What to Report?

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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.

Learn more about The Basics of Non-Conforming Event Management for Clinical Laboratory Services (online CE course)
What to Report?

Although the reporting of adverse events, complaints, and any issues that affect service quality or patient safety is a cause for corrective action, it is not always clear to know when to apply the CAPA process. Earlier, the risk involved with NCEs was mentioned. By assessing the amount of risk, 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 judgment 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. The policy would include examples of common NCEs and expected action when the event occurs. In addition, the laboratory's policy regarding when and how to document non-conforming events should be consulted.