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 R9-9-201 - Administration

Universal Citation: AZ Admin Code R 9-9-201

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

A. A licensee for a non-accredited procurement organization:

1. Is responsible for all issues of liability, ethical considerations, fiduciary issues, and compliance with applicable laws and regulations;
a. SOPs for all activities and services the procurement organization provides;

b. The qualifications for an administrator:
i. Who has at least a bachelor's degree in a health science or other science related field, and

ii. Is responsible for all services and activities at a procurement organization; and

c. The qualifications for a medical director:
i. Who is licensed pursuant to A.R.S. Title 32, Chapter 13 or 17; and

ii. Provides medical guidance to determine donor eligibility;

2. Shall adopt a quality management program; and

3. Shall review and evaluate the effectiveness of the quality management program in R9-9-202 at least once every 12 months.

B. An administrator of a non-accredited procurement organization:

1. Is directly accountable to the licensee for the operation, including all services and activities, provided by or at the procurement organization;

2. Has the authority and responsibility to manage the procurement organization as specified in SOPs;

3. Designates, in writing, an individual who is on the procurement organization's premises and is available when the administrator is not present on the premises.

C. A medical director of a non-accredited procurement organization:

1. Shall provide medical guidance to determine and establish donor eligibility as established in R9-9-204; and

2. May be the same individual as the administrator, if the individual's qualifications include management for all services and activities provided at a procurement organization.

D. A licensee of a non-accredited procurement organization shall ensure that the following programs at the procurement organization are established and maintained in compliance with state and federal laws and regulations:

1. A safety awareness and blood-borne pathogen training program; and

2. A cleaning program that mitigates potential cross-contamination between NTAD.

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

1. The procurement organization complies with vital records requirements in A.R.S. § 36-325;

2. An identification system according to A.R.S. § 36-851.03(A)(3)(b) for donors:
a. Is established and maintained, and

b. Assigns a unique identification number according to A.R.S. § 36-851.03(A)(6)(a);
i. For each donor, and

ii. Used to identify all NAM from a donor that is recovered and distributed;

3. SOPs are established, documented, and implemented that includes:
a. Job descriptions, duties, and qualifications, including required skills, knowledge, education, and experience for technicians and personnel members;

b. Orientation and in-service education for technicians and personnel members;

c. How a technician may submit a complaint related to services provided;

d. Donor records, including electronic records;

e. A quality management program, including incident reports;

f. Ethical practices;

g. An infectious control program;

h. Security, including evacuation procedures in the event of fire or disaster;

i. NTAD and NAM inventory controls; and

j. Contracted services;

4. SOPs for all services and activities are established, documented, and implemented for:
a. The proper use and maintenance of a donor consent form according to A.R.S. § 36-851.03(A)(3)(a);

b. Protocols and materials used to screen end-users prior to release and transfer of NAM according to A.R.S. § 36-851.03(A)(3)(c);

c. Donor screening and testing plan, including:
i. Acceptability assessment,

ii. Donor risk assessment,

iii. Medical records review,

iv. Donor eligibility, and

v. Infectious disease testing;

d. Acquisition of NTAD;
i. Donor verification;

ii. Donor identity;

iii. Acquisition records;

iv. Packaging, including packaging insert form that discloses disease status of tissue to the end-user;

v. Labeling;

vi. Transport; and

vii. Storage;

e. Preparation methods, including:
i. Receipt of NAM;

ii. Prevent airborne transmission, and

iii. Quarantine and storage, if applicable;

f. Release and transfer, including:
i. End-user eligibility review;

ii. Quality control review;

iii. Release of NAM;

iv. Exceptional release;

v. Failing review process; and

vi. Transfer to distribution for use, including out-of-state and international shipping;

g. Final disposition of donation according to A.R.S. § 36-851.03(A)(3)(f) and consistent with:
i. Board of Funeral Directors and Embalmers specified in 4 A.A.C. 12, Articles 3, 5, and 6;

ii. Vital Records and Public Health Statistics specified in A.R.S. Title 36, Chapter 3;

iii. Vital Records and Statistics specified in 9 A.A.C. 19;

iv. Health menaces specified in A.R.S. Title 36, Chapter 6, Article 1;

v. Disposition of Human Bodies specified in A.R.S. Title 36, Chapter 7; and

vi. Communicable Diseases and Infestations specified in 9 A.A.C. 6;

5. SOPs that all NTAD acquired by the procurement organization shall bear a label that:
a. Is written, printed, or graphic material used to identify NTAD/NAM, blood specimens, or other donor specimens; and

b. States according to A.R.S. § 36-851.03(A)(6)(b):
i. The NTAD or NAM is not for transplant or clinical use;

ii. Any condition and any limitation regarding the use of the NTAD or NAM;

iii. That universal precautions shall be used; and

iv. The contact information for the procurement organization;

6. SOPs are:
a. Maintained at the procurement organization and copies available to the Department for review upon request;

b. Reviewed at least once every three years and updated as needed; and

c. Available to technicians and personnel members; and

7. A loss or theft of NTAD or NAM is documented and reported to the appropriate law enforcement agency within 24 hours of discovery.

F. An administrator of a non-accredited procurement organization shall immediately report suspected misuse of NTAD or NAM.

G. An administrator of a non-accredited procurement organization shall ensure that a report specified in subsection (F) is documented and maintained in the donor's record as specified in R9-9-205(E).

H. A licensee of a non-accredited procurement organization shall ensure that the following information or documents are conspicuously posted on the premises:

1. The procurement organization's current license,

2. The name of the administrator and medical director,

3. The hours of operation, and

4. The evacuation plan listed in R9-9-302.

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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