Ariz. Admin. Code § 9-9A-102

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

Section R9-9A-102 - Definitions

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

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. "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. "Acquisition" means activities required to obtain a non-transplant anatomical donation.

4. "Administrator" means the individual responsible for the provision by a procurement organization of services and related activities.

5. "Applicant" means an individual or business organization requesting approval to operate a procurement organization.

6. "Application" means the information, documents, and fees required by the Department for licensure of a procurement organization.

7. "Business organization" means the same as "entity" in A.R.S. § 10-140.

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. "Department" means the Arizona Department of Health Services.

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. "Donor consent form" means the same as "document of gift" as defined in A.R.S. § 36-841.

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

a. Has been approved for usage before a donor acceptability assessment has been completed; or

b. Would not normally meet the established acceptability criteria, at the request of a researcher.

13. "Final disposition" means the same as in A.R.S. § 36-301.

14. "Licensee" means a person to whom the Department has issued a license to operate a procurement organization.

15. "Medical director" means a physician who meets the requirements in A.R.S. § 36-851.03.

16. "Non-transplant anatomical donation" means an anatomical gift intended to be used for education or research.

17. "Non-transplant anatomical material" means a non-transplant anatomical donation that has been prepared, packaged, labeled, and released to distribution inventory.

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. "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. "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. "Preparation" means an activity:

a. Performed to make a non-transplant anatomical donation ready for distribution; and

b. Includes cleaning, preservation, disarticulation, dissection, skeletonization, plastination, packaging, and labeling of the non-transplant anatomical donation.

22. "Procurement organization" means the same as "non-transplant anatomical donation organization," as defined in A.R.S. § 36841, and includes both accredited and non-accredited facilities.

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. "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. "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. "Transfer" means to convey responsibility and oversight for non-transplant anatomical material to another person.

Ariz. Admin. Code § R9-9A-102

New Section made by final expedited rulemaking at 30 A.A.R. 3657, effective 11/5/2024.