Title: 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.