Section 11-45-157 - Specific requirements for the use of radiopharmaceuticals for therapy(a) A licensee may use any radioactive material in a radiopharmaceutical and for a therapeutic use: (1) Which has been granted acceptance or approval by the U.S. Department of Health and Human Services; or(2) Which has been prepared and compounded in accordance with chapter 16-95.(b) Safety instruction. (1) A licensee shall provide oral and written radiation safety instruction for all personnel caring for patients undergoing radiopharmaceutical therapy. Refresher training shall be provided at intervals not to exceed one year.(2) To satisfy paragraph (1), the instruction shall describe the licensee's procedures for: (C) Contamination control;(E) Notification of the radiation safety officer or authorized user in case of the patient's death or medical emergency; and(F) Training for workers.(3) A licensee shall keep a record of individuals receiving instruction required by paragraph (1), a description of the instruction, the date of instruction, and the name of the individual who gave the instruction. Such record shall be maintained for inspection by the department for three years.(c) Safety precautions. (1) For each patient receiving radiopharmaceutical therapy and hospitalized for compliance with section 11-45-150, a licensee shall: (A) Provide a private room with a private sanitary facility;(B) Post the patient's door with a "Caution: Radioactive Material" sign and note on the door or on the patient's chart where and how long visitors may stay in the patient's room;(C) Authorize visits by individuals under eighteen years of age only on a case-by-case basis with the approval of the authorized user after consultation with the radiation safety officer;(D) Promptly after administration of the dosage, measure the dose rates in contiguous restricted and unrestricted areas with a radiation measurement survey instrument to demonstrate compliance with the requirements of subchapter 4 and retain a record of each survey that includes the time and date of the survey, a plan of the area or list of points surveyed, the measured dose rate at several points expressed in millirems (microsieverts) per hour, the instrument used to make the survey, and the initials of the individual who made the survey;(E) Either monitor material and items removed from the patient's room to determine that any contamination 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 these materials and items as radioactive waste;(F) Instruct the patient and, if practical, the patient's family, orally and in writing concerning radiation safety precautions that shall help to keep radiation dose to household members and the public as low as reasonably achievable before authorizing release of the patient;(G) Survey the patient's room and private sanitary facility for removable contamination with a radiation detection survey instrument before assigning another patient to the room. The room shall not be reassigned until removable contamination is less than two hundred disintegrations per minute (3.33 becquerels) per one hundred square centimeters.(2) For each non-hospitalized patient receiving radiopharmaceutical therapy, the licensee shall instruct the patient and, if practical, the patient's family, orally and in writing concerning radiation safety precautions that shall help to keep radiation doses to the household members and the public as low as reasonably achievable.(3) A licensee shall notify the radiation safety officer or the authorized user immediately if the patient expires or has a medical emergency.(d) A licensee authorized to use radioactive material for radiopharmaceutical therapy shall possess a portable radiation detection survey instrument capable of detecting dose rates over the range 0.1 millirem (one microsievert) per hour to fifty millirems (five hundred microsieverts) per hour, and a portable radiation measurement survey instrument capable of measuring dose rates over the range one millirem (ten microsieverts) per hour to one thousand millirems (ten millisieverts) per hour. The instruments shall be operable and calibrated in accordance with section 11-45-141.[Eff 11/12/99] (Auth: HRS §§ 321-10, 321-11, 321-71) (Imp: HRS §§ 321-1, 321-11(21), 321-71)