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Abstract Background Proficiency testing (PT) should identify systematic errors, which are likely to recur. The Clinical Laboratory Improvement Amendments of 1988 (CLIA) acceptance limits (ALs) include 3 standard deviations (3SD) and concentration limits. We investigated the ability of PT to detect systematic error, especially as affected by the different AL types. Methods We removed any ungradable, duplicate, and irregular scores from CLIA laboratory PT data from 2008 to 2018. We calculated the overall miss rate, unsatisfactory event rate, i.e., score <80 (4 of 5 correct), and event rates for score 100 to 0. We used paired t-tests and the Wilcoxon signed-rank test to compare miss rates and unsatisfactory event rates between short- and long-term PT participants. We used the binomial distribution to estimate the expected event scores under the assumption that all misses were independent (random). We compared observed event scores with their expected values as a ratio. Results Forty thousand five hundred ninety-six laboratories produced 15 140 128 event scores for 75 analytes. The distribution of event scores was skewed toward multiple event misses (score 0–60) compared to the predicted distribution. Miss rates and unsatisfactory rates were significantly higher for short-term laboratories. Plotting the log ratio of observed vs expected rates for event scores showed that the degree of systematic effect was substantial. The magnitude of the effect was less for 3SD ALs. Conclusions In an event, PT misses are often dependent. All ALs detected systematic error. Expressing systematic error using PT data could help to identify and remediate analytical issues.

The joint College of American Pathologists/American College of Medical Genetics and Genomics Cytogenetics Committee works to ensure competency and proficiency of clinical cytogenetics testing laboratories through proficiency testing programs for various clinical tests offered by such laboratories, including the evaluation of constitutional abnormalities. To review and analyze 20 years of constitutional chromosome analysis proficiency testing results (2003-2022), primarily utilizing G-banded karyograms. A retrospective review of results from 2003 through 2022 was performed, identifying challenges addressing constitutional disorders. The chromosomal abnormalities and overall performance were evaluated. A total of 184 cases from 161 proficiency testing challenges were administered from 2003 through 2022. Challenges consisted of metaphase images and accompanying clinical history for evaluation of numerical and/or structural abnormalities. Of the 184 cases, only 2 (1%) failed to reach an 80% grading consensus for recognition of the abnormality. Both cases illustrated the limitations of correctly characterizing some chromosomal abnormalities, including recombinant chromosomal abnormalities and isochromosome identification. In addition, 2 cases failed to reach a consensus for nomenclature reporting: 1 with an isochromosome and another with a duplication. This 20-year review illustrates the high rate of competency and proficiency of cytogenetic laboratories in the correct identification of constitutional chromosome abnormalities.

In Brazil, while there are legal regulations establishing technical requirements to promote quality management systems in forensic genetics laboratories based on ISO standards, accreditation is not yet mandatory. In this study, we assess the compliance of Brazilian forensic genetics laboratories with ISO/IEC 17025 and try to identify the challenges these labs face in meeting those standards. A survey was responded by the 28 laboratories of the Integrated Network of Genetic Profile Databases (RIBPG) in order to gauge compliance with eight critical criteria: personnel management, equipment management, equipment calibration, method validation, proficiency testing, internal auditing, risk management, and critical review. The results indicate that laboratories reported greater compliance with ISO/IEC 17025 clauses already mandated and audited under the current national quality standard (Resolution 12 of the CG-RIBPG), such as pessoal competence (64 %) and equipment management (57 %). However, the results also revealed challenges in meeting some ISO requirements, especially those related to procurement of external services such as calibration (29 %) and proficiency testing through accredited providers (14 %). This article highlights the need for strategic public policy projects to support forensic laboratory accreditation, including capacity-building, specialized training, and monitoring of implementation. External motivators for accreditation and strategies tailored to the specific needs of the laboratories are also necessary. ●Survey assessed compliance of Brazilian forensic genetics labs with ISO/IEC 17025.●Challenges identified include external calibration and proficiency testing.●89 % of laboratories found personnel competence criteria easy to meet.●Strategic public policies needed to support accreditation in forensic genetics.●Results emphasize tailored strategies to address labs' specific accreditation barriers.

In the last decade, there has been an increasing interest in measuring and evaluating intangible assets, not only by private firms but also by knowledge organizations such as universities, research centers, and testing laboratories. This paper aims to present a model for measuring and evaluating intangible assets developed for electrical equipment diagnosis and testing laboratories. For the proposal and selection of indicators and metrics that integrate the model, multicriteria decision support methods were embedded into the model, combined with fuzzy logic. The applicability of the model has been demonstrated through an empirical study in one electrical equipment diagnosis and testing laboratory that integrates the Laboratory Network of Eletrobras Enterprises (Relase) in Brazil. The results of this research can be replicated within Relase, which covers today a total of 98 laboratories, of which 16 are accredited for calibration services.

Compliance with all the requirements in the ISO/IEC 17025:2017 is crucial for testing and calibration laboratories in assuring the quality of measurement conducted in their laboratories. The latest version of the ISO/IEC 17025:2017 presents a different structure compared to the previous version, ISO/IEC 17025:2005. Therefore, amendments in the quality documents and the operational procedures in the laboratories are urgently required. However, not all laboratories’ personnel understand this new standard and know how to implement or incorporate this new version standard with their old version documents and operational procedures. It causes a problem for the testing and calibration laboratories, especially in Indonesia. This study is expected to provide enlightenment and hints for the laboratories struggling to comply with the ISO/IEC 17025:2017.

Microscopy performed on stained films of peripheral blood for detection, identification and quantification of malaria parasites is an essential reference standard for clinical trials of drugs, vaccines and diagnostic tests for malaria. The value of data from such research is greatly enhanced if this reference standard is consistent across time and geography. Adherence to common standards and practices is a prerequisite to achieve this. The rationale for proposed research standards and procedures for the preparation, staining and microscopic examination of blood films for malaria parasites is presented here with the aim of improving the consistency and reliability of malaria microscopy performed in such studies. These standards constitute the core of a quality management system for clinical research studies employing microscopy as a reference standard. They can be used as the basis for the design of training and proficiency testing programmes as well as for procedures and quality assurance of malaria microscopy in clinical research.

Background An understanding of viral testing rates is crucial to accurately estimate the pathogen‐specific hospitalisation burden. We aimed to estimate the patterns of testing for respiratory syncytial virus (RSV), influenza virus, parainfluenza virus (PIV) and human metapneumovirus (hMPV) by geographical location, age and time in children <5 years old in Western Australia. Methods We conducted a population‐based cohort study of children born between 1 January 2010 and 31 December 2021, utilising linked administrative data incorporating birth and death records, hospitalisations and respiratory viral surveillance testing records from state‐wide public pathology data. We examined within‐hospital testing rates using survival analysis techniques and identified independent predictors of testing using binary logistic regression. Results Our dataset included 46,553 laboratory tests for RSV, influenza, PIV, or hMPV from 355,021 children (52.5% male). Testing rates declined in the metropolitan region over the study period (RSV testing in infants: from 242.11/1000 child‐years in 2012 to 155.47/1000 child‐years in 2018) and increased thereafter. Conversely, rates increased in non‐metropolitan areas (e.g., RSV in Goldfields: from 364.92 in 2012 to 504.37/1000 child‐years in 2021). The strongest predictors of testing were age <12 months (adjusted odds ratio [aOR] = 2.25, 95% CI 2.20–2.31), preterm birth (<32 weeks: aOR = 2.90, 95% CI 2.76–3.05) and remote residence (aOR = 0.77, 95% CI 0.73–0.81). Conclusion These current testing rates highlight the potential underestimation of respiratory virus hospitalisations by routine surveillance and the need for estimation of the true burden of respiratory virus admissions.

In the latest revision of the ISO/IEC 17025 standard, General requirements for the competence of testing and calibration laboratories, published in 2017, the concept of risk-based thinking was introduced in its requirements. Although the new version introduces the concept, procedures to be adopted for the implementation of risk management in testing and calibration laboratories are not addressed. The article is conceptual in nature and summarizes information from the literature to assess the application of reputable risk management models and implement them in laboratories. Furthermore, it includes discussions on the implementation of risk management in the daily laboratory operations in a practical and effective way as per the requirements of ISO/IEC 17025.

BACKGROUND AND CONTEXT: Rural health services without an onsite laboratory lack timely access to haematology results. Set in New Zealand’s far north, this paper provides a rural nursing perspective on how a health service remote from a laboratory introduced a haematology analyser suitable for point-of-care use and established the associated quality assurance programme.ASSESSMENT OF PROBLEM: Five broad areas were identified that could impact on successful implementation of the haematology analyser: quality control, staff training, physical resources, costs, and human resource requirements.RESULTS: Quality control testing, staff training and operating the haematology analyser was more time intensive than anticipated. Finding adequate physical space for placement and operation of the analyser was challenging and costs per patient tests were higher than predicted due to low volumes of testing.STRATEGIES FOR IMPROVEMENT: Through a collaborative team approach, a modified quality assurance programme was agreed on with the supplier and regional point-of-care testing co-ordinator, resulting in a reduced cost per test. The supplier provided dedicated hours of staff training. Allocated time was assigned to run point-of-care testing quality assurance.LESSONS: Having access to laboratory tests can reduce inequalities for rural patients, but natural enthusiasm to introduce new point-of-care technologies and devices needs to be tempered by a thorough consideration of the realities on the ground. Quality assurance programmes need to fit the locality while being overseen and supported by laboratory staff knowledgeable in point-of-care testing requirements. Associated costs need to be sustainable in both human and physical resources.

Many production systems employ standardized statistical monitors that measure defect rates and cycle times, as indices of performance quality. Clinical laboratory testing, a system that produces test results, is amenable to such monitoring. To demonstrate patterns in clinical laboratory testing defect rates and cycle time using 7 College of American Pathologists Q-Tracks program monitors. Subscribers measured monthly rates of outpatient order-entry errors, identification band defects, and specimen rejections; median troponin order-to-report cycle times and rates of STAT test receipt-to-report turnaround time outliers; and critical values reporting event defects, and corrected reports. From these submissions Q-Tracks program staff produced quarterly and annual reports. These charted each subscriber's performance relative to other participating laboratories and aggregate and subgroup performance over time, dividing participants into best and median performers and performers with the most room to improve. Each monitor's patterns of change present percentile distributions of subscribers' performance in relation to monitoring durations and numbers of participating subscribers. Changes over time in defect frequencies and the cycle duration quantify effects on performance of monitor participation. All monitors showed significant decreases in defect rates as the 7 monitors ran variously for 6, 6, 7, 11, 12, 13, and 13 years. The most striking decreases occurred among performers who initially had the most room to improve and among subscribers who participated the longest. All 7 monitors registered significant improvement. Participation effects improved between 0.85% and 5.1% per quarter of participation. Using statistical quality measures, collecting data monthly, and receiving reports quarterly and yearly, subscribers to a comparative monitoring program documented significant decreases in defect rates and shortening of a cycle time for 6 to 13 years in all 7 ongoing clinical laboratory quality monitors.