Transplant Safety (TS) (Critical Access Hospitals / Critical Access Hospitals)
What tissue products are surveyed under the standards in the Transplant Safety chapter?
Tissue - Standards Applicability
Current | March 23, 2011
A. 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 acelluar (containing no cells), e.g. acellular dermal matrix. Products that are derived from human or non-human tissue and cellular materials, but which are rendered acellular at the time of use for the patient, are not surveyed under the tissue standards. Please check the manufacturer’s package insert for the product’s composition. A list of common tissue and cell products is also included in the introduction to the standards in the standards 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.