Compilation of Rules and Regulations of the State of Georgia
Department 111 - RULES OF DEPARTMENT OF COMMUNITY HEALTH
Chapter 111-8 - HEALTHCARE FACILITY REGULATION
Subject 111-8-10 - LICENSURE OF CLINICAL LABORATORIES
Rule 111-8-10-.17 - Quality Control for Sperm Banks/Embryology and Assisted Reproductive Technology (ART)

Universal Citation: GA Rules and Regs r 111-8-10-.17

Current through Rules and Regulations filed through September 23, 2024

(1) Sperm Banks. Facilities collecting semen specimens shall comply with the following:

(a) Sperm banks shall be staffed with personnel trained in the most current methods of cryobanking and who meet the personnel requirements of these rules.

(b) Records must contain a donor release and a complete history.

(c) Donor semen shall have specific identification codes for use during the freezing and storage processes. Codes shall in no way be linked to the donor or the recipient.

(d) Donor history shall include the following:

1. Interview;

2. Examination including personal, physical, sexual and genetic histories;

3. Examination of semen to ensure viability and motility, freedom from infection and/or foreign cells and freezing survival capabilities.

(e) Semen specimens shall be collected at the sperm bank and processing shall be initiated within one hour of collection. Test results and measurements shall be initiated within one hour of collection. Test results and measurements shall be documented concurrent with evaluation.

(f) An appropriate method of cryopreservation shall be chosen which ensures maximum viability and freedom from contamination. Documentation shall be available which validates the method chosen.

(g) Storage and handling instructions shall be made available to the requesting physician. Such instructions shall include handling and disposition of unused specimen. Donor semen shall not be refrozen or redistributed.

(2) Assisted Reproductive Technology (ART). Facilities providing ART shall comply with the following:

(a) The laboratory director must meet requirements at Rule 111-8-10-.06(2)(b) of these regulations; in addition, the director must have two years of documented experience in a laboratory performing ART procedures, have documented training of at least six months in an embryo laboratory which includes performing, at a minimum, each ART laboratory procedure 60 times. Included in the responsibilities of the director of the laboratory performing these procedures shall be:

1. To establish and monitor a program to ensure that aseptic conditions are maintained in the laboratory;

2. To assure that procedure manuals meet requirements at Rule 111-8-10-.09(2)(h);

3. Establish and monitor a quality assurance program that meets requirements at Rule 111-8-10-.06(3)(a), as applicable.

(b) An ART supervisor shall meet the requirements at Rule 111-8-10-.06(3)(b)1., 2., 3., or .06(4)(b)1., or 3., and have documented training which includes performing, at a minimum, each ART laboratory procedure sixty (60) times.

1. An ART supervisor must be accessible to laboratory personnel when ART procedures are performed, either on-site or via electronic means; and

2. An ART supervisor may perform director responsibilities as authorized, in writing, by the director.

1. Requirements at Rule 111-8-10-.06(4)(b)1., or 3.;

2. Have documented ART training for laboratory procedures; and

3. Training must include the performance of ART procedures at least 30 times under director and constant supervision.

(d) In addition to meeting all safety requirements at Rule 111-8-10-.08, an ART laboratory must also:

1. Be located in a secure place with access limited to authorized personnel;

2. Conduct laboratory activities under aseptic conditions; and

3. Use no radioisotopes in the laboratory where ART procedures are performed.

(e) In addition to meeting all quality assurance requirements at Rule 111-8-10-.09, an ART laboratory must also:

1. Verify that materials which come in contact with sperm, oocytes, and embryos have been tested and found to be non-toxic to the sperm, oocytes and embryos;

2. Ensure patient confidentiality throughout the testing phase; and

3. Require that an authorized person's request for testing must be written or electronic; and that an oral request must be followed within 24 hours by a written or electronic request.

(f) In addition to meeting all quality control requirements, as applicable, at Rule 111-8-10-.09, an ART laboratory must also:

1. Have documented criteria for assessment of oocyte morphology, maturity, fertilization, and embryo quality;

2. Document the insemination schedule relative to oocyte maturity;

3. Document volume, numbers, and quality of sperm used for insemination of each oocyte;

4. Document disposition of oocytes with an abnormal number of pronuclei; disposition of excess oocytes; and

5. Document critical time periods for various procedures.

(g) In addition to meeting specimen, reporting and records requirements at Rules 111-8-10-.11, .12, and .13, an ART laboratory must also:

1. Keep records for the pre- and post-washing and concentration for insemination, the outcome of insemination and culture, and quality of all embryos at transfer, and the identity of testing personnel;

2. Use a reliable tracking method for cryopreserved specimens;

3. Use permanent labeling of containers; and

4. Assure that records are indelible and legible, retained for two years on-site and for ten years beyond the date of final disposition or disposal of all specimens obtained during each patient's ART cycle.

(h) If the ART laboratory ceases operation, it must make provisions for records to be maintained for the required time frames.

O.C.G.A. § 31-22-1et seq.

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