Journal:ISO 15189 accreditation: Navigation between quality management and patient safety
| Full article title | ISO 15189 accreditation: Navigation between quality management and patient safety |
|---|---|
| Journal | Journal of Medical Biochemistry |
| Author(s) | Plebani, Mario; Sciacovelli, Laura |
| Author affiliation(s) | University-Hospital of Padova, Italy |
| Primary contact | Email: mario dot plebani at unipd dot it |
| Year published | 2017 |
| Volume and issue | 36 (3) |
| Page(s) | 225–230 |
| DOI | 10.1515/jomb-2017-0038 |
| ISSN | 1452-8266 |
| Distribution license | Creative Commons Attribution-NonCommercial-NoDerivs 3.0 Unported |
| Website | https://www.degruyter.com/view/j/jomb.2017.36.issue-3/jomb-2017-0038/jomb-2017-0038.xml |
| Download | https://www.degruyter.com/downloadpdf/j/jomb.2017.36.issue-3/jomb-2017-0038/jomb-2017-0038.xml (PDF) |
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Summary
Accreditation is a valuable resource for clinical laboratories, and the development of an international standard for their accreditation represented a milestone on the path towards improved quality and safety in laboratory medicine. The recent revision of the international standard, ISO 15189, has further strengthened its value not only for improving the quality system of a clinical laboratory but also for better answering the request for competence, focus on customers’ needs and ultimate value of laboratory services. Although in some countries more general standards such as ISO 9001 for quality systems or ISO 17025 for testing laboratories are still used, there is increasing recognition of the value of ISO 15189 as the most appropriate and useful standard for the accreditation of medical laboratories. In fact, only this international standard recognizes the importance of all steps of the total testing process, namely extra-analytical phases, the need to focus on technical competence in addition to quality systems, and the focus on customers’ needs. However, the number of accredited laboratories largely varies between European countries, and major differences affect the approaches to accreditation promoted by the national bodies. In particular, some national accreditation bodies perpetuate the use of fixed scopes, while the European co-operation for Accreditation (EA) and the European Federation of Laboratory Medicine (EFLM) Working Group promote the use of flexible scopes. Major issues in clinical laboratory accreditation are the verification of examination procedures for imprecision, trueness and diagnostic accuracy, and for estimating measurement uncertainty. In addition, quality indicators (QIs) are a fundamental requirement of the ISO 15189 international standard.
Keywords: medical laboratory accreditation, ISO 15189, flexible scope, quality, quality indicators
Introduction
Medical laboratories play an increasingly central role in modern health care systems, as laboratory data are an integral part of the physicians’ decision-making processes, enabling them to: a) identify risk factors and detect a predisposition to a disease, b) confirm or reject a diagnosis, c) guide patient management, and d) monitor the efficacy of therapy through dose-tailoring (personalized medicine).
To successfully achieve these goals, each medical laboratory should strive to assure quality, namely accuracy of results, safety (quality in the total testing process) and efficiency (cost containment). This, in turn, requires the management of medical, scientific, and technical expertise, by obtaining and properly utilizing resources such as personnel, laboratory equipment, supplies, and facilities. Implementation of ISO 15189 provides a foundation for quality in medical laboratories by linking the quality management system (QMS) to competence in all procedures and processes used in the total testing process (TTP).[1] If the QMS should be defined as "a set of interrelated or interacting elements that organizations use to direct and control how quality policies are implemented and quality objectives are achieved," in the case of medical laboratories, the TTP should be viewed as a set of interrelated and interacting processes starting from an appropriate request and sample collection to produce analytical results that have to be transformed into useful clinical information to allow better diagnoses and therapies.[2]
References
- ↑ "ISO 15189:2012 Medical laboratories -- Requirements for quality and competence". International Organization for Standardization. August 2014. https://www.iso.org/standard/56115.html.
- ↑ Blebani, M.; Sciacovelli, L.; Chiozza, M.L.; Panteghini, M. (2015). "Once upon a time: A tale of ISO 15189 accreditation". Clinical Chemistry and Laboratory Medicine 53 (8): 1127–9. doi:10.1515/cclm-2015-0355. PMID 25992514.
Notes
This presentation is faithful to the original, with only a few minor changes to presentation, including the addition of PMCID and DOI when they were missing from the original reference. Grammar and spelling were updated for readability and should not constitute "sufficient new creativity to be copyrightable"; no other modifications were made in accordance with the "no derivatives" portion of the distribution license.
