Ariz. Admin. Code § R9-7-722 - Safety Instruction and Precautions for Use of Unsealed Radioactive Material Requiring a Written Directive

A. A licensee shall provide radiation safety instruction, initially and at least annually, for all personnel caring for the patient or human research subject receiving radiopharmaceutical therapy and hospitalized for compliance with R9-7-717. To satisfy this requirement, the instruction shall describe the licensee's procedures for:

1. Patient or human research subject control,

2. Visitor control,

3. Contamination control, and

4. Waste control.

B. For each patient or human research subject who cannot be released under R9-7-717, a licensee shall:

1. Quarter the patient or the human research subject in a private room with a private sanitary facility;

2. Visibly post the patient's or the human research subject's room with a "Radioactive Materials" sign;

3. Note on the door or in the patient's or human research subject's chart where and how long visitors may stay in the patient's or the human research subject's room; and

4. Monitor material and items removed from the patient's or the human research subject's room to determine that their radioactivity cannot be distinguished from the natural background radiation level with a radiation detection survey instrument set on its most sensitive scale and with no interposed shielding, or handle the material and items as radioactive waste.

C. A licensee shall notify the Radiation Safety Officer, or his or her designee, and the authorized user as soon as possible if the patient or human research subject has a medical emergency or dies.

D. A licensee may use any unsealed byproduct material identified in R9-7-723(A)(2)(b)(vi) prepared for medical use and for which a written directive is required that is:

1. Obtained from:

a. A manufacturer or preparer licensed under R9-7-311 or equivalent Agreement State requirements, or

b. A PET radioactive drug producer licensed under R9-7-311 or equivalent Agreement State requirements;

2. Excluding production of PET radionuclides, prepared by:

a. An authorized nuclear pharmacist;

b. A physician who is an authorized user and who meets the requirements specified R-7-723; or

c. An individual under the supervision, as specified in R9-7-712, of the authorized nuclear pharmacist in subsection (D)(2)(a) or the physician who is an authorized user in subsection (D)(2)(b);

3. Obtained from and prepared by an NRC or Agreement State licensee for use in research in accordance with an Investigational New Drug (IND) protocol accepted by FDA; or

4. Prepared by the licensee for use in research in accordance with an Investigational New Drug (IND) protocol accepted by FDA.

D. E. A licensee shall retain records of instruction and safety procedures performed under this rule for three years from the date of the activity.

Notes

Ariz. Admin. Code § R9-7-722

New Section R9-7-722 recodified from R12-1-722at 24 A.A.R. 813, effective March 22, 2018 (Supp. 18-1). Amended by final expedited rulemaking at 25 A.A.R. 3561, effective 12/3/2019.