Article 4. General Technical Requirements
12VAC5-481-1800. Possession, use, and calibration of instruments used to measure the activity of unsealed radioactive material.
Article 4
General Technical Requirements
A. For direct measurements performed in accordance with 12VAC5-481-1820, licensees shall possess and use instrumentation to measure the activity of unsealed radioactive material before it is administered to each patient or human research subject.
B. Licensees shall test the instrumentation required by subsection A of this section in accordance with nationally recognized standards or the manufacturer's instructions.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.
12VAC5-481-1810. (Repealed.)
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; repealed, Virginia Register Volume 32, Issue 24, eff. August 25, 2016.
12VAC5-481-1820. Determination of dosages of unsealed radioactive material for medical use.
A. Licensees shall determine and record the activity of each dosage before medical use.
B. For a unit dosage, this determination shall be made by:
1. Direct measurement of the radioactivity; or
2. A decay correction based on activity or activity concentration determined by:
a. A manufacturer or preparer licensed under 12VAC5-481-480 I or equivalent NRC or other agreement state requirements;
b. An agency, NRC, or another agreement state licensee for use in research in accordance with Radioactive Drug Research Committee-approved protocol or Investigational New Drug (IND) protocol accepted by FDA; or
c. A PET radioactive drug producer licensed under 12VAC5-481-440 H or equivalent NRC or other agreement state requirements.
C. For other than unit dosages, this determination shall be made by:
1. Direct measurement of radioactivity;
2. Combination of measurement of radioactivity and mathematical calculations; or
3. Combination of volumetric measurements and mathematical calculations, based on the measurement made by:
a. A manufacturer or preparer licensed under 12VAC5-481-480 I or equivalent NRC or other agreement state requirements; or
b. A PET radioactive drug producer licensed under 12VAC5-481-440 H or equivalent NRC or other agreement state requirements.
D. Unless otherwise directed by the authorized user, licensees may not use a dosage if the dosage does not fall within the prescribed dosage range or the dosage differs from the prescribed dosage by more than 20%.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.
12VAC5-481-1830. Authorization for calibration, transmission, and reference sources.
Any person authorized by 12VAC5-481-1680 for medical use of radioactive material may receive, possess, and use any of the following radioactive material for check, calibration, transmission, and reference use:
1. Sealed sources, not exceeding 1.11 GBq (30 mCi) each, manufactured and distributed by a person licensed under 12VAC5-481-480 or equivalent NRC or other agreement state regulations.
2. Sealed sources, not exceeding 1.11 GBq (30 mCi) each, redistributed by a licensee authorized to redistribute the sealed sources manufactured and distributed by a person licensed under 12VAC5-481-480 or equivalent NRC or other agreement state regulations, providing the redistributed sealed sources are in the original packaging and shielding and are accompanied by the manufacturer's approved instructions.
3. Any radioactive material with a half-life not longer than 120 days in individual amounts not to exceed 0.56 GBq (15 mCi).
4. Any radioactive material with a half-life longer than 120 days in individual amounts not to exceed the smaller of 7.4 MBq (200 µCi) or 1000 times the quantities in 12VAC5-481-3730.
5. Technetium-99m in amounts as needed.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.
12VAC5-481-1840. Requirements for possession of sealed sources and brachytherapy sources.
A. Licensees in possession of any sealed source or brachytherapy source shall follow the radiation safety and handling instructions supplied by the manufacturer.
B. Licensees in possession of a sealed source shall:
1. Test the source for leakage before its first use unless the licensee has a certificate from the supplied indicating that the source was tested within six months before transfer to the licensee; and
2. Test the source for leakage at intervals not to exceed six months or at other intervals approved by the NRC or another agreement state in the Sealed Source and Device Registry.
C. To satisfy the leak test requirements of this section, licensees shall measure the sample so that the leak test can detect the presence of 0.005 µCi (185 Bq) of radioactive material in the sample.
D. If the leak test reveals the presence of 0.005 µCi (185 Bq) or more of removable contamination, the licensee shall:
1. Immediately withdraw the sealed source from use and store, dispose, or cause it to be repaired in accordance with the requirements in Parts III (12VAC5-481-380 et seq.) and IV (12VAC5-481-600 et seq.) of this chapter; and
2. File a report within five days of the leak test in accordance with 12VAC5-481-2080 C.
E. Licensees need not perform a leak test on the following sources:
1. Containing only radioactive material with a half-life of less than 30 days;
2. Containing only radioactive material as a gas;
3. Containing 100 µCi (3.7 MBq) or less of beta or gamma-emitting material;
4. Containing 10 µCi (0.37 MBq) or less of alpha-emitting material;
4. Seeds of iridium-192 encased in nylon ribbon; and
5. Sources stored and not being used. However, the licensee shall test each such source for leakage before any use or transfer unless it has been leak tested within six months before the date of use or transfer.
F. Licensees in possession of sealed sources or brachytherapy sources, except for gamma stereotactic radiosurgery sources, shall conduct a semi-annual physical inventory of all such sources in its possession.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.
12VAC5-481-1850. Labeling of vials and syringes.
Each syringe and vial that contains unsealed radioactive material shall be labeled to identify the radioactive drug. Each syringe shield and vial shield shall also be labeled unless the label on the syringe or vial is visible when shielded.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.
12VAC5-481-1860. Surveys of ambient radiation exposure rate.
A. In addition to the surveys required by Part IV (12VAC5-481-600 et seq.) of this chapter, licensees shall survey with a radiation detection survey instrument at the end of each day of use. Licensees shall survey all areas where unsealed radioactive material requiring a written directive was prepared for use or administered.
B. Licensees do not need to perform the surveys required by subsection A of this section in an area where patients or human research subjects are confined when they cannot be released under 12VAC5-481-1870.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.
12VAC5-481-1870. Release of individuals containing unsealed radioactive material or implants containing radioactive material.
A. Licensees may authorize the release from its control of any individual who has been administered unsealed radioactive material or implants containing radioactive material if the total effective dose equivalent to any other individual from exposure to the released individual is not likely to exceed 500 mrem (5 mSv).
B. Licensees shall provide the released individual, or the individual's parent or guardian, with instructions, including written instructions, on actions recommended to maintain doses to other individuals as low as is reasonable achievable if the total effective dose equivalent to any other individual is likely to exceed 100 mrem (1 mSv). If the total effective dose equivalent to a nursing infant or child could exceed 100 mrem (1 mSv), assuming there were no interruption of breast-feeding, the instructions shall also include:
1. Guidance on the interruption or discontinuation of breast-feeding; and
2. Information on the potential consequences, if any, on failure to follow guidance.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.
12VAC5-481-1880. Provision of mobile medical service.
A. The mobile medical service shall be licensed if the service receives, uses, or possesses radioactive material. The client of the mobile medical service shall be licensed if the client receives or possesses radioactive material to be used by a mobile medical service.
B. Licensees providing mobile medical service shall:
1. Obtain a letter signed by the management of each client for whom services are rendered that permits the use of radioactive material at the client's address and clearly delineates the authority and responsibility of the licensee and the client;
2. Inform the client's management who is on site at each client's address of use at the time that radioactive material is being administered;
3. Check instruments used to measure the activity of unsealed radioactive material for proper function before medical use at each client's address or on each day of use, whichever is more frequent. At a minimum, the check for proper function required by this subdivision shall include a constancy check;
4. Check survey instruments for proper operation with a dedicated check source before use at each client's address; and
5. Before leaving a client's address, survey all areas of use for dose rate and removable contamination to ensure compliance with the requirements in Part IV (12VAC5-481-600 et seq.) of this chapter.
C. A mobile medical service may not have radioactive material delivered from the manufacturer or the distributor to the client unless the client has a license allowing possession of the radioactive material. Radioactive material delivered to the client shall be received and handled in conformance with the client's license.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.
12VAC5-481-1890. Decay-in-storage.
Licensees may hold radioactive material with a physical half-life of less than or equal to 120 days for decay-in-storage before disposal without regard to its radioactivity if it:
1. Monitors material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding; and
2. Removes or obliterates all radiation labels, except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.