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 Covid-19 pandemic and ongoing war in Ukraine caused unprecedented disruption in healthcare, including cytopathology activities. This paper elucidates the effect of two consecutive disasters-the COVID-19 pandemic followed by the war-on cytopathology practice in Ukraine through a single-centre retrospective study. Total testing volumes, geographic distribution, and indicators of laboratory operations were assessed during three periods of 3 months each: the first 3 months of the acute phase of the war (March-May 2022, period 1); summer (June-August 2022, period 2); and the fall (September-November 2022, period 3, associated with massive attacks on the energy infrastructure in Ukraine). These data were compared with the corresponding periods in 2020, during the COVID-19 pandemic, and in 2021, the post-lockdown period. The ongoing war in Ukraine has caused a dramatic disruption in routine health maintenance and cytological practice. A net decline in both PAP testing and non-gynaecological pathology was associated with a geographic redistribution of cytopathological testing, and an increase in the rate of abnormal sample reporting. Despite these challenges, cytopathology practice in Ukraine demonstrates resilience, allowing for maintaining the healthcare system and addressing the needs of the civil population during the war. The ongoing war in Ukraine heavily affected cytological practice. The decline in PAP testing during the early period of the war was associated with an increase in the abnormal sample rate. Further study of the war\'s impact on the cervical pathology rate and the health of the population in the next decades is needed.

UNASSIGNED: Since 2007, national public health laboratories in the WHO Eastern Mediterranean Region (EMR) have participated in a regional external quality assessment scheme in bacteriology to improve testing proficiency.
UNASSIGNED: To assess laboratory performance in bacteriology in the EMR between 2011 and 2019 using the regional external quality assessment scheme.
UNASSIGNED: We analysed the accuracy of participant-reported data in bacterial identification, Gram stain microscopy, and antimicrobial susceptibility testing. For each category, we assessed the performance over time, the performance on multiple organisms, and whether a laboratory repeatedly failed to attain satisfactory results.
UNASSIGNED: Between 2011 and 2019, 70% of laboratories achieved satisfactory performance for bacterial identification and antimicrobial susceptibility testing, and 85% performed satisfactory Gram stain microscopy. Testing did not improve on multiple organisms and results were consistently low for some pathogens and test categories. Twenty-nine percent of laboratories underperformed throughout the study period.
UNASSIGNED: The unchanged performance over time and underperformance of laboratories highlight the need for improvements in the regional external quality assessment scheme. Participating laboratories and WHO need to work more actively to strengthen the problem areas.
التقييم الخارجي لجودة أداء المختبرات المتخصصة في علم الجراثيم في إقليم شرق المتوسط، 2011–2019.
همايون أصغر، كارين نهابتيان، أماني غنيم، فرانك كونينجز، أمينة الجرداني.
UNASSIGNED: منذ عام 2007 ، شاركت مختبرات الصحة العامة الوطنية في إقليم شرق المتوسط في مخطط إقليمي للتقييم الخارجي للجودة في علم الجراثيم لتحسين كفاءة الاختبارات.
UNASSIGNED: هدفت هذه الدراسة الى تقييم أداء المختبرات في مجال علم الجراثيم في إقليم شرق المتوسط بين عامَي 2011 و 2019 ، باستخدام النظام الإقليمي للتقييم الخارجي للجودة.
UNASSIGNED: حللنا دقة البيانات التي أبلغ بها المشاركون فيما يخص تحديد الجراثيم، والفحص المجهري لصبغة جرام، واختبار الحساسية لمضادات الميكروبات. وبالنسبة إلى كل فئة، قيمنا الأداء مع مرور الزمن، والأداء على كائنات حية متعددة، وما إذا كان المختبر قد فشل مرارًا في تحقيق نتائج مُرضية.
UNASSIGNED: بين عامَي 2011 و 2019 ، حقق 70 ٪ من المختبرات أداءً مُرضيًا في التعرف على الجراثيم وتحديدها واختبار الحساسية لمضادات الميكروبات، ونفذ 85 ٪ منها الفحصَ المجهري لصبغة جرام تنفيذًا مُرضيًا. ولم يتحسن مستوى الاختبار على كائنات حية متعددة، وكانت النتائج منخفضة باستمرار فيما يخص بعض مسببات الأمراض وفئات الاختبارات. وكان أداء 29 ٪ من المختبرات دون المستوى خلال فترة الدراسة.
UNASSIGNED: إن عدم تغيُُّّر الأداء بمرور الوقت والأداء القاصر للمختبرات يبرزان الحاجة إلى إدخال تحسينات على الخطة الإقليمية للتقييم الخارجي للجودة. لذا، يتعيََّّن على المختبرات المشارِكة و المختبرات المشاركة ومنظمة الصحة العالمية بحاجة إلى العمل بشكل أكثر نشاطا لتقوية مناطق المشاكل.
Évaluation externe de la qualité des performances des laboratoires en bactériologie dans la Région de la Méditerranée orientale, 2011-2019.
UNASSIGNED: Depuis 2007, les laboratoires de santé publique nationaux de la Région OMS de la Méditerranée orientale ont participé à un système régional d\'évaluation externe de la qualité en bactériologie afin d\'améliorer la bonne exécution des analyses.
UNASSIGNED: Évaluer les performances des laboratoires en bactériologie dans la Région de la Méditerranée orientale entre 2011 et 2019 à l\'aide du système régional d\'évaluation externe de la qualité.
UNASSIGNED: Nous avons analysé l\'exactitude des données communiquées par les participants concernant l\'identification bactérienne, la microscopie après coloration de Gram et les tests de sensibilité aux antimicrobiens. Pour chaque catégorie, nous avons évalué la performance au fil du temps, la performance sur plusieurs micro-organismes et avons vérifié si un laboratoire n\'a pas obtenu des résultats satisfaisants à plusieurs reprises.
UNASSIGNED: Entre 2011 et 2019, 70 % des laboratoires ont obtenu des résultats satisfaisants pour l\'identification bactérienne et les tests de sensibilité aux antimicrobiens, et 85 % ont effectué une microscopie après coloration de Gram satisfaisante. Les tests ne se sont pas améliorés sur plusieurs micro-organismes et les résultats étaient systématiquement faibles pour certains agents pathogènes et certaines catégories de tests. Vingt-neuf pour cent des laboratoires ont eu des résultats insuffisants tout au long de la période d\'étude.
UNASSIGNED: Les performances inchangées au cours du temps et les résultats insuffisants des laboratoires soulignent la nécessité d\'améliorer le système régional d\'évaluation externe de la qualité. Les laboratoires participants et l\'OMS doivent collaborer plus activement pour renforcer les domaines qui posent problème.

Medical laboratories may, at their own discretion, exceed but not undercut regulatory quality requirements. Available economic resources, however, may drive or hinder eagerness to exceed minimum requirements. Depending on the respective scopes of regulatory and economic framework conditions, differing levels of quality efforts to safeguard laboratory performance can be anticipated. However, this has not yet been investigated.
Immunohaematology external quality assessment (EQA) results collected by 26 EQA providers from their participant laboratories in 73 countries from 2004 to 2019 were evaluated. Error rates were aggregated in groups according to the respective national regulatory and economic framework conditions, to whether or not expert advice was provided in case of incorrect results, and the frequency of EQA samples.
These representative data indicate no association between national regulatory (mandatory participation in EQA, monitoring of performance of individual laboratories by authorities, financial consequences of incorrect results) and economic (level of national income, share of national health expenditure) conditions to the quality performance of medical laboratories in immunohaematology. However, EQA providers\' support for laboratories in the event of incorrect results appear to be associated with lower error rates, but a high EQA sample frequency with higher error rates.
Further research into the impact of introducing or changing services of EQA providers is needed to confirm the results found in this first of its kind study.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) presented numerous operational challenges to healthcare delivery networks responsible for implementing large scale detection of Coronavirus Disease 2019 (COVID-19), the infection caused by SARS-CoV-2. We describe testing performance, review data quality metrics, and summarize experiences during the scale up of laboratory-based detection of COVID-19 in the Veterans Health Administration, the largest healthcare system in the United States. During March 2020 to February 2021, we observed rapid increase in testing volume, decreases in test turnaround time, improvements in testing of hospitalized persons, changes in test positivity, and varying utilization of different tests. Though performance metrics improved over time, surges challenged testing capacity and data quality remained suboptimal. Future planning efforts should focus on fortifying supply chains for consumables and equipment repair, optimizing distribution of testing workload across laboratories, and improving informatics to accurately monitor operations and intent for testing during a public health emergency.

UNASSIGNED: Total laboratory automation (TLA) is an innovation in laboratory technology; however, the high up-front costs restrict its widespread adoption. To examine whether the capital investment for TLA is worthwhile, we analyzed its clinical- and cost-effectiveness for the expected payback period.
UNASSIGNED: Clinical chemistry tests and immunoassays performed in the clinical laboratory of a tertiary care hospital were divided into a post-TLA group, including 1,182,419 tests performed during December 2019, and a pre-TLA group, including 1,151,501 tests performed during December 2018. Laboratory information system data were used to measure clinical effectiveness, and depreciation data were used to calculate TLA costs.
UNASSIGNED: Laboratory performance improved after TLA adoption in all four key performance indicators: mean turn-around time (TAT), representing the timeliness of result reporting, decreased by 6.1%; the 99th percentile of TAT, representing the outlier rate, decreased by 13.3%; the TAT CV, representing predictability, decreased by 70.0%; and weighted tube touch moment (wTTM), representing staff safety, improved by 77.6%. Based on these effectiveness results, economic evaluation was performed using two approaches. First, the incremental cost-effectiveness ratio and wTTM were used as the most cost-effective performance indicators. Second, the expected payback period was calculated. Considering only staff cost reduction, it was anticipated that 4.75 yrs would be needed to payback the initial investment.
UNASSIGNED: TLA can significantly enhance laboratory performance, has a relatively quick payback period, and can reduce total hospital expenses in the long term. Therefore, the capital investment for TLA adoption is considered to be worthwhile.

Instrumented mouthpieces (IM) offer a means of measuring head impacts that occur in sport. Direct measurement of angular head kinematics is preferential for accuracy; however, existing IMs measure angular velocity and differentiate the measurement to calculate angular acceleration, which can limit bandwidth and consume more power. This study presents the development and validation of an IM that uses new, low-power accelerometers for direct measurement of linear and angular acceleration over a broad range of head impact conditions in American football. IM sensor accuracy for measuring six-degree-of-freedom head kinematics was assessed using two helmeted headforms instrumented with a custom-fit IM and reference sensor instrumentation. Head impacts were performed at 10 locations and 6 speeds representative of the on-field conditions associated with injurious and non-injurious impacts in American football. Sensor measurements from the IM were highly correlated with those from the reference instrumentation located at the maxilla and skull center of gravity. Based on pooled data across headform and impact location, R2 ≥ 0.94, mean absolute error (AE) ≤ 7%, and mean relative impact angle ≤ 11° for peak linear and angular acceleration and angular velocity while R2 ≥ 0.90 and mean AE ≤ 7% for kinematic-based injury metrics used in helmet tests.

UNASSIGNED: High-level monthly, quarterly and annual turn-around time (TAT) reports are used to assess laboratory performance across the National Health Laboratory Service in South Africa. Individual laboratory performances are masked by aggregate TAT reporting across network of testing facilities.
UNASSIGNED: This study investigated weekly TAT reporting to identify laboratory inefficiencies for intervention.
UNASSIGNED: CD4 TAT data were extracted for 46 laboratories from the corporate data warehouse for the 2016/2017 financial period. The total TAT median, 75th percentile and percentage of samples meeting organisational TAT cut-off (90% within 40 hours) were calculated. Total TAT was reported at national, provincial and laboratory levels. Provincial TAT performance was classified as markedly or moderately poor, satisfactory and good based on the percentage of samples that met the cut-off. The pre-analytical, testing and result review TAT component times were calculated.
UNASSIGNED: Median annual TAT was 18.8 h, 75th percentile was 25 h and percentage within cut-off was 92% (n = 3 332 599). Corresponding 75th percentiles of component TAT were 10 h (pre-analytical), 22 h testing and 1.6 h review. Provincial 75th percentile TAT varied from 17.6 h to 34.1 h, with three good (n = 13 laboratories), four satisfactory (n = 24 laboratories) and two poor performers (n = 9 laboratories) provinces. Weekly TAT analysis showed 12/46 laboratories (28.6%) without outlier weeks, 31/46 (73.8%) with 1-10 outlier weeks and 3/46 (6.5%) with more than 10 (highest of 20/52 weeks) outlier weeks.
UNASSIGNED: Masked TAT under-performances were revealed by weekly TAT analyses, identifying poorly performing laboratories needing immediate intervention; TAT component analyses identified specific areas for improvement.

The most common use of reclaimed asphalt pavement (RAP) is in the lower layers of a pavement structure, where it has been proven as a valid substitute for virgin materials. The use of RAP in surface mixes is more limited, since a major concern is that the high-RAP mixes may not perform as well as traditional mixes. To reduce risks or compromised performance, the use of RAP has commonly been controlled by specifications that limit the allowed amount of recycled material in the mixes. However, the ability to include greater quantities of RAP in the surface mix while maintaining a satisfying field performance would result in potential cost savings for the agencies and environmental savings for the public. The main purpose of this research was to produce highly recycled surface mixes capable of performing well in the field, verify the performance-based design procedure, and analyze the results. To produce the mixes, a balanced mix design (BMD) methodology was used and a comparison with traditional mixes, prepared in accordance with the requirements of the Virginia Department of Transportation\'s volumetric mix design, was performed. Through the BMD procedure, which featured the indirect tensile cracking test for evaluating cracking resistance and the Asphalt Pavement Analyzer (APA) for evaluating rutting resistance, it was possible to obtain a highly recycled mix (45% RAP) capable of achieving a better overall laboratory performance than traditional mixes designed using volumetric constraints while resulting in a reduction in production cost.

Exome sequencing has become an effective diagnostic method for Mendelian disorders. But the quality of services differs widely across laboratories in China, particularly in variant classification, even with the adoption of the ACMG guidelines. As an effort of quality control and improvement for better clinical utilization of exome sequencing, we assessed the exome data analysis and clinical reporting among Chinese laboratories. Five raw datasets of real clinical samples with associated phenotypes were sent to 53 laboratories. The participants independently performed secondary analysis, variant classification, and reporting. The first round of results was used for identifying problems associated with these aspects. Subsequently, we implemented several corrective actions and a training program was designed based on the identified issues. A second round of five datasets were sent to the same participants. We compared the performances in variant interpretation and reporting. A total of 85.7% (42/49) of participants correctly identified all the variants related with phenotype. Many lines of evidence using the ACMG guidelines were incorrectly utilized, which resulted in a large inter-laboratory discrepancy. After training, the evidence usage problems significantly improved, leading to a more consistent outcome. Participants improved their exome data analysis and clinical reporting capability. Targeted training and a deeper understanding of the ACMG guidelines helped to improve the clinical exome sequencing service in terms of consistency and accuracy in variant classification in China.