Ariz. Admin. Code § 9-9-201

Current through Register Vol. 30, No. 45, November 8, 2024

Section R9-9-201 - Administration

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.

Ariz. Admin. Code § R9-9-201

Reserved Section expired on June 30, 1999 under A.R.S. § 41-1056(E) upon receipt of notice from the Governor's Regulatory Review Council (Supp. 99-3). New Section made by final rulemaking at 28 A.A.R. 1517, effective 6/8/2022.