Once upon a time: a tale of ISO 15189 accreditation.

Abstract

There is no doubting that healthcare professionals gave the initial impetus for establishing hospital and laboratory accreditation systems, the main purpose of which is to improve quality and patient safety, as highlighted by eminent physicians, such as Ernest Amory Codman and Avedis Donabedian [1]. After an initial pioneering stage, essentially based on the peer-review concept, some regulatory activities have inevitably gained a footing in accreditation programs. In recent decades laboratory medicine has become increasingly subject to legislation and regulation, so much so that the voluntary and educational aspects of accreditation seem to have been overlooked and displaced by an emphasis on inspection and compliance. In addition, the mounting relevance of models for quality management may shift the focus of the accreditation from its main goal – particularly in health care and in laboratory medicine – of competently providing specific services. The evolution of the accreditation of clinical laboratories in different countries was once based on distinct models, standards, and accreditation bodies, and this led to confusion and disenchantment in the laboratory community. In particular, two distinct lines of International Standard development were applied to the medical laboratory. One, ISO 9001:2000 (the latest version issued in 2008) [2], focused on the “requirements for quality management systems” applicable to any organization, and the other, ISO 17025:1999 (the latest version issued in 2005) [3], originally designed to assess the technical competence of laboratories, is a generic standard used in the accreditation of any type of testing or calibration laboratory [4]. In 2003, after a long journey, the Working Group 1 of the Technical Committee, ISO/TC 212 “Clinical laboratory testing and in vitro diagnostic systems” (established in 1995), issued the first edition of an International Standard, the ISO 15189 “Medical laboratories – Requirements for quality and competence”, specifically designed for the medical laboratory [5]. ISO 15189 brought together the quality system requirements of ISO 9001 and the competency requirements of ISO/IEC 17025, addressing the specific needs of medical laboratory professionals worldwide. In particular, it incorporated sector specific issues of crucial importance in the provision of medical laboratory services. For example, it emphasizes the quality of not only the measurement but also that of the total service (e.g., consultation, turnaround time and cost-effectiveness), highlights important features of pre-and post-examination issues, focuses on patient outcomes and addresses ethics and the information needs of the medical laboratory [6]. The ISO 15189, developed with a significant contribution from the European Communities Confederation of Clinical Chemistry – EC4 – (now merged with the Federation of European Societies of Clinical Chemistry – FESCC – in the European Federation of Clinical Chemistry and Laboratory Medicine – EFLM), has been recognized by both the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and the International Laboratory Accreditation Co-operation (ILAC). However, the standards are only one of the four elements of an accreditation system as both the accreditation body and assessors/inspectors play a relevant role. Moreover, the user laboratory represents the fourth element. It is important to bear in mind that accreditation according to the ISO 15189 International Standard was conceived as a voluntary process, as is clearly highlighted by the inclusion of a specific clause (8.4.3 in the latest revision of the International Standard) on “continual improvement”. The evidence that in some countries, such as France and, at least in part, Belgium, accreditation according to the ISO 15189 is mandatory is further proof of its value and may facilitate the efforts of clinical laboratories to comply with a series of consensually developed and harmonized requirements other than with some national or regional standards. Yet, despite its growing global recognition by the main scientific organizations in the field of laboratory medicine, in many countries only a small number of laboratories are currently accredited [7]. The reasons for the variations between countries include differences in experience, competence, the interests of national