Novelty referencing tool for quality management requirements of medical laboratories upon the review of CAP and ISO accreditations

Abstract

Context: In this review, the advantages of accreditation for medical laboratories are highlighted with detailed case study in the department of Pathology and Laboratory Medicine at the American University of Beirut Medical Center. The comparison is based on the current accreditation which is the College of American Pathologists (CAP), Laboratory General Checklist version 2020 specifically, with the International Organization for Standardization (ISO) 15189:2012 for medical laboratories, the part of management requirements. Objectives: The aim of this study is to review and contrast detailed ISO 15189-2012 standard requirements with CAP Laboratory General Checklist 2020 requirements. Secondly, define the extent of conformity of lab activities based on CAP requirements that are consistent with ISO 15189:2012 standard requirements for medical laboratories. Also, to identify areas not tackled in CAP requirements, but PLM can tackle to fully meet ISO 15189:2012 standard requirements for medical laboratories. Research Methodology: Data was gathered from documents and standards requirement checklists besides interviews with the quality management personnel at AUBMC, followed by extensive research in journals and websites, and then a thorough qualitative document review was conducted. Conclusions: this paper provides a better understanding of the philosophy of both accreditation bodies and their different ways to request the same level of quality. With the new editions and the concept of harmonization led to the overlapping of CAP and ISO requirements. Finally, AUBMC PLM - which is CAP accredited - is already practicing quality management standards that meet the requirements of ISO 15189, and no adverse systemic reframing of their practices is required for acquiring the ISO accreditation. However, since standardization is key to optimization, besides the paradigmatic technical requirements that CAP provides, the improvement of management systems requested by ISO would bring an added value to the position and services of such a grand organization.