Like all Biomedical items, Blood donations are a highly regulated substance. The FDA and their subdivision, the Center for Biologics Evaluation and Research (CBER) collaborate to make sure hospitals and blood centers are keeping their establishments and operations suitable for a safe donation and transfusion. Both institutions do their best to ensure patients are getting their treatment as safely as possible. Noncompliant blood centers are harshly dealt with by the FDA and can result in fines reaching in the millions (Forbes). Understanding how the FDA implements their standards will help blood centers avoid fines and adopt proper solutions.
The FDA works to regulate blood donations and transfusions. CBER is an organization within the FDA that closely monitors healthcare centers, routinely inspecting an establishment’s status. Investigations take place every two years, searching for deviant procedures and unsuitable environments. During these inspections, CBER focuses on a few key areas. Blood centers are scanned for accurate record procedures and safe operations, along with testing for hazardous agents. The CBER is wary of the dangers associated with blood products and expects establishments to uphold their quality mandates. As stated by fda.gov, “problem” centers are inspected at an even higher rate. Chances are, if noncompliant centers are in operation, they will eventually be exposed.
Blood items require accurate data and traceability to pass inspections. The FDA has strengthened their standards in recent years, demanding an accurate record keeping system to keep track of unsuitable donors, movement of biologic items, and successful transfusions. The FDA views accurate records and traceability as an effective way to reduce transfusion errors and maximize patient safety. According to the FDA, budgeting issues are NOT an excuse for noncompliance. With the right integrator, there is a way to reach compliance without breaking the bank. Barcode scanning is a common, cost-effective solution for tracking. Alternatives like RFID tagging technology have also been used in the past with successful results.
