What is the scope of teaching and training of undergraduate students and trainees in point of care testing in United Kingdom universities and hospital laboratories?

Point of care testing (POCT) is an analytical test performed by a healthcare professional outside of a conventional laboratory. The global POCT market was valued at US$ 23.16 billion in 2016 and is forecasted to grow to US$ 36.96 billion in 2021. This upward trend for POCT has increased workload for pathology departments who manage POCT. This research aims to characterize and analyse the teaching and training of POCT at United Kingdom (UK) universities on Institute of Biomedical Science (IBMS) accredited biomedical science degrees, and at UK hospital laboratories. A freedom of information (FOI) request was sent in 2018 to all 52 UK universities with an accredited IBMS Biomedical science degree to request information on teaching of POCT, with a 100% response rate. Further FOI requests were sent to all National Health Service (NHS) hospital pathology departments in the UK, regarding POCT training provided to trainee Biomedical scientists, with a 97% response rate. Twelve of the degrees contained no POCT teaching, with a further 9 having no specific POCT teaching. Sixty-six laboratories confirmed that there was no POCT training. The university teaching hours varied between 0 and 35 hours. The median time spent teaching POCT at university was 2 hours. The laboratory teaching hours varied between 0 and 450 hours The median time spent teaching POCT in hospital laboratories was 3 hours. A content analysis of the learning outcomes provided by 29 universities showed that only 61% (84/137) were measurable and 26% (36/137) of the learning outcomes used action verbs that have previously been listed to be avoided in learning outcome writing. Only 9% (13/137) of outcomes specifically described POCT, with 8 of these being measurable. The findings demonstrate that although this is a commonly required skill for biomedical scientists, there is a clear lack of POCT teaching and training in the UK. To meet the new Quality Assurance Agency for Higher Education (QAA) guidelines, but most importantly to ensure the workforce is fit for the needs of the current healthcare system, the quality and quantity of POCT teaching and training needs to improve.

Benchmarking medical laboratory performance: survey validation and results for Europe, Middle East, and Africa.

OBJECTIVES: Medical laboratory performance is a relative concept, as are quality and safety in medicine. Therefore, repetitive benchmarking appears to be essential for sustainable improvement in health care. The general idea in this approach is to establish a reference level, upon which improvement may be strived for and quantified. While the laboratory community traditionally is highly aware of the need for laboratory performance and public scrutiny is more intense than ever due to the SARS-CoV-2 pandemic, few initiatives span the globe. The aim of this study was to establish a good practice approach towards benchmarking on a high abstraction level for three key dimensions of medical laboratory performance, generate a tentative snapshot of the current state of the art in the region of Europe, Middle East, and Africa (EMEA), and thus set the stage for global follow-up studies. METHODS: The questionnaire used and previously published in this initiative consisted of 50 items, roughly half relating to laboratory operations in general with the other half addressing more specific topics. An international sample of laboratories from EMEA was approached to elicit high fidelity responses with the help of trained professionals. Individual item results were analyzed using standard descriptive statistics. Dimensional reduction of specific items was performed using exploratory factor analysis and assessed with confirmatory factor analysis, resulting in individual laboratory scores for the three subscales of "Operational performance", "Integrated clinical care performance", and "Financial sustainability". RESULTS: Altogether, 773 laboratories participated in the survey, of which 484 were government hospital laboratories, 129 private hospital laboratories, 146 commercial laboratories, and 14 were other types of laboratories (e.g. research laboratories). Respondents indicated the need for digitalization (e.g. use of IT for order management, auto-validation), automation (e.g. pre-analytics, automated sample transportation), and establishment of formal quality management systems (e.g. ISO 15189, ISO 9001) as well as sustainably embedding them in the fabric of laboratory operations. Considerable room for growth also exists for services provided to physicians, such as "Diagnostic pathways guidance", "Proactive consultation on complex cases", and "Real time decision support" which were provided by less than two thirds of laboratories. Concordantly, the most important kind of turn-around time (TAT) for clinicians, sample-to-result TAT, was monitored by only 40% of respondents. CONCLUSIONS: Altogether, the need for stronger integration of laboratories into the clinical care process became apparent and should be a main trajectory of future laboratory management. Factor analysis confirmed the theoretical constructs of the questionnaire design phase, resulting in a reasonably valid tool for further benchmarking activities on the three aimed-for key dimensions.

It is time for open access in clinical care.

A healthcare center widely sharing its internal guidelines on how to treat COVID-19 patients "just wasn't done." As the pandemic raged at a Boston hospital, the next generation of clinical leaders pushed for change.

[POCT-management during the first wave of Covid-19 in France. Results of a national survey leaded by the SFBC-POCT Working Group]. / Gestion de la biologie délocalisée lors de la première vague de Covid-19 en France. Résultats de l'enquête nationale menée par le groupe de travail des EBMD de la SFBC.

During the first wave of Covid-19 in France, in spring 2020, healthcare institution's laboratory had to adapt itself quickly to the growing demand for emergency biology, in particular by reorganizing their POCT analyzers: redeployment of analyzers and/or new installations. In order to analyze this management, a subgroup of 15 hospital biologists from the SFBC Working Group "Biochemical markers of Covid-19" sent, in fall 2020, an on-line survey to French hospital laboratories using POCT. Answers analysis (n = 86) shows a territorial disparity related to the severity of the first wave: increased activity essentially in red zones, management of unexpected situations, training of additional nursing staff for 40 % of the laboratories... The survey also showed simplification of aspects related to accreditation those periods of health crisis. An additional survey, carried out in the spring of 2021, showed good overall satisfaction of the healthcare services (n = 139) concerning the services provided by biology in the POCT sector. Because of their great adaptation capacity, the laboratories and their POCT-teams have played a key role in the management of the first wave of Covid-19 in France. However, the success of these organizations requires an essential collaboration between laboratories and healthcare services. The results of this survey are fundamental in the context of the prolongation of the pandemia throughout the world with a POCT sector appearing to be growing.

Extended storage of SARS-CoV-2 nasopharyngeal swabs does not negatively impact results of molecular-based testing across three clinical platforms.

With the global outbreak of COVID-19, the demand for testing rapidly increased and quickly exceeded the testing capacities of many laboratories. Clinical tests which receive CE (Conformité Européenne) and Food and Drug Administration (FDA) authorisations cannot always be tested thoroughly in a real-world environment. Here we demonstrate the long-term stability of nasopharyngeal swab specimens for SARS-CoV-2 molecular testing across three assays recently approved by the US FDA under Emergency Use Authorization. This study demonstrates that nasopharyngeal swab specimens can be stored under refrigeration or even ambient conditions for 21 days without clinically impacting the results of the real-time reverse transcriptase-PCR testing.

Influenza surveillance case definitions miss a substantial proportion of older adults hospitalized with laboratory-confirmed influenza: A report from the Canadian Immunization Research Network (CIRN) Serious Outcomes Surveillance (SOS) Network.

OBJECTIVE: Older adults often have atypical presentation of illness and are particularly vulnerable to influenza and its sequelae, making the validity of influenza case definitions particularly relevant. We sought to assess the performance of influenza-like illness (ILI) and severe acute respiratory illness (SARI) criteria in hospitalized older adults. DESIGN: Prospective cohort study. SETTING: The Serious Outcomes Surveillance Network of the Canadian Immunization Research Network undertakes active surveillance for influenza among hospitalized adults. METHODS: Data were pooled from 3 influenza seasons: 2011/12, 2012/13, and 2013/14. The ILI and SARI criteria were defined clinically, and influenza was laboratory confirmed. Frailty was measured using a validated frailty index. RESULTS: Of 11,379 adult inpatients (7,254 aged ≥65 years), 4,942 (2,948 aged ≥65 years) had laboratory-confirmed influenza. Their median age was 72 years (interquartile range [IQR], 58-82) and 52.6% were women. The sensitivity of ILI criteria was 51.1% (95% confidence interval [CI], 49.6-52.6) for younger adults versus 44.6% (95% CI, 43.6-45.8) for older adults. SARI criteria were met by 64.1% (95% CI, 62.7-65.6) of younger adults versus 57.1% (95% CI, 55.9-58.2) of older adults with laboratory-confirmed influenza. Patients with influenza who were prefrail or frail were less likely to meet ILI and SARI case definitions. CONCLUSIONS: A substantial proportion of older adults, particularly those who are frail, are missed by standard ILI and SARI case definitions. Surveillance using these case definitions is biased toward identifying younger cases, and does not capture the true burden of influenza. Because of the substantial fraction of cases missed, surveillance definitions should not be used to guide diagnosis and clinical management of influenza.

Validation of GeneXpert testing for SARS-CoV-2 RNA in eight hospital laboratories in Oman.

In response to the current COVID-19 pandemic, numerous commercial assays have been developed for the detection of SARS-CoV-2 for use in the clinical diagnostic laboratories. To date, there is limited comparison of testing methods performed in different hospital laboratory sites. The aims of the study were to evaluate the analytical performance of Cepheid Xpert Xpress SARS-CoV-2 when compared to RT-PCR. This is a cross-sectional study. A total of 155 nasopharyngeal swabs were taken in duplicate from patients presenting with suspected COVID-19 to 8 hospitals in Oman. One swab was tested by the hospital laboratory and the duplicate swab was sent to the national Central Public Health Laboratory (CPHL) for testing. We compared the analytical performance of the commercially available point of care Cepheid Xpert Xpress SARS-CoV-2 assay which was used in the 8 different hospitals with assays including Liferiver, Sansure, TIB MOL BIOL, Kingfisher and COBAS 6800 by Roche which were performed at the CPHL. Testing of the duplicate swabs revealed excellent agreement of results with the viral loads of Ct values ranging from 16-43 for the E gene, 18-44 for the N gene and 17-44 for the ORF gene using the Liferiver assay. The overall sample sensitivity and specificity of the Cepheid Xpert Xpress SARS-CoV-2 assay were both 100% and there was 100% agreement across specimens. We conclude that the rapid GeneXpert and RT-PCR kits assessed in this study may be used for routine diagnostic testing of COVID-19 patients by experienced clinical microbiology diagnostic laboratories. Our results highlight the importance of rapid molecular testing at different sites within a country in a public health emergency.

Behind Every Great Infection Prevention Program is a Great Microbiology Laboratory: Key Components and Strategies for an Effective Partnership.

A great clinical microbiology laboratory supporting a great infection prevention program requires focusing on the following services: rapid and accurate identification of pathogens associated with health care-associated infections; asymptomatic surveillance for health care-acquired pathogens before infections arise; routine use of broad and flexible antimicrobial susceptibility testing to direct optimal therapy; implementation of epidemiologic tracking tools to identify outbreaks; development of clear result communication with interpretative comments for clinicians. These goals are best realized in a collaborative relationship with the infection prevention program so that both can benefit from the shared priorities of providing the best patient care.

The response of total testing process in clinical laboratory medicine to COVID-19pandemic.

INTRODUCTION: Following a pandemic, laboratory medicine is vulnerable to laboratory errors due to the stressful and high workloads. We aimed to examine how laboratory errors may arise from factors, e.g., flexible working order, staff displacement, changes in the number of tests, and samples will reflect on the total test process (TTP) during the pandemic period. MATERIALS AND METHODS: In 12 months, 6 months before and during the pandemic, laboratory errors were assessed via quality indicators (QIs) related to TTP phases. QIs were grouped as pre-, intra- and postanalytical. The results of QIs were expressed in defect percentages and sigma, evaluated with 3 levels of performance quality: 25th, 50th and 75th percentile values. RESULTS: When the pre- and during pandemic periods were compared, the sigma value of the samples not received was significantly lower in pre-pandemic group than during pandemic group (4.7σ vs. 5.4σ, P = 0.003). The sigma values of samples transported inappropriately and haemolysed samples were significantly higher in pre-pandemic period than during pandemic (5.0σ vs. 4.9σ, 4.3σ vs. 4.1σ; P = 0.046 and P = 0.044, respectively). Sigma value of tests with inappropriate IQC performances was lower during pandemic compared to the pre-pandemic period (3.3σ vs. 3.2σ, P = 0.081). Sigma value of the reports delivered outside the specified time was higher during pandemic than pre-pandemic period (3.0σ vs. 3.1σ, P = 0.030). CONCLUSION: In all TTP phases, some quality indicators improved while others regressed during the pandemic period. It was observed that preanalytical phase was affected more by the pandemic.

Laboratory professionals' attitudes towards ISO 15189:2012 accreditation: an anonymous survey of three Croatian accredited medical laboratories.

INTRODUCTION: Effective implementation and continual compliance with ISO 15189:2012 require ongoing commitment and active involvement of laboratory staff. Our aim was to assess attitudes regarding accreditation implementation by conducting a survey in three Croatian accredited medical laboratories. MATERIALS AND METHODS: An anonymous survey consisting of 34 questions was distributed either electronically or in a paper form a week prior to scheduled annual audits. Distributions of answers regarding age, work experience, laboratory workplace, and education level and according to the respective laboratory were compared. RESULTS: The overall response rate was 76% (225/297). Preference towards working in an accredited laboratory and a positive attitude were revealed by 70% and 56% participants, respectively, with better process documentation as the main advantage. Only 14% of responders considered themselves completely familiar with ISO 15189:2012. Total of 68% of responders felt that accreditation increases the usual workload, with excessive paperwork as the main contributor. Half of the responders declared partial agreement that accreditation requirements and expectations were clearly explained and claimed that their suggestions were taken into account only occasionally, which was especially emphasized by technical staff. The vast majority (89%) completely follow the prescribed protocols. Only 27% consider turnaround time monitoring useful. Competence assessment is considered efficient by 41% of responders. The majority (73%) prefer an online audit in times of COVID-19. CONCLUSIONS: Despite an overall positive attitude towards accreditation, further efforts are needed in providing better education about ISO 15189:2012 for technical staff and modifying formats of competence assessment, in order to achieve better adherence to ISO 15189:2012 requirements.

The rise in preanalytical errors during COVID-19 pandemic.

INTRODUCTION: The COVID-19 pandemic has posed several challenges to clinical laboratories across the globe. Amidst the outbreak, errors occurring in the preanalytical phase of sample collection, transport and processing, can further lead to undesirable clinical consequences. Thus, this study was designed with the following objectives: (i) to determine and compare the blood specimen rejection rate of a clinical laboratory and (ii) to characterise and compare the types of preanalytical errors between the pre-pandemic and the pandemic phases. MATERIALS AND METHODS: This retrospective study was carried out in a trauma-care hospital, presently converted to COVID-19 care centre. Data was collected from (i) pre-pandemic phase: 1st October 2019 to 23rd March 2020 and (ii) pandemic phase: 24th March to 31st October 2020. Blood specimen rejection rate was calculated as the proportion of blood collection tubes with preanalytical errors out of the total number received, expressed as percentage. RESULTS: Total of 107,716 blood specimens were screened of which 43,396 (40.3%) were received during the pandemic. The blood specimen rejection rate during the pandemic was significantly higher than the pre-pandemic phase (3.0% versus 1.1%; P < 0.001). Clotted samples were the commonest source of preanalytical errors in both phases. There was a significant increase in the improperly labelled samples (P < 0.001) and samples with insufficient volume (P < 0.001), whereas, a significant decline in samples with inadequate sample-anticoagulant ratio and haemolysed samples (P < 0.001). CONCLUSION: In the ongoing pandemic, preanalytical errors and resultant blood specimen rejection rate in the clinical laboratory have significantly increased due to changed logistics. The study highlights the need for corrective steps at various levels to reduce preanalytical errors in order to optimise patient care and resource utilisation.

Development of a qualitative real-time RT-PCR assay for the detection of SARS-CoV-2: a guide and case study in setting up an emergency-use, laboratory-developed molecular microbiological assay.

Developing and deploying new diagnostic tests are difficult, but the need to do so in response to a rapidly emerging pandemic such as COVID-19 is crucially important. During a pandemic, laboratories play a key role in helping healthcare providers and public health authorities detect active infection, a task most commonly achieved using nucleic acid-based assays. While the landscape of diagnostics is rapidly evolving, PCR remains the gold-standard of nucleic acid-based diagnostic assays, in part due to its reliability, flexibility and wide deployment. To address a critical local shortage of testing capacity persisting during the COVID-19 outbreak, our hospital set up a molecular-based laboratory developed test (LDT) to accurately and safely diagnose SARS-CoV-2. We describe here the process of developing an emergency-use LDT, in the hope that our experience will be useful to other laboratories in future outbreaks and will help to lower barriers to establishing fast and accurate diagnostic testing in crisis conditions.

The challenge of COVID-19 for a Clinical Microbiology Department.

OBJECTIVES: To quantify the workload and cost overload that the COVID-19 pandemic has meant for a Clinical Microbiology laboratory in a real-life scenario. METHODS: We compared the number of samples received, their distribution, the human resources, and the budget of a Microbiology laboratory in the COVID pandemic (March-December 2020) with the same months of the previous year. RESULTS: the total number of samples processed in the Clinical Microbiology laboratory in March to December 2020 increased 96.70% with respect to 2019 (from 246,060 to 483,993 samples), reflecting an increment of 127.50% when expressed as samples/1000 admissions (from 6057 to 13,780). The increase in workload was mainly at the expense of the virology (+2058%) and serology (+86%) areas. Despite additional personnel hiring, the samples processed per technician increased 12.5%. The extra cost attributed to Microbiology amounts to 6,616,511 euros (114.8%). CONCLUSIONS: This is the first study to provide quantitative figures about workload and cost increase caused by the COVID-19 in a Microbiology laboratory.

Impact of COVID-19 on a Neurosurgical Service: Lessons from the University of California San Diego.

BACKGROUND: The institution-wide response of the University of California San Diego Health system to the 2019 novel coronavirus disease (COVID-19) pandemic was founded on rapid development of in-house testing capacity, optimization of personal protective equipment usage, expansion of intensive care unit capacity, development of analytic dashboards for monitoring of institutional status, and implementation of an operating room (OR) triage plan that postponed nonessential/elective procedures. We analyzed the impact of this triage plan on the only academic neurosurgery center in San Diego County, California, USA. METHODS: We conducted a de-identified retrospective review of all operative cases and procedures performed by the Department of Neurosurgery from November 24, 2019, through July 6, 2020, a 226-day period. Statistical analysis involved 2-sample z tests assessing daily case totals over the 113-day periods before and after implementation of the OR triage plan on March 16, 2020. RESULTS: The neurosurgical service performed 1429 surgical and interventional radiologic procedures over the study period. There was no statistically significant difference in mean number of daily total cases in the pre-versus post-OR triage plan periods (6.9 vs. 5.8 mean daily cases; 1-tail P = 0.050, 2-tail P = 0.101), a trend reflected by nearly every category of neurosurgical cases. CONCLUSIONS: During the COVID-19 pandemic, the University of California San Diego Department of Neurosurgery maintained an operative volume that was only modestly diminished and continued to meet the essential neurosurgical needs of a large population. Lessons from our experience can guide other departments as they triage neurosurgical cases to meet community needs.

Surge-in-Place: Conversion of a Cardiac Catheterization Laboratory Into a COVID-19 Intensive Care Unit and Back Again.

In Spring 2020, the United States epicenter of COVID-19 was New York City, in which the borough of the Bronx was particularly affected. This Fall, there has been a resurgence of COVID-19 in Europe and the Midwestern United States. We describe our experience transforming our cardiac catheterization laboratories to accommodate an influx of COVID-19 patients so as to provide other hospitals with a potential blueprint. We transformed our pre/postprocedural patient care areas into COVID-19 intensive care and step-down units and maintained emergent invasive care for ST-segment elevation myocardial infarction using existing space and personnel.

Impact of COVID-19 pandemic on functioning of cytopathology laboratory: Experience and perspective from an academic centre in New York.

COVID-19 has extraordinarily impacted every facet of the health care facilities' operations. Various strategies and policies were implemented promptly to preserve resources, not only to provide medical care to the expected massive numbers of COVID-19 patients, but also to mitigate the contagion spread at the workplace to ensure safety of healthcare workers. All routine, non-essential medical services and procedures were ramped down and workers deemed non-essential were directed to work remotely from home to reduce the number of people at hospital premises and preserve much needed personal protective equipment that were in short supply at the outset of the pandemic. The laboratories did not remain unscathed and were under immense pressure to maintain workplace safety while being operational and provide best patient care with limited resources. In this paper, we share our experience and challenges that we faced in a cytopathology laboratory at a major academic centre in New York, USA during the peak of infection.

Laboratory-based surveillance of COVID-19 in the Greater Helsinki area, Finland, February-June 2020.

OBJECTIVES: The aim was to characterise age- and sex-specific severe acute respiratory syndrome coronavirus disease-2 (SARS-CoV-2) RT-PCR sampling frequency and positivity rate in Greater Helsinki area in Finland during February-June 2020. We also describe the laboratory capacity building for these diagnostics. METHODS: Laboratory registry data for altogether 80,791 specimens from 70,517 individuals was analysed. The data included the date of sampling, sex, age and the SARS-CoV-2 RT-PCR test result on specimens collected between 1 February and 15 June 2020. RESULTS: Altogether, 4057/80,791 (5.0%) of the specimens were positive and 3915/70,517 (5.6%) of the individuals were found positive. In all, 37% of specimens were from male and 67% from female subjects. While the number of positive cases was similar in male and female subjects, the positivity rate was significantly higher in male subjects: 7.5% of male and 4.4% of female subjects tested positive. The highest incidence/100,000 was observed in those aged ≥80 years. The proportion of young adults in positive cases increased in late May 2020. Large dips in testing frequency were observed during every weekend and also during public holidays. CONCLUSIONS: Our data suggest that men pursue SARS-CoV-2 testing less frequently than women. Consequently, a subset of coronavirus disease-2019 infections in men may have gone undetected. People sought testing less frequently on weekends and public holidays, and this may also lead to missing of positive cases. The proportion of young adults in positive cases increased towards the end of the study period, which may suggest their returning back to social behaviour with an increased risk of infection.

COVID-19 Pandemic Planning: Simulation Models to Predict Biochemistry Test Capacity for Patient Surges.

BACKGROUND: Patient surges beyond hospital capacity during the initial phase of the COVID-19 pandemic emphasized a need for clinical laboratories to prepare test processes to support future patient care. The objective of this study was to determine if current instrumentation in local hospital laboratories can accommodate the anticipated workload from COVID-19 infected patients in hospitals and a proposed field hospital in addition to testing for non-infected patients. METHODS: Simulation models predicted instrument throughput and turn-around-time for chemistry, ion-selective-electrode, and immunoassay tests using vendor-developed software with different workload scenarios. The expanded workload included tests from anticipated COVID patients in 2 local hospitals and a proposed field hospital with a COVID-specific test menu in addition to the pre-pandemic workload. RESULTS: Instrumentation throughput and turn-around time at each site was predicted. With additional COVID-patient beds in each hospital, the maximum throughput was approached with no impact on turnaround time. Addition of the field hospital workload led to significantly increased test turnaround times at each site. CONCLUSIONS: Simulation models depicted the analytic capacity and turn-around times for laboratory tests at each site and identified the laboratory best suited for field hospital laboratory support during the pandemic.

Adaptation of Clinical Laboratories to COVID 19 Pandemic: Changes in Test Panels, Overcoming Problems and Preparation Suggestions for Future Pandemics Adaptation of Clinical Laboratories to COVID 19 Pandemic.

BACKGROUND: For Coronavirus Disease 2019 (Covid-19) infection, clinical laboratories provide essential contributions in the diagnosis of infection, stage prognostication, and evaluation of disease severity. We aimed to show laboratory problems including changes of test numbers, changes of test panels, and differences of preanalytical errors during Covid-19 pandemic and, in the current study, we also intended to give solutions for the obstacles to guide other possible pandemics. METHODS: Our study was based on data between January 10, 2020, and May 10, 2020. The first Covid-19 case of the Republic of Turkey was seen March 10, 2020, which was determined as the threshold date for comparisons. This was a single center, data mining, retrospective study. RESULTS: The number of patients admitted to hospital were 34,260 and 15,573, the number of total tests were 66,263 and 42,066 before and after pandemic, respectively, for the two-month interval. Test percentage changes were increased for D-dimer 136%, fibrinogen 3,113%, troponin 6%, and LDH 17%. Test percentage changes were decreased for CBC 37%, sedimentation 45%, aPTT 30%, PT 37%, CRP 28%, ProCT 10%, ferritin 29%, CK-MB 27%, blood gases 47%, ALT 43%, AST 42%, urea 42%, creatinine 42%, triglycerides 45%, sodium 42%, potassium 41%, chloride 21%, urine culture 58%, and blood culture 44%. When preanalytical sources of errors were investigated no differences were found. CONCLUSIONS: Laboratories must take quick action and be prepared for changes in patient services during pandemics. The most reliable ways for this are past experiences, statistical analysis, co-operation with administrations, high quality communication skills, and a risk-based management system.