Ariz. Admin. Code § 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.
Notes
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