Chapter DHS 157

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.

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 History History: 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 157.83 DHS 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)(d) (d) Each administration is according to the written directive.

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.

DHS 157.83(3) (3) Medical events.

DHS 157.83(3)(a) (a) A registrant shall report any of the following medical events:

DHS 157.83(3)(a)1. 1. A dose that differs from the prescribed dose by more than 0.05 Sv (5 rem) effective dose equivalent, 0.5 Sv (50 rem) to an organ or tissue or 0.5 Sv (50 rem) shallow dose equivalent to the skin and any of the following exist:

DHS 157.83(3)(a)1.a. a. The total dose delivered differs from the prescribed dose by 20% or more.

DHS 157.83(3)(a)1.b. b. The fractionated dose delivered exceeds the prescribed dose, for a single fraction, by 50% or more.

DHS 157.83(3)(a)2. 2. A dose that exceeds 0.05 Sv (5 rem) effective dose equivalent, 0.5 Sv (50 rem) to an organ or tissue or 0.5 Sv (50 rem) shallow dose equivalent to the skin under any of the following conditions:

DHS 157.83(3)(a)2.a. a. An administration of a dose to the wrong patient or human research subject.

DHS 157.83(3)(a)2.b. b. An administration of a dose delivered by the wrong mode of treatment.

DHS 157.83(3)(a)3. 3. A dose to an organ outside the intended treatment volume that exceeds the expected dose to that organ by 0.5 Sv (50 rem) where the excess dose is greater than 50% of the expected dose to that organ.

DHS 157.83(3)(b) (b) In response to a medical event, a registrant shall do all of the following:

DHS 157.83(3)(b)1. 1. Notify the department by telephone or in person no later than 3 working days after discovery of the medical event.

DHS 157.83(3)(b)2. 2. Submit a written report to the department within 15 working days after discovery of the medical event. The written report shall include: the registrant’s name; the prescribing physician’s name; a brief description of the event; the effect on the patient; what improvements are needed to prevent recurrence; actions taken to prevent recurrence; whether the registrant notified the patient or the patient’s responsible relative or guardian and if not, why not; and if the patient was notified, what information was provided to the patient. This report may not include the patient’s name or other information that could lead to identification of the patient.

DHS 157.83 Note Note: Mail the report to the Department at: Department of Health Services, Radiation Protection Section, PO Box 2659, Madison WI 53701-2659.

DHS 157.83(3)(b)3. 3. Notify the referring physician and the patient of the medical event no later than 24 hours after the medical event’s discovery, unless the referring physician personally informs the registrant either that he or she will inform the patient or that, based on medical judgment, telling the patient would be harmful. The registrant is not required to notify the patient without first consulting the referring physician. If the referring physician or patient cannot be reached within 24 hours, the registrant shall notify the patient of the medical event as soon as possible. The registrant may not delay any appropriate medical care for the patient, including any necessary remedial care as a result of the medical event, because of any delay in notification.

DHS 157.83(3)(b)4. 4. Retain a record of each medical event for 3 years. The record shall contain all of the following:

DHS 157.83(3)(b)4.a. a. The names of all persons involved.

DHS 157.83(3)(b)4.b. b. The patient’s unique identification number.

DHS 157.83(3)(b)4.c. c. A brief description of the event, why it occurred and the effect on the patient.

DHS 157.83(3)(b)4.d. d. What improvements were identified and actions taken to prevent recurrence.

DHS 157.83(3)(b)4.e. e. Whether the registrant notified the patient or patient’s guardian and if not, why not, and if the patient was notified, what information was provided to the patient.

DHS 157.83(3)(b)4.f. f. If information was not given to the patient at the direction of the referring physician, the reason why the information was not given to the patient.

DHS 157.83(3)(b)5. 5. If the patient was notified, furnish, within 15 working days after discovery of the medical event, a written report to the patient by sending either a copy of the report that was submitted to the department, or a brief description of both the event and the consequences as they may affect the patient, if a statement is included that the report submitted to the department may be obtained from the registrant.

DHS 157.83(4) (4) Rights. Aside from the notification requirement, nothing in this section affects any rights or duties of registrants and physicians in relation to each other, patients or the patient’s responsible relatives or guardians.