SECTION 310:505-5-2. Permit Applications

(a)   Initial applications. Each new tissue bank shall submit a complete application for permit to operate a tissue bank and include with the completed application and fee:

(1)   A map or narrative description which identifies the proposed service area;

(2)   A description of the tissue transplantation needs in the proposed service area;

(3)   An explanation of the probable impact of the new tissue bank on existing tissue banks providing services in the proposed service area;

(4)   Evidence of accreditation by the American Association of Tissue Banks (AATB) or another nationally recognized accreditation organization for tissue agencies approved by the Commissioner;

(5)   The name of the Medical Director and evidence that he or she is currently licensed to practice medicine in Oklahoma; and

(6)   The names and credentials of all technical operations personnel who meet the requirements of OAC 310:505-5-7.

(b)   Existing tissue banks. Existing tissue banks applying for a permit for the first time after the effective date of these rules shall not be required to provide the information required at OAC 310:505-5-2(a)(1 - 3).

(c)   Renewal application. At least ninety (90) days prior to the expiration of their current permit, each tissue bank shall submit to the Department a complete application for permit to operate a tissue bank and include with the completed application and fee:

(1)   Evidence of accreditation by the AATB or another nationally recognized accreditation organization approved by the Commissioner;

(2)   The name of the Medical Director and evidence that he or she is currently licensed to practice medicine in Oklahoma; and

(3)   The names and credentials of all technical personnel who meet the requirements of OAC 310:505-5-7, including evidence of current certification by the AATB or another nationally recognized accrediting or certifying organization for tissue agencies and personnel approved by the Commissioner.

(d)   Notice of initial permit application. After a complete application for permit and fee for a new tissue bank has been received, the Department shall cause public notice of the new tissue bank to be published in the newspaper with the greatest circulation in the proposed service area of the new tissue bank. The Department shall also provide written notice of the initial permit application to each tissue bank in the state holding a current permit.

(e)   Action on permit application. The Department shall act to issue or deny each initial and renewal permit application within seventy-five (75) days of the publication of the notice for initial permit application, and within seventy-five (75) days of receipt of the complete application and fee for renewal permit application.

[Source: Added at 18 Ok Reg 1711, eff 5-25-01]