Laboratories accredited by, or seeking accreditation from, the College of American Pathologists (CAP) will also be required to implement a formal program for corrective and preventive actions. The terms NCE or CAPA are not specifically used in the Laboratory General Checklist*, but the following item clearly describes a similar process:
"GEN.20208 Identification of Non-Conforming Events Phase II
The QMS program includes a process to identify and record non-conforming events (NCE's).
NOTE: Non-conforming events include problems that may interfere with patient care/client services. There must be a process for recording problems involving the laboratory that are identified internally, as well as those identified through outside sources such as complaints from patients, physicians, or nurses. The process must be implemented in all sections of the laboratory, and on all shifts. Any problem that could potentially interfere with patient care/client services or safety must be addressed. Clinical, rather than business/management issues, should be emphasized.
*CAP Commission on Laboratory Accreditation- Laboratory Accreditation Program. Laboratory General Checklist. Northfield, IL: College of American Pathologists; October 24, 2022.
