QUALITY ASSURANCE IN THE CLINICAL LABORATORY: BENEFITS FOR ISO 15189 OR ISO 17025 ACCREDITATION

Clinical laboratories play a pivotal role in all stages of healthcare provision including diagnosis, prevention and treatment, as well as, epidemiology and Public Health policies. Laboratory diagnostics generally account for 3–5% of total health care costs. There are clear advantages to accreditation at the national level, regarding standardization of processes, policy, quality of results, systematic evaluation of suppliers and risk management. Nevertheless, accreditation requires resource investment in staff, metrology, proficiency testing and may slow development and innovation due to lack of flexibility. Thus the actual added value of accreditation to patient care should be balanced between its benefits and costs. Accreditation requirements for clinical laboratories vary globally: France and Hungary regulations demand accreditation for all fields of diagnostics, while Germany and Belgium restrict it to some analyses.

In Israel, certification of all clinical laboratories is mandatory since 2013 according to ISO 9001:2015. Concomitantly, the accreditation of clinical laboratories in Israel relies indirectly on the mandatory accreditation of all the hospitals by the JCI organization. Laboratory accreditation according to ISO 17025 or 15189 is on a voluntary basis only.

Using the experience of other countries and our personal experience with ISO’s 17025 and 15189 guidelines, we suggest a focused strategy on accreditation covering all the sub-specialties of microbiology in clinical laboratories to be considered. The strategy can cover a percentage of the total activity for each sub-specialty of microbiology, methods at risk such as methods for prenatal diagnosis or in-house methods, and methods used for notifiable infectious diseases. This strategy could be useful for improving the quality of services at the national and local levels, if the level of costs is acceptable.