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Cold Spring Harbor Perspectives in... Oct 2020Genetic counselors (GCs) possess several core competencies that provide direct benefit in the clinical laboratory setting. Communication with clients about complex... (Review)
Review
Genetic counselors (GCs) possess several core competencies that provide direct benefit in the clinical laboratory setting. Communication with clients about complex information such as test methodology or results and the skills of facilitation and translation of complex information were recognized as important skills early in the establishment of GCs in laboratories. The clinical expertise of GCs serves as the background and experience from which they facilitate complex laboratory cases. Early roles for GCs in the laboratory also included result reporting, case management, and test development. The scope of roles has broadened to include management, business development, education, telemedicine, research, and variant interpretation. With increasing value being placed on genetic counseling skills both in and outside of a clinical laboratory, the roles and positions of GCs will likely continue to expand.
Topics: Genetic Counseling; Humans; Laboratories; Professional Role; Professional-Patient Relations
PubMed: 31570375
DOI: 10.1101/cshperspect.a036574 -
Stroke Aug 2021
Review
Topics: Biomedical Research; Humans; Laboratories; Laboratory Personnel; Leadership; Mentors
PubMed: 34107733
DOI: 10.1161/STROKEAHA.121.035333 -
Disease Models & Mechanisms Oct 2022In 2021, the National Institutes of Health Advisory Committee to the Director (ACD) announced recommendations to improve the reproducibility of biomedical research using...
In 2021, the National Institutes of Health Advisory Committee to the Director (ACD) announced recommendations to improve the reproducibility of biomedical research using animals. In response, The Jackson Laboratory faculty and institutional leaders identified key strategies to further address this important issue. Taking inspiration from the evolution of clinical trials over recent decades in response to similar challenges, we identified opportunities for improvement, including establishment of common standards, use of genetically diverse populations, requirement for robust study design with appropriate statistical methods, and improvement in public databases to facilitate meta-analyses. In this Perspective, we share our response to ACD recommendations, with a specific focus on mouse models, with the aim of promoting continued active dialogue among researchers, using any animal system, worldwide. Such discussion will help to inform the biomedical community about these recommendations and further support their much-needed implementation.
Topics: Animals; Biomedical Research; Humans; Laboratories; Mice; Reproducibility of Results; Research Design; Research Personnel
PubMed: 36250972
DOI: 10.1242/dmm.049775 -
Annales de Biologie Clinique Dec 2017Medical biology laboratories rely especially on internal quality control (IQC) to monitor the performance of equipment and ensure results reliability. Strategies for... (Review)
Review
Medical biology laboratories rely especially on internal quality control (IQC) to monitor the performance of equipment and ensure results reliability. Strategies for these controls vary considerably from one laboratory to another. Some laboratories use Westgard's rules to detect drifts and are faced with a large number of false rejections caused by frequent runs of control samples and strategies that activate all rejection rules, regardless of the analyte considered. To minimize these rejections, some laboratories have combined several theories, sometimes despite the relevance of the resulting strategy. In this article, we want to explain the foundations of the main IQC theories and set out a strategy to optimize the detection of problems while minimizing false IQC rejections. We will also address some frequently asked questions from laboratories as part of ISO 15189 accreditation.
Topics: Accreditation; Biology; Humans; Laboratories; Medical Laboratory Science; Quality Control; Reproducibility of Results; Total Quality Management
PubMed: 29072175
DOI: 10.1684/abc.2017.1290 -
Clinical Chemistry and Laboratory... Jun 2020The global coronavirus disease 2019 (COVID-19) has presented major challenges for clinical laboratories, from initial diagnosis to patient monitoring and treatment.... (Review)
Review
The global coronavirus disease 2019 (COVID-19) has presented major challenges for clinical laboratories, from initial diagnosis to patient monitoring and treatment. Initial response to this pandemic involved the development, production, and distribution of diagnostic molecular assays at an unprecedented rate, leading to minimal validation requirements and concerns regarding their diagnostic accuracy in clinical settings. In addition to molecular testing, serological assays to detect antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are now becoming available from numerous diagnostic manufacturers. In both cases, the lack of peer-reviewed data and regulatory oversight, combined with general misconceptions regarding their appropriate use, have highlighted the importance of laboratory professionals in robustly validating and evaluating these assays for appropriate clinical use. The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Task Force on COVID-19 has been established to synthesize up-to-date information on the epidemiology, pathogenesis, and laboratory diagnosis and monitoring of COVID-19, as well as to develop practical recommendations on the use of molecular, serological, and biochemical tests in disease diagnosis and management. This review summarizes the latest evidence and status of molecular, serological, and biochemical testing in COVID-19 and highlights some key considerations for clinical laboratories operating to support the global fight against this ongoing pandemic. Confidently this consolidated information provides a useful resource to laboratories and a reminder of the laboratory's critical role as the world battles this unprecedented crisis.
Topics: Betacoronavirus; Biomarkers; COVID-19; Clinical Laboratory Services; Clinical Laboratory Techniques; Coronavirus; Coronavirus Infections; Humans; Laboratories; Pandemics; Pneumonia, Viral; SARS-CoV-2; Sensitivity and Specificity
PubMed: 32459192
DOI: 10.1515/cclm-2020-0722 -
Annals of Laboratory Medicine Jan 2012For many years, the clinical laboratory's focus on analytical quality has resulted in an error rate of 4-5 sigma, which surpasses most other areas in healthcare.... (Review)
Review
For many years, the clinical laboratory's focus on analytical quality has resulted in an error rate of 4-5 sigma, which surpasses most other areas in healthcare. However, greater appreciation of the prevalence of errors in the pre- and post-analytical phases and their potential for patient harm has led to increasing requirements for laboratories to take greater responsibility for activities outside their immediate control. Accreditation bodies such as the Joint Commission International (JCI) and the College of American Pathologists (CAP) now require clear and effective procedures for patient/sample identification and communication of critical results. There are a variety of free on-line resources available to aid in managing the extra-analytical phase and the recent publication of quality indicators and proposed performance levels by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) working group on laboratory errors and patient safety provides particularly useful benchmarking data. Managing the extra-laboratory phase of the total testing cycle is the next challenge for laboratory medicine. By building on its existing quality management expertise, quantitative scientific background and familiarity with information technology, the clinical laboratory is well suited to play a greater role in reducing errors and improving patient safety outside the confines of the laboratory.
Topics: Clinical Laboratory Techniques; Diagnostic Errors; Humans; Laboratories; Quality Assurance, Health Care; Specimen Handling
PubMed: 22259773
DOI: 10.3343/alm.2012.32.1.5 -
Journal of the American College of... May 2017
Topics: Adult; Cardiac Catheterization; Cardiac Surgical Procedures; Cardiology; Career Choice; Education, Medical, Graduate; Female; Heart Diseases; Humans; Laboratories; Male; Minimally Invasive Surgical Procedures; Pregnancy; Pregnancy Complications, Cardiovascular
PubMed: 28545642
DOI: 10.1016/j.jacc.2017.04.027 -
Biochemia Medica Oct 2023Reporting a measurement procedure and its analytical performance following method evaluation in a peer-reviewed journal is an important means for clinical laboratory... (Review)
Review
Reporting a measurement procedure and its analytical performance following method evaluation in a peer-reviewed journal is an important means for clinical laboratory practitioners to share their findings. It also represents an important source of evidence base to help others make informed decisions about their practice. At present, there are significant variations in the information reported in laboratory medicine journal publications describing the analytical performance of measurement procedures. These variations also challenge authors, readers, reviewers, and editors in deciding the quality of a submitted manuscript. The International Federation of Clinical Chemistry and Laboratory Medicine Working Group on Method Evaluation Protocols (IFCC WG-MEP) developed a checklist and recommends its adoption to enable a consistent approach to reporting method evaluation and analytical performance characteristics of measurement procedures in laboratory medicine journals. It is envisioned that the Laboratory Evaluation and Analytical Performance Characteristics (LEAP) checklist will improve the standardisation of journal publications describing method evaluation and analytical performance characteristics, improving the quality of the evidence base that is relied upon by practitioners.
Topics: Humans; Checklist; Laboratories; Clinical Laboratory Services
PubMed: 37841772
DOI: 10.11613/BM.2023.030505 -
Clinical Infectious Diseases : An... Dec 2023Capturing Data on Antimicrobial Resistance Patterns and Trends in Use in Regions of Asia (CAPTURA) gained insight into the range of national antimicrobial resistance...
Capturing Data on Antimicrobial Resistance Patterns and Trends in Use in Regions of Asia (CAPTURA) gained insight into the range of national antimicrobial resistance (AMR) stakeholders' long-term visions for AMR surveillance networks. As national AMR networks mature, stakeholders often contemplate adding laboratories to the network to achieve greater representativeness, boost data quantity, or meet other goals. Therefore, stakeholders should carefully select laboratories for expansion based on their goals and several practical criteria. Based on CAPTURA experience, the key criteria a national network may consider when expanding its AMR surveillance network include location, laboratory ownership, access to linked clinical and prescription databases, logistical ease, a laboratory's collaborative spirit, laboratory practices and equipment, laboratory staffing and quality assessments, laboratory methods and specimen types, data cleanliness and completeness, and the quantity of AMR data.
Topics: Humans; Anti-Bacterial Agents; Drug Resistance, Bacterial; Laboratories; Asia
PubMed: 38118012
DOI: 10.1093/cid/ciad548 -
Archives of Pathology & Laboratory... Apr 2019The laboratory total testing process includes preanalytic, analytic, and postanalytic phases, but most laboratory quality improvement efforts address the analytic phase....
CONTEXT.—
The laboratory total testing process includes preanalytic, analytic, and postanalytic phases, but most laboratory quality improvement efforts address the analytic phase. Expanding quality improvement to preanalytic and postanalytic phases via use of medical data warehouses, repositories that include clinical, utilization, and administrative data, can improve patient care by ensuring appropriate test utilization. Cross-department, multidisciplinary collaboration to address gaps and improve patient and system outcomes is beneficial.
OBJECTIVE.—
To demonstrate medical data warehouse utility for characterizing laboratory-associated quality gaps amenable to preanalytic or postanalytic interventions.
DESIGN.—
A multidisciplinary team identified quality gaps. Medical data warehouse data were queried to characterize gaps. Organizational leaders were interviewed about quality improvement priorities. A decision aid with elements including national guidelines, local and national importance, and measurable outcomes was completed for each gap.
RESULTS.—
Gaps identified included (1) test ordering; (2) diagnosis, detection, and documentation, and (3) high-risk medication monitoring. After examination of medical data warehouse data including enrollment, diagnoses, laboratory, pharmacy, and procedures for baseline performance, high-risk medication monitoring was selected, specifically alanine aminotransferase, aspartate aminotransferase, complete blood count, and creatinine testing among patients receiving disease-modifying antirheumatic drugs. The test utilization gap was in monitoring timeliness (eg, >60% of patients had a monitoring gap exceeding the guideline recommended frequency). Other contributors to selecting this gap were organizational enthusiasm, regulatory labeling, and feasibility of a significant laboratory role in addressing the gap.
CONCLUSIONS.—
A multidisciplinary process facilitated identification and selection of a laboratory medicine quality gap. Medical data warehouse data were instrumental in characterizing gaps.
Topics: Data Warehousing; Humans; Laboratories; Laboratory Proficiency Testing; Quality Assurance, Health Care
PubMed: 30525932
DOI: 10.5858/arpa.2018-0093-OA