| (11) Wiring. For panoramic irradiators, the licensee shall verify that the electrical wiring and electrical equipment that were installed meet the design specifications. (s) Training. (1) Before an individual is permitted to operate an irradiator without a supervisor present, who has completed the requirements of this paragraph and paragraphs (2) and (3) of this subsection, the individual shall be instructed in: (A) the fundamentals of radiation protection applied to irradiators (including the differences between external radiation and radioactive contamination, units of radiation dose, dose limits, why large radiation doses shall be avoided, how shielding and access controls prevent large doses, how an irradiator is designed to prevent contamination, the proper use of survey meters and individual monitoring devices, other radiation safety features of an irradiator, and the basic function of the irradiator); (B) the requirements of this section and §289.203 of this title that are relevant to the irradiator; (C) the operation of the irradiator; (D) those operating, safety, and emergency procedures listed in subsection (t) of this section that the individual is responsible for performing; and (E) case histories of accidents or problems involving irradiators. (2) Before an individual is permitted to operate an irradiator without a supervisor present, who has completed the requirements of this paragraph and paragraphs (1) and (3) of this subsection, the individual shall pass a written test on the instruction received consisting primarily of questions based on the licensee's operating, safety, and emergency procedures that the individual is responsible for performing and other operations necessary to safely operate the irradiator without supervision. (3) Before an individual is permitted to operate an irradiator without a supervisor present, who has completed the requirements of this paragraph and paragraphs (1) and (2) of this subsection, the individual shall have received on-the-job training or simulator training in the use of the irradiator as described in the license application. The individual shall also demonstrate the ability to perform those portions of the operating, safety, and emergency procedures that he or she is to perform. (4) The licensee shall conduct safety reviews for irradiator operators at least annually. The licensee shall give each operator a brief written test on the information. Each safety review shall include, to the extent appropriate, each of the following: (A) changes in operating, safety, and emergency procedures since the last review, if any; (B) changes in rules and license conditions since the last review, if any; (C) reports on recent accidents, mistakes, or problems that have occurred at irradiators, if any; (D) relevant results of inspections of operator safety performance; (E) relevant results of the facility's inspection and maintenance checks; and (F) a drill to practice an emergency or abnormal event procedure. (5) The licensee shall evaluate the safety performance of each irradiator operator at least annually to ensure that agency rules, license conditions, and operating, safety, and emergency procedures are followed. The licensee shall discuss the results of the evaluation with the operator and shall instruct the operator on how to correct any mistakes or deficiencies observed. (6) Individuals who will be permitted unescorted access to the radiation room of the irradiator or the area around the pool of an underwater irradiator, but who have not received the training required for operators and the RSO, shall be instructed and tested in any precautions they should take to avoid radiation exposure, any procedures or parts of procedures listed in subsection (t) of this section that they are expected to perform or comply with, and their proper response to alarms required in this section. Tests may be oral. (7) Individuals who shall be prepared to respond to alarms required by subsections (i)(2) and (9), (k), (l), and (w)(2) of this section shall be trained and tested on how to respond. Each individual shall be retested at least once a year. Tests may be oral. (t) Operating, safety, and emergency procedures. (1) The licensee shall have and follow written operating, safety, and emergency procedures for: (A) operation of the irradiator, including entering and leaving the radiation room; (B) use of individual monitoring devices; (C) surveying the shielding of panoramic irradiators; (D) monitoring pool water for contamination while the water is in the pool and before release of pool water to unrestricted areas; (E) leak testing of sources; (F) inspection and maintenance checks required by subsection (x) of this section; (G) loading, unloading, and repositioning sources, if the operations will be performed by the licensee; and (H) inspection of movable shielding required by subsection (i)(8) of this section, if applicable. (2) The licensee shall have and follow emergency or abnormal event procedures, appropriate for the irradiator type, for: (A) sources stuck in the unshielded position; (B) personnel overexposures; (C) a radiation alarm from the product exit portal monitor or pool monitor; (D) detection of leaking source, pool contamination, or alarm caused by contamination of pool water; (E) a low or high water level indicator, an abnormal water loss, or leakage from the source storage pool; (F) a prolonged loss of electrical power; (G) a fire alarm or explosion in the radiation room; (H) an alarm indicating unauthorized entry into the radiation room, area around pool, or another alarmed area; (I) natural phenomena, including an earthquake, a tornado, flooding, or other phenomena as appropriate for the geographical location of the facility; and (J) the jamming of automatic conveyor systems. (3) The licensee may revise operating, safety, and emergency procedures without agency approval only if all of the following conditions are met: (A) the revisions do not reduce the safety of the facility; (B) the revisions are consistent with the outline or summary of procedures including procedures for changes to operating, safety, and emergency procedures submitted with the license application; (C) the revisions have been reviewed and approved by the radiation safety officer; and (D) the users or operators are instructed and tested on the revised procedures before they are put into use. (4) Changes to operating, safety, and emergency procedures shall be submitted to the agency after the provisions of paragraph (3) of this subsection are completed. (u) Personnel monitoring. (1) Irradiator operators shall wear an individual monitoring device that is processed and evaluated by an accredited National Voluntary Laboratory Accreditation Program (NVLAP) processor while operating a panoramic irradiator or while in the area around the pool of an underwater irradiator. The personnel dosimeter processor must be accredited for high-energy photons in the normal and accident dose ranges (see §289.202(p)(3) of this title). Each personnel dosimeter must be assigned to and worn by only one individual. Film badges must be processed at least monthly, and other personnel dosimeters must be processed at least quarterly. After replacement, each film badge, a thermoluminescent dosimeter (TLD), or optically stimulated luminescence device (OSL) shall be returned to the supplier for processing within 14 calendar days of the exchange date specified by the personnel monitoring supplier or as soon as practicable. In circumstances that make it impossible to return each film badge, TLD, or OSL within 14 calendar days, such circumstances shall be documented and available for review by the agency. (2) Other individuals who enter the radiation room of a panoramic irradiator shall wear a dosimeter, which may be a pocket dosimeter. For groups of visitors, only two people who enter the radiation room are required to wear dosimeters. If pocket dosimeters are used to meet the requirements of the paragraph, a check of their response to radiation shall be done at least annually. Acceptable dosimeters shall read within plus or minus 30% of the true radiation dose. (v) Radiation surveys. Cont'd... |
