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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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American Association of Blood Banks (AABB)

The American Association of Blood Banks (AABB) also has requirements for a QMS, part of which includes a system for reporting occurrences.
The AABB's 29th edition of the Standards for Blood Bank and Transfusion Services* requires that laboratories:
Standard 9.0
"Shall have policies, processes, and procedures for data collection, analysis, and follow-up of issues requiring corrective and preventive action, including near-­miss events."
Standard 9.1
"Shall have a process for corrective action of deviations, non-conformances, and complaints relating to blood, blood components, issue, critical materials and services which include the following elements:
  • Description of the event
  • Investigation of the cause
  • Determination of the corrective action
  • Evaluation to ensure corrective action taken is effective"
*AABB Accreditation Program. Standards for Blood Bank and Transfusion Services, 29th edition. Bethesda, MD: American Association of Blood Banks; April 1, 2016.