1. A. A licensee of a procurement organization:

   1. 1. Is responsible for all issues of liability, ethical considerations, fiduciary issues, and compliance with applicable laws and regulations;

   2. 2. Shall comply with:

      1. a. A.R.S. § 36-325 and, as applicable, A.A.C. R9-19-303 or A.A.C. R9-19-304 related to death certificate registration; and
      2. b. A.R.S. § 36-326, A.A.C. R9-19-301, A.A.C. R9-19-308, and, if applicable, A.A.C. R9-19-311 related to the movement of non-transplant anatomical donations and non-transplant anatomical material; and
   3. 3. Shall adopt, maintain, and implement standard operating procedures, as applicable to the procurement organization.

2. B. A licensee of a procurement organization shall ensure that standard operating procedures are established, documented, and implemented that cover:

   1. 1. The proper use and maintenance of donor consent forms, including that a donor consent form:

      1. a. Includes:

         1. i. The intended use of the non-transplant anatomical material,
         2. ii. How the non-transplant anatomical material may be used,
         3. iii. A statement that the non-transplant anatomical material will be treated with dignity at all times, and
         4. iv. A statement that the non-transplant anatomical material may require international export to an end-user; and
      2. b. Is maintained in the donor’s record and retained for at least 10 years beyond the date of final disposition;

   2. 2. An electronic identification system for donors, which is established and maintained for non-transplant anatomical donations and non-transplant anatomical material, that:

      1. a. Assigns a unique identification number to the donor and the associated non-transplant anatomical donation and non-transplant anatomical material,
      2. b. Tracks the complete history of all non-transplant anatomical material, and
      3. c. Records the date and staff member involved in each significant step of the operation from the time of acquisition of the non-transplant anatomical donation through final disposition;

   3. 3. The screening of end-users prior to release and transfer of non-transplant anatomical material that:

      1. a. Require a written request for non-transplant anatomical material, containing:

         1. i. The name and address of the educational or research establishment making the request;
         2. ii. The name, title, and contact information of the individual at the educational or research establishment who will be accepting responsibility for the receipt, use, and disposition of the non-transplant anatomical material;
         3. iii. A description of the intended use;
         4. iv. The date and the approximate duration of use of the non-transplant anatomical material;
         5. v. A description of the venue in which the non-transplant anatomical material will be used and the environmental and security measures of the venue to ensure the safe and ethical utilization of the non-transplant anatomical material;
         6. vi. An assurance that universal precautions will be used when handling the non-transplant anatomical material;
         7. vii. The proposed final disposition of the non-transplant anatomical material;
         8. viii. An outline of proposed descriptive materials to be disseminated in connection with the use of the non-transplant anatomical material; and
         9. ix. Other supporting documentation that is relevant to the request; and

      2. b. Include the criteria for approving requested non-transplant anatomical material for use, including:

         1. i. The standards for acceptability of the educator or researcher for the use of non-transplant anatomical material;
         2. ii. The appropriateness of the intended use;
         3. iii. The types of venues in which the non-transplant anatomical material may be used;
         4. iv. What final disposition of the non-transplant anatomical material may be proposed, unless the non-transplant anatomical material is returned to the procurement organization; and
         5. v. The suitability of the proposed descriptive materials;
   4. 4. The process for requesting and criteria for approving the exceptional release of non-transplant anatomical material;

   5. 5. The labeling of non-transplant anatomical donations and non-transplant anatomical material with:

      1. a. The unique identification number specified in subsection (B)(2)(a),
      2. b. That the non-transplant anatomical donation or non-transplant anatomical material is not for transplant or clinical use,
      3. c. Any condition or limitation regarding the use of the non-transplant anatomical donation or non-transplant anatomical material,
      4. d. That universal precautions must be used in handling the non-transplant anatomical donation or non-transplant anatomical material,
      5. e. A disclosure of any disease state in the non-transplant anatomical donation or non-transplant anatomical material, and
      6. f. The name and contact information for the procurement organization;

   6. 6. The packaging and transport of non-transplant anatomical donations and non-transplant anatomical material to:

      1. a. Preserve the quality of the non-transplant anatomical donation or non-transplant anatomical material,
      2. b. Prevent potential cross-contamination between non-transplant anatomical donations or non-transplant anatomical material, and
      3. c. Protect the health and safety of personnel members and the public;

   7. 7. The distribution of non-transplant anatomical donations and non-transplant anatomical material, including methods for:

      1. a. Ensuring the quality and suitability of non-transplant anatomical donations and non-transplant anatomical material;
      2. b. Handling non-transplant anatomical donations and non-transplant anatomical material that do not meet quality control standards;
      3. c. Ensuring the eligibility of an end-user or other person to which non-transplant anatomical donations and non-transplant anatomical material may be transferred;
      4. d. Handling an end-user request that does not meet the criteria in subsection (B)(3)(b);

      5. e. The release of:

         1. i. Non-transplant anatomical donations to use, and
         2. ii. Non-transplant anatomical material to an end-user or other person to which non-transplant anatomical material may be transferred; and
      6. f. The exceptional release of the non-transplant anatomical material; and

   8. 8. The final disposition of non-transplant anatomical donations or non-transplant anatomical material, consistent with requirements in:

      1. a. A.R.S. Title 32, Chapter 12; A.R.S. Title 36, Chapter 7; and Subchapter B, related to funeral arrangements, cremation, or other final dispositions;
      2. b. A.R.S. Title 36, Chapter 3, and 9 A.A.C. 19, related to the movement of non-transplant anatomical donations or non-transplant anatomical material and reporting of the final disposition; and
      3. c. A.R.S. Title 36, Chapter 6, Articles 1, 2, and 4, related to non-transplant anatomical donations or non-transplant anatomical material infected with an agent causing a communicable disease.

3. C. A licensee of a procurement organization shall ensure that copies of standard operating procedures are:

   1. 1. Maintained at the procurement organization, and
   2. 2. Available for review by the Department within two hours of the Department’s request.

Historical Note

R9-9A-201 made under Subchapter A, Article 2, by final expedited rulemaking at 30 A.A.R. 3657 (November 29, 2024), with an immediate effective date of November 5, 2024 (Supp. 24-4).