Ga. Comp. R. & Regs. R. 111-8-10-.16 - Quality Control for Tissue Banks

Tissue banks which procure, store, or process human or animal tissue designed to be used for medical purposes in human beings shall conform to the procurement, storage and processing requirements listed in this section. The tissue bank must maintain donor and patient recipient records and communications. These records must be retained for not less than seven years after the distribution of the tissue material. These records shall be evaluated and reviewed by the director to ensure the suitability of the donated tissue for its intended use. Records must include the following:

(a) Each step in collection, preparation, testing, storage and distribution of the tissue must be documented concurrent with the performance of each step.

(b) Records must be legible and indelible and must include dates of testing, testing results, interpretations, assigned expiration date, if applicable, and the identity of the person performing the work.

(c) Donor identification and documentation of the pathological and microbiological evaluation of the donor shall be recorded.

(d) Each tissue and any component must be given a generic designation and a unique identification number which shall be used as the lot number throughout the collection, processing, distribution and utilization processes.

(e) All records concerning donor history, tissue processing and any other details deemed necessary (within the bounds of medical-legal and donor confidentiality) shall be available to authorized personnel upon request.

1. An adverse reaction file must be maintained.

2. An accurate inventory of all tissues (unprocessed, processed, and distributed) must be maintained.

3. There must be verification of step by step procedures under which tissue is procured, processed, tested and stored. Final disposition of the transplanted tissue must be recorded.

(f) Air drains, surfaces and water faucets shall include periodic sampling to ensure the tissue bank environment is maintained.

(g) The tissue bank shall have a system to prevent unauthorized entry either by physical configuration and/or an adequate security system.

(h) Procedures for recruiting donors shall be established and approved by appropriate officials.

(i) Permission to obtain tissues from living or non-living donors shall be documented through informed consent. Tissue banks must comply with Georgia Rules and Regulations for Anatomical Gifts, Chapter 111-8-5, as may be applicable.

(j) Tissues shall be processed by procedures which are appropriate for the type of tissue and the manner in which it is retrieved. Processing shall not change the physical properties of the tissues.

(k) Tissue preservation and types of storage containers shall ensure that the biological and biochemical properties are retained.

(l) Tissues shall be sent only to licensed and approved facilities that have accepted responsibility for proper handling and use. There shall be an agreement for notifications of the tissue bank if tissues are received in defective packaging, have been removed from sterile containers but not used, or have been lost. The following criteria for distribution must be met:

1. Transportation methods shall maintain proper environmental conditions during transit.

2. Excess product remaining after use shall be discarded unless the tissue bank retains control of the product and the product remains sterile.

3. Upon receipt of tissue, a record shall be made of its description, date received, and the tissue supplier and, if applicable, expiration dates.

4. Tissue shall not be dispensed without a documented order from the physician or other authorized health professional, and records of the person to whom this tissue was dispensed, and the integrity of the container and label.

(m) Records must be retained indefinitely to permit tracing of any tissue from the donor to all recipients or other final dispositions. Records must include the following:

1. Receipt, storage, and transportation information;

2. Identity of the source facility;

3. Type of tissue and the numeric or alphanumeric identification;

4. Name(s) of the recipient(s);

5. Personnel who prepared the tissue for dispensing;

6. Personnel who dispensed the tissue;

7. Personnel who accepted the tissue for use;

8. Dates of dispensing and transportation;

9. Identification of the ordering physician or other authorized health professional;

(n) Storage temperature records must be retained for five years.

(o) Container labels must include:

1. Name of product;

2. Name and address of tissue bank; and

3. Tissue identification number.

(p) Package labels must include:

1. Product name;

2. Name and address of the tissue bank;

3. Unique tissue identification number;

4. Expiration date of contents, if applicable;

5. Method of sterilization, if applicable;

6. Preservation and concentration or "no preservative" if preservative presents a safety factor;

7. Number of containers, if applicable;

8. Amount of product by weight;

9. Storage and handling instructions, including recommended storage temperature and special handling instructions relative to the product;

10. Sensitizing substances known to be present;

11. Antibiotics added during processing: type and calculated amount;

12. Product source, if a factor in safety of administration; and

13. A statement that the tissue donor was tested for HIV antibody and Hepatitis B surface antigen (HBsAg) using FDA approved tests and found to be nonreactive.

(q) Final container shall be packaged in a manner that ensures the integrity and sterility of the contents.

(r) A product insert must accompany all tissues.

(s) There shall be written procedures for tissue recall and notification of recipient centers of possible tissue contamination, errors detected in the processing, preparation or distribution process or other factors which may render the tissue unsuitable for its intended application.

(t) Standard nomenclature and units of measure shall be used to describe tissues and the processing they have undergone.

Notes

Ga. Comp. R. & Regs. R. 111-8-10-.16

O.C.G.A. § 31-22-1et seq.

Original Rule entitled "Quality Control for Tissue Banks" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.