Wisconsin Legislature: DHS 157.67(12)(e)

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 as soon as possible in writing of the results of each spot-check.

(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 medical physicist shall notify the licensee as soon as possible in writing of the results of the spot check.

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.

(15) Full 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 to assure proper functioning of the source exposure mechanism. The intervals between full inspection and servicing shall not to exceed 5 years for each teletherapy unit and shall not exceed 7 years for each gamma stereotactic radiosurgery unit.

(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.

(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.

(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 successful 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 a sealed source for a use authorized under sub. (1) to be a physician who meets any 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 have its certification process 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 Council of Postdoctoral 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 NRC or agreement state requirements at a medical facility authorized to use byproduct materials under sub. (1), 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 NRC or 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.

4. A written attestation obtained under sub. (18).

(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 successfully completed the requirements in sub. (17) (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 attestation must be obtained from either of the following:

(a) A preceptor authorized user who meets the requirements in sub. (17), s. DHS 157.61 (10), or equivalent NRC or agreement state requirements for an authorized user for each type of therapeutic medical unit for which the individual is requesting authorized user status.

(b) . A residency program director who affirms in writing that the attestation represents the consensus of the residency program faculty where at least one faculty member is an authorized user who meets the requirements in sub. (17), s. DHS 157.61 (10), or equivalent NRC or agreement state requirements user for each type of therapeutic medical unit for which the individual is requesting authorized user status. The residency training program must be 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 Council on Postdoctoral Training of the American Osteopathic Association and must include training and experience specified in sub. (17) (b).

History: CR 01-108: cr. Register July 2002 No. 559, eff. — see Note at the start of the chapter; correction in (4) (f) made under s. 13.93 (2m) (b) 7., Stats., Register July 2002 No. 559; CR 06-021: am. (9) (b) 2., 3., 6., 8. and 10., r. and recr. (17), cr. (18) Register September 2006, No. 609, eff. 10-1-06; CR 09-062: am. (8) (b) 1., (17) (b) 2. (intro.), 3. and (18) Register April 2010 No. 652, eff. 5-1-10; CR 16-078: am. (11) (f), (12) (b) 3. Register January 2018 No. 745, eff. 2-1-18; CR 22-015: r. (1) (intro.), renum. (1) (a) to (1) (a) (intro.) and am., cr. (1) (a) 1., renum. (1) (b) to (1) (a) 2. and am., cr. (1) (b), am. (4) (d) (intro.), (e), cr. (4) (g), (h), am. (15) (title), (a), (17) (intro.), (a) (intro.), 1., (b) 2. (intro.), 3., cr. (17) (b) 4., renum. (18) to (18) (intro.) and am., cr. (18) (a), (b) Register June 2023 No. 810, eff. 7-1-23; correction in numbering of (4) (h) made under s. 13.92 (4) (b) 1., Stats., Register June 2023 No. 810.

DHS 157.68 Radioactive drugs for medical use.

(1) Preparation. A licensee authorized to manufacture, prepare or transfer for commercial distribution or noncommercial transfer to medical use licensees in a consortium radioactive drugs shall ensure that any individual preparing the drugs is one of the following:

(a) An authorized nuclear pharmacist.