Maria Helena Vaisbich
Full Text Available INTRODUCTION: Nephrogenic diabetes insipidus is characterized by a lack of response in the distal nephron to the antidiuretic hormone arginine vasopressin. Manifestations include polyuria, polydipsia, hyposthenuria, recurrent episodes of dehydration and fever and growth failure. Most cases are caused by mutations in the AVPR2 gene. The mutant receptors are trapped intracellularly. METHOD: We studied five boys using clinical, laboratory and molecular data. The mean age at diagnosis was 14.6 months (range 6 to 24 and 12.2 years (7.8 to 19 after the follow-up period. The mean period of follow-up was 132.2 ± 50.9 months. RESULTS: The geometric means of the z-scores of weight and stature were -4.5 and -3.6, respectively, at diagnosis. At the last medical appointment, the z-scores of weight and stature were -0.3 and -0.9, respectively. Three patients were diagnosed with ureterohydronephrosis and exhibited increased post-void urine volume. Mutations in the AVPR2 gene were found in all patients, and the carrier status was confirmed in four of five cases. Two unrelated children presented identical mutations (S167L in arginine vasopressin R2. Two of the patients had a mutation that has already been described in other Brazilian families (R337X, and one patient showed a de novo mutation (Y128D in arginine vasopressin R2, since his mother's molecular analysis was normal. The recurrence risk for this family was significantly reduced. CONCLUSION: This study reports the clinical and laboratory characterization of Nephrogenic diabetes insipidus and reiterates the importance of the genetic basis that underlies the disease diagnosis and genetic counseling.
Federal Laboratory Consortium — The NDI specializes in applied research, development and performance of nondestructive inspection procedures (flourescent penetrant, magnetic particle, ultrasonics,...
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...
Sautter, Robert L; Thomson, Richard B
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.
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
Chapman, W. Max
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
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.
Handoo, Anil; Sood, Swaroop Krishan
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.
Mrak, Robert E.; Parslow, Tristram G.; Tomaszewski, John E.
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
Patel, Vaishali; McNamara, Lauren; Dullabh, Prashila; Sawchuk, Megan E; Swain, Matthew
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.
The Aging Aircraft NDI Validation Center (AANC) was established by the Federal Aviation Administration Technical Center (FAATC) at Sandia National Laboratories in August of 1991. The goal of the AANC is to provide independent validation of technologies intended to enhance the structural inspection of aging commuter and transport aircraft. The deliverables from the AANC`s validation activities are assessments of the reliability of existing and emerging inspection technologies as well as analyses of the cost benefits to be derived from their implementation. This paper describes the methodology developed by the AANC to assess the performance of NDI techniques. In particular, an experiment being developed to evaluate corrosion detection devices will be presented. The experiment uses engineered test specimens, as well as complete aircraft test beds to provide metrics for NDI validation.
Novak, Susan M; Marlowe, Elizabeth M
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.
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
Bakhtadze, Maxim A; Vernon, Howard; Zakharova, Olga B; Kuzminov, Kirill O; Bolotov, Dmitry A
Cross-cultural adaptation and psychometric testing. To perform a validated Russian translation and then to evaluate the validity and reliability of the Russian language version of the Neck Disability Index (NDI-RU). Neck pain is highly prevalent and can greatly affect daily activity. The Neck Disability Index (NDI) is the most frequently used scale for self-rating of disability due to neck pain. Its translated versions are applied in many countries. However, the Russian language version of the NDI has not been developed yet. Cross-cultural adaptation of the NDI-RU was performed according to established guidelines. Then, the NDI-RU was evaluated for content validity, concurrent criterion validity, internal consistency, test-retest reliability, factor structure, and minimum detectable change. Two hundred thirty-two patients took part in the study in total: 109 in validity (39.5 ± 10 yr), 123 in reliability (38.4 ± 11 yr; 80 in the test-retest phase). A culturally valid translation was achieved. NDI-RU total scores were distributed normally. Floor/ceiling effects were absent. Good values of Cronbach α were obtained for each item (from 0.80 to 0.84) and for the total NDI-RU (0.83). A 2-factor solution was found for the NDI-RU. The average interitem correlation coefficient was 0.53. Intraclass correlation coefficients for test-retest reliability coefficients ranged from 0.65 to 0.92 for different items and 0.91 for the total NDI-RU. Moderate correlation (Spearman rs = 0.62; P Russian language version of the Neck Disability Index resulted in a valid, reliable instrument that can be used both in clinical practice and scientific investigations. 1.
Melanson, Stacy E F; Lindeman, Neal I; Jarolim, Petr
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.
Lippi, Giuseppe; Favaloro, Emmanuel J
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.
Gray, Mark Girard [Los Alamos National Lab. (LANL), Los Alamos, NM (United States)
NDI based forward calculations of activation product concentrations can be systematically used to infer structural element concentrations from measured activation product concentrations with an iterative algorithm. The algorithm converges exactly for the basic production-depletion chain with explicit activation product production and approximately, in the least-squares sense, for the full production-depletion chain with explicit activation product production and nosub production-depletion chain. The algorithm is suitable for automation.
... 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...
Ramessur, Vinaysing; Hurreeram, Dinesh Kumar; Maistry, Kaylasson
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.
Szecsi, Pal Bela; Ødum, Lars
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...
Yokota, Hiromitsu; Yatomi, Yutaka
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.
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.
Askarian, Mehrdad; Motazedian, Nasrin; Palenik, Charles John
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.
Melo, Murilo R; Clark, Samantha; Barrio, Daniel
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.
Barth, Julian H
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.
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.
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.
Saadawi, Gilan; Harrison, James H.
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...
Buchan, Blake W.
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
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 ...
de Groot, Theun; Doornebal, Joan; Christensen, Birgitte M; Cockx, Simone; Sinke, Anne P; Baumgarten, Ruben; Bedford, Jennifer J; Walker, Robert J; Wetzels, Jack F M; Deen, Peter M T
Lithium is the mainstay treatment for patients with bipolar disorder, but it generally causes nephrogenic diabetes insipidus (NDI), a disorder in which the renal urine concentrating ability has become vasopressin insensitive. Li-NDI is caused by lithium uptake by collecting duct principal cells and downregulation of aquaporin-2 (AQP2) water channels, which are essential for water uptake from tubular urine. Recently, we found that the prophylactic administration of acetazolamide to mice effectively attenuated Li-NDI. To evaluate whether acetazolamide might benefit lithium-treated patients, we administered acetazolamide to mice with established Li-NDI and six patients with a lithium-induced urinary concentrating defect. In mice, acetazolamide partially reversed lithium-induced polyuria and increased urine osmolality, which, however, did not coincide with increased AQP2 abundances. In patients, acetazolamide led to the withdrawal of two patients from the study due to side effects. In the four remaining patients acetazolamide did not lead to clinically relevant changes in maximal urine osmolality. Urine output was also not affected, although none of these patients demonstrated overt lithium-induced polyuria. In three out of four patients, acetazolamide treatment increased serum creatinine levels, indicating a decreased glomerular filtration rate (GFR). Strikingly, these three patients also showed a decrease in systemic blood pressure. All together, our data reveal that acetazolamide does not improve the urinary concentrating defect caused by lithium, but it lowers the GFR, likely explaining the reduced urine output in our mice and in a recently reported patient with lithium-induced polyuria. The reduced GFR in patients prone to chronic kidney disease development, however, warrants against application of acetazolamide in Li-NDI patients without long-term (pre)clinical studies. Copyright © 2017 the American Physiological Society.
Bichet, Daniel G; Bockenhauer, Detlef
Nephrogenic diabetes insipidus (NDI), which can be inherited or acquired, is characterized by an inability to concentrate urine despite normal or elevated plasma concentrations of the antidiuretic hormone, arginine vasopressin (AVP). Polyuria with hyposthenuria and polydipsia are the cardinal clinical manifestations of the disease. About 90% of patients with congenital NDI are males with X-linked NDI who have mutations in the vasopressin V2 receptor (AVPR2) gene encoding the vasopressin V2 receptor. In less than 10% of the families studied, congenital NDI has an autosomal recessive or autosomal dominant mode of inheritance with mutations in the aquaporin-2 (AQP2) gene. When studied in vitro, most AVPR2 and AQP2 mutations lead to proteins trapped in the endoplasmic reticulum and are unable to reach the plasma membrane. Prior knowledge of AVPR2 or AQP2 mutations in NDI families and perinatal mutation testing is of direct clinical value and can avert the physical and mental retardation associated with repeated episodes of dehydration. Copyright © 2016 Elsevier Ltd. All rights reserved.
Ashkar, F.S.; Fishman, L.M.
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
Alvarez-Chavez, C R; Federico-Perez, R A; Gomez-Alvarez, A; Velazquez-Contreras, L E; Perez-Rios, R
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.
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.
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.
Brian H Shirts
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.
Ahmad, M Imteyaz; Ramesh, K L; Kumar, Ravi
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.
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
Oehmichen, Manfred; Hennig, Renate; Meissner, Christoph
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.
Full Text Available Isolated complex I deficiencies are one of the most commonly observed biochemical features in patients suffering from mitochondrial disorders. In the majority of these clinical cases the molecular bases of the diseases remain unknown suggesting the involvement of unidentified factors that are critical for complex I function.The Saccharomyces cerevisiae NDI1 gene, encoding the mitochondrial internal NADH dehydrogenase was previously shown to complement a complex I deficient strain in Caenorhabitis elegans with notable improvements in reproduction, whole organism respiration. These features indicate that Ndi1p can functionally integrate the respiratory chain, allowing complex I deficiency complementation. Taking into account the Ndi1p ability to bypass complex I, we evaluate the possibility to extend the range of defects/mutations causing complex I deficiencies that can be alleviated by NDI1 expression.We report here that NDI1 expressing animals unexpectedly exhibit a slightly shortened lifespan, a reduction in the progeny and a depletion of the mitochondrial genome. However, Ndi1p is expressed and targeted to the mitochondria as a functional protein that confers rotenone resistance to those animals and without affecting their respiration rate and ATP content.We show that the severe embryonic lethality level caused by the RNAi knockdowns of complex I structural subunit encoding genes (e.g. NDUFV1, NDUFS1, NDUFS6, NDUFS8 or GRIM-19 human orthologs in wild type animals is significantly reduced in the Ndi1p expressing worm.All together these results open up the perspective to identify new genes involved in complex I function, assembly or regulation by screening an RNAi library of genes leading to embryonic lethality that should be rescued by NDI1 expression.
Riba, Jordi; Barbanoj, Manel J
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.
Barker, Anna; Duster, Megan; Van Hoof, Sarah; Safdar, Nasia
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.
Kambe, M; Imidy, D; Matsubara, A; Sugimoto, Y
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.
Accetta, Nancy A; Gladstone, Elisa H; DiSogra, Charles; Wright, Elizabeth C; Briggs, Michael; Narva, Andrew S
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.
found that different capabilities were being used to determine inspection intervals for different aircraft . This led to an internal effort...capability of the NDI technique determines the inspection intervals and the Distribution Statement A. Approved for public release; distribution...damage and that the aircraft structure had to be inspectable . The results of the damage tolerance assessments were incorporated into USAF Technical
found that different capabilities were being used to determine inspection intervals for different aircraft . This led to an internal effort...capability of the NDI technique determines the inspection intervals and the Distribution Statement A. Approved for public release; distribution...damage and that the aircraft structure had to be inspectable . The results of the damage tolerance assessments were incorporated into USAF Technical
Autor leiab, et Ida-Virumaa peaks looma ühtse tugeva brändi, mille alusel tulevikuotsuseid teha. See peaks tooma välja soodsa asukoha eelised, võimalused, tööjõu kättesaadavuse, kasutusvalmid maa-alad, hinnad jne.
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…
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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.
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 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
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).
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
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.
Croxatto, A; Prod'hom, G; Faverjon, F; Rochais, Y; Greub, G
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.
Wang, Xin Ling; Song, Juan; Song, Qin Qin; Yu, Jie; Luo, Xiao Nuan; Wu, Gui Zhen; Han, Jun
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.
... 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...
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
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.
Inada, Masanori; Sato, Mayumi; Yoneyama, Akiko
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.
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.
Lopez, Joseph B; Jackson, David; Gammie, Alistair; Badrick, Tony
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.
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.
Forsyth, David S.; Fahr, Abbas; Leemans, Dirk V.; McRae, Ken I.
The economic drive towards using aircraft beyond their initial design life has created a great interest in damage-tolerance (DT) based maintenance. The DT approach relies on routine nondestructive inspections (NDI), and requires that the NDI performance to be quantified in terms probability of detection (POD) to determine the safe inspection intervals. The most common approach for determining NDI POD is to perform inspections on representative components or specimens simulating the actual parts. This approach is practical but can be very expensive. A more economical approach may be to use actual field inspection data to obtain POD. This approach is particularly attractive for airframe inspection techniques, since most airframe structures cannot be easily simulated. There are a number of difficulties with this approach: Firstly, there is usually a very limited amount of field data. This may require special statistical treatment. Secondly, crack growth data must exist to allow the estimation of flaw sizes at the inspection sites at inspection times before the flaws were found. These factors and others affect the confidence in the calculated POD, and must be quantified before POD data of this type can be used. In this work, data from full scale fatigue tests were analyzed, and methods of overcoming the problems of small sample sizes and crack growth data requirements were investigated.
Tufkova, Stoilka G; Yankov, Ivan V; Paskaleva, Diana A
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.
Soboleva, L A; Shul'diakov, A A; Oseeva, A O; Aleksandrova, E A
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.
Schwartz, Peter L.
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…
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.
Levin, Martin; Morgner, Raymond; Packer, Bernice
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.
... 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...
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.
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.
Kumar, Lokesh; Thakar, Alok; Thakur, Bhaskar; Sikka, Kapil
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.
Martín-Rabadán, Pablo; Martínez-Ruiz, Rocío; Cuadros, Juan; Cañavate, Carmen
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.
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.
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
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.
Mercedes Caridad García González
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.
Jordana-Lluch, Elena; Martró Català, Elisa; Ausina Ruiz, Vicente
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.
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.
Buljanović, Vikica; Patajac, Hrvoje; Petrovecki, Mladen
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
Buljanović, Vikica; Patajac, Hrvoje; Petrovečki, Mladen
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
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.
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
Hemarajata, Peera; Baghdadi, Jonathan D; Hoffman, Risa; Humphries, Romney M
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.
Sanches, Talita Rojas; Volpini, Rildo Aparecido; Massola Shimizu, Maria H; Bragança, Ana Carolina de; Oshiro-Monreal, Fabíola; Seguro, Antonio Carlos; Andrade, Lúcia
Lithium (Li)-treated patients often develop urinary concentrating defect and polyuria, a condition known as nephrogenic diabetes insipidus (NDI). In a rat model of Li-induced NDI, we studied the effect that sildenafil (Sil), a phosphodiesterase 5 (PDE5) inhibitor, has on renal expression of aquaporin-2 (AQP2), urea transporter UT-A1, Na(+)/H(+) exchanger 3 (NHE3), Na(+)-K(+)-2Cl(-) cotransporter (NKCC2), epithelial Na channel (ENaC; α-, β-, and γ-subunits), endothelial nitric oxide synthase (eNOS), and inducible nitric oxide synthase. We also evaluated cGMP levels in medullary collecting duct cells in suspension. For 4 wk, Wistar rats received Li (40 mmol/kg food) or no treatment (control), some receiving, in weeks 2-4, Sil (200 mg/kg food) or Li and Sil (Li+Sil). In Li+Sil rats, urine output and free water clearance were markedly lower, whereas urinary osmolality was higher, than in Li rats. The cGMP levels in the suspensions of medullary collecting duct cells were markedly higher in the Li+Sil and Sil groups than in the control and Li groups. Semiquantitative immunoblotting revealed the following: in Li+Sil rats, AQP2 expression was partially normalized, whereas that of UT-A1, γ-ENaC, and eNOS was completely normalized; and expression of NKCC2 and NHE3 was significantly higher in Li rats than in controls. Inulin clearance was normal in all groups. Mean arterial pressure and plasma arginine vasopressin did not differ among the groups. Sil completely reversed the Li-induced increase in renal vascular resistance. We conclude that, in experimental Li-induced NDI, Sil reduces polyuria, increases urinary osmolality, and decreases free water clearance via upregulation of renal AQP2 and UT-A1.
Kudo, Yoshiko; Osawa, Susumu
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.
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)
Martin, Bernardino Barcelo; Gomila, Isabel; Noce, Valeria
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 email@example.com.
Arvind Rishi MD; Syed T. Hoda MD; James M. Crawford MD, PhD
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...
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).
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
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.
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.
Stevens, C D
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.
Groot, T. de; Doornebal, J.; Christensen, B.M.; Cockx, S.; Sinke, A.P.; Baumgarten, R.; Bedford, J.J.; Walker, R.J.; Wetzels, J.F.M.; Deen, P.M.T.
Lithium is the mainstay treatment for patients with bipolar disorder, but it generally causes nephrogenic diabetes insipidus (NDI), a disorder in which the renal urine concentrating ability has become vasopressin insensitive. Li-NDI is caused by lithium uptake by collecting duct principal cells and
El Sayed, Khalid A; Chelette, Candace T
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.
Schmitz, Vanessa; Rosecler Bez el Boukhari, Marta
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.
Schmitz, Vanessa; Boukhari, Marta Rosecler Bez el
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
A.F. van Belkum (Alex); M. Welker (Martin); M. Erhard (Marcel); S. Chatellier (Sonia)
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
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 ...
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 ...
... 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, ...
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 ...
Cassel, Russell N.
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…
Nagase, Sumika; Kohguchi, Katsunori; Tohyama, Kaoru; Watanabe, Mikio; Iwatani, Yoshinori
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.
Akaike, Masashi; Fukutomi, Miki; Nagamune, Masami; Fujimoto, Akiko; Tsuji, Akiko; Ishida, Kazuko; Iwata, Takashi
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.
Annesley, Thomas M.; Cooks, Robert G.; Herold, David A.; Hoofnagle, Andrew N.
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
Ankie van den Broek
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.
Sacchini, Federico; Freeman, Kathleen P
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.
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.
Ewertsson, Mona; Allvin, Renée; Holmström, Inger K; Blomberg, Karin
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.
Hoerger, Thomas J.; Meadow, Ann
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
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.
Mancini, Irene; Pinzani, Pamela; Simi, Lisa
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...
Procop, Gary W; Yerian, Lisa M; Wyllie, Robert; Harrison, A Marc; Kottke-Marchant, Kandice
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.
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.
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.
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...
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
Moreno-Camacho, José L; Calva-Espinosa, Diana Y; Leal-Leyva, Yoseli Y; Elizalde-Olivas, Dolores C; Campos-Romero, Abraham; Alcántar-Fernández, Jonathan
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: firstname.lastname@example.org
Konnoff, Daniel C.; Plant, Thomas K.; Shiner, Elizabeth
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.
Pongrácz, Júlia; Kristóf, Katalin
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.
Isabel, Jeanne M
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.
Parsons, Patrick J.; Barbosa, Fernando
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.
Parsons, Patrick J.; Barbosa, Fernando
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
P S Rakesh
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.
Khatri, Roshan; K C, Sanjay; Shrestha, Prabodh; Sinha, J N
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.
Bakshi, Sonal R; Shukla, Shilin N; Shah, Pankaj M
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.
Rizk, Mostafa M; Zaki, Adel; Hossam, Nermine; Aboul-Ela, Yasmin
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.
Hoffmann, Johannes J M L
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.
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.
Grasas, Alex; Ramalhinho, Helena; Pessoa, Luciana S; Resende, Mauricio G C; Caballé, Imma; Barba, Nuria
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.
Bixler, E. O.; Kales, A.; Kales, J. D.
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.
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
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.
Hoda, Syed T.; Crawford, James M.
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
Arvind Rishi MD
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.
Andreu, Antonia; Matas, Lurdes
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.
Bugdayci, Guler; Oguzman, Hamdi; Arattan, Havva Yasemin; Sasmaz, Guler
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.
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.
Lauer, J L; VanDrunen, N A; Washburn, J W; Balfour, H H
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.
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
... 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...
O. V. Usacheva
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
Azemi, Mehmedali; Berisha, Majlinda; Ismaili-Jaha, Vlora; Kolgeci, Selim; Avdiu, Muharrem; Jakupi, Xhevat; Hoxha, Rina; Hoxha-Kamberi, Teuta
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...
Carlos Vilaplana Pérez
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
... 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...
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
Berenice L. Santos
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.
Costa, H.F.Z. da.
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)
Legrys, V A; Beck, S J; Laudicina, R J
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.
Kobashi, L I; Raible, D A
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.
Saroch, Atul; Arya, Vivek; Sinha, Nitin; Taneja, R S; Sahai, Pooja; Mahajan, R K
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.
Chang, Ronald; Fox, Erin E; Greene, Thomas J
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...
Zanatta, Djulie Anne de Lemos; Rossini, Mariane de Mello; Trapani Júnior, Alberto
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.
Kiehlbauch, Julia A.; Hannett, George E.; Salfinger, Max; Archinal, Wendy; Monserrat, Catherine; Carlyn, Cynthia
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
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.
Sinard, John H; Gershkovich, Peter
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.
Godolphin, W; Bodtker, K; Uyeno, D; Goh, L O
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.
Halac, Gulistan; Tekturk, Pinar; Eroglu, Saliha; Cikrikcioglu, Mehmet Ali; Cimendur, Ozlem; Kilic, Elif; Asil, Talip
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.
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.
[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].
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.
... 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...
... § 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...
Berenice L. Santos
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
Magnette, A; Chatelain, M; Chatelain, B; Ten Cate, H; Mullier, F
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
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.
... 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...
... 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...
... 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...
... 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...
... 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...
... 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...
Thue, Geir; Jevnaker, Marianne; Gulstad, Guri Andersen; Sandberg, Sverre
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.
Lale Gündoğdu Çelebi
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
... 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...
... 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...
Iwai, N; Nakamura, H; Miyazu, M; Kasai, K; Watanabe, Y; Taneda, Y; Ozaki, T; Matsui, S; Maki, T; Tauchi, N
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.
Hayward, C P M; Moffat, K A; George, T I; Proytcheva, M; Iorio, A
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.
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.
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...
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.
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
Grist, N R; Emslie, J A
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...
... 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...
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.
de Kieviet, Wim; Blaton, Victor; Kovacs, Gabor L; Palicka, Vladimir; Pulkki, Kari
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
... 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.
Wennig R; Humbel R-L
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.
Mugii, Naoki; Hasegawa, Minoru; Matsushita, Takashi; Hamaguchi, Yasuhito; Oohata, Sacihe; Okita, Hirokazu; Yahata, Tetsutarou; Someya, Fujiko; Inoue, Katsumi; Murono, Shigeyuki; Fujimoto, Manabu; Takehara, Kazuhiko
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...
Lazarus, Michelle D.; Dos Santos, Jason A.; Haidet, Paul M.; Whitcomb, Tiffany L.
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,…
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.
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
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
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.
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 ...
Anet Papazovska Cherepnalkovski
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.
... 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...
Nishibori, Masahiro; Asayama, Hitoshi; Kimura, Satoshi; Takagi, Yasushi; Hagihara, Michio; Fujiwara, Mutsunori; Yoneyama, Akiko; Watanabe, Takashi
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
Baron, Jason M.; Dighe, Anand S.
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
Jason M Baron
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.
Kouassi, Kafui; Fétéké, Lochina; Assignon, Selom; Dorkenoo, Ameyo; Napo-Koura, Gado
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.
Miller, Shelley; Humphries, Romney M
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.
Dubay, Christopher J.; Zimmerman, David; Popovich, Bradley
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.
Full Text Available OBJECTIVE: Narrow diameter implants (NDI (i.e. diameter <3.75 mm are a potential solution for specific clinical situations, such as reduced interradicular bone, thin alveolar crest and replacement of teeth with small cervical diameter. NDI have been available in clinical practice since the 1990s, but only few studies have analyzed their clinical outcome and no study have investigated NDI inserted in fresh-frozen bone (FFB grafts. Thus, a retrospective study on a series of NDI placed in homologue FFB was designed to evaluate their clinical outcome. MATERIAL AND METHODS: In the period between December 2003 and December 2006, 36 patients (22 females and 14 males, mean age 53 years with FFB grafts were selected and 94 different NDI were inserted. The mean follow-up was 25 months. To evaluate the effect of several host-, surgery-, and implant-related factors, marginal bone loss (MBL was considered an indicator of success rate (SCR. The Kaplan Meier algorithm and Cox regression were used. RESULTS: Only 5 out of 94 implants were lost (i.e. survival rate - SVR 95.7% and no differences were detected among the studied variables. On the contrary, the Cox regression showed that the graft site (i.e. maxilla reduced MBL. CONCLUSIONS: NDI inserted in FFB have a high SVR and SCR similar to those reported in previous studies on regular and NDI inserted in non-grafted jaws. Homologue FFB is a valuable material in the insertion of NDI.
Ulrich, Steve; Sutch, Tabitha; Szulczewski, Greg; Schweizer, Matthias; Barbosa, Newton; Araujo, Paulo
We investigate the P(NDI2OD-T2) photophysical properties via absorbance and fluorescence spectroscopy, in association with the experimental approach baptized Stokes Spectroscopy, which provides valuable material information through the acquisition and analysis of the fluorescence polarization degree. By changing solvents and using different samples such as solutions, thick, and thin films, it is possible to control the polarization degree spectrum associated to the fluorescence emitted by the polymer's isolated chains and aggregates. We show that the polarization degree could become a powerful tool to obtain information related to the samples morphology, which is connected to their microscopic structure. Moreover, the polarization degree spectra suggest that depolarization effects linked to energy and charge transfer mechanisms are likely taking place. Our findings indicate that P(NDI2OD-T2) polymers are excellent candidates for the advancement of organic technologies that rely on the emission and detection of polarized lights. © 2018 IOP Publishing Ltd.
Montoya, Jaime C; Rebulanan, Carina L; Parungao, Nico Angelo C; Ramirez, Bernadette
Globally, there are growing efforts to address diseases through the advancement in health research and development (R&D), strengthening of regional cooperation in science and technology (particularly on product discovery and development), and implementation of the World Health Assembly Resolution 61.21 (WHA61.21) on the Global Strategy and Plan of Action on Public Health, Innovation, and Intellectual Property (GSPA-PHI). As such, the Association of Southeast Asian Nations (ASEAN) is responding to this through the establishment of the ASEAN-Network for Drugs, Diagnostics, Vaccines, and Traditional Medicines Innovation (ASEAN-NDI). This is important in the ASEAN considering that infectious tropical diseases remain prevalent, emerging, and reemerging in the region. This paper looks into the evolution of the ASEAN-NDI from its inception in 2009, to how it is at present, and its plans to mitigate public health problems regionally and even globally.
Sun, Yushi; Sun, Changhong; Zhu, Harry; Wincheski, Buzz
Stress corrosion cracking in the relief radius area of a space shuttle primary reaction control thruster is an issue of concern. The current approach for monitoring of potential crack growth is nondestructive inspection (NDI) of remaining thickness (RT) to the acoustic cavities using an eddy current or remote field eddy current probe. EDM manufacturers have difficulty in providing accurate RT calibration standards. Significant error in the RT values of NDI calibration standards could lead to a mistaken judgment of cracking condition of a thruster under inspection. A tool based on eddy current principle has been developed to measure the RT at each acoustic cavity of a calibration standard in order to validate that the standard meets the sample design criteria.
Rishniw, Mark; Pion, Paul D; Maher, Tammy
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.
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.
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)
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
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
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
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.
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
Orofino-Costa, Rosane; de Macedo, Priscila Marques; Rodrigues, Anderson Messias; Bernardes-Engemann, Andréa Reis
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
Orofino-Costa, Rosane; Macedo, Priscila Marques de; Rodrigues, Anderson Messias; Bernardes-Engemann, Andréa Reis
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.
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.
Owen, Robert J; Zebala, Lukas P; Peters, Colleen; McAnany, Steven
Retrospective review. To determine the correlation of Patient-Reported Outcomes Measurement Information System (PROMIS) physical function with Neck Disability Index (NDI) and Modified Japanese Orthopedic Association (mJOA) scores in the surgical cervical myelopathy patient population. Outcome measures such as NDI and mJOA are essential for analyzing treatments for cervical myelopathy. Administrative burdens impose limits on completion of these measures. The PROMIS group developed an outcome measure to improve reporting of patient symptoms and function and to reduce administrative burden. Despite early success, NDI and mJOA have not been compared with PROMIS in patients with cervical myelopathy. This study determines the correlation of NDI and mJOA with PROMIS in surgical patients with cervical myelopathy. A total of 60 patients with cervical myelopathy undergoing surgery were included. PROMIS, NDI, and mJOA were collected preoperatively, and in the first 6 months postoperatively. Correlations between NDI, mJOA, and PROMIS were quantified using Pearson correlation coefficients. Students t tests were used to test significance. All 60 (100%) of patients completed preoperative questionnaires. Fifty-five (92%) of patients completed initial follow-up questionnaires within the first 6 months. PROMIS physical function and NDI demonstrated a strong negative correlation at baseline and in initial follow-up (R = -0.69, -0.76). PROMIS and mJOA demonstrated a strong positive correlation at baseline and in initial follow-up (R = 0.61, 0.72). PROMIS physical function has a strong negative correlation with NDI and a strong positive correlation with mJOA at baseline and in the early postoperative course in patients undergoing surgery for cervical myelopathy. Surgeons may factor these outcomes into the delivery and interpretation of patient-reported outcome measures in this population. Use of PROMIS may improve completion of outcome measures in the office and reduce
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.
Wu, Yanjun; Wellen, Jeremy W.; Sarkar, Susanta K.
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.
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.
Koh, Young Rae; Kim, Shine Young; Kim, In Suk; Chang, Chulhun L; Lee, Eun Yup; Son, Han Chul; Kim, Hyung Hoi
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.
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).
Todd, Christopher A; Sanchez, Ana M; Garcia, Ambrosia; Denny, Thomas N; Sarzotti-Kelsoe, Marcella
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.
Stewart, C A
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.
Parkin, Patricia C; Macarthur, Colin; Khambalia, Amina; Goldman, Ran D; Friedman, Jeremy N
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.
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 opportunistic infections and who were diagnosed with ICL from 2007 to 2015 were included in the study. A detailed history was taken; physical examination was performed and the nature of illness with which they presented was documented. Then, CD4 and CD8 counts were done and CD4 count was repeated after a 6-week interval. The patients were followed up until discharge or death. RESULTS The mean age was 37.50±9.55 years. There were six males (75% and two females (25%. Fever was a presenting symptom among six (75% of them. Two were diagnosed to have cutaneous cryptococcosis (25%, two with invasive aspergillosis (25% and four with tuberculosis (50%. Absolute lymphocyte count was less than 1200 in seven patients (87.5%, which roughly correlates with a CD4 count of less than 200 cells/μL, among PLWHIV. The mean CD4 count was 183.63±63.74 cells/μL during the first measurement and 214.43±103.98 cells/μL during the second one. Two patients died (37.5%. None of the patients were recorded to have any form of malignancy
Full Text Available Recently, David Barlow (2004, a pioneer in the field of anxiety disorders, has proposed that psychologists should abandon the concept of psychotherapy and rather use the one of “psychological treatment”. The provoking idea behind this proposal is that the concept of psychotherapy, relying on the notion of “therapeutic school” should be discarded by professional psychologists because it relies too much on conceptions based on pre-scientific models. Barlow (2004 insists that, today, psychology as an empirical science has gathered sufficient knowledge and know-how to found clinical practice. It is no longer necessary to rely on pre-scientific theories. Further, Barlow’s perspective opens clinical practice to the entire field of psychology, i.e. to the advances accomplished by research on emotion, cognition, learning, development, etc.
Türkkan, Emine; Berrak, Su Gülsün; Canpolat, Cengiz
The Beta ((3) thalassemia syndromes are a heterogeneous group of genetic disorders. The frequency of thalassemia is dependent on the ethnic origins of the patient population. Turkey is located in a geographic area of the world where thalassemia syndromes are common. The incidence rate of (3-thalassemia carriers was stated to be 2 per cent in Turkey. Clinical manifestations are diverse and range from asymptomatic hypochromia and microcytosis to profound anemia leading to death in early childho...
Objectives: The aim of this study wasto draw attention to the clinical course of the disease and some laboratoryfindings in cats diagnosed with Toxoplasmosis.Materials and Methods: Toxoplasma gondiiseropositive 14 cats were used in this study. A serologicalevaluation was carried out to determine the presence of Toxoplasmagondii specific IgG using commercial diagnostic kits, by theenzyme-linked immunosorbent assay method. Hematological andclinical changes of those cats were recorded. Results:...
Dozio, Elena; Di Gaetano, Nicola; Findeisen, Peter; Corsi Romanelli, Massimiliano Marco
This review summarizes current knowledge about glycated albumin. We review the changes induced by glycation on the properties of albumin, the pathological implications of high glycated albumin levels, glycated albumin quantification methods, and the use of glycated albumin as a complementary biomarker for diabetes mellitus diagnosis and monitoring and for dealing with long-term complications. The advantages and limits of this biomarker in different clinical settings are also discussed.
Albano Lilian M. J.
Full Text Available The mucopolysaccharidoses (MPS are a heterogeneous group of inborn errors of lysosomal glycosaminoglycan (GAG metabolism. The importance of this group of disorders among the inborn errors of metabolism led us to report 19 cases. METHOD: We performed clinical, radiological, and biochemical evaluations of the suspected patients, which allowed us to establish a definite diagnosis in 19 cases. RESULTS: Not all patients showed increased GAG levels in urine; enzyme assays should be performed in all cases with strong clinical suspicion. The diagnosis was made on average at the age of 48 months, and the 19 MPS cases, after a full clinical, radiological, and biochemical study, were classified as follows: Hurler -- MPS I (1 case; Hunter -- MPS II (2 cases; Sanfilippo -- MPS III (2 cases; Morquio -- MPS IV (4 cases; Maroteaux-Lamy -- MPS VI (9 cases; and Sly -- MPS VII (1 case. DISCUSSION: The high relative frequency of Maroteaux-Lamy disease contrasts with most reports in the literature and could express a population variability.
Witry, Matthew J; Doucette, William R
To identify states with laws that restrict to whom clinical laboratories may release copies of laboratory test results and to describe how these laws may affect pharmacists' ability to obtain patient laboratory test results. Researchers examined state statutes and administrative codes for all 50 states and the District of Columbia at the University of Iowa Law Library between June and July 2007. Researchers also consulted with lawyers, state Clinical Laboratory Improvement Amendments officers, and law librarians. Laws relating to the study objective were analyzed. 34 jurisdictions do not restrict the release of laboratory test results, while 17 states have laws that restrict to whom clinical laboratories can send copies of test results. In these states, pharmacists will have to use alternative sources, such as physician offices, to obtain test results. Pharmacists must consider state law before requesting copies of laboratory test results from clinical laboratories. This may be an issue that state pharmacy associations can address to increase pharmacist access to important patient information.
Gijsbers, C. F. M.; Benninga, M. A.; Büller, H. A.
Aim: To investigate the clinical and laboratory findings in children with recurrent abdominal pain (RAP). Methods: Consecutive patients with RAP (Apley criteria), age 4-16 years, referred to a secondary medical centre were evaluated by a standardized history, physical examination and laboratory
Mohammadzadeh, Niloofar; Safdari, Reza
Studies of the causes of cancer, early detection, prevention or treatment need accurate, comprehensive, and timely cancer data. The clinical laboratory provides important cancer information needed for physicians which influence clinical decisions regarding treatment, diagnosis and patient monitoring. Poor communication between health care providers and clinical laboratory personnel can lead to medical errors and wrong decisions in providing cancer care. Because of the key impact of laboratory information on cancer diagnosis and treatment the quality of the tests, lab reports, and appropriate lab management are very important. A laboratory information management system (LIMS) can have an important role in diagnosis, fast and effective access to cancer data, decrease redundancy and costs, and facilitate the integration and collection of data from different types of instruments and systems. In spite of significant advantages LIMS is limited by factors such as problems in adaption to new instruments that may change existing work processes. Applications of intelligent software simultaneously with existing information systems, in addition to remove these restrictions, have important benefits including adding additional non-laboratory-generated information to the reports, facilitating decision making, and improving quality and productivity of cancer care services. Laboratory systems must have flexibility to change and have the capability to develop and benefit from intelligent devices. Intelligent laboratory information management systems need to benefit from informatics tools and latest technologies like open sources. The aim of this commentary is to survey application, opportunities and necessity of intelligent clinical laboratory as a tool to increase cancer care management productivity.
In the last few decades, laboratory medicine has undergone monumental changes, and laboratory technology, which has made enormous advances, now has new clinical applications thanks to the identification of a growing number of biomarkers and risk factors conducive to the promotion of predictive and preventive interventions that have enhanced the role of laboratory medicine in health care delivering. However, the paradigm shift in the past 50 years has led to a gap between laboratory and clinic, with an increased risk of inappropriateness in test request and interpretation, as well as the consolidation of analytical work in focused factories and megastructurers oriented only toward achieving greater volumes, decreasing cost per test and generating a vision of laboratory services as simple commodities. A careful historical revision of the changing models for delivering laboratory services in the United States leads to the prediction that there are several reasons for counteracting the vision of clinical laboratory as a commodity, and restoring the true nature of laboratory services as an integral part of the diagnosis and therapy process. The present study, which reports on internal and external drivers for change, proposes an integrated vision of quality in laboratory medicine.
T.V. Sorokman; O.V. Makarova; V.G. Ostapchuk
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...
Dubay, Christopher J.; Zimmerman, David; Popovich, Bradley
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 ...
Metz, J.; Van der Walt, L.A.; Malan, J.M.
This bibliography is restricted mainly to AEC-supported projects which are considered to amply reflect the widespread use of radioisotopes in clinical and laboratory medicine in South Africa and which describe research with radioisotopes of some direct relevance to diagnostic-clinical or laboratory medicine, or both, but excluding therapy with isotopes. General information is given in this review on oncology, endocrinology, metabolism and nutrition, haematology, neurology, angiocardiology, pulmonology, gastroenterology, gynaecology and obstetrics, nephrology, immunology and transplantation, microbiology and parasitology
Full Text Available I laboratori clinici operano in stretto contatto con i pazienti e collaborano direttamente alla loro cura, in modo corresponsabile con i medici e i reparti ospedalieri. L’importanza della loro attività per la salute pubblica rende obbligatoria l’esplicitazione di alcuni punti finora spesso considerati ovvii. Ai pazienti dev’essere infatti garantito che: - i metodi di analisi utilizzati siano stati preliminarmente valutati, per confermare la loro rispondenza agli obiettivi dell’analisi stessa, verificati, per controllarne l’effettiva efficacia e, se necessario, validati per garantire che siano appropriati allo scopo; - il personale che esegue le analisi sia stato adeguatamente formato e quindi tecnicamente competente; - il laboratorio assicuri un’adeguata consulenza allo staff clinico che richiede le analisi, allo scopo di ottenere una sinergia tra il laboratorio e il clinico che ha in cura il paziente, sia nella fase di prelievo di materiale biologico, sia nella fase di interpretazione dei risultati. Tutto ciò è necessario per dimostrare ai pazienti
Full Text Available Background: Plant-origin foods are among the most important sources of food allergic reactions. An increase in the incidence of sesame seed allergy among children and adults has been reported in recent years. The aim of this preliminary study was to investigate the prevalence, importance and clinical manifestations of sesame allergy among Iranian patients.Methods: In a cross-sectional survey, 250 patients with suspected IgE-mediated food allergies completed a questionnaire and underwent skin prick tests with sesame extract as well as cross-reacting foods (walnut, soya and peanut. Total IgE and sesame-specific IgE levels were measured. Patients with positive skin test reactions and/or IgE specific for sesame without clinical symptoms were considered sensitive to sesame. The patients who also had clinical symptoms with sesame consumption were diagnosed as allergic to sesame.Results: Of the 250 patients enrolled in this study, 129 were male and 121 female, with a mean age of 11.7 years. The most common food allergens were cow's milk, egg, curry, tomato and sesame. Sesame sensitivity was found in 35 patients (14.1%. Only five patients (2% had sesame allergy. Sesame-sensitive patients had a significantly higher frequency of positive prick test to cross-reacting foods when compared to non-sensitized patients (p=0.00. The type of symptom was independent of gender and age of the patients, but urticaria and dermatitis-eczema were significantly more frequent in sensitized patients (p=0.008.Conclusions: This is the first study addressing the prevalence of sesame seed allergy in Iranian population. We found sesame to be a common and important cause of food allergy. The panel of foods recommended for use in diagnostic allergy tests should be adjusted.
Baroni, C; Marchionni, S
The use of calcium-phosphate casein on hypomineralized molars (molar incisor hypomineralization, MIH) has been proposed but not clinically investigated. Qualitative and quantitative effects of supplementation with a calcium-phosphate casein product on MIH molars were monitored over a period of three years. Molar replicas, minimally invasive biopsies and their SEM microphotographs, plus ESEM/EDX semi-quantitative peaks of elements present in affected enamel were evaluated. Mineralization, morphology, and porosity appeared markedly improved, with calcium and phosphate levels reaching almost normal levels at three years' follow-up. The hypothesis tested was rejected, since calcium-phosphate casein improved enamel morphology in vivo.
Emery, Paul; van der Heijde, Désirée; Østergaard, Mikkel
Evaluate relationships between MRI and clinical/laboratory/radiographic findings in rheumatoid arthritis (RA).......Evaluate relationships between MRI and clinical/laboratory/radiographic findings in rheumatoid arthritis (RA)....
Azemi, Mehmedali; Berisha, Majlinda; Ismaili-Jaha, Vlora; Kolgeci, Selim; Avdiu, Muharrem; Jakupi, Xhevat; Hoxha, Rina; Hoxha-Kamberi, Teuta
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 bacteria, viruses. protozoa and fungi was positive in 425 (49.76%) cases. From this number the test on bacteria was positive in 248 (58.62%) cases, on viruses it was positive in 165 (39.0%), on protozoa in 9 (2.12%) cases and on fungi only one case. Rotavirus was the most frequent one in viral test, it was isolated in 142 (86.06%) cases, adenoviruses were found in 9 (5.45%) cases and noroviruses in only one case. The same feces sample that contained rotavirus and adenoviruses were isolated in five cases, whereas rotavirus with bacteria was isolated in the same feces sample in five cases. The biggest number of cases 62 (43.66%) were of the age 6-12 months, whereas the smallest number 10 (7.04%) cases were of the age 37-60 months. There were 76 (53.52%) of cases of male gender, from rural areas there were 81 (57.04%) cases and there were 58 (40.80%) cases during the summer period. Among the clinical symptoms the most prominent were diarrhea, vomiting, high temperature, whereas the different degree of dehydration were present in all cases (the most common one was moderate dehydration). The most frequent one was isonatremic dehydration in 91 (64.08%) cases, less frequent one was hypernatremic dehydration in 14 (9.85%) cases. The majority of cases (97.89%) had lower blood pH values, whereas 67 (47.17%) cases had pH values that varied from 7.16 -7.20 (curve peak), normal values were registered in only 3 (2.11%) cases. Urea values were increased in 45 (31.07%) cases (the maximum value
Chew, L P; Chua, H H
In 2008, an outbreak of chikungunya infection occurred in Johor. We performed a retrospective review of all laboratory confirmed adult chikungunya cases admitted to Hospital Sultanah Aminah, Johor Bahru from April to August 2008, looking into clinical and laboratory features. A total of 18 laboratory confirmed cases of chikungunya were identified with patients presenting with fever, joint pain, rash and vomiting. Haemorrhagic signs were not seen. Lymphopenia, neutropenia, thrombocytopenia, raised liver enzymes and deranged coagulation profile were the prominent laboratory findings. We hope this study can help guide physician making a diagnosis of chikungunya against other arborviruses infection.
Men'shikov, V V
The article deals with the factors impacting the reliability of clinical laboratory information. The differences of qualities of laboratory analysis tools produced by various manufacturers are discussed. These characteristics are the causes of discrepancy of the results of laboratory analyses of the same analite. The role of the reference system in supporting the comparability of laboratory analysis results is demonstrated. The project of national standard is presented to regulate the requirements to standards and calibrators for analysis of qualitative and non-metrical characteristics of components of biomaterials.
McHardy, Ian H; Wu, Max; Shimizu-Cohen, Robyn; Couturier, Marc Roger; Humphries, Romney M
Despite recent advances in diagnostic technology, microscopic examination of stool specimens remains central to the diagnosis of most pathogenic intestinal protozoa. Microscopy is, however, labor-intensive and requires a skilled technologist. New, highly sensitive diagnostic methods have been developed for protozoa endemic to developed countries, including Giardia lamblia (syn. G. intestinalis/G. duodenalis) and Cryptosporidium spp., using technologies that, if expanded, could effectively complement or even replace microscopic approaches. To date, the scope of such novel technologies is limited and may not include common protozoa such as Dientamoeba fragilis, Entamoeba histolytica, or Cyclospora cayetanensis. This minireview describes canonical approaches for the detection of pathogenic intestinal protozoa, while highlighting recent developments and FDA-approved tools for clinical diagnosis of common intestinal protozoa.
Carbonnelle, Etienne; Nassif, Xavier
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.
Ehrmeyer, Sharon S; Laessig, Ronald H
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.
As of January 1, 2016, microbiology laboratories can choose to adopt a new quality control option, the Individualized Quality Control Plan (IQCP), under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). This voluntary approach increases flexibility for meeting regulatory requirements and provides laboratories the opportunity to customize QC for their testing in their unique environments and by their testing personnel. IQCP is an all-inclusive approach to quality based on risk management to address potential errors in the total testing process. It includes three main steps, (1) performing a risk assessment, (2) developing a QC plan, and (3) monitoring the plan through quality assessment. Resources are available from the Centers for Medicare & Medicaid Services, Centers for Disease Control and Prevention, American Society for Microbiology, Clinical and Laboratory Standards Institute, and accrediting organizations, such as the College of American Pathologists and Joint Commission, to assist microbiology laboratories implementing IQCP.
... certain in vitro clinical or laboratory testing under general license. 32.71 Section 32.71 Energy NUCLEAR... certain in vitro clinical or laboratory testing under general license. An application for a specific... only by physicians, veterinarians in the practice of veterinary medicine, clinical laboratories or...
Evangelopoulos, Angelos A; Dalamaga, Maria; Panoutsopoulos, Konstantinos; Dima, Kleanthi
In the early 80s, the word automation was used in the clinical laboratory setting referring only to analyzers. But in late 80s and afterwards, automation found its way into all aspects of the diagnostic process, embracing not only the analytical but also the pre- and post-analytical phase. While laboratories in the eastern world, mainly Japan, paved the way for laboratory automation, US and European laboratories soon realized the benefits and were quick to follow. Clearly, automation and robotics will be a key survival tool in a very competitive and cost-concious healthcare market. What sets automation technology apart from so many other efficiency solutions are the dramatic savings that it brings to the clinical laboratory. Further standardization will assure the success of this revolutionary new technology. One of the main difficulties laboratory managers and personnel must deal with when studying solutions to reengineer a laboratory is familiarizing themselves with the multidisciplinary and technical terminology of this new and exciting field. The present review/glossary aims at giving an overview of the most frequently used terms within the scope of laboratory automation and to put laboratory automation on a sounder linguistic basis.
Gong, Yanping; Adeli, Khosrow
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.
Full Text Available Brucellosis is a multisystem disease with diverse clinical presentations and involvement of the nervous system is considered to 5 to be 10% in adult patients and 1% in children. The presentations of neurobrucellosis includes meningoencephalitis, subarachnoid haemorrhage, myelitis, radiculoneuritis, intracerebral and epidural abscess, psychosis and vascular syndrome. Twenty-two patients with neurobrucellosis are described. Ten patients had meningoencephalitis, seven patients had meningitis, three patients had polyradiculopathy and one patient presented with spinal epidural abscess and one patient had brain abscess. Results of an agglutination test for Brucella in serum were positive for all patients (>1:160; eight of 15 patients had positive agglutination test in CSF. Five patients had positive blood cultures, 3 patients had positive bone marrow cultures and 2 of 15 patients had positive CSF cultures. All of cultures were Brucella Mellitensis. Antimicrobial treatment included concurrent administration of Doxycycline, Rifampin and Trimethoprim-Sulfametoxazole. Four patients received Dexamethason concurrently. In conclusion, nervous system involvement is a serious manifestation of brucellosis. As brucellosis is an endemic disease in Iran we suggest that brucellosis be investigated with neurological symptoms and signs.
Angela Smith, PharmD Candidate
Full Text Available Objective: To evaluate a pilot of a laboratory model for relating pharmacogenetics to clinical decision making. Case Study: This pilot was undertaken and evaluated to help determine if a pharmacogenetics laboratory should be included in the core Doctor of Pharmacy curriculum. The placement of the laboratory exercise in the curriculum was determined by identifying the point in the curriculum where the students had been introduced to the chemistry of deoxyribonucleic acid (DNA as well as instructed on the chemistry of genetic variation. The laboratory included cytochrome P450 2C19 genotyping relative to the *2 variant. Twenty-four students served as the pilot group. Students provided buccal swabs as the source of DNA. Students stabilized the samples and were then provided instructions related to sample preparation, polymerase chain reaction, and gel electrophoresis. The results were reported as images of gels. Students used a reference gel image to compare their results to. Students then applied a dosing algorithm to make a “clinical decision” relative to clopidogrel use. Students were offered a post laboratory survey regarding attitudes toward the laboratory. Twenty-four students completed the laboratory with genotyping results being provided for 22 students (91.7%. Sixteen students were wild-type (*1/*1, while six students were heterozygous (*1/*2. Twenty-three students (96% completed the post laboratory survey. All 23 agreed (6, 26.1% or strongly agreed (17, 73.9% that the laboratory “had relevance and value in the pharmacy curriculum”. Conclusion: The post pilot study survey exploring a laboratory model for pharmacogenetics related to clinical decision making indicated that such a laboratory would be viewed positively by students. This model may be adopted by colleges to expand pharmacogenetics education.
Schapkaitz, Elise; Mafika, Zipho
Critical value policies are used by clinical laboratories to decide when to notify caregivers of life-threatening results. Despite their widespread use, critical value policies have not been published locally. A survey was designed to determine critical value policies for haematology tests in South Africa. A survey was carried out on 136 identified laboratories across South Africa in January 2013. Of these, 36 responded. Data collected included critical value policies, critical values for haematology parameters, and critical value reporting. Of the 36 laboratories surveyed, 11.1% (n=4) were private, 33.3% (n=12) were affiliated to academic institutions and 55.6% (n=20) were peripheral or regional National Health Laboratory Service laboratories. All the laboratories confirmed that they had a critical value policy, and 83.3% of such policies were derived from local clinical opinion. Mean low and high critical limits for the most frequently listed tests were as follows: haemoglobin 20 g/dl, platelet count 1 000 ×10(9)/l, white cell count 46 ×10(9)/l, activated partial thromboplastin time >101 seconds, and international normalised ratio >6. In almost all cases critical value reporting was performed by the technologist on duty (97.2%). The majority of laboratories required that the person notified of the critical value be the doctor who ordered the test or the caregiver directly involved in the patient's care (83.3%); 73.3% of laboratories indicated that they followed an algorithm if the doctor/caregiver could not be reached. Each laboratory is responsible for establishing clinically relevant critical limits. Clinicians should be involved in developing the laboratory's critical value policy. The findings of this survey may be of value to local laboratories that are in the process of establishing or reviewing critical value policies.
David F. Kisor
Full Text Available Objective: To evaluate a pilot of a laboratory model for relating pharmacogenetics to clinical decision making. Case Study: This pilot was undertaken and evaluated to help determine if a pharmacogenetics laboratory should be included in the core Doctor of Pharmacy curriculum. The placement of the laboratory exercise in the curriculum was determined by identifying the point in the curriculum where the students had been introduced to the chemistry of deoxyribonucleic acid (DNA as well as instructed on the chemistry of genetic variation. The laboratory included cytochrome P450 2C19 genotyping relative to the *2 variant. Twenty-four students served as the pilot group. Students provided buccal swabs as the source of DNA. Students stabilized the samples and were then provided instructions related to sample preparation, polymerase chain reaction, and gel electrophoresis. The results were reported as images of gels. Students used a reference gel image to compare their results to. Students then applied a dosing algorithm to make a "clinical decision" relative to clopidogrel use. Students were offered a post laboratory survey regarding attitudes toward the laboratory. Twenty-four students completed the laboratory with genotyping results being provided for 22 students (91.7%. Sixteen students were wild-type (*1/*1, while six students were heterozygous (*1/*2. Twenty-three students (96% completed the post laboratory survey. All 23 agreed (6, 26.1% or strongly agreed (17, 73.9% that the laboratory "had relevance and value in the pharmacy curriculum" Conclusion: The post pilot study survey exploring a laboratory model for pharmacogenetics related to clinical decision making indicated that such a laboratory would be viewed positively by students. This model may be adopted by colleges to expand pharmacogenetics education. Type: Case Study
Reed, Robyn C; Kim, Sara; Farquharson, Kara; Astion, Michael L
Competency assessment is critical for laboratory operations and is mandated by the Clinical Laboratory Improvement Amendments of 1988. However, no previous reports describe methods for assessing competency in patient safety. We developed and implemented a Web-based tool to assess performance of 875 laboratory staff from 29 laboratories in patient safety. Question categories included workplace culture, categorizing error, prioritization of patient safety interventions, strength of specific interventions, and general patient safety concepts. The mean score was 85.0%, with individual scores ranging from 56% to 100% and scores by category from 81.3% to 88.6%. Of the most difficult questions (laboratory technologists. Computer-based competency assessments help laboratories identify topics for continuing education in patient safety.
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.
Alphus D. Wilson
The rapid development of new electronic technologies and instruments, utilized to perform many current clinical operations in the biomedical field, is changing the way medical health care is delivered to patients. The majority of test results from laboratory analyses, performed with these analytical instruments often prior to clinical examinations, are frequently used...
An enzymatic laboratory experiment based on the analysis of serum is described that is suitable for students of clinical chemistry. The experiment incorporates an introduction to mathematical method-comparison techniques in which three different clinical glucose analysis methods are compared using linear regression and Bland-Altman difference…
de Klerk, Gijs; Hegeman, J. Han; van der Velde, Detlef; van der Palen, Jacobus Adrianus Maria; ten Duis, Henk J.
Background: As more and more patients meeting the criteria for osteoporosis are referred to a fracture and osteoporosis outpatient clinic (FO clinic), the laboratory costs to screen for secondary osteoporosis also increases. This study was conducted to determine the value of screening on underlying
HANLEY, T.D.; STEER, M.D.
THIS REPORT DESCRIBES THE DESIGN OF A NEW CLINIC AND LABORATORY FOR SPEECH AND HEARING TO ACCOMMODATE THE THREE BASIC PROGRAMS OF--(1) CLINICAL TRAINING OF UNDERGRADUATE AND GRADUATE STUDENT MAJORS, (2) SERVICES MADE AVAILABLE TO THE SPEECH AND HEARING HANDICAPPED, AND (3) RESEARCH IN SPEECH PATHOLOGY, AUDIOLOGY, PSYCHO-ACOUSTICS, AND…
Howanitz, Peter J; Lehman, Christopher M; Jones, Bruce A; Meier, Frederick A; Horowitz, Gary L
Hemolysis is an important clinical laboratory quality attribute that influences result reliability. To determine hemolysis identification and rejection practices occurring in clinical laboratories. We used the College of American Pathologists Survey program to distribute a Q-Probes-type questionnaire about hemolysis practices to Chemistry Survey participants. Of 3495 participants sent the questionnaire, 846 (24%) responded. In 71% of 772 laboratories, the hemolysis rate was less than 3.0%, whereas in 5%, it was 6.0% or greater. A visual scale, an instrument scale, and combination of visual and instrument scales were used to identify hemolysis in 48%, 11%, and 41% of laboratories, respectively. A picture of the hemolysis level was used as an aid to technologists' visual interpretation of hemolysis levels in 40% of laboratories. In 7.0% of laboratories, all hemolyzed specimens were rejected; in 4% of laboratories, no hemolyzed specimens were rejected; and in 88% of laboratories, some specimens were rejected depending on hemolysis levels. Participants used 69 different terms to describe hemolysis scales, with 21 terms used in more than 10 laboratories. Slight and moderate were the terms used most commonly. Of 16 different cutoffs used to reject hemolyzed specimens, moderate was the most common, occurring in 30% of laboratories. For whole blood electrolyte measurements performed in 86 laboratories, 57% did not evaluate the presence of hemolysis, but for those that did, the most common practice in 21 laboratories (24%) was centrifuging and visually determining the presence of hemolysis in all specimens. Hemolysis practices vary widely. Standard assessment and consistent reporting are the first steps in reducing interlaboratory variability among results.
Full Text Available In the last 20 years in medical laboratories, numerous activities regarding quality and accreditation system were taken. Approach to this problem in European countries is different, so the task of the Accreditation Work Group of the Confederation of European societies for clinical chemistry (EC 4 to help the efforts to harmonize this issue. External quality control in clinical-chemical laboratories imposed the need for the implementation of quality management system. »Good laboratory practice« and its principles were adopted by nominated bodies, both international and national. In the beginning, the standard ISO 9001 was applied for certification and for accreditation EN 45001 and ISO Guide 25, which are prepared for testing and calibration laboratories. Standard ISO 17025 is the successor of the previous documents and for now it is a reference for mentioned laboratories. Accreditation Work Group of the Confederation of European societies for clinical chemistry (EC 4 made an amendment of the requirements for medical laboratories, which this standard describes. Standard draft ISO 15189 was adopted on February 2003 as a final version with requirements for medical laboratories.
Ejilemele, A A; Ojule, A C
Clinical laboratories are potentially hazardous work areas. Health and safety in clinical laboratories is becoming an increasingly important subject as a result of the emergence of highly infectious diseases such as hepatitis and HIV. This is even more so in developing countries where health and safety have traditionally been regarded as low priority issues, considering the more important health problems confronting the health authorities in these countries. We conducted a literature search using the medical subheadings titles on the INTERNET over a period of twenty years and summarized our findings. This article identifies hazards in the laboratories and highlights measures to make the laboratory a safer work place. It also emphasizes the mandatory obligations of employers and employees towards the attainment of acceptable safety standards in clinical laboratories in Third World countries in the face of the current HIV/AIDS epidemic in many of these developing countries especially in the sub-Saharan Africa while accommodating the increasing work load in these laboratories. Both the employer and the employee have major roles to play in the maintenance of a safe working environment. This can be achieved if measures discussed are incorporated into everyday laboratory practice.
Hayajneh, Wail A; Jdaitawi, Hussein; Al Shurman, Abdullah; Hayajneh, Yaseen A
To search for possible early clinical associations and laboratory abnormalities in children with severe dehydration in northern Jordan. We prospectively evaluated 251 children with acute gastroenteritis. Dehydration assessment was done following a known clinical scheme. Probable clinical associations and laboratory abnormalities were examined against the preassigned dehydration status. Children with severe dehydration had significantly more hypernatremia and hyperkalemia, less isonatremia, and higher mean levels of urea, creatinine, and glucose (P dehydration. Historic clinical characteristics of patients did not correlate to dehydration degree. Serum urea, creatinine, sodium, potassium, and glucose were useful independently in augmenting clinical examination to diagnose the degree of dehydration status among children presenting with gastroenteritis. Serum urea performed the best among all. On the contrary, none of the examined historical clinical patterns could be correlated to the dehydration status. Larger and multicenter studies are needed to validate our results and to examine their impact on final outcomes.
McMurray, Janet; Zérah, Simone; Hallworth, Michael
In 1997, the European Communities Confederation of Clinical Chemistry and Laboratory Medicine (EC4) set up a Register for European Specialists in Clinical Chemistry and Laboratory Medicine. The operation of the Register is undertaken by a Register Commission (EC4RC). During the last 12 years, more...... than 2200 specialists in Clinical Chemistry and Laboratory Medicine have joined the Register. In 2007, EC4 merged with the Forum of European Societies of Clinical Chemistry and Laboratory Medicine (FESCC) to form the European Federation of Clinical Chemistry and Laboratory Medicine (EFCC). Two previous...
Lehman, Christopher M; Howanitz, Peter J; Souers, Rhona; Karcher, Donald S
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.
Bamberg, Richard; Akroyd, Duane; Moore, Ti'eshia M
To assess the predictive ability of various aspects of the work environment for organizational commitment. A questionnaire measuring three dimensions of organizational commitment along with five aspects of work environment and 10 demographic and work setting characteristics was sent to a national, convenience sample of clinical laboratory professionals. All persons obtaining the CLS certification by NCA from January 1, 1997 to December 31, 2006. Only respondents who worked full-time in a clinical laboratory setting were included in the database. Levels of affective, normative, and continuance organizational commitment, organizational support, role clarity, role conflict, transformational leadership behavior of supervisor, and organizational type, total years work experience in clinical laboratories, and educational level of respondents. Questionnaire items used either a 7-point or 5-point Likert response scale. Based on multiple regression analysis for the 427 respondents, organizational support and transformational leadership behavior were found to be significant positive predictors of affective and normative organizational commitment. Work setting (non-hospital laboratory) and total years of work experience in clinical laboratories were found to be significant positive predictors of continuance organizational commitment. Overall the organizational commitment levels for all three dimensions were at the neutral rating or below in the slightly disagree range. The results indicate a less than optimal level of organizational commitment to employers, which were predominantly hospitals, by CLS practitioners. This may result in continuing retention problems for hospital laboratories. The results offer strategies for improving organizational commitment via the significant predictors.
Full Text Available Children suffer the highest burden of enteric fever among populations in South Asian countries. The clinical features are non–specific, vary in populations, and are often difficult to distinguish clinically from other febrile illnesses, leading to delayed or inappropriate diagnosis and treatment. We undertook a systematic review to assess the clinical profile and laboratory features of enteric fever across age groups, economic regions, level of care and antibiotic susceptibility patterns.
Maddox, Thomas M; Plomondon, Mary E; Petrich, Megan; Tsai, Thomas T; Gethoffer, Hans; Noonan, Gregory; Gillespie, Brian; Box, Tamara; Fihn, Stephen D; Jesse, Robert L; Rumsfeld, John S
A "learning health care system", as outlined in a recent Institute of Medicine report, harnesses real-time clinical data to continuously measure and improve clinical care. However, most current efforts to understand and improve the quality of care rely on retrospective chart abstractions complied long after the provision of clinical care. To align more closely with the goals of a learning health care system, we present the novel design and initial results of the Veterans Affairs (VA) Clinical Assessment, Reporting, and Tracking (CART) program-a national clinical quality program for VA cardiac catheterization laboratories that harnesses real-time clinical data to support clinical care and quality-monitoring efforts. Integrated within the VA electronic health record, the CART program uses a specialized software platform to collect real-time patient and procedural data for all VA patients undergoing coronary procedures in VA catheterization laboratories. The program began in 2005 and currently contains data on 434,967 catheterization laboratory procedures, including 272,097 coronary angiograms and 86,481 percutaneous coronary interventions, performed by 801 clinicians on 246,967 patients. We present the initial data from the CART program and describe 3 quality-monitoring programs that use its unique characteristics-procedural and complications feedback to individual labs, coronary device surveillance, and major adverse event peer review. The VA CART program is a novel approach to electronic health record design that supports clinical care, quality, and safety in VA catheterization laboratories. Its approach holds promise in achieving the goals of a learning health care system. Published by Elsevier Inc.
Harrison, Steven M; Dolinsky, Jill S; Knight Johnson, Amy E; Pesaran, Tina; Azzariti, Danielle R; Bale, Sherri; Chao, Elizabeth C; Das, Soma; Vincent, Lisa; Rehm, Heidi L
Data sharing through ClinVar offers a unique opportunity to identify interpretation differences between laboratories. As part of a ClinGen initiative, four clinical laboratories (Ambry, GeneDx, Partners Healthcare Laboratory for Molecular Medicine, and University of Chicago Genetic Services Laboratory) collaborated to identify the basis of interpretation differences and to investigate if data sharing and reassessment resolve interpretation differences by analyzing a subset of variants. ClinVar variants with submissions from at least two of the four participating laboratories were compared. For a subset of identified differences, laboratories documented the basis for discordance, shared internal data, independently reassessed with the American College of Medical Genetics and Genomics-Association for Molecular Pathology (ACMG-AMP) guidelines, and then compared interpretations. At least two of the participating laboratories interpreted 6,169 variants in ClinVar, of which 88.3% were initially concordant. Laboratories reassessed 242/724 initially discordant variants, of which 87.2% (211) were resolved by reassessment with current criteria and/or internal data sharing; 12.8% (31) of reassessed variants remained discordant owing to differences in the application of the ACMG-AMP guidelines. Participating laboratories increased their overall concordance from 88.3 to 91.7%, indicating that sharing variant interpretations in ClinVar-thereby allowing identification of differences and motivation to resolve those differences-is critical to moving toward more consistent variant interpretations.Genet Med advance online publication 09 March 2017.
Garg, Uttam; Zhang, Yan Victoria
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.
Skodvin, Brita; Aase, Karina; Brekken, Anita Løvås; Charani, Esmita; Lindemann, Paul Christoffer; Smith, Ingrid
Many countries are on the brink of establishing antibiotic stewardship programmes in hospitals nationwide. In a previous study we found that communication between microbiology laboratories and clinical units is a barrier to implementing efficient antibiotic stewardship programmes in Norway. We have now addressed the key communication barriers between microbiology laboratories and clinical units from a laboratory point of view. Qualitative semi-structured interviews were conducted with 18 employees (managers, doctors and technicians) from six diverse Norwegian microbiological laboratories, representing all four regional health authorities. Interviews were recorded and transcribed verbatim. Thematic analysis was applied, identifying emergent themes, subthemes and corresponding descriptions. The main barrier to communication is disruption involving specimen logistics, information on request forms, verbal reporting of test results and information transfer between poorly integrated IT systems. Furthermore, communication is challenged by lack of insight into each other's area of expertise and limited provision of laboratory services, leading to prolonged turnaround time, limited advisory services and restricted opening hours. Communication between microbiology laboratories and clinical units can be improved by a review of testing processes, educational programmes to increase insights into the other's area of expertise, an evaluation of work tasks and expansion of rapid and point-of-care test services. Antibiotic stewardship programmes may serve as a valuable framework to establish these measures. © The Author 2017. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy.
Sadeghian, Farideh; Kasaeian, Amir; Noroozi, Pirasteh; Vatani, Javad; Taiebi, Seiyed Hassan
Musculoskeletal disorders (MSDs) are an important health problem among healthcare workers, including clinical laboratory ones. The aim of the present study was to investigate the prevalence of MSDs and individual and psychosocial risk factors among clinical laboratory workers. A cross-sectional study was carried out among 156 workers of 30 clinical laboratories in 3 towns of Iran. The Nordic questionnaire with individual and psychosocial risk factors was used to collect data. Multiple logistic regression analysis was performed. The prevalence of reported MSDs among the study population was 72.4% in the past 12 months. The most prevalent MSDs were pain in the lower back and neck; 42.7% and 33.3%, respectively. Significant relations were found between MSDs and age, gender, heavy work at home and job control (p workers were high and associated with age, gender, heavy work at home and job control. More research into measuring these factors and workplace physical demands is suggested.
Salinas La Casta, Maria; Flores Pardo, Emilio; Uris Selles, Joaquín
to propose a set of indicators as a management tool for a clinical laboratory, by using the balanced scorecard internal business processes perspective. indicators proposed are obtained from different sources; external proficiency testing of the Valencia Community Government, by means of internal surveys and laboratory information system registers. One year testing process proportion indicators results are showed. internal management indicators are proposed (process, appropriateness and proficiency testing). The process indicators results show gradual improvement since its establishment. after one years of using a conceptually solid Balanced Scorecard Internal business processes perspective indicators, the obtained results validate the usefulness as a laboratory management tool.
Undrill, P E; Frazer, S C
A locally developed, computer-based clinical chemistry laboratory system has been in operation since 1970. This utilises a Digital Equipment Co Ltd PDP 12 and an interconnected PDP 8/F computer. Details are presented of the performance and quality control techniques incorporated into the system. Laboratory performance is assessed through analysis of results from fixed-level control sera as well as from cumulative sum methods. At a simple level the presentation may be considered purely indicative, while at a more sophisticated level statistical concepts have been introduced to aid the laboratory controller in decision-making processes. PMID:438340
Wang, Wei; Zhong, Kun; Yuan, Shuai; He, Falin; Du, Yuxuan; Hu, Zhehui; Wang, Zhiguo
This survey was initiated to obtain knowledge on the current situation of internal quality control (IQC) practice for tumour markers (TMs) in China. Additionally, we tried to acquire the most appropriate quality specifications. This survey was a current status survey. The IQC information had been collected via online questionnaires. All of 1821 clinical laboratories which participated in the 2016 TMs external quality assessment (EQA) programme had been enrolled. The imprecision evaluation criteria were the minimal, desirable, and optimal allowable imprecisions based on biological variations, and 1/3 total allowable error (TEa) and 1/4 TEa. A total of 1628 laboratories answered the questionnaires (89%). The coefficients of variation (CVs) of the IQC of participant laboratories varied greatly from 1% (5 th percentile) to 13% (95 th percentile). More than 82% (82 - 91%) of participant laboratories two types of CVs met 1/3 TEa except for CA 19-9. The percentiles of current CVs were smaller than cumulative CVs. A number of 1240 laboratories (76%) reported their principles and systems used. The electrochemiluminescence was the most used principle (45%) and had the smallest CVs. The performance of laboratories for TMs IQC has yet to be improved. On the basis of the obtained results, 1/3 TEa would be realistic and attainable quality specification for TMs IQC for clinical laboratories in China.
Konger, Raymond L; Ndekwe, Paul; Jones, Genea; Schmidt, Ronald P; Trey, Marty; Baty, Eric J; Wilhite, Denise; Munshi, Imtiaz A; Sutter, Bradley M; Rao, Maddamsetti; Bashir, Chowdry M
To implement an electronic laboratory utilization management system (laboratory expert system [LES]) to provide safe and effective reductions in unnecessary clinical laboratory testing. The LES is a set of frequency filter subroutines within the Veterans Affairs hospital and laboratory information system that was formulated by an interdisciplinary medical team. Since implementing the LES, total test volume has decreased by a mean of 11.18% per year compared with our pre-LES test volume. This change was not attributable to fluctuations in outpatient visits or inpatient days of care. Laboratory cost savings were estimated at $151,184 and $163,751 for 2012 and 2013, respectively. A significant portion of these cost savings was attributable to reductions in high-volume, large panel testing. No adverse effects on patient care were reported, and mean length of stay for patients remained unchanged. Electronic laboratory utilization systems can effectively reduce unnecessary laboratory testing without compromising patient care. Published by Oxford University Press on behalf of the American Society for Clinical Pathology, 2016. This work is written by US Government employees and is in the public domain in the US.
Garcia, Edna; Fisher, Patrick B
To inform the pathology and laboratory field of the most recent national wage data from the American Society for Clinical Pathology (ASCP). Historically, the results of this biennial survey have served as a basis for additional research on laboratory recruitment, retention, education, marketing, certification, and advocacy. The 2015 wage survey was conducted through collaboration between the ASCP's Institute of Science, Technology, and Policy in Washington, DC, and the ASCP Board of Certification in Chicago, Illinois. Electronic survey invitations were sent to individuals who are currently practicing in the field. Data reveal increased salaries since 2013 for all staff-level laboratory professionals surveyed except phlebotomists and pathologists' assistants. Laboratory assistants and phlebotomists, regardless of level, continue to have lower salaries while pathologists' assistants and administration personnel have higher salaries than the rest of the laboratory professions surveyed. Survey results put emphasis on strategic recruitment and retention by laboratory training programs and institutions that hire laboratory professionals. © American Society for Clinical Pathology, 2017. All rights reserved. For permissions, please e-mail: email@example.com
Garcia, Edna; Ali, Asma M; Soles, Ryan M; Lewis, D Grace
To determine the extent and distribution of workforce shortages within the nation's medical laboratories. Historically, the results of this biennial survey have served as a basis for additional research on laboratory recruitment, retention, education, marketing, certification, and advocacy. The 2014 Vacancy Survey was conducted through collaboration between American Society for Clinical Pathology's Institute of Science, Technology, and Policy in Washington, DC, and the Evaluation, Measurement, and Assessment Department and Board of Certification in Chicago, Illinois. Data were collected via an Internet survey that was distributed to individuals who were able to report on staffing and certifications for their laboratories. Data reveal increased overall vacancy rates since 2012 for all departments surveyed except cytology and cytogenetics. Also, results show higher anticipated retirement rates for both staff and supervisors. Overall certification rates are highest among laboratory personnel in cytogenetics, hematology/coagulation, and flow cytometry departments and lowest among phlebotomy, specimen processing, and anatomic pathology. Factors such as retirement and the improving economy are driving the need for more laboratory professionals. Recruitment of qualified laboratory professionals in the workforce and students in laboratory programs will be the key in fulfilling the higher vacancies revealed from the survey results in 2014. Copyright© by the American Society for Clinical Pathology.
Sturgeon, Catharine M; Hoffman, Barry R; Chan, Daniel W
BACKGROUND: This report presents updated National Academy of Clinical Biochemistry Laboratory Medicine Practice Guidelines summarizing quality requirements for the use of tumor markers. METHODS: One subcommittee developed guidelines for analytical quality relevant to serum and tissue-based tumor...... questions to ensure selection of the appropriate test, adherence to good clinical and laboratory practices (e.g., minimization of the risk of incorrect patient and/or specimen identification, tube type, or timing), use of internationally standardized and well-characterized methods, careful adherence...... records. Also mandatory is extensive validation encompassing all stages of analysis before introduction of new technologies such as microarrays and mass spectrometry. Provision of high-quality tumor marker services is facilitated by dialogue involving researchers, diagnostic companies, clinical...
Wolniak, Kristy; Goolsby, Charles; Choi, Sarah; Ali, Asma; Serdy, Nina; Stetler-Stevenson, Maryalice
Thorough review of current workload, staffing, and testing practices in clinical laboratories allows for optimization of laboratory efficiency and quality. This information is largely missing with regard to clinical flow cytometry laboratories. The purpose of this survey is to provide comprehensive, current, and accurate data on testing practices and laboratory staffing in clinical laboratories performing flow cytometric studies. Survey data was collected from flow cytometry laboratories through the ASCP website. Data was collected on the workload during a 1-year time period of full-time and part-time technical and professional (M.D./D.O./Ph.D. or equivalent) flow cytometry employees. Workload was examined as number of specimens and tubes per full time equivalent (FTE) technical and professional staff. Test complexity, test result interpretation, and reporting practices were also evaluated. There were 205 respondent laboratories affiliated predominantly with academic and health system institutions. Overall, 1,132 FTE employees were reported with 29% professional FTE employees and 71% technical. Fifty-one percent of the testing performed was considered high complexity and 49% was low complexity. The average number of tubes per FTE technologist was 1,194 per year and the average number of specimens per FTE professional was 1,659 per year. The flow cytometry reports were predominantly written by pathologists (57%) and were typically written as a separate report (58%). This survey evaluates the overall status of the current practice of clinical flow cytometry and provides a comprehensive dataset as a framework to help laboratory departments, directors, and managers make appropriate, cost-effective staffing decisions. © 2016 International Clinical Cytometry Society. © 2016 International Clinical Cytometry Society.
Saadawi, Gilan M; Harrison, James H
Clinical laboratory procedure manuals are typically maintained as word processor files and are inefficient to store and search, require substantial effort for review and updating, and integrate poorly with other laboratory information. Electronic document management systems could improve procedure management and utility. As a first step toward building such systems, we have developed a prototype electronic format for laboratory procedures using Extensible Markup Language (XML). Representative laboratory procedures were analyzed to identify document structure and data elements. This information was used to create a markup vocabulary, CLP-ML, expressed as an XML Document Type Definition (DTD). To determine whether this markup provided advantages over generic markup, we compared procedures structured with CLP-ML or with the vocabulary of the Health Level Seven, Inc. (HL7) Clinical Document Architecture (CDA) narrative block. CLP-ML includes 124 XML tags and supports a variety of procedure types across different laboratory sections. When compared with a general-purpose markup vocabulary (CDA narrative block), CLP-ML documents were easier to edit and read, less complex structurally, and simpler to traverse for searching and retrieval. In combination with appropriate software, CLP-ML is designed to support electronic authoring, reviewing, distributing, and searching of clinical laboratory procedures from a central repository, decreasing procedure maintenance effort and increasing the utility of procedure information. A standard electronic procedure format could also allow laboratories and vendors to share procedures and procedure layouts, minimizing duplicative word processor editing. Our results suggest that laboratory-specific markup such as CLP-ML will provide greater benefit for such systems than generic markup.
Song, Wenqi; Shen, Ying; Peng, Xiaoxia; Tian, Jian; Wang, Hui; Xu, Lili; Nie, Xiaolu; Ni, Xin
The program of continuous quality improvement in clinical laboratory processes for complete blood count (CBC) was launched via the platform of Beijing Children's Hospital Group in order to improve the quality of pediatric clinical laboratories. Fifteen children's hospitals of Beijing Children's Hospital group were investigated using the method of Chinese adapted continuous quality improvement with PDCA (Plan-Do-Check-Action). The questionnaire survey and inter-laboratory comparison was conducted to find the existing problems, to analyze reasons, to set forth quality targets and to put them into practice. Then, targeted training was conducted to 15 children's hospitals and the second questionnaire survey, self examinations by the clinical laboratories was performed. At the same time, the Group's online internal quality control platform was established. Overall effects of the program were evaluated so that lay a foundation for the next stage of PDCA. Both quality of control system documents and CBC internal quality control scheme for all of clinical laboratories were improved through this program. In addition, standardization of performance verification was also improved, especially with the comparable verification rate of precision and internal laboratory results up to 100%. In terms of instrument calibration and mandatory diagnostic rates, only three out of the 15 hospitals (20%) failed to pass muster in 2014 from 46.67% (seven out of the 15 hospitals) in 2013. The abnormal data of intraday precision variance coefficients of the five CBC indicator parameters (WBC, RBC, Hb, Plt and Hct) of all the 15 laboratories accounted for 1.2% (2/165) in 2014, a marked decrease from 9.6% (14/145) in 2013. While the number of the hospitals using only one horizontal quality control object for daily quality control has dropped to three from five. The 15 hospitals organized a total of 263 times of training in 2014 from 101 times in 2013, up 160%. The quality improvement program for
Armbruster, David A; Overcash, David R; Reyes, Jaime
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
Nailboard Records üllitas pagan-metal-bändi Tharaphita albumi "Raev" digipack-CD, millele on lisatud 1996. aastal ilmunud neljalooline demosalvestis "Kui varjud põlevad" ja dark-elektro-bändi Forgotten Sunrise demo "Behind The Abysmal Sky" (1993) ning minialbumi "Forever Sleeping Greystones" (1994) lood
Boyle, Maeve; Moore, John E; Whitehouse, Joanna L; Bilton, Diana; Downey, Damian G
There is much uncertainty as to how fungal disease is diagnosed and characterized in patients with cystic fibrosis (CF). A 19-question anonymous electronic questionnaire was developed and distributed to ascertain current practice in clinical microbiology laboratories providing a fungal laboratory service to CF centres in the UK. Analyses of responses identified the following: (1) current UK laboratory practice, in general, follows the current guidelines, but the scope and diversity of what is currently being delivered by laboratories far exceeds what is detailed in the guidelines; (2) there is a lack of standardization of fungal tests amongst laboratories, outside of the current guidelines; (3) both the UK CF Trust Laboratory Standards for Processing Microbiological Samples from People with Cystic Fibrosis and the US Cumulative Techniques and Procedures in Clinical Microbiology (Cumitech) Guidelines 43 Cystic Fibrosis Microbiology need to be updated to reflect both new methodological innovations, as well as better knowledge of fungal disease pathophysiology in CF; (4) there is a need for clinical medicine to decide upon a stratification strategy for the provision of new fungal assays that will add value to the physician in the optimal management of CF patients; (5) there is also a need to rationale what assays should be performed at local laboratory level and those which are best served at National Mycology Reference Laboratory level; and (6) further research is required in developing laboratory assays, which will help ascertain the clinical importance of 'old' fungal pathogens, as well as 'emerging' fungal pathogens.
Jafri, Lena; Khan, Aysha Habib; Ghani, Farooq; Shakeel, Shahid; Raheem, Ahmed; Siddiqui, Imran
Quality indicators for assessing the performance of a laboratory require a systematic and continuous approach in collecting and analyzing data. The aim of this study was to determine the frequency of errors utilizing the quality indicators in a clinical chemistry laboratory and to convert errors to the Sigma scale. Five-year quality indicator data of a clinical chemistry laboratory was evaluated to describe the frequency of errors. An 'error' was defined as a defect during the entire testing process from the time requisition was raised and phlebotomy was done until the result dispatch. An indicator with a Sigma value of 4 was considered good but a process for which the Sigma value was 5 (i.e. 99.977% error-free) was considered well controlled. In the five-year period, a total of 6,792,020 specimens were received in the laboratory. Among a total of 17,631,834 analyses, 15.5% were from within hospital. Total error rate was 0.45% and of all the quality indicators used in this study the average Sigma level was 5.2. Three indicators - visible hemolysis, failure of proficiency testing and delay in stat tests - were below 5 on the Sigma scale and highlight the need to rigorously monitor these processes. Using Six Sigma metrics quality in a clinical laboratory can be monitored more effectively and it can set benchmarks for improving efficiency.
Mostafavi, Ehsan; Pourhossein, Behzad; Chinikar, Sadegh
Crimean-Congo hemorrhagic fever (CCHF) is a zoonotic disease, which is usually transmitted to humans by tick bites or contact with blood or other infected tissues of livestock. Patients suffering from CCHF demonstrate an extensive spectrum of clinical symptoms. As it can take considerable time from suspecting the disease in hospital until reaching a definitive diagnosis in the laboratory, understanding the clinical symptoms and laboratory findings of CCHF patients is of paramount importance for clinicians. The data were collected from patients who were referred to the Laboratory of Arboviruses and Viral Hemorrhagic Fevers at the Pasteur institute of Iran with a primary diagnosis of CCHF between 1999 and 2012 and were assessed by molecular and serologic tests. Referred patients were divided into two groups: patients with a CCHF positive result and patients with a CCHF negative result. The laboratory and clinical findings of these two groups were then compared. Two-thousand five hundred thirty-six probable cases of CCHF were referred to the laboratory, of which 871 cases (34.3%) were confirmed to be CCHF. Contact with infected humans and animals increased the CCHF infection risk (P important role in patient survival and the application of the findings of this study can prove helpful as a key for early diagnosis. © 2014 Wiley Periodicals, Inc.
Malm, Johan; Marko-Varga, György
Patient care relies heavily on standardized tests performed in hospital laboratories, typically including clinical chemistry, pathology and microbiology. With the introduction of personalized medicine tremendous efforts have been made to identify new biomarkers of disease with various omics technologies, often including mass spectrometry. In order to validate new biomarkers and perform clinical studies high quality biobank samples are of key importance. In this editorial different aspects of mass spectrometry in future personalized medicine are discussed.
Sheila Moura Pone
Conclusions: Lethargy, abdominal distension, pleural effusion, and hypoalbuminemia were the best clinical and laboratorial markers of serious dengue disease in hospitalized children, while bleeding, severe hemorrhage, hemoconcentration and thrombocytopenia did not reach adequate diagnostic accuracy. In pediatric referral hospitals, the absence of hemoconcentration does not imply absence of plasma leakage, particularly in children with previous fluid replacement. These findings may contribute to the clinical management of dengue in children at referral hospitals.
Gargis, Amy S; Kalman, Lisa; Lubin, Ira M
Clinical microbiology and public health laboratories are beginning to utilize next-generation sequencing (NGS) for a range of applications. This technology has the potential to transform the field by providing approaches that will complement, or even replace, many conventional laboratory tests. While the benefits of NGS are significant, the complexities of these assays require an evolving set of standards to ensure testing quality. Regulatory and accreditation requirements, professional guidelines, and best practices that help ensure the quality of NGS-based tests are emerging. This review highlights currently available standards and guidelines for the implementation of NGS in the clinical and public health laboratory setting, and it includes considerations for NGS test validation, quality control procedures, proficiency testing, and reference materials. Copyright © 2016, American Society for Microbiology. All Rights Reserved.
Capunzo, Mario; Cavallo, Pierpaolo; Boccia, Giovanni; Brunetti, Luigi; Pizzuti, Sante
The authors have experimented the application of the Failure Mode and Effect Analysis (FMEA) technique in a clinical laboratory. FMEA technique allows: a) to evaluate and measure the hazards of a process malfunction, b) to decide where to execute improvement actions, and c) to measure the outcome of those actions. A small sample of analytes has been studied: there have been determined the causes of the possible malfunctions of the analytical process, calculating the risk probability index (RPI), with a value between 1 and 1,000. Only for the cases of RPI > 400, improvement actions have been implemented that allowed a reduction of RPI values between 25% to 70% with a costs increment of FMEA technique can be applied to the processes of a clinical laboratory, even if of small dimensions, and offers a high potential of improvement. Nevertheless, such activity needs a thorough planning because it is complex, even if the laboratory already operates an ISO 9000 Quality Management System.
Olofsson, Jan I; Banker, Manish R; Sjoblom, Late Peter
Several countries have in recent years introduced prescribed requirements for treatment and monitoring of outcomes, as well as a licensing or accreditation requirement for in vitro fertilization (IVF) clinics and their laboratories. It is commonplace for Assisted Reproductive Technology (ART) laboratories to be required to have a quality control system. However, more effective Total Quality Management systems are now being implemented by an increasing number of ART clinics. In India, it is now a requirement to have a quality management system in order to be accredited and to help meet customer demand for improved delivery of ART services. This review contains the proceedings a quality management session at the Indian Fertility Experts Meet (IFEM) 2010 and focuses on the creation of a patient-oriented best-in-class IVF laboratory.
Alphus D. Wilson
Electronic-detection technologies and instruments increasingly are being utilized in the biomedical field to perform a wide variety of clinical operations and laboratory analyses to facilitate the delivery of health care to patients. The introduction of improved electronic instruments for diagnosing diseases and for administering treatments has required new training of...
Puhakka, K B; Jurik, A G; Schiøttz-Christensen, Berit
OBJECTIVE: To compare a new MRI scoring system of the sacroiliac joints (SIJs) in early spondylarthropathy (SpA) with clinical and laboratory parameters. METHODS: Forty-one patients (24 males, 17 females) with a median age of 26 yr and a median duration of inflammatory low back pain of 19 months...
Uchida, Yoshitaka; Kitakata, Yuusuke; Uno, Kimiichi; Minoshima, Satoshi; Arimizu, Noboru.
This study evaluated the relationship between 111 In-labeled leukocyte scintigraphy and clinical information and laboratory findings in 24 patients with bone infection and 35 patients with abdominal infection. Fifty-nine scintigrams were retrospectively reviewed and classified into positive or negative results. As the laboratory findings, C-reactive protein (CRP) level, erythrocyte sedimentation rate (ESR) at 60 minutes, and peripheral blood leukocyte counts (WBCC) were evaluated. Clinical information such as presence of fever and administration of antibiotics was also compared. No significant relationship between the scintigraphic results and clinical as well as laboratory findings was observed in bone infection patients. CRP levels in positive scintigraphic patients were significantly higher than those in negative scintigraphic patients in the abdominal infection group, otherwise the other indices were not correlated with the scintigraphic results. A few patients with slightly increased CRP (mostly chronic cases) did not show positive scintigrams, suggesting an increased false negative rate of leukocyte scintigraphy in such circumstances. These results suggest that it is inappropriate to determine the application of leukocyte scintigraphy depending on clinical as well as laboratory findings, and leukocyte scintigraphy would yield additional information different from other indices when evaluating inflammatory foci. (author)
Langlois, Michel R; Wallemacq, Pierre
To face the economic pressures arising from the current socio-economic conjuncture, hospital laboratories are endangered by an increasing trend towards the outsourcing of clinical laboratory tests to external (mega-) laboratories. This should allow hospitals to meet their economic requirements, but with an increased risk of loss of medical quality and, mid- to long-term, loss of cost effectiveness of healthcare at the national level. To anticipate current developments (economical and technological) that inevitably will affect the future of laboratory medicine, hospital laboratories should be proactive and enhance efficiency, reduce costs by consolidation, integrate into regional networks, and form alliances or partnerships. To create additional value, the core competency of laboratory professionals must be refocused to provide medical knowledge services (consultative support to clinicians) related to in vitro diagnostic testing. To integrate cost-efficiency with medical quality, implementation of a matricial organization - operational vs. biomedical level - could be an interesting approach. This integrated structure should create total quality of laboratory testing, managing the entire medical diagnostic cycle from the pre-preanalytical to post-postanalytical phase.
Amukele, Timothy K; Michael, Kurt; Hanes, Mary; Miller, Robert E; Jackson, J Brooks
Patient Safety Monitoring in International Laboratories (JHU-SMILE) is a resource at Johns Hopkins University that supports and monitors laboratories in National Institutes of Health-funded international clinical trials. To determine the impact of the JHU-SMILE quality assurance scheme in sub-Saharan African laboratories, we reviewed 40 to 60 months of external quality assurance (EQA) results of the College of American Pathologists (CAP) in these laboratories. We reviewed the performance of 8 analytes: albumin, alanine aminotransferase, creatinine, sodium, WBC, hemoglobin, hematocrit, and the human immunodeficiency virus antibody rapid test. Over the 40- to 60-month observation period, the sub-Saharan laboratories had a 1.63% failure rate, which was 40% lower than the 2011 CAP-wide rate of 2.8%. Seventy-six percent of the observed EQA failures occurred in 4 of the 21 laboratories. These results demonstrate that a system of remote monitoring, feedback, and audits can support quality in low-resource settings, even in places without strong regulatory support for laboratory quality.
Mindaye, Tedla; Taye, Bineyam
Despite the fact that Ethiopia has scale up antiretroviral treatment (ART) program, little is known about the patient satisfaction with ART monitoring laboratory services in health facilities. We therefore aimed to assess patient satisfaction with laboratory services at ART clinics in public hospitals. Hospital based, descriptive cross sectional study was conducted from October to November 2010 among clients attending in nine public hospitals ART clinics in Addis Ababa Ethiopia. Patients' satisfaction towards laboratory services was assessed using exit interview structured questionnaire. Data were coded and entered using EPI info 2002 (Centers for Disease Control and Prevention Atlanta, GA) and analyzed using SPSS version 15 software (SPSS INC, Chicago, IL, USA). A total of 406 clients were involved in the study. Of these 255(62.8%) were females. The overall satisfaction rate for ART monitoring laboratory services was (85.5%). Patients were satisfied with measures taken by health care providers to keep confidentiality and ability of the person drawing blood to answer question (98.3% and 96.3% respectively). Moreover, the finding of this study revealed, statistical significant associations between the overall patients' satisfaction with waiting time to get blood drawing service, availability of ordered laboratory tests and waiting time to get laboratory result with (p ART monitoring laboratory services compared to those who underwent for more than 30 minutes. Overall, the satisfaction survey showed, most respondents were satisfied with ART monitoring laboratory services. However, factors such as improving accessibility and availability of latrines should be taken into consideration in order to improve the overall satisfaction.
Erdal, Erik P; Mitra, Debanjali; Khangulov, Victor S; Church, Stephen; Plokhoy, Elizabeth
Background Despite advances in clinical chemistry testing, poor blood sample quality continues to impact laboratory operations and the quality of results. While previous studies have identified the preanalytical causes of lower sample quality, few studies have examined the economic impact of poor sample quality on the laboratory. Specifically, the costs associated with workarounds related to fibrin and gel contaminants remain largely unexplored. Methods A quantitative survey of clinical chemistry laboratory stakeholders across 10 international regions, including countries in North America, Europe and Oceania, was conducted to examine current blood sample testing practices, sample quality issues and practices to remediate poor sample quality. Survey data were used to estimate costs incurred by laboratories to mitigate sample quality issues. Results Responses from 164 participants were included in the analysis, which was focused on three specific issues: fibrin strands, fibrin masses and gel globules. Fibrin strands were the most commonly reported issue, with an overall incidence rate of ∼3%. Further, 65% of respondents indicated that these issues contribute to analyzer probe clogging, and the majority of laboratories had visual inspection and manual remediation practices in place to address fibrin- and gel-related quality problems (55% and 70%, respectively). Probe maintenance/replacement, visual inspection and manual remediation were estimated to carry significant costs for the laboratories surveyed. Annual cost associated with lower sample quality and remediation related to fibrin and/or gel globules for an average US laboratory was estimated to be $100,247. Conclusions Measures to improve blood sample quality present an important step towards improved laboratory operations.
DiFrancesco, Robin; Rosenkranz, Susan L; Taylor, Charlene R; Pande, Poonam G; Siminski, Suzanne M; Jenny, Richard W; Morse, Gene D
Among National Institutes of Health HIV Research Networks conducting multicenter trials, samples from protocols that span several years are analyzed at multiple clinical pharmacology laboratories (CPLs) for multiple antiretrovirals. Drug assay data are, in turn, entered into study-specific data sets that are used for pharmacokinetic analyses, merged to conduct cross-protocol pharmacokinetic analysis, and integrated with pharmacogenomics research to investigate pharmacokinetic-pharmacogenetic associations. The CPLs participate in a semiannual proficiency testing (PT) program implemented by the Clinical Pharmacology Quality Assurance program. Using results from multiple PT rounds, longitudinal analyses of recovery are reflective of accuracy and precision within/across laboratories. The objectives of this longitudinal analysis of PT across multiple CPLs were to develop and test statistical models that longitudinally: (1) assess the precision and accuracy of concentrations reported by individual CPLs and (2) determine factors associated with round-specific and long-term assay accuracy, precision, and bias using a new regression model. A measure of absolute recovery is explored as a simultaneous measure of accuracy and precision. Overall, the analysis outcomes assured 97% accuracy (±20% of the final target concentration of all (21) drug concentration results reported for clinical trial samples by multiple CPLs). Using the Clinical Laboratory Improvement Act acceptance of meeting criteria for ≥2/3 consecutive rounds, all 10 laboratories that participated in 3 or more rounds per analyte maintained Clinical Laboratory Improvement Act proficiency. Significant associations were present between magnitude of error and CPL (Kruskal-Wallis P Kruskal-Wallis P < 0.001).
Bunyaratavej, Sumanas; Leeyaphan, Charussri; Rujitharanawong, Chuda; Muanprasat, Chanai; Matthapan, Lalita
Sixty novice Buddhist monks with tinea capitis confirmed according to clinical presentation and mycological laboratory finding were included in this study. Mixed-type clinical presentation was observed in approximately half of all cases, together with scarring alopecia (95%) and superficial fungal skin infection at locations other than the scalp (43.3%). The major isolated organism was Trichophyton violaceum, and mixed-organism infection was found in 27 cases (45%). Slow-onset presentation and an extensive area of infection were significantly associated with mixed-type clinical presentation. © 2017 Wiley Periodicals, Inc.
Birx, Deborah; de Souza, Mark; Nkengasong, John N
Strengthening national health laboratory systems in resource-poor countries is critical to meeting the United Nations Millennium Development Goals. Despite strong commitment from the international community to fight major infectious diseases, weak laboratory infrastructure remains a huge rate-limiting step. Some major challenges facing laboratory systems in resource-poor settings include dilapidated infrastructure; lack of human capacity, laboratory policies, and strategic plans; and limited synergies between clinical and research laboratories. Together, these factors compromise the quality of test results and impact patient management. With increased funding, the target of laboratory strengthening efforts in resource-poor countries should be the integrating of laboratory services across major diseases to leverage resources with respect to physical infrastructure; types of assays; supply chain management of reagents and equipment; and maintenance of equipment.
Juhanson, Jaanika, 1977-
Eelinfo 11. märtsil toimuva Vanemuise Sümfoonikute kontserdi kohta Vanemuise kontserdimajas. M. Korjuse vitriini avamisest 23. veebr. Teatri- ja Muusikamuuseumis, D. Kokkeri mälestusõhtust 29. veebr. TMMi Assauwe tornis. 4. märtsil EMA saalis toimunud puhkpilliorkestri ja bigbändi kontserdist
The diagnosis of infectious diseases and the role of the microbiology laboratory are currently undergoing a process of change. The need for overall efficiency in providing results is now given the same importance as accuracy. This means that laboratories must be able to produce quality results in less time with the capacity to interpret the results clinically. To improve the clinical impact of microbiology results, the new challenge facing the microbiologist has become one of process management instead of pure analysis. A proper project management process designed to improve workflow, reduce analytical time, and provide the same high quality results without losing valuable time treating the patient, has become essential. Our objective was to study the impact of introducing automation and computerization into the microbiology laboratory, and the reorganization of the laboratory workflow, i.e. scheduling personnel to work shifts covering both the entire day and the entire week. In our laboratory, the introduction of automation and computerization, as well as the reorganization of personnel, thus the workflow itself, has resulted in an improvement in response time and greater efficiency in diagnostic procedures.
Inal, Tamer C; Goruroglu Ozturk, Ozlem; Kibar, Filiz; Cetiner, Salih; Matyar, Selcuk; Daglioglu, Gulcin; Yaman, Akgun
Organizing work flow is a major task of laboratory management. Recently, clinical laboratories have started to adopt methodologies such as Lean Six Sigma and some successful implementations have been reported. This study used Lean Six Sigma to simplify the laboratory work process and decrease the turnaround time by eliminating non-value-adding steps. The five-stage Six Sigma system known as define, measure, analyze, improve, and control (DMAIC) is used to identify and solve problems. The laboratory turnaround time for individual tests, total delay time in the sample reception area, and percentage of steps involving risks of medical errors and biological hazards in the overall process are measured. The pre-analytical process in the reception area was improved by eliminating 3 h and 22.5 min of non-value-adding work. Turnaround time also improved for stat samples from 68 to 59 min after applying Lean. Steps prone to medical errors and posing potential biological hazards to receptionists were reduced from 30% to 3%. Successful implementation of Lean Six Sigma significantly improved all of the selected performance metrics. This quality-improvement methodology has the potential to significantly improve clinical laboratories. © 2017 Wiley Periodicals, Inc.
Azadmanjir, Zahra; Torabi, Mashallah; Safdari, Reza; Bayat, Maryam; Golmahi, Fatemeh
management challenges of clinical laboratories are more complicated for educational hospital clinical laboratories. Managers can use tools of business intelligence (BI), such as information dashboards that provide the possibility of intelligent decision-making and problem solving about increasing income, reducing spending, utilization management and even improving quality. Critical phase of dashboard design is setting indicators and modeling causal relations between them. The paper describes the process of creating a map for laboratory dashboard. the study is one part of an action research that begins from 2012 by innovation initiative for implementing laboratory intelligent dashboard. Laboratories management problems were determined in educational hospitals by the brainstorming sessions. Then, with regard to the problems key performance indicators (KPIs) specified. the map of indicators designed in form of three layered. They have a causal relationship so that issues measured in the subsequent layers affect issues measured in the prime layers. the proposed indicator map can be the base of performance monitoring. However, these indicators can be modified to improve during iterations of dashboard designing process.
Sancho, Leyla Gomes; Vargens, José Muniz da Costa; Sancho, Rafael Gomes
The organization of public clinical laboratories is experiencing changes without, however, an organizational assessment of its effectiveness. The study aimed to determine a parameter of effectiveness for public clinical laboratories of Belo Horizonte, Minas Gerais State, and set cut-off points for the sections of these laboratories. In order to do so, the total production and number of hours worked during a period of 7 months in the year 2008 were consolidated. Due to the entrance of the workers in the mode of production in the laboratories network, it could be observed a variability regarding the performance of these workers. The effectiveness parameter of the network was established in 29.90 tests per hour. As a consequence of this first analysis, the cut-off points are: 15.50 for the hematology section; 67.29 for chemistry; 6.45 for parasitology; 11.35 for urinalysis; 4.94 for microbiology and 19.03 for immunology. From these results, it was concluded that the working process in laboratories can generate a decrease in effectiveness.
Tutkin opinnäytetyössäni brändin ja musiikkivideon suhdetta toisiinsa. Työssä käsitellään lyhyesti myös tähteyttä. Esittelen ensin vähän historiaa ja peruskäsitteitä, minkä jälkeen käytän Michael Jacksonin Billie Jean -musiikkivideota esimerkkinä tutkiessani Michael Jacksonin brändiä. Teoksessa käytetään lähdeaineistoa sekä omaa analyysia. Keskityn tarkastelemaan musiikkivideoita, ja niihin liittyviä sisältöjä yleisesti, ei niinkään teknisesti. Toivon, että työstäni on apua jollekin,...
Ishida, Haku; Nakamura, Junji; Yoshida, Hiroshi; Koike, Masaru; Inoue, Yuji
We conducted a questionnaire survey regarding the current activities for protecting patients' privacy and the security of information systems (IS) related to the clinical laboratory departments of university hospitals, certified training facilities for clinical laboratories, and general hospitals in Yamaguchi Prefecture. The response rate was 47% from 215 medical institutions, including three commercial clinical laboratory centers. The results showed that there were some differences in management activities among facilities with respect to continuing education, the documentation or regulation of operational management for paper records, electronic information, remaining samples, genetic testing, and laboratory information for secondary use. They were suggested to be caused by differences in functions between university and general hospitals, differences in the scale of hospitals, or whether or not hospitals have received accreditation or ISO 15189. Regarding the IS, although the majority of facilities had sufficiently employed the access control to IS, there was some room for improvement in the management of special cases such as VIPs and patients with HIV infection. Furthermore, there were issues regarding the login method for computers shared by multiple staff, the showing of the names of personnel in charge of reports, and the risks associated with direct connections to systems and the Internet and the use of portable media such as USB memory sticks. These results indicated that further efforts are necessary for each facility to continue self-assessment and make improvements.
Su, Bin-Guang; Chen, Shao-Fen; Yeh, Shu-Hsing; Shih, Po-Wen; Lin, Ching-Chiang
To cope with the government's policies to reduce medical costs, Taiwan's healthcare service providers are striving to survive by pursuing profit maximization through cost control. This article aimed to present the results of cost evaluation using activity-based costing performed in the laboratory in order to throw light on the differences between costs and the payment system of National Health Insurance (NHI). This study analyzed the data of costs and income of the clinical laboratory. Direct costs belong to their respective sections of the department. The department's shared costs, including public expenses and administrative assigned costs, were allocated to the department's respective sections. A simple regression equation was created to predict profit and loss, and evaluate the department's break-even point, fixed cost, and contribution margin ratio. In clinical chemistry and seroimmunology sections, the cost per test was lower than the NHI payment and their major laboratory tests had revenues with the profitability ratio of 8.7%, while the other sections had a higher cost per test than the NHI payment and their major tests were in deficit. The study found a simple linear regression model as follows: "Balance=-84,995+0.543×income (R2=0.544)". In order to avoid deficit, laboratories are suggested to increase test volumes, enhance laboratory test specialization, and become marginal scale. A hospital could integrate with regional medical institutions through alliances or OEM methods to increase volumes to reach marginal scale and reduce laboratory costs, enhancing the level and quality of laboratory medicine.
Men'shikov, V V
The generalized data concerning the conditions of application of regulations of national standards in clinical diagnostic laboratories of medical organizations is presented. The primary information was provided by 14 regions of 6 federal administrative okrugs of Russia. The causes of challenges of application of requirements of standards are presented. They are mostly related with insufficient financial support, lacking of manpower, difficulties with reagents supply, inadequate technical maintenance of devices and absence of support of administration of medical organizations. The recommendations are formulated concerning the necessity of publishing the document of Minzdrav of Russia to determine the need in application of standards in laboratory practice.
Jiang, Yuanyuan; Jiang, Hongmin; Ding, Siyi; Liu, Qin
Timely delivery of correct results has long been considered as the goal of quality management in clinical laboratory. With increasing workload as well as complexities of laboratory testing and patient care, the traditional technical adopted like internal quality control (IQC) and external quality assessment (EQA) may not enough to cope with quality management problems for clinical laboratories. We applied failure mode and effects analysis (FMEA), a proactive tool, to reduce errors associated with the process beginning with sample collection and ending with a test report in a clinical chemistry laboratory. Our main objection was to investigate the feasibility of FMEA in a real-world situation, namely the working environment of hospital. A team of 8 people (3 laboratory workers, 2 couriers, 2 nurses, and 1 physician) from different departments who were involved in the testing process were recruited and trained. Their main responsibility was to analyze and score all possible clinical chemistry laboratory failures based on three aspects: the severity of the outcome (S), the likeliness of occurrence (O), and the probability of being detected (D). These three parameters were multiplied to calculate risk priority numbers (RPNs), which were used to prioritize remedial measures. Failure modes with RPN≥200 were deemed as high risk, meaning that they needed immediate corrective action. After modifications that were put, we compared the resulting RPN with the previous one. A total of 33 failure modes were identified. Many of the failure modes, including the one with the highest RPN (specimen hemolysis) appeared in the pre-analytic phase, whereas no high-risk failure modes (RPN≥200) were found during the analytic phase. High-priority risks were "sample hemolysis" (RPN, 336), "sample delivery delay" (RPN, 225), "sample volume error" (RPN, 210), "failure to release results in a timely manner" (RPN, 210), and "failure to identify or report critical results" (RPN, 200). The
Full Text Available Leber's hereditary optic neuropathy (LHON is a maternally inherited disorder with point mutations in mitochondrial DNA which result in loss of vision in young adults. The majority of mutations reported to date are within the genes encoding the subunits of the mitochondrial NADH-quinone oxidoreductase, complex I. Establishment of animal models of LHON should help elucidate mechanism of the disease and could be utilized for possible development of therapeutic strategies.We established a rat model which involves injection of rotenone-loaded microspheres into the optic layer of the rat superior colliculus. The animals exhibited the most common features of LHON. Visual loss was observed within 2 weeks of rotenone administration with no apparent effect on retinal ganglion cells. Death of retinal ganglion cells occurred at a later stage. Using our rat model, we investigated the effect of the yeast alternative NADH dehydrogenase, Ndi1. We were able to achieve efficient expression of the Ndi1 protein in the mitochondria of all regions of retinal ganglion cells and axons by delivering the NDI1 gene into the optical layer of the superior colliculus. Remarkably, even after the vision of the rats was severely impaired, treatment of the animals with the NDI1 gene led to a complete restoration of the vision to the normal level. Control groups that received either empty vector or the GFP gene had no effects.The present study reports successful manifestation of LHON-like symptoms in rats and demonstrates the potential of the NDI1 gene therapy on mitochondrial optic neuropathies. Our results indicate a window of opportunity for the gene therapy to be applied successfully after the onset of the disease symptoms.
Abanyie Francisca A
Full Text Available Abstract Background The diagnosis of malaria can be difficult in non-endemic areas, such as the United States, and delays in diagnosis and errors in treatment occur too often. Methods A nationwide survey of laboratories in the United States and its nine dependent territories was conducted in 2010 to determine factors that may contribute to shortcomings in the diagnosis of malaria. This survey explored the availability of malaria diagnostic tests, techniques used, and reporting practices. Results The survey was completed by 201 participants. Ninety percent reported that their laboratories had at least one type of malaria diagnostic test available on-site. Nearly all of the respondents' laboratories performed thick and thin smears on-site; approximately 50% had access to molecular testing; and only 17% had access to rapid diagnostic tests on-site. Seventy-three percent reported fewer than five confirmed cases of malaria in their laboratory during the 12-month period preceding the survey. Twenty-eight percent stated that results of species identification took more than 24 hours to report. Only five of 149 respondents that performed testing 24 hours a day, 7 days a week complied with all of the Clinical and Laboratory Standards Institute (CLSI guidelines for analysis and reporting of results. Conclusion Although malaria diagnostic testing services were available to a majority of U.S. laboratories surveyed, very few were in complete compliance with all of the CLSI guidelines for analysis and reporting of results, and most respondents reported very few cases of malaria annually. Laboratories' difficulty in adhering to the rigorous CLSI guidelines and their personnel's lack of practice and proficiency may account for delays and errors in diagnosis. It is recommended that laboratories that infrequently process samples for malaria seek opportunities for practice and proficiency training annually and take advantage of available resources to assist in
Sturgeon, Catharine; Hill, Robert; Hortin, Glen L; Thompson, Douglas
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
Stewien Klaus Eberhard
Full Text Available A clinical and laboratory evaluation of 11 children and young adults with measleslike rash was done during the measles outbreak in the Greater São Paulo Metropolitan area at the end of 1996 and spread over the country during 1997. Measles was laboratory confirmed in 07 patients by specific IgM detection in acute serum specimens using an IgM-capture EIA, by specific IgG seroconversion in serum pairs, and by reverse transcription PCR and virus isolation in peripheral blood lymphocytes. Clinical presentations were not always classic; one of the 07 cases had received measles vaccine and corresponded to modified clinical case of measles. The 4 remaining cases were negative for measles and were diagnosed as exanthem subitum (2 cases, scarlet fever and Kawasaki disease. The present study reinforces the view that clinical features alone are not sufficient for establishing an accurate diagnosis in the post-vaccine era, and a surveillance system based on sensitive laboratory results is needed so that it can confirm IgM-negative measles cases.
Matthew D Krasowski
Full Text Available Background: Autoverification is a process of using computer-based rules to verify clinical laboratory test results without manual intervention. To date, there is little published data on the use of autoverification over the course of years in a clinical laboratory. We describe the evolution and application of autoverification in an academic medical center clinical chemistry core laboratory. Subjects and Methods: At the institution of the study, autoverification developed from rudimentary rules in the laboratory information system (LIS to extensive and sophisticated rules mostly in middleware software. Rules incorporated decisions based on instrument error flags, interference indices, analytical measurement ranges (AMRs, delta checks, dilution protocols, results suggestive of compromised or contaminated specimens, and ′absurd′ (physiologically improbable values. Results: The autoverification rate for tests performed in the core clinical chemistry laboratory has increased over the course of 13 years from 40% to the current overall rate of 99.5%. A high percentage of critical values now autoverify. The highest rates of autoverification occurred with the most frequently ordered tests such as the basic metabolic panel (sodium, potassium, chloride, carbon dioxide, creatinine, blood urea nitrogen, calcium, glucose; 99.6%, albumin (99.8%, and alanine aminotransferase (99.7%. The lowest rates of autoverification occurred with some therapeutic drug levels (gentamicin, lithium, and methotrexate and with serum free light chains (kappa/lambda, mostly due to need for offline dilution and manual filing of results. Rules also caught very rare occurrences such as plasma albumin exceeding total protein (usually indicative of an error such as short sample or bubble that evaded detection and marked discrepancy between total bilirubin and the spectrophotometric icteric index (usually due to interference of the bilirubin assay by immunoglobulin (Ig M monoclonal
González Saldaña, Napoleón; Monroy Colín, Victor Antonio; Piña Ruiz, Georgina; Juárez Olguín, Hugo
Infectious mononucleosis (IM) or Mononucleosis syndrome is caused by an acute infection of Epstein-Barr virus. In Latin American countries, there are little information pertaining to the clinical manifestations and complications of this disease. For this reason, the purpose of this work was to describe the clinical and laboratory characteristics of infection by Epstein-Barr virus in Mexican children with infectious mononucleosis. A descriptive study was carried out by reviewing the clinical files of patients less than 18 years old with clinical and serological diagnosis of IM by Epstein-Barr virus from November, 1970 to July, 2011 in a third level pediatric hospital in Mexico City. One hundred and sixty three cases of IM were found. The most frequent clinical signs were lymphadenopathy (89.5%), fever (79.7%), general body pain (69.3%), pharyngitis (55.2%), hepatomegaly (47.2%). The laboratory findings were lymphocytosis (41.7%), atypic lymphocytes (24.5%), and increased transaminases (30.9%), there were no rupture of the spleen and no deaths among the 163 cases. Our results revealed that IM appeared in earlier ages compared with that reported in industrialized countries, where adolescents are the most affected group. Also, the order and frequency of the clinical manifestations were different in our country than in industrialized ones.
Martínez-Granados, Luis; Serrano, María; González-Utor, Antonio; Ortíz, Nereyda; Badajoz, Vicente; Olaya, Enrique; Prados, Nicolás; Boada, Montse; Castilla, Jose A
The aim of this study is to determine inter-laboratory variability on embryo assessment using time-lapse platform and conventional morphological assessment. This study compares the data obtained from a pilot study of external quality control (EQC) of time lapse, performed in 2014, with the classical EQC of the Spanish Society for the Study of Reproductive Biology (ASEBIR) performed in 2013 and 2014. In total, 24 laboratories (8 using EmbryoScope™, 15 using Primo Vision™ and one with both platforms) took part in the pilot study. The clinics that used EmbryoScope™ analysed 31 embryos and those using Primo Vision™ analysed 35. The classical EQC was implemented by 39 clinics, based on an analysis of 25 embryos per year. Both groups were required to evaluate various qualitative morphological variables (cell fragmentation, the presence of vacuoles, blastomere asymmetry and multinucleation), to classify the embryos in accordance with ASEBIR criteria and to stipulate the clinical decision taken. In the EQC time-lapse pilot study, the groups were asked to determine, as well as the above characteristics, the embryo development times, the number, opposition and size of pronuclei, the direct division of 1 into 3 cells and/or of 3 into 5 cells and false divisions. The degree of agreement was determined by calculating the intra-class correlation coefficients and the coefficient of variation for the quantitative variables and the Gwet index for the qualitative variables. For both EmbryoScope™ and Primo Vision™, two periods of greater inter-laboratory variability were observed in the times of embryo development events. One peak of variability was recorded among the laboratories addressing the first embryo events (extrusion of the second polar body and the appearance of pronuclei); the second peak took place between the times corresponding to the 8-cell and morula stages. In most of the qualitative variables analysed regarding embryo development, there was almost
Full Text Available The aim of this study is to determine inter-laboratory variability on embryo assessment using time-lapse platform and conventional morphological assessment. This study compares the data obtained from a pilot study of external quality control (EQC of time lapse, performed in 2014, with the classical EQC of the Spanish Society for the Study of Reproductive Biology (ASEBIR performed in 2013 and 2014. In total, 24 laboratories (8 using EmbryoScope™, 15 using Primo Vision™ and one with both platforms took part in the pilot study. The clinics that used EmbryoScope™ analysed 31 embryos and those using Primo Vision™ analysed 35. The classical EQC was implemented by 39 clinics, based on an analysis of 25 embryos per year. Both groups were required to evaluate various qualitative morphological variables (cell fragmentation, the presence of vacuoles, blastomere asymmetry and multinucleation, to classify the embryos in accordance with ASEBIR criteria and to stipulate the clinical decision taken. In the EQC time-lapse pilot study, the groups were asked to determine, as well as the above characteristics, the embryo development times, the number, opposition and size of pronuclei, the direct division of 1 into 3 cells and/or of 3 into 5 cells and false divisions. The degree of agreement was determined by calculating the intra-class correlation coefficients and the coefficient of variation for the quantitative variables and the Gwet index for the qualitative variables. For both EmbryoScope™ and Primo Vision™, two periods of greater inter-laboratory variability were observed in the times of embryo development events. One peak of variability was recorded among the laboratories addressing the first embryo events (extrusion of the second polar body and the appearance of pronuclei; the second peak took place between the times corresponding to the 8-cell and morula stages. In most of the qualitative variables analysed regarding embryo development, there
Bailey, R M
Until the mid-1960s the nonhospital clinical laboratory industry was dominated by pathologists. The ethics of medical professionalism protected the pathologists' market from price competition and from any serious threat from new entrants into the market. Immune from the competitive pressures of the marketplace, pathologists exerted monopoly control in local markets. That power was eroded by laboratories operated by technologists and bioanalysts and was finally overcome by the entry of large corporations into the industry. The market power of the largest corporate laboratories is now growing to a point where competition may again be thwarted. The professional ethics of pathologists allowed high prices, but there was little push toward higher volume. The commercial ethics of the corporate entrants brought lower prices but resulted in strong pressure for greater test quantities. In either case, the power wielded by the dominant producer would seem to go against the consumer's interests.
Sánchez-Romero, M Isabel; García-Lechuz Moya, Juan Manuel; González López, Juan José; Orta Mira, Nieves
The interpretation and the accuracy of the microbiological results still depend to a great extent on the quality of the samples and their processing within the Microbiology laboratory. The type of specimen, the appropriate time to obtain the sample, the way of sampling, the storage and transport are critical points in the diagnostic process. The availability of new laboratory techniques for unusual pathogens, makes necessary the review and update of all the steps involved in the processing of the samples. Nowadays, the laboratory automation and the availability of rapid techniques allow the precision and turn-around time necessary to help the clinicians in the decision making. In order to be efficient, it is very important to obtain clinical information to use the best diagnostic tools. Copyright © 2018 Elsevier España, S.L.U. and Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica. All rights reserved.
Vijayashree Thyagaraj; Karthik Ashok
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 (
Wang, Lu-nan; Zhang, Rui; Shen, Zi-yu; Chen, Wen-xiang; Li, Jin-ming
As with many studies carried out in European countries, a quality assurance program has been established by the National Center for Clinical Laboratories in China (NCCL). The results showed that the external quality assessment significantly improves laboratory performance for quantitative evaluation of hepatitis C virus (HCV) RNA. Serum panels were delivered twice annually to the clinical laboratories which performed HCV RNA detection in China. Each panel made up of 5 coded samples. All laboratories were requested to carry out the detection within the required time period and report on testing results which contained qualitative and/or quantitative test findings, reagents used and relevant information about apparatus. All the positive samples were calibrated against the first International Standard for HCV RNA in a collaborative study and the range of comparison target value (TG) designated as +/- 0.5 log. The numbers of laboratories reporting on qualitative testing results for the first and second time external quality assessment were 168 and 167 in the year of 2003 and increased to 209 and 233 in 2007; the numbers of laboratories reporting on quantitative testing results were 134 and 147 in 2003 and rose to 340 and 339 in 2007. Deviation between the mean value for quantitative results at home in 2003 and the target value was above 0.5 log, which was comparatively high. By 2007, the target value was close to the national average except for the low concentrated specimens (10(3) IU/ml). The percentage of results within the range of GM +/- 0.5 log(10) varied from 8.2% to 93.5%. Some laboratories had some difficulties in the exact quantification of the lowest (3.00 log IU/ml) as well as of the highest viral levels (6.37 log IU/ml) values, very near to the limits of the dynamic range of the assays. The comparison of these results with the previous study confirms that a regular participation in external quality assessment (EQA) assures the achievement of a high
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
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.
Giménez Marín, Ángeles; Rivas-Ruiz, Francisco
The aim of this study was to prepare, pilot and validate a questionnaire to evaluate patient safety in the specific context of clinical laboratories. A specific questionnaire on patient safety in the laboratory, with 62 items grouped into six areas, was developed, taking into consideration the diverse human and laboratory contextual factors which may contribute to producing errors. A pilot study of 30 interviews was carried out, including validity and reliability analyses using principal components factor analysis and Cronbach's alpha. Subsequently, 240 questionnaires were sent to 21 hospitals, followed by a test-retest of 41 questionnaires with the definitive version. The sample analyzed was composed of 225 questionnaires (an overall response rate of 80%). Of the 62 items initially assessed, 17 were eliminated due to non-compliance with the criteria established before the principal components factor analysis was performed. For the 45 remaining items, 12 components were identified, with an cumulative variance of 69.5%. In seven of the 10 components with two or more items, Cronbach's alpha was higher than 0.7. The questionnaire items assessed in the test-retest were found to be stable. We present the first questionnaire with sufficiently proven validity and reliability for evaluating patient safety in the specific context of clinical laboratories. This questionnaire provides a useful instrument to perform a subsequent macrostudy of hospital clinical laboratories in Spain. The questionnaire can also be used to monitor and promote commitment to patient safety within the search for continuous quality improvement. Copyright © 2011 SESPAS. Published by Elsevier Espana. All rights reserved.
Thuy, Nguyen Thanh, E-mail: firstname.lastname@example.org [National Institute of Hygiene and Epidemiology, 1 Yersin Street, Hai Ba Trung District, Hanoi (Viet Nam); Huy, Tran Quang, E-mail: email@example.com [National Institute of Hygiene and Epidemiology, 1 Yersin Street, Hai Ba Trung District, Hanoi (Viet Nam); Nga, Phan Thi [National Institute of Hygiene and Epidemiology, 1 Yersin Street, Hai Ba Trung District, Hanoi (Viet Nam); Morita, Kouichi [Department of Virology, Institute of Tropical Medicine, Global COE Program, Nagasaki University, Nagasaki (Japan); Dunia, Irene; Benedetti, Lucio [Institut Jacques Monod, UMR7592 Université Paris Diderot/CNRS, Paris (France)
We describe the ultrastructure of the NamDinh virus (NDiV), a new member of the order Nidovirales grown in the C6/36 mosquito cell line. Uninfected and NDiV-infected cells were investigated by electron microscopy 24–48 h after infection. The results show that the viral nucleocapsid-like particles form clusters concentrated in the vacuoles, the endoplasmic reticulum, and are scattered in the cytoplasm. Mature virions of NDiV were released as budding particles on the cell surface where viral components appear to lie beneath and along the plasma membrane. Free homogeneous virus particles were obtained by ultracentrifugation on sucrose gradients of culture fluids. The size of the round-shaped particles with a complete internal structure was 80 nm in diameter. This is the first study to provide information on the morphogenesis and ultrastructure of the first insect nidovirus NDiV, a missing evolutionary link in the emergence of the viruses with the largest RNA genomes. - Highlights: • NamDinh virus (NDiV), a new member of the order Nidovirales was tested in cultured cell line. • The morphogenesis and ultrastructure of NDiV were investigated by electron microscopy. • The viral nucleocapsid-like particles clustered and scattered in the cytoplasm. • NDiVs were released as budding particles on the cell surface. • The size of the viral particles with a complete internal structure was 80 nm in diameter.
Skipper, Mads; Musaeus, Peter; Nøhr, Susanne Backman
This study aimed to analyse and redesign the outpatient clinic in a paediatric department. The study was a joint collaboration with the doctors of the department (paediatric residents and specialists) using the Change Laboratory intervention method as a means to model and implement change in the outpatient clinic. This study was motivated by a perceived failure to integrate the activities of the outpatient clinic, patient care and training of residents. The ultimate goal of the intervention was to create improved care for patients through resident learning and development. We combined the Change Laboratory intervention with an already established innovative process for residents, 3-h meetings. The Change Laboratory intervention method consists of a well-defined theory (Cultural-historical activity theory) and concrete actions where participants construct a new theoretical model of the activity, which in this case was paediatric doctors' workplace learning modelled in order to improve medical social practice. The notion of expansive learning was used during the intervention in conjunction with thematic analysis of data in order to fuel the process of analysis and intervention. The activity system of the outpatient clinic can meaningfully be analysed in terms of the objects of patient care and training residents. The Change Laboratory sessions resulted in a joint action plan for the outpatient clinic structured around three themes: (1) Before: Preparation, expectations, and introduction; (2) During: Structural context and resources; (3) After: Follow-up and feedback. The participants found the Change Laboratory method to be a successful way of sharing reflections on how to optimise the organisation of work and training with patient care in mind. The Change Laboratory approach outlined in this study succeeded to change practices and to help medical doctors redesigning their work. Participating doctors must be motivated to uncover inherent contradictions in their
Arfvidsson, Cecilia; Severin, Paul; Holmes, Victoria; Mitchell, Richard; Bailey, Christopher; Cape, Stephanie; Li, Yan; Harter, Tammy
The AstraZeneca and Covance Laboratories Clinical Bioanalysis Alliance (CBioA) was launched in 2011 after a period of global economic recession. In this challenging environment, AstraZeneca elected to move to a full and centralized outsourcing model that could optimize the number of people supporting bioanalytical work and reduce the analytical cost. This paper describes the key aspects of CBioA, the innovative operational model implemented, and our ways of ensuring this was much more than simply a cost reduction exercise. As we have recently passed the first 5-year cycle, this paper also summarizes some of the concluding benefits, wins and lessons learned, and how we now plan to extend and develop the relationship even further moving into a new clinical laboratory partnership.
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.
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
Yapar, Derya; Erenler, Ali Kemal; Terzi, Özlem; Akdoğan, Özlem; Ece, Yasemin; Baykam, Nurcan
We aimed to determine clinical, laboratory and demographical characteristics of tularemia on admission to Emergency Department (ED). Medical data of 317 patients admitted to ED and subsequently hospitalized with suspected tularemia between January 1, 2011, and May 31, 2015, were collected. Patients were divided into 2 groups according to microagglutination test results, as tularemia (+) and tularemia (-). Of the 317 patients involved, 49 were found to be tularemia (+) and 268 were tularemia (-). Mean age of the tularemia (+) patients was found to be higher than that of tularemia (-) patients. When compared to tularemia (-) patients, a significant portion of patients in tularemia (+) patients were elderly, living in rural areas and had contact with rodents. When clinical and laboratory findings of the 2 groups were compared, any statistical significance could not be determined. Tularemia is a disease of elderly people living in rural areas. Contact with rodents also increases risk of tularemia in suspected patients. Copyright © 2015 Elsevier Inc. All rights reserved.
Parlak, Mehmet; Akbayram, Sinan; Doğan, Murat; Tuncer, Oğuz; Bayram, Yasemin; Ceylan, Nesrin; Özlük, Suat; Akbayram, Hatice Tuba; Öner, Abdurrahman
Brucellosis is the most common zoonotic disease worldwide and remains an important human disease especially in developing countries. The aim of the present study was to evaluate clinical manifestations and laboratory findings of childhood brucellosis in Van province of Eastern Turkey. To our knowledge, this is the largest series of childhood brucellosis reported in the literature. In this retrospective study, 496 children with brucellosis were assessed for the clinical manifestations and laboratory findings from July 2009 through December 2013. The diagnosis of brucellosis was based on clinical findings and a standard tube agglutination test (titer ≥ 1:160). Data were analyzed using Minitab version 16. The study included 496 children (boys, 60.5%) with a mean age of 10.0 ± 3.95 years (range, 1-16 years). The most frequent clinical symptoms were arthralgia (46.2%), fever (32.1%), and abdominal pain (17.1%) and the most common clinical signs were peripheral arthritis (10.1%), splenomegaly (2.2%) and hepatomegaly (1.8%). The most contagious seasons were summer and autumn (63.3%). Elevated lactate dehydrogenase and C-reactive protein and erythrocyte sedimentation rate were reported in 63.1%, 58.7%, and 55.2% of the patients, respectively. Anemia (20.4%), thrombocytopenia (15.5%), and leukopenia (12.1%) were the most common hematologic findings. Brucellosis remains a serious public health problem in Turkey. The clinical and laboratory characteristics of childhood brucellosis have been described in order to assist clinicians in diagnosing and monitoring the disease. © 2015 Japan Pediatric Society.
Robitaille, Line; Hoffer, L. John
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...
Lima, CSP; Vassalo, J; LorandMetze, I; Bechelli, APP; Souza, CA
A prospective study was undertaken to elucidate the clinical and laboratory differences between tie novo acute myeloid leukemia (AML) and AML with trilineage myelodysplasia (AML-TMDS). One hundred and seven patients with AML were diagnosed at the University Hospital between January 1987 and July 1992, and were followed until July 1995. TMDS was identified in 17 of them (16%). With regard to age and sex distribution no difference was found between AML patients with and without TMDS (p = 0.43, ...
SIMEONOVA, Galina; DINEV, Dinko; CHAPRAZOV, Tzvetan; ROYDEV, Rumen
The aim of the study was to identify predictors of mortality and to propose a new severity scoring system in dogs with acute abdominal syndrome. A retrospective study was carried out on 58 dogs presented with acute abdominal syndrome with American Society of Anesthesiologists grades III-IV and treated surgically by exploratory laparotomy. Medical records were reviewed and information regarding dog signalment, history, clinical, and laboratory data; surgical findings; and outcome was collected...
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
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.
Niloy Gan Chaudhuri; S. Vithyavathi; K. Sankar
Background: Dengue infection, an arthropod-borne viral hemorrhagic fever is caused by Arbovirus of Flavivirus genus and transmitted by Aedes aegypti, Aedes albopictus. Liver involvement in dengue fever is manifested by the elevation of transaminases representing reactive hepatitis, due to direct attack of virus itself or the use of hepatotoxic drugs. The objective of the study was to investigate clinical and laboratory profile of different dengue sub type's patients admitted for dengue fever....
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.
... therefrom, to human beings or animals. (2) Iodine-131, in units not exceeding 10 microcuries each for use in... microcuries each for use in in vitro clinical or laboratory tests not involving internal or external... (tritium), in units not exceeding 50 microcuries each for use in in vitro clinical or laboratory tests not...
Seo, Yu-Mi; Kang, Hyun-Mi; Lee, Sung-Churl; Yu, Jae-Won; Kil, Hong-Ryang; Rhim, Jung-Woo; Han, Ji-Whan; Lee, Kyung-Yil
This study aimed to analyse laboratory values according to fever duration, and evaluate the relationship across these values during the acute phase of Kawasaki disease (KD) to aid in the early diagnosis for early-presenting KD and incomplete KD patients. Clinical and laboratory data of patients with KD (n=615) were evaluated according to duration of fever at presentation, and were compared between patients with and without coronary artery lesions (CALs). For evaluation of the relationships across laboratory indices, patients with a fever duration of 5 days or 6 days were used (n=204). The mean fever duration was 6.6±2.3 days, and the proportions of patients with CALs was 19.3% (n=114). C-reactive proteins (CRPs) and neutrophil differential values were highest and hemoglobin, albumin, and lymphocyte differential values were lowest in the 6-day group. Patients with CALs had longer total fever duration, higher CRP and neutrophil differential values and lower hemoglobin and albumin values compared to patients without CALs. CRP, albumin, neutrophil differential, and hemoglobin values at the peak inflammation stage of KD showed positive or negative correlations each other. The severity of systemic inflammation in KD was reflected in the laboratory values including CRP, neutrophil differential, albumin, and hemoglobin. Observing changes in these laboratory parameters by repeated examinations prior to the peak of inflammation in acute KD may aid in diagnosis of early-presenting KD patients.
Zhang, Xiaoyan; Fei, Yang; Wang, Wei; Zhao, Haijian; Wang, Minqi; Chen, Bingquan; Zhou, Jie; Wang, Zhiguo
This survey was initiated to estimate the current status of turnaround time (TAT) monitoring of clinical biochemistry in China, provide baseline data for establishment of quality specifications and analyze the impact factors of TAT. 738 laboratories were included. Questionnaires involved general information and data of related indicators of TAT during 1 week were provided to participating laboratories. Nine quality indicators were covered, which were medians, 90th and outlier rates of pre-examination, examination, and post-examination TAT. The 25th percentile, median, and 75th percentile of TATs were calculated as optimum, desirable, and minimum quality specifications. Percentages and sigma values were used to describe the outlier rates. Mann-Whitney and Kruskal-Wallis tests were used to identify the potential impacts of TAT. Response rate of this survey was 46.44%. More than 50% of the laboratories indicated they had set up target TATs in three time intervals and monitored TATs generally. The post-examination TAT of most laboratories was 0min, while the pre-examination and examination TAT varied. Sigma values of outlier rates for 45%~60% of laboratories were above 4, while 15%~20% of labs whose sigma values were below 3. Group comparisons suggested nurse or mechanical pipeline transportation, link laboratory information system with hospital information system, and using computer reporting instead of printing report were related to shorter TATs. Despite of the remarkable progresses of TATs in China, there was also room to improve. Laboratories should strengthen the construction of information systems, identify reasons for TAT delay to improve the service quality continuously. © 2017 Wiley Periodicals, Inc.
Wadlin, Jill K.; Hanko, Gayle; Stewart, Rebecca; Pape, John; Nachamkin, Irving
We evaluated three commercial systems (RapID Yeast Plus System; Innovative Diagnostic Systems, Norcross, Ga.; API 20C Aux; bioMerieux-Vitek, Hazelwood, Mo.; and Vitek Yeast Biochemical Card, bioMerieux-Vitek) against an auxinographic and microscopic morphologic reference method for the ability to identify yeasts commonly isolated in our clinical microbiology laboratory. Two-hundred one yeast isolates were compared in the study. The RapID Yeast Plus System was significantly better than either API 20C Aux (193 versus 167 correct identifications; P clinically relevant yeasts. PMID:10325356
Schueller-Weidekamm, Claudia; Schueller, Gerd; Aringer, Martin; Weber, Michael; Kainberger, Franz
Objective: To explore the typical sonographic features of gray-scale and Power Doppler of acute and chronic gouty arthritis in conjunction with radiographic, clinical, and laboratory findings. Materials and methods: All hand, finger, and toe joints of 19 patients with acute and chronic gout were examined with gray-scale and Power Doppler sonography. The number and size of bone changes detected with sonography was compared to radiographic findings. Vascularization of the synovial tissue was scored on Power Doppler (grades 0-3), and was compared with clinical appearance, including swelling, tenderness, and redness (grades 0-3). Results: In acute gout, mild to moderate echogenic periarticular nodules with sonotransmission and hypervascularization of the edematous surrounding soft tissue were found. In chronic gout, tophaceous nodules completely blocked transmission of US wave, leading to strong reflexion and dorsal shadowing in a minority of cases. No significant difference in the detection of large bone changes (>2 mm) was found between sonography and radiography. However, gray-scale sonography was significantly more sensitive in the detection of small bone changes (p < 0.001). Power Doppler scores were statistically significantly higher than clinical examination scores (p < 0.001). Discussion: Sonography is superior to radiographs in evaluating small bone changes. The inflammatory process in joints can be better detected with Power Doppler sonography than with clinical examination. Typical sonographic appearance of acute and in particular of chronic gout might provide clues on gouty arthritis that adds to the information available from conventional radiography, clinical, and laboratory findings
Schueller-Weidekamm, Claudia [Department of Diagnostic Radiology, Medical University of Vienna, Waehringer Guertel 18-20, A-1090 Vienna (Austria)]. E-mail: firstname.lastname@example.org; Schueller, Gerd [Department of Diagnostic Radiology, Medical University of Vienna, Waehringer Guertel 18-20, A-1090 Vienna (Austria); Aringer, Martin [Department of Rheumatology, Internal Medicine III, Medical University of Vienna (Austria); Weber, Michael [Department of Diagnostic Radiology, Medical University of Vienna, Waehringer Guertel 18-20, A-1090 Vienna (Austria); Kainberger, Franz [Department of Diagnostic Radiology, Medical University of Vienna, Waehringer Guertel 18-20, A-1090 Vienna (Austria)
Objective: To explore the typical sonographic features of gray-scale and Power Doppler of acute and chronic gouty arthritis in conjunction with radiographic, clinical, and laboratory findings. Materials and methods: All hand, finger, and toe joints of 19 patients with acute and chronic gout were examined with gray-scale and Power Doppler sonography. The number and size of bone changes detected with sonography was compared to radiographic findings. Vascularization of the synovial tissue was scored on Power Doppler (grades 0-3), and was compared with clinical appearance, including swelling, tenderness, and redness (grades 0-3). Results: In acute gout, mild to moderate echogenic periarticular nodules with sonotransmission and hypervascularization of the edematous surrounding soft tissue were found. In chronic gout, tophaceous nodules completely blocked transmission of US wave, leading to strong reflexion and dorsal shadowing in a minority of cases. No significant difference in the detection of large bone changes (>2 mm) was found between sonography and radiography. However, gray-scale sonography was significantly more sensitive in the detection of small bone changes (p < 0.001). Power Doppler scores were statistically significantly higher than clinical examination scores (p < 0.001). Discussion: Sonography is superior to radiographs in evaluating small bone changes. The inflammatory process in joints can be better detected with Power Doppler sonography than with clinical examination. Typical sonographic appearance of acute and in particular of chronic gout might provide clues on gouty arthritis that adds to the information available from conventional radiography, clinical, and laboratory findings.
Kairisto, V; Poola, A
GraphROC for Windows is a program for clinical test evaluation. It was designed for the handling of large datasets obtained from clinical laboratory databases. In the user interface, graphical and numerical presentations are combined. For simplicity, numerical data is not shown unless requested. Relevant numbers can be "picked up" from the graph by simple mouse operations. Reference distributions can be displayed by using automatically optimized bin widths. Any percentile of the distribution with corresponding confidence limits can be chosen for display. In sensitivity-specificity analysis, both illness- and health-related distributions are shown in the same graph. The following data for any cutoff limit can be shown in a separate click window: clinical sensitivity and specificity with corresponding confidence limits, positive and negative likelihood ratios, positive and negative predictive values and efficiency. Predictive values and clinical efficiency of the cutoff limit can be updated for any prior probability of disease. Receiver Operating Characteristics (ROC) curves can be generated and combined into the same graph for comparison of several different tests. The area under the curve with corresponding confidence interval is calculated for each ROC curve. Numerical results of analyses and graphs can be printed or exported to other Microsoft Windows programs. GraphROC for Windows also employs a new method, developed by us, for the indirect estimation of health-related limits and change limits from mixed distributions of clinical laboratory data.
Chen, Ming-Shu; Wu, Ming-Hsun; Lin, Chih-Ming
The traditional criteria for acceptability of analytic quality may not be objective in clinical laboratories. To establish quality control procedures intended to enhance Westgard multi-rules for improving the quality of clinical biochemistry tests, we applied the Cp and Cpk quality-control indices to monitor tolerance fitting and systematic variation of clinical biochemistry test results. Daily quality-control data of a large Taiwanese hospital in 2009 were analyzed. The test items were selected based on an Olympus biochemistry machine and included serum albumin, aspartate aminotransferase, cholesterol, glucose and potassium levels. Cp and Cpk values were calculated for normal and abnormal levels, respectively. The tolerance range was estimated with data from 50 laboratories using the same instruments and reagents. The results showed a monthly trend of variation for the five items under investigation. The index values of glucose were lower than those of the other items, and their values were usually quality control, but also for revealing inter-laboratory qualitycontrol capability differences.
Giménez-Marín, Angeles; Rivas-Ruiz, Francisco; García-Raja, Ana M; Venta-Obaya, Rafael; Fusté-Ventosa, Margarita; Caballé-Martín, Inmaculada; Benítez-Estevez, Alfonso; Quinteiro-García, Ana I; Bedini, José Luis; León-Justel, Antonio; Torra-Puig, Montserrat
There is increasing awareness of the importance of transforming organisational culture in order to raise safety standards. This paper describes the results obtained from an evaluation of patient safety culture in a sample of clinical laboratories in public hospitals in the Spanish National Health System. A descriptive cross-sectional study was conducted among health workers employed in the clinical laboratories of 27 public hospitals in 2012. The participants were recruited by the heads of service at each of the participating centers. Stratified analyses were performed to assess the mean score, standardized to a base of 100, of the six survey factors, together with the overall patient safety score. 740 completed questionnaires were received (88% of the 840 issued). The highest standardized scores were obtained in Area 1 (individual, social and cultural) with a mean value of 77 (95%CI: 76-78), and the lowest ones, in Area 3 (equipment and resources), with a mean value of 58 (95%CI: 57-59). In all areas, a greater perception of patient safety was reported by the heads of service than by other staff. We present the first multicentre study to evaluate the culture of clinical safety in public hospital laboratories in Spain. The results obtained evidence a culture in which high regard is paid to safety, probably due to the pattern of continuous quality improvement. Nevertheless, much remains to be done, as reflected by the weaknesses detected, which identify areas and strategies for improvement.
Liu, Xuan; Jiang, Hui
Biosensors for proteins have shown attractive advantages compared to traditional techniques in clinical laboratory diagnosis. In virtue of modern fabrication modes and detection techniques, various immunosensing platforms have been reported on basis of the specific recognition between antigen-antibody pairs. In addition to profit from the development of nanotechnology and molecular biology, diverse fabrication and signal amplification strategies have been designed for detection of protein antigens, which has led to great achievements in fast quantitative and simultaneous testing with extremely high sensitivity and specificity. Besides antigens, determination of antibodies also possesses great significance for clinical laboratory diagnosis. In this review, we will categorize recent immunosensors for proteins by different detection techniques. The basic conception of detection techniques, sensing mechanisms, and the relevant signal amplification strategies are introduced. Since antibodies and antigens have an equal position to each other in immunosensing, all biosensing strategies for antigens can be extended to antibodies under appropriate optimizations. Biosensors for antibodies are summarized, focusing on potential applications in clinical laboratory diagnosis, such as a series of biomarkers for infectious diseases and autoimmune diseases, and an evaluation of vaccine immunity. The excellent performances of these biosensors provide a prospective space for future antibody-detection-based disease serodiagnosis.
Full Text Available Abstract Background The long-term prognosis of patients with colon cancer is dependent on many factors. To investigate the influence of a series of clinical, laboratory and morphological variables on prognosis of colon carcinoma we conducted a retrospective analysis of our data. Methods Ninety-two patients with colon cancer, who underwent surgical resection between January 1999 and December 2001, were analyzed. On survival analysis, demographics, clinical, laboratory and pathomorphological parameters were tested for their potential prognostic value. Furthermore, univariate and multivariate analysis of the above mentioned data were performed considering the depth of tumour invasion into the bowel wall as independent variable. Results On survival analysis we found that depth of tumour invasion (P Conclusion The various clinical, laboratory and patho-morphological parameters showed different prognostic value for colon carcinoma. In the future, preoperative prognostic markers will probably gain relevance in order to make a proper choice between surgery, chemotherapy and radiotherapy. Nevertheless, current data do not provide sufficient evidence for preoperative stratification of high and low risk patients. Further assessments in prospective large studies are warranted.
Grande, Michele; Milito, Giovanni; Attinà, Grazia Maria; Cadeddu, Federica; Muzi, Marco Gallinella; Nigro, Casimiro; Rulli, Francesco; Farinon, Attilio Maria
Background The long-term prognosis of patients with colon cancer is dependent on many factors. To investigate the influence of a series of clinical, laboratory and morphological variables on prognosis of colon carcinoma we conducted a retrospective analysis of our data. Methods Ninety-two patients with colon cancer, who underwent surgical resection between January 1999 and December 2001, were analyzed. On survival analysis, demographics, clinical, laboratory and pathomorphological parameters were tested for their potential prognostic value. Furthermore, univariate and multivariate analysis of the above mentioned data were performed considering the depth of tumour invasion into the bowel wall as independent variable. Results On survival analysis we found that depth of tumour invasion (P anismus, hematocrit, WBC count, fibrinogen value and CT scanning were significantly related to the degree of mural invasion of the cancer. On the multivariate analysis, fibrinogen value was the most statistically significant variable (P < 0.001) with the highest F-ratio (F-ratio 5.86). Finally, in the present study, the tumour site was significantly related neither to the survival nor to the mural invasion of the tumour. Conclusion The various clinical, laboratory and patho-morphological parameters showed different prognostic value for colon carcinoma. In the future, preoperative prognostic markers will probably gain relevance in order to make a proper choice between surgery, chemotherapy and radiotherapy. Nevertheless, current data do not provide sufficient evidence for preoperative stratification of high and low risk patients. Further assessments in prospective large studies are warranted. PMID:18778464
Joffe, Marshall; Hsu, Chi-yuan; Feldman, Harold I; Weir, Matthew; Landis, J R; Hamm, L Lee
Estimating equations using serum creatinine (SCr) are often used to assess glomerular filtration rate (GFR). Such creatinine (Cr)-based formulae may produce biased estimates of GFR when using Cr measurements that have not been calibrated to reference laboratories. In this paper, we sought to examine the degree of this variation in Cr assays in several laboratories associated with academic medical centers affiliated with the Chronic Renal Insufficiency Cohort (CRIC) Study; to consider how best to correct for this variation, and to quantify the impact of such corrections on eligibility for participation in CRIC. Variability of Cr is of particular concern in the conduct of CRIC, a large multicenter study of subjects with chronic renal disease, because eligibility for the study depends on Cr-based assessment of GFR. A library of 5 large volume plasma specimens from apheresis patients was assembled, representing levels of plasma Cr from 0.8 to 2.4 mg/dl. Samples from this library were used for measurement of Cr at each of the 14 CRIC laboratories repetitively over time. We used graphical displays and linear regression methods to examine the variability in Cr, and used linear regression to develop calibration equations. We also examined the impact of the various calibration equations on the proportion of subjects screened as potential participants who were actually eligible for the study. There was substantial variability in Cr assays across laboratories and over time. We developed calibration equations for each laboratory; these equations varied substantially among laboratories and somewhat over time in some laboratories. The laboratory site contributed the most to variability (51% of the variance unexplained by the specimen) and variation with time accounted for another 15%. In some laboratories, calibration equations resulted in differences in eligibility for CRIC of as much as 20%. The substantial variability in SCr assays across laboratories necessitates calibration
Blaya, Joaquin A; Yagui, Martin; Contreras, Carmen C; Palma, Betty; Shin, Sonya S; Yale, Gloria; Suarez, Carmen; Fraser, Hamish S F
13% of all drug susceptibility tests (DSTs) performed at a public laboratory in Peru were duplicate. To determine reasons for duplicate requests an online survey was implemented in the e-Chasqui laboratory information system. Results showed that 59.6% of tests were ordered because clinical staff was unaware of ordering guidelines or of a previous result. This shows a benefit of using a web-based system and the lack of laboratory information available to clinical staff in Peru.
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
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 characterisation and typing. However, with the introduction of molecular diagnostic methods and sequencing in most of the larger diagnostic and university hospital centres in high-income countries, the distinction between diagnostic and reference/public health laboratory functions has become less clear-cut. Given these developments, new ways of networking and data sharing are needed. Assuming that clinical and public health laboratories may be able to use the same data for their own purposes when sequence-based testing and typing are used, we explored ways to develop a collaborative approach and a jointly owned database (TYPENED) in the Netherlands. The rationale was that sequence data - whether produced to support clinical care or for surveillance -can be aggregated to meet both needs. Here we describe the development of the TYPENED approach and supporting infrastructure, and the implementation of a pilot laboratory network sharing enterovirus sequences and metadata.
In 1997, the European Communities Confederation of Clinical Chemistry and Laboratory Medicine (EC4) set up a Register for European Specialists in Clinical Chemistry and Laboratory Medicine. The operation of the Register is undertaken by a Register Commission (EC4RC). During the last 12 years, more than 2200 specialists in Clinical Chemistry and Laboratory Medicine have joined the Register. In 2007, EC4 merged with the Forum of European Societies of Clinical Chemistry and Laboratory Medicine (FESCC) to form the European Federation of Clinical Chemistry and Laboratory Medicine (EFCC). Two previous Guides to the Register have been published, one in 1997 and another in 2003. The third version of the Guide is presented in this article and is based on the experience gained and development of the profession since the last revision. Registration is valid for 5 years and the procedure and criteria for re-registration are presented as an Appendix at the end of the article.
In 1997, the European Communities Confederation of Clinical Chemistry and Laboratory Medicine (EC4) set up a Register for European Specialists in Clinical Chemistry and Laboratory Medicine. The operation of the Register is undertaken by a Register Commission (EC4RC). During the last 10 years, more than 2000 specialists in Clinical Chemistry and Laboratory Medicine have joined the Register. In 2007, EC4 merged with the Federation of European Societies of Clinical Chemistry and Laboratory Medicine (FESCC) to form the European Federation of Clinical Chemistry and Laboratory Medicine (EFCC). A Code of Conduct was adopted in 2003 and a revised and updated version, taking account particularly of the guidelines of the Conseil Européen des Professions Libérales (CEPLIS) of which EFCC is a member, is presented in this article. The revised version was approved by the EC4 Register Commission and by the EFCC Executive Board in Paris on 6 November, 2008.
Massambu, Charles; Mwangi, Christina
The rapid scale-up of the care and treatment programs in Tanzania during the preceding 4 years has greatly increased the demand for quality laboratory services for diagnosis of HIV and monitoring patients during antiretroviral therapy. Laboratory services were not in a position to cope with this demand owing to poor infrastructure, lack of human resources, erratic and/or lack of reagent supply and commodities, and slow manual technologies. With the limited human resources in the laboratory and the need for scaling up the care and treatment program, it became necessary to install automated equipment and train personnel for the increased volume of testing and new tests across all laboratory levels. With the numerous partners procuring equipment, the possibility of a multitude of equipment platforms with attendant challenges for procurement of reagents, maintenance of equipment, and quality assurance arose. Tanzania, therefore, had to harmonize laboratory tests and standardize laboratory equipment at different levels of the laboratory network. The process of harmonization of tests and standardization of equipment included assessment of laboratories, review of guidelines, development of a national laboratory operational plan, and stakeholder advocacy. This document outlines this process.
Vernon J Lee
Full Text Available BACKGROUND: Dengue and chikungunya are co-circulating vector-borne diseases with substantial overlap in clinical presentations. It is important to differentiate between them during first presentation as their management, especially for dengue hemorrhagic fever (DHF, is different. This study compares their clinical presentation in Singapore adults to derive predictors to assist doctors in diagnostic decision-making. METHODS: We compared 117 patients with chikungunya infection diagnosed with reverse transcription-polymerase chain reaction (RT-PCR with 917 dengue RT-PCR-positive adult patients (including 55 with DHF. We compared dengue fever (DF, DHF, and chikungunya infections by evaluating clinical characteristics of dengue and chikungunya; developing classification tools via multivariate logistic regression models and classification trees of disease etiology using clinical and laboratory factors; and assessing the time course of several clinical variables. FINDINGS: At first presentation to hospital, significantly more chikungunya patients had myalgia or arthralgia, and fewer had a sore throat, cough (for DF, nausea, vomiting, diarrhea, abdominal pain, anorexia or tachycardia than DF or DHF patients. From the decision trees, platelets <118 × 10(9/L was the only distinguishing feature for DF versus chikungunya with an overall correct classification of 89%. For DHF versus chikungunya using platelets <100 × 10(9/L and the presence of bleeding, the overall correct classification was 98%. The time course analysis supported platelet count as the key distinguishing variable. INTERPRETATION: There is substantial overlap in clinical presentation between dengue and chikungunya infections, but simple clinical and laboratory variables can predict these infections at presentation for appropriate management.
Wu, Yingping; Wu, Jianyong; Zhang, Zhihui; Cheng, Chen
The polymerase chain reaction (PCR) technique, one of the most commonly applied methods in diagnostic and molecular biology, has a frustrating downside: the occurrence of false-positive signals due to contamination. In previous research, various DNA decontamination methods have been developed to overcome this limitation. Unfortunately, the use of random or poorly focused sampling methods for monitoring air and/or object surfaces leads to the incomplete elimination during decontamination procedures. We herein attempted to develop a novel DNA decontamination method (environmental surveillance, including surface and air sampling) and quality management program for clinical molecular diagnostic laboratories (or clinical PCR laboratories). Here, we performed a step-by-step evaluation of current DNA decontamination methods and developed an effective procedure for assessing the presence of decontaminating DNA via PCR analysis. Performing targeted environmental surveillance by sampling, which reached optimal performance over 2 weeks, and the decontamination process had been verified as reliable. Additionally, the process was validated to not affect PCR amplification efficiency based on a comparative study. In this study, effective guidelines for DNA decontamination were developed. The method employed ensured that surface DNA contamination could be effectively identified and eliminated. Furthermore, our study highlighted the importance of overall quality assurance and good clinical laboratory practices for preventing contamination, which are key factors for compliance with regulatory or accreditation requirements. Taken together, we provided the evidence that the presented scheme ranged from troubleshooting to the elimination of surface contamination, could serve as critical foundation for developing regular environmental surveillance guidelines for PCR laboratories. © 2017 Wiley Periodicals, Inc.
Körber, Friedrich; Plebani, Mario
In the early 1960s, Joachim Brugsch, one of the founders of Clinical Chemistry and Laboratory Medicine (CCLM) (then Zeitschrift für Klinische Chemie), had the idea to found a journal in the upcoming field of clinical chemistry. He approached Ernst Schütte, who was associated with the De Gruyter publishing house through another journal, to participate, and Schütte thus became the second founder of this Journal. The aim was to create a vehicle allowing the experts to express their opinions and raise their voices more clearly than they could in a journal that publishes only original experimental papers, a laborious and difficult, but important endeavor, as the profession of clinical chemistry was still in the early stages of development at this time. The first issue of this Journal was published in early 1963, and today, we are proud to celebrate the 50th anniversary of CCLM. This review describes the development of this Journal in light of the political situation of the time when it was founded, the situation of the publisher Walter De Gruyter after the erection of the Berlin Wall, and the development of clinical chemistry, and later on, laboratory medicine as a well-acknowledged discipline and profession.
Grimes, Susan M; Ji, Hanlee P
Large clinical genomics studies using next generation DNA sequencing require the ability to select and track samples from a large population of patients through many experimental steps. With the number of clinical genome sequencing studies increasing, it is critical to maintain adequate laboratory information management systems to manage the thousands of patient samples that are subject to this type of genetic analysis. To meet the needs of clinical population studies using genome sequencing, we developed a web-based laboratory information management system (LIMS) with a flexible configuration that is adaptable to continuously evolving experimental protocols of next generation DNA sequencing technologies. Our system is referred to as MendeLIMS, is easily implemented with open source tools and is also highly configurable and extensible. MendeLIMS has been invaluable in the management of our clinical genome sequencing studies. We maintain a publicly available demonstration version of the application for evaluation purposes at http://mendelims.stanford.edu. MendeLIMS is programmed in Ruby on Rails (RoR) and accesses data stored in SQL-compliant relational databases. Software is freely available for non-commercial use at http://dna-discovery.stanford.edu/software/mendelims/.
Henning, Jolene M.; Weidner, Thomas G.; Snyder, Melissa; Dudley, William N.
Context: Peer-assisted learning (PAL) has been recommended as an educational strategy to improve students' skill acquisition and supplement the role of the clinical instructor (CI). How frequently students actually engage in PAL in different settings is unknown. Objective: To determine the perceived frequency of planned and unplanned PAL (peer modeling, peer feedback and assessment, peer mentoring) in different settings. Design: Cross-sectional study. Setting: Laboratory and collegiate clinical settings. Patients or Other Participants: A total of 933 students, 84 administrators, and 208 CIs representing 52 (15%) accredited athletic training education programs. Intervention(s): Three versions (student, CI, administrator) of the Athletic Training Peer Assisted Learning Survey (AT-PALS) were administered. Cronbach α values ranged from .80 to .90. Main Outcome Measure(s): Administrators' and CIs' perceived frequency of 3 PAL categories under 2 conditions (planned, unplanned) and in 2 settings (instructional laboratory, collegiate clinical). Self-reported frequency of students' engagement in 3 categories of PAL in 2 settings. Results: Administrators and CIs perceived that unplanned PAL (0.39 ± 0.22) occurred more frequently than planned PAL (0.29 ± 0.19) regardless of category or setting (F1,282 = 83.48, P < .001). They perceived that PAL occurred more frequently in the collegiate clinical (0.46 ± 0.22) than laboratory (0.21 ± 0.24) setting regardless of condition or category (F1,282 = 217.17, P < .001). Students reported engaging in PAL more frequently in the collegiate clinical (3.31 ± 0.56) than laboratory (3.26 ± 0.62) setting regardless of category (F1,860 = 13.40, P < .001). We found a main effect for category (F2,859 = 1318.02, P < .001), with students reporting they engaged in peer modeling (4.01 ± 0.60) more frequently than peer mentoring (2.99 ± 0.88) (P < .001) and peer assessment and feedback (2.86 ± 0.64) (P < .001). Conclusions: Participants
This paper discusses the biological basis of new treatment strategies that are being introduced into the clinic in the form of controlled clinical trials. There is an increasing awareness of the need for quality assurance in the design, execution and analysis of these trials. However there is little awareness of the need to critically assess the biological basis of the trial design, to ensure that no other biological principles have been contravened in the attempt to optimise just one of the many parameters that determine the differential in sensitivity between tumours and normal tissues. Some examples are given of the changes that have recently occurred in the laboratory interpretation of both the mechanism of action and the therapeutic gain of several novel approaches. If these are not considered, the carefully controlled clinical trials may be wasted, because of being based on an incomplete consideration of all the interconnected biological factors. (author)
Yang, Jeong Hwa
The study obtained the following conclusions by making a comparative study on fatty liver diagnosed by abdominal ultrasonography and clinical laboratory findings. I surveyed the value of abdominal ultrasound in 400 patients without clinical symptoms at C Health Clinic Center, Seoul. Compare with blood pressure was high (systolic/diastolic) in 7.5%/4.5% on persons who were diagnosed fatty liver. At the time of the diagnosis, Total cholesterol level was increased in fatty liver patients, HDL-cholesterol level was high in fatty liver patients. And Trigryceride level was increased in fatty liver persons, LDL-cholesterol was high in fatty liver persons. SGOT level was increased in 5.5% on patients who were diagnosed fatty liver, 0% on persons who were normal and SGPT level was high in 29.5% on people who were diagnosed fatty liver, 0% on patients who were diagnosed normal
Vanessa L. Strelow
Full Text Available ABSTRACT Meningococcal meningitis is a public health problem. The aim of this study was to describe the clinical characteristics of patients with meningococcal meningitis, and to identify associated factors with mortality. This was a retrospective study, between 2006 and 2011, at a referral center in São Paulo, Brazil. Logistic regression analysis was used to identify factors associated with mortality. We included 316 patients. The median age was 16 years (IQR: 7–27 and 60% were male. The clinical triad: fever, headache and neck stiffness was observed in 89% of the patients. The cerebrospinal triad: pleocytosis, elevated protein levels and low glucose levels was present in 79% of patients. Factors associated with mortality in the multivariate model were age above 50 years, seizures, tachycardia, hypotension and neck stiffness. The classic clinical and laboratory triads of meningococcal meningitis were variable. The fatality rate was low. Age, seizures and shock signs were independently associated with mortality.
Yang, Jeong Hwa [Cheju Halla College, Cheju (Korea, Republic of)
The study obtained the following conclusions by making a comparative study on fatty liver diagnosed by abdominal ultrasonography and clinical laboratory findings. I surveyed the value of abdominal ultrasound in 400 patients without clinical symptoms at C Health Clinic Center, Seoul. Compare with blood pressure was high (systolic/diastolic) in 7.5%/4.5% on persons who were diagnosed fatty liver. At the time of the diagnosis, Total cholesterol level was increased in fatty liver patients, HDL-cholesterol level was high in fatty liver patients. And Trigryceride level was increased in fatty liver persons, LDL-cholesterol was high in fatty liver persons. SGOT level was increased in 5.5% on patients who were diagnosed fatty liver, 0% on persons who were normal and SGPT level was high in 29.5% on people who were diagnosed fatty liver, 0% on patients who were diagnosed normal.
Gray, I P; Carter, J Y
Pathology services represent the rational, scientific basis of the practice of clinical care. It does not represent deus ex machina, an implausible solution to a complex plot, but rather the way in which clinical care can be audited, controlled, guided and kept appropriate to the funds and the skills available. Arguments are presented to support this statement as well as to analyse what is wrong with health care, from the point of view of laboratory medicine, in sub-Saharan Africa. In most African countries 'first world' technology has to be imported by economies barely able to sustain the basic requirements of human life. Badly needed foreign exchange is obtained by growing export crops at the cost of traditional lifestyle, disenfranchising communities, urbanisation, and even at the cost not being able to grow food. War, corruption, lack of accountability even in the Western sense of being able to go to the polls every so often, lack of empowerment, low literacy rate etc all debase the communities, with minimal exceptions, of Africa. Health care is under the same capricious rule as all other public services: investment in laboratories is poor and most have no access to a professional laboratory at all. More investment, not less; expansion of pathology services not restricting them, is needed throughout the continent.
Kim, Gi Beom; Lee, Jong Min; Sung, Yeong Soon; Kang, Duk Sik [Kyungpook Natioanl University College of Medicine, Daegu (Korea, Republic of); Kim, Ok Hwoa [Dongkang general Hospital, Ulsan (Korea, Republic of)
The hypereosinophilic syndrome (HES) commonly involves liver and spleen but only a few literature has reported the imaging features. In this article, we present the imaging features of the liver and spleen in HES patients together with clinical and laboratory features. This study included 5 HES patients with hepatic involvement. Extensive laboratory tests including multiple hematologic, serologic, parasitological, and immunologic examinations were performed. Imaging studies included CT, ultrasound (US)of upper abdomen and hepatosplenic scintigraphy. All patients were periodically examined by laboratory and imaging studies for 4 to 24 months. The common clinical presentations were weakness, mild fever, and dry cough. All patients revealed leukocytosis with eosinophilia of 40 to 80% and benign eosinophilic hyperplasia of the bone marrow. The percutaneous biopsy of the hepatic focal lesions performed in 2 patients showed numerous benigin eosinophilic infiltrates and one of them revealed combined calibration necrosis of hepatocytes. All cases revealed hepatomegaly with multiple focal lesions on at least on of CT, US, or scintigraphy. These findings completely disappeared in 2 to 6 months following medication of corticosteroid or antihistamines. The HES involved the liver and CT, US, or scintigraphic studies showed hepatic multifocal lesions with hepatomegaly. Differential diagnosis of these findings should include metastatic disease, lymphoma, leukemia, candidiasis or other opportunistic infections.
Kim, Gi Beom; Lee, Jong Min; Sung, Yeong Soon; Kang, Duk Sik; Kim, Ok Hwoa
The hypereosinophilic syndrome (HES) commonly involves liver and spleen but only a few literature has reported the imaging features. In this article, we present the imaging features of the liver and spleen in HES patients together with clinical and laboratory features. This study included 5 HES patients with hepatic involvement. Extensive laboratory tests including multiple hematologic, serologic, parasitological, and immunologic examinations were performed. Imaging studies included CT, ultrasound (US)of upper abdomen and hepatosplenic scintigraphy. All patients were periodically examined by laboratory and imaging studies for 4 to 24 months. The common clinical presentations were weakness, mild fever, and dry cough. All patients revealed leukocytosis with eosinophilia of 40 to 80% and benign eosinophilic hyperplasia of the bone marrow. The percutaneous biopsy of the hepatic focal lesions performed in 2 patients showed numerous benigin eosinophilic infiltrates and one of them revealed combined calibration necrosis of hepatocytes. All cases revealed hepatomegaly with multiple focal lesions on at least on of CT, US, or scintigraphy. These findings completely disappeared in 2 to 6 months following medication of corticosteroid or antihistamines. The HES involved the liver and CT, US, or scintigraphic studies showed hepatic multifocal lesions with hepatomegaly. Differential diagnosis of these findings should include metastatic disease, lymphoma, leukemia, candidiasis or other opportunistic infections
Emma J. Quinn
Full Text Available Reported cases of dengue are rising in South Australia (SA in travellers returning from dengue-endemic regions. We have undertaken a retrospective analysis to identify the clinical and laboratory characteristics of patients returning to SA with suspected dengue virus (DENV infection. From 488 requests, 49 (10% were defined by serology as acute dengue, with the majority of patients (75% testing as non-structural protein 1 (NS1 and/or IgM positive. Dengue was most commonly acquired in Indonesia (42.9% with clinical features of fever (95%, headache (41% and myalgia/arthralgia (56%. The presence of rash (36% and laboratory findings of neutropenia, leukopenia, thrombocytopenia, but not elevated C-reactive protein, were distinct from findings in DENV-seronegative patients. Available dengue seropositive samples were analysed by RT-PCR, with 14/32 (43.8% positive by a serotype non-specific DENV assay, but 28/32 positive (87.5% when also assessed by serotype-specific RT-PCR. Serotype analysis revealed the predominance of DENV-1 and DENV-2 and the presence of DENV-3, but not DENV-4 or Zika virus (ZIKV. Thus, dengue in returned travellers in SA presents in a manner consistent with World Health Organization (WHO definitions, with symptoms, travel history and laboratory results useful in prioritising the likelihood of dengue. This definition will assist the future management in DENV-non-endemic regions, such as SA.
Gunn-Christie, Rebekah G; Flatland, Bente; Friedrichs, Kristen R; Szladovits, Balazs; Harr, Kendal E; Ruotsalo, Kristiina; Knoll, Joyce S; Wamsley, Heather L; Freeman, Kathy P
In December 2009, the American Society for Veterinary Clinical Pathology (ASVCP) Quality Assurance and Laboratory Standards committee published the updated and peer-reviewed ASVCP Quality Assurance Guidelines on the Society's website. These guidelines are intended for use by veterinary diagnostic laboratories and veterinary research laboratories that are not covered by the US Food and Drug Administration Good Laboratory Practice standards (Code of Federal Regulations Title 21, Chapter 58). The guidelines have been divided into 3 reports: (1) general analytical factors for veterinary laboratory performance and comparisons; (2) hematology, hemostasis, and crossmatching; and (3) clinical chemistry, cytology, and urinalysis. This particular report is one of 3 reports and documents recommendations for control of preanalytical, analytical, and postanalytical factors related to urinalysis, cytology, and clinical chemistry in veterinary laboratories and is adapted from sections 1.1 and 2.2 (clinical chemistry), 1.3 and 2.5 (urinalysis), 1.4 and 2.6 (cytology), and 3 (postanalytical factors important in veterinary clinical pathology) of these guidelines. These guidelines are not intended to be all-inclusive; rather, they provide minimal guidelines for quality assurance and quality control for veterinary laboratory testing and a basis for laboratories to assess their current practices, determine areas for improvement, and guide continuing professional development and education efforts. © 2012 American Society for Veterinary Clinical Pathology.
Meyer, Ashley N D; Thompson, Pamela J; Khanna, Arushi; Desai, Samir; Mathews, Benji K; Yousef, Elham; Kusnoor, Anita V; Singh, Hardeep
Mobile applications for improving diagnostic decision making often lack clinical evaluation. We evaluated if a mobile application improves generalist physicians' appropriate laboratory test ordering and diagnosis decisions and assessed if physicians perceive it as useful for learning. In an experimental, vignette study, physicians diagnosed 8 patient vignettes with normal prothrombin times (PT) and abnormal partial thromboplastin times (PTT). Physicians made test ordering and diagnosis decisions for 4 vignettes using each resource: a mobile app, PTT Advisor, developed by the Centers for Disease Control and Prevention (CDC)'s Clinical Laboratory Integration into Healthcare Collaborative (CLIHC); and usual clinical decision support. Then, physicians answered questions regarding their perceptions of the app's usefulness for diagnostic decision making and learning using a modified Kirkpatrick Training Evaluation Framework. Data from 368 vignettes solved by 46 physicians at 7 US health care institutions show advantages for using PTT Advisor over usual clinical decision support on test ordering and diagnostic decision accuracy (82.6 vs 70.2% correct; P < .001), confidence in decisions (7.5 vs 6.3 out of 10; P < .001), and vignette completion time (3:02 vs 3:53 min.; P = .06). Physicians reported positive perceptions of the app's potential for improved clinical decision making, and recommended it be used to address broader diagnostic challenges. A mobile app, PTT Advisor, may contribute to better test ordering and diagnosis, serve as a learning tool for diagnostic evaluation of certain clinical disorders, and improve patient outcomes. Similar methods could be useful for evaluating apps aimed at improving testing and diagnosis for other conditions.
Holmes, Daniel T
Clinical scientists frequently need to compare two different bioanalytical methods as part of assay validation/monitoring. As a matter necessity, regression methods for quantitative comparison in clinical chemistry, hematology and other clinical laboratory disciplines must allow for error in both the x and y variables. Traditionally the methods popularized by 1) Deming and 2) Passing and Bablok have been recommended. While commercial tools exist, no simple open source tool is available. The purpose of this work was to develop and entirely open-source GUI-driven program for bioanalytical method comparisons capable of performing these regression methods and able to produce highly customized graphical output. The GUI is written in python and PyQt4 with R scripts performing regression and graphical functions. The program can be run from source code or as a pre-compiled binary executable. The software performs three forms of regression and offers weighting where applicable. Confidence bands of the regression are calculated using bootstrapping for Deming and Passing Bablok methods. Users can customize regression plots according to the tools available in R and can produced output in any of: jpg, png, tiff, bmp at any desired resolution or ps and pdf vector formats. Bland Altman plots and some regression diagnostic plots are also generated. Correctness of regression parameter estimates was confirmed against existing R packages. The program allows for rapid and highly customizable graphical output capable of conforming to the publication requirements of any clinical chemistry journal. Quick method comparisons can also be performed and cut and paste into spreadsheet or word processing applications. We present a simple and intuitive open source tool for quantitative method comparison in a clinical laboratory environment. Copyright © 2014 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.
Spizzichino, D.; Campobasso, C.; Gallozzi, P. L.; Dessi', B.; Traversa, F.
ReNDiS project is a useful tool for monitoring, analysis and management of information data on mitigation measures and restoration works of soil protection at national scale. The main scope of the project, and related monitoring activities, is to improve the knowledge about the use of national funds and efforts against floods and landslides risk and, as a consequence, to better address the preventive policies in future. Since 1999 after the disastrous mudflow event occurred in Sarno in 1998, which caused the loss of 160 human lives, an extraordinary effort was conducted by the Italian Government in order to promote preventive measures against the hydro geological risk over the entire Italian territory. The Italian Ministry for the Environment promoted several and annual soil protection programmes. The ReNDiS project (Repertory of mitigation measures for National Soil Protection) is carried out by ISPRA - Institute for Environmental protection and Research, with the aim of improving the knowledge about the results of preventive policies against floods and landslides in order to better address national funds as requested by the Minister itself. The repertory is composed by a main archive and two secondary interface, the first for direct data management (ReNDiS-ist) and the latter (ReNDiS-web) for the on-line access and public consultation. At present, ReNDiS database contains about 3000 records concerning those programmes, focused on restoration works but including also information on landslide typologies and processes. The monitoring project is developed taking into account all the information about each step of every mitigation measure from the initial funding phase until the end of the work. During present work, we have statistically analyzed the ReNDiS database in order to highlight the conformity between the characteristic and type of the hazard (identified in a specific area) and the corresponding mitigation measures adopted for risk reduction. Through specific
Full Text Available Background: Frequent infections is among the most frequent clinical dilemmas for primary care physicians. Immunodeficiency disorders are a heterogeneous group of illnesses that predispose patients to the recurrent infections, autoimmunity and malignancies. The aim of this study was to evaluate the clinical and laboratory data collected for the final diagnosis of patients referred with recurrent infections and suspected immunodeficiency to a local immunodeficiency clinic. Methods: This epidemiological study was carried out between April 2010 and September 2012 at the Immunodeficiency Clinic of Mashhad. All patients with clinical manifestations of immunodeficiency who were referred to our clinic during this period of time were included in this study. 41 patients aged from 10 months to 51 years, were evaluated. Results: Forty one patients, aged between 10 months and 51 years were evaluated. Eleven patients had a primary immunodeficiency, four cases had a secondary immunodeficiency, in three patients an underlying structural disease were found, eight patients were predisposed to recurrent infections as a result of allergies and finally, fifteen cases were found to be normal individuals. Discussion: Most patients with recurrent infection have a normal immune system. Allergic disorders are the most common predisposing factor to recurrent infection. However, as immunodeficiency disorders are potentially serious, early diagnosis can improve the quality of life and outcome and prevent severe sequels in future.
Reisler, Ronald B; Yu, Chenggang; Donofrio, Michael J; Warren, Travis K; Wells, Jay B; Stuthman, Kelly S; Garza, Nicole L; Vantongeren, Sean A; Donnelly, Ginger C; Kane, Christopher D; Kortepeter, Mark G; Bavari, Sina; Cardile, Anthony P
The Ebola virus (EBOV) outbreak in West Africa during 2013-2016 demonstrated the need to improve Ebola virus disease (EVD) diagnostics and standards of care. This retrospective study compared laboratory values and clinical features of 3 nonhuman primate models of lethal EVD to assess associations with improved survival time. In addition, the study identified laboratory values useful as predictors of survival, surrogates for EBOV viral loads, and triggers for initiation of therapeutic interventions in these nonhuman primate models. Furthermore, the data support that, in nonhuman primates, the Makona strain of EBOV may be less virulent than the Kikwit strain of EBOV. The applicability of these findings as potential diagnostic and management tools for EVD in humans warrants further investigation.
Mitchell, S.W.; McCormick, J.B.
Clinical specimens from patients infected with Lassa, Ebola, or Marburg virus may present a serious biohazard to laboratory workers. The authors have examined the effects of heat, alteration of pH, and gamma radiation on these viruses in human blood and on the electrolytes, enzymes, and coagulation factors measured in laboratory tests that are important in the care of an infected patient. Heating serum at 60 degrees C for 1 h reduced high titers of these viruses to noninfectious levels without altering the serum levels of glucose, blood urea nitrogen, and electrolytes. Dilution of blood in 3% acetic acid, diluent for a leukocyte count, inactivated all of these viruses. All of the methods tested for viral inactivation markedly altered certain serum proteins, making these methods unsuitable for samples that are to be tested for certain enzyme levels and coagulation factors
Posteraro, Brunella; De Carolis, Elena; Vella, Antonietta; Sanguinetti, Maurizio
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.
Van Sonnenberg, E.; Casola, G.; Wittich, G.R.; Stavas, J.; Quinn, S.F.; Gibbs, J.; Macaulay, S.; Schecter, M.S.; Edwards, K.C.
Percutaneous cecostomy or colostomy is a new interventional radiology procedure used for colonic decompression due to mechanical obstruction or pseudoobstruction. This paper describes our laboratory and initial clinical work with percutaneous colostomy. In our initial nine patient, it has served as a temporizing (five patients), definitive (three patients), or inadvertent maneuver (one patient). Methods of guidance were CT (three patients) and fluoroscopy (six patients). Catheters were placed both transperitoneally and retroperitoneally; laboratory work focused on these paths of introduction as well as catheter insertion and catheter type. The authors used catheters with retention devices preferentially, and these permit adherence of the colon to the abdominal wall. Both Seldinger and trocar techniques have been utilized. Leakage has resulted in minor abdominal pain; no patient has required operation due to percutaneous cecostomy. All procedures were successful and accomplished their goal
Levy, R.P.; Fabrikant, J.I.; Lyman, J.T.; Frankel, K.A.; Phillips, M.H.; Lawrence, J.H.; Tobias, C.A.
The first therapeutic clinical trial using accelerated heavy-charged particles in humans was performed at Lawrence Berkeley Laboratory (LBL) for the treatment of various endocrine and metabolic disorders of the pituitary gland, and as suppressive therapy for adenohypophyseal hormone-responsive carcinomas and diabetic retinopathy. In acromegaly, Cushing's disease, Nelson's syndrome and prolactin-secreting tumors, the therapeutic goal in the 433 patients treated has been to destroy or inhibit the growth of the pituitary tumor and control hormonal hypersecretion, while preserving a functional rim of tissue with normal hormone-secreting capacity, and minimizing neurologic injury. An additional group of 34 patients was treated for nonsecreting chromophobe adenomas. This paper discusses the methods and results of stereotactic helium-ion radiosurgery of the pituitary gland at Lawrence Berkeley Laboratory. 11 refs.
Levy, R.P.; Fabrikant, J.I.; Lyman, J.T.; Frankel, K.A.; Phillips, M.H.; Lawrence, J.H.; Tobias, C.A.
The first therapeutic clinical trial using accelerated heavy-charged particles in humans was performed at Lawrence Berkeley Laboratory (LBL) for the treatment of various endocrine and metabolic disorders of the pituitary gland, and as suppressive therapy for adenohypophyseal hormone-responsive carcinomas and diabetic retinopathy. In acromegaly, Cushing's disease, Nelson's syndrome and prolactin-secreting tumors, the therapeutic goal in the 433 patients treated has been to destroy or inhibit the growth of the pituitary tumor and control hormonal hypersecretion, while preserving a functional rim of tissue with normal hormone-secreting capacity, and minimizing neurologic injury. An additional group of 34 patients was treated for nonsecreting chromophobe adenomas. This paper discusses the methods and results of stereotactic helium-ion radiosurgery of the pituitary gland at Lawrence Berkeley Laboratory. 11 refs
Onsongo, Getiria; Erdmann, Jesse; Spears, Michael D; Chilton, John; Beckman, Kenneth B; Hauge, Adam; Yohe, Sophia; Schomaker, Matthew; Bower, Matthew; Silverstein, Kevin A T; Thyagarajan, Bharat
The introduction of next generation sequencing (NGS) has revolutionized molecular diagnostics, though several challenges remain limiting the widespread adoption of NGS testing into clinical practice. One such difficulty includes the development of a robust bioinformatics pipeline that can handle the volume of data generated by high-throughput sequencing in a cost-effective manner. Analysis of sequencing data typically requires a substantial level of computing power that is often cost-prohibitive to most clinical diagnostics laboratories. To address this challenge, our institution has developed a Galaxy-based data analysis pipeline which relies on a web-based, cloud-computing infrastructure to process NGS data and identify genetic variants. It provides additional flexibility, needed to control storage costs, resulting in a pipeline that is cost-effective on a per-sample basis. It does not require the usage of EBS disk to run a sample. We demonstrate the validation and feasibility of implementing this bioinformatics pipeline in a molecular diagnostics laboratory. Four samples were analyzed in duplicate pairs and showed 100% concordance in mutations identified. This pipeline is currently being used in the clinic and all identified pathogenic variants confirmed using Sanger sequencing further validating the software.
Beastall, Graham; Kenny, Desmond; Laitinen, Paivi; ten Kate, Joop
A definition has been agreed for the most senior professional (consultant) in clinical chemistry and laboratory medicine. A model job description for a consultant has been determined, which is intended to act as a toolkit to assist employing authorities and professional bodies to define the role of individual consultant posts. A total of 86 competences for a consultant have been designated and expressed in the form of simple generic proficiency standards. These competences have been allocated to six broad areas: clinical ; scientific ; technical ; communication ; management and leadership ; professional autonomy and accountability . The competences are intended to be illustrative rather than definitive and to enable the duties of any consultant post to be defined. Assessment of competence is likely to entail consideration of qualifications, registration status, continuing professional development and performance review. The project is intended as a guide to European societies of clinical chemistry and laboratory medicine. The guide should be capable of local interpretation to encourage a greater degree of commonality in the role of the consultant whilst protecting national identity. The guide should stimulate international understanding and collaboration and contribute to an overall improvement in the quality of practice.
Toki, Sayaka; Motegi, Sei-ichiro; Yamada, Kazuya; Uchiyama, Akihiko; Kanai, Sahori; Yamanaka, Masayoshi; Ishikawa, Osamu
Localized scleroderma (LSc) primarily affects skin, whereas systemic sclerosis (SSc) affects skin and various internal organs. LSc and SSc are considered to be basically different diseases, and there is no transition between them. However, LSc and SSc have several common characteristics, including endothelial cell dysfunction, immune activation, and excess fibrosis of the skin, and there exist several SSc cases complicated with LSc during the course of SSc. Clinical and laboratory characteristics of SSc patients with LSc remain unclear. We investigated the clinical and laboratory features of 8 SSc patients with LSc among 220 SSc patients (3.6%). The types of LSc included plaque (5/8), guttate (2/8), and linear type (1/8). All cases were diagnosed as having SSc within 5 years before or after the appearance of LSc. In three cases of SSc with LSc (37.5%), LSc skin lesions preceded clinical symptoms of SSc. Young age, negative antinuclear antibody, and positive anti-RNA polymerase III antibody were significantly prevalent in SSc patients with LSc. The positivity of anticentromere antibody tended to be prevalent in SSc patients without LSc. No significant difference in the frequency of complications, such as interstitial lung disease, reflux esophagitis, and pulmonary artery hypertension, was observed. The awareness of these characteristic of SSc with LSc are essential to establish an early diagnosis and treatment. © 2015 Japanese Dermatological Association.
Sheila Moura Pone
Full Text Available Abstract Objective: To evaluate the validity of clinical and laboratory signs to serious dengue disease in hospitalized children. Methods: Retrospective cohort of children (19 and negative likelihood ratio <0.6. Pleural effusion and abdominal distension had higher sensitivity (82.6%. History of bleeding (epistaxis, gingival or gastrointestinal bleeding and severe hemorrhage (pulmonary or gastrointestinal bleeding in physical examination were more frequent in serious dengue disease (p < 0.01, but with poor accuracy (positive likelihood ratio = 1.89 and 3.89; negative likelihood ratio = 0.53 and 0.60, respectively. Serum albumin was lower in serious dengue forms (p < 0.01. Despite statistical significance (p < 0.05, both groups presented thrombocytopenia. Platelets count, hematocrit, and hemoglobin parameters had area under the curve <0.5. Conclusions: Lethargy, abdominal distension, pleural effusion, and hypoalbuminemia were the best clinical and laboratorial markers of serious dengue disease in hospitalized children, while bleeding, severe hemorrhage, hemoconcentration and thrombocytopenia did not reach adequate diagnostic accuracy. In pediatric referral hospitals, the absence of hemoconcentration does not imply absence of plasma leakage, particularly in children with previous fluid replacement. These findings may contribute to the clinical management of dengue in children at referral hospitals.
Soylu, Alper; Kasap, Belde; Demir, Korcan; Türkmen, Mehmet; Kavukçu, Salih
We aimed to determine the predictability of clinical and laboratory variables for vesicoureteral reflux (VUR) in children with urinary tract infection (UTI). Data of children with febrile UTI who underwent voiding cystoureterography between 2002 and 2005 were evaluated retrospectively for clinical (age, gender, fever > or = 38.5 degrees C, recurrent UTI), laboratory [leukocytosis, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), pyuria, serum creatinine (S(Cr))] and imaging (renal ultrasonography) variables. Children with VUR (group 1) vs. no VUR (group 2) and children with high-grade (III-V) VUR (group 3) vs. no or low-grade (I-II) VUR (group 4) were compared. Among 88 patients (24 male), 38 had VUR and 21 high-grade VUR. Fever > or = 38.5 degrees C was associated with VUR [odds ratio (OR): 7.5]. CRP level of 50 mg/l was the best cut-off level for predicting high-grade VUR (OR 15.5; discriminative ability 0.89 +/- 0.05). Performing voiding cystourethrography based on this CRP level would result in failure to notice 9% of patients with high-grade VUR, whereas 69% of children with no/low-grade VUR would be spared from this invasive test. In conclusion, fever > or = 38 degrees C and CRP > 50 mg/l seem to be potentially useful clinical predictors of VUR and high-grade VUR, respectively, in pediatric patients with UTI. Further validation of these findings could limit unnecessary voiding cystourethrography.
Vashakidze, E; Mikadze, I
Crimean-Congo hemorrhagic fever virus transmitted to humans by Hyalomma ticks or by direct contact with the blood of infected humans or domestic animals. The most common clinical signs of CCHF are fever, nausea, headache, diarrhea, myalgia, petechial rash, and bleeding. CCHF is a severe disease in humans with a fatality rate up to 15-85%. This study was undertaken to determine the predictors of fatality among patients with CCHF based on epidemiological, clinical, and laboratory findings. 34 patients were enrolled in the study, aged 4 to 77; 17 - male and 17 female. 3 of them were fatal cases. All of them were from Shua Kartli: Khashuri, Gori and Kaspi districts, involved in farming/handling livestock and the history of tick bite was present in most of patients. Evaluation of the epidemiological characteristics of this cases showed that the female to male ratio was nearly similar. The disease is common in the rural areas of the region, mostly in the actively working age group and almost all patients were farmers. The results of our study show that the most cardinal clinical and laboratory features of Crimean-Congo hemorrhagic fever are - acute beginning of disease, high fever, intoxication and hemorrhagic symptoms, thrombocytopenia, high level of aminotransferases and creatine. Predictors of fatality are: an altered mental status, in early stage of disease dramatic decreased thrombocytes count and significantly high level of aspartate aminotransferase, also longer the mean prothrombin time and INR.
Alsius-Serra, A; Ballbé-Anglada, M; López-Yeste, M L; Buxeda-Figuerola, M; Guillén-Campuzano, E; Juan-Pereira, L; Colomé-Mallolas, C; Caballé-Martín, I
To describe the study of the comparability of the measurements levels of biological tests processed in biochemistry in Catlab's 4 laboratories. Quality requirements, coefficients of variation and total error (CV% and TE %) were established. Controls were verified with the precision requirements (CV%) in each test and each individual laboratory analyser. Fresh serum samples were used for the comparability study. The differences were analysed using a Microsoft Access® application that produces modified Bland-Altman plots. The comparison of 32 biological parameters that are performed in more than one laboratory and/or analyser generated 306 Bland-Altman graphs. Of these, 101 (33.1%) fell within the accepted range of values based on biological variability, and 205 (66.9%) required revision. Data were re-analysed based on consensus minimum specifications for analytical quality (consensus of the Asociación Española de Farmacéuticos Analistas (AEFA), the Sociedad Española de Bioquímica Clínica y Patología Molecular (SEQC), the Asociación Española de Biopatología Médica (AEBM) and the Sociedad Española de Hematología y Hemoterapia (SEHH), October 2013). With the new specifications, 170 comparisons (56%) fitted the requirements and 136 (44%) required additional review. Taking into account the number of points that exceeded the requirement, random errors, range of results in which discrepancies were detected, and range of clinical decision, it was shown that the 44% that required review were acceptable, and the 32 tests were comparable in all laboratories and analysers. The analysis of the results showed that the consensus requirements of the 4 scientific societies were met. However, each laboratory should aim to meet stricter criteria for total error. Copyright © 2015 SECA. Published by Elsevier Espana. All rights reserved.
Barletta, Giovanni; Zaninotto, Martina; Faggian, Diego; Plebani, Mario
The increasing need to reduce the costs of providing diagnostic laboratory services has prompted initiatives based on the centralization and consolidation of laboratory facilities. However, the majority of papers and experiences reported in literature focus on "cost per test" thus overlooking the real value of a laboratory service, which requires more complex economic evaluations, such as cost-benefit, cost-effectiveness, and cost-utility analysis. It is important to perform cost analysis, which is no mean feat, by taking into consideration all variables affecting the final and true cost per test. The present study was conducted in order to evaluate the costs of delivering laboratory services in 20 Italian clinical laboratories using a widely accepted methodology, the so-called "activity-based costing analysis". The finding of a trend towards a decrease in total costs - due to an increase in test volumes - attained statistical significance only for quantities of up to about 1,100,00 tests per year. For 1,800,00 tests and more, the cost per test appeared to range from 1.5 to 2.0 € irrespective of the different volumes. Regarding the relationship between volumes and number of staff, there is an evident linear relationship between the number of senior staff and volumes, whereas this trend is not observed in the case of medical technologists, the degree and type of automation strongly affecting this variable. The findings made in the present study confirm that the relationship between volumes and costs is not linear; since it is complex, numerous variables should be taken into account.
Reisfield, Gary M; Goldberger, Bruce A; Bertholf, Roger L
Urine drug testing (UDT) services are provided by a variety of clinical, forensic, and reference/specialty laboratories. These UDT services differ based on the principal activity of the laboratory. Clinical laboratories provide testing primarily focused on medical care (eg, emergency care, inpatients, and outpatient clinics), whereas forensic laboratories perform toxicology tests related to postmortem and criminal investigations, and drug-free workplace programs. Some laboratories now provide UDT specifically designed for monitoring patients on chronic opioid therapy. Accreditation programs for clinical laboratories have existed for nearly half a century, and a federal certification program for drug-testing laboratories was established in the 1980s. Standards of practice for forensic toxicology services other than workplace drug testing have been established in recent years. However, no accreditation program currently exists for UDT in pain management, and this review considers several aspects of laboratory accreditation and certification relevant to toxicology services, with the intention to provide guidance to clinicians in their selection of the appropriate laboratory for UDT surveillance of their patients on opioid therapy.
Mugii, Naoki; Hasegawa, Minoru; Matsushita, Takashi; Hamaguchi, Yasuhito; Oohata, Sacihe; Okita, Hirokazu; Yahata, Tetsutarou; Someya, Fujiko; Inoue, Katsumi; Murono, Shigeyuki; Fujimoto, Manabu; Takehara, Kazuhiko
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. 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. Videofluoroscopy swallow study (VFSS) was performed for all patients with clinical dysphagia (n = 13, 14.1%) but not for patients without clinical dysphagia. Typical findings of dysphagia (pharyngeal pooling, n = 11 and/or nasal regurgitation, n = 4) was detected by VFSS in all patients with clinical dysphagia. Eleven patients with dysphagia (84.6%) had anti-transcription intermediary factor 1γ (TIF-1γ) antibody. By univariate analysis, the average age and the male to female ratio, internal malignancy, and anti-TIF-1γ antibody were significantly higher and the frequency of interstitial lung diseases and manual muscle testing (MMT) scores of sternomastoid and dertoid muscles were significantly lower in patients with dysphagia than in patients without dysphagia. Among patients with anti-TIF-1γ antibody, the mean age, the ratios of male to female and internal malignancy were significantly higher and mean MMT scores of sternomastoid muscle were significantly lower in patients with dysphagia compared with patients without dysphagia. By multivariable analysis, the risk of dysphagia was strongly associated with the existence of internal malignancy and ant-TIF-1γ antibody and was also associated with reduced scores of manual muscle test of sternomastoid muscle. Dysphagia was markedly improved after the treatment against myositis in all 13 patients. These findings indicate that dysphagia can develop frequently in patients with internal malignancy, anti-TIF-1γ antibody, or severe muscle weakness of sternomastoid muscle.
Terzić, Dragica; Mijović, Gordana; Dupanović, Brankica; Drasković, Nenad; Svirtlih, Neda
Hepatitis E has many similarities in with hepatitis A concerning clinical picture, route of transmission and nonexistence of chronicity. Comparison of clinical and laboratory parameters of patients with hepatitis A and E to estimate characteristics of these diseases. Total of 54 patients divided into two groups was investigated: 27 had hepatitis A, others had hepatitis E. Detailed history past, clinical examination, liver function tests and ultrasonography of the upper abdomen, were done in all patients. Aetiology of viral hepatitis was investigated serologically by enzyme immunoassay (ELISA) using commercial kits for following viruses: Hepatitis A-E viruses, cytomegalovirus, and Epstein-Barr virus. Asymptomatic infections (29.6%) and clinical forms without jaundice (59.3%) were more frequent in patients with hepatitis E. Splenomegaly was found more frequent in patients with hepatitis A than in hepatitis E (66.7% vs. 33.3%). Patients with hepatitis E had significantly lower activity of aminotransferases than patients with hepatitis A. A significant increase of gamma-glutamyltranspeptidase was found in patients with hepatitis E (mean value: 120 IU/L). Our results are in concordance with other reports that hepatitis E virus infection is more common asymptomatic disease than hepatitis A. In addition, hepatocyte necrosis in hepatitis E is less extensive than in hepatitis A measured by the activity of aminotransferases. Contrary to that the value of gamma-glutamyltranspeptidase is more increased in hepatitis E than in hepatitis A without exact explanation so far: Viral hepatitis E and A have differences in some clinical features and laboratory parameters although both diseases principally have resolved without consequences after 6-8 weeks.
Vorob'ev, I.B.; Krivokhatskij, A.S.; Nekrasov, E.V.; Nikolaev, V.A.; Potapov, V.G.; Terent'ev, M.V.
Usability of a new equipment-technique combination for measuring radon activity in the air of radon laboratories and balneological clinics is studied. The complex includes nitrate-cellulose detector, radon chamber, Aist, Istra type spark counters and technique of spark counting. The method sensitivity is 50 Bqxm 3 , the error is 30%. Usability and advisability of track method in radon laboratories and balneological clinics for simultaneous measurement in several points of integral volumetric radon activities are confirmred. The method permits to carry out rapid and accurate bulk investigations. The results of determining mean volumetric radon activity in the air in different points of radon laboratory and radon clinics are presented
Quality management and accreditation in the analytical laboratory setting are developing rapidly and becoming the standard worldwide. Quality management refers to all the activities used by organizations to ensure product or service consistency. Accreditation is a formal recognition by an authoritative regulatory body that a laboratory is competent to perform examinations and report results. The Motherisk Drug Testing Laboratory is licensed to operate at the Hospital for Sick Children in Toronto, Ontario. The laboratory performs toxicology tests of hair and meconium samples for research and clinical purposes. Most of the samples are involved in a chain of custody cases. Establishing a quality management system and achieving accreditation became mandatory by legislation for all Ontario clinical laboratories since 2003. The Ontario Laboratory Accreditation program is based on International Organization for Standardization 15189-Medical laboratories-Particular requirements for quality and competence, an international standard that has been adopted as a national standard in Canada. The implementation of a quality management system involves management commitment, planning and staff education, documentation of the system, validation of processes, and assessment against the requirements. The maintenance of a quality management system requires control and monitoring of the entire laboratory path of workflow. The process of transformation of a research/clinical laboratory into an accredited laboratory, and the benefits of maintaining an effective quality management system, are presented in this article.
Full Text Available Feline hyperthyroidism (HT is a common endocrine disorder worldwide, but clinical and laboratory features might vary geographically. The aim of this retrospective study was to evaluate feline HT in Japan, and compare results to those of previous study for feline HT. We evaluated 48 feline HT cases clinical and laboratory features. Surprisingly, the youngest patient was 32 months of age (2 year 9 months. There was no significant difference among the study subjects in sex, but frequency of spayed/castrated cats was high (85.4%. Median age was 186 months (32-272 months. 91.3% (n=42 of subjects were over 10 years of age, and 8.7% (n=4 were under 10 years of age. Clinical symptoms included vomiting, 56.3% (n=27; diarrhea, 2.1% (n=1; hyperactivity, 12.5% (n=6; emaciation, 41.7% (n=20; polyuria and polydipsia, 22.9% (n=11; chronic weight loss, 60.4% (n=29; and palpated enlarged thyroid, 2.1% (n=1. Concurrent findings included chronic kidney disease, 20.8% (n=10; congestive heart failure, 20.8% (n=10; tachycardia (over 240 beats/min, 18.8% (n=9; gallop rhythm, 31.3% (n=15; neurological disorders such as hind-limb paralysis, 14.6% (n=7; cystitis, 8.7% (n=4; gingivitis, 4.2% (n=2; diabetes mellitus, 4.2% (n=2; and arterial thromboembolism, 6.3% (n=3. In addition, laboratory features (complete blood counts and biochemistry differed from those of previous reports in certain respects. Our results show that it might be important for practitioners to comprehend epidemiologic differences regarding feline HT worldwide.
Heloísa Marcelina da Cunha Palhares
Full Text Available OBJECTIVE: This study analyzed the frequency of cardiometabolic risk markers and metabolic syndrome occurrence in overweight and obese children and adolescents. METHODS: The participants included 161 overweight (n=65 and obese (n=96 individuals aged between 5 and 19 years. Clinical markers were assessed (body mass index, body fat percentage, waist circumference, acanthosis, systolic and diastolic blood pressures, laboratory parameters [glucose, insulin, cholesterol (total and fractions and triglyceride levels and homeostasis model assessment of insulin resistance (HOMA-IR index] and leptin and adiponectin levels. The frequency of changes, odds ratios and correlations among markers were determined. Metabolic syndrome was assessed according to International Diabetes Federation criteria. RESULTS: A high frequency of acanthosis (51.6%; increased waist circumference (45.4%, systolic blood pressure / diastolic blood pressure (8.1% / 9.3%, glucose (10%, insulin (36.9% and HOMA-IR (44.3% values; and reduced high-density lipoprotein levels (47.2% were observed. Leptin levels were increased in 95% of obese and in 66% of overweight subjects. Adiponectin was decreased in 29.5% of obese and in 34% of overweight subjects. An odd ratio analysis revealed a greater probability of increased waist circumference (9.0, systolic blood pressure (4.1, triglyceride (2.3 and insulin (2.9 levels and HOMA-IR (3.0 in the obese group than in the overweight group. The clinical and laboratory parameters and leptin levels exhibited significant correlations, whereas adiponectin was negatively correlated with systolic blood pressure. The occurrence rate of metabolic syndrome was 13.6%. CONCLUSIONS: The high frequency of changes in clinical, laboratory and adipokine markers indicates the need for early interventions aimed at preventing cardiometabolic complications in adulthood.
Zhu, Ying; Dong, Jing; Wang, Ping; Huang, Huifang; Jin, Xiaohua; Zhou, Jingou; Shi, Jingfang; Gu, Guohao; Chen, Jun; Xu, Jun; Song, Yanhui
Measuring the level of serum lipase has been used for the clinical diagnosis of acute pancreatitis. Reports showed that the serum lipase level increased in patients of clinical renal failure. In this study, we aimed to measure the change of serum lipase levels in chronic kidney diseases and determine whether it could serve as a clinical laboratory index for clinical renal failure diagnosis. Materials: The OLYMPUS AU5400 automatic biochemical analyzer was used to determine the serum levels of lipase and creatinine. The study included 120 cases in the clinical renal failure group, 76 cases in the nephrotic syndrome group, 81 cases in the chronic nephritis group, and 80 healthy controls from our hospital volunteers in the same period. We then compared the lipase levels and conducted statistical analyses among these groups. The serum lipase levels were 15.3 U/L, 79.8 U/L, 45.1 U/L, and 51.0 U/L in the normal control, clinical renal failure, nephrotic syndrome, and chronic nephritis groups, respectively. The lipase levels in the groups with diseases were significantly different compared with that of the normal control group (p renal failure group was significantly higher than that of the nephrotic syndrome group and chronic nephritis group (p chronic nephritis group (p > 0.05) was observed. Moreover, an association of the serum lipase with disease progression was observed in the study. Serum lipase is an effective serological index which can reflect the clinical changes in the clinical renal failure and tends to increase through the progression of renal dysfunction.
T. M. Azevedo
Full Text Available Accidents involving biological material can cause diseases to the professional healthcare and also bring psychosocial effects. The aim of this study was to characterize the accidents occurring with biological material with professional of clinical laboratories of Sinop-MT. Data were collected by a questionnaire consisting of sociodemographic and health variables. 21 (87.5% of respondents stated that they never suffered any kind of accident. One of the injured workers reported that there was involvement in your emotional life. It is observed underreporting of occupational accidents by employees affected, making it difficult to increase research on the subject and actions about the problem.
Whitby, L. G.; Simpson, D.
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
Endimiani, Andrea; Jacobs, Michael R
The evolution of resistance in Gram-negatives has challenged the clinical microbiology laboratory to implement new methods for their detection. Multidrug-resistant strains present major challenges to conventional and new detection methods. More rapid pathogen identification and antimicrobial susceptibility testing have been developed for use directly on specimens, including fluorescence in situ hybridization tests, automated polymerase chain reaction systems, microarrays, mass spectroscopy, next-generation sequencing, and microfluidics. Review of these methods shows the advances that have been made in rapid detection of resistance in cultures, but limited progress in direct detection from specimens. Copyright © 2016 Elsevier Inc. All rights reserved.
Pinheiro, Malone Santos; de Brito, Ana Maria Guedes; Jeraldo, Verônica de Lourdes Sierpe; Pinheiro, Kariny Souza
In Brazil the private health plans appear as an alternative to the public health assistance. This segment suffered great intensification in the seventies and eighties, culminating in the entry of large insurance company in the scenario of supplementary medicine. Quickly, the service providers associated with these insurance companies, consolidating them in the market and triggering a relationship of dependency. This article analyzed, in the form of a case report, a marketing dispute between clinical laboratories and a health plan, emphasizing the moral and ethical aspects involved in this episode.
Andrei Kelliton Fabretti
Full Text Available Malnutrition is a major factor associated with increased rates of mortality and readmission, longer hospital stays, and greater health care spending. Recognizing malnourished or at-risk animals allows for nutritional intervention and improved prognosis. This study evaluated the association between clinical, laboratory, and electrophoretic variables and the nutritional status (NS of hospitalized dogs in order to generate a profile of the sick dog and to facilitate the diagnosis of malnutrition. We divided 215 dogs into groups according to the severity of the underlying disease and we determined the clinical NS based on the assessment of the body condition score and the muscle mass score. The NS was classified as clinically well nourished, clinical moderate malnutrition, or clinical severe malnutrition. Statistical analyses were conducted by using the chi-square test or Fisher’s exact test; the Kruskal-Wallis test was used for continuous variables. A strong association was found between malnutrition and the severity of the underlying disease. In hospitalized dogs, low body mass index values, anemia, low hemoglobin concentrations, high fibrinogen concentrations, decreased albumin fraction, and increased gamma-globulin fraction (in electrophoresis were associated with malnutrition, reinforcing the classification of poor NS. However, the skin and coat characteristics, the total number of lymphocytes, blood glucose, cholesterol, and total protein concentration were not found to be good predictors of NS.
Full Text Available Abstract Background Community-acquired pneumonia (CAP is the most frequent infection-related cause of death. The reference standard to diagnose CAP is a new infiltrate on chest radiograph in the presence of recently acquired respiratory signs and symptoms. This study aims to evaluate the diagnostic and prognostic accuracy of clinical signs and symptoms and laboratory biomarkers for CAP. Methods 545 patients with suspected lower respiratory tract infection, admitted to the emergency department of a university hospital were included in a pre-planned post-hoc analysis of two controlled intervention trials. Baseline assessment included history, clinical examination, radiography and measurements of procalcitonin (PCT, highly sensitive C-reactive protein (hsCRP and leukocyte count. Results Of the 545 patients, 373 had CAP, 132 other respiratory tract infections, and 40 other final diagnoses. The AUC of a clinical model including standard clinical signs and symptoms (i.e. fever, cough, sputum production, abnormal chest auscultation and dyspnea to diagnose CAP was 0.79 [95% CI, 0.75–0.83]. This AUC was significantly improved by including PCT and hsCRP (0.92 [0.89–0.94]; p Conclusion PCT, and to a lesser degree hsCRP, improve the accuracy of currently recommended approaches for the diagnosis of CAP, thereby complementing clinical signs and symptoms. PCT is useful in the severity assessment of CAP.
Bertero, M T; Bazzan, M; Carignola, R; Montaruli, B; Silvestro, E; Sciascia, S; Vaccarino, A; Baldovino, S; Roccatello, D
We report the experience from the Antiphospholipid Antibodies (aPL) Regional Consortium in northwest Italy, meant to support clinical research and foster collaboration among health professionals regarding the diagnosis and management of antiphospholipid syndrome (APS) patients. This cohort-study (APS Piedmont Cohort) was designed to register the clinical characteristics at inception and associated immunological manifestations at diagnosis (if any) of patients who strictly fulfilled the current criteria for APS, all recruited at the Piedmont and Valle d'Aosta regions. Clinical and laboratory data from 217 APS patients (171 with vascular events, 33 with pregnancy morbidity and 13 with both), from 16 centres within the geographical area were collected. Venous thrombosis was recorded in 45.6% of patients, arterial thrombosis in 35%, small-vessel thrombosis in 1.12% and mixed arterial and venous thrombosis in the remaining 19.4% of the cases. Pregnancy morbidity included 19 patients with unexplained fetal death beyond the 10th week of pregnancy, 17 with premature birth before the 34th week and 10 with three or more unexplained spontaneous abortions before the 10th week of gestation. This consortium represents an instrument by which to audit clinical practice, to provide counselling to local centres and to sustain future basic and clinical APS research.
Blake Gibson MD
Full Text Available This concept paper addresses communication issues arising between physicians and their patients. To facilitate the communication of essential diagnostic pathology information to patients, and address their questions and concerns, we propose that “Pathology Explanation Clinics” be created. The Pathology Explanation Clinics would provide a channel for direct communications between pathologists and patients. Pathologists would receive special training as “Certified Pathologist Navigators” in preparation for this role. The goal of Pathology Explanation Clinics would be to help fill gaps in communication of information contained in laboratory reports to patients, further explain its relevance, and improve patient understanding of the meaning of such information and its impact on their health and health-care choices. Effort would be made to ensure that Certified Pathologist Navigators work within the overall coordination of care by the health-care team.
Lauridsen, Henrik Hein; Toftgård, Rie Castella; Nørgaard, Cita
resources of varying quality on the internet if this is not made available during teaching. The objective of this project was to design a new clinical skills laboratory with IT and video facilities to support learning processes. Methods Teaching principles were described before decisions on the design......Objective The principles of apprenticeship in clinical skills training are increasingly being challenged. First, most students are proficient in learning from visual multimedia and will expect this to be part of a modern university education. Second, students will often find visual teaching...... on a priori described teaching and learning designs related to active learning principles. This was a complex process involving teachers, IT-experts, e-learning specialists and a variety of university employees....
Ian F. Burgess
Full Text Available Context. During the late 1990s, insecticide resistance had rendered a number of treatment products ineffective; some companies saw this as an opportunity to develop alternative types of treatment. We investigated the possibility that a surfactant-based lotion containing 10% cocamide diethanolamine (cocamide DEA was effective to eliminate head louse infestation.Settings and Design. Initial in vitro testing of the lotion formulation versus laboratory reared body/clothing lice, followed by two randomised, controlled, community-based, assessor blinded, clinical studies.Materials and Methods. Preliminary laboratory tests were performed by exposing lice or louse eggs to the product using a method that mimicked the intended use. Clinical Study 1: Children and adults with confirmed head louse infestation were treated by investigators using a single application of aqueous 10% cocamide DEA lotion applied for 60 min followed by shampooing or a single 1% permethrin creme rinse treatment applied to pre-washed hair for 10 min. Clinical Study 2: Compared two treatment regimens using 10% cocamide DEA lotion that was concentrated by hair drying. A single application left on for 8 h/overnight was compared with two applications 7 days apart of 2 h duration, followed by a shampoo wash.Results. The initial laboratory tests showed a pediculicidal effect for a 60 min application but limited ovicidal effect. A longer application time of 8 h or overnight was found capable of killing all eggs but this differed between batches of test material. Clinical Study 1: Both treatments performed badly with only 3/23 (13% successful treatments using cocamide DEA and 5/25 (23.8% using permethrin. Clinical Study 2: The single overnight application of cocamide DEA concentrated by hair drying gave 10/56 (17.9% successes compared with 19/56 (33.9% for the 2 h application regimen repeated after 1 week. Intention to treat analysis showed no significant difference (p = 0.0523 between the
Phan, J C; Bush, T M; Donald, F; Ward, M
The prevalence rate and disease manifestations of systemic lupus erythematosus (SLE) have been noted to vary among different ethnic groups. There has been no description in the English literature of SLE in the Vietnamese population. This is the first report, which details the clinical and laboratory features as well as an estimation of the prevalence of SLE in patients with a Vietnamese ancestry living in the United States. We performed a retrospective chart review of clinical and laboratory features of patients of Vietnamese descent with SLE. The case finding was performed by a review of the rheumatology clinic records at two large teaching hospitals in Santa Clara County searching for patients with SLE with a Vietnamese surname. In addition, we recruited patients by contacting all of the rheumatologists practicing in the county. Twenty-three patients of Vietnamese descent were identified with SLE in Santa Clara County. The estimated prevalence of SLE in the patients of Vietnamese descent was 42 cases per 100 000 persons. Eighty-seven per cent of the cases were born in Vietnam. The clinical and laboratory features of SLE were similar to prior published reviews except for a relatively high prevalence of anti-RNP antibody (54%). The patients with anti-RNP antibody exhibited features of overlap syndrome. There was a high rate of exposure to tuberculosis (TB). Fifty-eight per cent of patients had a positive purified protein derivative (PPD) skin test and 27% of patients had a history of clinical TB. Forty-four per cent of patients had evidence of hepatitis B exposure. The prevalence of SLE in the Vietnamese population in Santa Clara County is similar to that of other Asian populations. There was a relatively high prevalence of anti-RNP antibody in our patient group which was associated with overlap features. As expected in an immigrant population from Southeast Asia, there was a high rate of prior exposure to tuberculosis and hepatitis B. Clinicians should diligently
Full Text Available Alertness to dengue and making a timely diagnosis is extremely important in the treatment of dengue and containment of dengue epidemics. We evaluated the complementary role of clinical-practice-based laboratory data in facilitating suspicion/diagnosis of dengue. One hundred overall dengue (57 dengue fever [DF] and 43 dengue hemorrhagic fever [DHF] cases and another 100 nondengue cases (78 viral infections other than dengue, 6 bacterial sepsis, and 16 miscellaneous diseases were analyzed. We separately compared individual laboratory variables (platelet count [PC] , prothrombin time [PT], activated partial thromboplastin time [APTT], alanine aminotransferase [ALT], and aspartate aminotransferase [AST] and varied combined variables of DF and/or DHF cases with the corresponding ones of nondengue cases. The sensitivity, specificity, accuracy, positive predictive value (PPV, and negative predictive value (NPV in the diagnosis of DF and/or DHF were measured based on these laboratory variables. While trade-off between sensitivity and specificity, and/or suboptimal PPV/NPV was found at measurements using these variables, prolonged APTT + normal PT + PC < 100 × 109 cells/L had a favorable sensitivity, specificity, PPV, and NPV in diagnosis of DF and/or DHF. In conclusion, these data suggested that prolonged APTT + normal PT + PC < 100 × 109 cells/L is useful in evaluating the likelihood of DF and/or DHF.
Elhoseeny, T A; Mohammad, E K
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
M. A. Godkov
Full Text Available ABSTRACT. Assessment of the immune status of patients with urgent types of pathology in the Institute for Emergency Medicine is performed according to three main objects of research: humoral , phagocytic and lymphocytic components of immune system . This complex allows to fully and adequately evaluate the condition of the immune system of patients at different stages of traumatic disease and after transplantation of organs and tissues , to forecast the probability of septic complications developing, adjust the therapy . During 45 years of work of immunological service formed the algorithm of the adequate immunological screening was formed, number of innovative methods of diagnosis was developed, the ideology of post-test counseling of patients by immunologists was created, mathematical methods of storage, modeling and processing of research results was introduced. Laboratory staff identified a number of medical and social factors in the spread of blood-borne viral infections (HIV, hepatitis B and C. New organizational and economic methods of management team were introduced in the laboratory. The basis of the work is equal integration of scientific and clinical staff of the laboratory.
Guo, Wei; Song, Binbin; Shen, Junfei; Wu, Jiong; Zhang, Chunyan; Wang, Beili; Pan, Baishen
To establish an indirect reference interval based on the test results of alanine aminotransferase stored in a laboratory information system. All alanine aminotransferase results were included for outpatients and physical examinations that were stored in the laboratory information system of Zhongshan Hospital during 2014. The original data were transformed using a Box-Cox transformation to obtain an approximate normal distribution. Outliers were identified and omitted using the Chauvenet and Tukey methods. The indirect reference intervals were obtained by simultaneously applying nonparametric and Hoffmann methods. The reference change value was selected to determine the statistical significance of the observed differences between the calculated and published reference intervals. The indirect reference intervals for alanine aminotransferase of all groups were 12 to 41 U/L (male, outpatient), 12 to 48 U/L (male, physical examination), 9 to 32 U/L (female, outpatient), and 8 to 35 U/L (female, physical examination), respectively. The absolute differences when compared with the direct results were all smaller than the reference change value of alanine aminotransferase. The Box-Cox transformation combined with the Hoffmann and Tukey methods is a simple and reliable technique that should be promoted and used by clinical laboratories.
Robitaille, Line; Hoffer, L John
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.
Hosoglu, S.; Geyik, M.F.; Balik, I.; Aygen, B.; Erol, S.; Aygencel, S.G.; Mert, A.; Saltoglu, N.; Doekmetas, I.; Felek, S.; Suembuel, M.; Irmak, H.; Aydin, K.; Ayaz, C.; Koekoglu, O.F.; Ucmak, H.; Satilmis, S.
A retrospective study was performed to assess the epidemiology, diagnosis, clinic, and laboratory of the patients with tuberculous meningitis (TBM) in a multicentral study. The medical records of adult cases with TBM treated at 12 university hospitals throughout Turkey, between 1985 and 1998 were reviewed using a standardized protocol. The diagnosis of TMB was established with the clinical and laboratory findings and/or microbiological confirmation in cerebrospinal fluid (CSF). The non-microbiologically confirmed cases were diagnosed with five diagnostic sub-criteria which CSF findings, radiological findings, extra-neural tuberculosis, epidemiological findings and response to antituberculous therapy. A total of 469 patients were included in this study. Majority of the patients were from Southeast Anatolia (164 patients, 35.0%) and (108 patients, 23.0%) from East Anatolia regions. There was a close contact with a tuberculous patient in 88 of 341 patients (25.8%) and with a tuberculous family member in 53 of 288 patients (18.4%). BCG scar was positive in 161 of 392 patients (41.1%). Tuberculin skin test was done in 233 patients and was found to be negative in 75. Totally 115 patients died (24.5%) of whom 23 died in 24 hour after admittance. The diagnosis was confirmed with clinical findings and CSF culture and/or Ziehl-Nelson staining in 88 patients (18.8%). Besides clinical criteria, there were three or more diagnostic sub-criteria in 252 cases (53.7%), two diagnostic sub-criteria in 99 cases (21.1%), and any diagnostic sub-criteria in 30 patients (6.4%). Since TBM is a very critical disease, early diagnosis and treatment may reduce fatal outcome and morbidity
Amesse Lawrence S
Full Text Available Abstract Background Platelet function disorders (PFDs have emerged as an important etiology of heavy menstrual bleeding (HMB in adolescents. However, neither clinical nor laboratory data have been methodically analyzed in this population subset. The objective of this study was to evaluate these parameters in order to distinguish characteristics of the disorder that in turn will lead to earlier diagnosis and therapy initiation. Methods Retrospective review of medical records from postmenarcheal adolescents with documented PFDs referred to a hemophilia treatment center and university faculty practices for bleeding diatheses with their clinical and laboratory data evaluated. Results Of 63 teens with documented PFDs, HMB was the most common clinical manifestation of PFD (43; 68.3%. Of these, 37 (86% were diagnosed with PFD either at or after menarche with the diagnosis based on HMB symptoms alone. Only 6 (14% were diagnosed with a PFD prior to menarche, based on associated bleeding, i.e., epistaxis, ecchymosis, and all developed HMB after menstruation onset. Interestingly, 20 girls were diagnosed with a PFD prior to menarche and of these, only 6 (30% went on to develop HMB after pubertal transition, while the majority (14; 70% did not. The average age-at-PFD diagnosis was 14.5yrs, significantly differing from the 10.9yrs average age-at-PFD diagnosis in their counterparts that, after menarche, did not develop HMB (PP P Conclusions Adolescents with PFDs and HMB appear to be clinically distinct from their non-HMB counterparts. This group of girls is characterized by HMB the major bleeding symptom, significantly high incidences of blood group O and the δ-SPD with a PFD diagnosed well after menarche. High false negative standard platelet function study results indicate additional diagnostic strategies, particularly for δ-SPD, should be considered.
Flegar-Mestrić, Zlata; Nazor, Aida; Perkov, Sonja; Surina, Branka; Kardum-Paro, Mirjana Mariana; Siftar, Zoran; Sikirica, Mirjana; Sokolić, Ivica; Ozvald, Ivan; Vidas, Zeljko
Since 2003 when the international norm for implementation of quality management in medical laboratories (EN ISO 15189, Medical laboratories--Particular requirements for quality and competence) was established and accepted, accreditation has become practical, generally accepted method of quality management and confirmation of technical competence of medical laboratories in the whole world. This norm has been translated into Croatian and accepted by the Croatian Institute for Norms as Croatian norm. Accreditation is carried out on voluntary basis by the Croatian Accreditation Agency that has up to now accredited two clinical medical biochemical laboratories in the Republic of Croatia. Advantages of accredited laboratory lie in its documented management system, constant improvement and training, reliability of test results, establishing users' trust in laboratory services, test results comparability and interlaboratory (international) test results acceptance by adopting the concept of metrological traceability in laboratory medicine.
Nascif, Ana K S; Terreri, Maria T R A; Len, Cláudio A; Andrade, Luis E C; Hilário, Maria O E
Nailfold capillaroscopy is an important tool for the diagnosis and follow-up of patients with rheumatic diseases, in particular dermatomyositis and scleroderma. A relationship has been observed in adults between improved capillaroscopic findings and reduced disease activity. Our aim was to correlate disease activity (clinical and laboratory data) and nailfold capillaroscopy findings in 18 patients with inflammatory myopathies. This prospective study included 13 juvenile dermatomyositis patients (Bohan and Peter criteria) (mean age of 8.8 years) and five patients with overlap syndrome (mean age of 15.7 years). We evaluated disease activity (skin abnormalities and muscle weakness, muscle enzymes and acute phase reactants) and its correlation with nailfold capillaroscopy findings (dilatation of isolated loops, dropout of surrounding vessels and giant capillary loops). We used a microscope with special light and magnification of 10 to 16X. Eighteen patients underwent a total of 26 capillaroscopic examinations, seven of them on two or more occasions (13 were performed during the active disease phase and 13 during remission). Twelve of the 13 examinations performed during the active phase exhibited scleroderma pattern and 8 of the 13 examinations performed during remission were normal. Therefore, in 20 of the 26 examinations clinical and laboratory data and nailfold capillaroscopy findings correlated (p = 0.01). Nailfold capillaroscopy is a non-invasive examination that offers satisfactory correlation with disease activity and could be a useful tool for the diagnosis and follow-up of inflammatory myopathies.
Kuperman, A A; Barg, A A; Fruchtman, Y; Shaoul, E; Rosenberg, N; Kenet, G; Livnat, T
Severe congenital factor VII (FVII) deficiency is a rare bleeding disorder. Prophylaxis with replacement therapy has been suggested to patients, yet the most beneficial dosing regimens and therapy intervals are still to be defined. Due to the lack of evidence-based data, we hereby present our experience with long-term administration and monitoring primary prophylaxis in children with severe FVII deficiency and an extremely high bleeding risk. Four children with familial FVII deficiency, treated by prophylactic recombinant activated factor VII (rFVIIa), 15-30μg/kg/dose, given 2-3 times weekly since infancy, are discussed. Clinical follow up and monitoring laboratory assays, including thrombin generation, measured at various time points after prophylactic rFVIIa administration are presented. Among our treated patients neither FVII activity nor thrombin generation parameters (both already declined 24h post rFVIIa administration) were able to predict the impact of prophylaxis, and could not be used as surrogate markers in order to assess the most beneficial treatment frequency. However, the long clinical follow-up and comprehensive laboratory assessment performed, have shown that early primary prophylaxis as administered in our cohort was safe and effective. Copyright © 2016 Elsevier Inc. All rights reserved.
Place, J F; Truchaud, A; Ozawa, K; Pardue, H; Schnipelsky, P
The incorporation of information-processing technology into analytical systems in the form of standard computing software has recently been advanced by the introduction of artificial intelligence (AI), both as expert systems and as neural networks.This paper considers the role of software in system operation, control and automation, and attempts to define intelligence. AI is characterized by its ability to deal with incomplete and imprecise information and to accumulate knowledge. Expert systems, building on standard computing techniques, depend heavily on the domain experts and knowledge engineers that have programmed them to represent the real world. Neural networks are intended to emulate the pattern-recognition and parallel processing capabilities of the human brain and are taught rather than programmed. The future may lie in a combination of the recognition ability of the neural network and the rationalization capability of the expert system.In the second part of the paper, examples are given of applications of AI in stand-alone systems for knowledge engineering and medical diagnosis and in embedded systems for failure detection, image analysis, user interfacing, natural language processing, robotics and machine learning, as related to clinical laboratories.It is concluded that AI constitutes a collective form of intellectual propery, and that there is a need for better documentation, evaluation and regulation of the systems already being used in clinical laboratories.
Carroll, Karen C.
SUMMARY Clostridium difficile is a formidable nosocomial and community-acquired pathogen, causing clinical presentations ranging from asymptomatic colonization to self-limiting diarrhea to toxic megacolon and fulminant colitis. Since the early 2000s, the incidence of C. difficile disease has increased dramatically, and this is thought to be due to the emergence of new strain types. For many years, the mainstay of C. difficile disease diagnosis was enzyme immunoassays for detection of the C. difficile toxin(s), although it is now generally accepted that these assays lack sensitivity. A number of molecular assays are commercially available for the detection of C. difficile. This review covers the history and biology of C. difficile and provides an in-depth discussion of the laboratory methods used for the diagnosis of C. difficile infection (CDI). In addition, strain typing methods for C. difficile and the evolving epidemiology of colonization and infection with this organism are discussed. Finally, considerations for diagnosing C. difficile disease in special patient populations, such as children, oncology patients, transplant patients, and patients with inflammatory bowel disease, are described. As detection of C. difficile in clinical specimens does not always equate with disease, the diagnosis of C. difficile infection continues to be a challenge for both laboratories and clinicians. PMID:23824374
Papanikolaou, Xenofon; Repousis, Panagiotis; Tzenou, Tatiana; Maltezas, Dimitris; Kotsopoulou, Maria; Megalakaki, Katerina; Angelopoulou, Maria; Dimitrakoloulou, Elektra; Koulieris, Efstathios; Bartzis, Vassiliki; Pangalis, Gerasimos; Panayotidis, Panagiotis; Kyrtsonis, Marie-Christine
Extramedullary plasmacytomas constitute a rare and not well studied subset of multiple myeloma (MM) relapses. We report the incidence, clinical-laboratory features and outcome of patients with MM and extramedullary relapse (ExMeR). A total of 303 patients with symptomatic MM were recorded in a 13-year period in two institutions. Twenty-eight cases of ExMeR (9%) were recorded. There was an increased frequency of elevated lactate dehydrogenase (LDH) (p = 0.026), bone plasmacytomas (p = 0.001) and fractures (p = 0.002) at diagnosis, in patients with ExMeR compared to the others. ExMeR was associated with an ominous outcome, high LDH, constitutional symptoms and a statistically significant decrease of monoclonal paraprotein compared to levels at diagnosis (p = 0.009). Prior treatment with bortezomib was associated with a decreased hazard of ExMeR (p = 0.041). Overall survival (OS) was decreased in patients with ExMeR compared to the others (38 vs. 59 months, p = 0.006). Patients with MM with ExMeR have a lower OS and their clinical and laboratory features differ from those without.
Many mycobacterial species are pathogenic to humans, with infection occurring worldwide. Infection with Mycobacterium tuberculosis is a well-described global phenomenon, but other mycobacterial species are increasingly shown to be the cause of both pulmonary and extrapulmonary infection and are managed differently from M. tuberculosis infection. Rapid and accurate differentiation of mycobacterial species is, therefore, critical to guide timely and appropriate therapeutic and public health management. This study evaluates two commercially available DNA strip assays, the Genotype Common Mycobacteria (CM) assay (Hain Lifescience, Nehren, Germany) and the Speed-oligo Mycobacteria assay (Vircell, Spain) for their usefulness in a clinical laboratory setting. Both assays were evaluated on 71 clinical mycobacterial isolates, previously identified using Gen-Probe AccuProbe and through a UK mycobacteriology reference laboratory, as well as 29 non-mycobacterial isolates. Concordant results were obtained for 98% of isolates using both assays. The sensitivity was 97% (95% confidence interval [CI]: 93.3-100%) for the CM assay and 98.6% (95% CI: 95.9-100%) for the Speed-oligo assay. Overall, both assays proved to be useful tools for rapid and sensitive mycobacterial species identification, although interpretation of results was easier with the CM assay. Finally, results were available within one day, compared to current identification times which range between seven days and four weeks.
Shelton, Jill T.; Elliott, Emily M.; Hill, B. D.; Calamia, Matthew R.; Gouvier, Wm. Drew
The working memory (WM) construct is conceptualized similarly across domains of psychology, yet the methods used to measure WM function vary widely. The present study examined the relationship between WM measures used in the laboratory and those used in applied settings. A large sample of undergraduates completed three laboratory-based WM measures (operation span, listening span, and n-back), as well as the WM subtests from the Wechsler Adult Intelligence Scale-III and the Wechsler Memory Scale-III. Performance on all of the WM subtests of the clinical batteries shared positive correlations with the lab measures; however, the Arithmetic and Spatial Span subtests shared lower correlations than the other WM tests. Factor analyses revealed that a factor comprising scores from the three lab WM measures and the clinical subtest, Letter-Number Sequencing (LNS), provided the best measurement of WM. Additionally, a latent variable approach was taken using fluid intelligence as a criterion construct to further discriminate between the WM tests. The results revealed that the lab measures, along with the LNS task, were the best predictors of fluid abilities. PMID:20161647
Maria Elizabete Mendes
Full Text Available INTRODUCTION: This paper presents the failure modes and effects analysis (FMEA tool in a clinical laboratory through the introduction of new technology for blood gas and serum ionized calcium in multi-parameter analyzers such as Point of Care Testing (POCT. OBJECTIVE: To present FMEA as a tool for risk managing and improvement with the introduction of new technologies in a public laboratory. METHODS: The change of multiparameter gas analyzer type POCT was defined and described as a process. Subsequently, the criteria were presented to the risk assessment and its quantification. We studied the failure modes that might occur in this process. We established three action plans involving improvements to be made in the technological change. FMEA was applied in two stages: at the beginning of the project and after the implementation of the proposed measures. RESULTS: The first plan involved administrative measures related to the bidding process; the second preventive action involved the possibility of which supplier would win the bid by studying the efficiency of the analyzer and its impact on productivity; the third set of actions was directed to improvements in the relationship with the clinical staff in order to minimize occasional complaints. The last actions referred to employing new employees to meet the growing demand. CONCLUSION: FMEA proved to be a reliable tool for performance improvement, which proactively identifies, prioritizes and mitigates patient risks.
Lopez, Alexa A.; Hiler, Marzena; Maloney, Sarah; Eissenberg, Thomas; Breland, Alison
Background Novel tobacco products entering the US market include electronic cigarettes (ECIGs) and products advertised to “heat, not burn” tobacco. There is a growing literature regarding the acute effects of ECIGs. Less is known about “heat, not burn” products. This study’s purpose was to expand existing clinical laboratory methods to examine, in cigarette smokers, the acute effects of a “heat, not burn” “loose-leaf tobacco vaporizer” (LLTV). Methods Plasma nicotine and breath carbon monoxide (CO) concentration and tobacco abstinence symptom severity were measured before and after two 10-puff (30-sec interpuff interval) product use bouts separated by 60 minutes. LLTV effects were compared to participants’ own brand (OB) cigarettes and an ECIG (3.3 V; 1.5 Ohm; 18 mg/ml nicotine). Results Relative to OB, LLTV increased plasma nicotine concentration to a lesser degree, did not increase CO, and appeared to not reduce abstinence symptoms as effectively. Relative to ECIG, LLTV nicotine and CO delivery and abstinence symptom suppression did not differ. Participants reported that both the LLTV and ECIG were significantly less satisfying than OB. Conclusions Results demonstrate that LLTVs are capable of delivering nicotine and suppressing tobacco abstinence symptoms partially; acute effects of these products can be evaluated using existing clinical laboratory methods. Results can inform tobacco product regulation and may be predictive of the extent that these products have the potential to benefit or harm overall public health. PMID:27768968
Bowker, S L; Savu, A; Donovan, L E; Johnson, J A; Kaul, P
To examine the validity of International Classification of Disease, version 10 (ICD-10) codes for gestational diabetes mellitus in administrative databases (outpatient and inpatient), and in a clinical perinatal database (Alberta Perinatal Health Program), using laboratory data as the 'gold standard'. Women aged 12-54 years with in-hospital, singleton deliveries between 1 October 2008 and 31 March 2010 in Alberta, Canada were included in the study. A gestational diabetes diagnosis was defined in the laboratory data as ≥2 abnormal values on a 75-g oral glucose tolerance test or a 50-g glucose screen ≥10.3 mmol/l. Of 58 338 pregnancies, 2085 (3.6%) met gestational diabetes criteria based on laboratory data. The gestational diabetes rates in outpatient only, inpatient only, outpatient or inpatient combined, and Alberta Perinatal Health Program databases were 5.2% (3051), 4.8% (2791), 5.8% (3367) and 4.8% (2825), respectively. Although the outpatient or inpatient combined data achieved the highest sensitivity (92%) and specificity (97%), it was associated with a positive predictive value of only 57%. The majority of the false-positives (78%), however, had one abnormal value on oral glucose tolerance test, corresponding to a diagnosis of impaired glucose tolerance in pregnancy. The ICD-10 codes for gestational diabetes in administrative databases, especially when outpatient and inpatient databases are combined, can be used to reliably estimate the burden of the disease at the population level. Because impaired glucose tolerance in pregnancy and gestational diabetes may be managed similarly in clinical practice, impaired glucose tolerance in pregnancy is often coded as gestational diabetes. © 2016 Diabetes UK.
Ishiguro, Takashi; Takayanagi, Noboru; Kagiyama, Naho; Shimizu, Yoshihiko; Yanagisawa, Tsutomu; Sugita, Yutaka
The diagnosis of allergic bronchopulmonary mycosis (ABPM) has traditionally relied widely on Rosenberg's criteria, which emphasize immunologic responses while overlooking the investigation of mucous plugs as a primary criterion. Therefore, the characteristics of biopsy-proven ABPM require further elucidation. The aim of this study was to analyze the clinical characteristics of biopsy-proven ABPM and address whether full compliance with clinical criteria, such as the presence of asthma, and certain laboratory findings is necessary to establish a diagnosis of ABPM. We retrospectively analyzed 17 patients with biopsy-proven ABPM focusing on causative fungi and laboratory findings. Causative fungi included Aspergillus sp. in seven patients, Schizophyllum commune in four patients, Penicillium sp. in two patients and unknown in five patients. Bronchial asthma was observed in 10 patients, eosinophilia was observed in 10 patients and an increased serum immunoglobulin (Ig) E level was observed in 14 of the 17 patients. IgG for Aspergillus sp. was positive in six of the seven patients with ABPM due to Aspergillus and turned positive in the remaining patient during follow-up. Technological limitations prevented the measurement of specific IgE for S. commune and IgG for S. commune and Penicillium sp. in most patients. Computed tomography revealed central bronchiectasis, pulmonary infiltration and mucous plugs in all patients. Causative fungi other than Aspergillus sp. are not uncommon, and immunological tests for other fungi should be popularized. Asthma and characteristic laboratory findings, such as peripheral blood eosinophilia, increased serum IgE and precipitating antibodies, may not always be required to diagnose ABPM. The importance of typical pathologic findings of mucous plugs for diagnosing ABPM requires reevaluation. Further studies are needed to establish more elaborate diagnostic criteria for ABPM.
Silvana Paula Cardin
Full Text Available ABSTRACT OBJECTIVE: Describe the clinical and laboratory profile, follow-up, and outcome of a series of cases of acute viral myositis. METHOD: A retrospective analysis of suspected cases under observation in the emergency department was performed, including outpatient follow-up with the recording of respiratory infection and musculoskeletal symptoms, measurement of muscle enzymes, creatine phosphokinase (CPK, lactate dehydrogenase (LDH, transaminases (AST and ALT, blood count, C-reactive protein, and erythrocyte sedimentation rate in the acute phase and during follow-up until normalization. RESULTS: Between 2000 and 2009, 42 suspected cases were identified and 35 (27 boys were included. The median age was 7 years and the diagnosis was reported in 89% in the first emergency visit. The observed respiratory symptoms were cough (31%, rhinorrhea (23%, and fever (63%, with a mean duration of 4.3 days. Musculoskeletal symptoms were localized pain in the calves (80%, limited ambulation (57%, gait abnormality (40%, and muscle weakness in the lower limbs (71%, with a mean duration of 3.6 days. There was significant increase in CPK enzymes (5507 ± 9180 U/L, LDH (827 ± 598 U/L, and AST (199 ± 245 U/L, with a tendency to leukopenia (4590 ± 1420 leukocytes/mm3. The complete recovery of laboratory parameters was observed in 30 days (median, and laboratory and clinical recurrence was documented in one case after 10 months. CONCLUSION: Typical symptoms with increased muscle enzymes after diagnosis of influenza and self-limited course of the disease were the clues to the diagnosis. The increase in muscle enzymes indicate transient myotropic activity related to seasonal influenza, which should be considered, regardless of the viral identification, possibly associated with influenza virus or other respiratory viruses.
Cardin, Silvana Paula; Martin, Joelma Gonçalves; Saad-Magalhães, Claudia
Describe the clinical and laboratory profile, follow-up, and outcome of a series of cases of acute viral myositis. A retrospective analysis of suspected cases under observation in the emergency department was performed, including outpatient follow-up with the recording of respiratory infection and musculoskeletal symptoms, measurement of muscle enzymes, creatine phosphokinase (CPK), lactate dehydrogenase (LDH), transaminases (AST and ALT), blood count, C-reactive protein, and erythrocyte sedimentation rate in the acute phase and during follow-up until normalization. Between 2000 and 2009, 42 suspected cases were identified and 35 (27 boys) were included. The median age was 7 years and the diagnosis was reported in 89% in the first emergency visit. The observed respiratory symptoms were cough (31%), rhinorrhea (23%), and fever (63%), with a mean duration of 4.3 days. Musculoskeletal symptoms were localized pain in the calves (80%), limited ambulation (57%), gait abnormality (40%), and muscle weakness in the lower limbs (71%), with a mean duration of 3.6 days. There was significant increase in CPK enzymes (5507±9180U/L), LDH (827±598U/L), and AST (199±245U/L), with a tendency to leukopenia (4590±1420) leukocytes/mm(3). The complete recovery of laboratory parameters was observed in 30 days (median), and laboratory and clinical recurrence was documented in one case after 10 months. Typical symptoms with increased muscle enzymes after diagnosis of influenza and self-limited course of the disease were the clues to the diagnosis. The increase in muscle enzymes indicate transient myotropic activity related to seasonal influenza, which should be considered, regardless of the viral identification, possibly associated with influenza virus or other respiratory viruses. Copyright © 2015 Sociedade Brasileira de Pediatria. Published by Elsevier Editora Ltda. All rights reserved.
Full Text Available Background and Design: Morphea is an inflammatory skin disease seen more frequently than systemic sclerosis in pediatric patients. Important functional deficiencies and cosmetic deformities may develop especially due to linear morphea. Patients may have accompanying extracutaneous involvement, family history of rheumatologic diseases and abnormalities in laboratory parameters like positive ANA and RF. It is important to evaluate pediatric patients accordingly and to carry out further examinations.Data about pediatric morphea in Turkish population could not be found in the literature. We aimed to evaluate epidemiological, clinical and laboratory findings, to compare the data with those in the literature and to propose a model for Turkish pediatric morphea which can be supported by future multicenter national studies. Materials and Methods: Fourteen pediatric morphea patients, 3 males and 11 females under the ageof 18, followed up at Uludag University, Medical Faculty, Dermatovenereology Department between 2000-2010 were enrolled in the study. Inclusion criterion was age under 18 years at diagnosis. Epidemiological, clinical and laboratory findings were analyzed retrospectively. Results: Only 3 patients were males. The mean age at disease onset was 9.5 years. The mean duration of disease was 21 months. Most frequent type was linear morphea. Two patients had contracture, one had shortness in the left lower extremity, and 4 patients had livedo reticularis. Raynaud’s phenomenon was positive in one case. Trauma and sunburn were the trigger factors detected. Behcet’s disease was reported in the father of one patient. One case was RF positive. Five patients had positive ANA in titers of 1/100, while a patient with generalised morphea had significantly higher titer (1/1000. Antihistone antibodies were positive in one patient and 2 cases were Lyme IgM positive.Conclusion: Early diagnosis and therapy are important since childhood morphea can cause
Sakyi, As; Laing, Ef; Ephraim, Rk; Asibey, Of; Sadique, Ok
Proficient laboratory service is the cornerstone of modern healthcare systems and has an impact on over 70% of medical decisions on admission, discharge, and medications. In recent years, there is an increasing awareness of the importance of errors in laboratory practice and their possible negative impact on patient outcomes. We retrospectively analyzed data spanning a period of 3 years on analytical errors observed in our laboratory. The data covered errors over the whole testing cycle including pre-, intra-, and post-analytical phases and discussed strategies pertinent to our settings to minimize their occurrence. We described the occurrence of pre-analytical, analytical and post-analytical errors observed at the Komfo Anokye Teaching Hospital clinical biochemistry laboratory during a 3-year period from January, 2010 to December, 2012. Data were analyzed with Graph Pad Prism 5(GraphPad Software Inc. CA USA). A total of 589,510 tests was performed on 188,503 outpatients and hospitalized patients. The overall error rate for the 3 years was 4.7% (27,520/58,950). Pre-analytical, analytical and post-analytical errors contributed 3.7% (2210/58,950), 0.1% (108/58,950), and 0.9% (512/58,950), respectively. The number of tests reduced significantly over the 3-year period, but this did not correspond with a reduction in the overall error rate (P = 0.90) along with the years. Analytical errors are embedded within our total process setup especially pre-analytical and post-analytical phases. Strategic measures including quality assessment programs for staff involved in pre-analytical processes should be intensified.
Ialongo, Cristiano; Bernardini, Sergio
The International Federation of Clinical Chemistry and Laboratory Medicine has introduced in recent times the turnaround time (TAT) as mandatory quality indicator for the postanalytical phase. Classic TAT indicators, namely, average, median, 90th percentile and proportion of acceptable test (PAT), are in use since almost 40 years and to date represent the mainstay for gauging the laboratory timeliness. In this study, we investigated the performance of the Six Sigma Z-score, which was previously introduced as a device for the quantitative assessment of timeliness. A numerical simulation was obtained modeling the actual TAT data set using the log-logistic probability density function. Five thousand replicates for each size of the artificial TAT random sample (n=20, 50, 250 and 1000) were generated, and different laboratory conditions were simulated manipulating the PDF in order to generate more or less variable data. The Z-score and the classic TAT indicators were assessed for precision (%CV), robustness toward right-tailing (precision at different sample variability), sensitivity and specificity. Z-score showed sensitivity and specificity comparable to PAT (≈80% with n≥250), but superior precision that ranged within 20% by moderately small sized samples (n≥50); furthermore, Z-score was less affected by the value of the cutoff used for setting the acceptable TAT, as well as by the sample variability that reflected into the magnitude of right-tailing. The Z-score was a valid indicator of laboratory timeliness and a suitable device to improve as well as to maintain the achieved quality level.
Rodriguez-Borja, Enrique; Villalba-Martinez, Celia; Barba-Serrano, Esther; Carratala-Calvo, Arturo
Failure to follow-up laboratory test results has been described as one of the major processes contributing to unsafe patient care. Currently, most of the laboratories do not know with certainty not only their rate of missed (or unreviewed) requests but the economical cost and impact that this issue implies. The aim of our study was to measure that rate and calculate the resulting costs. In January 2015, we checked in our Laboratory Information Management System (LIMS) for every emergency request from 1(st) July 2011 to 30(th) June 2014, if they had been reviewed by any allowed user or not. 319,064 requests were ordered during that period of time. Results were expressed as "ordered requests", "missed requests" and its percentage. Additionally, total cost of missed requests was calculated in euros (€). "Non-productive days" were theorised (as the days producing requests that were not reviewed) based on these results. 7924 requests (2.5%) were never reviewed by clinicians. This represented a total cost of 203,039 € and 27 "non-productive" days in three years. Significant differences between inpatients, outpatients and emergency department as well as different emergencies units were found after application of statistical analysis. In terms of resources, never reviewed or missed requests appear to be a not negligible problem for the clinical laboratory management. Electronic result delivery, with electronic endorsement to indicate follow-up of requests along with better systems of electronic requesting should be investigated as a way of improving patient outcomes and save unnecessary expenses.
Feldman, Leonard S; Shihab, Hasan M; Thiemann, David; Yeh, Hsin-Chieh; Ardolino, Margaret; Mandell, Steven; Brotman, Daniel J
Inpatient care providers often order laboratory tests without any appreciation for the costs of the tests. To determine whether we could decrease the number of laboratory tests ordered by presenting providers with test fees at the time of order entry in a tertiary care hospital, without adding extra steps to the ordering process. Controlled clinical trial. Tertiary care hospital. All providers, including physicians and nonphysicians, who ordered laboratory tests through the computerized provider order entry system at The Johns Hopkins Hospital. We randomly assigned 61 diagnostic laboratory tests to an "active" arm (fee displayed) or to a control arm (fee not displayed). During a 6-month baseline period (November 10, 2008, through May 9, 2009), we did not display any fee data. During a 6-month intervention period 1 year later (November 10, 2009, through May 9, 2010), we displayed fees, based on the Medicare allowable fee, for active tests only. We examined changes in the total number of orders placed, the frequency of ordered tests (per patient-day), and total charges associated with the orders according to the time period (baseline vs intervention period) and by study group (active test vs control). For the active arm tests, rates of test ordering were reduced from 3.72 tests per patient-day in the baseline period to 3.40 tests per patient-day in the intervention period (8.59% decrease; 95% CI, -8.99% to -8.19%). For control arm tests, ordering increased from 1.15 to 1.22 tests per patient-day from the baseline period to the intervention period (5.64% increase; 95% CI, 4.90% to 6.39%) (P fee data to providers at the time of order entry resulted in a modest decrease in test ordering. Adoption of this intervention may reduce the number of inappropriately ordered diagnostic tests.
Godwin, Zachary; Lima, Kelly; Greenhalgh, David; Palmieri, Tina; Sen, Soman; Tran, Nam K
The goal of this study is to quantify the number of medications administered to burn patients and identify potential drugs interfering with laboratory testing. The authors reviewed the medical records of 12 adult (age ≥ 18 years) burn patients with more than 20% TBSA burns from an existing glucose control database at our institution. Dose, interval, and route of medications administered from admission to discontinuation of intensive insulin therapy were recorded. Interfering drugs were identified based on established clinical chemistry literature. The retrospective cohort of adult burn patients exhibited a mean (SD) age of 37.9 (3.0) years. Mean TBSA burn was 51.3 (9.3)%. Disease severity determined by the average multiple organ dysfunction score was 5.4 (0.2). Mean and median medications administered per day were 42.1 (9.5) and 49 (with a daily range of 0-65), respectively. A total of 666 potential laboratory test interferences caused by medications were identified. There were 261 different effects (eg, increased glucose, decreased potassium). Multiple interferences, 71.0% (475/666), were caused by more than one medication. Investigation of the number of medications administered to a burn patient and delineation of potential laboratory test interferences has not been conducted in burn patients. Given the substantial number of medications administered to burn patients, physicians and laboratory personnel should work together to identify potential interferences and define appropriate countermeasures while enhancing the laboratorians understanding of this unique population. This synergistic partnership can lead to intelligent support tools and potentially autocorrecting instruments.
Hoxha, Teuta Faik; Azemi, Mehmedali; Avdiu, Muharrem; Ismaili-jaha, Vlora; Grajqevci, Violeta; Petrela, Ela
ABSTRACT Background: An accurate assessment of the degree of dehydration in infants and children is important for proper decision-making and treatment. This emphasizes the need for laboratory tests to improve the accuracy of clinical assessment of dehydration. The aim of this study was to assess the relationship between clinical and laboratory parameters in the assessment of dehydration. Methods: We evaluated prospectively 200 children aged 1 month to 5 years who presented with diarrhea, vomi...
Brown-Elliott, Barbara A.; Brown, June M.; Conville, Patricia S.; Wallace, Richard J.
The recent explosion of newly described species of Nocardia results from the impact in the last decade of newer molecular technology, including PCR restriction enzyme analysis and 16S rRNA sequencing. These molecular techniques have revolutionized the identification of the nocardiae by providing rapid and accurate identification of recognized nocardiae and, at the same time, revealing new species and a number of yet-to-be-described species. There are currently more than 30 species of nocardiae of human clinical significance, with the majority of isolates being N. nova complex, N. abscessus, N. transvalensis complex, N. farcinica, N. asteroides type VI (N. cyriacigeorgica), and N. brasiliensis. These species cause a wide variety of diseases and have variable drug susceptibilities. Accurate identification often requires referral to a reference laboratory with molecular capabilities, as many newer species are genetically distinct from established species yet have few or no distinguishing phenotypic characteristics. Correct identification is important in deciding the clinical relevance of a species and in the clinical management and treatment of patients with nocardial disease. This review characterizes the currently known pathogenic species of Nocardia, including clinical disease, drug susceptibility, and methods of identification. PMID:16614249
Full Text Available Biomedical science is a sensitive discipline and presents unique challenges due to its social character, continuous development and competitiveness. The issue of quality management systems and accreditation is gaining increasing interest in this sector. All over Europe, Health Services Units have started to introduce quality management systems and harmonization of criteria for accreditation is of increasing importance. Moreover, clinical laboratories, like the Assisted Reproduction laboratories and biochemical laboratories are required to apply a Quality Management System in order to ensure their correct, scientific and effective operation. Ultimately, it is a moral obligation for every health care organisation to supply the best possible care for the patient. The specific features and the diversity of clinical laboratories led to the introduction (2003 and, recently to the revision (2007 of the international standard ISO 15189, which is the first international standard developed specifically to address the requirements for accreditation of this type of laboratory. The basic principles for the quality assurance in the clinical laboratories are: x Complete and unambiguous standardized operating procedures. x Complete and unambiguous directives of operation. x Obligatory detailed written documentation, i.e., how each action is done, who will do it, where will this action take place and when. x Suitable scheduling of calibration/control/preventive maintenance of laboratory equipment and recording of each activity. x Distribution of responsibilities among the staff and continuous education and briefing according to current scientific data. x Complete and informed record file keeping. x Continuous improvement which is monitored with the adoption of quantified indicators. x Internal and external audit of all activities. x Troubleshooting. All these principles should be supported by the Management in order that the necessary adaptations should be made
Full Text Available Over the last decade several phase III microbicides trials have been conducted in developing countries. However, laboratories in resource constrained settings do not always have the experience, infrastructure, and the capacity to deliver laboratory data meeting the high standards of clinical trials. This paper describes the design and outcomes of a laboratory quality assurance program which was implemented during a phase III clinical trial evaluating the efficacy of the candidate microbicide Cellulose Sulfate 6% (CS .In order to assess the effectiveness of CS for HIV and STI prevention, a phase III clinical trial was conducted in 5 sites: 3 in Africa and 2 in India. The trial sponsor identified an International Central Reference Laboratory (ICRL, responsible for the design and management of a quality assurance program, which would guarantee the reliability of laboratory data. The ICRL provided advice on the tests, assessed local laboratories, organized trainings, conducted supervision visits, performed re-tests, and prepared control panels. Local laboratories were provided with control panels for HIV rapid tests and Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG amplification technique. Aliquots from respective control panels were tested by local laboratories and were compared with results obtained at the ICRL.Overall, good results were observed. However, discordances between the ICRL and site laboratories were identified for HIV and CT/NG results. One particular site experienced difficulties with HIV rapid testing shortly after study initiation. At all sites, DNA contamination was identified as a cause of invalid CT/NG results. Both problems were timely detected and solved. Through immediate feedback, guidance and repeated training of laboratory staff, additional inaccuracies were prevented.Quality control guidelines when applied in field laboratories ensured the reliability and validity of final study data. It is essential that sponsors
Joshua J. Todd
Full Text Available The ryanodine receptor 1-related congenital myopathies (RYR1-RM comprise a spectrum of slow, rare neuromuscular diseases. Affected individuals present with a mild-to-severe symptomatology ranging from proximal muscle weakness, hypotonia and joint contractures to scoliosis, ophthalmoplegia, and respiratory involvement. Although there is currently no FDA-approved treatment for RYR1-RM, our group recently conducted the first clinical trial in this patient population (NCT02362425. This study aimed to characterize novel RYR1 variants with regard to genetic, laboratory, muscle magnetic resonance imaging (MRI, and clinical findings. Genetic and histopathology reports were obtained from participant’s medical records. Alamut Visual Software was used to determine if participant’s variants had been previously reported and to assess predicted pathogenicity. Physical exams, pulmonary function tests, T1-weighted muscle MRI scans, and blood measures were completed during the abovementioned clinical trial. Six novel variants (two de novo, three dominant, and one recessive were identified in individuals with RYR1-RM. Consistent with established RYR1-RM histopathology, cores were observed in all biopsies, except Case 6 who exhibited fiber-type disproportion. Muscle atrophy and impaired mobility with Trendelenburg gait were the most common clinical symptoms and were identified in all cases. Muscle MRI revealed substantial inter-individual variation in fatty infiltration corroborating the heterogeneity of the disease. Two individuals with dominant RYR1 variants exhibited respiratory insufficiency: a clinical symptom more commonly associated with recessive RYR1-RM cases. This study demonstrates that a genetics-led approach is suitable for the diagnosis of suspected RYR1-RM which can be corroborated through histopathology, muscle MRI and clinical examination.
Dilly, Marc; Read, Emma K; Baillie, Sarah
Developing competence in clinical skills is important if graduates are to provide entry-level care, but it is dependent on having had sufficient hands-on practice. Clinical skills laboratories provide opportunities for students to learn on simulators and models in a safe environment and to supplement training with animals. Interest in facilities for developing veterinary clinical skills has increased in recent years as many veterinary colleges face challenges in training their students with traditional methods alone. For the present study, we designed a survey to gather information from established veterinary clinical skills laboratories with the aim of assisting others considering opening or expanding their own facility. Data were collated from 16 veterinary colleges in North America and Europe about the uses of their laboratory, the building and associated facilities, and the staffing, budgets, equipment, and supporting learning resources. The findings indicated that having a dedicated veterinary clinical skills laboratory is a relatively new initiative and that colleges have adopted a range of approaches to implementing and running the laboratory, teaching, and assessments. Major strengths were the motivation and positive characteristics of the staff involved, providing open access and supporting self-directed learning. However, respondents widely recognized the increasing demands placed on the facility to provide more space, equipment, and staff. There is no doubt that veterinary clinical skills laboratories are on the increase and provide opportunities to enhance student learning, complement traditional training, and benefit animal welfare.
Full Text Available Urinary tract infections (UTI cause a great number of morbidity and mortality. These infections are serious complications in pregnancy, patients with diabetes, polycystic kidneys disease, sickle cell anaemia, kidney transplant and in patients with functional or structural anomalies of the urinary tract. The aim of this investigation was to determine a dominant causative agents of UTI and some of the clinical and laboratory characteristics of acute community-acquired UTI in adult hospitalised patients. We studied 200 adult patients with acute community-acquired UTI hospitalised in the Clinic for Infectious Diseases Tuzla from January 2006 to December 2007. The patients were divided into two groups: a group of patients with E. coli UTI (147 and a group of patients with non-E. coli UTI (53. In these two groups, the symptoms and signs of illness, blood test and urine analysis results were analysed. Our results have shown that the patients with E. coli UTI frequently had fever higher than 38,5 degrees C (p<0,0001, chills (p=0,0349, headache (p=0,0499, cloudy urine (p<0,0001, proteinuria (p=0,0011 and positive nitrite-test (p=0,0002. The patients with non-E. coli UTI frequently had fever lower than 38,5 degrees C (p<0,0001 and urine specific gravity <1015 (p=0,0012. There was no significant difference in blood test results between patients with E. coli and non-E. coli UTI. These clinical and laboratory findings can lead us to early etiological diagnosis of these UTI before urine culture detection of causative agents, which takes several days. Early etiological diagnosis of the E. coli and non-E. coli UTI is necessary for an urgent administration of appropriate empirical antibiotic treatment. This is very important in prevention of irreversible kidney damage, prolonged treatment, complications, as well as recidives and chronicity of the illness.
Full Text Available BACKGROUND: Childhood meningitis continues to be an important cause of mortality in many countries. The search for rapid diagnosis of acute bacterial meningitis has lead to the further exploration of prognostic factors. This study was scheduled in an attempt to analyze various clinical symptoms as well as rapid laboratory results and provide an algorithm for the prediction of specific bacterial aetiology of childhood bacterial meningitis. METHODOLOGY AND PRINCIPAL FINDINGS: During the 32 year period, 2477 cases of probable bacterial meningitis (BM were collected from the Meningitis Registry (MR. Analysis was performed on a total of 1331 confirmed bacterial meningitis cases of patients aged 1 month to 14 years. Data was analysed using EPI INFO (version 3.4.3-CDC-Atlanta and SPSS (version 15.0-Chicago software. Statistically significant (p or = 15000/microL (OR 2.19 with a PPV of 77.8% (95%CI 40.0-97.2. For the diagnosis of Haemophilus influenzae, the most significant group of diagnostic criteria included, absence of haemorrhagic rash (OR 13.61, age > or = 1 year (OR 2.04, absence of headache (OR 3.01, CSF Glu < 40 mg/dL (OR 3.62 and peripheral WBC < 15,000/microL (OR 1.74 with a PPV of 58.5% (95%CI 42.1-73.7. CONCLUSIONS: The use of clinical and laboratory predictors for the assessment of the causative bacterial pathogen rather than just for predicting outcome of mortality seems to be a useful tool in the clinical management and specific treatment of BM. These findings should be further explored and studied.
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.
Roach, D.; Walkington, P.
Composite doublers, or repair patches, provide an innovative repair technique which can enhance the way aircraft are maintained. Instead of riveting multiple steel or aluminum plates to facilitate an aircraft repair, it is possible to bond a single Boron-Epoxy composite doubler to the damaged structure. Most of the concerns surrounding composite doubler technology pertain to long-term survivability, especially in the presence of non-optimum installations, and the validation of appropriate inspection procedures. This report focuses on a series of full-scale structural and nondestructive inspection (NDI) tests that were conducted to investigate the performance of Boron-Epoxy composite doublers. Full-scale tests were conducted on fuselage panels cut from retired aircraft. These full-scale tests studied stress reductions, crack mitigation, and load transfer capabilities of composite doublers using simulated flight conditions of cabin pressure and axial stress. Also, structures which modeled key aspects of aircraft structure repairs were subjected to extreme tension, shear and bending loads to examine the composite laminate's resistance to disbond and delamination flaws. Several of the structures were loaded to failure in order to determine doubler design margins. Nondestructive inspections were conducted throughout the test series in order to validate appropriate techniques on actual aircraft structure. The test results showed that a properly designed and installed composite doubler is able to enhance fatigue life, transfer load away from damaged structure, and avoid the introduction of new stress risers (i.e. eliminate global reduction in the fatigue life of the structure). Comparisons with test data obtained prior to the doubler installation revealed that stresses in the parent material can be reduced 30%--60% through the use of the composite doubler. Tests to failure demonstrated that the bondline is able to transfer plastic strains into the doubler and that
Collins, Susan M.; Hacek, Donna M.; Degen, Lisa A.; Wright, Marc O.; Noskin, Gary A.; Peterson, Lance R.
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
Cervellin, Gianfranco; Comelli, Ivan; Benatti, Mario; Sanchis-Gomar, Fabian; Bassi, Antonella; Lippi, Giuseppe
Rhabdomyolysis is a relatively rare condition, but its clinical consequences are frequently dramatic in terms of both morbidity and mortality. Although no consensus has been reached so far about the precise definition of this condition, the term rhabdomyolysis describes a rapid breakdown of striated, or skeletal, muscle. It is hence characterized by the rupture and necrosis of muscle fibers, resulting in release of cell degradation products and intracellular elements within the bloodstream and extracellular space. Notably, the percentage of patients with rhabdomyolysis who develop acute kidney injury, the most dramatic consequence, varies from 13% to over 50% according to both the cause and the clinical and organizational setting where they are diagnosed. Despite direct muscle injury (i.e., traumatic rhabdomyolysis) remains the most common cause, additional causes, frequently overlapping, include hypoxic, physical, chemical or biological factors. The conventional triad of symptoms includes muscle pain, weakness and dark urine. The laboratory diagnosis is essentially based on the measurement of biomarkers of muscle injury, being creatine kinase (CK) the biochemical "gold standard" for diagnosis, and myoglobin the "gold standard" for prognostication, especially in patients with non-traumatic rhabdomyolysis. The essential clinical management in the emergency department is based on a targeted intervention to manage the underlying cause, combined with infusion of fluids and eventually sodium bicarbonate. We will present and discuss in this article the pathophysiological and clinical features of non-traumatic rhabdomyolysis, focusing specifically on Emergency Department (ED) management. Copyright © 2017 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.
Savi, Eleonora; Incorvaia, Cristoforo; Boni, Elisa; Mauro, Marina; Peveri, Silvia; Pravettoni, Valerio; Quercia, Oliviero; Reccardini, Federico; Montagni, Marcello; Pessina, Laura; Ridolo, Erminia
Venom immunotherapy (VIT) is highly effective in preventing allergic reactions to insect stings, but the appropriate venom must be used to achieve clinical protection. In patients with multiple positive results to venoms, molecular allergy diagnostics or CAP-inhibition may identify the causative venom. Concerning allergy to venom from Polistes spp. it has been proposed that only the European species P. dominulus should be used for VIT. However, this recommendation is not present in any international guideline. Using both laboratory and clinical data, we aimed to evaluate the reliability of this proposal. We performed an in vitro study using CAP-inhibition to determine sensitization of 19 patients allergic to Polistes venom. The clinical study included 191 patients with positive tests to Polistes treated with VIT, 102 were treated with P. dominulus and 89 were treated with a mix of American Polistes (mAP). The difference in % of inhibition was significant concerning inhibition of P. dominulus sIgE by P. dominulus venom (79.8%) compared with inhibition by mAP venom (64.2%) and not significant concerning the inhibition of mAP sIgE by P. dominulus venom (80.1%) and by mAP venom (73.6%). Instead, the clinical protection from stings was not statistically different between the two kinds of venom. The data from CAP inhibition would suggest that the choice of either P. dominulus venom or mAP venom for VIT is appropriate in patients with CAP inhibition higher than 70%, but the clinical data show the same odds of protection from stings using for VIT P. dominulus or mAP venom.
Full Text Available Venom immunotherapy (VIT is highly effective in preventing allergic reactions to insect stings, but the appropriate venom must be used to achieve clinical protection. In patients with multiple positive results to venoms, molecular allergy diagnostics or CAP-inhibition may identify the causative venom. Concerning allergy to venom from Polistes spp. it has been proposed that only the European species P. dominulus should be used for VIT. However, this recommendation is not present in any international guideline. Using both laboratory and clinical data, we aimed to evaluate the reliability of this proposal.We performed an in vitro study using CAP-inhibition to determine sensitization of 19 patients allergic to Polistes venom. The clinical study included 191 patients with positive tests to Polistes treated with VIT, 102 were treated with P. dominulus and 89 were treated with a mix of American Polistes (mAP.The difference in % of inhibition was significant concerning inhibition of P. dominulus sIgE by P. dominulus venom (79.8% compared with inhibition by mAP venom (64.2% and not significant concerning the inhibition of mAP sIgE by P. dominulus venom (80.1% and by mAP venom (73.6%. Instead, the clinical protection from stings was not statistically different between the two kinds of venom.The data from CAP inhibition would suggest that the choice of either P. dominulus venom or mAP venom for VIT is appropriate in patients with CAP inhibition higher than 70%, but the clinical data show the same odds of protection from stings using for VIT P. dominulus or mAP venom.
Klainbart, Sigal; Agi, Limor; Bdolah-Abram, Tali; Kelmer, Efrat; Aroch, Itamar
OBJECTIVE To characterize clinical and laboratory findings in cats with naturally occurring sepsis, emphasizing hemostasis-related findings, and evaluate these variables for associations with patient outcomes. DESIGN Prospective, observational, clinical study. ANIMALS 31 cats with sepsis and 33 healthy control cats. PROCEDURES Data collected included history; clinical signs; results of hematologic, serum biochemical, and hemostatic tests; diagnosis; and outcome (survival vs death during hospitalization or ≤ 30 days after hospital discharge). Differences between cats with and without sepsis and associations between variables of interest and death were analyzed statistically. RESULTS The sepsis group included cats with pyothorax (n = 10), septic peritonitis (7), panleukopenia virus infection (5), bite wounds (5), abscesses and diffuse cellulitis (3), and pyometra (1). Common clinical abnormalities included dehydration (21 cats), lethargy (21), anorexia (18), pale mucous membranes (15), and dullness (15). Numerous clinicopathologic abnormalities were identified in cats with sepsis; novel findings included metarubricytosis, hypertriglyceridemia, and high circulating muscle enzyme activities. Median activated partial thromboplastin time and plasma D-dimer concentrations were significantly higher, and total protein C and antithrombin activities were significantly lower, in the sepsis group than in healthy control cats. Disseminated intravascular coagulopathy was uncommon (4/22 [18%] cats with sepsis). None of the clinicopathologic abnormalities were significantly associated with death on multivariate analysis. CONCLUSIONS AND CLINICAL RELEVANCE Cats with sepsis had multiple hematologic, biochemical, and hemostatic abnormalities on hospital admission, including several findings suggestive of hemostatic derangement. Additional research including larger numbers of cats is needed to further investigate these findings and explore associations with outcome.
Valappil, Ashraf V; Thiruvoth, Sohanlal; Peedikayil, Jabir M; Raghunath, Praveenkumar; Thekkedath, Manojan
The involvement of the central nervous system in the form of meningitis or meningoencephalitis is common in scrub typhus and is an important differential diagnosis of other lymphocytic meningitis like tuberculous meningitis (TBM). The aim of this study was to identify the clinical and laboratory parameters that may be helpful in differentiating scrub typhus meningitis from TBM. We compared of the clinical and laboratory features of 57 patients admitted with scrub typhus meningitis or TBM during a 3-year period. Patients who had abnormal cerebrospinal fluid (CSF) and positive scrub typhus enzyme-linked immunosorbent assay serology (n=28) were included in the scrub typhus meningitis group, while the TBM group included those who satisfied the consensus diagnostic criteria of TBM (n=29). Compared with the TBM group, the mean duration of symptoms was less in patients with scrub typhus meningitis, who also had a lower magnitude of neurological deficits, such as altered mental status and cranial nerve and motor deficits. Patients with scrub typhus meningitis had a lower CSF white blood-cell count (WBC) than the TBM group (130.8±213 195±175 cells/mm 3 , P=0.002), lower CSF protein elevation (125±120 vs. 195.2±108.2mg/dl, P=0.002), and higher CSF sugar (70.1±32.4 vs. 48.7±23.4mg/dl, P=0.006). Features predictive of the diagnosis of scrub typhus meningitis included the absence of neurological impairment at presentation, blood serum glutamic-oxaloacetic transaminase>40 international units (IU)/L, serum glutamic-pyruvic transaminase>60 IU/L, total blood leukocyte count>10,000/mm 3 , CSF protein50mg/dl, CSF WBC<100 cells/mm 3 . All patients with scrub typhus meningitis recovered completely following doxycycline therapy CONCLUSIONS: This study suggests that, clinical features, including duration of fever, neurological deficits at presentation and laboratory parameters such as CSF pleocytosis,CSF protein elevation, CSF sugar levels and liver enzyme values are helpful in
Hayward, C P M; Moffat, K A; George, T I; Proytcheva, M
Practice guidelines provide helpful support for clinical laboratories. Our goal was to assemble an inventory of publically listed guidelines on hematology laboratory topics, to create a resource for laboratories and for assessing gaps in practice-focused guidelines. PubMed and website searches were conducted to assemble an inventory of hematology laboratory-focused guidelines. Exclusions included annual, technical, or collaborative study reports, clinically focused guidelines, position papers, nomenclature, and calibration documents. Sixty-eight guidelines were identified on hematology laboratory practice topics from 12 organizations, some as joint guidelines. The median year of publication was 2010 and 15% were >10 years old. Coagulation topics had the largest numbers of guidelines, whereas some areas of practice had few guidelines. A minority of guidelines showed evidence of periodic updates, as some organizations did not remove or identify outdated guidelines. This inventory of current practice guidelines will encourage awareness and uptake of guideline recommendations by the worldwide hematology laboratory community, with the International Society for Laboratory Hematology facilitating ongoing updates. There is a need to encourage best guideline development practices, to ensure that hematology laboratory community has current, high-quality, and evidence-based practice guidelines that cover the full scope of hematology laboratory practice. © 2015 John Wiley & Sons Ltd.
Docherty, Charles; Hoy, Derek; Topp, Helena; Trinder, Kathryn
This paper details the results of the first phase of a project that used eLearning to support students' learning within a simulated environment. The locus was a purpose built Clinical Simulation Laboratory (CSL) where the School's newly adopted philosophy of Problem Based Learning (PBL) was challenged through lecturers reverting to traditional teaching methods. The solution, a student-centred, problem-based approach to the acquisition of clinical skills was developed using learning objects embedded within web pages that substituted for lecturers providing instruction and demonstration. This allowed lecturers to retain their facilitator role, and encouraged students to explore, analyse and make decisions within the safety of a clinical simulation. Learning was enhanced through network communications and reflection on video performances of self and others. Evaluations were positive, students demonstrating increased satisfaction with PBL, improved performance in exams, and increased self-efficacy in the performance of nursing activities. These results indicate that an elearning approach can support PBL in delivering a student centred learning experience.
Omidifar, Navid; Keshtkari, Ali; Dehghani, Mohammadreza; Shokripour, Mansoureh
OBJECTIVES: Teaching of clinical pathology to medical students has been ignored in many countries such as Iran. We aim to introduce a practical brief course and its proper timing. MATERIALS AND METHODS: Three groups of medical students from consecutive years of entrance passed a 1.5 working day practical course on the field. Their level of knowledge was assessed by pre- and post-tests. Their idea and satisfaction were gathered by questionnaires. RESULTS: Knowledge of students became significantly higher after the course. Their satisfaction was high. Students in later year of education got significantly higher marks. Most of the students wished such a course should be away from basic sciences period and as near as possible to internship. DISCUSSION: Due to overloaded curriculum of general medicine in Iran, we decided to run a brief practical course of laboratory medicine education for medical students. Although the course was practical, the knowledge of students became higher. Students with more clinical experience and knowledge absorbed more. Being actively involved in the classes lit the enthusiasm of students and made them satisfied with the course. It seemed that the course should be placed in later years of clinical training to get the best uptake and results. PMID:29114552
Yasini, Mobin; Ebrahiminia, Vahid; Duclos, Catherine; Venot, Alain; Lamy, Jean-Baptiste
Laboratory medicine is responsible for an important part of hospital expenditure. Providing appropriate decision support to laboratory test requesters at the point of care is one of the main incentives for implementing laboratory guidelines, which can improve medical care. Laboratory guidelines developed by local experts in the Parisian region and two national guidelines for dyslipidemia were analyzed to extract test ordering recommendations. Clinical conditions which can be a trigger to order or not to order laboratory tests were extracted and mapped with ICD10 and SNOMED CT: 43.1% of clinical conditions were matched by ICD10 whereas SNOMED CT covered 80.1% of these conditions. For the non-mapped conditions, the main problem was found to be the ambiguity of the terms used in the guidelines. Ordinal characteristics of some clinical conditions and using terms more specific than SNOMED CT were other causes of mapping failure. Applying consistent and explicit concepts in the development of guidelines would lead to better implementation. By resolving the guideline ambiguity, SNOMED CT is a good choice and covers almost all of the clinical conditions in laboratory guidelines which are needed to implement in a Clinical Decision Support System.
Fischman, S L; Truelove, R B; Hart, R; Cancro, L P
This study reports the laboratory, clinical, and microbiological finding of the safety testing and daily use of a dentifrice delivering 0.75% hydrogen peroxide and 5% baking soda. Laboratory studies using Ca45 labeled teeth and biologically stained teeth confirmed that the dentifrice did not decalcify enamel or bleach teeth. Over the course of a six-month period, 62 subjects using a hydrogen peroxide-baking soda dentifrice and 21 subjects using a control dentifrice were examined for oral soft tissue change and hard tissue alterations. No soft tissue changes attributable to the use of either dentifrice were noted. Experienced clinicians using Trubyte shade guide teeth observed no significant changes to the subjects' anterior teeth following 6 months use of the test dentifrice. Paired discrimination tests revealed that the examiners could distinguish color differences in the shade guide teeth at 0.7%. Microbiological monitoring of the subjects for six months use of their assigned dentifrice and for the following months on the control dentifrice, revealed neither an increased incidence of candida nor increased candida counts.
Wagar, Elizabeth A; Tamashiro, Lorraine; Yasin, Bushra; Hilborne, Lee; Bruckner, David A
Patient safety is an increasingly visible and important mission for clinical laboratories. Attention to improving processes related to patient identification and specimen labeling is being paid by accreditation and regulatory organizations because errors in these areas that jeopardize patient safety are common and avoidable through improvement in the total testing process. To assess patient identification and specimen labeling improvement after multiple implementation projects using longitudinal statistical tools. Specimen errors were categorized by a multidisciplinary health care team. Patient identification errors were grouped into 3 categories: (1) specimen/requisition mismatch, (2) unlabeled specimens, and (3) mislabeled specimens. Specimens with these types of identification errors were compared preimplementation and postimplementation for 3 patient safety projects: (1) reorganization of phlebotomy (4 months); (2) introduction of an electronic event reporting system (10 months); and (3) activation of an automated processing system (14 months) for a 24-month period, using trend analysis and Student t test statistics. Of 16,632 total specimen errors, mislabeled specimens, requisition mismatches, and unlabeled specimens represented 1.0%, 6.3%, and 4.6% of errors, respectively. Student t test showed a significant decrease in the most serious error, mislabeled specimens (P patient safety projects. Trend analysis demonstrated decreases in all 3 error types for 26 months. Applying performance-improvement strategies that focus longitudinally on specimen labeling errors can significantly reduce errors, therefore improving patient safety. This is an important area in which laboratory professionals, working in interdisciplinary teams, can improve safety and outcomes of care.
Sampson, Maureen L; Gounden, Verena; van Deventer, Hendrik E; Remaley, Alan T
The main drawback of the periodic analysis of quality control (QC) material is that test performance is not monitored in time periods between QC analyses, potentially leading to the reporting of faulty test results. The objective of this study was to develop a patient based QC procedure for the more timely detection of test errors. Results from a Chem-14 panel measured on the Beckman LX20 analyzer were used to develop the model. Each test result was predicted from the other 13 members of the panel by multiple regression, which resulted in correlation coefficients between the predicted and measured result of >0.7 for 8 of the 14 tests. A logistic regression model, which utilized the measured test result, the predicted test result, the day of the week and time of day, was then developed for predicting test errors. The output of the logistic regression was tallied by a daily CUSUM approach and used to predict test errors, with a fixed specificity of 90%. The mean average run length (ARL) before error detection by CUSUM-Logistic Regression (CSLR) was 20 with a mean sensitivity of 97%, which was considerably shorter than the mean ARL of 53 (sensitivity 87.5%) for a simple prediction model that only used the measured result for error detection. A CUSUM-Logistic Regression analysis of patient laboratory data can be an effective approach for the rapid and sensitive detection of clinical laboratory errors. Published by Elsevier Inc.
Full Text Available SUMMARYDuring recent decades, antifungal susceptibility testing has become standardized and nowadays has the same role of the antibacterial susceptibility testing in microbiology laboratories. American and European standards have been developed, as well as equivalent commercial systems which are more appropriate for clinical laboratories. The detection of resistant strains by means of these systems has allowed the study and understanding of the molecular basis and the mechanisms of resistance of fungal species to antifungal agents. In addition, many studies on the correlation of in vitro results with the outcome of patients have been performed, reaching the conclusion that infections caused by resistant strains have worse outcome than those caused by susceptible fungal isolates. These studies have allowed the development of interpretative breakpoints for Candida spp. and Aspergillus spp., the most frequent agents of fungal infections in the world. In summary, antifungal susceptibility tests have become essential tools to guide the treatment of fungal diseases, to know the local and global disease epidemiology, and to identify resistance to antifungals.
Interest on the part of the Physics Department at KSC in developing a computer interfaced lab with appeal to biology majors and a need to perform a clinical pulmonological study to fulfill a biology requirement led to the author's undergraduate research project in which a recording spirometer (typical cost: $15K) was constructed from readily available materials and a typical undergraduate lab computer interface. Simple components, including a basic photogate circuit, CPU fan, and PVC couplings were used to construct an instrument for measuring flow rates as a function of time. Pasco software was used to build an experiment in which data was collected and integration performed such that one could obtain accurate values for FEV1 (forced expiratory volume for one second) and FVC (forced vital capacity) and their ratio for a large sample of subjects. Results were compared to published norms and subjects with impaired respiratory mechanisms identified. This laboratory exercise is one with which biology students can clearly identify and would be a robust addition to the repertoire for a HS or college physics or biology teaching laboratory.
Li, Ke; Zhang, Zheng; Liu, Ning Fei; Feng, Shao Qing; Tong, Yun; Zhang, Ju Fang; Constantinides, Joannis; Lazzeri, Davide; Grassetti, Luca; Nicoli, Fabio; Zhang, Yi Xin
Swelling is the most common symptom of extremities lymphedema. Clinical evaluation and laboratory analysis were conducted after far infrared radiation (FIR) treatment on the main four components of lymphedema: fluid, fat, protein, and hyaluronan. Far infrared radiation is a kind of hyperthermia therapy with several and additional benefits as well as promoting microcirculation flow and improving collateral lymph circumfluence. Although FIR therapy has been applied for several years on thousands of lymphedema patients, there are still few studies that have reported the biological effects of FIR on lymphatic tissue. In this research, we investigate the effects of far infrared rays on the major components of lymphatic tissue. Then, we explore the effectiveness and safety of FIR as a promising treatment modality of lymphedema. A total of 32 patients affected by lymphedema in stage II and III were treated between January 2015 and January 2016 at our department. After therapy, a significant decrease of limb circumference measurements was noted and improving of quality of life was registered. Laboratory examination showed the treatment can also decrease the deposition of fluid, fat, hyaluronan, and protein, improving the swelling condition. We believe FIR treatment could be considered as both an alternative monotherapy and a useful adjunctive to the conservative or surgical lymphedema procedures. Furthermore, the real and significant biological effects of FIR represent possible future applications in wide range of the medical field.
Mavrikakis, M E; Sfikakis, P P; Kontoyannis, S A; Antoniades, L G; Kontoyannis, D A; Moulopoulou, D S
The clinical and laboratory parameters of calcific shoulder periarthritis (CSP) were examined in 900 patients with type II diabetes mellitus as well as in 350 age- and sex-matched control subjects. A threefold increased prevalence of CSP in diabetics compared with the control group was associated with the presence of longstanding and poorly controlled diabetes, hypercholesterolemia, and hypertriglyceridemia suggesting pronounced diabetic angiopathy, as well as with minor trauma and hypomagnesemia. Aging and serum calcium concentrations were not related to the presence of CSP. Thirty-two percent of diabetics with CSP were symptomatic; 15% of them presented with severe pain and restriction of shoulder movement. These findings confirm a close pathogenetic interrelation between CSP and diabetes mellitus.
Boissoneau, R; McPherson, J
Employee participation and involvement are at the leading edge of management thinking today. Not only behaviorally oriented managers, but managers of all styles include personnel in decision-making. The purpose of this article is to communicate to clinical laboratory managers some recent developments in people management. Several suggestions for team building and the desired outcome of worker participation are included. Although employee participation has been a major issue in management for 10 years, many business schools still emphasize only the traditional quantitative subjects of accounting, finance, statistics, and systems engineering. Obviously, these subjects are important, but modern managers must learn qualitative or behavioral material as well. Students are affected by the lack of a notable behavioral emphasis. Unfortunately, some students think that learning in the behavioral domain is unimportant. Too often, these students encounter problems later in their careers with employees and can only wish for greater knowledge.
Finan, Patrick H; Quartana, Phillip J; Smith, Michael T
This study investigated whether daily and laboratory assessed pain differs as a function of the temporal stability and valence of affect in individuals with chronic knee osteoarthritis (KOA). One hundred fifty-one men and women with KOA completed 14 days of electronic diaries assessing positive affect (PA), negative affect (NA), and clinical pain. A subset of participants (n =79) engaged in quantitative sensory testing (QST). State PA and NA were assessed prior to administration of stimuli that induced suprathreshold pain and temporal summation. Multilevel modeling and multiple regression evaluated associations of affect and pain as a function of valence (i.e., positive versus negative) and stability (i.e., stable versus state). In the diary, stable NA (B = -.63, standard error [SE] = .13, p affect-pain processes in the field may reflect individual differences in central pain facilitation.
Scammon, D L; Weiss, R
A study of customer satisfaction with clinical laboratory service is used as the basis for identifying potential improvements in service and more effectively targeting marketing activities to enhance customer satisfaction. Data on customer satisfaction are used to determine the aspects of service most critical to customers, how well the organization is doing in delivery of service, and how consistent service delivery is. Importance-performance analysis is used to highlight areas for future resource reallocation and strategic emphasis. Suggestions include the establishment of performance guidelines for customer contact personnel, the enhancement of timely delivery of reports via electronic transmission (computer and fax), and the development of standardized graphics for request and report forms to facilitate identification of appropriate request forms and guide clients to key items of information on reports.
Wilkinson, David S; Pontius, C Anne
Americans are demanding, independent people. In most aspects of our lives, we are used to walking into a store or other place of business with the expectation that the personnel working for the business will make every effort to satisfy our requests quickly and without the need for a third party to intervene or approve the transaction. Hence, the popularity of convenience stores, do-it-yourself stores and kits, and e-commerce. The delivery of health-care services, however, generally does not conform to this model. Before most diagnostic tests or treatments are ordered, patients usually consult a physician. In many cases, prior to tests or treatments being performed, additional consultations are required with insurance plans. But the winds of change, they are a-blowing. More and more, people demand an active role in managing their health care. One emerging trend is direct patient access to clinical laboratory testing (1).
Otmara Aranguren Barreto
Full Text Available The article aims to describe the clinical and laboratory features of a female patient suffering from pheochromocytoma. The case is a 52-year-old female patient who presents to our healthcare center with high blood pressure, cold limbs, sweating, jitteriness, and episodes of oppressive chest pain that appear several times per day. She also reports fatigue and a 13-kilogram weight loss. The sonogram revealed a nodular image in the right adrenal gland that had low echogenicity and regular margins measuring 5 mm. The image was confirmed with a contrast-enhanced adrenal CAT scan. Urine vanillylmandelic acid levels were high and an adrenal biopsy confirmed a pheochromocytoma measuring 4.5 x 3.5 x 3 cm.
Barkhatova, N A
Dynamic measurements of blood TNF-a, IL-IRA, CRP, oligopeptide, and lactoferrin levels in patients with systemic and local soft tissue infections revealed direct correlation between them which allowed to use these indicators for the diagnosis of systemic infections. Results of clinical and laboratory analyses provided a basis for distinguishing short-term systemic inflammatory response syndrome and sepsis and developing relevant diagnostic criteria. Sepsis combined with systemic inflammatory response syndrome persisting for more than 72 hours after the onset of adequate therapy was characterized by CRP levels > 30 mg/l, oligopeptides > 0.34 U, lactoferrin > 1900 ng/ml, TNF-a > 6 pg/ml, ILL-IRA systemic inflammatory response syndrome for less than 72 hours had lower TNF-a, CRP, oligopeptide, and lactoferrin levels with IL-IRA > 1500 pg/ml. This new approach to early diagnosis of systemic infections makes it possible to optimize their treatment and thereby enhance its efficiency.
... specified list of new Clinical Procedural Terminology (CPT) codes for clinical laboratory tests in calendar... are codified at 42 CFR part 414, subpart G. A newly created Current Procedural Terminology (CPT) code..., Medicare--Hospital Insurance; and Program No. 93.774, Medicare-- Supplementary Medical Insurance Program...
Ji Hae Choi
Full Text Available Purpose:The purpose of this study was to determine whether there is any difference in the clinical and laboratory characteristics of patients with autoantibody-positive and patients with autoantibody-negative type 1 diabetes at initial presentation. Methods:We analyzed 96 patients under 18 years of age with newly diagnosed type 1 diabetes. One or both of the pancreatic autoantibodies-glutamic acid decarboxylase autoantibodies (GADA and insulin autoantibody (IAA-were measured in all patients, and we reviewed clinical and laboratory characteristics according to the presence of these autoantibodies. Results:GADA was examined in 48 of 87 patients, and 55.2% of patients were positive. IAA was checked in 88 patients, and 39.8% were positive. Both GADA and IAA were measured in 83 patients, and 22.8% had both antibodies. The patients who had one or both autoantibodies (autoantibody-positive group were younger than those not having any autoantibody (autoantibody-negative group. The autoantibody-positive group had lower BMI, corrected sodium level, and serum effective osmolarity, compared to the autoantibody-negative group (P<0.05. Similar differences were found between the GADA-positive and GADA-negative groups. However, there were no significant differences between the IAA- positive and IAA-negative groups. Conclusion:The prevalence of pancreatic autoantibodies was significantly higher in the under-6 years age group than in the other age groups. These findings suggest that measurement of autoantibodies at the initial diagnosis of diabetes is very useful for detecting immune-mediated type 1 diabetes and providing intensive insulin therapy, especially in younger children.
van Pelt, Cindy; Verduin, Cees M.; Goessens, Wil H. F.; Vos, Margreet C.; Tümmler, Burkhard; Segonds, Christine; Reubsaet, Frans; Verbrugh, Henri; van Belkum, Alex
Cystic fibrosis (CF) predisposes patients to bacterial colonization and infection of the lower airways. Several species belonging to the genus Burkholderia are potential CF-related pathogens, but microbiological identification may be complicated. This situation is not in the least due to the poorly defined taxonomic status of these bacteria, and further validation of the available diagnostic assays is required. A total of 114 geographically diverse bacterial isolates, previously identified in reference laboratories as Burkholderia cepacia (n = 51), B. gladioli (n = 14), Ralstonia pickettii (n = 6), B. multivorans (n = 2), Stenotrophomonas maltophilia (n = 3), and Pseudomonas aeruginosa (n = 11), were collected from environmental, clinical, and reference sources. In addition, 27 clinical isolates putatively identified as Burkholderia spp. were recovered from the sputum of Dutch CF patients. All isolates were used to evaluate the accuracy of two selective growth media, four systems for biochemical identification (API 20NE, Vitek GNI, Vitek NFC, and MicroScan), and three different PCR-based assays. The PCR assays amplify different parts of the ribosomal DNA operon, either alone or in combination with cleavage by various restriction enzymes (PCR-restriction fragment length polymorphism [RFLP] analysis). The best system for the biochemical identification of B. cepacia appeared to be the API 20NE test. None of the biochemical assays successfully grouped the B. gladioli strains. The PCR-RFLP method appeared to be the optimal method for accurate nucleic acid-mediated identification of the different Burkholderia spp. With this method, B. gladioli was also reliably classified in a separate group. For the laboratory diagnosis of B. cepacia, we recommend parallel cultures on blood agar medium and selective agar plates. Further identification of colonies with a Burkholderia phenotype should be performed with the API 20NE test. For final confirmation of species identities, PCR
Varghese, George M; Janardhanan, Jeshina; Trowbridge, Paul; Peter, John V; Prakash, John A J; Sathyendra, Sowmya; Thomas, Kurien; David, Thambu S; Kavitha, M L; Abraham, Ooriapadickal C; Mathai, Dilip
This study sought to document the clinical and laboratory manifestations, genetic variability, and outcomes of scrub typhus, an often severe infection caused by Orientia tsutsugamushi, in South India. Patients admitted to a large teaching hospital with IgM ELISA-confirmed scrub typhus were evaluated. Clinical examination with a thorough search for an eschar, laboratory testing, chest X-ray, and outcome were documented and analyzed. Additionally, a 410-bp region of the 56-kDa type-specific antigen gene of O. tsutsugamushi was sequenced and compared with isolates from other regions of Asia. Most of the 154 patients evaluated presented with fever and non-specific symptoms. An eschar was found in 86 (55%) patients. Mild hepatic involvement was seen in most, with other organ involvement including respiratory, cardiovascular, and renal. Multi-organ dysfunction was noted in 59 (38.3%), and the fatality rate was 7.8%. Hypotension requiring vasoactive agents was found to be an independent predictor of mortality (p<0.001). The phylogeny of 26 samples showed 17 (65%) clustering with the Kato-like group and eight (31%) with the Karp-like group. The presentation of scrub typhus can be variable, often non-specific, but with potentially severe multi-organ dysfunction. Prompt recognition is key to specific treatment and good outcomes. Further study of the circulating strains is essential for the development of a successful vaccine and sensitive point-of-care testing. Copyright © 2013 International Society for Infectious Diseases. Published by Elsevier Ltd. All rights reserved.
Full Text Available Interpretation of laboratory test results with appropriate diagnostic accuracy requires reference or cutoff values. This study is a comprehensive determination of reference values for hematology and clinical chemistry in apparently healthy voluntary non-remunerated blood donors and pregnant women.Consented clients were clinically screened and counseled before testing for HIV, Hepatitis B, Hepatitis C and Syphilis. Standard national blood donors' questionnaire was administered to consented blood donors. Blood from qualified volunteers was used for measurement of complete hematology and chemistry parameters. Blood samples were analyzed from a total of 383 participants, 124 (32.4% males, 125 (32.6% non-pregnant females and 134 pregnant females (35.2% with a mean age of 31 years. Our results showed that the red blood cells count (RBC, Hemoglobin (HB and Hematocrit (HCT had significant gender difference (p = 0.000 but not for total white blood count (p>0.05 which was only significantly higher in pregnant verses non-pregnant women (p = 0.000. Hemoglobin and Hematocrit values were lower in pregnancy (P = 0.000. Platelets were significantly higher in females than men (p = 0.001 but lower in pregnant women (p = .001 with marked difference in gestational period. For clinical chemistry parameters, there was no significant difference for sodium, potassium and chloride (p>0.05 but gender difference exists for Bicarbonate (HCO3, Urea nitrogen, Creatinine as well as the lipids (p0.05.Hematological and Clinical Chemistry reference ranges established in this study showed significant gender differences. Pregnant women also differed from non-pregnant females and during pregnancy. This is the first of such comprehensive study to establish reference values among adult Nigerians and difference observed underscore the need to establish reference values for different populations.
Miri-Dashe, Timzing; Osawe, Sophia; Tokdung, Monday; Daniel, Monday Tokdung Nenbammun; Daniel, Nenbammun; Choji, Rahila Pam; Mamman, Ille; Deme, Kurt; Damulak, Dapus; Abimiku, Alash'le
Interpretation of laboratory test results with appropriate diagnostic accuracy requires reference or cutoff values. This study is a comprehensive determination of reference values for hematology and clinical chemistry in apparently healthy voluntary non-remunerated blood donors and pregnant women. Consented clients were clinically screened and counseled before testing for HIV, Hepatitis B, Hepatitis C and Syphilis. Standard national blood donors' questionnaire was administered to consented blood donors. Blood from qualified volunteers was used for measurement of complete hematology and chemistry parameters. Blood samples were analyzed from a total of 383 participants, 124 (32.4%) males, 125 (32.6%) non-pregnant females and 134 pregnant females (35.2%) with a mean age of 31 years. Our results showed that the red blood cells count (RBC), Hemoglobin (HB) and Hematocrit (HCT) had significant gender difference (p = 0.000) but not for total white blood count (p>0.05) which was only significantly higher in pregnant verses non-pregnant women (p = 0.000). Hemoglobin and Hematocrit values were lower in pregnancy (P = 0.000). Platelets were significantly higher in females than men (p = 0.001) but lower in pregnant women (p = .001) with marked difference in gestational period. For clinical chemistry parameters, there was no significant difference for sodium, potassium and chloride (p>0.05) but gender difference exists for Bicarbonate (HCO3), Urea nitrogen, Creatinine as well as the lipids (pchemistry parameters between pregnant and non-pregnant women in this study (p0.05). Hematological and Clinical Chemistry reference ranges established in this study showed significant gender differences. Pregnant women also differed from non-pregnant females and during pregnancy. This is the first of such comprehensive study to establish reference values among adult Nigerians and difference observed underscore the need to establish reference values for different populations.
Roberta Faria Camilo-Araújo
Full Text Available Objectives: To analyze the frequency of βS-globin haplotypes and alpha-thalassemia, and their influence on clinical manifestations and the hematological profile of children with sickle cell anemia. Method: The frequency of βS-globin haplotypes and alpha-thalassemia and any association with clinical and laboratorial manifestations were determined in 117 sickle cell anemia children aged 3–71 months. The confirmation of hemoglobin SS and determination of the haplotypes were achieved by polymerase chain reaction-restriction fragment length polymorphism, and alpha-thalassemia genotyping was by multiplex polymerase chain reaction (single-tube multiplex-polymerase chain reaction. Results: The genotype distribution of haplotypes was 43 (36.7% Central African Republic/Benin, 41 (35.0% Central African Republic/Central African Republic, 20 (17.0% Rare/atypical, and 13 (11.1% Benin/Benin. The frequency of the α3.7 deletion was 1.71% as homozygous (−α3.7/−α3.7 and 11.9% as heterozygous (−α3.7/αα. The only significant association in respect to haplotypes was related to the mean corpuscular volume. The presence of alpha-thalassemia was significantly associated to decreases in mean corpuscular volume, mean corpuscular hemoglobin and reticulocyte count and to an increase in the red blood cell count. There were no significant associations of βS-globin haplotypes and alpha-thalassemia with clinical manifestations. Conclusions: In the study population, the frequency of alpha-thalassemia was similar to published data in Brazil with the Central African Republic haplotype being the most common, followed by the Benin haplotype. βS-globin haplotypes and interaction between alpha-thalassemia and sickle cell anemia did not influence fetal hemoglobin concentrations or the number of clinical manifestations.
Jones, Bruce A; Bekeris, Leonas G; Nakhleh, Raouf E; Walsh, Molly K; Valenstein, Paul N
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.
Armbruster, David; Miller, Richard R
Clinical laboratories are moving towards global standardisation to produce equivalent test results across space and time. Standardisation allows use of evidence-based medicine, eliminates the need of method-specific reference intervals, decision levels and cut-offs, and can be achieved by application of metrological principles. For example, in vitro diagnostics (IVD) manufacturers can make kit calibrators traceable to internationally recognised reference materials and reference methods.
Faustino, Patricia C.; Terreri, Maria Teresa R.A.; Rocha, Antonio J. da; Zappitelli, Marcelo C.; Lederman, Henrique M.; Hilario, Maria Odete E.
The objective of this study was to determine the clinical and laboratory characteristics, psychiatric manifestations and magnetic resonance imaging (MRI) findings in children and adolescents with Sydenham chorea (SyC). The imaging examination was repeated 1 year after the acute phase of SyC. There were 19 patients with a mean age of 11.7 years and a predominance of females (79%);68% had generalized chorea and 53% moderate chorea. SyC presented as an isolated manifestation in 74%. No association between SyC and obsessive-compulsive disorder was found. Mental health problems were present in 45% of the patients. MRI analysis revealed persistent alterations in the caudate nucleus in three patients (16%), who presented recurrent episodes of chorea during the study. In one patient, MRI revealed the presence of nodular heteropathy close to the caudate nucleus region. We conclude that attention problems can be associated with acute clinical features of SyC and persistent alterations in the basal nuclei, evidenced by MRI, can be found in some patients who tend to suffer prolonged attacks and a greater number of recurrences. (orig.)
Rantanen, Kirsi K; Strandberg, Timo E; Stenholm, Sari S; Strandberg, Arto Y; Pitkälä, Kaisu H; Salomaa, Veikko V; Tilvis, Reijo S
To investigate clinical and laboratory variables associated with good subjective and objective health ("active and healthy aging", AHA) in a cohort of octogenarian men. Cross-sectional analyses of a longitudinal study. The Helsinki Businessmen Study in Finland. A socioeconomically homogenous cohort of men (baseline n = 3293), born in 1919-1934, has been followed up from the 1960s. From 2000, the men have been regularly sent mailed questionnaires and mortality has been retrieved from national registers. In 2010 survey, AHA was defined as independently responding to the mailed survey, feeling happy without cognitive or functional impairments and without major diseases. In 2010/11, a random subgroup men was clinically investigated and survivors with healthy and nonhealthy aging were compared. By 2010, 1788 men of the baseline cohort had died, and 894 men responded to the mailed survey. 154 (17.2 %) of those fulfilled the present AHA criteria. Increasing number of criteria were negatively (P active and healthy aging over their life course, which was significantly related to markers of frailty but not to the traditional vascular risk factors.
Csendes, A; Burdiles, P; Maluenda, F; Cortés, C; Korn, O; Rojas, J; Tepper, P; Huertas, C; Sagastume, H; Puente, G; Quezada, F; Csendes, P
Sixty percent of adults has typical symptoms of gastroesophageal reflux in Chile. To report the clinical and laboratory features of patients with gastroesophageal reflux. Five hundred thirty-four patients (255 male) with gastroesophageal reflux were included in a prospective protocol that included clinical analysis, manometry and endoscopy in all patients, barium swallow in 427, scintigraphy in 195, acid reflux test in 359, 24 h pH in 175, and differential potential of gastroesophageal mucosa in 73 patients. There was no correlation between the severity of symptoms and the endoscopical severity. Patients with Barret esophagus were 12 years older, were male in a greater proportion and had a higher proportion of manometrically incompetent sphincters than patients with esophageal reflux but without esophagitis or with erosive esophagitis. Severity of acid reflux, measured with 24 h pH monitoring was proportional to the endoscopical damage of the mucosa. There was a close relationship between the mucosal change limit determined with differential potentials and with endoscopy. No short esophagi were found. Patients with symptoms of gastroesophageal reflux must be assessed using several objective measures to determine the severity of their pathological alterations.
Lima, C S; Vassalo, J; Lorand-Metze, I; Bechelli, A P; Souza, C A
A prospective study was undertaken to elucidate the clinical and laboratory differences between de novo acute myeloid leukemia (AML) and AML with trilineage myelodysplasia (AML-TMDS). One hundred and seven patients with AML were diagnosed at the University Hospital between January 1987 and July 1992, and were followed until July 1995. TMDS was identified in 17 of them (16%). With regard to age and sex distribution no difference was found between AML patients with and without TMDS (p = 0.43, p = 0.54, respectively). The duration of symptoms at presentation in AML-TMDS was similar to those observed in de novo AML (p = 0.29). Hemoglobin values and platelet counts were similar in both groups of patients (p = 0.45, p = 0.44, respectively). However, peripheral white blood cell and neutrophil counts, as well as blast counts in AML-TMDS patients were lower than those observed in AML without TMDS patients (p leukemia transformation occurs in a more undifferentiated pluripotent stem cell, leading to a dysplastic residual hemopoiesis besides the blast proliferation; 2) the incidence of TMDS in our group of patients did not influence the clinical outcome after treatment of the disease.
Full Text Available Staging in rheumatoid arthritis (RA and evaluating the effectiveness of drug treatment involves the determination of radiological scores (for narrowing and erosions, this being the most specific changes and most commonly found in RA.Matherials and methods: Our study was condacted over a period of 12 months in Medical Rehabilitation Clinic of „Sf. Spiridon” Iasi Hospital, on a group of 40 women patients with RA in various stages of evolution. X-ray examination was done on hands and feet at the beginning and the end of the study period. There were computed radiographic Sharp scores for narrowing and erosions and the total score. Erosions were examined for 16 joints in each hand. For narrowing five joints were evaluated. For accuracy, radiological examination was done on mammography film. Rezults:After calculating Sharp scores - Van der Heide version - I compared them with the levels of clinical (HAQ, NAT, NAD, DAS28, bone densitometry and laboratory (ESR, CRP, rheumatoid factor, IL-1β parameters.Conclusions: The values of radiological scores for narrowing and erosions are directly correlate with DAS28, HAQ, rheumatoid factors levels and IgG values, and indirectly correlated with IL-1β levels.
Altintas, Ayse; Karabudak, Rana; Balci, Belgin P; Terzi, Murat; Soysal, Aysun; Saip, Sabahattin; Tuncer Kurne, Asli; Uygunoglu, Ugur; Nalbantoglu, Mecbure; Gozubatik Celik, Gokcen; Isik, Nihal; Celik, Yahya; Gokcay, Figen; Duman, Taskin; Boz, Cavit; Yucesan, Canan; Mangan, Mehmet Serhat; Celebisoy, Nese; Diker, Sevda; Colpak Isikay, Ilksen; Kansu, Tulay; Siva, Aksel
Neuromyelitis optica (NMO) is an immune-mediated, chronic relapsing, inflammatory disease characterized by severe attacks of optic neuritis and myelitis. To determine the demographic, clinical, and laboratory features; antibody status; and treatment modalities of patients with NMO and neuromyelitis optica spectrum disorders in a Turkish cohort from 11 centers. A total of 182 patients were included in this study. Data on age at disease onset, sex, type of attacks, clinical presentation, analysis of cerebrospinal fluid, serum antiaquaporin-4 antibody status, annual progression index, and medical and family histories were collected. Mean age was 38.43±12.40 years (range, 13 to 75 y), and mean age at disease onset was 31.29±12.40 years (median, 29 y; range, 10 to 74 y). In NMO group, the rate of NMO immunoglobulin (Ig)G positivity was 62.5%. The annual progression index was significantly higher in the longitudinally extending spinal cord lesion. The mean Expanded Disability Status Scale score was higher in the late than early-onset NMO group. Our results revealed a lower rate of NMO IgG positivity, more severe disability in patients with NMO/neuromyelitis optica spectrum disorders presenting with either transverse myelitis or late-onset NMO, and no correlation between disability and NMO IgG status.
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
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.
Buckingham, Steven C; Marshall, Gary S; Schutze, Gordon E; Woods, Charles R; Jackson, Mary Anne; Patterson, Lori E R; Jacobs, Richard F
To describe the clinical characteristics and course of children with laboratory-diagnosed Rocky Mountain spotted fever (RMSF) and to identify clinical findings independently associated with adverse outcomes of death or discharge with neurologic deficits. Retrospective chart review of 92 patients at six institutions in the southeastern and southcentral United States from 1990 to 2002. Statistical analyses used descriptive statistics and multiple logistic regression. Children with RMSF presented to study institutions after a median of 6 days of symptoms, which most commonly included fever (98%), rash (97%), nausea and/or vomiting (73%), and headache (61%); no other symptom or sign was present in >50% of children. Only 49% reported antecedent tick bites. Platelet counts were <150,000/mm3 in 59% of children, and serum sodium concentrations were <135 mEq/dL in 52%. Although 86% sought medical care before admission, only 4 patients received anti-rickettsial therapy during this time. Three patients died, and 13 survivors had neurologic deficits at discharge. Coma and need for inotropic support and intravenous fluid boluses were independently associated with adverse outcomes. Children with RMSF generally present with fever and rash. Delays in diagnosis and initiation of appropriate therapy are unacceptably common. Prognosis is guarded in those with hemodynamic instability or neurologic compromise at initiation of therapy.
Full Text Available Clinical Decision Support Systems have the potential to reduce lack of communication and errors in diagnostic steps in primary health care. Literature reports have showed great advances in clinical decision support systems in the recent years, which have proven its usefulness in improving the quality of care. However, most of these systems are focused on specific areas of diseases. In this way, we propose a rule-based expert system, which supports clinicians in primary health care, providing a list of possible diseases regarding patient’s laboratory tests results in order to assist previous diagnosis. Our system also allows storing and retrieving patient’s data and the history of patient’s analyses, establishing a basis for coordination between the various health care levels. A validation step and speed performance tests were made to check the quality of the system. We conclude that our system could improve clinician accuracy and speed, resulting in more efficiency and better quality of service. Finally, we propose some recommendations for further research.
Salih, Karimeldin Mohamed Ali; El-Samani, El-Fatih; Bilal, Jalal Ali; Eldouch, Widad; Ibrahim, Salah Ahmed
Blood culture is necessary for appropriate management of clinically severe pneumonia in children under five years of age. However, in limited resource countries it might be unduly costly and waste of valuable time because of the high negative culture rate. This study aims to identify clinical and laboratory parameters that potentially predict a positive blood culture in cases of severe pneumonia. A hospital based study, enrolled 189 cases satisfying the WHO definition of severe pneumonia. Age, gender, clinical history, physical examination, temperature, complete blood count, C-reactive protein, blood culture and Chest X Ray for all the patients were recorded. Forty one patients had positive blood culture giving a prevalence of 21.7%. All variables were used in a dichotomous manner. White Blood Count (WBC) more than 20 000, very high C-reactive protein (C-RP ≥8mg/L) and Temperature more than 40(o)C, had a positive predictive value of 46.1%, 44.3% and 40.0% respectively for a positive culture as well as a Negative Predictive Value of 91.1%, 91.6% and 91.7% respectively. The WBC more than 20 000 and temperature above 40(o)C had a significant association with a positive blood culture. Their adjusted Odds Ratios were 3.9 (95% CI: 1.4-10.90) and 3.1 (95% CI: 1.2-8.4) respectively. This was not the case for C-RP (Odds Ratio=2.2, 95% CI: 0.7-2.2) or positive Chest X Ray (Odds Ratio=1.5, 95% CI: 0.6-3.6). Temperature of more than 40(o)C, Very high C-RP and WBC of more than 20 000 are good indicators of a potential positive blood culture. It is therefore recommended that further research be undertaken to refine these predictors as screening tools before resorting to blood culture. It is also recommended that antibiotic treatment may be initiated on the basis of the high temperature and WBC, while waiting for the culture results.
Motschman, Courtney A; Gass, Julie C; Wray, Jennifer M; Germeroth, Lisa J; Schlienz, Nicolas J; Munoz, Diana A; Moore, Faith E; Rhodes, Jessica D; Hawk, Larry W; Tiffany, Stephen T
The selection criteria used in clinical trials for smoking cessation and in laboratory studies that seek to understand mechanisms responsible for treatment outcomes may limit their generalizability to one another and to the general population. We reviewed studies on varenicline versus placebo and compared eligibility criteria and participant characteristics of clinical trials (N=23) and laboratory studies (N=22) across study type and to nationally representative survey data on adult, daily USA smokers (2014 National Health Interview Survey; 2014 National Survey on Drug Use and Health). Relative to laboratory studies, clinical trials more commonly reported excluding smokers who were unmotivated to quit and for specific medical conditions (e.g., cardiovascular disease, COPD), although both study types frequently reported excluding for general medical or psychiatric reasons. Laboratory versus clinical samples smoked less, had lower nicotine dependence, were younger, and more homogeneous with respect to smoking level and nicotine dependence. Application of common eligibility criteria to national survey data resulted in considerable elimination of the daily-smoking population for both clinical trials (≥47%) and laboratory studies (≥39%). Relative to the target population, studies in this review recruited participants who smoked considerably more and had a later smoking onset age, and were under-representative of Caucasians. Results suggest that selection criteria of varenicline studies limit generalizability in meaningful ways, and differences in criteria across study type may undermine efforts at translational research. Recommendations for improvements in participant selection and reporting standards are discussed. Copyright Â© 2016 Elsevier Ireland Ltd. All rights reserved.
Nikolaev, N S; Nazarova, V V; Dobrovol'skaia, N Iu; Orlova, A V; Pchelova, N N
The article presents experience of clinical diagnostic laboratory of the Federal Center of traumatology, orthopedics and endoprosthesis replacement of Minzdrav of Russia (Cheboksary) in the area of quality management of medical laboratory services on the basis of evaluation of efficacy and effectiveness of processes. The factors effecting quality of functioning of clinical diagnostic laboratory are indicated. The criteria and indicators of efficacy of work of employees of clinical diagnostic laboratory are presented.
Sarkozi, Laszlo; Simson, Elkin; Ramanathan, Lakshmi
Thirty-six years of data and history of laboratory practice at our institution has enabled us to follow the effects of analytical automation, then recently pre-analytical and post-analytical automation on productivity, cost reduction and enhanced quality of service. In 1998, we began the operation of a pre- and post-analytical automation system (robotics), together with an advanced laboratory information system to process specimens prior to analysis, deliver them to various automated analytical instruments, specimen outlet racks and finally to refrigerated stockyards. By the end of 3 years of continuous operation, we compared the chemistry part of the system with the prior 33 years and quantitated the financial impact of the various stages of automation. Between 1965 and 2000, the Consumer Price Index increased by a factor of 5.5 in the United States. During the same 36 years, at our institution