Ariz. Admin. Code § 9-9-205

Current through Register Vol. 30, No. 45, November 8, 2024

Section R9-9-205 - Donor Records

A. A non-accredited procurement organization shall maintain a legible, reproducible record for each donor from whom it obtains NAM for at least 10 years beyond the date of final disposition according to A.R.S. § 36-851.03(A)(7).

B. To ensure traceability of NTAD and NAM, a non-accredited procurement organization shall:

1. Document each procedure performed on a NTAD and NAM related to processing and storing NAM;

2. For each document created in subsection (1), include:

a. The date and time for each procedure completed; and

b. The name of the technician who performed the procedure; and

3. Submit information required to register the death of a NTAD within seven calendar days after receiving the NTAD according to A.R.S. § 36-325.

C. A non-accredited procurement organization shall ensure a donor record is:

1. Confidential and kept in a location with controlled access,

2. Stored in a manner to prevent unauthorized access, and

3. Maintained in a manner to preserve the donor record's completeness and accuracy.

D. A non-accredited procurement organization shall ensure a donor record shall include the following donor information:

1. The donor's name;

2. The donor's unique identifying number specified in A.R.S. § 36-851.03(A)(6);

3. The donor's date of birth and date of death; and

4. The name and contact information of the person responsible for a donor's anatomical gift; if applicable.

E. A non-accredited procurement organization shall include the following donor records, as applicable:

1. Donor consent form or documentation of authorization for an anatomical gift includes:

a. The intended use of the NAM;

b. How the NAM may be used;

c. A statement that the NAM will be treated with dignity at all times; and

d. A statement that the NAM may require international export to an end-user;

2. Document of authorization "" a legal record of the gift, to take place postmortem, permitting and defining the scope of the postmortem acquisition and use of NAM for education and research, signed or otherwise recorded by the authorizing person, pursuant to law;

3. Documentation of gift "" the donor's legal record of the gift of NAM permitting and defining the scope of the postmortem acquisition and use of NAM for education and research. It must be signed or otherwise recorded by the donor or individual authorized under law to make a gift during the donor's lifetime;

4. Donor's death record specified in A.A.C. R9-19-303;

5. Human remains release form specified in A.A.C. R9-19-301;

6. Information for a death record specified in A.A.C. R9-19-302 for transporting human remains into the state;

7. Disposition-transit permit specified in A.A.C. R9-19-308;

8. Medical examiner's release of information specified in A.R.S. § 36-861;

9. All documents and permits that establish the chain of custody and identifies the individuals and organizations that had physical custody of the NAM;

10. Medical records, including:

a. Donor's physical assessment;

b. Risk assessment questionnaire;

c. Pathology and laboratory testing and reports;

d. Physician summaries;

e. Transfusion or infusion information; and

f. Plasma dilution calculations;

11. Information from the donor referral source;

12. Donor eligibility;

13. Donor acceptability assessment;

14. Physical assessment questionnaire;

15. Documentation related to distribution;

16. Serological results, when applicable;

17. Cremation authorization document;

18. Documentation related to NAM recovery, storage, and distribution activities;

19. Final disposition documentation, including all records demonstrating chain of custody; and

20. Documentation of the report in R9-9-201(F) and (G).

F. A donor's consent form shall be accessible to the donor's known consenter.

G. Upon demonstration of a legal right to acquire a donor's record, a non-accredited procurement organization shall provide access to:

1. An agent legally authorized or other individual designated at the time a donor gives consent;

2. An individual appointed by a court or authorized by state laws;

3. An individual of a procurement organization as identified by SOPs;

4. An individual from an approving accrediting body, if applicable; and

5. An individual from the Department or other regulatory agency authorized by state and federal laws or regulations.

H. Except for a donor record specified in subsection (A), a non-accredited procurement organization shall maintain documentation required by this Chapter for at least three years after the date of the documentation and provide copies of the documentation to the Department for review upon request.

Ariz. Admin. Code § R9-9-205

Reserved Section expired on June 30, 1999 under A.R.S. § 41-1056(E) upon receipt of notice from the Governor's Regulatory Review Council (Supp. 99-3). New Section made by final rulemaking at 28 A.A.R. 1517, effective 6/8/2022.