1. 1. “Acceptability assessment” means the evaluation by a procurement organization of available medical and social information about a donor to determine whether the donor meets criteria for making a non-transplant anatomical donation.
2. 2. “Accredited” means having a current and valid certificate of accreditation as a procurement organization from a nationally recognized agency that is approved by the Department.
3. 3. “Acquisition” means activities required to obtain a non-transplant anatomical donation.
4. 4. “Administrator” means the individual responsible for the provision by a procurement organization of services and related activities.
5. 5. “Applicant” means an individual or business organization requesting approval to operate a procurement organization.
6. 6. “Application” means the information, documents, and fees required by the Department for licensure of a procurement organization.
7. 7. “Business organization” means the same as “entity” in A.R.S. § 10-140.
8. 8. “Calendar day” means each day, not including the day of the act, event, or default from which a designated period of time begins to run, but including the last day of the period unless it is a Saturday, Sunday, statewide furlough day, or legal holiday, in which case the period runs until the end of the next day that is not a Saturday, Sunday, statewide furlough day, or legal holiday.
9. 9. “Department” means the Arizona Department of Health Services.
10. 10. “Distribution” means the process for release and transfer of non-transplant anatomical material to another procurement organization, an education facility, or a research facility, including the selection and evaluation of non-transplant anatomical material for the intended use.
11. 11. “Donor consent form” means the same as “document of gift” as defined in A.R.S. § 36-841.

12. 12. “Exceptional release” means the distribution of non-transplant anatomical material that:

    1. a. Has been approved for usage before a donor acceptability assessment has been completed; or
    2. b. Would not normally meet the established acceptability criteria, at the request of a researcher.
13. 13. “Final disposition” means the same as in A.R.S. § 36-301.
14. 14. “Licensee” means a person to whom the Department has issued a license to operate a procurement organization.
15. 15. “Medical director” means a physician who meets the requirements in A.R.S. § 36-851.03.
16. 16. “Non-transplant anatomical donation” means an anatomical gift intended to be used for education or research.
17. 17. “Non-transplant anatomical material” means a non-transplant anatomical donation that has been prepared, packaged, labeled, and released to distribution inventory.
18. 18. “Personnel member” means an individual who is identified as an employee, student, or volunteer for a procurement organization and performs activities directly related to acquisition, evaluation of a non-transplant anatomical donation, preparation, or distribution of non-transplant anatomical material.
19. 19. “Physical assessment” means a postmortem evaluation of a non-transplant anatomical donation to determine whether there is evidence of a condition, such as a viral or bacterial infection, that may affect the suitability of the non-transplant anatomical donation for use in education or research.
20. 20. “Premises” mean a facility and surrounding grounds that are designated by an applicant or a licensee and licensed by the Department as part of a procurement organization.

21. 21. “Preparation” means an activity:

    1. a. Performed to make a non-transplant anatomical donation ready for distribution; and
    2. b. Includes cleaning, preservation, disarticulation, dissection, skeletonization, plastination, packaging, and labeling of the non-transplant anatomical donation.
22. 22. “Procurement organization” means the same as “non-transplant anatomical donation organization,” as defined in A.R.S. § 36-841, and includes both accredited and non-accredited facilities.
23. 23. “Quality management program” means ongoing activities designed and implemented by a procurement organization to improve acquisition, evaluation of a non-transplant anatomical donation, preparation, or distribution of non-transplant anatomical material.
24. 24. “Standard operating procedure” means a documented process for carrying on business, providing services, or performing activities, with instructions for performing routine or repetitive tasks.
25. 25. “Storage” means the process of maintaining non-transplant anatomical donations and non-transplant anatomical material in a designated area that contains relevant equipment, instruments, and supplies until distribution or final disposition.
26. 26. “Transfer” means to convey responsibility and oversight for non-transplant anatomical material to another person.

In addition to the definitions in A.R.S. § 36-841, the following apply in this Subchapter, unless otherwise specified:

Historical Note

R9-9A-102 made under Subchapter A, Article 1, 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).