Title: Section 52-8.6 - Required laboratory tests
52-8.6 Required laboratory tests.
(a) For reproductive tissue banks located within New York State, all required clinical laboratory testing shall be performed by a laboratory operating under a permit issued by the department. For out-of-state reproductive tissue banks, all required clinical laboratory testing shall be performed by a laboratory which is approved by that state's regulating authority, the United State Health Care Financing Administration, or by the department. (b) The following laboratory tests shall be performed prior to donor acceptance and, except as specified in paragraph (g) of this section, initial collection of donor semen for clinical use:
(1) Blood shall be tested for:
(i) determination of ABO and Rh blood groups; and
(ii) antibodies to HIV-1, human immunodeficiency virus type 2 (HIV-2), human T-lymphotropic virus type I (HTLV-I), hepatitis B core antigen (HBc), and to hepatitis C virus (HCV), and for hepatitis B surface antigen (HBsAg) and syphilis.
(2) Semen or a urethral specimen shall be tested for infection with Neisseria gonorrhoeae,and urine or a urethral specimen shall be tested for infection with Chlamydia trachomatisusing a method that meets standards generally accepted by leading authorities in laboratory medicine.
(3) Semen shall be tested for sperm quality as measured against criteria set by the director in consultation with the medical director and medical advisory committee, including such parameters as ejaculate volume and sperm motility, concentration, morphology and cryosensitivity, including a post-thAw analysis. Sperm quality tests shall be repeated at a frequency determined by the director.
(c) All tests for infectious diseases shall be repeated at least every six months for as long as a donor is participating in the semen banking program, or whenever a donor reenters the program after an absence of longer than six months.
(d) Any semen stored from a donor testing repeatedly reactive for antibodies to HIV-1, HIV-2, HCV or HTLV-I, for syphilis infection or for HBsAg, shall be destroyed unless such semen is to be used for research studies authorized by section 4302 of the Public Health Law and approved by the appropriate institutional review board, in which case all semen samples from the donor shall be labeled, "For research use only," and immediately sequestered from other donor samples. Testing for antibody to hepatitis B core antigen (anti-HBc) shall be negative for donor acceptable. For semen donors testing positive for any indicator of HIV infection, the director shall advise the department and the attending physicians of all recipients who received semen that was collected any time after six months prior to the last negative test.
(e) Subsequent to testing as required in subdivision (b) of this section, all donated semen shall be frozen and quarantined for six months. After such time and prior to release of the semen for artificial insemination or assisted reproductive procedures, the donor shall be retested for HBsAg and antibodies to HIV-1, HIV-2, HCV and HBc. If the semen to be released originates from a directed donor, the recipient may be given the opportunity to waive the quarantine period in writing after being advised by the director, his/her designee, or the physician performing the insemination of the risks involved in doing so. In such cases, each of the tests required in paragraph (a)(1), (2) and (3) of this section, except tests for ABO and Rh blood groups, must have been performed after a date one month prior to the first donation and every three months thereafter, while the donor is engaged in donation.
(f) Semen shall not be made available for artificial insemination or assisted reproductive procedures if: (1) the donor's blood is repeatedly reactive in approved screening tests for HBsAg or antibodies to HIV-1, HTLV-I or HCV;
(2) the donor's blood is repeatedly reactive in approved screening tests for antibodies to HBc; (3) the donor's blood tests positively in approved tests for syphilis, unless a confirmatory test is negative; (4) the donor's semen or urethral specimen tests positive in approved tests for Neisseria gonorrhoeae; or (5) the donor's urine or urethral specimen reacts positively to approved tests for Chlamydia trachomatis. (g) A client-depositor who wishes to direct stored semen for use by a specific recipient, other than his current or active regular sexual partner, shall first be fully evaluated and tested in accordance with the requirements of sections 52-8.5, 52-8.6(b),(c),(d)and (f) of this Subpart. Tissue from such client-depositors shall not be released unless stored for at least six months prior to such testing. (h) Reproductive tissue donors who, based on their racial/ethnic background or family history, have been identified at increased risk of being carriers of Tay-Sachs disease, thalassemia, cystic fibrosis and/or sickle cell disease shall be tested for such carrier states. The reproductive tissue bank medical director, in consultation with the medical advisory committee, shall establish a policy specifying any other conditions that should be tested for, the testing to be performed on donors with particular racial/ethnic backgrounds and family histories, and the analytes to be tested for. (i) Testing requirements for oocyte donors shall be specified in a written policy approved by the reproductive tissue bank medical director in consultation with the medical advisory committee. At a minimum, donors shall, within one month of each donation, be tested and found negative for HBsAg, and for antibodies to HCV, HIV-1 and HIV-2. Oocytes and embryos stored from donors who test repeatedly reactive for antibodies to HIV-1, HIV-2, or HCV or for HBsAg, shall be destroyed, unless such tissue is to be used for research studies authorized by section 4302 of the Public Health Law and approved by the appropriate institutional review board, in which case all tissue samples from the donor shall be labeled, "For research use only," and immediately sequestered from the donor samples. For donors testing positive for any indicator of HIV infection, the director shall advise the department and the attending physicians of all recipients who received tissue that was collected at any time after six months prior to the last negative test. (j) Male and female contributors to donated embryos shall be tested as specified in section 52-8.6(i) of this Subpart prior to release of embryos for clinical use by others. (k) Results of all donor testing shall be made available, upon request, to the donors and to physicians using the donors' reproductive tissue in artificial insemination and assisted reproductive procedures. (l) Accurate, written donor profiles or other descriptions of pertinent donor characteristics shall be provided upon request to physicians ordering reproductive tissues.
VOLUME A-1 (Title 10)