OTS-7622.2

AMENDATORY SECTION(Amending WSR 98-13-037, filed 6/8/98, effective 7/9/98)

WAC 246-221-001   Purpose and scope.   (1) This chapter establishes standards for protection against radiation hazards. Except as otherwise specifically provided, this chapter applies to all licensees or registrants. The requirements of this chapter are designed to control the receipt, possession, use, transfer, and disposal of sources of radiation by any licensee or registrant so the total dose to an individual, including doses resulting from all sources of radiation other than background radiation, does not exceed the standards for protection against radiation prescribed in this chapter.

     (2) The limits in this chapter do not apply to doses due to background radiation, to exposure of patients to radiation for the purpose of medical diagnosis or therapy, to exposure from individuals administered radioactive material and released ((pursuant to)) under chapter((s 246-239 and)) 246-240 WAC, or to voluntary participation in medical research programs.

     (3) Nothing in this chapter shall be interpreted as limiting actions that may be necessary to protect health and safety in an emergency.

     (4) The definitions contained in WAC 246-220-010 also apply to this chapter. WAC 246-220-007, Statement of philosophy, is directly applicable to this chapter.

[Statutory Authority: RCW 70.98.050. 98-13-037, § 246-221-001, filed 6/8/98, effective 7/9/98; 94-01-073, § 246-221-001, filed 12/9/93, effective 1/9/94. Statutory Authority: RCW 70.98.050 and 70.98.080. 91-15-112 (Order 184), § 246-221-001, filed 7/24/91, effective 8/24/91. Statutory Authority: RCW 43.70.040. 91-02-049 (Order 121), recodified as § 246-221-001, filed 12/27/90, effective 1/31/91; Order 1095, § 402-24-010, filed 2/6/76; Order 1, § 402-24-010, filed 1/8/69; Rules (part), filed 10/26/66.]

     (a) The total effective dose equivalent to individual members of the public from the licensed or registered operation does not exceed 1 mSv (0.1 rem) in a year, exclusive of the dose contributions from background radiation, from any medical administration the individual has received, from exposure to individuals administered radioactive material and released ((pursuant to)) under chapter((s 246-239 and)) 246-240 WAC, from voluntary participation in medical research programs, and from the licensee's or registrant's disposal of radioactive material into sanitary sewerage in accordance with WAC 246-221-190; and

     (b) The dose in any unrestricted area from external sources, exclusive of the dose contributions from patients administered radioactive material and released ((pursuant to)) under chapter((s 246-239 and)) 246-240 WAC, does not exceed 0.02 mSv (0.002 rem) in any one hour.

     (2) If the licensee or registrant permits members of the public to have access to restricted areas, they shall be escorted and the limits for members of the public continue to apply to those individuals.

     (3) Notwithstanding subsection (1) of this section, a licensee or registrant may continue to operate a facility constructed and put into operation prior to January 1, 1994, where the annual dose limit for an individual member of the public is more than 1 mSv (0.1 rem) and less than 5 mSv (0.5 rem) total effective dose equivalent, ((provided)) if:

     (a) The facility's approved operating conditions for each radiation source remain the same. Any increase in the following operating conditions shall require reevaluation by the department and/or modification of the facility shielding applicable to the source of radiation to meet the 1 mSv (0.1 rem) total effective dose equivalent limit for individual members of the public: size of the radiation source, workload, or occupancy factors associated with the source of radiation; and

     (b) Any change in the permanent shielding of the facility due to remodeling, repair or replacement ((shall)) requires the facility to meet the 1 mSv (0.1 rem) total effective dose equivalent limit for individual members of the public for areas affected by that portion of the shielding.

     (4) Each licensee or registrant shall maintain records sufficient to demonstrate compliance with the dose limit for individual members of the public.

[Statutory Authority: RCW 70.98.050. 98-13-037, § 246-221-060, filed 6/8/98, effective 7/9/98; 94-01-073, § 246-221-060, filed 12/9/93, effective 1/9/94. Statutory Authority: RCW 70.98.050 and 70.98.080. 91-15-112 (Order 184), § 246-221-060, filed 7/24/91, effective 8/24/91. Statutory Authority: RCW 43.70.040. 91-02-049 (Order 121), recodified as § 246-221-060, filed 12/27/90, effective 1/31/91. Statutory Authority: RCW 70.98.080. 87-01-031 (Order 2450), § 402-24-040, filed 12/11/86. Statutory Authority: RCW 70.98.050. 81-01-011 (Order 1570), § 402-24-040, filed 12/8/80; Order 1095, § 402-24-040, filed 2/6/76; Order 1, § 402-24-040, filed 1/8/69; Rules (part), filed 10/26/66.]

     (2) Rooms or other areas in hospitals that are occupied by patients are not required to be posted with caution signs because of the presence of patients containing radioactive material ((provided that)) if the patient could be released from licensee control ((pursuant to)) under chapter((s 246-239 and)) 246-240 WAC.

     (3) Caution signs are not required to be posted in areas or rooms containing radioactive material for periods of less than eight hours ((provided that)) if:

     (a) The material is constantly attended during ((such)) those periods by an individual who ((shall)) takes ((the)) precautions necessary to prevent the exposure of any individual to radiation or radioactive material in excess of the limits established in ((this part)) these rules; and

     (b) ((Such)) The area or room is subject to the licensee's or registrant's control.

     (4) A room or other area is not required to be posted with a caution sign because of the presence of radioactive material prepared for transport and packaged and labeled in accordance with regulations of the United States Department of Transportation.

     (5) A room or area is not required to be posted with a caution sign because of the presence of a diagnostic X-ray system used solely for healing arts purposes.

     (6) The interior of a teletherapy room is not required to be posted with caution signs provided ((such)) the posting is conspicuously placed at the entrance(s) to the rooms.

     (7) A licensee is not required to label:

     (a) Containers holding licensed material in quantities less than the quantities listed in WAC 246-221-300; or

     (b) Containers holding licensed material in concentrations less than those specified in WAC 246-221-290, Table III; or

     (c) Containers attended by an individual who takes the precautions necessary to prevent the exposure of any individual to radiation or radioactive material in excess of the limits established by this chapter; or

     (d) Containers when they are in transport and packaged and labeled in accordance with the regulations of the United States Department of Transportation; or

     (e) Containers such as those located in water-filled canals, storage vaults, or hot cells, that are accessible only to individuals authorized to handle or use them, or to work in the vicinity of the containers, provided the contents are identified to these individuals by a readily available written record. The record shall be retained as long as the containers are in use for the purpose indicated on the record; or

     (f) Installed manufacturing or process equipment, such as chemical process equipment, piping, and tanks.

     (8) Each licensee, prior to removal or disposal of empty uncontaminated containers to unrestricted areas, shall remove or deface the radioactive material label or otherwise clearly indicate that the container no longer contains radioactive materials.

[Statutory Authority: RCW 70.98.050. 98-13-037, § 246-221-130, filed 6/8/98, effective 7/9/98; 94-01-073, § 246-221-130, filed 12/9/93, effective 1/9/94. Statutory Authority: RCW 70.98.050 and 70.98.080. 91-15-112 (Order 184), § 246-221-130, filed 7/24/91, effective 8/24/91. Statutory Authority: RCW 43.70.040. 91-02-049 (Order 121), recodified as § 246-221-130, filed 12/27/90, effective 1/31/91. Statutory Authority: RCW 70.98.080. 83-19-050 (Order 2026), § 402-24-095, filed 9/16/83. Statutory Authority: RCW 70.98.050. 81-01-011 (Order 1570), § 402-24-095, filed 12/8/80; Order 1095, § 402-24-095, filed 2/6/76.]

OTS-8022.2

AMENDATORY SECTION(Amending WSR 99-15-105, filed 7/21/99, effective 8/21/99)

WAC 246-232-001   Purpose and scope.   (1) This chapter prescribes rules governing licensing of radioactive material. ((No)) A person ((shall)) may not receive, possess, use, transfer, own or acquire radioactive material except as authorized in a specific or general license issued ((pursuant to)) under chapters 246-233 or 246-235 WAC or as otherwise provided in this chapter.

     (2) In addition to the requirements of this chapter, ((or)) and chapters 246-233 or 246-235 WAC, all licensees ((are subject to the requirements of)) must comply with chapters 246-220, 246-221, 246-222, 246-231, 246-247, and 246-254 WAC. Licensees engaged in the practice of nuclear medicine are subject to ((the requirements of)) chapter ((246-239)) 246-240 WAC, licensees engaged in industrial radiographic operations are subject to ((the requirements of)) chapter 246-243 WAC, licensees using sealed sources in the healing arts are subject to ((the requirements of)) chapter 246-240 WAC, licensees using radioactive material in well logging and subsurface tracer studies are subject to ((the requirements of)) chapter 246-244 WAC, licensees engaged in land disposal of radioactive waste are subject to ((the requirements of)) chapter 246-250 WAC, and licensees owning or operating uranium or thorium mills and associated mill tailings are subject to ((the requirements of)) chapter 246-252 WAC.

[Statutory Authority: RCW 70.98.050. 99-15-105, § 246-232-001, filed 7/21/99, effective 8/21/99. Statutory Authority: RCW 70.98.050 and 70.98.080. 91-15-112 (Order 184), § 246-232-001, filed 7/24/91, effective 8/24/91. Statutory Authority: RCW 43.70.040. 91-02-049 (Order 121), recodified as § 246-232-001, filed 12/27/90, effective 1/31/91. Statutory Authority: RCW 70.98.080. 83-19-050 (Order 2026), § 402-19-010, filed 9/16/83; 79-12-073 (Order 1459), § 402-19-010, filed 11/30/79, effective 1/1/80. Formerly chapter 402-20 WAC.]

     (2) A person who desires to use the capsules for research involving human subjects shall apply for and receive a specific license under chapters 246-240 and 246-235 WAC ((246-235-080)).

     (3) A person who desires to manufacture, prepare, process, produce, package, repackage, or transfer for commercial distribution these capsules shall apply for and receive a specific license from the United States Nuclear Regulatory Commission under Section 32.21 of 10 C.F.R. Part 32.

     (4) Nothing in this section relieves persons from complying with applicable United States Food and Drug Administration, other federal, and state requirements governing receipt, administration, and use of drugs.

[Statutory Authority: RCW 70.98.050. 01-02-068, § 246-232-014, filed 12/29/00, effective 1/29/01.]

OTS-7623.4

AMENDATORY SECTION(Amending WSR 98-13-037, filed 6/8/98, effective 7/9/98)

WAC 246-235-020   General requirements for the issuance of specific licenses.   A license application will be approved if the department determines that:

     (1) The applicant is qualified by reason of training and experience to use the material in question for the purpose requested in accordance with these regulations in ((such)) a manner ((as)) to minimize danger to public health and safety or property;

     (2) The applicant's proposed equipment, facilities, and procedures are adequate to minimize danger to public health and safety or property;

     (3) The issuance of the license will not ((be inimical to)) harm the health and safety of the public; and

     (4) The applicant satisfies any applicable special requirements in WAC 246-235-075 through 246-235-110, and chapters ((246-239)) 246-240 through 246-252 WAC.

     (5) ((In the case of)) When an application for a license to receive and possess radioactive material for commercial waste disposal by land burial, source material milling, or for the conduct of any other activity which the agency determines will significantly affect the quality of the environment, the ((department, before commencement of construction of the plant or facility in which the activity will be conducted, has concluded, after independently weighing the environmental, economic, technical and other benefits against environmental costs and considering available alternatives, that the action called for is the issuance of the proposed license, with any appropriate conditions to protect environmental values)) applicant shall not begin construction until the department has weighed the environmental, economic, technical, and other benefits against the environmental costs and has concluded that the issuance of the license is appropriate. Commencement of construction prior to ((such conclusion)) approval by the department shall be grounds for denial of a license to receive and possess radioactive material in ((such)) the plant or facility. As used in this paragraph the term "commencement of construction" means any clearing of land, excavation, or other substantial action that would adversely affect the environment of a site. The term does not mean site exploration, necessary borings to determine foundation conditions, or other preconstruction monitoring or testing to establish background information related to the suitability of the site or the protection of environmental values.

[Statutory Authority: RCW 70.98.050. 98-13-037, § 246-235-020, filed 6/8/98, effective 7/9/98. Statutory Authority: RCW 70.98.050 and 70.98.080. 91-15-112 (Order 184), § 246-235-020, filed 7/24/91, effective 8/24/91. Statutory Authority: RCW 43.70.040. 91-02-049 (Order 121), recodified as § 246-235-020, filed 12/27/90, effective 1/31/91. Statutory Authority: RCW 70.98.080. 87-01-031 (Order 2450), § 402-22-040, filed 12/11/86. Statutory Authority: Chapter 70.121 RCW. 81-16-031 (Order 1683), § 402-22-040, filed 7/28/81. Statutory Authority: RCW 70.98.080. 79-12-073 (Order 1459), § 402-22-040, filed 11/30/79, effective 1/1/80. Formerly WAC 402-20-060.]

     (d))) (1) Leak tests.

     (((i))) (a) Any licensee or registrant who possesses sealed sources as calibration or reference sources ((under (c) of this subsection)) shall ((cause)) test for leakage each sealed source containing radioactive material, other than Hydrogen-3, with a half-life greater than thirty days in any form other than gas ((to be tested for leakage)) and/or contamination at ((intervals not to exceed)) least every six months. In the absence of a certificate from a transferor indicating that a test has been made within six months prior to the transfer, the sealed sources shall not be used until tested. However, leak tests are not required when:

     (((A))) The source contains 100 microcuries or less of beta and/or gamma emitting material or 10 microcuries or less of alpha emitting material((;

     (B) The sealed source is stored and is not being used: Provided, a physical inventory of the source and wipe surveys of the storage area or storage container are conducted)) or the sealed source is stored and is not being used: Provided, a physical inventory of the source and wipe surveys of the storage area or storage container are conducted as required by these rules or license condition.

     (((ii))) (b) The leak test shall be capable of detecting the presence of 0.005 microcurie (185 becquerels) of radioactive material on the test sample. The test sample shall be taken from the sealed source or from the surfaces of the device in which the sealed source is mounted or stored on which contamination might be expected to accumulate. Records of leak test results shall be kept in units of microcuries and maintained for inspection by the department.

     (((iii))) (c) If the leak test reveals the presence of 0.005 microcurie or more of removable contamination, the licensee or registrant shall immediately withdraw the sealed source from use and shall cause it to be decontaminated and repaired or to be disposed of in accordance with chapters 246-235 and 246-221 WAC. The licensee must file a report ((shall be filed)) within five days of the test with the department describing the equipment involved, the test results, and the corrective action taken.

     (((e))) (2) Any licensee or registrant who possesses and uses calibration and reference sources ((under (c)(iv) of this subsection)) shall:

     (((i))) (a) Follow the radiation safety and handling instructions approved by the department, the United States Nuclear Regulatory Commission, an agreement state or a licensing state and furnished by the manufacturer on the label attached to the source, or permanent container thereof, or in the leaflet or brochure that accompanies the source, and maintain the instructions in a legible and conveniently available form; and

     (((ii))) (b) Conduct a quarterly physical inventory to account for all sources received and possessed. Records of the inventories shall be maintained for inspection by the department and shall include at a minimum the quantities and kinds of radioactive material, location of sources, name of person performing the inventory, and the date of the inventory.

     (((4) Human use of sealed sources. In addition to the requirements set forth in WAC 246-235-020, a specific license for human use of sealed sources will be issued only if the individual applicant or, if the application is made by an institution, the individual user:

     (a) Has specialized training in the diagnostic or therapeutic use of the sealed source considered, or has experience equivalent to such training; and

     (b) Is a physician.))

[Statutory Authority: RCW 70.98.050. 00-08-013, § 246-235-080, filed 3/24/00, effective 4/24/00; 98-13-037, § 246-235-080, filed 6/8/98, effective 7/9/98. Statutory Authority: RCW 70.98.050 and 70.98.080. 91-15-112 (Order 184), § 246-235-080, filed 7/24/91, effective 8/24/91. Statutory Authority: RCW 43.70.040. 91-02-049 (Order 121), recodified as § 246-235-080, filed 12/27/90, effective 1/31/91. Statutory Authority: RCW 70.98.080. 87-01-031 (Order 2450), § 402-22-070, filed 12/11/86; 83-19-050 (Order 2026), § 402-22-070, filed 9/16/83. Statutory Authority: RCW 70.98.050. 81-01-011 (Order 1570), § 402-22-070, filed 12/8/80. Statutory Authority: RCW 70.98.080. 79-12-073 (Order 1459), § 402-22-070, filed 11/30/79, effective 1/1/80. Formerly WAC 402-20-070.]

*Note:

Authority to transfer possession or control by the manufacturer, processor, or producer of any equipment, device, commodity or other product containing source material or byproduct material whose subsequent possession, use, transfer and disposal by all other persons who are exempted from regulatory requirements may be obtained only from the United States Nuclear Regulatory Commission, Washington, D.C. 20555.

     (1) The different types of broad licenses are ((set forth)) listed below:

     (a) A "Type A specific license of broad scope" is a specific license authorizing receipt, acquisition, ownership, possession, use and transfer of any chemical or physical form of the radioactive material specified in the license, but not exceeding quantities specified in the license, for any authorized purpose. The quantities specified are usually in the multicurie range.

     (b) A "Type B specific license of broad scope" is a specific license authorizing receipt, acquisition, ownership, possession, use and transfer of any chemical or physical form of radioactive material specified in WAC 246-235-140 Schedule B, for any authorized purpose. The possession limit for a Type B broad license, if only one radionuclide is possessed thereunder, is the quantity specified for that radionuclide in WAC 246-235-140 Schedule B, Column I. If two or more radionuclides are possessed ((thereunder)), the possession limit for each is determined as follows: For each radionuclide, determine the ratio of the quantity possessed to the applicable quantity specified in WAC 246-235-140 Schedule B, Column I, for that radionuclide. The sum of the ratios for all radionuclides possessed under the license shall not exceed unity.

     (c) A "Type C specific license of broad scope" is a specific license authorizing receipt, acquisition, ownership, possession, use and transfer of any chemical or physical form of radioactive material specified in WAC 246-235-140 Schedule B, for any authorized purpose. The possession limit for a Type C broad license, if only one radionuclide is possessed ((thereunder)), is the quantity specified for that radionuclide in WAC 246-235-140 Schedule B, Column II. If two or more radionuclides are possessed ((thereunder)), the possession limit is determined for each as follows: For each radionuclide determine the ratio of the quantity possessed to the applicable quantity specified in WAC 246-235-140 Schedule B, Column II, for that radionuclide. The sum of the ratios for all radionuclides possessed under the license shall not exceed unity.

     (2) The department will approve an application for a Type A specific license of broad scope ((will be approved)) if:

     (a) The applicant satisfies the general requirements specified in WAC 246-235-020.

     (b) The applicant has engaged in a reasonable number of activities involving the use of radioactive material; and

     (c) The applicant has established administrative controls and provisions relating to organization and management, procedures, recordkeeping, material control and accounting, and management review that are necessary to assure safe operations, including:

     (i) The establishment of a radiation safety committee composed of ((such persons as)) a radiation safety officer, a representative of management, and persons trained and experienced in the safe use of radioactive material;

     (ii) The appointment of a radiation safety officer who is qualified by training and experience in radiation protection, and who is available for advice and assistance on radiation safety matters; and

     (iii) The establishment of appropriate administrative procedures to assure:

     (A) Control of procurement and use of radioactive material;

     (B) Completion of safety evaluations of proposed uses of radioactive material which take into consideration such matters as the adequacy of facilities and equipment, training and experience of the user, and the operating or handling procedures; and

     (C) Review, approval, and recording by the radiation safety committee of safety evaluation of proposed uses prepared in accordance with item (2)(c)(iii)(B) of this section prior to use of the radioactive material.

     (3) The department will approve an application for a Type B specific license of broad scope ((will be approved)) if:

     (a) The applicant satisfies the general requirements specified in WAC 246-235-020; and

     (b) The applicant has established administrative controls and provisions relating to organization and management, procedures, recordkeeping, material control and accounting, and management review that are necessary to assure safe operations, including:

     (i) The appointment of a radiation safety officer who is qualified by training and experience in radiation protection, and who is available for advice and assistance on radiation safety matters; and

     (ii) The establishment of appropriate administrative procedures to assure:

     (A) Control of procurement and use of radioactive material;

     (B) Completion of safety evaluations of proposed uses of radioactive material which take into consideration such matters as the adequacy of facilities and equipment, training and experience of the user, and the operating or handling procedures; and

     (C) Review, approval, and recording by the radiation safety officer of safety evaluations of proposed uses prepared in accordance with item (3)(b)(ii)(B) of this section prior to use of the radioactive material.

     (4) The department will approve an application for a Type C specific license of broad scope ((will be approved)) if:

     (a) The applicant satisfies the general requirements specified in WAC 246-235-020.

     (b) The applicant submits a statement that radioactive material will be used only by, or under the direct supervision of individuals, who have received:

     (i) A college degree at the bachelor level, or equivalent training and experience, in the physical or biological sciences or in engineering; and

     (ii) At least forty hours of training and experience in the safe handling of radioactive material, and in the characteristics of ionizing radiation, units of radiation dose and quantities, radiation detection instrumentation, and biological hazards of exposure to radiation appropriate to the type and forms of radioactive material to be used; and

     (c) The applicant has established administrative controls and provisions relating to procurement of radioactive material, procedures, recordkeeping, material control and accounting, and management review necessary to assure safe operations.

     (5) Specific licenses of broad scope are subject to the following conditions:

     (a) Unless specifically authorized by the department, persons licensed under this section shall not:

     (i) Conduct tracer studies in the environment involving direct release of radioactive material;

     (ii) Receive, acquire, own, possess, use or transfer devices containing 100,000 curies or more of radioactive material in sealed sources used for irradiation of materials;

     (iii) Conduct activities for which a specific license issued by the department under chapter 246-240 WAC ((246-235-080 through)), WAC 246-235-086 or ((WAC)) 246-235-091 through 246-235-105 is required; or

     (iv) Add or cause the addition of radioactive material to any food, beverage, cosmetic, drug or other product designed for ingestion or inhalation by, or application to, a human being.

     (b) For each Type A specific license of broad scope ((issued under this part shall be subject to the condition that)) radioactive material possessed under the license may only be used by, or under the direct supervision of, individuals approved by the licensee's radiation safety committee.

     (c) For each Type B specific license of broad scope ((issued under this part shall be subject to the condition that)) radioactive material possessed under the license may only be used by, or under the direct supervision of, individuals approved by the licensee's radiation safety officer.

     (d) For each Type C specific license of broad scope ((issued under this part shall be subject to the condition that)) radioactive material possessed under the license may only be used by, or under the direct supervision of, individuals who satisfy the requirements of subsection (4) of this section.

[Statutory Authority: RCW 70.98.050. 00-08-013, § 246-235-090, filed 3/24/00, effective 4/24/00; 98-13-037, § 246-235-090, filed 6/8/98, effective 7/9/98. Statutory Authority: RCW 70.98.050 and 70.98.080. 91-15-112 (Order 184), § 246-235-090, filed 7/24/91, effective 8/24/91. Statutory Authority: RCW 43.70.040. 91-02-049 (Order 121), recodified as § 246-235-090, filed 12/27/90, effective 1/31/91. Statutory Authority: RCW 70.98.080. 79-12-073 (Order 1459), § 402-22-090, filed 11/30/79, effective 1/1/80. Formerly WAC 402-20-073.]

     (a) The applicant satisfies the general requirements specified in WAC 246-235-020 ((of this part));

     (b) The applicant submits evidence that:

     (i) The applicant is registered or licensed with the U.S. Food and Drug Administration (FDA) as a drug manufacturer; or

     (ii) The applicant is licensed as a nuclear pharmacy by the state board of pharmacy;

     (c) The applicant submits information on the radionuclide, chemical and physical form, maximum activity per vial, syringe, generator, or other container of the radiopharmaceutical, and shielding provided by the packaging of the radioactive material which is appropriate for safe handling and storage of radiopharmaceuticals by medical use licensees; and

     (d) The applicant satisfies the labeling requirements specified by the state board of pharmacy in WAC 246-903-020. For a drug manufacturer, the labels required by this subsection are in addition to the labeling required by the Food and Drug Administration (FDA) and may be separate from or, with the approval of FDA, may be combined with the labeling required by FDA.

     (2) A nuclear pharmacy licensee:

     (a) May prepare radiopharmaceuticals for medical use provided the radiopharmaceutical is prepared by or under the supervision of an authorized nuclear pharmacist.

     (b) May allow a pharmacist to work as an authorized nuclear pharmacist if this individual meets the state board of pharmacy requirements in WAC 246-903-030, Nuclear pharmacists.

     (c) Shall provide to the department a copy of each individual's letter of notification from the state board of pharmacy recognizing the individual as a nuclear pharmacist, ((no later than)) within thirty days ((after)) of the date the licensee allows the individual to work as an authorized nuclear pharmacist ((pursuant to)) under (b) of this subsection.

     (3) A manufacturer or nuclear pharmacy licensee shall possess and use instrumentation to measure the radioactivity of radiopharmaceuticals. The licensee shall have procedures for use of the instrumentation. The licensee shall measure, by direct measurement or by combination of measurements and calculations, the amount of radioactivity in dosages of alpha-, beta-, or photon-emitting radiopharmaceuticals, prior to transfer for commercial distribution. In addition, the licensee shall:

     (a) Perform tests before initial use, periodically, and following repair, on each instrument for accuracy, linearity, and geometry dependence, as appropriate for the use of the instrument; and make adjustments when necessary; and

     (b) Check each instrument for constancy and proper operation at the beginning of each day of use.

     (4) Nothing in this section relieves the licensee from complying with applicable FDA, other Federal, and state requirements governing radiopharmaceuticals.

[Statutory Authority: RCW 70.98.050. 98-13-037, § 246-235-100, filed 6/8/98, effective 7/9/98. Statutory Authority: RCW 70.98.050 and 70.98.080. 91-15-112 (Order 184), § 246-235-100, filed 7/24/91, effective 8/24/91. Statutory Authority: RCW 43.70.040. 91-02-049 (Order 121), recodified as § 246-235-100, filed 12/27/90, effective 1/31/91. Statutory Authority: RCW 70.98.050. 81-01-011 (Order 1570), § 402-22-110, filed 12/8/80. Statutory Authority: RCW 70.98.080. 79-12-073 (Order 1459), § 402-22-110, filed 11/30/79, effective 1/1/80. Formerly WAC 402-20-076.]

     (1) The applicant satisfies the general requirements in WAC 246-235-020 ((of this part));

     (2) The applicant submits sufficient information regarding each type of source or device pertinent to an evaluation of its radiation safety, including:

     (a) The radioactive material contained, its chemical and physical form and amount;

     (b) Details of design and construction of the source or device;

     (c) Procedures for, and results of, prototype tests to demonstrate that the source or device will maintain its integrity under stresses likely to be encountered in normal use and accidents;

     (d) For devices containing radioactive material, the radiation profile of a prototype device;

     (e) Details of quality control procedures to assure that production sources and devices meet the standards of the design and prototype tests;

     (f) Procedures and standards for calibrating sources and devices;

     (g) Legend and methods for labeling sources and devices as to their radioactive content; and

     (h) Instructions for handling and storing the source or device from the radiation safety standpoint, these instructions are to be included on a durable label attached to the source or device or attached to a permanent storage container for the source or device: Provided((,)) that instructions which are too lengthy for ((such)) the label may be summarized on the label and printed in detail on a brochure which is referenced on the label.

     (3) The label affixed to the source or device, or to the permanent storage container for the source or device, contains information on the radionuclide, quantity and date of assay, and a statement that the named source or device is licensed by the department for distribution to persons licensed ((pursuant to)) under chapter 246-240 WAC ((246-235-080(3) and Group VI of WAC 246-235-120 Schedule A)) or under equivalent regulations of the United States Nuclear Regulatory Commission, an agreement state or a licensing state: Provided((,)) that ((such)) the labeling for sources which do not require long term storage (((e.g., gold-198 seeds))) may be on a leaflet or brochure which accompanies the source.

     (4) ((In the event)) If the applicant desires that the source or device ((be required to)) be tested for leakage of radioactive material at intervals longer than six months, the applicant shall include in the application sufficient information to demonstrate that ((such)) the longer interval is justified by performance characteristics of the source or device or similar sources or devices and by design features that have a significant bearing on the probability or consequences of leakage of radioactive material from the source.

     (5) In determining the acceptable interval for test of leakage of radioactive material, the department will consider information that includes, but is not limited to:

     (a) Primary containment (source capsule);

     (b) Protection of primary containment;

     (c) Method of sealing containment;

     (d) Containment construction materials;

     (e) Form of contained radioactive material;

     (f) Maximum temperature withstood during prototype tests;

     (g) Maximum pressure withstood during prototype tests;

     (h) Maximum quantity of contained radioactive material;

     (i) Radiotoxicity of contained radioactive material; and

     (j) Operating experience with identical sources or devices or similarly designed and constructed sources or devices.

[Statutory Authority: RCW 70.98.050. 98-13-037, § 246-235-102, filed 6/8/98, effective 7/9/98.]

     (1) An application for a license to receive title to, receive, possess, and use source material for milling or byproduct material as defined in WAC 246-220-010 shall address the following:

     (a) Description of the proposed project or action.

     (b) Area/site characteristics including geology, demography, topography, hydrology and meteorology.

     (c) Radiological and nonradiological impacts of the proposed project or action, including waterway and ground water impacts.

     (d) Environmental effects of accidents.

     (e) Tailings disposal and decommissioning.

     (f) Site and project alternatives.

     (g) Description of how the provisions of chapter 246-252 WAC shall be met.

     (2) ((Pursuant to)) Under WAC ((246-235-080 (6)(a)(i))) 246-235-086, the applicant shall not commence construction of the project until the department has weighed the environmental, economic, technical, and other benefits against the environmental costs and has concluded that the issuance of the license is appropriate.

     (3) Prior to issuance of a license, the department shall hold a public hearing ((shall be held. The scope shall extend to the question of license issuance and)). The hearing will address the adequacy of the reclamation, disposal, decommissioning, and decontamination plans.

     (4) At least one full year prior to any major site construction, a preoperational monitoring program shall be conducted to provide complete baseline data on a milling site and its environs. Throughout the construction and operating phases of the mill, an operational monitoring program shall be conducted to measure or evaluate compliance with applicable standards and regulations; to evaluate performance of control systems and procedures; to evaluate environmental impacts of operation; and to detect potential long-term effects.

     (5) Prior to issuance of the license, the mill operator shall establish financial surety arrangements consistent with ((the requirements of)) WAC 246-252-030.

     (6) The applicant shall provide procedures describing the means employed to meet the following requirements during the operational phase of any project.

     (a) Milling operations shall be conducted so that all effluent releases are reduced to as low as is reasonably achievable below the limits of chapter 246-221 WAC.

     (b) The mill operator shall conduct at least a daily inspection of any tailings or waste retention systems. Records of ((such)) these inspections shall be maintained for review by the department.

     (c) The mill operator shall immediately notify the department of ((the following)):

     (i) Any failure in a tailings or waste retention system which results in a release of tailings or waste into unrestricted areas; and

     (ii) Any unusual conditions (conditions not contemplated in the design of the retention system) which if not corrected could lead to failure of the system and result in a release of tailings or waste into unrestricted areas.

     (7) An application for a license to own, receive, possess and use byproduct material as defined in WAC 246-220-010 shall contain proposed specifications relating to the emissions control and disposition of the byproduct material to achieve the requirements and objectives set forth in the criteria listed in WAC 246-252-030.

[Statutory Authority: RCW 70.98.050 and 70.98.080. 91-15-112 (Order 184), § 246-235-110, filed 7/24/91, effective 8/24/91. Statutory Authority: RCW 43.70.040. 91-02-049 (Order 121), recodified as § 246-235-110, filed 12/27/90, effective 1/31/91. Statutory Authority: RCW 70.98.080. 87-01-031 (Order 2450), § 402-22-150, filed 12/11/86. Statutory Authority: Chapter 70.121 RCW. 81-16-031 (Order 1683), § 402-22-150, filed 7/28/81.]

     The following section of the Washington Administrative Code is repealed:

WAC 246-235-120

Schedule A groups of medical uses of radioactive material (ref. WAC 246-235-080(3) and 246-235-100(9)).

OTS-7819.1

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     The following sections of the Washington Administrative Code are repealed:

WAC 246-239-001	Purpose and scope.
WAC 246-239-010	Definitions.
WAC 246-239-020	Radiation safety committee.
WAC 246-239-022	Policy and procedures for radiopharmaceutical administration.
WAC 246-239-025	Notifications, records, and reports of radiopharmaceutical misadministrations.
WAC 246-239-030	Personnel monitoring.
WAC 246-239-035	Bioassay.
WAC 246-239-040	Radiopharmaceuticals.
WAC 246-239-050	Radionuclide generators.
WAC 246-239-055	Release of individuals containing radiopharmaceuticals.
WAC 246-239-060	Laboratory safety.
WAC 246-239-070	Surveys.
WAC 246-239-080	Calibration and reference sources.
WAC 246-239-090	Instrumentation.
WAC 246-239-100	Radioactive gases.

OTS-7750.6

[Statutory Authority: RCW 43.70.040. 91-02-049 (Order 121), recodified as § 246-240-001, filed 12/27/90, effective 1/31/91; Order 1084, § 402-32-010, filed 1/14/76; Order 1, § 402-32-010, filed 1/8/69; Rules (part), filed 10/26/66.]

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     (2) If the research is conducted, funded, supported, or regulated by another federal agency that has implemented the Federal Policy for the Protection of Human Subjects (federal policy), the licensee shall, before conducting research:

     (a) Obtain review and approval of the research from an "institutional review board," as defined and described in the federal policy; and

     (b) Obtain "informed consent," as defined and described in the federal policy, from the human research subject.

     (3) If the research will not be conducted, funded, supported, or regulated by another federal agency that has implemented the federal policy, the licensee shall, before conducting research, apply for and receive a specific amendment to its medical use license. The amendment request must include a written commitment that the licensee will, before conducting research:

     (a) Obtain review and approval of the research from an "institutional review board," as defined and described in the federal policy; and

     (b) Obtain "informed consent," as defined and described in the federal policy, from the human research subject.

     (4) Nothing in this section relieves licensees from complying with the other requirements in this chapter.

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     (d) For all other brachytherapy, (i) prior to implantation: The radioisotope, number of sources, and source strengths; and (ii) after implantation but prior to completion of the procedure: The radioisotope, treatment site, and total source strength and exposure time (or, equivalently, the total dose).)) Address of use means the building or buildings that are identified on the license and where radioactive material may be received, prepared, used, or stored.

     Area of use means a portion of an address of use that has been set aside for the purpose of receiving, preparing, using, or storing radioactive material.

     Authorized medical physicist means an individual who:

     (1) Meets the requirements in WAC 246-240-072 and 246-240-081; or

     (2) Is identified as an authorized medical physicist or teletherapy physicist on a specific medical use license issued by the department, the U.S. Nuclear Regulatory Commission or agreement state prior to October 5, 2005.

     (3) A permit issued by a commission or agreement state broad scope medical use licensee prior to October 5, 2005; or

     (4) A permit issued by a commission master material license broad scope medical use permittee prior to October 5, 2005.

     Authorized nuclear pharmacist means a pharmacist who:

     (1) Meets the requirements in WAC 246-240-075 and 246-240-081; or

     (2) Is identified as an authorized nuclear pharmacist on a specific license issued by the department, the U.S. NRC or agreement state prior to October 5, 2005, that authorizes medical use or the practice of nuclear pharmacy; or

     (3) Is identified as an authorized nuclear pharmacist by a commercial nuclear pharmacy that has been authorized to identify authorized nuclear pharmacists; or

     (4) A permit issued by a commission master material licensee that authorizes medical use or the practice of nuclear pharmacy;

     (5) A permit issued by a commission or agreement state broad scope medical use licensee that authorizes medical use or the practice of nuclear pharmacy; or

     (6) A permit issued by a commission master material license board scope medical use permittee that authorizes medical use or the practice of nuclear pharmacy; or

     (7) Is designated as an authorized nuclear pharmacist in accordance with WAC 246-235-100(2).

     Authorized user means a physician, dentist, or podiatrist who:

     (1) Meets the requirements in WAC 246-240-081 and 246-240-154, 246-240-163, 246-240-210, 246-240-213, 246-240-216, 246-240-278, 246-240-301, or 246-240-399;

     (2) Is identified as an authorized user on a department, U.S. NRC, or agreement state license prior to October 5, 2005, that authorizes the medical use of radioactive material.

     (3) A permit issued by a commission master material licensee that is authorized to permit the medical use of by-product material;

     (4) A permit issued by a commission or agreement state specific licensee of broad scope that is authorized to permit the medical use of by-product material; or

     (5) A permit issued by a commission master material license broad scope permittee that is authorized to permit the medical use of by-product material.

     Brachytherapy means a method of radiation therapy in which sources are used to deliver a radiation dose at a distance of up to a few centimeters by surface, intracavitary, intraluminal, or interstitial application.

     Brachytherapy source means a radioactive source or a manufacturer-assembled source train or a combination of these sources that is designed to deliver a therapeutic dose within a distance of a few centimeters.

     Client's address means the area of use or a temporary job site for the purpose of providing mobile medical service in accordance with WAC 246-240-125.

     Dedicated check source means a radioactive source that is used to assure the constant operation of a radiation detection or measurement device over several months or years.

     Dentist means an individual licensed by a state or territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico to practice dentistry.

     High dose-rate remote afterloader, as used in this chapter, means a brachytherapy device that remotely delivers a dose rate in excess of 12 gray (1200 rads) per hour at the point or surface where the dose is prescribed.

     Low dose-rate remote afterloader, as used in this chapter, means a brachytherapy device that remotely delivers a dose rate of less than or equal to 2 gray (200 rads) per hour at the point or surface where the dose is prescribed.

     Management means the chief executive officer or other individual having the authority to manage, direct, or administer the licensee's activities, or that person's delegate or delegates.

     Manual brachytherapy, as used in this chapter, means a type of brachytherapy in which the brachytherapy sources (e.g., seeds, ribbons) are manually placed topically on or inserted either into the body cavities that are in close proximity to a treatment site or directly into the tissue volume.

     Medical event means an event that meets the criteria in WAC 246-240-651.

     Medical institution means an organization in which more than one medical discipline is practiced.

     Medical use means the intentional internal or external administration of radioactive material or the radiation from radioactive material to patients or human research subjects under the supervision of an authorized user.

     Medium dose-rate remote afterloader, as used in this chapter, means a brachytherapy device that remotely delivers a dose rate of greater than 2 gray (200 rads), but less than or equal to 12 grays (1200 rads) per hour at the point or surface where the dose is prescribed.

     Mobile medical service means the transportation of radioactive material to and its medical use at the client's address.

     Output means the exposure rate, dose rate, or a quantity related in a known manner to these rates from a brachytherapy source or a teletherapy, remote afterloader, or gamma stereotactic radiosurgery unit for a specified set of exposure conditions.

     Patient intervention means actions by the patient or human research subject, whether intentional or unintentional, such as dislodging or removing treatment devices or prematurely terminating the administration.

     Podiatrist means an individual licensed by a state or territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico to practice podiatry.

     Preceptor means an individual who provides or directs the training and experience required for an individual to become an authorized user, an authorized medical physicist, an authorized nuclear pharmacist, or a radiation safety officer.

     Prescribed dosage means the specified activity or range of activity of unsealed radioactive material as documented:

     (1) In a written directive; or

     (2) In accordance with the directions of the authorized user for procedures performed under WAC 246-240-151 and 246-240-157.

     Prescribed dose means:

     (1) For gamma stereotactic radiosurgery, the total dose as documented in the written directive;

     (2) For teletherapy, the total dose and dose per fraction as documented in the written directive;

     (3) For manual brachytherapy, either the total source strength and exposure time or the total dose, as documented in the written directive; or

     (4) For remote brachytherapy afterloaders, the total dose and dose per fraction as documented in the written directive.

     Pulsed dose-rate remote afterloader, as used in this chapter, means a special type of remote afterloading brachytherapy device that uses a single source capable of delivering dose rates in the "high dose-rate" range, but:

     (1) Is approximately one-tenth of the activity of typical high dose-rate remote afterloader sources; and

     (2) Is used to simulate the radiobiology of a low dose-rate treatment by inserting the source for a given fraction of each hour.

     Radiation safety officer means an individual who:

     (1) Meets the requirements in WAC 246-240-069 and 246-240-081;

     (2) Is identified as a radiation safety officer on a specific medical use license issued by the department prior to October 5, 2005, the U.S. NRC or an agreement state; or

     (3) A medical use permit issued by a commission master material licensee.

     Sealed source and device registry means the national registry that contains all the registration certificates, generated by both the U.S. NRC and the agreement states, that summarize the radiation safety information for the sealed sources and devices and describe the licensing and use conditions approved for the product.

     Stereotactic radiosurgery means the use of external radiation in conjunction with a stereotactic guidance device to very precisely deliver a therapeutic dose to a tissue volume.

     Structured educational program means an educational program designed to impart particular knowledge and practical education through interrelated studies and supervised training.

     Teletherapy, as used in this chapter, means a method of radiation therapy in which collimated gamma rays are delivered at a distance from the patient or human research subject.

     Temporary job site means a location where mobile medical services are conducted other than those location(s) of use authorized on the license.

     Therapeutic dosage means a dosage of unsealed radioactive material that is intended to deliver a radiation dose to a patient or human research subject for palliative or curative treatment.

     Therapeutic dose means a radiation dose delivered from a source containing radioactive material to a patient or human research subject for palliative or curative treatment.

     Treatment site means the anatomical description of the tissue intended to receive a radiation dose, as described in a written directive.

     Type of use means use of radioactive material under WAC 246-240-151, 246-240-157, 246-240-201, 246-240-251, 246-240-301, 246-240-351, or 246-240-501.

     Unit dosage means a dosage prepared for medical use for administration as a single dosage to a patient or human research subject without any further manipulation of the dosage after it is initially prepared.

     Written directive means an authorized user's written order for the administration of radioactive material or radiation from radioactive material to a specific patient or human research subject, as specified in WAC 246-240-060.

[Statutory Authority: RCW 70.98.050. 98-13-037, § 246-240-010, filed 6/8/98, effective 7/9/98. Statutory Authority: RCW 70.98.050 and 70.98.080. 92-06-008 (Order 245), § 246-240-010, filed 2/21/92, effective 3/23/92.]

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     (2) A specific license is not needed for an individual who:

     (a) Receives, possesses, uses, or transfers radioactive material in accordance with these rules under the supervision of an authorized user under in WAC 246-240-057, unless prohibited by license condition; or

     (b) Prepares unsealed radioactive material for medical use in accordance with these rules under the supervision of an authorized nuclear pharmacist or authorized user under WAC 246-240-057, unless prohibited by license condition.

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     (2) An application for a license for medical use of radioactive material as described in WAC 246-240-151, 246-240-157, 246-240-201, 246-240-251, 246-240-301, 246-240-351, and 246-240-501 must be made by:

     (a) Filing the original "Application for Radioactive Material License Medical," with the department that includes the facility diagram, equipment, and training and experience qualifications of the radiation safety officer, authorized user(s), authorized medical physicist(s), and authorized nuclear pharmacist(s); and

     (b) Submitting applicable procedures required by WAC 246-240-360, 246-240-378, 246-240-381, and 246-240-384.

     (3) A request for a license amendment or renewal must be made by:

     (a) Submitting an original of either to the department:

     (i) "Application for Radioactive Material License Medical"; or

     (ii) A letter requesting the amendment or renewal; and

     (b) Submitting applicable procedures required by WAC 246-240-360, 246-240-378, 246-240-381, and 246-240-384.

     (4) In addition to the requirements in subsections (2) and (3) of this section, an application for a license or amendment for medical use of radioactive material as described in WAC 246-240-501 must also include information regarding any radiation safety aspects of the medical use of the material that is not addressed in this chapter.

     (a) The applicant shall also provide specific information on:

     (i) Radiation safety precautions and instructions;

     (ii) Methodology for measurement of dosages or doses to be administered to patients or human research subjects; and

     (iii) Calibration, maintenance, and repair of instruments and equipment necessary for radiation safety.

     (b) The applicant or licensee shall also provide any other information requested by the department in its review of the application.

     (5) An applicant that satisfies the requirements specified in WAC 246-235-090 may apply for a Type A specific license of broad scope.

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     (1) Receives, prepares, or uses radioactive material for a type of use that is permitted under this chapter, but that is not authorized on the licensee's current license issued under this chapter;

     (2) Permits anyone to work as an authorized user, authorized nuclear pharmacist, or authorized medical physicist under the license, except:

     (a) For an authorized user, an individual who meets the requirements in WAC 246-240-154, 246-240-163, 246-240-210, 246-240-213, 246-240-216, 246-240-278, or 246-240-399;

     (b) For an authorized nuclear pharmacist, an individual who meets the requirements in WAC 246-240-075 and 246-240-081;

     (c) For an authorized medical physicist, an individual who meets the requirements in WAC 246-240-072 and 246-240-081;

     (d) An individual who is identified as an authorized user, an authorized nuclear pharmacist, or authorized medical physicist:

     (i) On an agreement state or U.S. NRC license or other equivalent license recognized by the department that authorizes the use of radioactive material in medical use or in the practice of nuclear pharmacy; or

     (ii) On a permit issued by a commission or agreement state specific license of broad scope that is authorized to permit the use of by-product material in medical use or in the practice of nuclear pharmacy;

     (iii) On a permit issued by a commission master material licensee that is authorized to permit the use of by-product material in medical use or in the practice of nuclear pharmacy; or

     (iv) By a commercial nuclear pharmacy that has been authorized to identify authorized nuclear pharmacists.

     (3) Changes radiation safety officers, except as provided in WAC 246-240-051;

     (4) Receives radioactive material in excess of the amount or in a different form, or receives a different radionuclide than is authorized on the license;

     (5) Adds to or changes the areas of use identified in the application or on the license, except for areas of use where radioactive material is used only in accordance with either WAC 246-240-151 or 246-240-157;

     (6) Changes the address(es) of use identified in the application or on the license; and

     (7) Revises procedures required by WAC 246-240-360, 246-240-378, 246-240-381, and 246-240-384, as applicable, where the revision reduces radiation safety.

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     (b) Considering the shielding by tissue.)) A licensee shall notify the department no later than thirty days after:

     (a) An authorized user, an authorized nuclear pharmacist, a radiation safety officer, or an authorized medical physicist permanently discontinues performance of duties under the license or has a name change;

     (b) The licensee's mailing address changes;

     (c) The licensee's name changes, but the name change does not constitute a transfer of control of the license as described in WAC 246-232-050(2); or

     (d) The licensee has added to or changed the areas of use identified in the application or on the license where radioactive material is used under either WAC 246-240-151 or 246-240-157.

     (2) The licensee shall send the documents required in this section to the department at P.O. Box 47827, Olympia WA 98504-7827.

[Statutory Authority: RCW 70.98.050. 98-13-037, § 246-240-025, filed 6/8/98, effective 7/9/98.]

     (1) WAC 246-240-019 regarding the need to file an amendment to the license for medical use of radioactive material, as described in WAC 246-240-501;

     (2) WAC 246-240-022;

     (3) WAC 246-240-022 regarding additions to or changes in the areas of use at the addresses identified in the application or on the license;

     (4) WAC 246-240-025;

     (5) WAC 246-240-025 for an authorized user, an authorized nuclear pharmacist, or an authorized medical physicist;

     (6) WAC 246-240-025 regarding additions to or changes in the areas of use identified in the application or on the license where radioactive material is used in accordance with either WAC 246-240-151 or 246-240-157;

     (7) WAC 246-240-122.

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     (a) The applicant has filed "Application for Radioactive Material License Medical" in accordance with the instructions in WAC 246-240-019;

     (b) The applicant has paid applicable fee under chapter 246-254 WAC;

     (c) The department finds the applicant equipped and committed to observe the safety standards established by the department in these regulations for the protection of the public health and safety; and

     (d) The applicant meets the requirements of chapter 246-232 WAC.

     (2) The department shall issue a license for mobile medical service if the applicant:

     (a) Meets the requirements in subsection (1) of this section; and

     (b) Assures that individuals or human research subjects to whom unsealed radioactive material, or radiation from implants containing radioactive material, will be administered may be released following treatment in accordance with WAC 246-240-122.

     (3) The department may, upon application of any interested person or upon its own initiative, grant exemptions from this chapter that it determines are authorized by law and will not endanger life or property or the common defense and security and are otherwise in the public interest.

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     (a) Requests for a license application, renewal, or amendment before submittal to the department;

     (b) Any individual before allowing that individual to work as an authorized user, authorized nuclear pharmacist, or authorized medical physicist; and

     (c) Radiation protection program changes that do not require a license amendment and are permitted under WAC 246-240-054;

     (2) A licensee's management shall appoint a radiation safety officer, who agrees, in writing, to be responsible for implementing the radiation protection program. The licensee, through the radiation safety officer, shall ensure that radiation safety activities are being performed in accordance with licensee-approved procedures and regulatory requirements.

     (3) For up to sixty days each year, a licensee may permit an authorized user or an individual qualified to be a radiation safety officer, under WAC 246-240-069 and 246-240-081, to function as a temporary radiation safety officer and to perform the functions of a radiation safety officer, under subsection (7) of this section, if the licensee takes the actions required in subsections (2), (5), (7), and (8) of this section and notifies the department in accordance with WAC 246-240-025.

     (4) A licensee may simultaneously appoint more than one temporary radiation safety officer under subsection (3) of this section, if needed to ensure that the licensee has a temporary radiation safety officer that satisfies the requirements to be a radiation safety officer for each of the different types of uses of radioactive material permitted by the license.

     (5) A licensee shall establish the authority, duties, and responsibilities of the radiation safety officer in writing.

     (6) Licensees that are authorized for two or more different types of use of radioactive material under WAC 246-240-201, 246-240-251, and/or 246-240-351, shall establish a radiation safety committee to oversee all uses of radioactive material permitted by the license. The committee must include an authorized user of each type of use permitted by the license, the radiation safety officer, a representative of the nursing service, and a representative of management who is neither an authorized user nor a radiation safety officer. The committee may include other members the licensee considers appropriate.

     (7) A licensee shall provide the radiation safety officer sufficient authority, organizational freedom, time, resources, and management prerogative, to:

     (a) Identify radiation safety problems;

     (b) Initiate, recommend, or provide corrective actions;

     (c) Stop unsafe operations; and

     (d) Verify implementation of corrective actions.

     (8) A licensee shall retain a record of actions taken under subsections (1), (2), and (5) of this section in accordance with WAC 246-240-551.

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     (a) The revision does not require a license amendment under WAC 246-240-022;

     (b) The revision is in compliance with this chapter and the license;

     (c) The revision has been reviewed and approved by the radiation safety officer and licensee management; and

     (d) The affected individuals are instructed on the revised program before the changes are implemented.

     (2) A licensee shall retain a record of each change in accordance with WAC 246-240-554.

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     (a) Instruct the supervised individual in the licensee's written radiation protection procedures, written directive procedures, this chapter, and license conditions with respect to the use of radioactive material; and

     (b) Require the supervised individual to follow the instructions of the supervising authorized user for medical uses of radioactive material, written radiation protection procedures established by the licensee, written directive procedures, regulations of these regulations, and license conditions with respect to the medical use of radioactive material.

     (2) A licensee that permits the preparation of radioactive material for medical use by an individual under the supervision of an authorized nuclear pharmacist or physician who is an authorized user, as allowed by WAC 246-240-016, shall:

     (a) In addition to the requirements in WAC 246-222-030, instruct the supervised individual in the preparation of radioactive material for medical use, as appropriate to that individual's involvement with radioactive material; and

     (b) Require the supervised individual to follow the instructions of the supervising authorized user or authorized nuclear pharmacist regarding the preparation of radioactive material for medical use, written radiation protection procedures established by the licensee, this chapter, and license conditions.

     (c) A licensee that permits supervised activities under subsections (1) and (2) of this section is responsible for the acts and omissions of the supervised individual.

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     If, because of the emergent nature of the patient's condition, a delay in order to provide a written directive would jeopardize the patient's health, an oral directive is acceptable. The information contained in the oral directive must be documented as soon as possible in writing in the patient's record. A written directive must be prepared within forty-eight hours of the oral directive.

     (2) The written directive must contain the patient or human research subject's name and the following information:

     (a) For any administration of quantities greater than 1.11 MBq (30 µCi) of sodium iodide I-131: The dosage;

     (b) For an administration of a therapeutic dosage of unsealed radioactive material other than sodium iodide I-131: The radioactive drug, dosage, and route of administration;

     (c) For gamma stereotactic radiosurgery: The total dose, treatment site, and values for the target coordinate settings per treatment for each anatomically distinct treatment site;

     (d) For teletherapy: The total dose, dose per fraction, number of fractions, and treatment site;

     (e) For high dose-rate remote afterloading brachytherapy: The radionuclide, treatment site, dose per fraction, number of fractions, and total dose; or

     (f) For all other brachytherapy, including low, medium, and pulsed dose rate remote afterloaders:

     (i) Before implantation: Treatment site, the radionuclide, and dose; and

     (ii) After implantation but before completion of the procedure: The radionuclide, treatment site, number of sources, and total source strength and exposure time (or the total dose).

     (3) A written revision to an existing written directive may be made if the revision is dated and signed by an authorized user before the administration of the dosage of unsealed radioactive material, the brachytherapy dose, the gamma stereotactic radiosurgery dose, the teletherapy dose, or the next fractional dose.

     If, because of the patient's condition, a delay in order to provide a written revision to an existing written directive would jeopardize the patient's health, an oral revision to an existing written directive is acceptable. The oral revision must be documented as soon as possible in the patient's record. A revised written directive must be signed by the authorized user within forty-eight hours of the oral revision.

     (4) The licensee shall retain a copy of the written directive in accordance with WAC 246-240-557.

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     (a) The patient's or human research subject's identity is verified before each administration; and

     (b) Each administration is in accordance with the written directive.

     (2) At a minimum, the procedures required by subsection (1) of this section must address the following items that are applicable to the licensee's use of radioactive material:

     (a) Verifying the identity of the patient or human research subject;

     (b) Verifying that the administration is in accordance with the treatment plan, if applicable, and the written directive;

     (c) Checking both manual and computer-generated dose calculations; and

     (d) Verifying that any computer-generated dose calculations are correctly transferred into the consoles of therapeutic medical units authorized by WAC 246-240-351.

     (3) A licensee shall retain a copy of the procedures required under subsection (1) of this section in accordance with WAC 246-240-560.

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     (1) Sealed sources or devices manufactured, labeled, packaged, and distributed in accordance with a license issued under WAC 246-235-102.

     (2) Sealed sources or devices noncommercially transferred from a U.S. NRC or agreement state licensee; or

     (3) Teletherapy sources manufactured and distributed in accordance with a license issued under chapter 246-232 WAC.

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     (1) Is certified by a specialty board whose certification process has been recognized by the department, the U.S. NRC, or an agreement state. (Specialty boards whose certification process has been recognized by the department, the U.S. Nuclear Regulatory Commission or an agreement state will be posted on the NRC's web page, at http://www.nrc.gov.) To be recognized, a specialty board shall require all candidates for certification to:

     (a) Hold a bachelor's or graduate degree from an accredited college or university in physical science or engineering or biological science with a minimum of twenty college credits in physical science;

     (b) Have five or more years of professional experience in health physics (graduate training may be substituted for no more than two years of the required experience) including at least three years in applied health physics;

     (c) Pass an examination administered by diplomates of the specialty board, which evaluates knowledge and competence in radiation physics and instrumentation, radiation protection, mathematics pertaining to the use and measurement of radioactivity, radiation biology, and radiation dosimetry; or

     (i) Hold a master's or doctor's degree in physics, medical physics, other physical science, engineering, or applied mathematics from an accredited college or university;

     (ii) Have two years of full-time practical training and/or supervised experience in medical physics:

     (A) Under the supervision of a medical physicist who is certified in medical physics by a specialty board recognized by the commission or an agreement state; or

     (B) In clinical nuclear medicine facilities providing diagnostic and/or therapeutic services under the direction of physicians who meet the requirements for authorized users under these rules before October 24, 2005; and

     (iii) Pass an examination, administered by diplomates of the specialty board, that assesses knowledge and competence in clinical diagnostic radiological or nuclear medicine physics and in radiation safety; or

     (d) Obtain written certification signed by a preceptor radiation safety officer that the individual has achieved a level of radiation safety knowledge sufficient to function independently as a radiation safety officer for a medical use licensee; or

     (2)(a) Has completed a structured educational program consisting of both:

     (i) Two hundred hours of didactic training in the following areas:

     (A) Radiation physics and instrumentation;

     (B) Radiation protection;

     (C) Mathematics pertaining to the use and measurement of radioactivity;

     (D) Radiation biology; and

     (E) Radiation dosimetry; and

     (ii) One year of full-time radiation safety experience under the supervision of the individual identified as the radiation safety officer on a department or agreement state license or license issued by the U.S. NRC that authorizes similar type(s) of use(s) of radioactive material involving the following:

     (A) Shipping, receiving, and performing related radiation surveys;

     (B) Using and performing checks for proper operation of instruments used to determine the activity of dosages, survey meters, and instruments used to measure radionuclides;

     (C) Securing and controlling radioactive material;

     (D) Using administrative controls to avoid mistakes in the administration of radioactive material;

     (E) Using procedures to prevent or minimize radioactive contamination and using proper decontamination procedures;

     (F) Using emergency procedures to control radioactive material; and

     (G) Disposing of radioactive material; and

     (b) Is a medical physicist who has been certified by a specialty board whose certification process has been recognized by the commission or an agreement state under WAC 246-240-072 and has experience in radiation safety for similar types of use of by-product material for which the licensee is seeking the approval of the individual as radiation safety officer and who meets the requirements in (d) and (e) of this subsection; or

     (3) Is an authorized user, authorized medical physicist, or authorized nuclear pharmacist identified on the licensee's license or a medical physicist who has been certified by a specialty board whose certification process has been recognized by the department, the U.S. Nuclear Regulatory Commission or an agreement state under WAC 246-240-072 and has experience with the radiation safety aspects of similar types of use of radioactive material for which the individual has radiation safety officer responsibilities; and

     (4) Has obtained written certification, signed by a preceptor radiation safety officer, that the individual has satisfactorily completed the requirements in (a) of this subsection and has achieved a level of radiation safety knowledge sufficient to function independently as a radiation safety officer for a medical use licensee; and

     (5) Has training in the radiation safety, regulatory issues, and emergency procedures for the types of use for which a licensee seeks approval. This training requirement may be satisfied by completing training that is supervised by an authorized medical physicist, authorized user, authorized nuclear pharmacist, or radiation safety officer, as appropriate, who is authorized for the type(s) of use for which the licensee is seeking approval.

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     (1) Is certified by a specialty board whose certification process has been recognized by the department, the U.S. Nuclear Regulatory Commission or an agreement state. (Specialty boards whose certification process has been recognized by the commission or an agreement state will be posted on the NRC's web page at http://www.nrc.gov.) To be recognized, a specialty board shall require all candidates for certification to:

     (a) Hold a master's or doctor's degree in physics, medical physics, other physical science, engineering, or applied mathematics from an accredited college or university;

     (b) Have two years of full-time practical training and/or supervised experience in medical physics:

     (i) Under the supervision of a medical physicist who is certified in medical physics by a specialty board recognized by the commission or an agreement state; or

     (ii) In clinical radiation facilities providing high energy, external beam therapy and brachytherapy services under the direction of physicians who meet the requirements for authorized users in WAC 246-240-278 or 246-240-399;

     (c) Pass an examination, administered by diplomates of the specialty board, which assesses knowledge and competence in clinical radiation therapy, radiation safety, calibration, quality assurance, and treatment planning for external beam therapy, brachytherapy, and stereotactic radiosurgery; and

     (d) Obtain written certification that the individual has achieved a level of competency sufficient to function independently as an authorized medical physicist for each type of therapeutic use for which the individual is requesting authorized medical physicist status. The written certification must be signed by a preceptor authorized medical physicist who meets the requirements in WAC 246-240-072 or equivalent agreement state or U.S. NRC requirements for an authorized medical physicist for each type of therapeutic medical unit for which the individual is requesting authorized medical physicist status; or

     (2)(a) Holds a master's or doctor's degree in physics, medical physics, other physical science, engineering, or applied mathematics from an accredited college or university; and has completed one year of full-time training in medical physics and an additional year of full-time work experience under the supervision of an individual who meets the requirements for an authorized medical physicist for the type(s) of use modalities for which the individual is seeking authorization. This training and work experience must be conducted in clinical radiation facilities that provide high energy, external beam therapy and brachytherapy services and must include:

     (i) Performing sealed source leak tests and inventories;

     (ii) Performing decay corrections;

     (iii) Performing full calibration and periodic spot checks of external beam treatment units, stereotactic radiosurgery units, and remote afterloading units as applicable; and

     (iv) Conducting radiation surveys around external beam treatment units, stereotactic radiosurgery units, and remote afterloading units as applicable; and

     (b) Has obtained written certification that the individual has satisfactorily completed the requirements in (a) of this subsection and has achieved a level of competency sufficient to function independently as an authorized medical physicist for each type of therapeutic medical unit for which the individual is requesting authorized medical physicist status. The written certification must be signed by a preceptor authorized medical physicist who meets the requirements in WAC 246-240-072 or equivalent U.S. NRC or agreement state requirements for an authorized medical physicist for each type of therapeutic medical unit for which the individual is requesting authorized medical physicist status; and

     (3) Has training for the type(s) of use in the modalities for which authorization is sought that includes hands-on device operation, safety procedures, clinical use, and the operation of a treatment planning system. This training requirement may be satisfied by satisfactorily completing either a training program provided by the vendor or by training supervised by an authorized medical physicist authorized for the type(s) of use for which the individual is seeking authorization.

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     (1) Is certified by a specialty board whose certification process has been recognized by the department, the U.S. Nuclear Regulatory Commission or an agreement state. (Specialty boards whose certification process has been recognized by the commission or an agreement state will be posted on the NRC's web page at http://www.nrc.gov.) To be recognized, a specialty board shall require all candidates for certification to:

     (a) Have graduated from a pharmacy program accredited by the American Council On Pharmaceutical Education (ACPE) or have passed the Foreign Pharmacy Graduate Examination Committee (FPGEC) examination;

     (b) Hold a current, active license to practice pharmacy;

     (c) Provide evidence of having acquired at least four thousand hours of training/experience in nuclear pharmacy practice. Academic training may be substituted for no more than two thousand hours of the required training and experience; and

     (d) Pass an examination in nuclear pharmacy administered by diplomates of the specialty board, which assesses knowledge and competency in procurement, compounding, quality assurance, dispensing, distribution, health and safety, radiation safety, provision of information and consultation, monitoring patient outcomes, research and development; or

     (2)(a) Has completed seven hundred hours in a structured educational program consisting of both:

     (i) Didactic training in the following areas:

     (A) Radiation physics and instrumentation;

     (B) Radiation protection;

     (C) Mathematics pertaining to the use and measurement of radioactivity;

     (D) Chemistry of radioactive material for medical use; and

     (E) Radiation biology; and

     (ii) Supervised practical experience in a nuclear pharmacy involving:

     (A) Shipping, receiving, and performing related radiation surveys;

     (B) Using and performing checks for proper operation of instruments used to determine the activity of dosages, survey meters, and, if appropriate, instruments used to measure alpha-or beta-emitting radionuclides;

     (C) Calculating, assaying, and safely preparing dosages for patients or human research subjects;

     (D) Using administrative controls to avoid medical events in the administration of radioactive material; and

     (E) Using procedures to prevent or minimize radioactive contamination and using proper decontamination procedures; and

     (b) Has obtained written certification, signed by a preceptor authorized nuclear pharmacist, that the individual has satisfactorily completed the requirements in (a) of this subsection and has achieved a level of competency sufficient to function independently as an authorized nuclear pharmacist.

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     (2) Physicians, dentists, or podiatrists identified as authorized users for the medical use of radioactive material on a license issued by the department or agreement state, or U.S. NRC broad scope license, or license issued before October 24, 2006, who perform only those medical uses for which they were authorized on that date need not comply with the training requirements of WAC 246-240-151 and 246-240-399.

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     (2) A licensee shall calibrate the instrumentation required in subsection (1) of this section in accordance with nationally recognized standards or the manufacturer's instructions.

     (3) A licensee shall retain a record of each instrument calibration required by this section in accordance with WAC 246-240-563.

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     (a) Calibrate all scales with readings up to 10 mSv (1000 mrem) per hour with a radiation source;

     (b) Calibrate two separated readings on each scale or decade that will be used to show compliance; and

     (c) Conspicuously note on the instrument the date of calibration.

     (2) A licensee may not use survey instruments if the difference between the indicated exposure rate and the calculated exposure rate is more than twenty percent.

     (3) A licensee shall retain a record of each survey instrument calibration in accordance with WAC 246-240-566.

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     (2) For a unit dosage, this determination must be made by:

     (a) Direct measurement of radioactivity; or

     (b) A decay correction, based on the activity or activity concentration determined by:

     (i) A manufacturer or preparer licensed under WAC 246-235-100 or equivalent U.S. NRC or agreement state requirements; or

     (ii) An agreement state or U.S. NRC licensee for use in research in accordance with a radioactive drug research committee-approved protocol or an investigational new drug (IND) protocol accepted by FDA.

     (3) For other than unit dosages, this determination must be made by:

     (a) Direct measurement of radioactivity;

     (b) Combination of measurement of radioactivity and mathematical calculations; or

     (c) Combination of volumetric measurements and mathematical calculations, based on the measurement made by a manufacturer or preparer licensed under WAC 246-235-100 or equivalent agreement state requirements.

     (4) Unless otherwise directed by the authorized user, a licensee may not use a dosage if the dosage does not fall within the prescribed dosage range or if the dosage differs from the prescribed dosage by more than twenty percent.

     (5) A licensee shall retain a record of the dosage determination required by this section in accordance with WAC 246-240-569.

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     (1) Sealed sources, not exceeding 1.11 GBq (30 mCi) each, manufactured and distributed by a person licensed under WAC 246-235-102 or equivalent agreement state or U.S. NRC regulations.

     (2) Sealed sources, not exceeding 1.11 GBq (30 mCi) each, redistributed by a licensee authorized to redistribute the sealed sources manufactured and distributed by a person licensed under WAC 246-235-102, if the redistributed sealed sources are in the original packaging and shielding and are accompanied by the manufacturer's approved instructions.

     (3) Any radioactive material with a half-life not longer than one hundred twenty days in individual amounts not to exceed 0.56 GBq (15 mCi).

     (4) Any radioactive material with a half-life longer than one hundred twenty days in individual amounts not to exceed the smaller of 7.4 MBq (200 µCi) or 1000 times the quantities in Schedule B of WAC 246-232-120.

     (5) Technetium-99m in amounts as needed.

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     (2) A licensee in possession of a sealed source shall:

     (a) Test the source for leakage before its first use unless the licensee has a certificate from the supplier indicating that the source was tested within six months before transfer to the licensee; and

     (b) Test the source for leakage at intervals not to exceed six months or at other intervals approved by the department, the U.S. NRC, or an agreement state in the sealed source and device registry.

     (3) To satisfy the leak test requirements of this section, the licensee shall ensure the sample is analyzed by such method that the leak test can detect the presence of 185 Bq (0.005 µCi) of radioactive material in the sample.

     (4) A licensee shall retain leak test records in accordance with WAC 246-240-572(1).

     (5) If the leak test reveals the presence of 185 Bq (0.005 µCi) or more of removable contamination, the licensee shall:

     (a) Immediately withdraw the sealed source from use and store, dispose, or cause it to be repaired in accordance with the requirements in chapters 246-221 and 246-232 WAC; and

     (b) File a report within five days of the leak test in accordance with WAC 246-240-657.

     (6) A licensee need not perform a leak test on the following sources:

     (a) Sources containing only radioactive material with a half-life of less than thirty days;

     (b) Sources containing only radioactive material as a gas;

     (c) Sources containing 3.7 MBq (100 µCi) or less of beta-or gamma-emitting material or 0.37 MBq (10 µCi) or less of alpha-emitting material;

     (d) Seeds of iridium-192 encased in nylon ribbon; and

     (e) Sources stored and not being used. However, the licensee shall test each source for leakage before any use or transfer unless it has been leak tested within six months before the date of use or transfer.

     (7) A licensee in possession of sealed sources or brachytherapy sources, except for gamma stereotactic radiosurgery sources, shall conduct a physical inventory of all the sources in its possession at intervals not to exceed six months. The licensee shall retain each inventory record in accordance with WAC 246-240-572.

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     (2) A licensee does not need to perform the surveys required by subsection (1) of this section in an area(s) where patients or human research subjects are confined when they cannot be released under WAC 246-240-122.

     (3) A licensee shall retain a record of each survey in accordance with WAC 246-240-575.

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     (2) A licensee shall provide the released individual, or the individual's parent or guardian, with instructions, including written instructions, on actions recommended to maintain doses to other individuals as low as is reasonably achievable if the total effective dose equivalent to any other individual is likely to exceed 1 mSv (0.1 rem). If the total effective dose equivalent to a nursing infant or child could exceed 1 mSv (0.1 rem) assuming there were no interruption of breast-feeding, the instructions must also include:

     (a) Guidance on the interruption or discontinuation of breast-feeding; and

     (b) Information on the potential consequences, if any, of failure to follow the guidance.

     (3) A licensee shall maintain a record of the basis for authorizing the release of an individual in accordance with WAC 246-240-578(1).

     (4) The licensee shall maintain a record of instructions provided to a breast-feeding female in accordance with WAC 246-240-578(2). NUREG-1556, Vol. 9, "Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Medical Licenses," describes methods for calculating doses to other individuals and contains tables of activities not likely to cause doses exceeding 5 mSv (0.5 rem).

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     (a) Obtain a letter signed by the management of each client to whom services are rendered that permits the use of radioactive material at the client's address and clearly delineates the authority and responsibility of the licensee and the client;

     (b) Check instruments used to measure the activity of unsealed radioactive material for proper function before medical use at each client's address or on each day of use, whichever is more frequent. At a minimum, the check for proper function required by this section must include a constancy check;

     (c) Check survey instruments for proper operation with a dedicated check source before use at each client's address; and

     (d) Before leaving a client's address, survey all areas of use to ensure compliance with chapter 246-221 WAC.

     (2) A mobile medical service may not have radioactive material delivered from the manufacturer or the distributor to the client unless the client has a license allowing possession of the radioactive material. Radioactive material delivered to the client must be received and handled in conformance with the client's license.

     (3) A licensee providing mobile medical services shall retain the letter required in subsection (1)(a) of this section and the record of each survey required in subsection (1)(d) of this section in accordance with WAC 246-240-581.

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     (a) Monitors radioactive material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding; and

     (b) Removes or obliterates all radiation labels, except for radiation labels on materials that are within containers and that will be managed as biomedical waste after they have been released from the licensee.

     (2) A licensee shall retain a record of each disposal permitted under subsection (1) of this section in accordance with WAC 246-240-584.

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     (1) Obtained from a manufacturer or preparer licensed under WAC 246-235-100(1) or equivalent U.S. NRC or agreement state requirements; or

     (2) Prepared by an authorized nuclear pharmacist, a physician who is an authorized user and who meets the requirements specified in WAC 246-240-163 or 246-240-210, or an individual under the supervision of either as specified in WAC 246-240-057; or

     (3) Obtained from and prepared by an agreement state or U.S. NRC licensee for use in research in accordance with a radioactive drug research committee-approved protocol or an investigational new drug (IND) protocol accepted by FDA; or

     (4) Prepared by the licensee for use in research in accordance with a radioactive drug research committee-approved application or an investigational new drug (IND) protocol accepted by FDA.

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     (1) Is certified by a medical specialty board whose certification process has been recognized by the department, the U.S. Nuclear Regulatory Commission or an agreement state. (Specialty boards whose certification process has been recognized by the department, the U.S. NRC or an agreement state will be posted on the NRC's web page at http://www.nrc.gov.) To be recognized, a specialty board shall require all candidates for certification to:

     (a) Meet the requirements in subsection (3)(a) of this section; and

     (b) Pass an examination, administered by diplomates of the specialty board, which assesses knowledge and competence in radiation safety, radionuclide handling, and quality control; or

     (2) Is an authorized user under WAC 246-240-163 or 246-240-210 or equivalent agreement state or U.S. NRC requirements; or

     (3)(a) Has completed sixty hours of training and experience in basic radionuclide handling techniques applicable to the medical use of unsealed radioactive material for uptake, dilution, and excretion studies. The training and experience must include:

     (i) Classroom and laboratory training in the following areas:

     (A) Radiation physics and instrumentation;

     (B) Radiation protection;

     (C) Mathematics pertaining to the use and measurement of radioactivity;

     (D) Chemistry of radioactive material for medical use; and

     (E) Radiation biology; and

     (ii) Work experience, under the supervision of an authorized user who meets the requirements in WAC 246-240-154, 246-240-163, or 246-240-210 or equivalent U.S. NRC or agreement state requirements, involving:

     (A) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;

     (B) Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters;

     (C) Calculating, measuring, and safely preparing patient or human research subject dosages;

     (D) Using administrative controls to prevent a medical event involving the use of unsealed radioactive material;

     (E) Using procedures to contain spilled radioactive material safely and using proper decontamination procedures; and

     (F) Administering dosages of radioactive drugs to patients or human research subjects; and

     (b) Has obtained written certification, signed by a preceptor authorized user who meets the requirements in WAC 246-240-154, 246-240-163, or 246-240-210 or equivalent agreement state or U.S. NRC requirements, that the individual has satisfactorily completed the requirements in (a) of this subsection and has achieved a level of competency sufficient to function independently as an authorized user for the medical uses authorized under WAC 246-240-151.

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     (1) Obtained from a manufacturer or preparer licensed under WAC 246-235-100(1) or equivalent agreement state or U.S. NRC requirements; or

     (2) Prepared by an authorized nuclear pharmacist, a physician who is an authorized user and who meets the requirements specified in WAC 246-240-163 or 246-240-210, or an individual under the supervision of either as specified in WAC 246-240-057;

     (3) Obtained from and prepared by an agreement state or U.S. NRC licensee for use in research in accordance with a radioactive drug research committee-approved protocol or an investigational new drug (IND) protocol accepted by FDA; or

     (4) Prepared by the licensee for use in research in accordance with a radioactive drug research committee-approved application or an investigational new drug (IND) protocol accepted by FDA.

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     (2) A licensee that uses molybdenum-99/technetium-99m generators for preparing a technetium-99m radiopharmaceutical shall measure the molybdenum-99 concentration of the first eluate after receipt of a generator to demonstrate compliance with subsection (1) of this section.

     (3) If a licensee is required to measure the molybdenum-99 concentration, the licensee shall retain a record of each measurement in accordance with WAC 246-240-587.

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     (1) Is certified by a medical specialty board whose certification process has been recognized by the department, the U.S. Nuclear Regulatory Commission or an agreement state. (Specialty boards whose certification process has been recognized by the commission or an agreement state will be posted on the U.S. NRC's web page at http://www.nrc.gov.) To be recognized, a specialty board shall require all candidates for certification to:

     (a) Satisfy the requirements in subsection (3)(a) of this section; and

     (b) Pass an examination, administered by diplomates of the specialty board, which assesses knowledge and competence in radiation safety, radionuclide handling, and quality control;

     (2) Is an authorized user under WAC 246-240-210 or equivalent agreement state or U.S. NRC requirements prior to October 24, 2005; or

     (3)(a) Has completed seven hundred hours of training and experience in basic radionuclide handling techniques applicable to the medical use of unsealed radioactive material for imaging and localization studies. The training and experience must include, at a minimum:

     (i) Classroom and laboratory training in the following areas:

     (A) Radiation physics and instrumentation;

     (B) Radiation protection;

     (C) Mathematics pertaining to the use and measurement of radioactivity;

     (D) Chemistry of radioactive material for medical use;

     (E) Radiation biology; and

     (ii) Work experience, under the supervision of an authorized user, who meets the requirements in WAC 246-240-163 or 246-240-210 or equivalent agreement state or U.S. NRC requirements, involving:

     (A) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;

     (B) Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters;

     (C) Calculating, measuring, and safely preparing patient or human research subject dosages;

     (D) Using administrative controls to prevent a medical event involving the use of unsealed radioactive material;

     (E) Using procedures to safely contain spilled radioactive material and using proper decontamination procedures;

     (F) Administering dosages of radioactive drugs to patients or human research subjects; and

     (G) Eluting generator systems appropriate for preparation of radioactive drugs for imaging and localization studies, measuring and testing the eluate for radionuclidic purity, and processing the eluate with reagent kits to prepare labeled radioactive drugs; and

     (b) Has obtained written certification, signed by a preceptor authorized user who meets the requirements in WAC 246-240-163 or 246-240-210 or equivalent agreement state or U.S. NRC requirements, that the individual has satisfactorily completed the requirements in (a) of this subsection and has achieved a level of competency sufficient to function independently as an authorized user for the medical uses authorized under WAC 246-240-151 and 246-240-157.

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     (1) Obtained from a manufacturer or preparer licensed under WAC 246-235-100(1) or equivalent agreement state or U.S. NRC requirements; or

     (2) Prepared by an authorized nuclear pharmacist, a physician who is an authorized user and who meets the requirements specified in WAC 246-240-163 or 246-240-210, or an individual under the supervision of either as specified in WAC 246-240-057; or

     (3) Obtained from and prepared by an agreement state or U.S. NRC licensee for use in research in accordance with an investigational new drug (IND) protocol accepted by FDA; or

     (4) Prepared by the licensee for use in research in accordance with an investigational new drug (IND) protocol accepted by FDA.

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     (1) A licensee shall provide radiation safety instruction, initially and at least annually, to personnel caring for patients or human research subjects who cannot be released under WAC 246-240-122. To satisfy this requirement, the instruction must be commensurate with the duties of the personnel and include:

     (a) Patient or human research subject control;

     (b) Visitor control, including:

     (i) Routine visitation to hospitalized individuals in accordance with WAC 246-221-060 (1)(a); and

     (ii) Visitation authorized in accordance with WAC 246-221-060(2);

     (c) Contamination control;

     (d) Waste control; and

     (e) Notification of the radiation safety officer, or their designee, and the authorized user if the patient or the human research subject has a medical emergency or dies.

     (2) A licensee shall retain a record of individuals receiving instruction in accordance with WAC 246-240-590.

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     (a) Quarter the patient or the human research subject either in:

     (i) A private room with a private sanitary facility; or

     (ii) A room, with a private sanitary facility, with another individual who also has received therapy with unsealed radioactive material and who also cannot be released under WAC 246-240-122;

     (b) Visibly post the patient's or the human research subject's room with a "Caution -- Radioactive Materials" sign.

     (c) Note on the door or in the patient's or human research subject's chart where and how long visitors may stay in the patient's or the human research subject's room; and

     (d) Either monitor material and items removed from the patient's or the human research subject's room to determine that their radioactivity cannot be distinguished from the natural background radiation level with a radiation detection survey instrument set on its most sensitive scale and with no interposed shielding, or handle the material and items as radioactive waste.

     (2) A licensee shall notify the radiation safety officer, or their designee, and the authorized user as soon as possible if the patient or human research subject has a medical emergency or dies.

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     (1) Is certified by a medical specialty board whose certification process has been recognized by the department, the U.S. Nuclear Regulatory Commission or an agreement state. (Specialty boards whose certification process has been recognized by the commission or an agreement state will be posted on the NRC's web page at http://www.nrc.gov.) To be recognized, a specialty board shall require all candidates for certification to:

     (a) Successfully complete a minimum of three years of residency training in a radiation oncology or nuclear medicine training program or a program in a related medical specialty that includes seven hundred hours of training and experience as described in subsection (2) of this section. Eligible training programs must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or Royal College of Physicians and Surgeons of Canada or the Committee on Postgraduate Training of the American Osteopathic Association;

     (b) Pass an examination, administered by diplomates of the specialty board, which tests knowledge and competence in radiation safety, radionuclide handling, quality assurance, and clinical use of unsealed by-product material; and

     (c) Obtain written certification that the individual has achieved a level of competency sufficient to function independently as an authorized user for the medical uses authorized under WAC 246-240-201. The written certification must be signed by a preceptor authorized user who meets the requirements in WAC 246-240-210 or equivalent U.S. NRC or agreement state requirements. The preceptor authorized user, who meets the requirements in WAC 246-240-210 must have experience in administering dosages in the same dosage category or categories (i.e., this section) as the individual requesting authorized user status; or

     (2) Has completed seven hundred hours of training and experience in basic radionuclide handling techniques applicable to the medical use of unsealed radioactive material requiring a written directive. The training and experience must include:

     (a) Classroom and laboratory training in the following areas:

     (i) Radiation physics and instrumentation;

     (ii) Radiation protection;

     (iii) Mathematics pertaining to the use and measurement of radioactivity;

     (iv) Chemistry of radioactive material for medical use; and

     (v) Radiation biology; and

     (b) Work experience, under the supervision of an authorized user who meets the requirements in subsection (1) or (2) of this section, or equivalent U.S. NRC or agreement state requirements. A supervising authorized user, who meets the requirements in this subsection, must also have experience in administering dosages in the same dosage category or categories (i.e., this section) as the individual requesting authorized user status. The work experience must involve:

     (i) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;

     (ii) Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters;

     (iii) Calculating, measuring, and safely preparing patient or human research subject dosages;

     (iv) Using administrative controls to prevent a medical event involving the use of unsealed radioactive material;

     (v) Using procedures to contain spilled radioactive material safely and using proper decontamination procedures;

     (vi) Eluting generator systems, measuring and testing the eluate for radionuclidic purity, and processing the eluate with reagent kits to prepare labeled radioactive drugs; and

     (vii) Administering dosages of radioactive drugs to patients or human research subjects involving a minimum of three cases in each of the following categories for which the individual is requesting authorized user status:

     (A) Oral administration of less than or equal to 1.22 gigabecquerels (33 millicuries) of sodium iodide I-131;

     (B) Oral administration of greater than 1.22 gigabecquerels (33 millicuries) of sodium iodide I-131. Experience with at least three cases in this also satisfies the requirement in (b)(vii)(A) of this subsection;

     (C) Parenteral administration of any beta emitter or a photon-emitting radionuclide with a photon energy less than 150 keV for which a written directive is required; and/or

     (D) Parenteral administration of any other radionuclide for which a written directive is required; and

     (E) Has obtained written certification that the individual has satisfactorily completed the requirements in this subsection (2) and has achieved a level of competency sufficient to function independently as an authorized user for the medical uses authorized under WAC 246-240-201. The written certification must be signed by a preceptor authorized user who meets the requirements in this section, or equivalent U.S. NRC or agreement state requirements. The preceptor authorized user, who meets the requirements in this subsection (2), must have experience in administering dosages in the same dosage category or categories (i.e., this section) as the individual requesting authorized user status.

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     (1) Is certified by a medical specialty board whose certification process includes all of the requirements in subsection (3) of this section and whose certification has been recognized by the department, the U.S. Nuclear Regulatory Commission or an agreement state. (Specialty boards whose certification process has been recognized by the commission or an agreement state will be posted on the NRC's web page at http://www.nrc.gov.); or

     (2) Is an authorized user under WAC 246-240-210 for uses listed in WAC 246-240-210 or 246-240-216, or equivalent agreement state or U.S. NRC requirements; or

     (3)(a) Has successfully completed eighty hours of classroom and laboratory training, applicable to the medical use of sodium iodide I-131 for procedures requiring a written directive. The training must include:

     (i) Radiation physics and instrumentation;

     (ii) Radiation protection;

     (iii) Mathematics pertaining to the use and measurement of radioactivity;

     (iv) Chemistry of radioactive material for medical use; and

     (v) Radiation biology; and

     (b) Has work experience, under the supervision of an authorized user who meets the requirements in WAC 246-240-210, 246-240-213, 246-240-216, or equivalent agreement state or U.S. NRC requirements. A supervising authorized user who meets the requirements in WAC 246-240-210(2), must have experience in administering dosages as specified in WAC 246-240-210. The work experience must involve:

     (i) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;

     (ii) Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters;

     (iii) Calculating, measuring, and safely preparing patient or human research subject dosages;

     (iv) Using administrative controls to prevent a medical event involving the use of radioactive material;

     (v) Using procedures to contain spilled radioactive material safely and using proper decontamination procedures; and

     (vi) Administering dosages to patients or human research subjects, that includes at least three cases involving the oral administration of less than or equal to 1.22 gigabecquerels (33 millicuries) of sodium iodide I-131; and

     (c) Has obtained written certification that the individual has satisfactorily completed the requirements in (a) and (b) of this subsection and has achieved a level of competency sufficient to function independently as an authorized user for medical uses authorized under WAC 246-240-201. The written certification must be signed by a preceptor authorized user who meets the requirements in WAC 246-240-210, 246-240-213, 246-240-216, or equivalent agreement state or U.S. NRC requirements. A preceptor authorized user, who meets the requirement in WAC 246-240-210, must have experience in administering dosages as specified in WAC 246-240-210.

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     (1) Is certified by a medical specialty board whose certification process includes all of the requirements in subsection (3) of this section and whose certification has been recognized by the department, the U.S. NRC or an agreement state. (Specialty boards whose certification process has been recognized by the commission or an agreement state will be posted on the NRC's web page at http://www.nrc.gov.); or

     (2) Is an authorized user under WAC 246-240-210 for uses listed in WAC 246-240-210, or equivalent agreement state or U.S. NRC requirements; or

     (3)(a) Has successfully completed eighty hours of classroom and laboratory training, applicable to the medical use of sodium iodide I-131 for procedures requiring a written directive. The training must include:

     (i) Radiation physics and instrumentation;

     (ii) Radiation protection;

     (iii) Mathematics pertaining to the use and measurement of radioactivity;

     (iv) Chemistry of radioactive material for medical use; and

     (v) Radiation biology; and

     (b) Has work experience, under the supervision of an authorized user who meets the requirements in WAC 246-240-210, 246-240-216, or equivalent agreement state or U.S. NRC requirements. A supervising authorized user, who meets the requirements in WAC 246-240-210(2), must have experience in administering dosages as specified in WAC 246-240-210.

     The work experience must involve:

     (i) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;

     (ii) Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters;

     (iii) Calculating, measuring, and safely preparing patient or human research subject dosages;

     (iv) Using administrative controls to prevent a medical event involving the use of radioactive material;

     (v) Using procedures to contain spilled radioactive material safely and using proper decontamination procedures; and

     (vi) Administering dosages to patients or human research subjects, that includes at least three cases involving the oral administration of greater than 1.22 gigabecquerels (33 millicuries) of sodium iodide I-131; and

     (c) Has obtained written certification that the individual has satisfactorily completed the requirements in (a) and (b) of this subsection and has achieved a level of competency sufficient to function independently as an authorized user for medical uses authorized under WAC 246-240-201. The written certification must be signed by a preceptor authorized user who meets the requirements in WAC 246-240-210, 246-240-216, or equivalent agreement state or U.S. NRC requirements. A preceptor authorized user, who meets the requirements in WAC 246-240-210(2), must have experience in administering dosages as specified in WAC 246-240-210.

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     (1) As approved in the sealed source and device registry; or

     (2) In research in accordance with an active investigational device exemption (IDE) application accepted by the FDA provided the requirements of WAC 246-240-066 are met.

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     (2) Immediately after removing the last temporary implant source from a patient or a human research subject, the licensee shall make a survey of the patient or the human research subject with a radiation detection survey instrument to confirm that all sources have been removed.

     (3) A licensee shall retain a record of the surveys required by subsections (1) and (2) of this section in accordance with WAC 246-240-593.

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     (2) As soon as possible after removing sources from a patient or a human research subject, a licensee shall return brachytherapy sources to a secure storage area.

     (3) A licensee shall maintain a record of the brachytherapy source accountability in accordance with WAC 246-240-596.

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     (1) The licensee shall provide radiation safety instruction, initially and at least annually, to personnel caring for patients or human research subjects who are receiving brachytherapy and cannot be released under WAC 246-240-122. To satisfy this requirement, the instruction must be commensurate with the duties of the personnel and include the:

     (a) Size and appearance of the brachytherapy sources;

     (b) Safe handling and shielding instructions;

     (c) Patient or human research subject control;

     (d) Visitor control, including both:

     (i) Routine visitation of hospitalized individuals in accordance with WAC 246-221-060 (1)(a); and

     (ii) Visitation authorized in accordance with WAC 246-221-060(2); and

     (e) Notification of the radiation safety officer, or their designee, and an authorized user if the patient or the human research subject has a medical emergency or dies.

     (2) A licensee shall retain a record of individuals receiving instruction in accordance with WAC 246-240-590.

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     (a) Not quarter the patient or the human research subject in the same room as an individual who is not receiving brachytherapy;

     (b) Visibly post the patient's or human research subject's room with a "Caution -- Radioactive Materials" sign; and

     (c) Note on the door or in the patient's or human research subject's chart where and how long visitors may stay in the patient's or human research subject's room.

     (2) A licensee shall have applicable emergency response equipment available near each treatment room to respond to a source:

     (a) Dislodged from the patient; and

     (b) Lodged within the patient following removal of the source applicators.

     (3) A licensee shall notify the radiation safety officer, or their designee, and an authorized user as soon as possible if the patient or human research subject has a medical emergency or dies.

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     (a) Determined the source output or activity using a dosimetry system that meets the requirements of WAC 246-240-366(1);

     (b) Determined source positioning accuracy within applicators; and

     (c) Used published protocols currently accepted by nationally recognized bodies to meet the requirements of (a) and (b) of this subsection.

     (2) A licensee may use measurements provided by the source manufacturer or by a calibration laboratory accredited by the American Association of Physicists in Medicine that are made in accordance with subsection (1) of this section.

     (3) A licensee shall mathematically correct the outputs or activities determined in subsection (1) of this section for physical decay at intervals consistent with one percent physical decay.

     (4) A licensee shall retain a record of each calibration in accordance with WAC 246-240-599.

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     (2) A licensee shall retain a record of the activity of each strontium-90 source in accordance with WAC 246-240-602.

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     (1) The source-specific input parameters required by the dose calculation algorithm;

     (2) The accuracy of dose, dwell time, and treatment time calculations at representative points;

     (3) The accuracy of isodose plots and graphic displays; and

     (4) The accuracy of the software used to determine sealed source positions from radiographic images.

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     (1) Is certified by a medical specialty board whose certification process has been recognized by the department, the U.S. NRC, or an agreement state. (Specialty boards whose certification process has been recognized by the commission or an agreement state will be posted on the NRC's web page at http://www.nrc.gov.) To be recognized, a specialty board shall require all candidates for certification to:

     (a) Successfully complete a minimum of three years of residency training in a radiation oncology program approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or Royal College of Physicians and Surgeons of Canada or the Committee on Postgraduate Training of the American Osteopathic Association;

     (b) Pass an examination, administered by diplomates of the specialty board, which tests knowledge and competence in radiation safety, radionuclide handling, treatment planning, quality assurance, and clinical use of high and low dose-rate brachytherapy; and

     (c) Obtain written certification, signed by a preceptor authorized user who meets the requirements in WAC 246-240-278 or equivalent U.S. NRC or agreement state requirements, that the individual has achieved a level of competency sufficient to function independently as an authorized user of manual brachytherapy sources for the medical uses authorized in WAC 246-240-251; or

     (2)(a) Has completed a structured educational program in basic radionuclide handling techniques applicable to the use of manual brachytherapy sources that includes:

     (i) Two hundred hours of classroom and laboratory training in the following areas:

     (A) Radiation physics and instrumentation;

     (B) Radiation protection;

     (C) Mathematics pertaining to the use and measurement of radioactivity; and

     (D) Radiation biology; and

     (ii) Five hundred hours of work experience, under the supervision of an authorized user who meets the requirements in WAC 246-240-278 or equivalent agreement state or U.S. NRC requirements at a medical institution, involving:

     (A) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;

     (B) Checking survey meters for proper operation;

     (C) Preparing, implanting, and removing brachytherapy sources;

     (D) Maintaining running inventories of material on hand;

     (E) Using administrative controls to prevent a medical event involving the use of radioactive material;

     (F) Using emergency procedures to control radioactive material; and

     (b) Has completed three years of supervised clinical experience in radiation oncology, under an authorized user who meets the requirements in WAC 246-240-278 or equivalent U.S. NRC or agreement state requirements, as part of a formal training program approved by the Residency Review Committee for Radiation Oncology of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Committee on Postdoctoral Training of the American Osteopathic Association. This experience may be obtained concurrently with the supervised work experience required by (a)(ii) of this subsection; and

     (c) Has obtained written certification, signed by a preceptor authorized user who meets the requirements in WAC 246-240-278 or equivalent agreement state or U.S. NRC requirements, that the individual has satisfactorily completed the requirements in (a) and (b) of this subsection and has achieved a level of competency sufficient to function independently as an authorized user of manual brachytherapy sources for the medical uses authorized under WAC 246-240-251.

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     (1) Is an authorized user under WAC 246-240-278 or equivalent agreement state or U.S. NRC requirements; or

     (2)(a) Has completed twenty-four hours of classroom and laboratory training applicable to the medical use of strontium-90 for ophthalmic radiotherapy. The training must include:

     (i) Radiation physics and instrumentation;

     (ii) Radiation protection;

     (iii) Mathematics pertaining to the use and measurement of radioactivity; and

     (iv) Radiation biology; and

     (b) Supervised clinical training in ophthalmic radiotherapy under the supervision of an authorized user at a medical institution that includes the use of strontium-90 for the ophthalmic treatment of five individuals.

     This supervised clinical training must involve:

     (i) Examination of each individual to be treated;

     (ii) Calculation of the dose to be administered;

     (iii) Administration of the dose; and

     (iv) Follow up and review of each individual's case history; and

     (c) Has obtained written certification, signed by a preceptor authorized user who meets the requirements in WAC 246-240-278, 246-240-281, or equivalent agreement state or U.S. NRC requirements, that the individual has satisfactorily completed the requirements in subsections (1) and (2) of this section and has achieved a level of competency sufficient to function independently as an authorized user of strontium-90 for ophthalmic use.

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     (1) Is certified by a specialty board whose certification process includes all of the requirements in subsections (2) and (3) of this section and whose certification has been recognized by the Department, the U.S. NRC, or an agreement state. (Specialty boards whose certification process has been recognized by the commission or an agreement state will be posted on the NRC's web page at http://www.nrc.gov.); or

     (2) Has completed eight hours of classroom and laboratory training in basic radionuclide handling techniques specifically applicable to the use of the device. The training must include:

     (a) Radiation physics and instrumentation;

     (b) Radiation protection;

     (c) Mathematics pertaining to the use and measurement of radioactivity;

     (d) Radiation biology; and

     (3) Has completed training in the use of the device for the uses requested.

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     (1) As approved in the sealed source and device registry; or

     (2) In research in accordance with an active investigational device exemption (IDE) application accepted by the FDA provided the requirements of WAC 246-240-066(1) are met.

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     (2) A licensee shall retain a record of these surveys in accordance with WAC 246-240-593.

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     (2) Except for low dose-rate remote afterloader units, only a person specifically licensed by the department, the U.S. NRC, or an agreement state shall install, replace, relocate, or remove a sealed source or source contained in other remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units.

     (3) For a low dose-rate remote afterloader unit, only a person specifically licensed by the department, the U.S. NRC, or an agreement state or an authorized medical physicist shall install, replace, relocate, or remove a sealed source(s) contained in the unit.

     (4) A licensee shall retain a record of the installation, maintenance, adjustment, and repair of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units in accordance with WAC 246-240-605.

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     (a) Secure the unit, the console, the console keys, and the treatment room when not in use or unattended;

     (b) Permit only individuals approved by the authorized user, radiation safety officer, or authorized medical physicist to be present in the treatment room during treatment with the source(s);

     (c) Prevent dual operation of more than one radiation producing device in a treatment room if applicable; and

     (d) Develop, implement, and maintain written procedures for responding to an abnormal situation when the operator is unable to place the source(s) in the shielded position, or remove the patient or human research subject from the radiation field with controls from outside the treatment room. These procedures must include:

     (i) Instructions for responding to equipment failures and the names of the individuals responsible for implementing corrective actions;

     (ii) The process for restricting access to and posting of the treatment area to minimize the risk of inadvertent exposure; and

     (iii) The names and telephone numbers of the authorized users, the authorized medical physicist, and the radiation safety officer to be contacted if the unit or console operates abnormally.

     (2) A copy of the procedures required by subsection (1)(d) of this section must be physically located at the unit console.

     (3) A licensee shall post instructions at the unit console to inform the operator of:

     (a) The location of the procedures required by subsection (1)(d) of this section; and

     (b) The names and telephone numbers of the authorized users, the authorized medical physicist, and the radiation safety officer to be contacted if the unit or console operates abnormally.

     (4) A licensee shall provide instruction, initially and at least annually, to all individuals who operate the unit, as appropriate to the individual's assigned duties, in:

     (a) The procedures identified in subsection (1)(d) of this section; and

     (b) The operating procedures for the unit.

     (5) A licensee shall ensure that operators, authorized medical physicists, and authorized users participate in drills of the emergency procedures, initially and at least annually.

     (6) A licensee shall retain a record of individuals receiving instruction required by subsection (4) of this section, in accordance with WAC 246-240-590.

     (7) A licensee shall retain a copy of the procedures required by subsections (1)(d) and (4)(b) of this section in accordance with WAC 246-240-608.

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     (2) A licensee shall equip each entrance to the treatment room with an electrical interlock system that will:

     (a) Prevent the operator from initiating the treatment cycle unless each treatment room entrance door is closed;

     (b) Cause the source(s) to be shielded when an entrance door is opened; and

     (c) Prevent the source(s) from being exposed following an interlock interruption until all treatment room entrance doors are closed and the source(s) on-off control is reset at the console.

     (3) A licensee shall require any individual entering the treatment room to assure, through the use of appropriate radiation monitors, that radiation levels have returned to ambient levels.

     (4) Except for low-dose remote afterloader units, a licensee shall construct or equip each treatment room with viewing and intercom systems to permit continuous observation of the patient or the human research subject from the treatment console during irradiation.

     (5) For licensed activities where sources are placed within the patient's or human research subject's body, a licensee shall only conduct treatments which allow for expeditious removal of a decoupled or jammed source.

     (6) In addition to the requirements specified in subsections (1) through (5) of this section, a licensee shall:

     (a) For medium dose-rate and pulsed dose-rate remote afterloader units, require:

     (i) An authorized medical physicist and either an authorized user or a physician, under the supervision of an authorized user, who has been trained in the operation and emergency response for the unit to be physically present during the initiation of all patient treatments involving the unit; and

     (ii) An authorized medical physicist and either an authorized user or an individual, under the supervision of an authorized user, who has been trained to remove the source applicator(s) in the event of an emergency involving the unit, to be immediately available during continuation of all patient treatments involving the unit.

     (b) For high dose-rate remote afterloader units, require:

     (i) An authorized user and an authorized medical physicist to be physically present during the initiation of all patient treatments involving the unit; and

     (ii) An authorized medical physicist and either an authorized user or a physician, under the supervision of an authorized user, who has been trained in the operation and emergency response for the unit, to be physically present during continuation of all patient treatments involving the unit.

     (c) For gamma stereotactic radiosurgery units, require an authorized user and an authorized medical physicist to be physically present throughout all patient treatments involving the unit.

     (d) Notify the radiation safety officer, or their designee, and an authorized user as soon as possible if the patient or human research subject has a medical emergency or dies.

     (7) A licensee shall have applicable emergency response equipment available near each treatment room to respond to a source:

     (a) Remaining in the unshielded position; or

     (b) Lodged within the patient following completion of the treatment.

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     (a) The system must have been calibrated using a system or source traceable to the National Institute of Science and Technology (NIST) and published protocols accepted by nationally recognized bodies; or by a calibration laboratory accredited by the American Association of Physicists in Medicine (AAPM). The calibration must have been performed within the previous two years and after any servicing that may have affected system calibration; or

     (b) The system must have been calibrated within the previous four years. Eighteen to thirty months after that calibration, the system must have been intercompared with another dosimetry system that was calibrated within the past twenty-four months by NIST or by a calibration laboratory accredited by the AAPM. The results of the intercomparison must indicate that the calibration factor of the licensee's system had not changed by more than two percent. The licensee may not use the intercomparison result to change the calibration factor. When intercomparing dosimetry systems to be used for calibrating sealed sources for therapeutic units, the licensee shall use a comparable unit with beam attenuators or collimators, as applicable, and sources of the same radionuclide as the source used at the licensee's facility.

     (2) The licensee shall have a dosimetry system available for use for spot-check output measurements, if applicable. To satisfy this requirement, the system may be compared with a system that has been calibrated in accordance with subsection (1) of this section. This comparison must have been performed within the previous year and after each servicing that may have affected system calibration. The spot-check system may be the same system used to meet the requirement in subsection (1) of this section.

     (3) The licensee shall retain a record of each calibration, intercomparison, and comparison in accordance with WAC 246-240-611.

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     (a) Before the first medical use of the unit; and

     (b) Before medical use under the following conditions:

     (i) Whenever spot-check measurements indicate that the output differs by more than five percent from the output obtained at the last full calibration corrected mathematically for radioactive decay;

     (ii) Following replacement of the source or following reinstallation of the teletherapy unit in a new location;

     (iii) Following any repair of the teletherapy unit that includes removal of the source or major repair of the components associated with the source exposure assembly; and

     (c) At intervals not exceeding one year.

     (2) To satisfy the requirement of subsection (1) of this section, full calibration measurements must include determination of:

     (a) The output within ±3 percent for the range of field sizes and for the distance or range of distances used for medical use;

     (b) The coincidence of the radiation field and the field indicated by the light beam localizing device;

     (c) The uniformity of the radiation field and its dependence on the orientation of the useful beam;

     (d) Timer accuracy and linearity over the range of use;

     (e) On-off error; and

     (f) The accuracy of all distance measuring and localization devices in medical use.

     (3) A licensee shall use the dosimetry system described in WAC 246-240-366(1) to measure the output for one set of exposure conditions. The remaining radiation measurements required in subsection (2)(a) of this section may be made using a dosimetry system that indicates relative dose rates.

     (4) A licensee shall make full calibration measurements required by subsection (1) of this section in accordance with published protocols accepted by nationally recognized bodies.

     (5) A licensee shall mathematically correct the outputs determined in subsection (2)(a) of this section for physical decay for intervals not exceeding one month for cobalt-60, six months for cesium-137, or at intervals consistent with one percent decay for all other nuclides.

     (6) Full calibration measurements required by subsection (1) of this section and physical decay corrections required by subsection (5) of this section must be performed by the authorized medical physicist.

     (7) A licensee shall retain a record of each calibration in accordance with WAC 246-240-614.

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     (a) Before the first medical use of the unit;

     (b) Before medical use under the following conditions:

     (i) Following replacement of the source or following reinstallation of the unit in a new location outside the facility; and

     (ii) Following any repair of the unit that includes removal of the source or major repair of the components associated with the source exposure assembly; and

     (c) At intervals not exceeding one calendar quarter for high dose-rate, medium dose-rate, and pulsed dose-rate remote afterloader units with sources whose half-life exceeds seventy-five days; and

     (d) At intervals not exceeding one year for low dose-rate remote afterloader units.

     (2) To satisfy the requirement of subsection (1) of this section, full calibration measurements must include, as applicable, determination of:

     (a) The output within ±5 percent;

     (b) Source positioning accuracy to within ±1 millimeter;

     (c) Source retraction with backup battery upon power failure;

     (d) Length of the source transfer tubes;

     (e) Timer accuracy and linearity over the typical range of use;

     (f) Length of the applicators; and

     (g) Function of the source transfer tubes, applicators, and transfer tube-applicator interfaces.

     (3) A licensee shall use the dosimetry system described in WAC 246-240-366(1) to measure the output.

     (4) A licensee shall make full calibration measurements required by subsection (1) of this section in accordance with published protocols accepted by nationally recognized bodies.

     (5) In addition to the requirements for full calibrations for low dose-rate remote afterloader units in subsection (2) of this section, a licensee shall perform an autoradiograph of the source(s) to verify inventory and source(s) arrangement at intervals not exceeding one calendar quarter.

     (6) For low dose-rate remote afterloader units, a licensee may use measurements provided by the source manufacturer that are made in accordance with subsections (1) through (5) of this section.

     (7) A licensee shall mathematically correct the outputs determined in subsection (2)(a) of this section for physical decay at intervals consistent with one percent physical decay.

     (8) Full calibration measurements required by subsection (1) of this section and physical decay corrections required by subsection (7) of this section must be performed by the authorized medical physicist.

     (9) A licensee shall retain a record of each calibration in accordance with WAC 246-240-614.

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     (a) Before the first medical use of the unit;

     (b) Before medical use under the following conditions:

     (i) Whenever spot-check measurements indicate that the output differs by more than five percent from the output obtained at the last full calibration corrected mathematically for radioactive decay;

     (ii) Following replacement of the sources or following reinstallation of the gamma stereotactic radiosurgery unit in a new location; and

     (iii) Following any repair of the gamma stereotactic radiosurgery unit that includes removal of the sources or major repair of the components associated with the source assembly; and

     (c) At intervals not exceeding one year, with the exception that relative helmet factors need only be determined before the first medical use of a helmet and following any damage to a helmet.

     (2) To satisfy the requirement of subsection (1) of this section, full calibration measurements must include determination of:

     (a) The output within ±3 percent;

     (b) Relative helmet factors;

     (c) Isocenter coincidence;

     (d) Timer accuracy and linearity over the range of use;

     (e) On-off error;

     (f) Trunnion centricity;

     (g) Treatment table retraction mechanism, using backup battery power or hydraulic backups with the unit off;

     (h) Helmet microswitches;

     (i) Emergency timing circuits; and

     (j) Stereotactic frames and localizing devices (trunnions).

     (3) A licensee shall use the dosimetry system described in WAC 246-240-366(1) to measure the output for one set of exposure conditions. The remaining radiation measurements required in subsection (2)(a) of this section may be made using a dosimetry system that indicates relative dose rates.

     (4) A licensee shall make full calibration measurements required by subsection (1) of this section in accordance with published protocols accepted by nationally recognized bodies.

     (5) A licensee shall mathematically correct the outputs determined in subsection (2)(a) of this section at intervals not exceeding one month for cobalt-60 and at intervals consistent with one percent physical decay for all other radionuclides.

     (6) Full calibration measurements required by subsection (1) of this section and physical decay corrections required by subsection (5) of this section must be performed by the authorized medical physicist.

     (7) A licensee shall retain a record of each calibration in accordance with WAC 246-240-614.

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     (a) Timer accuracy, and timer linearity over the range of use;

     (b) On-off error;

     (c) The coincidence of the radiation field and the field indicated by the light beam localizing device;

     (d) The accuracy of all distance measuring and localization devices used for medical use;

     (e) The output for one typical set of operating conditions measured with the dosimetry system described in WAC 246-240-366(2); and

     (f) The difference between the measurement made in (e) of this subsection and the anticipated output, expressed as a percentage of the anticipated output (i.e., the value obtained at last full calibration corrected mathematically for physical decay).

     (2) A licensee shall perform measurements required by subsection (1) of this section in accordance with written procedures established by the authorized medical physicist. That individual need not actually perform the spot-check measurements.

     (3) A licensee shall have the authorized medical physicist review the results of each spot-check within fifteen days. The authorized medical physicist shall notify the licensee as soon as possible in writing of the results of each spot-check.

     (4) A licensee authorized to use a teletherapy unit for medical use shall perform safety spot-checks of each teletherapy facility once in each calendar month and after each source installation to assure proper operation of:

     (a) Electrical interlocks at each teletherapy room entrance;

     (b) Electrical or mechanical stops installed for the purpose of limiting use of the primary beam of radiation (restriction of source housing angulation or elevation, carriage or stand travel and operation of the beam on-off mechanism);

     (c) Source exposure indicator lights on the teletherapy unit, on the control console, and in the facility;

     (d) Viewing and intercom systems;

     (e) Treatment room doors from inside and outside the treatment room; and

     (f) Electrically assisted treatment room doors with the teletherapy unit electrical power turned off.

     (5) If the results of the checks required in subsection (4) of this section indicate the malfunction of any system, a licensee shall lock the control console in the off position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system.

     (6) A licensee shall retain a record of each spot-check required by subsections (1) and (4) of this section, and a copy of the procedures required by subsection (2) of this section, in accordance with WAC 246-240-617.

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     (a) Before the first use of a high dose-rate, medium dose-rate, or pulsed dose-rate remote afterloader unit on a given day;

     (b) Before each patient treatment with a low dose-rate remote afterloader unit; and

     (c) After each source installation.

     (2) A licensee shall perform the measurements required by subsection (1) of this section in accordance with written procedures established by the authorized medical physicist. That individual need not actually perform the spot check measurements.

     (3) A licensee shall have the authorized medical physicist review the results of each spot-check within fifteen days. The authorized medical physicist shall notify the licensee as soon as possible in writing of the results of each spot-check.

     (4) To satisfy the requirements of subsection (1) of this section, spot-checks must, at a minimum, assure proper operation of:

     (a) Electrical interlocks at each remote afterloader unit room entrance;

     (b) Source exposure indicator lights on the remote afterloader unit, on the control console, and in the facility;

     (c) Viewing and intercom systems in each high dose-rate, medium dose-rate, and pulsed dose-rate remote afterloader facility;

     (d) Emergency response equipment;

     (e) Radiation monitors used to indicate the source position;

     (f) Timer accuracy;

     (g) Clock (date and time) in the unit's computer; and

     (h) Decayed source(s) activity in the unit's computer.

     (5) If the results of the checks required in subsection (4) of this section indicate the malfunction of any system, a licensee shall lock the control console in the off position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system.

     (6) A licensee shall retain a record of each check required by subsection (4) of this section and a copy of the procedures required by subsection (2) of this section in accordance with WAC 246-240-620.

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     (a) Monthly;

     (b) Before the first use of the unit on a given day; and

     (c) After each source installation.

     (2) A licensee shall:

     (a) Perform the measurements required by subsection (1) of this section in accordance with written procedures established by the authorized medical physicist. That individual need not actually perform the spot check measurements.

     (b) Have the authorized medical physicist review the results of each spot-check within fifteen days. The authorized medical physicist shall notify the licensee as soon as possible in writing of the results of each spot-check.

     (3) To satisfy the requirements of subsection (1)(a) of this section, spot-checks must, at a minimum:

     (a) Assure proper operation of:

     (i) Treatment table retraction mechanism, using backup battery power or hydraulic backups with the unit off;

     (ii) Helmet microswitches;

     (iii) Emergency timing circuits; and

     (iv) Stereotactic frames and localizing devices (trunnions).      (b) Determine:

     (i) The output for one typical set of operating conditions measured with the dosimetry system described in WAC 246-240-366(2);

     (ii) The difference between the measurement made in (b)(i) of this subsection and the anticipated output, expressed as a percentage of the anticipated output (i.e., the value obtained at last full calibration corrected mathematically for physical decay);

     (iii) Source output against computer calculation;

     (iv) Timer accuracy and linearity over the range of use;

     (v) On-off error; and

     (vi) Trunnion centricity.

     (4) To satisfy the requirements of subsection (1)(b) and (c) of this section, spot-checks must assure proper operation of:

     (a) Electrical interlocks at each gamma stereotactic radiosurgery room entrance;

     (b) Source exposure indicator lights on the gamma stereotactic radiosurgery unit, on the control console, and in the facility;

     (c) Viewing and intercom systems;

     (d) Timer termination;

     (e) Radiation monitors used to indicate room exposures; and

     (f) Emergency off buttons.

     (5) A licensee shall arrange for the repair of any system identified in subsection (3) of this section that is not operating properly as soon as possible.

     (6) If the results of the checks required in subsection (4) of this section indicate the malfunction of any system, a licensee shall lock the control console in the off position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system.

     (7) A licensee shall retain a record of each check required by subsections (3) and (4) of this section and a copy of the procedures required by subsection (2) of this section in accordance with WAC 246-240-623.

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     (a) Check survey instruments before medical use at each address of use or on each day of use, whichever is more frequent; and

     (b) Account for all sources before departure from a client's address of use.

     (2) In addition to the periodic spot-checks required by WAC 246-240-381, a licensee authorized to use mobile afterloaders for medical use shall perform checks on each remote afterloader unit before use at each address of use. At a minimum, checks must be made to verify the operation of:

     (a) Electrical interlocks on treatment area access points;

     (b) Source exposure indicator lights on the remote afterloader unit, on the control console, and in the facility;

     (c) Viewing and intercom systems;

     (d) Applicators, source transfer tubes, and transfer tube-applicator interfaces;

     (e) Radiation monitors used to indicate room exposures;

     (f) Source positioning (accuracy); and

     (g) Radiation monitors used to indicate whether the source has returned to a safe shielded position.

     (3) In addition to the requirements for checks in subsection (2) of this section, a licensee shall ensure overall proper operation of the remote afterloader unit by conducting a simulated cycle of treatment before use at each address of use.

     (4) If the results of the checks required in subsection (2) of this section indicate the malfunction of any system, a licensee shall lock the control console in the off position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system.

     (5) A licensee shall retain a record of each check required by subsection (2) of this section in accordance with WAC 246-240-626.

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     (2) The licensee shall make the survey required by subsection (1) of this section at installation of a new source and following repairs to the source(s) shielding, the source(s) driving unit, or other electronic or mechanical component that could expose the source, reduce the shielding around the source(s), or compromise the radiation safety of the unit or the source(s).

     (3) A licensee shall retain a record of the radiation surveys required by subsection (1) of this section in accordance with WAC 246-240-629.

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     (2) This inspection and servicing may only be performed by persons specifically licensed to do so by the department, the U.S. NRC or an agreement state.

     (3) A licensee shall keep a record of the inspection and servicing in accordance with WAC 246-240-632.

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     (1) The source-specific input parameters required by the dose calculation algorithm;

     (2) The accuracy of dose, dwell time, and treatment time calculations at representative points;

     (3) The accuracy of isodose plots and graphic displays;

     (4) The accuracy of the software used to determine sealed source positions from radiographic images; and

     (5) The accuracy of electronic transfer of the treatment delivery parameters to the treatment delivery unit from the treatment planning system.

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     (1) Is certified by a medical specialty board whose certification process has been recognized by the department, the U.S. NRC, or an agreement state. (Specialty boards whose certification process has been recognized by the commission or an agreement state will be posted on the NRC's web page at http://www.nrc.gov.) To be recognized, a specialty board shall require all candidates for certification to:

     (a) Successfully complete a minimum of three years of residency training in a radiation therapy program approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or Royal College of Physicians and Surgeons of Canada or the Committee on Postgraduate Training of the American Osteopathic Association; and

     (b) Pass an examination, administered by diplomates of the specialty board, which tests knowledge and competence in radiation safety, radionuclide handling, treatment planning, quality assurance, and clinical use of stereotactic radiosurgery, high and low dose-rate brachytherapy, and external beam therapy;

     (2)(a) Has completed a structured educational program in basic radionuclide techniques applicable to the use of a sealed source in a therapeutic medical unit that includes:

     (i) Two hundred hours of classroom and laboratory training in the following areas:

     (A) Radiation physics and instrumentation;

     (B) Radiation protection;

     (C) Mathematics pertaining to the use and measurement of radioactivity; and

     (D) Radiation biology; and

     (ii) Five hundred hours of work experience, under the supervision of an authorized user who meets the requirements in WAC 246-240-399 or equivalent agreement state or U.S. NRC requirements at a medical institution, involving:

     (A) Reviewing full calibration measurements and periodic spot-checks;

     (B) Preparing treatment plans and calculating treatment doses and times;

     (C) Using administrative controls to prevent a medical event involving the use of radioactive material;

     (D) Implementing emergency procedures to be followed in the event of the abnormal operation of the medical unit or console;

     (E) Checking and using survey meters; and

     (F) Selecting the proper dose and how it is to be administered; and

     (b) Has completed three years of supervised clinical experience in radiation therapy, under an authorized user who meets the requirements in WAC 246-240-399 or equivalent U.S. NRC or agreement state requirements, as part of a formal training program approved by the Residency Review Committee for Radiation Oncology of the Accreditation Council for Graduate Medical Education or Royal College of Physicians and Surgeons of Canada or the Committee on Postdoctoral Training of the American Osteopathic Association. This experience may be obtained concurrently with the supervised work experience required by (a)(ii) of this subsection; and

     (c) Has obtained written certification that the individual has satisfactorily completed the requirements in (a) and (b) of this subsection and has achieved a level of competency sufficient to function independently as an authorized user of each type of therapeutic medical unit for which the individual is requesting authorized user status. The written certification must be signed by a preceptor authorized user who meets the requirements in WAC 246-240-399 or equivalent U.S. NRC or agreement state requirements for an authorized user for each type of therapeutic medical unit for which the individual is requesting authorized user status; and

     (d) Has received training in device operation, safety procedures, and clinical use for the type(s) of use for which authorization is sought. This training requirement may be satisfied by satisfactory completion of a training program provided by the vendor for new users or by receiving training supervised by an authorized user or authorized medical physicist, as appropriate, who is authorized for the type(s) of use for which the individual is seeking authorization.

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     (1) Is certified by the:

     (a) American Board of Health Physics in Comprehensive Health Physics; or

     (b) American Board of Radiology; or

     (c) American Board of Nuclear Medicine; or

     (d) American Board of Science in Nuclear Medicine; or

     (e) Board of Pharmaceutical Specialties in Nuclear Pharmacy; or

     (f) American Board of Medical Physics in radiation oncology physics; or

     (g) Royal College of Physicians and Surgeons of Canada in nuclear medicine; or

     (h) American Osteopathic Board of Radiology; or

     (i) American Osteopathic Board of Nuclear Medicine; or

     (2) Has had classroom and laboratory training and experience as follows:

     (a) Two hundred hours of classroom and laboratory training that includes:

     (i) Radiation physics and instrumentation;

     (ii) Radiation protection;

     (iii) Mathematics pertaining to the use and measurement of radioactivity;

     (iv) Radiation biology; and

     (v) Radiopharmaceutical chemistry; and

     (b) One year of full-time experience as a radiation safety technologist at a medical institution under the supervision of the individual identified as the radiation safety officer on an agreement state or U.S. Nuclear Regulatory Commission license that authorizes the medical use of radioactive material; or

     (3) Is an authorized user identified on the licensee's license.

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     (1) Is certified in:

     (a) Nuclear medicine by the American Board of Nuclear Medicine; or

     (b) Diagnostic radiology by the American Board of Radiology; or

     (c) Diagnostic radiology or radiology by the American Osteopathic Board of Radiology; or

     (d) Nuclear medicine by the Royal College of Physicians and Surgeons of Canada; or

     (e) American Osteopathic Board of Nuclear Medicine in nuclear medicine; or

     (2) Has had classroom and laboratory training in basic radioisotope handling techniques applicable to the use of prepared radiopharmaceuticals, and supervised clinical experience as follows:

     (a) Forty hours of classroom and laboratory training that includes:

     (i) Radiation physics and instrumentation;

     (ii) Radiation protection;

     (iii) Mathematics pertaining to the use and measurement of radioactivity;

     (iv) Radiation biology; and

     (v) Radiopharmaceutical chemistry; and

     (b) Twenty hours of supervised clinical experience under the supervision of an authorized user and that includes:

     (i) Examining patients or human research subjects and reviewing their case histories to determine their suitability for radioisotope diagnosis, limitations, or contraindications;

     (ii) Selecting the suitable radiopharmaceuticals and calculating and measuring the dosages;

     (iii) Administering dosages to patients or human research subjects and using syringe radiation shields;

     (iv) Collaborating with the authorized user in the interpretation of radioisotope test results; and

     (v) Patient or human research subject follow up; or

     (3) Has successfully completed a six-month training program in nuclear medicine as part of a training program that has been approved by the Accreditation Council for Graduate Medical Education and that included classroom and laboratory training, work experience, and supervised clinical experience in all the topics identified in subsection (2) of this section.

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     (1) Is certified in:

     (a) Nuclear medicine by the American Board of Nuclear Medicine; or

     (b) Diagnostic radiology by the American Board of Radiology; or

     (c) Diagnostic radiology or radiology by the American Osteopathic Board of Radiology; or

     (d) Nuclear medicine by the Royal College of Physicians and Surgeons of Canada; or

     (e) American Osteopathic Board of Nuclear Medicine in nuclear medicine; or

     (2) Has had classroom and laboratory training in basic radioisotope handling techniques applicable to the use of prepared radiopharmaceuticals, generators, and reagent kits, supervised work experience, and supervised clinical experience as follows:

     (a) Two hundred hours of classroom and laboratory training that includes:

     (i) Radiation physics and instrumentation;

     (ii) Radiation protection;

     (iii) Mathematics pertaining to the use and measurement of radioactivity;

     (iv) Radiopharmaceutical chemistry; and

     (v) Radiation biology; and

     (b) Five hundred hours of supervised work experience under the supervision of an authorized user that includes:

     (i) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;

     (ii) Calibrating dose calibrators and diagnostic instruments and performing checks for proper operation of survey meters;

     (iii) Calculating and safely preparing patient or human research subject dosages;

     (iv) Using administrative controls to prevent the medical event of radioactive material;

     (v) Using procedures to contain spilled radioactive material safely and using proper decontamination procedures; and

     (vi) Eluting technetium-99m from generator systems, measuring and testing the eluate for molybdenum-99 and alumina contamination, and processing the eluate with reagent kits to prepare technetium-99m labeled radiopharmaceuticals; and

     (c) Five hundred hours of supervised clinical experience under the supervision of an authorized user that includes:

     (i) Examining patients or human research subjects and reviewing their case histories to determine their suitability for radioisotope diagnosis, limitations, or contraindications;

     (ii) Selecting the suitable radiopharmaceuticals and calculating and measuring the dosages;

     (iii) Administering dosages to patients or human research subjects and using syringe radiation shields;

     (iv) Collaborating with the authorized user in the interpretation of radioisotope test results; and

     (v) Patient or human research subject follow up; or

     (3) Has successfully completed a six-month training program in nuclear medicine that has been approved by the Accreditation Council for Graduate Medical Education and that included classroom and laboratory training, work experience, and supervised clinical experience in all the topics identified in subsection (2) of this section.

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     (1) Is certified by:

     (a) The American Board of Nuclear Medicine; or

     (b) The American Board of Radiology in radiology, therapeutic radiology, or radiation oncology; or

     (c) The Royal College of Physicians and Surgeons of Canada in nuclear medicine; or

     (d) The American Osteopathic Board of Radiology after 1984; or

     (2) Has had classroom and laboratory training in basic radioisotope handling techniques applicable to the use of therapeutic radiopharmaceuticals, and supervised clinical experience as follows:

     (a) Eighty hours of classroom and laboratory training that includes:

     (i) Radiation physics and instrumentation;

     (ii) Radiation protection;

     (iii) Mathematics pertaining to the use and measurement of radioactivity; and

     (iv) Radiation biology; and

     (b) Supervised clinical experience under the supervision of an authorized user at a medical institution that includes:

     (i) Use of iodine-131 for diagnosis of thyroid function and the treatment of hyperthyroidism or cardiac dysfunction in ten individuals; and

     (ii) Use of iodine-131 for treatment of thyroid carcinoma in three individuals.

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     (1) Eighty hours of classroom and laboratory training that includes:

     (a) Radiation physics and instrumentation;

     (b) Radiation protection;

     (c) Mathematics pertaining to the use and measurement of radioactivity; and

     (d) Radiation biology; and

     (2) Supervised clinical experience under the supervision of an authorized user that includes the use of iodine-131 for diagnosis of thyroid function, and the treatment of hyperthyroidism in ten individuals.

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     (1) Eighty hours of classroom and laboratory training that includes:

     (a) Radiation physics and instrumentation;

     (b) Radiation protection;

     (c) Mathematics pertaining to the use and measurement of radioactivity; and

     (d) Radiation biology; and

     (2) Supervised clinical experience under the supervision of an authorized user that includes the use of iodine-131 for the treatment of thyroid carcinoma in three individuals.

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     (1) Is certified in:

     (a) Radiology, therapeutic radiology, or radiation oncology by the American Board of Radiology; or

     (b) Radiation oncology by the American Osteopathic Board of Radiology; or

     (c) Radiology, with specialization in radiotherapy, as a British "Fellow of the Faculty of Radiology" or "Fellow of the Royal College of Radiology"; or

     (d) Therapeutic radiology by the Canadian Royal College of Physicians and Surgeons; or

     (2) Is in the active practice of therapeutic radiology, has had classroom and laboratory training in radioisotope handling techniques applicable to the therapeutic use of brachytherapy sources, supervised work experience, and supervised clinical experience as follows:

     (a) Two hundred hours of classroom and laboratory training that includes:

     (i) Radiation physics and instrumentation;

     (ii) Radiation protection;

     (iii) Mathematics pertaining to the use and measurement of radioactivity; and

     (iv) Radiation biology;

     (b) Five hundred hours of supervised work experience under the supervision of an authorized user at a medical institution that includes:

     (i) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;

     (ii) Checking survey meters for proper operation;

     (iii) Preparing, implanting, and removing sealed sources;

     (iv) Maintaining running inventories of material on hand;

     (v) Using administrative controls to prevent a medical event involving radioactive material; and

     (vi) Using emergency procedures to control radioactive material; and

     (c) Three years of supervised clinical experience that includes one year in a formal training program approved by the Residency Review Committee for Radiology of the Accreditation Council for Graduate Medical Education or the Committee on Postdoctoral Training of the American Osteopathic Association, and an additional two years of clinical experience in therapeutic radiology under the supervision of an authorized user at a medical institution that includes:

     (i) Examining individuals and reviewing their case histories to determine their suitability for brachytherapy treatment, and any limitations or contraindications;

     (ii) Selecting the proper brachytherapy sources and dose and method of administration;

     (iii) Calculating the dose; and

     (iv) Post-administration follow up and review of case histories in collaboration with the authorized user.

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     (1) Twenty-four hours of classroom and laboratory training that includes:

     (a) Radiation physics and instrumentation;

     (b) Radiation protection;

     (c) Mathematics pertaining to the use and measurement of radioactivity; and

     (d) Radiation biology;

     (2) Supervised clinical training in ophthalmic radiotherapy under the supervision of an authorized user at a medical institution that includes the use of strontium-90 for the ophthalmic treatment of five individuals that includes:

     (a) Examination of each individual to be treated;

     (b) Calculation of the dose to be administered;

     (c) Administration of the dose; and

     (d) Follow up and review of each individual's case history.

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     (1) Is certified in:

     (a) Radiology, diagnostic radiology, therapeutic radiology, or radiation oncology by the American Board of Radiology;

     (b) Nuclear medicine by the American Board of Nuclear Medicine;

     (c) Diagnostic radiology or radiology by the American Osteopathic Board of Radiology; or

     (d) Nuclear medicine by the Royal College of Physicians and Surgeons of Canada; or

     (2) Has had eight hours of classroom and laboratory training in basic radioisotope handling techniques specifically applicable to the use of the device that includes:

     (a) Radiation physics, mathematics pertaining to the use and measurement of radioactivity, and instrumentation;

     (b) Radiation biology;

     (c) Radiation protection; and

     (d) Training in the use of the device for the uses requested.

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     (1) Is certified in:

     (a) Radiology, therapeutic radiology, or radiation oncology by the American Board of Radiology; or

     (b) Radiation oncology by the American Osteopathic Board of Radiology; or

     (c) Radiology, with specialization in radiotherapy, as a British "Fellow of the Faculty of Radiology" or "Fellow of the Royal College of Radiology"; or

     (d) Therapeutic radiology by the Canadian Royal College of Physicians and Surgeons; or

     (2) Is in the active practice of therapeutic radiology, and has had classroom and laboratory training in basic radioisotope techniques applicable to the use of a sealed source in a therapeutic medical device, supervised work experience, and supervised clinical experience as follows:

     (a) Two hundred hours of classroom and laboratory training that includes:

     (i) Radiation physics and instrumentation;

     (ii) Radiation protection;

     (iii) Mathematics pertaining to the use and measurement of radioactivity; and

     (iv) Radiation biology;

     (b) Five hundred hours of supervised work experience under the supervision of an authorized user at a medical institution that includes:

     (i) Review of the full calibration measurements and periodic spot-checks;

     (ii) Preparing treatment plans and calculating treatment times;

     (iii) Using administrative controls to prevent medical events;

     (iv) Implementing emergency procedures to be followed in the event of the abnormal operation of the medical device or console; and

     (v) Checking and using survey meters; and

     (c) Three years of supervised clinical experience that includes one year in a formal training program approved by the Residency Review Committee for Radiology of the Accreditation Council for Graduate Medical Education or the Committee on Postdoctoral Training of the American Osteopathic Association and an additional two years of clinical experience in therapeutic radiology under the supervision of an authorized user at a medical institution that includes:

     (i) Examining individuals and reviewing their case histories to determine their suitability for teletherapy, remote afterloader, or gamma stereotactic radiosurgery treatment, and any limitations or contraindications;

     (ii) Selecting the proper dose and how it is to be administered;

     (iii) Calculating the doses and collaborating with the authorized user in the review of patients' or human research subjects' progress and consideration of the need to modify originally prescribed doses as warranted by patients' or human research subjects' reaction to radiation; and

     (iv) Post-administration follow up and review of case histories.

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     (1) Is certified by the American Board of Radiology in:

     (a) Therapeutic radiological physics; or

     (b) Roentgen ray and gamma ray physics; or

     (c) X-ray and radium physics; or

     (d) Radiological physics; or

     (2) Is certified by the American Board of Medical Physics in radiation oncology physics; or

     (3) Holds a master's or doctor's degree in physics, biophysics, radiological physics, or health physics, and has completed one year of full-time training in therapeutic radiological physics and an additional year of full-time work experience under the supervision of a medical physicist at a medical institution that includes the tasks listed in WAC 246-240-113, 246-240-369, 246-240-372, 246-240-375, 246-240-378, 246-240-381, 246-240-384, and 246-240-390, as applicable.

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     (1) Has current board certification as a nuclear pharmacist by the Board of Pharmaceutical Specialties; or

     (2)(a) Has completed seven hundred hours in a structured educational program consisting of both:

     (i) Didactic training in the following areas:

     (A) Radiation physics and instrumentation;

     (B) Radiation protection;

     (C) Mathematics pertaining to the use and measurement of radioactivity;

     (D) Chemistry of radioactive material for medical use; and

     (E) Radiation biology; and

     (ii) Supervised experience in a nuclear pharmacy involving the following:

     (A) Shipping, receiving, and performing related radiation surveys;

     (B) Using and performing checks for proper operation of dose calibrators, survey meters, and, if appropriate, instruments used to measure alpha- or beta-emitting radionuclides;

     (C) Calculating, assaying, and safely preparing dosages for patients or human research subjects;

     (D) Using administrative controls to avoid mistakes in the administration of radioactive material;

     (E) Using procedures to prevent or minimize contamination and using proper decontamination procedures; and

     (b) Has obtained written certification, signed by a preceptor authorized nuclear pharmacist, that the above training has been satisfactorily completed and that the individual has achieved a level of competency sufficient to independently operate a nuclear pharmacy.

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     (1) The applicant or licensee has submitted the information required by WAC 246-240-019; and

     (2) The applicant or licensee has received written approval from the department in a license or license amendment and uses the material in accordance with the regulations and specific conditions the department considers necessary for the medical use of the material.

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     (2) The licensee shall retain a copy of both authority, duties, and responsibilities of the radiation safety officer as required by WAC 246-240-051(5), and a signed copy of each radiation safety officer's agreement to be responsible for implementing the radiation safety program, as required by WAC 246-240-051(2), for the duration of the license. The records must include the signature of the radiation safety officer and licensee management.

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     (2) The record must contain:

     (a) The radiopharmaceutical;

     (b) The patient's or human research subject's name, or identification number if one has been assigned;

     (c) The prescribed dosage, the determined dosage, or a notation that the total activity is less than 1.1 MBq (30 µCi);

     (d) The date and time of the dosage determination; and

     (e) The name of the individual who determined the dosage.

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     (2) A licensee shall retain records of the semiannual physical inventory of sealed sources and brachytherapy sources required by WAC 246-240-113 for three years. The inventory records must contain the model number of each source, and serial number if one has been assigned, the identity of each source by radionuclide and its nominal activity, the location of each source, and the name of the individual who performed the inventory.

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     (a) Using the retained activity rather than the activity administered;

     (b) Using an occupancy factor less than 0.25 at 1 meter;

     (c) Using the biological or effective half-life; or

     (d) Considering the shielding by tissue.

     (2) A licensee shall retain a record that the instructions required by WAC 246-240-122(2) were provided to a breast-feeding female if the radiation dose to the infant or child from continued breast-feeding could result in a total effective dose equivalent exceeding 5 mSv (0.5 rem).

     (3) The records required by subsections (1) and (2) of this section must be retained for three years after the date of release of the individual.

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     (2) A licensee shall retain the record of each survey required by WAC 246-240-125 (1)(d) for three years. The record must include the date of the survey, the results of the survey, the instrument used to make the survey, and the name of the individual who performed the survey.

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     (2) For temporary implants, the record must include:

     (a) The number and activity of sources removed from storage, the time and date they were removed from storage, the name of the individual who removed them from storage, and the location of use; and

     (b) The number and activity of sources returned to storage, the time and date they were returned to storage, and the name of the individual who returned them to storage.

     (3) For permanent implants, the record must include:

     (a) The number and activity of sources removed from storage, the date they were removed from storage, and the name of the individual who removed them from storage;

     (b) The number and activity of sources not implanted, the date they were returned to storage, and the name of the individual who returned them to storage; and

     (c) The number and activity of sources permanently implanted in the patient or human research subject.

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     (2) The record must include:

     (a) The date of the calibration;

     (b) The manufacturer's name, model number, and serial number for the source and the instruments used to calibrate the source;

     (c) The source output or activity;

     (d) The source positioning accuracy within the applicators; and

     (e) The name of the individual, the source manufacturer, or the calibration laboratory that performed the calibration.

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     (2) The record must include:

     (a) The date and initial activity of the source as determined under WAC 246-240-269; and

     (b) For each decay calculation, the date and the source activity as determined under WAC 246-240-272.

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     (2) For each calibration, intercomparison, or comparison, the record must include:

     (a) The date;

     (b) The manufacturer's name, model numbers and serial numbers of the instruments that were calibrated, intercompared, or compared as required by WAC 246-240-366;

     (c) The correction factor that was determined from the calibration or comparison or the apparent correction factor that was determined from an intercomparison; and

     (d) The names of the individuals who performed the calibration, intercomparison, or comparison.

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     (2) The record must include:

     (a) The date of the calibration;

     (b) The manufacturer's name, model number, and serial number of the teletherapy, remote afterloader, and gamma stereotactic radiosurgery unit(s), the source(s), and the instruments used to calibrate the unit(s);

     (c) The results and an assessment of the full calibrations;

     (d) The results of the autoradiograph required for low dose-rate remote afterloader units; and

     (e) The signature of the authorized medical physicist who performed the full calibration.

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     (2) The record must include:

     (a) The date of the spot-check;

     (b) The manufacturer's name, model number, and serial number of the teletherapy unit, source and instrument used to measure the output of the teletherapy unit;

     (c) An assessment of timer linearity and constancy;

     (d) The calculated on-off error;

     (e) A determination of the coincidence of the radiation field and the field indicated by the light beam localizing device;

     (f) The determined accuracy of each distance measuring and localization device;

     (g) The difference between the anticipated output and the measured output;

     (h) Notations indicating the operability of each entrance door electrical interlock, each electrical or mechanical stop, each source exposure indicator light, and the viewing and intercom system and doors; and

     (i) The name of the individual who performed the periodic spot-check and the signature of the authorized medical physicist who reviewed the record of the spot-check.

     (3) A licensee shall retain a copy of the procedures required by WAC 246-240-378(2) until the licensee no longer possesses the teletherapy unit.

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     (2) The record must include, as applicable:

     (a) The date of the spot-check;

     (b) The manufacturer's name, model number, and serial number for the remote afterloader unit and source;

     (c) An assessment of timer accuracy;

     (d) Notations indicating the operability of each entrance door electrical interlock, radiation monitors, source exposure indicator lights, viewing and intercom systems, and clock and decayed source activity in the unit's computer; and

     (e) The name of the individual who performed the periodic spot-check and the signature of the authorized medical physicist who reviewed the record of the spot-check.

     (3) A licensee shall retain a copy of the procedures required by WAC 246-240-381(2) until the licensee no longer possesses the remote afterloader unit.

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     (2) The record must include:

     (a) The date of the spot-check;

     (b) The manufacturer's name, model number, and serial number for the gamma stereotactic radiosurgery unit and the instrument used to measure the output of the unit;

     (c) An assessment of timer linearity and accuracy;

     (d) The calculated on-off error;

     (e) A determination of trunnion centricity;

     (f) The difference between the anticipated output and the measured output;

     (g) An assessment of source output against computer calculations;

     (h) Notations indicating the operability of radiation monitors, helmet microswitches, emergency timing circuits, emergency off buttons, electrical interlocks, source exposure indicator lights, viewing and intercom systems, timer termination, treatment table retraction mechanism, and stereotactic frames and localizing devices (trunnions); and

     (i) The name of the individual who performed the periodic spot-check and the signature of the authorized medical physicist who reviewed the record of the spot-check.

     (3) A licensee shall retain a copy of the procedures required by WAC 246-240-384(2) until the licensee no longer possesses the gamma stereotactic radiosurgery unit.

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     (2) The record must include:

     (a) The date of the check;

     (b) The manufacturer's name, model number, and serial number of the remote afterloader unit;

     (c) Notations accounting for all sources before the licensee departs from a facility;

     (d) Notations indicating the operability of each entrance door electrical interlock, radiation monitors, source exposure indicator lights, viewing and intercom system, applicators, source transfer tubes, and transfer tube applicator interfaces, and source positioning accuracy; and

     (e) The signature of the individual who performed the check.

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     (2) The record must include:

     (a) The date of the measurements;

     (b) The manufacturer's name, model number and serial number of the treatment unit, source, and instrument used to measure radiation levels;

     (c) Each dose rate measured around the source while the unit is in the off position and the average of all measurements; and

     (d) The signature of the individual who performed the test.

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     (2) The record must contain:

     (a) The inspector's radioactive materials license number;

     (b) The date of inspection;

     (c) The manufacturer's name and model number and serial number of both the treatment unit and source;

     (d) A list of components inspected and serviced, and the type of service; and

     (e) The signature of the inspector.

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     (a) A dose that differs from the prescribed dose or dose that would have resulted from the prescribed dosage by more than 0.05 Sv (5 rem) effective dose equivalent, 0.5 Sv (50 rem) to an organ or tissue, or 0.5 Sv (50 rem) shallow dose equivalent to the skin; and

     (i) The total dose delivered differs from the prescribed dose by twenty percent or more;

     (ii) The total dosage delivered differs from the prescribed dosage by twenty percent or more or falls outside the prescribed dosage range; or

     (iii) The fractionated dose delivered differs from the prescribed dose, for a single fraction, by fifty percent or more.

     (b) A dose that exceeds 0.05 Sv (5 rem) effective dose equivalent, 0.5 Sv (50 rem) to an organ or tissue, or 0.5 Sv (50 rem) shallow dose equivalent to the skin from any of the following:

     (i) An administration of a wrong radioactive drug containing radioactive material;

     (ii) An administration of a radioactive drug containing radioactive material by the wrong route of administration;

     (iii) An administration of a dose or dosage to the wrong individual or human research subject;

     (iv) An administration of a dose or dosage delivered by the wrong mode of treatment; or

     (v) A leaking sealed source.

     (c) A dose to the skin or an organ or tissue other than the treatment site that exceeds by 0.5 Sv (50 rem) to an organ or tissue and fifty percent or more of the dose expected from the administration defined in the written directive (excluding, for permanent implants, seeds that were implanted in the correct site but migrated outside the treatment site).

     (2) A licensee shall report any event resulting from intervention of a patient or human research subject in which the administration of radioactive material or radiation from radioactive material results or will result in unintended permanent functional damage to an organ or a physiological system, as determined by a physician.

     (3) The licensee shall notify by telephone (360-236-3300) the department no later than the next calendar day after discovery of the medical event.

     (4) By an appropriate method listed in WAC 246-221-250, the licensee shall submit a written report to the department at P.O. Box 47827, Olympia WA 98504-7827 within fifteen days after discovery of the medical event.

     (a) The written report must include:

     (i) The licensee's name;

     (ii) The name of the prescribing physician;

     (iii) A brief description of the event;

     (iv) Why the event occurred;

     (v) The effect, if any, on the individual(s) who received the administration;

     (vi) What actions, if any, have been taken or are planned to prevent recurrence; and

     (vii) Certification that the licensee notified the individual (or the individual's responsible relative or guardian), and if not, why not.

     (b) The report may not contain the individual's name or any other information that could lead to identification of the individual.

     (5) The licensee shall provide notification of the event to the referring physician and also notify the individual who is the subject of the medical event no later than twenty-four hours after its discovery, unless the referring physician personally informs the licensee either that they will inform the individual or that, based on medical judgment, telling the individual would be harmful. The licensee is not required to notify the individual without first consulting the referring physician. If the referring physician or the affected individual cannot be reached within twenty-four hours, the licensee shall notify the individual as soon as possible thereafter. The licensee may not delay any appropriate medical care for the individual, including any necessary remedial care as a result of the medical event, because of any delay in notification. To meet the requirements of this section, the notification of the individual who is the subject of the medical event may be made instead to that individual's responsible relative or guardian. If a verbal notification is made, the licensee shall inform the individual, or appropriate responsible relative or guardian, that a written description of the event can be obtained from the licensee upon request. The licensee shall provide a written description if requested.

     (6) Aside from the notification requirement, nothing in this section affects any rights or duties of licensees and physicians in relation to each other, to individuals affected by the medical event, or to that individual's responsible relatives or guardians.

     (7) A licensee shall:

     (a) Annotate a copy of the report provided to the department with the:

     (i) Name of the individual who is the subject of the event; and

     (ii) Social Security number or other identification number, if one has been assigned, of the individual who is the subject of the event; and

     (b) Provide a copy of the annotated report to the referring physician, if other than the licensee, no later than fifteen days after the discovery of the event.

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     (2) A licensee shall report any dose to a nursing child that is a result of an administration of radioactive material to a breast-feeding individual that:

     (a) Is greater than 50 mSv (5 rem) total effective dose equivalent; or

     (b) Has resulted in unintended permanent functional damage to an organ or a physiological system of the child, as determined by a physician.

     (3) The licensee shall notify by telephone the department no later than the next calendar day after discovery of a dose to the embryo/fetus or nursing child that requires a report in subsection (1) or (2) of this section.

     (4) By an appropriate method listed in WAC 246-221-250, the licensee shall submit a written report to the department within fifteen days after discovery of a dose to the embryo/fetus or nursing child that requires a report in subsection (1) or (2) of this section.

     (a) The written report must include:

     (i) The licensee's name;

     (ii) The name of the prescribing physician;

     (iii) A brief description of the event;

     (iv) Why the event occurred;

     (v) The effect, if any, on the embryo/fetus or the nursing child;

     (vi) What actions, if any, have been taken or are planned to prevent recurrence; and

     (vii) Certification that the licensee notified the pregnant individual or mother (or the mother's or child's responsible relative or guardian), and if not, why not.

     (b) The report must not contain the individual's or child's name or any other information that could lead to identification of the individual or child.

     (5) The licensee shall provide notification of the event to the referring physician and also notify the pregnant individual or mother, both hereafter referred to as the mother, no later than twenty-four hours after discovery of an event that would require reporting under subsection (1) or (2) of this section, unless the referring physician personally informs the licensee either that they will inform the mother or that, based on medical judgment, telling the mother would be harmful. The licensee is not required to notify the mother without first consulting with the referring physician. If the referring physician or mother cannot be reached within twenty-four hours, the licensee shall make the appropriate notifications as soon as possible thereafter. The licensee may not delay any appropriate medical care for the embryo/fetus or for the nursing child, including any necessary remedial care as a result of the event, because of any delay in notification. To meet the requirements of this subsection, the notification may be made to the mother's or child's responsible relative or guardian instead of the mother. If a verbal notification is made, the licensee shall inform the mother, or the mother's or child's responsible relative or guardian, that a written description of the event can be obtained from the licensee upon request. The licensee shall provide a written description if requested.

     (6) A licensee shall:

     (a) Annotate a copy of the report provided to the department with the:

     (i) Name of the pregnant individual or the nursing child who is the subject of the event; and

     (ii) Social Security number or other identification number, if one has been assigned, of the pregnant individual or the nursing child who is the subject of the event; and

     (b) Provide a copy of the annotated report to the referring physician, if other than the licensee, no later than fifteen days after the discovery of the event.

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     The following sections of the Washington Administrative Code are repealed:

WAC 246-240-015	Policy and procedures for therapy administration.
WAC 246-240-020	Interstitial, intracavitary and superficial applications.
WAC 246-240-030	Teletherapy.
WAC 246-240-040	Special requirements for teletherapy licensees.
WAC 246-240-050	Notifications, records, and reports of therapy misadministrations.

© Washington State Code Reviser's Office