(1)A written directive must be prepared, dated and signed by an authorized user prior to administration of I-131 sodium iodide greater than 1.11 Megabecquerels (MBq) (30 microcuries (uCi)), or any therapeutic dosage of a radiopharmaceutical, or any therapeutic dose of radiation from radioactive material.
(2)The written directive must contain the patient or human research subject’s name and the following:
(a)For any administration of quantities greater than 1.11 MBq (30 uCi) of sodium iodide I-131 or I-125; the dosage;
(b)For a therapeutic administration of a radiopharmaceutical other than sodium iodide I-131: the radiopharmaceutical dosage, and route of administration;
(c)For gamma stereotactic radiosurgery: target coordinates (including gamma angle), collimator size, plug pattern, total dose for the treatment, and the total treatment volume for each anatomically distinct treatment site;
(d)For teletherapy: the total dose, dose per fraction, number of fractions, treatment site, and overall treatment period;
(e)For remote afterloading brachytherapy: the radionuclide, treatment site, dose per fraction, number of fractions, and total dose; or
(f)For all other brachytherapy:
(A)Prior to implantation: treatment site, the radionuclide, number of sources and source strengths or dose; and
(B)After implantation but prior to completion of the procedure: the radionuclide, treatment site, and total source strength and exposure time (or equivalently, the total dose).
(3)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 byproduct material, the brachytherapy dose, the gamma stereotactic radiosurgery dose, the teletherapy dose, or the next fractional dose.
(4)If, because of the patient’s condition, a delay in order to provide a written revision to an existing written directive would jeopardize the patient’s health, an oral revision to an existing written directive is acceptable. The oral revision must be documented as soon as possible in the patient’s record. A revised written directive must be signed by the authorized user within 48 hours of the oral revision.
(5)The licensee must retain the written directive in accordance with OAR 333-100-0057 (Maintenance of Records).
Rule 333-116-0105 — Written Directives,