Oklahoma § 63-2209.1 - Permits - Rules

§ 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.

Oklahoma Statutes - Title 63. Public Health and Safety

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.

Oklahoma Statutes - Title 63. Public Health and Safety

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.