DHS 157.73(13)(c)(c) A licensee may revise operating and emergency procedures without department approval only if all of the following conditions are met: DHS 157.73(13)(c)2.2. The revisions are consistent with the outline or summary of procedures submitted with the license application. DHS 157.73(13)(c)3.3. The revisions have been reviewed and approved by the radiation safety officer. DHS 157.73(13)(c)4.4. The users or operators are instructed and tested on the revised procedures before the procedures are implemented. DHS 157.73(14)(a)(a) Any irradiator operator shall wear a personnel dosimeter while operating a panoramic irradiator or while in the area around the pool of an underwater irradiator. The personnel dosimeter shall be capable of detecting high energy photons in the normal and accident dose ranges. Each personnel dosimeter shall be assigned to and worn by only one person. Film badges shall be replaced at least monthly and all other personnel dosimeters that require replacement shall be replaced at least quarterly. All personnel dosimeters must be evaluated at least quarterly or promptly after replacement, whichever is more frequent. DHS 157.73 NoteNote: See s. DHS 157.25 (1) (c) for instructions concerning dosimetry processing. DHS 157.73(14)(b)(b) A person other than an irradiator operator who enters the radiation room of a panoramic irradiator shall wear a dosimeter, which may be a pocket dosimeter. For groups of visitors, only 2 people who enter the radiation room are required to wear dosimeters. DHS 157.73(14)(c)(c) If pocket dosimeters are used to meet the requirements of par. (b), a check of their response to radiation shall be performed at least annually, at intervals not to exceed 13 months. Acceptable dosimeters shall read within plus or minus 20% of the true radiation dose. DHS 157.73(15)(a)(a) A radiation survey of the area outside the shielding of the radiation room of a panoramic irradiator shall be conducted with the sources in the exposed position before the facility starts to operate. A radiation survey of the area above the pool of pool irradiators shall be conducted after the sources are loaded but before the facility starts to operate. Additional radiation surveys of the shielding shall be performed at intervals not to exceed 3 years and before resuming operation after addition of new sources or any modification to the radiation room shielding or structure that might increase dose rates. DHS 157.73(15)(b)(b) If the radiation levels specified in sub. (3) are exceeded, the facility shall be modified to comply with the requirements in sub. (3). DHS 157.73(15)(c)(c) Portable radiation survey meters shall be calibrated at a frequency not to exceed 13 months to an accuracy of plus or minus 20% for the gamma energy of the sources in use. The calibration shall be performed at 2 points on each scale or, for digital instruments, at one point per decade over the range that will be used. Portable radiation survey meters shall be of a type that does not fail and read zero at high radiation dose rates. DHS 157.73(15)(d)(d) Water from the irradiator pool, other potentially contaminated liquids and sediments from pool vacuuming shall be monitored for radioactive contamination before release to unrestricted areas. Radioactive concentrations may not exceed those specified in Table II, Column 2 or Table III of ch. DHS 157 Appendix E. DHS 157.73(15)(e)(e) Before releasing resins for unrestricted use, the resins shall be monitored before release in an area with a background level less than 0.5 microsievert (0.05 mrem) per hour. The resins may be released only if the survey does not detect radiation levels above background radiation levels. The survey meter used shall be capable of detecting radiation levels of 0.5 microsievert (0.05 mrem) per hour. DHS 157.73(16)(a)(a) Each dry-source-storage sealed source shall be tested for leakage at intervals not to exceed 6 months using a leak test kit or a method approved by the department, the NRC, another agreement state or a licensing state. In the absence of a certificate from a transferor that a test has been made within the 6 months before the transfer, the sealed source may not be used until tested. The test shall be capable of detecting the presence of 200 becquerels (0.005 mCi) of radioactive material and shall be performed by a person approved by the department, the NRC, another agreement state or a licensing state to perform the test. DHS 157.73(16)(b)(b) For a pool irradiator, sources may not be put into the pool unless a licensee tests the sources for leaks or has a certificate from a transferor that a leak test has been performed within the 6 months before the transfer. Water from the pool shall be checked for contamination each day the irradiator operates. The check may be done either by using a radiation monitor on a pool water circulating system or by analysis of a sample of pool water. If a check for contamination is performed by analysis of a sample of pool water, the results of the analysis shall be available within 24 hours. If the licensee uses a radiation monitor on a pool water circulating system, the detection of above normal radiation levels shall activate an alarm. The alarm set-point shall be set as low as practical, but high enough to avoid false alarms. A licensee may reset the alarm set-point to a higher level if necessary to operate the pool water purification system to clear up contamination in the pool if specifically provided for in written emergency procedures. DHS 157.73(16)(c)(c) If a leaking source is detected, a licensee shall arrange to remove the leaking source from service and have it decontaminated, repaired or disposed of by a department, NRC, another agreement state or a licensing state licensee authorized to perform decontamination, repair or disposal. A licensee shall promptly check its personnel, equipment, facilities and irradiated product for radioactive contamination. No product may be shipped until the product has been checked and found free of contamination. If a product has been shipped that may have been inadvertently contaminated, the licensee shall arrange to locate and survey that product for contamination. If any personnel are found to be contaminated, decontamination shall be performed immediately. If contaminated equipment, facilities or products are found, a licensee shall arrange to have the equipment, facilities or products decontaminated or disposed of by the department, the U.S. nuclear regulatory commission, another agreement state or a licensing state licensee authorized to perform decontamination or disposal. If a pool is contaminated, a licensee shall arrange to clean the pool until the contamination levels do not exceed the appropriate concentration in Table II, Column 2 of ch. DHS 157 Appendix E. DHS 157.73(17)(a)(a) A licensee shall perform inspection and maintenance checks that include each of the following at the frequency specified in the license or license application: DHS 157.73(17)(a)3.3. Operability of the radiation monitor for radioactive contamination in pool water required by sub. (16) (b) using a radiation check source, if applicable. DHS 157.73(17)(a)7.7. Visual inspection of leak-tightness of systems through which pool water circulates. DHS 157.73(17)(a)8.8. Operability of the heat and smoke detectors and extinguisher system required by sub. (4), without turning extinguishers on. DHS 157.73(17)(a)12.12. Functioning and wear of the system, mechanisms and cables used to raise and lower sources. DHS 157.73(17)(a)13.13. Condition of the barrier to prevent products from hitting the sources or source mechanism as required by sub. (8). DHS 157.73(17)(b)(b) Malfunctions and defects found during inspection and maintenance checks shall be repaired within time frames specified in the license or license application. DHS 157.73(18)(a)(a) A pool water purification system shall maintain the conductivity of the pool water below 20 microsiemens per centimeter under normal circumstances. If pool water conductivity rises above 20 microsiemens per centimeter, a licensee shall take prompt actions to lower the pool water conductivity and shall take corrective actions to prevent future recurrences. DHS 157.73(18)(b)(b) A licensee shall measure the pool water conductivity frequently enough, but no less than weekly, to assure that the conductivity remains below 20 microsieverts per centimeter. Conductivity meters must be calibrated at least annually, at intervals not to exceed 13 months. DHS 157.73(19)(a)(a) Both an irradiator operator and at least one other person who is trained on how to respond and prepared to promptly render or summon assistance if the access control alarm sounds shall be present on site during any of the following times: DHS 157.73(19)(a)1.1. Whenever the irradiator is operated using an automatic product conveyor system. DHS 157.73(19)(a)2.2. Whenever the product is moved into or out of the radiation room when the irradiator is operated in a batch mode. DHS 157.73(19)(b)(b) A person who has received the training on how to respond to alarms described in sub. (12) (g) shall be on site at a panoramic irradiator at which product is exposed to radiation with no movement of the product. DHS 157.73(19)(c)(c) At an underwater irradiator, an irradiator operator shall be present at the facility whenever the product is moved into or out of the pool. Persons who move the product into or out of the pool of an underwater irradiator need not be qualified as irradiator operators, but shall have received the training described in sub. (12) (f) and (g). Static irradiations may be performed without a person present at the facility. DHS 157.73(20)(a)(a) Upon first entering the radiation room of a panoramic irradiator after an irradiation, the irradiator operator shall use a survey meter to determine that the source has returned to its fully shielded position. The operator shall check the functioning of the survey meter with a radiation check source prior to entry. DHS 157.73(20)(b)(b) Before exiting from and locking the door to the radiation room of a panoramic irradiator prior to a planned irradiation, the irradiator operator shall do all the following: DHS 157.73(20)(b)1.1. Visually inspect the entire radiation room to verify that no one else is in it. DHS 157.73(20)(b)2.2. Activate a control in the radiation room that permits the sources to be moved from the shielded position only if the door to the radiation room is locked within a preset time after setting the control. DHS 157.73(20)(c)(c) During a power failure, the area around the pool of an underwater irradiator may not be entered without using an operable and calibrated radiation survey meter unless the over-the-pool monitor required by sub. (5) (b) is operating with backup power. DHS 157.73(21)(a)(a) Irradiation of explosive material is prohibited unless a licensee has received prior written authorization from the department. Authorization may not be granted unless a licensee demonstrates that detonation of the explosive would not rupture the sealed sources, injure personnel, damage safety systems or cause radiation overexposures of personnel. DHS 157.73(21)(b)(b) Irradiation of more than small quantities of flammable material with a flash point below 140°F is prohibited in panoramic irradiators unless a licensee has received prior written authorization from the department. Authorization may not be granted unless a licensee demonstrates that a fire in the radiation room could be controlled without damage to sealed sources or safety systems and without radiation overexposures of personnel. DHS 157.73(22)(22) Records and retention periods. A licensee shall maintain all the following records at the irradiator for the periods specified: DHS 157.73(22)(a)(a) A copy of the license, the license conditions, documents incorporated into the license by reference and amendments thereto until superseded by new documents or until the department terminates the license for documents not superseded. DHS 157.73(22)(b)(b) Records of each individual’s training, tests and safety reviews provided to meet the requirements of sub. (12) (a) to (d), (f) and (g) until 3 years after the person terminates work. DHS 157.73(22)(c)(c) Records of the annual evaluations of the safety performance of irradiator operators required by sub. (12) (e) for 3 years after the evaluation. DHS 157.73(22)(d)(d) A copy of the current operating and emergency procedures required by sub. (13) until superseded or until the department terminates the license. Records of the radiation safety officer’s review and approval of changes in procedures as required by sub. (13) (c) 3. shall be retained for 3 years from the date of the change. DHS 157.73(22)(f)(f) Records of radiation surveys required by sub. (15) for 3 years from the survey date. DHS 157.73(22)(g)(g) Records of radiation survey meter calibrations required by sub. (15) and pool water conductivity meter calibrations required by sub. (18) (b) until 3 years from the calibration date. DHS 157.73(22)(h)(h) Records of the results of leak tests required by sub. (16) (a) and the results of contamination checks required by sub. (16) (b) for 3 years from the date of each test. DHS 157.73(22)(j)(j) Records of major malfunctions, significant defects, operating difficulties or irregularities, and major operating problems that involve required radiation safety equipment for 3 years after repairs are completed. DHS 157.73(22)(L)(L) Records on the design checks required by sub. (10) and the construction control checks as required by sub. (11) until the license is terminated. The records shall be signed and dated. The title or qualification of the person signing shall be included. DHS 157.73(23)(a)(a) In addition to the reporting requirements in other parts of this chapter, a licensee shall report to the department all of the following events: DHS 157.73(23)(a)7.7. Detection of radioactive contamination attributable to licensed radioactive material. DHS 157.73(23)(a)9.9. Water loss or leakage from the source storage pool, greater than the irradiator pool design parameters submitted by the licensee or applicant. DHS 157.73(23)(b)(b) For any event in par. (a), a licensee shall provide a telephone report within 24 hours that meets the requirements of s. DHS 157.32 (2) and a written report within 30 days that meets the requirements of s. DHS 157.32 (3). DHS 157.73 HistoryHistory: CR 01-108: cr. Register July 2002 No. 559, eff. — see Note at the start of the chapter; CR 06-021: am. (15) (c), (22) (k) and (m) Register October 2006 No. 610, eff. 11-1-06; correction in (15) (d), (16) (c) made under s. 35.17, Stats., Register January 2018 No. 745; CR 22-015: am. (12) (d) (intro.), (e), (g), (14) (a), (c), (18) (b), (22) (e) Register June 2023 No. 810, eff. 7-1-23. DHS 157.74(1)(1) General. The registrant shall be responsible for directing the operation of the x-ray systems under their administrative control. The registrant or the registrant’s agent shall ensure the requirements of this section are met. An x-ray system shall meet the provisions of this subchapter to be operated for diagnostic or screening purposes. All images, hard copy or electronic, shall be interpreted by a licensed practitioner for the patient record.
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Department of Health Services (DHS)
Chs. DHS 110-199; Health
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