R9-9A-201. General Administration Requirements for a Procurement Organization

A. A licensee of a procurement organization: 1. Is responsible for all issues of liability, ethical considerations, fiduciary issues, and compliance with applicable laws and regulations; 2. Shall comply with: 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 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. Shall adopt, maintain, and implement standard operating procedures, as applicable to the procurement organization. B. A licensee of a procurement organization shall ensure that standard operating procedures are established, documented, and implemented that cover: 1. The proper use and maintenance of donor consent forms, including that a donor consent form: a. Includes: i. The intended use of the non-transplant anatomical material, ii. How the non-transplant anatomical material may be used, iii. A statement that the non-transplant anatomical material will be treated with dignity at all times, and iv. A statement that the non-transplant anatomical material may require international export to an end-user; and b. Is maintained in the donor’s record and retained for at least 10 years beyond the date of final disposition; 2. An electronic identification system for donors, which is established and maintained for non-transplant anatomical donations and non-transplant anatomical material, that: a. Assigns a unique identification number to the donor and the associated non-transplant anatomical donation and non-transplant anatomical material, b. Tracks the complete history of all non-transplant anatomical material, and 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. The screening of end-users prior to release and transfer of non-transplant anatomical material that: a. Require a written request for non-transplant anatomical material, containing: i. The name and address of the educational or research establishment making the request; 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; iii. A description of the intended use; iv. The date and the approximate duration of use of the non-transplant anatomical material; 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; vi. An assurance that universal precautions will be used when handling the non-transplant anatomical material; vii. The proposed final disposition of the non-transplant anatomical material; viii. An outline of proposed descriptive materials to be disseminated in connection with the use of the non-transplant anatomical material; and ix. Other supporting documentation that is relevant to the request; and b. Include the criteria for approving requested non- transplant anatomical material for use, including: i. The standards for acceptability of the educator or researcher for the use of non-transplant anatomical material; ii. The appropriateness of the intended use; iii. The types of venues in which the non-transplant anatomical material may be used; 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 v. The suitability of the proposed descriptive materials; 4. The process for requesting and criteria for approving the exceptional release of non-transplant anatomical material; 5. The labeling of non-transplant anatomical donations and non-transplant anatomical material with: a. The unique identification number specified in subsection (B)(2)(a), b. That the non-transplant anatomical donation or non- transplant anatomical material is not for transplant or clinical use, c. Any condition or limitation regarding the use of the non-transplant anatomical donation or non-transplant anatomical material, d. That universal precautions must be used in handling the non-transplant anatomical donation or non-transplant anatomical material, e. A disclosure of any disease state in the non-transplant anatomical donation or non-transplant anatomical material, and f. The name and contact information for the procurement organization; 6. The packaging and transport of non-transplant anatomical donations and non-transplant anatomical material to: a. Preserve the quality of the non-transplant anatomical donation or non-transplant anatomical material, b. Prevent potential cross-contamination between non- transplant anatomical donations or non-transplant anatomical material, and c. Protect the health and safety of personnel members and the public; 7. The distribution of non-transplant anatomical donations and non-transplant anatomical material, including methods for: a. Ensuring the quality and suitability of non-transplant anatomical donations and non-transplant anatomical material; b. Handling non-transplant anatomical donations and non-transplant anatomical material that do not meet quality control standards; 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; d. Handling an end-user request that does not meet the criteria in subsection (B)(3)(b); e. The release of: i. Non-transplant anatomical donations to use, and ii. Non-transplant anatomical material to an end- user or other person to which non-transplant anatomical material may be transferred; and f. The exceptional release of the non-transplant anatomical material; and 8. The final disposition of non-transplant anatomical donations or non-transplant anatomical material, consistent with requirements in: 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; 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 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. C. A licensee of a procurement organization shall ensure that copies of standard operating procedures are: 1. Maintained at the procurement organization, and 2. Available for review by the Department within two hours of the Department’s request.