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 NoteNote: 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)(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)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)(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 HistoryHistory: 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 157.82DHS 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)(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.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.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.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)(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)2.2. Certification by the American board of medical physics in radiation oncology 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)3.3. Beam data acquisition and transfer for computerized dosimetry and supervision of its use. 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)(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 NoteNote: “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)(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. DHS 157.82(9)(9) Record retention. All records required by sub. (8) shall be retained for 3 years or until disposal is authorized by the department. Any required record generated prior to the last department inspection may be microfilmed or otherwise archived as long as a complete legible copy of the record may be retrieved. DHS 157.82 HistoryHistory: CR 01-108: cr. Register July 2002 No. 559, eff. 8-1-02; CR 09-062: cr. (2) (c) and (5) (c), am. (6) Register April 2010 No. 652, eff. 5-1-10. DHS 157.83DHS 157.83 Administrative policies and procedures for radiation therapy machines. DHS 157.83(1)(1) Written policies. A registrant shall have written policies and procedures to ensure that radiation will be administered as directed by an authorized user. The policies shall meet all of the following specific objectives: DHS 157.83(1)(a)(a) Prior to administration, a written directive is prepared for any external beam radiation therapy dose or electronic brachytherapy dose. A written revision to an existing written directive may be made prior to beginning treatment, or prior to delivery of a fractional dose, provided that the revision is dated and signed by an authorized user. If, because of the patient’s condition, a delay to provide a written revision to an existing written directive would jeopardize the patient’s health, an oral revision to an existing written directive shall be acceptable provided that the oral revision is documented immediately in the patient’s record and a revised written directive is signed by an authorized user within 24 hours of the oral revision. DHS 157.83(1)(b)(b) Prior to the administration of each course of radiation treatments, the patient’s identity is verified, by more than one method, as the person named in the written directive. DHS 157.83(1)(c)(c) External beam radiation therapy or electronic brachytherapy final plans of treatment and related calculations are according to the respective written directives. DHS 157.83(1)(e)(e) Any unintended deviation from the written directive is identified, documented, evaluated and appropriate action is taken. DHS 157.83(2)(2) Development of the operational procedures program. A therapy device registrant shall do all the following: DHS 157.83(2)(a)(a) Develop an operational procedures program that specifies staff duties and responsibilities, and equipment and procedures. The registrant shall implement the program upon issuance of a certificate of registration by the department. DHS 157.83(2)(b)(b) Develop procedures for and conduct a review of the program including, since the last review, an evaluation of a representative sample of patient administrations and all medical events to verify compliance with all aspects of the operational procedures program. DHS 157.83(2)(c)(c) Conduct program reviews at intervals not to exceed 12 months. DHS 157.83(2)(d)(d) Evaluate each of the reviews specified in par. (b) to determine the effectiveness of the program and, if required, make modifications to meet the requirements of par. (b). DHS 157.83(2)(e)(e) Maintain records of each review specified in par. (b), including the evaluations and findings of the review, in an auditable form for 3 years.
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Chs. DHS 110-199; Health
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