Section 120.521 - Written Directives(A) A written directive must be dated and signed by an authorized user prior to administration of I-131 sodium iodide greater than 1.11 megabecquerel (30 µCi), any therapeutic dosage of 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 will be acceptable, provided that the information contained in the oral directive is documented as soon as possible in writing in the patient's record and a written directive is prepared within 48 hours of the oral directive.
(B) The written directive must contain the patient or human research subject's name and the following: (1) For an administration of a dosage of radioactive drug containing radioactive material, the radioactive drug containing radioactive material, dosage, and route of administration;(2) For gamma stereotactic radiosurgery, the total dose, treatment site, and number of target coordinate settings per treatment for each anatomically distinct treatment site;(3) For teletherapy, the total dose, dose per fraction, number of fractions, and treatment site;(4) For high dose rate remote afterloading brachytherapy, the radionuclide, treatment site, dose per fraction, number of fractions, and total dose;(5) For permanent implant brachytherapy: (a) Before implantation: The treatment site, the radionuclide, and the total source strength; and(b) After implantation but before the patient leaves the post-treatment recovery area: The treatment site, the number of sources implanted, the total source strength implanted, and the date; or(6) For all other brachytherapy including LDR, MDR, and PDR:(a) Prior to implantation: treatment site, the radionuclide, and dose; and,(b) After implantation but prior to completion of the procedure: the radioisotope, treatment site, number of sources, and total source strength and exposure time (or, the total dose) and date.(C) A written revision to an existing written directive may be made provided that the revision is dated and signed by an authorized user prior to the administration of the dosage of radioactive drug containing radioactive material, the brachytherapy dose, the gamma stereotactic radiosurgery dose, the teletherapy dose, or the next fractional dose. 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 will be acceptable, provided that the oral revision is documented as soon as possible in the patient's record and a revised written directive is signed by the authorized user within 48 hours of the oral revision.
(D) The licensee shall retain the written directive in accordance with 105 CMR 120.590(C).Amended by Mass Register Issue 1480, eff. 10/14/2022.