Human Tissue/Non-Transplant Anatomic Bank License (DOH-2973, DOH-2973 (e-f), DOH-2973(i) DOH-2973(a))
This license is required to operate a non-transplant anatomic bank.Overview
A license is required for any person or facility that solicits, retrieves, performs donor selection and/or testing, preserves, transports, allocates, distributes, acquires, processes, stores or arranges for the storage of nontransplant anatomic parts, including bodies, body parts, organs, or tissues from living or cadaveric donors, for education or research purposes conducted at another facility.
Requirements
1. Copies of donor consent forms and applicable donor selection criteria and protocols, Sometimes Required2. Inspection, Sometimes Required
How to Apply
1. See form below.
Form(s)
NAME | FORM NUMBER | FORM AND INSTRUCTIONS AVAILABLE |
---|---|---|
Application for Licensure-Human Tissue Bank Nontransplant Anatomic Bank | DOH-2973 | DOH-2973 |
Form F, Disclosure of Ownership and Controlling Interest Statement | DOH-2973f | DOH-2973f |
Form A, Application for Licensure - Human Tissue Bank, For Limited Tissue Procurement Services | DOH-2973(a) | DOH-2973(a) |
Instructions | DOH-2973(i) | DOH-2973(i) |
Duration & Processing
Average Processing Time: | 60 Days |
---|---|
Term/Duration: | Biennial |
Renewable: | Yes - 2 years |
Automatically Sent: | No - Annual license update is sent to all licensed non-transplant anatomic banks. Upon review by department staff, certain changes may require submission of a new application. |
Additional Info: | Grace Period: Yes - 30 days, where applicable Late Penalty: Yes - Failure to comply will result in termination of the license |
Common Denial Reasons: Continued non-compliance with administrative and/or technical regulations
Additional Info
1. The agency has an appeal process for a denied application2. Permit/license must be posted
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