Quality activities associated with hospital tissue services.
Quality assurance is a vital component of a tissue service that aims to meet regulatory requirements and provide safe and functional tissue for surgical procedures in the institution. Many hospital transfusion services have or are in the process of assuming tissue service functions for their institutions, and the concepts of tissue quality assurance requirements should be familiar to the transfusion service. This review discusses the key aspects of tissue service quality assurance, including requirements for FDA registration, selection and qualification of tissue suppliers, recordkeeping, management of occurrences and tissue recalls, adverse event reporting, audits, and quality control. Comparing the similarities and differences between tissue and blood component regulatory requirements suggests transfusion service processes can be readily adapted to incorporate quality assurance for tissue service activities.
Hillberry
C M
CM
Department of Pathology, University of Iowa, 200 Hawkins Drive, Iowa City, Iowa 52242, USA.
Schlueter
A J
AJ
D001803:Blood Transfusion / Q000331:legislation & jurisprudence / Q000592:standards; D006748:Hospital Departments; D006801:Humans; D016347:Medical Records Systems, Computerized / Q000331:legislation & jurisprudence / Q000592:standards; D011787:Quality of Health Care / Q000331:legislation & jurisprudence / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration