CLSI is an organization that promotes the development and use of voluntary consensus standards and guidelines in the healthcare industry.
In the CLSI guidelines for Quality Systems, twelve Quality System Essentials are defined. One of the Quality Essentials is Occurrence Management. An occurrence is something that happens the does not conform to an organizations policies, processes or procedures.
CLSI's "Management of Nonconforming Laboratory Events; Approved Guideline", GP32-A, was developed specifically to provide guidance for clinical laboratories for the management of occurrences / events.
