function. Since immunoassay methods of similar design are also used for the diagnosis and management of anemia, malignancies, autoimmune and infectious diseases, cardiac damage, etc., biotin-related analytical interference is a problem that touches every area of internal medicine. It is important for healthcare personnel to become more aware of immunoassay methods that are vulnerable to biotin interference and to consider biotin supplements as potential sources of falsely increased or decreased test results, especially in cases where a lab result does not correlate with the clinical scenario. FDA = U.S. Food & Drug Administration FT3 = free tri-iodothyronine FT4 = free thyroxine IFUs = instructions for use LH = luteinizing hormone PTH = parathyroid hormone SA/B = streptavidin/biotin TFT = thyroid function test TSH = thyroid-stimulating hormone.

  2. Evaluation of a high resolution genotyping method for Chlamydia trachomatis using routine clinical samples.

    Directory of Open Access Journals (Sweden)

    Yibing Wang

    2011-02-01

    Full Text Available Genital chlamydia infection is the most commonly diagnosed sexually transmitted infection in the UK. C. trachomatis genital infections are usually caused by strains which fall into two pathovars: lymphogranuloma venereum (LGV and the genitourinary genotypes D-K. Although these genotypes can be discriminated by outer membrane protein gene (ompA sequencing or multi-locus sequence typing (MLST, neither protocol affords the high-resolution genotyping required for local epidemiology and accurate contact-tracing.We evaluated variable number tandem repeat (VNTR and ompA sequencing (now called multi-locus VNTR analysis and ompA or "MLVA-ompA" to study local epidemiology in Southampton over a period of six months. One hundred and fifty seven endocervical swabs that tested positive for C. trachomatis from both the Southampton genitourinary medicine (GUM clinic and local GP surgeries were tested by COBAS Taqman 48 (Roche PCR for the presence of C. trachomatis. Samples tested as positive by the commercial NAATs test were genotyped, where possible, by a MLVA-ompA sequencing technique. Attempts were made to isolate C. trachomatis from all 157 samples in cell culture, and 68 (43% were successfully recovered by repeatable passage in culture. Of the 157 samples, 93 (i.e. 59% were fully genotyped by MLVA-ompA. Only one mixed infection (E & D in a single sample was confirmed. There were two distinct D genotypes for the ompA gene. Most frequent ompA genotypes were D, E and F, comprising 20%, 41% and 16% of the type-able samples respectively. Within all genotypes we detected numerous MLVA sub-types.Amongst the common genotypes, there are a significant number of defined MLVA sub-types, which may reflect particular background demographics including age group, geography, high-risk sexual behavior, and sexual networks.

  3. Clinical outcomes and cost effectiveness of accelerated diagnostic protocol in a chest pain center compared with routine care of patients with chest pain.

    Science.gov (United States)

    Asher, Elad; Reuveni, Haim; Shlomo, Nir; Gerber, Yariv; Beigel, Roy; Narodetski, Michael; Eldar, Michael; Or, Jacob; Hod, Hanoch; Shamiss, Arie; Matetzky, Shlomi

    2015-01-01

    The aim of this study was to compare in patients presenting with acute chest pain the clinical outcomes and cost-effectiveness of an accelerated diagnostic protocol utilizing contemporary technology in a chest pain unit versus routine care in an internal medicine department. Hospital and 90-day course were prospectively studied in 585 consecutive low-moderate risk acute chest pain patients, of whom 304 were investigated in a designated chest pain center using a pre-specified accelerated diagnostic protocol, while 281 underwent routine care in an internal medicine ward. Hospitalization was longer in the routine care compared with the accelerated diagnostic protocol group (pdiagnostic protocol patients (98%) vs. 57 (20%) routine care patients underwent non-invasive testing, (pdiagnostic imaging testing was performed in 125 (44%) and 26 (9%) patients in the routine care and accelerated diagnostic protocol patients, respectively (pdiagnostic protocol patients compared with those receiving routine care was associated with a lower incidence of readmissions for chest pain [8 (3%) vs. 24 (9%), pdiagnostic protocol remained a predictor of lower acute coronary syndromes and readmissions after propensity score analysis [OR = 0.28 (CI 95% 0.14-0.59)]. Cost per patient was similar in both groups [($2510 vs. $2703 for the accelerated diagnostic protocol and routine care group, respectively, (p = 0.9)]. An accelerated diagnostic protocol is clinically superior and as cost effective as routine in acute chest pain patients, and may save time and resources.

  4. MODERN CLINICAL AND LABORATORY FEATURES OF ENTEROVIRAL MENINGITIS

    Directory of Open Access Journals (Sweden)

    O. V. Usacheva

    2014-04-01

    Full Text Available Among numerous viral meningitises from 80% to 90% of cases are accounted for meningitis of enteroviral etiology according to the international data. Despite the favorable disease course, there are forms which are characterized by severe damage of CNS. In order to improve diagnostics of enteroviral meningitis in this article we have made a comparative analysis of clinical and laboratory parameters in 23 patients with enteroviral meningitis and 18 patients with serous meningitis of non-enteroviral etiology. Anamnesis data and the major clinical manifestations of the disease dynamics were analyzed. Particular attention is paid to the comparison of diagnoses, by which patients were sent to infectious hospital, the symptoms that occurred during patients’ admission into hospitals and their severity. The presence and severity of meningeal symptoms and the indices of cerebrospinal fluid in the patients of the comparison group were analyzed in detail. It is shown that enteroviruses are the important factor in the development of meningitis in the children of younger age. The clinical picture of enteroviral meningitis often develops gradually for 2-3 days and includes the typical syndromes: intoxication and meningeal ones. Every third patient with enterovirus infection has diarrhea and catarrhal symptoms, that’s why it is difficult to diagnose meningitis in its early stages, but it allows to assume enteroviral etiology of the disease. The meningitis of enteroviral etiology is characterized by multiple meningeal signs, while the non-enteroviral meningitis is characterized by dissociation with the prevalence of the of Kernig’s and Brudzinski’s symptoms. The analysis of the laboratory data showed that the enteroviral meningitis is characterized by low (over 50-100 cells "mixed" pleocytosis (the ratio of lymphocytes and neutrophils is about 1:1. These data can be used for differential diagnosis between enteroviral meningitis and serous meningitis of

  5. Psychometric properties of the Spanish version of the Clinical Outcomes in Routine Evaluation – Outcome Measure

    Directory of Open Access Journals (Sweden)

    Trujillo A

    2016-06-01

    Full Text Available Adriana Trujillo,1,2 Guillem Feixas,1,2 Arturo Bados,1 Eugeni García-Grau,1 Marta Salla,1 Joan Carles Medina,1 Adrián Montesano,1,2 José Soriano,3 Leticia Medeiros-Ferreira,4 Josep Cañete,5 Sergi Corbella,6 Antoni Grau,7 Fernando Lana,8 Chris Evans9 1Department of Personality, Assessment and Psychological Treatments, Faculty of Psychology, 2Institute for Brain, Cognition and Behaviour, University of Barcelona, 3Hospital of the Holy Cross and Saint Paul, 4Nou Barris Mental Health Center, Barcelona, 5Hospital of Mataró, Sanitary Consortium of Maresme, Mataró, 6FPCEE, Blanquerna, Universitat Ramon Llull, 7Institute of Eating Disorders, Barcelona, 8MAR Health Park, CAEMIL, Santa Coloma de Gramenet, Spain; 9East London NHS Foundation Trust, NPDDNet, London, UK Objective: The objective of this paper is to assess the reliability and validity of the Spanish translation of the Clinical Outcomes in Routine Evaluation – Outcome Measure, a 34-item self-report questionnaire that measures the client’s status in the domains of Subjective well-being, Problems/Symptoms, Life functioning, and Risk.Method: Six hundred and forty-four adult participants were included in two samples: the clinical sample (n=192 from different mental health and primary care centers; and the nonclinical sample (n=452, which included a student and a community sample.Results: The questionnaire showed good acceptability and internal consistency, appropriate test–retest reliability, and acceptable convergent validity. Strong differentiation between clinical and nonclinical samples was found. As expected, the Risk domain had different characteristics than other domains, but all findings were comparable with the UK referential data. Cutoff scores were calculated for clinical significant change assessment.Conclusion: The Spanish version of the Clinical Outcomes in Routine Evaluation – Outcome Measure showed acceptable psychometric properties, providing support for using the

  6. Socio-demographic, Clinical and Laboratory Features of Rotavirus Gastroenteritis in Children Treated in Pediatric Clinic

    OpenAIRE

    Azemi, Mehmedali; Berisha, Majlinda; Ismaili-Jaha, Vlora; Kolgeci, Selim; Avdiu, Muharrem; Jakupi, Xhevat; Hoxha, Rina; Hoxha-Kamberi, Teuta

    2013-01-01

    Aim: The aim of work was presentation of several socio-demographic, clinical and laboratory characteristics of gastroenteritis caused by rotavirus. The examinees and methods: The examinees were children under the age of five years treated at the Pediatric Clinic due to acute gastroenteritis caused by rotavirus. Rotavirus is isolated by method chromatographic immunoassay by Cer Test Biotec. Results: From the total number of patients (850) suffering from acute gastroenteritis, feces test on bac...

  7. Absence of Decline of Kidney Function in Human Immunodeficiency Virus-Infected Patients Under Routine Clinical Management.

    Science.gov (United States)

    Boucquemont, Julie; Lawson-Ayayi, Sylvie; Rigothier, Claire; Bonnet, Fabrice; Proust-Lima, Cécile; Neau, Didier; Greib, Carine; Miremont-Salamé, Ghada; Dabis, François; Dupon, Michel; Dauchy, Frédéric-Antoine

    2017-01-01

    Since the introduction of antiretroviral therapy (ART), human immunodeficiency virus (HIV)-infected patients have a drastically improved prognosis but at the same time they are also more affected by non-HIV related complications, such as chronic kidney disease. The objective of our study was to investigate the effect of proteinuria and tenofovir (TDF)-containing ART regimens on the temporal evolution of estimated glomerular filtration rate (eGFR). Between April 2008 and October 2012, we enrolled 395 patients with a complete renal evaluation among patients from the ANRS C03 Aquitaine cohort, a prospective hospital-based cohort of HIV-1-infected patients under routine clinical management in southwestern France. eGFR was estimated at each patient follow-up visit. A linear mixed model was used to analyze eGFR dynamics, accounting for change in TDF by modeling eGFR trajectory according to treatment periods. At inclusion, 56.7% of patients were treated with TDF-containing ART regimens; prevalence of glomerular and tubular proteinuria was 7.9 and 10.8% respectively. A 1-year increase of cumulative exposure to TDF was significantly associated with a mean eGFR decrease of 1.27 mL/min/1.73 m2 (95% CI [-2.14 to -0.41]). Only a urine protein to creatinine ratio >100 mg/mmol and/or a urine albumin to creatinine ratio >70 mg/mmol were associated with eGFR trajectory (mean slope 6.18 mL/min/1.73 m2 per year; 95% CI [2.71 to 9.65]), whereas TDF use was not associated with such eGFR temporal evolution. Decline in kidney function is limited under routine clinical management with monitoring of renal function and interventions including decision to continue or discontinue TDF. © 2017 S. Karger AG, Basel.

  8. Lean-Agile Adaptations in Clinical Laboratory Accredited ISO 15189

    Directory of Open Access Journals (Sweden)

    Carlos Vilaplana Pérez

    2015-12-01

    Full Text Available It’s introduced Lean techniques in a Clinical Laboratory to improve the operability and the efficiency in continuous processes of analysis, failsafe systems, analysis of areas of value pursuit of zero defects and reduction of waste, and it promote continuous improvement in presented difficulties in adapting to the changing needs of the healthcare environment. Whereas it is necessary to incorporate certification and accreditation, note that the adaptability of the clinical laboratory to the changing needs of physicians in obtaining analytical information is reduced. The application of an agile methodology on analytical systems can provide a line of work that allows the incorporation of planning short work cycles on equips quickly with operational autonomy on the basis of demand and respecting the accreditation requirements and flexibility to ensure adequate performance as the intercomparison of results from the different units analytics, analytical quality and turnaround times. Between 2012 and 2014, a process of analysis and improvement was applied to circuits, a 5 s system, transportation of samples, inventory of reactive and samples, motion of personal and samples, reductions of waiting and delays, overproduction, over processing, and defects of results and reports. At last it seems necessary to apply the Agile methodology to adapt to the evolving necessities in time and the different origins of the samples. It’s have used modular systems where the modules of this study are programmed with immunoassay techniques and it has reduced the operative modules depending on the required activity, ensuring the goals of turnaround times, analytic quality, service, health care continuity, and keeping up with the ISO 15189 accreditation requirements. The results of applying the concept of Lean-Agile to a modular system allows us to reduce the associated costs to the seasonal variation of the health care demand and to adapt the system to the changes on

  9. The impact of routine open nonsuction drainage on fluid accumulation after thyroid surgery: a prospective randomised clinical trial.

    LENUS (Irish Health Repository)

    Neary, Peter M

    2012-01-01

    Thyroid drains following thyroid surgery are routinely used despite minimal supportive evidence. Our aim in this study is to determine the impact of routine open drainage of the thyroid bed postoperatively on ultrasound-determined fluid accumulation at 24 hours.

  10. 42 CFR 405.515 - Reimbursement for clinical laboratory services billed by physicians.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 2 2010-10-01 2010-10-01 false Reimbursement for clinical laboratory services... Criteria for Determining Reasonable Charges § 405.515 Reimbursement for clinical laboratory services billed... limitation on reimbursement for markups on clinical laboratory services billed by physicians. If a physician...

  11. Patients' experiences with routine outcome monitoring and clinical feedback systems: A systematic review and synthesis of qualitative empirical literature.

    Science.gov (United States)

    Solstad, Stig Magne; Castonguay, Louis Georges; Moltu, Christian

    2017-05-19

    Routine outcome monitoring (ROM) and clinical feedback (CF) systems have become important tools for psychological therapies, but there are challenges for their successful implementation. To overcome these challenges, a greater understanding is needed about how patients experience the use of ROM/CF. We conducted a systematic literature search of qualitative studies on patient experiences with the use of ROM/CF in mental health services. The findings from 16 studies were synthesized, resulting in four meta-themes: (1) Suspicion towards service providers, (2) Flexibility and support to capture complexity, (3) Empowering patients, and (4) Developing collaborative practice. We discuss the implications of these meta-themes for further development and implementation of ROM/CF into clinical practice, acknowledging the limitations of our review and suggesting avenues for further research. Clinical or methodological significance of this article: This article provides useful and actionable knowledge about the patient perspective on ROM/CF, an important discussion on the current state of research in this area, and useful and concrete suggestions for further avenues of research.

  12. Audit of Helicobacter pylori Testing in Microbiology Laboratories in England: To Inform Compliance with NICE Guidance and the Feasibility of Routine Antimicrobial Resistance Surveillance

    Directory of Open Access Journals (Sweden)

    Rosalie Allison

    2016-01-01

    Full Text Available Introduction. The National Institute for Health and Clinical Excellence (NICE guidance recommends that dyspeptic patients are tested for Helicobacter pylori using a urea breath test, stool antigen test, or serology. Antibiotic resistance in H. pylori is globally increasing, but treatment in England is rarely guided by susceptibility testing or surveillance. Aims. To determine compliance of microbiology laboratories in England with NICE guidance and whether laboratories perform culture and antibiotic susceptibility testing (AST. Methods. In 2015, 170 accredited English microbiology laboratories were surveyed, by email. Results. 121/170 (71% laboratories responded; 96% provided H. pylori testing (78% on site. 94% provided H. pylori diagnosis using stool antigen; only four provided serology as their noninvasive test; 3/4 of these encouraged urea breath tests in their acute trusts. Only 22/94 (23% of the laboratories performed H. pylori cultures from gastric biopsies on site; 9/22 performed AST, but the vast majority processed less than one specimen/week. Conclusions. Only five laboratories in England do not comply with NICE guidance; these will need the guidance reinforced. National surveillance needs to be implemented; culture-based AST would need to be centralised. Moving forward, detection of resistance in H. pylori from stool specimens using molecular methods (PCR needs to be explored.

  13. Glycogen storage disease type I: clinical and laboratory profile

    Directory of Open Access Journals (Sweden)

    Berenice L. Santos

    2014-12-01

    Full Text Available OBJECTIVES: To characterize the clinical, laboratory, and anthropometric profile of a sample of Brazilian patients with glycogen storage disease type I managed at an outpatient referral clinic for inborn errors of metabolism. METHODS: This was a cross-sectional outpatient study based on a convenience sampling strategy. Data on diagnosis, management, anthropometric parameters, and follow-up were assessed. RESULTS: Twenty-one patients were included (median age 10 years, range 1-25 years, all using uncooked cornstarch therapy. Median age at diagnosis was 7 months (range, 1-132 months, and 19 patients underwent liver biopsy for diagnostic confirmation. Overweight, short stature, hepatomegaly, and liver nodules were present in 16 of 21, four of 21, nine of 14, and three of 14 patients, respectively. A correlation was found between height-for-age and BMI-for-age Z-scores (r = 0.561; p = 0.008. CONCLUSIONS: Diagnosis of glycogen storage disease type I is delayed in Brazil. Most patients undergo liver biopsy for diagnostic confirmation, even though the combination of a characteristic clinical presentation and molecular methods can provide a definitive diagnosis in a less invasive manner. Obesity is a side effect of cornstarch therapy, and appears to be associated with growth in these patients.

  14. Autoimmune thyroiditis goitrogenic. Aspects of clinical and laboratorial diagnostic

    International Nuclear Information System (INIS)

    Costa, H.F.Z. da.

    1986-01-01

    To asses the accuracy achieved by the A.C.A.T. and other clinical and laboratorial criterion in the diagnoses of T.A.I.B. we investigated twenty patients with goiter and antimicrossomal antibodies titres of 1/1.600 or more. Analysing the parameters useful in the diagnosis, we found a significant correlation between the antimicrossomal antibodies titres and the basal TSH concentration, an elevated basal TSH and an exaggerated response to TRH independent of the patient clinical status reflecting in the majority of the cases a state of subclinical hypotyroidism; an irregular appearance of the radioisotope thyroid scan and a positive response to a perchlorate discharge test. We conclude that from the parameters useful in the T.A.I.B. diagnosis, the A.C.A.T. detection mainly the antimicrossomal antibodies, is an excellent tool to detect patients with a clinical suspect of thyroid auto-immune disease and when we found high tires in a patient with goiter and an elevated basal TSH concentration we can suggest T.A.I.B. diagnosis. (author)

  15. Legal aspects associated with dismissal from clinical laboratory education programs.

    Science.gov (United States)

    Legrys, V A; Beck, S J; Laudicina, R J

    1995-01-01

    To review academic dismissals, students' rights in dismissal cases, and several key cases involving academic and disciplinary dismissals. Recent academic literature and legal precedents. Not applicable. Not applicable. Students involved in dismissals are protected under the principles of constitutional law and/or contract law, depending on whether the institution is public or private. The basis for dismissal from educational programs is either academic or disciplinary in nature. In academic dismissals, a student has failed to meet either the cognitive or the noncognitive academic standards of the program. In disciplinary dismissals, a student has violated the institutional rules governing conduct. Policies that affect progress in the program and the dismissal process should be published and distributed to students, as well as reviewed for consistency with institutional policies. The amount of documentation needed in the defense of a dismissal decision has not been specified, but, in general, more is better. Procedures are suggested as a guide to dismissals in clinical laboratory programs.

  16. Biocarbon urinary conduit: laboratory experience and clinical applications.

    Science.gov (United States)

    Kobashi, L I; Raible, D A

    1980-07-01

    A new urinary conduit utilizing pure vitreous carbon has been used successfully in dogs. Pure carbon appears to be inert with respect to urine and urothelium. Lack of urinary salt encrustation on the exposed surface provides a well-functioning urinary conduit for vesical drainage. Twenty-one vesicostomies were performed in dogs. Careful follow-up and histologic studies of removed specimens were done to establish the biocompatibility of pure carbon. All vesicostomies functioned well. A description of the device, protocol, and results of laboratory experimentation are outlined. The surgical procedure is explained in detail. Results encourage the clinical trial of these devices in humans. Indications include patients with neurogenic vesicla dysfunction and those with total urinary incontinence, both of which require permanent indwelling catheters.

  17. Clinical and laboratory factors associated with mortality in dengue.

    Science.gov (United States)

    Saroch, Atul; Arya, Vivek; Sinha, Nitin; Taneja, R S; Sahai, Pooja; Mahajan, R K

    2017-04-01

    Dengue is endemic in more than 100 countries, giving rise to an increased number of deaths in the last five years in the South-East Asian region. We report our findings from a retrospective study of adults admitted with confirmed dengue at our institution. We studied the clinical and laboratory parameters associated with mortality in these patients. Of the 172 hospitalised patients studied, 156 (90.69 %) recovered while 16 (9.3%) died. Univariate analysis showed altered sensorium on presentation, lower haemoglobin and haematocrit levels, higher serum creatinine, higher serum transaminase and lower serum albumin levels to be significantly associated with mortality in dengue. Further, using stepwise multivariate logistic regression, altered sensorium ( P = 0.006) and hypoalbuminemia ( P = 0.013) were identified as independent predictors of mortality in dengue. Identification of these parameters early in the course of disease should prompt intensification of treatment in dengue cases.

  18. Abnormalities of laboratory coagulation tests versus clinically evident coagulopathic bleeding

    DEFF Research Database (Denmark)

    Chang, Ronald; Fox, Erin E; Greene, Thomas J

    2018-01-01

    BACKGROUND: Laboratory-based evidence of coagulopathy (LC) is observed in 25-35% of trauma patients, but clinically-evident coagulopathy (CC) is not well described. METHODS: Prospective observational study of adult trauma patients transported by helicopter from the scene to nine Level 1 trauma...... centers in 2015. Patients meeting predefined highest-risk criteria were divided into CC+ (predefined as surgeon-confirmed bleeding from uninjured sites or injured sites not controllable by sutures) or CC-. We used a mixed-effects, Poisson regression with robust error variance to test the hypothesis...... that abnormalities on rapid thrombelastography (r-TEG) and international normalized ratio (INR) were independently associated with CC+. RESULTS: Of 1,019 highest-risk patients, CC+ (n=41, 4%) were more severely injured (median ISS 32 vs 17), had evidence of LC on r-TEG and INR, received more transfused blood...

  19. Use of the National Committee for Clinical Laboratory Standards Guidelines for Disk Diffusion Susceptibility Testing in New York State Laboratories

    Science.gov (United States)

    Kiehlbauch, Julia A.; Hannett, George E.; Salfinger, Max; Archinal, Wendy; Monserrat, Catherine; Carlyn, Cynthia

    2000-01-01

    Accurate antimicrobial susceptibility testing is vital for patient care and surveillance of emerging antimicrobial resistance. The National Committee for Clinical Laboratory Standards (NCCLS) outlines generally agreed upon guidelines for reliable and reproducible results. In January 1997 we surveyed 320 laboratories participating in the New York State Clinical Evaluation Program for General Bacteriology proficiency testing. Our survey addressed compliance with NCCLS susceptibility testing guidelines for bacterial species designated a problem (Staphylococcus aureus and Enterococcus species) or fastidious (Streptococcus pneumoniae, Haemophilus influenzae, and Neisseria gonorrhoeae) organism. Specifically, we assessed compliance with guidelines for inoculum preparation, medium choice, number of disks per plate, and incubation conditions for disk diffusion tests. We also included length of incubation for S. aureus and Enterococcus species. We found overall compliance with the five characteristics listed above in 80 of 153 responding laboratories (50.6%) for S. aureus and 72 of 151 (47.7%) laboratories for Enterococcus species. The most common problem was an incubation time shortened to less than 24 h. Overall compliance with the first four characteristics was reported by 92 of 221 (41.6%) laboratories for S. pneumoniae, 49 of 163 (30.1%) laboratories for H. influenzae, and 11 of 77 (14.3%) laboratories for N. gonorrhoeae. Laboratories varied from NCCLS guidelines by placing an excess number of disks per plate. Laboratories also reported using alternative media for Enterococcus species, N. gonorrhoeae, and H. influenzae. This study demonstrates a need for education among clinical laboratories to increase compliance with NCCLS guidelines. PMID:10970381

  20. The clinical utility of the Cornell Scale for Depression in Dementia as a routine assessment in nursing homes.

    Science.gov (United States)

    Jeon, Yun-Hee; Li, Zhicheng; Low, Lee-Fay; Chenoweth, Lynn; O'Connor, Daniel; Beattie, Elizabeth; Liu, Zhixin; Brodaty, Henry

    2015-08-01

    To examine the clinical utility of the Cornell Scale for Depression in Dementia (CSDD) in nursing homes. 14 nursing homes in Sydney and Brisbane, Australia. 92 residents with a mean age of 85 years. Consenting residents were assessed by care staff for depression using the CSDD as part of their routine assessment. Specialist clinicians conducted assessment of depression using the Semi-structured Clinical Diagnostic Interview for DSM-IV-TR Axis I Disorders for residents without dementia or the Provisional Diagnostic Criteria for Depression in Alzheimer Disease for residents with dementia to establish expert clinical diagnoses of depression. The diagnostic performance of the staff completed CSDD was analyzed against expert diagnosis using receiver operating characteristic (ROC) curves. The CSDD showed low diagnostic accuracy, with areas under the ROC curve being 0.69, 0.68 and 0.70 for the total sample, residents with dementia and residents without dementia, respectively. At the standard CSDD cutoff score, the sensitivity and specificity were 71% and 59% for the total sample, 69% and 57% for residents with dementia, and 75% and 61% for residents without dementia. The Youden index (for optimizing cut-points) suggested different depression cutoff scores for residents with and without dementia. When administered by nursing home staff the clinical utility of the CSDD is highly questionable in identifying depression. The complexity of the scale, the time required for collecting relevant information, and staff skills and knowledge of assessing depression in older people must be considered when using the CSDD in nursing homes. Copyright © 2015 American Association for Geriatric Psychiatry. Published by Elsevier Inc. All rights reserved.

  1. Imaging tests in staging and surveillance of non-metastatic breast cancer: changes in routine clinical practice and cost implications.

    Science.gov (United States)

    De Placido, S; De Angelis, C; Giuliano, M; Pizzi, C; Ruocco, R; Perrone, V; Bruzzese, D; Tommasielli, G; De Laurentiis, M; Cammarota, S; Arpino, G; Arpino, G

    2017-03-14

    Although guidelines do not recommend computerised tomography (CT), positron emission tomography (PET) or magnetic resonance imaging (MRI) for the staging or follow-up of asymptomatic patients with non-metastatic breast cancer, they are often requested in routine clinical practice. The aim of this study was to determine the staging and follow-up patterns, and relative costs in a large population of breast cancer patients living and treated in a Southern Italian region. We analysed the clinical computerised information recorded by 567 primary-care physicians assisting about 650 000 inhabitants in the Campania region. Patients with non-metastatic breast cancer were identified and divided into calendar years from 2001 to 2010. The number of diagnostic tests prescribed per 100 patients (N/Pts) and the mean cost per patient was determined 3 months before diagnosis and up to 1 year after diagnosis. Costs are expressed in constant 2011 euros. We identified 4680 newly diagnosed cases of asymptomatic non-metastatic breast cancer. N/Pts increased significantly (Ptests'), and costs was unchanged. However, the number of CT, PET scans and MRI ('new tests')prescriptions almost quadrupled and the mean cost per patient related to these procedures significantly increased from [euro ]357 in 2001 to [euro ]830 in 2010 (Ptest prescriptions and relative costs significantly and steadily increased throughout the study period. At present there is no evidence that the delivery of new tests to asymptomatic patients improves breast cancer outcome. Well-designed clinical trials are urgently needed to shed light on the impact of these tests on clinical outcome and overall survival.

  2. "Many miles to go …": a systematic review of the implementation of patient decision support interventions into routine clinical practice.

    Science.gov (United States)

    Elwyn, Glyn; Scholl, Isabelle; Tietbohl, Caroline; Mann, Mala; Edwards, Adrian G K; Clay, Catharine; Légaré, France; van der Weijden, Trudy; Lewis, Carmen L; Wexler, Richard M; Frosch, Dominick L

    2013-01-01

    Two decades of research has established the positive effect of using patient-targeted decision support interventions: patients gain knowledge, greater understanding of probabilities and increased confidence in decisions. Yet, despite their efficacy, the effectiveness of these decision support interventions in routine practice has yet to be established; widespread adoption has not occurred. The aim of this review was to search for and analyze the findings of published peer-reviewed studies that investigated the success levels of strategies or methods where attempts were made to implement patient-targeted decision support interventions into routine clinical settings. An electronic search strategy was devised and adapted for the following databases: ASSIA, CINAHL, Embase, HMIC, Medline, Medline-in-process, OpenSIGLE, PsycINFO, Scopus, Social Services Abstracts, and the Web of Science. In addition, we used snowballing techniques. Studies were included after dual independent assessment. After assessment, 5322 abstracts yielded 51 articles for consideration. After examining full-texts, 17 studies were included and subjected to data extraction. The approach used in all studies was one where clinicians and their staff used a referral model, asking eligible patients to use decision support. The results point to significant challenges to the implementation of patient decision support using this model, including indifference on the part of health care professionals. This indifference stemmed from a reported lack of confidence in the content of decision support interventions and concern about disruption to established workflows, ultimately contributing to organizational inertia regarding their adoption. It seems too early to make firm recommendations about how best to implement patient decision support into routine practice because approaches that use a 'referral model' consistently report difficulties. We sense that the underlying issues that militate against the use of

  3. [Evaluation of clinical laboratories--assurance of their quality and competence].

    Science.gov (United States)

    Kawai, Tadashi

    2007-01-01

    Since ISO 15189:2003 was published, the accreditation program of clinical laboratories based on ISO 15189 has been introduced in many countries, except for those in USA where all clinical laboratories must be required to follow the federal law, CLIA'88. It will certainly help the accredited clinical laboratories improve their quality and competence. In relation to the activity of JCTLM, reference measurement laboratories will be accredited, based on ISO 15195 which is now under its review and amendment by ISO/TC212/WG2. In Japan, JCCLS (Japanese Committee for Clinical Laboratory Standards) and JAB (Japan Accreditation Board for Conformity Assessment) cojointly started the accreditation program for clinical laboratories, based on ISO 15189:2003, and a total of 15 laboratories including university hospitals, community hospitals and independent clinical laboratories have been accredited up until the end of 2006.

  4. Usefulness of 3-Tesla cardiac magnetic resonance imaging in the assessment of aortic stenosis severity in routine clinical practice.

    Science.gov (United States)

    Levy, Franck; Iacuzio, Laura; Civaia, Filippo; Rusek, Stephane; Dommerc, Carine; Hugues, Nicolas; Alexandrescu, Clara; Dor, Vincent; Tribouilloy, Christophe; Dreyfus, Gilles

    2016-11-01

    Recently, 1.5-Tesla cardiac magnetic resonance imaging (CMR) was reported to provide a reliable alternative to transthoracic echocardiography (TTE) for the quantification of aortic stenosis (AS) severity. Few data are available using higher magnetic field strength MRI systems in this context. To evaluate the feasibility and reproducibility of the assessment of aortic valve area (AVA) using 3-Tesla CMR in routine clinical practice, and to assess concordance between TTE and CMR for the estimation of AS severity. Ninety-one consecutive patients (60 men; mean age 74±10years) with known AS documented by TTE were included prospectively in the study. All patients underwent comprehensive TTE and CMR examination, including AVA estimation using the TTE continuity equation (0.81±0.18cm 2 ), direct CMR planimetry (CMRp) (0.90±0.22cm 2 ) and CMR using Hakki's formula (CMRhk), a simplified Gorlin formula (0.70±0.19cm 2 ). Although significant agreement with TTE was found for CMRp (r=0.72) and CMRhk (r=0.66), CMRp slightly overestimated (bias=0.11±0.18cm 2 ) and CMRhk slightly underestimated (bias=-0.11±0.17cm 2 ) AVA compared with TTE. Inter- and intraobserver reproducibilities of CMR measurements were excellent (r=0.72 and r=0.74 for CMRp and r=0.88 and r=0.92 for peak aortic velocity, respectively). 3-Tesla CMR is a feasible, radiation-free, reproducible imaging modality for the estimation of severity of AS in routine practice, knowing that CMRp tends to overestimate AVA and CMRhk to underestimate AVA compared with TTE. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

  5. Prevalence of etravirine mutations and impact on response to treatment in routine clinical care: the Swiss HIV Cohort Study (SHCS).

    Science.gov (United States)

    Scherrer, A U; Hasse, B; von Wyl, V; Yerly, S; Böni, J; Bürgisser, P; Klimkait, T; Bucher, H C; Ledergerber, B; Günthard, H F

    2009-11-01

    Etravirine (ETV) is a novel nonnucleoside reverse transcriptase inhibitor (NNRTI) with reduced cross-resistance to first-generation NNRTIs, which has been primarily studied in randomized clinical trials and not in routine clinical settings. ETV resistance-associated mutations (RAMs) were investigated by analysing 6072 genotypic tests. The antiviral activity of ETV was predicted using different interpretation systems: International AIDS Society-USA (IAS-USA), Stanford, Rega and Agence Nationale de Recherches sur le Sida et les hépatites virales (ANRS). The prevalence of ETV RAMs was higher in NNRTI-exposed patients [44.9%, 95% confidence interval (CI) 41.0-48.9%] than in treatment-naïve patients (9.6%, 95% CI 8.5-10.7%). ETV RAMs in treatment-naïve patients mainly represent polymorphism, as prevalence estimates in genotypic tests for treatment-naïve patients with documented recent (IAS-USA mutations (L100I, K101E/H/P and Y181C/I/V) reduced the treatment response at week 24. Most ETV RAMs in drug-naïve patients are polymorphisms rather than transmitted RAMs. Uncertainty regarding predictions of antiviral activity for ETV in NNRTI-treated patients remains high. The lowest activity was predicted for patients harbouring extensive multidrug-resistant viruses, thus limiting ETV use in those who are most in need.

  6. Custom software development for use in a clinical laboratory.

    Science.gov (United States)

    Sinard, John H; Gershkovich, Peter

    2012-01-01

    In-house software development for use in a clinical laboratory is a controversial issue. Many of the objections raised are based on outdated software development practices, an exaggeration of the risks involved, and an underestimation of the benefits that can be realized. Buy versus build analyses typically do not consider total costs of ownership, and unfortunately decisions are often made by people who are not directly affected by the workflow obstacles or benefits that result from those decisions. We have been developing custom software for clinical use for over a decade, and this article presents our perspective on this practice. A complete analysis of the decision to develop or purchase must ultimately examine how the end result will mesh with the departmental workflow, and custom-developed solutions typically can have the greater positive impact on efficiency and productivity, substantially altering the decision balance sheet. Involving the end-users in preparation of the functional specifications is crucial to the success of the process. A large development team is not needed, and even a single programmer can develop significant solutions. Many of the risks associated with custom development can be mitigated by a well-structured development process, use of open-source tools, and embracing an agile development philosophy. In-house solutions have the significant advantage of being adaptable to changing departmental needs, contributing to efficient and higher quality patient care.

  7. Automated blood-sample handling in the clinical laboratory.

    Science.gov (United States)

    Godolphin, W; Bodtker, K; Uyeno, D; Goh, L O

    1990-09-01

    The only significant advances in blood-taking in 25 years have been the disposable needle and evacuated blood-drawing tube. With the exception of a few isolated barcode experiments, most sample-tracking is performed through handwritten or computer-printed labels. Attempts to reduce the hazards of centrifugation have resulted in air-tight lids or chambers, the use of which is time-consuming and cumbersome. Most commonly used clinical analyzers require serum or plasma, distributed into specialized containers, unique to that analyzer. Aliquots for different tests are prepared by handpouring or pipetting. Moderate to large clinical laboratories perform so many different tests that even multi-analyzers performing multiple analyses on a single sample may account for only a portion of all tests ordered for a patient. Thus several aliquots of each specimen are usually required. We have developed a proprietary serial centrifuge and blood-collection tube suitable for incorporation into an automated or robotic sample-handling system. The system we propose is (a) safe--avoids or prevents biological danger to the many "handlers" of blood; (b) small--minimizes the amount of sample taken and space required to adapt to the needs of satellite and mobile testing, and direct interfacing with analyzers; (c) serial--permits each sample to be treated according to its own "merits," optimizes throughput, and facilitates flexible automation; and (d) smart--ensures quality results through monitoring and intelligent control of patient identification, sample characteristics, and separation process.

  8. Evaluation of a commercial microarray as a confirmation test for the presence of extended-spectrum beta-lactamases in isolates from the routine clinical setting.

    NARCIS (Netherlands)

    Platteel, T.N.; Stuart, J.W.; Voets, G.M.; Scharringa, J.; Sande, N. van de; Fluit, A.C.; Leverstein-van Hall, M.A.; Sturm, P.D.J.; et al.,

    2011-01-01

    Since the diagnostic characteristics of the Check-KPC ESBL microarray as a confirmation test on isolates obtained in a routine clinical setting have not been determined, we evaluated the microarray in a random selection of 346 clinical isolates with a positive ESBL screen test (MIC >1 mg/L for

  9. PNH revisited: Clinical profile, laboratory diagnosis and follow-up

    Directory of Open Access Journals (Sweden)

    Gupta P

    2009-01-01

    Full Text Available Background: Paroxysmal nocturnal hemoglobinuria (PNH is characterized by intravascular hemolysis, marrow failure, nocturnal hemoglobinuria and thrombophila. This acquired disease caused by a deficiency of glycosylphosphatidylinositol (GPI anchored proteins on the hematopoietic cells is uncommon in the Indian population. Materials and Methods: Data of patients diagnosed with PNH in the past 1 year were collected. Clinical data (age, gender, various presenting symptoms, treatment information and follow-up data were collected from medical records. Results of relevant diagnostic tests were documented i.e., urine analysis, Ham′s test, sucrose lysis test and sephacryl gel card test (GCT for CD55 and CD59. Results: A total of 5 patients were diagnosed with PNH in the past 1 year. Presenting symptoms were hemolytic anemia (n=4 and bone marrow failure (n=1. A GCT detected CD59 deficiency in all erythrocytes in 4 patients and CD55 deficiency in 2 patients. A weak positive PNH test for CD59 was seen in 1 patient and a weak positive PNH test for CD55 was seen in 3 patients. All patients were negative by sucrose lysis test. Ham′s test was positive in two cases. Patients were treated with prednisolone and/or androgen and 1 patient with aplastic anemia was also given antithymocyte globulin. A total of 4 patients responded with a partial recovery of hematopoiesis and 1 patient showed no recovery. None of the patients received a bone marrow transplant. Conclusion: The study highlights the diagnostic methods and treatment protocols undertaken to evaluate the PNH clone in a developing country where advanced methods like flowcytometry immunophenotyping (FCMI and bone marrow transplants are not routinely available.

  10. Burning mouth syndrome: Evaluation of clinical and laboratory findings.

    Science.gov (United States)

    Halac, Gulistan; Tekturk, Pinar; Eroglu, Saliha; Cikrikcioglu, Mehmet Ali; Cimendur, Ozlem; Kilic, Elif; Asil, Talip

    2016-07-30

    Burning mouth syndrome is a chronic and persistent painful condition characterized by burning sensation in the oral mucosa. We investigated the etiological factors of patients presented with the history of burning in the mouth who admitted our outpatient clinics over the 8-years period and who had no underlying identifiable local factors. We also tried to determine their demographic and clinical characteristics. Our aim was to investigate the association between burning mouth and psychiatric disorders such as depression and anxiety, chronic diseases like diabetes mellitus (DM) and other laboratory studies in patients complaining of solely burning in the mouth. The study included patients with the history of burning in mouth who presented in our outpatient clinic between 2005 and 2012. They were evaluated by a neurologist, a psychiatrist, an internist, and a dentist. Complete blood counts, biochemical analysis and cranial magnetic resonance imaging (MRI) were performed for all patients. A total of 26 (22 (84%) females, 4 (15%) males; mean age 55.9 years) patients were enrolled in this study. Five (19.2%) of the patients had depression, 2 (7.7%) had anxiety disorder, 2 (7.7%) had diabetes mellitus, 8 (30%) had B12 vitamin deficiency, 3 (11.5%) had decreased ferritin levels in blood, and 1 (3.8%) had folic acid deficiency. Cranial MRI of all patients were normal. Nine patients (34.6%) had no etiological causes. A multidisciplinary approach in the management of burning mouth and establishment of common criteria for the diagnosis would provide insight into the underlying pathophysiological mechanism.

  11. Cell Line Controls for the Genotyping of a Spectrum of Human Single Nucleotide Polymorphisms in the Clinical Laboratory.

    Science.gov (United States)

    Kimbacher, Christine; Paar, Christian; Freystetter, Andrea; Berg, Joerg

    2018-05-01

    Genotyping for clinically important single nucleotide polymorphisms (SNPs) is performed by many clinical routine laboratories. To support testing, quality controls and reference materials are needed. Those may be derived from residual patient samples, left over samples of external quality assurance schemes, plasmid DNA or DNA from cell lines. DNAs from cell lines are commutable and available in large amounts. DNA from 38 cell lines were examined for suitability as controls in 11 SNP assays that are frequently used in a clinical routine laboratory: FV (1691G>A), FII (20210G>A), PAI-1 4G/5G polymorphism, MTHFR (677C>T, 1298A>C), HFE (H63D, S65C, C282Y), APOE (E2, E3, E4), LPH (-13910C>T), UGT1A1 (*28, *36, *37), TPMT (*2, *3A, *3B, *3C), VKORC1 (-1639G>A, 1173C>T), CYP2C9 (*2, *3, *5). Genotyping was performed by real-time PCR with melting curve analysis and confirmed by bi-directional sequencing. We find an almost complete spectrum of genotypic constellations within these 38 cell lines. About 12 cell lines appear sufficient as genotypic controls for the 11 SNP assays by covering almost all of the genotypes. However, hetero- and homozygous genotypes for FII and the alleles TPMT*2, UGT1A1*37 and CYP2C9*5 were not detected in any of the cell lines. DNA from most of the examined cell lines appear suitable as quality controls for these SNP assays in the laboratory routine, as to the implementation of those assays or to prepare samples for quality assurance schemes. Our study may serve as a pilot to further characterize these cell lines to arrive at the status of reference materials.

  12. SU-E-T-23: A Developing Australian Network for Datamining and Modelling Routine Radiotherapy Clinical Data and Radiomics Information for Rapid Learning and Clinical Decision Support

    Energy Technology Data Exchange (ETDEWEB)

    Thwaites, D [University of Sydney, Camperdown, Sydney (Australia); Holloway, L [Ingham Institute, Sydney, NSW (Australia); Bailey, M; Carolan, M; Miller, A [Illawarra Cancer Care Centre, Wollongong, NSW (Australia); Barakat, S; Field, M [University of Sydney, Sydney, NSW (Australia); Delaney, G; Vinod, S [Liverpool Hospital, Liverpool, NSW (Australia); Dekker, A [Maastro Clinic, Maastricht (Netherlands); Lustberg, T; Soest, J van; Walsh, S [MAASTRO Clinic, Maastricht (Netherlands)

    2015-06-15

    Purpose: Large amounts of routine radiotherapy (RT) data are available, which can potentially add clinical evidence to support better decisions. A developing collaborative Australian network, with a leading European partner, aims to validate, implement and extend European predictive models (PMs) for Australian practice and assess their impact on future patient decisions. Wider objectives include: developing multi-institutional rapid learning, using distributed learning approaches; and assessing and incorporating radiomics information into PMs. Methods: Two initial standalone pilots were conducted; one on NSCLC, the other on larynx, patient datasets in two different centres. Open-source rapid learning systems were installed, for data extraction and mining to collect relevant clinical parameters from the centres’ databases. The European DSSs were learned (“training cohort”) and validated against local data sets (“clinical cohort”). Further NSCLC studies are underway in three more centres to pilot a wider distributed learning network. Initial radiomics work is underway. Results: For the NSCLC pilot, 159/419 patient datasets were identified meeting the PM criteria, and hence eligible for inclusion in the curative clinical cohort (for the larynx pilot, 109/125). Some missing data were imputed using Bayesian methods. For both, the European PMs successfully predicted prognosis groups, but with some differences in practice reflected. For example, the PM-predicted good prognosis NSCLC group was differentiated from a combined medium/poor prognosis group (2YOS 69% vs. 27%, p<0.001). Stage was less discriminatory in identifying prognostic groups. In the good prognosis group two-year overall survival was 65% in curatively and 18% in palliatively treated patients. Conclusion: The technical infrastructure and basic European PMs support prognosis prediction for these Australian patient groups, showing promise for supporting future personalized treatment decisions

  13. SU-E-T-23: A Developing Australian Network for Datamining and Modelling Routine Radiotherapy Clinical Data and Radiomics Information for Rapid Learning and Clinical Decision Support

    International Nuclear Information System (INIS)

    Thwaites, D; Holloway, L; Bailey, M; Carolan, M; Miller, A; Barakat, S; Field, M; Delaney, G; Vinod, S; Dekker, A; Lustberg, T; Soest, J van; Walsh, S

    2015-01-01

    Purpose: Large amounts of routine radiotherapy (RT) data are available, which can potentially add clinical evidence to support better decisions. A developing collaborative Australian network, with a leading European partner, aims to validate, implement and extend European predictive models (PMs) for Australian practice and assess their impact on future patient decisions. Wider objectives include: developing multi-institutional rapid learning, using distributed learning approaches; and assessing and incorporating radiomics information into PMs. Methods: Two initial standalone pilots were conducted; one on NSCLC, the other on larynx, patient datasets in two different centres. Open-source rapid learning systems were installed, for data extraction and mining to collect relevant clinical parameters from the centres’ databases. The European DSSs were learned (“training cohort”) and validated against local data sets (“clinical cohort”). Further NSCLC studies are underway in three more centres to pilot a wider distributed learning network. Initial radiomics work is underway. Results: For the NSCLC pilot, 159/419 patient datasets were identified meeting the PM criteria, and hence eligible for inclusion in the curative clinical cohort (for the larynx pilot, 109/125). Some missing data were imputed using Bayesian methods. For both, the European PMs successfully predicted prognosis groups, but with some differences in practice reflected. For example, the PM-predicted good prognosis NSCLC group was differentiated from a combined medium/poor prognosis group (2YOS 69% vs. 27%, p<0.001). Stage was less discriminatory in identifying prognostic groups. In the good prognosis group two-year overall survival was 65% in curatively and 18% in palliatively treated patients. Conclusion: The technical infrastructure and basic European PMs support prognosis prediction for these Australian patient groups, showing promise for supporting future personalized treatment decisions

  14. Additive value of amyloid-PET in routine cases of clinical dementia work-up after FDG-PET

    International Nuclear Information System (INIS)

    Brendel, Matthias; Schnabel, Jonas; Wagner, Leonie; Brendel, Eva; Meyer-Wilmes, Johanna; Unterrainer, Marcus; Schoenecker, Sonja; Prix, Catharina; Ackl, Nibal; Schildan, Andreas; Patt, Marianne; Barthel, Henryk; Sabri, Osama; Catak, Cihan; Pogarell, Oliver; Levin, Johannes; Danek, Adrian; Buerger, Katharina; Bartenstein, Peter; Rominger, Axel

    2017-01-01

    In recent years, several [ 18 F]-labeled amyloid-PET tracers have been developed and have obtained clinical approval. Despite their widespread scientific use, studies in routine clinical settings are limited. We therefore investigated the impact of [ 18 F]-florbetaben (FBB)-PET on the diagnostic management of patients with suspected dementia that was still unclarified after [ 18 F]-fluordeoxyglucose (FDG)-PET. All subjects were referred in-house with a suspected dementia syndrome due to neurodegenerative disease. After undergoing an FDG-PET exam, the cases were discussed by the interdisciplinary dementia board, where the most likely diagnosis as well as potential differential diagnoses were documented. Because of persistent diagnostic uncertainty, the patients received an additional FBB-PET exam. Results were interpreted visually and classified as amyloid-positive or amyloid-negative, and we then compared the individual clinical diagnoses before and after additional FBB-PET. A total of 107 patients (mean age 69.4 ± 9.7y) were included in the study. The FBB-PET was rated as amyloid-positive in 65/107. In 83% of the formerly unclear cases, a final diagnosis was reached through FBB-PET, and the most likely prior diagnosis was changed in 28% of cases. The highest impact was observed for distinguishing Alzheimer's dementia (AD) from fronto-temporal dementia (FTLD), where FBB-PET altered the most likely diagnosis in 41% of cases. FBB-PET has a high additive value in establishing a final diagnosis in suspected dementia cases when prior investigations such as FDG-PET are inconclusive. The differentiation between AD and FTLD was particularly facilitated by amyloid-PET, predicting a considerable impact on patient management, especially in the light of upcoming disease-modifying therapies. (orig.)

  15. The effect of sibutramine prescribing in routine clinical practice on cardiovascular outcomes: a cohort study in the United Kingdom.

    Science.gov (United States)

    Hayes, J F; Bhaskaran, K; Batterham, R; Smeeth, L; Douglas, I

    2015-09-01

    The marketing authorization for the weight loss drug sibutramine was suspended in 2010 following a major trial that showed increased rates of non-fatal myocardial infarction and cerebrovascular events in patients with pre-existing cardiovascular disease. In routine clinical practice, sibutramine was already contraindicated in patients with cardiovascular disease and so the relevance of these influential clinical trial findings to the 'real World' population of patients receiving or eligible for the drug is questionable. We assessed rates of myocardial infarction and cerebrovascular events in a cohort of patients prescribed sibutramine or orlistat in the United Kingdom. A cohort of patients prescribed weight loss medication was identified within the Clinical Practice Research Datalink. Rates of myocardial infarction or cerebrovascular event, and all-cause mortality were compared between patients prescribed sibutramine and similar patients prescribed orlistat, using both a multivariable Cox proportional hazard model, and propensity score-adjusted model. Possible effect modification by pre-existing cardiovascular disease and cardiovascular risk factors was assessed. Patients prescribed sibutramine (N=23,927) appeared to have an elevated rate of myocardial infarction or cerebrovascular events compared with those taking orlistat (N=77,047; hazard ratio 1.69, 95% confidence interval 1.12-2.56). However, subgroup analysis showed the elevated rate was larger in those with pre-existing cardiovascular disease (hazard ratio 4.37, 95% confidence interval 2.21-8.64), compared with those with no cardiovascular disease (hazard ratio 1.52, 95% confidence interval 0.92-2.48, P-interaction=0.0076). All-cause mortality was not increased in those prescribed sibutramine (hazard ratio 0.67, 95% confidence interval 0.34-1.32). Sibutramine was associated with increased rates of acute cardiovascular events in people with pre-existing cardiovascular disease, but there was a low absolute

  16. Additive value of amyloid-PET in routine cases of clinical dementia work-up after FDG-PET

    Energy Technology Data Exchange (ETDEWEB)

    Brendel, Matthias; Schnabel, Jonas; Wagner, Leonie; Brendel, Eva; Meyer-Wilmes, Johanna; Unterrainer, Marcus [University Hospital, LMU Munich, Department of Nuclear Medicine, Munich (Germany); Schoenecker, Sonja; Prix, Catharina; Ackl, Nibal [University Hospital, LMU Munich, Department of Neurology, Munich (Germany); Schildan, Andreas; Patt, Marianne; Barthel, Henryk; Sabri, Osama [University of Leipzig, Department of Nuclear Medicine, Leipzig (Germany); Catak, Cihan [Klinikum der Universitaet Muenchen, Institute for Stroke and Dementia Research, Munich (Germany); Pogarell, Oliver [University Hospital, LMU Munich, Department of Psychiatry, Munich (Germany); Levin, Johannes; Danek, Adrian [University Hospital, LMU Munich, Department of Neurology, Munich (Germany); DZNE - German Center for Neurodegenerative Diseases, Munich (Germany); Buerger, Katharina [Klinikum der Universitaet Muenchen, Institute for Stroke and Dementia Research, Munich (Germany); DZNE - German Center for Neurodegenerative Diseases, Munich (Germany); Bartenstein, Peter; Rominger, Axel [University Hospital, LMU Munich, Department of Nuclear Medicine, Munich (Germany); Munich Cluster for Systems Neurology (SyNergy), Munich (Germany)

    2017-12-15

    In recent years, several [{sup 18}F]-labeled amyloid-PET tracers have been developed and have obtained clinical approval. Despite their widespread scientific use, studies in routine clinical settings are limited. We therefore investigated the impact of [{sup 18}F]-florbetaben (FBB)-PET on the diagnostic management of patients with suspected dementia that was still unclarified after [{sup 18}F]-fluordeoxyglucose (FDG)-PET. All subjects were referred in-house with a suspected dementia syndrome due to neurodegenerative disease. After undergoing an FDG-PET exam, the cases were discussed by the interdisciplinary dementia board, where the most likely diagnosis as well as potential differential diagnoses were documented. Because of persistent diagnostic uncertainty, the patients received an additional FBB-PET exam. Results were interpreted visually and classified as amyloid-positive or amyloid-negative, and we then compared the individual clinical diagnoses before and after additional FBB-PET. A total of 107 patients (mean age 69.4 ± 9.7y) were included in the study. The FBB-PET was rated as amyloid-positive in 65/107. In 83% of the formerly unclear cases, a final diagnosis was reached through FBB-PET, and the most likely prior diagnosis was changed in 28% of cases. The highest impact was observed for distinguishing Alzheimer's dementia (AD) from fronto-temporal dementia (FTLD), where FBB-PET altered the most likely diagnosis in 41% of cases. FBB-PET has a high additive value in establishing a final diagnosis in suspected dementia cases when prior investigations such as FDG-PET are inconclusive. The differentiation between AD and FTLD was particularly facilitated by amyloid-PET, predicting a considerable impact on patient management, especially in the light of upcoming disease-modifying therapies. (orig.)

  17. Improved Pancreatic Adenocarcinoma Diagnosis in Jaundiced and Non-Jaundiced Pancreatic Adenocarcinoma Patients through the Combination of Routine Clinical Markers Associated to Pancreatic Adenocarcinoma Pathophysiology.

    Science.gov (United States)

    Ferri, María José; Saez, Marc; Figueras, Joan; Fort, Esther; Sabat, Miriam; López-Ben, Santiago; de Llorens, Rafael; Aleixandre, Rosa Núria; Peracaula, Rosa

    2016-01-01

    There is still no reliable biomarker for the diagnosis of pancreatic adenocarcinoma. Carbohydrate antigen 19-9 (CA 19-9) is a tumor marker only recommended for pancreatic adenocarcinoma follow-up. One of the clinical problems lies in distinguishing between this cancer and other benign pancreatic diseases such as chronic pancreatitis. In this study we will assess the value of panels of serum molecules related to pancreatic cancer physiopathology to determine whether alone or in combination could help to discriminate between these two pathologies. CA 19-9, carcinoembryonic antigen (CEA), C-reactive protein, albumin, insulin growth factor-1 (IGF-1) and IGF binding protein-3 were measured using routine clinical analyzers in a cohort of 47 pancreatic adenocarcinoma, 20 chronic pancreatitis and 15 healthy controls. The combination of CA 19-9, IGF-1 and albumin resulted in a combined area under the curve (AUC) of 0.959 with 93.6% sensitivity and 95% specificity, much higher than CA 19-9 alone. An algorithm was defined to classify the patients as chronic pancreatitis or pancreatic cancer with the above specificity and sensitivity. In an independent validation group of 20 pancreatic adenocarcinoma and 13 chronic pancreatitis patients, the combination of the four molecules classified correctly all pancreatic adenocarcinoma and 12 out of 13 chronic pancreatitis patients. Although this panel of markers should be validated in larger cohorts, the high sensitivity and specificity values and the convenience to measure these parameters in clinical laboratories shows great promise for improving pancreatic adenocarcinoma diagnosis.

  18. Improved Pancreatic Adenocarcinoma Diagnosis in Jaundiced and Non-Jaundiced Pancreatic Adenocarcinoma Patients through the Combination of Routine Clinical Markers Associated to Pancreatic Adenocarcinoma Pathophysiology.

    Directory of Open Access Journals (Sweden)

    María José Ferri

    Full Text Available There is still no reliable biomarker for the diagnosis of pancreatic adenocarcinoma. Carbohydrate antigen 19-9 (CA 19-9 is a tumor marker only recommended for pancreatic adenocarcinoma follow-up. One of the clinical problems lies in distinguishing between this cancer and other benign pancreatic diseases such as chronic pancreatitis. In this study we will assess the value of panels of serum molecules related to pancreatic cancer physiopathology to determine whether alone or in combination could help to discriminate between these two pathologies.CA 19-9, carcinoembryonic antigen (CEA, C-reactive protein, albumin, insulin growth factor-1 (IGF-1 and IGF binding protein-3 were measured using routine clinical analyzers in a cohort of 47 pancreatic adenocarcinoma, 20 chronic pancreatitis and 15 healthy controls.The combination of CA 19-9, IGF-1 and albumin resulted in a combined area under the curve (AUC of 0.959 with 93.6% sensitivity and 95% specificity, much higher than CA 19-9 alone. An algorithm was defined to classify the patients as chronic pancreatitis or pancreatic cancer with the above specificity and sensitivity. In an independent validation group of 20 pancreatic adenocarcinoma and 13 chronic pancreatitis patients, the combination of the four molecules classified correctly all pancreatic adenocarcinoma and 12 out of 13 chronic pancreatitis patients.Although this panel of markers should be validated in larger cohorts, the high sensitivity and specificity values and the convenience to measure these parameters in clinical laboratories shows great promise for improving pancreatic adenocarcinoma diagnosis.

  19. [Clinical governance and patient safety culture in clinical laboratories in the Spanish National Health System].

    Science.gov (United States)

    Giménez-Marín, Á; Rivas-Ruiz, F

    To conduct a situational analysis of patient safety culture in public laboratories in the Spanish National Health System and to determine the clinical governance variables that most strongly influence patient safety. A descriptive cross-sectional study was carried out, in which a Survey of Patient Safety in Clinical Laboratories was addressed to workers in 26 participating laboratories. In this survey, which consisted of 45 items grouped into 6 areas, scores were assigned on a scale from 0 to 100 (where 0 is the lowest perception of patient safety). Laboratory managers were asked specific questions about quality management systems and technology. The mean scores for the 26 participating hospitals were evaluated, and the following results observed: in 4of the 6areas, the mean score was higher than 70 points. In the third area (equipment and resources) and the fourth area (working conditions), the scores were lower than 60 points. Every hospital had a digital medical record system. This 100% level of provision was followed by that of an electronic request management system, which was implemented in 82.6% of the hospitals. The results obtained show that the culture of security is homogeneous and of high quality in health service laboratories, probably due to the steady improvement observed. However, in terms of clinical governance, there is still some way to go, as shown by the presence of weaknesses in crucial dimensions of safety culture, together with variable levels of implementation of fail-safe technologies and quality management systems. Copyright © 2017 SECA. Publicado por Elsevier España, S.L.U. All rights reserved.

  20. [Laboratory medicine in the obligatory postgraduate clinical training system--common clinical training program in the department of laboratory medicine in our prefectural medical university hospital].

    Science.gov (United States)

    Okamoto, Yasuyuki

    2003-04-01

    I propose a postgraduate common clinical training program to be provided by the department of laboratory medicine in our prefectural medical university hospital. The program has three purposes: first, mastering basic laboratory tests; second, developing the skills necessary to accurately interpret laboratory data; third, learning specific techniques in the field of laboratory medicine. For the first purpose, it is important that medical trainees perform testing of their own patients at bedside or in the central clinical laboratory. When testing at the central clinical laboratory, instruction by expert laboratory technicians is helpful. The teaching doctors in the department of laboratory medicine are asked to advise the trainees on the interpretation of data. Consultation will be received via interview or e-mail. In addition, the trainees can participate in various conferences, seminars, and meetings held at the central clinical laboratory. Finally, in order to learn specific techniques in the field of laboratory medicine, several special courses lasting a few months will be prepared. I think this program should be closely linked to the training program in internal medicine.

  1. Clinical and laboratory criteria for type 2 diabetes mellitus in children

    Directory of Open Access Journals (Sweden)

    T.V. Sorokman

    2018-02-01

    Full Text Available The purpose of this review was the analysis of literature data on clinical and laboratory criteria for type 2 diabetes mellitus in children. A review of scientific literature was conducted using Pubmed as the search engine by the keywords: diabetes mellitus, type 2 diabetes mellitus, clinical picture, laboratory criteria, risk factors, taking into consideration studies conducted in the last 10 years, citation review of relevant primary and review articles, conference abstracts, personal files, and contact with expert informants. The criterion for the selection of articles for the study was based on their close relevance to the topic, thus, out of 213 analyzed articles, the findings of the researchers covered in 21 articles were crucial. Type 2 mellitus is a multifactorial di­sease with hereditary predisposition. The majority of patients with type 2 diabetes mellitus indicate the presence of such a disease in the immediate family; in the presence of type 2 diabetes in one of the parents, the risk of its development during the life of the descendant is 40 %. In most cases, severe clinical manifestations are absent, and the diagnosis is established at a routine determination of glycemia level. The disease usually starts at the age of 10 years, with the overwhelming majority of patients having obesity and other components of the metabolic syndrome. Criteria for the diagnosis of type 2 diabetes are proposed by the International Society for Pediatric and Adolescent Diabetes. With a purpose of differential diagnosis of type 1 and type 2 diabetes in the onset of the disease, the level of insulin and C-peptide in the blood is determined both fasting, and during an oral glucose tolerance test.

  2. 42 CFR 493.1453 - Condition: Laboratories performing high complexity testing; clinical consultant.

    Science.gov (United States)

    2010-10-01

    ... Condition: Laboratories performing high complexity testing; clinical consultant. The laboratory must have a... 42 Public Health 5 2010-10-01 2010-10-01 false Condition: Laboratories performing high complexity testing; clinical consultant. 493.1453 Section 493.1453 Public Health CENTERS FOR MEDICARE & MEDICAID...

  3. 42 CFR 493.1415 - Condition: Laboratories performing moderate complexity testing; clinical consultant.

    Science.gov (United States)

    2010-10-01

    ... § 493.1415 Condition: Laboratories performing moderate complexity testing; clinical consultant. The laboratory must have a clinical consultant who meets the qualification requirements of § 493.1417 of this... 42 Public Health 5 2010-10-01 2010-10-01 false Condition: Laboratories performing moderate...

  4. Quantitative echocardiographic measures in the assessment of single ventricle function post-Fontan: Incorporation into routine clinical practice.

    Science.gov (United States)

    Rios, Rodrigo; Ginde, Salil; Saudek, David; Loomba, Rohit S; Stelter, Jessica; Frommelt, Peter

    2017-01-01

    Quantitative echocardiographic measurements of single ventricular (SV) function have not been incorporated into routine clinical practice. A clinical protocol, which included quantitative measurements of SV deformation (global circumferential and longitudinal strain and strain rate), standard deviation of time to peak systolic strain, myocardial performance index (MPI), dP/dT from an atrioventricular valve regurgitant jet, and superior mesenteric artery resistance index, was instituted for all patients with a history of Fontan procedure undergoing echocardiography. All measures were performed real time during clinically indicated studies and were included in clinical reports. A total of 100 consecutive patients (mean age = 11.95±6.8 years, range 17 months-31.3 years) completed the protocol between September 1, 2014 to April 29, 2015. Deformation measures were completed in 100% of the studies, MPI in 93%, dP/dT in 55%, and superior mesenteric artery Doppler in 82%. The studies were reviewed to assess for efficiency in completing the protocol. The average time for image acquisition was 27.4±8.8 (range 10-62 minutes). The average time to perform deformation measures was 10.8±5.5 minutes (range 5-35 minutes) and time from beginning of imaging to report completion was 53.4±13.7 minutes (range 27-107 minutes). There was excellent inter-observer reliability when deformation indices were blindly repeated. Patients with a single left ventricle had significantly higher circumferential strain and strain rate, longitudinal strain and strain rate, and dP/dT compared to a single right ventricle. There were no differences in quantitative indices of ventricular function between patients 10 years post-Fontan. Advanced quantitative assessment of SV function post-Fontan can be consistently and efficiently performed real time during clinically indicated echocardiograms with excellent reliability. © 2016, Wiley Periodicals, Inc.

  5. Glycogen storage disease type I: clinical and laboratory profile

    Directory of Open Access Journals (Sweden)

    Berenice L. Santos

    2014-11-01

    Full Text Available Objectives: To characterize the clinical, laboratory, and anthropometric profile of a sample of Brazilian patients with glycogen storage disease type I managed at an outpatient referral clinic for inborn errors of metabolism. Methods: This was a cross-sectional outpatient study based on a convenience sampling strategy. Data on diagnosis, management, anthropometric parameters, and follow-up were assessed. Results: Twenty-one patients were included (median age 10 years, range 1–25 years, all using uncooked cornstarch therapy. Median age at diagnosis was 7 months (range, 1–132 months, and 19 patients underwent liver biopsy for diagnostic confirmation. Overweight, short stature, hepatomegaly, and liver nodules were present in 16 of 21, four of 21, nine of 14, and three of 14 patients, respectively. A correlation was found between height-for-age and BMI-for-age Z-scores (r = 0.561; p = 0.008. Conclusions: Diagnosis of glycogen storage disease type I is delayed in Brazil. Most patients undergo liver biopsy for diagnostic confirmation, even though the combination of a characteristic clinical presentation and molecular methods can provide a definitive diagnosis in a less invasive manner. Obesity is a side effect of cornstarch therapy, and appears to be associated with growth in these patients. Resumo: Objetivos: Caracterizar o perfil clínico, laboratorial e antropométrico de uma amostra de pacientes brasileiros com doença de depósito de glicogênio tipo I tratados em um ambulatório de referência para erros inatos do metabolismo. Métodos: Este foi um estudo ambulatorial transversal com base em uma estratégia de amostragem de conveniência. Foram avaliados os dados com relação ao diagnóstico, tratamento, parâmetros antropométricos e acompanhamento. Resultados: Foram incluídos 21 pacientes (idade média de 10 anos, faixa 1-25 anos de idade, e todos se encontravam em terapia de amido de milho cru. A idade média na época do diagn

  6. Pre-analytical issues in the haemostasis laboratory: guidance for the clinical laboratories.

    Science.gov (United States)

    Magnette, A; Chatelain, M; Chatelain, B; Ten Cate, H; Mullier, F

    2016-01-01

    Ensuring quality has become a daily requirement in laboratories. In haemostasis, even more than in other disciplines of biology, quality is determined by a pre-analytical step that encompasses all procedures, starting with the formulation of the medical question, and includes patient preparation, sample collection, handling, transportation, processing, and storage until time of analysis. This step, based on a variety of manual activities, is the most vulnerable part of the total testing process and is a major component of the reliability and validity of results in haemostasis and constitutes the most important source of erroneous or un-interpretable results. Pre-analytical errors may occur throughout the testing process and arise from unsuitable, inappropriate or wrongly handled procedures. Problems may arise during the collection of blood specimens such as misidentification of the sample, use of inadequate devices or needles, incorrect order of draw, prolonged tourniquet placing, unsuccessful attempts to locate the vein, incorrect use of additive tubes, collection of unsuitable samples for quality or quantity, inappropriate mixing of a sample, etc. Some factors can alter the result of a sample constituent after collection during transportation, preparation and storage. Laboratory errors can often have serious adverse consequences. Lack of standardized procedures for sample collection accounts for most of the errors encountered within the total testing process. They can also have clinical consequences as well as a significant impact on patient care, especially those related to specialized tests as these are often considered as "diagnostic". Controlling pre-analytical variables is critical since this has a direct influence on the quality of results and on their clinical reliability. The accurate standardization of the pre-analytical phase is of pivotal importance for achieving reliable results of coagulation tests and should reduce the side effects of the influence

  7. Promoting Early Presentation of Breast Cancer in Older Women: Implementing an Evidence-Based Intervention in Routine Clinical Practice

    International Nuclear Information System (INIS)

    Forbes, L. J. L.; Forster, A. S.; Dodd, R. H.; Tucker, L.; Laming, R.; Ramirez, A. J.; Sellars, S.; Patnick, J.

    2012-01-01

    Women over 70 with breast cancer have poorer one-year survival and present at a more advanced stage than younger women. Promoting early symptomatic presentation in older women may reduce stage cost effectively and is unlikely to lead to overdiagnosis. After examining efficacy in a randomised controlled trial, we piloted a brief health professional-delivered intervention to equip women to present promptly with breast symptoms, as an integral part of the final invited mammogram at age ∼70, in the English National Health Service Breast Screening Programme. Methods. We trained mammographers, who then offered the intervention to older women in four breast screening services. We examined breast cancer awareness at baseline and one month in women receiving the intervention, and also in a service where the intervention was not offered. Results. We trained 27 mammographers to deliver the intervention confidently to a high standard. Breast cancer awareness increased 7-fold at one month in women receiving the intervention compared with 2-fold in the comparison service (odds ratio 15.2, 95% confidence interval 10.0 to 23.2). Conclusions. The PEP Intervention can be implemented in routine clinical practice with a potency similar to that achieved in a randomised controlled trial. It has the potential to reduce delay in diagnosis for breast cancer in older women.

  8. Promoting Early Presentation of Breast Cancer in Older Women: Implementing an Evidence-Based Intervention in Routine Clinical Practice

    Science.gov (United States)

    Forbes, Lindsay J. L.; Forster, Alice S.; Dodd, Rachael H.; Tucker, Lorraine; Laming, Rachel; Sellars, Sarah; Patnick, Julietta; Ramirez, Amanda J.

    2012-01-01

    Background. Women over 70 with breast cancer have poorer one-year survival and present at a more advanced stage than younger women. Promoting early symptomatic presentation in older women may reduce stage cost effectively and is unlikely to lead to overdiagnosis. After examining efficacy in a randomised controlled trial, we piloted a brief health professional-delivered intervention to equip women to present promptly with breast symptoms, as an integral part of the final invited mammogram at age ~70, in the English National Health Service Breast Screening Programme. Methods. We trained mammographers, who then offered the intervention to older women in four breast screening services. We examined breast cancer awareness at baseline and one month in women receiving the intervention, and also in a service where the intervention was not offered. Results. We trained 27 mammographers to deliver the intervention confidently to a high standard. Breast cancer awareness increased 7-fold at one month in women receiving the intervention compared with 2-fold in the comparison service (odds ratio 15.2, 95% confidence interval 10.0 to 23.2). Conclusions. The PEP Intervention can be implemented in routine clinical practice with a potency similar to that achieved in a randomised controlled trial. It has the potential to reduce delay in diagnosis for breast cancer in older women. PMID:23213334

  9. Externally Acquired Radiological Data for the Clinical Routine - A Review of the Reimbursement Situation in Germany.

    Science.gov (United States)

    Schreyer, Andreas G; Steinhäuser, René T; Rosenberg, Britta

    2018-02-07

     Interdisciplinary radiological conferences and boards can improve therapeutic pathways. Because of the reinterpretation and presentation of external image data, which already was read, an additional workload is created which is currently not considered by health care providers. In this review we discuss the ongoing basics and possibilities in health economy for a radiological second opinion for the outpatient and inpatient sector in Germany.  Based on up-to-date literature and jurisdiction, we discuss the most important questions for the reimbursement for second opinions and conference presentations of external image data in an FAQ format. Additionally, we focus on the recently introduced E-Health law accordingly.  Radiological services considering second opinion or board presentation of externally acquired image data are currently not adequately covered by health care providers. In particular, there is no reimbursement possibility for the inpatient sector. Only patients with private insurance or privately paid second opinions can be charged when these patients visit the radiologist directly.  Currently there is no adequate reimbursement possibility for a radiological second opinion or image demonstrations in clinical conferences. It will be essential to integrate adequate reimbursement by health care providers in the near future because of the importance of radiology as an essential diagnostic and therapeutic medical partner.   · Currently there is no reimbursement for image interpretation and presentation in boards.. · Second opinions can only be reimbursed for patients with private insurance or privately recompensed.. · The E-Health law allows reimbursement for tele-counsel in very complex situations.. · It will be crucial to integrate radiological second opinion in future reimbursement policies by health care providers.. · Schreyer AG, Steinhäuser RT, Rosenberg B. Externally Acquired Radiological Data for the Clinical Routine - A Review of

  10. A new model using routinely available clinical parameters to predict significant liver fibrosis in chronic hepatitis B.

    Directory of Open Access Journals (Sweden)

    Wai-Kay Seto

    Full Text Available OBJECTIVE: We developed a predictive model for significant fibrosis in chronic hepatitis B (CHB based on routinely available clinical parameters. METHODS: 237 treatment-naïve CHB patients [58.4% hepatitis B e antigen (HBeAg-positive] who had undergone liver biopsy were randomly divided into two cohorts: training group (n = 108 and validation group (n = 129. Liver histology was assessed for fibrosis. All common demographics, viral serology, viral load and liver biochemistry were analyzed. RESULTS: Based on 12 available clinical parameters (age, sex, HBeAg status, HBV DNA, platelet, albumin, bilirubin, ALT, AST, ALP, GGT and AFP, a model to predict significant liver fibrosis (Ishak fibrosis score ≥3 was derived using the five best parameters (age, ALP, AST, AFP and platelet. Using the formula log(index+1 = 0.025+0.0031(age+0.1483 log(ALP+0.004 log(AST+0.0908 log(AFP+1-0.028 log(platelet, the PAPAS (Platelet/Age/Phosphatase/AFP/AST index predicts significant fibrosis with an area under the receiving operating characteristics (AUROC curve of 0.776 [0.797 for patients with ALT <2×upper limit of normal (ULN] The negative predictive value to exclude significant fibrosis was 88.4%. This predictive power is superior to other non-invasive models using common parameters, including the AST/platelet/GGT/AFP (APGA index, AST/platelet ratio index (APRI, and the FIB-4 index (AUROC of 0.757, 0.708 and 0.723 respectively. Using the PAPAS index, 67.5% of liver biopsies for patients being considered for treatment with ALT <2×ULN could be avoided. CONCLUSION: The PAPAS index can predict and exclude significant fibrosis, and may reduce the need for liver biopsy in CHB patients.

  11. Clinical and Laboratory Findings in Patients with Tramadol Intoxication Referred to Razi Hospital During 2005-06

    Directory of Open Access Journals (Sweden)

    Morteza Rahbar Taromsari

    2012-03-01

    Full Text Available Introduction: Frequency of Tramadol intoxication is increasing as a result of its useas a drug for suppression of withdrawal symptoms by opioids abusers and its wideaccessibility of this drug. Tramadol intoxication can lead to death and, therefore, earlyidentification of its clinical manifestations is crucial since early detection of theintoxication and its treatment could improve patients' survival This study investigatedthe frequency of clinical and laboratory findings in Tramadol intoxication.Methods: In this cross-sectional study, patients with Tramadol intoxication whoreferred to Razi Hospital in Rasht, Iran, during 2005-06 were examined. Theirmedical records were surveyed for demographic data, past medical history,neurological examination, and routine laboratory tests. All data were statisticallyanalyzed by SPSS software version 14.Result: The majority of the 306 patients (83.3% male were in the age range of 20-40 years and 68.6% of them had been educated up to high school. The mean dose ofingested Tramadol was 746± 453mg (mean± SD. Agitation (25.2% and seizure(20.3% were the most frequent reported symptoms. Among laboratory abnormalities,the most common findings were prolonged PT (18.3% and increased ALT (5.6%.Conclusion: The most common clinical presentation was agitation and the mostcommon laboratory finding was prolonged PT. Of all the patients, 3 cases wereadmitted to ICU. Although Tramadol poisoning might lead to death, there was onlyone death after Tramadol poisoning in the current study.

  12. [Quality Management and Quality Specifications of Laboratory Tests in Clinical Studies--Challenges in Pre-Analytical Processes in Clinical Laboratories].

    Science.gov (United States)

    Ishibashi, Midori

    2015-01-01

    The cost, speed, and quality are the three important factors recently indicated by the Ministry of Health, Labour and Welfare (MHLW) for the purpose of accelerating clinical studies. Based on this background, the importance of laboratory tests is increasing, especially in the evaluation of clinical study participants' entry and safety, and drug efficacy. To assure the quality of laboratory tests, providing high-quality laboratory tests is mandatory. For providing adequate quality assurance in laboratory tests, quality control in the three fields of pre-analytical, analytical, and post-analytical processes is extremely important. There are, however, no detailed written requirements concerning specimen collection, handling, preparation, storage, and shipping. Most laboratory tests for clinical studies are performed onsite in a local laboratory; however, a part of laboratory tests is done in offsite central laboratories after specimen shipping. As factors affecting laboratory tests, individual and inter-individual variations are well-known. Besides these factors, standardizing the factors of specimen collection, handling, preparation, storage, and shipping, may improve and maintain the high quality of clinical studies in general. Furthermore, the analytical method, units, and reference interval are also important factors. It is concluded that, to overcome the problems derived from pre-analytical processes, it is necessary to standardize specimen handling in a broad sense.

  13. Comparison of Leishmania typing results obtained from 16 European clinical laboratories in 2014.

    Science.gov (United States)

    Van der Auwera, Gert; Bart, Aldert; Chicharro, Carmen; Cortes, Sofia; Davidsson, Leigh; Di Muccio, Trentina; Dujardin, Jean-Claude; Felger, Ingrid; Paglia, Maria Grazia; Grimm, Felix; Harms, Gundel; Jaffe, Charles L; Manser, Monika; Ravel, Christophe; Robert-Gangneux, Florence; Roelfsema, Jeroen; Töz, Seray; Verweij, Jaco J; Chiodini, Peter L

    2016-12-08

    Leishmaniasis is endemic in southern Europe, and in other European countries cases are diagnosed in travellers who have visited affected areas both within the continent and beyond. Prompt and accurate diagnosis poses a challenge in clinical practice in Europe. Different methods exist for identification of the infecting Leishmania species. Sixteen clinical laboratories in 10 European countries, plus Israel and Turkey, conducted a study to assess their genotyping performance. DNA from 21 promastigote cultures of 13 species was analysed blindly by the routinely used typing method. Five different molecular targets were used, which were analysed with PCR-based methods. Different levels of identification were achieved, and either the Leishmania subgenus, species complex, or actual species were reported. The overall error rate of strains placed in the wrong complex or species was 8.5%. Various reasons for incorrect typing were identified. The study shows there is considerable room for improvement and standardisation of Leishmania typing. The use of well validated standard operating procedures is recommended, covering testing, interpretation, and reporting guidelines. Application of the internal transcribed spacer 1 of the rDNA array should be restricted to Old World samples, while the heat-shock protein 70 gene and the mini-exon can be applied globally. This article is copyright of The Authors, 2016.

  14. Elevated Plasma Soluble CD14 and Skewed CD16+ Monocyte Distribution Persist despite Normalisation of Soluble CD163 and CXCL10 by Effective HIV Therapy: A Changing Paradigm for Routine HIV Laboratory Monitoring?

    Science.gov (United States)

    Castley, Alison; Berry, Cassandra; French, Martyn; Fernandez, Sonia; Krueger, Romano; Nolan, David

    2014-01-01

    Objective We investigated plasma and flow cytometric biomarkers of monocyte status that have been associated with prognostic utility in HIV infection and other chronic inflammatory diseases, comparing 81 HIV+ individuals with a range of treatment outcomes to a group of 21 healthy control blood donors. Our aim is to develop and optimise monocyte assays that combine biological relevance, clinical utility, and ease of adoption into routine HIV laboratory practice. Design Cross-sectional evaluation of concurrent plasma and whole blood samples. Methods A flow cytometry protocol was developed comprising single-tube CD45, CD14, CD16, CD64, CD163, CD143 analysis with appropriately matched isotype controls. Plasma levels of soluble CD14 (sCD14), soluble CD163 (sCD163) and CXCL10 were measured by ELISA. Results HIV status was associated with significantly increased expression of CD64, CD143 and CD163 on CD16+ monocytes, irrespective of the virological response to HIV therapy. Plasma levels of sCD14, sCD163 and CXCL10 were also significantly elevated in association with viremic HIV infection. Plasma sCD163 and CXCL10 levels were restored to healthy control levels by effective antiretroviral therapy while sCD14 levels remained elevated despite virological suppression (p<0.001). Conclusions Flow cytometric and plasma biomarkers of monocyte activation indicate an ongoing systemic inflammatory response to HIV infection, characterised by persistent alterations of CD16+ monocyte expression profiles and elevated sCD14 levels, that are not corrected by antiretroviral therapy and likely to be prognostically significant. In contrast, sCD163 and CXCL10 levels declined on antiretroviral therapy, suggesting multiple activation pathways revealed by these biomarkers. Incorporation of these assays into routine clinical care is feasible and warrants further consideration, particularly in light of emerging therapeutic strategies that specifically target innate immune activation in HIV

  15. Elevated plasma soluble CD14 and skewed CD16+ monocyte distribution persist despite normalisation of soluble CD163 and CXCL10 by effective HIV therapy: a changing paradigm for routine HIV laboratory monitoring?

    Directory of Open Access Journals (Sweden)

    Alison Castley

    Full Text Available OBJECTIVE: We investigated plasma and flow cytometric biomarkers of monocyte status that have been associated with prognostic utility in HIV infection and other chronic inflammatory diseases, comparing 81 HIV+ individuals with a range of treatment outcomes to a group of 21 healthy control blood donors. Our aim is to develop and optimise monocyte assays that combine biological relevance, clinical utility, and ease of adoption into routine HIV laboratory practice. DESIGN: Cross-sectional evaluation of concurrent plasma and whole blood samples. METHODS: A flow cytometry protocol was developed comprising single-tube CD45, CD14, CD16, CD64, CD163, CD143 analysis with appropriately matched isotype controls. Plasma levels of soluble CD14 (sCD14, soluble CD163 (sCD163 and CXCL10 were measured by ELISA. RESULTS: HIV status was associated with significantly increased expression of CD64, CD143 and CD163 on CD16+ monocytes, irrespective of the virological response to HIV therapy. Plasma levels of sCD14, sCD163 and CXCL10 were also significantly elevated in association with viremic HIV infection. Plasma sCD163 and CXCL10 levels were restored to healthy control levels by effective antiretroviral therapy while sCD14 levels remained elevated despite virological suppression (p<0.001. CONCLUSIONS: Flow cytometric and plasma biomarkers of monocyte activation indicate an ongoing systemic inflammatory response to HIV infection, characterised by persistent alterations of CD16+ monocyte expression profiles and elevated sCD14 levels, that are not corrected by antiretroviral therapy and likely to be prognostically significant. In contrast, sCD163 and CXCL10 levels declined on antiretroviral therapy, suggesting multiple activation pathways revealed by these biomarkers. Incorporation of these assays into routine clinical care is feasible and warrants further consideration, particularly in light of emerging therapeutic strategies that specifically target innate immune

  16. Influence of centrifugation conditions on the results of 77 routine clinical chemistry analytes using standard vacuum blood collection tubes and the new BD-Barricor tubes.

    Science.gov (United States)

    Cadamuro, Janne; Mrazek, Cornelia; Leichtle, Alexander B; Kipman, Ulrike; Felder, Thomas K; Wiedemann, Helmut; Oberkofler, Hannes; Fiedler, Georg M; Haschke-Becher, Elisabeth

    2018-02-15

    Although centrifugation is performed in almost every blood sample, recommendations on duration and g-force are heterogeneous and mostly based on expert opinions. In order to unify this step in a fully automated laboratory, we aimed to evaluate different centrifugation settings and their influence on the results of routine clinical chemistry analytes. We collected blood from 41 healthy volunteers into BD Vacutainer PST II-heparin-gel- (LiHepGel), BD Vacutainer SST II-serum-, and BD Vacutainer Barricor heparin-tubes with a mechanical separator (LiHepBar). Tubes were centrifuged at 2000xg for 10 minutes and 3000xg for 7 and 5 minutes, respectively. Subsequently 60 and 21 clinical chemistry analytes were measured in plasma and serum samples, respectively, using a Roche COBAS instrument. High sensitive Troponin T, pregnancy-associated plasma protein A, ß human chorionic gonadotropin and rheumatoid factor had to be excluded from statistical evaluation as many of the respective results were below the measuring range. Except of free haemoglobin (fHb) measurements, no analyte result was altered by the use of shorter centrifugation times at higher g-forces. Comparing LiHepBar to LiHepGel tubes at different centrifugation setting, we found higher lactate-dehydrogenase (LD) (P = 0.003 to centrifuged at higher speed (3000xg) for a shorter amount of time (5 minutes) without alteration of the analytes tested in this study. When using LiHepBar tubes for blood collection, a separate LD reference value might be needed.

  17. Laboratory Survey of Significant Bacteriuria in a Family Practice Clinic

    African Journals Online (AJOL)

    This study was carried out to determine the causative agents of significant bacteriuria and their antibiotic sensitivity pattern. ... high rate of antibiotic resistance suggest that many patients in this population will probably benefit more from treatment of UTI based on routine antibiotic sensitivity testing rather than empiric therapy.

  18. 76 FR 19188 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and...

    Science.gov (United States)

    2011-04-06

    ... DEPARTMENT OF VETERANS AFFAIRS Joint Biomedical Laboratory Research and Development and Clinical... the panels of the Joint Biomedical Laboratory Research and Development and Clinical Science Research.... Neurobiology-D June 10, 2011 Crowne Plaza DC/Silver Spring. Clinical Research Program June 13, 2011 VA Central...

  19. 78 FR 66992 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and...

    Science.gov (United States)

    2013-11-07

    ... DEPARTMENT OF VETERANS AFFAIRS Joint Biomedical Laboratory Research and Development and Clinical... the panels of the Joint Biomedical Laboratory Research and Development and Clinical Science Research..., behavioral, and clinical science research. The panel meetings will be open to the public for approximately...

  20. 75 FR 57833 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and...

    Science.gov (United States)

    2010-09-22

    ... DEPARTMENT OF VETERANS AFFAIRS Joint Biomedical Laboratory Research and Development and Clinical... the panels of the Joint Biomedical Laboratory Research and Development and Clinical Science Research... Crowne Plaza Clinical Research Program December 3, 2010 *VA Central Office Mental Hlth & Behav Sci-A...

  1. 78 FR 22622 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and...

    Science.gov (United States)

    2013-04-16

    ... DEPARTMENT OF VETERANS AFFAIRS Joint Biomedical Laboratory Research and Development and Clinical... the panels of the Joint Biomedical Laboratory Research and Development and Clinical Science Research... biomedical, behavioral and clinical science research. The panel meetings will be open to the public for...

  2. 77 FR 64598 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and...

    Science.gov (United States)

    2012-10-22

    ... DEPARTMENT OF VETERANS AFFAIRS Joint Biomedical Laboratory Research and Development and Clinical...) that the panels of the Joint Biomedical Laboratory Research and Development and Clinical Science... areas of biomedical, behavioral and clinical science research. The panel meetings will be open to the...

  3. 75 FR 23847 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and...

    Science.gov (United States)

    2010-05-04

    ... DEPARTMENT OF VETERANS AFFAIRS Joint Biomedical Laboratory Research and Development and Clinical... panels of the Joint Biomedical Laboratory Research and Development and Clinical Science Research and... & Behav Sci-A June 7, 2010 L'Enfant Plaza Hotel. Clinical Research Program June 9, 2010 *VA Central Office...

  4. Quality assurance of laboratory work and clinical use of laboratory tests in general practice in norway: a survey.

    Science.gov (United States)

    Thue, Geir; Jevnaker, Marianne; Gulstad, Guri Andersen; Sandberg, Sverre

    2011-09-01

    Virtually all the general practices in Norway participate in the Norwegian Quality Improvement of Laboratory Services in Primary Care, NOKLUS. In order to assess and develop NOKLUS's services, it was decided to carry out an investigation in the largest participating group, general practices. In autumn 2008 a questionnaire was sent to all Norwegian general practices asking for feedback on different aspects of NOKLUS's main services: contact with medical laboratory technologists, sending of control materials, use and maintenance of practice-specific laboratory binders, courses, and testing of laboratory equipment. In addition, attitudes were elicited towards possible new services directed at assessing other technical equipment and clinical use of tests. Responses were received from 1290 of 1552 practices (83%). The great majority thought that the frequency of sending out control material should continue as at present, and they were pleased with the feedback reports and follow-up by the laboratory technologists in the counties. Even after many years of practical experience, there is still a need to update laboratory knowledge through visits to practices, courses, and written information. Practices also wanted quality assurance of blood pressure meters and spirometers, and many doctors wanted feedback on their use of laboratory tests. Services regarding quality assurance of point-of-care tests, guidance, and courses should be continued. Quality assurance of other technical equipment and of the doctor's clinical use of laboratory tests should be established as part of comprehensive quality assurance.

  5. Anterior choroidal artery occlusions: Clinical and laboratory features

    Directory of Open Access Journals (Sweden)

    Lale Gündoğdu Çelebi

    2014-12-01

    Full Text Available OBJECTIVE: The anterior choroidal artery (ACHA irrigation area, this area is very volatile infarction incidence and clinical characteristics of classical knowledge. In our study, patients with infarct lesion limited irrigation area of Achan was to determine the clinical and laboratory features. METHODS: The patient group, magnetic resonance imaging, patients with lesions limited to the area by selecting Achan was created. In addition to the acute lesion Achan, the other in the sprawling grounds of the arteries of patients, additional lesions Those who define transient ischemic attack attributable to infarct Achan, the applicant passed before the first signs of neurological sequelae due to cerebrovascular disease and / or old lesions deemed capable of neurological deficits were excluded. Acha deciding that the irrigation area of the lesion, which is a deep dive irrigation area and medial thalamus, globus pallidus delimit the lateral thalamus formed the typical image of the lesion which were taken into account. For the superficial branch of the amygdala and hippocampus lentikülo-striate arteries occlusion seen in the posterior horn of the lateral ventricle of the lesion until komşuluğuna taken into account. RESULTS: A statistically significant difference in hypertension common modifiable risk factor for the highest rate (p <0.000. Pure motor or sensory examination in all patients except 1 patient showed signs of stroke. According to the classification of etiologic TOAST small vessel disease, significantly higher rate compared to other etiologies (p <0.000. Etiologic groups compared to the risk factors of hypertension and hyperlipidemia in patients with small vessel disease, atrial firillasyon (AF kardioemboli group was significantly higher (p = 0.035 and p = 0.011, p = 0.005. Introduction of the patients were between NIHSS 1-15 (6 + 3.2. Between mRS 0-4 at baseline (1.83 +1.22. Infarct area, Acha is one of the branches or the entire irrigation

  6. 75 FR 39028 - Clinical Laboratory Improvement Advisory Committee (CLIAC)

    Science.gov (United States)

    2010-07-07

    ... accommodate technological advances. Matters to be Discussed: The agenda will include agency updates from the... attendees are required to register for the meeting online at least 14 days in advance at http://wwwn.cdc.gov... Standards Branch, Division of Laboratory Science and Standards (proposed), Laboratory Science, Policy and...

  7. 76 FR 39879 - Clinical Laboratory Improvement Advisory Committee (CLIAC)

    Science.gov (United States)

    2011-07-07

    ... the standards to accommodate technological advances. Matters to be Discussed: The agenda will include... the meeting online at least 14 days in advance at http://www.cdc.gov/cliac/default.aspx by clicking... Information: Nancy Anderson, Chief, Laboratory Practice Standards Branch, Division of Laboratory Science and...

  8. [Laboratory and clinical evaluations of flomoxef sodium in neonates].

    Science.gov (United States)

    Iwai, N; Nakamura, H; Miyazu, M; Kasai, K; Watanabe, Y; Taneda, Y; Ozaki, T; Matsui, S; Maki, T; Tauchi, N

    1991-11-01

    Haemophilus influenzae which were responsible for these infections were all rated as "eradicated". Moreover, the drug, administered with or without prophylactic intentions showed complete prophylactic effects in all 27 cases tested. No side effects were observed in any of the patients. Concerning abnormal clinical laboratory results, increases in GOT were noted in 2, eosinophilia in 1, and thrombocytosis in 1, but these abnormalities were invariably mild and the normalized in 1 patient without treatment. The results suggest that FMOX is useful and safe also in neonates.

  9. Report on the International Society for Laboratory Hematology Survey on guidelines to support clinical hematology laboratory practice.

    Science.gov (United States)

    Hayward, C P M; Moffat, K A; George, T I; Proytcheva, M; Iorio, A

    2016-05-01

    Given the importance of evidence-based guidelines in health care, we surveyed the laboratory hematology community to determine their opinions on guideline development and their experience and interest in developing clinical hematology laboratory practice guidelines. The study was conducted using an online survey, distributed to members of the International Society for Laboratory Hematology (ISLH) in 2015, with analysis of collected, anonymized responses. A total of 245 individuals participated. Most worked in clinical and/or research laboratories (83%) or industry (11%). 42% felt there were gaps in current guidelines. The majority (58%) recommended that ISLH engages its membership in guideline development. Participants differed in their familiarity with, and use of, different organizations' guidelines. Participants felt it was important to follow best practice recommendations on guideline development, including engagement of experts, statement about conflict of interests and how they were managed, systematic review and grading evidence for recommendations, identifying recommendations lacking evidence or consensus, and public input and peer review of the guideline. Moreover, it was considered important to provide guidelines free of charge. Industry involvement in guidelines was considered less important. The clinical laboratory hematology community has high expectations of laboratory practice guidelines that are consistent with recent recommendations on evidence-based guideline development. © 2016 John Wiley & Sons Ltd.

  10. Physician Satisfaction With Clinical Laboratory Services: A College of American Pathologists Q-Probes Study of 81 Institutions.

    Science.gov (United States)

    McCall, Shannon J; Souers, Rhona J; Blond, Barbara; Massie, Larry

    2016-10-01

    -Assessment of customer satisfaction is a vital component of the laboratory quality improvement program. -To survey the level of physician satisfaction with hospital clinical laboratory services. -Participating institutions provided demographic information and survey results of physician satisfaction, with specific features of clinical laboratory services individually rated on a scale of 5 (excellent) to 1 (poor). -Eighty-one institutions submitted 2425 surveys. The median overall satisfaction score was 4.2 (10th percentile, 3.6; 90th percentile, 4.6). Of the 16 surveyed areas receiving the highest percentage of excellent/good ratings (combined scores of 4 and 5), quality of results was highest along with test menu adequacy, staff courtesy, and overall satisfaction. Of the 4 categories receiving the lowest percentage values of excellent/good ratings, 3 were related to turnaround time for inpatient "STAT" (tests performed immediately), outpatient STAT, and esoteric tests. The fourth was a new category presented in this survey: ease of electronic order entry. Here, 11.4% (241 of 2121) of physicians assigned below-average (2) or poor (1) scores. The 5 categories deemed most important to physicians included quality of results, turnaround times for inpatient STAT, routine, and outpatient STAT tests, and clinical report format. Overall satisfaction as measured by physician willingness to recommend their laboratory to another physician remains high at 94.5% (2160 of 2286 respondents). -There is a continued trend of high physician satisfaction and loyalty with clinical laboratory services. Physician dissatisfaction with ease of electronic order entry represents a new challenge. Test turnaround times are persistent areas of dissatisfaction, representing areas for improvement.

  11. Important clinical and laboratory correlates of glomerular filtration ...

    African Journals Online (AJOL)

    2015-02-03

    Feb 3, 2015 ... for glomerular changes seen in sickle cell disease (SCD). These include ... sex, frequency of crises per annum, as well as steady state laboratory indices .... nephropathy in sickle cell does not arise from a vaso‑occlusive effect.

  12. The National Market for Medicare Clinical Laboratory Testing

    Data.gov (United States)

    U.S. Department of Health & Human Services — Current Medicare payment policy for outpatient laboratory services is outdated. Future reforms, such as competitive bidding, should consider the characteristics of...

  13. Evaluation of Analytical Errors in a Clinical Chemistry Laboratory: A ...

    African Journals Online (AJOL)

    Course of action analysis has demonstrated that laboratory ... Data were analyzed with Graph Pad Prism 5(GraphPad Software Inc. CA USA). ... samples with their corresponding request slips and any errors .... Frequent changes of health care.

  14. Liposomal drug delivery system from laboratory to clinic

    Directory of Open Access Journals (Sweden)

    Kshirsagar N

    2005-01-01

    Full Text Available The main objective of drug delivery systems is to deliver a drug effectively, specifically to the site of action and to achieve greater efficacy and minimise the toxic effects compared to conventional drugs. Amongst various carrier systems, liposomes have generated a great interest because of their versatility. Liposomes are vesicular concentric bilayered structures, which are biocompatible, biodegradable and nonimmumnogenic. They can control the delivery of drugs by targeting the drug to the site of action or by site avoidance drug delivery or by prolonged circulation of drugs. Amphotericin B (Amp B remains the drug of choice in most systemic mycoses and also as a second line treatment for Kala azar. However, its toxic effects often limit its use. Although the liposome delivery system has been tried for several drugs, only a few have been used in patients due to the slow development of necessary large-scale pharmaceutical procedures. This paper reviews the development of the technique for liposomal Amphotericin B (L-Amp-LRC-1, FungisomeTM drug delivery system in our laboratory in collaboration with the department of Biochemistry, Delhi University in India and proving the safety and efficacy of this preparation in clinical practice. It also attempts to compare the efficacy and benefits of our product for Indian patients with those of similar products and it includes facts from the publications that flowed from our work. As compared to conventional Amp B, Fungisome is infused over a much shorter period requiring a smaller volume and no premedication. It was found to be safe in patients who had developed serious unacceptable toxicity with conventional Amp B. In renal transplant patients, Fungisome did not produce any nephrotoxicity. Fungisome is effective in fungal infections resistant to fluconazole, conventional Amp B and in virgin and resistant cases of visceral leishmaniasis. The cost of any drug is of great significance, especially in India

  15. Infections in British clinical laboratories, 1986-87.

    OpenAIRE

    Grist, N R; Emslie, J A

    1989-01-01

    During 1986-87 this continuing survey showed 15 specific infections in the staff of 235 laboratories, representing 28,524 person years of exposure. The community was the probable source of four of the five cases of tuberculosis and one of the five cases of salmonellosis. Occupational exposure was the probable cause of four infections by Shigella flexneri, three by Salmonella typhimurium, and one by S typhi, all affecting medical laboratory scientific officers (MLSOs) in microbiology. Occupati...

  16. 77 FR 26069 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and...

    Science.gov (United States)

    2012-05-02

    ... DEPARTMENT OF VETERANS AFFAIRS Joint Biomedical Laboratory Research and Development and Clinical Science Research and Development Services Scientific Merit Review Board, Notice of Meeting Amendment The... Development and Clinical Science Research and Development Services Scientific Merit Review Board have changed...

  17. The management of clinical laboratories in Europe: a FESCC survey. Forum of the European Societies of Clinical Chemistry and Laboratory Medicine.

    Science.gov (United States)

    de Kieviet, Wim; Blaton, Victor; Kovacs, Gabor L; Palicka, Vladimir; Pulkki, Kari

    2002-03-01

    The professional duties of the specialists in clinical chemistry differ from country to country in Europe. One of the main goals of the Strategic Plan of the Forum of the European Societies of Clinical Chemistry and Laboratory Medicine (FESCC; IFCC-Europe) is to promote a high scientific and professional standard in the field of clinical chemistry and laboratory medicine in Europe. This can be stimulated by the knowledge of the local conditions in each country and by striving towards a strong and harmonised position in all the European countries. In order to enhance the knowledge of the managerial situation of the specialists in clinical chemistry in Europe, FESCC launched a survey in September 2000. This survey provides information about the position of the specialists in clinical chemistry in the various disciplines in the medical laboratories and in hospitals, and about the advisory tasks and the managerial education during the post-graduate training in clinical chemistry. Of the 35 FESCC member countries 33 have participated in the survey (94%). The results show a rather heterogeneous situation in Europe caused by the local historical developments, the differences in academic background and the relative numbers of private and physicians' office laboratories. Large differences exist between the European countries in the disciplines of laboratory medicine that are headed by a specialist in clinical chemistry. In the different countries the clinical chemistry laboratories are headed by specialists in clinical chemistry in between 20% and 100% of the laboratories. The haematology, immunology, microbiology, therapeutic drug monitoring, molecular biology and haemostasis laboratories and departments of blood banking are headed by specialists in clinical chemistry in between 0% and 100% of the laboratories. The responsibilities for the various managerial tasks of the specialists in clinical chemistry show no uniformity in Europe. In the majority of the countries the

  18. Improvement of the quality control program of the clinical dosimeters calibration laboratory of the IPEN/CNEN-SP

    Energy Technology Data Exchange (ETDEWEB)

    Damatto, Willian B.; Potiens, Maria da Penha A.; Vivolo, Vitor, E-mail: wbdamatto@ipen.br, E-mail: mppotiens@ipen.br, E-mail: vivolo@ipen.br [Instituto de Pesquisas Energeticas e Nucleares (IPEN/CNEN-SP), Sao Paulo, SP (Brazil)

    2013-07-01

    A set of clinical dosimeters (thimble ionization chamber coupled to an electrometer) commonly used in radiotherapy in Brazil and sent to the Calibration Laboratory of IPEN were under several tests and analysis parameters for the dosimeters behaviour were established, specifying their sensitivities and operating characteristics. Applied tests were: repeatability, reproducibility and current leakage. Thus it was possible to determine the most common defects found in these equipment and the actions that could be taken to prevent it (clinical dosimeters quality control programs). The behaviour of 167 dosimeters was analyzed and in this study, 62 of them have been tested. The main problem detected during calibration tests was current leakage, i.e. electronic noise. The tests were applied to the routine measurements at the Calibration Laboratory implementing an ideal calibration procedure. New calibration criteria were established following international recommendations. Therefore, it was made the improvement of the quality control programme of the clinical dosimeters calibration laboratory, benefiting the users of such equipment with better consistent calibration measurements. (author)

  19. Improvement of the quality control program of the clinical dosimeters calibration laboratory of the IPEN/CNEN-SP

    International Nuclear Information System (INIS)

    Damatto, Willian B.; Potiens, Maria da Penha A.; Vivolo, Vitor

    2013-01-01

    A set of clinical dosimeters (thimble ionization chamber coupled to an electrometer) commonly used in radiotherapy in Brazil and sent to the Calibration Laboratory of IPEN were under several tests and analysis parameters for the dosimeters behaviour were established, specifying their sensitivities and operating characteristics. Applied tests were: repeatability, reproducibility and current leakage. Thus it was possible to determine the most common defects found in these equipment and the actions that could be taken to prevent it (clinical dosimeters quality control programs). The behaviour of 167 dosimeters was analyzed and in this study, 62 of them have been tested. The main problem detected during calibration tests was current leakage, i.e. electronic noise. The tests were applied to the routine measurements at the Calibration Laboratory implementing an ideal calibration procedure. New calibration criteria were established following international recommendations. Therefore, it was made the improvement of the quality control programme of the clinical dosimeters calibration laboratory, benefiting the users of such equipment with better consistent calibration measurements. (author)

  20. How does routinely delivered cognitive-behavioural therapy for gambling disorder compare to "gold standard" clinical trial?

    Science.gov (United States)

    Smith, David P; Fairweather-Schmidt, A Kate; Harvey, Peter W; Battersby, Malcolm W

    2018-03-01

    Currently, it is unknown whether treatment outcomes derived from randomized controlled trials (RCTs) of cognitive-behavioural therapy (CBT) for problem gamblers still hold when applied to patients seen in routine practice. Thus, data from an RCT of cognitive therapy versus exposure therapy for problem gambling versus patients of a gambling help service were compared. Assessments of problem gambling severity, psychosocial impairment, and alcohol use were undertaken at baseline and post-treatment and evaluated within a counterfactual framework. Findings showed that the contrast between routine CBT for pokies and horse betting had a significant effect, indicative of a 62% lower gambling urge score if routine CBT recipients had all been horse/track betters opposed to gambling with "pokies." However, the majority of contrasts indicated therapeutic outcomes achieved in routine CBT treatments were of equivalent robustness relative to RCT conditions. The present findings infer routine practice treatment outcomes are as efficacious as those generated in RCT contexts. Copyright © 2017 John Wiley & Sons, Ltd.

  1. Routine resite of peripheral intravenous devices every 3 days did not reduce complications compared with clinically indicated resite: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Rickard Claire M

    2010-09-01

    Full Text Available Abstract Background Peripheral intravenous device (IVD complications were traditionally thought to be reduced by limiting dwell time. Current recommendations are to resite IVDs by 96 hours with the exception of children and patients with poor veins. Recent evidence suggests routine resite is unnecessary, at least if devices are inserted by a specialised IV team. The aim of this study was to compare the impact of peripheral IVD 'routine resite' with 'removal on clinical indication' on IVD complications in a general hospital without an IV team. Methods A randomised, controlled trial was conducted in a regional teaching hospital. After ethics approval, 362 patients (603 IVDs were randomised to have IVDs replaced on clinical indication (185 patients or routine change every 3 days (177 patients. IVDs were inserted and managed by the general hospital medical and nursing staff; there was no IV team. The primary endpoint was a composite of IVD complications: phlebitis, infiltration, occlusion, accidental removal, local infection, and device-related bloodstream infection. Results IVD complication rates were 68 per 1,000 IVD days (clinically indicated and 66 per 1,000 IVD days (routine replacement (P = 0.86; HR 1.03; 95% CI, 0.74-1.43. Time to first complication per patient did not differ between groups (KM with log rank, P = 0.53. There were no local infections or IVD-related bloodstream infections in either group. IV therapy duration did not differ between groups (P = 0.22, but more (P = 0.004 IVDs were placed per patient in the routine replacement (mean, 1.8 than the clinical indication group (mean, 1.5, with significantly higher hospital costs per patient (P Conclusions Resite on clinical indication would allow one in two patients to have a single cannula per course of IV treatment, as opposed to one in five patients managed with routine resite; overall complication rates appear similar. Clinically indicated resite would achieve savings in equipment

  2. Standardization of 8-color flow cytometry across different flow cytometer instruments: A feasibility study in clinical laboratories in Switzerland.

    Science.gov (United States)

    Glier, Hana; Heijnen, Ingmar; Hauwel, Mathieu; Dirks, Jan; Quarroz, Stéphane; Lehmann, Thomas; Rovo, Alicia; Arn, Kornelius; Matthes, Thomas; Hogan, Cassandra; Keller, Peter; Dudkiewicz, Ewa; Stüssi, Georg; Fernandez, Paula

    2017-07-29

    The EuroFlow Consortium developed a fully standardized flow cytometric approach from instrument settings, through antibody panel, reagents and sample preparation protocols, to data acquisition and analysis. The Swiss Cytometry Society (SCS) promoted a study to evaluate the feasibility of using such standardized measurements of 8-color data across two different flow cytometry platforms - Becton Dickinson (BD) FACSCanto II and Beckman Coulter (BC) Navios, aiming at increasing reproducibility and inter-laboratory comparability of immunophenotypic data in clinical laboratories in Switzerland. The study was performed in two phases, i.e. a learning phase (round 1) and an analytical phase (rounds 2 and 3) consisting of a total of three rounds. Overall, 10 laboratories using BD FACSCanto II (n=6) or BC Navios (n=4) flow cytometers participated. Each laboratory measured peripheral blood samples from healthy donors stained with a uniform antibody panel of reagents - EuroFlow Lymphoid Screening Tube (LST) - applying the EuroFlow standardized protocols for instrument setup and sample preparation (www.EuroFlow.org). All data files were analyzed centrally and median fluorescence intensity (MedFI) values for individual markers on defined lymphocyte subsets were recorded; variability from reference MedFI values was assessed using performance scores. Data troubleshooting and discussion of the results with the participants followed after each round at SCS meetings. The results of the learning phase demonstrated that standardized instrument setup and data acquisition are feasible in routine clinical laboratories without previous experience with EuroFlow. During the analytical phase, highly comparable data were obtained at the different laboratories using either BD FACSCanto II or BC Navios. The coefficient of variation of MedFI for 7 of 11 markers performed repeatedly below 30%. In the last study round, 89% of participants scored over 90% MedFI values within the acceptance criteria

  3. Gouty arthritis in Nigerians: clinical and laboratory correlates ...

    African Journals Online (AJOL)

    ... diuretics and low dosage of aspirin may also be among the contributing factors. These factors are also increasingly been found in black Africans. ... The clinic serves as a major referral rheumatology clinic for Lagos and the adjoining states.

  4. [Historic Development of Clinical Biology Laboratories in Luxembourg].

    Science.gov (United States)

    Wennig R; Humbel R-L

    2014-01-01

    After a short overview on the development of diagnostic tools in clinical biology at an international level from Antiquity towards today, a history of the clinical biology including public and private institutions in Luxembourg will be outlined.

  5. Oropharyngeal Dysphagia in Dermatomyositis: Associations with Clinical and Laboratory Features Including Autoantibodies

    OpenAIRE

    Mugii, Naoki; Hasegawa, Minoru; Matsushita, Takashi; Hamaguchi, Yasuhito; Oohata, Sacihe; Okita, Hirokazu; Yahata, Tetsutarou; Someya, Fujiko; Inoue, Katsumi; Murono, Shigeyuki; Fujimoto, Manabu; Takehara, Kazuhiko

    2016-01-01

    Objective Dysphagia develops with low frequency in patients with dermatomyositis. Our objective was to determine the clinical and laboratory features that can estimate the development of dysphagia in dermatomyositis. Methods This study included 92 Japanese patients with adult-onset dermatomyositis. The associations between dysphagia and clinical and laboratory features including disease-specific autoantibodies determined by immunoprecipitation assays were analyzed. Results Videofluoroscopy sw...

  6. Practicing Handoffs Early: Applying a Clinical Framework in the Anatomy Laboratory

    Science.gov (United States)

    Lazarus, Michelle D.; Dos Santos, Jason A.; Haidet, Paul M.; Whitcomb, Tiffany L.

    2016-01-01

    The anatomy laboratory provides an ideal environment for the integration of clinical contexts as the willed-donor is often regarded as a student's "first patient." This study evaluated an innovative approach to peer teaching in the anatomy laboratory using a clinical handoff context. The authors introduced the "Situation,…

  7. Single and Combined Diagnostic Value of Clinical Features and Laboratory Tests in Acute Appendicitis

    NARCIS (Netherlands)

    Laméris, Wytze; van Randen, Adrienne; Go, Peter M. N. Y. H.; Bouma, Wim H.; Donkervoort, Sandra C.; Bossuyt, Patrick M. M.; Stoker, Jaap; Boermeester, Marja A.

    2009-01-01

    Objectives: The objective was to evaluate the diagnostic accuracy of clinical features and laboratory test results in detecting acute appendicitis. Methods: Clinical features and laboratory test results were prospectively recorded in a consecutive series of 1,101 patients presenting with abdominal

  8. The Role of the Clinical Laboratory in the Future of Health Care: Lean Microbiology

    Science.gov (United States)

    Samuel, Linoj

    2014-01-01

    This commentary will introduce lean concepts into the clinical microbiology laboratory. The practice of lean in the clinical microbiology laboratory can remove waste, increase efficiency, and reduce costs. Lean, Six Sigma, and other such management initiatives are useful tools and can provide dividends but must be accompanied by organizational leadership commitment to sustaining the lean culture in the laboratory setting and providing resources and time to work through the process. PMID:24574289

  9. Routine outcome monitoring and clinical decision-making in forensic psychiatry based on the Instrument for Forensic Treatment Evaluation

    NARCIS (Netherlands)

    van der Veeken, F.C.A.; Lucieer, Jacques; Bogaerts, S.

    2016-01-01

    Background Rehabilitation in forensic psychiatry is achieved gradually with different leave modules, in line with the Risk Need Responsivity model. A forensic routine outcome monitoring tool should measure treatment progress based on the rehabilitation theory, and it should be predictive of

  10. Clinical and Laboratory Predictors of Articular Disorders Among HIV ...

    African Journals Online (AJOL)

    laboratory features of HIV‑infected patients and articular disorders. Aims: To ... The recruitment of subjects for the study took place ..... [4-8,10]. The reported range is wide and reflects prevalence from ... this study may be close to the true value because the subjects .... hence higher ESR values, indicating widespread systemic.

  11. Audit of clinical-laboratory practices in haematology and blood ...

    African Journals Online (AJOL)

    In Tanzania, there is paucity of data for monitoring laboratory medicine including haematology. This therefore calls for audits of practices in haematology and blood transfusion in order to provide appraise practice and devise strategies that would result in improved quality of health care services. This descriptive ...

  12. Evaluation of Neonatal Hemolytic Jaundice: Clinical and Laboratory Parameters

    Directory of Open Access Journals (Sweden)

    Anet Papazovska Cherepnalkovski

    2015-12-01

    CONCLUSIONS: The laboratory profile in ABO/Rh isoimmunisation cases depicts hemolytic mechanism of jaundice. These cases carry a significant risk for early and severe hyperbilirubinemia and are eligible for neurodevelopmental follow-up. Hematological parameters and blood grouping are simple diagnostic methods that assist the etiological diagnosis of neonatal hyperbilirubinemia.

  13. 78 FR 44954 - Clinical Laboratory Improvement Advisory Committee (CLIAC)

    Science.gov (United States)

    2013-07-25

    ... pathology. Advancing laboratory interoperability in health information technology will also be discussed... for international registrants. Providing Oral or Written Comments: It is the policy of CLIAC to accept written public comments and provide a brief period for oral public comments whenever possible. Oral...

  14. Matrix-Assisted Laser Desorption Ionization–Time of Flight Mass Spectrometry: a Fundamental Shift in the Routine Practice of Clinical Microbiology

    Science.gov (United States)

    Clark, Andrew E.; Kaleta, Erin J.; Arora, Amit

    2013-01-01

    SUMMARY Within the past decade, clinical microbiology laboratories experienced revolutionary changes in the way in which microorganisms are identified, moving away from slow, traditional microbial identification algorithms toward rapid molecular methods and mass spectrometry (MS). Historically, MS was clinically utilized as a high-complexity method adapted for protein-centered analysis of samples in chemistry and hematology laboratories. Today, matrix-assisted laser desorption ionization–time of flight (MALDI-TOF) MS is adapted for use in microbiology laboratories, where it serves as a paradigm-shifting, rapid, and robust method for accurate microbial identification. Multiple instrument platforms, marketed by well-established manufacturers, are beginning to displace automated phenotypic identification instruments and in some cases genetic sequence-based identification practices. This review summarizes the current position of MALDI-TOF MS in clinical research and in diagnostic clinical microbiology laboratories and serves as a primer to examine the “nuts and bolts” of MALDI-TOF MS, highlighting research associated with sample preparation, spectral analysis, and accuracy. Currently available MALDI-TOF MS hardware and software platforms that support the use of MALDI-TOF with direct and precultured specimens and integration of the technology into the laboratory workflow are also discussed. Finally, this review closes with a prospective view of the future of MALDI-TOF MS in the clinical microbiology laboratory to accelerate diagnosis and microbial identification to improve patient care. PMID:23824373

  15. Matrix-assisted laser desorption ionization-time of flight mass spectrometry: a fundamental shift in the routine practice of clinical microbiology.

    Science.gov (United States)

    Clark, Andrew E; Kaleta, Erin J; Arora, Amit; Wolk, Donna M

    2013-07-01

    Within the past decade, clinical microbiology laboratories experienced revolutionary changes in the way in which microorganisms are identified, moving away from slow, traditional microbial identification algorithms toward rapid molecular methods and mass spectrometry (MS). Historically, MS was clinically utilized as a high-complexity method adapted for protein-centered analysis of samples in chemistry and hematology laboratories. Today, matrix-assisted laser desorption ionization-time of flight (MALDI-TOF) MS is adapted for use in microbiology laboratories, where it serves as a paradigm-shifting, rapid, and robust method for accurate microbial identification. Multiple instrument platforms, marketed by well-established manufacturers, are beginning to displace automated phenotypic identification instruments and in some cases genetic sequence-based identification practices. This review summarizes the current position of MALDI-TOF MS in clinical research and in diagnostic clinical microbiology laboratories and serves as a primer to examine the "nuts and bolts" of MALDI-TOF MS, highlighting research associated with sample preparation, spectral analysis, and accuracy. Currently available MALDI-TOF MS hardware and software platforms that support the use of MALDI-TOF with direct and precultured specimens and integration of the technology into the laboratory workflow are also discussed. Finally, this review closes with a prospective view of the future of MALDI-TOF MS in the clinical microbiology laboratory to accelerate diagnosis and microbial identification to improve patient care.

  16. [Software for illustrating a cost-quality balance carried out by clinical laboratory practice].

    Science.gov (United States)

    Nishibori, Masahiro; Asayama, Hitoshi; Kimura, Satoshi; Takagi, Yasushi; Hagihara, Michio; Fujiwara, Mutsunori; Yoneyama, Akiko; Watanabe, Takashi

    2010-09-01

    We have no proper reference indicating the quality of clinical laboratory practice, which should clearly illustrates that better medical tests require more expenses. Japanese Society of Laboratory Medicine was concerned about recent difficult medical economy and issued a committee report proposing a guideline to evaluate the good laboratory practice. According to the guideline, we developed software that illustrate a cost-quality balance carried out by clinical laboratory practice. We encountered a number of controversial problems, for example, how to measure and weight each quality-related factor, how to calculate costs of a laboratory test and how to consider characteristics of a clinical laboratory. Consequently we finished only prototype software within the given period and the budget. In this paper, software implementation of the guideline and the above-mentioned problems are summarized. Aiming to stimulate these discussions, the operative software will be put on the Society's homepage for trial

  17. Computerized provider order entry in the clinical laboratory

    Science.gov (United States)

    Baron, Jason M.; Dighe, Anand S.

    2011-01-01

    Clinicians have traditionally ordered laboratory tests using paper-based orders and requisitions. However, paper orders are becoming increasingly incompatible with the complexities, challenges, and resource constraints of our modern healthcare systems and are being replaced by electronic order entry systems. Electronic systems that allow direct provider input of diagnostic testing or medication orders into a computer system are known as Computerized Provider Order Entry (CPOE) systems. Adoption of laboratory CPOE systems may offer institutions many benefits, including reduced test turnaround time, improved test utilization, and better adherence to practice guidelines. In this review, we outline the functionality of various CPOE implementations, review the reported benefits, and discuss strategies for using CPOE to improve the test ordering process. Further, we discuss barriers to the implementation of CPOE systems that have prevented their more widespread adoption. PMID:21886891

  18. Computerized provider order entry in the clinical laboratory

    Directory of Open Access Journals (Sweden)

    Jason M Baron

    2011-01-01

    Full Text Available Clinicians have traditionally ordered laboratory tests using paper-based orders and requisitions. However, paper orders are becoming increasingly incompatible with the complexities, challenges, and resource constraints of our modern healthcare systems and are being replaced by electronic order entry systems. Electronic systems that allow direct provider input of diagnostic testing or medication orders into a computer system are known as Computerized Provider Order Entry (CPOE systems. Adoption of laboratory CPOE systems may offer institutions many benefits, including reduced test turnaround time, improved test utilization, and better adherence to practice guidelines. In this review, we outline the functionality of various CPOE implementations, review the reported benefits, and discuss strategies for using CPOE to improve the test ordering process. Further, we discuss barriers to the implementation of CPOE systems that have prevented their more widespread adoption.

  19. [External quality assessment in clinical biochemistry laboratories: pilot study in 11 laboratories of Lomé (Togo)].

    Science.gov (United States)

    Kouassi, Kafui; Fétéké, Lochina; Assignon, Selom; Dorkenoo, Ameyo; Napo-Koura, Gado

    2015-01-01

    This study aims to evaluate the performance of a few biochemistry analysis and make recommendations to the place of the stakeholders. It is a cross-sectional study conducted between the October 1(st), 2012 and the July 31, 2013 bearing on the results of 5 common examinations of clinical biochemistry, provided by 11 laboratories volunteers opening in the public and private sectors. These laboratories have analysed during the 3 cycles, 2 levels (medium and high) of serum concentration of urea, glucose, creatinine and serum aminotransferases. The performance of laboratories have been determined from the acceptable limits corresponding to the limits of total errors, defined by the French Society of Clinical Biology (SFBC). A system of internal quality control is implemented by all laboratories and 45% of them participated in international programs of external quality assessment (EQA). The rate of acceptable results for the entire study was of 69%. There was a significant difference (plaboratories engaged in a quality approach and the group with default implementation of the quality approach. Also a significant difference was observed between the laboratories of the central level and those of the peripheral level of our health system (plaboratories remains relatively unsatisfactory. It is important that the Ministry of Health put in place a national program of EQA with mandatory participation.

  20. Design of a Clinical Information Management System to Support DNA Analysis Laboratory Operation

    Science.gov (United States)

    Dubay, Christopher J.; Zimmerman, David; Popovich, Bradley

    1995-01-01

    The LabDirector system has been developed at the Oregon Health Sciences University to support the operation of our clinical DNA analysis laboratory. Through an iterative design process which has spanned two years, we have produced a system that is both highly tailored to a clinical genetics production laboratory and flexible in its implementation, to support the rapid growth and change of protocols and methodologies in use in the field. The administrative aspects of the system are integrated with an enterprise schedule management system. The laboratory side of the system is driven by a protocol modeling and execution system. The close integration between these two aspects of the clinical laboratory facilitates smooth operations, and allows management to accurately measure costs and performance. The entire application has been designed and documented to provide utility to a wide range of clinical laboratory environments.

  1. Practical experience with graphical user interfaces and object-oriented design in the clinical laboratory.

    Science.gov (United States)

    Wells, I G; Cartwright, R Y; Farnan, L P

    1993-12-15

    The computing strategy in our laboratories evolved from research in Artificial Intelligence, and is based on powerful software tools running on high performance desktop computers with a graphical user interface. This allows most tasks to be regarded as design problems rather than implementation projects, and both rapid prototyping and an object-oriented approach to be employed during the in-house development and enhancement of the laboratory information systems. The practical application of this strategy is discussed, with particular reference to the system designer, the laboratory user and the laboratory customer. Routine operation covers five departments, and the systems are stable, flexible and well accepted by the users. Client-server computing, currently undergoing final trials, is seen as the key to further development, and this approach to Pathology computing has considerable potential for the future.

  2. Houston Methodist variant viewer: An application to support clinical laboratory interpretation of next-generation sequencing data for cancer

    Directory of Open Access Journals (Sweden)

    Paul A Christensen

    2017-01-01

    Full Text Available Introduction: Next-generation-sequencing (NGS is increasingly used in clinical and research protocols for patients with cancer. NGS assays are routinely used in clinical laboratories to detect mutations bearing on cancer diagnosis, prognosis and personalized therapy. A typical assay may interrogate 50 or more gene targets that encompass many thousands of possible gene variants. Analysis of NGS data in cancer is a labor-intensive process that can become overwhelming to the molecular pathologist or research scientist. Although commercial tools for NGS data analysis and interpretation are available, they are often costly, lack key functionality or cannot be customized by the end user. Methods: To facilitate NGS data analysis in our clinical molecular diagnostics laboratory, we created a custom bioinformatics tool termed Houston Methodist Variant Viewer (HMVV. HMVV is a Java-based solution that integrates sequencing instrument output, bioinformatics analysis, storage resources and end user interface. Results: Compared to the predicate method used in our clinical laboratory, HMVV markedly simplifies the bioinformatics workflow for the molecular technologist and facilitates the variant review by the molecular pathologist. Importantly, HMVV reduces time spent researching the biological significance of the variants detected, standardizes the online resources used to perform the variant investigation and assists generation of the annotated report for the electronic medical record. HMVV also maintains a searchable variant database, including the variant annotations generated by the pathologist, which is useful for downstream quality improvement and research projects. Conclusions: HMVV is a clinical grade, low-cost, feature-rich, highly customizable platform that we have made available for continued development by the pathology informatics community.

  3. The quality of veterinary in-clinic and reference laboratory biochemical testing.

    Science.gov (United States)

    Rishniw, Mark; Pion, Paul D; Maher, Tammy

    2012-03-01

    Although evaluation of biochemical analytes in blood is common in veterinary practice, studies assessing the global quality of veterinary in-clinic and reference laboratory testing have not been reported. The aim of this study was to assess the quality of biochemical testing in veterinary laboratories using results obtained from analyses of 3 levels of assayed quality control materials over 5 days. Quality was assessed by comparison of calculated total error with quality requirements, determination of sigma metrics, use of a quality goal index to determine factors contributing to poor performance, and agreement between in-clinic and reference laboratory mean results. The suitability of in-clinic and reference laboratory instruments for statistical quality control was determined using adaptations from the computerized program, EZRules3. Reference laboratories were able to achieve desirable quality requirements more frequently than in-clinic laboratories. Across all 3 materials, > 50% of in-clinic analyzers achieved a sigma metric ≥ 6.0 for measurement of 2 analytes, whereas > 50% of reference laboratory analyzers achieved a sigma metric ≥ 6.0 for measurement of 6 analytes. Expanded uncertainty of measurement and ± total allowable error resulted in the highest mean percentages of analytes demonstrating agreement between in-clinic and reference laboratories. Owing to marked variation in bias and coefficient of variation between analyzers of the same and different types, the percentages of analytes suitable for statistical quality control varied widely. These findings reflect the current state-of-the-art with regard to in-clinic and reference laboratory analyzer performance and provide a baseline for future evaluations of the quality of veterinary laboratory testing. © 2012 American Society for Veterinary Clinical Pathology.

  4. Assessment of leadership among clinical laboratories managers of teaching hospitals: Quantum leadership approach

    Directory of Open Access Journals (Sweden)

    H. Dargahi

    2017-10-01

    Full Text Available Background: Quantum leadership approach causes efficient and effective procedures among health care organizations, specially clinical laboratories. Objective: This research was aimed to determine the status of quantum leadership dimensions among all management levels of clinical laboratories of teaching hospitals of medical sciences universities in Tehran. Methods: This descriptive, analytical and cross-sectional study was induced among 180 managers of 35 clinical laboratories of Iran, Shahid Beheshti and Tehran Universities of Medical Sciences 2016. The research tool was researcher - constructed questionnaire of quantum skills, demographic details that its content and face validity and reliability were confirmed. For analysis of data, T-test and ANOVA techniques were used. Findings: Most of the studied clinical laboratories managers were male, married, with 15-20 years work experiences, 1-5 years managerial services, and minimally one training courses in clinical laboratory management. The managers had relatively desired and desired score of quantum skills and leadership respectively. Also, there was significant correlation between quantum leadership with age (P=0.01, and with management training courses (P=0.02. Conclusion: It is expected this paradigm may change the clinical laboratory management in the near future with regards to desirability of quantum leadership dimensions among clinical laboratories.

  5. Laboratory-based surveillance in the molecular era: The typened model, a joint data-sharing platform for clinical and public health laboratories

    NARCIS (Netherlands)

    H.G.M. Niesters (Bert); J.W. Rossen (John); H.G.A.M. van der Avoort (Harrie); D. Baas; K. Benschop (Kimberley); E.C.J. Claas (Eric); A. Kroneman; N.M. van Maarseveen (Noortje); S.D. Pas (Suzan); W. van Pelt (Wilfred); J. Rahamat-Langendoen (Janette); R. Schuurman (Rob); H. Vennema (Harry); L. Verhoef; K.C. Wolthers (Katja); M.P.G. Koopmans D.V.M. (Marion)

    2013-01-01

    textabstractLaboratory-based surveillance, one of the pillars of monitoring infectious disease trends, relies on data produced in clinical and/or public health laboratories. Currently, diagnostic laboratories worldwide submit strains or samples to a relatively small number of reference laboratories

  6. Laboratory-based surveillance in the molecular era : the TYPENED model, a joint data-sharing platform for clinical and public health laboratories

    NARCIS (Netherlands)

    Niesters, H G; Rossen, J W; van der Avoort, H; Baas, D; Benschop, K; Claas, E C; Kroneman, A; van Maarseveen, N; Pas, S; van Pelt, W; Rahamat-Langendoen, J C; Schuurman, R; Vennema, H; Verhoef, L; Wolthers, K; Koopmans, Marion

    2013-01-01

    Laboratory-based surveillance, one of the pillars of monitoring infectious disease trends, relies on data produced in clinical and/or public health laboratories. Currently, diagnostic laboratories worldwide submit strains or samples to a relatively small number of reference laboratories for

  7. Laboratory-based surveillance in the molecular era: the TYPENED model, a joint data-sharing platform for clinical and public health laboratories

    NARCIS (Netherlands)

    Niesters, H. G.; Rossen, J. W.; van der Avoort, H.; Baas, D.; Benschop, K.; Claas, E. C.; Kroneman, A.; van Maarseveen, N.; Pas, S.; van Pelt, W.; Rahamat-Langendoen, J. C.; Schuurman, R.; Vennema, H.; Verhoef, L.; Wolthers, K.; Koopmans, M.

    2013-01-01

    Laboratory-based surveillance, one of the pillars of monitoring infectious disease trends, relies on data produced in clinical and/or public health laboratories. Currently, diagnostic laboratories worldwide submit strains or samples to a relatively small number of reference laboratories for

  8. Sporotrichosis: an update on epidemiology, etiopathogenesis, laboratory and clinical therapeutics*

    Science.gov (United States)

    Orofino-Costa, Rosane; de Macedo, Priscila Marques; Rodrigues, Anderson Messias; Bernardes-Engemann, Andréa Reis

    2017-01-01

    In the late 90's there was a change in both the route of transmission and the people at risk for sporotrichosis. This zoonotic cat-man alternative transmission route elicited changes in strategies to control the epidemic. There was a progressive increase in the number of cases involving especially children and the elderly. In addition to becoming hyperendemic, uncommon clinical pictures like immunoreactive clinical presentations or severe systemic cases have emerged. New species were identified and classified through molecular tools using more virulent clinical isolates, like S. brasiliensis, compared to the environmental isolates. Likewise, different species of Sporothrix have been associated with different geographic regions. The serological and molecular techniques are used as an auxiliary tool for the diagnosis and/or for species identification, although the isolation and the identification of Sporothrix spp. in clinical specimen is still the gold standard. Currently sporotrichosis epidemics requires the knowledge of the epidemiological-molecular profile to control the disease and the specific treatment. Itraconazole, potassium iodide, terfinafine, and amphotericin B are the available drugs in Brazil to treat sporotrichosis. The drug of choice, its posology, and treatment duration vary according to the clinical presentation, the Sporothrix species, and host immune status. New treatment choices, including a vaccine, are being developed; nevertheless, more clinical trials are required to confirm its efficacy. PMID:29166494

  9. Sporotrichosis: an update on epidemiology, etiopathogenesis, laboratory and clinical therapeutics.

    Science.gov (United States)

    Orofino-Costa, Rosane; Macedo, Priscila Marques de; Rodrigues, Anderson Messias; Bernardes-Engemann, Andréa Reis

    2017-01-01

    In the late 90's there was a change in both the route of transmission and the people at risk for sporotrichosis. This zoonotic cat-man alternative transmission route elicited changes in strategies to control the epidemic. There was a progressive increase in the number of cases involving especially children and the elderly. In addition to becoming hyperendemic, uncommon clinical pictures like immunoreactive clinical presentations or severe systemic cases have emerged. New species were identified and classified through molecular tools using more virulent clinical isolates, like S. brasiliensis, compared to the environmental isolates. Likewise, different species of Sporothrix have been associated with different geographic regions. The serological and molecular techniques are used as an auxiliary tool for the diagnosis and/or for species identification, although the isolation and the identification of Sporothrix spp. in clinical specimen is still the gold standard. Currently sporotrichosis epidemics requires the knowledge of the epidemiological-molecular profile to control the disease and the specific treatment. Itraconazole, potassium iodide, terfinafine, and amphotericin B are the available drugs in Brazil to treat sporotrichosis. The drug of choice, its posology, and treatment duration vary according to the clinical presentation, the Sporothrix species, and host immune status. New treatment choices, including a vaccine, are being developed; nevertheless, more clinical trials are required to confirm its efficacy.

  10. Reliability of routine clinical measurements of neonatal circumferences and research measurements of neonatal skinfold thicknesses: findings from the Born in Bradford study

    Science.gov (United States)

    West, Jane; Manchester, Ben; Wright, John; Lawlor, Debbie A; Waiblinger, Dagmar

    2011-01-01

    Summary West J, Manchester B, Wright J, Lawlor DA, Waiblinger D. Reliability of routine clinical measurements of neonatal circumferences and research measurements of neonatal skinfold thicknesses: findings from the Born in Bradford study. Paediatric and Perinatal Epidemiology 2011. Assessing neonatal size reliably is important for research and clinical practice. The aim of this study was to examine the reliability of routine clinical measurements of neonatal circumferences and of skinfold thicknesses assessed for research purposes. All measurements were undertaken on the same population of neonates born in a large maternity unit in Bradford, UK. Technical error of measurement (TEM), relative TEM and the coefficient of reliability are reported. Intra-observer TEMs for routine circumference measurements were all below 0.4 cm and were generally within ±2-times the mean. Inter-observer TEM ranged from 0.20 to 0.36 cm for head circumference, 0.19 to 0.39 cm for mid upper arm circumference and from 0.39 to 0.77 cm for abdominal circumference. Intra and inter-observer TEM for triceps skinfold thickness ranged from 0.22 to 0.35 mm and 0.15 to 0.54 mm, respectively. Subscapular skinfold thickness TEM values were 0.14 to 0.25 mm for intra-observer measurements and 0.17 to 0.63 mm for inter-observer measurements. Relative TEM values for routine circumferences were all below 4.00% but varied between 2.88% and 14.23% for research skinfold measurements. Reliability was mostly between 80% and 99% for routine circumference measurements and ≥70% for most research skinfold measurements. Routine clinical measurements of neonatal circumferences are reliably assessed in Bradford. Assessing skinfolds in neonates has variable reliability, but on the whole is good. The greater intra-observer, compared with inter-observer, reliability for both sets of measurements highlights the importance of having a minimal number of assessors whenever possible. PMID:21281329

  11. A clinical evaluation of placental growth factor in routine practice in high-risk women presenting with suspected pre-eclampsia and/or fetal growth restriction.

    Science.gov (United States)

    Ormesher, L; Johnstone, E D; Shawkat, E; Dempsey, A; Chmiel, C; Ingram, E; Higgins, L E; Myers, J E

    2018-03-13

    To evaluate the use of plasma Placental Growth Factor (PlGF), recommended by the recent NICE guidance, in women with suspected pre-eclampsia (PE) and/or fetal growth restriction (FGR). Non-randomised prospective clinical evaluation study in high-risk antenatal clinics in a tertiary maternity unit. PlGF testing was performed in addition to routine clinical assessment in 260 women >20 weeks' gestation with chronic disease (hypertension, renal disease ± diabetes) with a change in maternal condition or in women with suspected FGR to determine the impact on clinical management. Results were revealed and standardised care pathways followed. Outcome of pregnancies with a low PlGF (women had an adverse outcome (PE/birthweight women with PlGF 14 days. The PlGF result altered clinical management (surveillance or timing of birth) in 196/260 (75.4%) cases. Alternative PlGF thresholds did not significantly improve diagnostic performance. Our evaluation confirms the value of PlGF as a diagnostic tool for placental dysfunction. However, low PlGF in isolation should not trigger iatrogenic delivery. Further research linking placental pathology, maternal disease and maternal PlGF levels is urgently needed before this test can be implemented in routine clinical practice. Copyright © 2018. Published by Elsevier B.V.

  12. Incidence of ricket clinical symptoms and relation between clinical and laboratory findings in infants

    Directory of Open Access Journals (Sweden)

    Čukalović M.

    2014-01-01

    Full Text Available Rickets presents osteomalacia which is developed due to negative balance of calcium and / or phosphorus during growth and development. Therefore it appears only in children. The most common reason of insufficient mineralization is deficiency of vitamin D, which is necessary for inclusion of calcium in cartilage and bones. As result, proliferation of cartilage and bone tissue appears, creating calluses on typical places. Bones become soft and curve, resulting in deformities. Our present study included 86 infants, in whom, besides other diseases, clinical and laboratory signs of rickets were identified. In our study, rickets is most common (82.5% in infants older than 6 months. By clinical picture, craniotabes is present in 46.5% of cases, Harisson groove in 26.7%, rachitic bracelets in 17.4%, rachitic rosary in 17.4% and carpopedal spasms in 2.3% of cases. Leading biochemical signs of vitamin D deficient rickets is hypophosphatemia (in 87.3% of cases, normal calcemia (in 75.6% of cases and increased values of alkaline phosphatase (in 93% of cases. It has been shown that rickets in infant age may later affect higher incidence of juvenile diabetes, infection of lower respiratory tract, osteoporosis, and so on.

  13. First evaluation of automated specimen inoculation for wound swab samples by use of the Previ Isola system compared to manual inoculation in a routine laboratory: finding a cost-effective and accurate approach.

    Science.gov (United States)

    Mischnik, Alexander; Mieth, Markus; Busch, Cornelius J; Hofer, Stefan; Zimmermann, Stefan

    2012-08-01

    Automation of plate streaking is ongoing in clinical microbiological laboratories, but evaluation for routine use is mostly open. In the present study, the recovery of microorganisms from the Previ Isola system plated polyurethane (PU) swab samples is compared to manually plated control viscose swab samples from wounds according to the CLSI procedure M40-A (quality control of microbiological transport systems). One hundred twelve paired samples (224 swabs) were analyzed. In 80/112 samples (71%), concordant culture results were obtained with the two methods. In 32/112 samples (29%), CFU recovery of microorganisms from the two methods was discordant. In 24 (75%) of the 32 paired samples with a discordant result, Previ Isola plated PU swabs were superior. In 8 (25%) of the 32 paired samples with a discordant result, control viscose swabs were superior. The quality of colony growth on culture media for further investigations was superior with Previ Isola inoculated plates compared to manual plating techniques. Gram stain results were concordant between the two methods in 62/112 samples (55%). In 50/112 samples (45%), the results of Gram staining were discordant between the two methods. In 34 (68%) of the 50 paired samples with discordant results, Gram staining of PU swabs was superior to that of control viscose swabs. In 16 (32%) of the 50 paired samples, Gram staining of control viscose swabs was superior to that of PU swabs. We report the first clinical evaluation of Previ Isola automated specimen inoculation for wound swab samples. This study suggests that use of an automated specimen inoculation system has good results with regard to CFU recovery, quality of Gram staining, and accuracy of diagnosis.

  14. Elevated prothrombin time on routine preoperative laboratory results in a healthy infant undergoing craniosynostosis repair: Diagnosis and perioperative management of congenital factor VII deficiency.

    Science.gov (United States)

    Jones, Kareen L; Greenberg, Robert S; Ahn, Edward S; Kudchadkar, Sapna R

    2016-01-01

    Congenital factor VII deficiency is a rare bleeding disorder with high phenotypic variability. It is critical that children with congenital Factor VII deficiency be identified early when high-risk surgery is planned. Cranial vault surgery is common for children with craniosynostosis, and these surgeries are associated with significant morbidity mostly secondary to the risk of massive blood loss. A two-month old infant who presented for elective craniosynostosis repair was noted to have an elevated prothrombin time (PT) with a normal activated partial thromboplastin time (aPTT) on preoperative labs. The infant had no clinical history or reported family history of bleeding disorders, therefore a multidisciplinary decision was made to repeat the labs under general anesthesia and await the results prior to incision. The results confirmed the abnormal PT and the case was canceled. Hematologic workup during admission revealed factor VII deficiency. The patient underwent an uneventful endoscopic strip craniectomy with perioperative administration of recombinant Factor VIIa. Important considerations for perioperative laboratory evaluation and management in children with factor VII deficiency are discussed. Anesthetic and surgical management of the child with factor VII deficiency necessitates meticulous planning to prevent life threatening bleeding during the perioperative period. A thorough history and physical examination with a high clinical suspicion are vital in preventing hemorrhage during surgeries in children with coagulopathies. Abnormal preoperative lab values should always be confirmed and addressed before proceeding with high-risk surgery. A multidisciplinary discussion is essential to optimize the risk-benefit ratio during the perioperative period. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

  15. Multi-modality molecular imaging: pre-clinical laboratory configuration

    Science.gov (United States)

    Wu, Yanjun; Wellen, Jeremy W.; Sarkar, Susanta K.

    2006-02-01

    In recent years, the prevalence of in vivo molecular imaging applications has rapidly increased. Here we report on the construction of a multi-modality imaging facility in a pharmaceutical setting that is expected to further advance existing capabilities for in vivo imaging of drug distribution and the interaction with their target. The imaging instrumentation in our facility includes a microPET scanner, a four wavelength time-domain optical imaging scanner, a 9.4T/30cm MRI scanner and a SPECT/X-ray CT scanner. An electronics shop and a computer room dedicated to image analysis are additional features of the facility. The layout of the facility was designed with a central animal preparation room surrounded by separate laboratory rooms for each of the major imaging modalities to accommodate the work-flow of simultaneous in vivo imaging experiments. This report will focus on the design of and anticipated applications for our microPET and optical imaging laboratory spaces. Additionally, we will discuss efforts to maximize the daily throughput of animal scans through development of efficient experimental work-flows and the use of multiple animals in a single scanning session.

  16. ANTIFUNGAL SUSCEPTIBILITY TESTING: CURRENT ROLE FROM THE CLINICAL LABORATORY PERSPECTIVE

    Directory of Open Access Journals (Sweden)

    Brunella Posteraro

    2014-04-01

    Full Text Available Despite availability of many antifungal agents, antifungal clinical resistance occurs, perhaps as a result of an infecting organism found to be resistant in vitro to one or more antifungals tested. Thus, antifungal susceptibility testing (AFST results, if timely generated by the clinical microbiology and communicated to clinicians, can aid them in the therapeutic decision making, especially for difficult-to-treat invasive candidiasis and aspergillosis. Although recently refined AFST methods are commercially available to allow a close antifungal resistance surveillance in many clinical setting, novel assays, relying on short-time antifungal drug exposure of fungal isolates, are upcoming tools for AFST. Based on emerging technologies such as flow cytometry, MALDI-TOF mass spectrometry, and isothermal microcalorimetry, these assays could provide a reliable means for quicker and sensitive assessment of AFST.

  17. Internet-based CBT for social phobia and panic disorder in a specialised anxiety clinic in routine care: Results of a pilot randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Kim Mathiasen

    2016-05-01

    This study was not able to document statistically significant clinical effect of iCBT with minimal therapist contact compared to a waiting list control group in a specialised anxiety clinic in routine care. However, a large and significant effect was seen on self-reported quality of life. Although these results offer an interesting perspective on iCBT in specialised care, they should be interpreted with caution, due to the limitations of the study. A large scale fully powered RCT is recommended.

  18. Customer satisfaction survey with clinical laboratory and phlebotomy services at a tertiary care unit level.

    Science.gov (United States)

    Koh, Young Rae; Kim, Shine Young; Kim, In Suk; Chang, Chulhun L; Lee, Eun Yup; Son, Han Chul; Kim, Hyung Hoi

    2014-09-01

    We performed customer satisfaction surveys for physicians and nurses regarding clinical laboratory services, and for outpatients who used phlebotomy services at a tertiary care unit level to evaluate our clinical laboratory and phlebotomy services. Thus, we wish to share our experiences with the customer satisfaction survey for clinical laboratory and phlebotomy services. Board members of our laboratory designed a study procedure and study population, and developed two types of questionnaire. A satisfaction survey for clinical laboratory services was conducted with 370 physicians and 125 nurses by using an online or paper questionnaire. The satisfaction survey for phlebotomy services was performed with 347 outpatients who received phlebotomy services by using computer-aided interviews. Mean satisfaction scores of physicians and nurses was 58.1, while outpatients' satisfaction score was 70.5. We identified several dissatisfactions with our clinical laboratory and phlebotomy services. First, physicians and nurses were most dissatisfied with the specimen collection and delivery process. Second, physicians and nurses were dissatisfied with phlebotomy services. Third, molecular genetic and cytogenetic tests were found more expensive than other tests. This study is significant in that it describes the first reference survey that offers a survey procedure and questionnaire to assess customer satisfaction with clinical laboratory and phlebotomy services at a tertiary care unit level.

  19. Epidemiologic, clinical and laboratory aspects of hepatitis E

    Indian Academy of Sciences (India)

    HEV infection: Clinical features · Hepatitis virus superinfection · HEV and cirrhosis: methods · HEV superinfection in cirrhosis · Hepatitis E: host cell damage · Intracellular cytokine expression · Slide 34 · Cytokine-expressing CD4 cells (ORF2) · Cytokine-expressing CD8 cells (ORF2) · Cytokine-expressing CD4 cells (ORF3).

  20. Implementation of Good Clinical Laboratory Practice (GCLP) guidelines within the External Quality Assurance Program Oversight Laboratory (EQAPOL).

    Science.gov (United States)

    Todd, Christopher A; Sanchez, Ana M; Garcia, Ambrosia; Denny, Thomas N; Sarzotti-Kelsoe, Marcella

    2014-07-01

    The EQAPOL contract was awarded to Duke University to develop and manage global proficiency testing programs for flow cytometry-, ELISpot-, and Luminex bead-based assays (cytokine analytes), as well as create a genetically diverse panel of HIV-1 viral cultures to be made available to National Institutes of Health (NIH) researchers. As a part of this contract, EQAPOL was required to operate under Good Clinical Laboratory Practices (GCLP) that are traditionally used for laboratories conducting endpoint assays for human clinical trials. EQAPOL adapted these guidelines to the management of proficiency testing programs while simultaneously incorporating aspects of ISO/IEC 17043 which are specifically designed for external proficiency management. Over the first two years of the contract, the EQAPOL Oversight Laboratories received training, developed standard operating procedures and quality management practices, implemented strict quality control procedures for equipment, reagents, and documentation, and received audits from the EQAPOL Central Quality Assurance Unit. GCLP programs, such as EQAPOL, strengthen a laboratory's ability to perform critical assays and provide quality assessments of future potential vaccines. © 2013.

  1. Intelligent Routines

    CERN Document Server

    Anastassiou, George A

    “Intelligent Routines II: Solving Linear Algebra and Differential Geometry with Sage” contains numerous of examples and problems as well as many unsolved problems. This book extensively applies the successful software Sage, which can be found free online http://www.sagemath.org/. Sage is a recent and popular software for mathematical computation, available freely and simple to use. This book is useful to all applied scientists in mathematics, statistics and engineering, as well for late undergraduate and graduate students of above subjects. It is the first such book in solving symbolically with Sage problems in Linear Algebra and Differential Geometry. Plenty of SAGE applications are given at each step of the exposition.

  2. Audit of the autoantibody test, EarlyCDT®-lung, in 1600 patients: an evaluation of its performance in routine clinical practice.

    Science.gov (United States)

    Jett, James R; Peek, Laura J; Fredericks, Lynn; Jewell, William; Pingleton, William W; Robertson, John F R

    2014-01-01

    EarlyCDT(®)-Lung may enhance detection of early stage lung cancer by aiding physicians in assessing high-risk patients through measurement of biological markers (i.e., autoantibodies). The test's performance characteristics in routine clinical practice were evaluated by auditing clinical outcomes of 1613 US patients deemed at high risk for lung cancer by their physician, who ordered the EarlyCDT-Lung test for their patient. Clinical outcomes for all 1613 patients who provided HIPAA authorization are reported. Clinical data were collected from each patient's treating physician. Pathology reports when available were reviewed for diagnostic classification. Staging was assessed on histology, otherwise on imaging. Six month follow-up for the positives/negatives was 99%/93%. Sixty-one patients (4%) were identified with lung cancer, 25 of whom tested positive by EarlyCDT-Lung (sensitivity=41%). A positive EarlyCDT-Lung test on the current panel was associated with a 5.4-fold increase in lung cancer incidence versus a negative. Importantly, 57% (8/14) of non-small cell lung cancers detected as positive (where stage was known) were stage I or II. EarlyCDT-Lung has been extensively tested and validated in case-control settings and has now been shown in this audit to perform in routine clinical practice as predicted. EarlyCDT-Lung may be a complementary tool to CT for detection of early lung cancer. Copyright © 2013 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

  3. An audit of dental prescriptions between clinics and dental laboratories.

    Science.gov (United States)

    Stewart, C A

    2011-08-12

    To discover the quality of written instructions from dentists to dental technicians and the nature of non-compliant prescriptions. An audit of laboratory prescription compliance was conducted within an NHS Trust Dental Teaching Hospital to determine the level of communication between dentists and dental technicians. One hundred and fifty prescriptions were audited from dental undergraduates and qualified dentists throughout the different departments. A total of two-thirds of prescriptions were considered non-compliant and failed to meet relevant ethical and legal guidelines. This problem was seen throughout all departments and at all professional levels. A breakdown in communication between dentists and technicians through the use of prescriptions is evident even within a close working environment.

  4. Clinical and laboratory evaluation of thyroid function following total laryngectomy in laryngeal cancer

    Directory of Open Access Journals (Sweden)

    Motasaddi Zarandy M

    2007-07-01

    Full Text Available Background: Hypothyroidism is a well-documented complication after treatment of laryngeal cancer and is particularly significant among patients undergoing laryngectomy. We investigated the frequency of hypothyroidism in patients treated with total laryngectomy for laryngeal cancer. We also evaluated the effect of neck radiotherapy on thyroid function after total laryngectomy for laryngeal cancer. Methods: In a cross-sectional study, we evaluated 31 patients with laryngeal squamous cell carcinoma (mean age 53.6 years. Among these patients, 14 were treated with surgery only and 17 were treated with surgery plus radiotherapy. Laboratory evaluation included levels of thyroid stimulating hormone (TSH, free T4, free T3, and antithyroid antibodies both preoperatively and postoperatively at the first day, as well as one and six months after surgery. Results: All patients had normal thyroid function before treatment; however, after 6 months, five patients (16.1% were hypothyroid. Of these, three patients (9.6% had subclinical symptoms, including elevated thyroid-stimulating hormone with normal free T4, and two patients (6.5% showed clinical symptoms of hypothyroidism. Radiotherapy and neck dissection were significantly associated with higher incidences of hypothyroidism. Conclusion: Our data suggest that hypothyroidism occurs in a substantial proportion of patients undergoing surgery for laryngeal cancer. The results indicate that thyroid function studies should be routinely performed in the follow-up care of laryngeal cancer patients, especially if radiotherapy and neck dissection were part of the treatment. We suggest that this approach will improve the patient's quality of life and diminish the co-morbidity associated with this kind of surgery.

  5. Clinical and laboratory assessment of dehydration severity in children with acute gastroenteritis.

    Science.gov (United States)

    Parkin, Patricia C; Macarthur, Colin; Khambalia, Amina; Goldman, Ran D; Friedman, Jeremy N

    2010-03-01

    To evaluate clinical and laboratory assessment of dehydration severity in children, 1 to 36 months, with acute gastroenteritis. Clinical and laboratory measures and weight change following rehydration were collected for enrolled children. Pediatric emergency department. Likelihood ratio (LR+) and 95% confidence interval (CI): for a clinical score of 0, the LR+ was 2.2 (95% CI = 0.9-5.3); for a clinical score of 1 to 4, the LR+ was 1.3 (95% CI = 0.90-1.74); for a clinical score of 5 to 8, the LR+ was 5.2 (95% CI = 2.2-12.8); for a venous pH Dehydration Scale and laboratory measures into clinical decision-making algorithms to assess dehydration severity in children with acute gastroenteritis.

  6. CLINICAL AND LABORATORY PROFILE OF PATIENTS WITH IDIOPATHIC CD4 LYMPHOCYTOPENIA- A RARE CLINICAL ENTITY

    Directory of Open Access Journals (Sweden)

    Vijayashree Thyagaraj

    2017-01-01

    Full Text Available BACKGROUND Since 1989, several investigators have reported unusual cases of severe opportunistic infections associated with CD4 lymphocytopenia in the absence of human immunodeficiency virus infection. The cause of this condition is unknown. The Centres for Disease Control and Prevention (CDC defines Idiopathic CD4 T Lymphocytopenia (ICL as a clinical condition in which patients with depressed numbers of circulating CD4+ T-cell lymphocytes (<300 cells/μL or <20% of total T cells at a minimum of two separate time points at least 6 weeks apart, have no laboratory evidence of infection with human HIV-1 or HIV-2, or any defined immunodeficiency or therapy associated with depressed levels of CD4 T cells. The aim of the study is to analyse the clinical profile, opportunistic infections, laboratory parameters and outcome in terms of survival of patients diagnosed with ICL. MATERIALS AND METHODS Eight HIV negative patients who presented with opportun