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Electronic Code of Federal Regulations

e-CFR data is current as of June 2, 2020

Title 10Chapter IPart 35 → Subpart L


Title 10: Energy
PART 35—MEDICAL USE OF BYPRODUCT MATERIAL


Subpart L—Records


Contents
§35.2024   Records of authority and responsibilities for radiation protection programs.
§35.2026   Records of radiation protection program changes.
§35.2040   Records of written directives.
§35.2041   Records for procedures for administrations requiring a written directive
§35.2060   Records of calibrations of instruments used to measure the activity of unsealed byproduct material.
§35.2061   Records of radiation survey instrument calibrations.
§35.2063   Records of dosages of unsealed byproduct material for medical use.
§35.2067   Records of leaks tests and inventory of sealed sources and brachytherapy sources.
§35.2070   Records of surveys for ambient radiation exposure rate.
§35.2075   Records of the release of individuals containing unsealed byproduct material or implants containing byproduct material.
§35.2080   Records of mobile medical services.
§35.2092   Records of decay-in-storage.
§35.2204   Records of molybdenum-99, strontium-82, and strontium-85 concentrations.
§35.2310   Records of safety instruction.
§35.2404   Records of surveys after source implant and removal.
§35.2406   Records of brachytherapy source accountability.
§35.2432   Records of calibration measurements of brachytherapy sources.
§35.2433   Records of decay of strontium-90 sources for ophthalmic treatments.
§35.2605   Records of installation, maintenance, adjustment, and repair of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.
§35.2610   Records of safety procedures.
§35.2630   Records of dosimetry equipment used with remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.
§35.2632   Records of teletherapy, remote afterloader, and gamma stereotactic radiosurgery full calibrations.
§35.2642   Records of periodic spot-checks for teletherapy units.
§35.2643   Records of periodic spot-checks for remote afterloader units.
§35.2645   Records of periodic spot-checks for gamma stereotactic radiosurgery units.
§35.2647   Records of additional technical requirements for mobile remote afterloader units.
§35.2652   Records of surveys of therapeutic treatment units.
§35.2655   Records of full-inspection servicing for teletherapy and gamma stereotactic radiosurgery units.

§35.2024   Records of authority and responsibilities for radiation protection programs.

(a) A licensee shall retain a record of actions taken by the licensee's management in accordance with §35.24(a) for 5 years. The record must include a summary of the actions taken and a signature of licensee management.

(b) The licensee shall retain a copy of both authority, duties, and responsibilities of the Radiation Safety Officer as required by §35.24(e), and a signed copy of each Radiation Safety Officer's agreement to be responsible for implementing the radiation safety program, as required by §35.24(b), for the duration of the license. The records must include the signature of the Radiation Safety Officer and licensee management.

(c) For each Associate Radiation Safety Officer appointed under §35.24(b), the licensee shall retain, for 5 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 the licensee's management.

[67 FR 20370, Apr. 24, 2002, as amended at 83 FR 33111, July 16, 2018]

§35.2026   Records of radiation protection program changes.

A licensee shall retain a record of each radiation protection program change made in accordance with §35.26(a) for 5 years. The record must 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.

§35.2040   Records of written directives.

A licensee shall retain a copy of each written directive as required by §35.40 for 3 years.

§35.2041   Records for procedures for administrations requiring a written directive

A licensee shall retain a copy of the procedures required by §35.41(a) for the duration of the license.

§35.2060   Records of calibrations of instruments used to measure the activity of unsealed byproduct material.

A licensee shall maintain a record of instrument calibrations required by §35.60 for 3 years. The records must include the model and serial number of the instrument, the date of the calibration, the results of the calibration, and the name of the individual who performed the calibration.

§35.2061   Records of radiation survey instrument calibrations.

A licensee shall maintain a record of radiation survey instrument calibrations required by §35.61 for 3 years. The record must include the model and serial number of the instrument, the date of the calibration, the results of the calibration, and the name of the individual who performed the calibration.

§35.2063   Records of dosages of unsealed byproduct material for medical use.

(a) A licensee shall maintain a record of dosage determinations required by §35.63 for 3 years.

(b) The record must contain—

(1) The radiopharmaceutical;

(2) The patient's or human research subject's name, or identification number if one has been assigned;

(3) The prescribed dosage, the determined dosage, or a notation that the total activity is less than 1.1 MBq (30 µCi);

(4) The date and time of the dosage determination; and

(5) The name of the individual who determined the dosage.

§35.2067   Records of leaks tests and inventory of sealed sources and brachytherapy sources.

(a) A licensee shall retain records of leak tests required by §35.67(b) for 3 years. The records must include the model number, and 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.

(b) A licensee shall retain records of the semi-annual physical inventory of sealed sources and brachytherapy sources required by §35.67(g) for 3 years. The inventory records must contain the model number of each source, and serial number 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.

§35.2070   Records of surveys for ambient radiation exposure rate.

A licensee shall retain a record of each survey required by §35.70 for 3 years. The record must 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.

§35.2075   Records of the release of individuals containing unsealed byproduct material or implants containing byproduct material.

(a) A licensee shall retain a record of the basis for authorizing the release of an individual in accordance with §35.75, if the total effective dose equivalent is calculated by—

(1) Using the retained activity rather than the activity administered;

(2) Using an occupancy factor less than 0.25 at 1 meter;

(3) Using the biological or effective half-life; or

(4) Considering the shielding by tissue.

(b) A licensee shall retain a record that the instructions required by §35.75(b) 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 5 mSv (0.5 rem).

(c) The records required by paragraphs (a) and (b) of this section must be retained for 3 years after the date of release of the individual.

§35.2080   Records of mobile medical services.

(a) A licensee shall retain a copy of each letter that permits the use of byproduct material at a client's address, as required by §35.80(a)(1). Each letter must clearly delineate the authority and responsibility of the licensee and the client and must be retained for 3 years after the last provision of service.

(b) A licensee shall retain the record of each survey required by §35.80(a)(4) for 3 years. The record must 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.

§35.2092   Records of decay-in-storage.

A licensee shall maintain records of the disposal of licensed materials, as required by §35.92, for 3 years. The record must 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.

§35.2204   Records of molybdenum-99, strontium-82, and strontium-85 concentrations.

A licensee shall maintain a record of the molybdenum-99 concentration or strontium-82 and strontium-85 concentration tests required by §35.204(b) and (c) for 3 years. The record must include:

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

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

[72 FR 55932, Oct. 1, 2007]

§35.2310   Records of safety instruction.

A licensee shall maintain a record of safety instructions required by §§35.310 and 35.410 and the operational and safety instructions required by §35.610 for 3 years. The record must include a list of the topics covered, the date of the instruction, the name(s) of the attendee(s), and the name(s) of the individual(s) who provided the instruction.

[83 FR 33111, July 16, 2018]

§35.2404   Records of surveys after source implant and removal.

A licensee shall maintain a record of the surveys required by §§35.404 and 35.604 for 3 years. Each record must include the date and results of the survey, the survey instrument used, and the name of the individual who made the survey.

§35.2406   Records of brachytherapy source accountability.

(a) A licensee shall maintain a record of brachytherapy source accountability required by §35.406 for 3 years.

(b) For temporary implants, the record must include—

(1) 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

(2) 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.

(c) For permanent implants, the record must include—

(1) The number and activity of sources removed from storage, the date they were removed from storage, and the name of the individual who removed them from storage;

(2) The number and activity of sources not implanted, the date they were returned to storage, and the name of the individual who returned them to storage; and

(3) The number and activity of sources permanently implanted in the patient or human research subject.

§35.2432   Records of calibration measurements of brachytherapy sources.

(a) A licensee shall maintain a record of the calibrations of brachytherapy sources required by §35.432 for 3 years after the last use of the source.

(b) The record must include—

(1) The date of the calibration;

(2) The manufacturer's name, model number, and serial number for the source and the instruments used to calibrate the source;

(3) The source output or activity;

(4) The source positioning accuracy within the applicators; and

(5) The name of the individual, the source manufacturer, or the calibration laboratory that performed the calibration.

[67 FR 20370, Apr. 24, 2002, as amended at 68 FR 19326, Apr. 21, 2003]

§35.2433   Records of decay of strontium-90 sources for ophthalmic treatments.

(a) A licensee shall maintain a record of the activity of a strontium-90 source required by §35.433 for the life of the source.

(b) The record must include—

(1) The date and initial activity of the source as determined under §35.432; and

(2) For each decay calculation, the date and the source activity as determined under §35.433.

§35.2605   Records of installation, maintenance, adjustment, and repair of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.

A licensee shall retain a record of the installation, maintenance, adjustment, and repair of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units as required by §35.605 for 3 years. For each installation, maintenance, adjustment and repair, the record must include the date, description of the service, and name(s) of the individual(s) who performed the work.

§35.2610   Records of safety procedures.

A licensee shall retain a copy of the procedures required by §§35.610(a)(4) and (d)(2) until the licensee no longer possesses the remote afterloader, teletherapy unit, or gamma stereotactic radiosurgery unit.

§35.2630   Records of dosimetry equipment used with remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.

(a) A licensee shall retain a record of the calibration, intercomparison, and comparisons of its dosimetry equipment done in accordance with §35.630 for the duration of the license.

(b) For each calibration, intercomparison, or comparison, the record must include—

(1) The date;

(2) The manufacturer's name, model numbers and serial numbers of the instruments that were calibrated, intercompared, or compared as required by paragraphs (a) and (b) of §35.630;

(3) The correction factor that was determined from the calibration or comparison or the apparent correction factor that was determined from an intercomparison; and

(4) The names of the individuals who performed the calibration, intercomparison, or comparison.

§35.2632   Records of teletherapy, remote afterloader, and gamma stereotactic radiosurgery full calibrations.

(a) A licensee shall maintain a record of the teletherapy unit, remote afterloader unit, and gamma stereotactic radiosurgery unit full calibrations required by §§35.632, 35.633, and 35.635 for 3 years.

(b) The record must include—

(1) The date of the calibration;

(2) The manufacturer's name, model number, and serial number of the teletherapy, remote afterloader, and gamma stereotactic radiosurgery unit(s), the source(s), and the instruments used to calibrate the unit(s);

(3) The results and an assessment of the full calibrations;

(4) The results of the autoradiograph required for low dose-rate remote afterloader units; and

(5) The signature of the authorized medical physicist who performed the full calibration.

§35.2642   Records of periodic spot-checks for teletherapy units.

(a) A licensee shall retain a record of each periodic spot-check for teletherapy units required by §35.642 for 3 years.

(b) The record must include—

(1) The date of the spot-check;

(2) The manufacturer's name, model number, and serial number of the teletherapy unit, source and instrument used to measure the output of the teletherapy unit;

(3) An assessment of timer linearity and constancy;

(4) The calculated on-off error;

(5) A determination of the coincidence of the radiation field and the field indicated by the light beam localizing device;

(6) The determined accuracy of each distance measuring and localization device;

(7) The difference between the anticipated output and the measured output;

(8) 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; and

(9) 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) A licensee shall retain a copy of the procedures required by §35.642(b) until the licensee no longer possesses the teletherapy unit.

§35.2643   Records of periodic spot-checks for remote afterloader units.

(a) A licensee shall retain a record of each spot-check for remote afterloader units required by §35.643 for 3 years.

(b) The record must include, as applicable—

(1) The date of the spot-check;

(2) The manufacturer's name, model number, and serial number for the remote afterloader unit and source;

(3) An assessment of timer accuracy;

(4) 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; and

(5) 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) A licensee shall retain a copy of the procedures required by §35.643(b) until the licensee no longer possesses the remote afterloader unit.

§35.2645   Records of periodic spot-checks for gamma stereotactic radiosurgery units.

(a) A licensee shall retain a record of each spot-check for gamma stereotactic radiosurgery units required by §35.645 for 3 years.

(b) The record must include—

(1) The date of the spot-check;

(2) 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;

(3) An assessment of timer linearity and accuracy;

(4) The calculated on-off error;

(5) A determination of trunnion centricity;

(6) The difference between the anticipated output and the measured output;

(7) An assessment of source output against computer calculations;

(8) 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 devices (trunnions); and

(9) 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) A licensee shall retain a copy of the procedures required by §35.645(b) until the licensee no longer possesses the gamma stereotactic radiosurgery unit.

§35.2647   Records of additional technical requirements for mobile remote afterloader units.

(a) A licensee shall retain a record of each check for mobile remote afterloader units required by §35.647 for 3 years.

(b) The record must include—

(1) The date of the check;

(2) The manufacturer's name, model number, and serial number of the remote afterloader unit;

(3) Notations accounting for all sources before the licensee departs from a facility;

(4) 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, and source positioning accuracy; and

(5) The signature of the individual who performed the check.

§35.2652   Records of surveys of therapeutic treatment units.

(a) A licensee shall maintain a record of radiation surveys of treatment units made in accordance with §35.652 for the duration of use of the unit.

(b) The record must include—

(1) The date of the measurements;

(2) The manufacturer's name, model number and serial number of the treatment unit, source, and instrument used to measure radiation levels;

(3) Each dose rate measured around the source while the unit is in the off position and the average of all measurements; and

(4) The signature of the individual who performed the test.

§35.2655   Records of full-inspection servicing for teletherapy and gamma stereotactic radiosurgery units.

(a) A licensee shall maintain a record of the full-inspection servicing for teletherapy and gamma stereotactic radiosurgery units required by §35.655 for the duration of the use of the unit.

(b) The record must contain—

(1) The inspector's radioactive materials license number;

(2) The date of inspection;

(3) The manufacturer's name and model number and serial number of both the treatment unit and source;

(4) A list of components inspected and serviced, and the type of service; and

(5) The signature of the inspector.

[67 FR 20370, Apr. 24, 2002, as amended at 83 FR 33111, July 16, 2018]

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