12VAC5-481-2080. Reports.
A. Report and notification of a medical event.
1. Licensees shall report any event as a medical event, except for an event that results from patient intervention, in which the administration of radioactive material or radiation from radioactive material, except permanent implant brachytherapy, results in:
a. A dose that differs from the prescribed dose or dose that would have resulted from the prescribed dosage by more than 5 rem (0.05 Sv) effective dose equivalent, 50 rem (0.5 Sv) to an organ or tissue, or 50 rem (0.5 Sv) shallow dose equivalent to the skin; and
(1) The total dose delivered differs from the prescribed dose by 20% or more;
(2) The total dosage delivered differs from the prescribed dosage by 20% or more or falls outside the prescribed dosage range; or
(3) The fractionated dose delivered differs from the prescribed dose, for a single fraction, by 50% or more.
b. A dose that exceeds 5 rem (0.05 Sv) effective dose equivalent, 50 rem (0.5 Sv) to an organ or tissue, or 50 rem (0.5 Sv) shallow dose equivalent to the skin from any of the following:
(1) An administration of a wrong radioactive drug containing radioactive material or the wrong radionuclide for a brachytherapy procedure;
(2) An administration of a radioactive drug containing radioactive material by the wrong route of administration;
(3) An administration of a dose or dosage to the wrong individual or human research subject;
(4) An administration of a dose or dosage delivered by the wrong mode of treatment; or
(5) A leaking sealed source.
c. A dose to the skin or an organ or tissue other than the treatment site that exceeds by 50 rem (0.5 Sv) or more of the dose expected to that site if the administration had been given in accordance with the written directive prepared or revised before administration and 50% or more the expected dose to that site from the procedure if the administration had been given in accordance with the written directive prepared or revised before administration.
2. For permanent implant brachytherapy, the administration of radioactive material or radiation from radioactive material, excluding sources that were implanted in the correct site but migrated outside the treatment site, that result in the total source strength administered differing by 20% or more from the total source strength documented in the post-implantation portion of the written directive or the total source strength administered outside of the treatment site exceeding 20% of the total source strength documented in the post-implantation of the written directive or an administration involving any of the following: wrong radionuclide, the wrong individual or human research subject, sealed sources implanted directly into a location discontiguous from the treatment site as documented in the post-implantation portion of the written directive, or a leaking sealed source resulting in a dose that exceeds 50 rem (0.5 Sv) to an organ or tissue.
3. Licensees shall report any event resulting from intervention of a patient or human research subject in which the administration of radioactive material or radiation from radioactive material results or will result in unintended permanent functional damage to an organ or a physiological system, as determined by a physician.
4. Licensees shall notify the agency by telephone no later than the next calendar day after discovery of the medical event.
5. By an appropriate method listed in 12VAC5-481-150, licensees shall submit a written report to the agency within 15 days after discovery of the medical event.
a. The written report shall include:
(1) The licensee's name;
(2) The name of the prescribing physician;
(3) A brief description of the event;
(4) Why the event occurred;
(5) The effect, if any, on the individuals who received the administration;
(6) What actions, if any, have been taken or are planned to prevent recurrence; and
(7) Certification that the licensee notified the individual (or the individual's responsible relative or guardian), and if not, why not.
b. The report may not contain the individual's name or any other information that could lead to identification of the individual.
6. Licensees shall provide notification of the event to the referring physician and also notify the individual who is the subject of the medical event no later than 24 hours after its discovery, unless the referring physician personally informs the licensee either that he will inform the individual or that, based on medical judgment, telling the individual would be harmful. Licensees are not required to notify the individual without first consulting the referring physician. If the referring physician or the affected individual cannot be reached within 24 hours, licensees shall notify the individual as soon as possible thereafter. Licensees may not delay any appropriate medical care for the individual, including any necessary remedial care as a result of the medical event, because of any delay in notification. To meet the requirements of this subdivision, the notification of the individual who is the subject of the medical event may be made instead to that individual's responsible relative or guardian. If a verbal notification is made, licensees shall inform the individual, or appropriate responsible relative or guardian, that a written description of the event can be obtained from the licensee upon request. Licensees shall provide such a written description if requested.
6. Aside from the notification requirement, nothing in this section affects any rights or duties of licensees and physicians in relation to each other, to individuals affected by the medical event, or to that individual's responsible relatives or guardians.
7. Licensees shall:
a. Annotate a copy of the report provided to the agency with the:
(1) Name of the individual who is the subject of the event; and
(2) Identification number, or if no other identification number is available, the social security number of the individual who is the subject of the event; and
b. Provide a copy of the annotated report to the referring physician, if other than the licensee, no later than 15 days after the discovery of the event.
B. Report and notification of a dose to an embryo/fetus or a nursing child.
1. Licensees shall report any dose to an embryo/fetus that is greater than 500 mrem (5 mSv) dose equivalent that is a result of an administration of radioactive material or radiation from radioactive material to a pregnant individual unless the dose to the embryo/fetus was specifically approved, in advance, by the authorized user.
2. Licensees shall report any dose to a nursing child that is a result of an administration of radioactive material to a breast-feeding individual that:
a. Is greater than 5 mSv (500 rem) total effective dose equivalent; or
b. Has resulted in unintended permanent functional damage to an organ or a physiological system of the child, as determined by a physician.
3. Licensees shall notify the agency by telephone no later than the next calendar day after discovery of a dose to the embryo/fetus or nursing child that requires a report in accordance with subdivision 1 or 2 in this subsection.
4. By an appropriate method listed in 12VAC5-481-150, licensees shall submit a written report to the agency within 15 days after discovery of a dose to the embryo/fetus or nursing child that requires a report in subdivision 1 or 2 of this subsection.
a. The written report shall include
(1) The licensee's name;
(2) The name of the prescribing physician;
(3) A brief description of the event;
(4) Why the event occurred;
(5) The effect, if any, on the embryo/fetus or the nursing child;
(6) What actions, if any, have been taken or are planned to prevent recurrence; and
(7) Certification that the licensee notified the pregnant individual or mother (or the mother's or child's responsible relative or guardian), and if not, why not.
b. The report shall not contain the individual's or child's name or any other information that could lead to identification of the individual or child.
5. Licensees shall provide notification of the event to the referring physician and also notify the pregnant individual or mother, both hereafter referred to as "mother," no later than 24 hours after discovery of an event that would require reporting under subdivisions 1 or 2 of this subsection, unless the referring physician personally informs the licensee either that the mother will be informed or that, based on medical judgment, telling the mother would be harmful. Licensees are not required to notify the mother without first consulting with the referring physician. If the referring physician or mother cannot be reached within 24 hours, licensees shall make the appropriate notifications as soon as possible thereafter. Licensees may not delay any appropriate medical care for the embryo/fetus or for the nursing child, including any necessary remedial care as a result of the event, because of any delay in notification. To meet the requirements of this subdivision, the notification may be made to the mother's or child's responsible relative or guardian instead of the mother, when appropriate. If a verbal notification is made, licensees shall inform the mother, or the mother's or child's responsible relative or guardian, that a written description of the event can be obtained from the licensee upon request. Licensees shall provide such a written description if requested.
6. Licensees shall:
a. Annotate a copy of the report provided to the agency with the:
(1) Name of the pregnant individual or the nursing child who is the subject of the event; and
(2) Identification number, or if no other identification number is available, the social security number of the pregnant individual or the nursing child who is the subject of the event; and
b. Provide a copy of the annotated report to the referring physician, if other than the licensee, no later than 15 days after the discovery of the event.
C. Report of a leaking source.
1. Licensees shall file a report within five days if a leak test required by 12VAC5-481-1840 reveals the presence of 0.005 µCi (185 Bq) or more of removable contamination.
2. The report shall be filed with the agency by an appropriate method listed in 12VAC5-481-150. The written report shall include:
a. The model number and serial number, if assigned, of the leaking source;
b. The radionuclide and its estimated activity;
c. The results of the test;
d. The date of the test; and
e. The action taken.
D. Report and notification for an eluate exceeding permissible molybdenum-99, strontium-82, and strontium-85 concentrations.
1. Licensees shall notify the agency and the distributor of the generator by telephone within seven calendar days after discovery that an eluate exceeded the permissible concentration listed in 12VAC5-481-1930 A at the time of generator elution. The telephone 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.
2. By an appropriate method listed in 12VAC5-481-150, the licensee shall submit a written report to the agency within 30 calendar days after discovery of an eluate exceeding the permissible concentration at the time of generator elution. The written report shall 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; the probable cause and assessment of failure in the licensee's equipment, procedure, or training that contributed to the excessive readings if an error occurred in the licensee's breakthrough determination; and the information in the telephone report as required by subdivision 1 of this subsection.
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.