§ 63-2209.1. Permits - Rules.

A.  On or after November 1, 1999, no person, corporation, partnership, association or other legal entity shall establish, operate or maintain a tissue bank that procures bone, skin, or connective tissue unless that entity has been issued a permit by the State Department of Health.

B.  The State Board of Health shall promulgate rules necessary to implement the provisions of this section which shall include, but not be limited to:

1.  Requirements for the tissue banks to submit an initial permit application that identifies the proposed service area, the tissue transplantation patient needs in the service area, the probable impact of the establishment and operation of the entity on other tissue banks currently servicing the area, and whether the tissue bank is a for profit or not for profit entity;

2.  A requirement that tissue banks, within one (1) year after receipt of a permit, be accredited by the American Association of Tissue Banks or another nationally recognized accreditation organization for tissue agencies;

3.  Provisions that all tissue banks employ a procurement technician or other technical operations personnel certified as a Certified Tissue Bank Specialist by the American Association of Tissue Banks or another nationally recognized accreditation or certification organization for tissue agencies and personnel;

4.  A requirement that each tissue bank maintain compliance with federal Food and Drug Administration regulations;

5.  A provision that each tissue bank have a medical director who is a physician licensed to practice medicine in this state;

6.  Requirements for tissue banks to give priority in tissue distribution to the Oklahoma medical community and Oklahoma patients; and

7.  A requirement that each tissue bank submit an annual report to the Department which shall provide the accreditation status of the entity, report of regulatory or internal inspections that affect quality, the certification status of personnel employed by the tissue agency, identity and qualification of the current medical director, type and geographic origins of donor tissue obtained, and units of processed tissue used for patients in the service area of the tissue bank.

C.  A permit application or renewal thereof, shall be accompanied by a non-refundable fee established by the Board of Health not to exceed One Thousand Dollars ($1,000.00).

D.  Upon receipt of a complete initial permit application, the Department shall cause a public notice of the proposed tissue bank to be published in a newspaper with the greatest circulation.  The Department shall also provide written notice of the permit application to existing tissue banks in the state.  Any person or organization may submit written comments regarding the proposed tissue bank to the Department.

E.  The Department shall issue or deny an initial permit within seventy-five (75) days after publication of the notice.  All permits shall be issued for a period not to exceed thirty-six (36) months and shall automatically expire unless renewed.

F.  The Department may deny, revoke, suspend or not renew a permit for failure of a tissue bank to comply with the provisions of this section or rules promulgated pursuant thereto.  Any tissue bank that has been determined by the Department to have violated any provision of this section or rule promulgated pursuant thereto, is liable for an administrative penalty of no more than One Hundred Dollars ($100.00) for each day on which a violation occurs or continues.  The maximum administrative penalty shall not exceed Ten Thousand Dollars ($10,000.00) for any related series of violations.

G.  The issuance, denial, suspension, non-renewal or revocation of a permit may be appealed under the provisions of Article II of the Administrative Procedures Act, Section 308a of Title 75 of the Oklahoma Statutes.

H.  The Department may bring an action in a court of competent jurisdiction for equitable relief to redress or restrain any entity from providing tissue bank services without a valid permit.  Said court shall have jurisdiction to determine said action, and to grant the necessary appropriate relief, including but not limited to, mandatory or prohibitive injunctive relief or interim equitable relief.

Added by Laws 1999, c. 278, § 4, eff. July 1, 1999.  Amended by Laws 2001, c. 353, § 5, eff. Nov. 1, 2001.