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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).)

Objectives: Electroencephalography (EEG) technologists commonly screen continuous EEG. Until now, the inter-rater agreement or sensitivity for important EEG findings has been unknown in this group., Methods: Twenty-nine EEG technologists and three clinical neurophysiologists interpreted 90 five-minute samples of pediatric critical care EEG. Inter-rater agreement was examined with Cohen's kappa and Fleiss' kappa for EEG findings. A gold-standard consensus agreement was developed for examining sensitivity and specificity for seizures or discontinuity. Kruskal-Wallis tests with Benjamani-Hochberg corrections for multiple comparisons were utilized to examine associations between correct scoring and certification status and years of experience., Results: Aggregate agreement was moderate for seizures and fair for EEG background continuity among EEG technologists. Individual agreement for seizures and continuity varied from slight to substantial. For individual EEG technologists, sensitivity for seizures ranged from 44 to 93% and sensitivity for continuity ranged from 81 to 100%. Raters with Certified Long Term Monitoring credentials were more likely to identify seizures correctly., Significance: This is the first study to evaluate inter-rater agreement and interpretation correctness among EEG technologists interpreting pediatric critical care EEG. EEG technologists demonstrated better aggregate agreement for seizure detection than other EEG findings, yet individual results and internal consistency varied widely. These data provide important insight into the common practice of utilizing EEG technologists for screening critical care EEG., (Copyright © 2020 Elsevier Inc. All rights reserved.)

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.

Background: Major issues around the implementation of point-of-care testing (POCT) include: user type, regulatory control, ongoing quality monitoring and limited guideline adherence.59 December 2019, Print editionObjectives. To determine if there are significant differences in the results of a POC full blood count test between different levels of healthcare and non-medical 'lay' users compared with laboratory users (technologists/pathologists)., Methods: This article retrospectively reviews the technical evaluation database of the intensive care unit (ICU), Chris Hani Baragwanath Academic Hospital, Johannesburg, South Africa. We searched for samples analysed by doctors, clerks and laboratory personnel. A minimum number of 60 comparisons were required. Bland-Altman plots, Spearman's correlation and Passing-Bablok fit were used to analyse the dataset., Results: There were 72 comparisons for haematocrit (Hct), 98 for white cell count (WCC) and 137 for platelets (Plt) between the clerk and laboratory personnel. The correlations were 0.91, 0.96 and 0.92, respectively. All were statistically significant. Using the Bland-Altman method, there was good agreement between results of the clerk and those of the laboratory staff, with a mean bias of 0.5% (Hct), 0.1 × 109/L (WCC) and 10 × 109/L (Plt). An insufficient number of tests were performed by medical doctors for statistical comparison., Conclusions: With appropriate training, non-medical, non-healthcare lay users are able to perform a moderately complex POCT with similar accuracy as trained laboratory professionals. The focus should shift to equipment and quality management processes rather than the medical/technical qualification of the user.

Background: Laboratory analyses of blood samples are essential for diagnostics and therapy monitoring of patients with bleeding and thromboembolic diseases. Following publication of the core curriculum for clinical thrombosis and hemostasis, the International Society on Thrombosis and Haemostasis (ISTH) recognized that thrombosis and hemostasis laboratory specialists require distinct competencies that differ from medical doctors working clinically with patients. To address this gap the ISTH formed a working group of international hemostasis and thrombosis laboratory specialists to develop an evidence-based core curriculum for laboratory specialists., Objective: This research sought consensus from the international community on core competencies required for laboratory specialists in thrombosis and hemostasis., Methods: A draft list of 64 competencies was developed and an online stakeholder survey was circulated electronically to 15 302 ISTH members and contacts in the wider international community. The results were analyzed and used to develop the final approved core curriculum., Results: Three hundred and thirty responses contained meaningful data, with broad international representation of specialists. No draft competencies were excluded, and 58 were rated as "does" or "shows how." The Leik measure of consensus for most competences was "moderate" (n = 30) or "fair" (n = 32)., Conclusions: The development of an international core curriculum for laboratory specialists provides a foundation for the development and enhancement of education and quality management of the laboratory. Although there is no formal designation for laboratory specialists, international governing bodies and regulatory organizations are encouraged to consider the diagnostic core curriculum for development and accreditation of more standardized educational programs and formal assessment across jurisdictions., (© 2019 International Society on Thrombosis and Haemostasis.)

Problem Statement: To describe research mentorship strategies needed to strengthen oncology nursing science and ensure that a cadre of nurse scientists are available to carry out the research mission of the Oncology Nursing Society (ONS)., Design: Multimethod consensus-building approach by content experts of the ONS Research Mentorship Task Force and approval by the ONS Board of Directors was employed., Data Sources: Expert opinion, surveys, notes from an all-day research mentorship retreat, and literature review were used., Analysis: Content analysis was used to synthesize notes from the research mentorship retreat., Findings: Various strategies were identified to strengthen the pipeline of oncology nurse scientists and promote development across the career trajectory., Implications for Practice: Mentorship is essential to advance the growth and impact of oncology nursing science and requires support throughout the career trajectory.

Background: A quality medical laboratory service is an important part of the health care system. In developing countries like Ethiopia, the laboratory quality system remains weak due to several factors. Therefore, assessing the factors affecting quality of medical laboratory service is highly important in order to improve service quality., Objective: Assessment of factors affecting the quality of medical laboratory service in Gondar town public health facilities, Amhara regional state, Northwest Ethiopia, 2018., Methods: An institution based cross-sectional study was conducted at Gondar town governmental health facilities from March to April 2018. A pretested, self-administered, semi-structured questionnaire and checklist was used to collect the socio-demographic information of the study participants and to assess factors affecting the provision of quality medical laboratory services. Data were checked for completeness, entered, and analyzed using SPSS version 20 (IBM Corporation, Armonk, NY, USA). Data were reported in tables and figures. The strength of association between the dependent and independent variables was assessed by the chi-square test. A p-value < 0.05 was considered statistically significant., Results: A total of 103 medical laboratory professionals participated in the study. Of these, 62 (60.2%) were males. The majority of the study participants, 63 (61.2%), were laboratory technologists. Of these participants, 72 (69.9%) did not attend laboratory refresher training and 93 (90.3%) of participants were not satisfied with their salary. Sixty-three (61.2%) of the participants reported that their laboratory did not provide quality laboratory service. Lack of quality and adequate equipment, non-adherence to standard operating procedures, no continuing professional development, unavailability of adequate supplies and reagents, no customer service management, no regular internal and external quality assessment activity, no diagnostic service for all requested tests, no result verification, and laboratory safety were the major factors significantly associated with poor quality laboratory service (p < 0.05)., Conclusions: A high proportion of the study participants reported that their laboratory did not provide quality laboratory services. The shortage of adequate equipment, reagents, and lack of motivation and employees' recognitions are the major factors that affect the quality of laboratory services.

Background: Blood draws are a routine element of the pediatric patient experience. They are also associated with the greatest fear and pain for a child. Because of the limited literature regarding phlebotomists' knowledge, experience, training, or stress related to their use of comfort techniques during pediatric blood draws, this study explored current practices and training methods. Phlebotomist training tends to focus on clinical technique rather than pediatric or patient comfort support. The study includes aims to develop a measurement for phlebotomists' use of comfort techniques for pediatric blood draws., Method: Focus groups of parent advocates (n = 24) and pediatric phlebotomists (n = 11) reviewed the survey questionnaire, and it was revised before being e-mailed to hospital system phlebotomists (n = 128)., Results: Almost half of the sample group lacked training in child development. The most frequently used comfort measures were words of explanation and reassurance, positioning of the child, and distraction. Requesting child life specialist support and using pain management devices or topical anesthetics were used less often. Primary challenges to performing pediatric blood draws were anxious patients and parents., Conclusion: Phlebotomists' use of available comfort measures occurs infrequently. Including child development and comfort techniques in training programs is essential to providing pediatric patients with a more satisfactory experience., (© 2018 American Association for Clinical Chemistry.)

The introduction of dedicated phlebotomy teams certified for blood collection has been reported to be highly cost-effective by reducing contamination rates. However, data on their effects on blood volume and true positive rate are limited. Therefore, we investigated the effect of replacing interns with a phlebotomy team on blood culture results. We performed a 24-month retrospective, quasi-experimental study before and after the introduction of a phlebotomy team dedicated to collecting blood cultures in a 2700-bed tertiary-care hospital. The microbiology laboratory database was used to identify adult patients with positive blood culture results. During the study period, there were no changes in blood collection method, blood culture tubes, and the application of antiseptic measures. Blood volume was measured by the BACTEC™ FX system based on red blood cell metabolism. A total of 162,207 blood cultures from 23,563 patients were analyzed, comprising 78,673 blood cultures during the intern period and 83,534 during the phlebotomy team period. Blood volume increased from a mean of 2.1 ml in the intern period to a mean of 5.6 ml in the phlebotomy team period (p < 0.001). Introduction of the phlebotomy team also reduced contamination rate (0.27% vs. 0.45%, p < 0.001) and led to a higher true positive rate (5.87% vs. 5.01%, p < 0.05). The increased true positive rate associated with the phlebotomy team involved both gram-positive and gram-negative bacteria. The introduction of a dedicated phlebotomy team can increase blood volumes, reduce blood culture contamination rate, and increase true positive rate.

This article describes the need for, stratifies the complexity of, and proposes detailed lists of training competencies for diagnostic laboratory personnel using quantitative liquid chromatography-tandem mass spectrometry (LC-MS/MS) for patient care. Although quantitative LC-MS/MS is evolving toward greater automation with less need for technical expertise, gaps remain in resources for training and assessment., (Copyright © 2018 Elsevier Inc. All rights reserved.)

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.)

Background: Majority of musculoskeletal cross-sectional imaging requests have a non-revealing and non-specific clinical history of pain. However, the location of pain is very relevant towards arriving at a specific orthopedic diagnosis. The purpose of this research was to study the impact of skin marker placement and training of technologists prior to knee MRI in detection of clinically important findings., Methods: Total 200 consecutive left knee MRIs were evaluated before and after technologist training with regards to marker placement at the site of clinical symptoms or palpable finding. Marker location in relation to the knee was recorded and important findings were classified as correlated important finding, non-correlated important finding, other compartment important finding in non-correlated cases, and diffuse abnormality, i.e. tri-compartmental cartilage defects in both correlated and non-correlated cases. Differences among scans before and after technologist training were analyzed., Results: The marker placement was observed in higher proportion of patients in post-training scans (78% vs 60%, p = 0.00). The most common location of the marker was in anterior or anterolateral knee (32% and 34% cases, respectively). The marker-important finding correlation was also higher post training, but not statistically significant (53% versus 38%, p = 0.57). Important findings correlated with the marker in more than 50% of the scans in the post-training set., Conclusion: Marker placement can aid in detection of clinically important imaging finding and technologist training aids in increased rates of marker placement and improved correlation.

Purpose: To quantify consistency of endothelial cell density (ECD) measurements among technicians in a single US eye bank operating under typical operating conditions., Methods: In this retrospective analysis of 51 microscopy technicians using a semiautomated counting method on 35,067 eyes from July 2007 to May 2015, technician- and date-related marginal ECD effects were calculated using linear regression models. ECD variance was correlated with the number of specular microscopy technicians., Results: Technician mean ECDs ranged from 2386 ± 431 to 3005 ± 560 cells/mm. Nine technicians had statistically and clinically significant marginal effects. Annual mean ECDs adjusted for changes in technicians ranged from 2422 ± 433 to 2644 ± 430 cells/mm. The period of 2007 to 2009 had statistically and clinically significant marginal effects. There was a nonstatistically significant association between the number of technicians and ECD standard deviation., Conclusions: There was significant ECD variability associated with specular microscopy technicians and with the date of measurement. We recommend that eye banks collect data related to laboratory factors that have been shown to influence ECD variability.

Background: Although objective measures of cytotechnologist (CT) and cytopathologist (CP) performance exist, challenges remain. Two assumptions deserve examination: CPs' interpretations are correct, and CTs and CPs render interpretations independently of each other. This study presents a CT-CP interpretation comparison and provides insight into these assumptions., Methods: Every gynecologic cytology specimen examined by both a CT and a CP from December 2004 to March 2015 was extracted from the laboratory information system; glandular interpretations were excluded. Excel and SAS were used for CT-CP pair analysis. CT-CP pairs with fewer than 32 specimens (the lowest quartile) were excluded. For the remaining CT-CP pairs, 30 specimens or 10% of the specimens (whichever was higher) were randomly selected for comparison by a weighted κ statistic. κ values greater than 0.6 represented good agreement within CT-CP pairs., Results: This study evaluated 7116 of 53,241 gynecologic cytology specimens (13.4%) that received CT and CP interpretations. This resulted in 155 pair-specific κ values from 15 CTs and 16 CPs. In aggregate, the κ values had a mean of 0.64, a standard deviation of 0.14, a median of 0.65, and a range of 0.27 to 0.91. Nine CTs exhibited good agreement in the majority of their pair-specific κ values with CPs (high-concordance CTs; 88 pair-specific κ values). This allowed us to identify outlier CPs who did not demonstrate good agreement with high-concordance CTs (16 of 88 pair-specific κ values [18.2%])., Conclusions: Laboratories can use this κ to determine when CP levels of agreement with CTs depart from those of their peers. Adding this to established metrics can give a more nuanced impression of CP performance. Cancer Cytopathol 2017;125:576-80. © 2017 American Cancer Society., (© 2017 American Cancer Society.)

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

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.)

Background: The University of Maryland Medical System, like all other medical systems, is faced with providing the highest quality care in an environment of increased demands and competition for resources. Some responses to this pressure include improved integration, coordination, and efficiency. Laboratory integration has been highlighted by our medical system as a promising area for improvement. Standardization of practices, including job descriptions, is an important step on this journey., Methods: With the help of the Human Resources department and the laboratory directors, we conducted an assessment of existing titles and practices from across our medical system. Analysis and evaluation of job descriptions demonstrated some inconsistencies and opportunities for standardization. Discussion and dialogue allowed us to reach consensus on a standard philosophy, format, and approach., Results: We created a system wide Phlebotomist job description, based on current practice, which reflected the needs of our medical system. We will be able to use this tool to standardize other job titles, as well as for recruitment and as a basis for retention., Conclusion: This methodology can be easily duplicated and followed to evaluate and design job descriptions, as well as to reach consensus in an efficient and organized approach to job standardization in the laboratory., (© American Society for Clinical Pathology, 2016. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

While Medical Laboratory Technologists (MLTs) do not generally work directly with clinical healthcare teams they have proven to be invaluable contributors to team-based systematic quality improvement in healthcare. They were early adopters of standardized systemic performance measures coupled with explicit strategies for improving suboptimal performance. Their attentiveness to systemic analysis of systemic factors influencing performance has proven to be valuable in our quest to make care optimally safe and high quality.

Clinical applications of molecular-genetic testing are rapidly disseminating and expanding. A qualification system of technological professionals for molecular-genetic testing has been implemented and operating in Japan, aiming at educating and evaluating personnel who are to engage in molecular-genetic testing. It con- sists of two stages in career development with molecular analysis technologist and specialist, both of which need to be renewed every 5 years. The qualification is of significance across many fields. Human resource development of molecular-genetic testing is a cornerstone of quality assurance of measurement by medical and research laboratory personnel. In addition, expectations of the qualified personnel include the manage- ment of relevant guidelines, compliance regarding the use of personal genetic information (medical ethics) and bio-risk in the laboratories, as well as engagement in the biotechnology industry. [Review].

The scope of the biomedical laboratory scientist (BLS) differs in the world. The qualification systems for BLS are also different. Even the name of our profession is not standardized, like "BLS", "Medical Technologist (MT) ", "Medical Laboratory Scientist (MLS) ", "Medical Technician", and so on. We have only the "BLS" license, which is recognized by the Ministry of Health, Labour and Welfare in Japan. Many Asian countries have a qualification system similar to Japan. In the USA, BLSs are qualified by certain scientific organizations, and they are called "MT", "BLS", or "Specialist" in consideration of their education level. The International Association of Medical Laboratory Technologists (IAMLT) was founded by Ms. Elizabeth Pletscher and her Swiss colleagues in order to cooperate with international BLSs in 1954. Since the BLS education system has been improved, chief delegates from the world decided that we should call ourselves "BLS", and IAMLT was revised to the "International Federation of Biomedical Laboratory Science (IFBLS) " at the general assembly in 2002. IFBLS has tried to spread our name and occupation to the public though our international cooperation using the same name "BLS". IFBLS shares the core competence, but does not provide certification. The International Academy of Clinical Cytology (IAC) has provided international certification for cytolo- gists and cytotechnologists. The American Society of Clinical Pathology (ASCP) has certified overseas BLSs (ASCPi), and they are able to work in the USA as BLSs after passing the examination. These certifi- cations will be valid in limited areas. As the current situation, if someone would like to work in another country as a BLS, he/she will have to pass the domestic BLS examination. [Review].

We introduce our efforts to utilize education, training, competence assessment, and quality control of personnel engaged in urinary sediment and blood cell morphology examinations in our laboratory. There are no standard samples for these morphological examinations, and standardization has not been completed for all types of blood cells or urinary sediment components. We had been carrying out simultaneous microscopic examination involving trainee staff and senior laboratory technologists as a means of education and evaluation, but acceptance criteria were unclear. Moreover, we had continued our operation without assessment of the level of achievement of routine works or the competence of individual staff members. Taking the opportunity of receiving ISO 15189 certification, we have been able to establish clear standards for evaluating personnel education and training in morphological examinations. We will continuously make efforts to maintain and manage this system.

Background: The introduction of troponin assays with higher analytical sensitivity and enhanced performance has produced new challenges for both laboratory and clinician in the optimal investigation of patients with cardiovascular disease. After some years of collective experience with this new generation of assays, this survey aimed to assess the level of consensus that exists regarding their application., Methods: A questionnaire was designed, based on a review of published evidence and current opinion, to obtain information on a number of key areas relating to troponin analysis and reporting and was circulated to lead laboratory consultants across the UK and Ireland., Results: Completed questionnaires were received from 94 laboratory contacts. Sixty per cent of those who responded had implemented a high-sensitivity troponin assay, with the Roche Cobas troponin T high sensitivity assay the most widely used. It is evident that some confusion remains regarding the definition of high-sensitivity assays and there was considerable variation in practice, even among those using the same manufacturer's assay., Conclusions: There is a need for greater consensus in the approach to the clinical utilization of troponin assays with improved sensitivity and it is important that laboratories are fully aware of the capabilities of their assay and provide useful guidance to users. On the basis of survey findings and the existing evidence base, a number of recommendations have been proposed to improve current practice and enhance patient safety., (© The Author(s) 2015.)

Because of the increase in healthcare-associated infections, appearance of highly resistant bacteria, and that of emerging/re-emerging infectious diseases, it is necessary for the skills of clinical microbiological technologists and the associated technology to be improved. Technologist in Microbiology (4,717 certified) and Specialist in Microbiology (58 certified) are authorized qualifications in the field of examination for clinical microbiology, with a history of 60 years, and Clinical Microbiological Technologist (670 certified) and Infection Control Microbiological Technologist (ICMT) (528 certified) are necessary qualifications to become a member of an infection control team. As problems to be resolved, clarifying the relationships among the authorized qualifications, reconsidering the fairness of evaluating written examinations, and further consideration of the administration method for an increasing number of examinees need to be tackled.

Objective: The quality medical laboratory services play a vital role in healthcare systems. Iran has set national standards based on the international standard ISO15189. These standards came into force in September 2007. Given the important role of both laboratories professional and assessors in the standardization, this study aims to compare and analyze medical laboratory directors' and assessors' opinions about this process, its challenges and relevant solutions., Methods: This qualitative study was conducted on two populations in 2013. The first survey population consisted of 150 assessors. The second group consisted of directors working in medical laboratory settings. From all universities of medical sciences, 258 medical laboratories were randomly selected. Data were gathered using two open-ended questionnaires and analyzed using the thematic analysis., Results: Challenges and relevant solutions regarding the standardization and standards, the assessment process and assessor, laboratories, external entities and contextual factors across laboratories directors and assessors were derived and compared. Both groups had a positive attitude towards the standardization process. However, they expressed some concerns regarding the process and accordingly proposed solutions to overcome the challenges., Conclusion: This study provides insights into the challenges and solutions of the standardization from two professional groups' viewpoint. These two factors are closely related and should be considered when implementing standards since a positive perception of them increases the likelihood of successful standardization. Similarities and divergences regarding challenges and solutions of the standardization, in turn, can provide insights into how this process can be improved and deserve policy makers' attention to continue the progress.

Preparation of amniotic membrane (AM) by air drying method followed by radiation sterilization is simple and valuable approach; sterility and quality of the final AM product are depending on the quality management system at the tissue bank. Validation and substantiation of radiation sterilization dose (RSD) for tissue allografts is an essential step for the development and validation of the standard operating procedures (SOP). Application of SOP is perfectly relying on trained staff. Skills differences among personnel involved in AM preparation could have an effect on microbiological quality of the finished product and subsequently on the RSD required. AM were processed by four different couples of the tissue bank technicians. The AM grafts were randomly selected and subjected to bioburden test to validate and substantiate the 25 kGy RSD. Bioburden test for AM grafts were also useful to evaluate the skill of the tissue bank technicians and thus, to validate the current SOP for air dried AM. Moreover, the effect of placental source on bioburden counts on AM grafts was assessed. Substantiation of the 25 kGy RSD at a sterility assurance level of 10(-1), and sample item portion = 1, was carried out using Method VD max (25) of the International Organization for Standardization, document no. 11137-2 (ISO in Sterilization of healthcare products-radiation-part 2: establishing the sterilization dose, Method VDmax-substantiation of 25 kGy or 15 kGy as the sterilization dose, International Standard Organization, 2006). The results showed that there were no significant differences in the bioburdens of the four batches (α = 1 %), this means no significant differences in the skill of the four couples of the tissue bank technicians in terms of their ability to process AM according to the air dried AM SOP. The 25 kGy RSD was validated and substantiated as a valid sterilization dose for the AM prepared with the current established SOP at the Biotechnology Research Center experimental tissue bank. The donor's type of delivery, normal or caesarean, showed no significant effect on the levels of microbial counts on the tested AMs (α = 1 %).

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., (Copyright © 2014 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.)

Background: In response to the problem of erroneous readings due to miscoding when performing self-monitoring blood glucose (SMBG), this study introduces a user-friendly SMBG biosensor with an innovative auto-coding module on the meter and strip. Actual users characterized the performance of the SMBG systems., Methods: A total of 105 patients were incorporated in the study and Clarke error grid analysis (EGA) was administered to evaluate the clinical accuracy of the results obtained by the patients versus the technicians. All patients used the questionnaires to comment on the use of the auto-coding sensor., Results: In the imprecision test, the total CV of the 5 BG levels was 2.1%. In the EGA plot, the results of the auto-coding sensor were 96.2%, both lots A and B, in zone A for the patients and 99.0% and 97.1% for the technician. The paired t-test demonstrated no statistically significant difference between the patient and technician measurements. Regression analysis also demonstrated that the measurements taken by the patients agreed with those obtained using the laboratory method., Conclusions: The patients achieved satisfactory performance using the auto-coding SMBG sensor and derived similar results with both laboratory reference and operation by a technician., (Copyright © 2014 Elsevier B.V. All rights reserved.)

Objectives: To determine: (1) the accuracy of cytology scientists at assessing specimen adequacy by rapid on-site evaluation (ROSE) at fine needle aspiration (FNA) cytology collections; and (2) whether thyroid FNA with ROSE has lower inadequacy rates than non-attended FNAs., Methods: The ROSE of adequacy for 3032 specimens from 17 anatomical sites collected over a 20-month period was compared with the final report assessment of adequacy. ROSE was performed by 19 cytology scientists. The report profile for 1545 thyroid nodules with ROSE was compared with that for 1536 consecutive non-ROSE thyroid FNAs reported by the same cytopathologists during the study period., Results: ROSE was adequate in 75% (2276/3032), inadequate in 12% (366/3032) and in 13% (390/3032) no opinion was rendered. Of the 2276 cases assessed as adequate by ROSE, 2268 (99.6%) were finally reported as adequate for assessment; eight specimens had adequacy downgraded on the final report. Fifty eight per cent of cases with a ROSE assessment of inadequate were reported as adequate (212/366), whereas 93% (363/390) with no opinion rendered were reported as adequate. The overall final report adequacy rate for the 3032 specimens was 94% (2843/3032). Confirmation of a ROSE of adequacy at reporting was uniformly high amongst the 19 scientists, ranging from 98% to 100%. The inadequacy rate for thyroid FNAs with ROSE (6%) was significantly (P < 0.0001) lower than for non-ROSE thyroid FNAs (17%). A significantly (P = 0.02) higher proportion of adequate ROSE thyroid specimens was reported with abnormalities, compared with non-ROSE thyroid collections., Conclusions: Cytology scientists are highly accurate at determining specimen adequacy at ROSE for a wide range of body sites. ROSE of thyroid FNAs can significantly reduce inadequate reports., (© 2014 John Wiley & Sons Ltd.)

Objective: Immediate rapid on-site assessment (ROSA) of fine needle aspiration cytology (FNAC) specimens by biomedical scientists (BMS), the UK equivalent of cytotechnologists, or by pathologists may improve specimen quality and cellular adequacy rates for lymph node, head and neck and thyroid FNAC. The aim of this study was to evaluate the effect of introducing ROSA by BMS in an outpatient clinic setting., Methods: The adequacy rate and sensitivity of histological diagnosis for lymph node, thyroid and salivary gland FNAC samples were determined before and after the introduction of BMS ROSA. The additional financial costs and time required to perform this service were also estimated., Results: Thirty-one patients underwent ultrasound (US)-guided FNAC with ROSA and 151 without. ROSA reduced the number of FNAC insufficient in quality for diagnosis from 43% to 19% (P = 0.0194). The estimated additional cost for pathology per patient for ROSA was between £52.05 and £70.74, equivalent to €65.40/US $83.90 and €88.89/US $114.0, respectively, an increase of between 28% and 49% from the original cost. ROSA necessitated an additional 6 minutes clinic time per patient, reducing the number of patients that could be seen in an average clinic from 13 to 10 as well as requiring increased laboratory time for FNAC slide assessment., Conclusion: ROSA by suitably trained biomedical scientists and with appropriate consultant pathologist support can improve the quality of FNAC sampling for head and neck lesions. Although ROSA resulted in both additional financial and time costs, these are more than likely to be offset by a reduction in patients returning to clinic for repeat FNAC or undergoing unnecessary surgery., (© 2013 John Wiley & Sons Ltd.)

Objective: This report presents the results of a survey of the training and education of cytotechnologists (CTs) in 15 European countries and suggests guidelines on which future education should be developed., Methods: A questionnaire was sent to 25 countries in 2011: 14 with and 11 without a European Advisory Committee of Cytotechnology (EACC) member or representative. We received responses from 18 countries, among which three were excluded from the survey because they did not have CTs in training., Results: The number of fully trained and employed CTs in these 15 European countries varied from 35 to 2600. The level of responsibility for most CTs in 14 of these countries was intermediate (signing out negative and inadequate gynaecological samples), whereas seven also had a minority of CTs at an advanced level (signing out abnormal gynaecological samples). Basic education was equally divided (7/8) between countries requiring a bachelor degree or training in medical technology before entry into cytology training. The training in cytology was given as a separate course/education or a combination of separate courses and in-house training, but was often confined to gynaecological cytology. It was recognized that CTs should extend their activities with the advent of human papillomavirus (HPV) testing and vaccination. The training requirement for CTs was usually decided by the national professional society. Most cytology training programmes were accredited by academic institutions at university level and were recognized nationally in almost all of the countries. For most of the countries, the optimal education in the future should be at university level with a diploma in cytotechnology certified or accredited by the European Federation of Cytology Societies., Conclusion: The survey showed variation in basic education and cytology training, especially with respect to non-gynaecological cytology, although graduate entry was favoured. The role of CTs is changing and the education and training programmes need to adapt to these changes., (© 2014 John Wiley & Sons Ltd.)

Objectives: To discuss the role and training of cytotechnologists (CTs) in Europe, to identify areas of good practice and to provide an informed opinion to those providing guidelines for training and practice in Europe., Methods: All members of the Editorial Advisory Board of Cytopathology were invited to take part in a 'discussion forum' for which six topics were circulated in advance concerning the roles of CTs with regard to: (1) pre-screening slides; (2) 'signing out' reports; (3) carrying out ancillary techniques; (4) supervising laboratory staff; (5) taking part in rapid on-site evaluation (ROSE) of fine needle aspirates (FNAs); and (6) whether CTs were trained specifically in cytopathology or in general histopathology. Notes of the meeting were circulated by email and a final report was agreed by 22 participants from 17 predominantly European countries., Results: Training for CTs throughout Europe was variable, especially for non-gynaecological cytology, which was inconsistent with the range of activities required. The participants recommended graduate entry, preliminary training in general laboratory technology, and subsequent training to take account of the probability and, in some centres, the reality of primary cervical cancer screening changing from cytology to human papillomavirus (HPV) testing. They further recommended that CTs should perform HPV tests and take part in ROSE for FNAs, and they supported the European Federation of Cytology Societies developing guidelines for training and practice., Conclusion: With CT training added to a university-based education in laboratory or biomedical science, a career in cytotechnology should be an attractive option involving a diverse range of laboratory and clinically based activities., (© 2014 John Wiley & Sons Ltd.)

The Graft Processing subcommittee of the Worldwide Network for Blood and Marrow Transplantation wrote this guideline to assist physicians and laboratory technologists with the setting up of a cell processing laboratory (CPL) to support a hematopoietic stem cell transplant program, thereby facilitating the start-up of a transplant program in a new location and improving patient access to transplantation worldwide. This guideline describes the minimal essential features of designing such a laboratory and provides a list of equipment and supply needs and staffing recommendations. It describes the typical scope of services that a CPL is expected to perform, including product testing services, and discusses the basic principles behind the most frequent procedures. Quality management (QM) principles specific to a CPL are also discussed. References to additional guidance documents that are available worldwide to assist with QM and regulatory compliance are also provided.

Objective: To understand the current state of staff for Plasmodium microscopy examinations in Changzhou City in the early stage of eliminating malaria action, so as to provide the evidence for achieving the target of malaria elimination., Methods: The staff for Plasmodium microscopy examinations from medical institutions and centers for disease control and prevention at different levels were investigated by questionnaires and tests of the malaria related theory and microscopic operation., Results: Totally 95 people were investigated, and among them, 40.0% had college degree and 45.3% were university educated. There were 18.9% of them working on Plasmodium microscopy examinations for less than 1 year, 40.0% for 2-5 years, 18.9% for 6-10 years and 22.1% for more than 10 years. The numbers of person-time of provincial and municipal level training, district-level training, and unit-level training in the last year were 0.57, 0.59, and 0.14, respectively. Totally 18.9% of them had the experience of finding Plasmodium at work, and 97.9% of them considered it was necessary or very necessary to do Plasmodium microscopy examinations. However, 57.9% and 8.4% of them considered Plasmodium microscopy examinations increased their work load and work difficulty, respectively. The average correct rates of knowledge tests on malaria before and after training were 72.5% and 91.6% respectively (P < 0.05). The average mark of Plasmodium microscopic tests was 25.3 points (full mark being 50 points), and the passing rate (> or = 30 points) was 58.9%., Conclusion: The working experience of staff for Plasmodium microscopy examinations in Changzhou City is relatively poor, and the related training should be enhanced.

Objective: To evaluate the performance of cytotechnologists in assessing the adequacy and accuracy of the preliminary diagnosis for fine-needle aspirates of the liver., Study Design: We retrospectively analyzed 10 years of data and found 589 cases of ultrasound-guided fine-needle aspiration (FNA) of the liver with on-site evaluation of adequacy (OSEA). All the OSEA were performed by the cytopathologist because OSEA of liver FNA is not performed by cytotechnologists at our institution at present. After OSEA, the material was seen by cytotechnologists who rendered an adequacy assessment and preliminary diagnosis. We calculated the adequacy and accuracy statistics and compared the performance of the cytotechnologists with the OSEA and final interpretation., Results: There was no statistically significant difference in adequacy downgrade rate for cytotechnologist versus cytopathologist assessment during the study period (5 vs. 3%, p = 0.06). A total agreement of 88% was noted in overall diagnosis with 97% agreement in malignant cases., Conclusion: Cytotechnologists assess the adequacy of liver FNA accurately and there is therefore potential for them to perform OSEA for liver FNA., (© 2014 S. Karger AG, Basel.)

Background: Phlebotomy performed with poor adherence to venous blood specimen collection (VBSC) guidelines jeopardizes patient safety and may lead to patient suffering and adverse events. A first questionnaire study demonstrated low compliance to VBSC guidelines, motivating an educational intervention of all phlebotomists within a county council. The aim was to evaluate the impact of a large-scale educational intervention program (EIP) on primary health care phlebotomists' adherence to VBSC guidelines. We hypothesised that the EIP would improve phlebotomists' VBSC practical performance., Methods: The present study comprise primary health care centres (n = 61) from two county councils in northern Sweden. The final selected study group consisted of phlebotomists divided into an intervention group (n = 84) and a corresponding control group (n = 79). Both groups responded to a validated self-reported VBSC questionnaire twice. The EIP included three parts: guideline studies, an oral presentation, and an examination. Non-parametric statistics were used for comparison within and between the groups., Results: Evaluating the EIP, we found significant improvements in the intervention group compared to the control group on self-reported questionnaire responses regarding information search (ES = 0.23-0.33, p < 0.001-0.003), and patient rest prior to phlebotomy (ES = 0.27, p = 0.004). Test request management, patient identity control, release of venous stasis, and test tube labelling had significantly improved in the intervention group but did not significantly differ from the control group (ES = 0.22- 0.49, p = < 0.001- 0.006). The control group showed no significant improvements at all (ES = 0-0.39, p = 0.016-0.961)., Conclusions: The present study demonstrated several significant improvements on phlebotomists' adherence to VBSC practices. Still, guideline adherence improvement to several crucial phlebotomy practices is needed. We cannot conclude that the improvements are solely due to the EIP and suggest future efforts to improve VBSC. The program should provide time for reflections and discussions. Furthermore, a modular structure would allow directed educational intervention based on the specific VBSC guideline flaws existing at a specific unit. Such an approach is probably more effective at improving and sustaining adherence to VBSC guidelines than an EIP containing general pre-analytical practices.

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.)

As far as molecular biology is concerned, numerous are laboratories using in-house method. Used since many years, medical biologists have often a good practical knowledge about them. According to ISO 15189 accreditation, is this knowledge sufficient for the validation of these methods? We have asked this question ourselves about our in-house Leishmaniasis PCR.

Aims: The advanced specialist diploma in ophthalmic pathology was jointly ratified by the Royal College of Pathologists and the Institute of Biomedical Science in 2008. It results in extended roles for suitably qualified Biomedical Scientists (BMSs) in ophthalmic pathology specimen dissection and histological reporting of selected specimens, specifically non-neoplastic corneas. This study aimed to examine the reporting of corneal histology by a BMS training towards this diploma in comparison with a Consultant Ophthalmic Pathologist., Methods: This report covers a non-interventional, prospective examination of BMS's diagnostic skills. After 6 months training, 50 consecutive corneal cases were reported by the BMS and the same case reported by the consultant ophthalmic pathologist. The BMS's diagnosis was compared with the final consultant's diagnosis. This exercise was then repeated after 24 months of training., Results: After 6 months, the BMS's diagnoses matched the consultant diagnoses in 44/50 (88%) cases. After 24 months, the BMS's diagnoses matched the consultant diagnoses in 48/50 (96%) of cases., Conclusions: The results indicate that BMS's reporting of corneal histology is a real and safe possibility. Furthermore, it indicated deficiencies in BMS's diagnostic skills to inform further training/knowledge acquisition.

Introduction: Image-guided fine needle aspiration (FNA) of the musculoskeletal system is expensive to perform and repeat, so on-site evaluation of adequacy (OSEA) is increasingly used to ensure an optimal sample. Metastatic disease to the musculoskeletal system is not uncommon and often requires OSEA when sampled. At large academic centers, cytotechnologists have filled the increased demand for OSEA. However, the performance of cytotechnologists has not been compared with that of cytopathologists for OSEA in FNA of metastatic disease involving bone and soft tissue., Methods: We retrospectively analyzed 10 years of data in which both cytotechnologists and cytopathologists performed OSEA for 1,995 FNAs of bone and soft tissue sites in which metastatic malignancy was suspected or found. We calculated adequacy and accuracy statistics in conjunction with other variables including imaging modality, biopsy site, accompanying core biopsy, tissue type, final diagnosis, and number of smears., Results: A total of 1,995 aspirates of metastatic disease carcinoma, melanoma or lymphoma to bone or soft tissue had OSEA performed by cytotechnologists (681, 33.7%) or cytopathologists (1,314, 66.3%). The adequacy downgrade rate was statistically equivalent (4.1 vs. 3.6%; p = 0.64)., Conclusion: Cytotechnologists and cytopathologists perform with reasonable equivalence at OSEA of aspirates from metastatic carcinoma, melanoma or lymphoma involving bone or soft tissue.