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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 introduction to the Transplant Safety chapter found in the accreditation manual.

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.
Manual: Critical Access Hospital
Chapter: Transplant Safety TS
Last reviewed by Standards Interpretation: February 11, 2022 Represents the most recent date that the FAQ was reviewed (e.g. annual review).
First published date: April 11, 2016 This Standards FAQ was first published on this date.
This page was last updated on February 11, 2022 with update notes of: Review only, FAQ is current Types of changes and an explanation of change type: Editorial changes only: Format changes only. No changes to content. | Review only, FAQ is current: Periodic review completed, no changes to content. | Reflects new or updated requirements: Changes represent new or revised requirements.
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