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Tissue - Standards Applicability

What tissue products are surveyed under the standards in the Transplant Safety chapter?

Any examples are for illustrative purposes only.

The tissue standards apply to human and non-human cellular based products and any product classified as tissue by state law, regulation or the FDA, even if it is acellular (containing no cells).  Acellular dermal matrix, bone putty, and cancellous chips are examples of acellular products classified by the FDA as tissues, therefore, the tissue standards do apply based on FDA classification.

Products that are derived from human or non-human tissue and cellular materials, but rendered acellular at the time of use for the patient, are not surveyed under the tissue standards. Albumin and gamma globulin are examples of products derived from cellular products but rendered acellular through the manufacturing process. They are acellular at the time of patient use are not classified by the FDA as tissues, therefore, the tissue standards do not apply. Please check the manufacturer's package insert for the product's composition. If the FDA classification is not noted on the package insert, it may be necessary to research the product on the FDA website to determine classification. A list of common tissue and cell products can also be found in the Transplant Safety chapter of the accreditation manual on pages TS-7 and TS-8.

The tissue standards do not apply to products that do not meet the above description, including those that have tissue-like names or are otherwise associated with tissue usage. Examples include medical devices (acellular), medications, blood derivatives and combination products. These items may also require tracking to support patient notification in the event of a recall or investigation for an unexpected adverse event. However, the Joint Commission standards do not specify the same level of stringent documentation as is required for tracking tissue products.
Last updated on March 04, 2021
Manual: Critical Access Hospital
Chapter: Transplant Safety TS

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