Benchmarking medical laboratory performance on a global scale.

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

The surveys on quality indicators for the total testing process in clinical laboratories of Fujian Province in China from 2018 to 2023.

OBJECTIVES: This study investigates the application of 15 Quality Indicators (QIs) in clinical laboratories in Fujian Province, China, from 2018 to 2023. It identifies the main causes of laboratory errors and explores issues in the application of QIs, providing a reference for establishing provincial state-of-the-art and operational quality specifications (QSs). METHODS: All clinical laboratories in Fujian Province were organized to submit general information and original QIs data through the online External Quality Assessment (EQA) system of the National Clinical Laboratory Center (NCCL) for a survey of 15 QIs. Data from 2018 to 2023 were downloaded for statistical analysis, and the current QSs for the 15 QIs in Fujian Province were compared and analyzed with those published by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Working Group on Laboratory Errors and Patient Safety (WG-LEPS). RESULTS: QIs data from 542 clinical laboratories were collected. The survey on data sources showed that the number of laboratories recording QIs data using Laboratory Information Systems (LIS) increased annually, but the growth was modest and the proportion was less than 50 %. Among the laboratories using LIS to record QIs data, 133 continuously participated in this survey for six years, reporting different QIs. Over the six years, all reported QIs showed significant improvement or at least remained stable. The best median Sigma (σ) metrics were for the percentage of critical values notification and timely critical values notification, reaching 6σ, followed by the percentage of incorrect laboratory reports, with σ metrics ranging from 4.9σ to 5.1σ. In contrast, the percentage of tests covered by internal quality control (IQC) (1.5σ-1.7σ) and inter-laboratory comparison (0.1σ) remained consistently low. Compared to the QSs published by IFCC WG-LEPS, the QSs for the 15 QIs in Fujian Province in 2023 were stricter or roughly equivalent, except for the percentage of incorrect laboratory reports (Fujian Province: 0-0.221, IFCC WG-LEPS: 0-0.03). CONCLUSIONS: 1. The application of QIs has significantly improved the quality of testing in clinical laboratories in Fujian Province, but the percentage of tests covered by IQC and inter-laboratory comparison remain low; 2. Effective application of QIs requires the establishment of comprehensive LIS, unified calculation standards, and other supporting measures.

Evaluation of Cardiovascular Disease Risk in Patients with Type 2 Diabetes Mellitus Using Clinical Laboratory Markers.

Background: Cardiovascular diseases (CVD) are the main cause of death in the population with diabetes mellitus. This study purposed to determine clinical laboratory markers that might be correlated with the risk of CVD in individuals with type 2 diabetes mellitus (T2DM). Methods: Using data from the Clinical Center of the University of Debrecen from 2016 to 2020, we assessed cardiovascular risk in 5593 individuals with T2DM over a five-year follow-up period. There were 347 new cases of acute myocardial infarction (AMI) and stroke during the period. Following the stratification of these individuals into two groups according to the diagnosis of these CVDs until 2020, the risk of these CVDs was assessed through the utilization of the Chi-square test and Cox proportional hazards regression. Results: The findings of the Cox proportional hazards regression model showed that the number of HbA1C measurements per year (HR = 0.46, 95% CI 0.31-0.7), decreased levels of estimated glomerular filtration rate (eGFR) (HR = 1.6, 95% CI 1.04-2.47), and elevated triglyceride levels (HR = 1.56, 95% CI 1.06-2.29) were correlated with CVD in patients with T2DM. The area under the curve (AUC) was increased from 0.557 (95% CI 0.531-0.582) to 0.628 (95% CI 0.584-0.671) after the inclusion of the laboratory variables into the model showing improved discrimination for AMI and stroke. Conclusions: These findings indicated that eGFR, triglyceride, and the number of HbA1C per year are correlated with AMI and stroke in patients with T2DM.

The US FDA's proposed rule on laboratory-developed tests: Impacts on clinical laboratory testing.

Objectives: To solicit quantifiable feedback from clinical laboratorians on the U.S. Food and Drug Administration (FDA) proposed rule to regulate laboratory-developed tests (LDTs) as medical devices. Design and Methods: A ten-item questionnaire was developed and submitted to clinical laboratory customers of ARUP Laboratories, a national nonprofit clinical laboratory of the University of Utah Department of Pathology. Results: Of 503 clinical laboratory respondents, only 41 (8 %) support the FDA's proposed rule. 67 % of respondents work in laboratories that perform LDTs and were therefore asked additional questions regarding the proposed rule. 84 % of these respondents believe that the proposed rule will negatively impact their laboratories, while only 3 % believe that they have the financial resources to pay for FDA user fees. 61 % of respondents anticipate removing tests from their laboratory menus if the proposed rule is enacted, while an additional 33 % indicated that they do not yet know. Only 11 % of respondents believe that they would pursue FDA submissions for all of their existing LDTs if the final rule is enacted. The vast majority of respondents (>80 %) were either 'extremely concerned' or 'very concerned' about the impact of the proposed rule on patient access to essential testing, financial and personnel resources to comply, innovation, the FDA's ability to implement the rule, and send-out costs and test prices. Conclusions: The majority of clinical laboratorians surveyed do not support the FDA's proposed rule on LDTs and report having insufficient resources to comply with the rule if it is enacted.

Medical laboratory scientist motivation to pursue graduate education.

BACKGROUND: Medical laboratory staffing shortages have persisted, with challenges in maintaining adequate medical laboratory professionals. The career trajectory for medical laboratory scientists beyond entry level is ambiguous, but advancement opportunities are enhanced with specialist certifications and advanced degrees. OBJECTIVE: This study explored the motivation and preferences of medical laboratory scientists in pursuing graduate medical laboratory science education based on the importance of professional development, career advancement, recognition, and employment benefits. METHODS: A quantitative, cross-sectional, and descriptive correlational study surveyed American Society for Clinical Pathology Board of Certification-credentialed medical laboratory scientists using an online questionnaire. RESULTS: The overall response rate was 2.5%, and 1247 complete surveys were analyzed. Educational preferences varied by respondent age and amount of laboratory experience. Professional development, career advancement, recognition, and employment benefits were all important motivators for seeking graduate degrees, but those who were younger and had less experience indicated they were more important. CONCLUSION: This study suggests several areas of improvement for educational programs, health care organizations, and professional organizations to support the motivation of medical laboratory scientists to pursue graduate education.

Variables that impact HPV test accuracy during vaginal self collection workflow for cervical cancer screening.

Vaginal self collection (SC) is safe and effective for human papillomavirus (HPV) testing and can increase cervical cancer screening coverage for underserved women. To better understand the impact of SC methodology on HPV test outcomes, empirical testing was conducted using different swab collection workflows. Deposition of the collection swab into resuspension buffer resulted in a 2.4-cycle reduction in threshold detection of human beta-hemoglobin during PCR when compared to "swirl-and-toss". In addition, reducing the swab resuspension volume from 10 mL to 3 mL resulted in a 2.6-cycle reduction in threshold detection of human beta-globin. A systematic literature search (01/01/2020 to 08/02/2023) of Ovid Medline and Embase, followed by data extraction and analysis, was conducted to further assess the impact of resuspension volume on performance following SC. HPV test performance for SC, relative to clinician collection (CC), was calculated for detection of cervical pre-cancer. Data were stratified by the resuspension volume ratio of SC to CC being either ≥ 1.0 or < 1.0. SC with a volume ratio of ≥ 1.0 and < 1.0 had a relative ≥ CIN2 sensitivity of 92.0 % (95 % CI: 88.0, 96.0) and 97.0 % (95 % CI: 94.0, 100), respectively. Taken together, these results suggest that SC conditions can be modified to optimize sample recovery and performance, as part of cervical cancer screening.

Utility of Faster R-CNN in methodological comparison and evaluation of reticulocytes.

Objective: The purpose of this study was to evaluate the methodological comparison of reticulocytes by using the intelligent learning system Faster R-CNN, a set of reticulocyte image detection systems developed using deep neural networks. Methods: We selected 59 EDTA-K2 anticoagulated whole blood samples and calculated the RET% using seven different Sysmex XN full-automatic hematology analyzers with Faster R-CNN in the laboratory. We compared and evaluated the methods and statistically analyzed the correlation between the various test results. Results: The results indicated a high degree of consistency between the seven Sysmex XN full-automatic hematology analyzers and Faster R-CNN in detecting RET%. The correlation coefficients were 0.987, 0.984, 0.986, 0.987, 0.987, 0.988, and 0.986, respectively. Conclusion: We found that the Sysmex XN full-automatic hematology analyzers in our laboratory using the Faster R-CNN system met the requirements of the methodological comparison of reticulocyte detection and this intelligent learning system can be a useful clinical tool.

Managing hemolysis in serum neuron-specific enolase measurements - an automated algorithm for routine practice.

Neuron-specific enolase (NSE) derived from neurons and peripheral neuroendocrine cells is a biomarker for neuroendocrine tumors and for prognostication in comatose cardiac arrest survivors. However, as platelets and erythrocytes contain NSE, hemolysis causes falsely elevated NSE. We used native serum and hemolysate derived from the same patients to make serial dilutions, and subsequently measured NSE (mNSE) and hemolytic index (HI) in each dilution. An algorithm suitable for the laboratory information system was developed based on the mNSE, HI and the estimated gradient of hemolytic interference from 30 patients. We estimated the associated uncertainty of the corrected NSE (cNSE) results based on the observed range of the gradient and derived an equation for cNSE for samples with limited hemolysis (i.e. 5 < HI ≤ 30): cNSE = mNSE - HI × (0.34 ± 0.23) µg/L. By semi-quantitatively grading the contribution from limited hemolysis, a texted result noting the hemolysis-associated degree of uncertainty can accompany the cNSE result. The major challenge of hemolysis when using serum NSE as a biomarker can be managed using an automated algorithm for correction of NSE results based on degree of hemolysis. However, laboratorians and clinicians should be aware of the limitations associated with in vivo hemolysis.

Plasma D-asparagine and the D/L-serine ratio reflect chronic kidney diseases in children regardless of physique.

Biomarkers that accurately reflect renal function are essential in management of chronic kidney diseases (CKD). However, in children, age/physique and medication often alter established renal biomarkers. We studied whether amino acid enantiomers in body fluids correlate with renal function and whether they are influenced by physique or steroid medication during development. We conducted a prospective study of children 2 to 18 years old with and without CKD. We analyzed associations of serine/asparagine enantiomers in body fluids with major biochemical parameters as well as physique. To study consequences of kidney dysfunction and steroids on serine/asparagine enantiomers, we generated juvenile mice with uninephrectomy, ischemic reperfusion injury, or dexamethasone treatment. We obtained samples from 27 children, of which 12 had CKD due to congenital (n = 7) and perinatal (n = 5) causes. Plasma D-asparagine and the D/L-serine ratio had robust, positive linear associations with serum creatinine and cystatin C, and detected CKD with high sensitivity and specificity, uninfluenced by body size or biochemical parameters. In the animal study, kidney dysfunction increased plasma D-asparagine and the D/L-serine ratio, but dexamethasone treatment did not. Thus, plasma D-asparagine and the D/L-serine ratio can be useful markers for renal function in children.

Molecular Detection of SARS-CoV-2 From Throat Swabs Performed With or Without Specimen Collection From the Tonsils: Protocol for a Multicenter Randomized Controlled Trial.

BACKGROUND: Testing for SARS-CoV-2 is essential to provide early COVID-19 treatment for people at high risk of severe illness and to limit the spread of infection in society. Proper upper respiratory specimen collection is the most critical step in the diagnosis of the SARS-CoV-2 virus in public settings, and throat swabs were the preferred specimens used for mass testing in many countries during the COVID-19 pandemic. However, there is still a discussion about whether throat swabs have a high enough sensitivity for SARS-CoV-2 diagnostic testing, as previous studies have reported a large variability in the sensitivity from 52% to 100%. Many previous studies exploring the diagnostic accuracy of throat swabs lack a detailed description of the sampling technique, which makes it difficult to compare the different diagnostic accuracy results. Some studies perform a throat swab by only collecting specimens from the posterior oropharyngeal wall, while others also include a swab of the palatine tonsils for SARS-CoV-2 testing. However, studies suggest that the palatine tonsils could have a tissue tropism for SARS-CoV-2 that may improve the SARS-CoV-2 detection during sampling. This may explain the variation of sensitivity reported, but no clinical studies have yet explored the differences in sensitivity and patient discomfort whether the palatine tonsils are included during the throat swab or not. OBJECTIVE: The objective of this study is to examine the sensitivity and patient discomfort of a throat swab including the palatine tonsils compared to only swabbing the posterior oropharyngeal wall in molecular testing for SARS-CoV-2. METHODS: We will conduct a randomized controlled study to compare the molecular detection rate of SARS-CoV-2 by a throat swab performed from the posterior oropharyngeal wall and the palatine tonsils (intervention group) or the posterior oropharyngeal wall only (control group). Participants will be randomized in a 1:1 ratio. All participants fill out a baseline questionnaire upon enrollment in the trial, examining their reason for being tested, symptoms, and previous tonsillectomy. A follow-up questionnaire will be sent to participants to explore the development of symptoms after testing. RESULTS: A total of 2315 participants were enrolled in this study between November 10, 2022, and December 22, 2022. The results from the follow-up questionnaire are expected to be completed at the beginning of 2024. CONCLUSIONS: This randomized clinical trial will provide us with information about whether throat swabs including specimens from the palatine tonsils will improve the diagnostic sensitivity for SARS-CoV-2 molecular detection. These results can, therefore, be used to improve future testing recommendations and provide additional information about tissue tropism for SARS-CoV-2. TRIAL REGISTRATION: ClinicalTrials.gov NCT05611203; https://clinicaltrials.gov/study/NCT05611203. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/47446.

Laboratory specimen rejection rate and associated factors among referred specimens at Debre Markos Referral Hospital, Ethiopia: prospective cross-sectional study.

Introduction: laboratory errors mostly emerge from the pre-analytical phase, mainly those related to collection, handling, transportation, and storage of diagnostic specimens. Specimen rejection due to improper sample collection, may lead to poor patient outcomes, such as incorrect diagnosis, inappropriate treatment, and death. This study aimed to assess the specimen rejection rate and associated factors among referred specimens at Debre Markos Referral Hospital. Methods: a prospective cross-sectional study design was applied from January 2020 to April 2020 to investigate specimen rejection rate and associated factors among referred specimens. The study population was all laboratory specimens referred for viral load, CD4 count, gene expert, and early infant diagnosis to the Debre Markos Referral Hospital laboratory. The statistical analysis was done with Statistical Package for Social Sciences version 20.0 software. Results: of the total of 2750 specimens submitted to the laboratory from January 2020 to April 2020, 37 (1.34%) specimens were rejected due to different reasons like insufficient volume, hemolysis, and an inappropriate specimen container. Specimen collector training status and experience had a significant association with the specimen rejection rate. Conclusion: the results of our study show that the specimen rejection rate among referred specimens was high, indicating that more interventions are required to decrease the specimen rejection rate.

Evorpacept-Induced Interference and Application of a Novel Mitigation Agent, Evo-NR, in Pretransfusion Testing.

Introduction: Evorpacept is a CD47-blocking agent currently being developed for the treatment of various cancers. Interference by evorpacept in pretransfusion compatibility testing has been reported at limited plasma concentrations. Although various mitigation strategies have been proposed, none are practical. This in vitro study assessed evorpacept-induced interference at extended concentrations and investigated the capability of a novel mitigation agent, Evo-NR. Methods: Antibody screening tests were performed on evorpacept-spiked plasma with (anti-E and anti-Jka) or without alloantibodies at evorpacept concentrations up to 2,000 µg/mL using manual gel cards and automated analyzers. Evorpacept-coated red blood cells (RBCs) (rr [ce/ce], Fy[a+b-], S-s+) were tested by direct antiglobulin testing (DAT) and antigen typing using anti-Fyb and anti-S reagents at indirect antiglobulin testing (IAT) phase. Evo-NR was used to resolve the interference in plasma and RBC samples. Flow cytometry was used to assess the mitigation effects. Results: Evorpacept-spiked plasma showed panreactive interference in antibody screening tests using manual gel cards (2+ to 3+) and automated analyzers (4+). A carryover effect was also observed in the automated analyzers. The use of a 3- to 6-fold molar excess of Evo-NR effectively resolved the interference in the plasma and enabled accurate alloantibody identification. Although the reduction in evorpacept binding to RBCs was identified via flow cytometry, Evo-NR was incapable of resolving the serologic interference observed in DAT and antigen typing at IAT phase. Discussion: Evorpacept showed constant panreactivity and a carryover effect at high concentrations. Evo-NR successfully resolved the interference in the plasma samples and could be considered a practical and efficient mitigation solution. Implementation of Evo-NR has the potential to support RBC transfusion for patients undergoing evorpacept treatment.

Dynamic mirroring: unveiling the role of digital twins, artificial intelligence and synthetic data for personalized medicine in laboratory medicine.

In recent years, the integration of technological advancements and digitalization into healthcare has brought about a remarkable transformation in care delivery and patient management. Among these advancements, the concept of digital twins (DTs) has recently gained attention as a tool with substantial transformative potential in different clinical contexts. DTs are virtual representations of a physical entity (e.g., a patient or an organ) or systems (e.g., hospital wards, including laboratories), continuously updated with real-time data to mirror its real-world counterpart. DTs can be utilized to monitor and customize health care by simulating an individual's health status based on information from wearables, medical devices, diagnostic tests, and electronic health records. In addition, DTs can be used to define personalized treatment plans. In this study, we focused on some possible applications of DTs in laboratory medicine when used with AI and synthetic data obtained by generative AI. The first point discussed how biological variation (BV) application could be tailored to individuals, considering population-derived BV data on laboratory parameters and circadian or ultradian variations. Another application could be enhancing the interpretation of tumor markers in advanced cancer therapy and treatments. Furthermore, DTs applications might derive personalized reference intervals, also considering BV data or they can be used to improve test results interpretation. DT's widespread adoption in healthcare is not imminent, but it is not far off. This technology will likely offer innovative and definitive solutions for dynamically evaluating treatments and more precise diagnoses for personalized medicine.

Assessing Non-Laboratory Healthcare Professionals' Attitude towards the Importance of Patient Preparation for Laboratory Tests.

(1) Background: Various guidelines address patient preparation and its importance for venous blood sampling, such as the GP41 guideline issued by the Clinical Laboratory Standards Institute (CLSI) and the blood collection guidelines published by the World Health Organisation. Recommendations provided by national societies or international organisations in the field of radiology, such as The Contrast Media Safety Committee of the European Society of Urogenital Radiology, or in the field of laboratory medicine, such as the Working Group for Preanalytical Phase (WG-PRE) of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) and the Latin American Working Group for Preanalytical Phase (WG-PRE-LATAM) of the Latin American Confederation of Clinical Biochemistry (COLABIOCLI), also guide this practice. There is a notable lack of understanding regarding the viewpoints held by non-laboratory healthcare professionals concerning the significance of patient preparation for laboratory testing and the impact of typical factors associated with patient preparation. This study endeavours to bridge this gap by assessing the attitude of non-laboratory healthcare professionals in Lithuania regarding these pivotal aspects. (2) Methods: A self-designed anonymous questionnaire was disseminated among 141 public healthcare institutions in Lithuania. The internal consistency of the questionnaire was evaluated by computing Cronbach's alpha. Descriptive statistics were utilised for the variables, while comparisons of attitude among groups were conducted using Mann-Whitney U (for two groups) or Kruskal-Wallis (for more than two groups) for categorical and discrete indicators. The Kruskal-Wallis post-hoc test was employed for pairwise comparisons. A significance level of p-Value < 0.05 was applied to establish statistical significance. (3) Results: A total of 158 respondents constituted two distinct groups of healthcare professionals: nurses and physicians. Most of the participants either agreed or strongly agreed that patient preparation could introduce bias into laboratory test results. Professionals with less than 20 years of work experience or those who attended training in patient preparation for sampling within a 5-year timeframe exhibited stronger agreement regarding different preanalytical factors in patient preparation and their impact on laboratory test results compared to their counterparts. (4) Conclusions: Non-laboratory healthcare professionals who participated in this survey consider proper patient preparation for laboratory testing to be a significant step towards obtaining accurate test results. They also recognize the commonly acknowledged preanalytical factors as important for ensuring reliable test results. However, attitudes towards the importance of several preanalytical factors vary depending on whether non-laboratory healthcare professionals have more or less than 20 years of work experience, as well as whether they have attended any training on this topic within the last five years or have never attended such training.

Laboratory-based surveillance of chronic kidney disease in people with private health coverage in Brazil.

BACKGROUND: Although approximately 25% of Brazilians have private health coverage (PHC), studies on the surveillance of chronic kidney disease (CKD) in this population are scarce. The objective of this study was to estimate the prevalence of CKD in individuals under two PHC regimes in Brazil, who total 8,335,724 beneficiaries. METHODS: Outpatient serum creatinine and proteinuria results of individuals from all five regions of Brazil, ≥ 18 years of age, and performed between 10/01/2021 and 10/31/2022, were analyzed through the own laboratory network database. People with serum creatinine measurements were evaluated for the prevalence and staging of CKD, and those with simultaneous measurements of serum creatinine and proteinuria were evaluated for the risk category of the disease. CKD was classified according to current guidelines and was defined as a glomerular filtration rate (GFR) < 60 ml/min/1.73 m² estimated by the 2021 CKD-EPI equation. RESULTS: The number of adults with serum creatinine results was 1,508,766 (age 44.0 [IQR, 33.9-56.8] years, 62.3% female). The estimated prevalence of CKD was 3.8% (2.6%, 0.8%, 0.2% and 0.2% in CKD stages 3a, 3b, 4 and 5, respectively), and it was higher in males than females (4.0% vs. 3.7%, p < 0.001, respectively) and in older age groups (0.2% among 18-29-year-olds, 0.5% among 30-44-year-olds, 2.0% among 45-59-year-olds, 9.4% among 60-74-year-olds, and 32.4% among ≥ 75-year-olds, p < 0.001) Adults with simultaneous results of creatinine and proteinuria were 64,178 (age 57.0 [IQR, 44.8-67.3] years, 58.1% female). After adjusting for age and gender, 70.1% were in the low-risk category of CKD, 20.0% were in the moderate-risk category, 5.8% were in the high-risk category, and 4.1% were in the very high-risk category. CONCLUSION: The estimated prevalence of CKD was 3.8%, and approximately 10% of the participants were in the categories of high or very high-risk of the disease. While almost 20% of beneficiaries with PHC had serum creatinine data, fewer than 1% underwent tests for proteinuria. This study was one of the largest ever conducted in Brazil and the first one to use the 2021 CKD-EPI equation to estimate the prevalence of CKD.

Impact of Sample Type on D-Dimer Screening.

Background: The quality of laboratory test results depends on various factors, including sample type selection. Blood samples, such as whole blood, plasma and serum are commonly used for most clinical laboratory examinations. D-dimer parameters are frequently analysed in haematology laboratories and serve as biomarkers for coagulation activation and fibrinolysis. This study aimed to assess the impact of using different sample types on the quality of D-dimer test results. Method: An observational analytical method was used. D-dimer examination was performed using the fluorescent lateral flow immunoassay method. The study sample consisted of 26 participants aged between 18 years old and 22 years old who had no blood disorders. Whole blood and ethylenediaminetetraacetic acid (EDTA) plasma samples were used for the examination of D-dimer levels. Results: D-dimer levels in 26 participants using whole blood samples had a mean value of 0.23 mg/L (230 ng/mL), while plasma samples yielded a mean value of 0.14 mg/L (140 ng/mL). D-dimer levels obtained from whole blood samples were higher than plasma samples but remained within the normal range of 0 mg/L-0.5 mg/L (0 ng/mL-500 ng/mL). Conclusion: The results showed that whole blood samples were more practical than plasma samples. Nevertheless, plasma samples gave results within the normal range of D-dimer values.

Artificial Intelligence - Perception of Clinical Laboratories' Technical Staff a Nationwide Multicentre Survey in Pakistan.

Introduction: As Artificial Intelligence (AI) technology continues to assimilate into various industries, there is a huge scope in the healthcare industry specifically in clinical laboratories. The perspective of the laboratory professionals can give valuable insight on the ideal path to take for AI implementation. Methods: The study utilized a cross-sectional survey design and was conducted at the section of Chemical Pathology, Department of Pathology and Laboratory Medicine, the Aga Khan University (AKU), Karachi, Pakistan in collaboration with Consultant Pathologists of 9 clinical laboratories associated with teaching hospitals across Pakistan from October-November 2023. The survey was for a duration of 2 weeks and was circulated to all working laboratory technical staff after informed consent. Results: A total of 351 responses were received, of which 342 (male=146, female=196) responses were recorded after exclusion. Respondents ranged from technologists, faculty, residents, and coordinators, and were from different sections (chemical pathology, microbiology, haematology, histopathology, POCT). Out of the total 312 (91.2%) of respondents stated that they were at least somewhat familiar with AI technology. Experts in AI were only 2.0% (n=7) of all respondents, but 90% (n=6) of these were < 30 years old. 76.3% (n=261) of the respondents felt the need to implement more AI technology in the laboratories, with time saving (26.1%) and improving performances of tests (17.7%) cited to be the greatest benefits of AI. Security concerns (n=144) and a fear of decreasing personal touch (n=143) were the main concerns of the respondents while the younger employees had an increased fear of losing their jobs. 76.3% were in favour of an increase in AI usage in the laboratories. Conclusion: This study highlights a favourable perspective among laboratory professionals, acknowledging the potential of AI to enhance both the efficiency and quality of laboratory practices. However, it underscores the importance of addressing their concerns in the thoughtful implementation of this emerging technology.

Early detection of severe hypertriglyceridemia using teleconsultation in a clinical laboratory setting.

BACKGROUND: Teleconsultation in the context of clinical laboratories is a valuable tool for the early detection of dyslipidemia and prevention of cardiovascular risk. Here, we describe a patient who was referred to the Lipid Unit of the Virgen Macarena Hospital due to an alert for severe hypertriglyceridemia through its teleconsultation program. CASE PRESENTATION: A comprehensive clinical and biochemical study of the patient was carried out, and genetic testing was performed on the patient and his family. The proband and his family showed mild to severe hypertriglyceridemia and various secondary factors, together with a genetic background associated with a triglyceride-raising effect. CONCLUSION: This extensive study has identified a family at high risk of cardiovascular disease and acute pancreatitis. These findings can help maximize lifestyle changes and improve the clinical management of their dyslipidemia.

Evaluating proficiency testing implementation and identifying challenges that government comprehensive specialized hospital laboratories in northwest Ethiopia faced as they participated in the external quality assessment scheme: A document-based, interview-driven evaluation.

OBJECTIVES: To assess the implementation of proficiency testing in the northwest Ethiopian government comprehensive specialized hospital laboratories, with a focus on identifying and understanding the challenges encountered during their participation in the external quality assessment scheme. METHODS: A cross-sectional study was conducted among 3 comprehensive specialized hospitals in northwest Ethiopia, analyzing 41 documented laboratory test parameters from 2020 to 2022. In addition, face-to-face, in-depth interviews were carried out to identify the major challenges the participating institutions faced. RESULTS: The study covered a total of 41 tests across 9 cycles. Overall, proper implementation of proficiency testing was observed in 59.3% of the tests, with 61.8% maintaining consistent implementation status over 3 consecutive years. In addition, the overall performance of the laboratory was 54.3%, with a 68.7% participation rate. The predominantly identified challenges included the lack of participation, insufficient reagents and supplies, inadequacy of suitable proficiency testing materials, equipment malfunction and downtime, lack of management support, insufficient budget, and inadequate training and awareness. CONCLUSIONS: The results of this study highlight the ineffective implementation of proficiency testing. Contributing factors include personnel issues, equipment and supplies challenges, managerial shortcomings, difficulties with proficiency testing providers, budgetary constraints, and a lack of training and motivation.