12 Va. Admin. Code § 5-481-2070

Current through Register Vol. 41, No. 6, November 4, 2024

Section 12VAC5-481-2070 - Records

A. Records of authority and responsibilities for radiation protection programs.

1. Licensees shall retain a record of actions taken by the licensee's management in accordance with 12VAC5-481-1700 for five years. The record shall include a summary of the actions taken and a signature of licensee management.

2. Licensees shall retain a copy of both authority, duties, and responsibilities of the RSO as required by 12VAC5-481-1700 and a signed copy of each RSO's agreement to be responsible for implementing the radiation safety program, as required by 12VAC5-481-1700, for the duration of the license. The records shall include the signature of the RSO and licensee management.

3. For each associate radiation safety officer, the licensee shall retain for five years after the associate radiation safety officer is removed from the license, a copy of the written document appointing the associate radiation safety officer signed by licensee's management.

B. Records of radiation protection program changes. Licensees shall retain a record of each radiation protection program change made in accordance with 12VAC5-481-1700 F for five years. The record shall include a copy of the old and new procedures, the effective date of the change, and the signature of the licensee management that reviewed and approved the change.

C. Records of written directives. Licensees shall retain a copy of each written directive as required by 12VAC5-481-1720 for three years.

D. Records for procedures for administrations requiring written directive. Licensees shall retain a copy of the procedures required by 12VAC5-481-1730 for the duration of the license.

E. Records of dosages of unsealed radioactive material for medical use. Licensees shall maintain a record of dosage determinations required by 12VAC5-481-1820 for three years. The record shall contain the radiopharmaceutical; the patient's or human research subject's name or identification number if one has been assigned; the prescribed dosage, the determined dosage, or a notation that the total activity is less than 30 µCi (1.1 MBq); the date and time of dosage determination; and the name of the individual who determined the dosage.

F. Records of leak tests and inventory of sealed sources and brachytherapy sources.

1. Licensees shall retain records of leak tests required by 12VAC5-481-1840 for three years. The records shall include the model number, and the serial number, if one has been assigned, of each source tested; the identity of each source by radionuclide and its estimated activity; the results of the test; the date of the test; and the name of the individual who performed the test.

2. Licensees shall retain records of the semi-annual physical inventory of sealed sources and brachytherapy sources required by 12VAC5-481-1840 for three years. The inventory records shall contain the model number of each source, and serial number of each source if one has been assigned, the identity of each source by radionuclide and its nominal activity, the location of each source, and the name of the individual who performed the inventory.

G. Records of surveys for ambient radiation exposure rate. Licensees shall retain a record of each survey required by 12VAC5-481-1860 for three years. The record shall include the date of the survey, the results of the survey, the instrument used to make the survey, and the name of the individual who performed the survey.

H. Records of the release of individuals containing unsealed radioactive material or implants containing radioactive material.

1. Licensees shall retain a record signed by the authorized user of the basis for authorizing the release of an individual in accordance with 12VAC5-481-1870 for three years after the date of release if the total effective dose equivalent is calculated by:

a. Using the retained activity rather than the activity administered;

b. Using an occupancy factor less than 0.25 at 1 meter;

c. Using the biological or effective half-life; or

d. Considering the shielding by tissue.

2. Licensees shall retain a record for three years after the date of release of the instruction required by 12VAC5-481-1870 that were provided to a breast-feeding female if the radiation dose to the infant or child from continued breast-feeding could result in a total effective dose equivalent exceeding 500 mrem (5 mSv).

I. Records of mobile medical services.

1. Licensees shall retain a copy of each letter that permits the use of radioactive material at the client's address, as required by 12VAC5-481-1880. Each letter shall clearly delineate the authority and responsibility of the licensee and the client and shall be retained for three years after the last provision of service.

2. Licensees shall retain the record of each survey required by 12VAC5-481-1880 for three years. The record shall include the date of the survey, the results of the survey, the instrument used to make the survey, and the name of the individual who performed the survey.

J. Records of decay-in-storage. Licensees shall maintain records of the disposal of licensed materials, as required by 12VAC5-481-1890 for three years. The record shall include the date of the disposal, the survey instrument used, the background radiation level, the radiation level measured at the surface of each waste container, and the name of the individual who performed the survey.

K. Records of molybdenum-99, strontium-82 and strontium-85 concentrations. Licensee shall maintain a record of molybdenum-99 concentration or strontium-82 and stontrium-85 concentration tests required by 12VAC5-481-1930 for three years. The record shall include:

1. For each measured elution of technetium-99m, the ratio of measures expressed as microcuries of molybdenum-99 per millicurie of technetium-99m or kilobecquerel of molybdenum-99 per megabecquerel of technetium-99m, the time and date of the measurement, and the name of the individual who made the measurement; or

2. For each measured elution of rubidium-82, the ratio of the measures expressed as microcurie of strontium-82 per millicurie of rubidium-82 or kilobecquerel of strontium-82 per megabecquerel of rubidium-82, microcurie of strontium-85 per millicurie of rubidium-82 or kilobecquerel of strontium-85 per megabecquerel of rubidium-82, the time and date of the measurement, and the name of the individual who made the measurement.

L. Records of safety instruction. Licensees shall maintain a record of safety instructions and training required by 12VAC5-481-1960 and 12VAC5-481-1970 and the operational and safety instructions required by 12VAC5-481-2013 for three years. Each record shall include a list of topics covered, the date of the instruction or training, the names of the attendees, and the names of the individuals who provided the instruction.

M. Records of surveys after source implant and removal. Licensees shall maintain a record of the surveys required by 12VAC5-481-2011 and 12VAC5-481-2041 for three years. Each record shall include the date and results of the survey, the survey instrument used, and the name of the individual who made the survey.

N. Records of brachytherapy source accountability.

1. Licensee shall maintain a record of brachytherapy source accountability required by 12VAC5-481-2012 for three years.

2. For temporary implants, the record shall include the number and activity of sources removed from storage, the time and date they were removed from storage, the name of the individual who removed them from storage, and the location of use and the number and activity of sources returned to storage, the time and date they were returned to storage, and the name of the individual who returned them to storage.

3. For permanent implants, the record shall include the number and activity of sources removed from storage, the date they were removed from storage, the name of the individual who removed them from storage, the number and activity of sources not implanted, the date they were returned to storage, the name of the individual who returned them to storage, and the number and activity of sources permanently implanted in the patient or human research subject.

O. Records of calibration measurements of brachytherapy sources. Licensees shall maintain a record of the calibrations of brachytherapy sources required by 12VAC5-481-2015 for three years after the last use of the source. The record shall include the date of the calibration; the manufacturer's name, model number and serial number for the source and the instruments used to calibrate the source; the source output or activity; the source positioning accuracy within the applicators; and the name of the individual, the source manufacturer, or the calibration laboratory that performed the calibration.

P. Records of decay of strontrium-90 sources for ophthalmic treatments. Licensees shall maintain a record of the activity of a strontium-90 source required by 12VAC5-481-2016 for the life of the source. The record shall include the date and initial activity of the source as determined under 12VAC5-481-2016, and for each decay calculation, the date and the source activity as determined under 12VAC5-481-2016 and the signature of the authorized medical physicist.

Q. Records of installation, maintenance, adjustment, and repair of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units. Licensees shall retain a record of the installation, adjustment, maintenance, and repair of remote afterloaders units, teletherapy units, and gamma stereotactic radiosurgery units as required by 12VAC5-481-2042 for three years. For each installation, adjustment, maintenance, and repair, the record shall include the date, description of the service, and names of the individuals who performed the work.

R. Records of safety procedures. Licensees shall retain a copy of the procedures required by 12VAC5-481-2043 until the licensee no longer possesses the remote afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery unit.

S. Records of dosimetry equipment used with remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units. Licensees shall retain a record of the calibration, intercomparison, and comparisons of its dosimetry equipment done in accordance with 12VAC5-481-2044 for the duration of the license. For each calibration, intercomparison, or comparison, the record shall include the date; the manufacturer's name, model numbers, and serial numbers of the instruments that were calibrated, intercompared, or compared as required by 12VAC5-481-2044; the correction factor that was determined from the calibration or comparison or the apparent correction factor that was determined from an intercomparison; and the names of the individuals who performed the calibration, intercomparison, or comparison.

T. Records of teletherapy, remote afterloader, and gamma stereotactic radiosurgery full calibrations. Licensees shall maintain a record of the teletherapy unit, remote afterloader unit, and gamma stereotactic radiosurgery unit full calibrations required by 12VAC5-481-2045 for three years. The record shall include the date of calibration; the manufacturer's name, model number, and serial number of the teletherapy, remote afterloader, and gamma stereotactic radiosurgery unit, the source, and the instruments used to calibrate the unit; the results and an assessment of the full calibrations; the results of the autoradiograph required for low dose-rate remote afterloader units; and the signature of the authorized medical physicist who performed the full calibration.

U. Records of periodic spot-checks for teletherapy units, remote afterloader units, and gamma stereotactic radiosurgery units.

1. Licensees shall retain a record of each periodic spot-check for teletherapy units, remote afterloader units, and gamma stereotactic radiosurgery units required by 12VAC5-481-2046 for three years. The record shall include:

a. For each teletherapy unit; the date of the spot-check, the manufacturer's name, model number, and serial number, source, and instrument used to measure the output of the teletherapy unit; an assessment of timer linearity and constancy; the calculated on-off error; a determination of the coincidence of the radiation field and the field indicated by the light beam localizing device; the determined accuracy of each distance measuring and localization device; the difference between the anticipated output and the measured output; notations indicating the operability of each entrance door electrical interlock, each electrical or mechanical stop, each source exposure indicator light, and the viewing and intercom system and doors; the name of the individual who performed the periodic spot-check; and the signature of the authorized medical physicist who reviewed the record of the spot-check.

b. For each remote afterloader unit: the date of the spot-check, the manufacturer's name, model and serial number for the remote afterloader unit and source; an assessment of timer accuracy; notations indicating the operability of each entrance door electrical interlock, radiation monitors, source exposure indicator lights, viewing and intercom systems, and clock and decayed source activity in the unit's computer; the name of the individual who performed the periodic spot-check; and the signature of the authorized medical physicist who reviewed the record of the spot-check.

c. For each gamma stereotactic radiosurgery unit: the date of the spot-check, the manufacturer's name, model number, and serial number for the gamma stereotactic radiosurgery unit and the instrument used to measure the output of the unit; an assessment of timer linearity and accuracy; the calculated on-off error; a determination of trunnion centricity; the difference between the anticipated output and the measured output; an assessment of source output against computer calculations; notations indicating the operability of radiation monitors; helmet microswitches, emergency timing circuits, emergency off buttons, electrical interlocks, source exposure indicator lights, viewing and intercom systems; timer termination, treatment table retraction mechanism, and stereotactic frames and localizing device (trunnions); the name of the individual who performed the periodic spot-check; and the signature of the authorized medical physicist who reviewed the record of the spot-check.

2. Licensees shall retain a copy of the procedures required by 12VAC5-481-2046 A 2, 12VAC5-481-2046 B, and 12VAC5-481-2046 C 2 until the licensee no longer possesses the teletherapy unit, remote afterloader unit, or gamma stereotactic radiosurgery unit.

V. Records of additional technical requirements for mobile remote afterloader units. Licensees shall retain a record of each check for mobile remote afterloader units required by 12VAC5-481-2047 for three years. The record shall include the date of the check, the manufacturer's name, model number, and serial number of the remote afterloader unit; notations accounting for all sources before the licensee departs from a facility; notations indicating the operability of each entrance door electrical interlock, radiation monitors, source exposure indicator lights, viewing and intercom system, applicators, source transfer tubes, and transfer tube applicator interfaces; source positioning accuracy; and the signature of the individual who performed the check.

W. Records of surveys of therapeutic treatment units. Licensees shall maintain a record of radiation surveys of treatment units made in accordance with 12VAC5-481-2041 for the duration of use of the unit. The record shall include the date of the measurements, the manufacturer's name, model number, and serial number of the treatment unit; source and instrument used to measure radiation levels; each dose rate measured around the source while the unit is in the off position and the average of all measurements; and the signature of the individual who performed the test.

X. Records of five-year inspection for teletherapy and gamma stereotactic radiosurgery units. Licensees shall maintain a record of the full-inspection servicing for teletherapy and gamma stereotactic radiosurgery required by 12VAC5-481-2048 for the duration of use of the unit. The record shall include the inspector's radioactive materials license number, the date of inspection, the manufacturer's name, model number, and serial number of both the treatment unit and source, a list of components inspected and serviced, the type of service, and the signature of the inspector.

12 Va. Admin. Code § 5-481-2070

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; Amended, Virginia Register Volume 37, Issue 25, eff. 1/14/2022.

Statutory Authority: § 32.1-229 of the Code of Virginia.