Reporting Process for Blood Establishments to Notify the Food and Drug Administration of Errors and Accidents Affecting Blood

EXECUTIVE SUMMARY:

This final audit report points out that the Food and Drug Administration (FDA) generally processed error and accident reports in accordance with established procedures. However, improvements could be made in the timeliness of the reports and the use made of the reports. We recommended that the FDA; (1) expedite the development and issuance of revisions to the Federal regulation on error and accident reporting to be more specific concerning the time frame in which error and accident reports are required to be submitted, (2) expedite the development and issuance of a regulation to require unlicensed blood establishments to submit error and accident reports, and (3) expand the Center for Biologics Evaluation and Research's use of existing information in its current error and accident data base to identify blood establishments that regularly fail to submit error and accident reports in a timely manner, and provide additional trend analysis reports to the FDA field offices and blood establishments. The Public Health Service agreed with our recommendations.