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:
"Shall have policies, processes, and procedures for data collection, analysis, and follow-up of issues requiring corrective and preventive action, including near-miss events."
"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.