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. 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.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: