HAR §11-45-154. Reserved

§11-45-155 Specific requirements for the use of radiopharmaceuticals for uptake, dilution, or excretion studies. (a) A licensee may use any radioactive material in a radiopharmaceutical for a diagnostic use involving measurements of uptake, dilution, or excretion; (1) Which has been granted acceptance or approval by the U.S. Department of Health and Human Services; or (2) Which is prepared and compounded in accordance with chapter 16-95. (b) A licensee authorized to use radioactive material for uptake, dilution, excretion, imaging, and localization studies shall possess a portable radiation detection survey instrument capable of detecting dose rates over the range 0.1 millirem (1.0 microsievert) per hour to fifty millirems (five hundred microsieverts) per hour. The instrument shall be operable and calibrated in accordance with section 11-45-140. §11-45-155 45-132 [Eff 11/12/99] (Auth: HRS §§321-10, 321-11, 321-71) (Imp: HRS §§321-1, 321-11(21), 321-71) §11-45-156 Specific requirements for the use of radiopharmaceuticals, generators, and reagent kits for imaging and localization studies. (a) A licensee may use any radioactive material in a non-gaseous or non-aerosol diagnostic radiopharmaceutical or any generator or reagent kit for preparation and diagnostic use of a non-gaseous or non-aerosol radiopharmaceutical containing radioactive material: (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. (3) A licensee shall elute generators. (b) Radionuclide contaminants. (1) A licensee shall not administer a radiopharmaceutical containing: (A) Reserved. (B) More than 0.02 microcurie (0.02 kilobecquerel) of strontium-82 per millicurie (megabecquerel) of rubidium-82 chloride injection; (C) More than 0.2 microcurie (0.2 kilobecquerel) of strontium-85 per millicurie (megabecquerel) of rubidium-82 chloride injection. (2) A licensee preparing radiopharmaceuticals from radionuclide generators shall measure the concentration of radionuclide contaminant in each eluate or extract, as appropriate for the generator system, to determine compliance with the limits specified in paragraph (1). (3) A licensee who shall measure radionuclide contaminant concentration shall retain a record of each measurement. The record shall include, for each elution or extraction tested, the measured activity of the radiopharmaceutical expressed in millicuries (megabecquerels), the measured activity of contaminant expressed in microcuries (kilobecquerels), the ratio of the measures expressed in microcuries (kilobecquerels) of contaminant per millicurie (megabecquerel), the date of the test, and the initials of the individual who performed the test. (4) A licensee shall report immediately to the department each occurrence of radionuclide contaminant concentration exceeding the limits specified in paragraph (1). (c) Control of aerosols and gases. (1) A licensee who administers radioactive aerosols or gases shall do so with a system that shall keep airborne concentrations within the limits prescribed in subchapter 4. (2) The system shall provide collection and decay or disposal of the aerosol or gas in a shielded §11-45-157 45-133 container. (3) A licensee shall only administer radioactive gases in rooms that are at negative pressure compared to surrounding rooms. (4) Before receiving, using, or storing a radioactive gas, the licensee shall calculate the amount of time needed after a release to reduce the concentration in the area of use to the occupational limit in subchapter 4. The calculation shall be based on the highest activity of gas handled in a single container and the measured available air exhaust rate. (5) A licensee shall post the time calculated in paragraph (4) at the area of use and require that, in case of a gas spill, individuals evacuate the room until the posted time has elapsed. (6) A licensee shall check the operation of collection systems monthly and measure the ventilation rates in areas of use at intervals not to exceed six months. Records of these checks and measurements shall be maintained. (7) A copy of the calculations required in paragraph (4) shall be recorded and retained for the duration of the license. (d) A licensee authorized to use radioactive material for imaging and localization studies shall possess a portable radiation detection survey instrument capable of detecting dose rates over the range of 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) §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: (A) Patient control; §11-45-157 45-134 (B) Visitor control; (C) Contamination control; (D) Waste 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; §11-45-159 45-135 (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) §11-45-158 Specific requirements for the use of sealed sources for diagnosis. A licensee authorized to use radioactive material as a sealed source for diagnostic purposes shall have available for use 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 or 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 instrument 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) §11-45-159 Specific requirements for the use of sources for brachytherapy. (a) A licensee shall use radioactive sources in accordance with the manufacturer's radiation safety and handling instructions. (b) Safety instruction. (1) The licensee shall provide oral and written radiation safety instruction to all personnel caring for a patient receiving implant therapy. Refresher training §11-45-159 45-136 shall be provided at intervals not to exceed one year. (2) To satisfy paragraph (1), the instruction shall describe: (A) Size and appearance of the brachytherapy sources; (B) Safe handling and shielding instructions in case of a dislodged source; (C) Procedures for patient control; (D) Procedures for visitor control; (E) Procedures for notification of the radiation safety officer or authorized user if the patient expires or has a medical emergency; and (F) Training for workers. (3) A licensee shall maintain 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. (c) Safety precautions. (1) For each patient receiving implant therapy a licensee shall: (A) Not place the patient in the same room with a patient who is not receiving radiation therapy unless the licensee can demonstrate compliance with the radiation dose limits for individual members of the public as specified in subchapter 4 at a distance of one meter from the implant; (B) Post the patient's door with a "Caution: Radioactive Materials" sign and note on the door or 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 implanting the sources, survey the dose rates in contiguous restricted and unrestricted areas with a radiation measurement survey instrument to demonstrate compliance with subchapter 4 and retain a record of each survey that includes the time and date of the survey, a sketch 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; and (E) Provide the patient with radiation safety guidance that shall help keep the radiation dose to household members and the public as low as reasonably achievable before releasing the patient if the patient was administered a permanent implant. (2) A licensee shall notify the radiation safety officer §11-45-159 45-137 or authorized user immediately if the patient expires or has a medical emergency. (d) Brachytherapy sources inventory. (1) Each time brachytherapy sources are returned to an area of storage from an area of use, the licensee shall immediately count or otherwise verify the number returned to ensure that all sources taken from the storage area have been returned. (2) A licensee shall make a record of brachytherapy source utilization which includes: (A) The names of the individuals permitted to handle the sources; (B) The number and activity of sources removed from storage, the room number of use and patient's name, the time and date they were removed from storage, the number and activity of sources in storage after the removal, and the initials of the individual who removed the sources from storage; and (C) The number and activity of sources returned to storage, the room number of use and patient's name, the time and date they were returned to storage, the number and activity of sources in storage after the return, and the initials of the individual who returned the sources to storage. (3) Immediately after implanting sources in a patient and immediately after removal of sources from a patient, the licensee shall make a radiation survey of the patient and the area of use to confirm that no sources have been misplaced. The licensee shall make a record of each survey. (4) A licensee shall maintain records required in paragraphs (2) and (3). (e) Release of patients treated with temporary implants. (1) Immediately after removing the last temporary implant source from a patient, the licensee shall perform a radiation survey of the patient with a radiation detection survey instrument to confirm that all sources have been removed. The licensee shall not release from confinement for medical care a patient treated by temporary implant until all sources have been removed. (2) A licensee shall maintain a record of patient surveys which demonstrate compliance with paragraph (1). Each record shall include the date of the survey, the name of the patient, the dose rate from the patient expressed in millirems (microsieverts) per hour and measured within one meter from the patient, and the initials of the individual who made the survey. (f) A licensee authorized to use radioactive material for implant therapy shall possess a portable radiation detection survey instrument capable of detecting dose rates over a range 0.1 millirem (one microsievert) per hour to fifty millirems (five §11-45-159 45-138 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)