Ariz. Admin. Code § 9-9A-203

Current through Register Vol. 30, No. 50, December 13, 2024

Section R9-9A-203 - Additional Administrative Requirements for a Non-accredited Procurement Organization

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

1. Appoint an administrator who:

a. Has at least a bachelor's degree in a health science or other science-related field,

b. Has at least three years of experience in tissue banking or other related fields, and

c. Is responsible for all services and activities at the procurement organization;

2. Appoint a medical director who:

a. Is licensed under A.R.S. Title 32, Chapter 13 or 17;

b. Provides medical guidance to determine donor eligibility; and

c. May be the same individual as the administrator, if the individual's qualifications satisfy the requirements in both subsections (A)(1) and (2)(a);

3. Adopt a quality management program that, at a minimum, includes:

a. A method to identify, document, and evaluate incidents;

b. A method to collect data to evaluate the provision of procurement organization services;

c. A method to evaluate the data collected to identify a concern about the provision of procurement organization services;

d. A method to make changes or take action as a result of the identification of a concern about the provision of procurement organization services; and

e. The frequency of submitting a documented report required in subsection (A)(4) to the licensee;

4. Ensure that a documented report of quality management program activities is:

a. Submitted to the licensee that includes:

i. An identification of each concern about the provision of procurement organization services, and

ii. Any changes made or actions taken as a result of the identification of a concern about the provision of procurement organization services; and

b. Maintained by the procurement organization for at least 12 months after the date of the report;

5. Review and evaluate the effectiveness of the quality management program in subsection (A)(3) at least once every 12 months;

6. If any instance of use of a non-transplant anatomical donation or non-transplant anatomical material for a purpose other than for research, education, or another use specified in the donor consent form is detected:

a. Report the incident to the Department within seven calendar days after the incident is detected,

b. Maintain documentation of the report in a donor record, and

c. Ensure that the incident is reviewed through the quality assurance process with any steps taken to prevent a reoccurrence;

7. Unless otherwise specified in this Subchapter, ensure that any records or documentation required by this Subchapter are maintained for at least three years after the latest date entered on the report or document; and

8. Ensure that the following information is conspicuously posted on the premises:

a. The procurement organization's current license,

b. The names of the administrator and medical director,

c. The hours of operation, and

d. The evacuation plan listed in R9-9A-302(A)(5).

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

1. Is directly accountable to the licensee for the operations of the procurement organization, 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 standard operating procedures; and

3. Shall designate, in writing, an individual who is on the procurement organization's premises and is available and responsible for procurement organization operations when the administrator is not present on the premises.

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

1. Establishes, reviews, and approves standard operating procedures related to:

a. Donor eligibility, including:

i. The content and conducting of an acceptability assessment;

ii. The content and conducting of a physical assessment; and

iii. Screening for 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;

b. The criteria for and methods of verifying the suitability of a non-transplant anatomical donation for release for preparation;

c. The criteria and processes for the exceptional release of non-transplant anatomical material; and

d. Pre-established criteria for release of non-transplant anatomical material to an end-user;

2. Reviews and, if necessary, revises all standard operating procedures of a medical nature at least every three years;

3. Establishes a process for determining the eligibility of a donor, based on a comparison of the non-transplant anatomical donation with predetermined donor criteria;

4. Prior to release for use or distribution, signs the donor eligibility statement and non-transplant anatomical material disposition or release statement;

5. If designating another individual to perform tasks or functions assigned by the medical director, ensures that the individual:

a. Has the required training and education for performing the tasks or functions;

b. Has oversight when performing the tasks or functions assigned by the medical director; and

c. Performs the tasks or functions assigned by the medical director according to standard operating procedures, including, if applicable, the functions described in subsections (C)(3) and (4);

6. Reviews activities performed by a designee at least once every three months according to standard operating procedures established by the licensee; and

7. Establishes the criteria for ensuring that all appropriate parties are notified of confirmed positive infectious disease test results.

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

1. The following are established, maintained, and implemented in compliance with applicable state and federal laws and regulations:

a. A safety awareness and blood-borne pathogen training program, and

b. A cleaning program that mitigates potential cross-contamination between non-transplant anatomical donations; and

2. The medical director reviews and approves standard operating procedures related to the programs in subsections (D)(1)(a) and (b).

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

1. Specifies activities involving non-transplant anatomical donations and non-transplant anatomical material that a technician may provide;

2. Specifies the methods used to provide clinical oversight and training to personnel members, including when clinical oversight and training are provided to an individual or a group; and

3. Creates and maintains a technician's personnel record that includes:

a. Documentation of all completed training and education; and

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

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

1. Is only assigned duties described in a written job description;

2. Has the educational background, experience, and training sufficient to ensure that assigned tasks will be performed in accordance with the applicable standard operating procedures;

3. 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; and

4. Demonstrates competency to perform assigned tasks.

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

1. The qualifications, skill, and knowledge required for each type of personnel member is based on the activities and services the personnel member may provide, as established in the personnel member's 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 standard operating procedures.

H. A licensee of a non-accredited procurement organization shall ensure that a personnel member does not have direct interaction with non-transplant anatomical donations or non-transplant anatomical material unless specifically authorized by the licensee or administrator.

I. A licensee of a non-accredited procurement organization shall ensure a personnel record is established for the administrator, technicians, and other 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 standard operating procedures, 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.

J. 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.

K. A licensee of a non-accredited procurement organization shall ensure that a donor record:

1. Includes:

a. A copy of the donor consent form and any amendment to the consent form;

b. The name and contact information of the person responsible for the donor's anatomical gift; if applicable;

c. The donor's unique identifying number specified in R9-9A-201(B)(2)(a);

d. Documentation for registering the donor's death, as specified in A.A.C. R9-19-303 or A.A.C. R9-19-304, as applicable;

e. A disposition-transit permit specified in A.A.C. R9-19-308;

f. Any information from the donor referral source, including, as applicable:

i. Donor acceptability assessment, and

ii. Donor eligibility;

g. All documents and permits that establish the chain of custody and identification of the individuals and organizations that had physical custody of the non-transplant anatomical donation or non-transplant anatomical material;

h. Medical records, including as applicable:

i. The donor's physical assessment,

ii. Pathology and laboratory testing and reports,

iii. Physician summaries,

iv. Serological results,

v. Transfusion or infusion information, and

vi. Plasma dilution calculations;

i. Documentation related to activities involved in:

i. Recovery of the non-transplant anatomical donation,

ii. Preparation and storage of the non-transplant anatomical material, and

iii. Distribution of the non-transplant anatomical material; and

j. Final disposition documentation, including all records related to chain of custody;

2. Includes, if applicable:

a. A human remains release form specified in A.A.C. R9-19-301;

b. Information for transporting human remains, as defined in A.R.S. § 36-301, into the state, as specified in A.A.C. R9-19-311;

c. The release of information by a medical examiner, as specified in A.R.S. § 36-861;

d. Cremation authorization documents; and

e. Documentation related to the use of the non-transplant anatomical donation or non-transplant anatomical material for a purpose other than for research, education, or another use specified in the donor consent form; and

3. Is:

a. Confidential and kept in a location with controlled access;

b. Stored in a manner to prevent unauthorized access;

c. Maintained in a manner to preserve the donor record's completeness and accuracy; and

d. Made available to:

i. The donor's known consenter;

ii. An agent legally authorized by the donor or other individual designated at the time a donor gives consent;

iii. An individual appointed by a court or authorized by state laws;

iv. An individual of a procurement organization as identified by standard operating procedures;

v. An individual from an approving accrediting body, if applicable; and

vi. An individual from the Department or other regulatory agency authorized by state and federal laws or regulations.

L. A technician or other personnel member of a non-accredited procurement organization shall report to the administrator or medical director:

1. Any concern related to receiving, preparing, packaging, distributing, or transporting non-transplant anatomical donations or nontransplant anatomical material that may adversely affect the health and safety of others; and

2. Any personal health condition experienced by the technician or other personnel member related to receiving, preparing, packaging, distributing, or transporting non-transplant anatomical donations or non-transplant anatomical material.

M. If an administrator or medical director of a non-accredited procurement organization receives a report specified in subsection (L), the administrator or medical director shall:

1. Follow standard operating procedures to secure the area and eliminate exposure to others;

2. Notify appropriate health and law enforcement agencies, as applicable; and

3. Report the incident to the Department within seven calendar days after determining that a health condition in subsection (L) has occurred.

N. If a non-accredited procurement organization owns or maintains a vehicle for transporting non-transplant anatomical donations and non-transplant anatomical material, an administrator shall ensure the vehicle is:

1. Not used for a purpose other than transporting non-transplant anatomical donations and non-transplant anatomical material or conducting procurement organization business, and

2. Only operated by a procurement organization technician or designated and authorized individual when transporting non-transplant anatomical donations or non-transplant anatomical material.

O. If using another vehicle or type of transport for non-transplant anatomical donations or non-transplant anatomical material, an administrator of a non-accredited procurement organization shall ensure that the other vehicle or type of transport:

1. Is properly equipped for the transportation of non-transplant anatomical donations or non-transplant anatomical material;

2. Is compliant with all state laws and rules pertaining to transporting human remains; and

3. If transport is by air, complies with applicable standards established by the International Air Transport Association and Transport Security Administration.

Ariz. Admin. Code § R9-9A-203

New Section made by final expedited rulemaking at 30 A.A.R. 3658, effective 11/5/2024.