QUALITYASSURANCEINTHEBLOODBANK-AustinCommunityCollege.ppt

History of Regulation in Blood Bank In the years before the HIV epidemic, blood banks were perceived as organizations that provided a community service Increased occurrence of HIV and increased public scrutiny resulted in stricter FDA regulations FDA regulatory oversight has resulted in an increased effort to provide a safe, high-quality product at low cost Terms Quality control is the management of the testing process itself. Monitoring of equipment and instruments Determining that reagents are reacting appropriately. Quality Assurance includes the entire process of providing patient care, from the time the physician orders the test until treatment of patient based on results of test. Were appropriate lab tests ordered to determine the need for transfusion. Did the transfusion service perform appropriate testing of patient specimen and preparation of the appropriate component Was the transfusion administered properly. Did the patient obtain the anticipated benefit. Utilization review is the process of monitoring the appropriateness of transfusion. Continuous quality improvement involves reviewing the process of providing patient care with the goal of reducing rework, waste and inappropriate care. Good Manufacturing Practices (cGMPs) cGMPs are legal requirements established by the FDA These regulations specify what needs to be done without specifying how it needs to be done The cGMPs are only a part of the overall quality assurance (QA) program Quality Assurance Program (QA) QA comprises the combined activities performed by an organization Ensures the quality of products and services offered Must include cGMPs Activities must be planned and documented by written policies and procedures. Records If it is not recorded it NEVER happened. Most common violation. Thorough record keeping essential. Recreates EVERY step related to production and distribution of blood components including individuals involved. Creates an audit trail necessary to investigate errors. Origina