Arizona Administrative Code
Title 9 - HEALTH SERVICES
Chapter 9 - DEPARTMENT OF HEALTH SERVICES - PROCUREMENT ORGANIZATIONS
Article 4 - ADMINISTRATION FOR AN ACCREDITED PROCUREMENT ORGANIZATION
Section R9-9-403 - Tissue End-Users

Universal Citation: AZ Admin Code R 9-9-403

Current through Register Vol. 30, No. 38, September 20, 2024

A. A licensee of an accredited procurement organization shall establish, document, and implement SOPs to properly screen an end-user that includes:

1. A written request for NAM, including:
a. The name, address and affiliation of educator and research accepting responsibility for the acceptance, use, and disposition of the NAM;

b. A description of the intended use;

c. The date and the approximate duration of NAM use;

d. A description of the venue in which the NAM will be used and the security measures for the safe and ethical utilization of the venue;

e. An assurance that universal precautions will be used when handling NAM;

f. The proposed final disposition of the NAM;

g. An agreement to comply with procurement organization's policies, as applicable;

h. An outline of proposed promotional materials to be disseminated in connection with the use of NAM; and

i. Other supporting documentation that is relevant to the request; and

2. The criteria for approving requested NAM for use, including:
a. The acceptability of the educator and researcher for NAM utilization;

b. The appropriateness of the intended use;

c. Type of venue in which the NAM will be used;

d. Proposed final disposition of the NAM unless returned to the procurement organization; and

e. Proposed promotional materials.

B. A licensee of an accredited procurement organization shall establish, document, and implement a procedure that allows an end-users to request an exceptional release of NAM.

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