Arizona Administrative Code
Title 9 - HEALTH SERVICES
Chapter 9 - DEPARTMENT OF HEALTH SERVICES - PROCUREMENT ORGANIZATIONS
Article 1 - PROCUREMENT ORGANIZATION LICENSURE
Section R9-9-101 - Definitions

1. "Acceptability assessment" means the evaluation of available, if applicable, medical information about a donor to determine whether the donor meets qualifications as established by SOPs specified in R9-9-201(E)(4).

2. "Accrediting body" means a nationally recognized agency, approved by the Department, that provides certification for a person operating a procurement organization.

3. "Acquisition" means activities required to obtain a NTAD that is intended for use in education or research.

4. "Administrative completeness review time-frame" has the same meaning as in A.R.S. § 41-1072.

5. "Administrator" means the individual responsible for the services and activities provided by a procurement organization.

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

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

8. "Authorization" means permission given for NTAD acquisition by a donor or individual authorized by law.

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

10. "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.

11. "Controlling person" means an individual who, with respect to a business organization:

12. "Contracted services" means functions pertaining to the acquisition, screening, testing, preparing, storage, and distribution of NAM that another establishment agrees to perform.

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

14. "Distribution" means a process that includes selection and evaluation of intended use of NAM for release to another procurement organization, an education facility, or a research facility.

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

16. "Environmental services" means activities such as housekeeping, laundry, facility maintenance, or equipment maintenance.

17. "Exceptional release" means NAM that is approved for usage before a donor acceptability assessment or by a researcher requesting NAM that would not normally meet the established acceptability criteria.

18. "Final disposition" means the disposal of NAM through incineration, cremation, bio-cremation, burial, fully depleted by virtue of a particular use, or by another legal means.

19. "Licensee" means a person to whom the Department has issued a license to operate a non-transplant procurement organization or person designated by the licensee.

20. "Medical director" means a physician licensed in this state pursuant to A.R.S. Title 32, Chapter 13 or 17 who provides medical guidance for a licensed procurement organization according to A.R.S. § 36-851.03 or person designated by the medical director.

21. "Misuse" means to use NTAD and NAM for purposes other than for:

22. "Modification" means the substantial improvement, enlargement, reduction, alternation, or other substantial change in the facility or another structure on the premises at a procurement organization.

23. "Non-transplant anatomical donation" or "NTAD" means a donation of a whole body, organs or tissues authorized and used for education and research prior to release to distribution inventory.

24. "Non-transplant anatomical material" or "NAM" means a whole body or parts of a body donated for use in education or research that has been prepared, packaged, labeled, and released to distribution inventory.

25. "Overall time-frame" means the same as in A.R.S. § 41-1072.

26. "Person" means the same as in A.R.S. § 36-841.

27. "Personnel member" means individuals identified as employees, students, or volunteer who provides services and activities for a procurement organization.

28. "Pest control" means activities that minimize the presence of insects and vermin in a procurement organization to ensure the quality of NTAD and NAM and the health and safety of persons occupying or visiting.

29. "Physical assessment" means a postmortem documented evaluation of a deceased donor's body that may identify evidence of: high-risk behaviors, signs of HIV infection or hepatitis infection, other viral or bacterial infections, and trauma.

30. "Premises" mean a facility and surrounding grounds that are:

31. "Preparation" means any activity performed other than donor screening, donor testing, acquisition, storage, distribution, or dispensing functions to enable the use of NAM for education or research. It includes, but is not limited to, cleaning, preservation, disarticulation, dissection, skeletonization, plastination, packaging, and labeling of NAM.

32. "Procurement organization" means the same as "non-transplant anatomical donation organization" as defined in A.R.S. § 36-841 and may be either accredited by an accrediting body or non-accredited.

33. "Quality management program" means ongoing activities designed and implemented by a procurement organization to improve the delivery of services and activities related to NAM.

34. "Quarantine" means the identification of NTAD or NAM as not acceptable or yet to be determined as eligible for use in education or research, including NTAD or NAM whose suitability has not been determined.

35. "Release" means NAM approved by a procurement organization in accordance with criteria established by the medical director for transfer to an approved education and research facility.

36. "Risk assessment" means collecting and evaluating relevant medical history and social behavior obtained from an individual or individuals who have knowledge about the donor.

37. "Standard operating policies and procedures" or "SOPs" means a group of documents detailing the specific purposes and services provided by a licensed procurement organization including activities and methods by staff and personnel members in support of conducting business operations.

38. "Storage" means a designated area that contains equipment, instruments, and supplies to maintain NTAD or NAM until distribution or final disposition.

39. "Substantive review time-frame" means the same as in A.R.S. § 41-1072.

40. "Traceability" means the method to locate NTAD and NAM during any step of NTAD including obtaining authorization, acquisition, transport, assessing donor acceptability, preparation, packaging, labeling, storage, release, evaluation intended use, distribution, and final disposition.

41. "Transfer" means the conveyance or relocation of NAM to:

42. "Transport" means a method for relocating NAM from one place to another in a manner that provides conditions necessary to maintain the quality of the NAM for its intended use.

43. "Universal precautions" means the same as in A.R.S. § 32-1301.

44. "Working day" means a Monday, Tuesday, Wednesday, Thursday, or Friday that is not a state and federal holiday or a statewide furlough day.