WSR 06-05-019

PERMANENT RULES

DEPARTMENT OF HEALTH


[ Filed February 6, 2006, 4:01 p.m. , effective March 9, 2006 ]


     Effective Date of Rule: Thirty-one days after filing.

     Purpose: To update the regulations for medical use of radioactive material. These changes are required for compatibility with the United States Nuclear Regulatory Commission (NRC) regulations, 10 C.F.R. 35 and RCW 70.98.050.

     Citation of Existing Rules Affected by this Order: Repealing WAC 246-235-120, 246-239-001, 246-239-010, 246-239-020, 246-239-022, 246-239-025, 246-239-030, 246-239-035, 246-239-040, 246-239-050, 246-239-055, 246-239-060, 246-239-070, 246-239-080, 246-239-090, 246-239-100, 246-240-015, 246-240-020, 246-240-030, 246-240-040, and 246-240-050; and amending WAC 246-220-010, 246-221-001, 246-221-060, 246-221-130, 246-232-001, 246-232-014, 246-235-020, 246-235-080, 246-235-090, 246-235-100, 246-235-102, 246-235-110, 246-240-001, 246-240-010, and 246-240-025.

     Statutory Authority for Adoption: RCW 70.98.050.

      Adopted under notice filed as WSR 05-19-053 on September 15, 2005 and 05-24-115 on December 7, 2005.

     Changes Other than Editing from Proposed to Adopted Version: The NRC noted an error in the cross references in WAC 246-240-219 (4)(b) and (5). For consistency with 71 FR 1926, the reference in both cases was changed from WAC 246-240-210 (2)(b)(vii)(D) and/or (E) to WAC 246-240-210 (2)(b)(vii)(C) and/or (D).

     Number of Sections Adopted in Order to Comply with Federal Statute: New 0, Amended 0, Repealed 0; Federal Rules or Standards: New 116, Amended 16, Repealed 21; or Recently Enacted State Statutes: New 0, Amended 0, Repealed 0.

     Number of Sections Adopted at Request of a Nongovernmental Entity: New 0, Amended 0, Repealed 0.

     Number of Sections Adopted on the Agency's Own Initiative: New 0, Amended 0, Repealed 0.

     Number of Sections Adopted in Order to Clarify, Streamline, or Reform Agency Procedures: New 0, Amended 0, Repealed 0.

     Number of Sections Adopted Using Negotiated Rule Making: New 0, Amended 0, Repealed 0;      Pilot Rule Making: New 0, Amended 0, Repealed 0; or Other Alternative Rule Making: New 116, Amended 16, Repealed 21.

     Date Adopted: February 6, 2006.

Mary C. Selecky

Secretary

OTS-8021.3


AMENDATORY SECTION(Amending WSR 04-23-093, filed 11/17/04, effective 12/18/04)

WAC 246-220-010   Definitions.   As used in these regulations, these terms have the definitions set forth below. Additional definitions used only in a certain part will be found in that part.

     (1) "Absorbed dose" means the energy imparted by ionizing radiation per unit mass of irradiated material. The units of absorbed dose are the gray (Gy) and the rad.

     (2) "Accelerator produced material" means any material made radioactive by exposing it in a particle accelerator.

     (3) "Act" means Nuclear energy and radiation, chapter 70.98 RCW.

     (4) "Activity" means the rate of disintegration or transformation or decay of radioactive material. The units of activity are the becquerel (Bq) and the curie (Ci).

     (5) "Adult" means an individual eighteen or more years of age.

     (6) "Agreement state" means any state with which the United States Nuclear Regulatory Commission has entered into an effective agreement under section 274 b. of the Atomic Energy Act of 1954, as amended (73 Stat. 689).

     (7) "Airborne radioactive material" means any radioactive material dispersed in the air in the form of particulates, dusts, fumes, mists, vapors, or gases.

     (8) "Airborne radioactivity area" means a room, enclosure, or operating area in which airborne radioactive material exists in concentrations (a) in excess of the derived air concentration (DAC) specified in WAC 246-221-290, Appendix A, or (b) to ((such a)) the degree that an individual present in the area without respiratory protective equipment could exceed, during the hours an individual is present in a week, an intake of 0.6 percent of the annual limit on intake (ALI) or twelve DAC-hours.

     (9) "Air purifying respirator" means a respirator with an air-purifying filter, cartridge, or canister that removes specific air contaminants by passing ambient air through the air-purifying element.

     (10) "Alert" means events may occur, are in progress, or have occurred that could lead to a release of radioactive material but that the release is not expected to require a response by offsite response organizations to protect persons offsite.

     (11) "Annual limit on intake" (ALI) means the derived limit for the amount of radioactive material taken into the body of an adult worker by inhalation or ingestion in a year. ALI is the smaller value of intake of a given radionuclide in a year by the reference man that would result in a committed effective dose equivalent of 0.05 Sv (5 rem) or a committed dose equivalent of 0.5 Sv (50 rem) to any individual organ or tissue. ALI values for intake by ingestion and by inhalation of selected radionuclides are given in WAC 246-221-290.

     (12) "Assigned protection factor" (APF) means the expected workplace level of respiratory protection that would be provided by a properly functioning respirator or a class of respirators to properly fitted and trained users. Operationally, the inhaled concentration can be estimated by dividing the ambient airborne concentration by the APF.

     (13) "Atmosphere-supplying respirator" means a respirator that supplies the respirator user with breathing air from a source independent of the ambient atmosphere, and includes supplied-air respirators (SARs) and self-contained breathing apparatus (SCBA) units.

     (14) "Background radiation" means radiation from cosmic sources; naturally occurring radioactive materials, including radon, except as a decay product of source or special nuclear material, and including global fallout as it exists in the environment from the testing of nuclear explosive devices or from past nuclear accidents such as Chernobyl that contribute to background radiation and are not under the control of the licensee. "Background radiation" does not include sources of radiation from radioactive materials regulated by the department.

     (15) "Becquerel" (Bq) means the SI unit of activity. One becquerel is equal to 1 disintegration or transformation per second (s-1).

     (16) "Bioassay" means the determination of kinds, quantities or concentrations, and, in some cases, the locations of radioactive material in the human body, whether by direct measurement, in vivo counting, or by analysis and evaluation of materials excreted or removed from the human body. For purposes of these regulations, "radiobioassay" is an equivalent term.

     (17) "Byproduct material" means: (a) Any radioactive material (except special nuclear material) yielded in or made radioactive by exposure to the radiation incident to the process of producing or utilizing special nuclear material, and (b) the tailings or wastes produced by the extraction or concentration of uranium or thorium from any ore processed primarily for its source material content, including discrete surface wastes resulting from uranium or thorium solution extraction processes. Underground ore bodies depleted by these solution extraction operations do not constitute "byproduct material" within this definition.

     (18) "Calendar quarter" means ((not less than)) at least twelve ((consecutive weeks nor)) but no more than fourteen consecutive weeks. The first calendar quarter of each year ((shall)) begins in January and subsequent calendar quarters shall be ((so)) arranged ((such)) so that no day is included in more than one calendar quarter and no day in any one year is omitted from inclusion within a calendar quarter. ((No)) A licensee or registrant ((shall)) may not change the method of determining calendar quarters for purposes of these regulations ((except at the beginning of a calendar year)).

     (19) "Calibration" means the determination of (a) the response or reading of an instrument relative to a series of known radiation values over the range of the instrument, or (b) the strength of a source of radiation relative to a standard.

     (20) "CFR" means Code of Federal Regulations.

     (21) "Class" means a classification scheme for inhaled material according to its rate of clearance from the pulmonary region of the lung. Materials are classified as D, W, or Y, which applies to a range of clearance half-times: For Class D, Days, of less than ten days, for Class W, Weeks, from ten to one hundred days, and for Class Y, Years, of greater than one hundred days. For purposes of these regulations, "lung class" and "inhalation class" are equivalent terms. For "class of waste" see WAC 246-249-040.

     (22) "Collective dose" means the sum of the individual doses received in a given period of time by a specified population from exposure to a specified source of radiation.

     (23) "Committed dose equivalent" (HT,50) means the dose equivalent to organs or tissues of reference (T) that will be received from an intake of radioactive material by an individual during the fifty-year period following the intake.

     (24) "Committed effective dose equivalent" (HE,50) is the sum of the products of the weighting factors applicable to each of the body organs or tissues that are irradiated and the committed dose equivalent to each of these organs or tissues (HE,50 = ((&Sgr;)) Sgr; wT,HT,50).

     (25) "Constraint" or dose constraint means a value above which specified licensee actions are required.

     (26) "Controlled area." See "Restricted area."

     (27) "Curie" means a unit of quantity of radioactivity. One curie (Ci) is that quantity of radioactive material which decays at the rate of 3.7 x 1010 transformations per second (tps).

     (28) "Declared pregnant woman" means a woman who has voluntarily informed the licensee or registrant, in writing, of her pregnancy, and the estimated date of conception. The declaration remains in effect until the declared pregnant woman withdraws the declaration in writing or is no longer pregnant.

     (29) "Deep dose equivalent" (Hd), which applies to external whole body exposure, means the dose equivalent at a tissue depth of 1 centimeter (1000 mg/cm2).

     (30) "Demand respirator" means an atmosphere-supplying respirator that admits breathing air to the facepiece only when a negative pressure is created inside the facepiece by inhalation.

     (31) "Department" means the Washington state department of health, ((division)) office of radiation protection, which has been designated as the state radiation control agency under chapter 70.98 RCW.

     (32) "Depleted uranium" means the source material uranium in which the isotope Uranium-235 is less than 0.711 percent by weight of the total uranium present. Depleted uranium does not include special nuclear material.

     (33) "Derived air concentration" (DAC) means the concentration of a given radionuclide in air which, if breathed by the reference man for a working year of two thousand hours under conditions of light work, results in an intake of one ALI. For purposes of these regulations, the condition of light work is an inhalation rate of 1.2 cubic meters of air per hour for two thousand hours in a year. DAC values are given in WAC 246-221-290.

     (34) "Derived air concentration-hour" (DAC-hour) means the product of the concentration of radioactive material in air, expressed as a fraction or multiple of the derived air concentration for each radionuclide, and the time of exposure to that radionuclide, in hours. A licensee or registrant may take two thousand DAC-hours to represent one ALI, equivalent to a committed effective dose equivalent of 0.05 Sv (5 rem).

     (35) "Disposable respirator" means a respirator for which maintenance is not intended and that is designed to be discarded after excessive breathing resistance, sorbent exhaustion, physical damage, or end-of-service-life renders it unsuitable for use. Examples of this type of respirator are a disposable half-mask respirator or a disposable escape-only self-contained breathing apparatus (SCBA).

     (36) "Dose" is a generic term that means absorbed dose, dose equivalent, effective dose equivalent, committed dose equivalent, committed effective dose equivalent, total organ dose equivalent, or total effective dose equivalent. For purposes of these ((regulations)) rules, "radiation dose" is an equivalent term.

     (37) "Dose commitment" means the total radiation dose to a part of the body that will result from retention in the body of radioactive material. For purposes of estimating the dose commitment, it is assumed that from the time of intake the period of exposure to retained material will not exceed fifty years.

     (38) "Dose equivalent" (HT) means the product of the absorbed dose in tissue, quality factor, and all other necessary modifying factors at the location of interest. The units of dose equivalent are the sievert (Sv) and rem.

     (39) "Dose limits" means the permissible upper bounds of radiation doses established in accordance with these regulations. For purposes of these regulations, "limits" is an equivalent term.

     (40) "Dosimetry processor" means a person that processes and evaluates individual monitoring devices in order to determine the radiation dose delivered to the monitoring devices.

     (41) "dpm" means disintegrations per minute. See also "curie."

     (42) "Effective dose equivalent" (HE) means the sum of the products of the dose equivalent to each organ or tissue (HT) and the weighting factor (wT) applicable to each of the body organs or tissues that are irradiated (HE = ((&Sgr;)) Sgr; wTHT).

     (43) "Embryo/fetus" means the developing human organism from conception until the time of birth.

     (44) "Entrance or access point" means any opening through which an individual or extremity of an individual could gain access to radiation areas or to licensed radioactive materials. This includes entry or exit portals of sufficient size to permit human entry, without respect to their intended use.

     (45) "Exposure" means (a) being exposed to ionizing radiation or to radioactive material, or (b) the quotient of &Dgr;Q by &Dgr;m where "&Dgr;Q" is the absolute value of the total charge of the ions of one sign produced in air when all the electrons (negatrons and positrons) liberated by photons in a volume element of air having mass "&Dgr;m" are completely stopped in air. The special unit of exposure is the roentgen (R) and the SI equivalent is the coulomb per kilogram. One roentgen is equal to 2.58 x 10-4 coulomb per kilogram of air.

     (46) "Exposure rate" means the exposure per unit of time, such as roentgen per minute and milliroentgen per hour.

     (47) "External dose" means that portion of the dose equivalent received from any source of radiation outside the body.

     (48) "Extremity" means hand, elbow, arm below the elbow, foot, knee, and leg below the knee.

     (49) "Filtering facepiece" (dust mask) means a negative pressure particulate respirator with a filter as an integral part of the facepiece or with the entire facepiece composed of the filtering medium, not equipped with elastomeric sealing surfaces and adjustable straps.

     (50) "Fit factor" means a quantitative estimate of the fit of a particular respirator to a specific individual, and typically estimates the ratio of the concentration of a substance in ambient air to its concentration inside the respirator when worn.

     (51) "Fit test" means the use of a protocol to qualitatively or quantitatively evaluate the fit of a respirator on an individual.

     (52) "Former United States Atomic Energy Commission (AEC) or United States Nuclear Regulatory Commission (NRC) licensed facilities" means nuclear reactors, nuclear fuel reprocessing plants, uranium enrichment plants, or critical mass experimental facilities where AEC or NRC licenses have been terminated.

     (53) "Generally applicable environmental radiation standards" means standards issued by the United States Environmental Protection Agency (EPA) under the authority of the Atomic Energy Act of 1954, as amended, that impose limits on radiation exposures or levels, or concentrations or quantities of radioactive material, in the general environment outside the boundaries of locations under the control of persons possessing or using radioactive material.

     (54) "Gray" (Gy) means the SI unit of absorbed dose. One gray is equal to an absorbed dose of 1 joule/kilogram (100 rad).

     (55) "Healing arts" means the disciplines of medicine, dentistry, osteopathy, chiropractic, podiatry, and veterinary medicine.

     (56) "Helmet" means a rigid respiratory inlet covering that also provides head protection against impact and penetration.

     (57) "High radiation area" means any area, accessible to individuals, in which radiation levels from radiation sources external to the body could result in an individual receiving a dose equivalent in excess of 1 mSv (0.1 rem) in one hour at 30 centimeters from any source of radiation or 30 centimeters from any surface that the radiation penetrates. For purposes of these regulations, rooms or areas in which diagnostic X-ray systems are used for healing arts purposes are not considered high radiation areas.

     (58) "Hood" means a respiratory inlet covering that completely covers the head and neck and may also cover portions of the shoulders and torso.

     (59) "Human use" means the intentional internal or external administration of radiation or radioactive material to human beings.

     (60) "Immediate" or "immediately" means as soon as possible but no later than four hours after the initiating condition.

     (61) "IND" means investigatory new drug for which an exemption has been claimed under the United States Food, Drug and Cosmetic Act (Title 21 CFR).

     (62) "Individual" means any human being.

     (63) "Individual monitoring" means the assessment of:

     (a) Dose equivalent (i) by the use of individual monitoring devices or (ii) by the use of survey data; or

     (b) Committed effective dose equivalent (i) by bioassay or (ii) by determination of the time-weighted air concentrations to which an individual has been exposed, that is, DAC-hours.

     (64) "Individual monitoring devices" (individual monitoring equipment) means devices designed to be worn by a single individual for the assessment of dose equivalent ((such)) e.g., as film badges, thermoluminescent dosimeters (TLDs), pocket ionization chambers, and personal ("lapel") air sampling devices.

     (65) "Inspection" means an official examination or observation by the department including but not limited to, tests, surveys, and monitoring to determine compliance with rules, ((regulations,)) orders, requirements and conditions of the department.

     (66) "Interlock" means a device arranged or connected ((such)) so that the occurrence of an event or condition is required before a second event or condition can occur or continue to occur.

     (67) "Internal dose" means that portion of the dose equivalent received from radioactive material taken into the body.

     (68) "Irretrievable source" means any sealed source containing licensed material which is pulled off or not connected to the wireline downhole and for which all reasonable effort at recovery, as determined by the department, has been expended.

     (69) "Lens dose equivalent" (LDE) applies to the external exposure of the lens of the eye and is taken as the dose equivalent at a tissue depth of 0.3 centimeters (300 mg/cm2).

     (70) "License" means a license issued by the department ((in accordance with the regulations adopted by the department)).

     (71) "Licensed material" means radioactive material received, possessed, used, transferred, or disposed under a general or specific license issued by the department.

     (72) "Licensee" means any person who is licensed by the department ((in accordance with)) under these ((regulations)) rules and the act.

     (73) "Licensing state" means any state with regulations equivalent to the suggested state regulations for control of radiation relating to, and an effective program for, the regulatory control of NARM and which has been granted final designation by the Conference of Radiation Control Program Directors, Inc.

     (74) "Loose-fitting facepiece" means a respiratory inlet covering that is designed to form a partial seal with the face.

     (75) "Lost or missing licensed material" means licensed material whose location is unknown. This definition includes licensed material that has been shipped but has not reached its planned destination and whose location cannot be readily traced in the transportation system.

     (76) "Member of the public" means an individual except when the individual is receiving an occupational dose.

     (77) "Minor" means an individual less than eighteen years of age.

     (78) "Monitoring" means the measurement of radiation, radioactive material concentrations, surface area activities or quantities of radioactive material and the use of the results of these measurements to evaluate potential exposures and doses. For purposes of these regulations, radiation monitoring and radiation protection monitoring are equivalent terms.

     (79) "NARM" means any naturally occurring or accelerator-produced radioactive material. It does not include by-product, source, or special nuclear material. For the purpose of meeting the definition of a Licensing State by the Conference of Radiation Control Program Directors, Inc. (CRCPD), NARM refers only to discrete sources of NARM. Diffuse sources of NARM are excluded from consideration by the CRCPD for Licensing State designation purposes.

     (80) "Natural radioactivity" means radioactivity of naturally occurring nuclides.

     (81) "NDA" means a new drug application which has been submitted to the United States Food and Drug Administration.

     (82) "Negative pressure respirator" (tight-fitting) means a respirator in which the air pressure inside the facepiece is negative during inhalation with respect to the ambient air pressure outside the respirator.

     (83) "Nonstochastic effect" means a health effect, the severity of which varies with the dose and for which a threshold is believed to exist. Radiation-induced cataract formation is an example of a nonstochastic effect. For purposes of these ((regulations)) rules, a "deterministic effect" is an equivalent term.

     (84) "Nuclear Regulatory Commission" (NRC) means the United States Nuclear Regulatory Commission or its duly authorized representatives.

     (85) "Occupational dose" means the dose received by an individual in the course of employment in which the individual's assigned duties involve exposure to radiation or to radioactive material from licensed and unlicensed sources of radiation, whether in the possession of the licensee, registrant, or other person. Occupational dose does not include dose received: 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, or as a member of the public.

     (86) "Ore refineries" means all processors of a radioactive material ore.

     (87) "Particle accelerator" means any machine capable of accelerating electrons, protons, deuterons, or other charged particles in a vacuum and of discharging the resultant particulate or other radiation into a medium at energies usually in excess of 1 MeV.

     (88) "Permittee" means a person who has applied for, and received, a valid site use permit for use of the low-level waste disposal facility at Hanford, Washington.

     (89) "Person" means any individual, corporation, partnership, firm, association, trust, estate, public or private institution, group, agency, political subdivision of this state, any other state or political subdivision or agency thereof, and any legal successor, representative, agent or agency of the foregoing, but shall not include federal government agencies.

     (90) "Personal supervision" means supervision ((such that)) where the supervisor is physically present at the facility and in ((such)) sufficient proximity that contact can be maintained and immediate assistance given as required.

     (91) "Personnel monitoring equipment." See individual monitoring devices.

     (92) "Pharmacist" means an individual licensed by this state to compound and dispense drugs, and poisons.

     (93) "Physician" means ((an individual)) a medical doctor or doctor of osteopathy licensed by this state to prescribe and dispense drugs in the practice of medicine.

     (94) "Planned special exposure" means an infrequent exposure to radiation, separate from and in addition to the annual occupational dose limits.

     (95) "Positive pressure respirator" means a respirator in which the pressure inside the respiratory inlet covering exceeds the ambient air pressure outside the respirator.

     (96) "Powered air-purifying respirator" (PAPR) means an air-purifying respirator that uses a blower to force the ambient air through air-purifying elements to the inlet covering.

     (97) "Practitioner" means an individual licensed by the state in the practice of a healing art (i.e., physician, dentist, podiatrist, chiropractor, etc.).

     (98) "Pressure demand respirator" means a positive pressure atmosphere-supplying respirator that admits breathing air to the facepiece when the positive pressure is reduced inside the facepiece by inhalation.

     (99) "Public dose" means the dose received by a member of the public from exposure to sources of radiation under the licensee's or registrant's control or to radiation or radioactive material released by the licensee. Public dose does not include occupational dose or doses received 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, or from voluntary participation in medical research programs.

     (100) "Qualified expert" means an individual who has demonstrated to the satisfaction of the department he/she has the knowledge, training, and experience to measure ionizing radiation, to evaluate safety techniques, and to advise regarding radiation protection needs. The department reserves the right to recognize the qualifications of an individual in specific areas of radiation protection.

     (101) "Qualitative fit test" (QLFT) means a pass/fail fit test to assess the adequacy of respirator fit that relies on the individual's response to the test agent.

     (102) "Quality factor" (Q) means the modifying factor, listed in Tables I and II, that is used to derive dose equivalent from absorbed dose.


TABLE I
QUALITY FACTORS AND ABSORBED DOSE EQUIVALENCIES

TYPE OF RADIATION

Quality Factor

(Q)

Absorbed Dose Equal to

A Unit Dose Equivalenta

X, gamma, or beta radiation

and high-speed electrons

1 1
Alpha particles, multiple-

charged particles, fission

fragments and heavy particles of unknown charge

20 0.05
Neutrons of unknown energy 10 0.1
High-energy protons 10 0.1

a Absorbed dose in rad equal to 1 rem or the absorbed dose in gray equal to 1 Sv.

If it is more convenient to measure the neutron fluence rate rather than to determine the neutron dose equivalent rate in sievert per hour or rem per hour as required for Table I, then 0.01 Sv (1 rem) of neutron radiation of unknown energies may, for purposes of these regulations, be assumed to result from a total fluence of 25 million neutrons per square centimeter incident upon the body. If sufficient information exists to estimate the approximate energy distribution of the neutrons, the licensee or registrant may use the fluence rate per unit dose equivalent or the appropriate Q value from Table II to convert a measured tissue dose in gray or rad to dose equivalent in sievert or rem.

TABLE II
MEAN QUALITY FACTORS, Q, AND FLUENCE PER UNIT DOSE

EQUIVALENT FOR MONOENERGETIC NEUTRONS

Neutron

Energy

(MeV)

Quality Factora

(Q)

Fluence per Unit

Dose Equivalentb

(neutrons

cm-2 rem-1)

Fluence per Unit

Dose Equivalentb

(neutrons

cm-2 Sv-1)

(thermal) 2.5 x 10-8 2 980 x 106 980 x 108
1 x 10-7 2 980 x 106 980 x 108
1 x 10-6 2 810 x 106 810 x 108
1 x 10-5 2 810 x 106 810 x 108
1 x 10-4 2 840 x 106 840 x 108
1 x 10-3 2 980 x 106 980 x 108
1 x 10-2 2.5 1010 x 106 1010 x 108
1 x 10-1 7.5 170 x 106 170 x 108
5 x 10-1 11 39 x 106 39 x 108
1 11 27 x 106 27 x 108
2.5 9 29 x 106 29 x 108
5 8 23 x 106 23 x 108
7 7 24 x 106 24 x 108
10 6.5 24 x 106 24 x 108
14 7.5 17 x 106 17 x 108
20 8 16 x 106 16 x 108
40 7 14 x 106 14 x 108
60 5.5 16 x 106 16 x 108
1 x 102 4 20 x 106 20 x 108
2 x 102 3.5 19 x 106 19 x 108
3 x 102 3.5 16 x 106 16 x 108
4 x 102 3.5 14 x 106 14 x 108

a Value of quality factor (Q) at the point where the dose equivalent is maximum in a 30-cm diameter cylinder tissue-equivalent phantom.

b Monoenergetic neutrons incident normally on a 30-cm diameter cylinder tissue-equivalent phantom.

     (103) "Quantitative fit test" (QNFT) means an assessment of the adequacy of respirator fit by numerically measuring the amount of leakage into the respirator.

     (104) "Quarter" means a period of time equal to one-fourth of the year observed by the licensee, approximately thirteen consecutive weeks, providing that the beginning of the first quarter in a year coincides with the starting date of the year and that no day is omitted or duplicated in consecutive quarters.

     (105) "Rad" means the special unit of absorbed dose. One rad equals one-hundredth of a joule per kilogram of material; for example, if tissue is the material of interest, then 1 rad equals 100 ergs per gram of tissue. One rad is equal to an absorbed dose of 100 erg/gram or 0.01 joule/kilogram (0.01 gray).

     (106) "Radiation" means alpha particles, beta particles, gamma rays, X rays, neutrons, high-speed electrons, high-speed protons, and other particles capable of producing ions. For purposes of these regulations, ionizing radiation is an equivalent term. Radiation, as used in these regulations, does not include magnetic fields or nonionizing radiation, ((such as)) like radiowaves or microwaves, visible, infrared, or ultraviolet light.

     (107) "Radiation area" means any area, accessible to individuals, in which radiation levels could result in an individual receiving a dose equivalent in excess of 0.05 mSv (0.005 rem) in one hour at thirty centimeters from the source of radiation or from any surface that the radiation penetrates.

     (108) "Radiation machine" means any device capable of producing ionizing radiation except those devices with radioactive materials as the only source of radiation.

     (109) "Radiation safety officer" means an individual who has the knowledge and responsibility to apply appropriate radiation protection regulations and has been assigned ((such)) that responsibility by the licensee or registrant.

     (110) "Radiation source." See "Source of radiation."

     (111) "Radioactive material" means any material (solid, liquid, or gas) which emits radiation spontaneously.

     (112) "Radioactive waste" means any radioactive material which is no longer of use and intended for disposal or treatment for the purposes of disposal.

     (113) "Radioactivity" means the transformation of unstable atomic nuclei by the emission of radiation.

     (114) "Reference man" means a hypothetical aggregation of human physical and physiological characteristics determined by international consensus. These characteristics may be used by researchers and public health workers to standardize results of experiments and to relate biological insult to a common base.

     (115) "Registrable item" means any radiation machine except those exempted by RCW 70.98.180 or exempted by the department ((pursuant to)) under the authority of RCW 70.98.080.

     (116) "Registrant" means any person who is registered by the department or is legally obligated to register with the department in accordance with these ((regulations)) rules and the act.

     (117) "Registration" means registration with the department in accordance with the regulations adopted by the department.

     (118) "Regulations of the United States Department of Transportation" means the regulations in 49 CFR Parts 170-189, 14 CFR Part 103, and 46 CFR Part 146.

     (119) "Rem" means the special unit of any of the quantities expressed as dose equivalent. The dose equivalent in rem is equal to the absorbed dose in rad multiplied by the quality factor (1 rem = 0.01 Sv).

     (120) "Research and development" means: (a) Theoretical analysis, exploration, or experimentation; or (b) the extension of investigative findings and theories of a scientific or technical nature into practical application for experimental and demonstration purposes, including the experimental production and testing of models, devices, equipment, materials, and processes. Research and development does not include the internal or external administration of radiation or radioactive material to human beings.

     (121) "Respiratory protective equipment" means an apparatus, such as a respirator, used to reduce an individual's intake of airborne radioactive materials.

     (122) "Restricted area" means any area to which access is limited by the licensee or registrant for purposes of protecting individuals against undue risks from exposure to radiation and radioactive material. "Restricted area" ((shall)) does not include any areas used for residential quarters, although a separate room or rooms in a residential building may be set apart as a restricted area.

     (123) "Roentgen" (R) means the special unit of exposure. One roentgen equals 2.58 x 10-4 coulombs/kilogram of air.

     (124) "Sanitary sewerage" means a system of public sewers for carrying off waste water and refuse, but excluding sewage treatment facilities, septic tanks, and leach fields owned or operated by the licensee or registrant.

     (125) "Sealed source" means any radioactive material that is encased in a capsule designed to prevent leakage or the escape of the radioactive material.

     (126) "Self-contained breathing apparatus" (SCBA) means an atmosphere-supplying respirator for which the breathing air source is designed to be carried by the user.

     (127) "Shallow dose equivalent" (Hs), which applies to the external exposure of the skin of the whole body or the skin of an extremity, means the dose equivalent at a tissue depth of 0.007 centimeter (7 mg/cm2).

     (128) "SI" means an abbreviation of the International System of Units.

     (129) "Sievert" means the SI unit of any of the quantities expressed as dose equivalent. The dose equivalent in sievert is equal to the absorbed dose in gray multiplied by the quality factor (1 Sv = 100 rem).

     (130) "Site area emergency" means events may occur, are in progress, or have occurred that could lead to a significant release of radioactive material and that could require a response by offsite response organizations to protect persons offsite.

     (131) "Site boundary" means that line beyond which the land or property is not owned, leased, or otherwise controlled by the licensee or registrant.

     (132) "Source container" means a device in which radioactive material is transported or stored.

     (133) "Source material" means: (a) Uranium or thorium, or any combination thereof, in any physical or chemical form, or (b) ores which contain by weight one-twentieth of one percent (0.05 percent) or more of (i) uranium, (ii) thorium, or (iii) any combination thereof. Source material does not include special nuclear material.

     (134) "Source material milling" means the extraction or concentration of uranium or thorium from any ore processing primarily for its source material content.

     (135) "Source of radiation" means any radioactive material, or any device or equipment emitting or capable of producing ionizing radiation.

     (136) "Special nuclear material" means:

     (a) Plutonium, uranium-233, uranium enriched in the isotope 233 or in the isotope 235, and any other material that the United States Nuclear Regulatory Commission, ((pursuant to)) under the provisions of section 51 of the Atomic Energy Act of 1954, as amended, determines to be special nuclear material, but does not include source material; or

     (b) Any material artificially enriched in any of the foregoing, but does not include source material.

     (137) "Special nuclear material in quantities not sufficient to form a critical mass" means uranium enriched in the isotope U-235 in quantities not exceeding three hundred fifty grams of contained U-235; Uranium-233 in quantities not exceeding two hundred grams; Plutonium in quantities not exceeding two hundred grams; or any combination of them in accordance with the following formula: For each kind of special nuclear material, determine the ratio between the quantity of that special nuclear material and the quantity specified above for the same kind of special nuclear material. The sum of ((such)) the ratios for all of the kinds of special nuclear material in combination shall not exceed "1" (i.e., unity). For example, the following quantities in combination would not exceed the limitation and are within the formula:

175 (grams contained U-235)


          350

+
50 (grams U-233)


200

+
50 (grams Pu)


200

< 1

     (138) "Stochastic effect" means a health effect that occurs randomly and for which the probability of the effect occurring, rather than its severity, is assumed to be a linear function of dose without threshold. Hereditary effects and cancer incidence are examples of stochastic effects. For purposes of these regulations, probabilistic effect is an equivalent term.

     (139) "Supplied-air respirator" (SAR) or "airline respirator" means an atmosphere-supplying respirator for which the source of breathing air is not designed to be carried by the user.

     (140) "Survey" means an evaluation of the radiological conditions and potential hazards incident to the production, use, release, disposal, or presence of sources of radiation. When appropriate, ((such)) the evaluation includes, but is not limited to, tests, physical examinations, calculations and measurements of levels of radiation or concentration of radioactive material present.

     (141) "Test" means (a) the process of verifying compliance with an applicable regulation, or (b) a method for determining the characteristics or condition of sources of radiation or components thereof.

     (142) "These ((regulations)) rules" mean all parts of the rules for radiation protection of the state of Washington.

     (143) "Tight-fitting facepiece" means a respiratory inlet covering that forms a complete seal with the face.

     (144) "Total effective dose equivalent" (TEDE) means the sum of the deep dose equivalent for external exposures and the committed effective dose equivalent for internal exposures.

     (145) "Total organ dose equivalent" (TODE) means the sum of the deep dose equivalent and the committed dose equivalent to the organ or tissue receiving the highest dose.

     (146) "United States Department of Energy" means the Department of Energy established by Public Law 95-91, August 4, 1977, 91 Stat. 565, 42 U.S.C. 7101 et seq., to the extent that the department exercises functions formerly vested in the United States Atomic Energy Commission, its chairman, members, officers and components and transferred to the United States Energy Research and Development Administration and to the administrator thereof ((pursuant to)) under sections 104 (b), (c) and (d) of the Energy Reorganization Act of 1974 (Public Law 93-438, October 11, 1974, 88 Stat. 1233 at 1237, 42 U.S.C. 5814 effective January 19, 1975) and retransferred to the Secretary of Energy ((pursuant to)) under section 301(a) of the Department of Energy Organization Act (Public Law 95-91, August 4, 1977, 91 Stat. 565 at 577-578, 42 U.S.C. 7151, effective October 1, 1977).

     (147) "Unrefined and unprocessed ore" means ore in its natural form prior to any processing, such as grinding, roasting, beneficiating, or refining.

     (148) "Unrestricted area" (uncontrolled area) means any area which is not a restricted area. Areas where the external dose exceeds 2 mrem in any one hour or where the public dose, taking into account occupancy factors, will exceed 100 mrem total effective dose equivalent in any one year must be restricted.

     (149) "User seal check" (fit check) means an action conducted by the respirator user to determine if the respirator is properly seated to the face. Examples include negative pressure check, positive pressure check, irritant smoke check, or isoamyl acetate check.

     (150) "Very high radiation area" means an area, accessible to individuals, in which radiation levels from radiation sources external to the body could result in an individual receiving an absorbed dose in excess of 5 Gy (500 rad) in one hour at one meter from a source of radiation or one meter from any surface that the radiation penetrates.

     (151) "Waste handling licensees" mean persons licensed to receive and store radioactive wastes prior to disposal and/or persons licensed to dispose of radioactive waste.

     (152) "Week" means seven consecutive days starting on Sunday.

     (153) "Weighting factor" wT for an organ or tissue (T) means the proportion of the risk of stochastic effects resulting from irradiation of that organ or tissue to the total risk of stochastic effects when the whole body is irradiated uniformly. For calculating the effective dose equivalent, the values of wT are:


ORGAN DOSE WEIGHTING FACTORS
Organ or

Tissue

wT

Gonads 0.25
Breast 0.15
Red bone marrow 0.12
Lung 0.12
Thyroid 0.03
Bone surfaces 0.03
Remainder 0.30a
Whole Body 1.00b

a 0.30 results form 0.06 for each of 5 "remainder” organs, excluding the skin and the lens of the eye, that receive the highest doses.

b For the purpose of weighting the external whole body dose, for adding it to the internal dose, a single weighting factor, wT =1.0, has been specified. The use of other weighting factors for external exposure will be approved on a case-by-case basis until such time as specific guidance is issued.

     (154) "Whole body" means, for purposes of external exposure, head, trunk including male gonads, arms above the elbow, or legs above the knee.

     (155) "Worker" means an individual engaged in activities under a license or registration issued by the department and controlled by a licensee or registrant but does not include the licensee or registrant. Where the licensee or registrant is an individual rather than one of the other legal entities defined under "person," the radiation exposure limits for the worker also apply to the individual who is the licensee or registrant. If students of age eighteen years or older are subjected routinely to work involving radiation, then the students are considered to be workers. Individuals of less than eighteen years of age shall meet the requirements of WAC 246-221-050.

     (156) "Working level" (WL) means any combination of short-lived radon daughters in 1 liter of air that will result in the ultimate emission of 1.3 x 105 MeV of potential alpha particle energy. The short-lived radon daughters are -- for radon-222: polonium-218, lead-214, bismuth-214, and polonium-214; and for radon-220: polonium-216, lead-212, bismuth-212, and polonium-212.

     (157) "Working level month" (WLM) means an exposure to one working level for one hundred seventy hours -- two thousand working hours per year divided by twelve months per year is approximately equal to one hundred seventy hours per month.

     (158) "Year" means the period of time beginning in January used to determine compliance with the provisions of these regulations. The licensee or registrant may change the starting date of the year used to determine compliance by the licensee or registrant provided that the change is made at the beginning of the year and that no day is omitted or duplicated in consecutive years.

[Statutory Authority: RCW 70.98.050. 04-23-093, § 246-220-010, filed 11/17/04, effective 12/18/04; 01-05-110, § 246-220-010, filed 2/21/01, effective 3/24/01; 00-08-013, § 246-220-010, filed 3/24/00, effective 4/24/00; 99-15-105, § 246-220-010, filed 7/21/99, effective 8/21/99; 98-13-037, § 246-220-010, filed 6/8/98, effective 7/9/98; 95-01-108, § 246-220-010, filed 12/21/94, effective 1/21/95; 94-01-073, § 246-220-010, filed 12/9/93, effective 1/9/94. Statutory Authority: RCW 70.98.050 and 70.98.080. 91-15-112 (Order 184), § 246-220-010, filed 7/24/91, effective 8/24/91. Statutory Authority: RCW 43.70.040. 91-02-049 (Order 121), recodified as § 246-220-010, filed 12/27/90, effective 1/31/91. Statutory Authority: RCW 70.98.080. 87-01-031 (Order 2450), § 402-12-050, filed 12/11/86; 83-19-050 (Order 2026), § 402-12-050, filed 9/16/83. Statutory Authority: Chapter 70.121 RCW. 81-16-031 (Order 1683), § 402-12-050, filed 7/28/81. Statutory Authority: RCW 70.98.050. 81-01-011 (Order 1570), § 402-12-050, filed 12/8/80; Order 1095, § 402-12-050, filed 2/6/76; Order 708, § 402-12-050, filed 8/24/72; Order 1, § 402-12-050, filed 7/2/71; Order 1, § 402-12-050, filed 1/8/69; Rules (part), filed 10/26/66.]

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.]


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

WAC 246-221-060   Dose limits for individual members of the public.        (1) Each licensee or registrant shall conduct operations so that:

     (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.]


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

WAC 246-221-130   Exceptions from posting and labeling requirements.   (1) A room or area is not required to be posted with a caution sign because of the presence of a sealed source, provided the radiation level 30 centimeters from the surface of the source container or housing does not exceed 0.05 mSv (five millirem) per hour.

     (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.]


AMENDATORY SECTION(Amending WSR 01-02-068, filed 12/29/00, effective 1/29/01)

WAC 246-232-014   Exemption of C-14 urea diagnostic capsules for human use.   (1) Except as provided in subsections (2) and (3) of this section, a person is exempt from the requirements for a license set forth in chapters 246-233 and 246-235 WAC if the person receives, possesses, uses, transfers, owns, or acquires capsules containing 37 kilobequerels (1 microcurie) carbon-14 urea (allowing for nominal variation that may occur during the manufacturing process) each, for "in vivo" diagnostic use for humans.

     (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.]


AMENDATORY SECTION(Amending WSR 00-08-013, filed 3/24/00, effective 4/24/00)

WAC 246-235-080   Special requirements for ((issuance of specific licenses for medical use of radioactive material)) possession and use of medical calibration and reference sources.   (((1) Human use of radioactive material in institutions. In addition to the requirements set forth in WAC 246-235-020 a specific license for human use of radioactive material in institutions will be issued if:

     (a) The applicant has appointed a radiation safety committee to coordinate the use of radioactive material throughout that institution and to maintain surveillance over the institution's radiation safety program. Membership of the committee should include a specialist (where applicable a physician) from each department where radioactive material is used, a representative of the institution's management, a representative of the nursing staff, and a person trained in radiation safety. The radiation safety committee shall meet at least quarterly. Minutes shall be taken and maintained for two years for inspection by the department;

     (b) The applicant possesses adequate facilities for the clinical care of patients. The applicant is advised that construction of new radioisotope facilities and modification of existing facilities must also comply with the requirements of WAC 246-318-660 of the construction review section of the department;

     (c) The physician(s) designated on the application as the individual user(s) has (or have) substantial experience in the handling and administration of radioactive material and, where applicable, the clinical management of radioactive patients; and

     (d) If the application is for a license to use unspecified quantities or multiple types of radioactive material, the applicant's staff has substantial experience in the use of a variety of radioactive materials for a variety of human uses.

     (2) Licensing of individual physicians for human use of radioactive material. In addition to the requirements set forth in WAC 246-235-020 a specific license for the human use of radioactive material will be issued to an individual physician if:

     (a) The applicant has access to a hospital possessing adequate facilities to hospitalize and monitor the applicant's radioactive patients whenever it is advisable;

     (b) The applicant has extensive experience in the handling and administration of radioactive material and, where applicable, the clinical management of radioactive patients;

     (c) The application is for use in the applicant's practice in an office outside a medical institution; and

     (d) If the application is for use by an individual physician or group of physicians for a specific license to receive, possess or use radioactive material on the premises of a medical institution, the department will issue a specific license only if:

     (i) The use of radioactive material is limited to the:

     (A) Administration of radiopharmaceuticals for diagnostic or therapeutic purposes;

     (B) Performance of diagnostic studies on patients to whom a radiopharmaceutical has been administered;

     (C) Performance of in vitro diagnostic studies; or

     (D) Calibration and quality control checks of radioactive assay instrumentation, radiation safety instrumentation and diagnostic instrumentation;

     (ii) The physician brings the radioactive material with him or her and removes the radioactive material when he or she departs. (The institution cannot receive, possess or store radioactive material other than the amount of material remaining in the patient); and

     (iii) The medical institution does not hold a radioactive material license issued pursuant to the provisions of subsection (1) of this section.

     (3) Specific licenses for certain groups of medical uses of radioactive material.

     (a) Subject to the provisions of (b), (c) and (d) of this subsection an application for a specific license pursuant to subsection (1), (2) or (4) of this section, or for any medical use or uses of radioactive material specified in one or more of Groups I to VI, inclusive, of WAC 246-235-120, Schedule A, will be approved for all of the uses within the group or groups which include the use or uses specified in the application if:

     (i) The applicant satisfies the requirements of subsection (1), (2) or (4) of this section;

     (ii) The applicant, or the physician designated in the application as the individual user, has adequate clinical experience in the types of uses included in the group or groups;

     (iii) The applicant, or the physicians and all other personnel who will be involved in the preparation and use of the radioactive material, have adequate training and experience in the handling of radioactive material appropriate to their participation in the uses included in the group or groups;

     (iv) The applicant's radiation detection and measuring instrumentation is adequate for conducting the procedures involved in the uses included in the group or groups, specifically:

     (A) For Groups I through V, applicant must possess and use a calibrated and operable low-range survey instrument with a thin window (less than 7 mg/cm2) capable of detecting radiation levels of 0.05 milliroentgen per hour up to at least 20 milliroentgens per hour;

     (B) For Groups III, V, and VI, applicant must possess a calibrated and operable high-range survey instrument capable of detecting radiation levels up to at least one Roentgen per hour;

     (v) The applicant's radiation safety operating procedures are adequate for handling and disposal of the radioactive material involved in the uses included in the group or groups.

     (b) Any licensee or registrant who is authorized to use radioactive material pursuant to one or more groups in (a) of this subsection and WAC 246-235-120, Schedule A, is subject to the following conditions:

     (i) For Groups I, II, IV, and V, no licensee or registrant shall receive, possess or use radioactive material except as a radiopharmaceutical manufactured in the form to be administered to the patient, labeled, packaged and distributed in accordance with a specific license issued by the department pursuant to WAC 246-235-100, a specific license issued by the United States Nuclear Regulatory Commission pursuant to Section 32.72 of 10 CFR Part 32, or a specific license issued by an agreement state or a licensing state pursuant to equivalent regulations.

     (ii) For Group III, no licensee or registrant shall receive, possess or use generators or reagent kits containing radioactive material unless manufactured, labeled, packaged and distributed in accordance with a specific license issued by the department pursuant to WAC 246-235-100, a specific license issued by the United States Nuclear Regulatory Commission under Section 32.73 of 10 CFR Part 32, or a specific license issued by an agreement state or a licensing state under equivalent regulations.

     (iii) For Group VI, no licensee or registrant shall receive, possess or use radioactive material except as contained in a source or device that has been manufactured, labeled, packaged and distributed in accordance with a specific license issued by the department under WAC 246-235-102, a specific license issued by the United States Nuclear Regulatory Commission under Section 32.74 of 10 CFR Part 32, or a specific license issued to the manufacturer by an agreement state or a licensing state under equivalent regulations.

     (iv) For Group III, any licensee or registrant who uses generators or reagent kits shall elute the generator or process radioactive material with the reagent kit in accordance with instructions approved by the department, the United States Nuclear Regulatory Commission, an agreement state or a licensing state and are furnished by the manufacturer on the label attached to or in the leaflet or brochure which accompanies the generator or reagent kit.

     (c) Any licensee who is licensed under (a) of this subsection for one or more of the medical use groups in WAC 246-235-120, Schedule A, also is authorized, subject to the provisions of (c) and (d) of this subsection to receive, possess and use for calibration and reference standards:

     (i) Any radioactive material authorized for use under Group I, Group II, or Group III of WAC 246-235-120, Schedule A, with a half-life not longer than one hundred days, in amounts not to exceed 15 millicuries total;

     (ii) Any radioactive material authorized for use under Group I, Group II, or Group III of WAC 246-235-120, Schedule A, with half-life greater than one hundred days in amounts not to exceed 200 microcuries total;

     (iii) Technetium-99m in amounts not to exceed 50 millicuries;

     (iv) Any radioactive material excluding Radium-226, in amounts not to exceed fifteen millicuries per sealed source, contained in calibration or reference sources that have been manufactured, labeled, packaged, and distributed in accordance with a specific license issued by the department pursuant to WAC 246-235-102, a specific license issued by the United States Nuclear Regulatory Commission pursuant to Section 32.74 of 10 CFR Part 32, or a specific license issued to the manufacturer by an agreement state or a licensing state pursuant to equivalent regulations.

     (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.]


AMENDATORY SECTION(Amending WSR 00-08-013, filed 3/24/00, effective 4/24/00)

WAC 246-235-090   Special requirements for specific licenses of broad scope.   This section prescribes requirements for the issuance of specific licenses of broad scope for radioactive material ("broad licenses") and certain regulations governing holders of ((such)) these licenses.*


*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.]


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

WAC 246-235-100   Manufacture, preparation, or commercial transfer of radiopharmaceuticals for medical use.   (1) An application for a specific license to manufacture and, prepare, or transfer for commercial distribution radiopharmaceuticals containing radioactive material for use by persons licensed ((pursuant to)) under chapter 246-240 WAC ((246-235-080 (1), (2), or (3))) for medical use in humans will be approved if:

     (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.]


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

WAC 246-235-102   Manufacture and distribution of sources or devices containing radioactive material for medical use.   An application for a specific license to manufacture and distribute sources and devices containing radioactive material to persons licensed ((pursuant to)) under chapter 246-240 WAC ((246-235-080(3))) for use as a calibration or reference source ((or for the uses listed in Group VI of WAC 246-235-120 Schedule A of this part)) will be approved if:

     (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.]


AMENDATORY SECTION(Amending Order 184, filed 7/24/91, effective 8/24/91)

WAC 246-235-110   Special requirements for issuance of specific licenses for source material milling.   In addition to the requirements set forth in WAC 246-235-020, the department will issue a specific license for source material milling ((will be issued if)) when the applicant submits ((to the department)) a satisfactory application ((as described herein)) and meets the other conditions specified below:

     (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.]


REPEALER

     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

Chapter 246-239 WAC

RADIATION PROTECTION(( -- NUCLEAR MEDICINE)) FOR SUBSEQUENT USE


NEW SECTION
WAC 246-239-900   Directive.   The licensee/reader, looking for nuclear medicine regulations formerly located in chapter 246-239 WAC, "Radiation protection -- Nuclear medicine" is directed to the updated nuclear medicine regulations that are now contained entirely within chapter 246-240 WAC, "Radiation protection -- Medical use of radioactive material."

[]


REPEALER

     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-7750.10

Chapter 246-240 WAC

RADIATION PROTECTION -- MEDICAL ((THERAPY)) USE OF RADIOACTIVE MATERIAL


AMENDATORY SECTION(Amending Order 121, filed 12/27/90, effective 1/31/91)

WAC 246-240-001   Purpose and scope.   ((The provisions of this chapter apply to all licensees who use sealed sources in the healing arts and are in addition to, and not in substitution for, other applicable provisions of these regulations.)) This chapter contains the requirements and provisions for the medical use of radioactive material and for issuance of specific licenses authorizing the medical use of this material. These requirements and provisions provide for the radiation safety of workers, the general public, patients, and human research subjects. The requirements and provisions of chapters 246-220, 246-221, 246-222, 246-232, 246-235, and 246-254 WAC, apply to applicants and licensees subject to this chapter unless specifically exempted. When a requirement in this chapter differs from the requirement in an existing license condition, the requirement in this chapter shall govern.

[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.]


NEW SECTION
WAC 246-240-004   Other federal and state requirements.   Nothing in this chapter relieves the licensee from complying with applicable FDA, or other federal and state requirements governing radioactive drugs or devices.

[]


NEW SECTION
WAC 246-240-007   Provisions for the protection of human research subjects.   (1) A licensee may conduct research involving human research subjects only if it uses the radioactive materials specified on its license for the uses authorized on its license.

     (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.

[]


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

WAC 246-240-010   Definitions.   ((As used in this chapter, the following definitions apply:

     (1) "Authorized user" means a physician who is identified as an authorized user on a department, U.S. Nuclear Regulatory Commission or agreement state license that authorizes the medical use of radioactive material.

     (2) "Brachytherapy" means a method of radiation therapy in which sealed sources are utilized to deliver a radiation dose at a distance of up to a few centimeters, by surface, intracavitary, or interstitial application.

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

     (4) "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; or

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

     (5) "Recordable therapy event" means the administration of:

     (a) Radiation without a written directive where a written directive is required;

     (b) Radiation where a written directive is required without daily recording of each radiation dose in the appropriate record;

     (c) A teletherapy radiation dose when the calculated weekly administered dose exceeds the weekly prescribed dose by fifteen percent or more of the weekly prescribed dose; or

     (d) A brachytherapy radiation dose when the calculated administered dose differs from the prescribed dose by more than ten percent of the prescribed dose.

     (6) "Teletherapy" means therapeutic irradiation in which the source of radiation is at a distance from the body.

     (7) "Therapy misadministration" means the administration of:

     (a) A gamma stereotactic radiosurgery radiation dose:

     (i) Involving the wrong individual or wrong treatment site; or

     (ii) When the calculated total administered dose differs from the total prescribed dose by more than ten percent of the total prescribed dose;

     (b) A teletherapy radiation dose:

     (i) Involving the wrong individual, wrong mode of treatment, or wrong treatment site;

     (ii) When the treatment consists of three or fewer fractions and the calculated total administered dose differs from the total prescribed dose by more than ten percent of the total prescribed dose;

     (iii) When the calculated weekly administered dose exceeds the weekly prescribed dose by thirty percent or more of the weekly prescribed dose; or

     (iv) When the calculated total administered dose differs from the total prescribed dose by more than twenty percent of the total prescribed dose;

     (c) A brachytherapy radiation dose:

     (i) Involving the wrong individual, wrong radioisotope, or wrong treatment site (excluding, for permanent implants, seeds that were implanted in the correct site but migrated outside the treatment site);

     (ii) Involving a sealed source that is leaking;

     (iii) When, for a temporary implant, one or more sealed sources are not removed upon completion of the procedure; or

     (iv) When the calculated administered dose to the treatment site differs from the prescribed dose by more than twenty percent of the prescribed dose.

     (8) "Written directive" means an order in writing for a specific patient or human research subject, dated and signed by an authorized user prior to the administration of radiation, except as specified in (d) of this subsection, containing the following information:

     (a) For gamma stereotactic radiosurgery: Target coordinates, collimator size, plug pattern, and total dose;

     (b) For teletherapy: The total dose, dose per fraction, treatment site, and overall treatment period;

     (c) For high-dose-rate remote after loading brachytherapy: The radioisotope, treatment site, and total dose; or

     (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, 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 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.]


NEW SECTION
WAC 246-240-013   Maintenance of records.   Each record required by this chapter must be legible throughout the retention period specified by each department regulation. The record may be the original or a reproduced copy or a microform provided that the copy or microform is authenticated by authorized personnel and that the microform is capable of producing a clear copy throughout the required retention period. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records such as letters, drawings, and specifications, must include all pertinent information such as stamps, initials, and signatures. The licensee shall maintain adequate safeguards against tampering with and loss of records.

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NEW SECTION
WAC 246-240-016   License required.   (1) A person may manufacture, produce, acquire, receive, possess, prepare, use, or transfer radioactive material for medical use only in accordance with a specific license issued by the department, the U.S. NRC or an agreement state, or as allowed in subsection (2)(a) or (b) of this section.

     (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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NEW SECTION
WAC 246-240-019   Application for license, amendment, or renewal.   (1) An application must be signed by the applicant's or licensee's management.

     (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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NEW SECTION
WAC 246-240-022   License amendments.   A licensee shall apply for and must receive a license amendment before the licensee:

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

WAC 246-240-025   ((Release of individuals containing permanent implants.)) Notifications.   (1) ((The licensee may authorize the release from its control of any individual who has permanent implants containing radioactive material if the total effective dose equivalent to any other individual from exposure to the released individual is not likely to exceed 5 millisieverts (0.5 rem).

     (2) The licensee shall provide the released individual 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 millisievert (0.1 rem).

     (3) The licensee shall maintain a record of the basis for authorizing the release of an individual, for three years after the date of release, if the total effective dose equivalent is calculated by:

     (a) Using an occupancy factor less then 0.25 at 1 meter; or

     (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.]


NEW SECTION
WAC 246-240-028   Exemptions regarding Type A specific licenses of broad scope.   A licensee possessing a Type A specific license of broad scope for medical use, issued under WAC 246-235-090, is exempt from the provisions of:

     (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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NEW SECTION
WAC 246-240-031   License issuance and specific exemptions.   (1) The department shall issue a license for the medical use of radioactive material if:

     (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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NEW SECTION
WAC 246-240-051   Authority and responsibilities for the radiation protection program.   (1) In addition to the radiation protection program requirements of WAC 246-221-005, a licensee's management shall approve in writing:

     (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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NEW SECTION
WAC 246-240-054   Radiation protection program changes.   (1) A licensee may revise its radiation protection program without department approval if:

     (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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NEW SECTION
WAC 246-240-057   Supervision.   (1) A licensee that permits the receipt, possession, use, or transfer of radioactive material by an individual under the supervision of an authorized user, as allowed by WAC 246-240-016, shall in addition to the requirements in WAC 246-222-030:

     (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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NEW SECTION
WAC 246-240-060   Written directives.   (1) A written directive must be dated and signed by an authorized user before the administration of I-131 sodium iodide greater than 1.11 megabecquerels (MBq) (30 microcuries (µCi)), any therapeutic dosage of unsealed radioactive material or any therapeutic dose of radiation from radioactive material.

     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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NEW SECTION
WAC 246-240-063   Procedures for administrations requiring a written directive.   (1) For any administration requiring a written directive, the licensee shall develop, implement, and maintain written procedures to provide high confidence that:

     (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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NEW SECTION
WAC 246-240-066   Suppliers for sealed sources or devices for medical use.   For medical use, a licensee may only use:

     (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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NEW SECTION
WAC 246-240-069   Training for radiation safety officer.   Except as provided in WAC 246-240-078, the licensee shall require an individual fulfilling the responsibilities of the radiation safety officer under WAC 246-240-051 to be an individual who:

     (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 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; 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 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 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 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 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.

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NEW SECTION
WAC 246-240-072   Training for an authorized medical physicist.   Except as provided in WAC 246-240-078, the licensee shall require the authorized medical physicist to be an individual who:

     (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 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 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; 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 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 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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NEW SECTION
WAC 246-240-075   Training for an authorized nuclear pharmacist.   Except as provided in WAC 246-240-078, the licensee shall require the authorized nuclear pharmacist to be a pharmacist who:

     (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 and who meets the requirements in subsection (2)(b) of this section. (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 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, 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.

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NEW SECTION
WAC 246-240-078   Training for experienced radiation safety officer, teletherapy or medical physicist, authorized user, and nuclear pharmacist.   (1) An individual identified as a radiation safety officer, a teletherapy or medical physicist, or a nuclear pharmacist on a department, U.S. NRC, or agreement state license, or a permit issued by an agreement state or U.S. NRC broad scope licensee or master material license permit, or by a master material license permittee of broad scope before October 24, 2006, need not comply with the training requirements of WAC 246-240-278, 246-240-072, or 246-240-075, respectively.

     (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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NEW SECTION
WAC 246-240-081   Recentness of training.   Training and experience specified in WAC 246-240-069, 246-240-072, 246-240-075, 246-240-078, 246-240-154, 246-240-163, 246-240-210, 246-240-213, 246-240-216, 246-240-278, 246-240-281, 246-240-399, and 246-240-451 through 246-240-487 (inclusive), must have been obtained within the seven years preceding the date of application or the individual must have had related continuing education and experience since the required training and experience was completed.

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NEW SECTION
WAC 246-240-101   Possession, use, and calibration of instruments used to measure the activity of unsealed radioactive material.   (1) For direct measurements performed in accordance with WAC 246-240-107, a licensee shall possess and use instrumentation to measure the activity of unsealed radioactive material before it is administered to each patient or human research subject.

     (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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NEW SECTION
WAC 246-240-104   Calibration of survey instruments.   (1) A licensee shall calibrate the survey instruments used to show compliance with this section and WAC 246-240-587 before first use, annually, and following a repair that affects the calibration. A licensee shall:

     (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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NEW SECTION
WAC 246-240-107   Determination of dosages of unsealed radioactive material for medical use.   (1) A licensee shall determine and record the activity of each dosage before medical use.

     (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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NEW SECTION
WAC 246-240-110   Authorization for calibration, transmission, and reference sources.   Any person authorized by WAC 246-240-016 for medical use of radioactive material may receive, possess, and use any of the following radioactive material for check, calibration, transmission, and reference use:

     (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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NEW SECTION
WAC 246-240-113   Requirements for possession of sealed sources and brachytherapy sources.   (1) A licensee in possession of any sealed source or brachytherapy source shall follow the radiation safety and handling instructions supplied by the manufacturer.

     (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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NEW SECTION
WAC 246-240-116   Labeling of vials and syringes.   Each syringe and vial that contains unsealed radioactive material must be labeled to identify the radioactive drug. Each syringe shield and vial shield must also be labeled unless the label on the syringe or vial is visible when shielded.

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NEW SECTION
WAC 246-240-119   Surveys of ambient radiation exposure rate.   (1) In addition to the surveys required by chapter 246-221 WAC, a licensee shall survey with a radiation detection survey instrument at the end of each day of use. A licensee shall survey all areas where unsealed radioactive material requiring a written directive was prepared for use or administered.

     (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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NEW SECTION
WAC 246-240-122   Release of individuals containing unsealed radioactive material or implants containing radioactive material.   (1) A licensee may authorize the release from its control of any individual who has been administered unsealed radioactive material or implants containing radioactive material if the total effective dose equivalent to any other individual from exposure to the released individual is not likely to exceed 5 mSv (0.5 rem).

     (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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NEW SECTION
WAC 246-240-125   Provision of mobile medical service.   (1) A licensee who provides mobile medical service shall:

     (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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NEW SECTION
WAC 246-240-128   Decay-in-storage.   (1) A licensee may hold radioactive material with a physical half-life of less than one hundred twenty days for decay-in-storage before disposal without regard to its radioactivity if it:

     (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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NEW SECTION
WAC 246-240-151   Use of unsealed radioactive material for uptake, dilution, and excretion studies for which a written directive is not required.   Except for quantities that require a written directive under WAC 246-240-060(2), a licensee may use any unsealed radioactive material prepared for medical use for uptake, dilution, or excretion studies that is:

     (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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NEW SECTION
WAC 246-240-154   Training for uptake, dilution, and excretion studies.   Except as provided in WAC 246-240-078, the licensee shall require an authorized user of unsealed radioactive material for the uses authorized under WAC 246-240-151 to be a physician who:

     (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 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.) 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, 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 246-240-154, 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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NEW SECTION
WAC 246-240-157   Use of unsealed radioactive material for imaging and localization studies for which a written directive is not required.   Except for quantities that require a written directive under WAC 246-240-060(2), a licensee may use any unsealed radioactive material prepared for medical use for imaging and localization studies that is:

     (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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NEW SECTION
WAC 246-240-160   Permissible molybdenum-99 concentration.   (1) A licensee may not administer to humans a radiopharmaceutical that contains more than 5.55 kilobecquerel of molybdenum-99 per 37 megabecquerel of technetium-99m (0.15 microcurie of molybdenum-99 per millicurie of technetium-99m).

     (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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NEW SECTION
WAC 246-240-163   Training for imaging and localization studies.   Except as provided in WAC 246-240-078, the licensee shall require an authorized user of unsealed radioactive material for the uses authorized under WAC 246-240-157 to be a physician who:

     (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 and who meets the requirements in subsection (3)(b) of this section. (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, 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 246-240-163 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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NEW SECTION
WAC 246-240-201   Use of unsealed radioactive material for which a written directive is required.   A licensee may use any unsealed radioactive material prepared for medical use and for which a written directive is required that is:

     (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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NEW SECTION
WAC 246-240-204   Safety instruction.   In addition to the requirements of WAC 246-222-030:

     (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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NEW SECTION
WAC 246-240-207   Safety precautions.   (1) For each patient or human research subject who cannot be released under WAC 246-240-122, a licensee shall:

     (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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NEW SECTION
WAC 246-240-210   Training for use of unsealed radioactive material for which a written directive is required.   Except as provided in WAC 246-240-078, the licensee shall require an authorized user of unsealed radioactive material for the uses authorized under WAC 246-240-201 to be a physician who:

     (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 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 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, 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;

     (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 subsection (1)(a) and (b) of this section 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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NEW SECTION
WAC 246-240-213   Training for the oral administration of sodium iodide I-131 requiring a written directive in quantities less than or equal to 1.22 gigabecquerels (33 millicuries).   Except as provided in WAC 246-240-078, the licensee shall require an authorized user for the oral administration of sodium iodide I-131 requiring a written directive in quantities less than or equal to 1.22 gigabecquerels (33 millicuries), to be a physician who:

     (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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NEW SECTION
WAC 246-240-216   Training for the oral administration of sodium iodide I-131 requiring a written directive in quantities greater than 1.22 gigabecquerels (33 millicuries).   Except as provided in WAC 246-240-078, the licensee shall require an authorized user for the oral administration of sodium iodide I-131 requiring a written directive in quantities greater than 1.22 gigabecquerels (33 millicuries), to be a physician who:

     (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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NEW SECTION
WAC 246-240-219   Training for the parenteral administration of unsealed radioactive material requiring a written directive.   Except as provided in WAC 246-240-078, the licensee shall require an authorized user for the parenteral administration requiring a written directive, to be a physician who:

     (1) Is an authorized user under WAC 246-240-210 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 246-240-210 or 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 or 246-240-460 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 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 must be signed by a preceptor authorized user who meets the requirements in WAC 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 or 246-240-219, must have experience in administering dosages as specified in WAC 246-240-210 (2)(b)(vii)(C) and/or (D).

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NEW SECTION
WAC 246-240-251   Use of sources for manual brachytherapy.   A licensee shall use only brachytherapy sources for therapeutic medical uses:

     (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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NEW SECTION
WAC 246-240-254   Surveys after source implant and removal.   (1) Immediately after implanting sources in a patient or a human research subject, the licensee shall make a survey to locate and account for all sources that have not been implanted.

     (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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NEW SECTION
WAC 246-240-260   Brachytherapy source accountability.   (1) A licensee shall maintain accountability at all times for all brachytherapy sources in storage, transport, or use.

     (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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NEW SECTION
WAC 246-240-263   Safety instruction.   In addition to the requirements of WAC 246-222-030:

     (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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NEW SECTION
WAC 246-240-266   Safety precautions.   (1) For each patient or human research subject who is receiving brachytherapy and cannot be released under WAC 246-240-122, a licensee shall:

     (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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NEW SECTION
WAC 246-240-269   Calibration measurements of brachytherapy sources.   (1) Before the first medical use of a brachytherapy source on or after October 24, 2006, a licensee shall have:

     (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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NEW SECTION
WAC 246-240-272   Decay of strontium-90 sources for ophthalmic treatments.   (1) Only an authorized medical physicist shall calculate the activity of each strontium-90 source that is used to determine the treatment times for ophthalmic treatments. The decay must be based on the activity determined under WAC 246-240-269.

     (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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NEW SECTION
WAC 246-240-275   Therapy-related computer systems.   The licensee shall perform acceptance testing on the treatment planning system of therapy-related computer systems in accordance with published protocols accepted by nationally recognized bodies. At a minimum, the acceptance testing must include, as applicable, verification of:

     (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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NEW SECTION
WAC 246-240-278   Training for use of manual brachytherapy sources.   Except as provided in WAC 246-240-078, the licensee shall require an authorized user of a manual brachytherapy source for the uses authorized under WAC 246-240-251 to be a physician who:

     (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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NEW SECTION
WAC 246-240-281   Training for ophthalmic use of strontium-90.   Except as provided in WAC 246-240-078, the licensee shall require the authorized user of strontium-90 for ophthalmic radiotherapy to be a physician who:

     (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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NEW SECTION
WAC 246-240-301   Use of sealed sources for diagnosis.   A licensee shall use only sealed sources for diagnostic medical uses as approved in the sealed source and device registry.

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NEW SECTION
WAC 246-240-304   Training for use of sealed sources for diagnosis.   Except as provided in WAC 246-240-078, the licensee shall require the authorized user of a diagnostic sealed source for use in a device authorized under WAC 246-240-301 to be a physician, dentist, or podiatrist who:

     (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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NEW SECTION
WAC 246-240-351   Use of a sealed source in a remote afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery unit.   A licensee shall use sealed sources in photon emitting remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery units for therapeutic medical uses:

     (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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NEW SECTION
WAC 246-240-354   Surveys of patients and human research subjects treated with a remote afterloader unit.   (1) Before releasing a patient or a human research subject from licensee control, a licensee shall survey the patient or the human research subject and the remote afterloader unit with a portable radiation detection survey instrument to confirm that the source(s) has been removed from the patient or human research subject and returned to the safe shielded position.

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

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NEW SECTION
WAC 246-240-357   Installation, maintenance, adjustment, and repair.   (1) Only a person specifically licensed by the department, the U.S. NRC, or an agreement state shall install, maintain, adjust, or repair a remote afterloader unit, teletherapy unit, or gamma stereotactic radiosurgery unit that involves work on the source(s) shielding, the source(s) driving unit, or other electronic or mechanical component that could expose the source(s), reduce the shielding around the source(s), or compromise the radiation safety of the unit or the source(s).

     (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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NEW SECTION
WAC 246-240-360   Safety procedures and instructions for remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.   (1) A licensee shall:

     (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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NEW SECTION
WAC 246-240-363   Safety precautions for remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.   (1) A licensee shall control access to the treatment room by a door at each entrance.

     (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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NEW SECTION
WAC 246-240-366   Dosimetry equipment.   (1) Except for low dose-rate remote afterloader sources where the source output or activity is determined by the manufacturer, a licensee shall have a calibrated dosimetry system available for use. To satisfy this requirement, one of the following two conditions must be met:

     (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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NEW SECTION
WAC 246-240-369   Full calibration measurements on teletherapy units.   (1) A licensee authorized to use a teletherapy unit for medical use shall perform full calibration measurements on each teletherapy unit:

     (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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NEW SECTION
WAC 246-240-372   Full calibration measurements on remote afterloader units.   (1) A licensee authorized to use a remote afterloader unit for medical use shall perform full calibration measurements on each unit:

     (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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NEW SECTION
WAC 246-240-375   Full calibration measurements on gamma stereotactic radiosurgery units.   (1) A licensee authorized to use a gamma stereotactic radiosurgery unit for medical use shall perform full calibration measurements on each unit:

     (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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NEW SECTION
WAC 246-240-378   Periodic spot-checks for teletherapy units.   (1) A licensee authorized to use teletherapy units for medical use shall perform output spot-checks on each teletherapy unit once in each calendar month that include determination of:

     (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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NEW SECTION
WAC 246-240-381   Periodic spot-checks for remote afterloader units.   (1) A licensee authorized to use a remote afterloader unit for medical use shall perform spot-checks of each remote afterloader facility and on each unit:

     (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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NEW SECTION
WAC 246-240-384   Periodic spot-checks for gamma stereotactic radiosurgery units.   (1) A licensee authorized to use a gamma stereotactic radiosurgery unit for medical use shall perform spot-checks of each gamma stereotactic radiosurgery facility and on each unit:

     (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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NEW SECTION
WAC 246-240-387   Additional technical requirements for mobile remote afterloader units.   (1) A licensee providing mobile remote afterloader service shall:

     (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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NEW SECTION
WAC 246-240-390   Radiation surveys.   (1) In addition to the survey requirement in WAC 246-221-110(1), a person licensed under this chapter shall make surveys to ensure that the maximum radiation levels and average radiation levels from the surface of the main source safe with the source(s) in the shielded position do not exceed the levels stated in the sealed source and device registry.

     (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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NEW SECTION
WAC 246-240-393   Five-year inspection for teletherapy and gamma stereotactic radiosurgery units.   (1) A licensee shall have each teletherapy unit and gamma stereotactic radiosurgery unit fully inspected and serviced during source replacement or at intervals not to exceed five years, whichever comes first, to assure proper functioning of the source exposure mechanism.

     (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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NEW SECTION
WAC 246-240-396   Therapy-related computer systems.   The licensee shall perform acceptance testing on the treatment planning system of therapy-related computer systems in accordance with published protocols accepted by nationally recognized bodies. At a minimum, the acceptance testing must include, as applicable, verification of:

     (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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NEW SECTION
WAC 246-240-399   Training for use of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.   Except as provided in WAC 246-240-078, the licensee shall require an authorized user of a sealed source for a use authorized under WAC 246-240-351 to be a physician who:

     (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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NEW SECTION
WAC 246-240-451   Radiation safety officer.   Except as provided in WAC 246-240-078, the licensee shall require an individual fulfilling the responsibilities of the radiation safety officer as provided in WAC 246-240-051 to be an individual who:

     (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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NEW SECTION
WAC 246-240-454   Training for uptake, dilution, and excretion studies.   Except as provided in WAC 246-240-078, the licensee shall require the authorized user of a radiopharmaceutical in WAC 246-240-151 to be a physician who:

     (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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NEW SECTION
WAC 246-240-457   Training for imaging and localization studies.   Except as provided in WAC 246-240-078, the licensee shall require the authorized user of a radiopharmaceutical, generator, or reagent kit in WAC 246-240-157 to be a physician who:

     (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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NEW SECTION
WAC 246-240-460   Training for therapeutic use of unsealed radioactive material.   Except as provided in WAC 246-240-078, the licensee shall require the authorized user of radiopharmaceuticals in WAC 246-240-201 to be a physician who:

     (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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NEW SECTION
WAC 246-240-463   Training for treatment of hyperthyroidism.   Except as provided in WAC 246-240-078, the licensee shall require the authorized user of only iodine-131 for the treatment of hyperthyroidism to be a physician with special experience in thyroid disease who has had classroom and laboratory training in basic radioisotope handling techniques applicable to the use of iodine-131 for treating hyperthyroidism, and supervised clinical experience as follows:

     (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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NEW SECTION
WAC 246-240-466   Training for treatment of thyroid carcinoma.   Except as provided in WAC 246-240-078, the licensee shall require the authorized user of only iodine-131 for the treatment of thyroid carcinoma to be a physician with special experience in thyroid disease who has had classroom and laboratory training in basic radioisotope handling techniques applicable to the use of iodine-131 for treating thyroid carcinoma, and supervised clinical experience as follows:

     (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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NEW SECTION
WAC 246-240-469   Training for use of brachytherapy sources.   Except as provided in WAC 246-240-078 the licensee shall require the authorized user of a brachytherapy source listed in WAC 246-240-251 for therapy to be a physician who:

     (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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NEW SECTION
WAC 246-240-472   Training for ophthalmic use of strontium-90.   Except as provided in WAC 246-240-078, the licensee shall require the authorized user of only strontium-90 for ophthalmic radiotherapy to be a physician who is in the active practice of therapeutic radiology or ophthalmology, and has had classroom and laboratory training in basic radioisotope handling techniques applicable to the use of strontium-90 for ophthalmic radiotherapy, and a period of supervised clinical training in ophthalmic radiotherapy as follows:

     (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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NEW SECTION
WAC 246-240-475   Training for use of sealed sources for diagnosis.   Except as provided in WAC 246-240-078, the licensee shall require the authorized user of a sealed source in a device listed in WAC 246-240-301 to be a physician, dentist, or podiatrist who:

     (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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NEW SECTION
WAC 246-240-478   Training for use of therapeutic medical devices.   Except as provided in WAC 246-240-078, the licensee shall require the authorized user of a sealed source listed in WAC 246-240-351 to be a physician who:

     (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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NEW SECTION
WAC 246-240-481   Training for authorized medical physicist.   The licensee shall require the authorized medical physicist to be an individual who:

     (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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NEW SECTION
WAC 246-240-484   Training for an authorized nuclear pharmacist.   The licensee shall require the authorized nuclear pharmacist to be a pharmacist who:

     (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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NEW SECTION
WAC 246-240-487   Training for experienced nuclear pharmacists.   A licensee may apply for and must receive a license amendment identifying an experienced nuclear pharmacist as an authorized nuclear pharmacist before it allows this individual to work as an authorized nuclear pharmacist. A pharmacist who has completed a structured educational program as specified in WAC 246-240-484 before December 2, 1994, and who is working in a nuclear pharmacy would qualify as an experienced nuclear pharmacist. An experienced nuclear pharmacist need not comply with the requirements for a preceptor statement (WAC 246-240-484) and recentness of training (WAC 246-240-081) to qualify as an authorized nuclear pharmacist.

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NEW SECTION
WAC 246-240-501   Other medical uses of radioactive material or radiation from radioactive material.   A licensee may use radioactive material or a radiation source approved for medical use which is not specifically addressed in WAC 246-240-251 through 246-240-399 (inclusive) if:

     (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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NEW SECTION
WAC 246-240-551   Records of authority and responsibilities for radiation protection programs.   (1) A licensee shall retain a record of actions taken by the licensee's management in accordance with WAC 246-240-051(1) for five years. The record must include a summary of the actions taken and a signature of licensee management.

     (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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NEW SECTION
WAC 246-240-554   Records of radiation protection program changes.   A licensee shall retain a record of each radiation protection program change made in accordance with WAC 246-240-054(1) for five years. The record must include a copy of the old and new procedures; the effective date of the change; and the signature of the licensee management that reviewed and approved the change.

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NEW SECTION
WAC 246-240-557   Records of written directives.   A licensee shall retain a copy of each written directive as required by WAC 246-240-060 for three years.

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NEW SECTION
WAC 246-240-560   Records for procedures for administrations requiring a written directive.   A licensee shall retain a copy of the procedures required by WAC 246-240-063(1) for the duration of the license.

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NEW SECTION
WAC 246-240-563   Records of calibrations of instruments used to measure the activity of unsealed radioactive material.   A licensee shall maintain a record of instrument calibrations required by WAC 246-240-101 for three years. The records must include the model and serial number of the instrument, the date of the calibration, the results of the calibration, and the name of the individual who performed the calibration.

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NEW SECTION
WAC 246-240-566   Records of radiation survey instrument calibrations.   A licensee shall maintain a record of radiation survey instrument calibrations required by WAC 246-240-104 for three years. The record must include the model and serial number of the instrument, the date of the calibration, the results of the calibration, and the name of the individual who performed the calibration.

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NEW SECTION
WAC 246-240-569   Records of dosages of unsealed radioactive material for medical use.   (1) A licensee shall maintain a record of dosage determinations required by WAC 246-240-107 for three years.

     (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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NEW SECTION
WAC 246-240-572   Records of leak tests and inventory of sealed sources and brachytherapy sources.   (1) A licensee shall retain records of leak tests required by WAC 246-240-113 for three years. The records must include the model number, and serial number if one has been assigned, of each source tested; the identity of each source by radionuclide and its estimated activity; the results of the test; the date of the test; and the name of the individual who performed the test.

     (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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NEW SECTION
WAC 246-240-575   Records of surveys for ambient radiation exposure rate.   A licensee shall retain a record of each survey required by WAC 246-240-119 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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NEW SECTION
WAC 246-240-578   Records of the release of individuals containing unsealed radioactive material or implants containing radioactive material.   (1) A licensee shall retain a record of the basis for authorizing the release of an individual in accordance with WAC 246-240-122, if the total effective dose equivalent is calculated by:

     (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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NEW SECTION
WAC 246-240-581   Records of mobile medical services.   (1) A licensee shall retain a copy of each letter that permits the use of radioactive material at a client's address, as required by WAC 246-240-125. Each letter must clearly delineate the authority and responsibility of the licensee and the client and must be retained for three years after the last provision of service.

     (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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NEW SECTION
WAC 246-240-584   Records of decay-in-storage.   A licensee shall maintain records of the disposal of licensed materials, as required by WAC 246-240-128, for three years. The record must include the date of the disposal, the survey instrument used, the background radiation level, the radiation level measured at the surface of each waste container, and the name of the individual who performed the survey.

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NEW SECTION
WAC 246-240-587   Records of molybdenum-99 concentrations.   A licensee shall maintain a record of the molybdenum-99 concentration tests required by WAC 246-240-160(2) for three years. The record must include, for each measured elution of technetium-99m, the ratio of the measures expressed as kilobecquerel 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.

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NEW SECTION
WAC 246-240-590   Records of safety instruction.   A licensee shall maintain a record of safety instructions required by WAC 246-240-204, 246-240-263, and 246-240-360 for three years. The record must include a list of the topics covered, the date of the instruction, the name(s) of the attendee(s), and the name(s) of the individual(s) who provided the instruction.

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NEW SECTION
WAC 246-240-593   Records of surveys after source implant and removal.   A licensee shall maintain a record of the surveys required by WAC 246-240-354 and 246-240-593 for three years. Each record must include the date and results of the survey, the survey instrument used, and the name of the individual who made the survey.

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NEW SECTION
WAC 246-240-596   Records of brachytherapy source accountability.   (1) A licensee shall maintain a record of brachytherapy source accountability required by WAC 246-240-260 for three years.

     (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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NEW SECTION
WAC 246-240-599   Records of calibration measurements of brachytherapy sources.   (1) A licensee shall maintain a record of the calibrations of brachytherapy sources required by WAC 246-240-269 for three years after the last use of the source.

     (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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NEW SECTION
WAC 246-240-602   Records of decay of strontium-90 sources for ophthalmic treatments.   (1) A licensee shall maintain a record of the activity of a strontium-90 source required by WAC 246-240-272 for the life of the source.

     (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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NEW SECTION
WAC 246-240-605   Records of installation, maintenance, adjustment, and repair of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.   A licensee shall retain a record of the installation, maintenance, adjustment, and repair of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units as required by WAC 246-240-357 for three years. For each installation, maintenance, adjustment and repair, the record must include the date, description of the service, and name(s) of the individual(s) who performed the work.

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NEW SECTION
WAC 246-240-608   Records of safety procedures.   A licensee shall retain a copy of the procedures required by WAC 246-240-360 (1)(d) and (4)(b) until the licensee no longer possesses the remote afterloader, teletherapy unit, or gamma stereotactic radiosurgery unit.

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NEW SECTION
WAC 246-240-611   Records of dosimetry equipment used with remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.   (1) A licensee shall retain a record of the calibration, intercomparison, and comparisons of its dosimetry equipment done in accordance with WAC 246-240-366 for the duration of the license.

     (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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NEW SECTION
WAC 246-240-614   Records of teletherapy, remote afterloader, and gamma stereotactic radiosurgery full calibrations.   (1) A licensee shall maintain a record of the teletherapy unit, remote afterloader unit, and gamma stereotactic radiosurgery unit full calibrations required by WAC 246-240-369, 246-240-372, and 246-240-375 for three years.

     (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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NEW SECTION
WAC 246-240-617   Records of periodic spot-checks for teletherapy units.   (1) A licensee shall retain a record of each periodic spot-check for teletherapy units required by WAC 246-240-378 for three years.

     (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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NEW SECTION
WAC 246-240-620   Records of periodic spot-checks for remote afterloader units.   (1) A licensee shall retain a record of each spot-check for remote afterloader units required by WAC 246-240-381 for three years.

     (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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NEW SECTION
WAC 246-240-623   Records of periodic spot-checks for gamma stereotactic radiosurgery units.   (1) A licensee shall retain a record of each spot-check for gamma stereotactic radiosurgery units required by WAC 246-240-384 for three years.

     (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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NEW SECTION
WAC 246-240-626   Records of additional technical requirements for mobile remote afterloader units.   (1) A licensee shall retain a record of each check for mobile remote afterloader units required by WAC 246-240-387 for three years.

     (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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NEW SECTION
WAC 246-240-629   Records of surveys of therapeutic treatment units.   (1) A licensee shall maintain a record of radiation surveys of treatment units made in accordance with WAC 246-240-390 for the duration of use of the unit.

     (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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NEW SECTION
WAC 246-240-632   Records of five-year inspection for teletherapy and gamma stereotactic radiosurgery units.   (1) A licensee shall maintain a record of the five-year inspections for teletherapy and gamma stereotactic radiosurgery units required by WAC 246-240-393 for the duration of use of the unit.

     (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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NEW SECTION
WAC 246-240-651   Report and notification of a medical event.   (1) A licensee shall report any event, except for an event that results from patient intervention, in which the administration of radioactive material or radiation from radioactive material results in:

     (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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NEW SECTION
WAC 246-240-654   Report and notification of a dose to an embryo/fetus or a nursing child.   (1) A licensee shall report to the department at P.O. Box 47827, Olympia WA 98504-7827, (phone 360-236-3300), any dose to an embryo/fetus that is greater than 50 mSv (5 rem) dose equivalent that is a result of an administration of radioactive material or radiation from radioactive material to a pregnant individual unless the dose to the embryo/fetus was specifically approved, in advance, by the authorized user.

     (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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NEW SECTION
WAC 246-240-657   Report of a leaking source.   A licensee shall file a report within five days if a leak test required by WAC 246-240-113 reveals the presence of 185 Bq (0.005 µCi) or more of removable contamination. The report must be filed with the department, and sent to the department at P.O. Box 47827, Olympia WA 98504-7827, (phone 360-236-3300). The written report must include the model number and serial number if assigned, of the leaking source; the radionuclide and its estimated activity; the results of the test; the date of the test; and the action taken.

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REPEALER

     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.