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)

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). 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.

In the world of ISO standards, ISO 15189 is the only standard specifically implemented for a health care unit. It represents the achievement of a very important pathway, in which it was recognized that laboratory medicine, in the health care system, is an organization with a higher awareness about the importance of quality in the entire TTP and in which staff competence plays a predominant role as well. ISO 15189 accreditation guarantees the implementation of processes and procedures that comply with approved international and national guidelines that are the expression of laboratory good practice, but, first and foremost, also assures the competence of staff and the activities in which they are involved. In order to assure that ISO 15189 accreditation provides real added value to a laboratory, the lab must take into account:

• training of staff concerning accreditation's purpose;
• achieving awareness that all processes and procedures have to be implemented on the basis of the test purpose;
• interpreting correctly each requirement of ISO 15189;
• gaining knowledge of the guidelines that can lead towards the compliance of each requirement;
• demonstrating the competence and ability to translate into practice what is proposed in the guidelines in order to avoid compliance with the requirements becoming a bureaucratic and useless burden on procedures, in addition to increasing costs;
• implementing procedures according to harmonized criteria in order to assure the risk of accreditation with flexible scope is prevented; and
• performing of audits by assessors with high competence in the laboratory field where the tests in accreditation are involved, as well as in the implementation of quality management systems in the clinical laboratory.

A quality management system based only on management requirements guarantees a controlled system in which the efficacy is related to the objectives of the organization. The ISO 15189 accreditation requires compliance with stringent technical and professional requirements, in addition to management requirements. This peculiarity of ISO 15189 is the fundamental aspect that has a strong impact on patient safety. The assurance of medical laboratories' competence, in compliance with the ISO 15189 requirements, depends on the level of laboratory staff competence but, also, on the competence of the assessors during the audit. The assessors play a key role in the release of accreditation. The evaluation of suitable interpretation of a morphologic pattern and the congruity of the interpretation between different operators, for example, can be evaluated only by assessors with high competence in that specific area. Each laboratory activity has to be based on consensus criteria and harmonized procedures complying with technical requirements structured according to management requirements, and they have to be managed by staff with recognized qualifications and assessed by assessors with appropriate competence. Only if this aspect is adequately understood and stressed in the implementation of accreditation can the introduction of ISO 15189 translate into effectiveness for higher quality and patient safety.

ISO 15189 accreditation

The need to comply with quality requirements approved by recognized international bodies was born about 20 years ago. Medical laboratories around the world, in order to satisfy this need, used the available standards, and many laboratories were accredited in compliance with EN 45000, and later ISO 17025, national standards issued by professional bodies (CCKL, CPA, etc.), and — especially in Italy — ISO 9001. The limited value and appropriateness of these norms for medical laboratories promoted the development of a specific standard and, although the first draft was issued in 1997, only in 2003 was the first revision of the standard finally released. The standard was created based on the management requirements proposed in ISO 9001, as well as the technical requirements of ISO 17025 and specific professional requirements proposed by the European Communities Confederation of Clinical Chemistry (EC4). This standard takes into account all the needs of medical laboratories, namely all the steps of the entire testing process, starting from the appropriate test request to the right notification of laboratory reports and the role of further clinical advice provided by laboratory professionals. It focuses attention on both the items of the intra-analytical phase (e.g., verification and validation of examination procedures, measurement uncertainty, metrological aspects, etc.), and on the pre- and post-analytical phases (peculiar features of medical laboratories in comparison to testing laboratories). However, its limited adoption, particularly in some countries, has been affected by the request to accredit each single test (fixed scope), as typically requested by the ISO 17025 accreditation process. Only in 2008 was an accreditation process with a more flexible scope approved by the EA, and medical laboratories have started with ISO 15189 accreditation at an international level. Moreover, the identification of a unique national accreditation body has made clear which entity has to manage the accreditation of medical laboratories, promoting its diffusion.

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.