Sample records for good clinical laboratory

  1. The good laboratory practice and good clinical practice requirements for the production of radiopharmaceuticals in clinical research

    De Vos, FJ; De Decker, M; Dierckx, RA


    Radiopharmaceuticals account for more than 95% of the group of sterile pharmaceutical products and should therefore be handled and produced with care. Since the introduction of the European directive, all pharmaceuticals used in clinical studies must be prepared under good manufacturing practice (GM

  2. The good laboratory practice and good clinical practice requirements for the production of radiopharmaceuticals in clinical research

    De Vos, FJ; De Decker, M; Dierckx, RA


    Radiopharmaceuticals account for more than 95% of the group of sterile pharmaceutical products and should therefore be handled and produced with care. Since the introduction of the European directive, all pharmaceuticals used in clinical studies must be prepared under good manufacturing practice (GM

  3. Good Laboratory Standards for Clinical Next-Generation Sequencing Cancer Panel Tests

    Jihun Kim


    Full Text Available Next-generation sequencing (NGS has recently emerged as an essential component of personalized cancer medicine due to its high throughput and low per-base cost. However, no sufficient guidelines for implementing NGS as a clinical molecular pathology test are established in Korea. To ensure clinical grade quality without inhibiting adoption of NGS, a taskforce team assembled by the Korean Society of Pathologists developed laboratory guidelines for NGS cancer panel testing procedures and requirements for clinical implementation of NGS. This consensus standard proposal consists of two parts: laboratory guidelines and requirements for clinical NGS laboratories. The laboratory guidelines part addressed several important issues across multistep NGS cancer panel tests including choice of gene panel and platform, sample handling, nucleic acid management, sample identity tracking, library preparation, sequencing, analysis and reporting. Requirements for clinical NGS tests were summarized in terms of documentation, validation, quality management, and other required written policies. Together with appropriate pathologist training and international laboratory standards, these laboratory standards would help molecular pathology laboratories to successfully implement NGS cancer panel tests in clinic. In this way, the oncology community would be able to help patients to benefit more from personalized cancer medicine.

  4. Non-clinical studies in the process of new drug development - Part II: Good laboratory practice, metabolism, pharmacokinetics, safety and dose translation to clinical studies.

    Andrade, E L; Bento, A F; Cavalli, J; Oliveira, S K; Schwanke, R C; Siqueira, J M; Freitas, C S; Marcon, R; Calixto, J B


    The process of drug development involves non-clinical and clinical studies. Non-clinical studies are conducted using different protocols including animal studies, which mostly follow the Good Laboratory Practice (GLP) regulations. During the early pre-clinical development process, also known as Go/No-Go decision, a drug candidate needs to pass through several steps, such as determination of drug availability (studies on pharmacokinetics), absorption, distribution, metabolism and elimination (ADME) and preliminary studies that aim to investigate the candidate safety including genotoxicity, mutagenicity, safety pharmacology and general toxicology. These preliminary studies generally do not need to comply with GLP regulations. These studies aim at investigating the drug safety to obtain the first information about its tolerability in different systems that are relevant for further decisions. There are, however, other studies that should be performed according to GLP standards and are mandatory for the safe exposure to humans, such as repeated dose toxicity, genotoxicity and safety pharmacology. These studies must be conducted before the Investigational New Drug (IND) application. The package of non-clinical studies should cover all information needed for the safe transposition of drugs from animals to humans, generally based on the non-observed adverse effect level (NOAEL) obtained from general toxicity studies. After IND approval, other GLP experiments for the evaluation of chronic toxicity, reproductive and developmental toxicity, carcinogenicity and genotoxicity, are carried out during the clinical phase of development. However, the necessity of performing such studies depends on the new drug clinical application purpose.

  5. Non-clinical studies in the process of new drug development - Part II: Good laboratory practice, metabolism, pharmacokinetics, safety and dose translation to clinical studies

    E.L. Andrade

    Full Text Available The process of drug development involves non-clinical and clinical studies. Non-clinical studies are conducted using different protocols including animal studies, which mostly follow the Good Laboratory Practice (GLP regulations. During the early pre-clinical development process, also known as Go/No-Go decision, a drug candidate needs to pass through several steps, such as determination of drug availability (studies on pharmacokinetics, absorption, distribution, metabolism and elimination (ADME and preliminary studies that aim to investigate the candidate safety including genotoxicity, mutagenicity, safety pharmacology and general toxicology. These preliminary studies generally do not need to comply with GLP regulations. These studies aim at investigating the drug safety to obtain the first information about its tolerability in different systems that are relevant for further decisions. There are, however, other studies that should be performed according to GLP standards and are mandatory for the safe exposure to humans, such as repeated dose toxicity, genotoxicity and safety pharmacology. These studies must be conducted before the Investigational New Drug (IND application. The package of non-clinical studies should cover all information needed for the safe transposition of drugs from animals to humans, generally based on the non-observed adverse effect level (NOAEL obtained from general toxicity studies. After IND approval, other GLP experiments for the evaluation of chronic toxicity, reproductive and developmental toxicity, carcinogenicity and genotoxicity, are carried out during the clinical phase of development. However, the necessity of performing such studies depends on the new drug clinical application purpose.

  6. Clinical Laboratory Fee Schedule

    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...

  7. Good Laboratory Practice (GLP) status of Asian countries and its implementation in non-clinical safety studies in pharmaceutical drug development.

    Sasaki, Madoka; Hinotsu, Shiro; Kawakami, Koji


    Non-clinical animal studies to assess the safety of compounds under development have to comply with Good Laboratory Practice (GLP). The Organization for Economic Co-operation and Development (OECD) has established the Mutual Acceptance of Data (MAD) system in OECD member countries for the mutual acceptance of non-clinical safety study data. Since 1997 non-OECD-member countries have also been able to participate in the MAD system, if the country meets the level of standardized compliance with OECD GLP. Thus, several Asian non-OECD countries are trying to develop their GLP standards in order to become official members of the MAD system. Pharmaceutical companies face significant expense in the drug-development process, including the cost of non-clinical safety studies; in response, companies in Asian countries are seeking to establish GLP facilities to provide cost-effective services for drug development. To assess the quality and cost of GLP performance in Asian countries, in this study we approached GLP facilities in a number of Asian countries to obtain price and quality information on a 'virtual compound' to be assessed in non-clinical safety studies. Also, the development status of GLP in Asian countries in terms of policy and infrastructure was analyzed. We found that, among Asian countries, India and Singapore may be candidates for participation in te MAD system in terms of their compliance with GLP, language, and costs. These findings will be beneficial to pharmaceutical companies planning GLP studies in Asian countries.

  8. Good clinical practices in phase I studies.

    Decousus, H; Perpoint, B; Mismetti, P; Ollagnier, M; Queneau, P


    In France, official guidelines for good clinical practices in clinical trials were issued in 1987. In December 1988, a law was passed that fixed the requirements for carrying out experiments in healthy subjects. It will be completed by official guidelines for the structures in which experiments on healthy subjects (and patients as well, when the investigation would not benefit the health of the patients) may be conducted. Hence a battery of recent legal instructions precisely state what good clinical practices are in the setting of phase I studies. Of particular importance are: subject recruitment and selection methods and procedures; specific competence of the investigator, in particular to interpret the pre-trial data; necessary and sufficient facilities to guarantee the subjects' safety; careful quality control to check all laboratory procedures; necessity of written standard operating procedures.

  9. An inter-laboratory comparison of urinary 3-hydroxypropylmercapturic acid measurement demonstrates good reproducibility between laboratories

    Bailey Brian


    Full Text Available Abstract Background Biomarkers have been used extensively in clinical studies to assess toxicant exposure in smokers and non-smokers and have recently been used in the evaluation of novel tobacco products. The urinary metabolite 3-HPMA, a metabolite of the major tobacco smoke toxicity contributor acrolein, is one example of a biomarker used to measure exposure to tobacco smoke. A number of laboratories have developed liquid chromatography with tandem mass spectrometry (LC-MS/MS based methods to measure urinary 3-HPMA; however, it is unclear to what extent the data obtained by these different laboratories are comparable. Findings This report describes an inter-laboratory comparison carried out to evaluate the comparability of 3-HPMA measurement between four laboratories. A common set of spiked and authentic smoker and non-smoker urine samples were used. Each laboratory used their in-house LC-MS/MS method and a common internal standard. A comparison of the repeatability ('r', reproducibility ('R', and coefficient of variation for 3-HPMA demonstrated that within-laboratory variation was consistently lower than between-laboratory variation. The average inter-laboratory coefficient of variation was 7% for fortified urine samples and 16.2% for authentic urine samples. Together, this represents an inter-laboratory variation of 12.2%. Conclusion The results from this first inter-laboratory comparison for the measurement of 3-HPMA in urine demonstrate a reasonably good consensus between laboratories. However, some consistent measurement biases were still observed between laboratories, suggesting that additional work may be required to further reduce the inter-laboratory coefficient of variation.

  10. Result of China National Accreditation for Laboratories Achieving Good Credit


    @@ With the efforts of the past 10 years, the accreditation system for laboratories, which is complete in range, integrate on function and normative on operation, has been set up in China, and has achieved good reputation home and abroad. The result of laboratories accreditation is widely admitted and used in the international. Since the China national accreditation system for laboratories entering the international multilateral mutual recognition arrangement, the accreditation for laboratories has been playing an increasingly important role in the international trade. The testing result provided by the accreditation laboratories is required by many international-famous enterprises when they purchase in China, and there have been 37 economic systems admitting the result of China national accreditation for laboratories. More and more governmental departments require using accreditation for laboratories in the administrative management and law enforcement.

  11. [How to write a good clinical review?].

    Krause, B J; Khan, C; Antoch, G


    Clinical reviews are an important part of the medical literature offering the reader condensed information on a specific topic. In radiology and nuclear medicine most clinical reviews have a subjective character as they have been written in a rather narrative way. Based on their low level of evidence these narrative reviews are frequently not being considered for establishment of clinical guidelines. The aim of this paper is to aid the reader in writing a good clinical review by highlighting the different aspects of a systematic review.

  12. The clinic as a good corporate neighbor.

    Sass, Hans-Martin


    Clinics today specialize in health repair services similar to car repair shops; procedures and prices are standardized, regulated, and inflexibly uniform. Clinics of the future have to become Health Care Centers in order to be more respected and more effective corporate neighbors in offering outreach services in health education and preventive health care. The traditional concept of care for health is much broader than repair management and includes the promotion of lay health competence and responsibility in healthy social and natural environments. The corporate profile and ethics of the clinic as a good and competitive local neighbor will have to focus on [a] better personalized care, [b] education and services in preventive care, [c] direct or web-based information and advice for general, seasonal, or age related health risks, and on developing and improving trustworthy character traits of the clinic as a corporate person and a good neighbor.

  13. Corruption at the data capture stage and good laboratory practices

    Ziegler, E.; Lenk, H. [Max-Planck-Institut fuer Kohlenforschung, Muelheim (Germany)


    Possible sources of data corruption at the data capture stage include errors from the analogue input signal to be sampled, incorrect timing of the realtime sampling, loss of data on the data transmission path, and malfunctions of hardware and software components. Hardware and software measures to avoid such errors and provisions to adhere to good laboratory practice rules are discussed. 9 refs., 3 figs.

  14. Using Provenance to support Good Laboratory Practice in Grid Environments

    Ney, Miriam; Schreiber, Andreas


    Conducting experiments and documenting results is daily business of scientists. Good and traceable documentation enables other scientists to confirm procedures and results for increased credibility. Documentation and scientific conduct are regulated and termed as "good laboratory practice." Laboratory notebooks are used to record each step in conducting an experiment and processing data. Originally, these notebooks were paper based. Due to computerised research systems, acquired data became more elaborate, thus increasing the need for electronic notebooks with data storage, computational features and reliable electronic documentation. As a new approach to this, a scientific data management system (DataFinder) is enhanced with features for traceable documentation. Provenance recording is used to meet requirements of traceability, and this information can later be queried for further analysis. DataFinder has further important features for scientific documentation: It employs a heterogeneous and distributed data...

  15. 75 FR 1063 - Clinical Laboratory Improvement Advisory Committee (CLIAC)


    ... Laboratory Improvement Advisory Committee (CLIAC) In accordance with section 10(a)(2) of the Federal Advisory... under which clinical laboratories are regulated; the impact on medical and laboratory practice of... Testing Workgroup and discussion of the Workgroup's proposals related to good laboratory practices...

  16. Good manufacturing practices and clinical supplies.

    Levchuk, J W


    Quality characteristics must be assured through adherence to good manufacturing practices in the production, control, and testing of drug products intended for investigational as well as commercial use. A draft guideline on the preparation of investigational new drug products, soon to be available in final form, addresses questions that have been raised regarding acceptable practices and procedures to facilitate compliance with the CGMP regulations as applied to clinical supplies. Inspections of sterile clinical supplies production can be expected to include the areas most likely to influence product safety, quality, and uniformity in the same manner as would be expected regarding the manufacture of commercial batches. Some areas of particular significance in the manufacture of parenteral clinical supplies include validation of terminal sterilization, aseptic processing, and oxygen exclusion. The validation of the aseptic handling during lyophilization requires special attention. Other CGMP concerns include the provision of a quality control unit, avoiding packaging mixups, and being prepared for an amendment to the CGMP regulations regarding terminal sterilization.

  17. Informatics and the clinical laboratory.

    Jones, Richard G; Johnson, Owen A; Batstone, Gifford


    The nature of pathology services is changing under the combined pressures of increasing workloads, cost constraints and technological advancement. In the face of this, laboratory systems need to meet new demands for data exchange with clinical electronic record systems for test requesting and results reporting. As these needs develop, new challenges are emerging especially with respect to the format and content of the datasets which are being exchanged. If the potential for the inclusion of intelligent systems in both these areas is to be realised, the continued dialogue between clinicians and laboratory information specialists is of paramount importance. Requirements of information technology (IT) in pathology, now extend well beyond the provision of purely analytical data. With the aim of achieving seamless integration of laboratory data into the total clinical pathway, 'Informatics' - the art and science of turning data into useful information - is becoming increasingly important in laboratory medicine. Informatics is a powerful tool in pathology - whether in implementing processes for pathology modernisation, introducing new diagnostic modalities (e.g. proteomics, genomics), providing timely and evidence-based disease management, or enabling best use of limited and often costly resources. Providing appropriate information to empowered and interested patients - which requires critical assessment of the ever-increasing volume of information available - can also benefit greatly from appropriate use of informatics in enhancing self-management of long term conditions. The increasing demands placed on pathology information systems in the context of wider developmental change in healthcare delivery are explored in this review. General trends in medical informatics are reflected in current priorities for laboratory medicine, including the need for unified electronic records, computerised order entry, data security and recovery, and audit. We conclude that there is a

  18. Good Manufacturing Practices (GMP) / Good Laboratory Practices (GLP) Review and Applicability for Chemical Security Enhancements

    Iveson, Steven W. [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States). International Chemical Security Threat Reduction


    Global chemical security has been enhanced through the determined use and integration of both voluntary and legislated standards. Many popular standards contain components that specifically detail requirements for the security of materials, facilities and other vital assets. In this document we examine the roll of quality management standards and how they affect the security culture within the institutions that adopt these standards in order to conduct business within the international market place. Good manufacturing practices and good laboratory practices are two of a number of quality management systems that have been adopted as law in many nations. These standards are designed to protect the quality of drugs, medicines, foods and analytical test results in order to provide the world-wide consumer with safe and affective products for consumption. These standards provide no established security protocols and yet manage to increase the security of chemicals, materials, facilities and the supply chain via the effective and complete control over the manufacturing, the global supply chains and testing processes. We discuss the means through which these systems enhance security and how nations can further improve these systems with additional regulations that deal specifically with security in the realm of these management systems. We conclude with a discussion of new technologies that may cause disruption within the industries covered by these standards and how these issues might be addressed in order to maintain or increase the level of security within the industries and nations that have adopted these standards.

  19. [Clinical laboratory in the 21st century].

    Kawai, T


    Alvin Toffler has predicted that the "Third Wave" will be a society which be decentralized, diversified and customized, computer-dependent. Medical care and also clinical laboratory will be revolutionalized in a more or less similar direction to that predicted by him. Laboratory physicians and scientists should try to improve laboratory services, particularly establishment of adequate normal values, common expression of various laboratory results, introduction of medical decision making and recommended guideline for laboratory use in primary health care.

  20. Medical and Clinical Laboratory Technologists and Technicians

    ... Projected Employment, 2024 Change, 2014-24 Employment by Industry Percent Numeric SOURCE: U.S. Bureau of Labor Statistics, Employment Projections program Clinical laboratory technologists and technicians ...

  1. 78 FR 6330 - Clinical Laboratory Improvement Advisory Committee (CLIAC)


    ... HUMAN SERVICES Centers for Disease Control and Prevention Clinical Laboratory Improvement Advisory... related to improvement in clinical laboratory quality and laboratory medicine practice and specific... laboratory services; revisions to the standards under which clinical laboratories are regulated; the...

  2. Clinical and Laboratory Diagnosis of Intestinal Tuberculosis

    Xiao-Chun Shi


    Conclusions: ITB is difficult to diagnose even with modern medical techniques due to its nonspecific clinical and laboratory features. At present, combination of clinical, endoscopic, radiological, and pathological features continues to be the key to the diagnosis of ITB.

  3. Automation in the clinical microbiology laboratory.

    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.

  4. Good housekeeping: Safety and order in the scientific laboratory

    Sims, B. H. (Benjamin H.)


    Laboratory safety might not seem, at first, to be very profoundly related to scientific knowledge. Of course safety is a relatively trivial issue in many scientific settings, especially in comparison to the kind of safety concerns found, say, at a construction site or a chemical plant. However, as scientific work has come to involve more exotic chemicals, biological organisms, and forms of radiation, and generally become more industrial in character, safety has become more of a concern. This has occurred alongside a general expansion of government regulation of workplace safety during the 20thc entury, and a recent trend toward extending work lace safety efforts to new kinds of work, including administrative and professional tasks. As a result of these trends, scientists find that they are increasingly being held responsible for following safety regulations in their re{approx}earc

  5. Good clinical practice : Historical background and key aspects

    Otte, Andreas; Maier-Lenz, Herbert; Dierckx, Rudi A.

    Clinical research trials (both academic and industry sponsored) are increasingly playing a role in various medical disciplines, including younger fields of clinical trial interest, such as nuclear medicine research. Knowledge for and compliance with good clinical practice (GCP) is essential for

  6. Good clinical practice: Historical background and key aspects

    Otte, A.; Maier-Lenz, H.; Dierckx, R.A.


    Clinical research trials (both academic and industry sponsored) are increasingly playing a role in various medical disciplines, including younger fields of clinical trial interest, such as nuclear medicine research. Knowledge for and compliance with good clinical practice (GCP) is essential for anyo

  7. Good clinical practice : Historical background and key aspects

    Otte, A; Maier-Lenz, H; Dierckx, RA


    Clinical research trials (both academic and industry sponsored) are increasingly playing a role in various medical disciplines, including younger fields of clinical trial interest, such as nuclear medicine research. Knowledge for and compliance with good clinical practice (GCP) is essential for anyo

  8. Clinical and Laboratory Diagnosis of Intestinal Tuberculosis

    Xiao-Chun Shi; Li-Fan Zhang; Yue-Qiu Zhang; Xiao-Qing Liu; Gui-Jun Fei


    Background:Tuberculosis (TB) remains a worldwide problem.Intestinal TB (ITB) constitutes a major public health problem in developing countries and has been associated with significant morbidity and mortality.The aim of this study was to characterize the clinical,radiological,endoscopic,and pathological features of ITB and to define the strategy for establishing the diagnosis.Methods:A retrospective study (from January 2000 to June 2015) was carried out in Peking Union Medical College Hospital and all hospitalized cases were diagnosed as ITB during the study period were included.The relevant clinical information,laboratory results,microbiological,and radiological investigations were recorded.Results:Of the 85 cases,61 cases (71.8%) were ranged from 20 to 50 years.The ileocecal region was involved in about 83.5% (71/85) of patients.About 41.2% (35/85) of patients had co-existing extra ITB,especially active pulmonary TB.Abdominal pain (82.4%) was the most common presenting symptom followed by weight loss (72.9%) and fever (64.7%).Both T-cell spot of TB test (T-SPOT.TB) and purified protein derivatives (PPD) tests were performed in 26 patients:20 (76.9%) positive T-SPOT.TB and 13 (50.0%) positive PPD were detected,with a statistical significant difference (P =0.046).Twenty cases (23.5%) were histopathology and/or pathogen confirmed TB;27 cases (31.8%) were diagnosed by clinical manifestation consistent with ITB and evidence of active extra ITB;38 cases (44.7%) were diagnosed by good response to diagnostic anti-TB therapy.Conclusions:ITB is difficult to diagnose even with modem medical techniques due to its nonspecific clinical and laboratory features.At present,combination of clinical,endoscopic,radiological,and pathological features continues to be the key to the diagnosis of ITB.

  9. Service quality framework for 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.

  10. Immunosensors in Clinical Laboratory Diagnostics.

    Justino, Celine I L; Duarte, Armando C; Rocha-Santos, Teresa A P


    The application of simple, cost-effective, rapid, and accurate diagnostic technologies for detection and identification of cardiac and cancer biomarkers has been a central point in the clinical area. Biosensors have been recognized as efficient alternatives for the diagnostics of various diseases due to their specificity and potential for application on real samples. The role of nanotechnology in the construction of immunological biosensors, that is, immunosensors, has contributed to the improvement of sensitivity, since they are based in the affinity between antibody and antigen. Other analytes than biomarkers such as hormones, pathogenic bacteria, and virus have also been detected by immunosensors for clinical point-of-care applications. In this chapter, we first introduced the various types of immunosensors and discussed their applications in clinical diagnostics over the recent 6 years, mainly as point-of-care technologies for the determination of cardiac and cancer biomarkers, hormones, pathogenic bacteria, and virus. The future perspectives of these devices in the field of clinical diagnostics are also evaluated.

  11. Error tracking in a clinical biochemistry laboratory

    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...

  12. Observations on the 1996 clinical laboratory conferences.

    Kisner, H J


    The author reviews five trends in the laboratory and diagnostic industries. The five trends are: consolidation of both the diagnostic companies and clinical laboratories (hospital and commercial); pressure to cut costs; robotics; implication of new technology; and the pressure to cut costs by transitioning certain tasks to nontechnical personnel while dealing with an abundant labor supply.

  13. Risk Management in the Clinical Laboratory

    Njoroge, Sarah W


    Clinical laboratory tests play an integral role in medical decision-making and as such must be reliable and accurate. Unfortunately, no laboratory tests or devices are foolproof and errors can occur at pre-analytical, analytical and post-analytical phases of testing. Evaluating possible conditions that could lead to errors and outlining the necessary steps to detect and prevent errors before they cause patient harm is therefore an important part of laboratory testing. This can be achieved through the practice of risk management. EP23-A is a new guideline from the CLSI that introduces risk management principles to the clinical laboratory. This guideline borrows concepts from the manufacturing industry and encourages laboratories to develop risk management plans that address the specific risks inherent to each lab. Once the risks have been identified, the laboratory must implement control processes and continuously monitor and modify them to make certain that risk is maintained at a clinically acceptable level. This review summarizes the principles of risk management in the clinical laboratory and describes various quality control activities employed by the laboratory to achieve the goal of reporting valid, accurate and reliable test results. PMID:24982831

  14. Decision support for clinical laboratory capacity planning.

    van Merode, G G; Hasman, A; Derks, J; Goldschmidt, H M; Schoenmaker, B; Oosten, M


    The design of a decision support system for capacity planning in clinical laboratories is discussed. The DSS supports decisions concerning the following questions: how should the laboratory be divided into job shops (departments/sections), how should staff be assigned to workstations and how should samples be assigned to workstations for testing. The decision support system contains modules for supporting decisions at the overall laboratory level (concerning the division of the laboratory into job shops) and for supporting decisions at the job shop level (assignment of staff to workstations and sample scheduling). Experiments with these modules are described showing both the functionality and the validity.

  15. Miniaturization and globalization of clinical laboratory activities.

    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.

  16. Capillary electrophoresis and the clinical laboratory.

    Jabeen, Rukhsana; Payne, Deborah; Wiktorowicz, John; Mohammad, Amin; Petersen, John


    Over the past 15 years, CE as an analytical tool has shown great promise in replacing many conventional clinical laboratory methods, such as electrophoresis and HPLC. CE's appeal was that it was fast, used very small amounts of sample and reagents, was extremely versatile, and was able to separate large and small analytes, whether neutral or charged. Because of this versatility, numerous methods have been developed for analytes that are of clinical interest. Other than molecular diagnostic and forensic laboratories CE has not been able to make a major impact in the United States. In contrast, in Europe and Japan an increasing number of clinical laboratories are using CE. Now that automated multicapillary instruments are commercially available along with cost-effective test kits, CE may yet be accepted as an instrument that will be routinely used in the clinical laboratories. This review will focus on areas where CE has the potential to have the greatest impact on the clinical laboratory. These include analyses of proteins found in serum and urine, hemoglobin (A1c and variants), carbohydrate-deficient transferrin, forensic and therapeutic drug screening, and molecular diagnostics.

  17. Point-Counterpoint: Consolidated Clinical Microbiology Laboratories


    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. PMID:25253793

  18. Total quality management in clinical virology laboratories.

    Tibbets, M W; Gomez, R; Kannangai, R; Sridharan, G


    The diagnostic laboratories in India are progressively promoting higher standards and are moving towards accreditation and international acceptance. Hence, the concept of "Quality" will need to be understood and implemented. Total quality management (TQM) in a laboratory is an integrated program involving all laboratory staff and management. TQM is a framework to operate and it is aiming for integration, consistency, increase in efficiency and a continuous drive for improvement. A well structured clinical virology service will include serology setup, cell culture facility and capacity for molecular diagnosis. The quality of results from the laboratory is significantly influenced by many pre-analytical and post-analytical factors which needed attention. The end goal of the TQM should be to provide the best care possible for the patient.


    Marga GRĂDILĂ


    Full Text Available The paper presents data demonstrating the functionality of biological systems reconstituted with aquatic organisms developed under Good Laboratory Practice testing facility within Research - Development Institute for Plant Protection Bucharest for environmental risk assessment of four fungicides based on copper, according to Good Laboratory Practice requirements. For risk assessment, according to GLP were made the following steps: Good Laboratory Practice test facility was established, we have ensured adequate space for growth, acclimatization and testing for each test species, it was installed a complex water production instalation needed to perform tests, it was achieved control system for checking environmental conditions and have developed specific operating procedures that have been accredited according to Good Laboratory Practice.The results showed that biological systems model of the Good Laboratory Practice test facility in Research - Development Institute for Plant Protection meet the requirements of Organisation for Economic Co-operation and Development Guidelines regarding GLP, and after testing copper-based fungicides in terms of acute toxicity Cyprinus carpio and to Daphnia magna revealed that three of them (copper oxychloride, copper hydroxide and copper sulphate showed ecological efficiency, ie low toxicity. Metallic copper based fungicides showed a higher toxicity, resulting in fish toxicity symptoms: sleep, sudden immersion, faded, weakness, swimming in spiral, lack of balance, breathing slow and cumbersome, spasms and mortality.

  20. [Undergraduate teaching project on clinical laboratory medicine].

    Kayaba, Hiroyuki


    Undergraduate teaching in clinical laboratory medicine is at the center of contemporary medical education. Students are expected to learn advanced laboratory medicine and basic diagnostic skills such as blood sampling, peripheral blood cell counting, blood typing, cross match test, urinalysis, electrocardiography, and bacteriological examinations through their training program. In our department, we have compulsory lectures, a basic practical training course and an advanced training course for the medical students. The compulsory lectures are programmed for the students in the fourth grade to obtain basic knowledge of clinical laboratory medicine and the patho-physiology of diseases. The teaching staff makes every effort to make their lectures exciting and interesting. As we experienced as medical students in the past, boring lectures give students nothing but a nap. For every senior teaching staff in our school, it is obligatory to be evaluated on their lectures by the students and other teaching staff every year to improve their teaching skills and materials. Teaching materials utilizing personal computers and the Internet are becoming more and more important. The basic practical training course is for the students in the fifth grade. The laboratory technicians help us teach students basic diagnostic skills in this program. The students in the advanced training course have to attend morning conferences in the department, including reverse clinico-pathological conferences and laboratory investigations. The reversed clinico-pathological conferences are popular among the students. Through our training programs, we hope that the students raise many questions that they solve themselves in the future, as well as learning established clinical laboratory medicine.

  1. Pediatric echocardiography laboratory organization and clinical productivity.

    Lai, Wyman W; Srivastava, Shubhika; Cohen, Meryl S; Frommelt, Peter C; Allada, Vivek


    The American Society of Echocardiography's Committee on Pediatric Echocardiography Laboratory Productivity (C-PELP) was formed to study the organizational and productivity issues particular to academic pediatric echocardiography laboratories. After much deliberation, the committee chose studies per physician full-time equivalent per day --the average number of studies interpreted per day by a full-time echocardiography physician dedicated to the laboratory -as the primary measure of physician productivity. A survey was sent to 74 North American pediatric echocardiography laboratory directors. The aims of the survey were to (1) determine the annual laboratory volume and types of echocardiographic studies performed, (2) define the average number of studies performed by a pediatric cardiac sonographer in a year, (3) assess the productivity of echocardiography physicians, and (4) identify factors (programmatic or laboratory related) that affect clinical productivity. There were 54 responses to the C-PELP 2011 survey. The average number of studies per physician full-time equivalent per day was 15.0 + 4.5 (median, 13.8; range, 6.2 -27.1), and the average number of studies performed per year by a sonographer was 1,297 + 326 (median, 1,279; range 717 -2,475). These figures were not adjusted for case complexity, time requirement for transesophageal echocardiography, level of expertise, or availability of sonographer assistance. Moreover, the issues of study quality and accuracy were not addressed. The C-PELP 2011 survey gathered important information on the current organization and staffing of academic pediatric echocardiography laboratories, but the committee did not attempt to craft guidelines or recommendations on staffing requirements. The results of the survey, however, should provide a framework for additional investigation into the optimal structure and staffing of pediatric echocardiography laboratories. Copyright © 2013 American Society of Echocardiography

  2. Antiphospholipid syndrome: a clinical and laboratorial challenge

    Luci Maria Santana Dusse


    Full Text Available Antiphospholipid syndrome (APS is an acquired autoimmune thrombophilia characterized by the presence of a heterogeneous family of antibodies that bind to plasma proteins with affinity for phospholipid surfaces. The two major protein targets of antiphospholipid antibodies are prothrombin and β2-glycoprotein I (β2GPI. APS leads to aprothrombotic state, and it is characterized by the occurrence of arterial, venous or microvascular thrombosis or recurrent fetal loss. The diagnosis of APS is based on a set of clinical criteria and the detection of lupus anticoagulant (LA, anticardiolipin antibodies (ACA or anti-β2GPI in plasma. Although laboratory tests are essential for APS diagnosis, these tests have limitations associated with the robustness, reproducibility and standardization. The standardization of diagnostic tests for detection of APLAs has been a challenge and a variety of results have been obtained using different commercial kits and in-house techniques. An increased sensitivity of the ELISA kits for detection of ACA effectively has contributed to APS diagnosis. However, the lack of specificity associated with a high number of false-positive results is a clinical and laboratorial challenge, since such results may lead to mistaken clinical decisions, such as prescription of oral anticoagulant, leading to the risk of hemorrhaging. Furthermore, clinicians are often unfamiliar with these tests and have difficulty interpreting them, requiring interaction between clinical and laboratory professionals in order to ensure their correct interpretation.

  3. Polycystic ovary syndrome: clinical and laboratory evaluation

    Marcos Yorghi Khoury; Edmund Chada Baracat; Dolores Perovano Pardini; Mauro Abi Haidar; Eduardo Leme Alves da Motta; Geraldo Rodrigues de Lima


    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 testoster...

  4. Understanding the interface between clinical and laboratory staff

    Ankie van den Broek


    Full Text Available Background: The interface between clinicians and laboratory staff is where the two meet and work together to provide quality care to their clients (patients. Effectiveness of the interface depends on the way the two groups of professionals relate to and communicate with each other. The number and type of tests requested and the use of the test results for clinical decision making can be influenced by the interface between clinicians and laboratory staff. A model to understand the factors and dynamics around the interface is lacking.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. Normal 0 21 false false false NL X-NONE X-NONE

  5. Thai clinical laboratory responsible to economic crisis.

    Sirisali, K; Vattanaviboon, P; Manochiopinij, S; Ananskulwat, W


    Nowadays, Thailand encounters a serious economic crisis. A clear consensus has been made that a cost-saving system must be the important tool. Both private and government organizations are engaged in this situation. We studied the cost-saving in the clinical laboratory. A questionnaire was distributed to 45 hospital laboratories located in Bangkok. Results showed that efforts to control the cost are the essential policy. There was a variety of factors contributing to the cost-saving process. The usage of public utility, non-recycle material and unnecessary utility were reconsidered. Besides, capital cost (wages and salary) personnel incentive are assessed. Forty three of the 45 respondents had attempted to reduce the cost via curtailing the unnecessary electricity. Eliminating the needless usage of telephone-call. water and unnecessary material was also an effective strategy. A reduction of 86.9%, 80 % and 80.0% of the mentioned factors respectively, was reported. An inventory system of the reagent, chemical and supplies was focused. Most of the laboratories have a policy on cost-saving by decreased the storage. Twenty eight of the 45 laboratories considered to purchase the cheaper with similar quality reagents instead. And some one would purchase a bulky pack when it is the best bargain. A specific system "contact reagent with a free rent instrument" has been used widely (33.3%). Finally, a new personnel management system has been chosen. Workload has rearranged and unnecessary extra-hour work was abandoned.

  6. Molecular virology in the clinical laboratory.

    Josko, Deborah


    As one can see by the tests listed at, molecular diagnostic techniques have enabled the laboratory professionals to play an integral role in the identification and quantitation of viral infectious agents. Viral loads can be determined for HIV, HBV, and HCV using a variety of molecular methods such as real-time PCR, TMA, NASBA, and bDNA. Determining the amount of viral particles in a sample can not only monitor the status and progression of the disease, but can also guide recommendations for antiviral therapy. Other assays listed include cytomegalovirus, enterovirus, and human metapneumovirus detection, HPV testing, influenza and respiratory virus panels, and West Nile virus detection in blood donations using a variety of molecular methodologies. The use of molecular methodologies in the detection of viral pathogens has grown at an astounding rate, especially in the past two decades. It is now widely accepted that PCR is the "gold standard" for nucleic acid detection in the clinical laboratory as well as in research facilities. This article only touched on some of the common, widely used assays and platforms used in the identification process. With more and more assays being developed, the cost behind molecular testing has decreased since there are more competitors on the market. At one point, laboratorians may have thought of routine molecular testing as the wave of the future. It is obvious the future is upon us. Molecular diagnostics has become part of the daily, routine workload in most clinical laboratories. The advent of fully automated systems with faster turn around times has given laboratory professionals the tools necessary to report out accurate and sensitive results to clinicians who can ultimately improve patient care and outcomes by rendering a correct and rapid diagnosis.

  7. [Excessive spending by misuse of clinical laboratory].

    Benítez-Arvizu, Gamaliel; Novelo-Garza, Bárbara; Mendoza-Valdez, Antonia Lorena; Galván-Cervantes, Jorge; Morales-Rojas, Alejandro


    Seventy five percent or more of a diagnosis comes from a proper medical history along with an excellent physical examination. This leaves to the clinical laboratory the function of supporting the findings, determining prognosis, classifying the diseases, monitoring the diseases and, in the minimum of cases, establishing the diagnosis. In recent years there has been a global phenomenon in which the allocation of resources to health care has grown in an excessive way; the Instituto Mexicano del Seguro Social is not an exception with an increase of 29 % from 2009 to 2011; therefore, it is necessary to set containment and reduction without compromising the quality of patient care.

  8. Hidden sources of mercury in clinical laboratories.

    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.

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

    ZHYLA M.I.


    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.

  10. Polycystic ovary syndrome: clinical and laboratory evaluation

    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.

  11. Clinical and laboratory features of preleukemia patients

    施均; 邵宗鸿; 陈桂彬; 李克; 刘鸿; 张益枝; 和虹; 赵明峰; 何广胜; 张泓; 储榆林; 郝玉书


    Objective To explore prospective diagnostic criteria for preleukemia.Methods A case control study was done comparing the discrepancies on clinical and laboratory features between patients with preleukemia and those with chronic aplastic anemia (CAA) or atypical paroxysmal nocturnal hemoglubinuria (a-PNH).Results There were eight variables of significance: (1) lymphocytoid micromegakaryocytes in the bone marrow; (2) immature granulocytes in the peripheral blood; (3) ≥2.0% myeloblasts in the bone marrow; (4) positive periodic acid schiff (PAS) stained nucleated erythrocytes; (5) myeloid differentiation index ≥1.8; (6) typical colonal karyotypic abnormalities; (7) negative sister chromatid differentiation; (8) cluster/colony ratio of granulocyte-macrophage colony-forming units (CFU-GM)>4.0. The following criteria were assigned: A: to meet variable one and at least two of the other seven variables and B: to meet at least four of the eight variables. All of the patients with preleukemia met either A or B and none of the patients with CAA or a-PNH did. Conclusions Preleukemia is different from CAA or a-PNH. It has its own clinical and laboratory features, which may be useful for its prospective diagnosis.

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

    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.

  13. Good Clinical Practice Guidance and Pragmatic Clinical Trials: Balancing the Best of Both Worlds.

    Mentz, Robert J; Hernandez, Adrian F; Berdan, Lisa G; Rorick, Tyrus; O'Brien, Emily C; Ibarra, Jenny C; Curtis, Lesley H; Peterson, Eric D


    Randomized, clinical trials are commonly regarded as the highest level of evidence to support clinical decisions. Good Clinical Practice guidelines have been constructed to provide an ethical and scientific quality standard for trials that involve human subjects in a manner aligned with the Declaration of Helsinki. Originally designed to provide a unified standard of trial data to support submission to regulatory authorities, the principles may also be applied to other studies of human subjects. Although the application of Good Clinical Practice principles generally led to improvements in the quality and consistency of trial operations, these principles have also contributed to increasing trial complexity and costs. Alternatively, the growing availability of electronic health record data has facilitated the possibility for streamlined pragmatic clinical trials. The central tenets of Good Clinical Practice and pragmatic clinical trials represent potential tensions in trial design (stringent quality and highly efficient operations). In the present article, we highlight potential areas of discordance between Good Clinical Practice guidelines and the principles of pragmatic clinical trials and suggest strategies to streamline study conduct in an ethical manner to optimally perform clinical trials in the electronic age.

  14. Supply chain management in the clinical laboratory.

    McHugh, Thomas M


    Between 15 and 45 percent of a clinical laboratory's operating budget is spent on supplies. Given the size of this expenditure, laboratory managers must pay close attention to the supply chain and develop effective strategies to manage their inventory. Areas that need analysis include the carrying cost of supplies, the cost to generate a purchase order, methods to efficiently count supplies on hand, processes to ensure that lot number items are used before their expiration, and detailed analysis of the inventory. At the University of California-San Francisco Medical Center, we investigated options to manage our inventory and implemented a computerized system. The system required modifications to existing practices, which initially seemed unwieldy. However, after a relatively short learning curve, the improvement to operations has been significant, with a reduction in wasted reagents, fewer staff hours used to count supplies, and the ability to provide prompt analysis of the inventory for audits and discussions with administration. Focusing on the supply chain has allowed us to reduce inventory expenses by approximately 8 percent, reduce waste, given us a more focused understanding of our operations, and provided us with the ability to analyze our inventory easily.

  15. Near-drowning and clinical laboratory changes.

    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.

  16. Bringing ayahuasca to the clinical research laboratory.

    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.

  17. A Good Death? Report of the Second Newcastle Meeting on Laboratory Animal Euthanasia

    Hawkins, Penny; Prescott, Mark J.; Carbone, Larry; Dennison, Ngaire; Johnson, Craig; Makowska, I. Joanna; Marquardt, Nicole; Readman, Gareth; Weary, Daniel M.; Golledge, Huw D. R.


    Simple Summary Millions of laboratory animals are killed each year worldwide. However, there is a lack of consensus regarding what methods of killing are humane for many species and stages of development. This report summarises research findings and discussions from an international meeting of experts and stakeholders, with recommendations to inform good practice for humane killing of mice, rats and zebrafish. It provides additional guidance and perspectives for researchers designing projects that involve euthanasing animals, researchers studying aspects of humane killing, euthanasia device manufacturers, regulators, and institutional ethics or animal care and use committees that wish to review local practice. Abstract Millions of laboratory animals are killed each year worldwide. There is an ethical, and in many countries also a legal, imperative to ensure those deaths cause minimal suffering. However, there is a lack of consensus regarding what methods of killing are humane for many species and stages of development. In 2013, an international group of researchers and stakeholders met at Newcastle University, United Kingdom to discuss the latest research and which methods could currently be considered most humane for the most commonly used laboratory species (mice, rats and zebrafish). They also discussed factors to consider when making decisions about appropriate techniques for particular species and projects, and priorities for further research. This report summarises the research findings and discussions, with recommendations to help inform good practice for humane killing. PMID:27563926

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

    Brian H Shirts; Jackson, Brian R.; Baird, Geoffrey S.; Baron, Jason M.; Bryan Clements; Ricky Grisson; Ronald George Hauser; Taylor, Julie R.; Enrique Terrazas; Brad Brimhall


    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 laborator...

  19. 76 FR 5379 - Clinical Laboratory Improvement Advisory Committee (CLIAC)


    ... HUMAN SERVICES Centers for Disease Control and Prevention Clinical Laboratory Improvement Advisory..., revisions to the standards under which clinical laboratories are regulated; the impact on medical and laboratory practice of proposed revisions to the standards; and the modification of the standards...

  20. Computer validation in toxicology: historical review for FDA and EPA good laboratory practice.

    Brodish, D L


    The application of computer validation principles to Good Laboratory Practice is a fairly recent phenomenon. As automated data collection systems have become more common in toxicology facilities, the U.S. Food and Drug Administration and the U.S. Environmental Protection Agency have begun to focus inspections in this area. This historical review documents the development of regulatory guidance on computer validation in toxicology over the past several decades. An overview of the components of a computer life cycle is presented, including the development of systems descriptions, validation plans, validation testing, system maintenance, SOPs, change control, security considerations, and system retirement. Examples are provided for implementation of computer validation principles on laboratory computer systems in a toxicology facility.

  1. A Good Death? Report of the Second Newcastle Meeting on Laboratory Animal Euthanasia

    Penny Hawkins


    Full Text Available Millions of laboratory animals are killed each year worldwide. There is an ethical, and in many countries also a legal, imperative to ensure those deaths cause minimal suffering. However, there is a lack of consensus regarding what methods of killing are humane for many species and stages of development. In 2013, an international group of researchers and stakeholders met at Newcastle University, United Kingdom to discuss the latest research and which methods could currently be considered most humane for the most commonly used laboratory species (mice, rats and zebrafish. They also discussed factors to consider when making decisions about appropriate techniques for particular species and projects, and priorities for further research. This report summarises the research findings and discussions, with recommendations to help inform good practice for humane killing.

  2. Student perceptions of the clinical laboratory science profession.

    McClure, Karen


    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

  3. Correlation between the limit values of laboratory and clinical mycotoxicosis

    Stojanov Igor M.


    Full Text Available Analysis of feed for the presence of fungi and mycotoxins is a request necessary to meet in order to ensure a healthy and economical production in livestock. These tests are related to legal regulation which prescribes the maximum legislated content (MLC, both for the presence of mycotoxins and the total number of fungi in certain feeds. Health problems that can occur during the production of animals are sometimes caused by the presence of mycotoxins in the feed. Laboratory testing is a good practice to confirm a suspicion, and allows timely treatment of contaminated feed. Potential problems arise under circumstances when there is a clinical outcome of mycotoxicosis and animal and laboratory findings suggest that the obtained values are below the level that is within the MLC. For these reasons, the subject of our research was to investigate the occurrence of mycotoxins and mold in feed, as well as the clinical presentation for animals that were fed with the feed with allowed values of these agents according to the recommended levels. The aim of this paper was to highlight the problems associated with clinical correlation of sick animals and laboratory findings, and suggest their overcoming. In the period of one year, a total of 176 samples of feed (complete mixture for broilers, corn and soy products were examined for the presence of fungi, 106 samples were examined for the presence of mycotoxins and 26 flocks of broilers and turkeys were clinically observed. Standard methods were used for isolation of molds and the ELISA test was used for the detection of mycotoxins. Clinical and pathomorphological observation of the flocks was done to determine the natural indicators of production. Studies indicated a problem because clinical and pathomorphological findings in some cases were not correlated with laboratory findings of molds and mycotoxins in the feed, and in some cases it did not necessarily mean that the animals were healthy. Synergism and

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

    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.

  5. The importance of Good Clinical Practice guidelines and its role in clinical trials.

    Vijayananthan, A; Nawawi, O


    Good Clinical Practice (GCP) is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials. It also serves to protect the rights, integrity and confidentiality of trial subjects. It is very important to understand the background of the formation of the ICH-GCP guidelines as this, in itself, explains the reasons and the need for doing so. In this paper, we address the historical background and the events that led up to the formation of these guidelines. Today, the ICH-GCP guidelines are used in clinical trials throughout the globe with the main aim of protecting and preserving human rights.

  6. Clinical and laboratory features of hepatocellular carcinoma

    Andrés Cárdenas


    Full Text Available

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

    Clinical Manifestations

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

    Physical Exam

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

  7. "Good samples make good assays" – the problem of sourcing clinical samples for a standardization project.

    Van Houcke, Sofie K; Thienpont, Linda M


    Clinical samples are the cornerstone in all aspects related to in vitro diagnostic testing. They are particularly valuable in the process of establishing/validating metrological traceability, because they eliminate commutability issues potentially associated with artificial calibrators. Therefore, they are essential for IFCC standardization projects. However, sourcing clinical specimens is particularly challenging. It mostly turns out that only dedicated supply sources can accommodate the varying specifications within reasonable timelines. Here we describe the torturous experience in this regard of the IFCC Working Group for Standardization of Thyroid Function tests (since transformed into a Committee). We always focused on obtaining high quality samples in sufficient volume to serve all project participants. We applied a step-up approach: in phase I, we used high volume (200 mL of plasma/serum) single donations from apparently healthy individuals, and switched in phase II and III to medium-sized volume clinical samples (15 – 30 mL) from well-defined patient categories. In the first two phases we observed for some assays a sample-related discrepant analytical performance for total/free triiodothyronine and thyroid stimulating hormone (TSH), whereas in phase III we faced a severe delay in obtaining the relevant panels for free thyroxine (FT4) and TSH (n = 90 and n = 100, respectively). Additional experiments only allowed us to exclude hypothesized causes of the observations. We believe that there would be merit in a collaborative effort by chairholders of similar projects to establish a sample procurement infrastructure based on a solid relationship with commercial supply sources with the support of a significant number of committed clinicians.

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

    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.

  9. 42 CFR 414.510 - Laboratory date of service for clinical laboratory and pathology specimens.


    ... 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:...

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

    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.

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

    Akyar, Işin


    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.

  12. Clinical and laboratory characteristics of neonatal hypocalcemia

    Cho, Won Im; Yu, Hyeoh Won; Chung, Hye Rim; Shin, Choong Ho; Yang, Sei Won; Choi, Chang Won; Kim, Beyong Il


    To describe the clinical characteristics of full-term neonates with hypocalcemia and to suggest factors associated with neonatal hypocalcemia The medical records of full-term neonates with hypocalcemia were reviewed...

  13. If You Don't Have a Good Laboratory, Find a Good Volcano: Mount Vesuvius as a Natural Chemical Laboratory in Eighteenth-Century Italy.

    Guerra, Corinna


    This essay that examines the role of the volcano as a chemical site in the late eighteenth century, as the "new chemistry" spread throughout the southern Italian Kingdom of Naples, resulting in lively debates. In Naples itself, these scientific debates were not confined to academies, courts, and urban spaces. In the absence of well-equipped chemical laboratories, Neapolitan scholars also carried out research on chemistry on the slopes of Mount Vesuvius, a natural site that furnished them with all the tools and substances necessary for practising chemistry. By examining various Neapolitan publications on Vesuvius and the chemical reactions and products associated with its periodic eruptions, I argue that the volcano's presence contributed to a distinctive, local approach to chemical theory and practice. Several case studies examine the ways in which proximity to Vesuvius was exploited by Neapolitan scholars as they engaged with the new chemistry, including Giuseppe Vairo, Michele Ferrara, Francesco Semmola, and Emanuele Scotti.

  14. Quantifying the clinical relevance of a laboratory observer performance paradigm.

    Chakraborty, D P; Haygood, T M; Ryan, J; Marom, E M; Evanoff, M; McEntee, M F; Brennan, P C


    Laboratory observer performance measurements, receiver operating characteristic (ROC) and free-response ROC (FROC) differ from actual clinical interpretations in several respects, which could compromise their clinical relevance. The objective of this study was to develop a method for quantifying the clinical relevance of a laboratory paradigm and apply it to compare the ROC and FROC paradigms in a nodule detection task. The original prospective interpretations of 80 digital chest radiographs were classified by the truth panel as correct (C=1) or incorrect (C=0), depending on correlation with additional imaging, and the average of C was interpreted as the clinical figure of merit. FROC data were acquired for 21 radiologists and ROC data were inferred using the highest ratings. The areas under the ROC and alternative FROC curves were used as laboratory figures of merit. Bootstrap analysis was conducted to estimate conventional agreement measures between laboratory and clinical figures of merit. Also computed was a pseudovalue-based image-level correctness measure of the laboratory interpretations, whose association with C as measured by the area (rAUC) under an appropriately defined relevance ROC curve, is as a measure of the clinical relevance of a laboratory paradigm. Low correlations (e.g. κ=0.244) and near chance level rAUC values (e.g. 0.598), attributable to differences between the clinical and laboratory paradigms, were observed. The absolute width of the confidence interval was 0.38 for the interparadigm differences of the conventional measures and 0.14 for the difference of the rAUCs. The rAUC measure was consistent with the traditional measures but was more sensitive to the differences in clinical relevance. A new relevance ROC method for quantifying the clinical relevance of a laboratory paradigm is proposed.

  15. 75 FR 14448 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...


    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practices; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. SUMMARY: The Food and Drug Administration (FDA) Los...

  16. Mentoring for retention and advancement in the multigenerational clinical laboratory.

    Laudicina, R J


    Retention of recent graduates and other laboratory practitioners in the workplace will play a key role in addressing current and projected shortages of clinical laboratory scientists (CLS) and technicians (CLT). In addition, with overrepresentation of the aging Baby Boomer generation in laboratory supervisory and management positions, it is crucial not only to retain younger practitioners, but to prepare them for assuming these important functions in the future. Mentoring, a practice commonly employed in other professions, is widely considered to be useful in employee retention and career advancement. Mentoring has probably been used in the clinical laboratory profession, but has not been well documented. In the clinical laboratory environment, potential mentors are in the Veteran and Baby Boomer generations, and new practitioners who could benefit from mentoring are in Generation X. Generational differences among these groups may present challenges to the use of mentoring. This article will attempt to provide a better understanding of generational differences and show how mentoring can be applied in the setting of the clinical laboratory in order to increase retention and promote career advancement of younger practitioners. A panel of five laboratory managers provided examples of mentoring strategies. Definitions, benefits, and examples of mentoring are addressed in the accompanying article, "Passing the Torch: Mentoring the Next Generation of Laboratory Professionals".

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


    Dec 14, 2013 ... clinical and laboratory procedures, including general characteristics of women, indications and outcome, complications, ... that has to provide for supportive therapies, rehabilitation ... completed until the samples are analyzed in the laboratory ... involves the use of aspiration needles set made up of gauge.

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

    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.

  19. Evaluation of Analytical Errors in a Clinical Chemistry Laboratory: A ...

    Evaluation of Analytical Errors in a Clinical Chemistry. Laboratory: A 3 Year ... The number of tests reduced significantly over the 3‑year period, but this did not correspond .... 11 number of errors they classified under the analytical errors,.

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

    Tazawa, Hiromitsu


    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.

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

    shahram Khademvatan


    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.

  2. Integrated data acquisition system for medical device testing and physiology research in compliance with good laboratory practices.

    Koenig, Steven C; Woolard, Cary; Drew, Guy; Unger, Lauren; Gillars, Kevin; Ewert, Dan; Gray, Laman; Pantalos, George


    In seeking approval from the US Food and Drug Administration (FDA) for clinical trial evaluation of an experimental medical device, a sponsor is required to submit experimental findings and support documentation to demonstrate device safety and efficacy that are in compliance with Good Laboratory Practices (GLP). The objective of this project was to develop an integrated data acquisition (DAQ) system and documentation strategy for monitoring and recording physiological data when testing medical devices in accordance with GLP guidelines mandated by the FDA. Data aquisition systems were developed as stand-alone instrumentation racks containing transducer amplifiers and signal processors, analog-to-digital converters for data storage, visual display and graphical user-interfaces, power conditioners, and test measurement devices. Engineering standard operating procedures (SOP) were developed to provide a written step-by-step process for calibrating, validating, and certifying each individual instrumentation unit and the integrated DAQ system. Engineering staff received GLP and SOP training and then completed the calibration, validation, and certification process for the individual instrumentation components and integrated DAQ system. Eight integrated DAQ systems have been successfully developed that were inspected by regulatory affairs consultants and determined to meet GLP guidelines. Two of these DAQ systems were used to support 40 of the pre-clinical animal studies evaluating the AbiCor artificial heart (ABIOMED, Danvers, MA). Based in part on these pre-clinical animal data, the AbioCor clinical trials began in July 2001. The process of developing integrated DAQ systems, SOP, and the validation and certification methods used to ensure GLP compliance are presented in this article.

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

    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.

  4. Treatment intensification in a hypertension telemanagement trial: clinical inertia or good clinical judgment?

    Crowley, Matthew J; Smith, Valerie A; Olsen, Maren K; Danus, Susanne; Oddone, Eugene Z; Bosworth, Hayden B; Powers, Benjamin J


    Clinical inertia represents a barrier to hypertension management. As part of a hypertension telemanagement trial designed to overcome clinical inertia, we evaluated study physician reactions to elevated home blood pressures. We studied 296 patients from the Hypertension Intervention Nurse Telemedicine Study who received telemonitoring and study physician medication management. When a patient's 2-week mean home blood pressure was elevated, an "intervention alert" prompted study physicians to consider treatment intensification. We examined treatment intensification rates and subsequent blood pressure control. Patients generated 1216 intervention alerts during the 18-month intervention. Of 922 eligible intervention alerts, study physicians intensified treatment in 374 (40.6%). Study physician perception that home blood pressure was acceptable was the most common rationale for nonintensification (53.7%). When "blood pressure acceptable" was the reason for not intensifying treatment, the mean blood pressure was lower than for intervention alerts where treatment intensification occurred (135.3/76.7 versus 143.2/80.6 mm Hg; PBlood pressure acceptable intervention alerts were associated with the lowest incidence of repeat alerts (hazard ratio: 0.69 [95% CI: 0.58 to 0.83]), meaning that the patient home blood pressure was less likely to subsequently rise above goal, despite apparent clinical inertia. This telemedicine intervention targeting clinical inertia did not guarantee treatment intensification in response to elevated home blood pressures. However, when physicians did not intensify treatment, it was because blood pressure was closer to an acceptable threshold, and repeat blood pressure elevations occurred less frequently. Failure to intensify treatment when home blood pressure is elevated may, at times, represent good clinical judgment, not clinical inertia.

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

    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.

  6. Clinical laboratory technologist professional development in Camagüey

    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.

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

    Matsuo, Shuji


    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.

  8. Antiphospholipid antibody: laboratory, pathogenesis and clinical manifestations

    T. Ziglioli


    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.

  9. 1.2.Clinical laboratory diagnosis


    930212 Enzymatic analysis of serum total bileacids and clinical evaluation.WEI Youren (魏有仁),et al.Sino—Japan Friendship Hosp,Bei-jing,100029.CHin J Med Lab Technol 1993;16(1):11—14.An enzymatic colorimetric assay of serum to-tal bile acids (TBA) was reported for the firsttime in China.3 α-hydroxysteroid dehydroge-nase (3α-HSD) had been purified from pseu-domonas testosteroni in the sventies,and hadbeen used as a main enzyme reagent in the enzy-matic analysis of TBA.In this paper,the au-thors introduced a rapid,sensitive colorimetricassay using 3α-HSD,and a couple enzyme 5β-steroid Δ~4 dehydrogenase to imcrease the con-

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

    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

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

    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

  12. Establishing a stem cell culture laboratory for clinical trials

    Elíseo Joji Sekiya


    Full Text Available Adult stem/progenitor cells are found in different human tissues. An in vitro cell culture is needed for their isolation or for their expansion when they are not available in a sufficient quantity to regenerate damaged organs and tissues. The level of complexity of these new technologies requires adequate facilities, qualified personnel with experience in cell culture techniques, assessment of quality and clear protocols for cell production. The rules for the implementation of cell therapy centers involve national and international standards of good manufacturing practices. However, such standards are not uniform, reflecting the diversity of technical and scientific development. Here standards from the United States, the European Union and Brazil are analyzed. Moreover, practical solutions encountered for the implementation of a cell therapy center appropriate for the preparation and supply of cultured cells for clinical studies are described. Development stages involved the planning and preparation of the project, the construction of the facility, standardization of laboratory procedures and development of systems to prevent cross contamination. Combining the theoretical knowledge of research centers involved in the study of cells with the practical experience of blood therapy services that manage structures for cell transplantation is presented as the best potential for synergy to meet the demands to implement cell therapy centers.

  13. What makes a good clinical student and teacher? An exploratory study.

    Goldie, John; Dowie, Al; Goldie, Anne; Cotton, Phil; Morrison, Jill


    What makes a good clinical student is an area that has received little coverage in the literature and much of the available literature is based on essays and surveys. It is particularly relevant as recent curricular innovations have resulted in greater student autonomy. We also wished to look in depth at what makes a good clinical teacher. A qualitative approach using individual interviews with educational supervisors and focus groups with senior clinical students was used. Data was analysed using a "framework" technique. Good clinical students were viewed as enthusiastic and motivated. They were considered to be proactive and were noted to be visible in the wards. They are confident, knowledgeable, able to prioritise information, flexible and competent in basic clinical skills by the time of graduation. They are fluent in medical terminology while retaining the ability to communicate effectively and are genuine when interacting with patients. They do not let exam pressure interfere with their performance during their attachments. Good clinical teachers are effective role models. The importance of teachers' non-cognitive characteristics such as inter-personal skills and relationship building was particularly emphasised. To be effective, teachers need to take into account individual differences among students, and the communicative nature of the learning process through which students learn and develop. Good teachers were noted to promote student participation in ward communities of practice. Other members of clinical communities of practice can be effective teachers, mentors and role models. Good clinical students are proactive in their learning; an important quality where students are expected to be active in managing their own learning. Good clinical students share similar characteristics with good clinical teachers. A teacher's enthusiasm and non-cognitive abilities are as important as their cognitive abilities. Student learning in clinical settings is a

  14. Adherence to the Clinical Good Practical Guide of Bronchial Asthma in the Allergy Consultation

    Marisela Pérez Pacaréu; Rafael Zamora Puerta; Magalys Olivares Elegia; Rosa Naranjo Revollido


    Background: Bronchial asthma constitutes a high prevalence disease which gets the 10 % of our milieu. That’s why it is very important to assess its clinical management. The clinical good practice guide constitutes a group of orientations which outline the medical assistance based on what is considered as the best options for treatment and diagnosis. Objective: to determine the adherence of the medical personnel specialized on the clinical good practical guide in the diagnosis and treatment of...

  15. 75 FR 12554 - Clinical Laboratory Improvement Advisory Committee: Notice of Charter Renewal


    ... HUMAN SERVICES Centers for Disease Control and Prevention Clinical Laboratory Improvement Advisory...-463) of October 6, 1972, that the Clinical Laboratory Improvement Advisory Committee, Centers for..., Clinical Laboratory Improvement Advisory Committee, Centers for Disease Control and Prevention,...

  16. Clinical laboratory sciences curriculum redevelopment: an application of change theories.

    Mundt, Lillian; Vanik, Janet


    The Department of Clinical Laboratory Sciences at Rosalind Franklin University of Medicine and Science (RFUMS) experienced a steady decline in the number of applicants for the Clinical Laboratory Sciences (CLS) Program, even though the department regularly received inquiries from qualified students. The faculty recognized the undergraduate-degreed prospects' desires for both an advanced degree and the procurement of entry-level clinical laboratory knowledge and skills. To address this perceived need, the CLS department developed and implemented a new degree option, the entry-level master's. The new curriculum resulted from a transformational process incorporated into the normal developmental process of curriculum change. This article explores various change theories that were manifested during this transformation process, along with barriers to change and how to overcome them. In addition, the authors demonstrate the need for creation of this entry-level program and provide a curriculum outline.

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

    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.

  18. Quality of Control of Clinical-Biochemical Laboratories – Serbian Case

    Vinko Peric


    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.

  19. An error management system in a veterinary clinical laboratory.

    Hooijberg, Emma; Leidinger, Ernst; Freeman, Kathleen P


    Error recording and management is an integral part of a clinical laboratory quality management system. Analysis and review of recorded errors lead to corrective and preventive actions through modification of existing processes and, ultimately, to quality improvement. Laboratory errors can be divided into preanalytical, analytical, and postanalytical errors depending on where in the laboratory cycle the errors occur. The purpose of the current report is to introduce an error management system in use in a veterinary diagnostic laboratory as well as to examine the amount and types of error recorded during the 8-year period from 2003 to 2010. Annual error reports generated during this period by the error recording system were reviewed, and annual error rates were calculated. In addition, errors were divided into preanalytical, analytical, postanalytical, and "other" categories, and their frequency was examined. Data were further compared to that available from human diagnostic laboratories. Finally, sigma metrics were calculated for the various error categories. Annual error rates per total number of samples ranged from 1.3% in 2003 to 0.7% in 2010. Preanalytical errors ranged from 52% to 77%, analytical from 4% to 14%, postanalytical from 9% to 21%, and other error from 6% to 19% of total errors. Sigma metrics ranged from 4.1 to 4.7. All data were comparable to that reported in human clinical laboratories. The incremental annual reduction of error shows that use of an error management system led to quality improvement.

  20. Computerized Examination: Application to the Clinical Biochemistry Laboratory

    Bachmann, Kenneth A.


    Explains a computer exam format used with pharmacy students in a clinical biochemistry laboratory course. Student attitudes were assessed. Students felt that their final grade reflected their comprehension, exam pratical facilitated learning, exam format fostered retention and the questions were appropriate. (GS)

  1. Bioterrorism and the Role of the Clinical Microbiology Laboratory.

    Wagar, Elizabeth


    Regular review of the management of bioterrorism is essential for maintaining readiness for these sporadically occurring events. This review provides an overview of the history of biological disasters and bioterrorism. I also discuss the recent recategorization of tier 1 agents by the U.S. Department of Health and Human Services, the Laboratory Response Network (LRN), and specific training and readiness processes and programs, such as the College of American Pathologists (CAP) Laboratory Preparedness Exercise (LPX). LPX examined the management of cultivable bacterial vaccine and attenuated strains of tier 1 agents or close mimics. In the LPX program, participating laboratories showed improvement in the level of diagnosis required and referral of isolates to an appropriate reference laboratory. Agents which proved difficult to manage in sentinel laboratories included the more fastidious Gram-negative organisms, especially Francisella tularensis and Burkholderia spp. The recent Ebola hemorrhagic fever epidemic provided a check on LRN safety processes. Specific guidelines and recommendations for laboratory safety and risk assessment in the clinical microbiology are explored so that sentinel laboratories can better prepare for the next biological disaster.

  2. 77 FR 49448 - Food and Drug Administration Clinical Trial Requirements, Compliance, and Good Clinical Practice...


    ... interaction with FDA representatives. The program will focus on the relationships among FDA and clinical trial... Pharmaceutical Clinical Trial; (3) Medical Device Aspects of Clinical Research; (4) Adverse Event...

  3. The War on Cancer: Cold Spring Harbor Laboratory Is Fighting the Good Fight.

    Mertz, Leslie


    Located on the north shore of Long Island in New York, Cold Spring Harbor Laboratory (Figure 1) started out with a marine biology emphasis at the end of the 19th century, but it soon established itself as a prominent cancer research facility. That strong emphasis on cancer work continues today as this private, not-for-profit research institution enters its 127th year (Figure 2).

  4. 75 FR 51824 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...


    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. ] SUMMARY: The Food and Drug Administration (FDA) New Jersey...

  5. Sweet syndrome: Clinical and Laboratory Findings of 31 Cases

    Serap Güneş Bilgili


    Full Text Available Background and Design: Sweet syndrome is an inflammatory disease characterized by the abrupt onset of pain, red papules and plaques, fever, neutrophilic leukocytosis, and dermal neutrophilic infiltrate. There are not enough data about Sweet syndrome in Turkey. In this article, we studied clinical, laboratory, histopathological, and epidemiological characteristics of patients, who presented to our clinic, and compared the findings with the literature. Materials and Methods: All patients diagnosed with Sweet syndrome in our clinic between 2005 and 2011 were included in the study. The epidemiological, clinical, and laboratory findings were retrospectively evaluated. Results: A total of 31 patients with Sweet’s syndrome - 24 female (77.4%, 7 male (22.6%; aged 23-82 years – included in the study. The average age of the patients was 48 years. Cutaneous lesions were most frequently localized in the upper extremity. Conjunctivitis was the common systemic manifestation, followed by fever, arthralgia, and myalgia. The most common trigger factor was infections of the upper respiratory tract. In histopathological evaluations of skin biopsies, dense neutrophil infiltration compatible with Sweet syndrome was detected in the dermis. Also, findings of vasculitis were determined in 3 patients. Discussion: The clinical and laboratory findings in our study are mostly similar to those reported in the literature. We found evidence of vasculitis in 10% of cases, therefore, we think the presence of vasculitis does not necessarily rule out the diagnosis of Sweet syndrome

  6. Clinical Mass Spectrometry: Achieving Prominence in Laboratory Medicine

    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

  7. [Perspective for clinical laboratory management and its systematization--effects of the systematization of clinical laboratory management].

    Ito, S


    There are a large number of ideas concerning the systematization of clinical laboratory management. Therefore many types of laboratory systems have been constructed. As our hospital is not large, we adopted a small scale laboratory system. In introducing it, we expected not only an increase in value-added labor productivity by automating laboratory tests, but also an improvement in technologist's cost awareness. Consequently, new system equipment has itself performed the former in many sections, but not the latter. Improvement in cost awareness was caused by the technologist's routine work in managing reagent and material stocks. We found that this soft-type systematization has been more important than the advanced hard-type system.

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

    Kern, Matthias


    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.

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

    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.

  10. Realistic modeling of clinical laboratory operation by computer simulation.

    Vogt, W; Braun, S L; Hanssmann, F; Liebl, F; Berchtold, G; Blaschke, H; Eckert, M; Hoffmann, G E; Klose, S


    An important objective of laboratory management is to adjust the laboratory's capability to the needs of patients' care as well as economy. The consequences of management may be changes in laboratory organization, equipment, or personnel planning. At present only one's individual experience can be used for making such decisions. We have investigated whether the techniques of operations research could be transferred to a clinical laboratory and whether an adequate simulation model of the laboratory could be realized. First we listed and documented the system design and the process flow for each single laboratory request. These input data were linked by the simulation model (programming language SIMSCRIPT II.5). The output data (turnaround times, utilization rates, and analysis of queue length) were validated by comparison with the current performance data obtained by tracking specimen flow. Congruence of the data was excellent (within +/- 4%). In planning experiments we could study the consequences of changes in order entry, staffing, and equipment on turnaround times, utilization, and queue lengths. We conclude that simulation can be a valuable tool for better management decisions.

  11. [Good Practice of Clinical Physiology Examination for Patient Safety with a Team-Based Approach: Quality Practice in Ultrasonographic Examination].

    Asai, Satomi; Miyachi, Hayato


    For the safety of patient care, a team-based approach has been advocated as an effective measure. In clinical physiology examination, we have been making efforts to promote good practice for patient safety based on such an approach in Tokai University Hospital, as represented by quality practice in ultrasonographic examination. The entire process of ultrasonographic examination can be divided into three parts: pre-examination, examination, and post-examination processes. In each process of the examination, specific quality issues must be considered, eventually ensuring the quality and safety of patient care. A laboratory physician is responsible for not only quality assurance of examination, diagnosis, and reporting, but also patient safety. A laboratory physician can play a key role in all aspects of patient safety related to each process of the examination by taking a leadership role in the team-based approach.

  12. Statistical validation of reagent lot change in the clinical chemistry laboratory can confer insights on good clinical laboratory practice.

    Cho, Min-Chul; Kim, So Young; Jeong, Tae-Dong; Lee, Woochang; Chun, Sail; Min, Won-Ki


    Verification of new lot reagent's suitability is necessary to ensure that results for patients' samples are consistent before and after reagent lot changes. A typical procedure is to measure results of some patients' samples along with quality control (QC) materials. In this study, the results of patients' samples and QC materials in reagent lot changes were analysed. In addition, the opinion regarding QC target range adjustment along with reagent lot changes was proposed. Patients' sample and QC material results of 360 reagent lot change events involving 61 analytes and eight instrument platforms were analysed. The between-lot differences for the patients' samples (ΔP) and the QC materials (ΔQC) were tested by Mann-Whitney U tests. The size of the between-lot differences in the QC data was calculated as multiples of standard deviation (SD). The ΔP and ΔQC values only differed significantly in 7.8% of the reagent lot change events. This frequency was not affected by the assay principle or the QC material source. One SD was proposed for the cutoff for maintaining pre-existing target range after reagent lot change. While non-commutable QC material results were infrequent in the present study, our data confirmed that QC materials have limited usefulness when assessing new reagent lots. Also a 1 SD standard for establishing a new QC target range after reagent lot change event was proposed.

  13. Clinical laboratories, the select agent program, and biological surety (biosurety).

    Pastel, Ross H; Demmin, Gretchen; Severson, Grant; Torres-Cruz, Rafael; Trevino, Jorge; Kelly, John; Arrison, Jay; Christman, Joy


    The threat of bioterrorism has led to increased concerns over the availability of biological select agents and toxins (BSAT). Congress has implemented several public laws that have led to the development of federal regulations by the Centers for Disease Control and Prevention (CDC) and the US Department of Agriculture. The CDC regulation 42 CFR 73 has a direct impact on all clinical laboratories that may at some time identify BSAT in a clinical specimen. The Department of Defense has imposed a more stringent layer of regulation called biological surety (biosurety) on top of the requirements of 42 CFR 73 for military laboratories that possess BSAT. However,42 CFR 73 falls into the framework of biosurety. Both sets of regulations have four pillars (safety, physical security, agent account-ability, and personnel reliability) that are built on a foundation of training and covered by a roof of management (operations and plans).

  14. Clinical Laboratory Stressors Used to Study Alcohol–Stress Relationships

    Thomas, Suzanne; Bacon, Amy K.; Sinha, Rajita; Uhart, Magdalena; Adinoff, Bryon


    Understanding the biologic systems that underlie the relationship between stress and alcohol consumption may lead to better prevention efforts and more effective treatments for alcoholism. Clinical laboratory studies offer a unique opportunity to examine these relationships by using a controlled environment to study how an acute stressor affects alcohol drinking and alcohol craving, how individuals in recovery or those at risk for alcoholism may respond differently to stressors relative to co...

  15. Clinical and laboratory characteristics of Achromobacter xylosoxidans infection.


    Achromobacter xylosoxidans was isolated from six patients. The organism causes opportunistic infections in patients who are compromised. A. xylosoxidans is a catalase- and oxidase-positive, motile, gram-negative rod that oxidizes xylose and glucose. The organism exists in a water environment and may be confused with Pseudomonas species. Unlike pseudomonas, achromobacter has peritrichous flagella. The clinical and laboratory characteristics of A. xylosoxidans are presented.

  16. European registration process for Clinical Laboratory Geneticists in genetic healthcare

    Liehr, Thomas; Carreira, Isabel M.; Aktas, Dilek; Bakker, Egbert; Rodr?guez de Alba, Marta; Coviello, Domenico A; Florentin, Lina; Scheffer, Hans; Rincic, Martina


    Tremendous progress in genetics and genomics led to a wide range of healthcare providers, genetic tests, and more patients who can benefit from these developments. To guarantee and improve the quality of genetic testing, a unified European-based registration for individuals qualified in biomedicine was realized. Therefore a Europe-wide recognition of the profession ?European registered Clinical Laboratory Geneticist (ErCLG)' based on a syllabus of core competences was established which allows...

  17. Evaluation of Neonatal Hemolytic Jaundice: Clinical and Laboratory Parameters

    Anet Papazovska Cherepnalkovski; Vjekoslav Krzelj; Beti Zafirovska-Ivanovska; Todor Gruev; Josko Markic; Natasa Aluloska; Nikolina Zdraveska; Katica Piperkovska


    BACKGROUND: Neonatal jaundice that occurs in ABO or Rhesus issoimunisation has been recognized as one of the major risk factors for development of severe hyperbilirubinemia and bilirubin neurotoxicity. AIM: Aim of our study was to investigate clinical and laboratory parameters associated with hemolytic jaundice due to Rh and ABO incompatibility and compare results with the group of unspecific jaundice. MATERIAL AND METHODS: One hundred sixty seven (167) neonatal hyperbilirubinemia cas...

  18. Verification and validation of diagnostic laboratory tests in clinical virology.

    Rabenau, Holger F; Kessler, Harald H; Kortenbusch, Marhild; Steinhorst, Andreas; Raggam, Reinhard B; Berger, Annemarie


    This review summarizes major issues of verification and validation procedures and describes minimum requirements for verification and validation of diagnostic assays in clinical virology including instructions for CE/IVD-labeled as well as for self-developed ("home-brewed") tests or test systems. It covers techniques useful for detection of virus specific antibodies, for detection of viral antigens, for detection of viral nucleic acids, and for isolation of viruses on cell cultures in the routine virology laboratory.

  19. Laboratory evaluation of the Beckman Synchron CX3 clinical chemistry analyzer.

    Peake, M J; Pejakovic, M; White, G H


    In this evaluation of the Beckman Synchron CX3, the multi-analyte clinical chemistry analyzer exhibited high precision, good linearity, and no carryover for each of the eight analytes measured. Results obtained correlated well with those produced by our routine instrumentation (Beckman Astra, Varian atomic absorption spectrophotometer). The instrument can process up to 75 samples per hour (600 tests per hour if all tests available are requested) and, after calibration, can provide urgent results for the complete panel of tests within 2 1/2 min. The performance characteristics of this instrument make it ideal as a routine or a "stat" analyzer for commonly requested tests in the clinical chemistry laboratory.

  20. Good practice guidelines for clinical psychologists working in paediatric cochlear implant teams.

    Bathgate, Fionna; Bennett, Emily; Cropper, Jenny; Edwards, Lindsey; Emond, Alice; Gamble, Caroline; Kentish, Rosie; Samuel, Victoria


    There are relatively few clinical psychologists working in paediatric cochlear implant centres in the UK and in this respect we lag behind other countries such as the USA and The Netherlands. In an effort to promote the added value our profession can offer teams, the clinical psychologists working in paediatric CI centres have put together good practice guidelines. This article outlines the rationale for putting together the guidelines, highlights the unique contribution clinical psychologists can offer, outlines the evidence base for psychological input in this clinical population, and offers a fictional case study for illustration.

  1. Clinical and Laboratory Diagnosis of Dengue Virus Infection.

    Muller, David A; Depelsenaire, Alexandra C I; Young, Paul R


    Infection with any of the 4 dengue virus serotypes results in a diverse range of symptoms, from mild undifferentiated fever to life-threatening hemorrhagic fever and shock. Given that dengue virus infection elicits such a broad range of clinical symptoms, early and accurate laboratory diagnosis is essential for appropriate patient management. Virus detection and serological conversion have been the main targets of diagnostic assessment for many years, however cross-reactivity of antibody responses among the flaviviruses has been a confounding issue in providing a differential diagnosis. Furthermore, there is no single, definitive diagnostic biomarker that is present across the entire period of patient presentation, particularly in those experiencing a secondary dengue infection. Nevertheless, the development and commercialization of point-of-care combination tests capable of detecting markers of infection present during different stages of infection (viral nonstructural protein 1 and immunoglobulin M) has greatly simplified laboratory-based dengue diagnosis. Despite these advances, significant challenges remain in the clinical management of dengue-infected patients, especially in the absence of reliable biomarkers that provide an effective prognostic indicator of severe disease progression. This review briefly summarizes some of the complexities and issues surrounding clinical dengue diagnosis and the laboratory diagnostic options currently available. © The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail:

  2. Clinical and laboratory evaluation of hyperlipemic and hypothyroid patients

    Castro Ana Valéria Barros de


    Full Text Available OBJECTIVE: To determine the frequency of hypothyroidism in a sample of hyperlipemic patients and evaluate clinical and laboratory factors indicative of thyropathy among them. METHODS: Fifty-one hyperlipemic patients, grouped according to an earlier or recent diagnosis of their thyroid function into euthyroid and hypothyroid, were evaluated with clinical and laboratory examinations of blood levels of free T4 and TSH (by radioimmunoassay. Patients were on average 46.8±11.7 years old, predominantly of the female sex (62.5%; 31% had a previous diagnosis of hypothyroidism and were under treatment with thyroxin. RESULTS: Fourteen three percent of patients analyzed had hypothyroidism, which had not been detected before. Differentiating attributes of the groups analyzed were: a predominance of females among the hypothyroid patients and a higher HDL serum concentration among those recently diagnosed. CONCLUSION: In the present study, new cases of hypothyroidism in hyperlipemic patients were a frequent occurrence, yet few clinical and laboratory data except tests evaluating free T4 and TSH in the blood indicated which patients had thyroid dysfunction.

  3. Utilization and utility of clinical laboratory reports with graphical elements

    Brian H Shirts


    Full Text Available Background: Graphical reports that contain charts, images, and tables have potential to convey information more effectively than text-based reports; however, studies have not measured how much clinicians value such features. We sought to identify factors that might influence the utilization of reports with graphical elements postulating that this is a surrogate for relative clinical utility of these graphical elements. Materials and Methods: We implemented a pilot project at ARUP laboratories to develop online enhanced laboratory test reports that contained graphical elements. We monitored on-demand clinician access to reports generated for 48 reportable tests over 22 months. We evaluated utilization of reports with graphical elements by clinicians at all institutions that use ARUP as a reference laboratory using descriptive statistics, regression, and meta-analysis tools to evaluate groups of similar test reports. Results: Median download rate by test was 8.6% with high heterogeneity in download rates between tests. Test reports with additional graphical elements were not necessarily downloaded more often than reports without these elements. Recently implemented tests and tests reporting abnormal results were associated with higher download rates (P < 0.01. Higher volume tests were associated with lower download rates (P = 0.03. Conclusions: In select cases graphical information may be clinically useful, particularly for less frequently ordered tests and in on reports of abnormal results. The utilization data presented could be used as a reference point for other laboratories planning on implementing graphical reporting. However, between-test heterogeneity was high and in many cases graphical elements may add little clinical utility, particularly if these merely reinforce information already contained in text based reports.

  4. Clinical, laboratorial and radiographic predictors of Bordetella pertussis infection

    Camila Vieira Bellettini


    Full Text Available OBJECTIVE: To identify clinical, laboratorial and radiographic predictors for Bordetella pertussis infection.METHODS: This was a retrospective study, which analyzed medical records of all patients submitted to a molecular dignosis (qPCR for B. pertussis from September 2011 to January 2013. Clinical and laboratorial data were reviewed, including information about age, sex, signs/symptoms, length of hospitalization, blood cell counts, imaging findings, coinfection with other respiratory pathogens and clinical outcome.RESULTS: 222 cases were revised. Of these, 72.5% had proven pertussis, and 60.9% were under 1 year old. In patients aging up to six months, independent predictors for B. pertussisinfection were (OR 8.0, CI 95% 1.8-36.3; p=0.007 and lymphocyte count >104/µL (OR 10.0, CI 95% 1.8-54.5; p=0.008. No independent predictors of B. pertussisinfection could be determined for patients older than six months. Co-infection was found in 21.4% of patients, of which 72.7% were up to six months of age. Adenovirus was the most common agent (40.9%. In these patients, we were not able to identify any clinical features to detect patients presenting with a respiratory co-infection, even though longer hospital stay was observed in patients with co-infections (12 vs. 6 days; p=0.009.CONCLUSIONS: Cyanosis and lymphocytosis are independent predictors for pertussis in children up to 6 months old.

  5. Pharmacokinetic studies of neuromuscular blocking agents : Good Clinical Research Practice (GCRP)

    Viby-Mogensen, J; Ostergaard, D; Donati, F; Fisher, D; Hunter, J; Kampmann, JP; Kopman, A; Proost, JH; Rasmussen, SN; Skovgaard, LT; Varin, F; Wright, PMC


    In September 1997, an international consensus conference on standardization of studies of neuromuscular blocking agents was held in Copenhagen, Denmark. Based on the conference, a set of guidelines fur good clinical research practice (GCRT) in pharmacokinetic studies of neuromuscular blocking agents

  6. 77 FR 49449 - Food and Drug Administration Clinical Trial Requirements, Compliance, and Good Clinical Practice...


    ... to facilitate interaction with FDA representatives. The program will focus on the relationships among.... Topics for discussion include the following: (1) What FDA Expects in a Pharmaceutical Clinical Trial;...

  7. European registration process for Clinical Laboratory Geneticists in genetic healthcare.

    Liehr, Thomas; Carreira, Isabel M; Aktas, Dilek; Bakker, Egbert; Rodríguez de Alba, Marta; Coviello, Domenico A; Florentin, Lina; Scheffer, Hans; Rincic, Martina


    Tremendous progress in genetics and genomics led to a wide range of healthcare providers, genetic tests, and more patients who can benefit from these developments. To guarantee and improve the quality of genetic testing, a unified European-based registration for individuals qualified in biomedicine was realized. Therefore a Europe-wide recognition of the profession 'European registered Clinical Laboratory Geneticist (ErCLG)' based on a syllabus of core competences was established which allows for harmonization in professional education. The 'European Board of Medical Genetics division - Clinical Laboratory Geneticist' provides now since 3 years the possibility to register as an ErCLG. Applicants may be from all European countries and since this year also from outside of Europe. Five subtitles reflect the exact specialty of each ErCLG, who can reregister every 5 years. A previously not possible statistics based on ~300 individuals from 19 countries as holders of an ErCLG title provides interesting insights into the professionals working in human genetics. It could be substantiated that there are around twice as many females than males and that a PhD title was achieved by 80% of registered ErCLGs. Also most ErCLGs are still trained as generalists (66%), followed by such ErCLGs with focus on molecular genetics (23%); the remaining are concentrated either on clinical (6%), tumor (4%) or biochemical genetics (1%). In conclusion, besides MDs and genetic counselors/nurses an EU-wide recognition system for Clinical Laboratory Geneticist has been established, which strengthens the status of specialists working in human genetic diagnostics in Europe and worldwide.

  8. Acute tramadol poisoning and its clinical and laboratory findings

    Rahimi, Hamid Reza; Soltaninejad, Kambiz; Shadnia, Shahin


    Background: Tramadol is a centrally acting analgesic with opioid and nonopioid properties, which extensively used in the relief of mild to moderate pain. Tramadol poisoning is a common cause of acute pharmaceutical poisoning in Iran. There are a few studies about clinical and laboratory findings related to acute tramadol poisoning. Therefore, the aim of this study was to demonstrate the clinical and laboratory findings in tramadol acute poisoning cases. Materials and Methods: This was a retrospective descriptive study of patients with acute tramadol poisoning who referred to Loghman Hakim Hospital Poison Center during January to April 2012. Data such as patient's age, sex, time of ingestion, ingested dose, cause of poisoning, mean duration of hospitalization, patient's clinical presentations, laboratory findings, therapeutic measures, and patient's outcome have collected in a predesigned checklist. Results: A total of 144 patients including 111 men (77%) and 33 women (23%) with acute tramadol poisoning was included in this study. The mean ingested dose was 1971.2 mg (100-20000 mg). Seizure (47.91%) was the most frequent clinical symptom. Blood gas on admission showed pH (7.3 ± 0.1), PCO2 (49.7 ± 8.6 mmHg) and HCO3− (24.1 ± 3.8 mEq/L), indicating pure acute respiratory acidosis may be occurred in tramadol-intoxicated patients. There were significant differences between tramadol-intoxicated cases with and without a seizure with regard to the time interval between ingestion and admission on hospital, ingested dose and PCO2. Conclusion: Seizure and rise of PCO2 were the most findings in this study. PMID:25535500

  9. [The purpose of clinical laboratory accreditation in transplantation medicine].

    Flegar-Mestrić, Zlata; Nazor, Aida; Perkov, Sonja; Surina, Branka; Siftar, Zoran; Ozvald, Ivan; Vidas, Zeljko


    Although transplantation of solid organs has become a more standardized method of treatment, liver transplantation represents an exceptional multidisciplinary clinical procedure requiring understanding of specific pathophysiological changes that occur in the end stage of liver disease. Liver transplantation has been performed at Merkur University Hospital since 1998, with 360 transplantations performed to date. The most common indications are alcohol liver disease, cirrhosis caused by hepatitis B and C virus, hepatocellular carcinoma and cryptogenetic liver cirrhosis. Laboratory tests required for liver transplantation are performed at Department of Clinical Chemistry, Merkur University Hospital, accredited according to ISO 15189 in 2007 for the areas of clinical chemistry, laboratory hematology and coagulation, laboratory immunology-cell immunophenotyping, and molecular diagnosis. The complexity of liver transplant patients requires constant interaction between the anesthesiologist team and clinical laboratory, which has to ensure fast and efficient intraoperative monitoring of biochemical and liver profile: electrolytes and acid-base status, complete blood count, coagulation profile and monitoring of graft function according to the individual patient's health status. Dynamics of intraoperative changes is measured in whole arterial blood samples on a Nova Biomedical Stat Profile Critical Care Xpress mobile acid-base analyzer. Frequent monitoring of ionized calcium and magnesium levels is very important because of citrated blood transfusion and for appropriate therapeutic procedure. During anhepatic stage, there is a progressive increase in lactate level concentration. After reperfusion, a rapid increase in lactate clearance is an excellent indicator of stable graft initial function and its adequate size. During the transplantation procedure, there is usually a biphasic acid-base disturbance characterized by metabolic acidosis and then by metabolic alkalosis. The

  10. The increasing impact of laboratory medicine on clinical cardiology.

    Clerico, Aldo


    The practice of cardiology continues to evolve along with a better understanding of the pathophysiology of cardiovascular disease and the development of new therapeutic procedures. Consequently, new demands are being made on the in vitro diagnostics industry to improve the performance of existing cardiac markers and to develop novel markers for new cardiac disease indications. Indeed, in the last 20 years there has been a progressive increase in new laboratory tests for markers of cardiac diseases. Several highly sensitive and/or specific assays for the detection of myocardial ischemic damage as well as some immunoassays for cardiac natriuretic hormones, now considered a reliable marker of myocardial function, have become commercially available. In parallel, a growing number of some novel risk factors, which can be assessed and monitored by laboratory methods, have been added to the classical risk factors for cardiovascular disease. Finally, the recent explosion of genetic analysis may soon place at the clinical cardiologist's disposal many laboratory tests for defining the diagnosis at the molecular level, assessing new risk factors, and better targeting the pharmaceutical approaches in patients with cardiovascular disease. In the present article, after a brief description of the analytical tests included in these four groups, each group's impact on clinical cardiology is discussed in detail.

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

    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.

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

    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.

  13. ASVCP quality assurance guidelines: control of preanalytical, analytical, and postanalytical factors for urinalysis, cytology, and clinical chemistry in veterinary laboratories.

    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.

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


    Background 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. Methods 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. Results 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. Conclusions 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. PMID:24406140

  15. 77 FR 13513 - Modernizing the Regulation of Clinical Trials and Approaches to Good Clinical Practice; Public...


    .... ] Individuals who wish to attend or present at the public hearing must register on or before close of business..., increased frequency of outsourcing) and globalization are posing challenges for sponsors, clinical... globalization? For each of the suggested efforts, specifically identify how the effort could help mitigate...

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


    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

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

    Garzon, Alba C


    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.

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

    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.

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

    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

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

    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.

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

    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.

  2. Clinical and laboratory characteristics of women with uterine leiomiyoma

    Özgür ÖZKUL


    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.

  3. [Advanced data analysis and visualization for clinical laboratory].

    Inada, Masanori; Yoneyama, Akiko


    This paper describes visualization techniques that help identify hidden structures in clinical laboratory data. The visualization of data is helpful for a rapid and better understanding of the characteristics of data sets. Various charts help the user identify trends in data. Scatter plots help prevent misinterpretations due to invalid data by identifying outliers. The representation of experimental data in figures is always useful for communicating results to others. Currently, flexible methods such as smoothing methods and latent structure analysis are available owing to the presence of advanced hardware and software. Principle component analysis, which is a well-known technique used to reduce multidimensional data sets, can be carried out on a personal computer. These methods could lead to advanced visualization with regard to exploratory data analysis. In this paper, we present 3 examples in order to introduce advanced data analysis. In the first example, a smoothing spline was fitted to a time-series from the control chart which is not in a state of statistical control. The trend line was clearly extracted from the daily measurements of the control samples. In the second example, principal component analysis was used to identify a new diagnostic indicator for Graves' disease. The multi-dimensional data obtained from patients were reduced to lower dimensions, and the principle components thus obtained summarized the variation in the data set. In the final example, a latent structure analysis for a Gaussian mixture model was used to draw complex density functions suitable for actual laboratory data. As a result, 5 clusters were extracted. The mixed density function of these clusters represented the data distribution graphically. The methods used in the above examples make the creation of complicated models for clinical laboratories more simple and flexible.

  4. Good laboratory practice in the European Community. Role of the commission and the member states: external aspects.

    Berend, Klaus


    The paper recalls the history of the development of the OECD principles of good laboratory practice (GLP) and explains why the European Community has a role to play in the area of GLP. It presents briefly the current legal framework in the European Community (Directives 87/18/EEC and 88/320/EEC) and describes the role of the Commission and the member states in the practical implementation of the GLP principles within the European Community. Impacts of GLP on the relations of the European Community with third countries, both within the framework of the OECD and through bilateral trade agreements (mutual recognition agreements, MRA) based on article 133 of the treaty establishing the European Community, are then examined in greater detail.

  5. Lean-Agile Adaptations in Clinical Laboratory Accredited ISO 15189

    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

  6. Socio-demographic, Clinical and Laboratory Features of Rotavirus Gastroenteritis in Children Treated in Pediatric Clinic

    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...

  7. Review of clinical and laboratory features of human Brucellosis

    Mantur B


    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

  8. Glycogen storage disease type I: clinical and laboratory profile

    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.

  9. Clinical and laboratory features of typhoid fever in childhood

    Sylvia Retnosari


    Full Text Available The aims of the study were to review the clinical features of patient with suspected typhoid fever, to obtain features of the blood culture results, Widal, Typhidot tests and to identify the relationship between/prior antibiotic administration with laboratory findings. The study had been conducted since January 1, 1999 till January 31, 2000 with inclusion criteria (1 age of patient was 3 to 14 years, (2 patient with diagnosis of suspected typhoid fever and (3 gave consent to participate in the present study. Thirty-six patients were eligible for this study and the result showed that typhoid fever was encountered more commonly in girls with the most prevalent onset was in age 5 to 9 years and duration of fever was less than 8 days. Gastrointestinal tract disturbance was the most frequent complain after fever. Most patient showed negative results in blood culture examination and Widal test, and gave positive results in Typhidot/Typhidot M test as well. Antibiotic administration tended to influence blood culture and Widal test as to need consideration in evaluation of laboratory results. However, a conclusion still could not be drawn definitively that further study with adequate sample number and positive blood culture as criteria inclusion was needed.

  10. Clinical laboratory stressors used to study alcohol-stress relationships.

    Thomas, Suzanne; Bacon, Amy K; Sinha, Rajita; Uhart, Magdalena; Adinoff, Bryon


    Understanding the biologic systems that underlie the relationship between stress and alcohol consumption may lead to better prevention efforts and more effective treatments for alcoholism. Clinical laboratory studies offer a unique opportunity to examine these relationships by using a controlled environment to study how an acute stressor affects alcohol drinking and alcohol craving, how individuals in recovery or those at risk for alcoholism may respond differently to stressors relative to control subjects, and how alcohol differentially affects stress reactivity in these groups. This article reviews some of the most common physical, psychological, and pharmacological stressors used in stress-induction studies designed to reveal details about the relationship between stress reactivity and alcohol use and abuse.

  11. Clinical and laboratory factors associated with mortality in dengue.

    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.

  12. [Clinical, laboratory and therapeutics aspects of Sheehan's syndrome].

    Soares, Débora Vieira; Conceição, Flávia Lúcia; Vaisman, Mário


    Sheehan's syndrome is characterized by hypopituitarism that occurs as a result of ischemic pituitary necrosis due to severe postpartum hemorrhage. Nowadays it is not usually seen in developed countries because of the improvements in obstetric care. However, in developing countries it is still frequent and probably one of the most common causes of hypopituitarism. Most patients usually present it months to years later, with a history of failure of postpartum lactation, failure to resume menses and other signs of panhypopituitarism. In mild forms of the disease, patients may remain undetected and do not receive treatment for many years. Early diagnosis and appropriate treatment are important to reduce the morbimortality of the patients with Sheehan's syndrome. The aim of this review is to describe clinical, laboratory and therapeutic aspects of Sheehan's syndrome, including our experience in the replacement of recombinant GH in these patients.

  13. [For the improvement of management and assurance in clinical laboratories of education hospitals--from the meeting of clinical laboratory members of public university or college hospitals].

    Yoshida, Hiroshi


    Clinical laboratory members, composed of medical doctors, laboratory technologists and office staff from 8 public university or college hospitals and one medical center, have an annual meeting, in which achievements including tested numbers, income, outsourcing ratio, and so on were reported and various agendas from each institution were discussed. The number of agendas for general discussion and in the technologist division has been increasing, which reflects that variables, including management in clinical laboratories, needing solutions have been increasing. Information obtained through discussion could help in the determination of management and the improvement of education and quality assurance in clinical laboratories.

  14. Evaluation of clinical and laboratory correlates of sickle leg ulcers.

    Madu, Anazoeze Jude; Ubesie, Agozie; Madu, Kenechi Anthony; Okwor, Bismarck; Anigbo, Chukwudi


    The exact mechanism for the occurrence of sickle leg ulcers (SLUs) has not been fully explained, although, popular opinion supports a multifactorial etio-pathogenetic process. Leg ulceration in sickle cell is a chronic and debilitating condition which is difficult to treat and may worsen the psychosocial impact of this illness. This study aims to evaluate the laboratory and clinical correlates of SLUs. One hundred sixty-seven patients who had been diagnosed with sickle cell anemia (homozygous S) had their steady-state hemoglobin concentration (Hb), hematocrit, white cell count, platelet count, serum bilirubin, and aspartate transaminase (AST) as well as frequency of crisis per annum evaluated with respect to their relationship to the occurrence of leg ulcers. They were aged 6-53 years (mean age 24.3 years), and prevalence of leg ulcer was found to be 2.75 per 1000 (2.54 per 1000 in females and 2.83 per 1000 in males). The independent sample t-test showed a significant difference in the serum AST levels in those with SLU (p = 0.029), though a positive correlation did not exist. Other predictors of disease severity found to have positive relationship with each other were the AST and total serum bilirubin 0.207 (p = 0.012); Hb and age 0.130 (p = 0.035); Hb and white cell count -0.159 (p = 0.010), white cell count and age -0.113 (p = 0.018). SLUs do not occur in patients with severe disease in sickle cell. The clinical and laboratory indicators of severe sickle cell disease do not correlate positively with the occurrence of SLU. Serum AST may have a relationship with leg ulceration in these patients. Environmental factors most likely play a major part in the etiopathogenesis of leg ulcer and this may require further studies in different sociocultural settings.

  15. Obtaining valid laboratory data in clinical trials conducted in resource diverse settings: lessons learned from a microbicide phase III clinical trial.

    Tania Crucitti

    Full Text Available BACKGROUND: 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 [1]. METHODOLOGY: 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. RESULTS: 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. CONCLUSIONS: Quality control guidelines when applied in field laboratories ensured the reliability and validity

  16. Electroencephalographic neurofeedback: Level of evidence in mental and brain disorders and suggestions for good clinical practice.

    Micoulaud-Franchi, J-A; McGonigal, A; Lopez, R; Daudet, C; Kotwas, I; Bartolomei, F


    The technique of electroencephalographic neurofeedback (EEG NF) emerged in the 1970s and is a technique that measures a subject's EEG signal, processes it in real time, extracts a parameter of interest and presents this information in visual or auditory form. The goal is to effectuate a behavioural modification by modulating brain activity. The EEG NF opens new therapeutic possibilities in the fields of psychiatry and neurology. However, the development of EEG NF in clinical practice requires (i) a good level of evidence of therapeutic efficacy of this technique, (ii) a good practice guide for this technique. Firstly, this article investigates selected trials with the following criteria: study design with controlled, randomized, and open or blind protocol, primary endpoint related to the mental and brain disorders treated and assessed with standardized measurement tools, identifiable EEG neurophysiological targets, underpinned by pathophysiological relevance. Trials were found for: epilepsies, migraine, stroke, chronic insomnia, attentional-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, major depressive disorder, anxiety disorders, addictive disorders, psychotic disorders. Secondly, this article investigates the principles of neurofeedback therapy in line with learning theory. Different underlying therapeutic models are presented didactically between two continua: a continuum between implicit and explicit learning and a continuum between the biomedical model (centred on "the disease") and integrative biopsychosocial model of health (centred on "the illness"). The main relevant learning model is to link neurofeedback therapy with the field of cognitive remediation techniques. The methodological specificity of neurofeedback is to be guided by biologically relevant neurophysiological parameters. Guidelines for good clinical practice of EEG NF concerning technical issues of electrophysiology and of learning are suggested. These require validation by

  17. Clinical and laboratory characteristics of children with Kawasaki disease

    Fatih Akın


    Full Text Available Objective: In this study, we aimed to evaluate clinical and laboratory characteristics of patients with Kawasaki disease (KD in Konya region of Turkey. Methods: The hospital records of patients who were hospitalized with the diagnosis of KD in the Pediatrics Clinics of Konya Training and Research Hospital between May 2010 and June 2012 were reviewed retrospectively. Results: Seven cases were found to have the diagnosis of KD, two of whom were incomplete KD. Oropharynx changes were the most common (100% feature in our patients. Five (71% patients had bulbar conjunctivitis. Three (43% patients had erythema at the site of BCG inoculation. Adenopathy was present in all of our patients with the classical form. A desquamation was observed in one case at the seventh day of fever. No cardiac manifestation was seen. Elevated erythrocyte sedimentation rate and thrombocytosis were present in all patients. All of the patients were received intravenous immunoglobulin in the first ten days of the fever. Conclusion: KD should be considered as a possible diagnosis in any child presenting with prolonged fever. BCG reaction can be attributed as a diagnostic criterion for incomplete form of the disease especially in countries where BCG vaccination is routinely performed. Early treatment is essential to prevent cardiovascular complications.

  18. Custom software development for use in a clinical laboratory.

    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.

  19. Custom software development for use in a clinical laboratory

    John H Sinard


    Full Text Available 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.

  20. Clinical and laboratory diagnosis of dengue fever in travelers

    N. I. Khokhlova


    Full Text Available The paper presents the analysis of clinical and laboratory symptoms in 35 adult patients with denger fever, Novosibirsk residents, which travelled in endemic countries, mostly Tailand. The classic form of the disease was determined in all cases. The moderate form was in 71,5% patients, the severe form was in the rest ones. The diagnosis of dengue was verified by detection of specific immunoglobulin M and in some cases immunoglobulin G and also virus dengue NS1 antigen by immunochromatography. The dominant clinical symptoms in observed patients were fever for 3–8 days (100%, mostly high one (71,4%, asthenia (97,1%, anorexia (100%, myalgia or/and arthralgia (77,1%, exantema (60%, hepatomegaly (62,8%. The gematologic indicators were represented with thrombocytopenia in 91,4% patients (from 167 to 20×109/l и leucopenia in 85,7% patients (from 3,9 to 1,1×109/l. The cytolitic syndrom was revealed in 80% patients with predominance of aspartate aminotransferase activity in early period of the disease. 

  1. Percutaneous renal graft biopsy: a clinical, laboratory and pathological analysis

    Marilda Mazzali


    Full Text Available CONTEXT: Renal allograft biopsies have been used as a good method for monitoring the evolution of kidney transplants for at least 20 years.1 Histological analysis permits differential diagnosis of the causes of allograft dysfunction to be made. OBJECTIVES: To correlate the data of urinalysis and serum creatinine with histological diagnosis of renal graft in a group of renal transplant patients. DESIGN: Accuracy study, retrospective analysis. SETTING: A university terciary referral center. SAMPLE: 339 percutaneous allograft biopsies obtained from 153 patients. Blood and urine samples were obtained before the graft biopsy. MAIN MEASUREMENTS: Laboratory evaluation and hystological analysis (light microscopy, imunofluorescent eletronic microscopy. RESULTS: Most of the biopsies (58.9% were performed during the first month post-transplant. An increase in serum creatinine was associated with acute tubular and/or cortical necrosis. Proteinuria and normal serum creatinine were associated with glomerular lesions. Non-nephrotic range proteinuria and an increase in serum creatinine were associated with chronic rejection. CONCLUSIONS: Evaluation of serum creatinine and urinalysis can be useful in suggesting the histological graft diagnosis.

  2. Acute Viral Hepatitis A – Clinical, Laboratory and Epidemiological Characteristics

    Melinda HORVAT


    Full Text Available Background and Aims: Infection with hepatitis A virus is still one of the most common causes of hepatitis worldwide. The clinical manifestation of acute hepatitis A (AHA in adults can vary greatly, ranging from asymptomatic infection to severe and fulminant hepatitis. The aim of this study was to describe the demographic, clinical characteristics, laboratory features and hospital outcome of adult patients with AHA over a consecutive period of 4 years within an area from Eastern European country. Methods: Two hundred and two adult patients diagnosed with AHA were retrospective, observational and analytic analized over a period of 4 years. Based on prothrombin time less than 50, the study group was stratified in medium (79.2% and severe forms (20.8%. We investigated the clinical, laboratory and epidemiological features. Statistical analysis were applied to compare the medium and severe forms of AHA. Results: Most patients (72.7% were younger than 40 years. The main symptoms included: dyspepsia (72.07%, jaundice (86.63%, asteno-adynamia (86.72%, and flu-like symptoms (53.46%. The hemorrhagic cutaneous-mucous manifestations (6.93% associated with the severe forms of AHA (OR =12.19, 95%CI -3.59 - 41.3, p =0.001. We found statistically significant differences for PT (p <0.001, INR (p <0.001, TQ (p <0.001, ALAT (p <0.001, ASAT (p <0.001, ALP (p <0.001 and platelets (p =0.009 between severe and medium AHA forms. We found that TQ, INR, ALAT and ASAT have the highest diagnostic values, statistically significant (p <0.05 for severe AHA forms with AUC (0.99, 0.99, 0.72, 0.70 at values of sensitivity (95%, 90.5%, 89%, 95% and specificity (98%, 99%, 88%,94%. Conclusions Medium severity AHA forms were found in most of the study group patients (79.2%. The severe AHA forms were associated with hemorrhagic cutaneous-mucous manifestations (OR =12.19, p =0.001. The univariate analysis proved a negatively statistically significant correlation between IP and ALAT

  3. Pharmacokinetic studies of neuromuscular blocking agents: good clinical research practice (GCRP).

    Viby-Mogensen, J; Ostergaard, D; Donati, F; Fisher, D; Hunter, J; Kampmann, J P; Kopman, A; Proost, J H; Rasmussen, S N; Skovgaard, L T; Varin, F; Wright, P M


    In September 1997, an international consensus conference on standardization of studies of neuromuscular blocking agents was held in Copenhagen, Denmark. Based on the conference, a set of guidelines for good clinical research practice (GCRP) in pharmacokinetic studies of neuromuscular blocking agents is presented. Guidelines include: design of the study; relevant patient groups to investigate; test drug administration, sampling and analysis; pharmacokinetic analysis; pharmacokinetic/pharmacodynamic modeling; population pharmacokinetics; statistics; and presentation of pharmacokinetic data. The guidelines are intended to aid those working in this research area; it is hoped that they will assist researchers, editors of scientific papers, and pharmaceutical companies in improving the quality of pharmacokinetic studies.

  4. Developing a Framework for Evaluating Ethical Outcomes of Good Participatory Practices in TB Clinical Drug Trials.

    MacQueen, Kathleen M; Eley, Natalie T; Frick, Mike; Mingote, Laia Ruiz; Chou, Alicia; Seidel, Stephanie S; Hannah, Stacey; Hamilton, Carol


    Good Participatory Practice Guidelines for TB Drug Trials (GPP-TB) were issued in 2012, based on similar guidelines for HIV prevention and reflecting growing acceptance of the importance of community engagement and participatory strategies in clinical research. Though the need for such strategies is clear, evaluation of the benefits and burdens are needed. Working with a diverse group of global TB stakeholders including advocates, scientists, and ethicists, we used a Theory of Change approach to develop an evaluation framework for GPP-TB that includes a clearly defined ethical goal, a set of powerful strategies derived from GPP-TB practices for achieving the goal, and outcomes connecting strategies to goal. The framework is a first step in systematically evaluating participatory research in clinical trials.

  5. 78 FR 59704 - Medicare, Medicaid, and CLIA Programs; Clinical Laboratory Improvement Amendments of 1988...


    ... Laboratory Improvement Amendments of 1988 Exemption of Laboratories Licensed by the State of Washington... requirements of the Clinical Laboratory Improvement Amendments of 1988 (CLIA) for a period of 6 years. DATES... Laboratory Improvement Amendments of 1988 (CLIA) (Pub. L. 100-578), which was enacted on October 31,...

  6. Association between several clinical and radiological determinants with long-term clinical progression and good prognosis of lower limb osteoarthritis.

    Erlangga Yusuf

    Full Text Available OBJECTIVE: To investigate the factors associated with clinical progression and good prognosis in patients with lower limb osteoarthritis (OA. METHODS: Cohort study of 145 patients with OA in either knee, hip or both. Progression was defined as 1 new joint prosthesis or 2 increase in WOMAC pain or function score during 6-years follow-up above pre-defined thresholds. Patients without progression with decrease in WOMAC pain or function score lower than pre-defined thresholds were categorized as good prognosis. Relative risks (RRs for progression and good prognosis with 95% confidence interval (95% CI were calculated by comparing the highest tertile or category to the lowest tertile, for baseline determinants (age, sex, BMI, WOMAC pain and function scores, pain on physical examination, total range of motion (tROM, osteophytes and joint space narrowing (JSN scores, and for worsening in WOMAC pain and function score in 1-year. Adjustments were performed for age, sex, and BMI. RESULTS: Follow-up was completed by 117 patients (81%, median age 60 years, 84% female; 62 (53% and 31 patients (26% showed progression and good prognosis, respectively. These following determinants were associated with progression: pain on physical examination (RR 1.2 (1.0 to 1.5; tROM (1.4 (1.1 to 1.6; worsening in WOMAC pain (1.9 (1.2 to 2.3; worsening in WOMAC function (2.4 (1.7 to 2.6; osteophytes 1.5 (1.0 to 1.8; and JSN scores (2.3 (1.5 to 2.7. Worsening in WOMAC pain (0.1 (0.1 to 0.8 and function score (0.1 (0.1 to 0.7, were negatively associated with good prognosis. CONCLUSION: Worsening of self-reported pain and function in one year, limited tROM and higher osteophytes and JSN scores were associated with clinical progression. Worsening in WOMAC pain and function score in 1- year were associated with lower risk to have good prognosis. These findings help to inform patients with regard to their OA prognosis.

  7. Complement analysis 2016: Clinical indications, laboratory diagnostics and quality control.

    Prohászka, Zoltán; Nilsson, Bo; Frazer-Abel, Ashley; Kirschfink, Michael


    In recent years, complement analysis of body fluids and biopsies, going far beyond C3 and C4, has significantly enhanced our understanding of the disease process. Such expanded complement analysis allows for a more precise differential diagnosis and for critical monitoring of complement-targeted therapy. These changes are a result of the growing understanding of the involvement of complement in a diverse set of disorders. To appreciate the importance of proper complement analysis, it is important to understand the role it plays in disease. Historically, it was the absence of complement as manifested in severe infection that was noted. Since then complement has been connected to a variety of inflammatory disorders, such as autoimmune diseases and hereditary angioedema. While the role of complement in the rejection of renal grafts has been known longer, the significant impact of complement. In certain nephropathies has now led to the reclassification of some rare kidney diseases and an increased role for complement analysis in diagnosis. Even more unexpected is that complement has also been implicated in neural, ophtalmological and dermatological disorders. With this level of involvement in some varied and impactful health issues proper complement testing is clearly important; however, analysis of the complement system varies widely among laboratories. Except for a few proteins, such as C3 and C4, there are neither well-characterized standard preparations nor calibrated assays available. This is especially true for the inter-laboratory variation of tests which assess classical, alternative, or lectin pathway function. In addition, there is a need for the standardization of the measurement of complement activation products that are so critical in determining whether clinically relevant complement activation has occurred in vivo. Finally, autoantibodies to complement proteins (e.g. anti-C1q), C3 and C4 convertases (C3 and C4 nephritic factor) or to regulatory proteins

  8. Analysis of search in an online clinical laboratory manual.

    Blechner, Michael; Kish, Joshua; Chadaga, Vivek; Dighe, Anand S


    Online laboratory manuals have developed into an important gateway to the laboratory. Clinicians increasingly expect up-to-date laboratory test information to be readily available online. During the past decade, sophisticated Internet search technology has developed, permitting rapid and accurate retrieval of a wide variety of content. We studied the role of search in an online laboratory manual. We surveyed the utilization of search technology in publicly available online manuals and examined how users interact with the search feature of a laboratory handbook. We show how a laboratory can improve its online handbook through insights gained by collecting information about each user's activity. We also discuss future applications for search-related technologies and the potential role of the online laboratory manual as the primary laboratory information portal.

  9. 78 FR 44954 - Clinical Laboratory Improvement Advisory Committee (CLIAC)


    ... ] medicine practice and specific questions related to possible revision of the CLIA standards. Examples... laboratories are regulated; the impact of proposed revisions to the standards on medical and laboratory... laboratory interoperability in health information technology will also be discussed. Agenda items are...

  10. The Document of the Americas: Good Clinical Practices for Regulatory Authorities

    Ricardo Palacios


    Full Text Available In 1996, when the Guidelines for Good Clinical Practices of the International Conference on Harmonization (ICH were adopted, they sought to facilitate the actions of regulatory authorities over the different players of clinical research. These guidelines were created and incorporated to the legislation of the three regions of the world (United States, European Union, and Japan where most of the drugs, vaccines, biologicals, diagnostic tests, and medical devices are produced. The regulatory authorities from those three regions are characterized for their extensive technical capacity to execute their mission of promoting technological advances and protecting communities. However, undertaking this task has been difficult, partially because the ICH Good Clinical Practices defined responsibilities for Ethical Committees, Sponsors, and Investigators; but the regulatory authorities did not precise their own responsibilities or indicate how they would accomplish their duties in that document and, therefore, did not reach the harmonization of their practices in those subjects. Certainly, this point is one of the major advances offered by the Document of the Americas on Good Clinical Practices: helping the regulatory authorities of the continent to establish a common platform on how to perform their duties regarding clinical research. The possibilities that this common regulatory methodology offers to the authorities from our countries, with greater limitations in budget and in human resources than their ICH counterparts, are promising: it might allow unified staff training, conduction of joint inspections and, even, thinking of a mutual recognition for the actions of the authorities in each country, as occurred in Europe more than three decades ago. However, the promises have not been delivered in the desired extension: despite the March 2005 meeting held in the Dominican Republic, where the Document of the Americas was published, was held in March, 2005

  11. ORIGINAL ARTICLE: Identification of Practical Pharmacology Skills Useful for Good Clinical Practice

    V. Shilpa, R. Divya


    Full Text Available Background: Awareness about animal ethics is increasing everywhere. This increased awareness coupled with strict regulations discouraging the use of animals for routine experiments have tied the hands of many pharmacologists. They are now forced to develop alternative experiments without using animals. At present, there is acute need to come out with more innovative and useful practical exercises for pharmacology practical sessions. In this background, the present study was undertaken to develop the much-needed alternative experiments. Aims and Objective: To identify new pharmacological practical skills useful for good clinical practice. Material and Methods: A pre-tested questionnaire was administered to 110 doctors of different categories like house surgeons, postgraduate students, assistant professors and professors who are working in a tertiary care hospital. They were asked to give their suggestions regarding new pharmacology practical skills useful for good clinical practice. Statistical analysis: Responses of the participants to the questions asked were tabulated and analyzed. Suggestions given by them were listed out and studied. Results: Use of emergency drugs, dosage calculation, drugs used in pregnancy, case discussions and prescription writing exercises received a lot of support from the participants. Research methodology, cost calculation, animal experiments and interpretation of data of animal experiments did not receive support from the participants. Suggestions given by the participants regarding useful pharmacological skills belonged to the areas like therapeutics, safe use of drugs, recent advances, analysis of information given by the medical representatives and analyzing articles in journals for knowing the efficacy of drugs. Conclusion: Exercises relevant to the clinical practice, as identified in this study, can be introduced as practical pharmacology exercises. Steps are to be taken to highlight the importance of research

  12. Laboratory aspects of clinically significant rapidly growing mycobacteria

    R Set


    Full Text Available The pathogenic potential of the rapidly growing mycobacteria (RGM has started being recognized. This is due to more sensitive and specific techniques in the laboratory. The RGM are generally defined as nontuberculous species of mycobacteria that show visible growth on agar media within 7 days. RGM are widely distributed in nature and have been isolated from natural water, tap water, and soil. Several biochemical tests, high performance liquid chromatography, and molecular techniques have been developed for rapid identification of these species. The American Thoracic Society and the Infectious Disease Society of America recommend that RGM should be identified to the species level using a recognized acceptable methodology such as polymerase chain reaction restriction enzyme analysis or biochemical testing and routine susceptibility testing of RGM should include amikacin, imipenem, doxycycline, the fluorinated quinolones, a sulphonamide or trimethoprim-sulphamethoxazole, cefoxitin, clarithromycin, linezolid, and tobramycin. The diseases caused by these organisms have varied manifestations. They have been responsible for a number of healthcare-associated outbreaks and pseudo-outbreaks. For recognition of outbreaks, it is important to be familiar with the causative organisms like RGM which are most frequently involved in healthcare-associated outbreaks and pseudo outbreaks. It is essential to intervene as soon as possible to interrupt this transmission. Large gaps still exist in our knowledge of RGM. Unquestionably more studies are required. Through this review, we wish to emphasize that reporting of RGM from clinical settings along with their sensitivity patterns is an absolute need of the hour.

  13. 76 FR 1212 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and...


    ... AFFAIRS Joint Biomedical Laboratory Research and Development and Clinical Science Research and Development... Eligibility of the Joint Biomedical Laboratory Research and Development and Clinical Science Research and... areas of biomedical, behavioral and clinical science research. The panel meeting will be open to the...

  14. 76 FR 79273 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and...


    ... AFFAIRS Joint Biomedical Laboratory Research and Development and Clinical Science Research and Development... Eligibility of the Joint Biomedical Laboratory Research and Development and Clinical Science Research and... biomedical, behavioral, and clinical science research. The panel meeting will be open to the public for...

  15. A commentary on randomized clinical trials: How to produce them with a good level of evidence

    Olga Dumont Flecha


    Full Text Available Randomized clinical trial (RCT is the gold standard study for the evaluation of health interventions and is considered the second level of evidence for clinical decision making. However, the quality of the evidence produced by these studies is dependent on the methodological rigor employed at every stage of their execution. The purpose of randomization is to create groups that are comparable independent of any known or unknown potential confounding factor. A critical evaluation of the literature reveals that, for many years, RCTs have been developed based on inaccurate methodological criteria, and empirical evidence began to accumulate. Thus, guidelines were developed to assist authors, reviewers, and editors in the task of developing and assessing the methodological consistency of this type of study. The objective of this article is to review key aspects to design a good-quality RCT, supporting the scientific community in the production of reliable evidence and favoring clinical decision making to allow the patient to receive the best health care.

  16. Evaluation of clinical, laboratory, and electrophoretic profiles for diagnosis of malnutrition in hospitalized dogs

    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.

  17. [Trends of utilization of information technologies in clinical laboratory and pathology domain].

    Tofukuji, Ikuo


    The life expectancy of the Japanese population is one of longest in the world. Society is aging, with fewer children, increasing the total national medical payment in Japan. This situation has forced the Government to reduce the payment and to increase the efficiency of the medical system, so information technologies are expected to contribute to these policies. Electronic patient record systems (EPR) were expected to be used widely, but only 23% of clinical training hospitals have implemented them. This is mainly due to the lack of incentives and large costs to install EPR. Standardization is a good method to reduce system construction cost and increase its quality. New global IHE activities are expected to solve these problems with methodologies of workflow analyses, standard applications, tests and demonstrations. Laboratory information systems (LIS) have a long history and tradition of standard interfaces for connecting computers with analyzers. IHE activities for LIS are providing easy and secure connections with hospital information systems (HIS). Pathology departments also have their own information systems. IHE activities for pathology were launched in 2005, and we are now developing in collaboration with the international IHE pathology working group, HL7 SIG pathology and DICOM WG-26. Pathologists and technical experts in Japanese laboratories are encouraged to join IHE activities to ensure good results.

  18. High ear-piercing: an increasingly popular procedure with serious complications. Is good clinical practice exercised?

    Lyons, Marie; Stephens, Joanna; Wasson, Joseph; DeZoysa, Nilantha; Vlastarakos, Petros V


    This study aimed to explore the current practice of performing high ear-piercing regarding consent protocols, and methods of practice using questionnaire-based survey in Hertfordshire and North London. Recommendations for good clinical practice are also made. 100 establishments performing ear piercing were identified. A 16-item questionnaire on techniques used, methods of high-ear piercing, methods of sterilization, consent issues and aftercare was completed. Seventy-six establishments agreed to participate. All practitioners prepared the skin before piercing. 58 (76%) used a needle for piercing, 11 (15%) used a spring-loaded gun and seven (9%) used both. 97% of the practitioners obtained written consent before proceeding. 9 (12%) had a lower age limit of 16 years and three (4%) of 18 years. 27 piercers (36%) provided an aftercare leaflet, 41 (54%) warned the patients about risks of infection, 16 (21%) warned about cosmetic deformity and 1 (1%) specifically mentioned cauliflower ear. Results indicated that high ear piercing is an invasive procedure with a significant risk of complications leading to cosmetic deformity. Establishments should be required to counsel patients properly about the risks and potential complications of the procedure. A code of practice should be drawn up with a minimum age for piercing, requirement for proper consent, excellent hygiene and good information for postoperative care.

  19. Person-centric clinical trials: an opportunity for the good clinical practice (GCP)-practice-based research network.

    Curro, Frederick A; Robbins, Dennis A; Millenson, Michael L; Fox, Chester H; Naftolin, Frederick


    Practice-based research networks (PBRNs) can function as a platform for delivery of patient-centered care consistent with the Patient Protection and Affordable Care Act. Patient-centered (centric) clinical studies encourage the patient to be an integral part of study design and outcome. The patient's electronic health record contributes to the shared national health care data set. PBRNs integrate health care data in real time at the point of care and reflect the full context of the person's health. PBRNs designed under the principles of good clinical practice (GCP) validate studies related to comparative effectiveness research and drug development. PBRNs can generate large amounts of data from known patient histories so that side effects can be assessed in their totality. The larger and more diverse number of patients recruited suggests that point-of-care-data, where both provider and patient participate in the treatment, may be more robust in that side effects, drug-drug interactions and number of concomitant medications used may be identified earlier in the development process. The GCP PBRN concept affords continuous patient information for both care and research purposes. These all contribute to an ethical approach for the pharmaceutical industry to generate clinical research data for regulatory submission and to contribute to a HIPAA-compliant national database that could contribute to improved health care delivery and pharmacovigilance.

  20. Lenalidomide induced good clinical response in a patient with multiple relapsed and refractory Hodgkin's lymphoma

    Kolonic Slobodanka


    Full Text Available Abstract Background A 24-year-old female patient was diagnosed with classic Hodgkin's lymphoma in clinical stage II, and combination chemotherapy followed by radiotherapy was initiated. During the following 5 years, the disease progressed despite several standard therapeutic approaches, including autologous and allogeneic stem cell transplantation. Methods Lenalidomide (25 mg daily treatment was then initiated in a continuous dosing schedule. Positron emission tomography scans were performed before and during lenalidomide treatment. Hematologic and laboratory values, as well as physical condition were also assessed before and during lenalidomide treatment. Results Four months after continuous lenalidomide treatment, tumor load was significantly reduced, B symptoms had resolved, and the patient's physical condition had improved, allowing her to resume normal daily-living activities. Evaluations after 15 months of lenalidomide treatment indicated limited disease progression. Nevertheless, the patient was feeling well and maintaining a normal active life. Treatment was well tolerated, allowing the patient to remain on continuous dosing, which has now been maintained for 18 months. Conclusion Daily, long-term lenalidomide treatment provided clinical benefit and was well tolerated in a patient with relapsed, advanced classic Hodgkin's lymphoma.

  1. Customer Satisfaction Survey With Clinical Laboratory and Phlebotomy Services at a Tertiary Care Unit Level

    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...

  2. Implications of the introduction of laboratory demand management at primary care clinics in South Africa on laboratory expenditure

    Ozayr H. Mahomed


    Full Text Available Background: Diagnostic health laboratory services are regarded as an integral part of the national health infrastructure across all countries. Clinical laboratory tests contribute substantially to health system goals of increasing quality of care and improving patient outcomes.Objectives: This study aimed to analyse current laboratory expenditures at the primary healthcare (PHC level in South Africa as processed by the National Health Laboratory Service and to determine the potential cost savings of introducing laboratory demand management.Methods: A retrospective cross-sectional analysis of laboratory expenditures for the 2013/2014 financial year across 11 pilot National Health Insurance health districts was conducted. Laboratory expenditure tariff codes were cross-tabulated to the PHC essential laboratory tests list (ELL to determine inappropriate testing. Data were analysed using a Microsoft Access database and Excel software.Results: Approximately R35 million South African Rand (10% of the estimated R339 million in expenditures was for tests that were not listed within the ELL. Approximately 47% of expenditure was for laboratory tests that were indicated in the algorithmic management of patients on antiretroviral treatment. The other main cost drivers for non-ELL testing included full blood count and urea, as well as electrolyte profiles usually requested to support management of patients on antiretroviral treatment.Conclusions: Considerable annual savings of up to 10% in laboratory expenditure are possible at the PHC level by implementing laboratory demand management. In addition, to achieve these savings, a standardised PHC laboratory request form and some form of electronic gatekeeping system that must be supported by an educational component should be implemented.

  3. miRNA assays in the clinical laboratory: workflow, detection technologies and automation aspects.

    Kappel, Andreas; Keller, Andreas


    microRNAs (miRNAs) are short non-coding RNA molecules that regulate gene expression in eukaryotes. Their differential abundance is indicative or even causative for a variety of pathological processes including cancer or cardiovascular disorders. Due to their important biological function, miRNAs represent a promising class of novel biomarkers that may be used to diagnose life-threatening diseases, and to monitor disease progression. Further, they may guide treatment selection or dosage of drugs. miRNAs from blood or derived fractions are particularly interesting candidates for routine laboratory applications, as they can be measured in most clinical laboratories already today. This assures a good accessibility of respective tests. Albeit their great potential, miRNA-based diagnostic tests have not made their way yet into the clinical routine, and hence no standardized workflows have been established to measure miRNAs for patients' benefit. In this review we summarize the detection technologies and workflow options that exist to measure miRNAs, and we describe the advantages and disadvantages of each of these options. Moreover, we also provide a perspective on data analysis aspects that are vital for translation of raw data into actionable diagnostic test results.

  4. [External quality assessment in clinical biochemistry laboratories: pilot study in 11 laboratories of Lomé (Togo)].

    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 (p<0.002) between the performance of the group of laboratories 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 (p<0.047). The performance of the results provided by the laboratories remains relatively unsatisfactory. It is important that the Ministry of Health put in place a national program of EQA with mandatory participation.

  5. First-Year Residents' Caring, Medical Knowledge, and Clinical Judgment in Relation to Laboratory Utilization.

    Yarnold, Paul R.; And Others


    A study of 36 first-year Northwestern University (Illinois) medical residents found that students' medical knowledge was a predictor of increased laboratory test use, that clinical judgment was a predictor of decreased laboratory use, and that level of caring was statistically unrelated to amount of laboratory use. (Author/MSE)

  6. The National Market for Medicare Clinical Laboratory Testing

    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...

  7. The National Market for Medicare Clinical Laboratory Testing

    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...

  8. Liposomal drug delivery system from laboratory to clinic

    Kshirsagar N


    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

  9. Fulfilment assessment of the good clinical practices guidelines for community acquired pneumonia.

    Iris Gonzalez Morales


    Full Text Available Background: Community acquired pneumonia is the most common cause of infections found during the medical practice. Objective: To assess the fulfilment of the good clinical practices guidelines for the treatment of community acquired pneumonia. Methods: Prospective, descriptive study of series of cases developed in the Hospital “Dr. Gustavo Aldereguía Lima” between January, 1st and June 30th, 2006. 500 patients were studied which main diagnosis was pneumonia or bronchial pneumonia. The assessment tool includes four questions. A single-varied analysis was performed, with a confidence interval of 95%. The final result of this measurement was the fulfilment of the guidelines as excellent, fine, acceptable and not well, as well as the outcome in living and dead patients. Results: Patients older than 65 years of age are the most affected by  this disease and fatality is also higher in this age group; 40, 6% of admitted patients are classified as type III. Not performing thoracic radiography and inappropriate treatment led to a higher lethality risk. 53, 2 % of the clinical histories reflects a bad fulfillment of the guide, likewise the biggest lethality  was found  in that group (36,8 percent. Conclusions: The patients with pneumonias non serious are those that more are admitted in the center, with a non negligible lethality, although the highest  was found in the classes IV and V of pnemonia, that were considered the most serious pneumonias. The global adherence to the guide can be related with the final outcome of the patient.

  10. Laboratory approach for diagnosis of toluene-based inhalant abuse in a clinical setting

    Raka Jain


    Full Text Available The steady increase of inhalant abuse is a great challenge for analytical toxicologists. This review describes an overview of inhalant abuse including the extent of the problem, types of products abused, modes of administration, pharmacology and effects of inhalants, the role of laboratory, interpretation of laboratory results and clinical considerations. Regular laboratory screening for inhalant abuse as well as other substance abuse and health risk behaviors must be a part of standard clinical care.

  11. The role of the clinical laboratory in the future of health care: lean microbiology.

    Samuel, Linoj; Novak-Weekley, Susan


    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.

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

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


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

  13. The path to clinical proteomics research: integration of proteomics, genomics, clinical laboratory and regulatory science.

    Boja, Emily S; Rodriguez, Henry


    Better biomarkers are urgently needed to cancer detection, diagnosis, and prognosis. While the genomics community is making significant advances in understanding the molecular basis of disease, proteomics will delineate the functional units of a cell, proteins and their intricate interaction network and signaling pathways for the underlying disease. Great progress has been made to characterize thousands of proteins qualitatively and quantitatively in complex biological systems by utilizing multi-dimensional sample fractionation strategies, mass spectrometry and protein microarrays. Comparative/quantitative analysis of high-quality clinical biospecimen (e.g., tissue and biofluids) of human cancer proteome landscape has the potential to reveal protein/peptide biomarkers responsible for this disease by means of their altered levels of expression, post-translational modifications as well as different forms of protein variants. Despite technological advances in proteomics, major hurdles still exist in every step of the biomarker development pipeline. The National Cancer Institute's Clinical Proteomic Technologies for Cancer initiative (NCI-CPTC) has taken a critical step to close the gap between biomarker discovery and qualification by introducing a pre-clinical "verification" stage in the pipeline, partnering with clinical laboratory organizations to develop and implement common standards, and developing regulatory science documents with the US Food and Drug Administration to educate the proteomics community on analytical evaluation requirements for multiplex assays in order to ensure the safety and effectiveness of these tests for their intended use.

  14. Physician Satisfaction With Clinical Laboratory Services: A College of American Pathologists Q-Probes Study of 81 Institutions.

    McCall, Shannon J; Souers, Rhona J; Blond, Barbara; Massie, Larry


    -Assessment of customer satisfaction is a vital component of the laboratory quality improvement program. -To survey the level of physician satisfaction with hospital clinical laboratory services. -Participating institutions provided demographic information and survey results of physician satisfaction, with specific features of clinical laboratory services individually rated on a scale of 5 (excellent) to 1 (poor). -Eighty-one institutions submitted 2425 surveys. The median overall satisfaction score was 4.2 (10th percentile, 3.6; 90th percentile, 4.6). Of the 16 surveyed areas receiving the highest percentage of excellent/good ratings (combined scores of 4 and 5), quality of results was highest along with test menu adequacy, staff courtesy, and overall satisfaction. Of the 4 categories receiving the lowest percentage values of excellent/good ratings, 3 were related to turnaround time for inpatient "STAT" (tests performed immediately), outpatient STAT, and esoteric tests. The fourth was a new category presented in this survey: ease of electronic order entry. Here, 11.4% (241 of 2121) of physicians assigned below-average (2) or poor (1) scores. The 5 categories deemed most important to physicians included quality of results, turnaround times for inpatient STAT, routine, and outpatient STAT tests, and clinical report format. Overall satisfaction as measured by physician willingness to recommend their laboratory to another physician remains high at 94.5% (2160 of 2286 respondents). -There is a continued trend of high physician satisfaction and loyalty with clinical laboratory services. Physician dissatisfaction with ease of electronic order entry represents a new challenge. Test turnaround times are persistent areas of dissatisfaction, representing areas for improvement.

  15. Evaluation of Neonatal Hemolytic Jaundice: Clinical and Laboratory Parameters

    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.

  16. Unraveling Brazilian Indian population prostate good health: clinical, anthropometric and genetic features

    Mario M. de Lima Junior


    Full Text Available Purpose To compare dietary, lifestyle, clinical, anthropometric, genetic and prostatic features of Brazilian Indians and non-Indians (Amazon. Methods 315 men, 228 Indians and 89 non-Indians, ≥40 years old were submitted to digital rectal examination, serum prostate specific antigen (PSA, testosterone, TP53 and GSTP1 genotyping, anthropometric, lifestyle, dietary, personal and familial medical history. Prostatic symptoms were evaluated with the International Prostate Symptom Score (IPSS. Results Macuxis and Yanomamis represented 43.6% and 14.5% of Indians respectively who spontaneously referred no prostate symptoms. Mean IPSS was 7, range 3-19, with only 15% of moderate symptoms (score 8-19; Mean age was 54.7 years, waist circumference 86.6 cm, BMI 23.9 kg/m2. Yanomamis presented both lower BMI (21.4 versus 24.8 and 23.3, p=0,001 and prostate volume than Macuxis and “other ethnic groups” (15 versus 20, p=0.001. Testosterone (414 versus 502 and 512, p=0.207 and PSA (0.48 versus 0.6 and 0.41, p=0.349 were similar with progressive PSA increase with aging. Val/Val correlated with lower PSA (p=0.0361. Indians compared to control population presented: - TP53 super representation of Arg/Arg haplotype, 74.5% versus 42.5%, p<0.0001. -GSTP1 Ile/Ile 35.3% versus 60.9%; Ile/Val 45.9% versus 28.7%; Val/Val 18.8% versus 10.3%; p=0.0003. Conclusions Observed specific dietary, lifestyle, anthropometric and genetic profile for TP53 and GSTP1 may contribute to Brazilian Indian population prostate good health.

  17. National Academy of Clinical Biochemistry Laboratory Medicine Practice Guidelines for use of tumor markers in clinical practice

    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...

  18. Practice Makes Pretty Good: Assessment of Primary Literature Reading Abilities across Multiple Large-Enrollment Biology Laboratory Courses

    Sato, Brian K.; Kadandale, Pavan; He, Wenliang; Murata, Paige M. N.; Latif, Yama; Warschauer, Mark


    Primary literature is essential for scientific communication and is commonly utilized in undergraduate biology education. Despite this, there is often little time spent "training" our students how to critically analyze a paper. To address this, we introduced a primary literature module in multiple upper-division laboratory courses. In…

  19. Practice Makes Pretty Good: Assessment of Primary Literature Reading Abilities across Multiple Large-Enrollment Biology Laboratory Courses

    Sato, BK; Kadandale, P; He, W.; Murata, PMN; Latif, Y; Warschauer, M


    © 2014 B. K. Sato et al. Primary literature is essential for scientific communication and is commonly utilized in undergraduate biology education. Despite this, there is often little time spent training our students how to critically analyze a paper. To address this, we introduced a primary literature module in multiple upper-division laboratory courses. In this module, instructors conduct classroom discussions that dissect a paper as researchers do. While previous work has identified classro...

  20. 78 FR 28292 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and...


    ... AFFAIRS Joint Biomedical Laboratory Research and Development and Clinical Science Research and Development... Research and Development and Clinical Science Research and Development Services Scientific Merit Review... areas of biomedical, behavioral and clinical science research. The panel meetings will be open to the...

  1. Using the Revised Bloom's Taxonomy in the clinical laboratory: thinking skills involved in diagnostic reasoning.

    Su, Whei Ming; Osisek, Paul J; Starnes, Beth


    Achieving effective transfer of theoretical knowledge to clinical practice requires knowledge of thinking paradigms in relation to specific nursing content. It is a challenge to develop instructional designs for teaching and assessing implicit thought processes involved in clinical reasoning. The authors demonstrate the use of the Revised Bloom's Taxonomy to teach thinking skills involved in diagnostic reasoning in a clinical laboratory.

  2. Customer satisfaction survey with clinical laboratory and phlebotomy services at a tertiary care unit level.

    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.

  3. The clinical laboratory in the investigation of hemoglobin disorders

    Lais Pinto de Almeida; Annelise Corrêa Wengerkievicz; Nilceia Maria Viviani; Dulcinéia Martins Albuquerque; Maria Elizabete Mendes; Nairo Massakazu Sumita


    As alterações na síntese da hemoglobina resultam em um grupo de distúrbios hereditários, os quais podem ser classificados como hemoglobina variante, se a alteração tiver origem em uma mutação no gene da hemoglobina, produzindo cadeias anormais, ou como talassemias, se a estrutura é normal, porém a síntese ocorre em quantidade alterada. Este trabalho tem como objetivo descrever a condução do diagnóstico laboratorial de quatro casos de distúrbios da hemoglobina, a fim de ilustrar o papel do lab...

  4. Incidence of ricket clinical symptoms and relation between clinical and laboratory findings in infants

    Čukalović M.


    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.

  5. Professional behaviors, sense of belonging, and professional socialization of early career clinical laboratory scientists

    Schill, Janna Marie

    Professional socialization is a process that individuals experience as members of a profession and consists of the knowledge, attitudes, and experiences that influence and shape their professional identity. The process of professional socialization has not been studied in the clinical laboratory science profession. Clinical laboratory science is an allied health profession that is faced by a workforce shortage that has been caused by a decrease in new graduates, decreased retention of qualified professionals, and increased retirements. Other allied health professions such as nursing, athletic training, and pharmacy have studied professional socialization as a way to identify factors that may influence the retention of early career professionals. This mixed method study, which quantitatively used Hall's Professionalism Scale (1968) in addition to qualitative focus group interviews, sought to identify the professional attitudes and behaviors, sense of belonging, and professional socialization of early career clinical laboratory scientists. Early career clinical laboratory scientists were divided into two groups based upon the amount of work experience they had; new clinical laboratory science graduates have had less than one year of work experience and novice clinical laboratory scientists had between one and three years of work experience. This study found that early career clinical laboratory scientists have established professional identities and view themselves as members of the clinical laboratory science field within four proposed stages of professional socialization consisting of pre-arrival, encounter, adaptation, and commitment. New CLS graduates and novice clinical laboratory scientists were found to be at different stages of the professional stage process. New CLS graduates, who had less than one year of work experience, were found to be in the encounter stage. Novice clinical laboratory scientists, with one to three years of work experience, were found to

  6. Total quality management for clinical laboratories: a need or a new fashion?

    Libeer, J C


    In most European countries, concepts of quality management in medical laboratories have been proposed. These concepts are based on general standards for test laboratories (EN 45001, ISO 25) or specific adapted standards. Improvement of quality lays on the foundation of the implementation of quality systems in medical laboratories. This new approach will have consequences on management style and on working conditions. Efficacy on the implementation can only be tested by external audits. During this audit, not only the quality system and analytical competence must be examined, but also if there is a real contact between pathologists and clinicians and if laboratory results are clinically validated (clinical audit). This new vision on quality in medical laboratories will ask a reconsideration of the tasks, duties and knowledge of clinical pathologists.

  7. Pre-analytical phase in clinical chemistry laboratory

    Neogi SS


    Full Text Available The laboratory testing process is divided into the pre-analytical, analytical and post-analytical phases. For obtaining reliable test results, the prevention and detection of errors at all steps is required. While analytical standards have been developed by recognized quality control criteria, there is a scarcity in the development of standards for the preanalytical phase. This phase is most prone to errors as the steps involved are directly dependent on humans and are out of direct control of the laboratory. Such errors in preanalytical stage often only become apparent in the analytical or post-analytical phase. The development of a pre-analytical quality manual is essential in achieving total quality control. Correct practices and strategies of error prevention can reduce preanalytical errors. This review focuses on prevention of pre-analytical errors that occur while collecting a specimen of blood, urine and cerebrospinal fluid. Most of these can be easily prevented with understanding and education of the personnel involved in and responsible for executing this crucial pre-analytical phase.

  8. 76 FR 78933 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...


    ... interaction with FDA representatives. The program will focus on the relationships among FDA and clinical trial... discussion include the following: (1) What FDA Expects in a Pharmaceutical Clinical Trial; (2) Adverse...

  9. 76 FR 17138 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...


    ... interaction with FDA representatives. The program will focus on the relationships among FDA and clinical trial... include the following: (1) What FDA Expects in a Pharmaceutical Clinical Trial; (2) Adverse...

  10. 76 FR 51040 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...


    ..., in co-sponsorship with the Society of Clinical Research Associates (SoCRA) is announcing a public... Clinical Trial; (2) Adverse Event Reporting--Science, Regulation, Error, and Safety; (3) Part 11 Compliance...

  11. 77 FR 8886 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...


    ...-sponsorship with the Society of Clinical Research Associates (SoCRA) is announcing a public workshop. The... Pharmaceutical Clinical Trial; (2) Adverse Event Reporting--Science, Regulation, Error, and Safety; (3) Part 11...

  12. Clinical, laboratory and electrophysiological features of Morvan's fibrillary chorea.

    Lee, Will; Day, Timothy J; Williams, David R


    Morvan's Fibrillary Chorea (MFC) is a rare autoimmune disorder causally associated with auto-antibodies directed at the voltage-gated potassium channel (VGKC-Abs). It classically presents with sleep disturbances, neuromyotonia and dysautonomia. We aimed to systematically characterise the features of MFC by describing a patient and reviewing published literature. Case notes of 27 patients with MFC (one from our clinic and 26 from the literature) were reviewed and clinical data were extracted and analysed. We found that MFC mainly affects men (96%) and runs a subacute course over months. Neoplasia (56%), VGKC-Abs positivity (79%) and autoimmunity (41%) are frequent associations. Myokymia, insomnia and hyperhidrosis were almost universally described. Other autonomic features were present in 63% with the most common being cardiovascular and bowel disturbances. Clinical, radiological or electroencephalographical features of limbic encephalitis were present in 19% of patients. Outcome was fair with an overall recovery rate of 78%. All patients with malignancies underwent surgery. Immunotherapies including corticosteroids, intravenous immunoglobulins and plasma exchange were instituted in 22 patients and 19 (86%) responded. Of all symptomatic treatments tried, carbamazepine, phenytoin, sodium valproate, levetiracetam and niaprazine were found to be effective. The broad clinical spectrum of VGKC-Abs diseases can make early recognition of MFC difficult. Myokymia, insomnia and hyperhidrosis are invariably present. There may be abnormalities on cerebrospinal fluid testing and VGKC-Abs can occasionally be absent. Early initiation of immunotherapies and malignancy screening are important to prevent adverse outcomes in a condition that generally responds favourably to treatment.

  13. Clinical and laboratory findings in 220 children with recurrent abdominal pain

    C. Gijsbers; M.A. Benninga; H.R. Büller


    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 test

  14. The intelligent clinical laboratory as a tool to increase cancer care management productivity.

    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.


    Jerome H Reichman


    This article describes the growth and consequences of new intellectual property rights given to pharmaceutical developers, and it advocates treating clinical trials as a public good. Although the soaring cost of clinical trials is well known and discussed, too little attention is given to the underlying rationale for allowing drug developers to recoup their costs through the new intellectual property rights provided in multilateral, regional, and bilateral agreements. Known in the US as “mark...

  16. Implementation of a companion diagnostic in the clinical laboratory

    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...... of mutation under study, the sample to be assayed and its preparation procedure. In addition, the results of a molecular assay require a complex interpretation process of the analytical data as the patient's genotype, the translation of the identified variant into a predicted phenotype and knowledge......, as an example, the BRAF genotype analysis in tumor tissue samples for identification of melanoma patients that can benefit treatment with BRAF inhibitors. The manuscript is focused on the following aspects: i) medical rationale, ii) methodologies of analysis, iii) laboratory performance evaluation and iv...

  17. Clinical-Laboratory Parallels in Patients with Demodectic Blepharitis at Cosmecevtic’s Use

    I. B. Medvedev


    positive clinical effect with full 100% elimination of mites is recorded at 2/3 of all patients (60.7%. The efficacy of the cream «Demazol» according to clinical symptoms and laboratory parameters (akarogramm is reduced in patients of an advanced age (over 70 years and in patients with a high level of initial contamination of ticks or mites, from 5 to 15 on 1 eye. Overall, skin tolerance to the cream was good. Irritation after applying the cream was observed in 5 patients.

  18. Experimental Psychopathology: From laboratory studies to clinical practice

    Pierre Philippot


    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.

  19. Genetic, Clinical, and Laboratory Markers for DOCK8 Immunodeficiency Syndrome

    Jeremiah C. Davis


    Full Text Available DOCK8 immunodeficiency syndrome (DIDS is a combined immunodeficiency characterized by recurrent viral infections, severe atopy, and early onset malignancy. Genetic studies revealed large, unique deletions in patients from different families and ethnic backgrounds. Clinical markers of DIDS include atopic dermatitis, allergies, cutaneous viral infections, recurrent respiratory tract infections, and malignancy. Immune assessments showed T cell lymphopenia, hyper-IgE, hypo-IgM, and eosinophilia. The impaired lymphocyte functions in DIDS patients appear central for disease pathogenesis.

  20. Neocollagenesis and Neoelastinogenesis: From the Laboratory to the Clinic

    Mehta-Ambalal, Sujata R


    An internet search was made looking for articles about chemical and physical modalities that are known to induce collagen and elastin formation. Textbooks, independent articles, journals and books on pathology, biochemistry, aesthetic medicine and cosmetic and plastic surgery were used as references. Here, we take a look at various studies, in vitro and in vivo, that lend credence to the products and procedures used in clinical practice to induce neocollagenesis and neoelastinogenesis.

  1. Clinical and laboratorial study of 19 cases of mucopolysaccharidoses

    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.

  2. Sulforaphane: translational research from laboratory bench to clinic.

    Houghton, Christine A; Fassett, Robert G; Coombes, Jeff S


    Cruciferous vegetables are widely acknowledged to provide chemopreventive benefits in humans, but they are not generally consumed at levels that effect significant change in biomarkers of health. Because consumers have embraced the notion that dietary supplements may prevent disease, this review considers whether an appropriately validated sulforaphane-yielding broccoli sprout supplement may deliver clinical benefit. The crucifer-derived bioactive phytochemical sulforaphane is a significant inducer of nuclear factor erythroid 2-related factor 2 (Nrf2), the transcription factor that activates the cell's endogenous defenses via a battery of cytoprotective genes. For a broccoli sprout supplement to demonstrate bioactivity in vivo, it must retain both the sulforaphane-yielding precursor compound, glucoraphanin, and the activity of glucoraphanin's intrinsic myrosinase enzyme. Many broccoli sprout supplements are myrosinase inactive, but current labeling does not reflect this. For the benefit of clinicians and consumers, this review summarizes the findings of in vitro studies and clinical trials, interpreting them in the context of clinical relevance. Standardization of sulforaphane nomenclature and assay protocols will be necessary to remove inconsistency and ambiguity in the labeling of currently available broccoli sprout products. © 2013 International Life Sciences Institute.

  3. The good and the bad of poisonous plants: an introduction to the USDA-ARS Poisonous Plant Research Laboratory.

    Welch, Kevin D; Panter, Kip E; Gardner, Dale R; Stegelmeier, Bryan L


    This article provides an overview of the Poisonous Plant Research Laboratory (PPRL), about the unique services and activities of the PPRL and the potential assistance that they can provide to plant poisoning incidences. The PPRL is a federal research laboratory. It is part of the Agricultural Research Service, the in-house research arm of the U.S. Department of Agriculture. The mission of the PPRL is to identify toxic plants and their toxic compounds, determine how the plants poison animals, and develop diagnostic and prognostic procedures for poisoned animals. Furthermore, the PPRL's mission is to identify the conditions under which poisoning occurs and develop management strategies and treatments to reduce losses. Information obtained through research efforts at the PPRL is mostly used by the livestock industry, natural resource managers, veterinarians, chemists, plant and animal scientists, extension personnel, and other state and federal agencies. PPRL currently has 9 scientists and 17 support staff, representing various disciplines consisting of toxicology, reproductive toxicology, veterinary medicine, chemistry, animal science, range science, and plant physiology. This team of scientists provides an interdisciplinary approach to applied and basic research to develop solutions to plant intoxications. While the mission of the PPRL primarily impacts the livestock industry, spinoff benefits such as development of animal models, isolation and characterization of novel compounds, elucidation of biological and molecular mechanisms of action, national and international collaborations, and outreach efforts are significant to biomedical researchers. The staff at the PPRL has extensive knowledge regarding a number of poisonous plants. Although the focus of their knowledge is on plants that affect livestock, oftentimes, these plants are also poisonous to humans, and thus, similar principles could apply for cases of human poisonings. Consequently, the information provided

  4. [Assessment of the quality of laboratory diagnosis of intestinal parasitic diseases by the laboratories participating in the Federal System of External Quality Assessment of Clinical Laboratory Testing].

    Malakhov, V N; Dovgalev, A S; Astanina, S Iu; Serdiuk, A P


    In 2010-2013, the quality of microscopic detection of the causative agents ofparasitic diseases in the feces has been assessed by the specialists of the laboratories of the therapeutic-and-prophylactic institutions (TPIs) and Hygiene and Epidemiology Centers, Russian Inspectorate for the Protection of Consumer Rights and Human Welfare, which are participants of the Federal System of External Quality Assessment of Clinical Laboratory Testing. Thirty-two specimens containing 16 species of human helminths and 4 species of enteric protozoa in different combinations were examined. The findings suggest that the quality of microscopic detection of the causative agents of parasitic diseases is low in the laboratories of health care facilities and that the specialists of the laboratories of TPIs and Hygiene and Epidemiology Centers, Russian Inspectorate for the Protection of Consumer Rights and Human Welfare, do not not possess the knowledge and skills necessary to make a laboratory diagnosis of helminths and enteric protozoa. The average detection rates of helminths and protozoa were at a level of 64 and 36%, respectively. The correct results showed that the proportion of helminths and protozoa were 94.5 and 5.5%, respectively. According to the biological and epidemiological classification of helminths, there were higher detection rates for contact group parasites (Enterobius vermicularis and Hymenolepis nana) and geohelminths (Ascaris, Trichuris trichiura, and others). Biohelminths (Opisthorchis, tapeworms, and others) Were detectable slightly worse.

  5. Excellence in clinical laboratories: the standard ISO 15189:2007

    Antonio Scipioni


    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

  6. Sesame seed allergy: Clinical manifestations and laboratory investigations

    Fazlollahi MR.


    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.

  7. [The analytical reliability of clinical laboratory information and role of the standards in its support].

    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.

  8. Anaplastic thyroid carcinoma with rhabdomyoblastic differentiation : A case report with a good clinical outcome

    Olthof, Marijke; Persoon, Adrienne C. M.; Plukker, John T. M.; van der Wal, Jacqueline E.; Links, Thera P.


    Anaplastic thyroid carcinoma is a rare and highly malignant disease. Usually, this type of tumor is irresectable, and almost all patients die within 1 year after diagnosis. We present a case of anaplastic thyroid carcinoma with rhabdomyoblastic differentiation and good therapeutic outcome. A 76-year

  9. The Frequency of the Accidental Contamination with Laboratory Samples in Yazd Clinical Laboratories’ personnel in 2011

    Jafari, AA. (PhD


    Full Text Available Background and Objective: laboratory personnel have always accidental exposure to clinical samples, which can cause the transmission of infection. This threat can be prevented and controlled by education for the use of safety instruments. The purpose was to determine the frequency of accidental exposure to laboratory samples among Yazd laboratory personnel in 2011. Material and Methods: This descriptive cross-sectional study was conducted on 100 of Yazd clinical laboratory personnel. The data was collected, using a valid and reliable questioner, via interview and analyzed by means of SPSS software. Results: Eighty-six percent of the subjects reported an experience of accidental exposure to clinical samples, such as blood, serum and urine. The causes were carelessness (41% and work overload (29%. Needle- stick was the most prevalent injury (52% particularly in sampler workers (51% and in their hands (69%. There wasn’t significant relationship between accidental exposure to laboratory samples and the variables such as private and governmental laboratories (p=0.517, kind of employment (p=0.411, record of services (p=0.439 and academic degree (p=0.454. The subjects aged 20-29 (p=0.034 and worked in sampling unit had the highest accidental exposure. Conclusion: based on the results, inexperience of the personnel especially in sampling room, overload at work and ignorance of applying safety instruments are known as the most important reasons for accidental exposure to clinical samples. Keywords: Contamination; accidental Exposure; Infectious agents; laboratory; personnel

  10. Nomenclature and basic concepts in automation in the clinical laboratory setting: a practical glossary.

    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.

  11. Socio-demographic, Clinical and Laboratory Features of Rotavirus Gastroenteritis in Children Treated in Pediatric Clinic

    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

  12. Detection of intestinal protozoa in the clinical laboratory.

    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.

  13. Development and Use of Challenge Exams for Clinical Laboratory Nursing 2: Part 2 Final Report.

    Hattstaedt, Mary Jane; Isaac, Margaret M.

    The report describes the development of a set of equivalency tests for students in Nursing 2 who have had prior clinical laboratory training or experience in pediatrics, obstetrics, or geriatrics. For each of the three areas the examination packet includes: the course clinical objectives, the challenge examination objectives, a self-study guide, a…

  14. 77 FR 26069 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and...


    ... Development and Clinical Science Research and Development Services Scientific Merit Review Board, Notice of... Laboratory Research and Development and Clinical Science Research and Development Services Scientific Merit... science research. The panel meetings will be open to the public for approximately one-half hour at the...

  15. An Enzymatic Clinical Chemistry Laboratory Experiment Incorporating an Introduction to Mathematical Method Comparison Techniques

    Duxbury, Mark


    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…

  16. Theoretical and practical considerations for teaching diagnostic electronic-nose technologies to clinical laboratory technicians

    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...

  17. Good clinical outcomes from a 7-year holistic programme of fistula repair in Guinea

    Delamou, Alexandre; Diallo, Moustapha; Beavogui, Abdoul Habib; Delvaux, Thérèse; Millimono, Sita; Kourouma, Mamady; Beattie, Karen; Barone, Mark; Barry, Thierno Hamidou; Khogali, Mohamed; Edginton, Mary; Hinderaker, Sven Gudmund; Ruminjo, Joseph; Zhang, Wei-Hong; De Brouwere, Vincent


    Objectives Female genital fistula remains a public health concern in developing countries. From January 2007 to September 2013, the Fistula Care project, managed by EngenderHealth in partnership with the Ministry of Health and supported by USAID, integrated fistula repair services in the maternity wards of general hospitals in Guinea. The objective of this article was to present and discuss the clinical outcomes of 7 years of work involving 2116 women repaired in three hospitals across the country. Methods This was a retrospective cohort study using data abstracted from medical records for fistula repairs conducted from 2007 to 2013. The study data were reviewed during the period April to August 2014. Results The majority of the 2116 women who underwent surgical repair had vesicovaginal fistula (n = 2045, 97%) and 3% had rectovaginal fistula or a combination of both. Overall 1748 (83%) had a closed fistula and were continent of urine immediately after surgery. At discharge, 1795 women (85%) had a closed fistula and 1680 (79%) were dry, meaning they no longer leaked urine and/or faeces. One hundred and fifteen (5%) remained with residual incontinence despite fistula closure. Follow-up at 3 months was completed by 1663 (79%) women of whom 1405 (84.5%) had their fistula closed and 80% were continent. Twenty-one per cent were lost to follow-up. Conclusion Routine programmatic repair for obstetric fistula in low resources settings can yield good outcomes. However, more efforts are needed to address loss to follow-up, sustain the results and prevent the occurrence and/or recurrence of fistula. Objectifs La fistule génitale féminine reste un problème de santé publique dans les pays en développement. De janvier 2007 à septembre 2013, le projet Fistula Care, géré par Engender Health en partenariat avec le Ministère de la Santé et soutenu par l’USAID, a intégré les services de réparation de fistules dans les maternités des hôpitaux généraux en Guin

  18. [Vasculitic Peripheral Neuropathies: Clinical Features and Diagnostic Laboratory Tests].

    Ogata, Katsuhisa


    Vasculitic peripheral neuropathy (VPN) occurs due to ischemic changes of peripheral nerves, resulting from a deficit of vascular blood supply due to damaged vasa nervorum leading to vasculitis. VPN usually manifests as sensorimotor or sensory disturbances accompanied by pain, presenting as a type of multiple mononeuropathy, with a scattered distribution in distal limbs. VPN may also present as a mononeuropathy, distal symmetric polyneuropathy, plexopathy, or radiculopathy. The rapidity of VPN is variable, ranging from days to months, with symptoms occasionally changing with the appearance of new lesions. Careful history taking and neurological examination provides an exact diagnosis. The most common cause of VPN is primary vasculitis predominantly affecting small vessels, including vasa nervorum, anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis, and polyarteritis nodosa. Similar vasculitic processes can also result from a systemic collagen disorder or secondary vasculitis. Electrophysiological studies and pathological investigation of biopsied peripheral nerves and muscles are important for diagnosis of vasculitis. Serological tests, including ANCA, are useful for diagnosis of vasculitis. Accurate neurological examinations are essential for diagnosis and evaluation of clinical course.

  19. Neurobrucellosis: Clinical and laboratory findings in 22 patients

    Rasoolinejad M


    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.

  20. Sheehan syndrome: clinical and laboratory evaluation of 20 cases.

    Ozkan, Yusuf; Colak, Ramis


    Sheehan syndrome (SS) or post-partum pituitary necrosis is a pituitary insufficiency secondary to excessive post-partum blood losses. SS is a very significant cause of maternal morbidity and mortality in developing countries although it is a rarity in developed countries in which obstetrical care has been improved. In this study, we reviewed 20 cases retrospectively who were diagnosed as SS in our clinic. The patients aged 40 to 65 years with a mean age of 51.12 +/- 9.44 years (mean +/- SD). Time to make a definitive diagnosis of the disease ranged between 5 and 25 years with a mean of 16.35 +/- 4.74 years. Three of our patient (15%) had a previous diagnosis of SS. Three patients (15%) were referred to emergency service for hypoglycemia, three patients (15%) for hypothyroidism and one patient (5%) for hyponatremia. Dynamic examination of the pituitary revealed GH, Prolactin, FSH, TSH and ACTH insufficiency in all of the patients. One of our patients had a sufficient LH response to LHRH challenge. All of the patients were imaged with pituitary MRI. Eleven patients had empty sella and 9 patients had partial empty sella. SS is still a common problem in our country, especially in rural areas. Considering the duration of disease, important delays occur in diagnosis and treatment of the disease.

  1. The European Register of Specialists in Clinical Chemistry and Laboratory Medicine: guide to the Register, version 3-2010

    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...

  2. PNH revisited: Clinical profile, laboratory diagnosis and follow-up

    Gupta P


    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.




    Full Text Available INTRODUCTION: Malaria is a major health concern across the world and is endemic in our country. It is imperative for us to know the varied manifestations and lab features both classically described and rare features for early detection of this disease and further treatment. This study was undertaken to study the clinical features, lab features and complications of malaria in a tertiary care centre. METHODOLOGY: It is a retrospective study done on 75 cases of confirmed and treated cases of malaria for a period of one year in KIMS hospital, Bangalore. Detailed history examination and lab features of these patients were recorded and analyzed. RESULTS: A total of 75 cases of confirmed malaria were treated during study period of which 57[76%] were males Out of 75 cases 46[61%] had vivax malaria infection, 10[13%] had falciparum infection and 19[26%] had mixed infections of falciparum and vivax. In all 3 groups more number of cases was seen in age group of 18 – 40 years. fever was the major presentation (100% in the patients and Pain abdomen along with fever seen in 15 [20%] patients. Head ache was another predominant complaint in 35[46.6%] On examination Icterus was seen in 11 [14.6%] patients Pallor was seen in 13[17.3%] patients Systolic BP of 2ULN was seen in 9[12%] patients Out of these 6[8%] patients had severe malaria as defined by WHO category of severe malaria. CONCLUSIONS: Being more vigilant and well versed with the varied presentations/lab features of malaria and anticipating complications early, effective treatment can be instituted thus reducing the morbidity and mortality of this endemic disease.

  4. Yeast identification in the clinical microbiology laboratory: phenotypical methods.

    Freydiere, A M; Guinet, R; Boiron, P


    Emerging yeast pathogens are favoured by increasing numbers of immunocompromised patients and by certain current medical practices. These yeasts differ in their antifungal drug susceptibilities, and rapid species identification is imperative. A large variety of methods have been developed with the aim of facilitating rapid, accurate yeast identification. Significant recent commercial introductions have included species-specific direct enzymatic colour tests, differential chromogenic isolation plates, direct immunological tests, and enhanced manual and automated biochemical and enzymatic panels. Chromogenic isolation media demonstrate better detection rates of yeasts in mixed cultures than traditional media, and allow the direct identification of Candida albicans by means of colony colour. Comparative evaluation of rapid methods for C. albicans identification, including the germ tube test, shows that chromogenic media may be economically advantageous. Accurate tests for single species include the Bichrolatex Albicans and Krusei Color tests, both immunologically based, as well as the Remel Rapid Trehalose Assimilation Broth for C. glabrata. Among broad-spectrum tests, the RapID Yeast Plus system gives same-day identification of clinical yeasts, but performance depends on inoculum density and geographic isolate source. The API 20 C AUX system is considered a reference method, but newer systems such as Auxacolor and Fungichrom are as accurate and are more convenient. Among automated systems, the ID 32 C strip, the Vitek Yeast Biochemical Card and the Vitek 2 ID-YST system correctly identify >93% of common yeasts, but the ID-YST is the most accurate with uncommon yeasts, including C. dubliniensis. Spectroscopic methods such as Fourier transformed-infrared spectroscopy offer potential advantages for the future. Overall, the advantages of rapid yeast identification methods include relative simplicity and low cost. For all rapid methods, meticulous, standardized

  5. Clinical and Laboratory Findings of Patients with Breath Holding Spells

    Özlem Özdemir


    Full Text Available Aim: The aim of this prospective study was to evaluate the clinical characteristics; physical findings, cardiological, hematological and neurological problems; treatment approaches; and the prognosis of children with breath holding spells.Materials and Method: Seventhy patients were included in this study. All patients were evaluated with detailed history and physical examination. Complete blood count, serum iron and iron binding capacity were studied; cardiological (telecardiography, electrocardiography, if necessary echocardiography and event recorder and neurological investigations (electroencephalography were done during the admission. Patients with iron deficiency anemia and iron deficiency were treated with ferrous sulphate orally. In patients with normal hematological values, no medication was used. After a two-month treatment period patients underwent control hematological evaluation. Frequency of the spells, age of disappearance of spells (defined as 6 months without spells, disappearance ratios between the three groups were compared. Results: The percentage of cyanotic, palloric and mixt type of breath holding spells of 70 patients included in the study were 67.1, 14.3 and 18.6, respectively. It was determined that psychogenic factors played a role in 77.1% of our patients. There were iron deficiency anemia in 39 (55.7%, iron deficiency in 12 (17.2% and normal hematological parameters in 19 (27.1% of 70 patients. The QTc values were normal in all of them. EEG’s were normal in 56 (80%, dysrhythmic in 11 (15.7% and pathologic in (4.3%. There was a positive family history of breath holding spells in 44.3% of those with breath holding spells. Conclusion: We determined that there was a correlation between the iron levels and the frequency of spells. The lower the iron levels the higher the frequency of spells. There was a dramatic decrease of 92% in spells with low doses of iron supplementation especially in the anemic group. (Journal of

  6. [The issues and basic principles of training of physicians of clinical laboratory diagnostics].

    Morozova, V T; Naumova, E V


    The article considers the main positions concerning the clinical laboratory diagnostics as an independent clinical specialty and the principles of professional training and improvement of specialists. The basic issues complicating the training and improvement of personnel to be kept in line with actual needs of laboratory service of public health system are discussed. Among them are the availability of laboratory academic sub disciplines demanding a profound special theoretical education and technical skills; the need to account in the process of professional training the variety of forms, sizes and types of laboratory structures in different medical institutions; the need of special training programs for numerous specialists with non-medical basic education. The combination of the present system of postgraduate training of specialists on chairs of state educational organizations with initiative involvement of specialists in various public forms of permanent professional improvement (professional scientific societies meetings, research conferences, internet seminars, etc.) is supported Along with a positive appraisal of the existing system of training in the state educational institutions and corresponding regulation documents, a critique is expressed regarding certain actual documents which improperly limit the administrative functions of physicians of clinical laboratory diagnostics and complicate training of bacteriologists for clinical laboratories.


    Reichman, Jerome H


    This article describes the growth and consequences of new intellectual property rights given to pharmaceutical developers, and it advocates treating clinical trials as a public good. Although the soaring cost of clinical trials is well known and discussed, too little attention is given to the underlying rationale for allowing drug developers to recoup their costs through the new intellectual property rights provided in multilateral, regional, and bilateral agreements. Known in the US as "market exclusivity" and in Europe as "data exclusivity," these rights prohibit would-be generic producers from obtaining regulatory approval based on the original producers' undisclosed test data. Market and data exclusivity is codified in US and European domestic law as well as the North American Free Trade Agreement (NAFTA) and, to a lesser degree, the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Market and data exclusivity is binding an increasing number of developing countries via Free Trade Agreements (FTAs), which hinder developing countries from manufacturing generic drugs. At a minimum, negotiators should replace the norm of exclusive control over data with a liability rule, or take and pay rule, in which generic manufacturers can use original manufacturers' clinical trial data in exchange for reasonable compensation. A more fundamental solution requires questioning the status quo of proprietary clinical trial data. The conventional wisdom is that market and data exclusivity, and drug developers' consequent ability to limit competition from generics above and beyond patent protection, are a necessary incentive for drug developers to fund ever more expensive clinical trials. Clinical trial data, however, are public goods that will be undersupplied and over protected so long as private actors provide them. Moreover, manufacturers have an incentive to present clinical trial data so that they support regulatory approval at the expense of public




    This article describes the growth and consequences of new intellectual property rights given to pharmaceutical developers, and it advocates treating clinical trials as a public good. Although the soaring cost of clinical trials is well known and discussed, too little attention is given to the underlying rationale for allowing drug developers to recoup their costs through the new intellectual property rights provided in multilateral, regional, and bilateral agreements. Known in the US as “market exclusivity” and in Europe as “data exclusivity,” these rights prohibit would-be generic producers from obtaining regulatory approval based on the original producers’ undisclosed test data. Market and data exclusivity is codified in US and European domestic law as well as the North American Free Trade Agreement (NAFTA) and, to a lesser degree, the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Market and data exclusivity is binding an increasing number of developing countries via Free Trade Agreements (FTAs), which hinder developing countries from manufacturing generic drugs. At a minimum, negotiators should replace the norm of exclusive control over data with a liability rule, or take and pay rule, in which generic manufacturers can use original manufacturers’ clinical trial data in exchange for reasonable compensation. A more fundamental solution requires questioning the status quo of proprietary clinical trial data. The conventional wisdom is that market and data exclusivity, and drug developers’ consequent ability to limit competition from generics above and beyond patent protection, are a necessary incentive for drug developers to fund ever more expensive clinical trials. Clinical trial data, however, are public goods that will be undersupplied and over protected so long as private actors provide them. Moreover, manufacturers have an incentive to present clinical trial data so that they support regulatory approval at the

  9. "It feels good to be measured": clinical role-play, Walker Percy, and the tingles.

    Ahuja, Nitin K


    A large online community has recently formed around autonomous sensory meridian response (ASMR), a pleasant and poorly understood somatic reaction to specific interpersonal triggers. Its web-based manifestations include a variety of amateur videos designed to elicit the reaction, many of which feature protracted imitations of a clinician's physical exam. This analysis considers through a literary lens the proximity of this phenomenon to clinical diagnostics, focusing in particular on characterizations of spiritual isolation elaborated in Love in the Ruins (1971), the third novel by physician-writer Walker Percy (1916-1990). Within this speculative framework, the tendency to derive pleasure from clinical milieus, real or constructed, may be interpreted as a quality particular to the postmodern psyche. Viewing web-based clinical role-play in light of Percy's writing also underscores the possibility that routine diagnostic assessments may have independent therapeutic implications.

  10. The Study Of Clinical And Laboratory Finding In Wheat Allergy

    Farhoodi. A


    Full Text Available Food allergy is affecting 6-8 percent of infants. Wheat is major source of carbohydrate and protein in the people's nutrition in all worlds and also account for one of six main food allergens in children. The goal of this study is diagnosis of wheat allergic patients and description of its importance for better recognition of this disease."nMaterials and Methods: Among children with different symptoms of allergy (dermatologic - Gastro intestinal and respiratory symptoms referred to Immunology and allergy Department of Markaz Tebbi Kodakan, during one year, 35 cases was suspected to have wheat allergy. Skin prick test and IgE specific with wheat for all of them and open food challenge test with wheat for 11 patients without history of anaphylaxy were done. The criteria for diagnosis was based on a convincing history of anaphylaxis after ingestion of wheat or the positive result in food challenge with wheat in addition to positive skin prick test ( SPT or specific IgE ( Eliza with wheat."nResults: In 35 suspected cases to wheat allergy, SPT in 85/1 percent, specific IgE in 90/3 percent were positive. Food challenge test were done in 11 cases and was positive in 27/2 percent of patients. 24 patients were definitely diagnosed as wheat allergic ones. Anaphylaxis was the predominant clinical feature, accounted for 87 percent of acute symptoms which were repeated for two or more episode in 91 percent of the cases with anaphylaxis. In 50 percent of patients chronic symptoms like asthma and atopic dermatitis were also observed."nConclusion: The mean age of symptom was compatible with time of onset of complementary foods. Therefore, were proposed exclusive breastfeeding without maternal avoidance and not to be introducing wheat in infant regimen until 12 mouth of age. Anaphylaxis was occurred, repeatedly in these patients which demonstrate, in one part, severity of the reactions in our patients and in other part the probable existence of more cases

  11. Guidelines and good clinical practice recommendations for Contrast Enhanced Ultrasound (CEUS) in the liver - update 2012

    Claudon, Michel; Dietrich, Christoph F; Choi, Byung Ihn;


    Medizin/European Journal of Ultrasound for EFSUMB). These guidelines and recommendations provide general advice on the use of all currently clinically available ultrasound contrast agents (UCA). They are intended to create standard protocols for the use and administration of UCA in liver applications...

  12. Variation of topical application to skin under good clinical practice (GCP)

    Vind-Kezunovic, Dina; Serup, Jørgen Vedelskov


    clinical practice (GCP) study designed to investigate the local tolerability and safety on healthy skin of captopril 1% ointment versus a placebo ointment. Volunteers were instructed to apply an even layer of test ointment on a 51 cm(2) test area on the arm twice daily over a 3-week period. At weekly...

  13. Good clinical practice in dubious head trauma – the problem of retained intracranial foreign bodies

    Fischer BR


    Full Text Available Bernhard R Fischer,1 Yousef Yasin,2 Markus Holling,2 Volker Hesselmann31Department of Neurotraumatology, BG-University Hospital Bergmannsheil, Ruhr-University Bochum, Bochum, Germany; 2Department of Neurosurgery, 3Institute for Clinical Radiology, University Hospital of Muenster, Muenster, GermanyObjective: In young people, traumatic head and brain injuries are the leading cause of morbidity and mortality. In some cases, no neurological deficits are present, even after penetrating trauma. These patients have a greater risk of suffering from secondary injuries due to secondary infections, brain edema, and hematomas. We present a case report which illustrates that brain injuries that do not induce neurological deficits can still result in a fatal clinical course and death, with medicolegal consequences.Clinical presentation: A 19-year-old patient was admitted to hospital suffering from a head injury due to an assault. He reported that he was attacked from behind. Medical examination showed no neurological deficits, and only a small occipital wound. Neuroimaging of the cranium revealed that a knife blade was penetrating the cranial bone and touching the superior sagittal sinus.Intervention: After removing the foreign body, magnetic resonance imaging showed that the superior sagittal sinus remained open.Conclusion: We want to stress that possible problems can arise due to the retention of objects in the cranium, while also highlighting the risk of superficial clinical examination.Keywords: head trauma, guidelines, retained object, neuroimaging

  14. [Massive pulmonary artery thromboembolism after removal of sphenoid wing meningioma (clinical case with good outcome)].

    Lubnin, A Iu; Konovalov, A N; Markina, M S; Goriachev, A S


    The paper describes a clinical case of the severe potentially fatal postoperative complication--massive pulmonary thromboembolism--in a patient after uncomplicated removal of meningioma of the wing of os basilare. It also describes the problems in the diagnosis, treatment, prevention of perioperative deep venous thrombosis of the shin and subsequent pulmonary thromboembolism in neurosurgery patients.

  15. Identifying the Clinical Laboratory Tests from Unspecified "Other Lab Test" Data for Secondary Use.

    Pan, Xuequn; Cimino, James J


    Clinical laboratory results are stored in electronic health records (EHRs) as structured data coded with local or standard terms. However, laboratory tests that are performed at outside laboratories are often simply labeled "outside test" or something similar, with the actual test name in a free-text result or comment field. After being aggregated into clinical data repositories, these ambiguous labels impede the retrieval of specific test results. We present a general multi-step solution that can facilitate the identification, standardization, reconciliation, and transformation of such test results. We applied our approach to data in the NIH Biomedical Translational Research Information System (BTRIS) to identify laboratory tests, map comment values to the LOINC codes that will be incorporated into our Research Entities Dictionary (RED), and develop a reference table that can be used in the EHR data extract-transform-load (ETL) process.

  16. [Akita University Graduate School of Medicine: status of clinical laboratory medicine education].

    Ito, Wataru; Chihara, Junichi


    Education in laboratory medicine is important. However, many medical students and doctors cannot understand this importance. This problem may be caused by the unclear character of laboratory medicine in research as well as hospital work, resulting in a lack of staff in the Department of Laboratory Medicine. One of the characters of laboratory medicine is its all-inclusive actions unrestrained by medical specialty. Thus, we tell medical students that the staff of laboratory medicine are suitable members of the infection control team (ICT) and nutrition support team (NST) in lectures. Moreover, we also teach allergy, immunology, infection, and sex-specific medicine, which are some subjects the topics of research. Many students in Akita University recognize that the staff of the Department of Laboratory Medicine are specialists of infection and allergy. On the other hand, young doctors can also receive postgraduate clinical training and conduct research not restricted to allergy and infection. We have a policy whereby the Department of Laboratory Medicine always opens its door widely to everyone including students and doctors. Nine staff joined the Department of Laboratory Medicine of Akita University about ten years, and now, can fully provide students with medical education. To solve some problems regarding education in laboratory medicine, we should promote our roles in medical education as well as in hospitals, and increase the number of staff.

  17. Relevance of basic research to clinical data: good answers, wrong questions!

    Ben-Ari, Yehezkel; Holmes, Gregory L


    Do early seizures beget seizures later in life? Clinical data and experimental observations seem to answer that question differently, with a no and a yes, respectively, which may stem from an inadequate readout of what experimental data actually do tell us and a possible simplification of what clinical data indicate. Using specific experimental examples, it is possible to show that in the developing brain, seizures do produce long-lasting alterations of neuronal excitability, although ongoing seizures are not observed in adults. The findings suggest that the long-lasting changes in developmental programs and network activity that seizures induce do not necessarily lead to epilepsy, unless other events that remain to be identified occur.

  18. Looking good or doing better? Patterns of decoupling in the implementation of clinical directorates.

    Mascia, Daniele; Morandi, Federica; Cicchetti, Americo


    The interest toward hospital restructuring has risen significantly in recent years. In spite of its potential benefits, often organizational restructuring in health care produces unexpected consequences. Extant research suggests that institutional theory provides a powerful theoretical lens through which hospital restructuring can be described and explained. According to this perspective, the effectiveness of change is strongly related to the extent to which innovative arrangements, tools, or practices are adopted and implemented within hospitals. Whenever these new arrangements require a substantial modification of internal processes and practices, resistance to implementation emerges and organizational change is likely to become neutralized. This study analyzes how hospital organizations engage in decoupling by adopting but not implementing a new organizational model named clinical directorate. We collected primary data on the diffusion of the clinical directorate model, which was mandated by law in the Italian National Health Service to improve hospital services. We surveyed the adoption and implementation of the clinical directorate model by monitoring the presence of clinical governance tools (measures for the quality improvement of hospital services) within single directorates. In particular, we compared hospitals that adopted the model before (early adopters) or after (later adopters) the mandate was introduced. Hospitals were engaged in decoupling by adopting the new arrangement but not implementing internal practices and tools for quality improvement. The introduction of the law significantly affected the decoupling, with late-adopter hospitals being less likely to implement the adopted model. The present research shows that changes in quality improvement processes may vary in relation to policy makers' interventions aimed at boosting the adoption of new hospital arrangements. Hospital administrators need to be aware and identify the institutional changes

  19. What makes a good clinical app? Introducing the RCP Health Informatics Unit checklist.

    Wyatt, Jeremy C; Thimbleby, Harold; Rastall, Paul; Hoogewerf, Jan; Wooldridge, Darren; Williams, John


    Doctors increasingly rely on medical apps running on smart phones or tablet computers to support their work. However, these apps vary hugely in the quality of their data input screens, internal data processing, the methods used to handle sensitive patient data and how they communicate their output to the user. Inspired by Donabedian's approach to assessing quality and the principles of good user interface design, the Royal College of Physicians' Health Informatics Unit has developed and piloted an 18-item checklist to help clinicians assess the structure, functions and impact of medical apps. Use of this checklist should help clinicians to feel more confident about using medical apps themselves, about recommending them to their staff or prescribing them for patients. © Royal College of Physicians 2015. All rights reserved.

  20. GOOD or BAD Responder? Behavioural and Neuroanatomical Markers of Clinical Response to Donepezil in Dementia

    Gabriella Bottini


    Full Text Available We explored the neuropsychological and neuromorphometrical differences between probable Alzheimer's disease patients showing a good or a bad response to nine months treatment with donepezil. Before treatment, the neuropsychological profile of the two patient groups was perfectly matched. By the ninth month after treatment, the BAD-responders showed a decline of the MMSE score together with a progressive impairment of executive functions. A voxel-based morphometry investigation (VBM, at the time of the second neuropsychological assessment, showed that the BAD-responders had larger grey and white matter atrophies involving the substantia innominata of Meynert bilaterally, the ventral part of caudate nuclei and the left uncinate fasciculus, brain areas belonging to the cholinergic pathways. A more widespread degeneration of the central cholinergic pathways may explain the lack of donepezil efficacy in those patients not responding to a treatment that operates on the grounds that some degree of endogeneous release of acetylcholine is still available.

  1. Addressing the key communication barriers between microbiology laboratories and clinical units: a qualitative study.

    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.

  2. The characteristics of a good clinical teacher as perceived by resident physicians in Japan: a qualitative study.

    Kikukawa, Makoto; Nabeta, Hiromi; Ono, Maiko; Emura, Sei; Oda, Yasutomo; Koizumi, Shunzo; Sakemi, Takanobu


    It is not known whether the characteristics of a good clinical teacher as perceived by resident physicians are the same in Western countries as in non-Western countries including Japan. The objective of this study was to identify the characteristics of a good clinical teacher as perceived by resident physicians in Japan, a non-Western country, and to compare the results with those obtained in Western countries. Data for this qualitative research were collected using semi-structured focus group interviews. Focus group transcripts were independently analyzed and coded by three authors. Residents were recruited by maximum variation sampling until thematic saturation was achieved. Twenty-three residents participated in five focus group interviews regarding the perceived characteristics of a good clinical teacher in Japan. The 197 descriptions of characteristics that were identified were grouped into 30 themes. The most commonly identified theme was "provided sufficient support", followed by "presented residents with chances to think", "provided feedback", and "provided specific indications of areas needing improvement". Using Sutkin's main categories (teacher, physician, and human characteristics), 24 of the 30 themes were categorized as teacher characteristics, 6 as physician characteristics, and none as human characteristics. "Medical knowledge" of teachers was not identified as a concern of residents, and "clinical competence of teachers" was not emphasized, whereas these were the two most commonly recorded themes in Sutkin's study. Our results suggest that Japanese and Western resident physicians place emphasis on different characteristics of their teachers. We speculate that such perceptions are influenced by educational systems, educational settings, and culture. Globalization of medical education is important, but it is also important to consider differences in educational systems, local settings, and culture when evaluating clinical teachers.

  3. Implementation of External Quality Assessment Scheme in Clinical Chemistry for District Laboratories in Bhutan.

    Jamtsho, Rixin; Nuchpramool, Wilairat


    External Quality Assessment Scheme (EQAS) involves evaluation of a number of laboratories by an outside agency on the performance of a number of laboratories based on their analytical performance of tests on samples supplied by the external agency. In developing countries, establishment of national EQAS by preparing homemade quality control material is a useful scheme in terms of resources and time to monitor the laboratory performance. The objective of this study is to implement an EQAS to monitor the analytical performance of the district laboratories in Bhutan. Baseline information was collected through questionnaires. Lyophilized human serum including normal and abnormal levels were prepared and distributed to 19 participating laboratories. Nine routine analytes were included for the study. Their results were evaluated using Variance index scores (VIS) and Coefficient of variations (CV) was compared with Clinical Laboratory Improvement Act (CLIA) Proficiency Testing Criteria (PT) for each analyte. There was significant decrease in CV at the end of the study. The percentages of results in acceptable VIS as 'A' were 63, 60, 66, 69, 73 and 74, 75, 76 and 79 % in November 2009-July 2010 respectively. From our results, we concluded that, establishment of EQAS through distribution of home-made quality control material could be the useful scheme to monitor the laboratory performance in clinical chemistry in Bhutan.

  4. Comparative genomic hybridization: technical development and cytogenetic aspects for routine use in clinical laboratories.

    Lapierre, J M; Cacheux, V; Da Silva, F; Collot, N; Hervy, N; Wiss, J; Tachdjian, G


    Comparative genomic hybridization (CGH) offers a new global approach for detection of chromosomal material imbalances of the entire genome in a single experiment without cell culture. In this paper, we discuss the technical development and the cytogenetic aspects of CGH in a clinical laboratory. Based only on the visual inspection of CGH metaphase spreads, the correct identification of numerical and structural anomalies are reported. No commercial image analysis software was required in these experiments. We have demonstrated that this new technology can be set up easily for routine use in a clinical cytogenetics laboratory.

  5. Feedback is good or bad? Medical residents’ points of view on feedback in clinical education



    Full Text Available Introduction: Feedback is very important in education and can help quality in the training process and orient the trainees in clinical contexts. This study aimed to assess the residents’ points of view about feedback in clinical education at Shiraz University of Medical Sciences. Methods: The sample of this study included 170 medical residents attending medical workshops in Shiraz University of Medical Sciences. The residents filled a valid and reliable questionnaire containing 21 items on their perceptions of the feedback they got throughout the workshops. The data were analyzed using SPSS version 14. Results: The study revealed that residents, generally, have a positive perception of feedback in their training. The highest score belonged to the items such as “feedback was applicable to future work”, “feedback corrected my behavior”, “feedback worked as a motivation for education” and “feedback was specific in one subject”. Residents who had a negative feedback experience also increased their efforts to learn. The Surgery residents acquired the highest scores while radiology residents got the lowest. The difference between these groups was statistically significant (P = 0.000. Conclusion: The highest mean score belonged to internal medicine residents. This shows that residents believe that obstetrics & gynecology ward is a ward in which the formative assessment is much more powerful in comparison to the other three major wards. The surgery ward received the lowest score for formative assessment and this shows that the feedback in surgery ward is very low.

  6. [Standards, options and recommendations: Good clinical practice in the dietetic management of cancer patients: hospital catering].

    Dayot, F; Bataillard, A; Keré, C; Ducès, F; Bachmann, P; Blanc-Vincent, M P; Besnard, B; Bonneteau, C; Champetier, S; Claude, M; Combret, D; Cometto, F; Duguet, A; Duval, N; Finck, C; Freby-Lehner, A; Garabige, V; Lallemand, Y; Massoud, C; Meuric, J; Montane, C; Poirée, B; Puel, S; Rossignol, G; Roux-Bournay, P; Simon, M; Tran, M


    The "Standards, Options and Recommendations" (SOR) project, started in 1993, involves a collaboration between the Federation of the French Cancer Centres (FNCLCC), the 20 French Regional Cancer Centres, some French public university and general hospitals and private Clinics and medical scientific societies. Its main objective is the development of clinical practice guidelines to improve the quality of health care and outcome for cancer patients. The methodology is based on a literature review followed by a critical appraisal by a multidisciplinary group of experts to produce the draft guidelines which are then validated by specialists in cancer care delivery. To develop clinical practice guidelines for hospital catering for cancer patient using the methodology developed by the Standards, Options and Recommendations project. Data were identified by a literature search of Medline and the reference lists of experts in the groups. After the guidelines were drafted, they were validated by independent reviewers. The main recommendations are: 1) While taking into consideration the specific needs of cancer patients, the dietician is responsible for the hygiene, the sanitary quality of alimentation, the equilibrium and nutritional quality of the hospital catering. 2) Ordering and distribution of meals, and clearing up afterwards contribute to the quality of hospital catering and the personnel who do this should have time and be willing to listen to the patients. 3) The ordering of meals should be adapted to individual patient's requirements and must take into account the patient's medication. 4) The method of transporting the food chosen by the institution (cold or warm method) should be respected. The personnel responsible should receive regular and specific training to use the method correctly. 5) The intake of patients with nutritional follow-up should be reliably and reproducibly evaluated by the personnel after every meal. 6) Patient satisfaction should be assessed

  7. Definition of an XML markup language for clinical laboratory procedures and comparison with generic XML markup.

    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.

  8. Student teachers can be as good as associate professors in teaching clinical skills

    Tolsgaard, Martin G; Gustafsson, Amandus; Rasmussen, Maria B


    ' knowledge and skills. Participants evaluate satisfaction with teaching on nine statements immediately after the teaching. RESULTS: In total 59 first year medical students are included as participants in the experiment. The students taught by student teachers perform just as well as the students taught...... by associate professors and in one skill--catheterization--they perform even better, mean post- minus pre-test scores 65.5 (SD 12.9) vs. 35.0 (SD 23.3), One-way ANOVA, p Student teachers receive significantly more positive evaluations than associate professors on several statements......AIM: The aim of this study is to compare student teachers and clinical associate professors regarding the quality of procedural skills teaching in terms of participants' technical skills, knowledge and satisfaction with the teaching. METHODS: This is an experimental, randomized, controlled study...

  9. Modern multiple myeloma therapy: deep, sustained treatment response and good clinical outcomes.

    Landgren, O; Iskander, K


    In the USA at the beginning of this century, the average overall survival in patients with multiple myeloma was about 3 years. Around that time, three drugs (bortezomib, lenalidomide and thalidomide) were introduced for the treatment of multiple myeloma and, in 2012, carfilzomib received accelerated approval by the US Food and Drug Administration (FDA). Driven by access to better drugs, median overall survival in younger patients (aged 10 years by 2014. The FDA approved 14 new drugs for the treatment of cancer in 2015; four of these were approved for the treatment of myeloma (panobinostat, daratumumab, elotuzumab and ixazomib). In 2015 and 2016, expanded label indications were approved by the FDA for lenalidomide and carfilzomib, respectively. The recent increase in approved, highly effective combination therapies for patients with multiple myeloma has led the way to redefining the goals of therapy. Here, we review and provide a clinical perspective on the treatment goals and management of multiple myeloma in the era of modern therapy. Recent meta-analyses show that minimal residual disease (MRD) negativity is associated with longer progression-free and overall survival in patients with multiple myeloma. With the use of modern combination therapy, large proportions (>60-70%) of newly diagnosed multiple myeloma patients achieve complete responses and MRD negativity. Modern combination therapies induce rapid, deep and sustainable responses (including MRD negativity), supporting a treatment paradigm shift away from palliative two-drug combinations towards the use of modern, potent, three- or four-drug combination regimens in early lines of therapy. Data support the use of modern therapy upfront rather than reserving it for later stages of the disease. As survival time increases with modern combination therapies, development of early reliable surrogate end-points for survival, such as MRD negativity, are needed for expedited read-out of future randomized clinical

  10. Gene silencing by siRNAs and antisense oligonucleotides in the laboratory and the clinic

    Watts, Jonathan K.; Corey, David R.


    Synthetic nucleic acids are commonly used laboratory tools for modulating gene expression and have the potential to be widely used in the clinic. Progress towards nucleic acid drugs, however, has been slow and many challenges remain to be overcome before their full impact on patient care can be understood. Antisense oligonucleotides (ASOs) and small interfering RNAs (siRNAs) are the two most widely used strategies for silencing gene expression. We first describe these two approaches and contrast their relative strengths and weaknesses for laboratory applications. We then review the choices faced during development of clinical candidates and the current state of clinical trials. Attitudes towards clinical development of nucleic acid silencing strategies have repeatedly swung from optimism to depression during the past twenty years. Our goal is to provide the information needed to design robust studies with oligonucleotides, making use of the strengths of each oligonucleotide technology. PMID:22069063

  11. Clinical symptoms and laboratory findings supporting early diagnosis of Crimean-Congo hemorrhagic fever in Iran.

    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.

  12. Synchrony of clinical and laboratory surveillance for influenza in Hong Kong.

    Lin Yang

    Full Text Available BACKGROUND: Consultation rates of influenza-like illness (ILI in an outpatient setting have been regarded as a good indicator of influenza virus activity in the community. As ILI-like symptoms may be caused by etiologies other than influenza, and influenza virus activity in the tropics and subtropics is less predictable than in temperate regions, the correlation between of ILI and influenza virus activity in tropical and subtropical regions is less well defined. METHODOLOGY AND PRINCIPAL FINDINGS: In this study, we used wavelet analysis to investigate the relationship between seasonality of influenza virus activity and consultation rates of ILI reported separately by General Out-patient Clinics (GOPC and General Practitioners (GP. During the periods 1998-2000 and 2002-2003, influenza virus activity exhibited both annual and semiannual cycles, with one peak in the winter and another in late spring or early summer. But during 2001 and 2004-2006, only annual cycles could be clearly identified. ILI consultation rates in both GOPC and GP settings share a similar non-stationary seasonal pattern. We found high coherence between ILI in GOPC and influenza virus activity for the annual cycle, but this was only significant (p<0.05 during the periods 1998-1999 and 2002-2006. For the semiannual cycle high coherence (p<0.05 was also found significant during the period 1998-1999 and year 2003 when two peaks of influenza were evident. Similarly, ILI in GP setting is also associated with influenza virus activity for both the annual and semiannual cycles. On average, oscillation of ILI in GP and of ILI in GOPC preceded influenza virus isolation by approximately four and two weeks, respectively. CONCLUSIONS: Our findings suggest that consultation rates of ILI precede the oscillations of laboratory surveillance by at least two weeks and can be used as a predictor for influenza epidemics in Hong Kong. The validity of our model for other tropical regions needs to be

  13. Measles Outbreak in Macedonia: Epidemiological, Clinical and Laboratory Findings and Identification of Susceptible Cohorts

    Irena T Kondova; Zvonko Milenkovic; Sanja P Marinkovic; Golubinka Bosevska; Gordana Kuzmanovska; Goran Kondov; Sonja Alabakovska; Muller, Claude P.; Hübschen, Judith M


    OBJECTIVES: Despite a 92-99% national vaccination coverage since 2000, the former Yugoslav Republic of Macedonia experienced a large measles outbreak between 2010 and 2011. Here we investigate the characteristics of patients hospitalized during this outbreak at the Clinic of Infectious Diseases in Skopje. METHODS: Epidemiological, clinical and laboratory data of 284 measles patients, including 251 from Skopje (43.80% of the 573 reported cases) and 33 from elsewhere in Macedonia were collected...

  14. Detection of Cryptosporidium and Giardia in clinical laboratories in Europe--a comparative study.

    Manser, M; Granlund, M; Edwards, H; Saez, A; Petersen, E; Evengard, B; Chiodini, P


    To determine the routine diagnostic methods used and compare the performance in detection of oocysts of Cryptosporidium species and cysts of Giardia intestinalis in faecal samples by European specialist parasitology laboratories and European clinical laboratories. Two sets of seven formalin-preserved faecal samples, one containing cysts of Giardia intestinalis and the other, containing oocysts of Cryptosporidium, were sent to 18 laboratories. Participants were asked to examine the specimens using their routine protocol for detecting these parasites and state the method(s) used. Eighteen laboratories answered the questionnaire. For detection of Giardia, 16 of them used sedimentation/concentration followed by light microscopy. Using this technique the lower limit of detection of Giardia was 17.2 cysts/mL of faeces in the best performing laboratories. Only three of 16 laboratories used fluorescent-conjugated antibody-based microscopy. For detection of Cryptosporidium acid-fast staining was used by 14 of the 17 laboratories that examined the samples. With this technique the lower limit of detection was 976 oocysts/mL of faeces. Fluorescent-conjugated antibody-based microscopy was used by only five of the 17 laboratories. There was variation in the lower limit of detection of cysts of Giardia and oocysts of Cryptosporidium between laboratories using the same basic microscopic methods. Fluorescent-conjugated antibody-based microscopy was not superior to light microscopy under the conditions of this study. There is a need for a larger-scale multi-site comparison of the methods used for the diagnosis of these parasites and the development of a Europe-wide laboratory protocol based upon its findings.

  15. Adaptation of the application of good clinical practice depending on the features of specific research projects.

    Bertoye, Pierre-Henri; Courcier-Duplantier, Soizic; Best, Nicolas


    The conduct of clinical trials falls within a strict regulatory framework. The objective of the round table was to develop reasonable recommendations for the implementation of GCP according to the type of research and taking in account the risks and challenges related to this research. Two types of risks have been identified: those related to the characteristics of the research and those related to the impact of the study results. The group designed an evaluation table of these risks. The round table focused its investigations on 3 main themes: monitoring, the investigational medicinal product and undesirable effects. Three methods of monitoring adaptation were analysed in terms of advantages and disadvantages: the gradual approach, the central monitoring, monitoring on the basis of sampling. Examination of the investigational medicinal product focused on the medicinal product circuit. The group recommends using the following 'basic' decision-making tree, which takes three elements into account: 1) is it an investigational medicinal product?, 2) do the trial objectives and design require packaging specific to the research?, 3) is the risk of use higher than that in standard practice? Finally, adaptation of the implementation of GCP in terms of pharmacovigilance appeared very limited and could possibly be considered for the medicinal product, the subject of the research, which already holds a marketing authorisation, and for which the safety profile is well known; in this case, only simplified collection of non-serious adverse events may be envisaged, which may be implemented by designing and using a standard collection listing. The adaptation of the implementation of GCP is possible. This firstly takes into account the characteristics of the research: which objectives/which risks/which challenges. The options in terms of adaptation must be pre-defined, documented and justified; if necessary, they will also be re-assessed in the course of analysis.

  16. A FMEA clinical laboratory case study: how to make problems and improvements measurable.

    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.

  17. Surveying technologists: a novel method for establishing productivity standards in a clinical haematology laboratory.

    Jatoi, A; Jaromin, R; Grzybek, D; Nguyen, P L


    Personnel costs comprise the largest clinical laboratory expense. Yet standards to judge the productivity of personnel have not been established. A survey of the authors' own personnel was conducted to derive productivity standards in the Clinical Hematology Laboratory at the Massachusetts General Hospital, Boston, Massachusetts, USA. Technologists were asked how many white blood cell differentials they could perform in an eight-hour shift. Differential productivity was tracked before and after the survey. Of the respondents, 100 per cent failed to meet their own expectations of productivity. Nine technologists were tracked both before and after the survey was mailed and manifested a significant increase in productivity. These results suggest that technologists are objective in their assessment of their own productivity, that their opinions might be a resource for establishing productivity standards within the laboratory, and that such surveys may serve as motivational tools to augment productivity.

  18. The role of liquid chromatography-tandem mass spectrometry in the clinical laboratory

    van den Ouweland, Johannes M. W.; Kema, Ido P.


    Liquid chromatography coupled to mass spectrometry (LC-MS/MS) is increasingly used as a routine methodology in clinical laboratories for the analysis of low molecular weight molecules. The high specificity in combination with high sensitivity and multi-analyte potential makes it an attractive comple

  19. Computer-aided Diagnosis: How to Move from the Laboratory to the Clinic.

    Ginneken, B. van; Schaefer-Prokop, C.M.; Prokop, M.


    Computer-aided diagnosis (CAD), encompassing computer-aided detection and quantification, is an established and rapidly growing field of research. In daily practice, however, most radiologists do not yet use CAD routinely. This article discusses how to move CAD from the laboratory to the clinic. The

  20. Bridging the gap between clinical failure and laboratory fracture strength tests using a fractographic approach

    Aboushelib, M.N.; Feilzer, A.J.; Kleverlaan, C.J.


    Objective: The aim of this study was to analyze and to compare the fracture type and the stress at failure of clinically fractured zirconia-based all ceramic restorations with that of morphologically similar replicas tested in a laboratory setup. Methods: Replicas of the same shape and dimensions we

  1. The value of clinical and laboratory diagnostics for chest pain patients at the emergency department

    Jellema, Laurens-Jan C.; Backus, Barbra E.; Six, A. Jacob; Braam, Richard; Groenemeijer, Bjorn; van der Zaag-Loonen, Hester J.; Tio, Rene; van Suijlen, Jeroen D. E.


    Background: The focus during the diagnostic process for patients with acute chest pain is to discriminate patients who can be safely discharged from those who are at risk for an acute coronary syndrome (ACS). In this study the diagnostic value of the clinical examination is compared with laboratory

  2. A typology of evidence based practice research heuristics for clinical laboratory science curricula.

    Leibach, Elizabeth K; Russell, Barbara L


    A typology of EBP research heuristics was defined relative to clinical laboratory science levels of practice. Research skills requisite for CLS baccalaureate level are associated mainly with quality control of analytic processes. Research skills at master's level are associated with pre- and post-analytic investigations, as well. Doctoral level CLS practice portends to utilize research skills facilitating quality investigations at the systems level.

  3. Advanced methods for teaching electronic-nose technologies to diagnosticians and clinical laboratory technicians

    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...

  4. Bridging the gap between clinical failure and laboratory fracture strength tests using a fractographic approach

    Aboushelib, M.N.; Feilzer, A.J.; Kleverlaan, C.J.


    Objective: The aim of this study was to analyze and to compare the fracture type and the stress at failure of clinically fractured zirconia-based all ceramic restorations with that of morphologically similar replicas tested in a laboratory setup. Methods: Replicas of the same shape and dimensions

  5. Clinical and laboratory findings of 97 pediatric brucellosis patients in central Turkey.

    Yoldas, Tamer; Tezer, Hasan; Ozkaya-Parlakay, Aslinur; Sayli, Tulin Revide


    Brucellosis is a disease transmitted to humans by consumption of unpasteurized animal milk, or through direct contact with infected animals. The aim of this study was to evaluate clinical, laboratory findings of pediatric patients with brucellosis. Data of 97 patients diagnosed with brucellosis between January 2000 and December 2010 were evaluated retrospectively.

  6. Magnetic resonance imaging of sacroiliitis in early seronegative spondylarthropathy. Abnormalities correlated to clinical and laboratory findings

    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...

  7. Examination of the specific clinical symptoms and laboratory findings of Crimean-Congo hemorrhagic fever

    Cetin Kilinc


    Interpretation & conclusion: It was inferred that certain clinical symptoms and laboratory findings such as fever, headache, widespread body pain, fatigue, leucopenia, nausea, vomiting, high CK levels, thrombocytopenia, AST/ ALT elevation and elevated LDH levels are highly specific and are required to be considered in the definitive diagnosis of CCHF, particularly in regions where this infection is observed as endemic.

  8. 76 FR 38342 - Medicare Program; Clinical Laboratory Fee Schedule: Signature on Requisition


    ...; Clinical Laboratory Fee Schedule: Signature on Requisition AGENCY: Centers for Medicare & Medicaid Services... calendar year 2011 Physician Fee Schedule final rule with comment period that requires the signature of a... the prior policy that the signature of a physician or qualified non-physician practitioner is...

  9. Clinical microbiology: Should microbiology be a clinical or a laboratory speciality?

    Bhattacharya Sanjay


    Full Text Available Clinical microbiology is a specific combination of knowledge, attitude and practice aimed at direct clinical involvement in infectious disease management using the core principles of medical microbiology and clinical medicine. In this article certain areas in microbiology, where a more proactive approach could make a significant difference in clinical outcome has been delineated. The article reiterates the role of a medical microbiologist in a hospital setting. The practices described are the norm in well-organized hospitals. These areas include management of positive blood cultures, management of patients in intensive care units (ICUs, hospital infection control and public health microbiology, development of hospital and community anti-infective policy, organization of clinical-microbiological meetings and provision of emergency out-of-hours service. The implementation of this clinical approach and increased engagement with direct patient care would require changes in existing training structure and working patterns of medical and technical staffs in microbiology.

  10. Laboratory and clinical evaluation of on-site urine drug testing.

    Beck, Olof; Carlsson, Sten; Tusic, Marinela; Olsson, Robert; Franzen, Lisa; Hulten, Peter


    Products for on-site urine drug testing offer the possibility to perform screening for drugs of abuse directly at the point-of-care. This is a well-established routine in emergency and dependency clinics but further evaluation of performance is needed due to inherent limitations with the available products. Urine drug testing by an on-site product was compared with routine laboratory methods. First, on-site testing was performed at the laboratory in addition to the routine method. Second, the on-site testing was performed at a dependency clinic and urine samples were subsequently sent to the laboratory for additional analytical investigation. The on-site testing products did not perform with assigned cut-off levels. The subjective reading between the presence of a spot (i.e. negative test result) being present or no spot (positive result) was difficult in 3.2% of the cases, and occurred for all parameters. The tests performed more accurately in drug negative samples (specificity 96%) but less accurately for detecting positives (sensitivity 79%). Of all incorrect results by the on-site test the proportion of false negatives was 42%. The overall agreement between on-site and laboratory testing was 95% in the laboratory study and 98% in the clinical study. Although a high degree of agreement was observed between on-site and routine laboratory urine drug testing, the performance of on-site testing was not acceptable due to significant number of false negative results. The limited sensitivity of on-site testing compared to laboratory testing reduces the applicability of these tests.

  11. Anemia in inflammatory bowel disease: prevalence, differential diagnosis and association with clinical and laboratory variables

    Rodrigo Andrade Alves

    Full Text Available CONTEXT AND OBJECTIVES:Anemia is the most frequent extraintestinal complication of inflammatory bowel disease. This study aimed to: 1 determine the prevalence of anemia among patients with inflammatory bowel disease; 2 investigate whether routine laboratory markers are useful for diagnosing anemia; and 3 evaluate whether any association exists between anemia and clinical/laboratory variables.DESIGN AND SETTING:Cross-sectional at a federal university.METHODS:44 outpatients with Crohn's disease and 55 with ulcerative colitis were evaluated. Clinical variables (disease activity index, location of disease and pharmacological treatment and laboratory variables (blood count, iron laboratory, vitamin B12 and folic acid were investigated.RESULTS:Anemia and/or iron laboratory disorders were present in 75% of the patients with Crohn's disease and in 78.2% with ulcerative colitis. Anemia was observed in 20.5% of the patients with Crohn's disease and in 23.6% with ulcerative colitis. Iron-deficiency anemia was highly prevalent in patients with Crohn's disease (69.6% and ulcerative colitis (76.7%. Anemia of chronic disease in combination with iron deficiency anemia was present in 3% of the patients with Crohn's disease and in 7% of the patients with ulcerative colitis. There was no association between anemia and disease location. In ulcerative colitis, anemia was associated with the disease activity index.CONCLUSIONS:Most patients present iron laboratory disorders, with or without anemia, mainly due to iron deficiency. The differential diagnosis between the two most prevalent types of anemia was made based on clinical data and routine laboratory tests. In ulcerative colitis, anemia was associated with the disease activity index.

  12. Clinical features and dynamic ordinary laboratory tests differentiating dengue fever from other febrile illnesses in children.

    Chen, Chih-Ho; Huang, Yi-Chuan; Kuo, Kuang-Che; Li, Chung-Chen


    Dengue fever is not easily to be diagnosed before presentation of the classic symptoms. The study aimed to investigate the clinical features and dynamic laboratory tests in pediatric patients to facilitate dengue diagnosis. This retrospective study examined the medical records of all pediatric patients who were clinically suspected to have dengue from June to December 2014. Laboratory-positive dengue cases were confirmed by detecting non-structural protein NS1, reverse transcription-polymerase chain reaction of dengue virus, and dengue-specific IgM seroconversion. Of the 317 pediatric cases clinically suspected of dengue, 205 were laboratory-positive and 112 were laboratory-negative. In laboratory-positive cases, the most common clinical manifestation was skin rash in 156 (76.1%). Leukopenia occurred on days 1-5; thrombocytopenia, on days 2-7; prolonged activated partial thromboplastin time (aPTT), on days 1-4; and elevated transaminase levels, on days 3-11; and low CRP, on days 0-14. The specificity and positive predictive value (PPV) of combining of rash, itching and petechiae increased up to 100%. The PPV of combining of leukopenia, thrombocytopenia, and elevated transaminase levels reached 100% on day 2 as well as days 6-8. Leukopenia, thrombocytopenia, elevated aPTT, elevated transaminase levels, and low CRP could be used to differentiate dengue fever from other febrile illnesses. During dengue epidemics, combinations of the symptoms and laboratory findings are helpful to physicians for accurate diagnosis of dengue fever. Copyright © 2017. Published by Elsevier B.V.

  13. [Manual for the design of non-drug trials in primary care, taking account of Good Clinical Practice (GCP) criteria].

    Joos, Stefanie; Bleidorn, Jutta; Haasenritter, Jörg; Hummers-Pradier, Eva; Peters-Klimm, Frank; Gágyor, Ildikó


    In recent years studies not falling under the German Pharmaceutical Law ("non-drug trials") have also been increasingly expected to be conducted according to Good Clinical Practice (GCP) in order to ensure that uniform standards are maintained for data quality and patient safety. However, simple transfer of the GCP criteria is not always possible and often not useful. Given the fact that research questions regarding non-drug interventions are common in primary care (e.g., general practice), the "Network for Clinical Studies in General Practice" has developed a manual for planning and conducting non-drug trials. This manual is based on the GCP guideline, taking account of the conditions and circumstances in primary care settings. Both structure and relevant content of the manual are presented in the article. (As supplied by the authors).

  14. The laboratory of clinical virology in monitoring patients undergoing monoclonal antibody therapy.

    Cavallo, R


    The relevant efficacy of monoclonal antibodies (mAbs) has resulted in the successful treatment of several diseases, although susceptibility to infections remains a major problem. This review summarizes aspects of the literature regarding viral infections and mAbs, specifically addressing the risk of infection/reactivation, the measures that can reduce this risk, and the role played by the laboratory of clinical virology in monitoring patients undergoing mAb therapy. © 2011 The Author. Clinical Microbiology and Infection © 2011 European Society of Clinical Microbiology and Infectious Diseases.

  15. A Six Sigma approach to the rate and clinical effect of registration errors in a laboratory.

    Vanker, Naadira; van Wyk, Johan; Zemlin, Annalise E; Erasmus, Rajiv T


    Laboratory errors made during the pre-analytical phase can have an impact on clinical care. Quality management tools such as Six Sigma may help improve error rates. To use elements of a Six Sigma model to establish the error rate of test registration onto the laboratory information system (LIS), and to deduce the potential clinical impact of these errors. In this retrospective study, test request forms were compared with the tests registered onto the LIS, and all errors were noted before being rectified. The error rate was calculated. The corresponding patient records were then examined to determine the actual outcome, and to deduce the potential clinical impact of the registration errors. Of the 47 543 tests requested, 72 errors were noted, resulting in an error rate of 0.151%, equating to a sigma score of 4.46. The patient records reviewed indicated that these errors could, in various ways, have impacted on clinical care. This study highlights the clinical effect of errors made during the pre-analytical phase of the laboratory testing process. Reduction of errors may be achieved through implementation of a Six Sigma programme.

  16. Examination of Chinese NiTi wire by a combined clinical and laboratory approach.

    Mohlin, B; Müller, H; Odman, J; Thilander, B


    Chinese NiTi wire was compared with Nitinol and stainless steel wires in a combined laboratory and clinical examination. In the laboratory test, the loading and unloading-deflection properties of the wires were determined in a three-point bending test and their surface properties were studied in a scanning electron microscope. This test attempts to simulate a common clinical situation. The NiTi material showed a non-linear force-deflection relationship. The increase in force from 1 mm deflection and onwards was very slow and the force delivered during unloading from large deflections was almost constant. This behaviour was somewhat different for smaller downward deflections of NiTi wires. Plastic deformation was insignificant. The clinical study confirmed the laboratory results obtained, characterizing a wire material much superior to stainless steel and even superior to Nitinol for alignment purposes. In clinical use, however, the rate of fractures of NiTi wires turned out to be unsatisfactorily high. This disadvantage was not predicted by the three-point bending test. Scanning electron microscopy revealed surface defects and non-metallic inclusions in fractured NiTi wires. A combination of a bending test simulating a clinical situation and surface examination is recommended when new wire materials are to be tested.

  17. Why Public Health Agencies Cannot Depend on Good Laboratory Practices as a Criterion for Selecting Data: The Case of Bisphenol A

    Myers, John Peterson; vom Saal, Frederick S.; Akingbemi, Benson T.; Arizono, Koji; Belcher, Scott; Colborn, Theo; Chahoud, Ibrahim; Crain, D. Andrew; Farabollini, Francesca; Guillette, Louis J.; Hassold, Terry; Ho, Shuk-mei; Hunt, Patricia A.; Iguchi, Taisen; Jobling, Susan; Kanno, Jun; Laufer, Hans; Marcus, Michele; McLachlan, John A.; Nadal, Angel; Oehlmann, Jörg; Olea, Nicolás; Palanza, Paola; Parmigiani, Stefano; Rubin, Beverly S.; Schoenfelder, Gilbert; Sonnenschein, Carlos; Soto, Ana M.; Talsness, Chris E.; Taylor, Julia A.; Vandenberg, Laura N.; Vandenbergh, John G.; Vogel, Sarah; Watson, Cheryl S.; Welshons, Wade V.; Zoeller, R. Thomas


    Background In their safety evaluations of bisphenol A (BPA), the U.S. Food and Drug Administration (FDA) and a counterpart in Europe, the European Food Safety Authority (EFSA), have given special prominence to two industry-funded studies that adhered to standards defined by Good Laboratory Practices (GLP). These same agencies have given much less weight in risk assessments to a large number of independently replicated non-GLP studies conducted with government funding by the leading experts in various fields of science from around the world. Objectives We reviewed differences between industry-funded GLP studies of BPA conducted by commercial laboratories for regulatory purposes and non-GLP studies conducted in academic and government laboratories to identify hazards and molecular mechanisms mediating adverse effects. We examined the methods and results in the GLP studies that were pivotal in the draft decision of the U.S. FDA declaring BPA safe in relation to findings from studies that were competitive for U.S. National Institutes of Health (NIH) funding, peer-reviewed for publication in leading journals, subject to independent replication, but rejected by the U.S. FDA for regulatory purposes. Discussion Although the U.S. FDA and EFSA have deemed two industry-funded GLP studies of BPA to be superior to hundreds of studies funded by the U.S. NIH and NIH counterparts in other countries, the GLP studies on which the agencies based their decisions have serious conceptual and methodologic flaws. In addition, the U.S. FDA and EFSA have mistakenly assumed that GLP yields valid and reliable scientific findings (i.e., “good science”). Their rationale for favoring GLP studies over hundreds of publically funded studies ignores the central factor in determining the reliability and validity of scientific findings, namely, independent replication, and use of the most appropriate and sensitive state-of-the-art assays, neither of which is an expectation of industry-funded GLP

  18. Why public health agencies cannot depend on good laboratory practices as a criterion for selecting data: the case of bisphenol A.

    Myers, John Peterson; vom Saal, Frederick S; Akingbemi, Benson T; Arizono, Koji; Belcher, Scott; Colborn, Theo; Chahoud, Ibrahim; Crain, D Andrew; Farabollini, Francesca; Guillette, Louis J; Hassold, Terry; Ho, Shuk-mei; Hunt, Patricia A; Iguchi, Taisen; Jobling, Susan; Kanno, Jun; Laufer, Hans; Marcus, Michele; McLachlan, John A; Nadal, Angel; Oehlmann, Jörg; Olea, Nicolás; Palanza, Paola; Parmigiani, Stefano; Rubin, Beverly S; Schoenfelder, Gilbert; Sonnenschein, Carlos; Soto, Ana M; Talsness, Chris E; Taylor, Julia A; Vandenberg, Laura N; Vandenbergh, John G; Vogel, Sarah; Watson, Cheryl S; Welshons, Wade V; Zoeller, R Thomas


    In their safety evaluations of bisphenol A (BPA), the U.S. Food and Drug Administration (FDA) and a counterpart in Europe, the European Food Safety Authority (EFSA), have given special prominence to two industry-funded studies that adhered to standards defined by Good Laboratory Practices (GLP). These same agencies have given much less weight in risk assessments to a large number of independently replicated non-GLP studies conducted with government funding by the leading experts in various fields of science from around the world. We reviewed differences between industry-funded GLP studies of BPA conducted by commercial laboratories for regulatory purposes and non-GLP studies conducted in academic and government laboratories to identify hazards and molecular mechanisms mediating adverse effects. We examined the methods and results in the GLP studies that were pivotal in the draft decision of the U.S. FDA declaring BPA safe in relation to findings from studies that were competitive for U.S. National Institutes of Health (NIH) funding, peer-reviewed for publication in leading journals, subject to independent replication, but rejected by the U.S. FDA for regulatory purposes. Although the U.S. FDA and EFSA have deemed two industry-funded GLP studies of BPA to be superior to hundreds of studies funded by the U.S. NIH and NIH counterparts in other countries, the GLP studies on which the agencies based their decisions have serious conceptual and methodologic flaws. In addition, the U.S. FDA and EFSA have mistakenly assumed that GLP yields valid and reliable scientific findings (i.e., "good science"). Their rationale for favoring GLP studies over hundreds of publically funded studies ignores the central factor in determining the reliability and validity of scientific findings, namely, independent replication, and use of the most appropriate and sensitive state-of-the-art assays, neither of which is an expectation of industry-funded GLP research. Public health decisions

  19. Lean six sigma methodologies improve clinical laboratory efficiency and reduce turnaround times.

    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.

  20. Haemolysis: an overview of the leading cause of unsuitable specimens in clinical laboratories.

    Lippi, Giuseppe; Blanckaert, Norbert; Bonini, Pierangelo; Green, Sol; Kitchen, Steve; Palicka, Vladimir; Vassault, Anne J; Plebani, Mario


    Prevention of medical errors is a major goal of healthcare, though healthcare workers themselves have not yet fully accepted or implemented reliable models of system error, and neither has the public. While there is widespread perception that most medical errors arise from an inappropriate or delayed clinical management, the issue of laboratory errors is receiving a great deal of attention due to their impact on the quality and efficiency of laboratory performances and patient safety. Haemolytic specimens are a frequent occurrence in clinical laboratories, and prevalence can be as high as 3.3% of all of the routine samples, accounting for up to 40%-70% of all unsuitable specimens identified, nearly five times higher than other causes, such as insufficient, incorrect and clotted samples. This article focuses on this challenging issue, providing an overview on prevalence and leading causes of in vivo and in vitro haemolysis, and tentative guidelines on identification and management of haemolytic samples in clinical laboratories. This strategy includes continuous education of healthcare personnel, systematic detection/quantification of haemolysis in any sample, immediate clinicians warning on the probability of in vivo haemolysis, registration of non-conformity, completing of tests unaffected by haemolysis and request of a second specimen for those potentially affected.

  1. An audit of serological tests carried out at clinical laboratory of Ayub Teaching Hospital, Abbottabad.

    Ally, Sirajuddin Hassan; Ahmed, Ayesha; Hanif, Ruhila


    Clinical audit is an important tool for reviewing and improving the quality of service in clinical laboratories. Here we present an audit of total serology test requests and the frequency of positive tests out of these in a calendar year. This is an audit of serology tests carried out at Microbiology section of Clinical Laboratory of Ayub Teaching Hospital, Abbottabad. We counted all the serology test requests for the year 2004. These tests requests were grouped month wise. The frequency of positive tests out of the total test requests were calculated. The tests included Widal, Toxoplasma, Brucella, Anti DNA, Anti Nuclear factor (ANF), Rheumatoid Arthritis Factor (RAF), HIV, HBsAg, HCV, Intra Chromatographic Technique for tuberculosis (ICT-TB), Purified Protein Derivative (PPD), Venereal Disease Research Laboratory (VDRL) test, Anti-Streptolysin-O-test (ASOT) and pregnancy test. This audit gives a clear idea of trends of test requests in our hospital. It reflects accuracy of clinicians' judgment in some tests and failure in others, prevalence of different diseases, seasonal variation in number of test requests for some tests and impact of awareness campaigns on attitude of clinicians towards certain diseases. This will help us in planning our laboratory requirements to improve quality.

  2. [Security Management in Clinical Laboratory Departments and Facilities: Current Status and Issues].

    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.

  3. The detection of fake-bad and fake-good responding on the Millon Clinical Multiaxial Inventory III.

    Daubert, S D; Metzler, A E


    The purpose of this study was to examine the effectiveness of the 3 Modifying Indices of the Millon Clinical Multiaxial Inventory III (MCMI-III) in the detection of fake-bad and fake-good responding. The sample consisted of 160 psychiatric outpatients. Paired t tests were performed to examine the effects of instructional set (faking vs. standard instructions). As hypothesized, instructional set produced significant differences on Scale X, Scale Y, and Scale Z in both fake-bad and fake-good analyses. Single-scale cutoff scores were as effective as multiple-scale cutoffs. The overall rates of successful classification indicated moderate effectiveness and utility of the MCMI-III Modifying Indices in the detection of dissimulated responding. When base rates were varied to more closely approximate a general clinical population, overall classification accuracy increased, but identification of faking (positive predictive power) gradually eroded with declining base-rate estimates. At lower base rates of faking, MCMI-III standard cutoff points yielded a high number of false positives.

  4. Cost evaluation of clinical laboratory in Taiwan's National Health System by using activity-based costing.

    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.

  5. [The challenges of standardization in clinical diagnostic laboratories of medical organizations].

    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.

  6. Clinical and laboratory diagnosis of heparin-induced thrombocytopenia: an integrated approach.

    Cuker, Adam


    Heparin-induced thrombocytopenia (HIT) is a clinicopathologic disorder that predisposes to thrombosis. Diagnosis rests on a compatible clinical picture and laboratory evidence of antiplatelet factor 4 (PF4)/heparin antibodies that activate platelets in a heparin-dependent manner. Rapid and accurate diagnosis is paramount to avoid the perils of misdiagnosis. Clinical evaluation may be guided by scoring systems such as the 4Ts and HIT Expert Probability (HEP) score. Laboratory tests include immunoassays, such as the PF4/heparin enzyme-linked immunosorbent assay (ELISA) and functional tests such as the 14C-serotonin release assay and heparin-induced platelet activation assay. Clinical scoring systems and commercially available immunoassays have high sensitivity but modest specificity. Functional assays are more specific, but they are technically demanding. Novel laboratory assays with faster turnaround times, greater specificity, and lesser technical complexity are in development. A Bayesian approach that combines the 4T score and the PF4/heparin ELISA result may be used to estimate the probability of HIT and guide clinical decision making. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

  7. Clinical and Laboratory evaluation of measleslike rash in children and young adults

    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.

  8. Autoverification in a core clinical chemistry laboratory at an academic medical center

    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

  9. Good teacher, good tutor

    Couto LB


    Full Text Available Lucélio B Couto, Gustavo S Romão, Reinaldo B Bestetti  Department of Medicine, University of Ribeirão Preto, Ribeirão Preto, Brazil We have read with great interest the paper by Kassab et al, who have essentially shown that good teachers will be good tutors in a problem-based learning (PBL environment. We have been facing great difficulties to select tutors because there has been no tradition in PBL in our region in the preuniversity teaching. Furthermore, the majority of our teachers have been formed in a discipline-based medical curriculum. Therefore, it is reassuring to learn from the work by Kassab et al that subject-matter mastery is the powerful independent predictor of tutoring skills.  View the original paper by Kassab and colleagues.

  10. Simple Clinical and Laboratory Predictors of Chikungunya versus Dengue Infections in Adults

    Lee, Vernon J.; Chow, Angela; Zheng, Xiaohui; Carrasco, Luis R.; Cook, Alex R.; Lye, David C.; Ng, Lee-Ching; Leo, Yee-Sin


    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 chikungunya with an overall correct classification of 89%. For DHF versus chikungunya using platelets chikungunya infections, but simple clinical and laboratory variables can predict these infections at presentation for appropriate management. PMID:23029573

  11. The EC4 European syllabus for post-graduate training in clinical chemistry and laboratory medicine

    Wieringa, Gijsbert; Zerah, Simone; Jansen, Rob


    Laboratory medicine's practitioners across the European community include medical, scientific and pharmacy trained specialists whose contributions to health and healthcare is in the application of diagnostic tests for screening and early detection of disease, differential diagnosis, monitoring......, management and treatment of patients, and their prognostic assessment. In submitting a revised common syllabus for post-graduate education and training across the 27 member states an expectation is set for harmonised, high quality, safe practice. In this regard an extended 'Core knowledge, skills...... and competencies' division embracing all laboratory medicine disciplines is described. For the first time the syllabus identifies the competencies required to meet clinical leadership demands for defining, directing and assuring the efficiency and effectiveness of laboratory services as well as expectations...

  12. Development of an internal dynamic web site to promote quality assurance in a clinical laboratory.

    Pernet, Pascal; Mario, Nathalie; Vaubourdolle, Michel


    In clinical laboratories, one challenging quality assurance objective is to maintain standardized practices. Meeting this objective entails ensuring information flow, which is necessary to smooth running of the laboratory. To facilitate information flow, we developed an internal quality Web site on our local network. The dynamic generated pages of the site were constructed with EasyPHP v.1.6, a complete freeware package providing PHP dynamic language and databases. The site comprises various sections: general news, specific laboratory units news, documents (quality manual, guidelines, emergency processes), schedules, National Quality Control results, forum, etc. Five to 10 pages are updated each week. This work was facilitated by the use of PHP-written pages and data tables, which enable us to record in real time the operation of our assurance quality project and to improve traceability. This approach could be extended to other aspects of quality management and could help meet the future IS015189 standard requirements.

  13. External quality assessment on detection of hepatitis C virus RNA in clinical laboratories of China

    WANG Lu-nan; ZHANG Rui; SHEN Zi-yu; CHEN Wen-xiang; LI Jin-ming


    Background 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.Methods Serum panels were delivered twice annuatly 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.Results 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 (103 IU/ml). The percentage of results within the range of GM±0.5 log10 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.Conclusions The comparison of these results with the previous study confirms that a regular participation in external quality assessment (EQA) assures the

  14. Experience of quality management system in a clinical laboratory in Nigeria

    Rosemary A. Audu


    Full Text Available Issues: Quality-management systems (QMS are uncommon in clinical laboratories in Nigeria, and until recently, none of the nation’s 5 349 clinical laboratories have been able to attain the certifications necessary to begin the process of attaining international accreditation. Nigeria’s Human Virology Laboratory (HVL, however, began implementation of a QMS in 2006, and in 2008 it was determined that the laboratory conformed to the requirements of ISO 9001:2000 (now 2008, making it the first diagnostic laboratory to be certified in Nigeria. The HVL has now applied for the World Health Organization (WHO accreditation preparedness scheme. The experience of the QMS implementation process and the lessons learned therein are shared here.Description: In 2005, two personnel from the HVL spent time studying quality systems in a certified clinical laboratory in Dakar, Senegal. Following this peer-to-peer technical assistance, several training sessions were undertaken by HVL staff, a baseline assessment was conducted, and processes were established. The HVL has monitored its quality indicators and conducted internal and external audits; these analyses (from 2007 to 2009 are presented herein.Lessons learned: Although there was improvement in the pre-analytical and analytical indicators analysed and although data-entry errors decreased in the post-analytical process, the delay in returning laboratory test results increased significantly. There were several factors identified as causes for this delay and all of these have now been addressed except for an identified need for automation of some high-volume assays (currently being negotiated. Internal and external audits showed a trend of increasing non-conformities which could be the result of personnel simply becoming lax over time. Application for laboratory accreditation, however, could provide the renewed vigour needed to correct these non-conformities.Recommendation: This experience shows that

  15. Microbial contamination of removable prosthodontic appliances from laboratories and impact of clinical storage.

    Williams, D W; Chamary, N; Lewis, M A O; Milward, P J; McAndrew, R


    Decontamination of dental instruments has recently been the subject of considerable debate. However, little information is available on the potential bacterial colonisation of dental appliances returning from dental laboratories and their need for decontamination. This study investigated the extent and nature of microbial contamination of removable prosthodontic appliances produced at different dental laboratories and stored in two clinical teaching units (CTU 1 and CTU 2) of a dental hospital and school. Forty consecutive dental prosthodontic appliances that were being stored under varying conditions in the two clinical teaching units were selected for study; the appliances having been produced 'in-house' (hospital laboratory) or 'out-of-house' (external commercial laboratory). Two appliances, that were known to have undergone decontamination before storage, were used as controls. Swabs were taken according to a standard protocol and transferred to the microbiological laboratory with bacterial growth expressed as colony forming units (cfu) per cm(2). Microbial sampling yielded growth from 23 (58%) of the 40 appliances studied (CTU 1, n = 22; CTU 2, n = 18), with 38% of these having a high level of contamination (>42,000 cfu/cm(2)). The predominant bacteria isolated were Bacillus spp. (57%), pseudomonads (22%) and staphylococci (13%). Fungi of the genus Candida were detected in 38% of the samples. There was no significant difference in contamination of the appliances in relation to either their place of production or the CTU (p >0.05). However, the level of contamination was significantly higher (p = 0.035) for those appliances stored in plastic bag with fluid (n = 16) compared to those stored on models (n = 19). No growth was recovered from the two appliances that had undergone decontamination before storage. The research showed that appliances received from laboratories are often contaminated and therefore there is a need for routine disinfection of such items

  16. Sigma metrics in clinical chemistry laboratory – A guide to quality control

    Usha S. Adiga


    Full Text Available Background: Six sigma is a process of quality measurement and improvement program used in industries. Sigma methodology can be applied wherever an outcome of a process is to be measured. A poor outcome is counted as an error or defect. This is quantified as defects per million (DPM. Six sigma provides a more quantitative frame work for evaluating process performance with evidence for process improvement and describes how many sigma fit within the tolerance limits. Sigma metrics can be used effectively in laboratory services. The present study was undertaken to evaluate the quality of the analytical performance of clinical chemistry laboratory by calculating sigma metrics. Methodology: The study was conducted in the clinical biochemistry laboratory of Karwar Institute of Medical Sciences, Karwar. Sigma metrics of 15 parameters with automated chemistry analyzer, transasia XL 640 were analyzed. The analytes assessed were glucose, urea, creatinine, uric acid, total bilirubin (BT, direct bilirubin (BD, total protein, albumin, SGOT, SGPT, ALP, Total cholesterol, triglycerides, HDL and Calcium. Results: We have sigma values <3 for Urea, ALT, BD, BT, Ca, creatinine (L1 and urea, AST, BD (L2. Sigma lies between 3-6 for Glucose, AST, cholesterol, uric acid, total protein(L1 and ALT, cholesterol, BT, calcium, creatinine and glucose (L2.Sigma was more than 6 for Triglyceride, ALP, HDL, albumin (L1 and TG, uric acid, ALP, HDL, albumin, total protein(L2. Conclusion: Sigma metrics helps to assess analytical methodologies and augment laboratory performance. It acts as a guide for planning quality control strategy. It can be a self assessment tool regarding the functioning of clinical laboratory.

  17. The paediatric change laboratory: optimising postgraduate learning in the outpatient clinic.

    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

  18. The European Register of Specialists in Clinical Chemistry and Laboratory Medicine: guide to the Register, version 3-2010

    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, mor...

  19. [Management and accounting solution required in clinical laboratory department in the hospital and the balanced scorecard (BSC)].

    Takahashi, Toshiro


    This is to describe required accounting knowledge and the techniques for the clinical laboratory department management level people to operate their division from the viewpoint of management. Especially, the necessity and the efficacy of the BSC implementation in the clinical laboratory department are being explained.

  20. Clinical and clinical laboratory correlates in sea otters dying unexpectedly in rehabilitation centers following the Exxon Valdez oil spill

    Rebar, A.H.; Lipscomb, T.P.; Harris, R.K.; Ballachey, B.E.


    Following the Exxon Valdez oil spill, 347 oiled sea otters (Enhydra lutris) were treated in rehabilitation centers. Of these, 116 died, 94 within 10 days of presentation. Clinical records of 21 otters dying during the first 10 days of rehabilitation were reviewed to define the laboratory abnormalities and clinical syndromes associated with these unexpected deaths. The most common terminal syndrome was shock characterized by hypothermia, lethargy, and often hemorrhagic diarrhea. In heavily and moderately oiled otters, shock developed within 48 hours of initial presentation, whereas in lightly oiled otters shock generally occurred during the second week of captivity. Accompanying laboratory abnormalities included leukopenia with increased numbers of immature neutrophils (degenerative left shift), lymphopenia, anemia, azotemia (primarily prerenal), hyperkalemia, hypoproteinemia/hypoalbuminemia, elevations of serum transaminases, and hypoglycemia. Shock associated with hemorrhagic diarrhea probably occurred either as a direct primary effect of oiling or as an indirect effect secondary to confinement and handling in the rehabilitation centers. Lightly oiled otters were less likely to die from shock than were heavily oiled otters (22% vs. 72%, respectively). Heavily oiled otters developed shock more rapidly and had greater numbers of laboratory abnormalities, suggesting that exposure to oil was an important contributing factor.

  1. MALDI-TOF mass spectrometry identification of filamentous fungi in the clinical laboratory.

    Ranque, Stéphane; Normand, Anne-Cécile; Cassagne, Carole; Murat, Jean-Benjamin; Bourgeois, Nathalie; Dalle, Frédéric; Gari-Toussaint, Martine; Fourquet, Patrick; Hendrickx, Marijke; Piarroux, Renaud


    This study aimed to validate the effectiveness of a standardised procedure for the MALDI-TOF mass spectrometry (MS)-based identification on a large sample of filamentous fungi routinely identified in university hospitals' laboratories. Non-dermatophyte filamentous fungi prospectively isolated in the routine activity of five teaching hospitals in France were first identified by conventional methods in each laboratory and then by MS in one centre. DNA sequence-based identification resolved discrepancies between both methods. In this study, of the 625 analysed filamentous fungi of 58 species, 501 (80%) and 556 (89%) were correctly identified by conventional methods and MS respectively. Compared with the conventional method, MS dramatically enhanced the performance of the identification of the non-Aspergillus filamentous fungi with a 31-61% increase in correct identification rate. In conclusion, this study on a large sample of clinical filamentous fungi taxa demonstrates that species identification is significantly improved by MS compared with the conventional method. The main limitation is that MS identification is possible only if the species is included in the reference spectra library. Nevertheless, for the routine clinical laboratory, MS provides the means to attain markedly accurate results in filamentous fungi identification, which was previously restricted to only a few reference laboratories. © 2013 Blackwell Verlag GmbH.

  2. EFLM WG-Preanalytical phase opinion paper: local validation of blood collection tubes in clinical laboratories.

    Lippi, Giuseppe; Cornes, Michael P; Grankvist, Kjell; Nybo, Mads; Simundic, Ana-Maria


    The selection or procurement of blood collection devices in healthcare facilities is often an underestimated issue. This is probably due to different factors including the lack of knowledge of policymakers, hospital administrators and even laboratory managers about the importance of preanalytical quality and phlebotomy process, as well as to the absence of reliable guidelines or recommendations on how to precisely assess the quality of blood collection devices around the globe. With the awareness that a gap remains between manufacturers' and local validation of blood collection devices, the Working Group for Preanalytical Phase (WG-PRE) of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) has drafted a consensus document aimed to provide a set of essential requisites, technical criteria (e.g. presence of physical defects, malfunctioning, safety problems) and clinical issues for supporting laboratory professionals in organization blood collection tubes tenders and validating new devices before local routine implementation. The laboratory professionals should also make sure that the tenders accurately and strictly define the responsibilities for validation experiments and the potential consequences in the case the validation outcome shows that tubes due not fulfill the expectations.

  3. Proposals for the mitigation of the environmental impact of clinical laboratories.

    Lopez, Joseph B; Badrick, Tony


    Laboratories should be aware of the carbon footprint resulting from their activities and take steps to mitigate it as part of their societal responsibilities. Once committed to a mitigation programme, they should announce an environmental policy, secure the support of senior management, initiate documentation, institute a staff training programme, schedule environmental audits and appoint an environmental manager. Laboratories may aspire to be accredited to one of the standards for environmental management, such as the ISO 14000. As environmental and quality issues are linked, the improvement in the environmental management of an organisation will ultimately lead to improved quality system performance. Indeed, environmental management could conceivably come under overall quality management. Although there will be initial costs, good environmental practices can bring savings. Environmental improvement should be based on the 3R concept to reduce, reuse and recycle. Several policy initiatives may be introduced. These include a green purchasing policy for equipment, laboratory furniture and reagents as well as the management of packaging wastes. There are several ways to reduce energy, water usage and wastage. A reduction of test numbers and collection tubes should be attempted. Paper management involves all aspects of 3R. The recycling of solvents and general wastes should be practised where feasible. The construction new laboratories or renovations to existing ones are opportunities to make them more environmentally-friendly. The advocacy of policies to associates and the inclusion of environmentally-friendly conditions on contractors are integral parts of the programme.

  4. Establishing benchmarks and metrics for disruptive technologies, inappropriate and obsolete tests in the clinical laboratory.

    Kiechle, Frederick L; Arcenas, Rodney C; Rogers, Linda C


    Benchmarks and metrics related to laboratory test utilization are based on evidence-based medical literature that may suffer from a positive publication bias. Guidelines are only as good as the data reviewed to create them. Disruptive technologies require time for appropriate use to be established before utilization review will be meaningful. Metrics include monitoring the use of obsolete tests and the inappropriate use of lab tests. Test utilization by clients in a hospital outreach program can be used to monitor the impact of new clients on lab workload. A multi-disciplinary laboratory utilization committee is the most effective tool for modifying bad habits, and reviewing and approving new tests for the lab formulary or by sending them out to a reference lab. Copyright © 2013 Elsevier B.V. All rights reserved.

  5. Using the e-Chasqui, web-based information system, to determine laboratory guidelines and data available to clinical staff.

    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.

  6. Laboratory-based surveillance in the molecular era: the TYPENED model, a joint data-sharing platform for clinical and public health 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, 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.

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

    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


    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, throughp...

  8. Epidemiologival, clinical, pathological and laboratory findings of botulism in cattle in the State of Santa Catarina

    Luciane Orbem Veronezi


    The study was carried out through the epidemiological, clinical, pathological and laboratory findings of botulism in cattle in the state of Santa Catarina, during the period from 1987 to 2008. The data were obtained through information from the files of the Department of Animal Pathology CAV/UDESC and in the properties which the disease continued to occur. In properties with the botulism associated phosphorus deficiency cattle, the animals were kept on native pastures, in most ...

  9. Evaluation of Vitek 2 for identification of yeasts in the clinical laboratory.

    Meurman, O; Koskensalo, A; Rantakokko-Jalava, K


    The Vitek 2 system was compared with conventional assimilation, fermentation and morphological methods for its ability to identify yeast isolates from among 151 clinical specimens and 16 known type culture or quality control strains. An unequivocal identification was obtained for 155 (92.8%) isolates, with low discrimination for nine (5.4%) and false identification for three (1.8%) isolates. All isolates of Candida albicans, Candida glabrata and Candida krusei were identified correctly. It was concluded that the Vitek 2 system offers an excellent alternative for the identification of yeasts in a clinical laboratory.

  10. Role of the clinical pathology laboratory in the evaluation of endometrial carcinomas for Lynch syndrome.

    Djordjevic, Bojana; Broaddus, Russell R


    Molecular diagnostic testing of endometrial carcinomas in the pathology laboratory has recently emerged as a key component of the clinical evaluation of Lynch syndrome in many centers. Testing modalities involve immunohistochemical and PCR-based analyses. This article outlines the routine application of these analyses, provides a practical guide for troubleshooting some of the common technical issues related to their performance, and reviews common pitfalls in their interpretation. Discrepancies between tissue testing and genetic testing results are discussed in the context of the current understanding of endometrial cancer biology. The merits of universal versus targeted tissue testing based on clinical patient history and histological tumor appearance are also addressed.

  11. The European Register of Specialists in Clinical Chemistry and Laboratory Medicine: Code of Conduct, Version 2--2008.

    McMurray, Janet


    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.

  12. The European Register of Specialists in Clinical Chemistry and Laboratory Medicine: guide to the Register, version 3-2010.

    McMurray, Janet


    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.

  13. Meta-analysis of the clinical and laboratory parameters of SFTS patients in China.

    Liu, Miao-Miao; Lei, Xiao-Ying; Yu, Xue-Jie


    Severe fever with thrombocytopenia syndrome (SFTS) is an emerging hemorrhagic fever in East Asia, which is caused by a novel bunyavirus-SFTSV. Many studies have reported the clinical characters of SFTS patients, but the reports were not consistent and a systematic summary of clinical manifestations and laboratory parameters are not available. A comprehensive literature research of Web of Science, PubMed, Wan Fang Data, and Chinese National Knowledge Infrastructure databases was conducted on articles which have described the clinical characters of SFTS patients. Data from selected studies were pooled by using STATA VERSION 12.0 software. Nine articles comprising 844 laboratory-confirmed SFTSV cases were included in this meta-analysis. The pooled case fatality rate was 16% (95% CI: 0.13-0.19). The major clinical characters of patients with SFTSV infection were fever, thrombocytopenia, leucopenia, gastrointestinal symptoms, and central nervous system manifestations. The risk factors for severe disease included bleeding tendency, central nervous system manifestations, elevated serum enzymes, and high viral load. Although there is no specific antiviral therapy for SFTSV infection, symptomatic treatment and supportive therapy including intensive monitoring is the most essential part of case management. The major clinical characters of patients with SFTSV infection were fever, thrombocytopenia, leucopenia and gastrointestinal symptoms, and central nervous system manifestations. The risk factors for severity and fatality among SFTS patients included: old age, CNS manifestations, bleeding tendency, elevated serum enzymes, and high vial load.

  14. Impact of sonography in gouty arthritis: Comparison with conventional radiography, clinical examination, and laboratory findings

    Schueller-Weidekamm, Claudia [Department of Diagnostic Radiology, Medical University of Vienna, Waehringer Guertel 18-20, A-1090 Vienna (Austria)]. E-mail:; 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.

  15. Evaluation of the Beckman Synchron CX4 clinical chemistry analyzer in a hospital laboratory.

    Ambus, T; Korogyi, N; DeCampos, F; Groom, B; Innanen, V T


    The Beckman Synchron CX4 random-access multianalyzer was evaluated in a medium sized hospital laboratory. The instrument does end-point, rate, and multipoint assays and carries on-board reagents for 24 tests. In addition to predefined tests, the instrument can be programmed for 100 user-defined tests; these are stored on the hard disk and can utilize up to three component reagents each. The throughput is 200 tests per hour. There is stat testing capability. In our evaluation, within-run and between-run precision and linearity were good, and no reagent carryover was detected. There was good correlation with the in-house methodology for the 19 tests evaluated. A disadvantage at the time of evaluation was interference by elevated bilirubin on creatinine, phosphorus, uric acid, and triglycerides. This problem of interference is being addressed by the manufacturer.

  16. Application of indices Cp and Cpk to improve quality control capability in clinical biochemistry laboratories.

    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 <2. In contrast to the Cp value for cholesterol, Cpk of cholesterol was lower than 2, indicating a systematic error that should be further investigated. This finding suggests a degree of variation or failure to meet specifications that should be corrected. The study indicated that Cp and Cpk could be applied not only for monitoring variations in quality control, but also for revealing inter-laboratory qualitycontrol capability differences.

  17. The Reproducibility of Changes in Diagnostic Figures of Merit Across Laboratory and Clinical Imaging Reader Studies.

    Samuelson, Frank W; Abbey, Craig K


    In this paper we examine which comparisons of reading performance between diagnostic imaging systems made in controlled retrospective laboratory studies may be representative of what we observe in later clinical studies. The change in a meaningful diagnostic figure of merit between two diagnostic modalities should be qualitatively or quantitatively comparable across all kinds of studies. In this meta-study we examine the reproducibility of relative measures of sensitivity, false positive fraction (FPF), area under the receiver operating characteristic (ROC) curve, and expected utility across laboratory and observational clinical studies for several different breast imaging modalities, including screen film mammography, digital mammography, breast tomosynthesis, and ultrasound. Across studies of all types, the changes in the FPFs yielded very small probabilities of having a common mean value. The probabilities of relative sensitivity being the same across ultrasound and tomosynthesis studies were low. No evidence was found for different mean values of relative area under the ROC curve or relative expected utility within any of the study sets. The comparison demonstrates that the ratios of areas under the ROC curve and expected utilities are reproducible across laboratory and clinical studies, whereas sensitivity and FPF are not. Published by Elsevier Inc.

  18. Variability of Creatinine Measurements in Clinical Laboratories: Results from the CRIC Study

    Joffe, Marshall; Hsu, Chi-yuan; Feldman, Harold I.; Weir, Matthew; Landis, J.R.; Hamm, L. Lee


    across laboratories necessitates calibration of SCr measures to a common standard. Failing to do so may substantially affect study eligibility and clinical interpretations when they are determined by Cr-based estimates of GFR. PMID:20389058

  19. [Analysis of good practices for inhabitant participation in the clinical management units of the Andalusian Health Service (Spain)].

    Gómez Martínez, M Eugenia; Pastor Moreno, Guadalupe; Pérez Corral, Olivia; Iriarte de Los Santos, M Teresa; Mena Jiménez, Ángel Luis; Escudero Espinosa, M Cecilia; García Romera, Inmaculada; Blanco García, Martín Germán; Martín Barato, Amelia

    To discover good practices for inhabitant participation in the clinical management units (CMUs) of the Andalusian Health Service (AHS) (Spain) and to explore the reasons perceived by CMU and AHS professionals that may influence the presence and distribution of those good practices among the CMU. Study with mixed methodology carried out in Andalusia (Spain) in two phases (2013-2015). Firstly, an online survey was delivered to the Directors of the CMUs which had set up an inhabitant participation commission. In a second phase, a qualitative study was carried out through semi-structured interviews with professionals from the Andalusian Health Service with previous experience in inhabitant participation. A descriptive analysis of the quantitative information and a semantic content analysis of the qualitative information were carried out. 530 CMUs took part in the survey. The inhabitant participation practices more often implemented in the CMUs are those related to the informing and consultation levels. Twelve professionals were interviewed in the second phase. Other practices with higher inhabitant involvement and delegation are secondary. The barriers which were identified by professionals are related to the beliefs and attitudes of the inhabitants, the professionals, the health system and the environment. The main practices for inhabitant participation in the CMUs are related to the most basic levels of participation. The method and dynamics which facilitate inhabitant empowerment within the health system are not clearly recognised. Copyright © 2016 SESPAS. Publicado por Elsevier España, S.L.U. All rights reserved.

  20. Good clinical practice guide for opioids in pain management: the three Ts - titration (trial, tweaking (tailoring, transition (tapering

    Flaminia Coluzzi


    Full Text Available ABSTRACT BACKGROUND AND OBJECTIVES: Achieving good clinical practice in the use of opioids as part of a comprehensive pain management regimen can face significant challenges. Despite guidelines from governmental and pain society/organization sources, there are still significant hurdles. A review of some basic tenets of opioid analgesia based on current published knowledge and experiences about this important healthcare imperative is warranted. CONTENT: Consistent with guidelines, the literature supports using the lowest total opioid dose that provides adequate pain control with the fewest adverse effects. Titration (or trial during opioid initiation is a way of starting low and going slow (and assessing the appropriateness of a specific opioid and formulation. Recognizing that multiple factors contribute to an individual's personal experience of pain, the physical, psychological, social, cultural, spiritual, pharmacogenomic, and behavioral factors of the individual patient should be taken into account (tweaking, or tailoring. Finally, for those patients for whom transition (tapering from opioid is desired, doing so too rapidly can have negative consequences and minimization of problems during this step can be achieved by proper tapering. CONCLUSION: We conclude that a simultaneously aggressive, yet conservative, approach is advocated in the literature in which opioid therapy is divided into three key steps (the 3 T's: titration (or trial, tweaking (or tailoring, and transition (or tapering. Establishment of the 3 T's along with the application of other appropriate good medical practice and clinical experience/judgment, including non-pharmacologic approaches, can assist healthcare providers in the effort to achieve optimal management of pain.

  1. Clinical and Laboratory Presentation of Hairy Cell Leukemia (Hcl and Rate of Response to Cladribine

    M Forat Yazdi


    Full Text Available Introduction: HCL is a rare malignant condition that is curable if diagnosed early. HCL can present with reduced blood cells and splenomegaly which maybe misdiagnosed with other conditions. The aim of the present study was to determine the frequency of early clinical and laboratory findings as well as the response rate of patients to the standard treatment regimen of Cladribine. Methods: The study was an uncontrolled clinical trial including 25 HCL patients referring to Oncology Clinics of Shahid Sadoughi (Yazd - Iran and Shahid Beheshti (Tehran - Iran between 1999 and 2005. Data was gathered by a pre–designed questionnaire. 21 out of 25 patients were treated with Cladribine and the clinical and laboratory response was assessed. Results: Of the 25 patients studied, 20 patients (80% were male and 5 patients (20% were female. Most of the patients at diagnosis were 55–67 years old and the most common presenting symptom was fatigue and lassitude secondary to anemia. Two patients were asymptomatic and were diagnosed incidentally. Splenomegaly was the main clinical finding which was present in about 80% of the males and all of the females. Accordingly, hairy cells in the peripheral blood smear, leukopenia and anemia were the most common laboratory findings. In contrast to previous results, pancytopenia was found in only 60% of the patients. Response rate was 90% (19 out of 21 of which 61.9% (13 patients and 28.5% (6 patients had complete remission (CR and partial remission (PR, respectively. Conclusion: According to the results, it can be concluded that HCL should be considered as a possible diagnosis in the context of fatigue, splenomegaly and reduced blood cell count. The results of the present study were similar to other similar international studies.

  2. [The clinical immunology laboratory in diagnosis and monitoring of systemic lupus erythematosus and connective tissue diseases].

    Sinico, R A; Radice, A


    The laboratory and particularly clinical immunology laboratories have an essential role in diagnosing and monitoring systemic lupus erythematosus (SLE), as well as other connective tissue diseases. The role of the clinical immunology laboratory in these diseases is to confirm or exclude diagnosis, to monitor disease activity, and to identify subgroup of patients. To obtain the best results in terms of diagnostic performance and clinical usefulness, the following recommendations should be fulfilled: anti-nuclear antibodies (ANA) determination by indirect immunofluorescence on Hep-2 cells is an effective screening assay in patients with clinical features of SLE. A negative ANA test makes the diagnosis of SLE unlikely. Anti-dsDNA antibodies are highly specific for SLE and are associated with renal involvement. The method of choice for anti-dsDNA is the Farr assay; however, the necessity of using radioactive materials reduces its applicability. As an alternative, immunofluorescence on Crithidia Luciliae can be used in the diagnostic phase due to its high specificity. The detection of antibodies to extractable nuclear antigens (ENA) and to phospholipids (lupus anticoagulant and anti-cardiolipin antibodies) is useful in identifying subgroups of patients at risk for some clinical manifestations. Anti-dsDNA measurement with a quantitative assay (the Farr assay or ELISA) is currently the best method to monitor disease activity along with complement levels. New assays (anti-C1q and anti-nucleosome antibodies) have been recently proposed for the diagnosis (anti-nucleosome) and monitoring of SLE patients (anti-C1q and anti-nucleosome antibodies), with promising results.

  3. Measurement of cholesterol and other lipoprotein constituents in the clinical laboratory.

    Warnick, G R


    Measurements of lipids and lipoproteins in the clinical laboratory have become increasingly important because of their predictive association with cardiovascular diseases, especially coronary artery disease. The US National Institutes of Health-sponsored National Cholesterol Education Program and counterparts in other countries have developed national consensus guidelines for diagnosis and treatment of coronary artery disease which provide risk cut-points and define use of the lipid/lipoprotein analytes in case finding and therapy. Total and low density lipoprotein cholesterol and triglycerides are measured as positive risk factors and high density lipoprotein cholesterol as an inverse risk factor for coronary artery disease. A National Cholesterol Education Program-sponsored expert laboratory panel has developed guidelines for measurements with requisite analytical performance targets for total error and corresponding precision and bias. The US Centers for Disease Control and Prevention have established reference methods for total and high density lipoprotein cholesterol and for triglycerides, with a method for low density lipoprotein cholesterol in development. Standardization programs for research laboratories and a Cholesterol Reference Method Laboratory Network for diagnostic manufacturers and clinical laboratories provide reliable access and documentation of traceability to accepted reference methods. Methods for the lipid/lipoprotein analytes have improved dramatically in recent years and, coupled with improved chemistry analyzer systems and more attention to standardization by manufacturers, offer considerable improvement in analytical performance. Fully automated homogeneous assays for high density lipoprotein cholesterol and newer similar assays for low-density lipoprotein cholesterol have potential for better precision as well as more convenient and cost-effective measurements. Attention to pre-analytical sources of variation is also important in making

  4. [Histological view of ethics in medicine and handling of residual samples in clinical laboratories].

    Yoshida, Hiroshi


    One of the important ethical issues in clinical laboratory medicine is whether organs and/or specimens should belong to the examinees. Tracing back to ancient Greece, an episode of the death of Asklepios, killed by Zeus to revive the dead, and the great contribution of Hippocrates to medicine including the vow and ethics of medicine, have been described. In the relationship between doctors and patients, the former had been superior to the latter for more than 2400 years, however, the situation has been changing from that to the same position since 1960th, along with the development of bioethics from medical ethics. For the promotion of bioethics, world medical associations have contributed declarations and continuous discussion. The declarations are based on the avoidance of actions detrimental to the life, health, privacy or dignity of examinees. On the medical use of human organs and specimens in relation to human rights, the mind and the body, discussion has continued, however, a consensus on the details has not been reached. A view on the use of residual samples for methodological study, teaching and research in the clinical laboratory was proposed by the Japanese Society of Laboratory Medicine in 2002. Briefly, it included confidentiality of the laboratory staff, responsibility of the laboratory director, the absence of a necessity to obtain consent for the use of residual samples for methodological study when they are made anonymous or pooled, and the recommendation to obtain a judgement by an ethics committee for research use. The background and discussion for the proposal and the current situation on how to obtain consent from patients in Japan are mentioned.

  5. Simple clinical and laboratory predictors of Chikungunya versus dengue infections in adults.

    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.

  6. Accuracy of the Clinical Diagnosis of Vaginitis Compared to a DNA Probe Laboratory Standard

    Lowe, Nancy K.; Neal, Jeremy L.; Ryan-Wenger, Nancy A.


    Objective To estimate the accuracy of the clinical diagnosis of the three most common causes of acute vulvovaginal symptoms (bacterial vaginosis, candidiasis vaginitis, and trichomoniasis vaginalis) using a traditional, standardized clinical diagnostic protocol compared to a DNA probe laboratory standard. Methods This prospective clinical comparative study had a sample of 535 active duty United States military women presenting with vulovaginal symptoms. Clinical diagnoses were made by research staff using a standardized protocol of history, physical examination including pelvic examination, determination of vaginal pH, vaginal fluid amines test, and wet-prep microscopy. Vaginal fluid samples were obtained for DNA analysis. The research clinicians were blinded to the DNA results. Results The participants described a presenting symptom of abnormal discharge (50%), itching/irritation (33%), malodor (10%), burning (4%), or others such as vulvar pain and vaginal discomfort. According to laboratory standard, there were 225 cases (42%) of bacterial vaginosis 76 cases (14%) of candidiasis vaginitis, 8 cases (1.5%) of trichomoniasis vaginalis, 87 cases of mixed infections (16%), and 139 negative cases (26%). For each single infection, the clinical diagnosis had a sensitivity and specificity of 80.8% and 70.0% for bacterial vaginosis; 83.8% and 84.8% for candidiasis vaginitis; and 84.6% and 99.6% for trichomoniasis vaginalis when compared to the DNA probe standard. Conclusion Compared to a DNA probe standard, clinical diagnosis is 81-85% sensitive and 70- 99% specific for bacterial vaginosis, candida vaginitis, and trichomoniasis. Even under research conditions that provided clinicians with sufficient time and materials to conduct a thorough and standardized clinical evaluation, the diagnosis and therefore, subsequent treatment of these common vaginal problems remains difficult. PMID:19104364


    A.D. Sialakouma; Palmer, G A; M. Botsaki; X. Papanikou; N.M. Vaxevanidis


    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 laboratori...


    A.D. Sialakouma; Palmer, G A; M. Botsaki; X. Papanikou; N.M. Vaxevanidis


    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 laboratori...

  9. 50th anniversary of Clinical Chemistry and Laboratory Medicine--a historical overview.

    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.

  10. Procedural elements involved in maintaining bioanalytical data integrity for good laboratory practices studies and regulated clinical studies

    James, Christopher A.; Hill, Howard M.


    This article describes procedural elements involved in ensuring the integrity of bioanalytical data. These elements can be divided into 3 areas. First, there are those ensuring the integrity of the analyte until analysis, through correct sample collection, handling, shipment, and storage procedures. Incorrect procedures can lead to loss of analyte via instability, addition of analyte through contamination or instability of related metabolites, or changes in the matrix composition that may adv...

  11. Implementation of the OECD principles of good laboratory practice in test facilities complying with a quality system accredited to the ISO/IEC 17025 standard

    Feller, Etty


    Laboratories with a quality system accredited to the ISO/IEC 17025 standard have a definite advantage, compared to non-accredited laboratories, when preparing their facilities for the implementation...

  12. Meningococcal meningitis: clinical and laboratorial characteristics, fatality rate and variables associated with in-hospital mortality

    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.

  13. Study on fatty liver diagnosed by abdominal ultrasonography and clinical laboratory findings

    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.

  14. Clinical, laboratory and ultrasonographic findings in Egyptian buffalo (Bubalus bubalis with caecal and colonic dilatation

    Arafat Khalphallah


    Full Text Available The present study was conducted to describe the clinical, laboratory and ultrasonographic findings of caecal and colonic dilatation in Egyptian buffalo (Bubalus bubalis. A total number of forty buffaloes were included in the study and divided into two groups: control group (n = 20 and diseased group (n = 20. Diseased buffalo were admitted to the Veterinary Teaching Hospital at Assiut University-Egypt. Each of the diseased animals was subjected to clinical, rectal, laboratory and ultrasonographic examinations. Clinically, buffalo with dilated caecum/colon showed reduced appetite, distended right abdomen, abdominal pain and tensed abdomen. Rectal examination indicated empty rectum with the presence of mucus and dilated loop of caecum and/or colon. Buffalo with dilated caecum/colon showed significant (P < 0.05 hypoproteinemia and hypoalbuminemia with significant (P < 0.05 increase in blood serum activities of aspartate aminotransferase (AST and alkaline phosphatase (ALK. Ultrasonographically, the dilated caecum and proximal loop of colon occupied the last right three intercostal space (ICSs particularly their ventral part, intertangled with the liver dorsally in these ICSs. Dilated colon did not hinder the visibility of the liver. The dilated caecum/colon also filled the whole right flank region, with hiding of right kidney, loops and peristaltic movement of the small intestines. The closest wall of the dilated caecum and proximal loop of the colon was imaged as thick semi-circular echogenic line. The furthest wall and contents of dilated caecum/colon were not imaged. In conclusion, buffalo with caecal and/or colonic dilatation have non-specific clinical and laboratory findings; however the affected animals show characteristic ultrasonographic findings.

  15. Time study of clinical and nonclinical workload in pathology and laboratory medicine.

    Trotter, Martin J; Larsen, Erik T; Tait, Nicholas; Wright, James R


    We describe a detailed, cross-sectional, self-report time study of laboratory physician tasks in a regionalized, multisite academic setting, using custom data collection templates programmed into personal digital assistants (PDAs). The 7-week study was completed by 56 medical and scientific staff (86% participation rate). Participants recorded 12,781 PDA entries of specific tasks completed during the study period. The mean number of entries per worked day per participant was 8.14 (range, 1.96-14.33). Study results demonstrated that professional staff worked, on average, 53.5 hours per week. Percentage work time spent in each activity area was as follows: clinical, direct, 50.6%; administration, 18.5%; clinical, indirect, 9.5%; research, 8.2%; learning/continuing education, 5.3%; teaching, 4.9%; and quality assurance, 3.1%. These percentages varied significantly by laboratory medicine subspecialty and by type of academic appointment. The findings confirm that activities not directly involved with patient care, such as administration, quality assurance, teaching, research, and professional development, typically occupy 40% to 50% of a laboratory physician's time.

  16. Hypereosinophilic syndrome: Clinical, laboratory, and imaging manifestations in patients with hepatic involvement

    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.

  17. Three cases of CLIPPERS: a serial clinical, laboratory and MRI follow-up study.

    Kastrup, O; van de Nes, J; Gasser, T; Keyvani, K


    The aim of the study was to further determine the pathophysiology, clinical course, MRI-features and response to therapy of chronic lymphocytic inflammation with pontine perivascular enhancement responsive to steroids (CLIPPERS), which has recently been proposed as a rare chronic inflammatory central nervous system disorder responsive to immunosuppressive therapy. Three patients with this rare entity underwent serial clinical and bimonthly MRI follow-up over a period of up to 16 months. Extensive laboratory work-up and brain biopsy were performed. Intravenous methylprednisolone or oral dexamethasone was administered as treatment, additionally cyclophosphamide in one patient. Clinically, diplopia, nystagmus, ataxia and facial paresthesia were the cardinal symptoms. Magnetic resonance imaging (MRI) disclosed patchy spot-like gadolinium enhancement in a "salt-and-pepper like appearance" in the pons, midbrain and cerebellum, in two cases with thalamic and in the other with spinal involvement. Brain biopsies demonstrated a predominantly angiocentric but also diffuse infiltration pattern by small mature lymphocytes. Treatment with steroids led to rapid clinical improvement and marked resolution of MRI lesions. As discontinuation of steroids led to clinical relapse, one patient was treated with a further course of steroids and the other with steroids and cyclophosphamide as immunosuppressive therapy. This led to stable remission with only mild clinical residue and normalization of MRI. Extensive laboratory and radiological work-up could not identify any other cause of the disease. Of note, in two cases a marked elevation of IgE in serum was found initially and throughout the course. CLIPPERS seems to be a distinct inflammatory central nervous system disorder. It shows characteristic MRI core features. Extrapontine involvement seems to be frequent. Histologically it is characterised by predominantly angiocentric infiltration by small mature lymphocytes. A pathogenetic

  18. Clinical results of stereotactic hellium-ion radiosurgery of the pituitary gland at Lawrence Berkeley Laboratory

    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.

  19. Physicochemical inactivation of Lassa, Ebola, and Marburg viruses and effect on clinical laboratory analyses

    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.

  20. Application of PCR-based methods for diagnosis of intestinal parasitic infections in the clinical laboratory.

    Verweij, Jaco J


    For many years PCR- and other DNA-based methods of pathogen detection have been available in most clinical microbiology laboratories; however, until recently these tools were not routinely exploited for the diagnosis of parasitic infections. Laboratories were initially reluctant to implement PCR as incorporation of such assays within the algorithm of tools available for the most accurate diagnosis of a large variety of parasites was unclear. With regard to diagnosis of intestinal parasitic infections, the diversity of parasites that one can expect in most settings is far less than the parasitological textbooks would have you believe, hence developing a simplified diagnostic triage is feasible. Therefore the classical algorithm based on population, patient groups, use of immuno-suppressive drugs, travel history etc. is also applicable to decide when to perform and which additional techniques are to be used, if a multiplex PCR panel is used as a first-line screening diagnostic.

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

    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.

  2. Choosing the right laboratory: a review of clinical and forensic toxicology services for urine drug testing in pain management.

    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.

  3. Assessment of noise levels in clinical and laboratory areas of dental teaching institution, Ahmedabad

    Sujal M Parkar


    Full Text Available Aim: To measure and assess the noise levels produced by different dental equipments. Materials and Methods: Measurement of the noise level was performed in preclinics, clinics, and dental laboratory of different departments of Ahmedabad Dental College and Hospital. The noise levels were determined using a Mini sound meter (CEM USA, which was placed at the dentist′s and laboratory technician′s ear level and at a distance of 1 m from a main noise source. The level of noise was measured in decibel (dB while the instruments were at maximum running speed. Results: In dental laboratory, the nosiest dental equipment was gypsum lathe trimmer with the noise level ranging from 87.36 to 98.3 dB. In preclinical area, the sound produced by low-speed air-rotor ranges from 66.68 to 69.28 dB. In clinical areas, the highest noise produced was by high-speed air-rotor (73.36 to 81.8 dB. The noise created by suction pump when in contact with mucosa was in range from 73.1 to 80.32 dB. The noise levels generated during cutting were significantly higher (P < 0.05 than those of noncutting, which was proved in the course of the measurements. Conclusion: At the end of the study it can be concluded that the sound levels are below that causes damage to the human ear (85 dB. However, dental technicians and other personnel working all day in noisy laboratories could be at risk of Noise-Induced Hearing Loss if they did not choose not to wear ear protection.

  4. Clinical and laboratory signs associated to serious dengue disease in hospitalized children

    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.

  5. Gender and Ethnicity Based Differences in Clinical and Laboratory Features of Myasthenia Gravis

    Fawzi Abukhalil


    Full Text Available Background. Previous reports describe ethnicity based differences in clinical and laboratory features between Caucasians and African Americans with myasthenia gravis. However, it is not known whether these findings apply to other ethnicities. Methods. Retrospective analysis of all patients treated for myasthenia gravis during a three-year period at a community based medical center. Results. A total of 44 patients were included, including 19 of Hispanic, 16 of African American, 6 of Caucasian, and 3 of Asian ethnicities. Female gender was more common among those with Hispanic, Asian, and African American ethnicities compared to Caucasian ethnicity (p=0.029. Anti-acetylcholine receptor antibody subtypes demonstrated no significant ethnicity based differences in either generalized or ocular myasthenia gravis. A trend was noted towards greater frequency of blocking antibodies among Hispanics (52.6% compared to African American (37.5% and Caucasian (33.3% patients (p=0.059. Generalized but not ocular myasthenia patients showed greater frequency of anti-muscle specific kinase antibodies in Asians and Hispanics compared to African Americans and Caucasians (p=0.041. Conclusions. The results of this study support the existence of ethnicity based differences in clinical and laboratory features of myasthenia gravis. Further study of genetic factors influencing clinical features of myasthenia gravis is indicated.

  6. Age of onset influences on clinical and laboratory profile of patients with systemic lupus erythematosus.

    Sassi, Rafael Hennemann; Hendler, Jordana Vaz; Piccoli, Giovana Fagundes; Gasparin, Andrese Aline; da Silva Chakr, Rafael Mendonça; Brenol, João Carlos Tavares; Monticielo, Odirlei André


    The present study aims to evaluate differences in clinical and laboratory manifestations and medication use in the different ages of disease onset in patients with systemic lupus erythematosus (SLE). This cross-sectional study consisted of 598 SLE patients (550 female and 48 male), who attended the Rheumatology Clinic of the Hospital de Clínicas de Porto Alegre between 2003 and 2015. Demographic, clinical and laboratory data were collected. The patients were classified into three groups according to their ages at disease diagnosis. Mean age of diagnosis was 33.6 ± 14.3 years, and the median (25th-75th percentile) disease duration was 13 (7-20) years. Among the patients studied, 419 (70%) were adult-onset (aSLE), 90 (14.8%) were late-onset (lSLE) and 89 (14.8%) were childhood-onset (cSLE). The female to male ratio was higher in aSLE (18:1) compared to the other groups (p = 0.001). Arthritis was predominantly found in aSLE (78.5%) when compared with lSLE (57.7%) (p drugs.

  7. Clinical and laboratory features of systemic sclerosis complicated with localized scleroderma.

    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.

  8. Direct oral anticoagulants and antiplatelet agents. Clinical relevance and options for laboratory testing.

    Sibbing, D; Spannagl, M


    Oral anticoagulants and platelet receptor blockers are widely used in clinical practice with the aim of reducing the risk of thrombotic complications in patients with cardiovascular diseases. Their regular intake and adequate antithrombotic action is vital and this is way numerous assays have been developed for laboratory testing and monitoring of these agents. Available assays can be stratified into pharmacokinetic and pharmacodynamic assays. Such assays are increasingly used in clinical routine and their daily use is triggered by the advent of the novel direct oral anticoagulants (DOACs) as an alternative for vitamin K antagonist (VKA) treatment, which are dabigatran, rivaroxaban and apixaban, and by the advent of prasugrel or ticagrelor as an alternative for clopidogrel with regard to platelet P2Y12 receptor inhibition. In this review the most important and most commonly used laboratory assays are summarized as well as their clinical implications with the focus on DOACs as an alternative for VKAs and the different P2Y12 receptor blockers for antiplatelet treatment.

  9. Mediterranean spotted fever: clinical and laboratory characteristics of 415 Sicilian children

    Rubino Raffaella


    Full Text Available Abstract Background Mediterranean spotted fever (MSF is an acute febrile, zoonotic disease caused by Rickettsia conorii and transmitted to humans by the brown dogtick Rhipicephalus sanguineus. Nearly four hundred cases are reported every year (mainly from June to September on the Italian island of Sicily. The aim of the study was to analyze the clinical and laboratory characteristics of patients with MSF and the efficacy of the drugs administered. Methods Our study was carried out on 415 children with MSF, during the period January 1997 – December 2004, at the "G. Di Cristina" Children's hospital in Palermo, Sicily, Italy. On admission patients' clinical history, physical and laboratory examination and indirect immunofluorescence antibody test (IFAT for Rickettsia conorii were performed. Diagnosis was considered confirmed if the patients had an MSF diagnostic score greater than or equal to 25 according to the Raoult's scoring system. All patients were treated with chloramphenicol or with macrolides (clarithromycin or azithromycin. Results Fever, rash and tache noire were present in 386 (93%, 392 (94.5% and 263 (63.4% cases respectively. Eighteen (4.6% children showed atypical exanthema. Chloramphenicol and newer macrolides all appeared to be effective and safe therapies. Conclusion Clinical features of 415 children with MSF were similar to those reported by other authors except for a lower incidence of headache, arthralgia and myalgia and a higher frequency of epato-splenomegaly. Concerning therapy, clarithromycin can be considered a valid alternative therapy to tetracyclines or chloramphenicol especially for children aged

  10. Clinical evaluation of analytical variations in serum creatinine measurements: why laboratories should abandon Jaffe techniques

    Drion Iefke


    Full Text Available Abstract Background Non-equivalence in serum creatinine (SCr measurements across Dutch laboratories and the consequences hereof on chronic kidney disease (CKD staging were examined. Methods National data from the Dutch annual external quality organization of 2009 were used. 144 participating laboratories examined 11 pairs of commutable, value-assigned SCr specimens in the range 52–262 μmol/L, using Jaffe or enzymatic techniques. Regression equations were created for each participating laboratory (by regressing values as measured by participating laboratories on the target values of the samples sent by the external quality organization; area under the curves were examined and used to rank laboratories. The 10th and 90th percentile regression equation were selected for each technique separately. To evaluate the impact of the variability in SCr measurements and its eventual clinical consequences in a real patient population, we used a cohort of 82424 patients aged 19–106 years. The SCr measurements of these 82424 patients were introduced in the 10th and 90th percentile regression equations. The newly calculated SCr values were used to calculate an estimated glomerular filtration rate (eGFR using the 4-variable Isotope Dilution Mass Spectrometry traceable Modification of Diet in Renal Disease formula. Differences in CKD staging were examined, comparing the stratification outcomes for Jaffe and enzymatic SCr techniques. Results Jaffe techniques overestimated SCr: 21%, 12%, 10% for SCr target values 52, 73 and 94 μmol/L, respectively. For enzymatic assay these values were 0%, -1%, -2%, respectively. eGFR using the MDRD formula and SCr measured by Jaffe techniques, staged patients in a lower CKD category. Downgrading to a lower CKD stage occurred in 1-42%, 2-37% and 12–78.9% of patients for the 10th and 90th percentile laboratories respectively in CKD categories 45–60, 60–90 and >90 ml/min/1.73 m2. Using enzymatic techniques, downgrading

  11. Clinical and Laboratory Findings of Lead Hepatotoxicity in the Workers of a Car Battery Manufacturing Factory

    Bita Dadpour


    Full Text Available Background: Occupational lead poisoning is common in workers of some industries, but lead hepatotoxicity has rarely been reported. Several animal studies have revealed lead induced liver damage but clinical studies concerning the manifestations of lead induced liver toxicity in humans are scares. This study was designed to investigate the clinical manifestations and pathological parameters of hepatic dysfunction and its relationship with blood and urine lead concentrations in a car battery-manufacturing workers. Methods: This cross sectional study was carried out in Mashhad, Iran, during April-June 2011. One hundred and twelve workers underwent blood and urine sampling for determination of lead concentrations and liver function tests. Clinical signs and symptoms of possible lead hepatotoxicity were investigated. Results: Mean (±SD age of the workers was 28.78 (±5.17 yr with a daytime work of 8.67 (±1.41 h and mean work duration of 3.89 (±2.40 yr. Mean blood lead concentration (BLC and urine lead concentration (ULC were 398.95 (±177.41 µg/l and 83.67(±50 μg/l, respectively. We found no correlation between the clinical findings and BLC or ULC. A weak correlation (R: 0.27, P=0.087 between serum alkaline phosphatase concentration and BLC was obtained. No significant relationship was found between other liver function tests and BLC or ULC. Conclusion: We found no specific clinical and laboratory abnormalities of liver in the workers of car battery manufacturer who had chronic lead toxicity. Further investigations with more specific laboratory tests such as LDH5 and gamma glutamyl transferase (GGT as well as novel biomarkers of metal induced hepatotoxicity might be helpful in evaluating lead hepatotoxicity.

  12. Evaluation of clinical and laboratory markers of cardiometabolic risk in overweight and obese children and adolescents

    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.

  13. [Ethical issues in a market dispute between clinical laboratories and a health plan: case report].

    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.

  14. Current research on cigarette toxicity: critical appraisal in view of clinical laboratory

    Prajwal Gyawali


    Full Text Available Cigarette smoking has been implicated as a potential risk factor for development and progression of chronic obstructive pulmonary disease (COPD and cardiovascular disease (CVD, including ischemic heart disease. Although, several methods are in existence to measuring cigarette toxicity, evidence regarding adoption of a gold standard technique is still imprecise. In this study, we reviewed articles describing methods of measuring cigarette toxicity in relation to clinical laboratory practice. A critical analysis of the benefits and limitations of each method in relation to low-middle income countries is discussed. [Int J Res Med Sci 2016; 4(6.000: 1785-1793

  15. Diagnostic and prognostic accuracy of clinical and laboratory parameters in community-acquired pneumonia

    Nusbaumer Charly


    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.

  16. LC-MS/MS analysis of steroids in the clinical laboratory.

    Keevil, Brian G


    Liquid chromatography-tandem mass spectrometry (LC-MS/MS) is a powerful tool that is changing the way we analyse steroids in the clinical laboratory. It is already opening up the field of steroid analysis in endocrinology and is providing new applications for individual steroids and panels of steroids in different clinical conditions. LC-MS/MS is now well-accepted technology and is increasingly being used to replace problematic immunoassay methods because of greater sensitivity and specificity. Improved sample preparation, modern chromatography methods, and sensitive, faster scanning mass spectrometers have all played a role in improving LC-MS/MS. LC-MS/MS is also playing a key role in improving the quality of assays through the development of reference measurement procedures, characterisation of reference materials and multi-site calibration programmes. There is increasing interest in multiplexing steroid assays into panels of diagnostic tests to aid and improve the diagnosis and monitoring of disease.

  17. Designing a clinical skills training laboratory with focus on video for better learning

    Lauridsen, Henrik Hein; Toftgård, Rie Castella; Nørgaard, Cita

    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...... 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......, (b) FAIR principle, (c) description of before-under-after procedures, and (d) requirements specifications. IT-companies were invited to provide technological solutions and make bids. Results Four teaching principles were developed with specific IT requirements specifications. The meeting process...

  18. Enhancing nursing informatics competencies and critical thinking skills using wireless clinical simulation laboratories.

    Cholewka, Patricia A; Mohr, Bernard


    Nursing students at New York City College of Technology are assigned client care experiences that focus on common alterations in health status. However, due to the unpredictability of client census within any healthcare facility, it is not possible for all students to have the same opportunity to care for clients with specific medical conditions. But with the use of patient simulators in a dedicated Clinical Simulation Laboratory setting, students can be universally, consistently, and repeatedly exposed to programmed scenarios that connect theory with the clinical environment. Outcomes from using patient simulators include improved nursing knowledge base, enhanced critical thinking, reflective learning, and increased understanding of information technology for using a Personal Digital Assistant and documenting care by means of an electronic Patient Record System. An innovative nursing education model using a wireless, inter-connective data network was developed by this college in response to the need for increasing nursing informatics competencies and critical thinking skills by students in preparation for client care.

  19. A history of HbA1c through Clinical Chemistry and Laboratory Medicine.

    Gillery, Philippe


    HbA(1c) was discovered in the late 1960s and its use as marker of glycemic control has gradually increased over the course of the last four decades. Recognized as the gold standard of diabetic survey, this parameter was successfully implemented in clinical practice in the 1970s and 1980s and internationally standardized in the 1990s and 2000s. The use of standardized and well-controlled methods, with well-defined performance criteria, has recently opened new directions for HbA(1c) use in patient care, e.g., for diabetes diagnosis. Many reports devoted to HbA1c have been published in Clinical Chemistry and Laboratory Medicine (CCLM) journal. This review reminds the major steps of HbA(1c) history, with a special emphasis on the contribution of CCLM in this field.

  20. Laboratory and clinical trials of cocamide diethanolamine lotion against head lice

    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

  1. Laboratory and clinical trials of cocamide diethanolamine lotion against head lice

    Brunton, Elizabeth R.; Brown, Christine M.


    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 treatments

  2. [Role and future aspects of hospital clinical laboratories in medical team approaches].

    Suwabe, Akira


    The recent progress in medicine increases the routine works of the physicians or nurses and decreases the chances to obtain the new information on the laboratory medicine. Although the patients desire to know their test results in detail, it is likely to be difficult to obtain them from the physician in charge. Thereby, the quality of the medical services may be deteriorated. In these situations, needs of the medical team approaches in which the medical technologists (MTs) in the hospital laboratories participate are increasing. In Japan, there are a variety of medical team approaches in which MTs are involved. In our university hospital, MTs play important roles in the infection control team (ICT), in the nutrition support team (NST), in the educational class for the patients with diabetes mellitus, in the clinical research center, in the order-made medicine realizing project, in the infertility center and in the laboratory information room. In April 2010, the new payment system for the team approaches such as ICT or NST was established. In the future, the team approaches other than ICT or NST could be chosen for the subjects for the payment if they are recognized as important. The goal of the team approaches is to realize a patient-oriented medicine. MTs can reconfirm that they are working as one of the medical staffs through these team approaches. It is important to always find out a possibility of new team approaches.

  3. Clinical and laboratory characteristics of adolescents with platelet function disorders and heavy menstrual bleeding

    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.

  4. Accreditation of medical laboratories in Croatia--experiences of the Institute of Clinical Chemistry, University Hospital "Merkur", Zagreb.

    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.


    A.D. Sialakouma


    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

  6. Use of artificial intelligence in analytical systems for the clinical laboratory.

    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.

  7. Diagnosis of Clostridium difficile Infection: an Ongoing Conundrum for Clinicians and for 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

  8. Indirect laryngeal surgery in the clinical voice laboratory: the renewal of a lost art.

    Hogikyan, N D; Pynnonen, M


    Since the advent of precision instruments and safe techniques for direct laryngoscopic surgery under general anesthesia, indirect laryngeal surgery has become very uncommon. A review of the recent literature finds that few authors advocate indirect surgery under topical anesthesia, and many otolaryngologists dismiss this technique as being either of only historical interest or an idiosyncratic method practiced only by a handful of clinicians. The societal mandate for cost-effective healthcare and the availability of relatively low-cost, high-quality endoscopes and video equipment warrant a renewed and broader interest in this type of surgery. In this article, we review a series of 27 indirect surgical procedures performed under topical anesthesia in the clinical voice laboratory. We discuss the indications, outcomes, advantages, and disadvantages of this surgery, and we present a brief analysis of its cost-effectiveness. We conclude that indirect laryngeal surgery in the clinical voice laboratory is an effective, safe, efficient, and less costly alternative to some procedures routinely performed under general anesthesia.

  9. Molecular-based mycobacterial identification in a clinical laboratory setting: a comparison of two methods.

    O'Donnell, N


    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.

  10. Epidemiological, clinical and laboratory findings of infectious keratitis at Mansoura Ophthalmic Center, Egypt

    Badawi, Amani E; Moemen, Dalia; El-Tantawy, Nora L


    AIM To analyze the epidemiological, clinical and laboratory findings of infectious keratitis. METHODS A retrospective study on cases of infective keratitis, attended our institution from Mar. 2013 to Feb. 2015, was done at Mansoura Ophthalmic Center, Egypt. Corneal scrapings were performed and processed for direct microscopy and culture in appropriate media using standard laboratory protocols. RESULTS Out of 245 patients enrolled for study, 247 corneal scrapings were obtained. Ocular trauma was the most common predisposing factor (51.4%), followed by diabetes mellitus (15.1%). Cultures were positive in 110 scraping samples (44.5%): 45.5% samples had pure fungal infection, 40% had pure bacterial infections and 10% had mixed fungal and bacterial growths. Acanthamoeba was detected in 5 (4.5%) samples. The most common fungal pathogen was Aspergillus spp. (41%). The most common bacterial isolates were Staphylococcus aureus (38.2%) and Pseudomonas aeruginosa (21.8%). CONCLUSION Incidence of fungal keratitis is high in our region. Therapeutic approach can initially be based on clinical features and sensitivity/resistance patterns. Microbiological research should direct the antimicrobial treatment. Antibiotic resistance to fluoroquinolones and aminoglycosides is an important consideration. PMID:28149778

  11. Practical way to develop 10-color flow cytometry protocols for the clinical laboratory

    Tárnok, Attila; Bocsi, Jozsef


    The latest development of commercial routine flow cytometers (FCM) is that they are equipped with three (blue, red, violet) or more lasers and many PMT detectors. Nowadays routine clinical instruments are capable of detecting 10 or more fluorescence colors simultaneously. Thereby, presenting opportunities for getting detailed information on the single cell level for cytomics and systems biology for improve diagnostics and monitoring of patients. The University Leipzig, Germany) recently started a cluster of excellence to study the molecular background of life style and environment associated diseases, enrolling 25000 individuals (LIFE). To this end the most comprehensive FCM protocol has to be developed for this study. We aimed to optimize fluorochrome and antibody combinations to the characteristics of the instrument for successful 10-color FCM. Systematic review of issues related to sampling, preparation, instrument settings, spillover and compensation matrix, reagent performance, and general principles of panel construction was performed. 10-color FCM enables for increased accuracy in cell subpopulation identification, the ability to obtain detailed information from blood specimens, improved laboratory efficiency, and the means to consistently detect major and rare cell populations. Careful attention to details of instrument and reagent performance allows for the development of panels suitable for screening of samples from healthy and diseased donors. The characteristics of this technique are particularly well suited for the analysis of broad human population cohorts and have the potential to reach the everyday practice in a standardized way for the clinical laboratory.

  12. Performance of the tutorial function in the Professor of Hematology, specialty: Clinical Laboratory.

    Oriol Meneses Echemendia


    Full Text Available In the context of the battle of ideas, arises the career, degree in health technology, imposing new challenges to the medical university context, inserting new actors to the teaching - learning process and with them the professor-tutor's figure. For that reason , an evaluative project was developed in the hematology profile in the specialty of clinical laboratory, with the purpose of elaborating a strategy for the improvement of the teaching tutorial, on the base of systematic-structural-functional model; giving answer to the main detected problems. To carry out the study was used a qualitative focus, selecting the integrated paradigm. It was done an investigation action in the seven municipal university headquarters of the county where the process of teaching-learning of the new pedagogic model is developed in the profile. once selecting the scale of priority of the detected difficulties using the interaction and the interdependence among investigator and investigated, the "methodological strategy for the improvement of the teaching tutorial in hematology of clinical laboratory" was designed to propose three strategic actions, valued positively by the expert ones who endorsed the feasibility and effectiveness of their setting in practice to contribute to the improvement of the teaching tutorial in the formation of health technologies.

  13. Stability and inactivation of HTLV-III/LAV under clinical and laboratory environments.

    Resnick, L; Veren, K; Salahuddin, S Z; Tondreau, S; Markham, P D


    The stability of human T-cell lymphotropic virus type III/lymphadenopathy-associated virus (HTLV-III/LAV) under environmental conditions encountered in a clinical or laboratory setting and its inactivation by commonly used chemical disinfectants were investigated. Under our experimental conditions utilizing a highly concentrated viral preparation, virus with an initial infectious titer of approximately 7 log10 tissue culture infectious dose (TCID50) per milliliter can be recovered for more than a week from an aqueous environment held at room temperature (23 to 27 degrees C) or at 36 to 37 degrees C. Virus recovery is reduced at a rate of approximately 1 log10TCID50 per 20 minutes when held at 54 to 56 degrees C. Dried and held at room temperature, HTLV-III/LAV retains infectivity for more than three days with a reduction of approximately 1 log10TCID50 per nine hours. Viral infectivity is undetectable and reduced more than 7 log10TCID50 within one minute with 0.5% sodium hypochlorite, 70% alcohol, or 0.5% nonidet-P40, and within ten minutes with 0.08% quaternary ammonium chloride or with a 1:1 mixture of acetone-alcohol. These results help provide a rational basis to prevent the accidental spread of HTLV-III/LAV in the laboratory or clinical setting.

  14. Clinical-Laboratory Significance of Myelofibrosis in Patients with Multiple Myeloma

    Yuliya A. D'yachkova


    Full Text Available Background: Currently, there are not many studies of correlations between myelofibrosis (MF and clinical-laboratory data on multiple myeloma (MM. Methods and Results: In our study, MF was evaluated according to the scale of the European consensus (2005. Additionally, we used an automated morphometric study. The inverse correlations between the prevalence of MF and the total number of erythroid cells and megakaryocytes, as well as hemoglobin level were found. The total relative area of fibrosis tissue (Srel.fibr.tis. in initial and advanced MF>20% was associated with anemia requiring a blood transfusion.The development of severe anemia was observed in patients with a greater relative area of Srel.fibr.tis. The direct correlations between Srel.fibr.tis. and relative area of tumor tissue (Srel.tum.tis., between Srel.fibr.tis. and the level of total serum protein, between Srel.fibr.tis. and daily proteinuria were found both in initial and in advanced MF. Additionally, a direct correlation between Srel.fibr.tis. and the number of plasma cells was revealed in initial MF. Greater Srel.fibr.tis. in initial and advanced MF was found in patients with chronic renal failure. Conclusion: The clinical-laboratory significance of MF in MM is an inhibition of erythroid cells and megakaryocytes and development of anemia. The relative area of fibrous tissue is a marker of tumor volume and tumor progression.

  15. [Hospital management and the role of clinical microbiology laboratory for preventing nosocomial infection].

    Ichiyama, S


    Nosocomial infection is a serious issue in the hospital management. Countermeasures for this issue have been discussed from various points including clinical and laboratory medicine, nursing as well as hospital administration. This issue is of great importance to those of us medical practitioners, who engage in diagnosis and treatment of infectious diseases. The role of clinical microbiology laboratories for prevention of nosocomial infection includes performing epidemiological survey, giving information and education, and training and instruction to medical staff. In order to instruct and inspect the countermeasures against nosocomial infection, it is necessary to have a dedicated team in the hospital. We have organized an infection control team(ICT) to collect information and offer training and instruction regarding nosocomial infection. The ICT activities include 1) inspecting if the nosocomial infection control manual is followed correctly, 2) reporting the results of epidemiological survey regarding nosocomial infection, 3) offering the information regarding antimicrobial agents and disinfectants, 4) offering the information regarding the isolation of microorganisms in the hospital and their antimicrobial sensitivities, 5) cost calculation for nosocomial infection control.

  16. Clinical and laboratory description of a series of cases of acute viral myositis

    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.

  17. Evaluation of menstrual cycle-related changes in 85 clinical laboratory analytes.

    Masuda, Shiori; Ichihara, Kiyoshi; Yamanishi, Hachiro; Hirano, Yutaka; Tanaka, Yuji; Kamisako, Toshinori


    The menstrual cycle-related changes in clinical laboratory values were analysed by use of data obtained in the Asian multicentre study aimed at derivation of common reference intervals for 85 major clinical laboratory tests. Among 1876 healthy female volunteers, 893 had regular menstruation. They were classified into five groups according to dates between sample collection and the start of the last menstrual cycle: early follicular phase (1-6 days), late follicular phase (7-12 days), ovulatory phase (13-16 days), early luteal phase (17-22 days), and late luteal phase (23-31 days). Multiple linear regression analysis was performed to evaluate the menstrual cycle-related changes in test results. The magnitude was expressed as a standard deviation ratio of between-phase standard deviation to between-individual standard deviation based on nested ANOVA. Aside from obvious changes for four sex hormones (oestradiol, progesterone, follicle-stimulating hormone, and luteinizing hormone), we observed statistically significant menstrual cycle-related changes in the following tests (standard deviation ratio >0.15): Na, Cl, creatine kinase, C-reactive protein, serum amyloid A, carbohydrate antigen 125, and parathyroid hormone were higher during the early follicular phase, while insulin, total cholesterol, and white blood cell were higher during the luteal phase. Significant associations of those test items with the four sex hormones were revealed. The menstrual cycle-related changes in laboratory test results were revealed in some commonly tested items other than sex hormones. The findings are of interest in understanding female physiology in relation to hormonal changes, but the magnitude of changes is rather small and not very relevant in interpreting test results. © The Author(s) 2016.

  18. A Survey of Established Veterinary Clinical Skills Laboratories from Europe and North America: Present Practices and Recent Developments.

    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.

  19. Clinical epidemiology of laboratory-confirmed Buruli ulcer in Benin: a cohort study.

    Vincent, Quentin B; Ardant, Marie-Françoise; Adeye, Ambroise; Goundote, Aimé; Saint-André, Jean-Paul; Cottin, Jane; Kempf, Marie; Agossadou, Didier; Johnson, Christian; Abel, Laurent; Marsollier, Laurent; Chauty, Annick; Alcaïs, Alexandre


    Buruli ulcer, caused by Mycobacterium ulcerans, was identified as a neglected emerging infectious disease by WHO in 1998. Although Buruli ulcer is the third most common mycobacterial disease worldwide, understanding of the disease is incomplete. We analysed a large cohort of laboratory-confirmed cases of Buruli ulcer from Pobè, Benin, to provide a comprehensive description of the clinical presentation of the disease, its variation with age and sex, and its effect on the occurrence of permanent functional sequelae. Between Jan 1, 2005, and Dec 31, 2011, we prospectively collected clinical and laboratory data from all patients with Buruli ulcer diagnosed at the Centre de Dépistage et de Traitement de l'Ulcère de Buruli in Pobè, Benin. We followed up patients to assess the frequency of permanent functional sequelae. All analyses were done on cases that were laboratory confirmed. 1227 cases of laboratory-confirmed Buruli ulcer were included in the analysis. Typically, patients with Buruli ulcer were children (median age at diagnosis 12 years) presenting with a unique (1172 [96%]) large (≥15 cm, 444 [36%]) ulcerative (805 [66%]) lesion of the lower limb (733 [60%]). Atypical clinical presentation of Buruli ulcer included Buruli ulcer osteomyelitis with no identifiable present or past Buruli ulcer skin lesions, which was recorded in at least 14 patients. The sex ratio of Buruli ulcer widely varied with age, with male patients accounting for 57% (n=427) of patients aged 15 years and younger, but only 33% (n=158) of those older than 15 years (odds ratio [OR] 2·59, 95% CI 2·04-3·30). Clinical presentation of Buruli ulcer was significantly dependent on age and sex. 54 (9%) male patients had Buruli ulcer osteomyelitis, whereas only 28 (4%) of female patients did (OR 2·21, 95% CI 1·39-3·59). 1 year after treatment, 229 (22% of 1043 with follow-up information) patients presented with permanent functional sequelae. Presentation with oedema, osteomyelitis, or large (

  20. Clinical and laboratory characteristics of acute community-acquired urinary tract infections in adult hospitalised patients.

    Piljic, Dilista; Piljic, Dragan; Ahmetagic, Sead; Ljuca, Farid; Porobic Jahic, Humera


    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.

  1. Diagnostic clinical and laboratory findings in response to predetermining bacterial pathogen: data from the Meningitis Registry.

    Maria Karanika

    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.

  2. Demographic, clinical, and laboratory features of Turkish patients with late onset ankylosing spondylitis.

    Karaarslan, Ahmet; Yilmaz, Hatice; Aycan, Hakan; Orman, Mehmet; Kobak, Senol


    Ankylosing spondylitis (AS) is a chronic inflammatory disease, which typically begins in early decades of life with primarily axial joints involvement. This disease rarely affects patients older than 50 years of age. The aim of this study was to compare and evaluate the demographic, clinical, and laboratory features of late onset and early onset AS patients who were followed up in a single rheumatology center. A total of 339 patients who have been diagnosed with AS according to modified New York criteria were included in the study. The patients whose initial symptoms were observed after 50 years of age were accepted as late onset AS. Out of 339 patients, 27 (7.9%) were diagnosed as late onset AS and 312 (92.3%) patients were evaluated as early onset AS. Of 27 late onset patients, 10 were male and 17 were female. Delay in the diagnosis was 5.8 years for early onset AS, while it was 3.8 years for late onset AS (p = 0.001). Higher levels of acute phase reactants and more methotrexate (MTX) use were detected in early onset AS patients compared to late onset AS (p = 0.001, p = 0.007, respectively). Statistically, there was no difference between these two groups, with regard to disease clinical activity indexes, anthropometric measurement parameters, uveitis and peripheral joint involvement. In this study, we showed that early and late onset AS patients may present with different clinical, genetic, and laboratory features. Late onset AS patients are characterized with lower human leukocyte antigen-B27 sequence, less inflammatory sign, delayed diagnosis, and less MTX and anti-tumor necrosis factor alpha drug usage.

  3. Demographic, clinical, and laboratory features of Turkish patients with late onset ankylosing spondylitis

    Ahmet Karaarslan


    Full Text Available Ankylosing spondylitis (AS is a chronic inflammatory disease, which typically begins in early decades of life with primarily axial joints involvement. This disease rarely affects patients older than 50 years of age. The aim of this study was to compare and evaluate the demographic, clinical, and laboratory features of late onset and early onset AS patients who were followed up in a single rheumatology center. A total of 339 patients who have been diagnosed with AS according to modified New York criteria were included in the study. The patients whose initial symptoms were observed after 50 years of age were accepted as late onset AS. Out of 339 patients, 27 (7.9% were diagnosed as late onset AS and 312 (92.3% patients were evaluated as early onset AS. Of 27 late onset patients, 10 were male and 17 were female. Delay in the diagnosis was 5.8 years for early onset AS, while it was 3.8 years for late onset AS (p = 0.001. Higher levels of acute phase reactants and more methotrexate (MTX use were detected in early onset AS patients compared to late onset AS (p = 0.001, p = 0.007, respectively. Statistically, there was no difference between these two groups, with regard to disease clinical activity indexes, anthropometric measurement parameters, uveitis and peripheral joint involvement. In this study, we showed that early and late onset AS patients may present with different clinical, genetic, and laboratory features. Late onset AS patients are characterized with lower human leukocyte antigen-B27 sequence, less inflammatory sign, delayed diagnosis, and less MTX and anti-tumor necrosis factor alpha drug usage.

  4. Vestibular migraine in children and adolescents: clinical findings and laboratory tests

    Thyra eLanghagen


    Full Text Available Introduction: Vestibular migraine (VM is the most common cause of episodic vertigo in children. We summarize the clinical findings and of laboratory test results in a cohort of children and adolescents with VM. We discuss the limitations of current classification criteria for dizzy children. Methods: A retrospective chart analysis was performed on 118 children with suspected VM at a tertiary care center. Patients with complaints related to migraine and who presented with vertigo/dizziness were grouped in the following categories: (1 definite vestibular migraine (dVM; (2 probable vestibular migraine (pVM; (3 suspected vestibular migraine (sVM; (4 benign paroxysmal vertigo (BPV; and (5 migraine with/without aura (oM according to the International Classification of Headache Disorders, 3rd edition (beta version. Results: The mean age of all patients was 12±3 years (range 3-18 years, 70 females. 36 patients (30% fulfilled criteria for dVM, 33 (28% for pVM, 34 (29% for sVM, 7 (6% for BPV, and 8 (7% for oM. Somatoform vertigo co-occurred in 27% patients. Episodic syndromes were reported in 8%; the family history of migraine was positive in 65%. Mild central ocular motor signs were found in 24% (most frequently horizontal saccadic pursuit. Laboratory tests showed that about 20% had pathological function of the horizontal vestibulo-ocular reflex, and almost 50% had abnormal postural sway patterns. Conclusion: Patients with definite, probable, and suspected VM do not differ in the frequency of ocular motor, vestibular, or postural abnormalities. VM is the best explanation for their symptoms. It is essential to establish diagnostic criteria in clinical studies. In clinical practice, however, the most reasonable diagnosis should be made in order to begin treatment. Such a procedure also minimizes the fear of the parents and children, reduces the need to interrupt leisure time and school activities, and prevents the development of somatoform vertigo.

  5. [Brucellosis: retrospective evaluation of the clinical, laboratory and epidemiological features of 151 cases].

    Demiroğlu, Y Ziya; Turunç, Tuba; Alişkan, Hikmet; Colakoğlu, Sule; Arslan, Hande


    The aim of this study was to retrospectively evaluate the clinical and laboratory characteristics, complications and treatment oucomes of 151 brucellosis cases (age range: 15-79 years; 89 female), who were followed in our clinic between the period of January 2003-July 2005. Of them, 66.2% were diagnosed as acute, 23.8% as subacute and 9.9% as chronic brucellosis. Risk factors were detected as consumption of unpasteurized milk and diary products (80%), stock-breeding (14%) and risky profession such as veterinary, laboratory technician and butcher (3.3%). Most common complaints were arthralgia (87.4%), malaise (86%), fever (79.5%), sweating (78%), and waist pain (71%). In view of laboratory findings, increased erytrocyte sedimentation rate was detected in 61.6%, C-reactive protein positivity in 60%, lymphomonocytosis in 44.4% and anemia in 51.7% of them. Blood cultures were performed from 125 of the patients, and 64 (51.2%) of them yielded Brucella spp. The other specimens in which bacterial growth were detected in one of each, were bone marrow, sternoclavicular joint, psoas abscess, urine and pleural fluid. Standard tube agglutination (STA) test was found negative in 1.3% of patients who were culture positive, while it was positive at 1/160 titer in 20.5%, at 1/320 in 14%, at 1/640 in 14.6% and > or = 1/1280 in 49.7 percent. The most common complication was found as musculo-skeletal system involvement (30 spondylodiscitis, 15 sacroileitis, five peripheric arthritis, one tendinitis) with a rate of 33.7 percent. Other complications were nervous system involvement in 6% (two acute and seven chronic meningitis), genitourinary involvement in 5.3% (five epididymo-orchitis, two prostatitis, one with Brucella positive urine culture), peritonitis in 0.6% and skin involvement in 0.6 percent. Seven different therapy protocols were applied to the patients according to complications and case specialty, however doxycycline+rifampicin combination during six weeks was the most

  6. [Specific clinical, epidemiological patterns and laboratory diagnostics of enterovirus infection in the Republic of Belarus].

    Amvros'eva, T V; Poklonskaia, N V; Bogush, Z F; Kazinets, O N; Germanovich, F A; Fisenko, E G; Titov, L P; Kvacheva, Z B; Bezruchko, A A; Scheslenok, E P


    The clinical and epidemiological patterns as well as the results of the laboratory verification of the outbreak of enterovirus infection (EVI) in Minsk during the period of summer-autumn, 2000, are presented. During this outbreak a variety of clinical forms were observed, the serous meningitis being prevalent (57.5%). Practically simultaneous occurrence of infection on the territory of all administrative districts of the city, the predominant involvement of children aged up to 14 years into the outbreak, a high proportion of simultaneous casualities in the multiple foci. A number of circulating enteroviruses (EV)--ECHO 30, ECHO 6 of three serotypes and Coxsackie B5--were simultaneously isolated from clinical material. EV of the same serotypes were isolated from tap drinking water, and neutralizing antibodies to these serotypes were often detected in the patients blood sera. Infectious EV were also present in samples of bottled water and in water reservoirs used for bathing. The routes of EV transmission and the improvement of EVI control are discussed.


    S Afsharpaiman


    Full Text Available "nBrucellosis is not uncommon in children in endemic areas. We described clinical and laboratory features and therapeutic regimens for brucellosis in children under 14 who admitted in the Pediatric Medical Center Hospital, Tehran, Iran from March 1988 until February 2001. The male: female ratio was 2:1. Family history of brucellosis and consumption of un-pasteurized milk and dairy products was positive in 20.4% and 65.9%, respectively. The common clinical findings were arthritis (79.5%, fever (77.4%, anorexia (61.4%, sweating (52.3%, splenomegaly (43.2%, hepatomegaly (34.1% and lymphadenopathy (13.65. Anemia, leukopenia and thrombocytopenia were recorded in 56.8%, 31.8% and 9.1%, respectively. Out of all patients, seropositivity rate for brucellosis was found in 97.7% using serum agglutination test. Culture of blood and bone marrow specimen were positive in 30% and 50% of samples obtained, respectively. Rifampin and co-trimoxazole were the most commonly used combination in 68.1%. The overall relapse rate was 13.6%. Arthritis and fever were the most common clinical findings of brucellosis. Wright test is a very sensitive method to detect brucella infection. Public education and control measures should be applied to prevent the zoonotic and human brucellosis. 

  8. Demographic, clinical, laboratory and treatment characteristics of spondyloarthritis patients with and without acute anterior uveitis

    Marcelo Gehlen

    Full Text Available CONTEXT AND OBJECTIVE: Acute anterior uveitis is a common extra-articular manifestation in spondyloarthritis patients. The aim of this study was to compare demographic, clinical, laboratory and treatment data among spondyloarthritis patients with and without acute anterior uveitis. DESIGN AND SETTING: This was a cross-sectional analytical study at the Rheumatology Outpatient Clinic of the Evangelical University Hospital, Curitiba, Brazil. METHODS: Spondyloarthritis patients with without acute anterior uveitis were compared regarding demographic data, spondyloarthritis subtype, peripheral arthritis, enthesitis, disease activity, functional index, physical examination, radiological involvement, HLA-B27 and treatment. RESULTS: Presence of acute anterior uveitis was not found to have any relationship with functional index, degree of radiological involvement, peripheral arthritis or enthesitis. Acute anterior uveitis showed a negative association with skin manifestations (P = 0.04 and a trend towards higher disease activity (P = 0.06. CONCLUSION: In the study sample, it could not be shown that AAU had any association with the functional and radiological prognoses. The patients with spondyloarthritis with and without acute anterior uveitis did not differ clinically except for a higher proportion of ankylosing spondylitis and smaller presence of skin involvement in those with uveitis.

  9. Using Elearning techniques to support problem based learning within a clinical simulation laboratory.

    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.

  10. Porphyria cutanea tarda. Clinical features and laboratory findings in 40 patients.

    Grossman, M E; Bickers, D R; Poh-Fitzpatrick, M B; Deleo, V A; Harber, L C


    Porphyria cutanea tarda is the most common disorder of porphyrin metabolism in the United States and Europe. This report presents the clinical, laboratory and pathologic features of 40 patients with porphyria cutanea tarda. Each patient was followed up for variable times during 1960-76 at the Clinical Research Center and the Dermatology Service of the Columbia-Presbyterian Medical Center; at the New York University Medical Center; or at the Rockefeller University Hospital. Earlier age at onset; diminution of alcohol ingestion as the major etiologic factor; and, an increased incidence in females indicate new environmental influences. The most frequently associated etiologic factor, aside from alcohol intake, was use of estrogens for contraception; postmenopausal syndrome; or treatment of prostatic carcinoma. Cutaneous findings in the patients included bullae (85%); increased skin fragility (75%); facial hypertrichosis (63%); hyperpigmentation (55%); sclerodermoid changes (18%); and, dystrophic calcification with ulceration (8%). Diabetes mellitus was found in 15%; systemic lupus erythematosus in 5%; elevated serum iron level in 62%; and, abnormal liver function test results in 60%. Histologic abnormalities were seen in liver biopsies of 34 patients. Phlebotomy is the treatment of choice. In 32 patients so treated, clinical remissions averaged 30.9 months. 31% (10 patients) had a relapse but additional phlebotomies resulted in 2nd remissions. Chloroquine and plasmaphoresis treatments were also briefly discussed.

  11. 检验科医院感染的原因分析及对策%Clinical Laboratory for Hospital Infections Cause Analysis and Countermeasures



    Objective To analyze the cause of the infection, clinical laboratory, and discusses how to implement the management measures can reduce the incidence of clinical laboratory infection. Methods By summarizing our nearly ifve years hospital clinical laboratory infection, reasons, and according to the reasons discussed corresponding prevention clinical laboratory infection management countermeasures. Results Clinical laboratory infection, reason is more complex, and many factors are, in the ifnal analysis, is associated with the hospital management within the value degree, but also related to not form relatively strict rules system and good abide by the rules and regulations of the atmosphere is closely related to second and clinical laboratory staff lack of basic knowledge, to prevent infection in hospital hardware facilities old also have relations. Conclusion Management personnel to clinical laboratory infection, attaches great importance to, formulate strict rules and regulations and rewards and punishments measures, and strengthen the staff to prevent infection knowledge awareness and mission, update the concept of staff, on a regular basis, hardware facilities for inspection and disinfect or replacement, ensure good working atmosphere and working environment, to prevent and control hospital clinical laboratory infection probability play an important role.%目的分析检验科发生感染的原因,并探讨实施怎样的管理对策可以降低检验科感染的发生率。方法通过总结归纳我院近五年院内检验科发生感染的原因,并根据原因探讨相应的预防检验科发生感染的管理对策。结果检验科发生感染的原因比较复杂,与众多因素有着关联,归根结底是与医院内管理人员的不重视程度有关,而且与不能形成相对严格的规则制度和良好的遵守规章制度的风气密切相关,其次与检验科的工作人员缺乏基础的预防感染知识、医院内的硬件设施


    D. G. Rekalov


    Full Text Available Rheumatoid arthritis (RA leads not only to a rapid development of disability, but can influence the life of these patients. One-third of patients with rheumatoid arthritis may have signs of disability during the first 3 years of the onset of the disease, while mortality in patients with RA almost two times higher in comparison with the general population. Analysis of recent prospective studies on the progression of the pathological process and predicting of the long-term outcomes in RA clearly indicate the need for clinical evaluation and a comprehensive laboratory and instrumental diagnosis of the disease in the initial manifestations of the most followed by early adequate pathogenetic therapy. The purpose of this survey was to determine modern clinical aspects of diagnosis, the possibility of standard and specialized instrumental examinations in patients with eRA, followed by predicting long-term results. We studied 52 specialized publications on clinical classification and a modern laboratory and diagnostic tests for eRA. This review presents the data of the importance of differentiation of several stages of RA in relation to the time factor. The data on the sensitivity and specificity of the diagnostic classification and clinical criteria of eRA and an algorithm for the identification of the disease were presented. It was shown prognostic value of the main serological markers of RA, and the predictive value for early detection of antibodies to the circulating peptide as a marker of the severity of bone-destructive changes in patients with certain clinical manifestations. Antibodies to the circulating peptide (ACPA can be detected many years before the onset of RA. Study of anti-citrulline mutated vimentin (anti-MCV in patients with eRA can be applied as a marker of activity of the process and the subsequent possibility of use for predicting long-term results. This review presents the major diagnostic errors using standard instrumental

  13. Impact of educational intervention on knowledge, attitude and awareness of good clinical practice among health care providers

    Divya Goel


    Conclusion: A day's training program on GCP guidelines may help to increase the knowledge as well as awareness about principles and techniques of clinical research, which will increase the credibility of clinical research in the country.

  14. Cerebrospinal fluid abnormalities in patients with syphilis: association with clinical and laboratory features.

    Marra, Christina M; Maxwell, Clare L; Smith, Stacy L; Lukehart, Sheila A; Rompalo, Anne M; Eaton, Molly; Stoner, Bradley P; Augenbraun, Michael; Barker, David E; Corbett, James J; Zajackowski, Mark; Raines, Charles; Nerad, Judith; Kee, Romina; Barnett, Scott H


    To define clinical and laboratory features that identify patients with neurosyphilis. Subjects (n=326) with syphilis but no previous neurosyphilis who met 1993 Centers for Disease Control and Prevention criteria for lumbar puncture underwent standardized history, neurological examination, venipuncture, and lumbar puncture. Neurosyphilis was defined as a cerebrospinal fluid (CSF) white blood cell count >20 cells/ microL or reactive CSF Venereal Disease Research Laboratory (VDRL) test result. Sixty-five subjects (20.1%) had neurosyphilis. Early syphilis increased the odds of neurosyphilis in univariate but not multivariate analyses. In multivariate analyses, serum rapid plasma reagin (RPR) titer > or =1 : 32 increased the odds of neurosyphilis 10.85-fold in human immunodeficiency virus (HIV)-uninfected subjects and 5.98-fold in HIV-infected subjects. A peripheral blood CD4+ T cell count < or =350 cells/ microL conferred 3.10-fold increased odds of neurosyphilis in HIV-infected subjects. Similar results were obtained when neurosyphilis was more stringently defined as a reactive CSF VDRL test result. Serum RPR titer helps predict the likelihood of neurosyphilis. HIV-induced immune impairment may increase the risk of neurosyphilis.




    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.

  16. Efficacy and safety of far infrared radiation in lymphedema treatment: clinical evaluation and laboratory analysis.

    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.

  17. Importance/performance analysis: a tool for service quality control by clinical laboratories.

    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.

  18. A screening strategy for phenotypic detection of carbapenemase in the clinical laboratory.

    Yan, Yu-Zhong; Sun, Kang-De; Pan, Li-Hong; Fan, Hui-Qin; Yang, Huan-Zhang; Lu, Yan-Chun; Shi, Yi


    Nosocomial infections caused by carbapenemase-producing Enterobacteriaceae have emerged as an important challenge worldwide and represent a great limitation for antimicrobial therapy. Detection of carbapenemase in Enterobacteriaceae species also remains challenging. Although the modified Hodge test is recommended, it lacks specificity and is unable to distinguish between carbapenemase types. Here, we demonstrated a screening strategy for the phenotypic detection of carbapenemases among Enterobacteriaceae isolates in the clinical laboratory by using ethylenediaminetetraacetic acid and phenylboronic acid. This strategy displayed an overall 100% sensitivity and 98.6% specificity for carbapenemase detection in Enterobacteriaceae, which was superior to that of the modified Hodge test (98.0% sensitivity and 84.3% specificity), and it also discriminated the carbapenemase phenotypes of KPC-2, VIM-1, and OXA-48.

  19. Polymyalgia rheumatica (PMR): clinical, laboratory, and immunofluorescence studies in 13 patients.

    Shintani, Shuzo; Shiigai, Tatsuo; Matsui, Yoshiki


    Thirteen elderly patients with polymyalgia rheumatica (PMR) are presented. The clinical and laboratory findings suggest that many progressive symptoms are due to the non-specific inflammatory changes in various organs of the body, especially in muscles and joints. An immunofluorescence study of muscle biopsy specimens revealed IgG, IgA, and fibrinogen deposits in the perifascicular area of the perimysium. This finding suggests that immune complexes play a role in the pathogenesis of this condition and that the pathophysiology of PMR is an interstitial inflammatory process. We think that the inflammatory findings affecting the interstitial tissue of muscles in the immunofluorescence study are relatively specific to PMR, and will be affected by steroid treatment.

  20. Comparison of four types of diet using clinical, laboratory and psychological studies.

    Lockie, A H; Carlson, E; Kipps, M; Thomson, J


    Thirty-seven people of different dietary habits-vegans, ovolactovegetarians, whole-food omnivores and average omnivores-were studied using nine-day weighed food intakes, clinical and laboratory assessments, standard psychology questionnaires, measurements of urinary cortisol and catecholamine levels and questionnaires on life-style and health factors. The vegan diet most clearly approximated current thinking on diet, as expressed in the NACNE Report, but was deficient in vitamin D, riboflavin, and vitamin B12. Cholesterol levels were significantly higher in both diet and serum in all groups compared with the vegans. There was no significant difference in social background, money spent on food, exercise, smoking, stress levels or psychological parameters between groups.

  1. Clinical and laboratory features of pheochromocytoma in a 52-year-old female patient

    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.

  2. Comparison of clinical and laboratory characteristics in children with type 1 diabetes according to pancreatic autoantibodies

    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&lt;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.

  3. Assessment of clinical and laboratory parameters that reflect inflammatory response and organ function in sepsis

    Herdiman T. Pohan


    APTT were prolong in severe sepsis and septic shock more than 18.8 and  48 seconds respectively. The d-dimer was also increased mostly in all groups. In conclusions that clinical examinations include level of consciousness, heart rate, mean arterial pressure, temperature and respiration rate and additional laboratory examinations include hamatological, biochemical, blood gas analysis and coagulation  examinations can be used as parameters in diagnosis of sepsis. Some parameters include level of consciousness (Glasgow coma scale, serum creatinine, hemoglobin, platelet count and fibrinogen can differ sepsis according to severity. (Med J Indones 2005; 14: 26-32Keywords: Clinical response, SIRS, sepsis

  4. Utility and necessity of repeat testing of critical values in the clinical chemistry laboratory.

    Aijun Niu

    Full Text Available CONTEXT: Routine repeat testing of critical values is a long-standing practice in many clinical laboratories; however, its usefulness and necessity remain to be empirically established and no regulatory requirements yet exist for verification of the critical value results obtained by repeat analysis. OBJECTIVE: To determine whether repeat testing of critical values is useful and necessary in a clinical chemistry laboratory. METHODS: A total of 601 chemistry critical values (potassium, n = 255; sodium, n = 132; calcium, n = 108; glucose, n = 106 obtained from 72,259 routine clinical chemistry specimens were repeat tested. The absolute value and the percentage of difference between the two testing runs were calculated for each of the four critical values and then compared with the allowable error limit put forth in the College of American Pathologists (CAP. RESULTS: Among the repeat data for the 601 critical values, a total of 24 showed large differences between the initial result and the repeated result which exceeded the CAP limits for allowable error. The number and rates (% of large differences for within and outside the analytical measurement range (AMR were 12 (2.1% and 12 (41.4%, respectively. For the 572 critical values within the AMR for each test category, the mean absolute difference (mmol/L and difference(% between the two testing runs were: potassium, 0.1 mmol/L (2.7%; sodium, 2.1 mmol/L (1.7%; calcium, 0.05 mmol/L (3.0%; glucose, 0.18 mmol/L (2.6%. CONCLUSIONS: When the initial chemistry critical values are within the AMR, repeated testing does not improve accuracy and is therefore unnecessary. When the initial chemistry critical values are outside the AMR, however, the benefit of repeated testing justifies its performance and makes it necessary. Performing repeat clinical testing on a case-by-case, rather than routine, basis can improve patient care by delivering critical values more rapidly while providing savings

  5. Laboratory and clinical tests of a prototype pressure sensor for clincial assessment of prosthetic socket fit.

    Polliack, A A; Craig, D D; Sieh, R C; Landsberger, S; Mcneal, D R


    Lower limb prosthetic socket fabrication is a highly refined process relying on the prosthetist's skill and experience. Despite their best efforts, patients often return with complications. Additionally, clinical application of technological advances for the quantification of biomechanical factors at the socket interface has not changed in practice. Measuring pressure levels at the stump/socket interface could provide valuable information in the process of prosthetic socket fabrication, fit and modification. This paper presents findings on the performance of a prototype capacitance pressure sensor designed for prosthetic socket use. Bench tests using compressed air were performed to measure accuracy, hysteresis and drift responses in both a flatbed chamber and a custom-modified pressure vessel. For the contoured testing, the sensors were placed on nine sites on a positive trans-tibial stump mould and enveloped with a silicone liner. Additionally, a preliminary clinical evaluation was performed with two trans-tibial amputee subjects at the nine sites during normal ambulation. Bench test results showed that the prototype capacitance sensor performed well in all categories, exhibiting a 2.42% (flatbed) and 9.96% (contoured) accuracy error, a 12.93% (flatbed) and 12.95% (contoured) hysteresis error, and a 4.40% (flatbed) and 6.20% (contoured) drift error. The clinical study showed that after three hours of continual use, no noticeable sensor drift occurred between pre and post-test calibration values. The results from this study were encouraging and the authors hope to conduct further laboratory and clinical trials to assess the influence of shear force and dynamic loading on sensor response.

  6. Molecular analysis and association with clinical and laboratory manifestations in children with sickle cell anemia

    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.

  7. Comprehensive reference ranges for hematology and clinical chemistry laboratory parameters derived from normal Nigerian adults.

    Timzing Miri-Dashe

    Full Text Available BACKGROUND: 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. METHODS AND FINDINGS: 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. CONCLUSIONS: 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.

  8. [The quality management in clinical diagnostic laboratory in conditions of the Federal Center of traumatology, orthopedics and endoprosthesis replacement of Minzdrav of Russia (Cheboksary)].

    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.

  9. Clinical utility of the cryptococcal antigen lateral flow assay in a diagnostic mycology laboratory.

    Brendan J McMullan

    Full Text Available BACKGROUND: Cryptococcus neoformans causes life-threatening meningitis. A recently introduced lateral flow immunoassay (LFA to detect cryptococcal antigen (CRAG is reportedly more rapid and convenient than standard latex agglutination (LA, but has not yet been evaluated in a diagnostic laboratory setting. METHODS: One hundred and six serum, 42 cerebrospinal fluid (CSF, and 20 urine samples from 92 patients with known or suspected cryptococcosis were tested by LA and LFA, and titres were compared. Results were correlated with laboratory-confirmed cryptococcosis. Serial samples were tested in nine treated patients. RESULTS: Twenty-five of 92 patients had confirmed cryptococcosis; all sera (n = 56 from these patients were positive by LFA (sensitivity 100%, 95% confidence interval (CI 93.6-100% compared with 51/56 positive by LA (sensitivity 91.1%, 95% CI 80.7-96.1%. Fifty sera from 67 patients without cryptococcosis tested negative in both assays. While LA yielded more false negative results (5/56 this did not reach statistical significance (p = 0.063. Nine CSF samples from patients with cryptococcal meningitis yielded positive results using both assays while 17/18 urine samples from patients with cryptococcosis were positive by the LFA. The LFA detected CRAG in C. gattii infection (n = 4 patients. Agreement between titres obtained by both methods (n = 38 samples was imperfect; correlation between log-transformed titres (r was 0.84. Turn-around-time was 20 minutes for the LFA and 2 h for LA. The cost per qualitative sample was 18USD and 91 USD, respectively and per quantitative sample was 38USD and 144USD, respectively. CONCLUSIONS: Qualitative agreement between the LFA and LA assays performed on serum and CSF was good but agreement between titres was imperfect. Ease of performance of the LFA and the capacity for testing urine suggest it has a role in the routine laboratory as a rapid diagnostic test or point-of-care test.

  10. Management of stress and stress-related diseases: Emerging computer-based technologies and the rationale for clinical laboratory assessment

    Ezekiel Uba Nwose; Ross Stuart Richards


    Background : Over the years, the issue of stress management in mental health has been discussed without reference to the clinical laboratory perspectives. Translational research and the vast array of emerging diagnostic technologies in alternative medical practice are now bridging the gap. While it would be scientific arrogance for the clinical practitioner and scientist to ignore the trend, the new technologies seeking clinical acceptability necessarily require expatiation of the scientific ...

  11. Clinical and laboratory features of children with insulin dependent diabetes mellitus of more than two years

    Jose R. L. Batubara


    Full Text Available The incidence rate of IDDM in our clinic during the period from 1989 to 1998 was 0.028%. There were twentyfour IDDM patients with duration of illness of more than 2 years, with a male to female ratio of 1: 1.5. Most of these patients had no diabetic family history and had good nutritional status. The insulin dosage used by these patients ranged between 0.67 - 0.72 IU/kg/day with a mean of 1.06 IU/kg/day. The average frequency of blood glucose home monitoring was less than ideal. Twenty-two out of the 24 patients were fully controlled metabolically; however, these patients still have polyuria, polydipsia, and polyphagia.

  12. Strongyloidiasis: prevalence, risk factors, clinical and laboratory features among diarrhea patients in Ibadan Nigeria.

    Dada-Adegbola, H O; Oluwatoba, O A; Bakare, R A


    Strongyloidiasis is a parasitic infection caused by Strongyloides stercoralis. The infection is usually mild or asymptomatic in normal immunocompetent individuals, but could be very severe or even fatal due to hyper infection in individuals who are immunosuppressed. This study aimed at determining the prevalence, risk factors and features of strongyloidiasis among diarrhea patients in Ibadan. This is a descriptive cross-sectional study of diarrhea patients from a teaching hospital, three major government hospitals and one mission hospital in Ibadan. Self administered questionnaire, clinical assessment and laboratory investigations were used to confirm health status and presence of S. stercoralis. Diagnosis was made by microscopic examination of stool in saline preparation and formol-ether concentration. One thousand and ninety patients, (562 (51.6%) males and 528 (48.4%) females) consisting 380 (34.9%) children and 710 (65.1%) adults who had diarrhea were studied. The prevalence rate for the parasite among diarrhea patients was 3.0%. While the risk factor for infection remains contact with contaminated soil, malnutrition, steroid therapy, HIV/AIDS, lymphomas, tuberculosis, and chronic renal failure. Others are maleness, institutionalism and alcoholism. Predominant clinical presentations are abdominal pain, chronic diarrhea, and bloating and weight loss, Strongyloides stercoralis should be considered in diarrhea patients who are either malnourished or immunosuppressed.

  13. Clinical manifestation and laboratory findings in positive blood culture in neonatal septicemia

    Gholamreza Khademi


    Full Text Available Background/objective: Neonatal septicemia is one of the major causes of mortality in newborns. The aim of this study is to evaluate the clinical manifestations and laboratory findings in positive blood culture in neonatal septicemia. Methods: In this retrospective study, we allocated 100 records positive blood culture of neonates suffering from septicemia. A questionnaire was completed for each patient consisting the age at admission, gender, weight at birth, admission time, type of delivery, pre- or post-term delivery and the clinical symptoms. Types of organism causing sepsis, and their resistance to antibiotics were evaluated and method for empirical treatment was recommended. Results: Respiratory distress, cyanosis and lethargy were more common in the patients. The antibiogram showed Ampicillin resistance in 86% and Gentamycin resistance in 66% of studied records. Also, 36% cases of positive blood culture with gram-negative and 64% with gram-positive bacteria were observed. The most common bacteria in blood cultures were negative-coagulase Staphylococcus (%35, Staphylococcus Aureus (%24, Klebsiella (%18, respectively. Other bacteria were Enterobacter, Escherichia coli and Enterococcus (%5, Acinetobacter (%3, Pseudomonas aeruginosa and Negative-Gram Bacilli (%2 and Ceratia (%1. The most common effective antibiotics against bacterial growth in Antibiograms were Vancomycin, Cephalosporin, Amikacin, Co-trimoxazole and Gentamycin. Conclusion: Since the most common bacteria in neonatal septicemia cases were negative-coagulase Staphylococcus, Staphylococcus Aureus, Klebsiella, the pediatricians must select the regiments that cover gram-negative bacteria for empirical antibiotic treatments.

  14. Measles outbreak in Macedonia: epidemiological, clinical and laboratory findings and identification of susceptible cohorts.

    Irena T Kondova

    Full Text Available OBJECTIVES: Despite a 92-99% national vaccination coverage since 2000, the former Yugoslav Republic of Macedonia experienced a large measles outbreak between 2010 and 2011. Here we investigate the characteristics of patients hospitalized during this outbreak at the Clinic of Infectious Diseases in Skopje. METHODS: Epidemiological, clinical and laboratory data of 284 measles patients, including 251 from Skopje (43.80% of the 573 reported cases and 33 from elsewhere in Macedonia were collected. RESULTS: The most affected age groups were children up to 4 years of age and adolescents/adults of 15 years and older. Most patients were unvaccinated (n=263, 92.61% and many had non-Macedonian nationalities (n=156, 54.93% or belonged to the Roma ethnicity (n=73, 25.70%. Bronchopneumonia and diarrhea were the most common complications. Eighty-two out of 86 tested patients (95.35% had measles-specific IgM antibodies. The outbreak was caused by the measles variant D4-Hamburg. CONCLUSIONS: The epidemic identified pockets of susceptibles in Skopje and indicated that additional vaccination opportunities in particular for people with non-Macedonian nationality and traveler communities are warranted to ensure efficient measles control in Macedonia. The high attack rate among children of less than 1 year suggests that vaccination before 12 months of age should be considered in high risk settings.

  15. Enzymatic degradation of polygalacturonic acid by Yersinia and Klebsiella species in relation to clinical laboratory procedures.

    Starr, M P; Chatterjee, A K; Starr, P B; Buchanan, G E


    As scored by several specified plating procedures, clinical and environmental strains of Yersinia enterocolitica, Yersinia pseudotuberculosis, and Klebsiella pneumoniae "Oxytocum" showed detectable, albeit generally weak, ability to digest polygalacturonic (pectic) acid. None of these bacterial strains had the vigorous and rapid pectolytic activity on these polygalacturonic acid-containing media that is typical of soft-rot Erwinia species, although some of the Oxytocum strains came fairly close. Analyses of the pectolytic enzyme contents of the cells and culture supernatants of the Yersinia and Klebsiella species revealed that readily detectable quantities of cell-bound polygalacturonic acid trans-eliminase and hydrolytic polygalacturonase were formed by the Yersinia and Klebsiella species; however, the total units of enzyme activity produced by these bacteria were, in general, lower than were produced by soft-rot Erwinia species. Furthermore, unlike the situation in soft-rot Erwinia cultures, these pectolytic enzymes of Yersinia and Klebsiella species were not excreted rapidly and massively into the growth medium. Cultures of other enterobacteria (Citrobacter species, Enterobacter species, Erwinia amylovora, Erwinia herbicola, Escherichia coli, Proteus species, Salmonella typhimurium, and Serratia marcescens) showed no pectolytic ability whatsoever by any of the plating procedures used and (to the extent they were so examined) produced no pectolytic enzymes detectable either in their cells or culture supernatants. This slow or weak release of pectolytic enzymes by Yersinia and Klebsiella species has a bearing on clinical laboratory procedures suitable for detecting their pectolytic activity; methods adequate for this purpose are detailed.

  16. Corelations between radiological score with clinical and laboratory parameters in rheumatoid arthritis

    Mihaela Chicu


    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.

  17. Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorder Patients in Turkish Cohort: Demographic, Clinical, and Laboratory Features.

    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.

  18. Comparison of Leishmania typing results obtained from 16 European clinical laboratories in 2014.

    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.

  19. Clinical, laboratory, psychiatric and magnetic resonance findings in patients with Sydenham chorea

    Faustino, Patricia C.; Terreri, Maria Teresa R.A.; Rocha, Antonio J. da; Zappitelli, Marcelo C.; Lederman, Henrique M.; Hilario, Maria Odete E. [Universidade Federal de Sao Paulo, Sao Paulo (Brazil)


    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.)

  20. Tularemia in Children: Evaluation of Clinical, Laboratory and Treatment Outcomes of 15 Tularemia Cases

    Ekrem Koyuncu


    Full Text Available Introduction: Tularemia is a zoonotic diseases caused by Francisella tularensis. The aim of this study was to evaluate the clinical and laboratory findings of 15 children with the diagnosis of tularemia.Materials and Methods: Fifteen cases admitted with fever, sore throat, lymphadenopathy and a F. tularensis antibody titer of 1/160 and above in the microagglutination test (MAT were evaluated retrospectively. Their sociodemographic characteristics, contact with animals, history of tick bite, duration of complaints, clinical and laboratory findings, treatments and clinical courses were studied.Results: The mean age of patients was 11.5±5.1 (3-17 years and 61.3% were male. Fifty-three percent of the patients were living in rural areas, and had contact with contaminated water. Swelling in the neck (93.3%, sore throat (66.7% and fever (66.7% were the most frequently observed symptoms. Oropharyngeal tularemia (66.7% was predominated. In 27% of the patients LAPs were drained surgically, and in 13.3% of cases they were drained by itself. The mean duration between onset of tularemia symptoms and diagnosis was 53±45.3 (5-150 days. Sixty percent of patients were received beta-lactam-antibiotics before admission. It was noted that 6 patients with suppurative lymph nodes were admitted to hospital within median 61 (20-150 days, while others were admitted within median 35 (5-75 days (p<0.05. Mean leukocyte count was 8558.6±1384.5 (6030-11400/mm3, mean CRP was 5.8±2.9 (1-6.7 mg/dl, and mean ESR was 33.1±28.9 (6-103 mm/h. MAT showed that titers ranged from 1/160 to 1/1280. Gentamicin was given in seven patients (47%, streptomycin in five patients (33%, and doxycycline in 3 patients (20%.Conclusions: Tularemia should to be taken into account in the differential diagnosis in patients having tonsillopharyngitis and cervical lymphadenopathy without response to beta-lactam antibiotics in rural areas. (Journal of Current Pediatrics 2013;11:61-6

  1. Clinical presentation and laboratory findings for the first autochthonous cases of dengue fever in Madeira island, Portugal, October 2012.

    Alves, M J; Fernandes, P L; Amaro, F; Osório, H; Luz, T; Parreira, P; Andrade, G; Zé-Zé, L; Zeller, H


    An outbreak of dengue fever in Madeira island was reported in 2012. Clinical and laboratory findings of the first two laboratory-confirmed autochthonous cases are reported. Both cases had fever (≥38 °C) and petechial rash. Symptoms also included myalgia, asthenia, nausea, vomiting, anorexia, diffuse abdominal pain, and diarrhoea. The two cases were confirmed by serology and one tested positive for a dengue viral sequence. Dengue virus serotype DEN-1 was identified with probable Central or South American origin.

  2. Prediction of dengue disease severity among pediatric Thai patients using early clinical laboratory indicators.

    James A Potts

    Full Text Available Dengue virus is endemic in tropical and sub-tropical resource-poor countries. Dengue illness can range from a nonspecific febrile illness to a severe disease, Dengue Shock Syndrome (DSS, in which patients develop circulatory failure. Earlier diagnosis of severe dengue illnesses would have a substantial impact on the allocation of health resources in endemic countries.We compared clinical laboratory findings collected within 72 hours of fever onset from a prospective cohort children presenting to one of two hospitals (one urban and one rural in Thailand. Classification and regression tree analysis was used to develop diagnostic algorithms using different categories of dengue disease severity to distinguish between patients at elevated risk of developing a severe dengue illness and those at low risk. A diagnostic algorithm using WBC count, percent monocytes, platelet count, and hematocrit achieved 97% sensitivity to identify patients who went on to develop DSS while correctly excluding 48% of non-severe cases. Addition of an indicator of severe plasma leakage to the WHO definition led to 99% sensitivity using WBC count, percent neutrophils, AST, platelet count, and age.This study identified two easily applicable diagnostic algorithms using early clinical indicators obtained within the first 72 hours of illness onset. The algorithms have high sensitivity to distinguish patients at elevated risk of developing severe dengue illness from patients at low risk, which included patients with mild dengue and other non-dengue febrile illnesses. Although these algorithms need to be validated in other populations, this study highlights the potential usefulness of specific clinical indicators early in illness.

  3. Evaluation of clinical manifestations and laboratory findings of primary hyperparathyroidism in Imam Hospital (1988-1998

    Alam Salimi M


    Full Text Available Introduction: Clinical manifestations of primary hyper-para-thyroidism (pHPT had been dramatically changed during last 25 years. Evaluation of changes in clinical findings was the aim of this study. Materials and methods: In a retrospective, descriptive case series, patients' records of all 47 pHPT (44 females, 3 males from 1988 till 1998 were studied. Patients’ clinical presentations, signs and symptoms, laboratory and radiologic findings were reviewed and the results were compared with 34 patients' studied during 1978-1987. Serum Ca>10.5 mg/dl with increased or high normal PTH were the diagnostic criteria of pHPT. Results: Patients’ age range was 11-70 and mean ±SD was 38±16 years, with a female to male ratio of 14:1. 57 percent of the patients had bone pain and muscle weakness, 12 percent were asymptomatic, 10 percent had pathologic fractures, 8 percent had renal stones, 8 percent had symptoms of hypercalcemia, and 2 percent had giant cell lesion. The mean±SD of serum calcium was 11.48±1.16 mg/dl, phosphorus was 2.4±0.6 mg/dl and 24-h urinary Ca was 294±197 mg. Serum PTH was increased from 1.5 to 500 folds. The frequency of single adenoma in right inferior, left inferior, and left superior gland were 43 percent, 30 percent, and 13 percent respectively. Conclusion: In the study 12 percent of patients were asymptomatic whereas there was no asymptomatic case in the previous study. Prevalence of severe bone disease and the interval between onset of symptoms and diagnosis was also reduced. According to this study detection of pHPT in asymptomatic phase remarkably increased.

  4. Clinical and laboratory peculiarities of acute myocardial infarction after chronic tonsillitis

    Shvarts Y.G.


    Full Text Available Aim: The definition of the relationship of clinical and laboratory features of acute myocardial infarction depending on the suffering of chronic tonsillitis. Materials and methods. The study included 54 patients with acute myocardial infarction suffering for 1-2 days. The collection of the anamnesis, assessment of clinical factors, inspection of the palatine tonsils, clinical and biochemical blood tests have been done. Markers of myocardial necrosis, an electrocardiogram with calculation of a dispersion of interval QT, echocardiogram have been taken into account. Results. 45 of 54 patients reported the symptoms of chronic tonsillitis in their lifetime. At 17 patients the previous diagnosis of chronic tonsillitis has been made, in 6 of them bilateral tonsillectomy was held. All of the patients were divided into 2 groups: 1 with proven chronic tonsillitis (17 patients and 2 — the others (37 patients. At patients with chronic tonsillitis substantially more developed acute heart failure at sick this group glucose of the blood at receipt was higher than in 2 groups (p=0,004, given distinction was independent of presence of diabetes. According to the echocardiography 1 group of patients determined course-diastolic dimensions of the right ventricle increase in comparison with 2 groups (p=0,01. Conclusion. In patients with chronic tonsillitis more severe course of acute myocardial infarction has been determined, which became evident in the relatively high values of blood glucose on admission. The frequent development of congestive heart failure, and increase of the course-diastolic dimensions of the right ventricle have been also revealed.

  5. Clinical and laboratory aspects of a trichinellosis outbreak in Izmir, Turkey

    Turk M.


    Full Text Available Epidemiological, clinical and laboratory data were collected during an outbreak of trichinellosis, which occurred in Izmir, Turkey, between January and March 2004. The source of the infection was raw meatballs made with a mixture of uncooked beef and pork. Of 474 persons who were admitted at the Ataturk Training and Research Hospital during this period with a history of raw meatball consumption, the diagnosis of trichinellosis was confirmed for 154 (32.5 %, 87 males and 67 females; mean age 31 years, range 6-67 years. Among persons with a confirmed diagnosis, 79 % had myalgia, 77 % weakness and malaise, 63 % arthralgia, 40 % jaw pain, 68 % fever, 63 % periorbital and/or facial oedema, 49 % oedema at the trunk and limb, 42 % abdominal pain, 40 % nausea and vomiting, 28 % diarrhoea, 23 % subconjunctival haemorrhage, 25 % macular or petechial rash, 4 % subungual haemorrhage, 15 % cardiac complaints and 0.2 % neurological complaints. Nine patients (5.8 % were hospitalised due to severe myalgia (n = 2, high fever (n = 3, neurological manifestations (n = 1, thrombophlebitis (n = 2 and palmar erythema (n = 1. Eosinophilia was present in 88 % of the confirmed cases at the admission. Elevated levels of serum creatine phosphokinase, lactic dehydrogenase and aspartate aminotransferase were detected in 72 %, 70 % and 16 % of the confirmed cases, respectively. The seroconversion occurred in most of the infected people between the 4th and 6th weeks after the infection. All of the confirmed cases were treated with mebendazole. People with severe symptoms were treated also with prednisolone (60 mg/day for three days and those with a moderately severe clinical pattern received a non-steroid anti-inflammatory drug (naproxen sodium, 550 mg/day. All confirmed cases recovered without any clinical sequela.

  6. Epidemiological, clinical and laboratory features of murine typhus in central Tunisia.

    Aouam, A; Toumi, A; Ben Brahim, H; Loussaief, C; Jelliti, B; Ben Romdhane, F; Ben Yahia, S; Khairallah, M; Chakroun, M


    Murine typhus is an endemic zoonosis. It is difficult to diagnose because of its non-specific clinical manifestations. Our objective was to describe the epidemiological, clinical, laboratory, and treatment features of murine typhus. We conducted a retrospective study of 73 adult patients hospitalized for murine typhus from 2006 to 2011. The diagnosis was confirmed by a single titer of IgM≥128 or by seroconversion to typhus group antigen identified by indirect fluorescent assay. The mean age of patients was 33.1 years (range, 13-68 years). Thirty-eight patients (52%) lived in rural or suburban areas; neither fleabites nor exposure to rats were reported. The most common clinical symptoms were: fever, headache, and myalgia. A maculopapular and non-confluent rash was observed in 47 patients (64.4%). No inoculation eschar was observed in any patient. Eight patients presented with interstitial pneumonia and two with lymphocytic meningitis. The diagnosis was confirmed by indirect fluorescence assay in every case. A single titer of IgM ≥ 128 was found in 62 (84.9%) cases. The other 11 cases were diagnosed by seroconversion. All patients were given antibiotics. Tetracyclines were prescribed in 57 cases (78%). The two patients presenting with meningitis were treated with fluoroquinolone. The outcome was favorable for all patients and no relapse was observed. The features of murine typhus are non-specific. The definitive diagnosis is based on serologic testing by indirect fluorescent assay. Cyclins were the most prescribed antibiotics. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

  7. Estimation of the coefficient of variation from laboratory analysis of split specimens for quality control in clinical trials.

    Connett, J E; Lee, W W


    An explicit statistical model is proposed for the coefficient of variation for laboratory analyses of constituents of blood, serum, saliva, or other specimens. A method for computing the maximum likelihood estimate of the key parameter is described, and compared with two simpler noniterative estimates. Validity of the model is explored by analysis of data from the central laboratory of a large cooperative clinical trial. Simulation studies are employed to compare the accuracy of the three estimators of the coefficient of variation. For most laboratory measurements for which the model is valid, one of the two noniterative estimates is nearly as accurate and unbiased as the maximum likelihood estimate.

  8. Nursing students' experiences of and satisfaction with the clinical learning environment: the role of educational models in the simulation laboratory and in clinical practice.

    Cremonini, Valeria; Ferri, Paola; Artioli, Giovanna; Sarli, Leopoldo; Piccioni, Enrico; Rubbi, Ivan


    Student satisfaction is an important element of the effectiveness of clinical placement, but there is little consensus in the literature as to the preferred model of clinical experience for undergraduate nursing students. The aim of this study was assess, for each academic year, students' perception of the roles of nurse teachers (NT) and clinical nurse supervisors (CNS) who perform tutoring in both apprenticeship and laboratories and to identify and evaluate students' satisfaction with the environment of clinical learning. This analytic cross-sectional study was conducted in a sample of 173 nursing students in the Northern Italy. The research instrument used is the Clinical learning environment, supervision and nurse teacher (CLES+T) evaluation scale. Data were statistically analysed. 94% of our sample answered questionnaires. Students expressed a higher level of satisfaction with their training experiences. The highest mean value was in the sub-dimension "Pedagogical atmosphere on the ward". Third year students expressed higher satisfaction levels in their relationship with the CNS and lower satisfaction levels in their relationship with the NT. This result may be due to the educational model that is adopted in the course, in which the simulation laboratory didactic activities of the third year are conducted by CNS, who also supervises experiences of clinical learning in the clinical practice. The main finding in this study was that the students' satisfaction with the supervisory relationship and the role of NT depend on how supervision in the clinical practice and in the simulation laboratory is organized.

  9. Revolutionizing clinical microbiology laboratory organization in hospitals with in situ point-of-care.

    Stéphan Cohen-Bacrie

    Full Text Available BACKGROUND: Clinical microbiology may direct decisions regarding hospitalization, isolation and anti-infective therapy, but it is not effective at the time of early care. Point-of-care (POC tests have been developed for this purpose. METHODS AND FINDINGS: One pilot POC-lab was located close to the core laboratory and emergency ward to test the proof of concept. A second POC-lab was located inside the emergency ward of a distant hospital without a microbiology laboratory. Twenty-three molecular and immuno-detection tests, which were technically undemanding, were progressively implemented, with results obtained in less than four hours. From 2008 to 2010, 51,179 tests yielded 6,244 diagnoses. The second POC-lab detected contagious pathogens in 982 patients who benefited from targeted isolation measures, including those undertaken during the influenza outbreak. POC tests prevented unnecessary treatment of patients with non-streptococcal tonsillitis (n = 1,844 and pregnant women negative for Streptococcus agalactiae carriage (n = 763. The cerebrospinal fluid culture remained sterile in 50% of the 49 patients with bacterial meningitis, therefore antibiotic treatment was guided by the molecular tests performed in the POC-labs. With regard to enterovirus meningitis, the mean length-of-stay of infected patients over 15 years old significantly decreased from 2008 to 2010 compared with 2005 when the POC was not in place (1.43±1.09 versus 2.91±2.31 days; p = 0.0009. Altogether, patients who received POC tests were immediately discharged nearly thrice as often as patients who underwent a conventional diagnostic procedure. CONCLUSIONS: The on-site POC-lab met physicians' needs and influenced the management of 8% of the patients that presented to emergency wards. This strategy might represent a major evolution of decision-making regarding the management of infectious diseases and patient care.

  10. Quality assessment of vitamin D metabolite assays used by clinical and research laboratories.

    Carter, G D; Berry, J; Durazo-Arvizu, R; Gunter, E; Jones, G; Jones, J; Makin, H L J; Pattni, P; Phinney, K W; Sempos, C T; Williams, E L


    The Vitamin D External Quality Assessment Scheme (DEQAS) was launched in 1989 and monitors the performance of 25-hydroxyvitamin D (25-OHD) and 1,25- dihydroxyvitamin D (1,25(OH)2D) assays. In April 2015 a pilot scheme for 24,25-dihydroxyvitamin D (24,25(OH)2D) was introduced. The 25-OHD scheme is accuracy - based with target values assigned by the NIST Reference Measurement Procedure (RMP) for 25-OHD2 and 25-OHD3. A similar method is used to assign values for 3-epi-25-OHD. Five samples of human serum are distributed quarterly to over 1000 participants in 58 countries (April 2016) and clinical laboratories are expected to submit results within approximately 5 weeks. Research laboratories with assays run less frequently are not given a deadline. Archived samples with NIST- assigned values are also available. Performance is assessed on the first four samples with the fifth reserved for investigations e.g. recovery experiments or to assess the influence of other serum constituents such as lipids. DEQAS provides rapid feedback, with an on-line preliminary report available immediately after a participant submits results and a comprehensive report soon after the results deadline. In 2015, DEQAS investigations revealed that several 25-OHD immunoassays under-recovered 25-OHD2 and 25-OHD results were falsely low on a sample with a modestly raised triglyceride concentration. An RMP for 1,25 (OH)2D is not yet available and results are judged against the Method Mean. Free advice is available from the DEQAS Advisory Panel which includes experts on methodology and biostatistics. DEQAS collaborates closely with the Vitamin D Standardization Program (VDSP) and both organizations have successfully worked with participants and manufacturers to improve the accuracy of vitamin D assays. Copyright © 2017 Elsevier Ltd. All rights reserved.

  11. Will Regulatory and Financial Considerations Dampen Innovation in the Clinical Microbiology Laboratory?

    Gilligan, Peter H; Miller, Melissa B


    Over a million prosthetic joints are placed in patients in the United States annually. Of those that fail, 25% will be due to infection, with an estimated cost approaching 1 billion dollars. Despite the clinical and economic importance of these infections, the techniques for their detection are relatively insensitive. An innovative method for detecting these infections by using blood culture bottles (BCB) to culture specimens of periprosthetic tissue (PPT) was described in a recent article [T. N. Peel, et al., mBio 7(1):e01776-15, 2016, doi:10.1128/mBio.01776-15]. There are two potential stumbling blocks to the widespread implementation of this innovation. First, the FDA judges such an application of BCB as an "off-label use" and as such, a laboratory-developed test (LDT). LDTs are coming under greater scrutiny by the FDA and may require extensive, costly validation studies in laboratories that adopt this methodology. Second, the Center for Medicare and Medicaid Services has established a Hospital Acquired Condition Reduction Act under which institutions performing in the lowest quartile forfeit 1% of their Medicare reimbursement. Hospital-acquired infections are an important component of this quality metric. Although prosthetic joint infection (PJI) rates are not currently a hospital quality metric, given their cost and increasing frequency, it is reasonable to expect that they may become one. Will those with financial oversight allow an innovative technique that will require an expensive validation and may put the institution at risk for loss of CMS reimbursement?

  12. Effects of ostracism and sex on alcohol consumption in a clinical laboratory setting.

    Bacon, Amy K; Cranford, Alexi N; Blumenthal, Heidemarie


    Drinking to cope with negative affect is a drinking pattern that leads to problematic alcohol use both in college and after graduation. Despite theory and correlational evidence to this effect, establishing a link between stress and alcohol consumption among college students in the laboratory has yielded both a limited number of studies and, at times, inconsistent results. The present study attempts to resolve these issues through investigating the effects of an ecologically relevant stressor-ostracism-on alcohol consumption in a clinical laboratory setting. Social drinking college students (N = 40; 55% female) completed a 5-min game of Cyberball and were randomly assigned either to be included or excluded in the virtual ball-toss game. The amount (in ml) of beer consumed in a subsequent mock taste test served as our primary dependent variable, with breath alcohol concentration (BrAC) as a secondary dependent variable. Results indicated that excluded participants reported a trend toward an increase in negative affect from pre- to post-Cyberball, and endorsed significantly lower self-esteem, belonging, control, and belief in a meaningful existence compared to included participants. A significant Sex × Condition effect indicated that excluded women consumed less beer than both included women and excluded men, supported by a nonsignificant trend in BrAC. Men did not differ in their consumption of beer as a result of Cyberball condition. Implications of sex and social context on alcohol use are discussed, as well as ostracism as a method for investigating relationships between social stress and alcohol use.

  13. Clinical and laboratory differences between Epstein-Barr and cytomegalovirus infectious mononucleosis in children

    Medović Raša


    Full Text Available Introduction. Infective mononucleosis is most commonly caused by Epstein-Barr virus (EBV, and in smaller percentage by cytomegalovirus (CMV. Objective. The aim of this paper was to determine the clinical and laboratory differences between EBV and CMV infectious mononucleosis in children. Methods. Cohort retrospective analytical research was conducted. We used data from medical history in six years period and monitored anamnestic data, frequency of inspection and palpation obtained data during physical examination, several laboratory tests, abdomen ultrasonography examination finding and emergence of disease complications. Statistical processing of data has been performed using SPSS 20. Results. Total number of examined children was 137, out of which 85.4% were with EBV and 14.6% with CMV infection. Affected children were most commonly younger than eight years. Boys were affected more often. There was no difference in frequency of high temperature, sore throat, bad breath, and respiratory symptomatology between examined children. Differences were discovered in frequency of stomachaches, eyelid swelling, skin rash and fatigue. Differences were not proven in the frequency of angina, lymphadenopathy and splenohepatomegaly between the groups. Values of transaminases and lactic dehydrogenases significantly decreased after seven days of hospitalization in both groups. In children with EBV, values of transaminases declined faster than in children with CMV. Anemia and bacterial superinfection of pharynx were most common disease complications. Thrombocytopenia was more common in children with CMV infection. Average duration of hospitalization was 6.7 days. Conclusion. In children with CMV abdominal pain, eyelid swelling, skin rash, fatigue and thrombocytopenia were more common. In children with EBV values of transaminases declined significantly faster.

  14. Optimized molecular resolution of cross-contamination alerts in clinical mycobacteriology laboratories

    de Viedma Darío


    Full Text Available Abstract Background The phenomenon of misdiagnosing tuberculosis (TB by laboratory cross-contamination when culturing Mycobacterium tuberculosis (MTB has been widely reported and it has an obvious clinical, therapeutic and social impact. The final confirmation of a cross-contamination event requires the molecular identification of the same MTB strain cultured from both the potential source of the contamination and from the false-positive candidate. The molecular tool usually applied in this context is IS6110-RFLP which takes a long time to provide an answer, usually longer than is acceptable for microbiologists and clinicians to make decisions. Our purpose in this study is to evaluate a novel PCR-based method, MIRU-VNTR as an alternative to assure a rapid and optimized analysis of cross-contamination alerts. Results MIRU-VNTR was prospectively compared with IS6110-RFLP for clarifying 19 alerts of false positivity from other laboratories. MIRU-VNTR highly correlated with IS6110-RFLP, reduced the response time by 27 days and clarified six alerts unresolved by RFLP. Additionally, MIRU-VNTR revealed complex situations such as contamination events involving polyclonal isolates and a false-positive case due to the simultaneous cross-contamination from two independent sources. Conclusion Unlike standard RFLP-based genotyping, MIRU-VNTR i could help reduce the impact of a false positive diagnosis of TB, ii increased the number of events that could be solved and iii revealed the complexity of some cross-contamination events that could not be dissected by IS6110-RFLP.

  15. Usually Available Clinical and Laboratory Data Are Insufficient for a Valid Medication Review: A Crossover Study.

    Hurkens, K P G M; Mestres-Gonzalvo, C; de Wit, H A J M; van der Kuy, P H M; Janknegt, R; Verhey, F; Schols, J M G A; Stehouwer, C D A; Winkens, B; Mulder, W


    To establish the quality of medication reviews performed by nursing home physicians, general practitioners and pharmacists. 15 Pharmacists, 13 general practitioners and 18 nursing home physicians performed a medication review for three cases (A, B and C), at three evaluation moments. First, they received the medication list. Secondly, they also received laboratory results and reason for admission and finally, we added medical history. Remarks were divided into 6 categories, i.e. indication without medication, medication without indication, contraindications/ interactions, dosage problems, double medication and wrong medication. Remarks were compared to the remarks made by our expert panel and scored according to our grading model as appropriate (0 to +3) or missed or potentially harmful (-1). For each medication error category, the percentage of participants who made this error was computed. After the first evaluation moment, the overall estimated mean percentage score was -1.7% for case A, 3.9% for case B, and 8.7% for case C. After the second review, this score was 15.0% for case A, 19.8% for case B, and 22.2% for case C. This further increased to 30.0% for case A, 36.7% for case B and 44% for case C at the final evaluation. The absence of medication where there was an indication (indication without medication) was frequently missed and did not improve after adding the extra information regarding laboratory results, reason for admission and finally medical history. Increasing clinical information helps physicians and pharmacists to improve their medication reviews, however, additional information was still related with a high margin of error. Detection of certain errors becomes easier with additional information, whereas other errors remain undetected. To achieve a high standard of medication review, we have to change the way medication reviews should be performed.

  16. The good EULAR response at the first year is strongly predictive of clinical remission in rheumatoid arthritis: results from the TARAC cohort.

    Darawankul, Budsakorn; Chaiamnuay, Sumapa; Pakchotanon, Rattapol; Asavatanabodee, Paijit; Narongroeknawin, Pongthorn


    The purpose of this study was to identify the prevalence and prognostic factors of clinical remission in patients with rheumatoid arthritis (RA). The Thai Army Rheumatoid Arthritis Cohort (TARAC) patients were included if baseline data were available. Clinical remission was defined as 28-joint count disease activity scores (DAS28) EULAR response at the end of the first year of treatment (OR 2.75, 95 % CI 1.08-6.99, p = 0.03) were associated with clinical remission in univariate analysis. In multivariate regression analysis, only a good EULAR response at the first year was significantly correlated with clinical remission in this study (OR 3.1, 95 % CI 1.15-8.36, p = 0.03). Although remission is currently a treatment goal in patients with RA, only one-seventh of patients have achieved sustained clinical remission in clinical practice. The good EULAR response at the end of the first year was an independent predictive factor of clinical remission.


    Shevchenko OS


    Full Text Available Introduction. Today there are more than 150 species of nontuberculous mycobacteria (NTMB known, of which 99 were registered in Europe. Due to the similar clinical picture with tuberculosis, mycobacterioses are difficult to diagnose and often occur with TB as a mixed infection. Also, there are cases of NTMB detection in the sputum of persons previously suffered with tuberculosis, which can lead to a false diagnosis of recurrent disease. Currently, the role of atypical mycobacteria in human pathology is increasing. Atypical mycobacteria are characterized by a wide spectrum of sustainability and potential pathogenicity to humans and animals. It is generally accepted that the reservoir of infection are animals and the environment (water, soil. NTMB presence in water can lead to the erroneous diagnosis of mycobacteriosis due to laboratory contamination of samples with nontuberculous mycobacteria from the outside. Moreover recently it has been found the possibility of transferring NTMB from person to person on the background of existing lung disease. For many types of infections reservoir still has not been found. Aim of this work was to study identified in the Kharkiv region cases of non-tuberculous mycobacterioses, features of their clinical manifestations and laboratory diagnostic options. Materials and Methods. We examined 32 patients (25 men and 7 women, residents of Kharkiv and Kharkiv region, Ukraine, who were diagnosed with "non-tuberculous mycobacteriosis of lungs" during 2014-2016. Patients were examined with routine diagnostic algorithm for TB. Nontuberculous mycobacteriosis was diagnosed on the basis of NTMB growth in BACTEC system, after which the diagnosis was verified by the following criteria: 1. Smear: the absence of formation of Cord-factor (in the smear NTMB are located scattering; 2. Negative immunoassay (ID-test; 3. Negative GeneXpert MTB/RIF Then non-tuberculous mycobacteria were identificated by investigation on solid media

  18. Fatal dengue hemorrhagic fever in adults: emphasizing the evolutionary pre-fatal clinical and laboratory manifestations.

    Ing-Kit Lee

    Full Text Available BACKGROUND: A better description of the clinical and laboratory manifestations of fatal patients with dengue hemorrhagic fever (DHF is important in alerting clinicians of severe dengue and improving management. METHODS AND FINDINGS: Of 309 adults with DHF, 10 fatal patients and 299 survivors (controls were retrospectively analyzed. Regarding causes of fatality, massive gastrointestinal (GI bleeding was found in 4 patients, dengue shock syndrome (DSS alone in 2; DSS/subarachnoid hemorrhage, Klebsiella pneumoniae meningitis/bacteremia, ventilator associated pneumonia, and massive GI bleeding/Enterococcus faecalis bacteremia each in one. Fatal patients were found to have significantly higher frequencies of early altered consciousness (≤24 h after hospitalization, hypothermia, GI bleeding/massive GI bleeding, DSS, concurrent bacteremia with/without shock, pulmonary edema, renal/hepatic failure, and subarachnoid hemorrhage. Among those experienced early altered consciousness, massive GI bleeding alone/with uremia/with E. faecalis bacteremia, and K. pneumoniae meningitis/bacteremia were each found in one patient. Significantly higher proportion of bandemia from initial (arrival laboratory data in fatal patients as compared to controls, and higher proportion of pre-fatal leukocytosis and lower pre-fatal platelet count as compared to initial laboratory data of fatal patients were found. Massive GI bleeding (33.3% and bacteremia (25% were the major causes of pre-fatal leukocytosis in the deceased patients; 33.3% of the patients with pre-fatal profound thrombocytopenia (<20,000/µL, and 50% of the patients with pre-fatal prothrombin time (PT prolongation experienced massive GI bleeding. CONCLUSIONS: Our report highlights causes of fatality other than DSS in patients with severe dengue, and suggested hypothermia, leukocytosis and bandemia may be warning signs of severe dengue. Clinicians should be alert to the potential development of massive GI bleeding

  19. Clinical characteristics and laboratory analyses of acute myeloid leukemia with t(16;21)(p11;q22)

    Zhang, Zhifen; ZOU, JIANWEN; Li, Yuantang; Liu, Zhanfeng; Xu, Rui; TIAN, WENJUN; ZHAO, ZONGCHEN; Sun, Hui; Han, Jingying; Wang, Jia; Zhang, Bingchang; Ju, Ying


    The present study reviewed three patients with acute myeloid leukemia (AML) who had the specific genetic abnormality t(16;21)(p11;q22). To investigate the clinical and laboratory characteristics of AML with t(16;21)(p11;q22) translocation, the similarities and differences of clinical characteristics and laboratory examinations were compared, and a literature review was conducted. According to the French-American-British classification system, patient 1 was M4, patient 2 was M1 and patient 3 w...

  20. Pharmaco-epidemiological, clinical and laboratory characteristics of drug-induced liver injury in tuberculosis

    M. V. Koroleva


    Full Text Available Objective: improving the efficiency of pharmacotherapy of drug-induced liver injury in tuberculosis by clarifying pharmaco-epidemiological, clinical and laboratory features.Materials and Methods: A retrospective analysis of primary medical records of 250 patients with pulmonary tuberculosis, patients «Volgograd Regional Clinical TB Dispensary № 1». We evaluated the dynamics of biochemical parameters characterizing the development of hepatic cytolytic syndrome, examined the impact of gender and age on the incidence of liver damage, we investigated the relationship of clinical tuberculosis and chemotherapy regimen with the incidence of drug-induced liver injury, examined the clinical manifestations of liver disease.Results: Drug-induced liver injury as a complication of a specific anti-TB treatment was diagnosed in 67 patients (26,8%. In 170 patients (68,0% showed increase in alanine aminotransferase and asparaginaminotrasferazy. Hepatotoxicity significantly more common in patients with disseminated tuberculosis with the collapse of the lung tissue, smear, and a high degree of disease severity. Risk factors for drug liver damage were female gender and age older than 50 years. Women develop liver disease at an earlier date, and displays it harder than men. The earliest and most informative routine biochemical tests, reflecting the state of the liver in the dynamics are ALT and AST. It was found that the mode of the standard anti-TB treatment determines the type of liver injury: the first, 2a and 3rd modes prevails cytolytic hepatocellular type, with 2b mode – combined (mixed type 4th – type of cholestatic liver damage. It was found that repeated, after the development of hepatotoxic reactions, the appointment of anti-TB drugs without gepatoprotektsii in 94% of patients leads to repeated drug-induced liver damage. Cancel specific therapy against the background of cytolytic syndrome promotes the formation of

  1. [Evaluation of clinical and laboratory findings of adult visceral leishmaniasis cases].

    Ural, Serap; Kaptan, Figen; Sezak, Nurbanu; El, Sibel; Örmen, Bahar; Türker, Nesrin; Demirdal, Tuna; Vardar, İlknur; Özkan Çayıröz, Pınar; Çakalağaoğlu, Fulya


    Visceral leishmaniasis (VL, kala-azar) is a zoonotic infection caused by Leishmania species which are transmitted to humans by the bites of infected female phlebotomine sandflies. Leishmania infantum is the responsible species of VL in Aegean, Mediterranean, and Central Anatolia regions of Turkey mainly observed sporadically in pediatric age groups. The aim of this study was to evaluate the clinical and laboratory findings of adult patients with VL who were admitted to our hospital. A total of 10 patients (3 female, 7 male; age range: 18-67 years, mean age: 39.3 ± 16.51) followed in the infectious diseases clinic of the hospital between 2000 and 2013 were evaluated retrospectively. The diagnosis of VL was based on the presence of appropriate clinical and physical examination, as well as biochemical findings, positive serological test results (indirect fluorescent antibody test, and rK39 rapid antigen test) and/or detection of amastigote forms of parasite in the bone marrow aspiration samples. Of the cases three were diagnosed with both bone marrow and serology positivity, five with bone marrow positivity and one of each only with liver biopsy and positive serology result. Time interval from onset of the symptoms until the establishment of the specific clinical diagnosis was ranged from 2 to 12 weeks. The most frequent initial symptoms were fever, fatigue and abdominal distension. None of the patients had immunosupressive conditions such as HIV infection, corticosteroid use, immunosupressive treatment, or transplantation. All the patients were from Aegean region and six were living in rural areas. In all cases, hepatosplenomegaly, increased erythrocyte sedimentation rate, albumin/globulin ratio inversion, anemia, leukopenia and among nine cases trombocytopenia were detected. In one case acute renal failure has been developed before treatment and the patient was admitted to dialysis program. Bacterial superinfection occurred in two cases. Patients were treated with

  2. Clinical feasibility and safety of a novel miniature mobile cardiac catheterization laboratory in diagnosis and treatment for coronary heart disease

    Liang Ming; Han Yaling; Wang Geng; Yao Tianming; Sun Jingyang; Li Fei; Xu Kai


    Background The lack of medical facilities causes delayed diagnosis and treatment of coronary heart disease in remote mountainous area and/or at disaster site.The miniature mobile cardiac catheterization laboratory was developed to be an intervention platform for coronary heart disease diagnosis and treatment by our team.Pre-clinical research indicated that the miniature mobile cardiac catheterization laboratory performed well in the rescue of critical cardiovascular diseases,even ST-segment elevation myocardial infarction.The present study aimed to evaluate the clinical safety and timeliness of the miniature mobile cardiac catheterization laboratory for emergent coronary interventional diagnosis and treatment.Methods X-ray radiation safety and disinfection efficacy in the miniature mobile cardiac catheterization laboratory were tested during working status.Coronary angiography and/or percutaneous coronary intervention were performed in remote mountainous areas on patients who were first diagnosed as having coronary heart disease by senior interventional cardiologists.The percutaneous coronary intervention procedures and results from patients in the miniature mobile cardiac catheterization laboratory were compared with patients who were treated in the hospital catheter lab.Results The X-ray radiation dosages in the miniature mobile cardiac catheterization laboratory were 39.55 μGy/s,247.4 μGy/h,90.3 μGy/h and 39.4 μGy/h which were corresponded to 0 m,1 m,2 m and 3 m away from the tube central of the medium C-arm.And the radiation dosages used in the miniature mobile cardiac catheterization laboratory were less than the corresponding positions in the hospital catheter lab.The numbers of bacteria colonies in the miniature mobile cardiac catheterization laboratory in different environments range from (60±8) cfu/m3 to (120±10) cfu/m3 and met the demands of percutaneous coronary intervention.A total of 17 patients who received angiography in the miniature mobile

  3. Norovirus infection: features of epidemiology and clinical and laboratory manifestations at the present stage

    N.V. Pronko


    Full Text Available Background. Among most significant for practical medicine infections, acute intestinal infections of viral etiology are becoming increasingly topical [2, 4]. According to domestic and foreign literature, up to 70 % of gastroenteritis occur during cold seasons of the year and are induced by viruses [3, 5]. The range of the factors producing viral diarrheas is rather wide. One of the comparatively new acute intestinal infections (AII producing factors is noroviruses [5, 6]. The prevalence of noroviruses has been little studied, and the clinical picture has been characterized insufficiently. This can be explained by insufficient diagnostics and registration of this infection [3, 6, 7]. Aim of the work: analysis of the morbidity and determination of clinical laboratory features of noroviral infection (NVI in children according to the data of the Regional Clinical Infectious Di­seases Hospital in Grodno. Materials and methods. A comprehensive clinical laboratory analysis of 1,105 case histories of children aged 1 month to 14 years with verified viral intestinal infection, who were admitted to Grodno Regional Clinical Infectious Diseases Hospital from January 2013 to December 2016, was carried out. The patients were divided according to the final clinical diagnosis in the following way: rotaviral infection (RVI was found in 676 (61.2 % individuals, adenoviral intestinal infection (AVI — in 212 (19.2 %, NVI was detected in 156 (14.1 % and enteroviral infection — in 61 (5.5 % persons. The examination was carried out according to the protocols approved by the Ministry of Health of the Republic of Belarus. Results. As our study showed, at the period analyzed the viral intestinal diseases amounted to 70.4 % of all the cases of diseases in the structure of AII in children. Patients hospitalized with viral diarrhea showed prevalence of RVI (61.2 %. NVI was the third by the incidence among viral diarrheas, and it was registered in 14.1 % of the cases

  4. Clinical-laboratory characteristics of ANA-positive chronic idiopathic urticaria.

    Magen, Eli; Waitman, Dan-Andrei; Dickstein, Yoav; Davidovich, Valentina; Kahan, Natan R


    Despite the established association between chronic idiopathic/spontaneous urticaria (CIU) and presence of antinuclear antibodies (ANAs), the prevalence of autoimmune comorbidities in this population has not been analyzed. Here, we aim to identify clinical and laboratory manifestations associated with ANA-positive CIU. ANA-positive patients were identified via electronic data capture from the electronic patient record database of Leumit Health care Services (LHS) of Israel. Patient characteristics, medical histories, and details of diagnostic workup, medical treatment, and follow-up were retrieved by performing a chart review of electronic patient records (EPRs). The prevalence of target diseases among ANA(+) CIU(+), ANA(+) CIU(-), and ANA(-) CIU(+) patients was calculated. A total of 91 ANA(+) CIU(+), 3131 ANA(+) CIU(-), and 478 ANA(-) CIU(+) patients were identified. The ANA(+) CIU(+) group was characterized by higher prevalence of Sjögren's syndrome (SS)-A 52 antibodies (Ab) (7.7% versus 2.4%; p = 0.008), SS-A 60 Ab (11% versus 2.8%; p = ANA(-) CIU(+) group. Additionally, ANA(+) CIU(+) patients were more likely to be diagnosed with thyroid autoimmune diseases, higher C-reactive protein (6.4 ± 10.3 versus 4.1 ± 8.8 mg/L; p = 0.027), and more profound basopenia (0.04 ± 0.09 versus 0.15 ± 0.11 cell/mm(3); p ANA(-) CIU patients. More ANA(+) CIU(+) patients were resistant to four-fold standard licensed doses of antihistamines than ANA(-) CIU(+) patients [11 (12.1%) versus 29 (6.1%); p = 0.046]. ANA-positive CIU is characterized by higher prevalence of SS-A 52, SS-A 60, and SS-B antibodies and poorer clinical response to antihistamine medications.

  5. Historical milestones in measurement of HDL-cholesterol: impact on clinical and laboratory practice.

    Langlois, Michel R; Blaton, Victor H


    High-density lipoprotein cholesterol (HDL-C) comprises a family of particles with differing physicochemical characteristics. Continuing progress in improving HDL-C analysis has originated from two separate fields-one clinical, reflecting increased attention to HDL-C in estimating risk for coronary heart disease (CHD), and the other analytical, reflecting increased emphasis on finding more reliable and cost-effective HDL-C assays. Epidemiologic and prospective studies established the inverse association of HDL-C with CHD risk, a relationship that is consistent with protective mechanisms demonstrated in basic research and animal studies. Atheroprotective and less atheroprotective HDL subpopulations have been described. Guidelines on primary and secondary CHD prevention, which increased the workload in clinical laboratories, have led to a revolution in HDL-C assay technology. Many analytical techniques including ultracentrifugation, electrophoresis, chromatography, and polyanion precipitation methods have been developed to separate and quantify HDL-C and HDL subclasses. More recently developed homogeneous assays enable direct measurement of HDL-C on an automated analyzer, without the need for manual pretreatment to separate non-HDL. Although homogeneous assays show improved accuracy and precision in normal serum, discrepant results exist in samples with atypical lipoprotein characteristics. Hypertriglyceridemia and monoclonal paraproteins are important interfering factors. A novel approach is nuclear magnetic resonance spectroscopy that allows rapid and reliable analysis of lipoprotein subclasses, which may improve the identification of individuals at increased CHD risk. Apolipoprotein A-I, the major protein of HDL, has been proposed as an alternative cardioprotective marker avoiding the analytical limitations of HDL-C.

  6. Epidemiology, Clinical Presentation, Laboratory Diagnosis, Antimicrobial Resistance, and Antimicrobial Management of Invasive Salmonella Infections

    Sjölund-Karlsson, Maria; Gordon, Melita A.; Parry, Christopher M.


    SUMMARY Salmonella enterica infections are common causes of bloodstream infection in low-resource areas, where they may be difficult to distinguish from other febrile illnesses and may be associated with a high case fatality ratio. Microbiologic culture of blood or bone marrow remains the mainstay of laboratory diagnosis. Antimicrobial resistance has emerged in Salmonella enterica, initially to the traditional first-line drugs chloramphenicol, ampicillin, and trimethoprim-sulfamethoxazole. Decreased fluoroquinolone susceptibility and then fluoroquinolone resistance have developed in association with chromosomal mutations in the quinolone resistance-determining region of genes encoding DNA gyrase and topoisomerase IV and also by plasmid-mediated resistance mechanisms. Resistance to extended-spectrum cephalosporins has occurred more often in nontyphoidal than in typhoidal Salmonella strains. Azithromycin is effective for the management of uncomplicated typhoid fever and may serve as an alternative oral drug in areas where fluoroquinolone resistance is common. In 2013, CLSI lowered the ciprofloxacin susceptibility breakpoints to account for accumulating clinical, microbiologic, and pharmacokinetic-pharmacodynamic data suggesting that revision was needed for contemporary invasive Salmonella infections. Newly established CLSI guidelines for azithromycin and Salmonella enterica serovar Typhi were published in CLSI document M100 in 2015. PMID:26180063

  7. Resampling approach for determination of the method for reference interval calculation in clinical laboratory practice.

    Pavlov, Igor Y; Wilson, Andrew R; Delgado, Julio C


    Reference intervals (RI) play a key role in clinical interpretation of laboratory test results. Numerous articles are devoted to analyzing and discussing various methods of RI determination. The two most widely used approaches are the parametric method, which assumes data normality, and a nonparametric, rank-based procedure. The decision about which method to use is usually made arbitrarily. The goal of this study was to demonstrate that using a resampling approach for the comparison of RI determination techniques could help researchers select the right procedure. Three methods of RI calculation-parametric, transformed parametric, and quantile-based bootstrapping-were applied to multiple random samples drawn from 81 values of complement factor B observations and from a computer-simulated normally distributed population. It was shown that differences in RI between legitimate methods could be up to 20% and even more. The transformed parametric method was found to be the best method for the calculation of RI of non-normally distributed factor B estimations, producing an unbiased RI and the lowest confidence limits and interquartile ranges. For a simulated Gaussian population, parametric calculations, as expected, were the best; quantile-based bootstrapping produced biased results at low sample sizes, and the transformed parametric method generated heavily biased RI. The resampling approach could help compare different RI calculation methods. An algorithm showing a resampling procedure for choosing the appropriate method for RI calculations is included.

  8. Diagnosis of genital herpes simplex virus infection in the clinical laboratory


    Since the type of herpes simplex virus (HSV) infection affects prognosis and subsequent counseling, type-specific testing to distinguish HSV-1 from HSV-2 is always recommended. Although PCR has been the diagnostic standard method for HSV infections of the central nervous system, until now viral culture has been the test of choice for HSV genital infection. However, HSV PCR, with its consistently and substantially higher rate of HSV detection, could replace viral culture as the gold standard for the diagnosis of genital herpes in people with active mucocutaneous lesions, regardless of anatomic location or viral type. Alternatively, antigen detection—an immunofluorescence test or enzyme immunoassay from samples from symptomatic patients--could be employed, but HSV type determination is of importance. Type-specific serology based on glycoprotein G should be used for detecting asymptomatic individuals but widespread screening for HSV antibodies is not recommended. In conclusion, rapid and accurate laboratory diagnosis of HSV is now become a necessity, given the difficulty in making the clinical diagnosis of HSV, the growing worldwide prevalence of genital herpes and the availability of effective antiviral therapy. PMID:24885431

  9. Pre-Clinical Traumatic Brain Injury Common Data Elements: Toward a Common Language Across Laboratories.

    Smith, Douglas H; Hicks, Ramona R; Johnson, Victoria E; Bergstrom, Debra A; Cummings, Diana M; Noble, Linda J; Hovda, David; Whalen, Michael; Ahlers, Stephen T; LaPlaca, Michelle; Tortella, Frank C; Duhaime, Ann-Christine; Dixon, C Edward


    Traumatic brain injury (TBI) is a major public health issue exacting a substantial personal and economic burden globally. With the advent of "big data" approaches to understanding complex systems, there is the potential to greatly accelerate knowledge about mechanisms of injury and how to detect and modify them to improve patient outcomes. High quality, well-defined data are critical to the success of bioinformatics platforms, and a data dictionary of "common data elements" (CDEs), as well as "unique data elements" has been created for clinical TBI research. There is no data dictionary, however, for preclinical TBI research despite similar opportunities to accelerate knowledge. To address this gap, a committee of experts was tasked with creating a defined set of data elements to further collaboration across laboratories and enable the merging of data for meta-analysis. The CDEs were subdivided into a Core module for data elements relevant to most, if not all, studies, and Injury-Model-Specific modules for non-generalizable data elements. The purpose of this article is to provide both an overview of TBI models and the CDEs pertinent to these models to facilitate a common language for preclinical TBI research.

  10. Clinical and laboratory characteristics of chronic hepatitis C on the early stages of development

    N. S. Zhevnerova


    Full Text Available Aim of the research – to assess the clinical and laboratory parameters in patients with chronic hepatitis C (CHC on the early stages of development and their comparison with the level of galectin3. The study included 78 patients with oligosymptomatic course of the disease and minimal liver fibrosis in the most cases. In the most patients with stages of the disease exceeding 8 years, viral load was over a million copies/ml. In 10 % of patients on the early stages of the disease, changes corresponding to severe liver fibrosis and cirrhosis F3 and F4 were detected. Moderate correlation of ALT activity, viral load and low severity with the duration of the disease was identified. There is a trend towards a higher level of galectin3 in a long course of CHC in comparison with earlier stages of its development, with significantly higher average level of galectin-3 in patients with minimal liver fibrosis (F0–F1 as compared to advanced stages, suggesting its importance in the launching and initial mechanisms of fibrogenesis.


    E. N. Simovanyan


    Full Text Available Adverse course of enterovirus-71 infection (EVI-71 in children, frequent development of the nervous system pathology determine the need for early disease diagnosis. The study included 139 children aged 6 months to 13 years. Modern EVI-71 features is a frequent defeat of children aged from 3 to 7 years, attending organized groups, the priority development of combined moderate severity forms without nervous system pathology. EVI-71 is characterized by cyclical course, appearance in the first two disease days fever, murrain-like, catarrhal, lymphoproliferative syndromes, conjunctivitis, headaches. The second stage of the disease (3— 6 days in 37.9% children accompanied by attaching of meningitis and meningoencephalitis symptoms (common cerebral, meningeal and encephalic syndromes, changes in cerebrospinal fluid. In the EVI-71 diagnosis must be observed epidemiological history, clinical and laboratory parameters, detection of enterovirus-71 and its RNA from feces, oropharyngeal mucus and cerebrospinal fluid. Patients with EVI-71 need for combined treatment, including causal agents and pathogenetic therapy. 

  12. Behaviour of Clinical, Anthropometric and Laboratory Variables in Patients with Metabolic Syndrome

    Madelaine Hernández Tamayo


    Full Text Available Background: Diagnosing patients with metabolic syndrome is important because of the high prevalence and risk they present. Objective: to determine the behaviour of some clinical, anthropometric and laboratory variables in patients with metabolic syndrome. Methods: A descriptive study was conducted. The sample included 161 patients selected at random in different research stages from a universe including all the patients who attended six different consultations in Urbano Noris municipality, Holguín, from September 2008 to June 2009. Diagnosis was performed according to the ATP-III. Variance analysis and Fisher's exact test in SPSS (α = 0.05 were applied. Results: Patients with metabolic syndrome (n = 103: 63.97% presented values over average weight, height, waist circumference, body mass index, systolic blood pressure, plasma cholesterol, LDL, triglycerides and glucose. Their HDL levels were lower. A significant association between metabolic syndrome and CRP, microalbuminuria, alterations in blood sugar levels and hypertension was proved. Conclusions: The importance of characterizing the metabolic syndrome for future interventions was determined.

  13. Rare hereditary red blood cell enzymopathies associated with hemolytic anemia - pathophysiology, clinical aspects, and laboratory diagnosis.

    Koralkova, P; van Solinge, W W; van Wijk, R


    Hereditary red blood cell enzymopathies are genetic disorders affecting genes encoding red blood cell enzymes. They cause a specific type of anemia designated hereditary nonspherocytic hemolytic anemia (HNSHA). Enzymopathies affect cellular metabolism, which, in the red cell, mainly consists of anaerobic glycolysis, the hexose monophosphate shunt, glutathione metabolism, and nucleotide metabolism. Enzymopathies are commonly associated with normocytic normochromic hemolytic anemia. In contrast to other hereditary red cell disorders such as membrane disorders or hemoglobinopathies, the morphology of the red blood cell shows no specific abnormalities. Diagnosis is based on detection of reduced specific enzyme activity and molecular characterization of the defect on the DNA level. The most common enzyme disorders are deficiencies of glucose-6-phosphate dehydrogenase (G6PD) and pyruvate kinase (PK). However, there are a number of other enzyme disorders, often much less known, causing HNSHA. These disorders are rare and often underdiagnosed, and the purpose of this review. In this brief review, we provide an overview of clinically relevant enzymes, their function in red cell metabolism, and key aspects of laboratory diagnosis.

  14. Recurrent respiratory disorders in Polish Konik horses - clinical and laboratory findings

    Niedźwiedź Artur


    Full Text Available The aim of this study was to investigate the causes of chronic respiratory disorders in Polish Konik horses maintained in a stable and pasture, under condition typical for pleasure horses in Poland. The study was conducted on 14 adult horses, consistent with regard to environment and living conditions. The horses were divided into two groups: seven horses not affected by any respiratory problem (control group and seven horses with history of lower airway disease (study group. Clinical and laboratory evaluation, endoscopic examination, bronchoalveolar lavage, tracheal wash, and lung ultrasound were performed in all horses. Median (25th and 75th percentiles for bronchoalveolar lavage fluid differential cell count in control horses was 55.8 (49.8 and 59.1 of macrophages, 41 (38.5 and 45.9 of lymphocytes, and 5.1 (4.1 and 5.3 of neutrophils, whereas in the study group they were 32.8 (25.9 and 35.7 of macrophages, 59.8 (51.3 and 64.8 of lymphocytes, and 38.1 (34.8 and 41.1 of neutrophils. It was concluded that chronic respiratory disorders in Polish Konik horses were probably caused by recurrent airway obstruction.

  15. An educational intervention to increase awareness reduces unnecessary laboratory testing in an internal medicine resident-run clinic.

    Leung, Erika; Song, Shuang; Al-Abboud, Omar; Shams, Shahed; English, John; Naji, Wisam; Huang, Yafei; Robison, Leon; Balis, Fred; Kawsar, Hameem I


    At our resident-run clinic in an underserved community, laboratory test costs in 2013 exceeded the government subsidy by $400 000. To optimize limited resources and improve patient care, an education program to reduce testing was implemented. Between November 2014 and January 2015, residents attended lectures on utilization of laboratory testing, focusing on standard practice guidelines, and analyses of unnecessary tests. Multivariate nonparametric statistical methods and subgroup analysis were used to evaluate cost reduction. There were 453 clinic visits during the intervention period and 471 visits during the control period. Lectures were independently associated with a significant laboratory cost reduction. Median laboratory cost per visit decreased from $106.00 to $74.00. Total cost in the study period decreased from $79 403 to $51 463. There were similar reductions of laboratory costs in two subgroups: age groups of <50 years and ≥50 years, new encounters, and follow-up visits . In the analysis of individual tests, the cost of TSH and Vitamin D tests had the greatest reduction ($8176 and $5088 respectively). An appropriate physician education program can reduce laboratory tests and costs. Screening tests with inadequate evidence support were reduced most, whereas those with proven benefits did not decrease significantly.

  16. Pulmonary embolism in the elderly: a review on clinical, instrumental and laboratory presentation

    Luca Masotti


    Full Text Available Luca Masotti1,8, Patrick Ray2, Marc Righini3, Gregoire Le Gal4, Fabio Antonelli5, Giancarlo Landini1, Roberto Cappelli6, Domenico Prisco7, Paola Rottoli81Internal Medicine, Cecina Hospital, Cecina, Italy; 2Department of Emergency Medicine, Centre Hospitalo-Universitaire Pitié-Salpêtrière, Université Pierre et Marie Curie-Paris 6, Paris, France; 3Division of Angiology and Hemostasis, Geneva University Hospital and Faculty of Medicine, Geneva, Switzerland; 4Department of Internal Medicine and Chest Diseases, Brest University Hospital, Brest, France; 5Clinical Chemistry, Cecina Hospital, Cecina, Italy; 6Department of Internal, Cardiovascular and Geriatric Medicine, University of Siena, Siena, Italy; 7Department of Critical Care Medicine, Thrombosis Centre, Careggi Hospital, Florence, Italy; 8Departiment of Clinical Medicine and Immunological Sciences, Division of Respiratory Diseases, University of Siena, Siena, ItalyObjective: Diagnosis of pulmonary embolism (PE remains difficult and is often missed in the elderly due to nonspecific and atypical presentation. Diagnostic algorithms able to rule out PE and validated in young adult patients may have reduced applicability in elderly patients, which increases the number of diagnostic tools use and costs. The aim of the present study was to analyze the reported clinical presentation of PE in patients aged 65 and more.Materials and Methods: Prospective and retrospective English language studies dealing with the clinical, instrumental and laboratory aspects of PE in patients more than 65 and published after January 1987 and indexed in MEDLINE using keywords as pulmonary embolism, elderly, old, venous thromboembolism (VTE in the title, abstract or text, were reviewed.Results: Dyspnea (range 59%–91.5%, tachypnea (46%–74%, tachycardia (29%–76%, and chest pain (26%–57% represented the most common clinical symptoms and signs. Bed rest was the most frequent risk factor for VTE (15%–67%; deep vein

  17. Medical expert systems developed in j.MD, a Java based expert system shell: application in clinical laboratories.

    Van Hoof, Viviane; Wormek, Arno; Schleutermann, Sylvia; Schumacher, Theo; Lothaire, Olivier; Trendelenburg, Christian


    Growing complexity of diagnostic tests, combined with increased workload, stringent laboratory accreditation demands, continuous shortening of turn-around-time and budget restrictions have forced laboratories to automate most of their iterative tasks. Introduction of artificial intelligence by means of expert systems has gained an important place in this automation process. Different parts of clinical laboratory activity can benefit from their implementation and the present project deals with one aspect, namely the clinical interpretation of diagnostic tests. This paper describes how j.MD, a new Java based expert system shell, was used to reprogram the expert system for interpretation of amylase isoenzyme patterns that has been in use for many years in our laboratory, and that was originally programmed in Pro.MD, a Prolog based expert system shell. One of the most important advantages of the j.MD system is its bidirectional link with the laboratory information system. This project shows how expert systems for the interpretation of complex diagnostic tests that demand specific expertise can become an integrated part of the automated clinical chemistry lab.

  18. Decreased Sperm Motility Retarded ICSI Fertilization Rate in Severe Oligozoospermia but Good-Quality Embryo Transfer Had Achieved the Prospective Clinical Outcomes

    Zheng, Jufeng; Lu, Yongning; Qu, Xianqin; Wang, Peng; Zhao, Luiwen; Gao, Minzhi; Shi, Huijuan; Jin, Xingliang


    Introduction Spermatozoa motility is the critical parameter to affect the treatment outcomes during assisted reproductive technologies (ART), but its reproductive capability remains a little informed in condition of severe male factor infertility. This retrospective cohort study aimed to evaluate the effects of reduced sperm motility on the embryological and clinical outcomes in intra-cytoplasmic sperm injection (ICSI) treatment of severe oligozoospermia. Patients and Methods 966 cycles (812 couples) of severe oligozoospermia diagnosed by spermatozoa count ≤ 5 × 106/mL and motile spermatozoa ≤ 2 × 106/mL were divided into four groups in according to the number of motile spermatozoa in one ejaculate on the day of oocyte retrieval (Group B—E). The control (Group A) was 188 cycles of moderate oligozoospermia with spermatozoa count > 5 × 106/mL and motile spermatozoa > 2 × 106/mL. All female partners were younger than 35 years of age. Logistic regression analyzed embryological outcomes (the rates of fertilization, cleavage and good-quality embryo) and clinical outcomes (the rates of pregnancy, implantation, early miscarriage and live birth). Quality of embryo transfer (ET) was divided into three classes as continuous factor to test the effects of embryo quality on clinical outcomes. Results The reduction in the number of motile sperm in four groups of severe oligozoospermia gave rise to comparable inability of the fertilization (p < 0.001) and a decreased rate of good-quality embryo at Day 3 (p < 0.001) by compared to the control. The cleavage rate of the derived zygotes was similar to the control. ET classes significantly affected the clinical outcomes (p < 0.001). Class I ET gave rise to similar rates of clinical outcomes between five groups, but Class II and Class III ET retarded the rates of pregnancy, implantation and live birth and this particularly occurred in Group C, D and E. The rate of early miscarriage was not comparably different between groups

  19. Clinical features and pitfalls in the laboratory diagnosis of dengue in travellers

    Frank Christina


    Full Text Available Abstract Background Several enzyme-linked immunosorbent assay (ELISA-kits are commercially available for the rapid diagnosis of dengue infection, and have demonstrated good sensitivity and specificity in paired serum samples. In practice, however, often only one blood sample is available from febrile travellers returning from dengue endemic areas. Methods To evaluate the diagnostic value of positive dengue antibody-titres performed by a standard ELISA (PanBio IgM- and IgG-ELISA in single serum samples (regarded as "probable infection", 127 positive samples were further analyzed using envelope/membrane IgM-, and nonstructural protein 1 IgM- and IgG-ELISAs, immunofluorescence assays, and real-time reverse transcription polymerase chain reaction assays (RT-PCR. A combination of the test-results served as the diagnostic "gold standard". A total of 1,035 febrile travellers returning from dengue-endemic countries with negative dengue-serology and RT-PCR served as controls to compare clinical and haematological features. Results Overall, only 64 (positive predictive value = 50% of the probable cases were confirmed by additional analysis and 54 (42.5% were confirmed to be "false-positive". Rash was the only clinical feature significantly associated with confirmed dengue fever. The combination of thrombocytopenia and leucopenia was present in 40.4% of confirmed and in 6.1% of false-positive cases. Thus, the positive predictive value for the combination of positive PanBio-ELISA plus the two haematological features was 90.5%. Conclusion The examination of paired serum samples is considered the most reliable serodiagnostic procedure for dengue. However, if only one blood sample is available, a single positive ELISA-result carries a high rate of false-positivity and should be confirmed using a second and more specific diagnostic technique. In the absence of further testing, platelet and white blood cell counts are helpful for the correct interpretation.

  20. Clinical and Laboratory Features, Treatment and Prognosis in Children with Guillian-Barre Syndrome

    N. A. Suponeva


    Full Text Available A retrospective study of 42 cases of acute flaccid paralysis (AFP in children aged between 7 months and 15 years, registered at the Municipal Clinical Hospital №1 throughout a 7 year period (2007—2014, was performed to investigate the features of pediatric Guillian-Barre Syndrome (GBS. GBS has shown to be the most common cause of AFP in children, with prevalence of 74% of all 31 cases. Clinical manifestations, functional status, laboratory and electrodiagnostic data were evaluated in group of 31 children in order to highlight particular features of childhood GBS in Russia. The highest frequency of GBS was observed in children aged between 1 to 3 with the median 6 [3; 11] years. Boys with GBS outnumbered girls by a 2,1:1 ratio. No seasonal dependence has been observed, with children equally suffering from this disease without a seasonal pattern throughout the year. According to the electrophysiological and clinical data, 24 children were diagnosed with acute inflammatory demyelinating polyradiculoneuropathy (AIDP (77%, 5 with acute motor axonal neuropathy (AMAN (16% and 2 with аcute motor-sensory axonal neuropathy (AMSAN in a total of cases (7%. Several exclusive features of GBS in children for Russia were discovered. The most common initial symptom was limb pain, with the impartial sensory disturbance found only in 13% of the patients observed, 10% of which were paresthesias and the remaining 3% belonging to hypostesias. Children reached the nadir state rapidly, the median time from onset to nadir was 9.5 [6,25; 12,5] days. Cranial nerve dysfunction at nadir was observed in a greater percentage of patients (51% compared to that of 23% cases at the onset, with the facial palsy increasing from 10 to 32% and the bulbar palsy from 12 to 19%. The patients were given intravenous immunoglobulin in various doses: from 0.2 to 1.75 mg/kg per course (0.5 [0.5; 0.8] g/kg and/or plasmapheresis with a median volume of 93 [81; 100] ml/kg per

  1. Clinical and laboratory features of pancreatic steatosis in children with overweight and obesity

    N.Yu. Zavgorodnyaya


    Full Text Available Background. Nonalcoholic fatty pancreas disease is a pathological condition associated with obesity and components of the metabolic syndrome. Clinical features of the pancreatic steatosis can be caused by exocrine insufficiency, which is accompanied with the development of dysbiotic changes and intestinal disorders. The aim of the study was to examine the clinical and laboratory features of pancreatic steatosis in children with overweight and obesity. Materials and methods. We determined the presence of pancreatic steatosis by ultrasound examination of the abdominal cavity in 24 children with disorders of the gastrointestinal tract. To characterize the state of the intestinal microbiota, a hydrogen breath test with a load of glucose or lactose was carried out. Determination of hepatic steatosis was performed using transient liver elastography (FibroScan with determination of controlled attenuation parameter. Patients were divided into 2 groups: a control group (S0 was presented by 12 patients without pancreatic steatosis, the main group (S+ — 12 patients with pancreatic steatosis. Results. Pancreatic steatosis in children with overweight and obesity was characterized by nonspecific clinical picture with the prevalence of dyspepsia. Children with pancreatic steatosis had lower levels of serum amylase compared to control group (mean value was (30.40 ± 12.45 mmol/l in the main group and (51.88 ± 19.81 mmol/l — in the control, p < 0.05. Also, patients of the main group had significantly more common incudence of steatorrhea during coprological study (75 % of children of the main group vs. 33.3 % in the control group, p < 0.05. Pancreatic steatosis in children was associated with development of small intestinal bacterial overgrowth (50 % of children of the main group vs. 8.3 % in the control group, p < 0.05. Among patients with pancreatic steatosis, 41.6 % had signs of liver steatosis, whereas pancreatic steatosis was found in 62.5 % of

  2. Generation of anti-idiotype antibodies for application in clinical immunotherapy laboratory analyses.

    Liu, Zhanqi; Panousis, Con; Smyth, Fiona E; Murphy, Roger; Wirth, Veronika; Cartwright, Glenn; Johns, Terrance G; Scott, Andrew M


    The chimeric monoclonal antibody ch806 specifically targets the tumor-associated mutant epidermal growth factor receptor (de 2-7EGFR or EGFRVIII) and is currently under investigation for its potential use in cancer therapy. The humanised monoclonal antibody hu3S193 specifically targets the Lewis Y epithelial antigen and is currently in Phase I clinical trials in patients with advanced breast, colon, and ovarian carcinomas. To assist the clinical evaluation of ch806 and hu3S193, laboratory assays are required to monitor their serum pharmacokinetics and quantitate any immune responses to the antibodies. Mice immunized with ch806 or hu3S193 were used to generate hybridomas producing antibodies with specific binding to ch806 or hu3S193 and competitive for antigen binding. These anti-idiotype antibodies (designated Ludwig Melbourne Hybridomas, LMH) were investigated as reagents suitable for use as positive controls for HAHA or HACA analyses and for measuring hu3S193 or ch806 in human serum. Anti-idiotypes with the ability to concurrently bind two target antibody molecules were identified, which enabled the development of highly reproducible, sensitive, specific ELISA assays for determining serum concentrations of hu3S193 and ch806 with a 3 ng/mL limit of quantitation using LMH-3 and LMH-12, respectively. BIAcore analyses determined high apparent binding affinity for both idiotypes: LMH-3 binding immobilized hu3S193, Ka = 4.76 x 10(8) M(-1); LMH-12 binding immobilised ch806, Ka = 1.74 x 10(9) M(-1). Establishment of HAHA or HACA analysis of sera samples using BIAcore was possible using LMH-3 and LMH-12 as positive controls for quantitation of immune responses to hu3S193 or ch806 in patient sera. These anti-idiotypes could also be used to study the penetrance and binding of ch806 or hu3S193 to tumor cells through immunohistochemical analysis of tumor biopsies. The generation of anti-idiotype antibodies capable of concurrently binding a target antibody on each variable

  3. Aerobic vaginitis and mixed infections: comparison of clinical and laboratory findings.

    Fan, Aiping; Yue, Yingli; Geng, Nv; Zhang, Huiying; Wang, Yingmei; Xue, Fengxia


    To investigate the clinical features of aerobic vaginitis (AV) and mixed infections with AV to achieve efficient diagnosis. From April 2008 to August 2009, 657 consecutive outpatients with vaginal symptoms in gynecology clinic in the General Hospital of Tianjin Medical University were investigated. Samples were taken for examination of vaginal discharge and fresh wet mount microscopy. AV, bacterial vaginosis (BV), vulvovaginal candidiasis (VVC), and trichomonal vaginitis (TV) were diagnosed according to standardized definitions. Sixty patients with single AV were randomly selected over the same period. Each patient accepted moxifloxacin therapy. Two kinds of treatment course (400 mg qd, 6 days or 400 mg qd, 12 days) were given. Clinical features and laboratory test results in the first visit and follow-ups were recorded and statistically analyzed. Among the 657 cases, AV was found in 23.74 % of the cases (156/657). AV mixed infections were diagnosed in 53.85 % (84/156): the mixed infections included VVC (32/84, 38.10 %), BV (31/84, 36.90 %), and TV (21/84, 25.00 %). Common symptoms of AV were a change in the characteristics of the discharge (44/72, 61.11 %) and increased discharge (30/72, 41.67 %). Vaginal pH was usually higher than 4.5 (63/72, 87.50 %). Enterococcus faecalis, Streptococcus viridans, Escherichia coli, and Staphylococcus epidermidis were frequently isolated. There is no statistically significant difference between two moxifloxacin treatment groups (p > 0.05). Cure rate was 89.7 % in 6-day group, and 71.4 % in 12-day group. AV is a common vaginal infection, and it is often mixed with other infections, especially VVC, BV and TV. The symptoms and signs of AV mixed infections are atypical. If a patient has vaginal complaints, it is necessary to determine whether AV or mixed infections are present. Oral moxifloxacin is effective in treating AV, and an appropriate course should be selected taking the severity of AV into consideration.

  4. The clinical features, laboratory findings, treatment and follow-up results of patients with morphea

    Nehir Parlak


    Full Text Available Objective: Morphea, also known as localized scleroderma, is a rare skin disease of unknown pathogenesis, characterized by fibrosis in the skin and subcutaneous tissue. In this study, we aim to evaluate the demographic features, clinical characteristics, laboratory findings, and response to treatment in patients diagnosed with morphea. Materials and Methods: The findings of fifty eight patients diagnosed with morphea were retrospectively evaluated between 1995-2011. All patients' clinical symptoms, concomitant diseases, symptoms, immunological features and presence of peripheral eosinophilia were investigated. Treatment methods, response to therapy of 40 patients whose treatment continued for 2-12 months were examined. Fourty nine patients (84.5% were female and 9 patients (15.5% were male of 58 patients who were diagnosed with morphea. The mean age of patients was 42.33±18.44 years (range: 7-75 years. Diagnosis was made histopathologically in all cases. Borrelia antibodies were negative in all patients enrolling the study. Thirty six patients (62.1% had plaque type, 17 patients (29.3% had generalized type, 3 patients (5.2% had mixed type (linear + plaque and 2 patients (3.4% had linear type of morphea. ANA was found to be positive in 12 (26.2% of 46 patients. Considering the relationship between the clinical types of morphea with ANA, 38.5% of plaque type, 53.8% of generalized type, 7.7% of mixed type patients showed ANA positivity. ANA positivity was statistically significant in patients with generalized morphea (p=0.027. Peripheral eosinophilia was detected in one case in whom lesions were generalized (2.1%. Colchicine therapy was given to 23 cases. Complete and partial response rates are 47.8% and 26.1%, respectively. However, 17.4% of patients remained stable and progression was noted in 8.7% of the cases. Conclusion: In conclusion, plaque type morphea is the most common type of morphea. ANA positivity was statistically significant in

  5. Type I primary neuropathic amyloidosis (Andrade, Portuguese: a clinical and laboratory study of 21 cases

    Eduardo M. Azevedo


    Full Text Available The authors present a review of 21 cases with the diagnosis of type I amyloid neuropathy based on epidemiological data, clinical evolution and histopathological findings. They call attention to the possibility of cranial nerves involvement (hyposmia, diplopia, masseterian hypotrophy, peripheral facial paralysis, hypoacusis, dysphonia, laryngeal paralysis, dysphagia, and trapezium muscle hypotrophy, to the severeness of the digestive symptoms, to the precocity of the autonomic disorders, and to the rather high incidence (6 cases of heart involvement. The electromyography showed anterior horn involvement in 3 cases. The electrocardiography showed repolarization disorders in 11 cases, left ventricular overload in 6 cases and atrioventricular block in 5 cases. The serum proteins electrophoresis showed frequent abnormalities, but no typical curve could be obtained. The barium-contrasted X-rays of the gastrointestinal tract showed no anatomical lesions, but functional abnormalities (hypo or hypermotility were found in 14 examinations. The Schilling test showed impairment of vitamin B12 absorption in 50% of the cases. However, with the concomitant administration of intrinsic factor (3 cases there was improvement of its absorption. This proves that the gastric mucosa plays an important role in the disease malabsorption. The test with labeled-triolein showed slow absorption in 2 cases and steatorrhea in 3 (6 tests. For the confirmation of the amyloid deposits, the best histopathological procedure was nerve biopsy. In men, when the nerve biopsy was negative, testicular biopsy has shown to be a good option.

  6. Clinical Practice as Natural Laboratory for Psychotherapy Research: A Guide to Case-Based Time-Series Analysis

    Borckardt, Jeffrey J.; Nash, Michael R.; Murphy, Martin D.; Moore, Mark; Shaw, Darlene; O'Neil, Patrick


    Both researchers and practitioners need to know more about how laboratory treatment protocols translate to real-world practice settings and how clinical innovations can be systematically tested and communicated to a skeptical scientific community. The single-case time-series study is well suited to opening a productive discourse between practice…

  7. 78 FR 31560 - Medicare Program; Public Meeting in Calendar Year 2013 for New Clinical Laboratory Test Payment...


    ... auditorium of the Centers for Medicare & Medicaid Services (CMS), Central Building, 7500 Security Boulevard... [CMS-1451-N] Medicare Program; Public Meeting in Calendar Year 2013 for New Clinical Laboratory Test Payment Determinations AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION:...

  8. Magnetic resonance cholangiopancreatography uncovering massive gallbladder mucocele in a patient with ambiguous clinical and laboratory findings: A case report

    Queennie Reyes


    Conclusion: Magnetic resonance cholangiopancreatography should be considered as a complementary imaging modality to assess patients presenting with atypical biliary symptoms, particularly when ultrasound is equivocal or inconclusive, clinical and laboratory findings are non-specific, and computer tomography is contraindicated. Magnetic resonance cholangiopancreatography can also be considered in patients with acute cholecystitis not adherent to a specific severity grade.

  9. Using pathology-specific laboratory profiles in Clinical Pathology to reduce inappropriate test requesting: two completed audit cycles

    Baricchi Roberto


    Full Text Available Abstract Background Systematic reviews have shown that, although well prepared, the Consensus Guidelines have failed to change clinical practice. In the healthcare district of Castelnovo né Monti (Reggio Emilia, Italy, it became necessary for the GPs and Clinical Pathologists to work together to jointly define laboratory profiles. Methods Observational study with two cycles of retrospective audit on test request forms, in a primary care setting. Objectives of the study were to develop pathology-specific laboratory profiles and to increase the number of provisional diagnoses on laboratory test request forms. A Multiprofessional Multidisciplinary Inter-hospital Work Team developed pathology-specific laboratory profiles for more effective test requesting. After 8 training sessions that used a combined strategy with multifaceted interventions, the 23 General Practitioners (GPs in the trial district (Castelnovo nè Monti tested the profiles; the 21 GPs in the Puianello district were the control group; all GPs in both districts participated in the trial. All laboratory tests for both healthcare districts are performed at the Laboratory located in the trial district. A baseline and a 1-year audit were performed in both districts on the GPs’ request forms. Results Seven pathology-specific laboratory profiles for outpatients were developed. In the year after the first audit cycle: 1 the number of tests requested in the trial district was distinctly lower than that in the previous year, with a decrease of about 5% (p  Conclusions The first audit cycle showed a significant decrease in the number of tests ordered only in the trial district. The combined strategy used in this study improved the prescriptive compliance of most of the GPs involved. The presence of the clinical pathologist is seen as an added value.

  10. EC4 European Syllabus for Post-Graduate Training in Clinical Chemistry and Laboratory Medicine: version 3 - 2005.

    Zerah, Simone; McMurray, Janet; Bousquet, Bernard; Baum, Hannsjorg; Beastall, Graham H; Blaton, Vic; Cals, Marie-Josèphe; Duchassaing, Danielle; Gaudeau-Toussaint, Marie-Françoise; Harmoinen, Aimo; Hoffmann, Hans; Jansen, Rob T; Kenny, Desmond; Kohse, Klaus P; Köller, Ursula; Gobert, Jean-Gérard; Linget, Christine; Lund, Erik; Nubile, Giuseppe; Opp, Matthias; Pazzagli, Mario; Pinon, Georges; Queralto, José M; Reguengo, Henrique; Rizos, Demetrios; Szekeres, Thomas; Vidaud, Michel; Wallinder, Hans


    The EC4 Syllabus for Postgraduate Training is the basis for the European Register of Specialists in Clinical Chemistry and Laboratory Medicine. The syllabus: Indicates the level of requirements in postgraduate training to harmonise the postgraduate education in the European Union (EU); Indicates the level of content of national training programmes to obtain adequate knowledge and experience; Is approved by all EU societies for clinical chemistry and laboratory medicine. The syllabus is not primarily meant to be a training guide, but on the basis of the overview given (common minimal programme), national societies should formulate programmes that indicate where knowledge and experience is needed. The main points of this programme are: Indicates the level of requirements in postgraduate training to harmonise the postgraduate education in the European Union (EU); Indicates the level of content of national training programmes to obtain adequate knowledge and experience; Is approved by all EU societies for clinical chemistry and laboratory medicine. Knowledge in biochemistry, haematology, immunology, etc.; Pre-analytical conditions; Evaluation of results; Interpretations (post-analytical phase); Laboratory management; and Quality insurance management. The aim of this version of the syllabus is to be in accordance with the Directive of Professional Qualifications published on 30 September 2005. To prepare the common platforms planned in this directive, the disciplines are divided into four categories: Indicates the level of requirements in postgraduate training to harmonise the postgraduate education in the European Union (EU); Indicates the level of content of national training programmes to obtain adequate knowledge and experience; Is approved by all EU societies for clinical chemistry and laboratory medicine. Knowledge in biochemistry, haematology, immunology, etc.; Pre-analytical conditions; Evaluation of results; Interpretations (post-analytical phase); Laboratory

  11. Panorama brasileiro do Programa de Boas Práticas de Laboratório. Impacto na redução do uso de animais | Brazilian Good Laboratory Practices Perspective. Impact on reduction in animal use

    Elisa Rosa dos Santos


    Full Text Available Boas Práticas de Laboratório, sistema da qualidade que abrange o processo organizacional e as condições nas quais estudos não clínicos são realizados, visa garantir a uniformidade, consistência, confiabilidade, reprodutibilidade, qualidade e integridade dos testes. O Instituto Brasileiro de Meio Ambiente e dos Recursos Naturais Renováveis introduziu formalmente a Boas Práticas de Laboratório em 1994. Em 1995, o INMETRO iniciou o Programa BPL para reconhecimento e monitoramento baseados em procedimentos, normas, regulamentos administrativos e legais, que estabelecem orientações, políticas e diretrizes para a Coordenação Geral de Acreditação atuar, com total responsabilidade e autoridade, como Autoridade Brasileira de Monitoramento aos princípios das BPL. Estudos BPL são reconhecidos pelos países membros e não membros com adesão plena, aos atos da Organização para a Cooperação e Desenvolvimento Econômico em função do acordo de mútua aceitação de dados e promove redução do número de animais utilizados devido a não repetição dos testes e adoção de métodos alternativos validados. No Brasil, há 31 instalações BPL ativas e cinco realizam testes toxicológicos in vivo. A Resolução Normativa no 17/2014 do Conselho Nacional de Controle da Experimentação Animal estabelece que os testes utilizando animais que tenham métodos alternativos validados reconhecidos pelo Conselho sejam substituídos em até cinco anos, sendo essencial a ampliação da base laboratorial BPL. ---------------------------------------------------------------------------------------- Good Laboratory Practice (GLP, a quality system covering the organizational process and the conditions under which non-clinical studies are conducted, aims to ensure uniformity, consistency, reliability, reproducibility, quality, and integrity of the safety tests. The Brazilian Institute of Environment and Renewable Natural Resources formally introduced GLP

  12. Clinical immunology review series: an approach to the use of the immunology laboratory in the diagnosis of clinical allergy.

    Williams, P; Sewell, W A C; Bunn, C; Pumphrey, R; Read, G; Jolles, S


    In the last 10 years UK immunology laboratories have seen a dramatic increase in the number and range of allergy tests performed. The reasons for this have been an increase in the incidence of immunoglobulin E (IgE)-mediated allergic disease set against a background of greater public awareness and more referrals for assessment. Laboratory testing forms an integral part of a comprehensive allergy service and physicians treating patients with allergic disease need to have an up-to-date knowledge of the range of tests available, their performance parameters and interpretation as well as the accreditation status of the laboratory to which tests are being sent. The aim of this review is to describe the role of the immunology laboratory in the assessment of patients with IgE-mediated allergic disease and provide an up-to-date summary of the tests currently available, their sensitivity, specificity, interpretation and areas of future development.

  13. Use of bar code labels on collection tubes for specimen management in the clinical laboratory.

    Tilzer, L L; Jones, R W


    A new generation in specimen handling has arrived with the introduction of bar code readers on medical laboratory equipment. The incorporation of this technology into laboratory information systems offers a streamlining of specimen workflow never before achievable in a laboratory environment. The use of evacuated collection tubes as the primary sampling container on a random-access chemistry analyzer interfaced to a laboratory information system creates a very simplified sampling/analysis system with tremendous advantages. There are significant labor savings, superior service to clinicians, and reduced chances for clerical error.

  14. [Extended-spectrum-beta-lactamase-producing Proteus mirabilis: laboratory-based surveillance in cooperation with 12 clinical laboratories in the Kinki Region of Japan].

    Nakamura, Tatsuya; Komatsu, Masaru; Shimakawa, Kouichi; Sueyoshi, Noriyuki; Satoh, Kaori; Toyokawa, Masahiro; Nishio, Hisaaki; Wada, Yasunao; Orita, Tamaki; Kofuku, Tomomi; Sakamoto, Masako; Okamoto, Kiyotaka; Akagi, Masahiro; Kinoshita, Shohiro


    We studied 247 strains of Proteus mirabilis collected during the 6 months from November 2003 to April 2004 from 12 clinical laboratories in the Kinki region of Japan for the production of extended-spectrum beta-lactamase (ESBL). Eighteen strains (7.3%) showed MICs for cefpodoxime of > or = 2 microg/mL and 13 strains (5.2%) were positive for the double-disk synergy test. Susceptibility depended on genotype. MICs for cefepime, cefozopran, and cefpirome were high (> or = 8 microg/mL), and that for ceftazidime was low (0.12-0.5 microg/mL). Meropenem showed the lowest MIC (ESBL genotype by the polymerase chain reaction showed that 12 of 13 strains were CTX-M2 types. CTX-M9 was detected in a single laboratory. The clinical background showed 5 strains in urine samples. Twelve of 13 strains were detected in patients with minimal devices use. No symptoms were found in most cases of established syndrome. Analysis of PCR fingerprint profiles of random amplified polymorphic DNA patterns showed that 6 of 7 strains from hospital 1 showed the same pattern, and 5 of 5 strains from hospital 13 showed the same pattern, suggesting the nosocomial spread of P. mirabilis in each hospital.

  15. Clinical and laboratory evaluation of thyroid function following total laryngectomy in laryngeal cancer

    Motasaddi Zarandy M


    Full Text Available Background: Hypothyroidism is a well-documented complication after treatment of laryngeal cancer and is particularly significant among patients undergoing laryngectomy. We investigated the frequency of hypothyroidism in patients treated with total laryngectomy for laryngeal cancer. We also evaluated the effect of neck radiotherapy on thyroid function after total laryngectomy for laryngeal cancer. Methods: In a cross-sectional study, we evaluated 31 patients with laryngeal squamous cell carcinoma (mean age 53.6 years. Among these patients, 14 were treated with surgery only and 17 were treated with surgery plus radiotherapy. Laboratory evaluation included levels of thyroid stimulating hormone (TSH, free T4, free T3, and antithyroid antibodies both preoperatively and postoperatively at the first day, as well as one and six months after surgery. Results: All patients had normal thyroid function before treatment; however, after 6 months, five patients (16.1% were hypothyroid. Of these, three patients (9.6% had subclinical symptoms, including elevated thyroid-stimulating hormone with normal free T4, and two patients (6.5% showed clinical symptoms of hypothyroidism. Radiotherapy and neck dissection were significantly associated with higher incidences of hypothyroidism. Conclusion: Our data suggest that hypothyroidism occurs in a substantial proportion of patients undergoing surgery for laryngeal cancer. The results indicate that thyroid function studies should be routinely performed in the follow-up care of laryngeal cancer patients, especially if radiotherapy and neck dissection were part of the treatment. We suggest that this approach will improve the patient's quality of life and diminish the co-morbidity associated with this kind of surgery.

  16. Contribution of laboratory methods in diagnosing clinically suspected ocular toxoplasmosis in Brazilian patients.

    Mattos, Cinara C B; Meira, Cristina S; Ferreira, Ana I C; Frederico, Fábio B; Hiramoto, Roberto M; Almeida, Gildásio C; Mattos, Luiz C; Pereira-Chioccola, Vera L


    This prospective study evaluated the value of laboratorial diagnosis in ocular toxoplasmosis analyzing peripheral blood samples from a group of Brazilian patients by immunologic and molecular methods. We analyzed blood samples from 184 immunocompetent patients with ocular disorders divided into 2 groups: Group I, composed of samples from 49 patients with ocular toxoplasmosis diagnosed by clinical features; Group II, samples from 135 patients with other ocular diseases. Samples were assayed by conventional polymerase chain reaction (cnPCR), real-time PCR (qPCR) for Toxoplasma gondii, indirect immunofluorescence reaction (IF), avidity test (crude tachyzoite lysate as antigen), and excreted-secreted tachyzoite proteins as antigen (ESA-ELISA). cnPCR and qPCR profiles were concordant in all samples. Positive PCR was shown in 40.8% of group I patients. The majority of the positive blood samples (75%) were taken from patients with toxoplasmic retinochoroiditis scars, and the others (25%), from patients with retinal exudative lesions. Despite that 86 of the 135 patients from Group II had asymptomatic toxoplasmosis, all DNA blood samples had negative PCR. Concordant results were shown in the data obtained by serologic methods. Around 24% of the patients with ocular toxoplasmosis had high antibody titers determined by ESA-ELISA and IF. Anti-ESA antibodies are shown principally in patients with active infection. Collectively, these data demonstrate the presence of tachyzoites in the blood of patients with chronic infection, supporting the idea of recurrent disease. Circulating parasites in blood of immunocompetent individuals may be associated with the reactivation of the ocular disease.

  17. The clinical and laboratory characteristics of acute spontaneous urticaria and its progression to chronic spontaneous urticaria.

    Magen, Eli; Zueva, Ekaterina; Mishal, Joseph; Schlesinger, Menachem


    The natural history of the progression from acute spontaneous urticaria (ASU) to chronic spontaneous urticaria (CSU), CSU remains poorly understood. To identify clinical and laboratory patient attributes that may be predictive of ASU progression to CSU. We prospectively studied consecutive adult patients (age ≥ 18 years) with a diagnosis of urticaria of urticaria activity score assessment were performed in all the patients at baseline and then at weeks 7, 12, 24, and 48. Of 114 patients with acute urticaria and without identifiable causes, 73 patients (64%) were included in the ASU group, 41 patients in the CSU group (36%), and 44 healthy subjects in the control group. At baseline, 26 patients in the CSU group (63.4%) had a positive ASST result, whereas only 17 patients with a positive ASST result (23.3%) were revealed in the ASU group (p < 0.001). Patients with baseline ASST positive results were characterized by more profound basopenia (mean [standard deviation], 0.05 ± 0.08 cell/mm(3)) and more anti-thyroid peroxidase antibodies (18 [41.8%]) than those with the negative baseline ASST result (mean [standard deviation], 0.13 ± 0.09 cell/mm(3), p < 0.001 more profound basopenia; and 13 (18.1%), p = 0.009 more thyroid peroxidase antibodies). We observed the disappearance of ASST positive result in some patients with CSU with baseline positive ASST results, whereas, in some subjects with CSU, baseline negative ASST results came to be positive results throughout the study period. A baseline positive ASST result of patients with ASU was a significant determinant (odds ratio 5.91 [95% confidence interval, 2.57-13.62]; p < 0.001) for a CSU diagnosis at week 7. The patients with ASU who progressed toward CSU were characterized by a positive ASST result, thyroid autoimmunity, and profound basopenia at baseline.

  18. Cable plates and onlay allografts in periprosthetic femoral fractures after hip replacement: laboratory and clinical observations.

    Howell, Jonathan R; Masri, Bassam A; Garbuz, Donald S; Greidanus, Nelson V; Duncan, Clive P


    Fractures of the femur after total hip replacement are an increasingly common and technically challenging problem. The results of nonsurgical treatment are poor. When the general condition of the patient allows, these injuries should be treated surgically. Several surgical treatments can be used to treat these fractures, and classification of the fracture assists the surgeon in the choice of procedure. Over the past decade, cable plate fixation systems and onlay strut allografts have become two of the most commonly used methods of fixation for fractures associated with hip prostheses. The ideal method of fixation is yet to be determined. However, laboratory studies have shown that dual fixation using either a lateral plate and anterior strut graft or two strut grafts produces the strongest construct. Cables rather than smooth wires should be used for fixation, and fixation strength increases with the number of cables used. The use of screws proximally produces a strong fixation but there are theoretical disadvantages to using screws around a femoral implant. Clinical data show high rates of fracture union using cable plate fixation, cortical onlay allograft fixation, and combined fixation methods for fractures that occur around well-fi