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 must 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. Each organization must check with their state for the status of Tissue License Requirements.
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.
The source facility must 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. Each organization must check with their state for the status of Tissue License Requirements.
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.
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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