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The article discusses the evolution of dermatopathology education at Harvard Medical School, particularly focusing on the contributions of Dr. Martin C. Mihm, Jr. The program was established in 1975 and has since expanded to two training programs at different Harvard-affiliated institutions. Graduates have excelled in various fields, including academia, research, and commercial enterprises. The legacy of Dr. Mihm continues to inspire excellence in teaching, investigation, and patient care within the field of dermatopathology. [Extracted from the article]

The EN ISO 15189:2022 standard, titled “Medical laboratories – Requirements for quality and competence,” is a significant update to the regulations for medical laboratories. The revised standard was published on December 6, 2022, replacing both EN ISO 15189:2012 and EN ISO 22870:2016. Key objectives of the revision include: 1. Alignment with ISO/IEC 17025:2017, 2. Removal of unintended prescription, 3. Focus on patient interest and safety, 4. Minimization of new requirements, and 5. Improved clarity of text. Dedicating to harmonizing accreditation processes across Europe the EFLM Committee on Accreditation and ISO/CEN standards (C: A/ISO) has produced this guidance document to assist the laboratory medicine community in understanding and implementing the criteria of the EN ISO 15189 revision. Two main objectives of the guidance in educating both laboratories and accreditation bodies with their assessors as well as other stakeholders in laboratory medicine were agreed on. Firstly, to clarify the relevant changes covering all paragraphs of the standard and secondly to make an impact analysis on previous C: A/ISO guidance documents. [ABSTRACT FROM AUTHOR]

The main stakeholders in external quality assessment (EQA) programs are the participants, in whose interests these challenges are ultimately organised. EQA schemes in the medical field contribute to improving the quality of patient care by evaluating the analytical and diagnostic quality of laboratory and point-of-care tests (POCT) by independent third parties and, if necessary, pointing out erroneous measurement results and analytical or diagnostic improvement potential. Other benefits include the option of using EQA samples for other important laboratory procedures, such as the verification or validation of in vitro diagnostic medical devices (IVD-MDs), a contribution to the estimation of measurement uncertainty, a means of training and educating laboratory staff through educational EQA programmes or samples, or even for independent and documented monitoring of staff competence, such as on samples with unusual or even exceptional characteristics. Participation in an EQA scheme for beneficiaries like medical, microbiological and histo- and molecular pathology laboratories, users of POCT and self-testing systems as well as National Metrology Institutes, calibration laboratories and reference laboratories that are dedicated to specific tasks and have particular expectations of the EQA scheme are presented here. [ABSTRACT FROM AUTHOR]

Direct-to-consumer testing (DTCT) refers to commercial laboratory tests initiated by laypersons without the involvement of healthcare professionals. As this market grows in size and variety of products, a clear definition of DTCT to ground the conceptualization of their harms and benefits is needed. We describe how three different modalities of DTCT (home self-testing, self-sampled tests, and direct access tests) present caveats to the traditional testing process ('brain-to-brain loop'), and how this might differ between medical vs. non-medical laboratories. We make recommendations for ways to improve quality and reduce errors with respect to DTCT. The potential benefits and harms of DTCT will invariably depend on the context and situation of individual consumers and the types of tests involved. Importantly, implications for both consumers and the healthcare system should be considered, such as the effects on improving health outcomes and reducing unnecessary testing and use of clinical resources. 'Consumer initiation' must be a central defining characteristic of DTCT, to clearly demarcate the key drawbacks as well as opportunities of this type of testing from a laboratory specialists' perspective. The concept of 'consumer initiated testing' should also help define DTCT regulation, and provide a locus of efforts to support consumers as the main decision-makers in the purchasing and conducting of these tests in the absence of clinician gatekeeping. [ABSTRACT FROM AUTHOR]

AbstractPoor analytical quality may be the bane of medical use of laboratory tests, and the fight against excessive analytical variability presents a daily struggle. Laboratories should prioritize the perspectives and needs of their customers (the patients and healthcare personnel). Among them, comparability of results from the same patient sample when measured by different laboratories using different in vitro diagnostic (IVD) medical devices is a logical priority to avoid result misinterpretation and potential patient harm. Harmonization (standardization) of laboratory measurements can be achieved by establishing metrological traceability of the results on clinical samples to stated higher-order references and providing an estimate of the uncertainty of measurement (MU). This estimate should be based on an MU budget including all known MU contributions generated by the employed calibration hierarchy, which in turn should be validated against fit-for-purpose maximum allowable MU derived according to internationally recommended models. In this report, we review the available strategies for establishing, evaluating, and monitoring analytical quality, drawing on three decades experience in the field. We discuss the most important aspects that may influence obtaining and maintaining analytical standardization in laboratory medicine, and offer practical solutions aimed at educating all stakeholders for the achievement of harmonized laboratory results. To fully implement the recommended approaches, all involved parties—i.e. reference providers, IVD manufacturers, medical laboratories, and External Quality Assessment organizers—must agree on their importance and enhance their specific knowledge. [ABSTRACT FROM AUTHOR]

This paper focuses on the estimation of efficiency within the medical laboratories industry, a sector of vital importance in healthcare due to its provision of essential diagnostic services. To this end, we employ three distinct stochastic frontier models to evaluate the technical efficiency of the medical laboratory industry. Our benchmark model stands out by considering the presence of heterogeneity, leading to robust findings compared to alternative models. The mean efficiency estimate is determined to be 70.6%, while the median efficiency estimate stands at 70.0%. Remarkably, our results highlight that the production technology employed in US medical laboratories demonstrates constant returns to scale. Moreover, our study delves into the intricate relationship between firm efficiency and market valuation. Our findings reveal a positive and statistically significant correlation between efficiency and market valuation. More specifically, a 1% increase in efficiency corresponds to a 1.08% increase in market valuation. [ABSTRACT FROM AUTHOR]

Background: In recent years, human microbiome research has flourished and has drawn attention from both healthcare professionals and general consumers as the human microbiome is now recognized as having a significant influence on human health. This has led to the emergence of companies offering microbiome testing services. Some of these services are sold directly to the consumer via companies' websites or via medical laboratory websites. Methodology: In order to provide an overview of the consumer experience proposed by these microbiome testing services, one single faecal sample was sent to six different companies (five based in Europe and one based in the USA). Two out of the six testing kits were commercialized by medical laboratories, but without any requirement for a medical prescription. The analyses and reports received were discussed with a panel of experts (21 experts from 8 countries) during an online workshop. Results: This workshop led to the identification of several limitations and challenges related to these kits, including over-promising messages from the companies, a lack of transparency in the methodology used for the analysis and a lack of reliability of the results. The experts considered the interpretations and recommendations provided in the different reports to be premature due to the lack of robust scientific evidence and the analyses associated with the reports to be of limited clinical utility. The experts also discussed the grey areas surrounding the regulatory status of these test kits, including their positioning in the European market. The experts recommended a distinction between regulatory requirements based on the intended use or purpose of the kit: on the one hand, test kits developed to satisfy consumer curiosity, with a clear mention of this objective, and no mention of any disease or risk of disease, and on the other hand, in vitro diagnostic (IVD) CE-marked test kits, which could go deeper into the analysis and interpretation of samples, as such a report would be intended for trained healthcare professionals. Conclusions: Recommendations or actions, specific to the context of use of microbiome testing kits, are listed to improve the quality and the robustness of these test kits to meet expectations of end users (consumers, patients and healthcare professionals). The need for standardization, robust scientific evidence, qualification of microbiome-based biomarkers and a clear regulatory status in Europe are the main issues that will require attention in the near future to align laboratory development with societal needs and thus foster translation into daily health practice. [ABSTRACT FROM AUTHOR]

Background: Medical diagnostic laboratories as high‐risk environments are often exposed to unpredictable situations such as patient fainting, blood pressure drops, chemical spills, and burns. These life‐threatening events defined as medical emergencies and necessitate urgent actions. Hence, determining the most common medical emergencies in medical laboratories, so understanding and planning strategies to effective management seems to be crucial. Objective: This study aimed to investigate medical crises in Iranian medical laboratories. Methods: In this cross‐sectional study, data collection was performed by a simple random sampling method through electronic and paper questionnaires filled by personnel in private and hospital laboratories in different provinces. Results: The most frequent medical emergencies were patient fainting, staff needle stick, and patient's blood pressure dropping. The occurrence of medical emergencies was 24% and 76% in men and women, respectively. Out of all, treatment was administered at the scene of the accident in 37.1% of cases, and 28.1% were discharged after sampling. Moreover, 51% of the medical diagnostic laboratories had a trolley code, with injection devices and angiocaths as available tools. In 81% of the laboratories, practicing for probable medical emergencies was not possible. A significant relationship was found between the type of client (laboratory personnel or the referring person) and the type of emergency event (p < 0.05). Conclusions: Considering the prevalence and importance of handling medical emergencies in a short time, it is necessary to design training courses for laboratory personnel and expert them to encountering with unpredictable threats in order to help affected individuals. [ABSTRACT FROM AUTHOR]

Objective: To assess the fibrinogen function in patients with hepatitis B-related cirrhosis and explore the relationship between dysfibrinogenemia and bleeding and thrombotic events. Methods: Medical records and laboratory data of the patients with hepatitis B-related cirrhosis were collected. Patients were categorized into three groups based on the Child-Pugh score. Fibrinogen activity and antigen, fibrinogen-bound sialic acid (FSA), fibrinogen polymerization and fibrinolysis kinetic analysis, thrombin-antithrombin complex (TAT) and plasmin-α2-antiplasmin complex (PAP) were detected. Results: Eighty patients with seventeen, thirty-eight and twenty-five in Child-Pugh A, B and C, respectively, were included. Seventeen patients experienced bleeding events and eight patients had thrombotic events. Fibrinogen activity and antigen levels were reduced with the severity of cirrhosis. Twenty-two patients exhibited dysfibrinogenemia. The FSA levels in patients with non-dysfibrinogenemia and those with dysfibrinogenemia were increased to 1.25 and 1.37 times of healthy controls, negatively correlated with fibrinogen activity (ρ = −0.393, p = 0.006). Compared to healthy controls, the amount of clot formation was reduced (p < 0.001), the polymerization was delayed (p < 0.001) and the rate of fibrinolysis was reduced (p < 0.001). The TAT levels were significantly increased in the Child-Pugh C patients compared to the Child-Pugh B patients (p = 0.032) while the PAP levels were comparable among 3 groups (p = 0.361). Conclusion: Sialylation of fibrinogen is one of the main causes of modifications of fibrinogen in patients with hepatitis B-related cirrhosis. The polymerization and fibrinolysis functions of fibrinogen are impaired. The degree of impaired fibrinolysis function is more severe than that of polymerization function, and may be partly related to the occurrence of thrombotic events. [ABSTRACT FROM AUTHOR]

Context.--Substantial variability between different antibody titration methods has been identified since the development and introduction of the uniform procedure in 2008. Objective.--To determine whether more recent methods or techniques decrease interlaboratory and intralaboratory variation measured using proficiency testing. Design.--Proficiency test data for antibody titration between 2014 and 2018 were obtained from the College of American Pathologists. Interlaboratory and intralaboratory variations were compared by analyzing the distribution of titer results by method and phase, comparing the results against the supplier's quality control titer, and by evaluating the distribution of paired titer results when each laboratory received a sample with the same titer twice. Results.--A total of 1337 laboratories participated in the antibody titer proficiency test during the study period. Only 54.1% (5874 of 10 852) of anti-D and 63.4% (3603 of 5680) of anti-A reported responses were within 1 titer of the supplier's intended result. Review of the agreement between laboratories of the same methodology found that 78.4% (3139 of 4004) for anti-A and 89.0% (9655 of 10 852) of laboratory responses for anti-D fell within 1 titer of the mode response. When provided with 2 consecutive samples of the same titer (anti-D titer: 16), 85% (367 of 434) of laboratories using the uniform procedure and 80% (458 of 576) using the other method reported a titer difference of 1 or less. Conclusions.--Despite advances, interlaboratory and intralaboratory variance for this assay remains high in comparison with the strong reliance on titer results in clinical practice. There needs to be a reevaluation of the role of this test in clinical decision-making. [ABSTRACT FROM AUTHOR]

The article discusses the reforms in the pharmaceutical industry in Uzbekistan, highlighting the government's focus on developing the sector through legal frameworks and support for local enterprises. Efforts to promote the cultivation and export of medicinal plants like licorice are also emphasized. Various measures, including the establishment of social pharmacies and the creation of the "Tashkent Pharma Park" cluster, aim to enhance the production and accessibility of medicines in the country. The article underscores the significant growth in the pharmaceutical market and local production of medicines in recent years, positioning Uzbekistan as a key player in the CIS pharmaceutical market. [Extracted from the article]

Background Objectives Methods Results Conclusions Trichophyton mentagrophytes ITS genotype VII (TMVII) has recently been identified in France as the causative agent of dermatophyte infections transmitted during sexual activity among men who have sex with men (MSM).Our objective was to provide new insights into the epidemiology, clinical presentation and treatment of TMVII infections based on cases diagnosed from October 2022 to September 2023 in three medical mycology laboratories in Paris. Additionally, we aimed to perform molecular characterization of TMVII strains collected in Paris, as well as in Switzerland.We identified all isolates from skin and hair belonging to the T. mentagrophytes complex by sequencing the ITS region. For isolates corresponding to TMVII, clinical data were retrieved from medical records. For all available TMVII strains that we isolated since January 2021, we sequenced tef1α and tubb and determined the MAT locus idiomorph.We identified 32 cases of TMVII Infections. All cases occurred in men, 30 of whom reported having sex with men. Fifteen cases were sporadic cases including four among sex workers. The other 17 cases belonged to a single cluster involving a tantric masseur who infected 15 clients and his roommate. The median time from massage to lesion onset was 16 [2–52] days. Except for one patient, all other patients received systemic antifungal treatment with terbinafine. We observed five patients whose cultures remained positive even after 3–4 weeks of treatment and five patients experienced a relapse of the infection after discontinuing antifungal treatment. All French isolates exhibited identical tef1α and tubb sequences, as well as the same MAT idiomorph locus. They displayed variations in the tef1α sequence compared to isolates from Switzerland and the Czech Republic.We confirm the active circulation of TMVII among MSM in France, which is associated with challenges in diagnosis, treatment and prevention. [ABSTRACT FROM AUTHOR]

Although the concept of bias appears consolidated in laboratory science, some important changes in its definition and management have occurred since the introduction of metrological traceability theory in laboratory medicine. In the traceability era, medical laboratories should rely on manufacturers who must ensure traceability of their in vitro diagnostic medical devices (IVD-MD) to the highest available references, providing bias correction during the trueness transfer process to calibrators before they are marketed. However, sometimes some bias can be observed arising from an insufficient correction during the traceability implementation. This source of bias can be discovered by the IVD-MD surveillance by traceability-based external quality assessment and confirmed by ad-hoc validation experiments. The assessment of significance should be based on its impact on measurement uncertainty (MU) of results. The IVD manufacturer, appropriately warned, is responsible to take an immediate investigation and eventually fix the problem with a corrective action. Even if IVD-MD is correctly aligned in the validation steps and bias components are eliminated, during ordinary use the system may undergo systematic variations such as those caused by recalibrations and lot changes. These sources of randomly occurring bias are incorporated in the estimate of intermediate reproducibility of IVD-MD through internal quality control and can be tolerated until the estimated MU on clinical samples fulfils the predefined specifications. A readjustment of the IVD-MD by the end-user must be undertaken to try to correct the bias becoming significant. If the bias remains, the IVD manufacturer should be requested to rectify the problem. [ABSTRACT FROM AUTHOR]

There is a widely spread belief in the Bayesian network (BN) community that the overall accuracy of results of BN inference is not too sensitive to the precision of their parameters. We present the results of several experiments in which we put this belief to a test in the context of medical diagnostic models. We study the deterioration of accuracy under random symmetric noise but also biased noise that represents overconfidence and underconfidence of human experts.Our results demonstrate consistently, across all models studied, that while noise leads to deterioration of accuracy, small amounts of noise have minimal effect on the diagnostic accuracy of BN models. Overconfidence, common among human experts, appears to be safer than symmetric noise and much safer than underconfidence in terms of the resulting accuracy. Noise in medical laboratory results and disease nodes as well as in nodes forming the Markov blanket of the disease nodes has the largest effect on accuracy. In light of these results, knowledge engineers should moderately worry about the overall quality of the numerical parameters of BNs and direct their effort where it is most needed, as indicated by sensitivity analysis. [ABSTRACT FROM AUTHOR]

Background Appropriate age- and sex-specific reference intervals for alkaline phosphatase (ALP) are essential to identify patients with hypophosphatasia (low ALP) and to avoid unnecessary ALP isoenzymes analysis (elevated ALP). This study used patient ALP historical data to statistically derive sex- and age-specific reference intervals. Methods The ALP values reported as part of clinical management during an 18 month period (from July 2021 to March 2023) were obtained. Following logarithmic transformation of ALP data and repeated removal of outliers, cumulative frequency plots were generated using a modified Hoffmann approach to derive age- and sex-specific reference intervals. Results Age-specific ALP reference intervals ranged from 110 to 250 and 120 to 295 U/L for males and females <15 days old, 80 to 400 and 90 to 380 U/L for males and females 15 days to 1 year old, 105 to 280 and 90 to 290 U/L for males and females 1 to 10 years old, 75 to 300 and 90 to 300 U/L for males and females 10 to 13 years old, 80 to 300 and 60 to 175 U/L for males and females 13 to 15 years old, 55 to 150 and 60 to 180 U/L for males and females 15 to 18 years old, and 55 to 140 and 60 to 147 U/L for male and female adults, respectively (>18 years old). Conclusion By applying derived ranges, a retrospective review of ALP isoenzymes would eliminate 24.5% of requests. Additionally, 9 neonates would have required investigation for possible hypophosphatasia. [ABSTRACT FROM AUTHOR]

A correction is presented to the article "Performance of Clinical, Laboratory and Imaging Features for Diagnosing Spondyloarthritis — A Systemic Lierature Review and Meta-analysis," which appeared in the 2024 issue of the magazine.

Context.--: Regulatory T-cell (Treg) detection in peripheral blood, based on flow cytometry, is invaluable for diagnosis and treatment of immune-mediated diseases. However, there is a lack of reliable methods to verify the performance, which is pivotal toward standardization of the Tregs assay. Objective.--: To conduct standardization studies and verify the performance of 3 commercially available reagent sets for the Tregs assay based on flow cytometry and agreement analysis for Treg detection across the different reagent sets. Design.--: The analytical performance of Tregs assay using reagent sets supplied by 3 manufacturers was evaluated after establishing the gating strategy and determining the optimal antibody concentration. Postcollection sample stability was evaluated, as well as the repeatability, reproducibility, reportable range, linearity, and assay carryover. Agreement between the different assays was assessed via Bland-Altman plots and linear regression analysis. The relationship between the frequency of CD4+CD25+CD127low/- Tregs and CD4+CD25+Foxp3+ Tregs was evaluated. Results.--: The postcollection sample stability was set at 72 hours after collection at room temperature. The accuracy, repeatability, reproducibility, and accuracy all met the requirements for clinical analysis. Excellent linearity, with R2 ≥0.9 and no assay carryover, was observed. For reportable range, a minimum of 1000 events in the CD3+CD4+ gate was required for Tregs assay. Moreover, the results for Tregs labeled by antibodies from the 3 manufacturers were in good agreement. The percentage of CD4+CD25+CD127low/- Tregs was closely correlated with CD4+CD25+Foxp3+ Tregs. Conclusions.--: This is the first study to evaluate systematically the measurement performance of Tregs in peripheral blood by flow cytometry, which provides a practical solution to verifying the performance of flow cytometry-based immune monitoring projects in clinical practice. [ABSTRACT FROM AUTHOR]

Data and results from interlaboratory comparison (ILC) studies, external quality assessment (EQA) and proficiency testing (PT) activities are important and valuable contributions both to the further development of all disciplines of medical laboratory diagnostics, and to the evaluation and comparison of in vitro diagnostic assays. So far, however, there are no recommendations as to which essential items should be addressed in publications on interlaboratory comparisons. The European Organization of External Quality Assurance Providers in Laboratory Medicine (EQALM) recognized the need for such recommendations, and these were developed by a group of experts. The result of this endeavor is the EQALM Statement on items recommended to be addressed in publications on interlaboratory comparison activities (PubILC), in conjunction with a user-friendly checklist. Once adopted by authors and journals, the EQALM Statement will ensure essential information and/or study-related facts are included within publications on EQA/PT activities. [ABSTRACT FROM AUTHOR]

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. 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. 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. 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. [ABSTRACT FROM AUTHOR]

While Six Sigma is used in different disciplines to improve quality, Tony Badric and Elvar Theodorsson in a recent paper in CCLM have questioned Six Sigma application in medical laboratory concluding Six Sigma has provided no value to medical laboratory. In addition, the authors have expanded their criticism to Total Analytical Error (TAE) model and statistical quality control. To address their arguments, we have explained the basics of TAE model and Six Sigma and have shown the value of Six Sigma to medical laboratory. [ABSTRACT FROM AUTHOR]

Laboratory medical reports are often not intuitively comprehensible to non-medical professionals. Given their recent advancements, easier accessibility and remarkable performance on medical licensing exams, patients are therefore likely to turn to artificial intelligence-based chatbots to understand their laboratory results. However, empirical studies assessing the efficacy of these chatbots in responding to real-life patient queries regarding laboratory medicine are scarce. Thus, this investigation included 100 patient inquiries from an online health forum, specifically addressing Complete Blood Count interpretation. The aim was to evaluate the proficiency of three artificial intelligence-based chatbots (ChatGPT, Gemini and Le Chat) against the online responses from certified physicians. The findings revealed that the chatbots' interpretations of laboratory results were inferior to those from online medical professionals. While the chatbots exhibited a higher degree of empathetic communication, they frequently produced erroneous or overly generalized responses to complex patient questions. The appropriateness of chatbot responses ranged from 51 to 64 %, with 22 to 33 % of responses overestimating patient conditions. A notable positive aspect was the chatbots' consistent inclusion of disclaimers regarding its non-medical nature and recommendations to seek professional medical advice. The chatbots' interpretations of laboratory results from real patient queries highlight a dangerous dichotomy – a perceived trustworthiness potentially obscuring factual inaccuracies. Given the growing inclination towards self-diagnosis using AI platforms, further research and improvement of these chatbots is imperative to increase patients' awareness and avoid future burdens on the healthcare system. [ABSTRACT FROM AUTHOR]

Farmed cervids are of growing economic importance in the midwestern United States. Although diseases of wild and captive cervids have been examined in more northerly climates, little information exists on the health challenges of deer in the Midwest. We characterized and summarized the causes of mortality in farmed white-tailed deer (Odocoileus virginianus) submitted to the University of Missouri Veterinary Medical Diagnostic Laboratory (Columbia, MO, USA) over a 19-y period (2004–2023). Of 388 cases examined, 253 (65%) were carcasses submitted for autopsy, and 135 (35%) cases were tissue samples harvested by field veterinarians. Infectious disease was the most common cause of mortality (n = 335; 86.3%). Of infectious causes, primary pneumonia was most common (n = 140; 41.7%), followed by septicemia (n = 68; 20.1%), and primary enteritis (n = 64; 19.1%). Viruses were detected in 18% of pneumonia cases. The most common non-infectious diagnoses were emaciation and trauma (both 4 each; 1%). Thirteen animals (3.4%) died of unknown causes. Forty-nine percent of cases were juvenile deer <1-y-old. Most cases were received in the summer (212; 54.6%). Infectious diseases, particularly bacteria and viruses, pose a significant health challenge to farmed deer in the midwestern United States. [ABSTRACT FROM AUTHOR]

Background: The purpose of clinical microbiology testing is to provide important information for clinical diagnosis and treatment. The correct collection, processing, and transportation of specimens are the key to the success of clinical microbiological examination. Methods: Retrospective analysis was done on the composition and causes of unqualified microbial samples submitted by clinical departments from 2019 to 2020 at the Affiliated Hospital of Nantong University. The solutions were proposed from the perspective of nursing management. Results: In 2019, the hospital received 64,244 clinical microbial specimens. The unqualified rate of samples was 8.96%, of which the unqualified sputum accounted for 84.74%. After strengthening the communication with the medical laboratory, increasing publicity and training, and improving the information system and other auxiliary monitoring functions, the unqualified rate of clinical microbial specimens was reduced to 6.05% in 2020. Conclusions: Continuously improving the theoretical and practical abilities of nurses can reduce the unqualified rate of samples. [ABSTRACT FROM AUTHOR]

The medical laboratory plays a crucial role within a hospital setting and is responsible for the examination and analysis of patient specimens to accurately diagnose various ailments. The burden on medical laboratory personnel has significantly increased, particularly in the context of the ongoing global COVID-19 pandemic. Worldwide, the implementation of comprehensive and extended COVID-19 screening programs has placed a significant strain on healthcare professionals. This burden has led to exhaustion among medical employees, limiting their ability to effectively track laboratory resources, such as medical equipment and consumables. Therefore, this study proposed an artificial intelligence (AI)-based solution that contributes to a more efficient and less labor-intensive workflow for medical workers in laboratory settings. With the ultimate goal to reduce the burden on healthcare providers by streamlining the process of monitoring and managing these resources, the objective of this study is to design and develop an AI-based system for consumables tracking in medical laboratories. In this work, the effectiveness of two object detection models, namely, YOLOv5x6 and YOLOv8l, for the administration of consumables in medical laboratories was evaluated and analyzed. A total of 570 photographs were used to create the dataset, capturing the objects in a variety of settings. The findings indicate that both detection models demonstrate a notable capability to achieve a high mean average precision. This underscores the effectiveness of computer vision in the context of consumable goods detection scenarios and provides a reference for the application of real-time detection models in tracking systems within medical laboratories.

* Context.--Next-generation sequencing-based approaches using RNA have increasingly been used by clinical laboratories for the detection of fusion genes, intragenic rearrangements, and exon-skipping events. Correspondingly, the College of American Pathologists (CAP) has advanced RNA sequencing proficiency testing (PT) to ensure optimal performance of these assays. Objective.--To report on laboratory performance and practices of RNA sequencing for the detection of fusion genes, intragenic rearrangements, and exon-skipping events using CAP PT data from 8 mailings (2018-A through 2021-B). Design.--CAP PT RNA sequencing program results from 153 laboratories across 24 proficiency test specimens, interrogating 22 distinct engineered fusion transcripts, were analyzed for correct identification of the fusion event, associated performance variables, and laboratory practices. Results.--Overall, the 4-year program detection rate (sensitivity) was 95.5% (1486 of 1556 results). False-negative rates were 3.6% (53 of 1463) and 18.3% (17 of 93) for fusion gene and intragenic rearrangement/exon-skipping events, respectively. Only 19 false-positive results were reported among the 8 PT mailings, and most were likely the result of preanalytical or postanalytical errors. There were no practice characteristics (eg, instrumentation, sequencing method) significantly associated with the fusion detection results. Conclusions.--These data reveal a high overall sensitivity and specificity for fusion gene detection by participating laboratories using clinical RNA sequencing. Performance was comparable across all laboratories, regardless of methodology. The fraction of false-negative results for intragenic rearrangement/exon-skipping events was greater than that for the chimeric fusion genes. False-negative results could not be attributed to any specific practice characteristics., Fusion oncogenes represent valuable biomarkers that aid in diagnostic classification and prognostication, as well as serving as therapeutic targets. (1-4) Examples of structural alterations/mutations that may lead to chimeric fusions [...]

Background: A pilot HIV testing programme, Au Labo sans Ordo (ALSO; "to the laboratory without prescription") was implemented in two French Fast-Track Cities Initiative areas from 07/2019 to 12/2020. ALSO aimed to remove barriers to HIV testing by providing free testing with widespread access through all laboratories, extended opening hours, and no prescription requirements. Objectives: Assessing the ALSO programme in terms of testing activity, user characteristics, and costs, compared to other HIV testing offers. Methods: Laboratories and STI clinics reported the monthly numbers of tests performed and positive tests. Two short surveys were carried out 12 months apart in people who sought HIV testing. In each offer, the mean costs of HIV testing have been estimated according to negative or positive results using a microcosting approach. Results: During the study period, 214/264 laboratories reported performing 38,941 ALSO tests that accounted for 7.2% of laboratory HIV testing activity. Positivity rates of ALSO and prescribed tests were similar (2.2/1000) but lower than that in STI clinics (6.0/1000). Heterosexual men, and individuals with multiple sexual partners, poor health insurance and few visits to GPs were more likely to use the ALSO offer than tests upon prescription. Compared to ALSO, STI clinic users were younger, more exposed to HIV and with a less favourable socio-economic situation. ALSO had low costs: €13 for a negative test, €163 for a positive test and €5,388 to identify an HIV-positive person (versus €9,068 in STI clinics and €20,126 with prescribed tests). Conclusion: ALSO has attracted users less likely to visit STI clinics or to seek a prescribed test, particularly heterosexual men. Activities, user profiles and costs suggested the complementarity of the HIV testing offers and the relevance of making them coexist. French health authorities have decided to maintain and expand this programme to complement existing HIV testing offers. [ABSTRACT FROM AUTHOR]

Down syndrome (DS) is defined by an extra copy of chromosome 21 and confers an increased susceptibility to hematological disorders. Transient abnormal myelopoiesis (TAM) and myeloid‐leukemia associated with Down syndrome (ML‐DS) are two conditions that need to be accurately diagnosed to provide appropriate management. Both TAM and ML‐DS are characterized by proliferation of megakaryoblasts carrying a mutation in the GATA1 gene. Here, we report four cases with educational significance, highlighting typical diagnostic features that facilitate the differentiation between these two conditions, thereby assisting clinicians and medical laboratory professionals in effectively managing and monitoring these patients. [ABSTRACT FROM AUTHOR]

Background: Lean methodology, originally developed in the manufacturing sector, is a process management philosophy focused on maximizing value by eliminating waste. Its application in laboratory settings, particularly concerning laboratory turnaround times (TAT), involves a systematic approach to identifying inefficiencies and optimizing processes to enhance value for end customers. Methods: This systematic review was registered in PROSPERO with identification number (CRD42024552350) and reported based on the 2020 PRISMA checklist. An extensive search strategy was performed using PubMed, Scopus, and Embase databases and gray literatures. Advanced searching was used using Boolean operators (AND & OR). After articles were exported to endnote x8, duplications were removed and articles were selected based on titles, abstracts, and full texts. The illegibility of the articles was independently assessed by the three authors (NC, DMB, and BBT), and the disagreements were settled through scientific consensus. Methodological quality was assessed using JBI critical appraisal checklist. Discussion: In this review, electronic databases search yielded 1261 articles, of which 7 met the inclusion criteria. The review demonstrated, implementation of lean principle into the routine laboratory testing had an overall impact 76.1% on reducing laboratory TAT. Transportation, manual data processing, inefficient workflow, and the heavy workload were identified as the main wasteful procedures. To eliminate these non-value-added steps, several intervention techniques were implemented, including the use of a barcoding system, process redesign, workflow optimization, hiring additional staff, and relocating the sample collection room closer to the result distribution center. Lean implementation is crucial in the medical laboratory industry for optimizing processes, reducing TAT, and ultimately enhancing customer satisfaction. As a result, all clinical laboratories should adopt and implement lean principles in their routine testing processes. The medical laboratory industry should also proactively look for and apply lean tools, provide ongoing training, and foster awareness among laboratory staffs. [ABSTRACT FROM AUTHOR]

Iron deficiency anemia is a significant global health concern, diagnosed by measuring hemoglobin concentrations in combination with plasma ferritin concentration. This study investigated the variability in ferritin reference intervals among laboratories in the Netherlands and examined how this affects the identification of iron-related disorders.Ferritin reference intervals from 52 Dutch ISO15189-certified medical laboratories were collected. Ferritin, hemoglobin and mean corpuscular volume data of non-anemic apparently healthy primary care patients, measured by four laboratory platforms (Beckman, Abbott, Siemens, and Roche), were collected (n=397,548). Median ferritin levels were determined per platform, stratified by sex and age. The proportion of ferritin measurements outside of the reference interval was calculated using the reference intervals from the 52 laboratories (using a total of n=1,093,442 ferritin measurements). Lastly, ferritin data from 3,699 patients as captured in general practitioner (GP) data from the PHARMO Data Network were used to assess the variation of abnormal ferritin measurements per GP.Median plasma ferritin concentrations were approximately four times higher in men and twice as high in postmenopausal women compared to premenopausal women. Moreover, there are substantial differences in the median plasma ferritin concentration between the four platforms. However, even among laboratories using the same platform, ferritin reference intervals differ widely. This leads to significant differences in the percentages of measurements classified as abnormal, with the percentage of ferritin measurements below the reference limit in premenopausal women ranging from 11 to 53 %, in postmenopausal women from 3 to 37 %, and in men from 2 to 19 %. The percentage of ferritin measurements above the reference limit in premenopausal women ranged from 0.2 to 11 %, in postmenopausal women from 3 to 36 % and in men from 7 to 32 %.The lack of harmonization in ferritin measurement and the disagreement in plasma ferritin reference intervals significantly impact the interpretation of the iron status of patients and thereby the number of iron disorder diagnoses made. Standardization or harmonization of the ferritin assays and establishing uniform reference intervals and medical decision limits are essential to reduce the substantial variability in clinical interpretations of ferritin results. [ABSTRACT FROM AUTHOR]

Introduction: In 2018, the Australasian College for Emergency Medicine (ACEM) and the Royal College of Pathologists of Australasia (RCPA) produced a guideline to encourage appropriate pathology requesting in the Emergency Department (ED). Objective: To assess adherence to the ACEM/RCPA pathology testing guideline in a regional ED. Methods, Design, Setting and Participants: This was a retrospective observational study conducted at a regional Australian ED over 7 days. Adults with a presenting complaint encompassed by the guideline were included. All blood tests were audited against the guideline recommendations and classified as indicated or non‐indicated. Chi‐squared analyses were performed to explore the association between presenting complaint and non‐indicated testing. Main Outcome Measure: The primary outcome was the number of non‐indicated blood tests. Results: Forty percent of tests ordered were not clinically indicated, with non‐indicated testing occurring during 87% of encounters. The C‐reactive protein (CRP) was the test most frequently ordered outside of guidelines (94% non‐indicated). Patients presenting with lower abdominal pain accounted for nearly one‐quarter of all non‐indicated tests. Conclusions: Blood tests were commonly requested outside of the guideline recommendations and interventions to improve pathology stewardship are required. [ABSTRACT FROM AUTHOR]

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 performance and interpretation of activated partial thromboplastin time (APTT) and prothrombin time (PT) plasma mixing tests in clinical laboratories in all regions of the world. The following areas are included in this document: preanalytical, analytical, postanalytical, and quality assurance considerations as they relate to the proper performance and interpretation of plasma mixing tests. The recommendations are based on good laboratory practice, published data in peer‐reviewed literature, and expert opinion. [ABSTRACT FROM AUTHOR]

Microsporum canis is considered one of the filamentous fungi that cause surface fungal contagion in the humans and animals. The present study aimed to diagnose M. canis via the molecular method and differentiating its local Iraqi isolates from global isolates. Microscopic examination showed 55 specimens with M. canis from 130 specimens collected from children aged between 4-10 years suspected of dermatophytes who attended Medical City Laboratories and Baghdad Hospital in Baghdad city from 1/12/2022 to 1/3/2023. The results showed that the frequency of M. canis infections was 55/130 (42.31%). The results demonstrated significant differences in the animals' contact (p <0.0001), lesions (0.03) and habitation area (p =0.002). Whilst the ages appeared with non-significant differences (p =0.6). In order to confirm the microscopic examination and compare the Iraqi isolates with other global ones, the 55 positive results with M. canis were further diagnosed by using internal transcribed spacer (ITS) 1 and 4 universal primers with a size of 550 bp for PCR amplicons. PCR amplicons sequencing showed only one isolate of M. Canis that differed from global isolates registered in the database of NCBI. The Iraqi local isolate of M. canis was registered with accession number: OM185328. In conclusion, the PCR technique using ITS rDNA aided in confirming the detection of dermatophytes. [ABSTRACT FROM AUTHOR]

Introduction: The COVID-19 pandemic has underscored the necessity of investigating the relationship between radiological and laboratory findings with disease outcome in COVID-19 patients. This study aimed to explore the association between CT-scan finding and laboratory results with disease outcome, including recovery without complications, ICU admission, or mortality. Methods: This retrospective cross-sectional study analyzed medical records and laboratory data from COVID-19 patients at Ghaem Hospital, Mashhad, Iran, from September 2020 to September 2022. All demographic, laboratory findings, as well as CT-scan data such as ground-glass opacity, consolidation, pleural effusion, cardiomegaly, mediastinal lymphadenopathy, and pulmonary involvement score at admission were collected. Patients were categorized based on their death/alive status and compared for all study variables. Results: Significance differences were observed for CT-score values between deceased patients and those who recovered (P<0.001), indicating a more severe lung changes in patients who died due to COVID-19. Additionally ICU-admitted patients had higher likelihood of underlying comorbidities and elevated CT-score levels. Laboratory markers such as ESR, Ferritin, LDH, Neutrophil count, and RDW were significantly higher in patients requiring ICU admission (P<0.05). Deceased patients were more likely to have underlying diseases, ground glass opacity, cardiomegaly, and higher CT-scores. Laboratory markers such as ESR, CRP, Ferritin, LDH, and others were also significantly higher in expired patients. Conclusion: There was a strong association between laboratory and CT-scan findings with disease mortality in COVID-19 patients. The combination of laboratory markers and CT-scan findings can serve as robust predictors of disease outcomes. Further studies are needed to validate these findings in larger cohorts. [ABSTRACT FROM AUTHOR]

To ensure the quality of their analyses, medical laboratories carry out internal quality control (IQC) on a daily basis. IQC involves control samples with known target values for all parameters used by a laboratory in clinical practice. The use of IQC enables the laboratory to monitor the accuracy and precision of laboratory results. The use of appropriate IQC strategies has been accepted in medical laboratories for decades, and IQC has been included in international recommendations and guidelines. The term "IQC strategy" (also termed a quality control plan) refers to the types of IQC materials to be measured, the frequency of IQC events, the number of concentration levels in each IQC event, and the IQC rules to be used. A scientifically sound IQC strategy must follow two principles, namely, (1) statistical follow-up on the IQC results generated in the laboratory by means of Levey–Jennings control charts and Westgard rules (i.e., quality control by means of statistical procedures) and (2) the determination of limits on the basis of medical considerations and the definition of analytical goals (quality control on the basis of medical relevance). In this narrative review, we describe the fundamental principles of an adequate IQC strategy for laboratorians and nonlaboratorians. [ABSTRACT FROM AUTHOR]

Pathology is the bridge between basic science and clinical practice. An inadequate perception of pathology leads to an incomplete understanding of diseases, which consequently affects its management. This study aims to identify medical students' perceptions of pathology in medical colleges around Saudi Arabia and use their feedback to improve teaching strategies. A validated online self-structured questionnaire form was distributed to medical students in basic and clinical years, including private and governmental universities in all regions of Saudi Arabia. The study comprised a total of 476 medical students. It revealed that n = 226 (48%) of the participants were not aware of pathologists' roles, and n = 262 (55%) of students reported that the main reason was insufficient exposure to actual pathology practice. A total of n = 209 (44%) students believed the current teaching methods in the basic years were insufficient to provide clear perceptions of pathology. The majority of participants n = 366 (77%) chose practical sessions as the most effective strategy in teaching pathology. Our study demonstrated that medical students require more engagement in laboratories to improve their perception. We suggest that Saudi medical schools need to deliver more comprehensive and practical teaching methods that reflect the actual practice of pathology. [ABSTRACT FROM AUTHOR]

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In the reform of medical laboratory courses, innovative teaching methods and the development of a teaching assessment system are crucial. However, in past practices, assessments have encountered some issues: a greater emphasis on recording outcomes, neglecting supervision of the process; a focus on summarizing writing, overlooking the importance of analysis and improvement. In the teaching process of Jilin University's Oncological Rehabilitation Experimental Teaching Demonstration Center, the Peer-Assisted Learning (PAL) model is employed to enhance students' learning approaches. The innovative incorporation of Direct Observation of Procedural Skills (DOPS) and Mini-Clinical Evaluation Exercise (Mini-CEX) facilitates effective assessment and feedback. The combination of these reform measures not only addresses issues in experimental teaching but also enhances the internalization of students' knowledge and skills. In this study, we applied the evaluation systems of Direct Observation of Procedural Skills and Mini-Clinical Evaluation Exercise (Mini-CEX) to the comprehensive laboratory course in oncological rehabilitation. We utilized questionnaires to assess the impact of these reforms on students, aiming to evaluate the effectiveness of the course modifications. Statistical analysis of the data revealed a high level of student approval and a strong willingness to learn under the new evaluation system. Compared to traditional teaching methods, the introduction of DOPS and Mini-CEX significantly enhanced students' overall competencies and improved the quality of the oncological rehabilitation course. Our approach represents an innovative reform, suggesting that incorporating DOPS and Mini-CEX into teaching could provide a widely applicable and promising new educational method. This paper explores and systematically elaborates on the reform and practice of the teaching model and formative assessment in the comprehensive laboratory course of oncological rehabilitation. [ABSTRACT FROM AUTHOR]

Laboratory medicine has undergone a deep and multifaceted revolution in the course of human history, in both organizational and technical terms. Over the past century, there has been a growing recognition of the need to centralize numerous diagnostic activities, often similar or identical but located in different clinical departments, into a common environment (i.e., the medical laboratory service), followed by a progressive centralization of tests from smaller laboratories into larger diagnostic facilities. Nevertheless, the numerous technological advances that emerged at the beginning of the new millennium have helped to create a new testing culture characterized by a countervailing trend of decentralization of some tests closer to patients and caregivers. The forces that have driven this (centripetal) counter-revolution essentially include a few key concepts, namely "home testing", "portable or even wearable devices" and "remote patient monitoring". By their very nature, laboratory medical services and remote patient testing/monitoring are not contradictory, but may well coexist, with the choice of one or the other depending on the demographic and clinical characteristics of the patient, the type of analytical procedure and the logistics and local organization of the care system. Therefore, this article aims to provide a general overview of patient self-testing, with a particular focus on portable and wearable (including implantable) devices. [ABSTRACT FROM AUTHOR]

Canadian Society for Medical Laboratory Science (CSMLS) is Canada’s national certifying body and professional society for medical laboratory professionals. Their research revealed increasing levels of workplace stress among their member- ship and concerns regarding burnout. The implications of ignoring this trend could have led to significant workplace issues and concerns with medical laboratory testing and analysis. Consequently, CSMLS developed the Mental Health Toolkit, a dynamic website featuring mental health concepts, self-assessment tools, coping skills, and strategies to better manage stress. The Mental Health Toolkit is available free to CSMLS members. It was used as a resource for mental health by medical laboratory professionals during the height of the COVID pandemic. CSMLS continues to embrace education and awareness regarding mental health to help address stigma among medical laboratory professionals. [ABSTRACT FROM AUTHOR]

In the presence of haemolysis, the interpretation of the Lactate dehydrogenase (LDH) activity result is a major operational challenge for medical laboratories: if the origin is intravascular, then the measurement will reflect the clinical reality, but in extravascular haemolysis, the laboratory will be confronted with an artefactual increase leading to false-positive high results. The aim of our study was to evaluate the adjustment of LDH concentration results according to the haemolysis index (HI). After designed a mathematical model to correct the LDH measured as a function of the haemolysis index using a Cobas 8000 analyser (Roche diagnostics, Mannheim, Germany), LDH measurement of seventy-four duplicate samples were tested before and after exposure to extravascular haemolysis process. After in vitro haemolysis process, a significant increase haemolysis index (Man-Whitney U-Test p < 0.0001) were observed. Before process the HI median was 4 [2.0 − 6.75] and after HI median was 18 [10 − 35.75]. Without correction, LDH results showed a significant increase (p < 0.001) after haemolysis process and substantial analytical discrepancies (31/74) were observed according to TEa of CLIA. After correction, data showed no significant difference (p = 0.497) and the mathematical algorithm allowed to reduce the analytical discrepancies (2/74). If haemolysis was present in vitro, the mathematical algorithm increased the accuracy of the LDH results. However, the lack of discrimination between in vivo and in vitro haemolysis requires caution and the results should be reported only as a commentary to inform the clinician. [ABSTRACT FROM AUTHOR]

Medical microbiology laboratories play an essential role in patient care—appertaining to infectious diseases diagnostics and treatment, infection prevention, and antimicrobial stewardship. Collaboration between clinicians and the microbiology laboratory can promote and enhance the safety, quality, and efficiency of patient care. We review practical, evidence-informed core concepts to explicate how effective partnership between clinicians and the microbiology laboratory improves patient outcomes. [ABSTRACT FROM AUTHOR]

Exhaled breath tests (BTs) are the main diagnostic method for fructose and lactose malabsorption/intolerance (FI and LI, respectively) and for detecting small intestine bacterial or methanogen overgrowth (SIBO/IMO). Although FI/LI-BTs may provide evidence of the presence of SIBO/IMO, there is limited literature evaluating their reliability for this purpose. The objective of this study was to assess the sensitivity and specificity of FI/LI-BTs in detecting SIBO and their concordance with SIBO-BTs in the identification of IMO. In this retrospective observational study, FI/LI-BTs and SIBO-BTs performed in the same patients within a period of 6 weeks were selected from 652 gas chromatography-based BTs. A total of 146 BTs from 67 eligible adult patients were identified. LI-BTs had higher specificity than FI-BT in detecting SIBO (93.8 % vs. 72.7 %). In contrast, FI-BTs showed higher sensitivity (60.0 % vs. 28.6 %) as FI was more frequently established in SIBO-positive patients (70 % vs. 29 %). With regard to IMO, concordance with LI-BT was 100 %, with a 27 % of false negatives on FI-BTs. Findings suggestive of SIBO or IMO on LI-BTs were highly consistent with those of SIBO-BTs. In contrast, the rate of false positives for SIBO and the rate of false negative for IMO on FI-BTs was 27 % in both cases. [ABSTRACT FROM AUTHOR]

The history of standardization relating to the activities of medical laboratories traces the development of quality system standards in the world, and their evolution. In this study, we have included the key benchmarks that represent the stages of the quality system's evolution in recent decades. Accreditation of medical laboratories has become compulsory in most countries, regarding national or international standards. International acknowledgment of the effectiveness of the results delivered to the many stakeholders, particularly patients and prescribers, is conferred through the use of standards. The ISO 15189 standard represents the latest and most specific international standards for medical laboratories of all types. More research is necessary to study if laboratory practices reflect the evolution of standards within the medical laboratory field. [ABSTRACT FROM AUTHOR]

Background: Medical laboratories play crucial roles in healthcare, and effective enterprise risk management (ERM) is necessary to ensure business continuity, patient safety, and quality of care. In medical laboratories, ERM is important for enhancing patient safety, regulatory compliance and accreditation, quality management, business continuity, and cyber security. By following ERM principles and approaches, the medical laboratories can proactively manage their risks, improve patient safety, and maintain a high level of quality and reliability of outcomes. However, implementing ERM in medical laboratories faces unique challenges. This study explored the specific challenges and offers practical solutions for overcoming them to ensure successful ERM implementation in Harare, Zimbabwe. Methodology: A cross‐sectional survey was done through 41 self‐administered questionnaires and interviews with medical laboratory staff from the six main medical laboratories in Harare. Data were analyzed using the Statistical Package for Social Sciences version 22. Quantitative data were analyzed using descriptive statistics such as frequencies and percentages. Qualitative data were analyzed using mean scores of Likert scale responses. Results: The main challenges identified in the study included increased workload, staffing, organizational structures, timeliness of information, inadequate information technology support, and insufficient financial support in ERM. These can be addressed by portfolio management of risks, leveraging on cutting edge technology, restructuring to ensure swift responses to issues and redistributing staff workload, and training personnel to avoid burnouts and ensure maximum efficiency. Conclusion: Implementing ERM in medical laboratories requires understanding and addressing these challenges. By following the ERM principles and approaches the medical laboratories can proactively manage their risks, improve patient safety and maintain a high level of quality and reliability of outcomes ERM is still a new approach in the sector and needs further research. [ABSTRACT FROM AUTHOR]

Background: The community-based health insurance (CBHI) scheme is a growing initiative aimed at enhancing healthcare access for the most impoverished members of the community. The Ethiopian CBHI scheme aims to enhance access to essential healthcare services, including medical laboratory services, for the poorest members of the community, but there is limited evidence on satisfaction levels. The aim of this study was to assess the satisfaction level of CBHI beneficiaries with laboratory services and their associated factors among selected public hospitals in Jimma Zone, Oromia Region, Ethiopia. Methods: A facility-based cross-sectional study was conducted on selected public hospitals in the Jimma Zone from September to October 2023. A total of 421 CBHI beneficiaries were enrolled in the study using a convenient sampling technique, and interviewers administered structured questionnaires to collect data. Data were entered into Epi-data and analyzed using the Statistical Package of Social Sciences version 25. Descriptive analysis was used to summarize independent variables; bivariate and multivariable logistic regression analyses were done to test the association between independent and dependent variables; and statistical significance was declared at P<0.05. Results: More than half (55.8%) of the 419 study participants were female. Above half, 57.5% of the respondents were satisfied by the clinical laboratory services at public hospitals in Jimma Zone. Components with a higher satisfaction rate were providers' professional appearances (98.3%), procedures for specimen collection (87.6%), and availability of entertainment facilities at the waiting area (67.8%). On the contrary, longer waiting times to receive the test results (76.6%), inefficiency of the reception area (74.7%), and the inability of professionals to explain diagnostic procedures (58.0%) were associated with higher rates of dissatisfaction. Educational status and the number of hospital visits were found to have a statistically significant association with level of satisfaction with laboratory services. Conclusions: CBHI beneficiaries' satisfaction with laboratory service was at a moderate level in Jimma Zone public hospitals. Therefore, attention should be given to continuous monitoring of patients' satisfaction with services, improving reception areas, and practicing routine explanations about the purposes and procedures during specimen collection to improve the beneficiaries' satisfaction level with clinical laboratory services. [ABSTRACT FROM AUTHOR]

Introduction: Breast cancer poses a significant health challenge in Sub-Saharan Africa, particularly in Ghana, where late-stage diagnoses and limited healthcare access contribute to elevated mortality rates. This study focuses on the crucial role of pathology and laboratory medical (PALM) services in the timely diagnosis of breast cancer within Ghana. Methods: A cross-sectional survey of hospitals was completed from November 2020 to October 2021, with 94.8% of identified in-country hospitals participating. Pathology service-related parameters assessed included whether pathology was available for the diagnosis of breast cancer on-site or via external referral, the number of pathology personnel, additional breast cancer diagnostic capabilities including estrogen and progesterone and/or HER2 testing, and the time from biopsy to patients receiving their results. Geospatial mapping was used to identify areas of limited access. Results: Of the 328 participating hospitals, 136 (41%) reported breast cancer pathology services, with only 6 having on-site capabilities. Pathology personnel, comprising 15 consultants and 15 specialists, were concentrated in major referral centers, particularly in Greater Accra and Kumasi. An assessment of referral patterns suggested that 75% of the population reside within an hour of breast cancer pathology services. Among the 136 hospitals with access to breast cancer pathology, only a limited number reported that results included ER/PR (38%) and HER2 testing (33%). Conclusion: Ghana has been able to ensure significant pathology service availability through robust referral pathways with centralized labs. Despite this, difficulties persist with the majority of pathology results not including hormone receptor testing which is important in providing tumor specific treatment. [ABSTRACT FROM AUTHOR]

Background: Infections with soil-transmitted helminths (STH) and schistosomiasis (SCH) result in a significant global health burden, particularly in rural communities in low and middle-income countries. While microscopy remains the primary diagnostic method for STH and SCH in resource-limited settings, nucleic acid amplification tests (NAATs) are gaining prominence as tools for evaluation of public health control programs in endemic countries, and individual diagnosis in high-income countries. Despite the high sensitivity and specificity of NAATs, previous research has highlighted inter-laboratory variations, both in technical and clinical performance, justifying the need for continuous proficiency testing. Methodology: Results from 5 rounds over a 5-year period of the so far only longitudinal international Helminth External Molecular Quality Assessment Scheme (HEMQAS), coordinated by the Dutch Foundation for Quality Assessment in Medical Laboratories (SKML), were examined in order to (i) assess the diagnostic proficiency of laboratories in detecting helminths in stool and (ii) identify potential factors contributing to variations in performance. Outcome and conclusions: Thirty-six laboratories, from 18 countries and 5 continents, participated in HEMQAS. The overall diagnostic performances were satisfying, with remarkably low numbers (<2%) of false-positive results. False-negative results were more often reported for stool (15%) than for DNA (5%) samples. False-negative results varied largely between targets (the highest number (29%) for Trichuris trichiura). Twenty-five laboratories provided a sufficient number of results for a robust comparison between participating laboratories, which confirmed substantial inter-laboratory variability in quantitative NAAT results (Cq-values). This variability likely arises from differences in pre-treatment, DNA isolation and DNA-target amplification procedures. This study emphasizes the complexity of molecular diagnosis for STH and SCH, highlighting the critical role of proper stool preparation and DNA isolation methods. The results underscore the necessity for laboratory professionals and public health decision-makers to recognize these complexities and continuously undertake external quality assessment schemes to ensure accurate and reliable performance in molecular diagnosis. Author summary: Parasitic worms cause significant global health challenges, particularly in rural communities in low and middle-income countries. Laboratory tests that detect parasite DNA in human stool are increasingly being used for the diagnosis of parasitic worm infections. While parasite DNA detection can be an excellent diagnostic tool, its performance in clinical practice varies considerably, as demonstrated by previous research. To ensure the quality in diagnostic testing of these parasitic worms, it is important that laboratories evaluate the diagnostic performance of their DNA-based tests by participating in a so-called external quality assessment scheme (EQAS). This study, focusing on the first five-yearly rounds of the so far only longitudinal international EQAS to date, reveals that quantitative DNA detection results are not directly comparable across laboratories due to substantial inter-laboratory variability. This variability mainly stems from differences in pre-treatment and DNA isolation protocols, and to a lesser extent from differences in DNA target amplification procedures. Furthermore, the study underscores the complexity of molecular diagnosis for parasitic worms in clinical practice and the necessity for laboratories to engage in EQAs to guarantee the proper functioning of these diagnostic tests. [ABSTRACT FROM AUTHOR]

Introduction: Direct oral anticoagulants (DOACs) reflect anticoagulation agents given to treat or prevent thrombosis, having largely replaced vitamin K antagonists (VKAs) such as warfarin. DOACs are given in fixed daily doses and generally do not need monitoring. However, there may be a variety of reasons that justify measurement of plasma DOAC levels in individual patients. Methods: We report updated findings for DOAC testing in our geographic region, using recent data from the RCPAQAP, an international external quality assessment (EQA) program, currently with some 40–60 participants in each of the different DOAC (rivaroxaban, apixaban, dabigatran) modules, to assess laboratory performance in this area. Data has been assessed for the past 5 years (2019–2023 inclusive), with 20 samples each per DOAC. Results: Data shows a limited repertoire of assays in use, and mostly consistency in reported numerical values when assessing proficiency samples. Available assays mostly comprised reagents from four manufacturing suppliers. There was good consistency across what participants identified as 'DOAC detected', but some variability when participants attempted to grade DOAC levels as low vs moderate vs high. Inter‐laboratory/method coefficient of variation (CVs) were generally <15% for each DOAC, when present at >100 ng/mL. Conclusion: We hope our findings, reflecting on mostly consistent reporting of DOAC levels and interpretation provides reassurance for clinicians requesting these measurements, and helps support their implementation in regions where there is a paucity of test availability. [ABSTRACT FROM AUTHOR]