Influence of DIN EN ISO 15189 on the correctness of results in clinical virology

Abstract

Abstract To date more than 400 medical laboratories in Germany are accredited based on DIN EN ISO 15189 (Medical laboratories – requirements for quality and competence). In Germany, a new version of the DIN EN ISO 15189 has been published in 2014. This standard includes overall criteria but no requirements specific for certain disciplines of laboratory medicine. The present study examined how technical requirements, mainly for quality assurance and analytic methods, influence the correctness of results in clinical virology. Experts from laboratories, industry, DAkkS (German Accreditation Body) and from standardization have been interviewed. The qualitative content analysis showed that fulfilling technical requirements increased the correctness of examination results and minimized the risks for patient care and safety. Furthermore, we studied how effective internal quality controls, assay-controls as well as additional controls, assure HIV-p24-antigen and anti-HBs results. Additional controls recommended by DIN EN ISO 15189 (so called “run controls”) clearly indicated inaccuracies of HIV antigen measurement that were undetected by manufacturer’s controls. Also for anti-HBs examination, such internal controls provided by the manufacturer did not guarantee correct results. Therefore, we conclude that fulfilling DIN EN ISO 15189, usually confirmed by accreditation, has a positive influence on correctness of results in clinical virology, ultimately improving patient care.