Section 216-RICR-40-20-9.7 - Unsealed Radioactive Material - Written Directive Not Required9.7.1Use of Unsealed Radioactive Material for Uptake, Dilution, or Excretion Studies for Which a Written Directive is Not RequiredFor the purpose of this Part, requirements for use of unsealed radioactive material for uptake, dilution, and excretion studies for which a written directive is not required are defined by 10 C.F.R. § 35.100.
9.7.2Training for Uptake, Dilution, and Excretion StudiesFor the purpose of this Part, training requirements for uptake, dilution, and excretion studies are defined by 10 C.F.R. § 35.190.
9.7.3Use of Unsealed Radioactive Material for Imaging and Localization Studies for Which a Written Directive is Not RequiredA. For the purpose of this Part, requirements for use of unsealed radioactive material for imaging and localization studies for which a written directive is not required are defined by 10 C.F.R. § 35.200.B. Provided the conditions of §9.7.6 of this Part are met, a licensee shall use radioactive aerosols or gases only if specific application is made to and approved by the Agency.C. Technetium-99m pertechnetate as an aerosol for lung function studies is not subject to the restrictions in §9.7.3(B) of this Part.9.7.4Permissible Molybdenum-99, Strontium-82, and Strontium-85 ConcentrationsA. For the purpose of this Part, permissible Molybdenum-99, Strontium-82, and Strontium-85 concentrations are defined by 10 C.F.R. §§ 35.204(a) through (c).B. A licensee shall maintain a record of the Molybdenum-99 concentration or Strontium-82 and Strontium-85 concentration tests required by §9.7.4(A) of this Part for three (3) years. The record must include: 1. For each measured elution of Technetium-99m, the ratio of the measures expressed as kilobecquerel of Molybdenum-99 per megabecquerel of Technetium-99m (or microcuries of molybdenum per millicurie of technetium), the time and date of the measurement, and the name of the individual who made the measurement; or2. For each measured elution of Rubidium-82, the ratio of the measures expressed as kilobecquerel of Strontium-82 per megabecquerel of Rubidium-82 (or microcuries of Strontium-82 per millicurie of rubidium), kilobecquerel of Strontium-85 per megabecquerel of Rubidium-82 (or microcuries of Strontium-85 per millicurie of rubidium), the time and date of the measurement, and the name of the individual who made the measurement.C. A licensee shall report immediately to the Agency, and to the distributor of the generator within seven (7) calendar days after discovery, that an eluate exceeded the permissible concentration specified in §9.7.4(A) of this Part. The report to the Agency must include the manufacturer, model number, and serial number (or lot number) of the generator; the results of the measurement; the date of the measurement; whether dosages were administered to patients or human research subjects, when the distributor was notified, and the action taken.D. The licensee shall submit a written report to the Agency within thirty (30) calendar days after discovery of an eluate exceeding the permissible concentration at the time of generator elution. The written report must include the action taken by the licensee; the patient dose assessment; the methodology used to make this dose assessment if the eluate was administered to patients or human research subjects; and the probable cause and an assessment of failure in the licensee's equipment, procedures or training that contributed to the excessive readings if an error occurred in the licensee's breakthrough determination; and the information in the report required by §9.7.4(C) of this Part.9.7.5Training for Imaging and Localization StudiesFor the purpose of this Part, training requirements for imaging and localization studies are defined by 10 C.F.R. § 35.290.
9.7.6Control and Storage of Volatiles, Aerosols and GasesA. A licensee who administers radioactive aerosols or gases shall do so with a system that will keep airborne concentrations within the limits prescribed by §§1.7.1 and 1.8.1 of this Subchapter.B. The system shall either be directly vented to the atmosphere through an air exhaust or provide for collection and decay or disposal of the aerosol or gas in a shielded container.C. A licensee shall only administer radioactive gases in rooms that are at negative pressure compared to surrounding rooms.D. 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 listed in § 1.18 of this Subchapter. The calculation shall be based on the highest activity of gas handled in a single container and the measured available air exhaust rate.E. A licensee shall post the time calculated in §9.7.6(D) of this Part at the area of use and require that, in case of a gas spill, individuals evacuate the room until the posted time has elapsed.F. 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 (6) months. Records of these checks and measurements shall be maintained for three (3) years.G. A copy of the calculations required in §9.7.6(D) of this Part shall be recorded and retained for the duration of the license.H. A licensee shall store volatile radioactive materials and radioactive gases in a radiation shield and container.I. A licensee shall store and use a multidose container in a properly functioning fume hood.216 R.I. Code R. § 216-RICR-40-20-9.7
Adopted effective 1/1/2019
Amended effective 5/25/2022