Establishing the Reportable Interval for Routine Clinical Laboratory Tests: A Data-Driven Strategy Leveraging Retrospective Electronic Medical Record Data.

BACKGROUND: This paper presents a data-driven strategy for establishing the reportable interval in clinical laboratory testing. The reportable interval defines the range of laboratory result values beyond which reporting should be withheld. The lack of clear guidelines and methodology for determining the reportable interval has led to potential errors in reporting and patient risk. METHODS: To address this gap, the study developed an integrated strategy that combines statistical analysis, expert review, and hypothetical outlier calculations. A large data set from an accredited clinical laboratory was utilized, analyzing over 124 million laboratory test records from 916 distinct tests. The Dixon test was applied to identify outliers and establish the highest and lowest non-outlier result values for each test, which were validated by clinical pathology experts. The methodology also included matching the reportable intervals with relevant Logical Observation Identifiers Names and Codes (LOINC) and Unified Code for Units of Measure (UCUM)-valid units for broader applicability. RESULTS: Upon establishing the reportable interval for 135 routine laboratory tests (493 LOINC codes), we applied these to a primary care laboratory data set of 23 million records, demonstrating their efficacy with over 1% of result records identified as implausible. CONCLUSIONS: We developed and tested a data-driven strategy for establishing reportable intervals utilizing large electronic medical record (EMR) data sets. Implementing the established interval in clinical laboratory settings can improve autoverification systems, enhance data reliability, and reduce errors in patient care. Ongoing refinement and reporting of cases exceeding the reportable limits will contribute to continuous improvement in laboratory result management and patient safety.

Considerations for the use of biochemical laboratory registry data in clinical and public health research.

OBJECTIVES: To inform researchers of central considerations and limitations when applying biochemical laboratory-generated registry data in clinical and public health research. STUDY DESIGN AND SETTING: After review of literature on registry-based studies and the utilization of clinical laboratory registry data, relevant paragraphs and their applicability toward the creation of considerations for the use of biochemical registry data in research were evaluated. This led to the creation of an initial ten considerations. These were elaborated, edited, and merged after several read-throughs by all authors and discussed thoroughly under influence by the authors' personal experiences with laboratory databases and research registries in Denmark, leading to the formulation of five central considerations with corresponding items and illustrative examples. RESULTS: We recommend that the following considerations should be addressed in studies relying on biochemical laboratory-generated registry data: why are biochemical laboratory data relevant to examine the hypothesis, and how were the variable(s) utilized in the study? What were the primary indications for specimen collection in the study population of interest? Were there any pre-analytical circumstances that could influence the test results? Are data comparable between producing laboratories and within the single laboratory over time? Is the database representative in terms of completeness of study populations and key variables? CONCLUSION: It is crucial to address key errors in laboratory registry data and acknowledge potential limitations.

Human Centered Decision-Making for COVID-19 Testing Center Location Selection: Tamil Nadu-A Case Study.

This paper proposes a blend of three techniques to select COVID-19 testing centers. The objective of the paper is to identify a suitable location to establish new COVID-19 testing centers. Establishment of the testing center in the needy locations will be beneficial to both public and government officials. Selection of the wrong location may lead to lose both health and wealth. In this paper, location selection is modelled as a decision-making problem. The paper uses fuzzy analytic hierarchy process (AHP) technique to generate the criteria weights, monkey search algorithm to optimize the weights, and Technique for Order of Preference by Similarity to Ideal Solution (TOPSIS) method to rank the different locations. To illustrate the applicability of the proposed technique, a state named Tamil Nadu, located in India, is taken for a case study. The proposed structured algorithmic steps were applied for the input data obtained from the government of India website, and the results were analyzed and validated using the government of India website. The ranks assigned by the proposed technique to different locations are in aligning with the number of patients and death rate.

Investigation of the quantitative detection of serum Helicobacter pylori antibody in clinical laboratories in China.

BACKGROUND: This study aimed to investigate the implementation and quality control of the quantitative detection of serum Helicobacter pylori (H. pylori) antibody in clinical laboratories in China. METHODS: Online external quality assessment (EQA) questionnaires were distributed to the clinical laboratories by National Center for Clinical Laboratories (NCCL) of China. We collected information on the quantitative detection procedures of serum H. pylori antibody in clinical laboratories, including detection reagents, methods, instruments, calibrators, and internal quality control (IQC). We distributed quality control products to some select laboratories that conducted quantitative detection and analyzed the obtained test data. We evaluated the quantitative detection procedure based on the standard evaluation criteria set at a target value of ±30%. RESULTS: 70.9% (146/206) of the laboratories conducted quantitative detection of H. pylori antibody; 29.1% (60/206) of the laboratories performed qualitative detection. Domestic reagents and matching calibrators accounted for more than 97.1% (200/206) of all reagents. Latex-enhanced immunoturbidimetry was used in 89.7% (131/146) of the laboratories for quantitative determination, while the colloidal gold method was used in 66.7% (40/60) of the laboratories for qualitative determination. A total of 130 laboratories participated in the EQA; 123 completed the assessment, and the pass rate was 75.6% (93/123). CONCLUSION: Clinical quantitative detection of serum H. pylori antibody is performed at a high rate in China. Thus, further studies on the specificity of commercial detection reagents are needed. EQAs are useful to monitor and improve the detection quality of H. pylori antibodies.

The commercial genetic testing landscape for Parkinson's disease.

INTRODUCTION: There have been no specific guidelines regarding which genes should be tested in the clinical setting for Parkinson's disease (PD) or parkinsonism. We evaluated the types of clinical genetic testing offered for PD as the first step of our gene curation. METHODS: The National Institutes of Health (NIH) Genetic Testing Registry (GTR) was queried on 12/7/2020 to identify current commercial PD genetic test offerings by clinical laboratories, internationally. RESULTS: We identified 502 unique clinical genetic tests for PD, from 28 Clinical Laboratory Improvement Amendments (CLIA)-approved clinical laboratories. These included 11 diagnostic PD panels. The panels were notable for their differences in size, ranging from 5 to 62 genes. Five genes for variant query were included in all panels (SNCA, PRKN, PINK-1, PARK7 (DJ1), and LRRK2). Notably, the addition of the VPS35 and GBA genes was variable. Panel size differences stemmed from inclusion of genes linked to atypical parkinsonism and dystonia disorders, and genes in which the link to PD causation is controversial. CONCLUSION: There is an urgent need for expert opinion regarding which genes should be included in a commercial laboratory multi-gene panel for PD.

A practical guide to chimerism analysis: Review of the literature and testing practices worldwide.

BACKGROUND AND PURPOSE: Currently there are no widely accepted guidelines for chimerism analysis testing in hematopoietic cell transplantation (HCT) patients. The objective of this review is to provide a practical guide to address key aspects of performing and utilizing chimerism testing results. In developing this guide, we conducted a survey of testing practices among laboratories that are accredited for performing engraftment monitoring/chimerism analysis by either the American Society for Histocompatibility & Immunogenetics (ASHI) and/or the European Federation of Immunogenetics (EFI). We interpreted the survey results in the light of pertinent literature as well as the experience in the laboratories of the authors. RECENT DEVELOPMENTS: In recent years there has been significant advances in high throughput molecular methods such as next generation sequencing (NGS) as well as growing access to these technologies in histocompatibility and immunogenetics laboratories. These methods have the potential to improve the performance of chimerism testing in terms of sensitivity, availability of informative genetic markers that distinguish donors from recipients as well as cost. SUMMARY: The results of the survey revealed a great deal of heterogeneity in chimerism testing practices among participating laboratories. The most consistent response indicated monitoring of engraftment within the first 30 days. These responses are reflective of published literature. Additional clinical indications included early detection of impending relapse as well as identification of cases of HLA-loss relapse.

Repercusión de la pandemia COVID-19 en la práctica de la cardiología intervencional en Chile: datos aportados por la encuesta del grupo Stent-Save a Life! LATAM working group / Decrease in the activity of interventional cardiology in Chile: a report from the "Stent-Save a Life! LATAM working group"

RESUMEN: Introducción: El Stent-Save a Life! (SSL) LATAM working group diseñó una encuesta para objetivar la reducción de la actividad de los laboratorios de hemodinamia en Latinoamérica durante la pandemia COVID-19. Ante la amenaza de nuevos confinamientos en Chile, nos propusimos objetivar las consecuencias de la primera ola de contagios en nuestra actividad. Objetivos: Discutir la repercusión de la pandemia en la cardiología intervencional en Chile. Métodos: El grupo SSL realizó una encuesta telemática a todos los países de Latinoamérica incluido Chile. Se registraron las coronariografías (CAG), intervenciones coronarias percutáneas (ACTP) e intervenciones estructurales, comparando dos períodos determinados por el confinamiento por la pandemia, cada uno de dos semanas. Pre-COVID-19: período previo al confinamiento, y COVID-19: período durante el confinamiento. Se analizan, a partir de esta encuesta, los resultados aplicados a nuestro país. Resultados: Se obtuvo respuesta de trece centros. Hubo una reducción en el número global de procedimientos entre período Pre-COVID-19 y COVID-19 de un 65,1%. Se reportó una disminución de 67% en las CAG, de un 59,4% en las ACTP y de un 92% en los procedimientos terapéuticos estructurales. Entre ambos períodos se redujo la consulta por Síndrome Coronario Agudo por elevación del segmento ST (SCACEST) en 40,8%. Conclusiones: En nuestro país se objetivó una reducción marcada de la actividad asistencial de la cardiología intervencional durante la pandemia COVID-19 y una disminución significativa en el número de pacientes tratados por SCACEST. Los resultados de nuestro país son similares a los reportados por países de Latinoamérica, Europa y Norteamérica.

ABSTRACT: Background: The Stent-Save a Life! (SSL) LATAM working group designed a survey to demonstrate the reduction in the activity of cardiac catheterization laboratories in Latin America during the COVID-19 pandemic. Considering the risk of a new confinement in Chile, we decided to assess the impact of the first wave of contagions on our activity. Aims: To discuss the repercussion of the COVID-19 pandemic on the activity of interventional cardiology in Chile. Methods: The SSL group conducted a telematic survey in all Latin American countries. Coronary angiography, coronary interventions (PCI) and structural interventions were registered, comparing two periods of two weeks duration each: before and during COVID-19 confinement. Results obtained in Chile are analyzed. Results: Thirteen centers in Chile answered the survey. There was an overall decrease of 65.1% in the number of procedures between the pre and the post COVID-19 periods. Coronary angiographies decreased 67%, PCI 59.4% and therapeutical structural procedures 92%. The reduction in acute coronary syndrome with ST segment elevation (STEMI) was 40,8% between periods. Conclusions: In Chile, a significant reduction in healthcare activity related to interventional cardiology and a significant decrease in the number of patients treated with STEMI was observed during the COVID-19 pandemic. The results are similar to those reported by Latin American, European and North American countries.

Patient engagement in preclinical laboratory research: A scoping review.

BACKGROUND: 'Patient engagement' involves meaningful collaboration between researchers and 'patient partners' to co-create research. It helps ensure that research being conducted is relevant to its ultimate end-users. Although patient engagement within clinical research has been well documented, the prevalence and effects of patient engagement in translational preclinical laboratory research remain unclear. The aim of this scoping review is to present current patient engagement activities reported in preclinical laboratory research. METHODS: MEDLINE, Embase, and grey literature were systematically searched from inception to April 2021. Studies that described or investigated patient engagement in preclinical laboratory research were included. Patient engagement activities where patients (i.e. patients, family members, caregivers or community members) provided input, or consultation on at least one element of the research process were eligible for inclusion. Study characteristics and outcomes were extracted and organized thematically. FINDINGS: 32 reports were included (30 primary studies, 1 narrative review, and 1 researcher guide). Most studies engaged patients at the education or priority setting stages (n=26). The most frequently reported benefit of patient engagement was 'providing a mutual learning opportunity'. Reported barriers to patient engagement reflected concerns around 'differences in knowledge and research experience' and how this may challenge communication and limit meaningful collaboration. INTERPRETATION: Patient engagement is feasible and beneficial for preclinical laboratory research. Future work should focus on assessing the impacts of patient engagement in this area of research. FUNDING: None.