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Clinical Chemistry and Laboratory... Apr 2023The analytical quality of the clinical laboratory results has shown a significant improvement over the past decades, thanks to the joint efforts of different... (Review)
Review
The analytical quality of the clinical laboratory results has shown a significant improvement over the past decades, thanks to the joint efforts of different stakeholders, while the comparability among the results produced by different laboratories and methods still presents some critical issues. During these years, () published several papers on the harmonization issue over all steps in the Total Testing Process, training an important number of laboratory professionals in evaluating and monitoring all the criticisms inherent to the pre-analytical, as well as analytical and post analytical phases: from the consensus statement on the most informative testing in emergency setting, to the prevention and detection of hemolysis or to patients identification and tube labeling procedures, as far as to different approaches to harmonize hormones measurements or to describe new reference methods or to harmonize the laboratory report. During these years the commitment of the journal, devoted to the harmonization processes has allowed to improve the awareness on the topic and to provide specific instruments to monitor the rate of errors and to improve patients safety.
Topics: Humans; Laboratories; Patient Safety; Clinical Laboratory Techniques
PubMed: 36383396
DOI: 10.1515/cclm-2022-1111 -
Indian Journal of Medical Microbiology 2012This review attempts to clarify the concepts of Laboratory Quality Management System (Lab QMS) for a medical testing and diagnostic laboratory in a holistic way and... (Review)
Review
This review attempts to clarify the concepts of Laboratory Quality Management System (Lab QMS) for a medical testing and diagnostic laboratory in a holistic way and hopes to expand the horizon beyond quality control (QC) and quality assurance. It provides an insight on accreditation bodies and highlights a glimpse of existing laboratory practices but essentially it takes the reader through the journey of accreditation and during the course of reading and understanding this document, prepares the laboratory for the same. Some of the areas which have not been highlighted previously include: requirement for accreditation consultants, laboratory infrastructure and scope, applying for accreditation, document preparation. This section is well supported with practical illustrations and necessary tables and exhaustive details like preparation of a standard operating procedure and a quality manual. Concept of training and privileging of staff has been clarified and a few of the QC exercises have been dealt with in a novel way. Finally, a practical advice for facing an actual third party assessment and caution needed to prevent post-assessment pitfalls has been dealt with.
Topics: Accreditation; Clinical Laboratory Techniques; Humans; Laboratories; Quality Assurance, Health Care
PubMed: 22664426
DOI: 10.4103/0255-0857.96647 -
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 -
Frontiers in Cellular and Infection... 2022At a time when diagnostic bacteriological testing procedures have become more complex and their associated costs are steadily increasing, the expected benefits of Total... (Review)
Review
At a time when diagnostic bacteriological testing procedures have become more complex and their associated costs are steadily increasing, the expected benefits of Total laboratory automation (TLA) cannot just be a simple transposition of the traditional manual procedures used to process clinical specimens. In contrast, automation should drive a fundamental change in the laboratory workflow and prompt users to reconsider all the approaches currently used in the diagnostic work-up including the accurate identification of pathogens and the antimicrobial susceptibility testing methods. This review describes the impact of TLA in the laboratory efficiency improvement, as well as a new fully automated solution for AST by disk diffusion testing, and summarizes the evidence that implementing these methods can impact clinical outcomes.
Topics: Anti-Bacterial Agents; Automation, Laboratory; Drug Resistance, Bacterial; Laboratories
PubMed: 35186794
DOI: 10.3389/fcimb.2022.807668 -
Revue Scientifique Et Technique... Jun 2021The validation of diagnostic methods (and the subsequent results generated by a laboratory) are improved through participation in inter-laboratory comparisons (IC), such...
The validation of diagnostic methods (and the subsequent results generated by a laboratory) are improved through participation in inter-laboratory comparisons (IC), such as proficiency-testing (PT) programmes and other exercises referred to as 'ring tests' or 'ring trials' (RTs). This is a requirement to comply with international quality standards. Validating a method is a continuous process and taking part in ongoing PT programmes supports the management of a method's life cycle, providing continuing assessment of fitness (sometimes referred to as the 'validation retention status'). Proficiency-testing panel designs ensure that the methods used, particularly diagnostic specificity and sensitivity, are suitably challenged. Appraising PT results over time can illustrate whether the laboratory's performance is stable, improving or worsening, and proficiency tests can also highlight variations in the performance of assays. The development of new proficiency tests can support the implementation of novel diagnostics technologies, such as whole genome sequencing and point-of-care testing, and assist in cross-sectoral partnerships focusing on One Health approaches, which are high on the agenda for infectious disease control. For example, the rapid design and distribution of emergency exempted assays for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) means that these assays were not as rigorously evaluated as assays for established infectious diseases. Therefore, participation in PT programmes for SARS-CoV-2 is essential to understand the performance of these assays. While other mechanisms help to underpin laboratory activities, PT has been, and should remain, an integral part of laboratory quality assurance. Resources must be directed towards increasing and improving the quality of PT (for example, availability and accessibility of suitable biological and reference materials are essential for a PT provider to execute its duties), to support established and novel methods such as genomic and point-of-care tests.
Topics: Animals; COVID-19; Laboratories; Reference Standards; SARS-CoV-2
PubMed: 34140731
DOI: 10.20506/rst.40.1.3217 -
Philosophical Transactions of the Royal... Aug 2015Research and development can be classified into three categories: technology adoption, technology extension, and knowledge and technology creation. In general,... (Review)
Review
Research and development can be classified into three categories: technology adoption, technology extension, and knowledge and technology creation. In general, technology adoption is embedded in operational forensic science laboratory practice but the latter two categories require partnerships with industry and/or academia both to conduct the research and implement the outcomes. In a 2012 survey, Australian and New Zealand forensic science laboratories identified a number of 'roadblocks' to undertaking research and operationalizing research outcomes. These included insufficient time and funding, a lack of in-house research experience and the absence of a tangible research culture. Allied to this is that, increasingly, forensic science research is conducted in a 'commercial in confidence' environment and the outcomes are not readily or cost-effectively available to be integrated into operational forensic science laboratories. The paper is predominantly reflective of the current situation in Australia and New Zealand.
Topics: Australia; Forensic Sciences; Laboratories; New Zealand; Research; Research Support as Topic
PubMed: 26101286
DOI: 10.1098/rstb.2014.0261 -
Clinical Chemistry and Laboratory... Apr 2023Method evaluation is one of the critical components of the quality system that ensures the ongoing quality of a clinical laboratory. As part of implementing new methods...
Method evaluation is one of the critical components of the quality system that ensures the ongoing quality of a clinical laboratory. As part of implementing new methods or reviewing best practices, the peer-reviewed published literature is often searched for guidance. From the outset, () has a rich history of publishing methods relevant to clinical laboratory medicine. An insight into submissions, from editors' and reviewers' experiences, shows that authors still struggle with method evaluation, particularly the appropriate requirements for validation in clinical laboratory medicine. Here, we consider through a series of discussion points an overview of the status, challenges, and needs of method evaluation from the perspective of clinical laboratory medicine. We identify six key high-level aspects of clinical laboratory method evaluation that potentially lead to inconsistency. 1. Standardisation of terminology, 2. Selection of analytical performance specifications, 3. Experimental design of method evaluation, 4. Sample requirements of method evaluation, 5. Statistical assessment and interpretation of method evaluation data, and 6. Reporting of method evaluation data. Each of these areas requires considerable work to harmonise the practice of method evaluation in laboratory medicine, including more empirical studies to be incorporated into guidance documents that are relevant to clinical laboratories and are freely and widely available. To further close the loop, educational activities and fostering professional collaborations are essential to promote and improve the practice of method evaluation procedures.
Topics: Humans; Laboratories, Clinical; Clinical Laboratory Services; Clinical Laboratory Techniques; Laboratories
PubMed: 36327459
DOI: 10.1515/cclm-2022-0878 -
Tropical Medicine & International... Apr 2014Efforts to combat the HIV/AIDS pandemic have underscored the fragile and neglected nature of some national health laboratories in Africa. In response, national and... (Review)
Review
Efforts to combat the HIV/AIDS pandemic have underscored the fragile and neglected nature of some national health laboratories in Africa. In response, national and international partners and various governments have worked collaboratively over the last several years to build sustainable laboratory capacities within the continent. Key accomplishments reflecting this successful partnership include the establishment of the African-based World Health Organization Regional Office for Africa (WHO-AFRO) Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA); development of the Strengthening Laboratory Management Toward Accreditation (SLMTA) training programme; and launching of a Pan African-based institution, the African Society for Laboratory Medicine (ASLM). These platforms continue to serve as the foundations for national health laboratory infrastructure enhancement, capacity development and overall quality system improvement. Further targeted interventions should encourage countries to aim at integrated tiered referral networks, promote quality system improvement and accreditation, develop laboratory policies and strategic plans, enhance training and laboratory workforce development and a retention strategy, create career paths for laboratory professionals and establish public-private partnerships. Maintaining the gains and ensuring sustainability will require concerted action by all stakeholders with strong leadership and funding from African governments and from the African Union.
Topics: Africa South of the Sahara; Clinical Laboratory Techniques; Developing Countries; HIV Infections; Health Policy; Humans; International Cooperation; Laboratories; National Health Programs; Pandemics; Population Surveillance; Public-Private Sector Partnerships; Quality Improvement; Time Factors; World Health Organization
PubMed: 24506521
DOI: 10.1111/tmi.12269 -
Clinical Chemistry and Laboratory... Dec 2016This document is based on the original recommendation of the Expert Panel on the Theory of Reference Values of the International Federation of Clinical Chemistry and... (Review)
Review
This document is based on the original recommendation of the Expert Panel on the Theory of Reference Values of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC), updated guidelines were recently published under the auspices of the IFCC and the Clinical and Laboratory Standards Institute (CLSI). This document summarizes proposals for recommendations on: (i) The terminology, which is often confusing, noticeably concerning the terms of reference limits and decision limits. (ii) The method for the determination of reference limits according to the original procedure and the conditions, which should be used. (iii) A simple procedure allowing the medical laboratories to fulfill the requirements of the regulation and standards. The updated document proposes to verify that published reference limits are applicable to the laboratory involved. Finally, the strengths and limits of the revised recommendations (especially the selection of the reference population, the maintenance of the analytical quality, the choice of the statistical method used…) will be briefly discussed.
Topics: Chemistry, Clinical; Clinical Laboratory Services; Humans; Laboratories; Reference Standards
PubMed: 27748267
DOI: 10.1515/cclm-2016-0793 -
Clinical Chemistry and Laboratory... Apr 2013Evidence of the acute lack of interchangeable laboratory results and consensus in current practice among clinical laboratories has underpinned greater attention to... (Review)
Review
Evidence of the acute lack of interchangeable laboratory results and consensus in current practice among clinical laboratories has underpinned greater attention to standardization and harmonization projects. Although the focus is mainly on the standardization of measurement procedures, the scope of harmonization goes beyond method and analytical results: it includes all other aspects of laboratory testing, including terminology and units, report formats, reference intervals and decision limits, as well as test profiles and criteria for the interpretation of results. This review provides further insight on the issue of harmonization in laboratory medicine in view of the urgent need for a complete picture now that old and new drivers are calling for more effective efforts in this field. The main drivers for standardization and harmonization projects are first and foremost patient safety, but also the increasing trends towards consolidation and networking of clinical laboratories, accreditation programs, clinical governance, and advances in Information Technology (IT), including the electronic patient record. The harmonization process, which should be considered a three-tier approach involving local, national and international fronts, must go beyond the harmonization of methods and analytical results to include all other aspects of laboratory testing. A pertinent example of the importance of a complete picture in harmonization programs is given by the National Bone Health Alliance working in the field of bone turnover markers in cooperation with scientific societies including the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC).
Topics: Accreditation; Humans; Laboratories; Quality Control; Quality Indicators, Health Care; Reference Values; Specimen Handling; Uncertainty
PubMed: 23435100
DOI: 10.1515/cclm-2013-0075