Section DHS 157.82 - General administrative requirements for facilities using therapeutic radiation machines for human use(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.(2) TRAINING FOR RADIATION THERAPY USERS. (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: 1. Certified or board eligible in one or more of the following: a. Radiology or therapeutic radiology by the American board of radiology.b. Radiation oncology by the American osteopathic board of radiology.c. Radiology, with specialization in radiotherapy, as a British "Fellow of the Faculty of Radiology" or "Fellow of the Royal College of Radiology". d. Therapeutic radiology by the Canadian royal college of physicians and surgeons.2. Actively practices therapeutic radiology and has completed all of the following:a. The radiation therapy residency.b. Two hundred hours of instruction in basic radiation techniques applicable to the use of an external beam radiation therapy unit.c. Five hundred hours of supervised work experience in therapeutic radiology. d. A minimum of 3 years of supervised clinical experience or 5 years of post graduate clinical experience in therapeutic radiology.3. Has equivalent training and submits the training of the prospective user physician for department review on a case-by-case basis.(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.(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.(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: (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.(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.(4) MEDICAL PHYSICIST SUPPORT. (a) The services of a medical physicist is required in facilities having one or more therapeutic radiation machines.(b) The registrant for any therapeutic radiation machine shall require the medical physicist to have any of the following:1. Certification by the American board of radiology in one or more of the following: a. Therapeutic radiological physics.b. Roentgen-ray and gamma-ray physics.c. X-ray and radium physics. 2. Certification by the American board of medical physics in radiation oncology physics.3. Certification by the Canadian college of medical physics.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.(c) The medical physicist shall be responsible for all of the following:1. Full calibrations and protection surveys.2. Supervision and review of dosimetry.3. Beam data acquisition and transfer for computerized dosimetry and supervision of its use.4. Quality control, including quality control check review.5. Consultation with the physician user in treatment planning, as needed.6. Performance of calculations and assessments regarding medical events.7. Acceptance testing of the machine after any repair or service that may have altered the machine's performance characteristics. (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.(5) QUALIFICATION OF OPERATORS. (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. 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/.
(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.(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.(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.(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.(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: (a) Report of acceptance testing.(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.(c) Records of maintenance or modifications performed on the therapeutic radiation machines, as well as the names of persons who performed these services. (d) Signature of each person authorizing the return of a therapeutic radiation machine to clinical use after service, repair or upgrade.(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.Wis. Admin. Code Department of Health Services DHS 157.82
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.