Search

Objectives: With the exception of states that require licensure, there is no uniform requirement for certification or for education from the National Accrediting Agency for Clinical Laboratory Science (NAACLS) accredited laboratory science program for employment in a laboratory, under the Clinical Laboratory Improvement Amendments (CLIA) of 1988. The objective of the Value of Education and Certification (VEC) study was to determine if lack of NAACLS-accredited education and Medical Laboratory Technician (MLT)/Medical Laboratory Scientist (MLS) certification was associated with laboratory errors., Methods: This cross-sectional study used personnel and testing/reporting error data from 739 laboratorians, involving five laboratory partners., Results: MLS-certified individuals were 33% less likely to make errors (p=0.0473) and MLT-certified individuals were 71% less likely to make errors (p=0.0014) compared to those who were not certified. MLS-certified laboratorians were twice as likely to make testing/reporting errors compared to those who were MLT certified, which was significant (p=0.0238). Education level and accredited laboratory education were not associated with testing/reporting errors., Conclusion: Our data suggest that lack of MLS and MLT certification are independently associated with laboratory testing/reporting errors.

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).)

Background: Although there are concerns that inadequate breast positioning in mammographic examinations may lead to cancers being missed, few studies have examined the quality of breast positioning, especially in the Canadian context. Our objective was to assess the quality of breast positioning in mammographic examinations in a Quebec-wide representative sample of technologists., Methods: This quality improvement study was part of a professional inspection launched by the Ordre des technologues en imagerie médicale, en radio-oncologie et en électrophysiologie médicale du Québec among its members. The inspection was conducted between May and July 2017 on a proportionate stratified random sample of all active technologists certified in mammography in Quebec. Each technologist provided images from 15 consecutive mammographic examinations they performed in the previous 6 months. The quality of positioning was then evaluated by senior technologists using a quality assessment tool specifically developed for this inspection. A technologist was deemed to have failed the professional inspection when at least 7 of the 15 mammographic examinations were scored as critical failures. Proportions were calculated accounting for sampling weights and correction for finite population., Results: Among the 520 technologists certified in mammography in Quebec, 76 technologists (14.6%) were randomly selected for the professional inspection and contributed images from 1127 mammographic examinations. Thirty-eight technologists (weighted percentage 50.3%, 95% confidence interval [CI] 37.6% to 63.0%) failed the professional inspection. Overall, 492 mammographic examinations (43.7%, 95% CI 38.6% to 48.8%) had at least 1 image scored as a critical failure., Interpretation: Half of the technologists performing mammographic examinations in Quebec who participated in this study failed the inspection, and a substantial proportion of their mammographic examinations demonstrated critical failures in breast positioning. Overall, our findings are concordant with those of previous studies and highlight the need for additional investigations assessing the quality of breast positioning in mammographic examinations in other jurisdictions., Competing Interests: Competing interests: Julie Rouette has received consulting fees from Biogen for work unrelated to this study. Nathaniel Bouganim has received consulting fees from Amgen, Novartis and Roche for work unrelated to this study. Nathaniel Lasry is a shareholder of iMD Research, which received a contract to assist with the design of the professional inspection of technologists from the Ordre des technologues en imagerie médicale, en radio-oncologie et en électrophysiologie médicale du Québec. Laurent Azoulay has received consulting fees from Janssen and Pfizer for work unrelated to this study. No other competing interests were declared., (© 2021 CMA Joule Inc. or its licensors.)

Background: The coronavirus disease 2019 (COVID 19) is a zoonotic viral infection that originated in Wuhan, China, in December 2019. It was declared a pandemic by the World Health Organization shortly thereafter. This pandemic is going to have a lasting impact on the functioning of pathology laboratories due to the frequent handling of potentially infectious samples by the laboratory personnel. To deal with this unprecedented situation, various national and international guidelines have been put forward outlining the precautions to be taken during sample processing from a potentially infectious patient., Purpose: Most of these guidelines are centered around laboratories that are a part of designated COVID 19 hospitals. However, proper protocols need to be in place in all laboratories, irrespective of whether they are a part of COVID 19 hospital or not as this would greatly reduce the risk of exposure of laboratory/hospital personnel. As part of a laboratory associated with a rural cancer hospital which is not a dedicated COVID 19 hospital, we aim to present our institute's experience in handling pathology specimens during the COVID 19 era., Conclusion: We hope this will address the concerns of small to medium sized laboratories and help them build an effective strategy required for protecting the laboratory personnel from risk of exposure and also ensure smooth and optimum functioning of the laboratory services., Competing Interests: None

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: An audit aims to verify conformance to required processes, assess their implementation, and define the targets of quality control., Aims: To evaluate preanalytic and analytic phases of surgical histopathology in a tertiary healthcare center., Setting and Design: An observational retrospective and prospective study over 3 months each of year 2013 and 2014., Materials and Methods: Biopsy, small resections, large organ resections, bone marrow aspirate/biopsy (BMA/BMB), and frozen section samples received in surgical histopathology were categorized as I to V, respectively. A manual audit was done for preanalytical phase (adequacy of clinical information and grossing adequacy) and analytical phase [turnaround time (TAT) and tissue section quality]., Statistical Analysis: Qualitative data was assessed by Chi-Square test. Quantitative data was assessed using One-Way Analysis of Variance., Results: Among 3179 total cases, category I to V had 1558 (49%), 1099 (34.6%), 342 (10.8%), 124 (3.8%), and 56 (1.8%) cases, respectively. Category I had shortest TAT but maximum number of inadequately sent specimens and recuts. Category III had maximum cases with inadequate clinical history, grossing errors, additional sections, and longest TAT. Category IV had maximum cases with poor quality sections. Category V had maximum cases with inadequate demographic details and clinical investigations. BMB (114, 91.9%) was more useful than BMA for diagnosis. Mean TAT for fixed tissues and frozen tissues was 3.6 ± 1.8 days and 26.6 ± 11.2 min, respectively., Conclusions: Total 25% of annual workload was studied by an observational, manual audit. Quality indicators were achieved as per international norms despite limited resources. Remedial actions were suggested for technicians, clinicians, and pathologists to minimize errors., Competing Interests: None

The coronavirus disease (COVID-19) pandemic has placed the clinical laboratory and testing for SARS-CoV-2 front and center in the worldwide discussion of how to end the outbreak. Clinical laboratories have responded by developing, validating, and implementing a variety of molecular and serologic assays to test for SARS-CoV-2 infection. This has played an essential role in identifying cases, informing isolation decisions, and helping to curb the spread of disease. However, as the demand for COVID-19 testing has increased, laboratory professionals have faced a growing list of challenges, uncertainties, and, in some situations, controversy, as they have attempted to balance the need for increasing test capacity with maintaining a high-quality laboratory operation. The emergence of this new viral pathogen has raised unique diagnostic questions for which there have not always been straightforward answers. In this commentary, the author addresses several areas of current debate, including (i) the role of molecular assays in defining the duration of isolation/quarantine, (ii) whether the PCR cycle threshold value should be included on patient reports, (iii) if specimen pooling and testing by research staff represent acceptable solutions to expand screening, and (iv) whether testing a large percentage of the population is feasible and represents a viable strategy to end the pandemic., (Copyright © 2020 American Society for Microbiology.)

Background: During COVID-19 lockdown, non-urgent medical procedures were suspended. Grade of urgency of electroencephalography (EEG) may vary according to the clinical indication, setting, and status of infection of SARS-CoV-2 virus. "Italian Society of Clinical Neurophysiology" (SINC), "Italian League Against Epilepsy" (LICE), and the "Italian Association of Neurophysiology Technologists" (AITN) aimed to provide clinical and technical recommendation for EEG indications and recording standards in this pandemic era., Methods: Presidents of SINC, LICE, and AITN endorsed three members per each society to formulate recommendations: classification of the degree of urgency of EEG clinical indications, management and behavior of physicians and neurophysiology technologists, hygiene and personal protection standards, and use of technical equipment., Results: Scientific societies endorsed a paper conveying the recommendation for EEG execution in accordance with clinical urgency, setting (inpatients/outpatients), status of SARS-CoV-2 virus infection (positive, negative and uncertain), and phase of governmental restrictions (phase 1 and 2). Briefly, in phase 1, EEG was recommended only for those acute/subacute neurological symptoms where EEG is necessary for diagnosis, prognosis, or therapy. Outpatient examinations should be avoided in phase 1, while they should be recommended in urgent cases in phase 2 when they could prevent an emergency room access. Reduction of staff contacts must be encouraged through rescheduling job shifts. The use of disposable electrodes and dedicated EEG devices for COVID-19-positive patients are recommended., Conclusions: During the different phases of COVID-19 pandemic, the EEG should be reserved for patients really benefiting from its execution in terms of diagnosis, treatment, prognosis, and avoidance of emergency room access.

Introduction: Telecytology using real-time microscopy has gained popularity for rapid on-site evaluations (ROSE). Although proficiency testing is routinely used in cytopathology, no established means of competency assessment is currently available for telecytology. Our aim was to determine the feasibility of a dynamic (real-time) platform to assess telecytology competency., Methods: Remote Medical Technology dynamic (real-time) video streaming platform for ROSE is used at our institution, and short video clips of telecytology cases were recorded using Camtasia Studio 8 software during different ROSE sessions. Selected MP4 videos (range 13-88 seconds, mean 33 seconds), along with clinical histories, were used to build a multiple-choice question test with one training case and 20 test cases, utilising Tutor (Philips) software to host the web-based test. The test was voluntary for cytopathologists and cytotechnologists. Answers and feedback from test takers were analysed., Results: Thirteen participants-four cytopathologists and nine cytotechnologists-previously trained to use telecytology, volunteered to take the test. Individual scores ranged from 10 (50%) to 19 (95%) with a median of 16 (80%). Most feedback received involved technical difficulties., Conclusions: We present, to the best of our knowledge, the first tool to assess telecytology competency for ROSE using pre-recorded dynamic streaming videos. Despite technical challenges related to incorporating videos into a web-based test, the test was feasible and provided users with valuable feedback about their ROSE performance. Future effort will be devoted to establishing a more user-friendly test platform and establishing a benchmark for passing scores., (© 2020 John Wiley & Sons Ltd.)

In response to the recent COVID-19 pandemic, many laboratories are involved in research supporting SARS-CoV-2 vaccine development and clinical trials. Flow cytometry laboratories will be responsible for a large part of this effort by sorting unfixed antigen-specific lymphocytes. Therefore, it is critical and timely that we have an understanding of risk assessment and established procedures of infectious cell sorting. Here we present procedures covering the biosafety aspects of sorting unfixed SARS-CoV-2-infected cells and other infectious agents of similar risk level. These procedures follow the ISAC Biosafety Committee guidelines and were recently approved by the National Institutes of Health Institutional Biosafety Committee for sorting SARS-CoV-2-infected cells. © 2020 International Society for Advancement of Cytometry., (© 2020 International Society for Advancement of Cytometry.)

At the end of February, the Italian National Health Service reported a hot spot of Coronavirus disease in the Lombardy region. COVID-19 is a highly pathogenic viral infection which poses some challenges for healthcare workers. Indeed, Pathology Departments are involved in reorganizing samples' management, from their delivery until their processing, according to National and WHO guidelines. Since Lombardy has been declared COVID-19 hot spot, due to decreasing number of surgical procedures, our Department adopted a policy to reduce personnel, allowing pathologists to work remotely during the outbreak. Lacking clear information about viral load on tissue samples, all human specimens must be considered potentially infectious, as well as patients during post-mortem examinations, and clinical information on COVID-19 status is mandatory. It is also important that Pathology staff receive an adequate training, and adherence to rules should be always accompanied by common sense., (Copyright © 2020 Cieri, De Carlo, Valeri, Belsito, Lancellotti, Roncalli and Colombo.)

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.

Owing to a persistently high blood culture contamination rate of 3.2% exceeding the target rate of <3%, a midwestern United States hospital began a series of 3 additive interventions. After collecting phlebotomist data for approximately 3 months, reporting of individual contamination rates commenced. A specialized trainer reeducated staff with high rates, which resulted in a modest decrease in contamination rates (3.2% to 2.8%, P = 0.23). A second, additional intervention requiring phlebotomists to wear hair nets and face masks resulted in marked improvement from a mean of 2.8% to 1.1% (P < .0001). In a final, third addition, whenever possible, the replacement of nursing staff by phlebotomy staff for blood specimen collection did not result in a significant change in mean contamination (P = 0.81). Overall, the mean contamination rate progressively declined in a stepwise manner from 3.2% to 1.2% (P = .0013), with the greatest decline after adding hair nets and face masks., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Specialists of human genetic diagnostics can be divided into four groups: Medical Geneticists (MDG), Genetic Nurses and/or Counsellors (GN/GC), Clinical Laboratory Geneticists (CLG) and Laboratory Genetics Technicians (LGT). While the first two groups are in direct patient contact, the work of the latter two, of equal importance for patient care, are often hidden as they work behind the scenes. Herein the first study on the rights and duties of CLGs is presented. We present the results of a survey performed in 35 European and 18 non-European countries with 100 participating specialists. A national CLG title is available in 60% of European countries, and in 77% of the surveyed European countries a CLG can be the main responsible head of the laboratory performing human genetic tests. However, in only 20% of European countries is a lab-report valid with only a CLGs' signature - even though the report is almost always formulated by the CLG, and an interpretation of the obtained results in a clinical context by the CLG is expected in nearly 90% of European countries. Interestingly, CLGs see patients in 30% of European countries, and are also regularly involved in student education. Overall, the CLG profession includes numerous duties, which are quite similar in all regions of the world. Strikingly, the CLG's rights and responsibilities of leading a lab, or signing a report are regulated differently according to country specific regulations. Overall, the CLG is a well-recognized profession worldwide and often working within a multidisciplinary team of human genetic diagnostics professionals.

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.

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

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.)

Introduction: Bone marrow biopsy (BMB) is crucial for the diagnosis, staging, and monitoring of a variety of hematologic diseases. Obtaining an adequate BMB can be challenging given the need to balance patient comfort with acquisition of high quality specimens. We had observed variable BMB quality at our institution with poor quality specimens sometimes affecting diagnosis. We thus undertook this quality improvement (QI) project to improve the quality of diagnostic BMB specimens., Methods: We used an A3 QI process to identify factors possibly influencing BMB quality. We collected baseline data on 211 BMB, with short and long-term follow-up data on a further 382 cases. We used clinical conferences to discuss data, perform peer comparisons and identify strategies to create a sustainable improvement in BMB quality., Results: Baseline data showed that BMB length was influenced most by the individual performer, with some influence of needle gauge. Other factors such as sedation, BMB indication were noncontributory. BMB lengths improved following performer education and individual performer data comparisons (15.2 mm post vs 12.8 mm baseline, P < .0001) and with use of an 8- rather than 11-gauge needle (18.3 mm 8-gauge vs 13.3 mm 11-gauge P < .0001), and were sustained over the long term., Conclusions: Education on BMB standards, sharing of performer data, and changing needle gauge are relatively straightforward methods to improve BMB quality, leading to easier pathology diagnosis., (© 2018 John Wiley & Sons Ltd.)

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.)

Our mostly manual, agar-based clinical microbiology laboratory is slowly but steadily being redefined by automation and innovation. Ironically, the oldest test, the Gram stain test, is still manually read and interpreted by trained personnel. In a proof-of-concept study, Smith et al. (J. Clin. Microbiol. 56:e01521-17, 2018, https://doi.org/10.1128/JCM.01521-17) used computer imaging with a deep convolutional neural network to examine and interpret Gram-stained slides from positive blood culture bottles. In light of the shortage of medical technologists/microbiologists and the need for results from positive blood culture bottles 24/7, this paper paves the way for the next innovations for the clinical microbiology laboratory of the future., (Copyright © 2018 American Society for Microbiology.)

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.)

The inherent risk involved in the provision of healthcare services leads to the inevitable requirement of health human resource oversight to protect the public from harm (Bayne 2012). As healthcare systems evolve, so do theoretical models for, and practical applications of, health human resource oversight policy and processes. The College of Medical Laboratory Technologists of Ontario (CMLTO), as one of 26 health regulatory bodies in Ontario, implements programs or processes to enact and support changes in the knowledge, skill and judgment of their members. Determining what healthcare trends are affecting different healthcare professions and professionals, and how a regulatory institution, with a very specific mandate prescribed by government legislation, can enable necessary changes is explored in this paper through a case study of the CMLTO's journey to redefine "professionalism" and enable evolving practices of medical laboratory technologists (MLTs). A brief overview of health professional regulation, explored through a functional taxonomy, provides a contextual foundation to the CMLTO's journey to redefine professionalism. This approach also enables a discussion of the "sharpening" of certain regulatory approaches, that is, that opportunities to improve regulatory approaches are revealed via public feedback and modifications are made to rectify the historic experiences of the public. As the role of regulatory institutions continues to evolve to include a more prominent focus on proactive approaches to regulation, the ability to enable and support healthcare practitioners to respond to changes in the healthcare system becomes increasingly important. The case of the CMLTO's journey to redefine professionalism highlights an opportunity for a profession, and indeed its professionals, to evolve their culture to contribute their unique value to the healthcare system in response to system-level trends.

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.

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

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

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.)

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 %).