Title: Section 52-2.9 - Required records

Effective Date

11/01/2000

52-2.9 Required records.

(a) Complete and accurate records of tissue and nontransplant anatomic parts released shall be kept by the tissue banks or nontransplant anatomic banks distributing the tissue. Such records shall be open to inspection by the department. For all donated tissue and nontransplant anatomic parts, 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 bank to any person or entity, except upon the written consent of the donor or the person authorized by law to make the donation, or 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 tissue bank to any person or entity, except upon the written consent of the recipient, or except to authorized employees of the department, or as permitted by law.

(b) Complete and accurate records of tissue and nontransplant anatomic parts released for transplantation, transfer, artificial insemination, implantation, research and education shall be kept by the tissue transplantation facility or insemination/implantation site. Such records shall be open to inspection by the department and shall be kept for at least seven (7) years after transplantation or six (6) months after the expiration date of the tissue, whichever is longer. In cases of reproductive tissue transfer/artificial insemination/implantation, records shall be kept for at least seven (7) years after the release of tissue not resulting in live births and twenty-five (25) years for tissue resulting in live births. Nontransplant anatomic banks shall retain records for five (5) years after release of nontransplant anatomic parts for research or education purposes. 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 tissue transplantation facility or insemination/implantation site to any person or entity, except upon the written consent of the recipient, or except to authorized employees of the department, or as permitted by law.

(c) The following donation records shall be kept by each comprehensive tissue procurement service:

(1) donor's full name, address at time of donation, identification code, date of birth or age, and date and time of death, if a cadaveric donor;

(2) documentation of evaluations of physical condition, if a cadaveric donor;

(3) pertinent donor medical history, including, but not limited to, autopsy reports, donation questionnaires and other donor solicitation materials;

(4) documentation of donor informed consent or consent of the person authorized by law to consent to the donation, if applicable, including such person's address, unless this record is retained by a limited tissue procurement service;

(5) date and time of collection, and description and quantity of tissue retrieved;

(6) any reported changes in donor health status, if applicable;

(7) outcome of transplantation, transfer, artificial insemination and implantation procedures, if known, and any reports from facilities using the tissue, which would affect the donor's acceptability;

(8) records specified in the Subpart specific to each category of tissue; and

(9) documentation of staff training, certification and continuing education.

(d) The following records shall be kept by each limited tissue procurement service:

(1) a record of each referral to a comprehensive tissue procurement service, including the donor's name or other identification, the date and time of referral, the name of the person making the referral, the name of the comprehensive tissue procurement service, and whether the records specified in paragraphs (2) and (3) of this subdivision have been transferred to the comprehensive tissue procurement service;

(2) medical and social history information obtained from the donor, donor's family, and other individuals, including the names of the persons obtaining and giving the information, unless this record is transferred to a comprehensive tissue procurement service; and

(3) documentation of donor informed consent or consent of the person authorized by law to consent to the donation, if applicable, including such person's address, unless the record is transferred to a comprehensive tissue procurement service.

(e) The following records shall be kept by each tissue processing facility:

(1) an acquisition log or other similar record indicating:

(i) donor's identification code and/or unique tissue product number;

(ii) name and address of the tissue bank from which the tissue was acquired;

(iii) date of receipt of the tissue; and

(iv) tissue location in the storage chamber;

(2) description of tissue received for processing;

(3) methods used for acquisition, processing, distribution and storage of the tissue;
(4) air quality measurements for critical and controlled work areas, if applicable;
(5) disposition of the tissue, including, but not limited to, distribution records, destruction logs, and autoclaving or incineration records; (6) results of all laboratory tests performed on donors and donated tissue, including documentation of review of test results prior to release of the tissue;

(7) documentation of labeling and packaging inspection prior to tissue transport to a tissue transplantation facility or release for transplantation, transfer, artificial insemination or implantation;

(8) records specified in the Subpart specific to each category of tissue; and

(9) documentation of staff training, certification and continuing education.

(f) The following records shall be kept by each tissue storage facility:

(1) an acquisition log or other similar record indicating:

(i) donor's identification code and/or unique tissue product number;

(ii) date of receipt of tissue;

(iii) name and address of tissue bank providing the tissue; and

(iv) location of the tissue in the storage chamber; and

(2) a record of the disposition of the tissue, including, but not limited to, distribution records, destruction logs, and autoclave or incineration records.

(g) The following records shall be kept by each tissue transplantation facility or insemination/implantation site:

(1) the name of the tissue bank providing the tissue, and unique tissue product number;

(2) a description of the tissue;

(3) results of any laboratory tests performed;

(4) a log of the disposition of the tissue, including, but not limited to, name or identification code of recipient, tissue product return records, destruction logs and autoclaving or incineration records;

(5) condition of the tissue upon receipt, including any loss noted of liquid nitrogen, dry ice, or other coolant;

(6) date of transplant, transfer, artificial insemination or implantation;

(7) quantity of tissue used;

(8) outcome of the tranplantation, artificial insemination, transfer or implantation procedure, including, but not limited to, any adverse outcome or infectious disease in the recipient, which shall be reported to the tissue bank from which the tissue was obtained; and

(9) record specified in the Subpart specific to each category of tissue.

(h) Records shall be kept in insemination/implantation sites as specified in Subpart 52-8.

(i) Nontransplant anatomic banks which solicit, retrieve, release or store nontransplant anatomic parts shall keep the following information: (1) if known, donor's full name, address at the time of donation, identification code, date of birth or age, and date and time of death if a cadaveric donor; (2) documentation of donor informed consent or consent of the person authorized by law to consent to the donation, if applicable, including such person's address; (3) records of distribution of all nontransplant anatomic parts; (4) if applicable, name and address of the nontransplant anatomic bank from which the nontransplant anatomic part was acquired; (5) if applicable, date of receipt of the nontransplant anatomic part from the nontransplant anatomic bank; (6) location of nontransplant parts in storage, including documentation tracing nontransplant anatomic parts to specific donors; and (7) if known, disposition of the nontransplant anatomic parts once their use in education or research is ended, including the names of the funeral directors, cemeteries or crematories involved in disposition.

Volume

VOLUME A-1 (Title 10)

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