The CAP has 30 official liaisons to various organizations who attend scientific meetings or designate others to do so. Here is a report from two outbound liaisons to ISO working group 1 quality and competence in the medical laboratory.
William J. Castellani, MD; Frank Schneider, MD
January 2023—The fourth edition of the International Organization for Standardization’s ISO 15189, Medical Laboratories—Requirements for Quality and Competence, was published at the end of 2022. This international standard, adopted as an accreditation standard by many countries around the world, applies principles of quality management to the clinical laboratory and has general requirements for competent performance of testing. In the United States, ISO 15189 has been implemented voluntarily by close to 100 laboratories as an adjunct to CLIA ’88 regulations or CAP accreditation.
This revised version of ISO 15189 is organized differently to align with other ISO “conformity assessment standards” (documents used to assess management systems and testing laboratories). It includes some required harmonized elements but still recognizes the unique focus and purpose of the clinical laboratory.
The new version of ISO 15189 places greater emphasis on the needs of the patient and risk management. It also expands on measurement uncertainty and traceability and incorporates point-of-care testing.
Patients are typically removed from direct involvement with the laboratory after providing the sample. Their needs are addressed through other “users” of the laboratory—that is, the caregiver taking care of them and ordering the tests. Throughout the new edition, the ultimate service to the patient has been made explicit and emphasized.
The revised standard reflects the emphasis that ISO 9001:2015, Quality Management Systems—Requirements, places on addressing risks. “Risk-based thinking” (referred to in ISO 15189 as risk management) is a foundational aspect of the management system in ISO 15189, not only in understanding the risks inherent in day-to-day activities but also in addressing future harm when issues (nonconformities) arise. As such, it supplants “preventive action” as an ongoing process for addressing these issues. An example of risk management in ISO 15189 is mislabeled specimens, including “clinically critical or irreplaceable sample[s],” an issue that clinical laboratories well understand. ISO 22367, Medical Laboratories—Application of Risk Management to Medical Laboratories (CAP TODAY, https://bit.ly/SoS_052020), serves as an excellent resource for managing risk in clinical laboratories. To this end, it is accepted that a laboratory in compliance with ISO 9001 covers many, though not necessarily all, of the quality requirements of ISO 15189.
Earlier versions of the standard introduced requirements for measurement uncertainty and traceability. Measurement uncertainty addresses the likely range around a quantitative result that the “true” value actually is. Traceability focuses on how to ensure that the result for a given test today can be compared to the result for that test last year and the result that may be obtained next year. Both concepts are addressed in greater detail in this edition.
This ISO 15189 revision, though holding close to quality and competence requirements in earlier editions of the standard, represents a useful evolution to address how clinical laboratories serve their users with a primary focus on patient care. This standard identifies supplemental ISO documents that were developed to assist laboratories in understanding and complying with these requirements.
Dr. Castellani, formerly professor of pathology at Penn State Hershey College of Medicine, is a member of the CAP Standards Committee, CAP accreditation interregional commissioner, and member of the CAP Checklists Committee. Dr. Schneider, also a member of the Standards Committee, is associate professor, Department of Pathology and Laboratory Medicine, Emory University School of Medicine, and scientific director, cancer tissue and pathology shared resource, Winship Cancer Institute of Emory University.