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Recording and Reporting Transfusion Reactions

After the medical director has reviewed the laboratory results from a transfusion reaction investigation, the interpretation is recorded on the patient's permanent medical record. The transfusion service must retain the records of the test results, interpretations, and reaction classification indefinitely.
In the U.S., if a complication of blood collection or transfusion is confirmed to be fatal, the Director, Office of Compliance Biologics Quality must be notified as soon as possible. A written report is required within 7 days. The facility performing the compatibility testing is responsible for submitting the report. This report is required regardless of whether or not the death was a result of an error.
A fatal or non­fatal transfusion reaction is reportable as a Biological Product Deviation if the event is due to an error in the manufacturing of a blood product. "Manufacturing" includes specimen collection, testing, and all of the steps in preparing and issuing the product. Use of a mislabeled specimen would be a reportable error regardless of whether the mislabeling occurred in the transfusion service.
Accrediting organizations need to be notified as well, if a fatality occurs or if there is a non-­fatal transfusion event that occurs as a result of an error.