Creating a Blueprint for the Future: Lessons Learned From Public Health Laboratories in the COVID-19 Response.

Public health laboratories have played a central role in the US response to COVID-19. Since the earliest days, myriad issues have impeded the laboratory community's ability to keep pace with the overwhelming demand for effective tests. In this article, the Association of Public Health Laboratories and a subset of its members examine the response to date and evaluate lessons learned from 4 main categories: testing surges, supplies, staffing, and regulations and policy. Within these categories, the authors offer recommendations intended both to improve the ongoing COVID-19 response and to strengthen planning for future outbreaks.

Thoughts and expectations of young professionals about the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM).

Objectives: Young laboratory medicine professionals (YLMPs) are the future of clinical laboratories. Although everyday practice shows significant differences among countries, especially during residency training, most of them face the same challenges. Besides promoting scientific, professional and clinical aspects of laboratory medicine in Europe, the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) should take into consideration YLMPs' concerns and interests to help them achieve excellence. The aim of this survey was to assess the opinion and expectations of YLMPs about their involvement in the activities of EFLM. Methods: An online survey was distributed to YLMPs in Europe through different channels. The questionnaire consisted of 21 items grouped into five sections: demographic questions, opinion about the current status of YLMPs within EFLM, YLMPs network, suggestions and opportunities, and scientific training and exchange. Where appropriate, responses from residents and specialists were compared. Results: A total of 329 valid responses were obtained from 53 different countries. Countries with the highest number of participants were Spain, Turkey, Croatia and Romania. A significant percentage would like to know more about EFLM and their activities (86%) and wish EFLM promoted networking and scientific exchanges (95%), for instance by means of a European YLMPs network (93%). EFLMLabX project was widely unknown (75%). Conclusions: YLMPs demand better connection to share concerns about daily healthcare duties, to keep updated and to advance professionally. EFLM needs to improve their advertising through national societies to increase YLMPs' participation. In addition to international meetings and congresses, respondents have emphasized that workshops and other small group activities would significantly help promote laboratory medicine practice in Europe.

Voices from the Field: Supporting the Educational Needs of Cytotechnologists.

INTRODUCTION: Sustaining a well-trained, competitive, and marketable cytotechnology workforce is a major goal of the American Society of Cytopathology/American Society for Clinical Pathology Workgroup Focusing on Emerging Roles in Cytopathology (ASC/ASCP Workgroup). This article describes the data collection initiatives performed by the Workgroup to confirm cytotechnologist (CT) perceived educational needs to keep pace with emerging practice changes in the workplace. In response to data collected, the Workgroup created Advanced Cytopathology Education (ACE)da unique, innovative educational resource designed to fulfill this need. MATERIALS AND METHODS: Data collection efforts included annual needs assessment surveys to gauge CT participants' preferred topics and learning modalities. These data were used to design and prioritize ACE topics. Program evaluations were also administered to evaluate participants' perceptions of program quality and effectiveness at meeting their educational needs. RESULTS: Research findings reveal CT education needs to align with emerging practice areas as reported in other Workgroup data collection efforts. The incorporation of new entry-level competencies in cytotechnology training programs prepares new CT graduates, but there is no standardized mechanism for formal, robust, and recognized ongoing education for other practicing CTs. CONCLUSIONS: This article highlights the educational endeavors carried out by the Workgroup in fulfilling the educational needs of practicing CTs as communicated through various data collection efforts. As CT responsibilities evolve, ASC and Workgroup efforts will continue to focus on providing educational support for current practicing CTs who need training in emerging practice areas.

Demystifying EQA statistics and reports.

Reports act as an important feedback tool in External Quality Assessment (EQA). Their main role is to score laboratories for their performance in an EQA round. The most common scores that apply to quantitative data are Q- and Z-scores. To calculate these scores, EQA providers need to have an assigned value and standard deviation for the sample. Both assigned values and standard deviations can be derived chemically or statistically. When derived statistically, different anomalies against the normal distribution of the data have to be handled. Various procedures for evaluating laboratories are able to handle these anomalies. Formal tests and graphical representation techniques are discussed and suggestions are given to help choosing between the different evaluations techniques. In order to obtain reliable estimates for calculating performance scores, a satisfactory number of data is needed. There is no general agreement about the minimal number that is needed. A solution for very small numbers is proposed by changing the limits of evaluation.Apart from analyte- and sample-specific laboratory evaluation, supplementary information can be obtained by combining results for different analytes and samples. Various techniques are overviewed. It is shown that combining results leads to supplementary information, not only for quantitative, but also for qualitative and semi-quantitative analytes.

Comprehensive evaluation of contemporary assisted reproduction technology laboratory operations to determine staffing levels that promote patient safety and quality care.

OBJECTIVE: To consider how staffing requirements have changed with evolving and increasingly more complex assisted reproduction technology (ART) laboratory practice. DESIGN: Analysis by four laboratory directors from three different ART programs of the level of complexity and time requirements for contemporary ART laboratory activities to determine adequate staffing levels. SETTING: University-based and private ART programs. PATIENT(S): None. INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): Human resource requirements for ART procedures. RESULT(S): Both complexity and time required for completion of a contemporary ART cycle have increased significantly compared with the same requirements for the "traditional cycle" of the past. The latter required roughly 9 personnel hours, but a contemporary cycle can require up to 20 hours for completion. Consistent with this increase, a quantitative analysis shows that the number of embryologists required for safe and efficient operation of the ART laboratory has also increased. This number depends on not only the volume but also the types of procedures performed: the higher the number of complex procedures, the more personnel required. An interactive Personnel Calculator is introduced that can help determine staffing needs. CONCLUSION(S): The increased complexity of the contemporary ART laboratory requires a new look at the allocation of human resources. Our work provides laboratory directors with a practical, individualized tool to determine their staffing requirements with a view to increasing the safety and efficiency of operations. The work could serve as the basis for revision of the 2008 American Society for Reproductive Medicine (ASRM) staffing guidelines.

Causes of historically low abstract submissions for the ASCLS annual meeting.

The Abstract Review Committee (ARC) has an ongoing objective of encouraging abstract submissions for the American Society of Clinical Laboratory Science's (ASCLS) Annual Meeting. The purpose of this research study was to survey ASCLS members to determine the cause of historically low abstract submissions and how submissions could be increased. An electronic survey was developed and sent to ASCLS members via electronic mail blast. The survey focused on five areas: 1) participant demographics, 2) positives and negatives of the current submission and review process, 3) suggestions for improvement, 4) barriers to participation, and 5) level of attendance at poster and oral presentation sessions at annual meetings. Results of the survey indicated that the foremost reason cited for not submitting an abstract was lack of active research. The ARC believes limited research activity is due to the lack of educational preparedness of educators and practitioners to conduct research.

[Assessment of scientific production after initial medical education at the Faculty of Medicine of Angers from 2002 to 2008]. / La production scientifique issue de la formation initiale à la faculté de médecine d'Angers entre 2002 et 2008 : de bonne qualité mais insuffisante.

INTRODUCTION: The activity of scientific publication after initial medical education is unclear. The purpose of this study was to evaluate the proportion of MD theses and Board certification manuscripts resulting in a publication, their impact in terms of SIGAPS points and the main difficulties in the publication of this work. METHODS: MD theses sustained from 2002 to 2008 at the Faculty of Medicine of Angers have been identified from the "Système universitaire de documentation" (SUDOC), catalog, and specialty certification manuscripts (Board and Complementary Board) directly to diplomates. Publications were searched in Medline via Pubmed, ISI Web of Knowledge and in the three SIGAPS reports from 2002 to 2008. A survey aimed at determining the barriers to publication and the way to suppress them was launched to all MD directors and specialty mentors. RESULTS: Five hundred and ninety-eight theses were sustained, 311 (52%) in general medicine and 287 (48%) in specialties. One hundred and sixty-five theses have resulted in publication (28%) of which 97 (16%) indexed in Medline via Pubmed (11% in general medicine and 22% in specialty). Thirty-three of these 97 articles (35%) were published in journals of high quality classes A, B or C of SIGAPS classification. These articles from theses represented 4.17% of the SIGAPS scoring of the hospital calculated on a total of 2088 articles over this period. Two hundred and four specialty certification manuscripts resulted in 69 articles (33.8%), 50 (24.5%) indexed in Medline. The rate of publication of these specialty manuscripts, Board and Complementary Board, were respectively 31% (45/145) and 40.7% (24/59). They represented 1.9% (432 points) total SIGAPS score. The main barriers to publication were lack of time of directors, remote students after the promotion and the lack of logistic resources. CONCLUSION: Scientific publications issued from initial medical education at the Faculty of Medicine of Angers was of good quality but quantitatively insufficient, and contributed poorly to the University Hospital funding despite a significant number of diplomates. Logistical support should be considered in order to promote scientific production after initial medical education.

Optimizing the technological and informational relationship of the health care process and of the communication between physician and patient--factors that have an impact on the process of diagnosis from the physician's and the patient's perspectives.

OBJECTIVE: The optimization of a diagnosis process and fluency in the Health Care sector in Romania. A key to discover this complex process was to determine a correlation between the physicians and the use of information technology, on one side and the patients' perspective on the other. HYPOTHESIS: Integrating information technology in a physician's activity will lead to lower costs and less time spent while diagnosing patients. Using the electronic medical records and introducing a unified database with the patients' medical histories will make the process of diagnosis easier. METHODS: We studied the diagnosis from the point of view of 304 patients in a public hospital and 320 physicians working there. RESULTS: We believed that time and accessibility to different physicians makes the diagnosis process a burden for a patient and implicitly lead to dissatisfaction with health care services. We supposed that the burden of diagnosis for physicians comes from the lack of Internet connection and computer usage knowledge. We have found out that most physicians know how to use the computer at an intermediate level and have access to Internet, online journals and databases and do not use emails to a higher extent to communicate to other specialists, but do not rely entirely on the electronic medical records. Most physicians think that it is not technology, which stands in the way of proper and fast diagnosis but the financing and the paper work from the Romanian health system. Solutions that might be taken into account to entirely motivate physicians to use electronic medical records are: 1. Adjustments can be made to the computer software interface in order to make the design more consistent (to eliminate the paper forms) and user friendly. 2. Physicians can be provided with more training and knowledge. DISCUSSION: After some statistical tests have been applied to find a correlation between the chosen variables, we have reached the conclusion that the results are encouraging and there is no correlation between the degree of the impact of Preventive Medicine and the healthy behavior of the respondents.

Willingness and preferences of nurses related to learning with technology.

To what extent are nurses willing to learn with technology-enhanced tools, such as online education, podcasts, webcasts, mobile learning, and realistic simulations? What factors influence their willingness? This article includes a description of a mixed methodology study that addressed these questions. Nurses of all ages indicated a willingness to learn with a variety of technological tools. Primary determinants of willingness were associated with ease of use, familiarity, convenience, and perceived benefit.

Hospital utilization and characteristics of patients experiencing recurrent readmissions within children's hospitals.

CONTEXT: Early hospital readmission is emerging as an indicator of care quality. Some children with chronic illnesses may be readmitted on a recurrent basis, but there are limited data describing their rehospitalization patterns and impact. OBJECTIVES: To describe the inpatient resource utilization, clinical characteristics, and admission reasons of patients recurrently readmitted to children's hospitals. DESIGN, SETTING, AND PATIENTS: Retrospective cohort analysis of 317,643 patients (n = 579,504 admissions) admitted to 37 US children's hospitals in 2003 with follow-up through 2008. MAIN OUTCOME MEASURE: Maximum number of readmissions experienced by each child within any 365-day interval during the 5-year follow-up period. RESULTS: In the sample, 69,294 patients (21.8%) experienced at least 1 readmission within 365 days of a prior admission. Within a 365-day interval, 9237 patients (2.9%) experienced 4 or more readmissions; time between admissions was a median 37 days (interquartile range [IQR], 21-63). These patients accounted for 18.8% (109,155 admissions) of all admissions and 23.2% ($3.4 billion) of total inpatient charges for the study cohort during the entire follow-up period. Tests for trend indicated that as the number of readmissions increased from 0 to 4 or more, the prevalences increased for a complex chronic condition (from 22.3% [n = 55,382/248,349] to 89.0% [n = 8225/9237]; P < .001), technology assistance (from 5.3% [n = 13,163] to 52.6% [n = 4859]; P < .001), public insurance use (from 40.9% [n = 101,575] to 56.3% [n = 5202]; P < .001), and non-Hispanic black race (from 21.8% [n = 54,140] to 34.4% [n = 3181]; P < .001); and the prevalence decreased for readmissions associated with an ambulatory care-sensitive condition (from 23.1% [62,847/272,065] to 14.0% [15,282/109,155], P < .001). Of patients readmitted 4 or more times in a 365-day interval, 2633 (28.5%) were rehospitalized for a problem in the same organ system across all admissions during the interval. CONCLUSIONS: Among a group of pediatric hospitals, 18.8% of admissions and 23.2% of inpatient charges were accounted for by the 2.9% of patients with frequent recurrent admissions. Many of these patients were rehospitalized recurrently for a problem in the same organ system.

Tumour marker requesting in primary care and the role of the laboratory.

AIMS: To review the incidence of multiple tumour marker (TM) requesting in the primary care setting and determine whether the rationale for requesting a TM panel is in agreement with evidence-based guidelines. METHODS: Data-mining software was used to retrospectively identify multiple TM requests and requesting practices of GP surgeries over a 34-month period for α-fetoprotein, CA125, CA15-3, CA19-9, carcinoembryonic antigen and prostate-specific antigen. The appropriateness of each test was reviewed by a clinical biochemist in accordance with National Association of Clinical Biochemistry best-practice guidelines. RESULTS: 505 multiple TM requests were identified which corresponded to 1304 TM tests. Comparison with best-practice guidelines suggested that 68% of request cards contained no appropriate TM request, and 84% of the tests requested were inappropriate. CONCLUSION: A review of requesting practices in primary care for TMs highlights the need for laboratories to be more proactive in educating their users on their clinical utility and limitations.

Graduate education in clinical laboratory science is the glass half full or half empty?

OBJECTIVE: To evaluate the 2007 and 1990 data on the number and characteristics of programs offering graduate level degrees in Clinical Laboratory Science. DESIGN/SETTING/PARTICIPANT: Data were collected from published sources (Directory of Graduate Programs for Clinical Laboratory Practitioners) and analyzed at the University of Minnesota. Specific data regarding the kinds of advanced programs and the number of graduates per year, the number of program openings and closures, program requirements were collected, as well as data regarding the number and employment of graduates of Master's degree programs at two long-standing public institutions. INTERVENTION: Not Applicable. MAIN OUTCOME MEASURE: The tabulation of degree, program, and graduate data, together with the first position taken by graduates of two M.S. programs. RESULTS: The numbers of graduate level programs and graduates decreased between 1990 and 2007, from 39 to 28 identified Master's level programs, but with only a slight increase from two to five doctoral programs. Several prominent and historically important Master's level programs have closed since the first edition (1990) of the Directory. Detailed analysis of the data from two Master's level programs showed that the first positions for graduating students were predominantly research related and in the same state as the degree-granting institution. CONCLUSION: The number of advanced programs and graduates are relatively small in clinical laboratory science; however M.S. graduates are successful in obtaining positions. These positions are predominantly geographically related to the degree-granting institution, indicating an intellectual and economic impact of the programs in the regions they are located.

Scholarly activities of the most productive CLS faculty and schools in the U.S.A.

OBJECTIVES: To assess the research and scholarship of the most productive clinical laboratory science faculty and schools in the United States. DESIGN: In 2008 a national study involving 106 college and university CLS programs was conducted to determine which faculty members were most productive in research activities. A questionnaire was sent electronically to all faculty (n=448) of 106 NAACLS accredited programs. Data from 275 respondents (61%), from 93 programs (89%) were analyzed. SETTING: The study took place at The Ohio State University with collaboration from the University of Minnesota. PARTICIPANTS: Clinical laboratory science faculty within a four-year university or college sponsoring a NAACLS-accredited CLS program, were invited to participate. MAIN OUTCOME MEASURES: To quantitate faculty scholarly productivity by point assessment, to assess the top 10% of faculty based on funding, publications, abstracts, presentations, books and chapters, and to identify the 15 highest ranking institutions in terms of their collective faculty research contributions. CONCLUSIONS: The top 10% of clinical laboratory science faculty (n=28) are performing almost 50% of scholarship in the profession, with major contributions in funding garnered and international presentations. These individuals also generally hold a doctorate, are full professors and tenured. Among the 15 highest ranked colleges and universities with CLS programs, and by cumulative faculty contributions, most are classified as research institutions.

Measuring the U.S. health care system: a cross-national comparison.

The Organization for Economic Cooperation and Development (OECD) tracks and reports annually on more than 1,200 health system measures across 30 industrialized countries, ranging from population health status and nonmedical determinants of health to health care resources and utilization. Based on analysis of OECD health data from 2008, the United States continues to differ markedly from other countries on a number of health system measures. The U.S. has a comparatively low number of hospital beds and physicians per capita, and patients in the U.S. have fewer hospital and physician visits than most other countries. At the same time, spending per hospital visit is highest in the U.S., and American patients are among the most likely to receive procedures requiring complex technology. The nation now ranks in the bottom quartile in life expectancy among OECD countries and has seen the smallest improvement in this metric over the past 20 years.

Association between physician specialty and uptake of new medical technologies: HPV tests in Florida Medicaid.

BACKGROUND: It is well established that specialists often adopt new medical technologies earlier than generalists, and that racial and ethnic minority patients are less likely than White patients to receive many procedures and prescription drugs. However, little is known about the role that specialists or generalists may play in reducing racial and ethnic disparities in uptake of new medical technologies. Human papillomavirus (HPV) DNA tests, introduced as a cervical cancer screening tool in 2000, present a rich context for exploring patterns of use across patient and provider subgroups. OBJECTIVE: To identify patient characteristics and the provider specialty associated with overall and appropriate use of HPV DNA tests over time, and to examine the associations between clinical guidelines and adoption of the test in an underserved population. DESIGN: Retrospective longitudinal study using Florida Medicaid administrative claims data. PARTICIPANTS: Cervical cancer screening test claims for 415,239 female beneficiaries ages 21 to 64 from July 2001 through June 2006. MAIN MEASURES: Overall and appropriate use of HPV DNA tests. KEY RESULTS: Although minority women were initially less likely than White women to receive HPV DNA tests, test use grew more rapidly among Black and Hispanic women compared to White women. Obstetricians/gynecologists were significantly more likely than primary care providers to administer HPV DNA tests. Release of the first set of clinical guidelines was associated with a large increase in the use of HPV DNA tests (adjusted odds ratio: 2.46, p<0.0001); subsequent guidelines were associated with more modest increases. CONCLUSIONS: Uptake of new cervical cancer screening protocols can occur quickly among traditionally underserved groups and may be aided by early adoption by specialists.

Current organisation of clinical cytology in Croatia.

Current cytological service in Croatia is organised in 46 cytological organisational units in 23 towns with total of 350 employees: 101 specialists of clinical cytology, 20 residents in clinical cytology, 141 cytotechnologists (cytoscreeners), 45 health technicians, and 25 administrators and 18 auxiliary personnel. In spite of employment of significant number of cytotechnologists in the last ten years, there is still an unacceptable ratio of number of cytologists and cytotechnologists (1:1.4) which is the result of unresolved education of cytotechnologists which should be permanent, complete and acknowledged. Education and scientific promotion of cytologists is continuous and today our profession has 31 masters of science and 9 doctors of science, one of which is the assistant professor, and four of them are associate or full professors at medical schools in Zagreb and Osijek. Croatian cytology, in average, is in its "best years", i.e. an average cytologist is 46-years-old and cytotechnologist is averagely 43-years-old, but "suffers" from personnel deficit. With regard to the type of activity, the most numerous are units dealing the entire diagnostic cytology (72%), 13% general cytology without gynaecological cytology, while 15% are engaged in one diagnostic field (gynaecological, pulmological or thyroid cytology). According to accessible data, total of 770996 cytological examinations were done in Croatia in 2008. The increasing application of additional methods (cytochemical, immunocytochemical, molecular, cytogenetics and computer-assisted image analysis) has become a trend in numerous cytological units. Exclusively morphological analysis of standard stained samples is performed in 37% of units, morphological and cytochemical staining methods are used in 17% of units, and additional immunocytochemical methods in 30% of units. According to the long tradition of cytology in Croatia, that has progressed thanks to the enthusiasm and great effort of our teachers, we believe that the following generations of cytologists will continue working on its improvement and will be able to concord the basic cytomorphology and sophisticated diagnostic procedures with other diagnostics, to stay the field of optimal results in the shortest time with the reasonable price.

Statistics in the world of medical devices: the contrast with pharmaceuticals.

Medical devices play a vital role in people's lives as these products are revolutionizing medicine with breathtaking advances in both the treatment and the detection of many diseases. While a similar, primarily therapeutic, revolution is ongoing in the pharmaceutical world; the focus here is the effect this device revolution is having on the statistical world. The similarities and differences between medical devices and pharmaceutical drugs are explored in terms of their natures, industries, and how they are regulated in the U.S. and globally. Statistical issues concerning the evaluation of devices versus those of drugs are compared and contrasted. These trends are creating new challenges for the statistical world in the development and evaluation of these new medical products.