Guidelines for Managing Tissue Allografts in Hospitals

The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) recently established requirements for hospitals that receive, store, transplant, or distribute human tissue. This Guideline follows the structure of the JCAHO requirements and provides the rationale for the requirements as well as suggestions for processes that should be in place for quality management of tissue activities. Included is a crosswalk that links the JCAHO requirements with applicable AABB standards.Sections cover:Oversight Responsibility for Tissue ManagementSupplier Qualification (including FDA registration, state licensing, and hospital-specific requirements)Inspection and Documentation on ReceiptProcess Control for Tissue AllograftsTraceability and Record-KeepingStorage of Transplantable TissueInvestigating and Reporting Adverse EventsHandling Tissue Recalls and Withdrawals