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 QM Patient Care Services Phase II
The QM program includes a process to identify and evaluate errors, incidents and other problems that may interfere with patient care services.
NOTE: There must be an organized program for documentation of 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 program must be implemented in all sections of the laboratory, and on all shifts. Any problem that could potentially interfere with patient care or safety must be addressed. Clinical, rather than business/management issues, should be emphasized. The laboratory must document investigation and resolution of these problems. Laboratories must perform root cause analysis of any unexpected event involving death or serious physical or psychological injury, or risk thereof (including “near misses” and sentinel events). Laboratories must be able to demonstrate appropriate risk-reduction activities based on such root cause analyses."
*CAP Commission on Laboratory Accreditation- Laboratory Accreditation Program. Laboratory General Checklist. Northfield, IL: College of American Pathologists; August 17, 2016.