Article 7. Manual Brachytherapy
12VAC5-481-2010. Use of sources for manual brachytherapy.
Licensees shall use only brachytherapy sources:
1. As approved in the Sealed Source and Device Registry for manual brachytherapy medical use. The manual brachytherapy sources may be used for manual brachytherapy uses that are not explicitly listed in the Sealed Source and Device Registry but must be used in accordance with the radiation safety conditions and limitations described in the Sealed Source and Device Registry; or
2. In research to deliver therapeutic doses for medical use in accordance with an active Investigational Device Exemption application accepted by the U.S. Food and Drug Administration provided the requirements of 12VAC5-481-1740 are met.
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; Volume 37, Issue 25, eff. January 14, 2022.
12VAC5-481-2011. Surveys after source implant and removal.
A. Immediately after implanting sources in a patient or a human research subject, the licensee shall make a survey to locate and account for all sources that have not been implanted.
B. Immediately after removing the last temporary implant source from a patient or a human research subject, the licensee shall make a survey of the patient or the human research subject with a radiation detection survey instrument to confirm that all sources have been removed.
C. A licensee shall retain a record of the surveys required by subsections A and B of this section in accordance with 12VAC5-481-2070 O.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 32, Issue 24, eff. August 25, 2016.
12VAC5-481-2012. Brachytherapy sources accountability.
A. Licensees shall maintain accountability at all times for all brachytherapy sources in storage or use.
B. As soon as possible after removing sources from a patient or a human research subject, licensees shall return brachytherapy sources to a secure storage area.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 32, Issue 24, eff. August 25, 2016.
12VAC5-481-2013. Safety instruction.
A. In addition to the requirements of 12VAC5-481-2270, licensees shall provide radiation safety instruction initially and at least annually, to personnel caring for patients or human research subjects who are receiving brachytherapy and cannot be released under 12VAC5-481-1870.
B. To satisfy this requirement, the instruction shall be commensurate with the duties of the personnel and include:
1. Size and appearance of the brachytherapy sources;
2. Safe handling and shielding instructions;
3. Patient or human research subject control;
4. Visitor control, including both:
a. Routine visitation of hospitalized individuals in accordance with 12VAC5-481-720 A 1; and
b. Visitation authorized in accordance with 12VAC5-481-720 C; and
5. Notification of the RSO, or his designee, and an AU if the patient or the human research subject has a medical emergency or dies. The licensee shall also notify the agency if it is possible that any individual could receive exposures in excess of regulatory limits as a result of the deceased's body.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 32, Issue 24, eff. August 25, 2016.
12VAC5-481-2014. Safety precautions.
A. For each patient or human research subject who is receiving brachytherapy and cannot be released under 12VAC5-481-1870, licensees shall:
1. Not quarter the patient or human research subject in the same room as an individual who is not receiving brachytherapy;
2. Visibly post the patient's or human research subject's room with a "Radioactive Materials" sign; and
3. Note on the door or in the patient's or human research subject's chart where and how long visitors may stay in the patient's or human research subject's room.
B. Licensees shall have applicable emergency response equipment available near each treatment room to respond to a source that becomes:
1. Dislodged from the patient; and
2. Lodged within the patient following removal of the source applicators.
C. Licensees shall notify the RSO, or his designee, and an AU as soon as possible if the patient or human research subject has a medical emergency or dies.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 32, Issue 24, eff. August 25, 2016.
12VAC5-481-2015. Calibration measurements of brachytherapy sources.
A. Before the first medical use of a brachytherapy source, licensees shall have:
1. Determined the source output or activity using a dosimetry system that meets the requirements of 12VAC5-481-2044;
2. Determined source positioning accuracy with applicators; and
3. Used published protocols currently accepted by nationally recognized bodies to meet the requirements of subdivision 1 and 2 of this subsection.
B. Instead of a licensee making its own measurements as required in subsection A of this section, the licensee may use measurements provided by the source manufacturer or by a calibration laboratory accredited by the American Association of Physicists in Medicine that are made in accordance with subsection A of this section.
C. A licensee shall mathematically correct the outputs or activities determined in subsection A of this section for physical decay at intervals consistent with 1.0% physical decay.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 32, Issue 24, eff. August 25, 2016.
12VAC5-481-2016. Strontium-90 sources for ophthalmic treatments.
A. Licensees who use strontium-90 for ophthalmic treatments must ensure that certain activities as specified in subsection B of this section are performed by either:
1. An authorized medical physicist; or
2. An individual who:
a. Is identified as on ophthalmic physicist on a specific medical use license issued the agency, NRC, or another agreement state; permit issued by an agency, NRC, or another agreement state broad scope licensee; medical use permit issued by a NRC master material licensee; or permit issued by a NRC master material broad scope medical use permittee;
b. Holds a master's or doctor's degree in physics, medical physics, other physical sciences, engineering, or applied mathematics from an accredited college or university;
c. Has successfully completed one year of full-time training in medical physics and an additional year of full-time work experience under the supervision of a medical physicist; and
d. Has documented training in the following:
(1) The creation, modification, and completion of written directives;
(2) Procedures for administrations requiring a written directive; and
(3) Performing the calibration measurements of brachytherapy sources as detailed in 12VAC5-481-2015.
B. The individuals who are identified in subsection A of this section must:
1. Calculate the activity of each strontium-90 sources that is used to determine the treatment times for ophthalmic treatments. The decay must be based on the activity determined under 12VAC5-481-2015; and
2. Assist the licensee in developing, implementing, and maintaining written procedures to provide a high confidence that the administration is in accordance with the written directive. These procedures must include the frequencies that the individual meeting the requirements in subsection A of this section will observe treatments, review the treatment methodology, calculate treatment time for prescribed dose, and review records to verify that the administrations were in accordance with the written directive.
C. Licensees must retain a record of the activity of each strontium-90 source in accordance with 12VAC5-481-2070 P.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 32, Issue 24, eff. August 25, 2016; amended, Virginia Register Volume 37, Issue 25, eff. January 14, 2022; Errata, 38:10 VA.R. 902 January 3, 2022.
12VAC5-481-2017. Therapy-related computer systems.
Licensees shall perform acceptance testing on the treatment planning system of therapy-related computer systems in accordance with published protocols accepted by nationally recognized bodies. At a minimum, the acceptance testing shall include, as applicable, verification of:
1. The source-specific input parameters required by the dose calculation algorithm;
2. The accuracy of dose, dwell time, and treatment time calculations at representative points;
3. The accuracy of isodose plots and graphic displays; and
4. The accuracy of the software used to determine sealed source positions from radiographic images.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 32, Issue 24, eff. August 25, 2016.
12VAC5-481-2018. Training for use of manual brachytherapy sources.
Except as provided in 12VAC5-481-1780, licensees shall require an authorized user of a manual brachytherapy source for uses authorized under 12VAC5-481-2010 to be a physician:
1. Who is certified by a medical specialty board whose certification process has been recognized by the NRC, the agency, or an agreement state. The names of board certifications that have been recognized by the NRC or an agreement state are posted on the NRC's Medical Uses Licensee Toolkit Web page. To have its certification process recognized, a specialty board shall require all candidates for certification to:
a. Successfully complete a minimum of three years of residency training in a radiation oncology program approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association; and
b. Pass an examination administered by diplomates of the specialty board that tests knowledge and competence in radiation safety, radionuclide handling, treatment planning, quality assurance, and clinical use of manual brachytherapy; or
2. Who has:
a. Completed a structured educational program in basic radionuclide handling techniques applicable to the use of manual brachytherapy sources that includes:
(1) 200 hours of classroom and laboratory training in the following areas:
(a) Radiation physics and instrumentation;
(b) Radiation protection;
(c) Mathematics pertaining to the use and measurement of radioactivity; and
(d) Radiation biology; and
(2) 500 hours of work experience, under the supervision of an authorized user who meets the requirements in this subsection, 12VAC5-481-1780, or equivalent NRC or another agreement state requirements at a medical facility authorized to use radioactive material under 12VAC5-481-2010, involving:
(a) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;
(b) Checking survey meters for proper operation;
(c) Preparing, implanting, and removing brachytherapy sources;
(d) Maintaining running inventories of material on hand;
(e) Using administrative controls to prevent a medical event involving the use of radioactive material;
(f) Using emergency procedures to control radioactive material; and
b. Completed three years of supervised clinical experience in radiation oncology, under an AU who meets the requirements in this section, 12VAC5-481-1780, or equivalent NRC or another agreement state requirements, as part of a formal training program approved by the Residency Review Committee for Radiation Oncology of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association. This experience may be obtained concurrently with the supervised work experience required by subdivision 2 a (2) of this section.
3. Who has obtained written attestation that the individual has satisfactorily completed the requirements in subdivision 2 of this section and has achieved a level of competency sufficient to function independently as an AU of manual brachytherapy sources for the medical uses authorized in 12VAC5-481-2010. This attestation must be obtained from either:
a. A preceptor authorized user who meets the requirements in this section, 12VAC5-481-1780, or equivalent NRC or other agreement state requirements; or
b. A residency program director who affirms in writing that the attestation represents the residency program faculty where at least one faculty member is an authorized user who meets the requirement in this section, 12VAC5-481-1780, or equivalent NRC or other agreement state requirements and concurs with the attestation provided by the residency program director. The residency training program must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience specific in subsection 2 of this section.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 32, Issue 24, eff. August 25, 2016; amended, Virginia Register Volume 37, Issue 25, eff. January 14, 2022; Volume 39, Issue 24, eff. August 16, 2023.
12VAC5-481-2019. Training for ophthalmic use of strontium-90.
Except as provided in 12VAC5-481-1780, licensees shall require the AU of strontium-90 for ophthalmic radiotherapy to be a physician:
1. Who is an authorized user (AU) under 12VAC5-481-2018 or equivalent NRC or other Agreement state requirements; or
2. Who has:
a. Completed 24 hours of classroom and laboratory training applicable to the medical use of strontium-90 for ophthalmic radiotherapy. The training shall include:
(1) Radiation physics and instrumentation;
(2) Radiation protection;
(3) Mathematics pertaining to the use and measurement of radioactivity; and
(4) Radiation biology; and
b. Clinical training in ophthalmic radiotherapy under the supervision of an authorized user at a medical institution, clinic, or private practice that includes the use of strontium-90 for the ophthalmic treatment of five individuals. This supervised clinical training shall involve:
(1) Examination of each individual to be treated;
(2) Calculation of the dose to be administered;
(3) Administration of the dose; and
(4) Follow up and review of each individual's case history; and
c. Obtained written attestation, signed by a preceptor AU who meets the requirements in 12VAC5-481-1780, 12VAC5-481-2018, this section, or equivalent NRC or other Agreement state requirements, that the individual has satisfactorily completed the requirements in this subdivision 2 and is able to independently fulfill the radiation safety-related duties as an authorized user of strontium-90 for ophthalmic use.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 32, Issue 24, eff. August 25, 2016; amended, Virginia Register Volume 37, Issue 25, eff. January 14, 2022.