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Context.—: Knowledge of laboratory staff turnover rates are important to laboratory medical directors and hospital administrators who are responsible for ensuring adequate staffing of their clinical laboratories. The current turnover rates for laboratory employees are unknown., Objective.—: To determine the 3-year average employee turnover rates for clinical laboratory staff and to survey the types of institutional human resource practices that may be associated with lower turnover rates., Design.—: We collected data from participating laboratories spanning a 3-year period of 2015-2017, which included the number of full-time equivalent (FTE) staff members that their laboratories employed in several personnel and departmental categories, and the number of laboratory staff FTEs who vacated each of those categories that institutions intended to refill. We calculated the 3-year average turnover rates for all laboratory employees, for several personnel categories, and for major laboratory departmental categories, and assessed the potential associations between 3-year average all laboratory staff turnover rates with institutional human resource practices., Results.—: A total of 23 (20 US and 3 international) participating institutions were included in the analysis. Among the 21 participants providing adequate turnover data, the median of the 3-year average turnover rate for all laboratory staff was 16.2%. Among personnel categories, ancillary staff had the lowest median (11.1% among 21 institutions) and phlebotomist staff had the highest median (24.9% among 20 institutions) of the 3-year average turnover rates. Among laboratory departments, microbiology had the lowest median (7.8% among 18 institutions) and anatomic pathology had the highest median (14.3% among 14 institutions) of the 3-year average turnover rates. Laboratories that developed and communicated clear career paths to their employees and that funded external laboratory continuing education activities had significantly lower 3-year average turnover rates than laboratories that did not implement these strategies., Conclusions.—: Laboratory staff turnover rates among institutions varied widely. Two human resource practices were associated with lower laboratory staff turnover rates.

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.

Objectives: To describe current qualitative and quantitative aspects of research engagement and other scholarly activities conducted by clinical laboratory science (CLS) professionals across a range of employment settings., Design: A link to a 3-part online survey was sent by electronic mail to 7,572 members of the American Society for Clinical Laboratory Science and 500 program directors., Setting: email message, on-line survey, Participants: all ASCLS members and all directors of accredited clinical laboratory educational programs, Main Outcome Measures: Quantitative and qualitative measures of professionals' engagement in research and other scholarly activities, Results: 556 of 7572 (7.3%) persons completed the survey. Thirty-two percent of survey respondents reported spending between 1 to > 40 work hours per week conducting research with 68% of respondents not participating in research activities. Conducting research is an employment requirement for 18% of survey participants. Twenty-nine percent of respondents have published at least one research article, and 47% of respondents who conduct research have published studies in the journal Clinical Laboratory Science. More than 57% of respondents participate in non-research scholarly activities as part of their employment. CLS professionals who conduct research are more likely to do applied, clinical, or educational research than other types of research. Fifty-seven percent of respondents who conduct research lack external funding for their work. Ninety-three percent of total research dollars is obtained by respondents who hold the Ph.D. degree. The perception of the importance of conducting research varies by employment position. Barriers to participation in research include lack of inclusion of research in the job description, time constraints, inadequate research funding, limited opportunity, and lack of space and equipment., Conclusions: CLS professionals participate in research in limited numbers, and are more likely to engage in non-research types of scholarly activities. Numerous barriers are identified which impose limits to conducting research. Over half of CLS's research efforts lack external funding. Although there was broad representation among participants across educational levels, employment settings, and job positions, the number of survey respondents was limited. Possible directions for future research include conducting this survey using members of additional professional organizations.

Some clinical laboratories require workers who have basic knowledge in molecular techniques (such as fluorescent in situ hybridization and polymerase chain reaction). Exclusively molecular diagnostic laboratories need workers to be competent in a variety of cutting edge molecular technologies, such as DNA sequencing, array-based comparative genomic hybridization, quantitative polymerase chain reaction, and many other techniques. Having only one certification for molecular biology at the entry level, as newly prescribed by the Board of Certification, doesn't accurately define the two very differently trained types of people these differing types of laboratories require. Creating a second molecular certification, at the specialist level, would address this issue positively.

Background: As early as 2001, the Food and Drug Administration (FDA) required blood centers and hospital transfusion services to report events associated with testing, storage, or distribution of blood products that deviated from current good manufacturing practices or affected the safety, purity, or potency of the product. Between 2004 and 2009, an average of only 8.6% of hospitals reported blood product deviations., Study Design and Methods: Case scenarios designed to evaluate knowledge of FDA reportable deviations were developed and sent for evaluation to the Center for Biologics Evaluation and Research (CBER) and FDA division directors for FDA reportable deviations. A final survey containing eight cases was launched in a web-based online survey tool and sent to blood bank medical technologists. Additional information was queried regarding job title/responsibilities and the size of the blood center and/or transfusion service., Results: There were 176 respondents to the survey. Only 5.7% (10/176) answered all questions correctly. Analysis by job title and place of employment revealed no correlation to the number of correct responses. More importance was attached to deviations involving quality control, blood bank identification, unit specifications, and antibody identification. Less importance was attached to deviations involving phlebotomist's initials, failure to issue units in the computer, and using a recent sample from a previous hospitalization., Conclusion: This study revealed that blood bankers did not have clear understanding of what constituted an FDA reportable occurrence. Size or type of blood establishment or individual job title was not associated with more knowledge of FDA reportable deviations., (© 2011 American Association of Blood Banks.)

Objective: Identify and remedy difficulties in the preparation of online students for certification examination success., Design: The final examination scores for the CLS Seminar course for the 2008 class of 27 on-campus and 10 online students were compared for statistical differences in seven examination areas. Problem areas were identified and changes in the CLS Seminar course were made in 2009 to improve the scores of the online students. The examination scores for the 2009 class of 33 on-campus and 10 online students were studied to determine improvement. Student's two-tailed t-test was used to determine statistical significance of differences between scores of on-campus and online students., Interventions: Interactive video over the web; used to answer online student questions, review games, more class time, and more recorded review sessions; were added to the Seminar. The study guides provided during preceptorships were tied to the objectives of the seminar course and the questions on examinations. Specific objectives for each question missed on the final examinations were provided to the student., Results: In 2008, examination scores for online students were lower in two of seven areas by a statistically significant amount than on-campus students. The difference approached significance in a third area. After interventions in 2009, the examinations scores had equalized with the exception of one area, Immunology., Conclusion: Increasing the amount and method of review in areas deemed important to online education was successful in improving examination scores.

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.

A large-scale practice analysis was undertaken by the American Society for Clinical Pathology Board of Registry to help maintain the validity of its certification examinations. The complete data sample of 1152 practicing phlebotomy technicians, medical laboratory technicians, and medical technologists was found to be demographically representative of the overall sample of 3097 respondents. The first study goal was to identify reliable task scales performed by phlebotomy technicians, medical laboratory technicians, and medical technologists. Thirty-eight task scales were initially found. Second, discriminant analysis was used to predict membership in one of these certification groups based on a more parsimonious combination of task scales. Task scale distinctions among phlebotomy technicians, medical laboratory technicians, and medical technologists were found. Study implications and limitations are discussed.

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 4-year study examined 165 medical technologists generally in the achievement phase of their careers. After distinguishing between two types of skills, fundamental and complex, different antecedents for each type of skill were found. Prior professional commitment was related positively to fundamental skills, whereas professional withdrawal intent was related negatively. Prior scholarly professional development and job involvement were related positively to complex skills, whereas job insecurity was related negatively. Complex skills time acquisition had a stronger positive relationship to complex skills than the relationship of fundamental skills time acquisition to fundamental skills.

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.

Objective: The study was undertaken to assess educators', practitioners', and managers' perceptions of the future job expectations of clinical laboratory scientists (CLSs) and their opinions on the skills that are expected of CLSs at entry-level and with experience., Design: Survey participants were given a list of 44 competencies related to clinical laboratory science (CLS) practice and were asked whether they would expect a graduate of a respected CLS program to perform each competency in one of three educational categories: the first year of practice, with three to five years of experience but no additional education, or with three to five years of experience plus additional education. The competencies were subclassified into one of four major management functions: laboratory operations, human resource management, financial operations, or communications/consultation. Surveys also included eight Lickert-type questions designed to assess the respondents' opinions on the future job expectations of CLS practitioners., Participants: The sample for the survey included 280 directors of CLS educational programs, 600 managers randomly selected from the Clinical Laboratory Management Association (CLMA) membership, and 600 practitioners randomly selected from the American Society for Clinical Laboratory Science (ASCLS) membership., Main Outcome Measures: The percent of respondents selecting each educational category was tabulated and each competency was assigned to one educational category based onthe highest percent of respondents selecting that category. The means of the responses to the Lickert-type questions were calculated for all respondents and for each group of respondents (educators, managers, and practitioners)., Results: Response rates of 58% (educators), 28% (practitioners), and 39% (managers) were obtained. Of the 44 competencies in the survey, four were expected at career-entry, 17 were expected of CLS graduates with work experience but no additional education, and 23 were expected of CLS graduates with experience plus additional education. Competencies expected in the first year of practice were primarily scientific and technical. With three to five years of practice and no additional education, the expectations for practitioners were primarily in laboratory operations and communications/consultation areas. The majority of the human resource management and financial operations competencies were expected with three to five years of practice and additional education. All participants agreed that CLS staff-level practitioners need more management and administrative skills and that, in the future, CLS practitioners will spend less time performing laboratory tests and more time solving problems. CLS managers were more positive than CLS educators in response to statements asserting that CLT practitioners and non-certified personnel will have an increased role in the laboratory in the future., Conclusion: This study suggests that extensive laboratory operations and communication skills are expected of CLS graduates without any additional education beyond their CLS programs. CLS educators should adequately address those areas in the curriculum. Competence in other non-technical skills may not be expected without the benefit of post-baccalaureate education and in these areas, CLS programs can provide a foundation for future learning.