Arizona Administrative Code
Title 9 - HEALTH SERVICES
Chapter 9 - DEPARTMENT OF HEALTH SERVICES - PROCUREMENT ORGANIZATIONS
Article 2 - ADMINISTRATION FOR A NON-ACCREDITED PROCUREMENT ORGANIZATION
Section R9-9-204 - Medical Director, Administrator, Technicians, and Personnel Members

Universal Citation: AZ Admin Code R 9-9-204

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

A. A licensee of a non-accredited procurement organization shall ensure that the medical director:

1. Establishes, reviews, and approves all SOPs of a medical nature, including:
a. Donor eligibility related to:
i. Screenings,

ii. Testing plans,

iii. Acceptability assessment;

b. Sampling plan and methods verifying NTAD release;

c. Exceptional release criteria and processes of NAM; and

d. Pre-established release criteria;

2. Reviews all SOPs of a medical nature at least every three years;

3. Approves a designee having training and education for performing tasks and functions assigned by the medical director;

4. Has oversight and performs review of designee activities according to procedures established by the licensee;

5. Makes a determination regarding the eligibility criteria of each donor based on a comparison with predetermined donor criteria;

6. Prior to release for use or distribution, signs the donor eligibility statement and NAM disposition or release statement; and

7. Establish a criteria that ensures all appropriate parties are notified of confirmed positive infectious disease test results.

B. A licensee of a non-accredited procurement organization shall ensure that the administrator:

1. Has at least three years of experience in tissue banking or other related fields;

2. Shall define NTAD or NAM activities that a technician may provide;

3. Shall define the methods used to provide clinical oversight and training including when clinical oversight and training is provided to an individual or a group; and

4. Shall ensure a technician's personnel record includes:
a. Documentation of all completed training and education; and

b. A written job description, including all primary duties.

C. A licensee of a non-accredited procurement organization shall ensure that a technician:

1. Has the educational background, experience, and training sufficient to assure assigned tasks will be performed in accordance with the established SOPs;

2. Provides a copy of a transcript or diploma in health science or other field of science for which the technician received a degree or certificate, if applicable;

3. Demonstrates competency to perform assigned tasks; and

4. Has duties required by the technician described in a written job description.

D. A licensee of a non-accredited procurement organization shall ensure that:

1. The qualifications, skill, and knowledge required for each type of technician and personnel member is based on the activities and services a personnel member may provide as established in the personnel job description; and

2. A personnel member's qualifications, skills, and knowledge are verified and documented:
a. Before the personnel member provides procurement organization services and

b. According to SOPs.

E. A licensee of a non-accredited procurement organization shall ensure that a personnel member does not have direct interaction with NTAD and NAM unless specifically authorized by the licensee or administrator.

F. A licensee of a non-accredited procurement organization shall ensure a personnel record is established for the administrator, technicians, and personnel members that includes:

1. The individual's name, date of birth, home address, and contact telephone number;

2. The individual's starting date of employment or volunteer service and, if applicable, the ending date; and

3. Documentation applicable to an individual's duties, as required by SOPs, including the individual's:
a. Education and experience;

b. In service education and continuing education, if applicable; and

c. Evidence of Hepatitis B vaccination or refusal of Hepatitis B vaccine for individuals whose job-related responsibilities involve the potential exposure to blood-borne pathogens, if applicable.

G. A licensee of a non-accredited procurement organization shall ensure that a personnel record is:

1. Maintained throughout an individual's period of employment or volunteer service in or for the procurement organization;

2. Maintained for at least three years after the last date that an individual's employment or volunteer service in or for the procurement organization; and

3. Provided to the Department when requested.

Disclaimer: These regulations may not be the most recent version. Arizona may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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