Challenges and Controversies to Testing for COVID-19.

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.

Procedures for Flow Cytometry-Based Sorting of Unfixed Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infected Cells and Other Infectious Agents.

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.

Electroencephalography during SARS-CoV-2 outbreak: practical recommendations from the task force of the Italian Society of Neurophysiology (SINC), the Italian League Against Epilepsy (LICE), and the Italian Association of Neurophysiology Technologists (AITN).

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.

Assessing competency for remote telecytology rapid on-site evaluation using pre-recorded dynamic video streaming.

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.

Improvement of blood culture contamination rate, blood volume, and true positive rate after introducing a dedicated phlebotomy team.

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.

Assessment of Quality of Medical Laboratory Services Provision and Associated Factors in Public Health Facilities at Gondar Town, Amhara Regional State, Northwest Ethiopia.

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.

Waltzing around Sacred Cows on the Way to the Future.

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.

Skin marker placement by technologist prior to knee MRI helps identify clinically relevant pathologies.

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.

Competency assessment in laboratory medicine: Standardization and utility for technical staff assessment and recertification in Saudi Arabia.

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.

[Qualification System for BLS -Domestically and Internationally-].

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].

[Education and Career Development of Laboratory Personnel through Qualification System of Molecular Analysis Technologist and Specialist}.

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].

[Education and Training of Personnel in Morphology].

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.

'By the work, one knows the workman': the practice and profession of the embryologist and its translation to quality in the embryology laboratory.

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.

[Authorized Qualifications of Staff Conducting Examinations in the Field of Clinical Microbiology].

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.

Rapid on-site evaluation of fine needle aspiration specimens by cytology scientists: a review of 3032 specimens.

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.

Training and practice of cytotechnologists: a discussion forum focused on Europe.

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.

Survey of training and education of cytotechnologists in Europe.

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.

Rapid on-site assessment of specimens by biomedical scientists improves the quality of head and neck fine needle aspiration cytology.

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.

Substantiation of 25 kGy radiation sterilization dose for banked air dried amniotic membrane and evaluation of personnel skill in influencing finished product bioburden.

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 %).

Association of Laboratory Science Education and Certification with Laboratory Errors: The Value of Education and Certification Study.

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.