Ariz. Admin. Code § 9-7-904

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

Section R9-7-904 - Registration of Particle Accelerators Used in the Practice of Medicine or Human Research

A. The requirements in this Section supplement the registration requirements in R9-7-903.

B. An applicant that is a "medical institution," as defined in Article 7 of this Chapter, and performing human research shall appoint a radiation safety committee that:

1. Consists of at least four individuals including:

a. An authorized user of each type of use permitted by the registration,

b. The Radiation Safety Officer,

c. A representative of the nursing service,

d. A representative of management who is neither an authorized user nor a Radiation Safety Officer, and

e. Any other members the registrant selects;

2. Meets at least once in each 12-month period, unless otherwise specified by registration condition;

3. Only conducts business if at least 50 percent of the membership of the committee are present including the Radiation Safety Officer and the management representative;

4. Includes in the minutes of each radiation safety committee meeting a reference to any discussion or documents related to the review required in R9-7-407(C);

5. Reviews the radiation safety program for all sources of radiation as required in R9-7-407(C);

6. Establishes a table that contains investigational levels for occupational and public dose that, when exceeded, will initiate an investigation and consideration of actions by the Radiation Safety Officer; and

7. Establishes the safety objectives of the quality management program required by subsection (E).

C. The applicant shall ensure that an individual designated as an authorized user is an Arizona licensed physician, approved by the radiation safety committee, if applicable, who has documentation that the individual is either:

1. Certified in radiation oncology by the:

a. American Board of Radiology;

b. American Osteopathic Board of Radiology; or

c. Royal College of Physicians and Surgeons of Canada; or

2. Engaged in the active practice of therapeutic radiolog and has completed:

a. At least 200 hours of instruction in basic techniques applicable to the use of a particle accelerator, including

classroom and laboratory training in all of the following subjects:

i. Radiation physics and instrumentation,

ii. Radiation protection,

iii. Mathematics pertaining to the use and measurement of radiotherapy, and

iv. Radiation biology;

b. At least 500 hours of supervised work experience under the supervision of an authorized user at a medical institution, including:

i. Reviewing full calibration measurements and periodic spot checks,

ii. Preparing treatment plans and calculating treatment times,

iii. Using administrative controls to prevent misadministration,

iv. Implementing emergency procedures to be followed in the event of the abnormal operation of a particle accelerator, and

v. Checking and using survey meters;

c. A minimum of three years of supervised clinical experience:

i. Consisting of:

(1) At least one year in a formal training program approved by the Residency Review Committee for Radiology of the Accreditation Council for Graduate Medical Education or the Committee on Postdoctoral Training of the American Osteopathic Association, and

(2) At least an additional two years of clinical experience in therapeutic radiology under the supervision of an authorized user at a medical institution; and

ii. Including:

(1) Examining individuals and reviewing their case histories to determine their suitability for treatment, noting any limitations or contraindications;

(2) Selecting the proper dose and how it is to be administered;

(3) Calculating the therapy doses and collaborating with the authorized user in the review of patients' or human research subjects' progress and consideration of the need to modify originally prescribed doses, as warranted by patients' or human research subjects' reaction to radiation; and

(4) Post-administration follow up and review of case histories; and

d. Is qualified to independently act as an authorized user, signed by the individual supervising the clinical experience in subsection (C)(2)(c).

D. With the application the applicant shall provide the name of each authorized user to the Department so the names can be listed on the registration form, and so that the Department can determine whether the authorized user's training and experience satisfies the requirements in subsection (C).

E. Each registrant shall establish and maintain a written quality management program to provide high confidence that the radiation produced by the particle accelerator will be administered as directed by an authorized user. The quality management program shall include, at minimum, the tests and checks listed in Appendix A.

F. Each registrant shall ensure that a particle accelerator is calibrated by an authorized medical physicist who meets the training and experience qualifications in R9-7-711.

G. At the time of application for registration or when a therapy program is expanded to multiple sites, each applicant or registrant shall provide the Department with:

1. A description of the quality management program, developed, maintained, and implemented according to the American Society for Radiation Oncology's 2019 "Safety is No Accident: A Framework for Quality Radiation Oncology Care," incorporated by reference, available under R9-7-101, and containing no future editions;

2. A listing of the professional staff assigned to the facility; and

3. The expected ratio of patient workload to staff member.

H. If the staffing ratio exceeds the recommended levels in the document incorporated by reference in subsection (G)(1), the applicant shall provide to the Department for approval the justification for the larger ratio and the safety considerations that have been addressed in establishing the program.

I. A registrant shall ensure that:

1. Two radiation therapy technologists are at the treatment console for all procedures;

2. An authorized user and authorized medical physicist are:

a. At the treatment console for all single fraction special procedures, such as stereotactic radiosurgery (SRS), a method of external beam radiotherapy that delivers a precisely targeted high dose of radiation in a single session;

b. At the treatment console for the first fraction of all special procedures using multiple fractions, such as:

i. Stereotactic radiotherapy (SRT), a method of external beam radiotherapy in which radiotherapy is delivered from many different angles around the body of a patient, with the beams meeting at the tumor in such a manner that the tumor receives a high dose of radiation and the tissues around the tumor receive a much lower dose; or

ii. Stereotactic body radiation therapy (SBRT), a method of external beam radiotherapy that delivers a precisely targeted high dose of radiation to an extracranial target in five or fewer fractions; and

c. On-site and within range for patient care access for subsequent fractions of the special procedures specified in subsection (I)(2)(b);

3. For all Intensity-Modulated Radiation Therapy (IMRT), the planned doses are verified by direct measurement;

4. Except as provided in subsection (J), an authorized user is on-site and available for consultation about patient care; and

5. The health and safety of a patient are maintained.

J. If a registrant meets the requirements of a Critical Access Hospital, according to 42 CFR, Part 485, Subpart F, Conditions of Participation: Critical Access Hospitals, the registrant may allow a radiation therapy technologist to perform a procedure under general supervision if the registrant ensures that:

1. The registrant or an authorized user:

a. Has established a written protocol for the application of radiation to a patient for each procedure that may be conducted by a radiation therapy technologist under the general supervision of an authorized user, including follow-up instructions for the patient;

b. Reviews and, as necessary, revises the written protocols in subsection (J)(1)(a) at least annually; and

c. Documents the review in subsection (J)(1)(b) with a signature and date of signature;

2. The procedure is not a special procedure;

3. A radiation therapy technologist follows the applicable written protocol established according to subsection (J)(1)(a) when delivering radiation to a patient; and

4. At least every six months, an authorized user:

a. Observes each radiation therapy technologist, while the radiation therapy technologist is performing a procedure, for adherence to the applicable written protocol in subsection (J)(1)(a); and

b. Documents the observation and the assessment in subsection (J)(4)(a);

5. An authorized user is on-site and available for consultation about patient care at least once every five working days, as shown in documentation maintained by the registrant; and

6. The health and safety of a patient are maintained.

K. A registrant that uses the general supervision in compliance with subsection (J) shall develop, maintain, and implement policies and procedures to monitor:

1. The performance of a procedure by a radiation therapy technologist under general supervision, and

2. The quality of patient care.

Ariz. Admin. Code § R9-7-904

New Section R9-7-904 recodified from R12-1-904at 24 A.A.R. 813, effective March 22, 2018 (Supp. 18-1). Amended by final expedited rulemaking at 28 A.A.R. 3533, effective 11/2/2022. Amended by final expedited rulemaking at 30 A.A.R. 385, effective 2/8/2024.