Ariz. Admin. Code § 9-9A-201

Current through Register Vol. 30, No. 50, December 13, 2024

Section 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.

Ariz. Admin. Code § R9-9A-201

New Section made by final expedited rulemaking at 30 A.A.R. 3658, effective 11/5/2024.