The 2012 Hospital & Laboratory Accreditation Standards
Introduction to Standards TS.03.01.01, TS.03.02.01, and TS.03.03.01
The following standards apply to hospitals that store or issue tissue. This includes any areas outside of the clinical laboratory that store or issue tissue; for example, surgery and outpatient centers or tissue banks. They apply to human and nonhuman cellular-based transplantable and implantable products whether classified by the U.S. Food and Drug Administration (FDA) as a tissue or a medical device. Collagen and tissue products derived from plastics and polymers are not considered cellular-based products and are not evaluated under these standards.
Specific tissue transplant requirements apply to autologous tissue. This includes policies and procedures for identifying, tracking, storing, and handling atuologous tissue, in addition to investigating tissue adverse events. Also, if the state in which an organization resides classifies something as tissue that falls outside the scope of The Joint Commission definitions, the standards would apply.
Examples of Tissue and Cell Products
The organization uses standardized procedures to acquire, receive, store, and issue
tissues.
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Other Cellular- and tissue-based transplant or implant products whether classified by the U.S. Food and Drug Administration as a tissue or a medical device.
Other tissues that are classified as tissues by state law and regulation.
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