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 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)(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:
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.c.
c. A brief description of the event, why it occurred and the effect on the patient.
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.
DHS 157.83 History
History: CR 01-108: cr.
Register July 2002 No. 559, eff. 8-1-02;
CR 06-021: am. (2) (b)
Register October 2006 No. 610, eff. 11-1-06;
CR 09-062: am. (1) (a) and (c)
Register April 2010 No. 652, eff. 5-1-10;
CR 16-078: am. (3) (b) 1., renum. (3) (b) 2. a. to (3) (b) 2. and am., r. (3) (b) 2. b., am. (3) (b) 4. d.
Register January 2018 No. 745, eff. 2-1-18.
DHS 157.84
DHS 157.84 Technical requirements for facilities using therapeutic radiation machines. DHS 157.84(1)(a)
(a) A registrant shall ensure that radiation protection surveys of all new facilities and existing facilities not previously surveyed are performed with an operable, calibrated survey instrument. The radiation protection survey shall be performed by or under the direction of a medical physicist and shall verify that, with the therapeutic radiation machine in a “BEAM-ON" condition, with the largest clinically available treatment field and with a scattering phantom in the useful beam of radiation, all of the following requirements are met:
DHS 157.84(1)(b)
(b) A radiation protection survey shall be performed prior to any subsequent medical use after making any of the following changes:
DHS 157.84(1)(b)2.
2. Any change in the location of the therapeutic radiation machine within the treatment room.
DHS 157.84(1)(b)4.
4. Using the therapeutic radiation machine in a manner that could result in increased radiation levels in areas outside the external beam radiation therapy treatment room.
DHS 157.84(1)(b)5.
5. Replacing the therapeutic radiation machine in an existing treatment room.
DHS 157.84(1)(c)1.
1. Instances where the facility, in the opinion of the medical physicist, is in violation of applicable regulations.
DHS 157.84(1)(c)6.
6. The instruments used to measure radiation levels and their last date of calibration.
DHS 157.84(1)(c)7.
7. A floor plan of the areas surrounding the treatment room that were surveyed.
DHS 157.84(1)(c)8.
8. The radiation level at several points in each area expressed in microsieverts or millirems per hour.
DHS 157.84(1)(c)9.
9. The calculated maximum level of radiation over a period of one week for each restricted and unrestricted area.
DHS 157.84(1)(d)
(d) If the results of radiation protection surveys indicate any radiation levels in excess of the respective limit, the registrant shall lock the control in the “OFF" position and may not use the unit except under one or more of the following conditions:
DHS 157.84(1)(d)1.
1. As may be necessary to repair, replace or test the therapeutic radiation machine, the therapeutic radiation machine shielding or the treatment room shielding.
DHS 157.84(1)(d)2.
2. Until the registrant has received a specific exemption from the department.
DHS 157.84(2)
(2)
Modification of radiation therapy unit or room before beginning a treatment program. If the survey indicates that a person in an unrestricted area may be exposed to levels of radiation greater than those permitted by s.
DHS 157.23 (1) (a) and
(b), before beginning the treatment program, the registrant shall do all of the following:
DHS 157.84(2)(c)
(c) Include in the report the results of the initial survey, a description of the modification made and the results of the second survey.
DHS 157.84(2)(d)
(d) Submit facility design information to the department prior to installation of a therapeutic radiation machine of higher energy into a room not previously approved for that energy and receive approval from the department prior to actual installation of the therapeutic radiation machine.
DHS 157.84(3)(a)1.1. A registrant shall have a calibrated dosimetry system available for use. The dosimetry system shall be calibrated by a certified calibration facility at least every 24 months and after any servicing that may affect system calibration.
DHS 157.84(3)(a)2.
2. For beams with energies greater than one MeV, the dosimetry system shall be calibrated for Cobalt-60.
DHS 157.84(3)(a)3.
3. For beams with energies equal to or less than one MeV, the dosimetry system shall be calibrated at an energy or energy range appropriate for the radiation being measured.
DHS 157.84(3)(b)
(b) A registrant shall have a dosimetry system for quality control check measurements. The system may be compared with another system whose calibration is traceable to the national institute of standards and technology. The comparison shall be performed at least every 24 months and after each servicing that may affect system calibration.
DHS 157.84(3)(c)
(c) A registrant shall maintain a record of each dosimetry system calibration, intercomparison and comparison for the duration of the registration. For each calibration, intercomparison or comparison, the record shall include all of the following:
DHS 157.84(3)(c)2.
2. The model and serial numbers of the instruments that were calibrated, inter-compared or compared.
DHS 157.84(3)(c)4.
4. The names of the persons who performed the calibration, intercomparison or comparison.
DHS 157.84(3)(c)5.
5. Evidence that the intercomparison was performed by or under the direct supervision and in the physical presence of a medical physicist.
DHS 157.84(4)
(4)
Survey instruments. Except for dermatology offices with systems operating at less than 150 kV, each facility location authorized to use a therapeutic radiation machine shall possess appropriately calibrated portable monitoring equipment. Equipment shall include a portable radiation measurement survey instrument capable of measuring dose rates over the range 10
µSv (one mrem) per hour to 10 mSv (1000 mrem) per hour. The survey instruments shall be operable and calibrated.
