Search

Background: The adherence of medical laboratory technicians (MLT) to infection control guidelines is essential for reducing the risk of exposure to infectious agents. This study explored the adherence of MLT towards infection control practices during the COVID-19 pandemic., Method: The study population consisted of MLT (n = 444) who worked in private and government health sectors in Jordan. A self-reported survey was used to collect data from participants., Findings: More than 87% of the participants reported adherence to hand-washing guidelines and using personal protective equipment (PPE) when interacting with patients (74.5%), and handling clinical samples (70.0%). Besides, 88.1%, 48.2%, and 7.7% reported wearing of lab coats, face masks, and goggles, at all times, respectively. The majority reported increased adherence to infection control practices during the COVID-19 pandemic. This includes increased PPE use at the workplace (94.2%), increased frequency of disinfection of laboratory surfaces (92.4%) and laboratory equipment (86.7%), and increased frequency of handwashing/use of antiseptics (94.6%). Having a graduate degree was significantly associated with increased adherence of participants to the daily use of goggles/eye protection (p = 0.002), and the use of PPE while handling clinical samples (p = 0.011). Having work experience of >10 years was associated with increased adherence to the use of PPE while handling clinical samples (p = 0.001)., Conclusion: MLT reported very good adherence with most assessed infection control practices. In addition, they reported increased conformity with infection control guidelines during the COVID-19 pandemic., Competing Interests: The authors have no competing interests to declare., (Copyright: © 2021 The Author(s).)

Objective: Total quality management, which basically involves pre-analytical, analytical, and postanalytical phases, is relatively more difficult in cytopathology due to descriptive reports and subjective variability. The pre-analytical phase of total quality management constitutes a major burden of errors in the laboratory and it has not been widely studied in cytopathology except in cervical Pap smears. The present study was therefore conducted to study the pre-analytical phase over 5 years from April 2013 until May 2018 at an ISO 15189: 2012-certified cytopathology laboratory, in a resource-limited setting. It was also intended to study the level of satisfaction of the patients and the training of the professionals provided in the cytology lab so as to improve and maintain high quality standards., Methods: The study included all the documents relating to the quality program used in the last 5 years in a medical institute situated in the north sub-Himalayan region of India. All the data were recorded and analysed for pre-analytical analysis of the total quality management system., Results: In total, 20,130 samples were received for cytological investigation. The total number of errors which were detected in the cytopathology lab were 1,430, constituting 7.1% of the total investigations done. The pre-analytical phase errors comprised 57% of the total errors (815/1,430), analytical errors constituted 11% (157/1,430), while postanalytical errors represented 32% (458/1,430). Incompletely filled requisition forms constituted the most common pre-analytical error (38%). There was a gradual decrease in the errors with time, but with a sudden increase between January to June 2015 due to new technicians joining during that period., Conclusion: Pre-analytical quality management is an essential component for maintaining the quality and reducing the errors in the cytopathology lab. Documentation, continuous training, and maintenance of internal and external quality control with quality charts are the key for successful quality management. The identification of non-conformance with root-cause analysis and provision of scope for continuous improvement is vital for quality improvement in the lab. Patient satisfaction is an important aspect of quality in the lab, which should be combined with the satisfaction of the personnel working in the lab., (© 2018 S. Karger AG, Basel.)

The Strengthening Laboratory Management Toward Accreditation (SLMTA) program and subsequent Stepwise Laboratory Quality Improvement Process Toward Accreditation (SLIPTA) checklist were a response to the need for high-quality laboratories to combat the human immunodeficiency virus (HIV) epidemic and provide patients with the highest-quality care. The two tools work together to create a culture of quality in laboratories and allow the identification of gaps. The ultimate goal for any laboratory is to achieve a standard benchmark for quality and these programs have been highly successful in initially affecting the HIV epidemic but continuously improving laboratory quality across all diseases., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Purpose: The assessment of technical staff members' competency has been a challenge for laboratory workers, to ensure patient safety and high quality services. The aim of this study was to (1) investigate awareness on best ways to assess lab competencies; (2) identify existing institutional methods of competency assessment and how staff perceptions; and (3) gather opinions of respondents about a proposed program for competency assessment in laboratory medicine., Methods: A cross-sectional survey was conducted, followed by an interview and discussion with laboratory stakeholders about a proposed competency assessment program that included all the six procedural elements of laboratory personnel competency assessment. An online questionnaire was sent via email to different hospitals in Saudi Arabia through survey monkey. A proposed competency assessment program was circulated via email to laboratory stakeholders who agreed to be enrolled in structured interviews., Results: A total of 47 out of the 168 (25.3%) laboratory workers responded to the emailed survey administered via survey monkey. Among the survey respondents, 16 out of the 47 (34%) participated in the structured interview and the discussion and formed the community of practice group that provided insight and opinion about the proposed competency program. Among stakeholders, 87.2% practiced in accredited laboratories. Over half (52%) of respondents positively rated the proposed program. Results of interviews and discussions revealed suggestions about continuous ongoing assessment, such as the inclusion of laboratory quality management and safety as separate items to be unified for all sections., Conclusions: The proposed competency assessment program overcomes challenges noted in competency assessment and has been positively received by stakeholders. This program will be validated by a group of experts then implemented as part of a core curriculum for laboratory staff, in their assessment, certification, recertification, registration, evaluation and licensure in sample laboratories in Saudi Arabia. The program will be monitored and evaluated during and after implementation for processes and outcomes. Conclusions will be utilized for national competency program. This study represents an important step towards the implementation of a standardized laboratory competence assessment program at a national level.

Background: The 2015 Institue of Medicine report Improving Diagnosis in Health Care highlighted that diagnostic errors cause patient harm and that improvement in the diagnostic process requires better collaboration among physicians and laboratory professionals. The purpose of this study is to understand why physicians do not contact laboratory professionals when facing diagnostic challenges and identify opportunities for laboratory professionals to become more recognized members of the clinical care team., Methods: A random sample of 31,689 physicians from the American Medical Association Masterfile were surveyed about diagnostic challenges in laboratory test ordering and results interpretation, solutions to these challenges, and interactions with laboratory professionals., Results: We received responses from 1768 physicians (5.6%). When faced with diagnostic challenges, they reported using electronic resources because they find it difficult and time-consuming to contact the laboratory. Only 20% had an effective way to access laboratory professionals, mostly seeking help for logistical but less for clinical issues. Continuing medical education, professional articles, and updates from the laboratory were helpful., Conclusions: Laboratory professionals have an opportunity to play a greater role in the diagnostic process by becoming active members of the clinical care team, beyond providing results. This study provides strategies to increase laboratory professionals' role in the diagnostic process., (American Society for Clinical Pathology, 2016. This work is written by US Government employees and is in the public domain in the US.)

The purpose of this document is to educate providers of veterinary laboratory diagnostic testing in any setting about comparative testing. These guidelines will define, explain, and illustrate the importance of a multi-faceted laboratory quality management program which includes comparative testing. The guidelines will provide suggestions for implementation of such testing, including which samples should be tested, frequency of testing, and recommendations for result interpretation. Examples and a list of vendors and manufacturers supplying control materials and services to veterinary laboratories are also included., (© 2015 American Society for Veterinary Clinical Pathology.)

The embryologist presides over the fulfillment of a patient's treatment in the laboratory for IVF through use of assisted reproduction techniques, and is in a unique position to impart quality to the process. Although the technical skill of the embryologist is critical, the embryologist's contribution to quality is equally conveyed through a knowledge of reproductive biology, keen observation and judgment, astute decision-making, the 'grit' to work under pressure and time constraints, and a sense of mission in the provision and continual development of a safe and effective laboratory. The embryologist also ensures that the laboratory complies with the regulations of federal, state, local and institutional authorities and the recommendations and guidelines of professional associations. In these roles, the embryologist assumes unique responsibilities counterbalanced by the unique rewards of assisting patients in having a family. This article aspires to illuminate this singular profession for those who may be contemplating a career in embryology and act as a resource for those who seek insight into this amalgam of basic science, technical proficiency, and managerial skill and acumen that characterize the practice of clinical embryology and the myriad of ways that practitioners contribute to the quality of assisted reproduction techniques and patient care., (Copyright © 2015 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.)

This document provides a general overview for physicians of the qualities and conditions necessary for good management practices within the endocrinology, andrology, and embryology laboratories in the United States. It is intended as an addendum to previously published guidelines that further detail these responsibilities., (Copyright © 2014 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.)

The purpose of this paper by the Regulatory Affairs Committee (RAC) of the American Society for Veterinary Clinical Pathology (ASVCP) is to review the current regulatory guidances (eg, guidelines) and published recommendations for best practices in veterinary toxicologic clinical pathology, particularly in the pharmaceutical and biotechnology industries, and to utilize the combined experience of ASVCP RAC to provide updated recommendations. Discussion points include (1) instrumentation, validation, and sample collection, (2) routine laboratory variables, (3) cytologic laboratory variables, (4) data interpretation and reporting (including peer review, reference intervals and statistics), and (5) roles and responsibilities of clinical pathologists and laboratory personnel. Revision and improvement of current practices should be in alignment with evolving regulatory guidance documents, new technology, and expanding understanding and utility of clinical pathology. These recommendations provide a contemporary guide for the refinement of veterinary toxicologic clinical pathology best practices., (© 2013 American Society for Veterinary Clinical Pathology.)

Context: Cytopathology experts, interested stakeholders, and representatives from the College of American Pathologists, the Centers for Disease Control and Prevention, the American Society of Cytopathology, the Papanicolaou Society of Cytopathology, the American Society for Clinical Pathology, and the American Society of Cytotechnology convened the Gynecologic Cytopathology Quality Consensus Conference to present preliminary consensus statements developed by working groups, including the Cytologic-Histologic Correlations Working Group 4, using results from surveys and literature review. Conference participants voted on statements, suggested changes where consensus was not achieved, and voted on proposed changes., Objectives: To document existing practices in gynecologic cytologic-histologic correlation, to develop consensus statements on appropriate practices, to explore standardization, and to suggest improvement in these practices., Data Sources: The material is based on survey results from 546 US laboratories, review of the literature from 1988 to 2011, and the College of American Pathologists Web site for consensus comments and additional survey questions., Conclusions: Cytologic-histologic correlations can be performed retrospectively, during initial case review, or both. At minimum, all available slides should be reviewed for a high-grade squamous intraepithelial lesion Papanicolaou test with negative biopsies. The preferred monitor for correlations is the positive predictive value of a Papanicolaou test. Laboratories should design cytologic-histologic correlation programs to explore existing or perceived quality deficiencies.

Context: There are many long-standing quality monitors for cytopathology laboratories and their cytotechnologists and pathologists. Many of these monitors are based on tradition and empirical good intentions. There is no established standard as to how results of these monitors should be used in a quality assurance program., Objective: To review practices that are typically part of a general quality program in cytopathology laboratories and to provide statements regarding good laboratory practices that laboratories may find useful in a quality assurance program in their own setting., Data Sources: An expert working group evaluated results from a national laboratory survey, responses from follow-up questions posted on a Web site, and findings from the literature. The group created statements on good laboratory practices related to general quality practices and quality assurance in gynecologic cytopathology. These were discussed and voted on at a consensus conference., Conclusions: Laboratories follow many metrics. Most laboratories facilitate comparison of individual metrics against the laboratory's metrics: 81.1% for cytotechnologists and 59.6% for pathologists. The majority of laboratories facilitate comparison of individual cytotechnologist metrics with other cytotechnologists, but less frequently metrics from pathologists with other individuals. The most common methods to recognize variance in performance in individuals were by identifying outliers from the data or by user-defined action limits. The most common method to address variance was an attempt to identify the cause of the variance and conduct a focused review. Quality metrics should be monitored for the laboratory as a whole and in selected cases for both individual pathologists and cytotechnologists. Results should be shared with individuals, and newly hired primary screeners should be monitored. Reviewing selected cases is a useful quality tool. Low-volume methodologies, such as conventional Papanicolaou tests, should have additional oversight.

Aims: This paper details the development of a new type of pathology laboratory productivity unit, the benchmarking complexity unit (BCU). The BCU provides a comparative index of laboratory efficiency, regardless of test mix. It also enables estimation of a measure of how much complex pathology a laboratory performs, and the identification of peer organisations for the purposes of comparison and benchmarking., Methods: The BCU is based on the theory that wage rates reflect productivity at the margin. A weighting factor for the ratio of medical to technical staff time was dynamically calculated based on actual participant site data. Given this weighting, a complexity value for each test, at each site, was calculated. The median complexity value (number of BCUs) for that test across all participating sites was taken as its complexity value for the Benchmarking in Pathology Program., Results: The BCU allowed implementation of an unbiased comparison unit and test listing that was found to be a robust indicator of the relative complexity for each test. Employing the BCU data, a number of Key Performance Indicators (KPIs) were developed, including three that address comparative organisational complexity, analytical depth and performance efficiency, respectively. Peer groups were also established using the BCU combined with simple organisational and environmental metrics., Conclusions: The BCU has enabled productivity statistics to be compared between organisations. The BCU corrects for differences in test mix and workload complexity of different organisations and also allows for objective stratification into peer groups.

Data correlating individual screening sensitivity in gynecologic cytology and workload is limited. We compared the estimated sensitivity of manual screening of SurePath slides with individual workload. Estimated sensitivity determined by rapid prescreening was correlated with total workload in a laboratory performing manual screening of SurePath preparations for a 1 year period. There were 12 CTs with a total daily workload ranging from 8-35 slides. The mean estimated sensitivity for SurePath was 97.0% (range 91-100%). The mean estimated sensitivity for the lowest half workload (8-23 slides/day) was significantly higher than that for the highest half workload (23-35 slides/day) (98.3 versus 95.7%, P ≤ 0.001). The highest workload that achieved 100% estimated sensitivity was 30 slides/day. For manual screening of SurePath slides, individual estimated sensitivity is correlated with workload even at relatively low daily workloads., (Copyright © 2010 Wiley Periodicals, Inc.)

The President's Emergency Plan for AIDS Relief (PEPFAR) programme for the Caribbean Region was established in 2008 to address health system challenges, including fragile laboratory services and systems. The laboratory component of this programme consisted of several phases: assessment of laboratory needs of all 12 countries engaged in the programme; addressing gaps identified during the assessment; and monitoring and evaluation of the progress achieved. After one year of PEPFAR collaboration with national governments and other partners, laboratory services and systems greatly improved. Some of the milestones include: (1) the accreditation of a public laboratory; (2) improved access to HIV diagnosis with faster turnaround time; (3) establishment of capacity for platforms for DNA PCR, viral load and HIV drug resistance; (4) development of the laboratory workforce; and (5) establishment of a framework for implementation of sustainable quality management systems for laboratory accreditation. The progress recorded in strengthening laboratory health systems after one year of initiating this collaboration shows that with a rigorous initial assessment, programme design and intervention and strategic partnership, national laboratory health systems can be greatly enhanced to support programme implementation. Continued collaboration and country leadership is critical to create an integrated and sustainable laboratory network in the Caribbean.

Objective: Virtually all the general practices in Norway participate in the Norwegian Quality Improvement of Laboratory Services in Primary Care, NOKLUS. In order to assess and develop NOKLUS's services, it was decided to carry out an investigation in the largest participating group, general practices., Design: In autumn 2008 a questionnaire was sent to all Norwegian general practices asking for feedback on different aspects of NOKLUS's main services: contact with medical laboratory technologists, sending of control materials, use and maintenance of practice-specific laboratory binders, courses, and testing of laboratory equipment. In addition, attitudes were elicited towards possible new services directed at assessing other technical equipment and clinical use of tests., Results: Responses were received from 1290 of 1552 practices (83%). The great majority thought that the frequency of sending out control material should continue as at present, and they were pleased with the feedback reports and follow-up by the laboratory technologists in the counties. Even after many years of practical experience, there is still a need to update laboratory knowledge through visits to practices, courses, and written information. Practices also wanted quality assurance of blood pressure meters and spirometers, and many doctors wanted feedback on their use of laboratory tests., Conclusion: Services regarding quality assurance of point-of-care tests, guidance, and courses should be continued. Quality assurance of other technical equipment and of the doctor's clinical use of laboratory tests should be established as part of comprehensive quality assurance.

A sociological survey of 240 clinical laboratory workers and 350 patients could reveal the most important problems in the extra-analytical phase of a laboratory process: the level of computerization of laboratories; the application of a closed vacuum blood sampling system; a need for improving the interaction between laboratory service specialists and clinicians; the necessity for laboratory diagnosis specialists to hold lectures and seminars for clinicians; inadequate interaction between patients and attending physicians; a patient's failure to follow the study preparation instructions; a patient's dissatisfaction with a process of drawing up a referral protocol for laboratory studies; and a queue for biomaterial sampled for laboratory studies.

The provision of matching of clinical laboratory examinations results needs the application of unified technologies on all stages of medical care. The project of regulations of standardized analytical technologies is presented. The basic principles of description of standardized analytical technologies and development of all stages of examinations is exposed including requirements to specialists, security techniques, preanalytical stage, quality control, labor expenditures.

A robust quality-assurance program is essential for laboratories that perform molecular genetic testing to maintain high-quality testing and be able to address challenges associated with performance or delivery of testing services as the use of molecular genetic tests continues to expand in clinical and public health practice. This unit discusses quality-assurance and quality-improvement considerations that are critical for molecular genetic testing performed for heritable diseases and conditions. Specific discussion is provided on applying regulatory standards and best practices in establishing/verifying test performance, ensuring quality of the total testing process, monitoring and maintaining personnel competency, and continuing quality improvement. The unit provides a practical reference for laboratory professionals to use in recognizing and addressing essential quality-assurance issues in human molecular genetic testing. It should also provide useful information for genetics researchers, trainees, and fellows in human genetics training programs, as well as others who are interested in quality assurance and quality improvement for molecular genetic testing., (2011 by John Wiley & Sons, Inc.)

The medical biology laboratory accreditation according to the Iso 15189 standard, which main lines are mentioned in the article, is henceforth becoming a statutory obligation in France. All laboratories must apply, at least partly, to the COFRAC, by 31(st) October 2012. The EFS has largely anticipated the necessary steps to reach this objective and has developed an approach based on six basic processes. To date, 24 laboratories of various technical fields are accredited and several other submissions are pending. The Iso 15189 standard requirements match those already implemented at the EFS with the Certification. The trade standard operating procedures are almost included in the risk control management. Through the involvement of all the EFS members following precision action plans based on the sharing of successful experiences and the harmonization of trade practices, this compulsory objective will be reached and the deadline respected., (Copyright © 2011 Elsevier Masson SAS. All rights reserved.)

This proposal contains unique requirements for a cytological study of lymph node specimens at the cytological and clinical diagnostic laboratories of health care facilities certified for this kind of work. The paper gives requirements for the performance of technologies, for specialists and auxiliary personnel, specialists' knowledge and skills, medical staff safeguarding. The conditions for rendering a service, necessary equipment, ware, and reagents are described in details. The specific features of a pre-analytical stage, methods for the fixation and staining of smears, the interpretation and recording of findings, and the control of the quality of a performed study, as well as the cost characteristics in conventional units of man-hours. The developed technology may be of great importance to the health care facilities certified for rendering this service.

Owing to lack of governmental regulation of veterinary laboratory performance, veterinarians ideally should demonstrate a commitment to self-monitoring and regulation of laboratory performance from within the profession. In response to member concerns about quality management in veterinary laboratories, the American Society for Veterinary Clinical Pathology (ASVCP) formed a Quality Assurance and Laboratory Standards (QAS) committee in 1996. This committee recently published updated and peer-reviewed Quality Assurance Guidelines on the ASVCP website. The Quality Assurance 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 on 1) general analytic factors for veterinary laboratory performance and comparisons, 2) hematology and hemostasis, and 3) clinical chemistry, endocrine assessment, and urinalysis. This report documents recommendations for control of general analytical factors within veterinary clinical laboratories and is based on section 2.1 (Analytical Factors Important In Veterinary Clinical Pathology, General) of the newly revised ASVCP QAS Guidelines. These guidelines are not intended to be all-inclusive; rather, they provide minimum guidelines for quality assurance and quality control for veterinary laboratory testing. It is hoped that these guidelines will provide a basis for laboratories to assess their current practices, determine areas for improvement, and guide continuing professional development and education efforts., (©2010 American Society for Veterinary Clinical Pathology.)

Several challenges arise from the wide application of molecular genetic analyses, among them the need to introduce rules to evaluate molecular genetic test systems as well as test laboratories. This article specifically addresses laboratories performing molecular genetic tests for diagnosis, prevention and therapy of various diseases. The topics that will be discussed will support these laboratories to achieve and sustain a high quality and avoid mistakes and errors. The article covers important preanalytic, analytic and postanalytic aspects in regard to molecular genetic testing as well as quality management issues. In addition laboratory responsibilities, training of personnel, data protection issues, as well as informed consent aspects will be discussed. Beyond that, some molecular genetic methods will be dealt with in regard to potential quality criteria.

Directors of all major BioSafety Level 4 (BSL-4) laboratories in the United States met in 2008 to review the current status of biocontainment laboratory operations and to discuss the potential impact of a proposed 2-person security rule on maximum-containment laboratory operations. Special attention was paid to the value and risks that would result from a requirement that 2 persons be physically present in the laboratory at all times. A consensus emerged indicating that a video monitoring system represents a more efficient, economical standard; provides greater assurance that pathogens are properly manipulated; and offers an increased margin of employee safety and institutional security. The 2-person security rule (1 to work and 1 to observe) may decrease compliance with dual responsibilities of safety and security by placing undue pressure on the person being observed to quickly finish the work, and by placing the observer in the containment environment unnecessarily.

Objective: To compare data on the practices of molecular genetic testing (MGT) in laboratories in the United States with those in 18 other countries., Methods: A Web-based survey of MGT laboratory directors (n = 827; response rate 63%) in 18 countries on three continents was carried out, and the response from U.S. laboratories compared to all others. Quality assurance and reporting indices were developed and calculated for each responding laboratory., Results: A comparison of U.S. results with all other countries identified differences in laboratory setting, personnel qualifications, and the specific tests being offered, but similar rates of adherence to MGT quality standards and reporting practices were found. The survey also documented substantial transborder flow of specimens, most commonly due to the lack of availability of the test in the United States or because the test was available only through a research protocol, highlighting the need for common reporting and practice guidelines for the international MGT community., Conclusion: The findings presented here provide further support for the need to consider the application of the Organisation for Economic Cooperation and Development (OECD) Guidelines and the establishment of compatible accreditation programs or equivalent mechanisms across national borders to ensure the quality of laboratory services and the clinical usefulness of molecular genetic test reports for referred specimens.

The practical bench application of molecular tests (here defined as nucleic acid-based tests) in a routine testing situation is not without its challenges. This paper outlines the approaches we take at the Veterinary Laboratories Agency (VLA) and highlights some of the practical issues which we have found to be important for the successful introduction and use of molecular tests in a routine testing environment. The potential advantages of molecular tests, and factors which dictate which tests are adopted for routine testing, are discussed before giving some examples of molecular tests in routine use at the VLA. The instrumentation, reagents and assays we use are outlined, followed by sections of how we approach validation and how we manage and resource the transfer of molecular tests into routine use.

Background: Inaccurate malaria results can lead to patient mismanagement, misperceptions about malaria resistance patterns and public health misinformation. All laboratories need to be able to demonstrate that their results are accurate. Establishing and maintaining a system for monitoring test accuracy is a complex, expensive and technically demanding process, which very few poor countries have been able to implement. This study described the process and assessed the feasibility of establishing a nation-wide system for improving the accuracy of malaria-related tests in peripheral laboratories in Ghana., Programme Implementation: A baseline survey of all 693 laboratory staff in 205 sub-regional government and mission health laboratories in Ghana was conducted by a national network of laboratory supervisors. Survey results guided a training programme to improve test accuracy. Outcomes included changes in the quality of laboratory tests and the system was considered to be feasible if >50% of laboratory staff in each region received training and if test accuracy could be documented., Programme Indicators: 74% (mean) of the 693 laboratory staff were assistants with no professional qualifications. There were marked differences between regions in the availability of essential resources for malaria diagnosis (e.g. microscopes). 93% of laboratory staff received training; in six months there were increases of 11% and 7% respectively in the number of laboratories producing haemoglobin and malaria microscopy results of acceptable quality., Conclusions: It is possible to establish a system for improving and monitoring test accuracy in peripheral laboratories on a country-wide basis in a developing country using a model that could be adapted for use in other countries and for other components of health care provision.

The laboratory comprises an invaluable part of the total health care provided to patients. Competency assessment is one method by which we can verify that our employees are competent to perform laboratory testing and report accurate and timely results. To derive the greatest benefit from the inclusion of competency assessment in the laboratory, we must be sure that we are addressing areas where our efforts can be best utilized to optimize patient care. To be competent, an employee must know how to perform a test, must have the ability to perform the test, must be able to perform the test properly without supervision, and know when there is a problem with the test that must be solved. In some cases, competency assessment protocols may demonstrate areas of competence but can fail to disclose incompetence. For example, challenges of low-complexity tasks (such as reading the technical procedure manual) are inferior to challenges that measure understanding and execution of a protocol, and poorly designed competency challenges will probably not detect substandard laboratory performance. Thus, if we are to receive the greatest benefit from our competency assessment programs, which may be time-consuming for the supervisors and the staff as well, we must not only meet the letter of the law but also find a way to make these assessments meaningful, instructive, and able to detect areas of concern. As we address competency assessment in our laboratories, we must understand that when done properly, competency assessment will reward our organizations and assist us in providing the best possible care to our patients.

The availability of molecular genetic tests for the identification of mutant gene carriers, and for assessing individual genetic response to pharmacologic agents, infectious agents, and other environmental exposures, is expected to result in the increased use of the molecular genetic testing laboratory by primary care physicians. However, a number of concerns have been raised about such testing including the need for safeguards to protect patient privacy, and if the interface between genetic testing laboratories and the ordering physician facilitates the appropriate clinical use of the test result. In this study, genetic counselors were surveyed to determine their practices with regard to the clinical issues of informed consent and confidentiality in the context of genetic testing, and to assess their level of satisfaction with the reporting practices of molecular genetic testing laboratories. The results of this survey revealed that there is variability in the practices of genetic counselors with regard to obtaining informed consent, and that there are areas for improvement with regard to molecular genetic test reports, particularly in terms of interpretation of results., (Copyright 2003 Wiley-Liss, Inc.)

We noted that our competency assessment activities did not predict actual performance and, in questioning why, we discovered a world very similar to our experience in clinical testing. We found that, with careful attention to measurement design, we could detect incompetent performance and find improvement opportunities. This article explores several of the design principles on which one can build competency measurements. It also discusses the reasons why organizations should invest in this activity, which go beyond the most obvious reason--it is the right thing to do.

This final rule revises and responds to comments on certain laboratory requirements issued pursuant to the Clinical Laboratory Improvement Amendments of 1988 (CLIA), Pub. L. 100-578. Specifically, this final rule sets forth requirements for certain quality control (QC) provisions and personnel qualifications; consolidates and reorganizes the requirements for patient test management, QC, and quality assurance; and changes the consensus required for grading proficiency testing challenges. To ensure a smooth transition to the new provisions for directors of high complexity testing who are not board certified (but who have doctoral degrees), we will not be holding facilities out of compliance with the provisions of the rule concerning directors who are not board certified until the effective date of this new rule, to the extent the facilities are otherwise in compliance with the requirements for laboratory directors.

The educational system and the introduction of legislation of clinical medicine are both still in developing stage in Cambodia where only 10 years have passed since the establishment of a new government. In order to maintain good health of all Cambodian citizens and to improve the quality of care in health services, it should be necessary to implement an appropriate educational system for both laboratory technologists and technicians. To conduct refreshment training course for laboratory workers with provision of the instruments, material and reagents is another way to make improvement of it in public hospitals. It should be also required to overcome economic problems how to absorb medical expense and to understand the importance for doctors to diagnose with scientific data of clinical examinations. Maturation of the total medical system in this country should be necessary and suggestions from neighboring countries with views toward the world standard would be expected.

There is a wide consensus that an external review mechanism, both in the form of a peer review, accreditation and certification according to the ISO 9000 series, is more than its standards. The survey process, the role of inspectors and standard interpretation contribute to the essence of the programme itself. Above all, the criteria used for the selection, training and appraisal of inspectors are of paramount importance. While the ISO norms do not require certification bodies to employ "peer reviewers" for the healthcare sector, experience in this sector is the main criterion for recruiting inspectors in accreditation and peer review programmes. However, the ISO/IEC Guide 58, for the setting up and operation of a laboratory accreditation body, specifies that inspectors should have appropriate technical knowledge of the specific calibrations, tests or types of calibration or tests for which accreditation is sought. Training, updating and assessment of inspectors are clearly defined under ISO, but are also systematic under accreditation programmes. Part-time inspectors who are professionals currently practising in a healthcare facility and are in touch with the day-to-day work reality are preferred for accreditation programmes which have self-regulation, education and quality improvement as their main concerns, while full-time and external inspectors are used in external review mechanisms with registration and certification as their main concerns. As well as harmonising the standards for accreditation, it is important to obtain consensus on the criteria to use for the selection, training and assessment of inspectors in order to ensure that different national or international programmes gain mutual recognition.

In Part I of this series, I introduced the concept of memes (1). Memes are ideas or concepts, the information world equivalent of genes. The goal of this series of articles is to infect you with my memes, so that you will assimilate, translate, and express them. We discovered that no matter what our area of expertise or "-ology," we all are in the information business. Our goal is to be in the wisdom business. We saw that when we convert raw data into wisdom we are moving along a value chain. Each step in the chain adds a different amount of value to the final product: timely, relevant, accurate, and precise knowledge which can then be applied to create the ultimate product in the value chain: wisdom. In Part II of this series, I infected you with a set of memes for measuring the cost of adding value (2). In Part III of this series, I infected you with a new set of memes for measuring the added value of knowledge, i.e., intellectual capital (3). In Part IV of this series, I will infect you with memes for measuring the value of people, structural, and customer capital.

The Clinical Laboratory Improvement Amendments of 1988 (CLIA'88) established national standards of laboratory practice and test performance in the areas of registration and certification, inspection, proficiency testing, personnel qualifications, quality control, patient test management, and quality assurance. A memorandum of agreement between the Department of Health and Human Services and the Department of Defense (DOD) established the DOD Clinical Laboratory Improvement Program (CLIP) and authorized the Assistant Secretary of Defense for Health Affairs to develop CLIA'88-comparable regulations governing DOD laboratories. In implementing the DOD program, the CLIA'88 regulations were adopted to the maximum extent possible and modified only as required to meet those unique DOD missions that precluded compliance. This article provides an abbreviated historical background on CLIA'88/CLIP, defines the testing categories identified under the CLIP regulations, and briefly describes the process for application and requirements for compliance.

The introduction of automated chemical analyzers in the laboratory service has the potential of adversely affecting professionalism in laboratory practice. The present study assesses the quality of medical laboratory technicians in Trinidad and Tobago using structured questionnaires. Some of the critical questions included job status, years of experience, training, qualification(s) and knowledge of quality assurance and its application. About 82% of laboratory technicians responded to the study. The majority of technicians (62%) had diploma certificates while only one (1.2%) had a postgraduate degree. Although the majority (91.7%) of technicians knew about quality assurance, 36% learnt on the job and 59% knew they were not professionally trained. The results showed that there is paucity of highly trained laboratory technicians in Trinidad and Tobago and this has significant implications on the technical initiative and quality of medical laboratory practice in this country. We recommend the establishment of appropriate professional institutions for training medical laboratory technologists and regular expert inspection and accreditation of all medical laboratories in the country.