Header:
WISCONSIN ADMINISTRATIVE CODE
DEPARTMENT OF HEALTH SERVICES
CHAPTER DHS 157. RADIATION PROTECTION
SUBCHAPTER VI -- MEDICAL USE OF RADIOACTIVE MATERIAL
Date:
08/31/2009
Document:
DHS 157.67 Photon emitting remote afterloader, teletherapy and gamma stereotactic radiosurgery units.
(1) USE OF A SEALED SOURCE IN A REMOTE AFTERLOADER, TELETHERAPY OR GAMMA STEREOTACTIC RADIOSURGERY UNIT. A licensee shall use sealed sources in photon emitting remote after-loader units, teletherapy units or gamma stereotactic units for therapeutic medical uses that meet one of the following criteria:
(a) Is approved in the sealed source and device registry.
Note: The sealed source and device registrations may be obtained from the manufacturer or by writing the department at: Department of Health Services, Radiation Protection Section, P.O. Box 2659, Madison WI 53701-2659.
(b) In research under an effective investigational device exemption application accepted by the FDA, provided the requirements of s. DHS 157.61 (6) (a) are met.
Note: The FDA requirements for investigational devices may be found at: http://www.fda.gov/cber/ind/indpubs.htm
(2) SURVEYS OF PATIENTS AND HUMAN RESEARCH SUBJECTS TREATED WITH A REMOTE AFTERLOADER UNIT. (a) Before releasing a patient or a human research subject from licensee control, a licensee shall make a survey of the patient or the human research subject and the remote afterloader unit with a portable radiation detection survey instrument to confirm that the source has been removed from the patient or human research subject and returned to the safe shielded position.
(b) A licensee shall retain a record of the surveys under s. DHS 157.71 (16).
(3) INSTALLATION, MAINTENANCE, ADJUSTMENT AND REPAIR. (a) A person shall be specifically licensed by the department, NRC or another agreement state to install, maintain, adjust or repair a remote afterloader unit, teletherapy unit or gamma stereotactic radiosurgery unit that involves work on the source shielding, the source driving unit used to move the source or other electronic or mechanical component that could expose the source, reduce the shielding around the source or compromise the radiation safety of the unit or the source.
(b) Except for low dose-rate remote afterloader units, only a person specifically licensed by the department, NRC or another agreement state may install, replace, relocate or remove a sealed source or source contained in other remote afterloader units, teletherapy units or gamma stereotactic units.
(c) For a low dose-rate remote afterloader unit, only a person specifically licensed by the department, NRC or another agreement state, or an authorized medical physicist, shall install, replace, relocate or remove a sealed source contained in the unit.
(d) A licensee shall retain a record of the installation, maintenance, adjustment and repair done on remote afterloader units, teletherapy units and gamma stereotactic radiosurgery units under s. DHS 157.71 (19).
(4) SAFETY PROCEDURES AND INSTRUCTIONS FOR REMOTE AFTERLOADER, TELETHERAPY AND GAMMA STEREOTACTIC RADIOSURGERY UNITS. (a) A licensee shall do all of the following:
1. Secure the unit, console, console keys and the treatment room when unattended or not in use.
2. Permit only individuals approved by the authorized user, radiation safety officer or authorized medical physicist to be present in the treatment room during treatment with the source.
3. Prevent dual operation of more than one radiation producing device in a treatment room, if applicable.
4. Develop, implement and maintain written procedures for responding to an abnormal situation when the operator is unable to place the source in the shielded position or remove the patient or human research subject from the radiation field with controls from outside the treatment room. The procedure shall include all the following:
a. Instructions for responding to equipment failures and the names of the persons responsible for implementing corrective actions.
b. The process for restricting access to and posting signs in the proximity of the treatment area to minimize the risk of inadvertent exposure.
c. The names and telephone numbers of the authorized users, the authorized medical physicist and the radiation safety officer to be contacted if the unit or console operates abnormally.
(b) A copy of the procedures required by par. (a) 4. shall be physically located at the unit console.
(c) A licensee shall post instructions at the unit console to inform the operator of both of the following:
1. The location of the procedures required by par. (a) 4.
2. The names and telephone numbers of the authorized users, the authorized medical physicist and the radiation safety officer to be contacted if the unit or console operates abnormally.
(d) A licensee shall provide instruction, initially and at least annually, to all persons who operate the unit, as appropriate to the person's assigned duties, in all the following:
1. The procedures identified in par. (a) 4.
2. The operating procedures for the unit.
(e) A licensee shall ensure that operators, authorized medical physicists and authorized users participate in drills of the emergency procedures, initially and at least annually thereafter.
(f) A licensee shall retain a record of individuals receiving instruction required under s. DHS 157.71 (15).
(5) SAFETY PRECAUTIONS FOR REMOTE AFTERLOADER, TELETHERAPY AND GAMMA STEREOTACTIC RADIOSURGERY UNITS. (a) A licensee shall control access to the treatment room by a door at each entrance.
(b) A licensee shall equip each entrance to the treatment room with an electrical interlock system that accomplishes all the following:
1. Prevents the operator from initiating the treatment cycle unless each treatment room entrance door is closed.
2. Causes the source to be shielded promptly when an entrance door is opened.
3. Prevents the source from being exposed following an interlock interruption until all treatment room entrance doors are closed and the source on-off control is reset at the console.
(c) A licensee shall require any person entering the treatment room to assure, via appropriate radiation monitors, that radiation levels have returned to ambient levels.
(d) Except for low-dose remote afterloader units, a licensee shall construct or equip each treatment room with viewing and intercom systems to permit continuous observation of the patient or the human research subject from the treatment console during irradiation.
(e) For licensed activities where sources are placed within the patient's or human research subject's body, a licensee shall only conduct treatments that allow for expeditious removal of a decoupled or jammed source.
(f) A licensee shall do all the following:
1. For medium dose-rate and pulsed dose-rate remote afterloader units, require all the following:
a. An authorized medical physicist and either an authorized user or a physician, under the supervision of an authorized user, who has been trained in the operation and emergency response for the unit to be physically present during the initiation of all patient treatments involving the unit.
b. An authorized medical physicist and either an authorized user or a person under the supervision of an authorized user who has been trained to remove the source applicator in the event of an emergency involving the unit to be immediately available during continuation of all patient treatments involving the unit.
2. For high dose-rate remote afterloader units, require all the following:
a. An authorized user and an authorized medical physicist to be physically present during the initiation of all patient treatments involving the unit.
b. An authorized medical physicist and either an authorized user or a physician, under the supervision of an authorized user, who has been trained in the operation and emergency response for the unit to be physically present during continuation of all patient treatments involving the unit.
3. For gamma stereotactic radiosurgery units, require an authorized user and an authorized medical physicist to be physically present throughout all patient treatments involving the unit.
4. Notify the radiation safety officer or his or her designee and an authorized user immediately if the patient or human research subject has a medical emergency or if the patient dies.
(g) A licensee shall have available near each treatment room, emergency response equipment, as applicable, to respond to all of the following:
1. A source inadvertently remaining in the unshielded position.
2. A source inadvertently lodged within the patient following completion of the treatment.
(6) DOSIMETRY EQUIPMENT. (a) Except for low dose-rate remote afterloader sources where the source output or activity is determined by the manufacturer, a licensee shall have a calibrated dosimetry system available for use. To satisfy this requirement, one of the following conditions shall be met:
1. The system shall have been calibrated using a system or source traceable to the national institute of standards and technology and published protocols accepted by nationally recognized bodies, or by a calibration laboratory accredited by the American association of physicists in medicine. The calibration shall have been performed within the previous 2 years and after any servicing that may have affected system calibration.
Note: An example of a nationally recognized body is the American Association of Physicists in Medicine.
2. The system shall have been calibrated within the previous 4 years. Eighteen to 30 months after that calibration, the system shall have been compared to another dosimetry system that was calibrated within the past 24 months by the national institute of standards and technology or by a calibration laboratory accredited by the American association of physicists in medicine. The results of the comparison shall have indicated that the calibration factor of the licensee's system had not changed by more than 2%. A licensee may not use the intercomparison result to change the calibration factor. When comparing dosimetry systems to be used for calibrating sealed sources for therapeutic units, a licensee shall use a comparable unit with beam attenuators or collimators, as applicable, and sources of the same radionuclide as the source used at the licensee's facility.
(b) A licensee shall have available for use a dosimetry system for spot-check output measurements to periodically measure the radiation output of the device for consistency, if applicable. To satisfy this requirement, the system may be compared with a system that has been calibrated under par. (a). The comparison shall have been performed within the previous 12 months and after each servicing that may have affected system calibration. The spot-check system may be the same system used to meet the requirement in par. (a).
(c) A licensee shall retain a record of each calibration and comparison under s. DHS 157.71 (20).
(7) FULL CALIBRATION MEASUREMENTS ON TELETHERAPY UNITS. (a) A licensee authorized to use a teletherapy unit for medical use shall perform full calibration measurements on each teletherapy unit under any of the following circumstances:
1. Before the first medical use of the unit.
2. Before medical use under all of the following conditions:
a. Whenever spot-check measurements indicate that the output differs by more than 5% from the output obtained at the last full calibration corrected mathematically for radioactive decay.
b. Following replacement of the source or following reinstallation of the teletherapy unit in a new location.
c. Following any repair of the teletherapy unit that includes removal of the source or major repair of the components associated with the source exposure assembly.
3. At intervals not exceeding one year.
(b) To satisfy the requirements of par. (a), full calibration measurements shall include determination of all of the following:
1. The output within plus or minus 3% for the range of field sizes and for the distance or range of distances used for medical use.
2. The coincidence of the radiation field and the field indicated by the light beam localizing device.
3. The uniformity of the radiation field and its dependence on the orientation of the useful beam.
4. Timer accuracy and linearity over the range of use.
5. On-off error.
6. The accuracy of all distance measuring and localization devices in medical use.
(c) A licensee shall use the dosimetry system described in sub. (6) (a) to measure the output for one set of exposure conditions. The remaining radiation measurements required in par. (b) may be made using a dosimetry system that indicates relative dose rates.
(d) A licensee shall perform a full calibration required by par. (a) under published protocols accepted by nationally recognized bodies.
Note: An example of such a nationally recognized body is the American Association of Physicists in Medicine.
(e) A licensee shall mathematically correct the outputs determined in par. (b) 1. for physical decay for intervals not exceeding one month for cobalt-60, 6 months for cesium-137 or at intervals consistent with one percent decay for all other nuclides.
(f) Full calibration measurements required by par. (a) and physical decay corrections required by par. (e) shall be performed by an authorized medical physicist.
(g) A licensee shall retain a record of each calibration under s. DHS 157.71 (21).
(8) FULL CALIBRATION MEASUREMENTS ON REMOTE AFTERLOADER UNITS. (a) A licensee authorized to use a remote afterloader unit for medical use shall perform a full calibration measurement on each unit under any of the following circumstances:
1. Before the first medical use of the unit.
2. Before medical use under all the following conditions:
a. Following replacement of any source or following reinstallation of the unit in a new location outside the facility.
b. Following any repair of the unit that includes removal of the source or major repair of the components associated with the source exposure assembly.
3. Each calendar quarter, at intervals not exceeding 100 days for high dose-rate, medium dose-rate and pulsed dose-rate remote afterloader units with sources whose half-life exceeds 75 days.
4. At intervals not exceeding one year for low dose-rate remote afterloader units.
(b) To satisfy the requirement of par. (a), a full calibration measurement shall include, as applicable, determination of all the following:
1. The output within 5%.
2. Source positioning accuracy to within plus or minus one millimeter.
3. Source retraction with backup battery upon power failure.
4. Length of the source transfer tubes.
5. Timer accuracy and linearity over the typical range of use.
6. Length of the applicators.
7. Function of the source transfer tubes, applicators and transfer tube-applicator interfaces.
(c) In addition to the requirement for full calibration for low dose-rate remote afterloader units in par. (b), a licensee shall perform an autoradiograph of the source to verify inventory and source arrangement at intervals not exceeding one calendar quarter.
(d) A licensee shall use the dosimetry system described in sub. (6) (a) to measure the output.
(e) A licensee shall make a full calibration measurement required by par. (a) under published protocols accepted by nationally recognized bodies.
(f) For low dose-rate remote afterloader units, a licensee may use measurements provided by the source manufacturer that are made under pars. (a) to (e).
(g) A licensee shall mathematically correct the outputs determined in par. (b) 1. for physical decay at intervals consistent with one percent physical decay.
(h) A full calibration measurement required by par. (a) and physical decay correction required by par. (g) shall be performed by the authorized medical physicist.
(i) A licensee shall retain a record of each calibration under s. DHS 157.71 (21).
(j) In addition to the requirements for full calibration for low dose rate remote afterloaders, as specified in par. (b), a licensee shall perform an autoradiograph of the source or sources to verify inventory and source arrangement at intervals not to exceed 3 months.
(9) FULL CALIBRATION MEASUREMENTS ON GAMMA STEREOTACTIC RADIOSURGERY UNITS. (a) A licensee authorized to use a gamma stereotactic radiosurgery unit for medical use shall perform full calibration measurements on each unit under any of the following circumstances:
1. Before the first medical use of the unit.
2. Before medical use under all of the following conditions:
a. Whenever spot-check measurements indicate that the output differs by more than 5% from the output obtained at the last full calibration corrected mathematically for radioactive decay.
b. Following replacement of the sources or following reinstallation of the gamma stereotactic radiosurgery unit in a new location.
c. Following any repair of the gamma stereotactic radiosurgery unit that includes removal of the sources or major repair of the components associated with the source assembly.
3. At intervals not exceeding one year, with the exception that relative helmet factors need only be determined before the first medical use of a helmet and following any damage to the helmet.
(b) To satisfy the requirement of par. (a), a full calibration measurement shall include determination of all the following:
1. The output within plus or minus 3%.
2. Relative helmet factors to verify that the helmet material provides the required shielding to the patient.
3. Isocenter coincidence to confirm the centering accuracy of the radiation beam relative to the helmet openings.
4. Timer accuracy and linearity over the range of use.
5. On-off error.
6. Trunnion centricity to determine the rotational center of the source relative to the helmet openings.
7. Treatment table retraction mechanism, using backup battery power or hydraulic backups with the main power to the unit off.
8. Helmet microswitches to determine if the switches terminate the radiation beam when tripped by unintended movement of the helmet.
9. Emergency timing circuits.
10. Stereotactic frames and localizing devices (trunnions).
(c) A licensee shall use the dosimetry system described in sub. (6) (a) to measure the output for one set of exposure conditions. The remaining radiation measurements required in par. (b) 1. may be made using a dosimetry system that indicates relative dose rates.
(d) A licensee shall make a full calibration measurement required by par. (a) under published protocols accepted by nationally recognized bodies.
Note: An example of such a nationally recognized body is the American Association of Physicists in Medicine.
(e) A licensee shall mathematically correct the outputs determined in par. (b) 1. at intervals not exceeding one month for cobalt-60 and at intervals consistent with one percent physical decay for all other radionuclides.
(f) A full calibration measurement required by par. (a) and physical decay correction required by par. (e) shall be performed by an authorized medical physicist.
(g) A licensee shall retain a record of each calibration under s. DHS 157.71 (21).
(10) PERIODIC SPOT-CHECKS FOR TELETHERAPY UNITS. (a) A licensee authorized to use teletherapy units for medical use shall perform output spot-checks on each teletherapy unit once in each calendar month that include determination of all of the following:
1. Timer constancy and timer linearity over the range of use.
2. On-off error.
3. The coincidence of the radiation field and the field indicated by the light beam localizing device.
4. The accuracy of all distance measuring and localization devices used for medical use.
5. The output for one typical set of operating conditions measured with the dosimetry system described in sub. (6) (b).
6. The difference between the measurement made in this subd. 5. and the anticipated output expressed as a percentage of the anticipated output, which is the value obtained at last full calibration corrected mathematically for physical decay.
(b) A licensee shall perform measurements required by par. (a) under procedures established by the authorized medical physicist. The authorized medical physicist need not actually perform the spot check measurements.
(c) A licensee shall have the authorized medical physicist review the results of each spot-check within 15 working days. The authorized medical physicist shall notify the licensee in writing of the results of each spot-check within 10 working days.
(d) A licensee authorized to use a teletherapy unit for medical use shall perform safety spot-checks of each teletherapy facility once in each calendar month and after each source installation to assure proper operation of all of the following:
1. Electrical interlocks at each teletherapy room entrance.
2. Electrical or mechanical stops installed to limit use of the primary beam of radiation.
Note: Examples of the limitations in subd. 2. include restriction of source housing angulation or elevation, carriage or stand travel and operation of the beam on-off mechanism.
3. Source exposure indicator lights on the teletherapy unit, on the control console and in the facility.
4. Viewing and intercom systems.
5. Treatment room doors from inside and outside the treatment room.
6. Electrically assisted treatment room doors with the teletherapy unit electrical power turned off.
(e) If the results of the checks required in par. (d) indicate the malfunction of any system, a licensee shall lock the control console in the off position and not use the unit except as may be necessary to repair, replace or check the malfunctioning system.
(f) A licensee shall retain a record of each spot-check required by pars. (a) and (d), under s. DHS 157.71 (22).
(11) PERIODIC SPOT-CHECKS FOR REMOTE AFTERLOADER UNITS. (a) A licensee authorized to use remote afterloader units for medical use shall perform a spot-check of each remote afterloader facility and on each unit according to the following criteria:
1. At the beginning of each day of use of a high dose-rate, medium dose-rate or pulsed dose-rate remote afterloader unit.
2. Prior to each patient treatment with a low dose-rate remote afterloader unit.
3. After each source installation.
(b) A licensee shall have an authorized medical physicist establish written procedures for performing the spot-checks required in par. (a) of this section. The authorized medical physicist need not actually perform the spot check measurements.
(c) To satisfy the requirements of par. (a), a spot-check shall assure proper operation of all of the following:
1. Electrical interlocks at each remote afterloader unit room entrance.
2. Source exposure indicator lights on the remote afterloader unit, on the control console and in the facility.
3. Viewing and intercom systems in each high dose-rate, medium dose-rate and pulsed dose-rate remote afterloader facility.
4. Emergency response equipment.
5. Radiation monitors used to indicate the source position.
6. Timer accuracy.
7. The date and time of the clock in the unit's computer.
8. Decayed source activity in the unit's computer.
(d) If the results of the checks required in par. (c) indicate the malfunction of any system, a licensee shall lock the control console in the off position and not use the unit except as necessary to repair, replace or check the malfunctioning system.
(e) A licensee shall retain a record of each check required by par. (c) under s. DHS 157.71 (23).
(f) A licensee shall have an authorized medical physicist review the results of each spot-check within 15 working days of the spot check. The authorized medical physicist shall notify the licensee in writing of the results of each spot-check within 10 working days.
(12) PERIODIC SPOT-CHECKS FOR GAMMA STEREOTACTIC RADIOSURGERY UNITS. (a) A licensee authorized to use a gamma stereotactic radiosurgery unit for medical use shall perform spot-checks of each gamma stereotactic radiosurgery facility and on each unit at all of the following times:
1. Monthly.
2. At the beginning of each day of use.
3. After each source installation.
(b) A licensee shall have an authorized medical physicist do all the following:
1. Establish written procedures for performing the spot-checks required in par. (a).
2. Review the results of each spot-check required by par. (a) 1. within 15 working days of the check. The authorized medical physicist need not actually perform the spot-check measurements.
3. The authorized physicist shall notify the licensee in writing of the results of the spot check review within 10 working days.
(c) To satisfy the requirements of par. (a) 1., a spot-check shall do all of the following:
1. Assure proper operation of treatment table retraction mechanism, using backup battery power or hydraulic backups with the unit off; helmet microswitches; emergency timing circuits and stereotactic frames and localizing devices.
2. Determine all of the following:
a. The output for one typical set of operating conditions measured with the dosimetry system described in sub. (6) (b).
b. The difference between the measurement made in subd. 2. a. and the anticipated output expressed as a percentage of the anticipated output.
c. Source output against computer calculation.
d. Timer accuracy and linearity over the range of use.
e. On-off error.
f. Trunnion centricity.
(d) To satisfy the requirements of par. (a) 2. and 3., a spot-check shall assure proper operation of all of the following:
1. Electrical interlocks at each gamma stereotactic radiosurgery room entrance.
2. Source exposure indicator lights on the gamma stereotactic radiosurgery unit, on the control console and in the facility.
3. Viewing and intercom systems.
4. Timer termination of the radiation beam.
5. Radiation monitors used to indicate room exposures.
6. Emergency off buttons.
(e) A licensee shall arrange for prompt repair of any system identified in par. (c) or (d) that is not operating properly.
(f) If the results of the checks required in par. (d) indicate the malfunction of any system, a licensee shall lock the control console in the off position and not use the unit except as may be necessary to repair, replace or check the malfunctioning system.
(g) A licensee shall retain a record of each check required by pars. (c) and (d) under s. DHS 157.71 (24).
(13) ADDITIONAL TECHNICAL REQUIREMENTS FOR MOBILE REMOTE AFTERLOADER UNITS. (a) A licensee providing mobile remote afterloader service shall do all of the following:
1. Check survey instruments before medical use at each client's address of use or on each day of use, whichever is more frequent.
2. Account for all sources before departure from a client's address of use.
(b) In addition to the periodic spot-checks required by sub. (11), a licensee authorized to use mobile afterloaders for medical use shall perform checks on each remote afterloader unit before use at each address. A check shall be made to verify the operation of all the following:
1. Electrical interlocks on treatment area access points.
2. Source exposure indicator lights on the remote afterloader unit, on the control console and in the facility.
3. Viewing and intercom systems.
4. Applicators, source transfer tubes and transfer tube-applicator interfaces.
5. Radiation monitors used to indicate room exposures.
6. Accuracy of source positioning.
7. Radiation monitors used to indicate whether the source has returned to a safe shielded position.
(c) A licensee shall ensure overall proper operation of the remote afterloader unit by conducting a simulated cycle of treatment before use at each address of use.
(d) If the results of the checks required in par. (b) indicate the malfunction of any system, a licensee shall lock the control console in the off position and not use the unit except as may be necessary to repair, replace or check the malfunctioning system.
(e) A licensee shall retain a record of each check required by par. (b) under s. DHS 157.71 (25).
(14) RADIATION SURVEYS. (a) In addition to the survey requirement in s. DHS 157.25 (1), a person licensed to possess or use photon emitting remote afterloader, teletherapy or gamma stereotactic radiosurgery units shall perform surveys of the device and ensure the results of the surveys from the surface of the main source safe, with the sources in the shielded position, do not exceed the maximum and average radiation levels listed in the sealed source and device registry.
(b) A licensee shall make the survey required by par. (a) at installation of a new source and following repairs to source shielding, a source driving unit or other electronic or mechanical component that could expose a source, reduce the shielding around a source or compromise the radiation safety of the unit or a source.
(c) A licensee shall retain a record of the radiation surveys required by par. (a) under s. DHS 157.71 (26).
(15) FIVE-YEAR INSPECTION FOR TELETHERAPY AND GAMMA STEREOTACTIC RADIOTHERAPY UNITS. (a) A licensee shall have each teletherapy unit and gamma stereotactic radiosurgery unit inspected for proper operation and serviced during source replacement or at intervals not to exceed 5 years, whichever comes first, to assure proper functioning of the source exposure mechanism.
(b) Inspection and servicing of a teletherapy or gamma stereotactic radiosurgery unit may only be performed by a person specifically licensed to do so by the department, the NRC or another agreement state.
(c) A licensee shall keep a record of the inspection and servicing under s. DHS 157.71 (27).
(16) THERAPY-RELATED COMPUTER SYSTEMS. A licensee shall perform acceptance testing on the treatment planning system under published protocols accepted by nationally recognized bodies. The acceptance testing shall include, as applicable, verification of all of the following:
(a) Source-specific input parameters required by the dose calculation algorithm used to calculate the dose to the patient.
(b) Accuracy of dose, dwell time of the radioactive source at a particular location and treatment time calculations at representative points.
(c) Accuracy of isodose graphic plots on paper and graphic displays.
(d) Accuracy of the software used to determine radioactive source positions from radiographic images.
(e) Accuracy of electronic transfer of the treatment delivery parameters to the treatment delivery unit from the treatment planning system that was used to calculate the patient dose and radioactive source dwell times.
Note: An example of such a nationally recognized body is the American Association of Physicists in Medicine.
(17) TRAINING FOR USE OF REMOTE AFTERLOADER, TELETHERAPY AND GAMMA STEREOTACTIC RADIOSURGERY UNITS. A licensee shall require an authorized user of a sealed source for a use authorized under sub. (1) to have received training in device operation, safety procedures, and clinical use for the type of use for which authorization is sought. This training requirement may be satisfied by satisfactory completion of a training program provided by the vendor for new users or by receiving training supervised by an authorized user or authorized medical physicist, as appropriate, who is authorized for the type of use for which the individual is seeking authorization. Except as provided in s. DHS 157.61 (10), a licensee shall require an authorized user of sealed source for a use authorized under sub. (1) to have obtained written attestation under sub. (18) and to be a physician who meets either of the following requirements:
(a) Is certified by a medical specialty board whose certification process has been recognized by the department, the NRC or an agreement state. To be recognized, a specialty board shall require all candidates for certification to do all of the following:
1. Successfully complete a minimum of 3 years of residency training in a radiation therapy program 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 committee on post-graduate training of the American osteopathic association.
2. Pass an examination, administered by diplomates of the specialty board, which tests knowledge and competence in radiation safety, radionuclide handling, treatment planning, quality assurance, and clinical use of stereotactic radiosurgery, remote afterloaders and external beam therapy.
Note: Specialty boards whose certification processes have been recognized by the Department, the NRC or an agreement state will be posted on the NRC's web site at www.nrc.gov.
(b) Has completed a structured educational program in basic radionuclide techniques applicable to the use of a sealed source in a therapeutic medical unit that includes all of the following:
1. Two hundred hours of classroom and laboratory training in all the following areas:
a. Radiation physics and instrumentation.
b. Radiation protection.
c. Mathematics pertaining to the use and measurement of radioactivity.
d. Radiation biology.
2. Five hundred hours of work experience, under the supervision of an authorized user who meets the requirements in this subsection, s. DHS 157.61 (10), or equivalent agreement state requirements at a medical institution, involving all of the following:
a. Reviewing full calibration measurements and periodic spot checks.
b. Preparing treatment plans and calculating treatment doses and times.
c. Using administrative controls to prevent a medical event involving the use of radioactive material.
d. Implementing emergency procedures to be followed in the event of the abnormal operation of the medical unit or console.
e. Checking and using survey meters.
f. Selecting the proper dose and how it is to be administered.
3. Three years of supervised clinical experience in radiation therapy under an authorized user who meets the requirements in this subsection, s. DHS 157.61 (10), or equivalent agreement state requirements, as part of a formal training program approved by the residency review committee for radiation oncology of the accreditation council for graduate medical education or royal college of physicians and surgeons of Canada or the committee on postdoctoral training of the American osteopathic association. This experience may be obtained concurrently with the supervised work experience required by subd. 2.
(18) WRITTEN ATTESTATION. A licensee shall require an authorized user of a sealed source for a use authorized under sub. (17) to have obtained written attestation that the individual has satisfactorily completed the requirements in sub. (17) (a) 1. or (b), and has achieved a level of competency sufficient to function independently as an authorized user of each type of therapeutic medical unit for which the individual is requesting authorized user status. The written attestation shall be signed by a preceptor authorized user who meets the requirements in sub. (17), s. DHS 157.61 (10), or equivalent agreement state requirements for an authorized user for each type of therapeutic medical unit for which the individual is requesting authorized user status.
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