Chapter DHS 157

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.

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) (1) Radiation protection surveys.

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)(a)1. 1. Radiation levels in restricted areas are not likely to cause personnel exposures in excess of the limits specified in s. DHS 157.22 (1) (a).

DHS 157.84(1)(a)2. 2. Radiation levels in unrestricted areas do not exceed the limits specified in s. DHS 157.23 (1) (a) and (b).

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)1. 1. Any change in the treatment room shielding.

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)3. 3. Relocating the therapeutic radiation machine.

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) (c) The survey record shall indicate all of the following:

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)2. 2. The date of the measurements.

DHS 157.84(1)(c)3. 3. The reason the survey is required.

DHS 157.84(1)(c)4. 4. The radiation therapy machine manufacturer’s name.

DHS 157.84(1)(c)5. 5. The model and serial number of the therapeutic radiation machine.

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)(c)10. 10. The signature of the person responsible for conducting the survey.

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)(a) (a) Equip the unit with beam direction interlocks or add additional radiation shielding to ensure compliance with s. DHS 157.23 (1) (a) and (b).

DHS 157.84(2)(b) (b) Perform the survey again.

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) (3) Dosimetry equipment.

DHS 157.84(3)(a) (a)

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)1. 1. The date.

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)3. 3. The correction factors that were determined.

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 mSv (one mrem) per hour to 10 mSv (1000 mrem) per hour. The survey instruments shall be operable and calibrated.

DHS 157.84(5) (5) Shielding and safety design requirements.

DHS 157.84(5)(a) (a) Facility design information for all new installations of a therapeutic radiation machine or installations of a therapeutic radiation machine of higher energy into a room not previously approved for that energy shall be submitted to the department and approved by the department prior to actual installation of the therapeutic radiation machine.

DHS 157.84(5)(b) (b) Observation and communication with the patient shall be possible at all times.

DHS 157.84 History History: CR 01-108: cr. Register July 2002 No. 559, eff. 8-1-02; CR 16-078: cr. (1) (b) 5. Register January 2018 No. 745, eff. 2-1-18.

DHS 157.85 DHS 157.85 Therapeutic radiation machines.

DHS 157.85(1) (1) Leakage radiation.

DHS 157.85(1)(a) (a) When a therapeutic radiation machine is operated at its maximum dose rate, the leakage air kerma rate may not exceed the value specified at the distance specified for that classification of therapeutic radiation machine.

DHS 157.85(1)(b) (b) Leakage radiation from contact therapy systems may not exceed one mGy (103 mR) per hour at 5 centimeters from the surface of the tube housing assembly. Contact therapy tube housing assemblies shall have a removable shield of material, equivalent in attenuation to 0.5 millimeters of lead at 100 kV, which may be positioned over the entire useful beam exit port during periods when the beam is not in use.

DHS 157.85(1)(c) (c) Leakage radiation from systems operating at 150 kV or less may not exceed one mGy (103 mR) per hour at one meter from the tube housing.

DHS 157.85(1)(d) (d) Leakage radiation from systems operating above 150 kV may not exceed 0.1% of the useful beam one meter from the source housing for any of its operating conditions.

DHS 157.85(2) (2) Permanent beam-limiting devices. Permanent, non-adjustable collimators used for limiting the useful beam shall provide at least the same degree of attenuation as required for the tube housing assembly.

DHS 157.85(3) (3) Adjustable or removable beam-limiting devices.

DHS 157.85(3)(a) (a) All removable beam-limiting devices or diaphragms may not transmit more than one percent of the useful beam for the most penetrating beam used. This paragraph does not apply to beam shaping blocks or shaping materials.

DHS 157.85(3)(b) (b) When adjustable beam-limiting devices are used, the position and shape of the useful beam shall be indicated by a light beam. These devices may transmit not more than 5% of the useful beam.

DHS 157.85(4) (4) Filter systems. The filter system shall be designed to meet all of the following requirements:

DHS 157.85(4)(a) (a) Accidental displacement of filters is not possible at any tube orientation.

DHS 157.85(4)(b) (b) If the proper filter is not in place, an interlock system shall prevent irradiation.

DHS 157.85(4)(c) (c) The air kerma rate escaping from the filter placement opening slot in the tube head may not exceed 100 mGy (one rad) per hour at one meter under any operating conditions.

DHS 157.85(4)(d) (d) Each filter shall be marked as to its material of construction and its thickness.

DHS 157.85(4)(e) (e) Each wedge filter that is removable from the system shall be clearly marked with an identification number. For removable wedge filters, the nominal wedge angle shall appear on the wedge or wedge tray. If the wedge or wedge tray is significantly damaged, the wedge transmission factor shall be reestablished.

DHS 157.85(4)(f) (f) If the absorbed dose rate information relates exclusively to operation with a field flattening filter or beam scattering foil in place, that foil or filter shall be removable only by the use of tools.

DHS 157.85(5) (5) Tube immobilization.

DHS 157.85(5)(a) (a) An x-ray tube shall be mounted so that it cannot accidentally turn or slide with respect to the opening in the tube housing through which radiation is emitted.

DHS 157.85(5)(b) (b) The tube housing assembly shall be capable of being immobilized.

DHS 157.85(6) (6) Emergency switches. At least one emergency power cutoff switch shall be present. If more than one emergency power cutoff switch is installed and not all switches are tested at once, each switch shall be tested on a rotating basis. Safety quality control checks of the emergency power cutoff switches may be conducted at the end of the treatment day to minimize possible stability problems with the therapeutic radiation machine.

DHS 157.85(7) (7) Source marking. An x-ray tube housing assembly shall be marked so that it is possible to determine the location of the focal spot to within 5 millimeters and the marking shall be readily accessible for use during calibration procedures.

DHS 157.85(8) (8) Timer.

DHS 157.85(8)(a) (a) A suitable irradiation control device shall be provided to terminate the irradiation after a preset time interval or after a preset radiation dose has been delivered.

DHS 157.85(8)(b) (b) A timer with a display shall be provided at the treatment control panel. The timer shall have a pre-set time selector and an elapsed time or time remaining indicator.

DHS 157.85(8)(c) (c) A timer shall be a cumulative timer that activates with an indication of “BEAM-ON” and retains its reading after irradiation is interrupted or terminated. After irradiation is terminated and before irradiation may be reinitiated, it shall be necessary to reset the elapsed time indicator.

DHS 157.85(8)(d) (d) A timer shall terminate irradiation when a pre-selected time has elapsed, if any dose monitoring system present has not previously terminated irradiation.

DHS 157.85(8)(e) (e) A timer may not permit an exposure if set at zero.

DHS 157.85(8)(f) (f) A timer may not activate until the shutter is opened when irradiation is controlled by a shutter mechanism unless calibration includes a timer end effect correction to compensate for mechanical lag.

DHS 157.85(8)(g) (g) A timer shall be accurate to within one percent of the selected value or one second, whichever is greater.

DHS 157.85(9) (9) Control panel indicators. An x-ray unit shall have all of the following:

DHS 157.85(9)(a) (a) An indication at the control panel of whether electrical power is on and if activation of the x-ray tube is possible.