Article 6. Unsealed Byproduct Material - Written Directive Required
12VAC5-481-1950. Use of unsealed radioactive material for which a written directive is required.
Licensees may use any unsealed radioactive material identified in subdivision 2 b (7) of 12VAC5-481-1980 prepared for medical use and for which a written directive is required that is:
1. Obtained from a manufacturer or preparer licensed under 12VAC5-481-480 I or equivalent NRC or other Agreement state requirements or a PET radioactive drug producer licensed under 12VAC5-481-440 H or equivalent NRC or another agreement state requirements;
2. Excluding production of PET radionuclides, prepared by an ANP; a physician who is an authorized user (AU) and who meets the requirements specified in 12VAC5-481-1940 or 12VAC5-481-1980; or an individual under the supervision, as specified in 12VAC5-481-1710, of an ANP or the physician who is an AU;
3. Obtained from and prepared by an agency, NRC, or another agreement state licensee for use in research in accordance with an investigational new drug (IND) protocol accepted by U.S. Food and Drug Administration (FDA); or
4. Prepared by the licensee for use in research in accordance with an IND protocol accepted by FDA.
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.
12VAC5-481-1960. Safety instruction.
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 cannot be released under 12VAC5-481-1870. To satisfy this requirement, the instruction shall be commensurate with the duties of the personnel and include:
1. Patient or human research subject control;
2. Visitor control, including:
a. Routine visitation to hospitalized individuals in accordance with 12VAC5-481-720 A 1; and
b. Visitation authorized in accordance with 12VAC5-481-720 C;
3. Contamination control;
4. Waste control; and
5. Notification of the RSO, or his designee, and an authorized user 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 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.
12VAC5-481-1970. Safety precautions.
A. For each patient or human research subject who cannot be released under 12VAC5-481-1870, licensees shall:
1. Quarter the patient or the human research subject either in:
a. A private room with a private sanitary facility; or
b. A room, with a private sanitary facility, with another individual who also has received therapy with unsealed byproduct material and who also cannot be released under 12VAC5-481-1870;
2. Visibly post the patient's or the human research subject's room with a "Radioactive Materials" sign;
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; and
4. Either monitor material and items removed from the patient's or human research subject's room to determine that their radioactivity 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 the material and items as radioactive waste.
B. 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 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.
12VAC5-481-1980. Training for use of unsealed radioactive material for which a written directive is required.
Except as provided in 12VAC5-481-1780, licensees shall require an authorized user (AU) of unsealed radioactive material for the uses authorized under 12VAC5-481-1950 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 and who meets the requirements in subdivision 2 b (7) of this section. 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; or
2. Who has completed 700 hours of training and experience, including a minimum of 200 hours of classroom and laboratory training, in basic radionuclide handling techniques applicable to the medical use of unsealed radioactive material requiring a written directive. The training and experience shall include:
a. Classroom and laboratory training in the following areas:
(1) Radiation physics and instrumentation;
(2) Radiation protection;
(3) Mathematics pertaining to the use and measurement of radioactivity;
(4) Chemistry of radioactive material for medical use; and
(5) Radiation biology; and
b. Work experience under the supervision of an AU who meets the requirements in this section, 12VAC5-481-1780, or equivalent NRC or another agreement state requirements. A supervising AU, who meets the requirements of this subdivision 2 shall also have experience in administering dosages in the same dosage category or categories (i.e., subdivision 2 b (7) of this section) as the individual requesting authorized user status. The work experience shall involve:
(1) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;
(2) Performing quality control procedures on instruments used to determine the activity of dosages, and performing checks for proper operation of survey meters;
(3) Calculating, measuring, and safely preparing patient or human research subject dosages;
(4) Using administrative controls to prevent a medical event involving the use of unsealed radioactive material;
(5) Using procedures to contain spilled radioactive material safely and using proper decontamination procedures;
(6) (Reserved.)
(7) Administering dosages of radioactive drugs to patients or human research subjects from the three categories in this subdivision 2 b (7). Radioactive drugs containing radionuclides in categories not included in this subdivision are regulated under 12VAC5-481-2060.This work experience must involve a minimum of three cases in each of the following categories (experience with at least three cases in subdivision 2 b (7) (b) of this section also satisfies the requirements of subdivision 2 b (7) (a) of this section) for which the individual is requesting authorized user status.
(a) Oral administration of less than or equal to 33 mCi (1.22 GBq) of sodium iodide I-131, for which a written directive is required;
(b) Oral administration of greater than 33 mCi (1.22 GBq) of sodium iodide I-131;
(c) Parenteral administration of any radioactive drug that contains a radionuclide that is primarily used for its electron emission, beta radiation characteristics, alpha characteristics, or photon energy of less than 150 keV, for which a written directive is required; and
3. Who has obtained written attestation that the individual has satisfactorily completed the requirements in subdivision 2 b of this section and is able to independently fulfill the radiation safety-related duties as an authorized user for oral administration of greater than 1.22 gigabecquerels (33 millicuries) of sodium iodide I-131 for medical uses authorized under 12VAC5-481-1950. The written attestation shall be obtained from either:
a. A preceptor AU who meets the requirements in this section, 12VAC5-481-1780, or equivalent NRC or other agreement state requirements and has experience in administering dosages in the same dosage category (i.e., subdivision 2 b (7) of this section) as the individual requesting authorized user status; or
b. A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements of this section, 12VAC5-481-1780, or equivalent NRC or other agreement state requirements; has experience in administering dosages in the same dosage category as the individual requesting the authorized user status; 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 the training and experience specified in subdivision 2 b of this section.
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; Errata, 38:10 VA.R. 902 January 3, 2022.
12VAC5-481-1990. Training for the oral administration of sodium iodide (I-131) requiring a written directive in quantities less than or equal to 33 mCi (1.22 GBq).
Except as provided in 12VAC5-481-1780, licensees shall require an authorized user (AU) for the oral administration of sodium iodide (I-131) requiring a written directive in quantities less than or equal to 33 mCi (1.22 GBq) to be a physician:
1. Who is certified by a medical specialty board whose certification process includes all of the requirements of subdivision 3 of this section and 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 Licensee Toolkit Web page; or
2. Who is an AU under 12VAC5-481-1980 for uses listed in subdivision 2 b (7) (a) and (b) of 12VAC5-481-1980, 12VAC5-481-2000, or equivalent NRC or other agreement state requirements; or
3. Who has:
a. Completed 80 hours of classroom and laboratory training, applicable to the medical use of sodium iodide (I-131) for procedures requiring a written directive. The training shall include:
(1) Radiation physics and instrumentation;
(2) Radiation protection;
(3) Mathematics pertaining to the use and measurement of radioactivity;
(4) Chemistry of byproduct material for medical use; and
(5) Radiation biology; and
b. Work experience under the supervision of an AU who meets the requirements in this section, 12VAC5-481-1780, 12VAC5-481-1980, 12VAC5-481-2000, or equivalent NRC or another agreement state requirements. A supervising AU who meets the requirements in subdivision 2 of 12VAC5-481-1980 shall also have experience in administering dosages as specified in subdivision 2 b (7) (a) or subdivision 2 b (7) (b) of 12VAC5-481-1980. The work experience shall involve:
(1) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;
(2) Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters;
(3) Calculating, measuring, and safely preparing patient or human research subject dosages;
(4) Using administrative controls to prevent a medical event involving the use of byproduct material;
(5) Using procedures to contain spilled byproduct material safely and using proper decontamination procedures; and
(6) Administering dosages to patients or human research subjects, that includes at least three cases involving the oral administration of less than or equal to 33 mCi (1.22 GBq) of sodium iodide (I-131); and
4. Obtained written attestation that the individual has satisfactorily completed the requirements in subdivision 3 of this section and is able to independently fulfill the radiation safety-related duties as an authorized user for oral administration of less than or equal to 1.22 gigabecquerels (33 millicuries) of sodium iodide I-131 for medical uses authorized under 12VAC5-481-1950. The attestation must be obtained from either:
a. A preceptor authorized user who meets the requirements in this section, 12VAC5-481-1780, 12VAC5-481-1980, 12VAC5-481-2000, or equivalent NRC or other agreement state requirements and has experience in administering dosages as specified in subdivision 2 b (7) (a) or (b) of 12VAC5-481-1980; or
b. A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in this section, 12VAC5-481-1780, 12VAC5-481-1980, 12VAC5-481-2000, or equivalent NRC or other agreement state requirements, has experience in administering dosages as specified in 12VAC5-481-1980 2 b (7) (a) or (b), 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 specified in subdivision 3 of this section.
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.
12VAC5-481-2000. Training for the oral administration of sodium iodide (I-131) requiring a written directive in quantities greater than 33 mCi (1.22 GBq).
Except as provided in 12VAC5-481-1780, licensees shall require an authorized user (AU) for the oral administration of sodium iodide (I-131) requiring a written directive in quantities greater than 33 mCi (1.22 GBq) to be a physician:
1. Who is certified by a medical specialty board whose certification process includes all of the requirements in subdivision 3 of this section and 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; or
2. Who is an AU under 12VAC5-481-1980 for uses listed in subdivision 2 b (7) (b) of 12VAC5-481-1980 or equivalent NRC or other agreement state requirements; or
3. Who has:
a. Completed 80 hours of classroom and laboratory training, applicable to the medical use of sodium iodide (I-131) for procedures requiring a written directive. The training shall include:
(1) Radiation physics and instrumentation;
(2) Radiation protection;
(3) Mathematics pertaining to the use and measurement of radioactivity;
(4) Chemistry of radioactive material for medical use; and
(5) Radiation biology; and
b. Work experience, under the supervision of an AU who meets the requirements in this section, 12VAC5-481-1780, 12VAC5-481-1980, or equivalent NRC or other agreement state requirements. A supervising AU who meets the requirements in subdivision 2 of 12VAC5-481-1980 shall also have experience in administering dosages as specified in subdivision 2 b (7) (b) of 12VAC5-481-1980. The work experience shall involve:
(1) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;
(2) Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters;
(3) Calculating, measuring, and safely preparing patient or human research subject dosages;
(4) Using administrative controls to prevent a medical event involving the use of radioactive material;
(5) Using procedures to contain spilled radioactive material safely and using proper decontamination procedures; and
(6) Administering dosages to patients or human research subjects that includes at least three cases involving the oral administration of greater than 33 mCi (1.22 GBq) of sodium iodide (I-131); and
c. Obtained written attestation that the individual has satisfactorily completed the requirements in subdivision 3 of this section and is able to independently fulfill the radiation safety-related duties as an authorized user for oral administration of greater than 1.22 gigabecquerels (33 millicuries) of sodium iodide I-131 for medical uses authorized under 12VAC5-481-1950. The written attestation must be obtained by either:
(1) A preceptor authorized user who meets the requirements in this section, 12VAC5-481-1780, 12VAC5-481-1980, or equivalent NRC or other Agreement state requirements and has experience in administering dosages as specified in subdivision 2 b (7) (b) of 12VAC5-481-1980; or
(2) A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements of this section, 12VAC5-481-1780, 12VAC5-481-1980, or equivalent NRC or other agreement state requirements; has experience in administering dosages as specified in 12VAC5-481-1980 2 b (7) (b); 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 as specified in this subdivision 3.
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.
12VAC5-481-2001. Training for the parenteral administration of unsealed radioactive material requiring a written directive.
Except as provided in 12VAC5-481-1780, licensees shall require an authorized user (AU) for the parenteral administration requiring a written directive to be a physician:
1. Who is an AU under 12VAC5-481-1980 for uses listed in subdivision 2 b (7) (c) of 12VAC5-481-1980 or equivalent NRC or other Agreement state requirements; or
2. Who is an AU under 12VAC5-481-2018, 12VAC5-481-2040, or equivalent NRC or other agreement state requirements and who meets the requirements in subdivision 4 of this section; or
3. Who is certified by a medical specialty board whose certification process has been recognized by the NRC, the agency, or an agreement state under 12VAC5-481-2018 or 12VAC5-481-2040 and who meets the requirements in subdivision 4 of this section;
4. Who has:
a. Completed 80 hours of classroom and laboratory training applicable to parenteral administrations. The training shall include:
(1) Radiation physics and instrumentation;
(2) Radiation protection;
(3) Mathematics pertaining to the use and measurement of radioactivity;
(4) Chemistry of radioactive material for medical use; and
(5) Radiation biology; and
b. Work experience under the supervision of an AU who meets the requirements in this section, 12VAC5-481-1780, 12VAC5-481-1980, or equivalent NRC or other Agreement state requirements in the parenteral administration listed in 12VAC5-481-1980 2 b (7) (c). A supervising AU who meets the requirements in this section, 12VAC5-481-1980, or equivalent NRC or other agreement state requirements shall have experience in administering dosages in the same category as the individual requesting authorized user status. The work experience shall involve:
(1) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;
(2) Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters;
(3) Calculating, measuring, and safely preparing patient or human research subject dosages;
(4) Using administrative controls to prevent a medical event involving the use of unsealed radioactive material;
(5) Using procedures to contain spilled radioactive material safely and using proper decontamination procedures; and
(6) Administering dosages to patients or human research subjects that include at least three cases of the parenteral administration as specified in 12VAC5-481-1980 2 b (7) (c); and
5. Obtained a written attestation that the individual has satisfactorily completed the requirements in subdivision 4 of this section and is able to independently fulfill the radiation safety-related duties as an authorized user for the parenteral administration of unsealed byproduct material requiring a written directive. The written attestation shall be obtained from either:
a. A preceptor AU who meets the requirements in this section, 12VAC5-481-1780, 12VAC5-481-1980, or equivalent NRC or other agreement state requirements. A preceptor AU who meets the requirements in this section, 12VAC5-481-1980, or equivalent NRC or other agreement state requirements shall have experience in administering dosages in the same category as the individual requesting authorized user status; or
b. A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements of this section, 12VAC5-481-1780, 12VAC5-481-1980, or equivalent NRC or other agreement state requirements; has experience in administering dosages in the same dosage category as the individual requesting authorized user status; 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 of Postdoctoral Training of the American Osteopathic Association and must include training and experience specified in subdivision 4 of this section.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 24, Issue 18, eff. June 12, 2008; amended, Virginia Register Volume 32, Issue 24, eff. August 25, 2016; Errata 37:14 VA.R. 2151 March 1, 2021; Volume 37, Issue 25, eff. January 14, 2022; Errata 38:10 VA.R. 902 January 3, 2022.