.08 Tissue Bank Standards — General.

A. Applicable Laws. A tissue bank shall comply with all requirements and standards in this chapter as well as with other applicable federal, State, and local laws, regulations, and rules.

B. Governing Body. Unless provided by the institution of which it is a part, a tissue bank shall have a governing body consisting of individuals from various professions, that determines the scope of activities to be pursued by the tissue bank and is responsible for issues of:

(1) Liability;

(2) Ethical considerations;

(3) Fiduciary responsibility; and

(4) Compliance with the standards and requirements of this chapter and those of the tissue bank's standard operating procedure manual.

C. Facilities.

(1) General. The physical facilities of a tissue bank shall meet all applicable federal, State, and local laws, including but not limited to:

(a) Engineering;

(b) Fire;

(c) Safety;

(d) Health; and

(e) Sanitation.

(2) Physical Plant. The physical plant of a tissue bank shall be designed or arranged to meet operational needs with plumbing, drainage, lighting, ventilation, space, and handwashing facilities for personnel and donors if applicable.

(3) Designated Space. Personnel of a tissue bank shall perform the following critical tissue bank procedures in designated areas:

(a) Processing;

(b) Quarantine storage of in-process materials;

(c) Other quarantining;

(d) Labeling;

(e) Storage of distributable inventory;

(f) Quality assurance and control functions;

(g) Receipt and storage of containers, supplies, and reagents;

(h) Storage of medical waste;

(i) Irradiation and other sterilization procedures; and

(j) Final product inspection and distribution activities.