Original Notice.

     Exempt from preproposal statement of inquiry under RCW 34.05.310(4).

     Title of Rule and Other Identifying Information: Chapter 246-240 WAC, Radiation protection-medical use of radioactive material, the department is proposing to adopt federal rule changes to make the rule consistent with the federal Nuclear Regulatory Commission's (NRC) rules and make editorial changes.

     Hearing Location(s): Department of Health, Town Center 2, Room 158, 111 Israel Road S.E., Tumwater, WA 98513, on April 9, 2013, at 10:30 a.m.

     Date of Intended Adoption: April 23, 2013.

     Submit Written Comments to: Michelle K. Austin, P.O. Box 47827, Tumwater, WA 98504-7827, e-mail http://www3.doh.wa.gov/policyreview/, fax (360) 236-2266, by April 9, 2013.

     Assistance for Persons with Disabilities: Contact Michelle K. Austin by April 1, 2013, TTY (800) 833-6388 or 711.

     Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: This rule making is necessary to adopt NRC's rule changes titled "2009-1: Medical use of byproduct material - authorized user clarification." Under the formal state agreement between the governor and NRC, the office of radiation protection (the state radiation control program) is required to remain compatible with NRC's rules. This is done through rule revisions to make state rules consistent with, and at least as stringent as, NRC rules.

     Reasons Supporting Proposal: This rule making is required to comply with RCW 70.98.050 (4)(d) and a formal agreement signed between the state of Washington and the Atomic Energy Commission under section 274 of the Atomic Energy Act of 1954 as amended (42 U.S.C. sec. 2021), the Energy Policy Act of 2005.

     Statutory Authority for Adoption: RCW 70.98.050.

     Statute Being Implemented: RCW 70.98.050.

     Rule is necessary because of federal law, 74 F.R. 33901.

     Name of Proponent: Department of health, governmental.

     Name of Agency Personnel Responsible for Drafting, Implementation and Enforcement: Curt DeMaris, 111 Israel Road S.E., Tumwater, WA 98501, (360) 236-3323.

     No small business economic impact statement has been prepared under chapter 19.85 RCW. Under RCW 19.85.025 and 34.05.310 (4)(c), a small business economic impact statement is not required for proposed rules that adopt or incorporate by reference - without material change - federal statutes or regulations, Washington state law, the rules of other Washington state agencies, or national consensus codes that generally establish industry standards.

     A cost-benefit analysis is not required under RCW 34.05.328. The agency did not complete a cost-benefit analysis under RCW 34.05.328. RCW 34.05.328 (5)(b)(iii) exempts rules that adopt or incorporate by reference without material change federal statutes or regulations, Washington state law, the rules of other Washington state agencies, or national consensus codes that generally establish industry standards.

February 25, 2013

Mary C. Selecky

Secretary

OTS-5162.5

AMENDATORY SECTION(Amending WSR 11-03-068, filed 1/18/11, effective 2/18/11)

WAC 246-240-010   Definitions, abbreviations, and acronyms.   The definitions, abbreviations, and acronyms in this section and in WAC 246-220-010 apply throughout this chapter unless the context clearly indicates otherwise.

     (1) "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.

     (((1))) (2) "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.

     (((2))) (3) "Attestation" means written certification under oath.

     (4) "Authorized medical physicist" means an individual who:

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

     (b) Is identified as an authorized medical physicist or teletherapy physicist on:

     (i) A specific medical use license issued by the department, ((the U.S. Nuclear Regulatory Commission)) NRC or an agreement state;

     (ii) A medical use permit issued by a ((U.S.)) NRC master material licensee;

     (iii) A permit issued by a ((U.S.)) NRC or agreement state broad scope medical use licensee; or

     (iv) A permit issued by a ((U.S.)) NRC master material license broad scope medical use permittee.

     (((3))) (5) "Authorized nuclear pharmacist" means a pharmacist who:

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

     (b) Is identified as an authorized nuclear pharmacist on:

     (i) A specific license issued by the department, ((the U.S.)) NRC or an agreement state, that authorizes medical use or the practice of nuclear pharmacy;

     (ii) A permit issued by a ((U.S.)) NRC master material licensee that authorizes medical use or the practice of nuclear pharmacy;

     (iii) A permit issued by a ((U.S.)) NRC or agreement state broad scope medical use licensee that authorizes medical use or the practice of nuclear pharmacy; or

     (iv) A permit issued by a ((U.S.)) NRC master material license broad scope medical use permittee that authorizes medical use or the practice of nuclear pharmacy; or

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

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

     (((4))) (6) "Authorized user" means a physician, dentist, or podiatrist who:

     (a) 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; or

     (b) Is identified as an authorized user on:

     (i) A department, ((U.S.)) NRC, or agreement state license that authorizes the medical use of radioactive material; or

     (ii) A permit issued by a ((U.S.)) NRC master material licensee that is authorized to permit the medical use of radioactive material; or

     (iii) A permit issued by a department, ((U.S.)) NRC, or agreement state specific licensee of broad scope that is authorized to permit the medical use of radioactive material; or

     (iv) A permit issued by a ((U.S.)) NRC master material license broad scope permittee that is authorized to permit the medical use of radioactive material.

     (((5))) (7) "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.

     (((6))) (8) "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.

     (((7))) (9) "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.

     (((8))) (10) "Cyclotron" means a particle accelerator in which the charged particles travel in an outward spiral or circular path. A cyclotron accelerates charged particles at energies usually in excess of 10 mega-electron volts and is commonly used for production of short half-life radionuclides for medical use.

     (((9))) (11) "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.

     (((10))) (12) "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.

     (((11))) (13) "FDA" means the U.S. Food and Drug Administration.

     (14) "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.

     (((12))) (15) "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.

     (((13))) (16) "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.

     (((14))) (17) "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.

     (((15))) (18) "Medical event" means an event that meets the criteria in WAC 246-240-651.

     (((16))) (19) "Medical institution" means an organization in which more than one medical discipline is practiced.

     (((17))) (20) "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.

     (((18))) (21) "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.

     (((19))) (22) "Mobile medical service" means the transportation of radioactive material to and its medical use at the client's address.

     (((20))) (23) "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.

     (((21))) (24) "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.

     (((22))) (25) "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.

     (((23))) (26) "Positron emission tomography (((PET))) radionuclide production facility" means a facility operating an accelerator for the purpose of producing ((PET)) positron emission tomography radionuclides.

     (((24))) (27) "Preceptor" means an individual who provides, directs, or verifies training and experience required for an individual to become an authorized user, an authorized medical physicist, an authorized nuclear pharmacist, or ((a)) an authorized radiation safety officer.

     (((25))) (28) "Prescribed dosage" means the specified activity or range of activity of unsealed radioactive material as documented:

     (a) In a written directive; or

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

     (((26))) (29) "Prescribed dose" means:

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

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

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

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

     (((27))) (30) "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:

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

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

     (((28) Radiation safety officer means an individual who:

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

     (b) 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

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

     (29))) (31) "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.

     (((30))) (32) "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.

     (((31))) (33) "Structured educational program" means an educational program designed to impart particular knowledge and practical education through interrelated studies and supervised training.

     (((32))) (34) "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.

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

     (((34))) (36) "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.

     (((35))) (37) "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.

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

     (((37))) (39) "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.

     (((38))) (40) "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.

     (((39))) (41) "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. 11-03-068, § 246-240-010, filed 1/18/11, effective 2/18/11. Statutory Authority: RCW 70.98.050 and 70.98.080. 09-06-003, § 246-240-010, filed 2/18/09, effective 3/21/09. Statutory Authority: RCW 70.98.050. 07-14-131, § 246-240-010, filed 7/3/07, effective 8/3/07; 06-05-019, § 246-240-010, filed 2/6/06, effective 3/9/06; 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.]

     (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.

[Statutory Authority: RCW 70.98.050. 06-05-019, § 246-240-016, filed 2/6/06, effective 3/9/06.]

     (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; or

     (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)) NRC or an agreement state specific license of broad scope ((that)) which is ((authorized)) licensed to ((permit)) authorize the use of ((by-product)) radioactive material in medical use or in the practice of nuclear pharmacy;

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

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

[Statutory Authority: RCW 70.98.050. 06-05-019, § 246-240-022, filed 2/6/06, effective 3/9/06.]

     (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.

[Statutory Authority: RCW 70.98.050. 06-05-019, § 246-240-051, filed 2/6/06, effective 3/9/06.]

     (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 an agreement state medical use licensee; or

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

[Statutory Authority: RCW 70.98.050. 07-14-131, § 246-240-066, filed 7/3/07, effective 8/3/07; 06-05-019, § 246-240-066, filed 2/6/06, effective 3/9/06.]

     (1) Is certified by a specialty board whose certification process has been recognized by the department, ((the U.S.)) NRC, or an agreement state, and who meets the requirements of subsections (4) and (5) of this section. (Specialty boards whose certification process has been recognized by the department, ((the U.S. Nuclear Regulatory Commission)) NRC, or an agreement state will be posted on ((the)) NRC's web page, at ((http://www.nrc.gov.)) http://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html.) 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; and

     (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)) NRC 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 in WAC 246-240-078, 246-240-163 or 246-240-210; 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 under oath)) attestation 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 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) 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; or

     (b) Is a medical physicist who has been certified by a specialty board whose certification process has been recognized by the department, ((the U.S.)) NRC, or an agreement state under WAC 246-240-072 and has experience in radiation safety for similar types of use of radioactive material for which the licensee is seeking the approval of the individual as radiation safety officer and who meets the requirements in subsections (4) and (5) of this section; 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)) NRC 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 under oath)) attestation, signed by a preceptor radiation safety officer, that the individual has satisfactorily completed the requirements in subsection (5) of this section, and in subsection (1)(a) and (b), or (c)(i) and (ii) of this section, or subsection (2)(a) or (b) of this section, or subsection (3) of this section 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.

[Statutory Authority: RCW 70.98.050. 11-03-068, § 246-240-069, filed 1/18/11, effective 2/18/11; 07-14-131, § 246-240-069, filed 7/3/07, effective 8/3/07; 06-05-019, § 246-240-069, filed 2/6/06, effective 3/9/06.]

     (1) Is certified by a specialty board whose certification process has been recognized by the department, ((the U.S. Nuclear Regulatory Commission)) NRC or an agreement state and who meets the requirements in subsections (2)(b) and (3) of this section. (Specialty boards whose certification process has been recognized by ((the commission)) NRC or an agreement state will be posted on ((the)) NRC's web page at ((http://www.nrc.gov.)) http://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html.) 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)) NRC or an agreement state; or

     (ii) In clinical radiation facilities providing high energy, external beam therapy (photons and electrons with energies greater than or equal to one million electron volts) and brachytherapy services under the direction of physicians who meet the requirements for authorized users in WAC 246-240-078, 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; 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 under oath)) attestation that the individual has satisfactorily completed the requirements in subsections (1)(a) and (b) and (3), or (2)(a) and (3) of this section, 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 under oath)) attestation must be signed by a preceptor authorized medical physicist who meets the requirements in WAC 246-240-072, 246-240-078, 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.

[Statutory Authority: RCW 70.98.050. 11-03-068, § 246-240-072, filed 1/18/11, effective 2/18/11; 07-14-131, § 246-240-072, filed 7/3/07, effective 8/3/07; 06-05-019, § 246-240-072, filed 2/6/06, effective 3/9/06.]

     (1) Is certified by a specialty board whose certification process has been recognized by the department, ((the U.S. Nuclear Regulatory Commission)) NRC or an agreement state and who meets the requirements in subsection (2)(b) of this section. (Specialty boards whose certification process has been recognized by ((the commission)) NRC or an agreement state will be posted on ((the)) NRC's web page at ((http://www.nrc.gov.)) http://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html.) 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 two 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 under oath)) attestation, signed by a preceptor authorized nuclear pharmacist, that the individual has satisfactorily completed the requirements in subsections (1)(a), (b), and (c) or (2)(a) of this section and has achieved a level of competency sufficient to function independently as an authorized nuclear pharmacist.

[Statutory Authority: RCW 70.98.050. 11-03-068, § 246-240-075, filed 1/18/11, effective 2/18/11; 06-05-019, § 246-240-075, filed 2/6/06, effective 3/9/06.]

     (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.

     (3) Individuals who need not comply with training requirements as described in this section may serve as preceptors for, and supervisors of, applicants seeking authorization on state of Washington radioactive materials licenses for the same uses for which these individuals are authorized.

[Statutory Authority: RCW 70.98.050. 11-03-068, § 246-240-078, filed 1/18/11, effective 2/18/11; 06-05-019, § 246-240-078, filed 2/6/06, effective 3/9/06.]

     (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, producer, 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, producer, 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.

[Statutory Authority: RCW 70.98.050 and 70.98.080. 09-06-003, § 246-240-107, filed 2/18/09, effective 3/21/09. Statutory Authority: RCW 70.98.050. 06-05-019, § 246-240-107, filed 2/6/06, effective 3/9/06.]

     (1) Sealed sources, not exceeding 1.11 gigabecquerels (30 millicuries) 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 gigabecquerels (30 millicuries) each, redistributed by a licensee authorized to redistribute the sealed sources manufactured and distributed by a person licensed under WAC 246-235-102, or equivalent agreement state or ((U.S.)) NRC regulations 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 gigabecquerels (15 millicuries).

     (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 megabecquerels (200 microcuries) or 1000 times the quantities in Schedule B of WAC 246-232-120.

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

[Statutory Authority: RCW 70.98.050 and 70.98.080. 09-06-003, § 246-240-110, filed 2/18/09, effective 3/21/09. Statutory Authority: RCW 70.98.050. 07-14-131, § 246-240-110, filed 7/3/07, effective 8/3/07; 06-05-019, § 246-240-110, filed 2/6/06, effective 3/9/06.]

     (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 becquerels (0.005 microcuries) 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 becquerels (0.005 microcurie((s))) 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 megabecquerels (100 microcuries) or less of beta- or gamma-emitting material or 0.37 megabecquerel((s)) (10 microcuries) 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.

[Statutory Authority: RCW 70.98.050 and 70.98.080. 09-06-003, § 246-240-113, filed 2/18/09, effective 3/21/09. Statutory Authority: RCW 70.98.050. 06-05-019, § 246-240-113, filed 2/6/06, effective 3/9/06.]

     (1) Obtained from a manufacturer, producer, 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, or a physician who is an authorized user and who meets the requirements specified in WAC 246-240-163, or 246-240-210 and 246-240-163 (3)(a)(ii)(G), 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.

[Statutory Authority: RCW 70.98.050 and 70.98.080. 09-06-003, § 246-240-151, filed 2/18/09, effective 3/21/09. Statutory Authority: RCW 70.98.050. 07-14-131, § 246-240-151, filed 7/3/07, effective 8/3/07; 06-05-019, § 246-240-151, filed 2/6/06, effective 3/9/06.]

     (1) Is certified by a medical specialty board whose certification process has been recognized by the department, ((the U.S. Nuclear Regulatory Commission)) NRC or an agreement state and who meets the requirements of subsection (3)(b) of this section. (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.)) http://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html.) 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 subsection (3)(a) of this section; or

     (3)(a) Has completed sixty hours of training and experience, including a minimum of eight hours of classroom and laboratory training, 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 246-240-078, 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 under oath)) attestation, signed by a preceptor authorized user who meets the requirements in WAC 246-240-078, 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.

[Statutory Authority: RCW 70.98.050. 11-03-068, § 246-240-154, filed 1/18/11, effective 2/18/11; 07-14-131, § 246-240-154, filed 7/3/07, effective 8/3/07; 06-05-019, § 246-240-154, filed 2/6/06, effective 3/9/06.]

     (1) Obtained from a manufacturer, producer, 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 and 246-240-163 (3)(a)(ii)(G), 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.

[Statutory Authority: RCW 70.98.050 and 70.98.080. 09-06-003, § 246-240-157, filed 2/18/09, effective 3/21/09. Statutory Authority: RCW 70.98.050. 07-14-131, § 246-240-157, filed 7/3/07, effective 8/3/07; 06-05-019, § 246-240-157, filed 2/6/06, effective 3/9/06.]

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

     (2) Is an authorized user under WAC 246-240-210 and meets the requirements in WAC 246-240-163 (3)(a)(ii)(G) and 246-240-210 or equivalent agreement state or ((U.S.)) NRC requirements; or

     (3)(a) Has completed seven hundred hours of training and experience, including a minimum of eighty hours of classroom and laboratory training, 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 246-240-078, 246-240-163, or 246-240-210 and 246-240-163 (3)(a)(ii)(G), 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 under oath)) attestation, signed by a preceptor authorized user who meets the requirements in WAC 246-240-078, 246-240-163, or 246-240-210 and 246-240-163 (3)(a)(ii)(G) 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.

[Statutory Authority: RCW 70.98.050. 11-03-068, § 246-240-163, filed 1/18/11, effective 2/18/11; 07-14-131, § 246-240-163, filed 7/3/07, effective 8/3/07; 06-05-019, § 246-240-163, filed 2/6/06, effective 3/9/06.]

     (1) Obtained from a manufacturer, producer, 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.

[Statutory Authority: RCW 70.98.050 and 70.98.080. 09-06-003, § 246-240-201, filed 2/18/09, effective 3/21/09. Statutory Authority: RCW 70.98.050. 06-05-019, § 246-240-201, filed 2/6/06, effective 3/9/06.]

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

     (a) Successfully complete a residency training in a radiation therapy 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 under oath)) attestation 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 under oath)) attestation must be signed by a preceptor authorized user who meets the requirements in WAC 246-240-078, 246-240-210, or equivalent ((U.S.)) NRC or agreement state requirements. The preceptor authorized user, who meets the requirements in WAC 246-240-078 or 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, including a minimum of two hundred hours of classroom and laboratory training, 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 for which a written directive is required;

     (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 under oath)) attestation that the individual has satisfactorily completed the requirements in subsection (1)(a) and (2)(b)(vii) of this section, WAC 246-240-078, 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 under oath)) attestation 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 also have experience in administering dosages in the same dosage category or categories (i.e., this section) as the individual requesting authorized user status.

[Statutory Authority: RCW 70.98.050. 11-03-068, § 246-240-210, filed 1/18/11, effective 2/18/11; 07-14-131, § 246-240-210, filed 7/3/07, effective 8/3/07; 06-05-019, § 246-240-210, filed 2/6/06, effective 3/9/06.]

     (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)) NRC or an agreement state. (Specialty boards whose certification process has been recognized by ((the commission)) NRC or an agreement state will be posted on ((the)) NRC's web page at ((http://www.nrc.gov.)) http://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html.); or

     (2) Is an authorized user under WAC 246-240-210 for uses listed in WAC 246-240-210 (2)(b)(vii)(A) and (B), 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 246-240-078, 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 also have experience in administering dosages as specified in WAC 246-240-210 (2)(b)(vii)(A) or (B). 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 under oath)) attestation 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 under oath)) attestation must be signed by a preceptor authorized user who meets the requirements in WAC 246-240-078, 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(2), must also have experience in administering dosages as specified in WAC 246-240-210 (2)(b)(vii)(A) or (B).

[Statutory Authority: RCW 70.98.050. 11-03-068, § 246-240-213, filed 1/18/11, effective 2/18/11; 07-14-131, § 246-240-213, filed 7/3/07, effective 8/3/07; 06-05-019, § 246-240-213, filed 2/6/06, effective 3/9/06.]

     (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)) NRC or an agreement state will be posted on ((the)) NRC's web page at ((http://www.nrc.gov.)) http://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html.); or

     (2) Is an authorized user under WAC 246-240-210 for uses listed in WAC 246-240-210 (2)(b)(vii)(B), 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 246-240-078, 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 also have experience in administering dosages as specified in WAC 246-240-210 (2)(b)(vii)(B).

     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 under oath)) attestation 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 under oath)) attestation must be signed by a preceptor authorized user who meets the requirements in WAC 246-240-078, 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 (2)(b)(vii)(B).

[Statutory Authority: RCW 70.98.050. 11-03-068, § 246-240-216, filed 1/18/11, effective 2/18/11; 07-14-131, § 246-240-216, filed 7/3/07, effective 8/3/07; 06-05-019, § 246-240-216, filed 2/6/06, effective 3/9/06.]

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

     (2) Is an authorized user under WAC 246-240-278 or 246-240-399, or equivalent agreement state or ((U.S.)) NRC requirements and who meets the requirements in subsection (4) of this section; or

     (3) Is certified by a medical specialty board whose certification process has been recognized by the ((U.S.)) NRC or an agreement state under WAC 246-240-278 or 246-240-399, and who meets the requirements in subsection (4) of this section.

     (4)(a) Has successfully completed eighty hours of classroom and laboratory training, applicable to parenteral administrations, for which a written directive is required, of any beta emitter or any photon-emitting radionuclide with a photon energy less than 150 keV, ((and/))or parenteral administration of any other radionuclide for which a written directive is required. 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 246-240-078, 246-240-210, 246-240-219, or equivalent agreement state or ((U.S.)) NRC requirements, in the parenteral administration, for which a written directive is required, of any beta emitter or any photon-emitting radionuclide with a photon energy less than 150 keV, ((and/))or parenteral administration of any other radionuclide for which a written directive is required. A supervising authorized user who meets the requirements in WAC 246-240-210 must have experience in administering dosages as specified in WAC 246-240-210 (2)(b)(vii)(C) ((and/))or (D). 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; and

     (vi) Administering dosages to patients or human research subjects, that include at least three cases involving the parenteral administration, for which a written directive is required, of any beta emitter, or any photon-emitting radionuclide with a photon energy less than 150 keV ((and/))or at least three cases involving the parenteral administration of any other radionuclide, for which a written directive is required; and

     (5) Has obtained written ((certification under oath)) attestation that the individual has satisfactorily completed the requirements in subsection (2) or (3) of this section, and has achieved a level of competency sufficient to function independently as an authorized user for the parenteral administration of unsealed radioactive material requiring a written directive. The written ((certification under oath)) attestation must be signed by a preceptor authorized user who meets the requirements in WAC 246-240-078, 246-240-210, 246-240-219, or equivalent agreement state or ((U.S.)) NRC requirements. A preceptor authorized user, who meets the requirements in WAC 246-240-210, must have experience in administering dosages as specified in WAC 246-240-210 (2)(b)(vii)(C) ((and/))or (D).

[Statutory Authority: RCW 70.98.050. 11-03-068, § 246-240-219, filed 1/18/11, effective 2/18/11; 07-14-131, § 246-240-219, filed 7/3/07, effective 8/3/07; 06-05-019, § 246-240-219, filed 2/6/06, effective 3/9/06.]

     (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)) NRC or an agreement state will be posted on ((the)) NRC's web page at ((http://www.nrc.gov.)) http://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html.) 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 under oath)) attestation, 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 246-240-078, 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 246-240-078, 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 under oath)) attestation, signed by a preceptor authorized user who meets the requirements in WAC 246-240-078, 246-240-278 or equivalent agreement state or ((U.S.)) NRC requirements, that the individual has satisfactorily completed the requirements in subsection (1)(a) of this section, or (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.

[Statutory Authority: RCW 70.98.050. 11-03-068, § 246-240-278, filed 1/18/11, effective 2/18/11; 07-14-131, § 246-240-278, filed 7/3/07, effective 8/3/07; 06-05-019, § 246-240-278, filed 2/6/06, effective 3/9/06.]

     (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 under oath)) attestation, signed by a preceptor authorized user who meets the requirements in WAC 246-240-078, 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.

[Statutory Authority: RCW 70.98.050. 11-03-068, § 246-240-281, filed 1/18/11, effective 2/18/11; 06-05-019, § 246-240-281, filed 2/6/06, effective 3/9/06.]

     (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)) NRC or an agreement state will be posted on ((the)) NRC's web page at ((http://www.nrc.gov.)) http://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html.); 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.

[Statutory Authority: RCW 70.98.050. 06-05-019, § 246-240-304, filed 2/6/06, effective 3/9/06.]

     (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.

[Statutory Authority: RCW 70.98.050. 06-05-019, § 246-240-357, filed 2/6/06, effective 3/9/06.]

     (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.

[Statutory Authority: RCW 70.98.050. 06-05-019, § 246-240-393, filed 2/6/06, effective 3/9/06.]

     (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)) NRC or an agreement state will be posted on ((the)) NRC's web page at ((http://www.nrc.gov.)) http://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html.) 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; or

     (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 246-240-078, 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 246-240-078, 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 under oath)) attestation that the individual has satisfactorily completed the requirements in subsection (1)(a) of this section, or (a) and (b), and (d) 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 under oath)) attestation must be signed by a preceptor authorized user who meets the requirements in WAC 246-240-078, 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.

[Statutory Authority: RCW 70.98.050. 11-03-068, § 246-240-399, filed 1/18/11, effective 2/18/11; 07-14-131, § 246-240-399, filed 7/3/07, effective 8/3/07; 06-05-019, § 246-240-399, filed 2/6/06, effective 3/9/06.]

     (1) The record must include, for each measured elution of technetium-99m, the ratio of the measures expressed as kilobecquerels of molybdenum-99 per megabecquerel of technetium-99m (or microcuries of molybdenum per millicurie of technetium), the time and date of the measurement, and the name of the individual who made the measurement.

     (2) For each measured elution of rubidium-82, the ratio of the measures expressed as kilobecquerels of strontium-82 per megabecquerel of rubidium-82 (or microcuries of strontium-82 per millicurie of rubidium), ((and/))or kilobecquerels of strontium-85 per megabecquerel of rubidium-82 (or microcuries of strontium-85 per millicurie of rubidium), the time and date of the measurement, and the name of the individual who made the measurement.

[Statutory Authority: RCW 70.98.050 and 70.98.080. 09-06-003, § 246-240-587, filed 2/18/09, effective 3/21/09. Statutory Authority: RCW 70.98.050. 06-05-019, § 246-240-587, filed 2/6/06, effective 3/9/06.]