SubPart 52-8 - Reproductive Tissue Banks

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-8.1 - Definitions

52-8.1 Definitions. As used in this Part:

(a) Anonymous donormeans a donor whose identity is unknown to the recipient.

(b) Artificial inseminationmeans the placement of semen within the body of a recipient.

(c) Assisted reproductive proceduremeans a medical procedure intended to result in conception, including, but not limited to,
in vitrofertilization (including intracytoplasmic sperm injection), embryo transfer and gamete intrafallopian transfer.

(d) Client-depositormeans an individual who deposits reproductive tissue prior to intended or potential use in artificial insemination or assisted reproductive procedures performed on his regular sexual partner, or a woman who deposits reproductive tissue for processing into embryos and subsequent implantation into the same woman.

(e) Directed donormeans a donor who is known to the recipient and who directs his or her reproductive tissue for use by a particular recipient. This includes a man providing semen to a surrogate, but who is not the regular sexual partner of the recipient.

(f) Donormeans a person who provides reproductive tissue for use in artificial insemination or assisted reproductive procedures performed on recipients other than that person or that person's regular sexual partner, and includes directed donors.

(g) Reproductive tissue bankmeans a facility which acquires, processes, stores, distributes and/or releases reproductive tissue to an insemination/implantation site for use in artificial insemination or assisted reproductive procedures. Reproductive tissue banks include, but are not limited to semen banks, oocyte donation programs and embryo banks.

(h) Insemination/implantation sitemeans a location at which artificial insemination or assisted reproductive procedures are performed, using reproductive tissue from anonymous donors, directed donors and/or client-depositors. Licensed insemination/implantation sites may undertake, without additional licensure, semen processing, limited to washing, concentrating and storing of semen from patients of physicians associated with the licensed insemination/implantation sites or the patients' regular sexual partners, as well as limited semen storage (less than six months' duration).

(i) Recipientmeans a woman who receives reproductive tissue from a donor or client-depositor.

(j) Semen processing facilitymeans a tissue processing facility that processes semen for use by other licensed reproductive tissue banks and insemination/implantation sites.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-8.2 - Licensure

52-8.2 Licensure. Reproductive tissue banks, insemination/implantation sites and semen processing facilities shall not operate unless licensed as tissue banks pursuant to Subpart 52-2 of this Part.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-8.3 - Administrative responsibility

52-8.3 Administrative responsibility.

The reproductive tissue bank director shall assume overall responsibility for operation of the reproductive tissue bank. The reproductive tissue bank director shall meet the requirements of section 52-2.5(a)(2) of this Part. The training and/or experience requirements specified in section 52-2.5 of this Part shall be in the field of reproductive endocrinology, andrology, human fertility or a closely related field. The reproductive tissue bank director shall develop and implement policies and procedures consistent with this Subpart for the operation of the bank. If the reproductive tissue bank director is not a physician, a medical director who meets the requirements of section 52-2.5(a)(3) of this Part shall be retained. Except for insemination/implantation sites, reproductive tissue banks shall have a medical advisory committee, composed of at least five members with experience and expertise in the fields of human fertility, infectious disease, clinical pathology or related fields, who shall be responsible for monitoring the medical efficacy of the reproductive tissue bank and reviewing operating policies and procedures. If the bank acquires reproductive tissue from donors, a qualified microbiologist, clinical pathologist or infectious disease specialist, and a geneticist shall serve either as members of or consultants to the committee.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-8.4 - Direction and medical direction

52-8.4 Direction and medical direction.

(a) Medical direction of a reproductive tissue bank shall be provided by the medical director in consultation with the medical advisory committee, if applicable.

(b) Except for insemination/implantation sites, the reproductive tissue bank director, in consultation with the medical director, if not the same person, and the medical advisory committee shall monitor the efficacy of the reproductive tissue banking program and shall, as a minimum, develop:

(1) medical criteria for donor participation;

(2) quality standards for sperm, oocytes, embryos and other reproductive tissue, as applicable; and

(3) guidelines for determining a maximum number of offspring per donor to minimize the probability of consanguinity.

(c) The reproductive tissue bank director shall be responsible for selection of donors who meet the medical criteria and the technical/scientific operation of the reproductive tissue bank, and shall make available to the physician performing each artificial insemination or assisted reproductive procedure the donor's medical history and other pertinent nonidentifying characteristics of the donor, so that recipient counseling may be provided.

(d) Artificial insemination and all assisted reproductive procedures shall be ordered only by a licensed physician, physician's assistant or nurse practitioner. Artificial insemination procedures shall be performed only by:

(1) a licensed physician;

(2) a licensed physician's assistant; (3) a licensed nurse practitioner; or
(4) a licensed registered nurse who has been trained in the technical aspects of artificial insemination by a licensed physician, licensed physician's assistant or licensed nurse practitioner employed by the insemination/implantation site, and is supervised by such a physician, physician's assistant or nurse practitioner.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-8.5 - Donor qualifications

52-8.5 Donor qualifications.

(a) The reproductive tissue bank shall initially screen and periodically assess donors for conditions that may adversely affect the quality of reproductive tissue or impair the recipient's and/or the offspring's health. Reproductive tissue donor screening shall, except as provided in Section 52-8.6(g), be performed prior to the initial collection of reproductive tissue for clinical use, and shall include a physical examination, as well as an examination for indications of sexually transmissible diseases.

(b) A complete medical history, both individual and family, including first-degree and second-degree relatives, shall be obtained from each reproductive tissue donor prior to any collection of tissue for clinical use, and shall include, but not be limited to, incidence of the following:

(1) major malformations of complex cause that result in serious functional or cosmetic defects, including, but not limited to spina bifida or heart malformations;

(2) major genetic disorders, including:

(i) autosomal dominant or X-linked disorders for which age of onset extends beyond the age of the donor;

(ii) autosomal dominant disorders with reduced penetrance; and (iii) autosomal recessive disorders;

(3) for semen donors, systemic disease which may affect the decision to use the semen;

(4) for semen donors, infectious skin disease that may create a risk of contamination of the semen;

(5) history of sexually transmissible disease, including herpes simplex virus type 2;

(6) more than one sexual partner within the last six months;

(7) previous exclusion from blood donation for reasons of infectious disease;

(8) receipt of a blood transfusion within the past year;

(9) for semen donors, known episodes of trichomoniasis in a sexual partner;

(10) history of an occupation with increased risk of radiation or chemical exposure, or known such exposure;

(11) known history of alcohol abuse;

(12) history of behavior or factors which place the donor at increased risk for human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, as determined by the United States Public Health Service (USPHS);

(13) all conditions listed in section 52-3.4(a) of this Part; and

(14) other conditions as determined by the reproductive tissue bank director, medical director and medical advisory committee.

(c) Except for those factors currently identified by the USPHS as posing an increased risk for HIV infection, the factors in subdivision (b) above need not necessarily exclude a donor, but the reproductive tissue bank medical director or the attending physician shall counsel the recipient about potential associated risks if such a donor's reproductive tissue is accepted. Persons with an HIV risk factor identified by the USPHS shall not be accepted as anonymous donors.

(d) Recipients' physicians shall be notified if a semen donor's age at the time of donation is older than 44 years. Recipients' physicians shall be notified if an oocyte donor's age at the time of donation is older than 34 years.

(e) Potential anonymous donors with a history of behavior or factors which place them at increased risk for HIV infection or other infectious diseases, pursuant to section 52-3.4(a)(8) of this Part, shall be excluded.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

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 acceptance. 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.

 

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-8.7 - Collection, storage and disposition of reproductive tissue

52-8.7 Collection, storage and disposition of reproductive tissue.

(a) Semen collection containers shall be clean and non-toxic to sperm.

(b) Each semen collection container shall be labeled legibly prior to collection with the donor's or client-depositor's name or identification code, unless another system is used to ensure absolute identification, and shall also be labeled at the time of collection with the date and time of collection.

(c) Semen storage containers and support vehicles shall be labeled so as to maintain identification throughout all phases of processing, storage and distribution, in a manner not subject to deterioration at low temperatures. Such containers and/or vehicles shall be labeled with the reproductive tissue bank identification and semen specimen collection date, donor's identification code or, in the case of a client-depositor, his name and semen specimen collection date. Semen shall be frozen with a suitable cryopreservative and stored continuously until placed in either a freezer section reserved for semen, equipped with a thermometer, or a liquid nitrogen storage tank. The thermometer shall be calibrated at least annually against a National Institute of Standards and Technology (NIST)-certified thermometer, or a thermometer that has been tested against, and found to be in agreement with, an NIST-certified thermometer. Thermometers shall be either visually monitored daily or continuously monitored mechanically, and, if applicable, liquid nitrogen levels shall be checked at least twice a week for fluctuations in temperature potentially affecting the quality of the semen. Storage shall be at a temperature of minus 130 degrees Celsius or lower. Semen from client-depositor shall be stored in freezer section or tank separate from that for donor semen, and shall not be exposed to ambient air unless absolutely necessary. Temperature records or liquid nitrogen level records shall be available for inspection by the department for the entire period of storage and for one year afterward.

(d) Frozen semen in transit from a reproductive tissue bank to an insemination/implantation site shall be maintained in liquid nitrogen or vapor until immediately prior to the artificial insemination or assisted reproductive procedure. Frozen semen shall be transported by the bank or its agents, the staff of the insemination/implantation site, or the recipient with the written authorization of her physician.
(e) The insemination/implantation site shall inspect semen samples for proper labeling and appearance immediately after thawing. If the physical appearance is abnormal or there is indication or suspicion of overt microbial contamination, the semen shall not be utilized for artificial insemination or other assisted reproductive procedures.

(f) Reproductive tissue stored for a client-depositor shall not be destroyed or released for other purposes as a result of nonpayment of storage fees or for any other reasons, without documentation that the client-depositor was given at least 30 days' written notice by certified mail, return receipt requested.

(g) Oocytes shall be collected, processed and stored as oocytes or embryos according to written procedures approved by the reproductive tissue bank director in consultation with the medical director and the medical advisory committee. Storage containers and support vehicles shall be labeled or segregated so as to maintain tissue identification throughout all phases of processing, storage and distribution, in a manner not subject to deterioration at low temperatures. Final embryo containers shall be labeled with the identification code or name of the source of both the component oocyte and spermatozoan. (h) Embryos shall not be created for donation by fertilizing donor oocytes with donor semen, except at the request of a specific patient who intends to use such embryos for her own treatment. (i) Embryos shall not be created using semen or oocytes of client-depositors or directed donors who are blood relatives of the other gamete provider to a degree that their sexual contact would constitute incest under New York State law.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-8.8 - Informed consent

52-8.8 Informed consent.

(a) Reproductive tissue banks shall obtain written informed consent from the donor for participation in the donation program, after the director or a designee has provided information to the donor on the procedures for collection, storage and use of semen, oocytes or embryos, and the risks of any drugs, surgical procedures and/or anesthesia administered. The informed consent shall include:

(1) a statement that the donor has been informed that his or her name and address will be kept on file by the reproductive tissue bank, and advised of the restrictions on release of donor-identifying information specified in section 52-8.9 of this Subpart;

(2) authorization for performance of genetic and infectious disease marker testing, consistent with statutory requirements for genetic testing;

(3) notification of all currently known ways in which the donor's reproductive tissue and resulting embryos may be used. If the reproductive tissue bank accepts reproductive tissue with restrictions on the manner in which embryos created may be used, the consent also shall include a statement that the reproductive tissue bank has informed the donor that it will make a good faith effort to ensure that the donor's restrictions are respected, but that it cannot guarantee that the recipients of the reproductive tissue will abide by the donor's restrictions;

(4) authorization for disclosure of the donor's medical history information to potential recipients and their physicians, consistent with statutory requirements for the disclosure of genetic and other medical information;

(5) an explanation of the oocyte donor's extent of responsibility for any costs of any medical complications associated with oocyte donation; and

(6) a statement that the reproductive tissue donor has the right to withdraw his/her consent to donation up until such time that a specific recipient has begun an assisted reproduction cycle in reliance on the availability of tissue from that donor.

(b) Reproductive tissue banks shall obtain written informed consent from the client-depositor for participation in the semen, oocyte or embryo storage program, after the director or a designee has provided information to the client-depositor on the procedures for collection/storage and retrieval of semen, oocytes or embryos, and the risks of any drugs, surgical procedures and/or anesthesia administered, as well as procedures for payment for semen, oocyte or embryo storage. The informed consent shall include the male client-depositor's specific instructions for disposition of frozen semen upon his death. The reproductive tissue bank shall maintain and adhere to written procedures for ensuring that the client-depositor's instructions are followed.

(c) The insemination/implantation site shall obtain written informed consent from the recipient for receipt of donated reproductive tissue, after a physician has explained the risks and benefits of the procedure, made available details of the medical history of the donor or donors, and, if applicable, notified the recipient that reproductive tissue bank records are required to be kept for the periods of time specified in section 52-8.9(a) of this Subpart and that the outcome of the procedure is required to be reported to the reproductive tissue bank.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-8.9 - Required records

52-8.9 Required records.

(a) Reproductive tissue bank records shall be open to inspection by the department and shall be kept for at least seven years after release of reproductive tissue for artificial inseminations or assisted reproductive procedures not resulting in a live birth, and 25 years for inseminations or assisted reproductive procedures known to have resulted in a live birth. For all donated reproductive tissue, the donor's name, address and any other information which would directly or indirectly identify the donor shall not be disclosed or released by the reproductive tissue bank to any person or entity, except upon written informed consent of the donor, or except to authorized employees of the department or as permitted by law. The recipient's name, address and any other information which would directly or indirectly identify the recipient shall not be disclosed or released by the insemination/implantation site to any person or entity, except upon written informed consent of the recipient, or except to authorized employees of the department or as permitted by law.

(b) In addition to the recordkeeping requirements of section 52-2.9(c) of this Part, each reproductive tissue bank shall maintain applicable donor/client depositor records which include:

(1) for donors, pertinent family history of any genetic disorders;

(2) documentation of donor and client-depositor written informed consent;

(3) for semen donors, outcome of any prior insemination or other assisted reproductive procedures, if known, including number of successful pregnancies, if any, and any reports from insemination/implantation sites which would affect the donor's acceptability; and (4) documented approval of the reproductive tissue bank director, or his/her designee, of the acceptability of the donor.

(c) In addition to the recordkeeping requirements of section 52-2.9(e) and (f) of this Part, each reproductive tissue bank shall maintain applicable records which include:

(1) donor's identification code or client-depositor's name;

(2) for semen donations, documentation of laboratory cryosensitivity testing, and, if performed, results of viability checks after thawing and during storage, if any;

(3) the name of the insemination/implantation site, the physician or other person authorized by law to perform artificial insemination or assisted reproductive procedures, and/or receive reproductive tissue, and the name of the person communicating the order for distribution of the tissue;

(4) the recipient's name, if the name has been provided to the reproductive tissue bank with her informed consent, or the recipient's identification code, if used;

(5) documentation of training, certification, licensure, if required by law, and continuing education for each staff member; and

(6) any adverse outcomes, including infectious diseases in recipients or their offspring and genetic defects in offspring, which shall be reported to the donors if there is any possibility that the donor's reproductive tissue contributed to the adverse outcome.

(d) The following records shall be kept, separate from the recipient's records, by an insemination/implantation site for each insemination or assisted reproductive procedure performed:

(1) donor's identification code or name, if the reproductive tissue originates from a client-depositor;

(2) evidence that reproductive tissue from donors and/or client-depositors has been obtained from a reproductive tissue bank licensed pursuant to Subpart 52-2 of this Part;

(3) disposition of the reproductive tissue, including, but not limited to, the name or identification code of the recipient, destruction logs, and autoclaving or incineration records;

(4) the name and signature of the ordering physician or other person authorized by law to order issuance of the reproductive tissue;

(5) results of sperm viability checks, if performed; and

(6) signature of the person receiving the sample and conditions of the sample upon receipt.

(e) The insemination/implantation site shall document the outcome of the artificial insemination or assisted reproductive procedure, including, but not limited to, any known adverse outcome in the infant or infectious disease in the recipient, as well as any known successful pregnancies. This information shall also be reported to the reproductive tissue bank releasing the tissue, even if the reproductive tissue bank is the same entity as the insemination/implantation site.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-8.10 - Quality assurance and safety

52-8.10 Quality assurance and safety.

The requirements of section 52-3.5 of this Part shall be met.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete

Section 52-8.11 - Compliance with standards

52-8.10 Compliance with standards.

A reproductive tissue bank, shall allow admission to representatives of the department for the purpose of inspecting the premises and evaluating operating procedures, equipment, and records, including lists of physicians or facilities to whom or to which reproductive tissue has been released, to determine compliance with the standards in this Part. If the Commissioner determines that a significant likelihood exists that adequate safeguards are not implemented at a reproductive tissue bank, the department may require that reproductive tissue not be released pending a hearing. Such hearing shall commence within 15 days of any suspension pursuant to this section.

Effective Date: 
Wednesday, November 1, 2000
Doc Status: 
Complete