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Diagnosis (Berlin, Germany) Mar 2019Several lines of evidence now confirm that the vast majority of errors in laboratory medicine occur in the extra-analytical phases of the total testing processing,... (Review)
Review
Several lines of evidence now confirm that the vast majority of errors in laboratory medicine occur in the extra-analytical phases of the total testing processing, especially in the preanalytical phase. Most importantly, the collection of unsuitable specimens for testing (either due to inappropriate volume or quality) is by far the most frequent source of all laboratory errors, thus calling for urgent strategies for improving blood sample quality and managing data potentially generated measuring unsuitable specimens. A comprehensive overview of scientific literature leads us to conclude that hemolyzed samples are the most frequent cause of specimen non-conformity in clinical laboratories (40-70%), followed by insufficient or inappropriate sample volume (10-20%), biological samples collected in the wrong container (5-15%) and undue clotting (5-10%). Less frequent causes of impaired sample quality include contamination by infusion fluids (i.e. most often saline or glucose solutions), cross-contamination of blood tubes additives, inappropriate sample storage conditions or repeated freezing-thawing cycles. Therefore, this article is aimed to summarize the current evidence about the most frequent types of unsuitable blood samples, along with tentative recommendations on how to prevent or manage these preanalytical non-conformities.
Topics: Blood Chemical Analysis; Blood Specimen Collection; Hemolysis; Humans; Laboratories; Medical Errors; Pre-Analytical Phase
PubMed: 29794250
DOI: 10.1515/dx-2018-0018 -
Biochemia Medica Feb 2021Calculating the sample size in scientific studies is one of the critical issues as regards the scientific contribution of the study. The sample size critically affects...
Calculating the sample size in scientific studies is one of the critical issues as regards the scientific contribution of the study. The sample size critically affects the hypothesis and the study design, and there is no straightforward way of calculating the effective sample size for reaching an accurate conclusion. Use of a statistically incorrect sample size may lead to inadequate results in both clinical and laboratory studies as well as resulting in time loss, cost, and ethical problems. This review holds two main aims. The first aim is to explain the importance of sample size and its relationship to effect size (ES) and statistical significance. The second aim is to assist researchers planning to perform sample size estimations by suggesting and elucidating available alternative software, guidelines and references that will serve different scientific purposes.
Topics: Data Interpretation, Statistical; Laboratories; Models, Theoretical; Sample Size; Software
PubMed: 33380887
DOI: 10.11613/BM.2021.010502 -
Journal of Visualized Experiments : JoVE May 2012Microorganisms are present on all inanimate surfaces creating ubiquitous sources of possible contamination in the laboratory. Experimental success relies on the ability...
Microorganisms are present on all inanimate surfaces creating ubiquitous sources of possible contamination in the laboratory. Experimental success relies on the ability of a scientist to sterilize work surfaces and equipment as well as prevent contact of sterile instruments and solutions with non-sterile surfaces. Here we present the steps for several plating methods routinely used in the laboratory to isolate, propagate, or enumerate microorganisms such as bacteria and phage. All five methods incorporate aseptic technique, or procedures that maintain the sterility of experimental materials. Procedures described include (1) streak-plating bacterial cultures to isolate single colonies, (2) pour-plating and (3) spread-plating to enumerate viable bacterial colonies, (4) soft agar overlays to isolate phage and enumerate plaques, and (5) replica-plating to transfer cells from one plate to another in an identical spatial pattern. These procedures can be performed at the laboratory bench, provided they involve non-pathogenic strains of microorganisms (Biosafety Level 1, BSL-1). If working with BSL-2 organisms, then these manipulations must take place in a biosafety cabinet. Consult the most current edition of the Biosafety in Microbiological and Biomedical Laboratories (BMBL) as well as Material Safety Data Sheets (MSDS) for Infectious Substances to determine the biohazard classification as well as the safety precautions and containment facilities required for the microorganism in question. Bacterial strains and phage stocks can be obtained from research investigators, companies, and collections maintained by particular organizations such as the American Type Culture Collection (ATCC). It is recommended that non-pathogenic strains be used when learning the various plating methods. By following the procedures described in this protocol, students should be able to: Perform plating procedures without contaminating media. Isolate single bacterial colonies by the streak-plating method. Use pour-plating and spread-plating methods to determine the concentration of bacteria. Perform soft agar overlays when working with phage. Transfer bacterial cells from one plate to another using the replica-plating procedure. Given an experimental task, select the appropriate plating method.
Topics: Asepsis; Bacteriological Techniques; Containment of Biohazards; Environment, Controlled; Equipment Contamination; Laboratories; Sterilization; Viral Plaque Assay
PubMed: 22617405
DOI: 10.3791/3064 -
Journal of Virology Aug 2021Starting work in a virology research laboratory as a new technician, graduate student, or postdoc can be complex, intimidating, confusing, and stressful. From laboratory...
Starting work in a virology research laboratory as a new technician, graduate student, or postdoc can be complex, intimidating, confusing, and stressful. From laboratory logistics to elemental expectations to scientific specifics, there is much to learn. To help new laboratory members adjust and excel, a series of guidelines for working and thriving in a virology laboratory is presented. While guidelines may be most helpful for new laboratory members, everyone, including principal investigators, is encouraged to use a set of published guidelines as a resource to maximize the time and efforts of all laboratory members. The topics covered here are safety, wellness, balance, teamwork, integrity, reading, research, writing, speaking, and timelines.
Topics: Guidelines as Topic; Humans; Laboratories; Research Design; Research Personnel; Virology
PubMed: 34319158
DOI: 10.1128/JVI.01112-21 -
Fertility and Sterility Jan 2022Delivery of fertility treatment involves both teamwork within a discipline as well as teaming across multiple work areas, such as nursing, administrative, laboratory,... (Review)
Review
Delivery of fertility treatment involves both teamwork within a discipline as well as teaming across multiple work areas, such as nursing, administrative, laboratory, and clinical. In contrast to small autonomous centers, the in vitro fertilization (IVF) laboratory team in large clinics must function both as a team with many members and a constellation of teams to deliver seamless, safe, and effective patient-centered care. Although this review primarily focuses on teamwork within the IVF laboratory, which comprises clinical laboratory scientists and embryologists who perform both diagnostic and therapeutic procedures, it also discusses the laboratory's wider role with other teams of the IVF clinic, and the role of teaming (the ad hoc creation of multidisciplinary teams) to function highly and address critical issues.
Topics: Female; Fertilization in Vitro; Humans; Interdisciplinary Communication; Laboratories; Male; Patient Care Team; Patient-Centered Care; Pregnancy; Reproductive Medicine
PubMed: 34763833
DOI: 10.1016/j.fertnstert.2021.09.031 -
Annals of Laboratory Medicine May 2014Harmonization of clinical laboratory results means that results are comparable irrespective of the measurement procedure used and where or when a measurement was made.... (Review)
Review
Harmonization of clinical laboratory results means that results are comparable irrespective of the measurement procedure used and where or when a measurement was made. Harmonization of test results includes consideration of pre-analytical, analytical, and post-analytical aspects. Progress has been made in each of these aspects, but there is currently poor coordination of the effort among different professional organizations in different countries. Pre-analytical considerations include terminology for the order, instructions for preparation of the patient, collection of the samples, and handling and transportation of the samples to the laboratory. Key analytical considerations include calibration traceability to a reference system, commutability of reference materials used in a traceability scheme, and specificity of the measurement of the biomolecule of interest. International organizations addressing harmonization include the International Federation for Clinical Chemistry and Laboratory Medicine, the World Health Organization, and the recently formed International Consortium for Harmonization of Clinical Laboratory Results (ICHCLR). The ICHCLR will provide a prioritization process for measurands and a service to coordinate global harmonization activities to avoid duplication of effort. Post-analytical considerations include nomenclature, units, significant figures, and reference intervals or decision values for results. Harmonization in all of these areas is necessary for optimal laboratory service. This review summarizes the status of harmonization in each of these areas and describes activities underway to achieve the goal of fully harmonized clinical laboratory testing.
Topics: Chemistry, Clinical; Documentation; Guidelines as Topic; Laboratories; Reference Values
PubMed: 24790905
DOI: 10.3343/alm.2014.34.3.187 -
The Journal of Applied Laboratory... Jan 2023Anomaly detection is an integral component of operating a clinical laboratory. It covers both the recognition of laboratory errors and the rapid reporting of clinically... (Review)
Review
BACKGROUND
Anomaly detection is an integral component of operating a clinical laboratory. It covers both the recognition of laboratory errors and the rapid reporting of clinically impactful results. Procedures for identifying laboratory errors and highlighting critical results can be improved by applying modern data-driven approaches.
CONTENT
This review will prepare the reader to appraise anomaly detection literature, identify common sources of anomalous results in the clinical laboratory, and offer potential solutions for common shortcomings in current laboratory practices.
SUMMARY
Laboratories should implement data-driven approaches to detect technical anomalies and keep them from entering the medical record, while also using the full array of clinical metadata available in the laboratory information system for context-dependent, patient-centered result interpretations.
Topics: Humans; Laboratories; Clinical Laboratory Services
PubMed: 36610428
DOI: 10.1093/jalm/jfac114 -
Clinical Chemistry and Laboratory... Aug 2020The definition and enforcement of reference measurement systems, based on the implementation of metrological traceability of patient results to higher-order (reference)... (Review)
Review
The definition and enforcement of reference measurement systems, based on the implementation of metrological traceability of patient results to higher-order (reference) methods and/or materials, together with a clinically acceptable level of measurement uncertainty (MU), are fundamental requirements to produce accurate and equivalent laboratory results. The MU associated with each step of the traceability chain should be governed to obtain a final combined MU on clinical samples fulfilling the requested performance specifications. MU is useful for a number of reasons: (a) for giving objective information about the quality of individual laboratory performance; (b) for serving as a management tool for the medical laboratory and in vitro diagnostics (IVD) manufacturers, forcing them to investigate and eventually fix the identified problems; (c) for helping those manufacturers that produce superior products and measuring systems to demonstrate the superiority of those products; (d) for identifying analytes that need analytical improvement for their clinical use and ask IVD manufacturers to work for improving the quality of assay performance and (e) for abandoning assays with demonstrated insufficient quality. Accordingly, the MU should not be considered a parameter to be calculated by medical laboratories just to fulfill accreditation standards, but it must become a key quality indicator to describe both the performance of an IVD measuring system and the laboratory itself.
Topics: Biological Assay; Humans; Laboratories; Quality Control; Reference Standards; Uncertainty
PubMed: 32126011
DOI: 10.1515/cclm-2019-1336 -
Australian Critical Care : Official... Jul 2021With the increasing complexity of procedures being performed in the cardiac catheterisation laboratory, the multidisciplinary team has the challenge of providing safe...
BACKGROUND
With the increasing complexity of procedures being performed in the cardiac catheterisation laboratory, the multidisciplinary team has the challenge of providing safe care to patients who present with a multitude of healthcare needs. Although the use of a surgical safety checklist has become standard practice in operating theatres worldwide, the use of a pre-procedure checklist has not been routinely adopted into interventional cardiology.
OBJECTIVE
The aim of this study was to design and evaluate a pre-procedure checklist specific to the cardiac catheterisation laboratory.
METHOD
A descriptive, exploratory design was used to develop a specifically designed pre-procedure checklist for use in the cardiac catheterisation laboratory in a private hospital in Melbourne, Australia. The pre-procedure checklist was developed by exploring the multidisciplinary team's opinion regarding the organisation's previous surgical pre-procedure checklist through a pre-implementation survey and focus groups. Following an expert review, and implementation of the proposed pre-procedure checklist, a post-implementation survey was completed.
RESULTS
Thirty-five (70%) cardiac catheterisation laboratory healthcare professionals completed the pre-implementation survey, with 31 (62%) completing the post-implementation survey. Ninety-one per cent of participants agreed that important clinical information required for interventional procedures was not documented on the previous surgical checklist. A specific checklist was developed from the results of the survey and six focus groups (N = 25) and implemented in the cardiac catheterisation laboratory. In the post-implementation survey, participants identified that the cardiac catheterisation laboratory specific pre-procedure checklist included all relevant clinical information and improved documentation of patient information.
CONCLUSION
The development of a specific cardiac catheterisation laboratory pre-procedure checklist has led to an improved transfer of pertinent clinical information required prior to procedures being performed in the unit. The outcome of this study has implications for other cardiac catheterisation laboratories with the potential to standardise practice within interventional cardiology practice and improve patient safety outcomes.
Topics: Cardiac Catheterization; Checklist; Humans; Laboratories; Operating Rooms; Patient Safety
PubMed: 33518405
DOI: 10.1016/j.aucc.2020.10.005 -
Biochemia Medica Feb 2019Quantiles and percentiles represent useful statistical tools for describing the distribution of results and deriving reference intervals and performance specification in... (Review)
Review
Quantiles and percentiles represent useful statistical tools for describing the distribution of results and deriving reference intervals and performance specification in laboratory medicine. They are commonly intended as the sample estimate of a population parameter and therefore they need to be presented with a confidence interval (CI). In this work we discuss three methods to estimate CI on quantiles and percentiles using parametric, nonparametric and resampling (bootstrap) approaches. The result of our numerical simulations is that parametric methods are always more accurate regardless of sample size when the procedure is appropriate for the distribution of results for both extreme (2.5 and 97.5) and central (25, 50 and 75) percentiles and corresponding quantiles. We also show that both nonparametric and bootstrap methods suit well the CI of central percentiles that are used to derive performance specifications through quality indicators of laboratory processes whose underlying distribution is unknown.
Topics: Humans; Laboratories; Models, Statistical; Reference Values; Sample Size
PubMed: 30591808
DOI: 10.11613/BM.2019.010101