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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.
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Seguros de Salud Comunitarios , Hospitales Públicos , Humanos , Etiopía , Femenino , Masculino , Adulto , Estudios Transversales , Persona de Mediana Edad , Adulto Joven , Adolescente , Encuestas y Cuestionarios , Satisfacción del Paciente/estadística & datos numéricos , Accesibilidad a los Servicios de Salud , Servicios de Laboratorio Clínico/estadística & datos numéricosRESUMEN
Proficiency testing (PT) is an impartial laboratory performance-evaluating system using an independent body. It is a mandatory accreditation requirement and means for improving the laboratory's performance. The study aimed to evaluate the performance of PT, with a focus on identifying and discussing determinants that influence PT performance at comprehensive specialized hospitals in northwest Ethiopia. A retrospective cross-sectional study was carried out from 2020 to 2022. Using a convenient sampling technique, laboratory tests with recorded PT results in each hospital laboratory were included. A data collection template and customized checklists were used to collect the data. Epi Data Version 3.1 for data entry and STATA Version 14.1 for cleaning and analysis were used. Binary logistic regression analyses were used. Variables with p < 0.05 in the multivariable logistic regression were considered to be statistically significant. Over nine cycles, 3807 PT challenges were distributed. The total failure rate of the laboratories was 32.4%, with a peak failure rate of 40.3% in 2020, after which the failure rate was decline to 20.6% in 2022. Among the five laboratory sections, molecular biology had the lowest failure rate (22.2%), while microbiology had the highest failure rate (56.5%). Multivariate logistic regression revealed that PT results reported without appropriate unit of measurement (AOR 7.5), lack of corrective action for PT nonconformance (AOR 7.1), and reagent unavailability (AOR 6.1) had significant effects on PT performance (p < 0.001). The results of this study showed that the overall performance of the laboratory was lower. Reporting PT results without appropriate units of measurement and not taking corrective action for PT nonconformance were the major aggravating factors for high failure rates.
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Servicios de Laboratorio Clínico , Estudios Retrospectivos , Etiopía , Estudios Transversales , HospitalesRESUMEN
OBJECTIVE: We utilized Premier Hb9210 analyzer (HPLC method; Trinity Biotech, Jamestown, NY) for measuring HBA1c in whole blood. As our laboratory is transitioning to Abbott system, we compared HbA1c values obtained by Alinity c and Premier Hb9210. METHODS: The Premier Hb9210 analyzer is based on boronate affinity high performance liquid chromatography with analytical measurement range of 3.8 to 18.5%. The Alinity c Hemoglobin A1c assay measured both total hemoglobin and HbA1c (enzymatic assay) in whole blood and then calculated %HbA1c. The analytical measurement range of this assay is 4 to 14% of HbA1c. We evaluated the analytical performance of Alinity c HbA1c by evaluating precision and also comparing 77 clinical samples with our reference HPLC method. RESULTS: Both Alinity c HbA1c and Premier HB9210 have excellent total precision. Plotting HbA1c results obtained by the Premier Hb9210 analyzer in the x-axis (currently used reference method) and the corresponding values obtained by the Alinity c assay, we observed the following regression equation: y=0.9473x+0.1548 ( n=77, r=0.99). DISCUSSION: Our result indicates that HbA1c enzymatic assay on the Alinity c analyzer showed values comparable to HPLC method. However, at the decision points (2.8% average negative bias at >6.4% and 3.3% average negative bias at 7%), HbA1c values obtained by the Alinity c analyzer were lower than the reference method. CONCLUSIONS: We conclude that HbA1c assay on the Alinity c analyzer is a viable alternative to HPLC for measuring HbA1c in clinical laboratories but values at the decision points must be interpreted with caution and if necessary should be repeated by a reference HPLC method.
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Servicios de Laboratorio Clínico , Pruebas Hematológicas , Humanos , Hemoglobina Glucada , Cromatografía Líquida de Alta Presión , InmunoensayoRESUMEN
OBJECTIVE: Data from DNA genotyping via a 96-SNP panel in a study of 25,015 clinical samples were utilized for quality control and tracking of sample identity in a clinical sequencing network. The study aimed to demonstrate the value of both the precise SNP tracking and the utility of the panel for predicting the sex-by-genotype of the participants, to identify possible sample mix-ups. RESULTS: Precise SNP tracking showed no sample swap errors within the clinical testing laboratories. In contrast, when comparing predicted sex-by-genotype to the provided sex on the test requisition, we identified 110 inconsistencies from 25,015 clinical samples (0.44%), that had occurred during sample collection or accessioning. The genetic sex predictions were confirmed using additional SNP sites in the sequencing data or high-density genotyping arrays. It was determined that discrepancies resulted from clerical errors (49.09%), samples from transgender participants (3.64%) and stem cell or bone marrow transplant patients (7.27%) along with undetermined sample mix-ups (40%) for which sample swaps occurred prior to arrival at genome centers, however the exact cause of the events at the sampling sites resulting in the mix-ups were not able to be determined.
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Servicios de Laboratorio Clínico , Secuenciación de Nucleótidos de Alto Rendimiento , Humanos , Trasplante de Médula Ósea , Genotipo , LaboratoriosRESUMEN
OBJECTIVES: Informal payments (IPs) are unofficial cash or in-kind payments for goods or services that should be covered by the health care system. They are a common but regressive method of financing health care in low- and lower-middle-income countries (LMICs). This study aims to characterize the prevalence and impact of IPs on pathology and laboratory medicine (PALM) services. METHODS: From September 2021 to September 2022, PALM staff were surveyed about the frequency, determinants, and impacts of IPs in their respective workplaces. RESULTS: In total, 268 responses were received, and 46.6% (125/268) reported experience with IPs. These 125 participants were more likely to work in the public sector and in LMICs. Approximately 65% reported accepting IPs to perform tests or release results. Obtaining faster results was the most commonly perceived reason for patients offering IPs. Overall, participants reported that IPs had more negative than positive impacts on their workplace. CONCLUSIONS: This represents a first step in characterizing IPs within PALM and how this practice may affect access to these services in LMICs. Specifically, the fact that faster turnaround time was the most frequently perceived reason for offering IPs uncovers a potential barrier to improving PALM capacity in these regions.
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Servicios de Laboratorio Clínico , Humanos , Servicios de Laboratorio Clínico/economía , Servicios de Laboratorio Clínico/estadística & datos numéricos , Encuestas y Cuestionarios , Femenino , Masculino , Adulto , Financiación Personal , Países en Desarrollo , Atención a la Salud/economía , Patología Clínica/economía , Persona de Mediana EdadRESUMEN
Importance: The US heart allocation system prioritizes medically urgent candidates with a high risk of dying without transplant. The current therapy-based 6-status system is susceptible to manipulation and has limited rank ordering ability. Objective: To develop and validate a candidate risk score that incorporates current clinical, laboratory, and hemodynamic data. Design, Setting, and Participants: A registry-based observational study of adult heart transplant candidates (aged ≥18 years) from the US heart allocation system listed between January 1, 2019, and December 31, 2022, split by center into training (70%) and test (30%) datasets. Adult candidates were listed between January 1, 2019, and December 31, 2022. Main Outcomes and Measures: A US candidate risk score (US-CRS) model was developed by adding a predefined set of predictors to the current French Candidate Risk Score (French-CRS) model. Sensitivity analyses were performed, which included intra-aortic balloon pumps (IABP) and percutaneous ventricular assist devices (VAD) in the definition of short-term mechanical circulatory support (MCS) for the US-CRS. Performance of the US-CRS model, French-CRS model, and 6-status model in the test dataset was evaluated by time-dependent area under the receiver operating characteristic curve (AUC) for death without transplant within 6 weeks and overall survival concordance (c-index) with integrated AUC. Results: A total of 16â¯905 adult heart transplant candidates were listed (mean [SD] age, 53 [13] years; 73% male; 58% White); 796 patients (4.7%) died without a transplant. The final US-CRS contained time-varying short-term MCS (ventricular assist-extracorporeal membrane oxygenation or temporary surgical VAD), the log of bilirubin, estimated glomerular filtration rate, the log of B-type natriuretic peptide, albumin, sodium, and durable left ventricular assist device. In the test dataset, the AUC for death within 6 weeks of listing for the US-CRS model was 0.79 (95% CI, 0.75-0.83), for the French-CRS model was 0.72 (95% CI, 0.67-0.76), and 6-status model was 0.68 (95% CI, 0.62-0.73). Overall c-index for the US-CRS model was 0.76 (95% CI, 0.73-0.80), for the French-CRS model was 0.69 (95% CI, 0.65-0.73), and 6-status model was 0.67 (95% CI, 0.63-0.71). Classifying IABP and percutaneous VAD as short-term MCS reduced the effect size by 54%. Conclusions and Relevance: In this registry-based study of US heart transplant candidates, a continuous multivariable allocation score outperformed the 6-status system in rank ordering heart transplant candidates by medical urgency and may be useful for the medical urgency component of heart allocation.
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Insuficiencia Cardíaca , Trasplante de Corazón , Obtención de Tejidos y Órganos , Adulto , Femenino , Humanos , Masculino , Persona de Mediana Edad , Bilirrubina , Servicios de Laboratorio Clínico , Corazón , Factores de Riesgo , Medición de Riesgo , Insuficiencia Cardíaca/mortalidad , Insuficiencia Cardíaca/cirugía , Estados Unidos , Asignación de Recursos para la Atención de Salud/métodos , Valor Predictivo de las Pruebas , Obtención de Tejidos y Órganos/métodos , Obtención de Tejidos y Órganos/organización & administraciónRESUMEN
OBJECTIVES: Healthcare has a considerable environmental impact, yet it has been largely overlooked. Clinical laboratories, in particular, consume significantly more energy and water per unit area compared to standard office buildings. It is crucial to raise awareness among laboratories about the significance of embracing eco-friendly practices. Numerous energy-saving measures do not incur additional costs but necessitate a shift in organizational culture and mindset. DESIGN & METHODS: This paper conducts a cost-benefit analysis of energy consumption at the Laboratory Medicine Unit of University Hospital of Padova, beginning with laboratory refrigerators and freezers. RESULTS: The need to rationalize the existing units, especially the combined refrigerators-freezers, and reorganize the contents of the Ultra-Low Temperature freezers with an energy-saving perspective has emerged. CONCLUSIONS: By implementing these practices, this initiative can gradually expand to encompass more green activities in the future.
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Servicios de Laboratorio Clínico , Conservación de los Recursos Naturales , Humanos , Laboratorios ClínicosRESUMEN
In October 2023, the Food and Drug Administration (FDA) released a proposed rule that ends enforcement discretion for laboratory-developed tests (LDTs). The FDA's proposal outlines a five-stage implementation to begin regulating LDTs as they do for commercial in vitro diagnostics (IVDs), including modified FDA-approved/cleared tests. We outline here concerns from the clinical and public health microbiology laboratory perspective. It is our opinion that LDTs performed by individual Clinical Laboratory Improvement Amendments-certified diagnostic laboratories should not be regulated in the same way as commercial IVDs. This rule, if finalized, will negatively impact the diagnostic services currently offered by clinical and public health laboratories and, therefore, patients and the providers who care for them. Ending enforcement discretion will likely stifle diagnostic innovation and decrease access to diagnostic testing and health equity. Furthermore, the lack of infrastructure, including personnel and funding, at the FDA and diagnostic laboratories to support the required submissions for review is an obstacle. Like the FDA, diagnostic laboratories prioritize patient safety, accurate clinical diagnostics, and health equity. Since the scope of the LDT landscape is currently unknown, we are supportive of a registration process, along with non-burdensome adverse event reporting, to first understand the scope of clinical use of LDTs and any associated safety concerns. Any regulatory rule should be based on data that have been gathered systematically, not anecdotes or case reports. A rule must also balance the potential negative impact to patient care with realistic safety risks for infectious disease diagnostics.
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Servicios de Laboratorio Clínico , Laboratorios , Humanos , Estados Unidos , United States Food and Drug AdministrationRESUMEN
OBJECTIVE: Deterioration index (DI) is a computer-generated score at a specific frequency that represents the overall condition of hospitalized patients using a variety of clinical, laboratory and physiologic data. In this paper, a contrastive transfer learning method is proposed and validated for early prediction of adverse events in hospitalized patients using DI scores. METHODS AND PROCEDURES: An unsupervised contrastive learning (CL) model with a classifier is proposed to predict adverse outcome using a single temporal variable (DI scores). The model is pretrained on an unsupervised fashion with large-scale time series data and fine-tuned with retrospective DI score data. RESULTS: The performance of this model is compared with supervised deep learning models for time series classification. Results show that unsupervised contrastive transfer learning with a classifier outperforms supervised deep learning solutions. Pretraining of the proposed CL model with large-scale time series data and fine-tuning that with DI scores can enhance prediction accuracy. CONCLUSION: A relationship exists between longitudinal DI scores of a patient and the corresponding outcome. DI scores and contrastive transfer learning can be used to predict and prevent adverse outcomes in hospitalized patients. CLINICAL IMPACT: This paper successfully developed an unsupervised contrastive transfer learning algorithm for prediction of adverse events in hospitalized patients. The proposed model can be deployed in hospitals as an early warning system for preemptive intervention in hospitalized patients, which can mitigate the likelihood of adverse outcomes.
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Servicios de Laboratorio Clínico , Pacientes , Humanos , Estudios Retrospectivos , Algoritmos , Aprendizaje AutomáticoRESUMEN
Portable medical sensors play an important role in healthcare services, especially in rural communities. Many telehealth systems use these devices for providing patients' vital information from a distance to remote doctors. Erroneous data will not only mislead the remote doctor for correct diagnosis but it will cause health threats to these unreached community people. Therefore, it is very important to identify good sensors with an acceptable level of accuracy but within the affordable price of the available sensors in the market. This study aims to identify quality portable cholesterol sensors with high accuracy with the reference of the Japanese clinical pathology laboratory as a gold standard. We have considered cholesterol sensors that measure total cholesterol for this study that are commonly used in the developing countries of Asia. We found that out of four, three of them were very much erroneous and cannot be recommended even for primary healthcare.
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Servicios de Laboratorio Clínico , Telemedicina , Humanos , Asia , Colesterol , LaboratoriosRESUMEN
In the SMART-CARE project- a systems medicine approach to stratification of cancer recurrence in Heidelberg, Germany - a streamlined mass-spectrometry (MS) workflow for identification of cancer relapse was developed. This project has multiple partners from clinics, laboratories and computational teams. For optimal collaboration, consistent documentation and centralized storage, the linked data repository was designed. Clinical, laboratory and computational group members interact with this platform and store meta- and raw-data. The specific architectural choices, such as pseudonymization service, uploading process and other technical specifications as well as lessons learned are presented in this work. Altogether, relevant information in order to provide other research groups with a head-start for tackling MS data management in the context of systems medicine research projects is described.
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Servicios de Laboratorio Clínico , Neoplasias , Humanos , Manejo de Datos , Documentación , Espectrometría de Masas , Neoplasias/terapiaRESUMEN
Inappropriate ordering practices, either under or over ordering of diagnostic tests, are recognized problems with possible negative downstream consequences. As the menu of clinical tests, especially molecular tests grows, it is becoming increasingly important to provide guidance to providers on the appropriate utilization. Diagnostic stewardship programs have been established at many institutions to help direct the appropriate utilization of laboratory testing to ultimately guide patient management and treatment decisions. Many molecular tests have now received Clinical Laboratory Improvement Amendments (CLIA)-waived status for use in a point-of-care (POC) setting; however, parallel diagnostic stewardship programs have not been established to help guide providers on how best to use these tests. In this article, we will discuss the available molecular POC tests and opportunities and challenges for establishing diagnostic stewardship programs for molecular testing performed in the POC setting.
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Servicios de Laboratorio Clínico , Sistemas de Atención de Punto , Humanos , Pruebas en el Punto de Atención , Técnicas de Diagnóstico Molecular , LaboratoriosRESUMEN
This article will discuss diagnostic stewardship from the perspective of those who are just starting, or have recently started, a diagnostic stewardship effort. This document will provide guidance on how to identify opportunities for intervention and tools that can be used to affect change. Specifically, we will discuss key components of a diagnostic stewardship committee, referral laboratory testing, prior authorization, miscellaneous test orders, establishing a laboratory test formulary, and conclude with some specific examples of interventions that can be considered.
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Servicios de Laboratorio Clínico , Laboratorios ClínicosRESUMEN
Syndromic respiratory panels are now widely available in clinical microbiology laboratories and health care institutions. These panels can rapidly diagnose infections and detect antimicrobial resistance genes allowing for more rapid therapeutic optimization compared to standard microbiology approaches. However, given reimbursement concerns and limitations of multiplex molecular testing and results interpretation, maximum clinical utility and positive clinical outcomes depend on active diagnostic stewardship. Here, the authors review clinical outcomes of both upper and lower respiratory panels and present diagnostic stewardship strategies for optimal use of respiratory panels.
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Antiinfecciosos , Programas de Optimización del Uso de los Antimicrobianos , Servicios de Laboratorio Clínico , Antiinfecciosos/uso terapéutico , Técnicas de Diagnóstico Molecular/métodosRESUMEN
This paper is a description of the ICSH guidance for internal quality control (IQC) policy for blood cell counters. It follows from and links to a separate ICSH review for such policies and practices. The ICSH has gathered information regarding the current state of practice through review of published guidance from regulatory bodies, a questionnaire to six major cell counter manufacturers and a survey issued to 191 diagnostic laboratories in four countries (China, the Republic of Ireland, Spain, and the United Kingdom) on their IQC practice and approach to the use of commercial IQC materials. This has revealed diversity both in guidance and in practice around the world. There is diversity in guidance from regulatory organizations in regard to IQC methods each recommends, clinical levels to use and frequency to run commercial controls, and finally recommended sources of commercial control materials. The diversity in practice among clinical laboratories spans the areas of IQC methods used, derivation of target values, and action limits used with commercial control materials, and frequency of running commercial controls materials. These findings and their implications for IQC Practice are addressed in this guidance document, which proposes a harmonized approach to address the issues faced by diagnostic laboratories.
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Células Sanguíneas , Servicios de Laboratorio Clínico , Humanos , Control de Calidad , Laboratorios , Laboratorios ClínicosRESUMEN
INTRODUCTION: This paper is a report of an ICSH review of policies and practices for internal quality control (IQC) policy for haematology cell counters among regulatory bodies, cell counter manufacturers and diagnostic laboratories. It includes a discussion of the study findings and links to separate ICSH guidance for such policies and practices. The application of internal quality control (IQC) methods is an essential pre-requisite for all clinical laboratory testing including the blood count (Full Blood Count, FBC, or Complete Blood Count, CBC). METHODS: The ICSH has gathered information regarding the current state of practice through review of published guidance from regulatory bodies, a questionnaire to six major cell counter manufacturers (Abbott Diagnostics, Beckman Coulter, Horiba Medical Diagnostic Instruments & Systems, Mindray Medical International, Siemens Healthcare Diagnostics and Sysmex Corporation) and a survey issued to 191 diagnostic laboratories in four countries (China, Republic of Ireland, Spain and the United Kingdom) on their IQC practice and approach to use of commercial IQC materials. RESULTS: This has revealed diversity both in guidance and in practice around the world. There is diversity in guidance from regulatory organizations in regard to IQC methods each recommends, clinical levels to use and frequency to run commercial controls, and finally recommended sources of commercial controls. The diversity in practice among clinical laboratories spans the areas of IQC methods used, derivation of target values and action limits used with control materials, and frequency of running commercial controls materials. CONCLUSIONS: These findings and their implications for IQC Practice are discussed in this paper. They are used to inform a separate guidance document, which proposes a harmonized approach to address the issues faced by diagnostic laboratories.
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Servicios de Laboratorio Clínico , Laboratorios , Humanos , Control de Calidad , Células Sanguíneas , Técnicas de Laboratorio ClínicoRESUMEN
BACKGROUND: Colorectal cancer (CRC) is a leading cause of cancer incidence and mortality. Screening can result in reductions in incidence and mortality, but there are many challenges to uptake and follow-up. CONTENT: Here, we will review the changing epidemiology of CRC, including increasing trends for early and later onset CRC; evidence to support current and emerging screening strategies, including noninvasive stool and blood-based tests; key challenges to ensuring uptake and high-quality screening; and the critical role that clinical laboratories can have in supporting health system and public health efforts to reduce the burden of CRC on the population. SUMMARY: Clinical laboratories have the opportunity to play a seminal role in optimizing early detection and prevention of CRC.
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Servicios de Laboratorio Clínico , Neoplasias Colorrectales , Humanos , Detección Precoz del Cáncer , Laboratorios Clínicos , Transporte Biológico , Neoplasias Colorrectales/diagnóstico , Neoplasias Colorrectales/epidemiologíaRESUMEN
CONTEXT.: Two major categories of laboratories performing nonwaived testing under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) are the Certificate of Accreditation (CoA) and Certificate of Compliance (CoC) laboratories. Accreditation organizations collect more detailed laboratory personnel information than the Centers for Medicare & Medicaid Services (CMS) Quality Improvement and Evaluation System (QIES). OBJECTIVE.: To estimate total numbers of testing personnel and testing volumes in CoA and CoC laboratories, by laboratory type and state. DESIGN.: We developed a statistical inference method by using the respective correlations between testing personnel counts and test volume by laboratory type. RESULTS.: QIES reported 33 033 active CoA and CoC laboratories in July 2021. We estimated testing personnel to be 328 000 (95% CI, 309 000-348 000), which is supported by the count of 318 780 reported by the US Bureau of Labor Statistics. There were twice as many testing personnel in hospital laboratories as in independent laboratories (158 778 versus 74 904, P < .001). Independent laboratories had the highest test volume per person, which was twice as high as physician office laboratories (62 228 versus 30 102, P < .001). Hospital and independent laboratories comprised 34% of all CoA and CoC laboratories but performed the largest portion of testing (81%). Physician office laboratories, accounting for 44% of all CoA and CoC laboratories, performed a comparatively low proportion of total tests (9%). CONCLUSIONS.: Numbers of testing personnel vary considerably by laboratory type and across states. These data can provide valuable insight when assessing laboratory workforce training needs and planning for public health emergencies.