I discussed below the results of the unannounced survey by our accreditation body, the Joint Commission. We are also subject to inspections by other regulatory agencies. One is conducted by the Food and Drug Administration, to ensure that our handling of blood products (i.e., blood banking and transfusion) is carried out in accordance with federal standards. The inspections are completely unannounced. There are no black-out dates, so we are not given blocks of time for which we can expect an inspection.
The standard enforced by the FDA is called "current Good Manufacturing Practice" (cGMP). The rules of cGMP cover areas such as organization and personnel, facilities, equipment, supplies and reagents, standard operating procedures, labeling, compatibility testing, records, adverse reaction files, and deviation reporting. The goal, of course, is to ensure that the blood products we collect from donors, process, crossmatch, and transfuse to our patients high certain standards for safety, purity, potency, and labeling.
Our unannounced inspection started on August 7. The inspector spent 5 full days touring our facilities, interviewing staff in our Pathology Department and on the floors, observing operations, and reviewing documents and records. By touring the blood banks and the Infusion & Pheresis Unit, the inspector checked to see that our facilities were clean and orderly. During this inspection, the inspector observed an autologous whole blood donation in the Infusion & Pheresis Unit. In the blood bank, she observed our processes for receipt of blood from our outside blood suppliers as well as our processes for management of our inventory, including confirmation of the blood component ABO and Rh type. Additionally, she reviewed the functionality of our blood bank computer system related to product testing, patient testing and product distribution for transfusion.
The inspector also checked for proper storage and handling of blood products. Blood storage refrigerators and freezers were audited for proper temperature and proper labeling and segregation by ABO and Rh type. Records of temperature monitoring and alarm conditions were reviewed to ensure that products were maintained at the proper temperature at all times. Disposition records were reviewed to ensure that products not suitable for transfusion were destroyed.
Written standard operating procedures were also checked for evidence of timely reviews. Training records of new employees were reviewed, as were quality control records of equipment, such as the blood irradiator, and also for reagents used in blood typing and compatibility testing.
I am pleased to report that the FDA inspector found no reportable issues or recommendations. We are quite pleased with this result. We always want to be able to assure our patients that blood products they receive at this hospital have been prepared following good manufacturing practice in order to ensure the products’ safety, purity, and effectiveness.