64E-5.607. Authority and Responsibilities

(1) A licensee shall provide sufficient authority and organizational freedom to the radiation safety officer and the radiation safety committee to:

(a) Identify radiation safety problems;

(b) Initiate, recommend, or provide solutions;

(c) Require and verify implementation of corrective actions; and

(d) Stop unsafe operations.

(2) A licensee shall establish in writing and keep current the authority, duties, responsibilities, and radiation safety activities of the radiation safety officer and the radiation safety committee.

(3) Authorized users shall have the following special responsibilities:

(a) For written directives:

1. A written directive must be dated and signed by an authorized user before the administration of I-131 as sodium iodide greater than 1.11 megabecquerels (MBq) (30 microcuries ([micro]Ci)), any therapeutic dosage of unsealed radioactive material or any therapeutic dose of radiation from material; or

2. Due to 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 provided:

a. The information contained in the oral directive must be documented as soon as possible in writing in the patient’s record; and

b. A written directive must be prepared within 48 hours of the oral directive.

3. The written directive must contain the patient or human research subject’s name and the following information:

a. For any administration of quantities greater than 1.11 MBq (30 [micro]Ci) of sodium iodide I-131: the dosage;

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

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

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

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

f. For all other brachytherapy;

(I) Before implantation: treatment site, the radionuclide, and dose; and

(II) After implantation but before completion of the procedure: the radionuclide, treatment site, number of sources, and total source strength and exposure time (or the total dose).

4. A written revision to an existing written directive may be made if the revision is dated and signed by an authorized user before the administration of the dosage of unsealed radioactive material, the brachytherapy dose, high dose remote afterloader dose, the gamma stereotactic radiosurgery dose, the teletherapy dose, or the next fractional dose; or

5. Due to 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 provided:

a. The information contained in the oral directive must be documented as soon as possible in the patient’s record; and

b. A written directive must be prepared within 48 hours of the oral directive.

(b) Review personally the patient’s case to assure that the therapeutic radiation procedure is appropriate;

(c) Review personally the patient’s case or develop and implement adequate written procedures to assure that the diagnostic radiation procedure is appropriate.

(d) Prior to administration, the authorized user must document deviations from the diagnostic clinical procedures manual for each patient.

(e) Use radioactive material or direct technologists and physicians in training in using radioactive material;

(f) Interpret results of diagnostic procedures; and

(g) Review regularly the progress of the patient receiving therapy and modify the originally prescribed dose if needed.

(4) The licensee shall retain a copy of the written directives specified in paragraph 64E-5.607(3)(a), F.A.C., for three years.

Rulemaking Authority 404.051, 404.061, 404.071, 404.081, 404.141 FS. Law Implemented 404.022, 404.051(1), (4), (5), (6), (8), (9), (10), (11), 404.061(2), (3), 404.071(1), 404.081, 404.141 FS. History–New 8-25-91, Amended 5-12-93, Formerly 10D-91.713, Amended 2-11-10, 12-26-13.