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Background: In previous publications, the Task Force on Reference Measurement System Implementation proposed a procedural approach combining a critical review of entries available in the Joint Committee on Traceability in Laboratory Medicine (JCTLM) database with a comparison of this information against analytical performance specifications for measurement uncertainty (MU) and applied it to a group of 13 measurands., Content: Here we applied this approach to 17 additional measurands, of which measurements are frequently requested. The aims of the study were (a) to describe the main characteristics for implementing traceability and the potential to fulfill the maximum allowable MU (MAU) at the clinical sample level of certified reference materials and reference measurement procedures listed in the JCTLM database; (b) to discuss limitations and obstacles, if any, to the achievement of the required quality of laboratory measurements; and (c) to provide a gap analysis by highlighting what is still missing in the database. Results were integrated with those obtained in the previous study, therefore offering an overview of where we are and what is still missing in the practical application of the metrological traceability concept to 30 common biochemical tests employed in laboratory medicine., Summary: Our analysis shows that for 28 out of 30 measurands, conditions exist to correctly implement metrological traceability to the International System of units and fulfill at least the MAU of the minimum quality level derived according to internationally recommended models. For 2 measurands (serum albumin and chloride), further improvements in MU of higher-order references would be necessary., (© Association for Diagnostics & Laboratory Medicine 2024. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

Background: Appropriate clinical decision-making relies on the interpretation of equivalent measurement results in the context of valid clinical decision limits. Besides guideline-based decision limits, reference intervals (RIs) are commonly used to discriminate between abnormal results and results from "healthy" individuals. This study evaluated the suitability of RIs in light of the analytical bias for laboratories in the Netherlands using one standardized, one harmonized, and one unharmonized measurand (creatinine, hemoglobin, and ferritin, respectively)., Methods: Three types of data were collected: (a) external quality assessment (EQA) performance data from the Dutch Foundation for Quality Assurance in Laboratory Medicine (SKML); (b) the RIs reported by laboratories for a 55-year-old female; and (c) harmonized RIs established by using unique routine patient results using RefineR. Routinely used RIs (b) were compared to the harmonized RIs (c) and evaluated in combination with the analytical bias at the lower and upper reference limits., Results: Laboratories reported a variety of routinely used RIs that were inconsistent with the analytical bias, with differences between measurement procedures. The use of assays that perform within allowable bias limits does not automatically guarantee that the appropriate RI is used, allowing potential for structural misinterpretation of important diagnoses in patients., Conclusions: The use of RIs that are inconsistent with the analytical bias causes unnecessary between-laboratory differences in clinical decision-making. Adopting harmonized RIs facilitates similar interpretation of results across facilities. Harmonized RIs can be adopted immediately if the observed bias is acceptable or eliminated, or after standardization/harmonization of measurands without complete metrological traceability., (© Association for Diagnostics & Laboratory Medicine 2024.)

Background: The accurate measurement of α-fetoprotein (AFP) is critical for clinical diagnosis. However, different AFP immunoassays may yield different results. Appropriate AFP reference materials (RMs) were selected and assigned accurate values for applications with external quality assessment (EQA) programs to standardize AFP measurements., Methods: Forty individual clinical samples and six different concentrations of candidate RMs (Can-RMs, L1-L6) were prepared by the Beijing Center for Clinical Laboratories. The Can-RMs were assigned target values by performing five immunoassays, using WHO International Standard 72/225 as a calibrator, and sent to 45 clinical laboratories in Beijing for AFP measurements. The commutability of all RMs was assessed based on CLSI and the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) approaches. Analytical performance was assessed for compliance based on accuracy (total error, TE), trueness (bias), and precision (CV)., Results: The Can-RMs were commutable for all immunoassays using the CLSI approach and for 6 of 10 assay combinations using the IFCC approach. RMs diluted in WHO RM 72/225 were commutable among all assays with the CLSI approach, except for serum matrix (Autolumo vs. Roche analyzer) and diluted water matrix (Abbott vs. Roche/Mindray analyzer), whereas some inconclusive and non-commutable results were found using the IFCC approach. The average pass rates based on the TE, bias, and CV were 91%, 81%, and 95%, respectively., Conclusions: The commutability of the RMs differed between both evaluation approaches. The Can-RMs exhibited good commutability with the CLSI approach, suggesting their suitability for use with that approach as commutable EQA materials with assigned values and for monitoring the performance of AFP measurements.

The Division of AIDS (DAIDS) Good Clinical Laboratory Practice (GCLP) Guidelines establish a framework to guide the oversight of laboratories supporting DAIDS-sponsored clinical research or trials. Compliance with these guidelines promotes data reliability, consistency, and validity, and the safety of the clinical research or trial participants and laboratory staff, as well as ensures adherence to regulatory requirements. This article describes the application of the DAIDS GCLP Guidelines, the DAIDS Integrated Laboratory Oversight Framework, and the coordinated efforts of the collaborative oversight team of laboratory experts to support and monitor the performance of over 175 participating laboratories worldwide. Data from two self-administered online surveys conducted in 2017 and 2023 assessed the laboratory staff's experience implementing the GCLP Guidelines. The results of the 2017 survey were instrumental in informing changes to GCLP audit activities and promoting harmonization in the approach to laboratory oversight. A key finding from the 2023 survey results is the preference for hybrid GCLP training, encompassing face-to-face and online modules. Overall, both surveys acknowledged satisfaction with applying and implementing GCLP Guidelines. The need to effectively disseminate information about DAIDS laboratory oversight requirements to support the improved implementation of GCLP Guidelines was notable from both survey results. The collaborative team of laboratory experts and the integrated oversight approach promote knowledge-sharing and accountability to support the application of the GCLP Guidelines and compliance monitoring. The systematic implementation of the integrated laboratory oversight activities helped identify valuable lessons for improving laboratory performance and opportunities to strengthen quality oversight for laboratories participating in clinical research or trials.

The Division of AIDS (DAIDS) Good Clinical Laboratory Practice (GCLP) Guidelines establish a framework to guide the oversight of laboratories supporting DAIDS-sponsored clinical research or trials. Compliance with these guidelines promotes data reliability, validity, and safety of the clinical research or trial participants and laboratory staff and ensures adherence to regulatory requirements. Acknowledgment and adoption of the DAIDS GCLP Guidelines are critical in building laboratory capacity and preparedness for conducting clinical trials. In collaboration with DAIDS, laboratory experts support the implementation of the DAIDS Integrated Laboratory Oversight Framework (Framework) activities. This article describes the implementation of the GCLP Guidelines, the Framework activities, and the coordinated efforts to strengthen laboratory performance. The Framework activities include four components: Quality Assurance Oversight, GCLP Audits, GCLP Training, and Laboratory Quality Improvement. Comparison of GCLP Guidelines with other regulations or standards, including U.S. Clinical Laboratory Improvement Amendments regulation 42 CFR 493, College of American Pathologists, World Health Organization GCLP, and International Organization for Standardization, ISO 15189:2012 standards, highlighted the differences and similarities to guide integration and harmonization efforts. Processes related to the Framework activities are outlined in detail, including key data derived from the managed activities of over 175 laboratories worldwide. Via the evolution of the DAIDS GCLP Guidelines and laboratory oversight workflows, the laboratories participating in DAIDS-sponsored clinical research and trials have successfully participated in internal and external regulatory audits. The collaborative and integrated oversight approach promotes knowledge-sharing and accountability to support the implementation of the DAIDS GCLP Guidelines and compliance monitoring. Lessons learned have helped with the implementation of the DAIDS integrated laboratory oversight approach and quality oversight programs at multiple laboratories worldwide.

Diagnostic stewardship (DxS) has gained traction in recent years as a cross-disciplinary method to improve the quality of patient care while appropriately managing resources within the healthcare system. Clinical microbiology laboratorians have been highly engaged in DxS efforts to guide best practices with conventional microbiology tests and more recently with molecular infectious disease diagnostics. Laboratories can experience resistance to their role in DxS, especially when the clinical benefits, motivations for interventions, and underlying regulatory requirements are not clearly conveyed to stakeholders. Clinical laboratories must not only ensure ethical practices but also meet obligatory requirements to steward tests responsibly. In this review, we aim to support clinical microbiology laboratorians by providing the background and resources that demonstrate the laboratory's essential role in DxS. The heart of this review is to collate regulatory and accreditation requirements that, in essence, mandate DxS practices as a long-standing, core element of high-quality laboratory testing to deliver the best possible patient care. While examples of the clinical impact of DxS are plentiful in the literature, here, we focus on the operational and regulatory justification for the laboratory's role in stewardship activities., Competing Interests: E.M.M. is an employee of Quest Diagnostics, a commercial clinical reference laboratory, and owns stock in the company.

Introduction. Laboratory participation in external quality assessment (EQA) programmes including proficiency testing (PT) is a requirement of clinical laboratory conformance to ISO 15189:2022 Medical laboratories - Requirements for quality and competence . PT is one EQA method whereby laboratories are sent blinded samples for characterization by routine laboratory diagnostic methods. Importantly, PT enables a laboratory's performance to be evaluated in comparison to the standard reference methods and to the performance of other peer laboratories using similar diagnostic methods. Gap statement. The desired outcome of participating in PT is to help laboratories identify possible sources of error in each step of the total testing process and particularly in their test methods during the analytical phase. Aim. This cross-sectional study investigated the impact of using matrix-assisted laser desorption ionization time-of-flight mass spectrometry (MALDI-TOF MS) compared to conventional phenotypic biochemical testing on laboratory performance in a clinical bacteriology PT scheme. Methodology. During a 6-year period from 2017-2022, the Canadian Microbiology Proficiency Testing implemented 112 PT challenges comprising 22 different sample types and included 61 different bacterial species. This was translated into 5883 graded test events for analysis. Multiple logistic regression techniques were employed to explore the association between the test method employed and laboratory performance. The sample type and aerobic classification of challenge organisms were included as confounding variables. Results. Laboratories using MALDI-TOF MS performed significantly better in characterizing microorganisms than laboratories using phenotypic biochemical testing alone [odds ratio OR = 5.68, confidence interval (CI): 3.92, 8.22] regardless of the sample type and aerobic classification. Notably, our analysis identified a significant association between anaerobic organisms and laboratory performance (OR: 0.24, CI: 0.17-0.35), suggesting that culturing and identifying fastidious organisms remains a significant obstacle for many clinical microbiology laboratories. Conclusions. Although no method is infallible and its performance will depend on the validation and quality assurance procedures, this finding may help the management in the decision for implementing MALDI-TOF MS in the microbiology laboratory. This study highlights the important role PT providers play in the objective assessment of laboratory performance and how it can provide evidence for quality improvement.

Background: Before a new test can be routinely used in your laboratory, its reliability must be established in the laboratory where it will be used. International standards demand validation and verification procedures for new tests. The International Organization for Standardization (ISO) 15189 was recently updated, and the European Commission's In Vitro Diagnostic Regulation (IVDR) came into effect. These events will likely increase the need for validation and verification procedures., Objectives: This paper aims to provide practical guidance in validating or verifying microbiology tests, including antimicrobial susceptibility tests in a clinical microbiology laboratory., Sources: It summarizes and interprets certain parts of standards such as ISO 15189:2022, and regulations, such as IVDR 2017/746 regarding validation or verification of a new test in a routine clinical microbiology laboratory., Content: The reasons for choosing a new test and the outline of the validation and verification plan are discussed. Furthermore, the following topics are touched upon: the choice of reference standard, number of samples, testing procedures, how to solve the discrepancies between results from new test and reference standard, and acceptance criteria. Arguments for selecting certain parameters (such as reference standard and sample size) and examples are given., Implications: With the expected increase in validation and verification procedures because of the implementation of IVDR, this paper may aid in planning and executing these procedures., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Laboratory medicine plays a crucial role in patient care, contributing to approximately 70 % of clinical decisions. In collaboration with clinicians, laboratory medicine specialists perform analyses that are useful for diagnosis, screening and prevention. Laboratories are known for their efficiency, which is reached through a rigorous quality system. However, errors can occur, especially given the complexity of the total testing process. These errors may lead to severe consequences, such as incorrect diagnoses or delays in treatment. Errors can occur at every stage of the total testing process, those related to the pre-analytical phase being the most prevalent. To reduce medical errors related to laboratory processes, it is essential to provide training for medical and paramedical staff, optimize production automation, and leverage technological advancements. These considerations have led to the creation of a French Working Group on Sources of Errors in Laboratory Medicine, under the aegis of the French lean society of clinical chemistry and laboratory medicine (Société Française de Biologie Clinique - SFBC). The objectives of this working group are to produce an educational handbook on sources of errors in laboratory medicine, provide training for clinical chemists, and conducting applied research projects to better understand the mechanisms behind specific errors. Ultimately, the aim is to minimize errors and enhance the quality of laboratory tests.

The single-specimen pneumatic tube (PTS) is a commonly used rapid specimen delivery system in modern clinical laboratories. However, its impact on sample integrity and laboratory test results remains controversial. The installation and configuration of single-specimen PTS are unique to their institution. We sought to validate our single-specimen PTS by comparing routine chemistry, immunology, and hematology results with a repeat sample integrity index for manual transport. In 2023, 30 employees were randomly selected from the company medical examination, and three tubes of procoagulant serum samples and three tubes of EDTA anticoagulant blood samples were collected from each of them. Group A uses a single specimen PTS at 8 m/s, Group B uses a single specimen PTS at 15 m/s, and Group C uses manual transfer. Specimens from all three groups were simultaneously analysed for ALT, AST, TG, TC, LDL, K, NA, CI, TSH, hs-cTnT, NSE, Cyfra21-1 and haematological analysis. The differences between the three groups of NSE and Cyfra21-1 were statistically significant (P < 0.05). The differences of the rest of the items were not statistically significant. The difference in NSE was not statistically significant between groups A and B (P = 0.401), B and C, and C and A (P < 0.05). The difference in Cyfra21-1 was not statistically significant between groups A and B (P = 0.897), B and C (P = 0.052), and C and A (P = 0.145). Individual sample PTS should be validated for testing prior to use to ensure the results' accuracy.

Background: The integrity of clinical research and machine learning models in healthcare heavily relies on the quality of underlying clinical laboratory data. However, the preprocessing of this data to ensure its reliability and accuracy remains a significant challenge due to variations in data recording and reporting standards., Methods: We developed lab2clean, a novel algorithm aimed at automating and standardizing the cleaning of retrospective clinical laboratory results data. lab2clean was implemented as two R functions specifically designed to enhance data conformance and plausibility by standardizing result formats and validating result values. The functionality and performance of the algorithm were evaluated using two extensive electronic medical record (EMR) databases, encompassing various clinical settings., Results: lab2clean effectively reduced the variability of laboratory results and identified potentially erroneous records. Upon deployment, it demonstrated effective and fast standardization and validation of substantial laboratory data records. The evaluation highlighted significant improvements in the conformance and plausibility of lab results, confirming the algorithm's efficacy in handling large-scale data sets., Conclusions: lab2clean addresses the challenge of preprocessing and cleaning clinical laboratory data, a critical step in ensuring high-quality data for research outcomes. It offers a straightforward, efficient tool for researchers, improving the quality of clinical laboratory data, a major portion of healthcare data. Thereby, enhancing the reliability and reproducibility of clinical research outcomes and clinical machine learning models. Future developments aim to broaden its functionality and accessibility, solidifying its vital role in healthcare data management., (© 2024. The Author(s).)

Objectives: This study aimed to assess the validity of external quality assessment (EQA) laboratory results across various cultural and environmental contexts and to identify potential improvement areas., Methods: The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Task Force on Global Laboratory Quality (TF-GLQ) conducted a 2-year study (2022 and 2023) in which EQA materials, related software and online training was provided by a commercial vendor to 100 laboratories in ten IFCC member society countries. The results were analysed on a monthly basis by the TF-GLQ, to show the number of submissions per country, tests per lab, acceptability rates, random failures and to get a measure of which analytes performed poorly., Results: The EQA material was dispatched on a quarterly basis. Some countries had problems with customs releasing the material in a timely manner, resulting in laboratories not receiving them on time leading to no submission. We report here the results for the second year of the survey. The number of examinations varied between laboratories, ranging from seven to 84 analytes. Of the ten countries surveyed, six averaged greater than 90 % acceptable results over the whole 12-months cycle, one had unacceptable results for two of the nine months they returned results and the other four were considered to not perform to an acceptable standard., Conclusions: All 100 participating laboratories indicated satisfaction with the EQA survey and related services, including on-site training, and report handling. However, specimen receiving issues, suggest benefits in dispatching materials for a full 12-month cycle. Significant discrepancies in EQA performance indicate that four countries require long-term assistance, training and guidance. To ensure reliable patient results, promoting EQA in certain countries is essential to achieve the required level of quality., (© 2024 Walter de Gruyter GmbH, Berlin/Boston.)

Background: Clinical laboratories frequently implement the same tests and internal quality control (QC) rules on identical instruments. It is unclear whether individual QC targets for each analyser or ones that are common to all instruments are preferable. This study modelled how common QC targets influence assay error detection before examining their effect on real-world data., Methods: The effect of variable bias and imprecision on error detection and false rejection rates when using common or individual QC targets on two instruments was simulated. QC data from tests run on two identical Beckman instruments (6-month period, same QC lot, n > 100 points for each instrument) determined likely real-world consequences., Results: Compared to individual QC targets, common targets had an asymmetrical effect on systematic error detection, with one instrument assay losing detection power more than the other gained. If individual in-control assay standard deviations (SDs) differed, then common targets led to one assay failing QC more frequently. Applied to two analysers (95 QC levels and 45 tests), common targets reduced one instrument's error detection by ≥ 0.4 sigma on 15/45 (33%) of tests. Such targets also meant 14/45 (31%) of assays on one in-control instrument would fail over twice as frequently as the other (median ratio 1.62, IQR 1.20-2.39) using a 2SD rule., Conclusions: Compared to instrument-specific QC targets, common targets can reduce the probability of detecting changes in individual assay performance and cause one in-control assay to fail QC more frequently than another. Any impact on clinical care requires further investigation., Competing Interests: Declaration of conflicting interestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Histotechnology educational programs are accredited by the National Accrediting Agency for Clinical Laboratory Sciences (NAACLS) and currently number fewer than 50 in the United States which contributes to the shortages of laboratory personnel. A survey tool designed with REDCap software was distributed to all programs identified on the NAACLS website and consisted of three parts: a) program information, b) facility information, and c) challenges. Programs are located primarily in large urban centers where populations are most concentrated. The median class size was 6 which may explain the excellent student outcomes to include 96% graduation rates and 90.7% board of registry examination pass rates. Overall, programs had ample equipment, funding, and administrative support. Costs to attend the programs were relatively low (<$3,000 per semester) for over half of the programs. However, due to the small number of accredited education programs across the US, potential students do not often have access to an institution in their area. The programs indicated that the most common challenge was recruitment of adequate high-quality candidates which may explain, in part, the persistent shortage of personnel in the histology laboratory.

Patient-based real-time QC (PBRTQC) uses patient-derived data to assess assay performance. PBRTQC algorithms have advanced in parallel with developments in computer science and the increased availability of more powerful computers. The uptake of Artificial Intelligence in PBRTQC has been rapid, with many stated advantages over conventional approaches. However, until this review, there has been no critical comparison of these. The PBRTQC algorithms based on moving averages, regression-adjusted real-time QC, neural networks and anomaly detection are described and contrasted. As Artificial Intelligence tools become more available to laboratories, user-friendly and computationally efficient, the major disadvantages, such as complexity and the need for high computing resources, are reduced and become attractive to implement in PBRTQC applications.

Background: Quality healthcare is a global priority, reliant on robust health systems for evidence-based medicine. Clinical laboratories are the backbone of quality healthcare facilitating diagnostics, treatment, patient monitoring, and disease surveillance. Their effectiveness depends on sustainable delivery of accurate test results. Although the Strengthening Laboratory Management Towards Accreditation (SLMTA) programme has enhanced laboratory quality in low-income countries, the long-term sustainability of this improvement remains uncertain., Objective: To explore the sustainability of quality performance in clinical laboratories in Rwanda following the conclusion of SLMTA., Methods: A quasi-experimental design was adopted, involving 47 laboratories divided into three groups with distinct interventions. While one group received continuous mentorship and annual assessments (group two), interventions for the other groups (groups one and three) ceased following the conclusion of SLMTA. SLMTA experts collected data for 10 years through assessments using WHO's StepwiseLaboratory Quality Improvement Process Towards Accreditation (SLIPTA) checklist. Descriptive and t-test analyses were conducted for statistical evaluation., Results: Improvements in quality were noted between baseline and exit assessments across all laboratory groups (mean baseline: 35.3%, exit: 65.8%, p  < 0.001). However, groups one and three experienced performance declines following SLMTA phase-out (mean group one: 64.6% in reference to 85.8%, p  = 0.01; mean group three: 57.3% in reference to 64.7%, p  < 0.001). In contrast, group two continued to enhance performance even years later (mean: 86.6%compared to 70.6%, p  = 0.03)., Conclusion: A coordinated implementation of quality improvement plan that enables regular laboratory assessments to pinpoint and address the quality gaps is essential for sustaining quality services in clinical laboratories.

Background and Aims: To investigate performance of D-dimer assays in China and address analytical quality issues., Materials and Methods: D-dimer assays data were collected from China National External Quality Assessment Scheme (China NEQAS) from 2014 to 2022. We analyzed reagents, assay results, reporting unit and cutoffs in 2022 China NEQAS. Interlaboratory coefficient variations (CVs) and influence of modified/unmodified test systems on CVs were investigated over 9 years., Results: There were 82 reagent brands in China NEQAS, but 55 reagent instructions did not indicate expression unit (DDU or FEU). Up to 7-fold of the ratio of max-to-min mean results was shown among different assays with same unit on the same sample. A prevalence of FEU (63.4%) over DDU (17.1%) was observed. Although 669 laboratories (37.9%) among 1766 laboratories used reagents without VTE exclusion claim, they also reported cutoffs. The CVs of only two assays were decreasing over years. CVs of modified test systems were higher than those of unmodified systems before improvement., Conclusions: Expression unit should be required to label in package inserts by regulatory authority. Laboratory professionals should follow instructions for use and prefer unmodified test systems for clinical safely application. Harmonization of reporting units through collaborative efforts is the promising step., (Copyright © 2024 Elsevier B.V. All rights reserved.)

Objectives: This article describes Pathologists Overseas (PO) experience supporting external quality assessment (EQA) programs in 10 clinical laboratories across 3 countries between 2009 and 2017., Methods: Laboratories were enrolled in the condensed chemical pathology EQA program provided by the Royal College of Pathologists of Australasia Quality Assurance Program. Participants were given an initial 2- to 4-day in-person training, followed by 1 year of active feedback on performance via emails or phone calls by a PO volunteer., Results: There were 2 performance metrics: percentage of reported results as a measure of compliance and percentage of acceptable reported results as a measure of accuracy. Laboratories demonstrated high compliance with result reporting, with medians of 69.9%, 71.7%, and 81.3% before, during, and after feedback, respectively. Concomitant medians for the percentage of acceptable reported results were 41.2%, 57.3%, and 53.5%, respectively. Six laboratories had low performance in terms of accuracy at baseline (<60%). Active feedback improved the percentage of acceptable reported results for these lower-performing laboratories., Conclusions: External quality assessment programs can be successfully adopted long term by laboratories in low-resource settings. Active feedback requires significant time and effort but could be especially beneficial for laboratories with poor baseline performance., (© The Author(s) 2024. Published by Oxford University Press on behalf of American Society for Clinical Pathology. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

Background We aimed to evaluate the 3-year participation status of tuberculosis (TB) laboratories in public health laboratories (PHL) tuberculosis external quality assessment (EQA) and EQA results. Method During 2018-2020, PHLs participated in the EQA programme organized annually by the National Tuberculosis Reference Laboratory (NTRL). Five kinds of EQA samples were sent to the participating laboratories on three parameters, including microscopy, culture and phenotypic first-line drug susceptibility testing and they were asked to perform according to the standard protocol. The results were taken over by the Tuberculosis Laboratories Surveillance Network (TULSA) web system and analysed. Results A total of 24 PHLs participated in the EQA in 2018; 30 in 2019 and 23 in 2020. In terms of sensitivity, specificity, accuracy and reproducibility in microscopy, respectively, in 2018, 20 of the laboratories were 100%, 4 of them 80%, and in culture 16 of them were 100% and 2 of them 80%; in 2019, 28 of them were 100%, 2 of them 80%, and in culture 11 of them were 100%, 6 of them 80%, 1 of them 60%; in 2020, 20 of them were 100%, 3 of them 80%, and in culture 13 of them were 100% and 3 of them 80%. Conclusion It is beneficial for laboratories working on TB to participate in EQA in terms of evaluating the accuracy and reliability of the method used.

In Burkina Faso, the implementation of the quality management system remains weak in diagnostic laboratories. Integrating mentoring into the life of clinical diagnostic laboratories, a qualified mentor is essential for quality system control. The objective of this study was to evaluate the impact of the mentoring process on quality improvement. Mentoring process was implemented at nine laboratories. The process consisted of a one-week mentor stay in the laboratory as one visit, with four in total. The SLIPTA checklist was used as a measurement tool. Two audits were performed (before and after the implementation of the mentoring process. The audit data were analyzed to estimate the effect of mentoring on quality improvement. A score difference of 24.55% was found significant between the two audits (paired Student's t-test p-value = 0.0002). The variables non-conformities, corrective/preventive actions, and facilities/safety have factored more than eight points between the two audits. However, the management/customer service and information one have only slightly increased (2.27 and 0.63, respectively). Mentoring has improved the quality management system in laboratories. However, some points of the process need to be improved to bring these laboratories toward international accreditation.

Internal quality control in clinical chemistry laboratories are based on analyzing samples of stable control materials among the patient samples. The control results are interpreted by using quality control rules that usually are designed to detect systematic errors. The best rules have a high probability of error detection (P ed ), i.e. to detect the maximal allowable (critical) systematic error and a low probability of false rejection (P fr , false alarm). In this work we show that quality control rules can be represented by points on a ROC curve which appears when P ed is plotted against P fr and only the control limit is varied . Further, we introduce a new method for choosing the optimal control limit, analogous to choosing the optimal operating point on the ROC curve of a diagnostic test. This decision needs knowledge of the pretest probability of a critical systematic error, the benefit of detecting it when it occurs and the cost of false alarm. The ROC curve analysis showed that if rules based on N  = 2 are used, mean rules outperform Westgard rules because the ROC curve of the mean rules was lying above the ROC curves of the Westgard rules. A mean rule also had a lower maximum expected increase in the number of unacceptable patient results reported during the presence of an out-of-control error condition (Max E(N UF )) than comparable Westgard rules.

Background and Aims: Laboratory performance as a relative concept needs repetitive benchmarking for continuous improvement of laboratory procedures and medical processes. Benchmarking as such establishes reference levels as a basis for improvements efforts for healthcare institutions along the diagnosis cycle, with the patient at its center. But while this concept seems to be generally acknowledged in laboratory medicine, a lack of practical implementation hinders progress at a global level. The aim of this study was to examine the utility of a specific combination of indicators and survey-based data collection approach, and to establish a global benchmarking dataset of laboratory performance for decision makers in healthcare institutions., Methods: The survey consisted of 44 items relating to laboratory operations in general and three subscales identified in previous studies. A global sample of laboratories was approached by trained professionals. Results were analyzed with standard descriptive statistics and exploratory factor analysis. Dimensional reduction of specific items was performed using confirmatory factor analysis, resulting in individual laboratory scores for the three subscales of "Operational performance," "Integrated clinical care performance," and "Financial sustainability" for the high-level concept of laboratory performance., Results and Conclusions: In total, 920 laboratories from 55 countries across the globe participated in the survey, of which 401 were government hospital laboratories, 296 private hospital laboratories, and 223 commercial laboratories. Relevant results include the need for digitalization and automation along the diagnosis cycle. Formal quality management systems (ISO 9001, ISO 15189 etc.) need to be adapted more broadly to increase patient safety. Monitoring of key performance indicators (KPIs) relating to healthcare performance was generally low (in the range of 10-30% of laboratories overall), and as a particularly salient result, only 19% of laboratories monitored KPIs relating to speeding up diagnosis and treatment. Altogether, this benchmark elucidates current practice and has the potential to guide improvement efforts and standardization in quality & safety for patients and employees alike as well as sustainability of healthcare systems around the globe., Competing Interests: MM, EA, and RL are employees of Abbott, and Abbott provided in-kind support (dissemination of the questionnaire by sales staff) for this study. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Huf, Mohns, Almeta, Lister, Buchta, Demyanets, Buchberger and Ettl.)

The Westgard quality control (QC) rules are often applied in infectious diseases serology to validate the quality of results, but this requires a reasonable tradeoff between maximum sensitivity to errors and minimum false rejections. This article, in addition to illustrate the six sigma methodology in the QC management of the (anti-HCV Architect®) test, it discusses the main influencing factors on sigma value. Data from low positive and in-kit control materials spreading over 6 months and using four reagent kits, were used to calculate the precision of the test. The difference between the control material reactivity and the cut-off defined the error budget. Sigma values were > 6, which indicates that the method produces four erroneous results per million tests. The application of the six sigma concept made it possible to argue the choice of the new QC strategy (use of 13S rule with one positive control) and to relax the existing QC rules. This work provides a framework for infectious diseases serology laboratories to evaluate tests performances against a quality requirement and design an optimal QC strategy.

Objectives: Clinical laboratories face limitations in implementing advanced quality control (QC) methods with existing systems. This study aimed to develop a web-based application to addresses this gap, and improve QC practices., Methods: QC Constellation, a web application built using Python 3.11, integrates various statistical QC modules. These include Levey-Jennings charts with Westgard rules, sigma-metric calculations, exponentially weighted moving average (EWMA) and cumulative sum (CUSUM) charts, and method decision charts. Additionally, it offers a risk-based QC section and a patient-based QC module aligning with modern QC practices. The codes and the web application links for QC Constellation were shared at https://github.com/hikmetc/QC&#95;Constellation, and http://qcconstellation.com, respectively., Results: Using synthetic data, QC Constellation demonstrated effective implementation of Levey-Jennings charts with user-friendly features like checkboxes for Westgard rules and customizable moving averages graphs. Sigma-metric calculations for hypothetical performance values of serum total cholesterol were successfully performed using allowable total error and maximum allowable measurement uncertainty goals, and displayed on method decision charts. The utility of the risk-based QC module was exemplified by assessing QC plans for serum total cholesterol, showcasing the application's capability in calculating risk-based QC parameters including maximum unreliable final patient results, risk management index, and maximum run size and offering risk-based QC recommendations. Similarly, the patient-based QC and optimization modules were demonstrated using simulated sodium results., Conclusions: In conclusion, QC Constellation emerges as a pivotal tool for laboratory professionals, streamlining the management of quality control and analytical performance monitoring, while enhancing patient safety through optimized QC processes., (© 2024 Walter de Gruyter GmbH, Berlin/Boston.)

Background: Sigma metrics have been adapted for the clinical laboratory to incorporate observed accuracy, precision, and total error allowed. The higher the Sigma level for a process, the better performance that process has. A limitation of studies assessing Sigma metrics is that they are performed on a small number of well-controlled systems., Methods: An algorithm was developed to extract QC data and derive the Sigma metric for 115 analytes from sites connected to the QuidelOrtho E-Connectivity® database. The median of these results was then used to derive the Sigma metric for each assay., Results: In this analysis, 79 out of 115 (68.7%) of the assays assessed achieved 6 Sigma or better and 98 out of 115 (85.2%) achieved 5 Sigma or better., Conclusions: This study has demonstrated a methodology that can be used to condense Sigma metrics from hundreds of analyzers into a single metric of assay quality. Because these analyzers are running in working laboratories from around the world, this analysis can serve as a baseline for understanding the assay performance achieved in the presence of variabilities such as lab-to-lab, instrument-to-instrument, material handling, environmental conditions, and reagent lot. The significant number of assays demonstrating high Sigma levels did so despite this variation. The ability of the methods reported here to include hundreds of analyzers represents a novel approach for assessing Sigma metrics in clinical laboratories., (© Association for Diagnostics & Laboratory Medicine 2024.)

Critical test results in clinical laboratories are crucial for timely patient care, serving as indicators of potentially life-threatening conditions. Despite their importance, a notable heterogeneity in management practices exists globally. This study investigates the current practices of managing critical results at Danish clinical biochemistry laboratories and identifies areas prone for improvement. A comprehensive online survey was distributed to all 21 Danish clinical biochemistry laboratories regarding their critical result management, including documentation practices, critical limit selection, and quality assurance measures. A total of 17 laboratories (81%) responded. The answers revealed a generally uniform approach to managing critical results, with all laboratories having 24-h reporting, local instructions and using the telephone as communication channel. However, variations were noted in documentation practices and critical limit selection. Notably, 23.5% of the laboratories reported that one out of every ten critical results was not reported, indicating a significant risk of delayed critical results. This is further complicated by the limited use of predefined timeframes for reporting and also, only few laboratories actively monitored response times. The findings emphasize the need for more standardized documentation and evaluation practices to align with international standards and to enhance patient safety. While the laboratories showed a commitment to standardized procedures, the study emphasizes the necessity of a National or Nordic guideline to supplement the ISO 15189:2022. This study is a step towards optimizing critical result management, not only in Danish clinical biochemistry laboratories but also across various laboratory specialties, thereby improving overall laboratory quality, efficiency, and patient safety.

Background: This study aims to evaluate the ability of laboratories to perform spinal muscular atrophy (SMA) genetic testing in newborns based on dried blood spot (DBS) samples, and to provide reference data and advance preparation for establishing the pilot external quality assessment (EQA) scheme for SMA genetic testing of newborns in China., Methods: The pilot EQA scheme contents and evaluation principles of this project were designed by National Center for Clinical Laboratories (NCCL), National Health Commission. Two surveys were carried out in 2022, and 5 batches of blood spots were submitted to the participating laboratory each time. All participating laboratories conducted testing upon receiving samples, and test results were submitted to NCCL within the specified date., Results: The return rates were 75.0% (21/28) and 95.2% (20/21) in the first and second surveys, respectively. The total return rate of the two examinations was 83.7% (41/49). Nineteen laboratories (19/21, 90.5%) had a full score passing on the first survey, while in the second survey twenty laboratories (20/20, 100%) scored full., Conclusions: This pilot EQA survey provides a preliminary understanding of the capability of SMA genetic testing for newborns across laboratories in China. A few laboratories had technical or operational problems in testing. It is, therefore, of importance to strengthen laboratory management and to improve testing capacity for the establishment of a national EQA scheme for newborn SMA genetic testing.

Pre-analytical deficiencies (PADs) are a major source of errors in anatomical pathology, accounting for about 70% of laboratory deficiencies. These can lead to incorrect diagnoses, delayed treatments, and increased healthcare costs. As part of a quality improvement initiative, we retrospectively identified and characterized 237 PADs documented over a 1-year period in a tertiary care academic center. The most common PADs were errors in specimen procurement (56%), handling of samples within the lab (16%), accessioning (10%), incomplete requisitions (9%), and transportation-related issues (7%). Strategies were then devised to mitigate these errors. Categorization of pre- and intra-laboratory PADs was refined into eight categories (collection, requisition, specimen container, transportation, receiving, accessioning, preparation, and communications) in the laboratory information system. Mandatory PAD documentation was implemented for accessioning staff. Post-implementation, prospective analysis identified that the most common PADs were related to surgical requisitions (75%). Among these, missing ordering physician's signature was the most common, accounting for 67.7% of requisition-related PADs and 50.8% of all PADs. Other common PADs included incomplete information of specimens, clinical information, patient information, physician information, source location, collection time, incorrect requisition forms, and illegible handwritten information. This study highlights the importance of identifying and addressing PADs in the anatomical pathology laboratory setting as well as the potential benefits of implementing standardized documentation and quality improvement processes to address these deficiencies., (© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Purpose: Indian Council of Medical Research (ICMR) initiated an Inter-Laboratory Quality Control testing (ILQC) program for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) testing. Under this program, SARS-CoV-2 testing laboratories across the country submit specimens to the assigned State Quality Control (SQCs) laboratories for ILQC testing. This study aimed to investigate the performance of public and private SARS-CoV-2 testing laboratories in Delhi and highlights the country's effort in ramping up testing facility with close monitoring of the quality of Covid-19 testing results., Methods: In the present study, two-years of SARS-CoV-2 testing data is included. During July 2020 through February 2022, a total of 1791 anonymised specimens were received from 56 public and private laboratories. These specimens were processed by reverse transcriptase - polymerase chain reaction (RT-PCR) tests as per National Institute of Virology (NIV) protocol and the results were uploaded on the ICMR quality control/quality assurance (QC/QA) portal without directly conveying the results to respective participating laboratories. This portal generated a final report stating concordance and intimate results to individual laboratories., Results: Among the 1791 specimens, 25 were rejected and the remaining 1766 were tested. Among these specimens 1691 (95.75%) revealed concordance, and 75 (4.24%) were discordant. A total of 29 laboratories had 100% concordance, 21 laboratories had over 90% concordance and six laboratories had over 80% concordance., Conclusions: The study demonstrates that the establishment of an inter-laboratory comparison program for SARS-CoV-2 testing helped in monitoring quality of SARS-CoV-2 testing in the country., Competing Interests: Declaration of competing interest The authors declare that there is no conflict of interest., (Copyright © 2024 Indian Association of Medical Microbiologists. Published by Elsevier B.V. All rights reserved.)

Analytical performance specifications (APS) are used for the quantitative assessment of assay analytical performance, with the aim of providing information appropriate for clinical care of patients. One of the major locations where APS are used is in the routine clinical laboratory. These may be used to assess and monitor assays in a range of settings including method selection, method verification or validation, external quality assurance, internal quality control and assessment of measurement uncertainty. The aspects of assays that may be assessed include imprecision, bias, selectivity, sample type, analyte stability and interferences. This paper reviews the practical use of APS in a routine clinical laboratory, using the laboratory I supervise as an example., (© 2024 Walter de Gruyter GmbH, Berlin/Boston.)

The goal of metrological traceability is to have equivalent results for a measurand in clinical samples (CSs) irrespective of the in-vitro diagnostic medical device (IVD-MD) used for measurements. The International Standards Organization standard 17511 defines requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples used with IVD-MDs. Each step in metrological traceability has an uncertainty associated with the value assigned to a material. The uncertainty at each step adds to the uncertainty from preceding steps such that the combined uncertainty gets larger at each step. The combined uncertainty for a CS result must fulfil an analytical performance specification (APS) for the maximum allowable uncertainty ( umax CS ). The umax CS can be partitioned among the steps in a metrological traceability calibration hierarachy to derive the APS for maximum allowable uncertainty at each step. Similarly, the criterion for maximum acceptable noncommutability bias can be derived from the umax CS . One of the challenges in determining if umax CS is fulfilled is determining the repeatability uncertainty ( u Rw ) from operating an IVD-MD within a clinical laboratory. Most of the current recommendations for estimating u Rw from internal quality control data do not use a sufficiently representative time interval to capture all relevant sources of variability in measurement results. Consequently, underestimation of u Rw is common and may compromise assessment of how well current IVD-MDs and their supporting calibration hierarchies meet the needs of clinical care providers., (© 2024 the author(s), published by De Gruyter, Berlin/Boston.)

Introduction: Clinical laboratories serve a critical role in increasing the efficiency of patient care. Choosing the right test, getting trustworthy results and appropriate interpretation are of utmost importance in improving the patient's well-being. Quality management strategies should be applied in routine patient care because laboratory errors have a major impact on the quality of patient care. In sigma metrics, errors identified are quantified as percentage errors or defects per million (DPM). It aims at improving the quality control (QC) process by forming an appropriate strategy., Aim and Objectives: To analyze the internal quality control (IQC) of hematology analytes using the sigma metrics method and to devise the frequency of IQC by the results of six sigma metric analysis., Materials and Methods: This study was conducted in a tertiary care center of western India. Internal quality control (IQC) data sets of five analytes- Red Blood Cell count (RBC), Hemoglobin (Hb), Hematocrit (Hct), White blood cell count (WBC), and Platelet count (PLT) were analyzed retrospectively of six months using Beckman Coulter DXH 800 hematology analyzers., Results: The observed sigma value was >6 for Hb, TLC, and PLT, indicating excellent results and requiring no modification in IQC. The Sigma value was between 3 and 4 for RBC and Hct suggested the need for improvement in quality control (QC) processes. No analytes showed a Sigma value of <3., Conclusion: Sigma metrics provide a quantitative framework that helps to assess analytic methodologies and can serve as an important self-assessment tool for quality assurance in the clinical laboratory., (Copyright © 2023 Copyright: © 2023 Indian Journal of Pathology and Microbiology.)

Objectives: Even if the topic of the analytical quality required to provide laboratory results "fit for purpose" exists since the beginning of the modern medical laboratory, there is the suspect that the expression "Analytical Performance Specifications" (APS) is not well-known. To investigate this aspect a survey was conducted., Methods: A questionnaire with seven questions related to the knowledge about the topic, the sources of information and the criteria used by the laboratories to set the APS and their applications was prepared. It was distributed to all the clinical pathology laboratories of Lombardy Region (143) and to the members of SIBioC Laboratory Medicine (excluding Lombardy)., Results: We received 201 replies: 127 from Lombardy and 74 from the rest of Italy. Fifteen percent declared to ignore the meaning of APS and only 64 % of those knowing the meaning of the term declared to use them in the daily practice. The state-of-the-art was the principle used more frequently to set APS (about 48 %) followed by biological variation (41 %), and APS were typically applied to set goals for Internal Quality Control for selected measurands. Usually imprecision or total error APS were used, much less frequently uncertainty APS. In fact only 27 % of the laboratories declared to have calculated the measurement uncertainty for part or the majority of their measurands., Conclusions: Even considering the limits of a survey that relies upon self-declarations, it appears clearly that, at list in Italy, there is some work to be done to promote the concept and the use of APS., (© 2024 Walter de Gruyter GmbH, Berlin/Boston.)

Analytical performance specifications (APS) are usually compared to the intermediate reproducibility uncertainty of measuring a particular measurand using a single in vitro diagnostic medical device (IVD MD). Healthcare systems assembling multiple laboratories that include several IVD MDs and cater to patients suffering from long-term disease conditions mean that samples from a patient are analyzed using a few IVD MDs, sometimes from different manufacturers, but rarely all IVD MDs in the healthcare system. The reproducibility uncertainty for results of a measurand measured within a healthcare system and the components of this measurement uncertainty is useful in strategies to minimize bias and overall measurement uncertainty within the healthcare system. The root mean squares deviation (RMSD) calculated as the sample standard deviation (SD) and relative SD includes both imprecision and bias and is appropriate for expressing such uncertainties. Results from commutable stabilized internal and external control samples, from measuring split natural patient samples or using big-data techniques, are essential in monitoring bias and measurement uncertainties in healthcare systems. Variance component analysis (VCA) can be employed to quantify the relative contributions of the most influential factors causing measurement uncertainty. Such results represent invaluable information for minimizing measurement uncertainty in the interest of the healthcare system's patients., (© 2024 Walter de Gruyter GmbH, Berlin/Boston.)

Objectives: There appears to be marked discrepancies between total IgE reference intervals (RIs) in use by many laboratories and those recommended by published studies. The aim of this study was therefore to review total IgE RIs currently reported by Scandinavian and British laboratories and to compare these to published RIs identified by a literature review., Methods: Relevant laboratories were identified by test directories provided by the national accreditation bodies in Norway, Sweden, Denmark and the UK. Total IgE RIs and their sources were acquired by accessing laboratory user handbooks or by an electronic survey. In addition a literature review of published total IgE RI studies was performed., Results: From 172 accredited laboratories providing total IgE analysis, data was acquired from 122 laboratories. An adult upper reference limit between 81 to 150 kU/L was reported by 89% of these. Denmark and Sweden reported the most harmonised RIs whilst Norway and the UK exhibited the least degree of harmonisation. Published adult ( n  = 6) and paediatric ( n  = 6) RI studies reported markedly higher upper limits than those currently in use by the laboratories included in this study. There were also large variations in the number of age strata in use for paediatric RIs., Conclusion: This study demonstrates large variations in currently utilised IgE RIs by Scandinavian and British accredited laboratories and most report markedly lower RIs than those recommended by recent RI publications. Many laboratories likely utilise outdated RIs and should consider critically reviewing and updating their RIs.

Objective: To assess the inter-laboratory comparability and intra-assay reproducibility of full blood count (FBC) results., Design: Exploratory cross-sectional study., Setting: Three and two selected medical laboratories in the northern and southern zones, respectively., Participants: Forty-nine individuals per zone; 16 type 2 diabetes mellitus, 16 with HbAS haemoglobin type and 17 normal samples., Intervention: Each sample was run eleven times through the analysers in the participating laboratories to evaluate intra-laboratory reproducibility and comparability of FBC results., Main Outcome Measure: Intra-laboratory reproducibility was evaluated using %coefficient variation (%CV). Interlaboratory comparisons were assessed through t-test or One-Way ANOVA for two-sample and three-sample tests. All statistical testing was undertaken using the two-tailed assumption., Result: Statistically significantly different haemoglobin levels were estimated in both northern and southern zones (mean difference 0.00 g/dL to 3.75 g/dL vs 0.18 g/dL to 1.92 g/dL respectively). Also, total WBC counts significantly differed across laboratories in both northern and southern zones (mean difference 0.15 ×10 9 /L - 3.86 ×10 9 /L vs 0.02 ×10 9 /L to 1.39 ×10 9 /L respectively). Furthermore, platelet counts significantly differed across the participating laboratories in the northern and southern zones (mean difference 0.40 ×10 9 /L to 299.76 ×10 9 /L vs 5.7 ×10 9 /L to 76.9 ×10 9 /L respectively). Moreover, there was evidence of non-reproducibility of results within the respective laboratories in each zone as the respective %CV were outside the acceptable limits., Conclusion: The intra-laboratory non-reproducibility and inter-laboratory non-comparability of FBC results highlight the need to establish a national quality assessment scheme to harmonise laboratory practices nationwide., Funding: This study was funded by the University of Cape Coast Individual-Led Research Support Grant (RSG-INDI-CoHAS-2019-107)., Competing Interests: Conflict of interest: None declared., (Copyright © The Author(s).)

Aim: The study objective was to evaluate the performance of sthemO 301 system and to compare it with the analyzer used in our university hospital laboratory (STA R Max® 2), for a selection of hemostasis parameters., Methods: Method comparison (according to CLSI EP09-A3), carryover (according to CLSI H57-A), APTT sensitivity to heparin (according to CLSI H47-A2), HIL level assessment, and productivity were performed using leftover samples from our laboratory (n > 1000). Commercial quality control materials were used to evaluate precision (according to CLSI EP15-A3) and accuracy. The assays tested on sthemO 301 were: PT, APTT (silica and kaolin activators), fibrinogen (Fib), thrombin time (TT), chromogenic and clotting protein C (PC) activity, and von Willebrand factor antigen (VWF:Ag) levels., Results: All intra-assay and inter-assay precision CVs were below the maximal precision limit proposed by the French Group for Hemostasis and Thrombosis (GFHT). Accuracy was verified with bias below GFHT criteria and most Z-scores were between -2 and +2. No clinically relevant carryover was detected. Silica APTT reagent sensitivity to unfractionated heparin was moderate, as expected. Productivity results were consistent over the 10 repeats performed. The overall agreement between the two systems was excellent for all assays, with Spearman rank correlation coefficient all above 0.9 and slopes of Passing-Bablok correlation near 1 and intercepts close to 0., Conclusion: For the methods tested, sthemO 301 system met all the criteria to implement a novel coagulation analyzer in the laboratory and result comparability with STA R Max® 2 was good., (© 2023 The Authors. Journal of Clinical Laboratory Analysis published by Wiley Periodicals LLC.)

There is limited guidance on laboratory reporting and interpretation of lipids and lipoproteins used in cardiovascular risk stratification. This contributes to inconsistencies in lipid reporting across clinical laboratories. Recently, the Canadian Cardiovascular Society (CCS) published the 2021 CCS guidelines for the management of dyslipidemia for the prevention of cardiovascular disease in the adult. A subcommittee of the Working Group on Reference Interval Harmonization of the Canadian Society of Clinical Chemists has developed harmonized lipid reporting recommendations that are aligned with the 2021 CCS guidelines, to improve the standardization of lipid assessment and clinical decision-making. The proposed harmonized lipid reporting recommendations were critically reviewed by a broad range of laboratory and clinical experts across Canada. Feedback from approximately 30 expert reviewers was reviewed by the Working Group on Reference Interval Harmonization lipid subcommittee, and consensus decisions were incorporated into the 2021 harmonized lipid reporting recommendations. In this position statement, we provide 6 recommendations for laboratory reporting of lipid parameters. These recommendations include implementing the new National Institutes of Health equation to replace the Friedewald equation for calculating low-density lipoprotein cholesterol, offering lipoprotein (a), either as an in-house or send-out test, and using assays that report lipoprotein (a) in molar units (nmol/L). We also developed a harmonized lipid reporting format with interpretive comments that includes flagging results based on screening patients using treatment decision thresholds in a primary prevention setting. Overall, harmonized lipid reporting will help bridge the gap between clinical guideline recommendations and clinical laboratory reporting and interpretation, and will improve cardiovascular risk assessment across Canada., (Copyright © 2022 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

Background: This study aimed to investigate the implementation and quality control of the quantitative detection of serum Helicobacter pylori (H. pylori) antibody in clinical laboratories in China., Methods: Online external quality assessment (EQA) questionnaires were distributed to the clinical laboratories by National Center for Clinical Laboratories (NCCL) of China. We collected information on the quantitative detection procedures of serum H. pylori antibody in clinical laboratories, including detection reagents, methods, instruments, calibrators, and internal quality control (IQC). We distributed quality control products to some select laboratories that conducted quantitative detection and analyzed the obtained test data. We evaluated the quantitative detection procedure based on the standard evaluation criteria set at a target value of ±30%., Results: 70.9% (146/206) of the laboratories conducted quantitative detection of H. pylori antibody; 29.1% (60/206) of the laboratories performed qualitative detection. Domestic reagents and matching calibrators accounted for more than 97.1% (200/206) of all reagents. Latex-enhanced immunoturbidimetry was used in 89.7% (131/146) of the laboratories for quantitative determination, while the colloidal gold method was used in 66.7% (40/60) of the laboratories for qualitative determination. A total of 130 laboratories participated in the EQA; 123 completed the assessment, and the pass rate was 75.6% (93/123)., Conclusion: Clinical quantitative detection of serum H. pylori antibody is performed at a high rate in China. Thus, further studies on the specificity of commercial detection reagents are needed. EQAs are useful to monitor and improve the detection quality of H. pylori antibodies., (© 2021 The Authors. Journal of Clinical Laboratory Analysis published by Wiley Periodicals LLC.)

This guidance document has been prepared on behalf of the International Council for Standardization in Haematology (ICSH). The aim of the document is to provide guidance and recommendations for the processing of citrated blood samples for coagulation tests in clinical laboratories in all regions of the world. The following areas are included in this document: Sample transport including use of pneumatic tubes systems; clots in citrated samples; centrifugation; primary tube storage and stability; interfering substances including haemolysis, icterus and lipaemia; secondary aliquots-transport, storage and processing; preanalytical variables for platelet function testing. The following areas are excluded from this document, but are included in an associated ICSH document addressing collection of samples for coagulation tests in clinical laboratories; ordering tests; sample collection tube and anticoagulant; preparation of the patient; sample collection device; venous stasis before sample collection; order of draw when different sample types are collected; sample labelling; blood-to-anticoagulant ratio (tube filling); influence of haematocrit. The recommendations are based on published data in peer-reviewed literature and expert opinion., (© 2021 John Wiley & Sons Ltd.)

Background: The measurement method for experimental resolution and related data to evaluate analytical performance is poorly explored in clinical research. We established a method to measure the experimental resolution of clinical tests, including biochemical tests, automatic hematology analyzer methods, immunoassays, chemical experiments, and qPCR, to evaluate their analytical performance., Methods: Serially diluted samples in equal proportions were measured, and correlation analysis was performed between the relative concentration and the measured value. Results were accepted for p ≤ 0.01 of the correlation coefficient. The minimum concentration gradient (eg, 10%) was defined as the experimental resolution. For this method, the smaller the value, the higher the experimental resolution and the better the analytical performance., Results: The experimental resolution of the most common biochemical indices reached 10%, with some even reaching 1%. The results of most counting experiments showed experimental resolution up to 10%, whereas the experimental resolution of the classical chemical assays reached 1%. Unexpectedly, the experimental resolution of more sensitive assays, such as immunoassays was only 25% when using the manual method and 10% for qPCR., Conclusion: This study established a method for measuring the experimental resolution of laboratory assays and provides a new index for evaluating the reliability of methods in clinical laboratories., (© 2021 The Authors. Journal of Clinical Laboratory Analysis published by Wiley Periodicals LLC.)

The adoption of whole genome sequencing (WGS) data over the past decade for pathogen surveillance, and decision-making for infectious diseases has rapidly transformed the landscape of clinical microbiology and public health. However, for successful transition to routine use of these techniques, it is crucial to ensure the WGS data generated meet defined quality standards for pathogen identification, typing, antimicrobial resistance detection and surveillance. Further, the ongoing development of these standards will ensure that the bioinformatic processes are capable of accurately identifying and characterising organisms of interest, and thereby facilitate the integration of WGS into routine clinical and public health laboratory setting. A pilot proficiency testing (PT) program for WGS of infectious agents was developed to facilitate widely applicable standardisation and benchmarking standards for WGS across a range of laboratories. The PT participating laboratories were required to generate WGS data from two bacterial isolates, and submit the raw data for independent bioinformatics analysis, as well as analyse the data with their own processes and answer relevant questions about the data. Overall, laboratories used a diverse range of bioinformatics tools and could generate and analyse high-quality data, either meeting or exceeding the minimum requirements. This pilot has provided valuable insight into the current state of genomics in clinical microbiology and public health laboratories across Australia. It will provide a baseline guide for the standardisation of WGS and enable the development of a PT program that allows an ongoing performance benchmark for accreditation of WGS-based test processes., (Copyright © 2021 Royal College of Pathologists of Australasia. Published by Elsevier B.V. All rights reserved.)

In the field of laboratory medicine, proficiency testing is a vehicle used to improve the reliability of reported results. When proficiency tests are unavailable for a given analyte, an alternative approach is required to ensure adherence to the International Organization for Standardization (ISO) 15189:2012 standard. In this study, we report the results of a split-sample testing program performed as an alternative to a formal PT. This testing method was based on recommendations provided in the Clinical and Laboratory Standards Institute (CLSI) QMS24 guideline. Two different laboratories measured, in duplicate, the heparan sulfate concentration in five samples using ultra-performance liquid chromatography and tandem mass spectrometry. The data analysis to determine the criterion used for the comparability assessment between the two laboratories was based on Appendix E of the QMS24 guideline. Mean interlaboratory differences fell within the maximum allowable differences calculated from the application of the QMS24 guideline, indicating that the results obtained by the two laboratories were comparable across the concentrations tested. Application of the QMS24 split-sample testing procedure allows laboratories to objectively assess test results, thus providing the evidence needed to face an accreditation audit with confidence. However, due to the limitations of statistical analyses in small samples (participants and/or materials), laboratory specialists should assess whether the maximum allowable differences obtained are suitable for the intended use, and make adjustments if necessary., (Copyright © 2021 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.)

Background and Purpose: Currently there are no widely accepted guidelines for chimerism analysis testing in hematopoietic cell transplantation (HCT) patients. The objective of this review is to provide a practical guide to address key aspects of performing and utilizing chimerism testing results. In developing this guide, we conducted a survey of testing practices among laboratories that are accredited for performing engraftment monitoring/chimerism analysis by either the American Society for Histocompatibility & Immunogenetics (ASHI) and/or the European Federation of Immunogenetics (EFI). We interpreted the survey results in the light of pertinent literature as well as the experience in the laboratories of the authors., Recent Developments: In recent years there has been significant advances in high throughput molecular methods such as next generation sequencing (NGS) as well as growing access to these technologies in histocompatibility and immunogenetics laboratories. These methods have the potential to improve the performance of chimerism testing in terms of sensitivity, availability of informative genetic markers that distinguish donors from recipients as well as cost., Summary: The results of the survey revealed a great deal of heterogeneity in chimerism testing practices among participating laboratories. The most consistent response indicated monitoring of engraftment within the first 30 days. These responses are reflective of published literature. Additional clinical indications included early detection of impending relapse as well as identification of cases of HLA-loss relapse., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Dr. Askar has received compensation as a member of the scientific advisory board for CareDx, Inc. Dr. Blouin, Dr. Ye, and Ms. Williams declare no potential competing interests., (Copyright © 2021 American Society for Histocompatibility and Immunogenetics. Published by Elsevier Inc. All rights reserved.)

Introduction: There have been no specific guidelines regarding which genes should be tested in the clinical setting for Parkinson's disease (PD) or parkinsonism. We evaluated the types of clinical genetic testing offered for PD as the first step of our gene curation., Methods: The National Institutes of Health (NIH) Genetic Testing Registry (GTR) was queried on 12/7/2020 to identify current commercial PD genetic test offerings by clinical laboratories, internationally., Results: We identified 502 unique clinical genetic tests for PD, from 28 Clinical Laboratory Improvement Amendments (CLIA)-approved clinical laboratories. These included 11 diagnostic PD panels. The panels were notable for their differences in size, ranging from 5 to 62 genes. Five genes for variant query were included in all panels (SNCA, PRKN, PINK-1, PARK7 (DJ1), and LRRK2). Notably, the addition of the VPS35 and GBA genes was variable. Panel size differences stemmed from inclusion of genes linked to atypical parkinsonism and dystonia disorders, and genes in which the link to PD causation is controversial., Conclusion: There is an urgent need for expert opinion regarding which genes should be included in a commercial laboratory multi-gene panel for PD., (Copyright © 2021 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Background: The six sigma model has been widely used in clinical laboratory quality management. In this study, we first applied the six sigma model to (a) evaluate the analytical performance of urinary biochemical analytes across five laboratories, (b) design risk-based statistical quality control (SQC) strategies, and (c) formulate improvement measures for each of the analytes when needed., Methods: Internal quality control (IQC) and external quality assessment (EQA) data for urinary biochemical analytes were collected from five laboratories, and the sigma value of each analyte was calculated based on coefficients of variation, bias, and total allowable error (TEa). Normalized sigma method decision charts for these urinary biochemical analytes were then generated. Risk-based SQC strategies and improvement measures were formulated for each laboratory according to the flowchart of Westgard sigma rules, including run sizes and the quality goal index (QGI)., Results: Sigma values of urinary biochemical analytes were significantly different at different quality control levels. Although identical detection platforms with matching reagents were used, differences in these analytes were also observed between laboratories. Risk-based SQC strategies for urinary biochemical analytes were formulated based on the flowchart of Westgard sigma rules, including run size and analytical performance. Appropriate improvement measures were implemented for urinary biochemical analytes with analytical performance lower than six sigma according to the QGI calculation., Conclusions: In multilocation laboratory systems, a six sigma model is an excellent quality management tool and can quantitatively evaluate analytical performance and guide risk-based SQC strategy development and improvement measure implementation., (© 2021 The Authors. Journal of Clinical Laboratory Analysis published by Wiley Periodicals LLC.)