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Title: Section 52-8.5 - Donor qualifications

Effective Date


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.


VOLUME A-1 (Title 10)