Section 157.71. Records.

 

(1)   Records of authority and responsibilities for radiation protection programs.

(a) A licensee shall retain a record of actions taken by the licensee's management under s. DHS 157.61 (1) (a) for 5 years. The record shall include a summary of the actions taken and a signature of licensee management.

(b) A licensee shall retain a current copy of the authorities, duties and responsibilities of the radiation safety officer as required by s. DHS 157.61 (1) (d) . The record shall include the signature of the radiation safety officer and licensee management.

(2)   Records of radiation protection program safety changes. A licensee shall retain a record of each radiation protection program change made under s. DHS 157.61 (2) (a) for 5 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.

(3)   Records of written directives. A licensee shall retain a copy of each written directive as required by s. DHS 157.61 (4) for 3 years.

(4)   Records of medical events.

(a) A licensee shall retain a record of medical events reported under s. DHS 157.72 (1) for 3 years.

(b) The record shall contain all of the following:

1. The licensee's name.

2. Names of the persons involved.

3. The social security number or other identification number, if one has been assigned, of any person who is the subject of a medical event.

4. A brief description of the event and why it occurred.

5. The effect, if any, on any individual.

6. The actions, if any, taken or planned to prevent recurrence.

7. Whether the licensee notified the affected individual or the affected individual's responsible relative or guardian and, if not, whether the failure to notify was based on guidance from the referring physician.

(5)   Record of a dose to an embryo or fetus or a nursing child. A licensee shall retain a record of a dose to an embryo or fetus or a nursing child reported under s. DHS 157.72 (2) for 3 years. The record shall contain all of the following:

(a) The licensee's name.

(b) The names of all the individuals involved.

(c) The social security number or other identification number, if one has been assigned of the pregnant individual or nursing child who is the subject of the event.

(d) A brief description of the event, why it occurred, any effect on the embryo or fetus or nursing child and any actions taken or planned to prevent recurrence.

(e) Whether the licensee notified the pregnant individual or mother, or the mother's or child's responsible relative or guardian, and if the licensee did not, whether such failure to notify was based on guidance from the referring physician.

(6)   Records of instrument calibrations. A licensee shall maintain a record of instrument calibrations required by s. DHS 157.62 (1) for 3 years. The record shall 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.

(7)   Records of radiation survey instrument calibrations. A licensee shall maintain a record of radiation survey instrument calibrations required by s. DHS 157.62 (2) for 3 years. The record shall include the date of the calibration, the results of the calibration, the name of the person who performed the calibration, and the model and serial number of the instrument.

(8)   Records of dosages of unsealed radioactive material for medical use. A licensee shall maintain a record of dosage determinations required by s. DHS 157.62 (3) for 3 years. The record shall contain the radiopharmaceutical, 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 1.1 MBq (30 m Ci), the date and time of the dosage determination and the name of the individual who determined the dosage.

(9)   Records of possession of sealed sources and brachytherapy sources.

(a) A licensee shall retain a record of leak tests required by s. DHS 157.62 (5) (b) for 3 years. The record shall contain the model number and serial number if one has been assigned of each source tested, the identity of each source radionuclide and its estimated activity, the results of the test, the date of the test and the name of the person who performed the test.

(b) A licensee shall retain a record of the semi-annual physical inventory of sealed sources and brachytherapy sources required by s. DHS 157.62 (5) (g) for 3 years. The inventory record shall contain the model number of each source and serial number if one has been assigned, the identity of each source radionuclide and its nominal activity, the location of each source and the name of the person who performed the inventory.

(10)   Records of surveys for ambient radiation exposure rate. A licensee shall retain a record of each survey required by s. DHS 157.62 (7) for 3 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 person who performed the survey.

(11)   Records of the release of persons containing radioactive drugs or implants containing radioactive material.

(a) A licensee shall retain a record of the basis for authorizing the release of a person for 3 years after the date of release if the total effective dose equivalent is calculated by any of the following methods:

1. Using the retained radioactivity in the body rather than the radioactivity administered.

2. Using an occupancy factor less than 0.25 at one meter to determine radiation exposure to persons physically near the patient.

3. Using the biological or effective half-life of the radioactive material retained in the body.

4. Considering the shielding by tissue to calculate the exposure to persons physically near the patient.

(b) A licensee shall retain a record for 3 years after the date of release that the instructions required by s. DHS 157.62 (8) (b) were provided to a breast-feeding woman 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).

(12)   Records of administrative and technical requirements that apply to the provision of mobile services.

(a) A licensee shall retain a copy of the letter that permits the use of radioactive material at a client's address of use, as required by s. DHS 157.62 (9) (a) 1. , for 3 years after the last provision of service.

(b) A licensee shall retain the record of each survey required by s. DHS 157.62 (9) (a) 4. for 3 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 person who performed the survey.

(13)   Records of decay-in-storage. A licensee shall maintain a record of the disposal of licensed materials as required by s. DHS 157.62 (10) for 3 years. The record shall include the date of the disposal, the survey instrument used, the background dose rate, the dose rate measured at the surface of each waste container and the name of the person who performed the disposal.

(14)   Records of contaminant concentration. A licensee shall maintain a record of the contaminant concentration tests required by s. DHS 157.63 (3) (b) for 3 years. The record shall include, for each measured elution or extract, all of the following:

(a) The ratio of the measures expressed as kilobecquerel (microcurie) of molybdenum-99, strontium -82 or strontium-85 per megabecquerel of technetium-99m or rubidium-82 chloride injection.

(b) The time and date of the measurement.

(c) The name of the person who made the measurement.

(15)   Records of instruction and training. A licensee shall maintain a record of instructions and training required by ss. DHS 157.64 (2) , 157.65 (4) and 157.67 (4) for 3 years. The record shall include a list of the topics covered, the date of the instruction or training, the names of the attendees and the names of the persons who provided the instruction.

(16)   Records of radiation surveys of patients and human research subjects. A licensee shall maintain a record of the surveys required by ss. DHS 157.65 (2) and 157.67 (2) for 3 years. Each record shall include the date and results of the survey, the survey instrument used and the name of the person who made the survey.

(17)   Records of brachytherapy source inventory.

(a) A licensee shall maintain a record of brachytherapy source accountability required by s. DHS 157.65 (3) for 3 years.

(b) For temporary implants, the record shall include all of the following:

1. The number and activity of sources removed from storage, the time and date they were removed from storage, the name of the person who removed them from storage and the location of use.

2. The number and activity of sources returned to storage, the time and date they were returned to storage and the name of the person who returned them from storage.

(c) For permanent implants, the record shall include all of the following:

1. The number and activity of sources removed from storage, the date they were removed from storage and the name of the person who removed them from storage.

2. The number and activity of sources returned to storage, the date they were returned to storage and the name of the person who returned them to storage.

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

(18)   Records of calibrations on brachytherapy sources. A licensee shall maintain a record of the calibrations on brachytherapy sources required by s. DHS 157.65 (6) for 3 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 instruments used to calibrate the source, the source output or activity, source positioning accuracy within applicators and the signature of the authorized medical physicist.

(19)   Records of installation, maintenance, adjustment and repair. A licensee shall retain a record of the installation, maintenance, adjustment and repair of remote afterloader units, teletherapy units and gamma stereotactic units as required by s. DHS 157.67 (3) for 3 years. For each installation, maintenance, adjustment and repair, the record shall include the date, description of the service and names of the persons who performed the work.

(20)   Records of dosimetry equipment.

(a) A licensee shall retain a record of the calibration, intercomparison and comparisons of its dosimetry equipment done under s. DHS 157.67 (6) for the duration of the license.

(b) For each calibration, intercomparison or comparison, the record shall include all of the following:

1. The date.

2. The model numbers and serial numbers of the instruments that were calibrated, intercompared or compared.

3. The correction factor that was determined from the calibration or comparison or the apparent correction factor that was determined from an intercomparison.

4. The names of the persons who performed the calibration, intercomparison or comparison.

(21)   Records of teletherapy, remote afterloader and gamma stereotactic radiosurgery full calibrations.

(a) A licensee shall maintain a record of the teletherapy, remote afterloader and gamma stereotactic radiosurgery full calibrations required by s. DHS 157.67 (7) to (9) for 3 years.

(b) The record required under par. (a) shall include all of the following:

1. The date of the calibration.

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

3. The results and an assessment of the full calibrations.

4. The results of the autoradiograph required for low dose-rate remote afterloader units.

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

(22)   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 s. DHS 157.67 (10) for 3 years.

(b) The record required under par. (a) shall include all of the following:

1. The date of the spot-check.

2. The manufacturer's name, model number and serial number for 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.

9. The name of the person who performed the periodic spot-check and the signature of the authorized medical physicist who reviewed the record of the spot-check.

(23)   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 s. DHS 157.67 (11) for 3 years.

(b) The record required under par. (a) shall include all of the following, 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.

5. The name of the person who performed the periodic spot-check and the signature of the authorized medical physicist who reviewed the record of the spot-check.

(24)   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 s. DHS 157.67 (12) for 3 years.

(b) The record required under par. (a) shall include all of the following:

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.

9. The name of the person who performed the periodic spot-check and the signature of the authorized medical physicist who reviewed the record of the spot-check.

(25)   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 s. DHS 157.67 (13) for 3 years.

(b) The record required under par. (a) shall include all the following:

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 and source transfer tubes and source positioning accuracy.

5. The signature of the person who performed the check.

(26)   Records of surveys of therapeutic treatment units.

(a) A licensee shall maintain a record of radiation surveys of treatment units made under s. DHS 157.67 (14) for the duration of use of the unit.

(b) The record required under par. (a) shall include all the following:

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.

4. The signature of the person who performed the test.

(27)   Records of 5-year inspection for teletherapy and gamma stereotactic radiosurgery units.

(a) A licensee shall maintain a record of the 5-year inspections for teletherapy and gamma stereotactic radiosurgery units required by s. DHS 157.67 (15) for the duration of use of the unit.

(b) The record required under par. (a) shall contain all the following:

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.

5. The signature of the inspector.

(28)   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 s. DHS 157.65 (6) for the life of the source.

(b) The record required under par. (a) shall include both of the following:

1. The initial activity of the source and date.

2. For each decay calculation, the date and the source activity as determined under s. DHS 157.65 (6) .

CR 01-108 : cr. Register July 2002 No. 559 , eff. — see Note at the start of the chapter; CR 06-021 : r. and recr. (14) Register October 2006 No. 610 , eff. 11-1-06.