Section DHS 157.84 - Technical requirements for facilities using therapeutic radiation machines(1) RADIATION PROTECTION SURVEYS. (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: 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).2. Radiation levels in unrestricted areas do not exceed the limits specified in s. DHS 157.23(1) (a) and (b).(b) A radiation protection survey shall be performed prior to any subsequent medical use after making any of the following changes:1. Any change in the treatment room shielding.2. Any change in the location of the therapeutic radiation machine within the treatment room.3. Relocating the therapeutic radiation machine.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.5. Replacing the therapeutic radiation machine in an existing treatment room.(c) The survey record shall indicate all of the following:1. Instances where the facility, in the opinion of the medical physicist, is in violation of applicable regulations.2. The date of the measurements.3. The reason the survey is required.4. The radiation therapy machine manufacturer's name.5. The model and serial number of the therapeutic radiation machine.6. The instruments used to measure radiation levels and their last date of calibration.7. A floor plan of the areas surrounding the treatment room that were surveyed.8. The radiation level at several points in each area expressed in microsieverts or millirems per hour.9. The calculated maximum level of radiation over a period of one week for each restricted and unrestricted area.10. The signature of the person responsible for conducting the survey.(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: 1. As may be necessary to repair, replace or test the therapeutic radiation machine, the therapeutic radiation machine shielding or the treatment room shielding.2. Until the registrant has received a specific exemption from the department.(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: (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).(b) Perform the survey again.(c) Include in the report the results of the initial survey, a description of the modification made and the results of the second survey.(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.(3) DOSIMETRY EQUIPMENT. (a)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.2. For beams with energies greater than one MeV, the dosimetry system shall be calibrated for Cobalt-60.3. 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.(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.(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: 2. The model and serial numbers of the instruments that were calibrated, inter-compared or compared.3. The correction factors that were determined.4. The names of the persons who performed the calibration, intercomparison or comparison.5. Evidence that the intercomparison was performed by or under the direct supervision and in the physical presence of a medical physicist.(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.(5) SHIELDING AND SAFETY DESIGN REQUIREMENTS. (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.(b) Observation and communication with the patient shall be possible at all times.Wis. Admin. Code Department of Health Services DHS 157.84
CR 01-108: cr. Register July 2002 No. 559, eff. 8-1-02.Amended by, CR 16-078: cr. (1) (b) 5. Register January 2018 No. 745, eff. 2/1/2018