a. Principles and operation of the fluoroscopic x-ray system.
b. Biological effects of x-ray.
c. Principles of radiation protection.
d. Fluoroscopic outputs.
e. High level control options.
f. Dose reduction techniques for fluoroscopic x-ray systems.
g. Applicable state and federal regulations.
(12) AIR KERMA MEASUREMENTS. Annual measurements of both typical and maximum air kerma shall be made by a medical physicist or a person approved by a medical physicist.
Note: Materials should be placed in the useful beam to protect the imaging system when conducting these periodic measurements. Air kerma measurements do not include backscatter.
SECTION 54. DHS 157.77 (2) (g) is amended to read:
DHS 157.77 (2) (g) Exposure control location. The x-ray exposure control shall be placed so that the operator may view the patient while making any exposure and at least 3 feet1 meter (3.3 feet) from the end of the protective barrier.
SECTION 55. DHS 157.79 (2) (c) is amended to read:
DHS 157.79 (2) (c) A deadmandead-man type of exposure switch shall be provided with an electrical cord of sufficient length so that the operator or the assistant, may stand out of the useful beam and at least 2 meters (6.5 feet) from the table during all x-ray exposures. A foot operated exposure switch may be used and this switch may be integrated into the table base or the foot switch may be on a 2 meter (6.5 feet) cord.
SECTION 56. DHS 157.80 (2) (a) is renumbered DHS 157.80 (2) (a) 1. and 3. and amended to read:
DHS 157.80 (2) OPERATING PROCEDURES. (a) 1. A CT x-ray system for human use may only be operated for diagnostic procedures by an American registry of radiologic technologists certified person who has been specifically trained in its operation.
3. Combination systems which are designated as PET/CT shall be operated by a person qualified by training in the safe use of radioactive materials and who meets the training requirements of Appendix L.
SECTION 57. DHS 157.80 (2) (a) 2. is created to read:
DHS 157.80 (2) (a) 2. A CT x-ray system for veterinary use may only be operated for diagnostic procedures by a person who is certified by the American registry of radiological technologists or has completed training equivalent to the requirements of Appendix L and has been specifically trained in its operation.
SECTION 58. DHS 157.81 (1) and (2) are amended to read:
DHS 157.81 Shielding plan review. (1) PLAN REVIEW AND APPROVAL. Prior to construction, the floor plans, shielding specifications and equipment arrangement of all new installations, or modifications of existing installations, utilizing ionizing radiation machines, including dental CT and dental cephalometric machines, shall be submitted to the department for review and approval.
(2) EXEMPTIONS. Dental intraoral and panoramic, mammography, and bone density devices are exempt from this section.
SECTION 59. DHS 157.81 (3) (c) 7. is created to read:
DHS 157.81 (3) (c) 7. The x-ray exposure control shall be located within the shielded area and at least 1 meter (3.3 feet) from the open end of the protective barrier, excluding mammography units.
SECTION 60. DHS 157.82 (2) (c) and (5) (c) are created to read:
DHS 157.82 (2) (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.
(5) (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.
SECTION 61. DHS 157.82 (6) is amended to read:
DHS 157.82 (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.
Operators, authorized users and medical physicists for electronic brachytherapy shall participate in drills of the emergency procedures, required by s. DHS 157.85(16)(g) 5., initially and at least annually thereafter.
SECTION 62. DHS 157.83 (1) (a) and (c) are amended to read:
DHS 157.83 (1) (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 prior to administration of the external beam radiation therapy dose, or the next external beam radiation therapy fractional dose. 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.
(c) External beam radiation therapy or electronic brachytherapy final plans of treatment and related calculations are according to the respective written directives.
SECTION 63. DHS 157.85 (13) (em) is created to read:
DHS 157.85 (13) (em) Full calibration for electronic brachytherapy units shall include all of the following:
1. Timer accuracy and linearity over the typical range of use.
2. Proper operation of back-up exposure control devices.
3. The output within 2 % of the expected value, if applicable, or determination of the output if there is no expected value.
4. Evaluation that the relative dose distribution about the source is within 5 % of the expected value.
5. Source position accuracy to within 1 millimeter within the applicator.
6. Determination of the proper length of source transfer tubes and applicators.
7. Determination of the operability of the source transfer tubes, applicators and transfer tube-applicator interfaces.
SECTION 64. DHS 157.85 (14) (e) is amended to read:
DHS 157.85 (14) (e) A registrant shall have the medical physicist review and sign the results of each radiation output quality control check and notify the registrant of results within 10 working days of the date that the check was performed.
SECTION 65. DHS 157.85 (14) (fm) is created to read:.
DHS 157.85 (14) (fm) If the results of the quality control checks indicate malfunction of any system, the registrant shall prevent clinical use of the system until repaired.
SECTION 66. DHS 157.85 (14) (g) 4. is amended to read:
DHS 157.85 (14) (g) 4. Viewing and intercom systems
, if applicable.
SECTION 67. DHS 157.85 (14) (g) 6. and (gm) are created to read:
DHS 157.85 (14) (g) 6. If applicable, the integrity of all cables, catheters or parts of the device that carry high voltages.
(gm) Daily quality control checks for electronic brachytherapy shall include all the following:
1. The output of the x-ray source falls within 3 % of expected values, which includes output as a function of time or output as a function of setting on a monitor chamber.
2. Verification of the consistency of the dose distribution to within 3 % of that found during calibration.
3. Validation of the operation of positioning methods to assure that the treatment dose exposes the intended location to within 1 mm.
4. Inspection of all treatment components on the day of use.
SECTION 68. DHS 157.85 (16) (g) is created to read:
DHS 157.85 (16) (g) A registrant for electronic brachytherapy shall do all of the following:
1. Ensure the electronic brachytherapy unit is inoperable, either by hardware or password, when unattended by qualified staff or service personnel.
2. Secure the unit, console, console keys and the treatment room when unattended or not in use.
3. Prevent dual operation of more than one radiation producing device in a treatment room, if applicable.
4. Create a written procedure for safe operation of each device.
5. Develop, implement and maintain written procedures for responding to an abnormal situation. The procedure shall include all the following:
a. Instructions for responding to equipment failures and the names of the persons responsible for implementing corrective actions.
b. The names and telephone numbers of the licensed practitioner, the medical physicist, the radiation safety officer and the manufacturer to be contacted if the unit or console operates abnormally.
6. Maintain a copy of the procedures required by subd. 4. and 5. at the unit console.
7. Ensure all of the following is done during treatment:
a. Only individuals approved by the authorized user, radiation safety officer or medical physicist may be present in the treatment room.
b. Protective shielding shall be available for persons in the treatment room.
c. A radiation survey is performed when the unit and/or shielding is portable to verify proper shielding placement immediately upon initiation of treatment.
d. A medical physicist and operator shall be physically present during the initiation and course of patient treatment.
e. A medical physicist or operator shall monitor the position of all persons in the treatment room to prevent unshielded exposure.
f. A medical physicist or operator shall monitor all entrances to prevent entering individuals from unshielded exposure.
g. Only mechanical supporting or restraining devices may be used to hold a patient in position, when applicable.
SECTION 69. DHS 157.88 (3) (a) (intro.) is amended to read:
DHS 157.88 (3) (intro.) NOTIFICATIONS AND REPORTS TO INDIVIDUALS. (a)
Radiation exposure reports. Every 12 months, a licensee or registrant shall provide a written report of radiation exposure to each employee who is required to be monitored for radiation exposure under s.
DHS 157.25 (2) if the employee's annual dose exceeds 1 mSv (100 mrem) TEDE or 1 mSv (100 mrem) to any individual organ or tissue. The report shall include all of the following:
SECTION 70. DHS 157.92 (2) (c) 5. (intro.) and (3) (a) (intro.)and (b) are amended to read:
DHS 157.92 (2) (c) 5. (intro.) Liquid solutions of uranyl nitrate enriched in uranium-235 to a maximum of two percent by weightmass, provided that all the following conditions apply:
(3)
TRANSPORT OF LICENSED MATERIAL. (a) A licensee who transports licensed material outside the site of usage, as specified in the department license, or on public highways, or who delivers licensed material to a carrier for transport, shall
comply with the applicable requirements of the DOT regulations in 49 CFR 107, 171 to 180, and 390 to 397, appropriate to the mode of transport and do all the following:
(b) If the regulations of the U.S. department of transportation are not applicable to a shipment of licensed material, a licensee shall comply with the requirements of 49 CFR 170 to 189107, 171 to 180, and 390 to 397, appropriate to the mode of transport as if the shipment was subject to the regulations. A request for modification, waiver or exemption from these requirements and any notification referred to in these requirements shall be submitted in writing to the department.
SECTION 71. APPENDIX E, List of Elements (page 439) is amended to read:
List of Elements
Atomic
Name Symbol Number
Actinium Ac 89
Aluminum A 13
Americium Am 95
Antimony Sb 51
Argon Ar 18
Arsenic As 33
Astatine At 85
Barium Ba 56
Berkelium Bk 97
Beryllium Be 4
Bismuth Bi 83
Bromine Br 35
Cadmium Cd 48
Calcium Ca 20
Californium Cf 98
Carbon C 6
Cerium Ce 58
Cesium Cs 55
Chlorine Cl 17
Chromium Cr 24
Cobalt Co 27
Copper Cu 29
Curium Cm 96
Dysprosium Dy 66
Einsteinium Es 99
Erbium Er 68
Europium Eu 63
Fermium Fm 100
Fluorine F 9
Francium Fr 87
Gadolinium Gd 64
Gallium Ga 31
Germanium Ge 32
Gold Au 79
Hafnium Hf 72
Holmium Ho 67
Hydrogen H 1
Indium In 49
Iodine I 53
Iridium Ir 77
Iron Fe 26
Krypton Kr 36
Lanthanum La 57
Lead Pb 82
Lutetium Lu 71
Magnesium Mg 12
Manganese Mn 25
Mendelevium Md 101
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List of Elements (cont.)
Atomic
Name Symbol Number
Mercury Hg 80
Molybdenum Mo 42
Neodymium Nd 60
Neptunium Np 93
Nickel Ni 28
Niobium Nb 41
Nitrogen N 7
Osmium Os 76
Oxygen O 8
Palladium Pd 46
Phosphorus P 15
Platinum Pt 78
Plutonium Pu 94
Polonium Po 84
Potassium K 19
Praseodymium Pr 59
Promethium Pm 61
Protactinium Pa 91
Radium Ra 88
Radon Rn 86
Rhenium Re 75
Rhodium Rh 45
Rubidium Rb 37
Ruthenium Ru 44
Samarium Sm 62
Scandium Sc 21
Selenium Se 34
Silicon Si 14
Silver Ag 47
Sodium Na 11
Strontium Sr 38
Sulfur S 16
Tantalum Ta 73
Technetium Tc 43
Tellurium Te 52
Terbium Tb 65
Thallium Tl 81
Thorium Th 90
Thulium Tm 69
Tin Sn 50
Titanium Ti 22
Tungsten W 74
Uranium U 92
Vanadium V 23
Xenon Xe 54
Ytterbium Yb 70
Yttrium Y 39
Zinc Zn 30
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SECTION 72. APPENDIX O, s. II is amended to read:
II. a. For individual radionuclides whose identities are known, but which are not listed in TABLE VI, the determination of the values of A1 and A2 requires department approval, except that the values of A1 and A2 in TABLE VIIVIII may be used without obtaining department approval.
b. For individual radionuclides whose identities are known, but which are not listed in Table VII, the exempt material activity concentration and exempt consignment activity values contained in Table VIII may be used. Otherwise, the licensee shall obtain prior department approval of the exempt material activity concentration and exempt consignment activity values for radionuclides not listed in Table VII, before shipping the material.
c. The licensee shall submit requests for prior approval, described under paragraphs II(a) and II(b) of this Appendix, in writing to the department.
SECTION 73. APPENDIX O, s. IV, par. (a) is amended to read:
(a) For special form radioactive material, the maximum quantity transported in a Type A package is as follows:
where B(i) is the activity of radionuclide i and A1(i) is the A1 value for radionuclide I.
SECTION 74. APPENDIX O, s. IV, par. (b) is renumbered and amended to read:
(b) For normal form radioactive material, the maximum quantity transported in a Type A package is as follows:
