Section R12-1-707. Written Directives

A.      A licensee shall ensure that a written directive is dated and signed by an authorized user before the administration of I-131 sodium iodide greater than 1.11 MBq (30 microcuries (µCi)), any therapeutic dosage of unsealed radioactive material or any therapeutic dose of radiation from radioactive material. If, because of the emergent nature of the patient’s condition, a delay in order to provide a written directive would jeopardize the patient’s health, an oral directive is acceptable. The infor- mation contained in the oral directive shall be documented as soon as possible in writing in the patient’s record. A written directive shall be prepared within 48 hours of the oral direc- tive.

B.       A written directive shall contain the patient or human research subject’s name and the following information:

1.        For any administration of quantities greater than 1.11 MBq (30 µCi) of sodium iodide I-131: the dosage;

2.        For an administration of a therapeutic dosage of unsealed radioactive material other than sodium iodide I-131: the radiopharmaceutical, dosage, and route of administration;

3.        For gamma stereotactic radiosurgery: the total dose, treat- ment site, and values for the target coordinate settings per treatment for each anatomically distinct treatment site;

4.        For teletherapy: the total dose, dose per fraction, number of fractions, and treatment site;

5.        For high dose-rate remote afterloading brachytherapy: the radionuclide, treatment site, dose per fraction, number of fractions, and total dose; or

6.        For all other brachytherapy, including low, medium, and pulsed dose rate remote afterloaders:

a.         Before  implantation:  treatment  site,  the  radionu- clide, and dose; and

b.        After implantation but before completion of the pro- cedure: the radionuclide, treatment site, number of

sources, and total source strength and exposure time (or the total dose).

C.      The licensee shall retain a copy of the written directive for three years after creation of the record.

Historical Note

New Section adopted by final rulemaking at 5 A.A.R. 1817, effective May 12, 1999 (Supp. 99-2). Amended by

final rulemaking at 9 A.A.R. 1126, effective May 9, 2003 (Supp. 03-1). Section repealed; new Section made by final rulemaking at 13 A.A.R. 1217, effective May 5,

2007 (Supp. 07-1).