Investigation of the long-term yield of auditing for conformity with the ISO 15189:2012 quality standard in a hospital pathology laboratory.

INTRODUCTION

Pathology laboratories are increasingly seeking accreditation to quality standards to assure Quality of Service (QoS). However, there is little data available regarding the value of this in laboratories with well-established Quality Management Systems (QMS). Moreover, critics of accreditation claim it redirects resources toward trivial issues. Our objective was to investigate the value of auditing for conformity with the ISO 15189:2012 standard in such laboratories.

DESIGN

and Methods: In total, 483 Audit-Identified Non-Conformities (AINCs) were documented within our department since transitioning to an ISO 15189:2012 compliant QMS. The potential consequences of these were assessed by three clinical laboratorians who assigned them into categories based on their likely impact. These were: (no clear consequences); (potential for poor QoS/harm); and (Likely to cause poor QoS/harm). Additionally, total numbers/severity of Real-Time Non-Conformities (RTNCs) detected outside of auditing were examined to provide additional insight into the effects of accreditation on QoS.

RESULTS

According to majority decision: 395 (81.8%) of AINCs were classified , 88 (18.2%) were , and none were . The relative proportion of AINCs also rose over time. Total numbers and severity of RTNCs dropped in the short-term following transition to an ISO 15189:2012 QMS, but steadily rose thereafter.

CONCLUSIONS

Our data suggest auditing for conformity with ISO 15189:2012 standards may be effective in attaining accreditation, but may have diminishing returns in the long-term once the QMS is established, unless there is continual improvement in the audit process to promote better use of resources.