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Tissue Source Facilities - Licensing and Registration Verification

What is The Joint Commission looking for in regards to verification of registration and licensing of tissue suppliers?

Any examples are for illustrative purposes only.

The source facility should be registered with the US Food and Drug Administration (FDA) and licensed by the state, if the state in which the implanting organization resides requires licensure.

Annual registration is required by the FDA each December for all tissue suppliers who recover, screen, test, process, label, package, or distribute tissues. Suppliers are expected to be compliant with the FDA regulations that apply to their operations. Healthcare organizations that only receive and store tissues for implantation or transplantation within their facility are not required to be registered with the FDA. Licensing is state dependent. As of March 2007, five states require licensing, which include New York, Florida, California, Georgia, and Maryland.

The Joint Commission standards can be met by requesting from the source facility copies of their current state license (when applicable) and FDA registration and keeping them on file. For FDA registration, the supplier's registration status may also be checked annually by using the FDA's online database.
Last updated on April 10, 2020
Manual: Ambulatory
Chapter: Transplant Safety TS

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