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The page below is a sample from the LabCE course The Basics of Non-Conforming Event Management for Clinical Laboratory Services. Access the complete course and earn ASCLS P.A.C.E.-approved continuing education credits by subscribing online.

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What to Report?

Although the reporting of adverse events, complaints, and any issues that affect service quality or patient safety are definitely causes for corrective action, it is not always clear to know when to use the CAPA process. Earlier, the risk involved with NCEs was mentioned. Assess the amount of risk and you will be able to determine how to prioritize or whether to even initiate your CAPA documentation. Generally, corrective and preventive actions are reserved for systematic issues that affect the quality of your laboratory services.
Managers and employees of laboratory services must often use their best judgement of when to perform corrective action. However, with some planning, a policy that specifically delineates when to write-up a corrective/preventive action can be derived that lists common NCEs and what action is expected.
Consult your laboratory's policy regarding when and how to document non-conforming events.