Title: Section 52-8.9 - Required records

Effective Date

11/01/2000

52-8.8 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 semin 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/implementation 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 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.

Volume

VOLUME A-1 (Title 10)

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