AABB Standards requires that all variances are documented and investigated and corrective actions taken when necessary. Any time a blood component is found to be defective (e.g. broken seal, leaking, discoloration, clots, etc.), mislabeled, or testing results incomplete or not documented, the cause should be investigated by the Donor Center and reported back to the initiator of the report in writing.
- All transfusion services must inspect all blood components upon receipt (e.g. for leakage, broken seals, improper temperature, clots, discoloration, gas, etc.).
- Labels must be compared to the consignment sheet for complete concordance.
- If units are found that are not listed or mislabeled, they must be reported in writing to the Donor Center and returned as-is for investigations.
- If the unit is leaking or broken, ensure standard/universal precautions are taking to minimize contact with the fluids.
- Damaged blood components must not be used. Units with mislabelings or other discrepancies between the labels and the consignment sheets may be used when such errors are corrected and officially reported by the Donor Center.
- Use the standard incident (occurrence variance) report form (OVA) for each and every variance.
- The submitting location should keep a copy of the OVA and immediately forward the original to the Transfusion Quality Section.
- The Donor Center should investigate the variance and prepare a written investigative report and submit to the Division Head, Transfusion Medicine.
- Donor Center investigations should be completed within one calendar week.
- The Donor Center should forward a copy of the completed written investigation to the transfusion service which initiated the investigation.
- The copy of the investigation report should be attached to the OVA and kept at the local site.
- Transfusion Quality shall include these variances in its monthly reports.
Standards for Blood Banks and Transfusion Services, Current Edition, AABB, Bethesda, Maryland, USA