Chapter DHS 157

DHS 157.80(1)(f)5. 5. Two-way aural communication shall exist between the patient and the operator at the control panel.

DHS 157.80(1)(f)6. 6. A viewing window, or viewing system, such as closed circuit television or an equivalent, shall be installed to permit continuous observation of the patient during irradiation. The window or viewing system shall be installed such that the operator, located at the control position, can continuously observe the patient during irradiation. When the primary viewing system is electronic, an alternative system shall be available for use in the event of failure of the primary viewing system.

DHS 157.80(2) (2) Operating procedures.

DHS 157.80(2)(a) (a)

DHS 157.80(2)(a)1. 1. A CT x-ray system for human use may only be operated for diagnostic procedures by an American registry of radiologic technologists certified person who is licensed as a radiographer by the State of Wisconsin or has met the radiographer license exemptions and has been specifically trained in its operation.

DHS 157.80(2)(a)2. 2. A CT x-ray system for veterinary use may only be operated for diagnostic procedures by a person who is certified by the American registry of radiological technologists or has completed training equivalent to the requirements of ch. DHS 157 Appendix L and has been specifically trained in its operation.

DHS 157.80(2)(a)3. 3. Combination systems which combine CT with another imaging device that uses radioactive material shall be operated by a person qualified by training in the safe use of radioactive materials and who meets the training requirements of ch. DHS 157 Appendix L.

DHS 157.80(2)(b) (b) Information shall be available at the control panel regarding the operation and calibration of the system. The information shall include all of the following components:

DHS 157.80(2)(b)1. 1. Dates of the latest calibration and spot checks and the location within the facility where the results of those tests may be obtained.

DHS 157.80(2)(b)2. 2. Instructions on the use of the CT dosimetry phantom including a schedule of spot checks appropriate for the system, allowable variations for the indicated parameters and the results of at least the most recent spot checks conducted on the system.

DHS 157.80(2)(b)3. 3. The distance in millimeters between the tomographic plane and the reference plane if a reference plane is utilized.

DHS 157.80(2)(b)4. 4. A current technique chart or list of protocols available at the control panel, which specifies for each routine examination the CT conditions of operation and the number of scans per examination including body part size and correct kV/mA for that body part. The technique chart or a list of protocols shall be used to adjust techniques based on the body part being examined.

DHS 157.80(2)(c) (c) Calibration and spot check measurements shall be made at a frequency recommended by the manufacturer or established by a medical physicist. If the calibration or spot check of the CT x-ray system identifies that a system operating parameter has exceeded a tolerance established by the medical physicist, use of the CT x-ray system on patients shall be limited to those uses permitted by established written instructions of the medical physicist.

DHS 157.80(2)(d) (d) A facility shall follow the manufacturer’s daily start up routines and preventative maintenance schedules for a specific computed tomography x-ray system.

DHS 157.80 History History: CR 01-108: cr. Register July 2002 No. 559, eff. 8-1-02; CR 06-021: renum. (1) (a) and (c) to be (1) (a) 1. and (c) 1., cr. (1) (a) 2. and 3. and (c) 2. and 3., am. (2) (a) Register October 2006 No. 610, eff. 11-1-06; CR 09-062: renum. (2) (a) to be (2) (a) 1. and 3. and am., cr. (2) (a) 2. Register April 2010 No. 652, eff. 5-1-10; CR 16-078: r. (1) (b) (intro.), cr. (1) (f) 5., 6., am. (2) (a) 1., (b) 4., (c) Register January 2018 No. 745, eff. 2-1-18; correction in (2) (a) 2., 3. made under s. 35.17, Stats., Register January 2018 No. 745; CR 22-015: am. (1) (c) 2. Register June 2023 No. 810, eff. 7-1-23.

DHS 157.81 DHS 157.81 Shielding plan review.

DHS 157.81(1) (1) Plan review and approval. Prior to construction, the floor plans, shielding specifications and equipment arrangement of all new installations, or modifications of existing installations, utilizing ionizing radiation machines, including dental CT and dental cephalometric machines, shall be submitted to the department for review and approval.

DHS 157.81 Note Note: Plans may be mailed to the department at: Department of Health Services, Radiation Protection Section, P.O. Box 2659, Madison WI 53701-2659 or package delivery to: Department of Health Services, Radiation Protection Section, Room 150, 1 West Wilson St, Madison WI 53702-0007.

DHS 157.81(2) (2) Exemptions. Dental intraoral and panoramic, mammography, and bone density devices are exempt from this section.

DHS 157.81(3) (3) Plan submittal requirements.

DHS 157.81(3)(a) (a) A shielding plan for a facility with two or more x-ray rooms shall include a medical physicist or person approved by a medical physicist recommendation for shielding.

DHS 157.81(3)(b) (b) A shielding plan submitted for department review shall include all of the following:

DHS 157.81(3)(b)1. 1. The maximum rated technique factors of each machine.

DHS 157.81(3)(b)2. 2. A scale drawing of the room in which a stationary radiation machine system is located with such drawing indicating the use of areas adjacent to the room and an estimation of the extent of occupancy by a person in such areas. In addition, the drawing shall include all of the following:

DHS 157.81(3)(b)2.a. a. The type and thickness of materials, or lead equivalency, of each protective barrier.

DHS 157.81(3)(b)2.b. b. The use and occupancy of the areas surrounding an x-ray room, including occupied areas above or below an x-ray room.

DHS 157.81(3)(b)2.c. c. The construction materials used for the floor and ceiling, if appropriate.

DHS 157.81(3)(c) (c) The operator booth described in the shielding plan shall be designed to meet all the following requirements:

DHS 157.81(3)(c)1. 1. The view area of the window shall be at least 0.09 m2 (144 square inches).

DHS 157.81(3)(c)2. 2. The window shall be placed so that the edge of the view window is at least 0.45 meters (18 inches) from the end of the barrier. The window shall be placed so that the patient may be observed at all times and each entrance to the room is observed from the operator position. Patient and entrance observation may be accomplished by the use of electronic devices or mirrors.

DHS 157.81(3)(c)3. 3. The shielding value of the window shall be equal to the wall in which it is mounted.

DHS 157.81(3)(c)4. 4. Booth walls shall be 2.1 meters (7 feet) in height and permanently attached to the floor or walls. The booth shall be at least 1.3 meters (4 feet) from the nearest vertical cassette holder or 0.3 meters (one foot) from the nearest corner of the examining table.

DHS 157.81(3)(c)5. 5. When a door or moveable panel is used as an integral part of the booth structure, it shall have a permissive device that prevents an exposure when the door or panel is not closed.

DHS 157.81(3)(c)6. 6. Verbal communication with the patient shall be possible at all times during the x-ray procedure.

DHS 157.81(3)(c)7. 7. The x-ray exposure control shall be located within the shielded area and at least 1 meter (3.3 feet) from the open end of the protective barrier, excluding mammography units.

DHS 157.81(4) (4) Operational analysis. The department may require additional modifications to a shielding plan after initial approval of the plan if a subsequent analysis of operating conditions indicates the possibility of a person receiving a dose in excess of the limits prescribed in ss. DHS 157.22 (1) and (5) to (8) and 157.23 (1) and (2). An existing x-ray room constructed using 5 mSv (500 mrem) as the public exposure limit may continue to operate without modification until the x-ray equipment is replaced or the room is modified.

DHS 157.81 History History: CR 01-108: cr. Register July 2002 No. 559, eff. 8-1-02; CR 06-021: am. (3) (a) Register October 2006 No. 610, eff. 11-1-06; CR 09-062: am. (1) and (2), cr. (3) (c) 7. Register April 2010 No. 652, eff. 5-1-10; CR 22-015: am. (4) Register June 2023 No. 810, eff. 7-1-23.

DHS 157.82 DHS 157.82 General administrative requirements for facilities using therapeutic radiation machines for human use.

DHS 157.82(1) (1) Administrative controls. A registrant shall be responsible for directing the operation of the therapeutic radiation machines that have been registered with the department. All persons operating a therapeutic radiation machine shall be instructed in and shall comply with the provisions of the radiation safety requirements of ss. DHS 157.22 (1) and (5) to (8) and 157.25 (2). A therapeutic radiation machine that does not meet the provisions of this subchapter but is of a type accepted by the US food and drug administration may not be used for irradiation of human patients.

DHS 157.82(2) (2) Training for radiation therapy users.

DHS 157.82(2)(a) (a) A registrant for any therapeutic radiation machine, except dermatology units under 150 kV, shall require the authorized user to be a physician who meets any of the following requirements:

DHS 157.82(2)(a)1. 1. Certified or board eligible in one or more of the following:

DHS 157.82(2)(a)1.a. a. Radiology or therapeutic radiology by the American board of radiology.

DHS 157.82(2)(a)1.b. b. Radiation oncology by the American osteopathic board of radiology.

DHS 157.82(2)(a)1.c. c. Radiology, with specialization in radiotherapy, as a British “Fellow of the Faculty of Radiology” or “Fellow of the Royal College of Radiology”.

DHS 157.82(2)(a)1.d. d. Therapeutic radiology by the Canadian royal college of physicians and surgeons.

DHS 157.82(2)(a)2. 2. Actively practices therapeutic radiology and has completed all of the following:

DHS 157.82(2)(a)2.a. a. The radiation therapy residency.

DHS 157.82(2)(a)2.b. b. Two hundred hours of instruction in basic radiation techniques applicable to the use of an external beam radiation therapy unit.

DHS 157.82(2)(a)2.c. c. Five hundred hours of supervised work experience in therapeutic radiology.

DHS 157.82(2)(a)2.d. d. A minimum of 3 years of supervised clinical experience or 5 years of post graduate clinical experience in therapeutic radiology.

DHS 157.82(2)(a)3. 3. Has equivalent training and submits the training of the prospective user physician for department review on a case-by-case basis.

DHS 157.82(2)(b) (b) A dermatologist using x-ray units under 150 kV shall be board certified in dermatology or have 40 hours of instruction and 100 hours of supervised therapeutic work using x-ray units for the treatment of skin diseases.

DHS 157.82(2)(c) (c) A registrant for electronic brachytherapy shall require the authorized user to complete device specific instruction from the manufacturer or individual trained by the manufacturer, and training on procedures required by s. DHS 157.85 (16) (g) 4. and 5.

DHS 157.82(3) (3) Visiting users. A registrant may permit any physician qualified under sub. (2) to act as a visiting user under the term of the registrant’s registration for up to 60 days per year under all the following conditions:

DHS 157.82(3)(a) (a) The visiting user has the prior written permission of the registrant’s management and if the use occurs on behalf of an institution, the institution’s radiation safety committee.

DHS 157.82(3)(b) (b) The registrant maintains copies of all records documenting the qualifications of the visiting user for 3 years from the date of the last visit.

DHS 157.82(4) (4) Medical physicist support.

DHS 157.82(4)(a) (a) The services of a medical physicist is required in facilities having one or more therapeutic radiation machines.

DHS 157.82(4)(b) (b) The registrant for any therapeutic radiation machine shall require the medical physicist to have any of the following:

DHS 157.82(4)(b)1. 1. Certification by the American board of radiology in one or more of the following:

DHS 157.82(4)(b)1.a. a. Therapeutic radiological physics.

DHS 157.82(4)(b)1.b. b. Roentgen-ray and gamma-ray physics.

DHS 157.82(4)(b)1.c. c. X-ray and radium physics.

DHS 157.82(4)(b)1.d. d. Radiological physics.

DHS 157.82(4)(b)2. 2. Certification by the American board of medical physics in radiation oncology physics.

DHS 157.82(4)(b)3. 3. Certification by the Canadian college of medical physics.

DHS 157.82(4)(b)4. 4. A master’s or doctor’s degree in physics, biophysics, radiological physics or health physics and have completed one year of full-time training in therapeutic radiological physics and one year of full-time work experience under the supervision of a medical physicist at a medical institution. A person qualifying under this subdivision shall work under the supervision of a medical physicist qualified under subd. 1., 2. or 3. A registrant employing a physicist who qualifies under this subdivision shall provide the department with a statement of training and experience, signed by the preceptor medical physicist or provide a letter from another state accepting the person as a therapeutic medical physicist.

DHS 157.82(4)(c) (c) The medical physicist shall be responsible for all of the following:

DHS 157.82(4)(c)1. 1. Full calibrations and protection surveys.

DHS 157.82(4)(c)2. 2. Supervision and review of dosimetry.

DHS 157.82(4)(c)3. 3. Beam data acquisition and transfer for computerized dosimetry and supervision of its use.

DHS 157.82(4)(c)4. 4. Quality control, including quality control check review.

DHS 157.82(4)(c)5. 5. Consultation with the physician user in treatment planning, as needed.

DHS 157.82(4)(c)6. 6. Performance of calculations and assessments regarding medical events.

DHS 157.82(4)(c)7. 7. Acceptance testing of the machine after any repair or service that may have altered the machine’s performance characteristics.

DHS 157.82(4)(d) (d) If the medical physicist is not a full-time employee of the registrant, the operating procedures shall also specifically address how the medical physicist is to be contacted for problems or emergencies, as well as the specific actions to be taken until the medical physicist may be contacted.

DHS 157.82(5) (5) Qualification of operators.

DHS 157.82(5)(a) (a) A person who will be operating a therapeutic radiation machine for medical use shall be an American registry of radiologic technologists registered radiation therapy technologist or a user authorized under sub. (2) or (3). A person who is not an ARRT registered radiation therapy technologist shall submit evidence that he or she has satisfactorily completed a radiation therapy technologist training program that complies with the requirements of the joint review committee on education in radiologic technology.

DHS 157.82 Note Note: “Essentials and Guidelines of an Accredited Educational Program for the Radiation Therapy Technologist”, Joint Review Committee on Education in Radiologic Technology, 1988, establishes the requirements for a therapy technologist training program. The document is available at: http://www.jrcert.org/.

DHS 157.82(5)(b) (b) The names and training of all personnel currently authorized to operate a therapeutic radiation machine shall be kept on file at the facility. Information on former operators shall be retained for a period of at least 3 years beyond the last date they were authorized to operate a therapeutic radiation machine at that facility.

DHS 157.82(5)(c) (c) A person who will be operating an electronic brachytherapy unit shall complete device specific instruction from the manufacturer or individual trained by the manufacturer, and training on procedures required by s. DHS 157.85 (16) (g) 4. and 5.

DHS 157.82(6) (6) Safety procedures. Written safety procedures and rules, including any restrictions required for the safe operation of the particular therapeutic radiation machine, shall be developed by a medical physicist and shall be available in the control area of a therapeutic radiation machine. The operator shall be able to demonstrate familiarity with these rules.

DHS 157.82(7) (7) Written directive required. Persons may not be exposed to the useful beam except for medical therapy purposes and unless exposure has been ordered in writing by a physician user qualified under sub. (2) or (3). This provision specifically prohibits deliberate exposure of an person for training, demonstration or other non-healing arts purposes.

DHS 157.82(8) (8) Information and records. The registrant shall maintain all of the following information in a separate file or package for each therapeutic radiation machine for inspection by the department:

DHS 157.82(8)(a) (a) Report of acceptance testing.

DHS 157.82(8)(b) (b) Records of all surveys, calibrations and periodic quality control checks of the therapeutic radiation machine, as well as the names of persons who performed those activities.

DHS 157.82(8)(c) (c) Records of maintenance or modifications performed on the therapeutic radiation machines, as well as the names of persons who performed these services.

DHS 157.82(8)(d) (d) Signature of each person authorizing the return of a therapeutic radiation machine to clinical use after service, repair or upgrade.