Title: Section 52-4.6 - Tissue processing facilities

52-4.6 Tissue processing facilities.

(a) A facility which processes cardiovascular tissue shall be licensed by the department as a tissue processing facility. Such facilities shall make available to the department a statement of the procedures used in the preparation, testing and preservation of the tissue or tissues distributed, or offered for use. The premises, equipment, procedures, records, circulars of instruction and tissues shall be available for inspection and/or testing by the department as required. Copies of all brochures and other informational materials and instructions, including descriptions of methods of tissue handling, shall be available to the department. Each container of tissue shall be clearly labeled with the donor identification code or a unique tissue identification number, unit size and expiration date, if applicable.

(b) Aseptic processing of cardiovascular tissue shall be performed in separately defined work areas with:

(1) floors, walls and ceilings with nonporous smooth surfaces that are easily cleaned;

(2) temperature and humidity controls;

(3) an air supply filtered through high efficiency particulate air filters with positive pressure differentials between rooms;

(4) a system for monitoring environmental conditions;

(5) a system for cleaning and disinfecting a room and equipment to produce aseptic conditions; and

(6) adequate space for staff, and storage of garments and equipment.

(c) Critical work areas in which sterile tissue containers or aseptically retrieved cardiovascular tissue are exposed to the environment shall have an air quality of no more than 100 particles (less than or equal to 0.5 micron) per cubic foot of air and no more than one bacterial colony forming unit per 10 cubic feet of air. Critical work areas shall have a positive pressure gradient greater than or equal to 0.05 inches of water relative to an adjacent less clean area. Critical surfaces shall be sterile and shall not interact with the tissue so as to affect the quality of the tissue adversely.