reglab/statecodes huggingface dataset:
Washington Administrative Code › Title 246 - Health, Department of › RADIATION › Chapter 246-237 - Radiation protection Physical protection of category 1 and category 2 quantities of radioactive material › Section 246-237-900 - Appendix A: Table 1-Category 1 and Category 2 thresholds

Current through Register Vol. 24-14, July 15, 2024
Terabecquerel (TBq) values are the regulatory standard. The
				  curie (Ci) values specified are obtained by converting from the TBq value. The
				  curie values provided for practical usefulness only.
Radioactive
							 material
Category 1 (TBq)
Category 1 (Ci)
Category 2 (TBq)
Category 2 (Ci)
Americium-241
60
1,620
0.6
16.2
Americium-241/Be
60
1,620
0.6
16.2
Californium-252
20
540
0.2
5.40
Cobalt-60
30
810
0.3
8.10
Curium-244
50
1,350
0.5
13.5
Cesium-137
100
2,700
1
27.0
Gadolinium-153
1,000
27,000
10
270
Iridium-192
80
2,160
0.8
21.6
Plutonium-238
60
1,620
0.6
16.2
Plutonium-239/Be
60
1,620
0.6
16.2
Promethium-147
40,000
1,080,000
400
10,800
Radium-226
40
1,080
0.4
10.8
Selenium-75
200
5,400
2
54.0
Strontium-90
1,000
27,000
10
270
Thulium-170
20,000
540,000
200
5,400
Ytterbium-169
300
8,100
3
81.0
Note: Calculations Concerning Multiple Sources or Multiple
				  Radionuclides
The "sum of fractions" methodology for evaluating
				  combinations of multiple sources or multiple radionuclides is to be used in
				  determining whether a location meets or exceeds the threshold and is thus
				  subject to the requirements of this chapter.
I. If multiple sources of the same
				radionuclide or multiple radionuclides are aggregated at a location, the sum of
				the ratios of the total activity of each of the radionuclides must be
				determined to verify whether the activity at the location is less than the
				Category 1 or Category 2 thresholds of Table 1, as appropriate. If the
				calculated sum of the ratios, using the equation below, is greater than or
				equal to 1.0, then the applicable requirements of this chapter apply.
II. First determine the total activity for
				each radionuclide from Table 1. This is done by adding the activity of each
				individual source, material in any device, and any loose or bulk material that
				contains the radionuclide. Then use the equation below to calculate the sum of
				the ratios by inserting the total activity of the applicable radionuclides from
				Table 1 in the numerator of the equation and the corresponding threshold
				activity from Table 1 in the denominator of the equation. Calculations must be
				performed in metric values (TBq) and the numerator and denominator values must
				be in the same units.
R1= total activity for radionuclide
				  1
R2= total activity for radionuclide
				  2
RN= total activity for radionuclide
				  n
AR1= activity threshold for
				  radionuclide 1
AR2= activity threshold for
				  radionuclide 2
ARN= activity threshold for
				  radionuclide n
Click to view
				  image
Reviser's note:
The brackets and enclosed
					 material in the text of the above section occurred in the copy filed by the
					 agency and appear in the Register pursuant to the requirements of
					 RCW
					    34.08.040.
Washington Administrative Code › Title 246 - Health, Department of › RADIATION › Chapter 246-239 - Radiation protection for subsequent use › Section 246-239-900 - Directive

Current through Register Vol. 24-14, July 15, 2024
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."
Statutory Authority:
					 RCW
					 70.98.050. 06-05-019, § 246-239-900,
					 filed 2/6/06, effective 3/9/06.
Washington Administrative Code › Title 246 - Health, Department of › RADIATION › Chapter 246-240 - Radiation protection Medical use of radioactive material › GENERAL PROVISIONS › Section 246-240-001 - Purpose and scope

Current through Register Vol. 24-14, July 15, 2024
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 chapters246-220,
					 246-221, 246-222, 246-232, 246-235, and 246-254 WAC, apply to applicants and
					 licensees subject to this chapter unless specifically
					 exempted.
Statutory Authority:
						RCW
						70.98.050. 11-03-068, § 246-240-001,
						filed 1/18/11, effective 2/18/11; 06-05-019, § 246-240-001, filed 2/6/06,
						effective 3/9/06. 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.
Washington Administrative Code › Title 246 - Health, Department of › RADIATION › Chapter 246-240 - Radiation protection Medical use of radioactive material › GENERAL PROVISIONS › Section 246-240-004 - Other federal and state requirements

Current through Register Vol. 24-14, July 15, 2024
Nothing in this chapter relieves the licensee from
					 complying with applicable FDA, or other federal and state requirements
					 governing radioactive drugs or devices.
Statutory Authority:
						RCW
						70.98.050. 06-05-019, § 246-240-004,
						filed 2/6/06, effective 3/9/06.
Washington Administrative Code › Title 246 - Health, Department of › RADIATION › Chapter 246-240 - Radiation protection Medical use of radioactive material › GENERAL PROVISIONS › Section 246-240-007 - Provisions for the protection of human research subjects

Current through Register Vol. 24-14, July 15, 2024
(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.
Washington Administrative Code › Title 246 - Health, Department of › RADIATION › Chapter 246-240 - Radiation protection Medical use of radioactive material › GENERAL PROVISIONS › Section 246-240-010 - Definitions, abbreviations, and acronyms

Current through Register Vol. 24-14, July 15, 2024
The definitions, abbreviations, and acronyms in this
					 section and in WAC 246-220-010 apply throughout this chapter unless the context
					 clearly indicates otherwise.
(1)
				  "Address of use" means the building or buildings that are identified on the
				  license and where radioactive material may be received, prepared, used, or
				  stored.
(2) "Area of use" means a
				  portion of an address of use that has been set aside for the purpose of
				  receiving, preparing, using, or storing radioactive material.
(3) "Associate radiation safety officer"
				  means an individual who:
(a) Meets the
				  requirements in WAC 246-240-069 and 246-240-081; and
(b) Is currently identified as an associate
				  radiation safety officer for the types of use of radioactive material for which
				  the individual has been assigned duties and tasks by the radiation safety
				  officer on:
(i) A specific medical use license
				  issued by the department, NRC, or an agreement state; or
(ii) A medical use permit issued by an NRC
				  master material licensee.
Washington Administrative Code › Title 246 - Health, Department of › RADIATION › Chapter 246-240 - Radiation protection Medical use of radioactive material › GENERAL PROVISIONS › Section 246-240-013 - Maintenance of records

Current through Register Vol. 24-14, July 15, 2024
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.
Statutory Authority:
						RCW
						70.98.050. 06-05-019, § 246-240-013,
						filed 2/6/06, effective 3/9/06.
Washington Administrative Code › Title 246 - Health, Department of › RADIATION › Chapter 246-240 - Radiation protection Medical use of radioactive material › GENERAL PROVISIONS › Section 246-240-016 - License required

Current through Register Vol. 24-14, July 15, 2024
(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, 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 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.
Washington Administrative Code › Title 246 - Health, Department of › RADIATION › Chapter 246-240 - Radiation protection Medical use of radioactive material › GENERAL PROVISIONS › Section 246-240-019 - Application for license, amendment, or renewal

Current through Register Vol. 24-14, July 15, 2024
(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, associate radiation safety
				  officers, authorized users, authorized medical physicists, ophthalmic
				  physicists, and authorized nuclear pharmacists; and
(b) Submitting applicable procedures required
				  by WAC
				  246-240-360,
				  246-240-378,
				  246-240-381,
				  and
				  246-240-384.
Washington Administrative Code › Title 246 - Health, Department of › RADIATION › Chapter 246-240 - Radiation protection Medical use of radioactive material › GENERAL PROVISIONS › Section 246-240-022 - License amendments

Current through Register Vol. 24-14, July 15, 2024
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, ophthalmic physicist, authorized nuclear pharmacist, or authorized
				  medical physicist under the license, except:
(a) For an authorized user, an individual who
				  meets the requirements in WAC
				  246-240-154,
				  246-240-163,
				  246-240-210,
				  246-240-213,
				  246-240-216,
				  246-240-278,
				  or
				  246-240-399;
(b) For an authorized nuclear pharmacist, an
				  individual who meets the requirements in WAC
				  246-240-075
				  and
				  246-240-081;
(c) For an authorized medical physicist, an
				  individual who meets the requirements in WAC
				  246-240-072
				  and
				  246-240-081;
				  or
(d) An individual who is
				  identified as an authorized user, an authorized nuclear pharmacist, authorized
				  medical physicist, or ophthalmic physicist:
(i) On an agreement state or 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 NRC
				  or an agreement state specific license of broad scope which is licensed to
				  authorize the use of radioactive material in medical use or in the practice of
				  nuclear pharmacy;
(iii) On a permit
				  issued by NRC master material licensee that is licensed to authorize the use of
				  radioactive material in medical use or in the practice of nuclear pharmacy;
				  or
(iv) By a commercial nuclear
				  pharmacy that has been licensed to authorize nuclear pharmacists.
Washington Administrative Code › Title 246 - Health, Department of › RADIATION › Chapter 246-240 - Radiation protection Medical use of radioactive material › GENERAL PROVISIONS › Section 246-240-025 - Notifications

Current through Register Vol. 24-14, July 15, 2024
(1) A licensee
				  shall notify the department no later than 30 days after:
(a) An authorized user, an authorized nuclear
				  pharmacist, a radiation safety officer, an associate radiation safety officer,
				  ophthalmic physicist, 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);
(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
				  if the change does not include the addition or relocation of either an area
				  where PET radionuclides are produced or a PET radioactive drug delivery line
				  from the PET radionuclide or PET radioactive drug production area;
(e) The licensee obtains a sealed source for
				  use in manual brachytherapy from a different manufacturer or with a different
				  model number than authorized by its license for which it did not require a
				  license amendment as provided in WAC
				  246-240-022(9).
				  The notification must include the manufacturer and model number of the sealed
				  source, the isotope, and the quantity per sealed source; or
(f) The licensee permits 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 in accordance with WAC
				  246-240-051(3).
Washington Administrative Code › Title 246 - Health, Department of › RADIATION › Chapter 246-240 - Radiation protection Medical use of radioactive material › GENERAL PROVISIONS › Section 246-240-028 - Exemptions regarding Type A specific licenses of broad scope

Current through Register Vol. 24-14, July 15, 2024
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(2);
(3) WAC
				  246-240-022(6) 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(1)(a) for an authorized user, an authorized nuclear pharmacist, or an authorized
				  medical physicist, or an ophthalmic physicist;
(5) WAC
				  246-240-025(1)(d) 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;
(6) WAC
				  246-240-066.
Statutory Authority:
						RCW
						   70.98.050. 06-05-019, § 246-240-028,
						filed 2/6/06, effective 3/9/06.
Washington Administrative Code › Title 246 - Health, Department of › RADIATION › Chapter 246-240 - Radiation protection Medical use of radioactive material › GENERAL PROVISIONS › Section 246-240-031 - License issuance and specific exemptions

Current through Register Vol. 24-14, July 15, 2024
(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.
Washington Administrative Code › Title 246 - Health, Department of › RADIATION › Chapter 246-240 - Radiation protection Medical use of radioactive material › GENERAL ADMINISTRATIVE REQUIREMENTS › Section 246-240-051 - Authority and responsibilities for the radiation protection program

Current through Register Vol. 24-14, July 15, 2024
(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;
Washington Administrative Code › Title 246 - Health, Department of › RADIATION › Chapter 246-240 - Radiation protection Medical use of radioactive material › GENERAL ADMINISTRATIVE REQUIREMENTS › Section 246-240-054 - Radiation protection program changes

Current through Register Vol. 24-14, July 15, 2024
(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.
Washington Administrative Code › Title 246 - Health, Department of › RADIATION › Chapter 246-240 - Radiation protection Medical use of radioactive material › GENERAL ADMINISTRATIVE REQUIREMENTS › Section 246-240-057 - Supervision

Current through Register Vol. 24-14, July 15, 2024
(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.
Washington Administrative Code › Title 246 - Health, Department of › RADIATION › Chapter 246-240 - Radiation protection Medical use of radioactive material › GENERAL ADMINISTRATIVE REQUIREMENTS › Section 246-240-060 - Written directives

Current through Register Vol. 24-14, July 15, 2024
(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 (30
				  microcuries), 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 48 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 megabecquerels (30 microcuries)
				  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;
(f) For
				  permanent implant brachytherapy:
(i) Before
				  implantation: The treatment site, the radionuclide, and the total source
				  strength; and
(ii) After
				  implantation but before the patient leaves the post-treatment recovery area:
				  The treatment site, the number of sources implanted, the total source strength
				  implanted, and the date; or
(g) For all other brachytherapy, including
				  low, medium, and pulsed dose rate remote afterloaders:
(i) Before implantation: The 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), and
				  date.
Washington Administrative Code › Title 246 - Health, Department of › RADIATION › Chapter 246-240 - Radiation protection Medical use of radioactive material › GENERAL ADMINISTRATIVE REQUIREMENTS › Section 246-240-063 - Procedures for administrations requiring a written directive

Current through Register Vol. 24-14, July 15, 2024
(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.
Washington Administrative Code › Title 246 - Health, Department of › RADIATION › Chapter 246-240 - Radiation protection Medical use of radioactive material › GENERAL ADMINISTRATIVE REQUIREMENTS › Section 246-240-066 - Suppliers for sealed sources or devices for medical use

Current through Register Vol. 24-14, July 15, 2024
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 medical use licensee;
				  or
(3) Teletherapy sources
				  manufactured and distributed in accordance with a license issued under chapter
				  246-232 WAC.
Statutory Authority:
						RCW
						70.98.050. 07-14-131, § 246-240-066,
						filed 7/3/07, effective 8/3/07; 06-05-019, § 246-240-066, filed 2/6/06,
						effective 3/9/06.
Washington Administrative Code › Title 246 - Health, Department of › RADIATION › Chapter 246-240 - Radiation protection Medical use of radioactive material › GENERAL ADMINISTRATIVE REQUIREMENTS › Section 246-240-069 - Training for radiation safety officer and associate radiation safety officer

Current through Register Vol. 24-14, July 15, 2024
Except as provided in WAC
					 246-240-078,
					 the licensee shall require an individual fulfilling the responsibilities of the
					 radiation safety officer or an individual assigned duties and tasks as an
					 associate 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, NRC, or an agreement state, and who meets the requirements
				  of subsection (4) of this section. The names of board certifications that have
				  been recognized by the department, NRC, or an agreement state are posted on the
				  NRC's medical uses licensee toolkit web page. To have its certification process
				  recognized, a specialty board shall require all candidates for certification
				  to:
(a)
(i)
				  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 20
				  college credits in physical science;
(ii) 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
(iii)
				  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
Washington Administrative Code › Title 246 - Health, Department of › RADIATION › Chapter 246-240 - Radiation protection Medical use of radioactive material › GENERAL ADMINISTRATIVE REQUIREMENTS › Section 246-240-072 - Training for an authorized medical physicist

Current through Register Vol. 24-14, July 15, 2024
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, NRC,
				  or an agreement state and who meets the requirements in subsection (3) of this
				  section. The names of board certifications that have been recognized by the
				  department, NRC, or an agreement state are posted on the NRC's medical uses
				  licensee toolkit web page. To have its certification process 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 department, NRC, or an agreement state; or
(ii) In clinical radiation facilities
				  providing high energy, external beam therapy (photons and electrons with
				  energies greater than or equal to one million electron volts) and brachytherapy
				  services under the direction of physicians who meet the requirements for
				  authorized users in WAC
				  246-240-078,
				  246-240-278
				  or
				  246-240-399;
(c) Pass an examination,
				  administered by diplomates of the specialty board, which assesses knowledge and
				  competence in clinical radiation therapy, radiation safety, calibration,
				  quality assurance, and treatment planning for external beam therapy,
				  brachytherapy, and stereotactic radiosurgery; or
Washington Administrative Code › Title 246 - Health, Department of › RADIATION › Chapter 246-240 - Radiation protection Medical use of radioactive material › GENERAL ADMINISTRATIVE REQUIREMENTS › Section 246-240-075 - Training for an authorized nuclear pharmacist

Current through Register Vol. 24-14, July 15, 2024
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, NRC, or an
				  agreement state. The names of board certifications that have been recognized by
				  the department, NRC, or an agreement state are posted on the NRC's medical uses
				  licensee toolkit web page. To have its certification process recognized, a
				  specialty board shall require all candidates for certification to:
(a) Have graduated from a pharmacy program
				  accredited by the Accreditation Council for Pharmacy 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 4,000 hours of training/experience in nuclear pharmacy practice. Academic
				  training may be substituted for no more than 2,000 hours of the required
				  training and experience; and
(d)
				  Pass an examination in nuclear pharmacy administered by dip-lomates 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
Washington Administrative Code › Title 246 - Health, Department of › RADIATION › Chapter 246-240 - Radiation protection Medical use of radioactive material › GENERAL ADMINISTRATIVE REQUIREMENTS › Section 246-240-081 - Recentness of training

Current through Register Vol. 24-14, July 15, 2024
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, and
					 246-240-399, 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.
Statutory Authority:
						RCW
						70.98.050. 07-14-131, § 246-240-081,
						filed 7/3/07, effective 8/3/07; 06-05-019, § 246-240-081, filed 2/6/06,
						effective 3/9/06.
Washington Administrative Code › Title 246 - Health, Department of › RADIATION › Chapter 246-240 - Radiation protection Medical use of radioactive material › GENERAL ADMINISTRATIVE REQUIREMENTS › Section 246-240-101 - Possession, use, and calibration of instruments used to measure the activity of unsealed radioactive material

Current through Register Vol. 24-14, July 15, 2024
(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.
Statutory Authority:
						RCW
						70.98.050. 06-05-019, § 246-240-101,
						filed 2/6/06, effective 3/9/06.
Washington Administrative Code › Title 246 - Health, Department of › RADIATION › Chapter 246-240 - Radiation protection Medical use of radioactive material › GENERAL TECHNICAL REQUIREMENTS › Section 246-240-104 - Calibration of survey instruments

Current through Register Vol. 24-14, July 15, 2024
(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.
Washington Administrative Code › Title 246 - Health, Department of › RADIATION › Chapter 246-240 - Radiation protection Medical use of radioactive material › GENERAL TECHNICAL REQUIREMENTS › Section 246-240-107 - Determination of dosages of unsealed radioactive material for medical use

Current through Register Vol. 24-14, July 15, 2024
(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, producer, or preparer licensed under WAC
				  246-235-100
				  or equivalent NRC or agreement state requirements; or
(ii) An agreement state or NRC licensee for
				  use in research in accordance with a radioactive drug research
				  committee-approved protocol or an investigational new drug protocol accepted by
				  FDA.
Washington Administrative Code › Title 246 - Health, Department of › RADIATION › Chapter 246-240 - Radiation protection Medical use of radioactive material › GENERAL TECHNICAL REQUIREMENTS › Section 246-240-110 - Authorization for calibration, transmission, and reference sources

Current through Register Vol. 24-14, July 15, 2024
(1) 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:
(a) Sealed sources, not
				  exceeding 1.11 gigabecquerels (30 millicuries) each, manufactured and
				  distributed by a person licensed under WAC
				  246-235-102
				  or equivalent agreement state or NRC regulations;
(b) Sealed sources, not exceeding 1.11
				  gigabecquerels (30 millicuries) each, redistributed by a licensee authorized to
				  redistribute the sealed sources manufactured and distributed by a person
				  licensed under WAC
				  246-235-102,
				  or equivalent agreement state or NRC regulations, provided the redistributed
				  sealed sources are in the original packaging and shielding and are accompanied
				  by the manufacturer's approved instructions;
(c) Any radioactive material with a half-life
				  not longer than 120 days in individual amounts not to exceed 0.56
				  gigabecquerels (15 millicuries);
(d) Any radioactive material with a half-life
				  longer than 120 days in individual amounts not to exceed the smaller of 7.4
				  megabecquerels (200 microcuries) or 1,000 times the quantities in Schedule B of
				  WAC
				  246-232-120;
				  or
(e) Technetium-99m in amounts as
				  needed.
Washington Administrative Code › Title 246 - Health, Department of › RADIATION › Chapter 246-240 - Radiation protection Medical use of radioactive material › GENERAL TECHNICAL REQUIREMENTS › Section 246-240-113 - Requirements for possession of sealed sources and brachytherapy sources

Current through Register Vol. 24-14, July 15, 2024
(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, NRC,
				  or an agreement state in the sealed source and device
				  registry.
Washington Administrative Code › Title 246 - Health, Department of › RADIATION › Chapter 246-240 - Radiation protection Medical use of radioactive material › GENERAL TECHNICAL REQUIREMENTS › Section 246-240-116 - Labeling of vials and syringes

Current through Register Vol. 24-14, July 15, 2024
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.
Statutory Authority:
						RCW
						70.98.050. 06-05-019, § 246-240-116,
						filed 2/6/06, effective 3/9/06.
Washington Administrative Code › Title 246 - Health, Department of › RADIATION › Chapter 246-240 - Radiation protection Medical use of radioactive material › GENERAL TECHNICAL REQUIREMENTS › Section 246-240-119 - Surveys of ambient radiation exposure rate

Current through Register Vol. 24-14, July 15, 2024
(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 areas 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.
Statutory Authority:
						RCW
						   70.98.050. 06-05-019, § 246-240-119,
						filed 2/6/06, effective 3/9/06.
Washington Administrative Code › Title 246 - Health, Department of › RADIATION › Chapter 246-240 - Radiation protection Medical use of radioactive material › GENERAL TECHNICAL REQUIREMENTS › Section 246-240-122 - Release of individuals containing unsealed radioactive material or implants containing radioactive material

Current through Register Vol. 24-14, July 15, 2024
(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 five 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 one mSv (0.1 rem).
				  If the total effective dose equivalent to a nursing infant or child could
				  exceed one 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 breastfeeding; and
(b) Information on the potential
				  consequences, if any, of failure to follow the guidance.
Washington Administrative Code › Title 246 - Health, Department of › RADIATION › Chapter 246-240 - Radiation protection Medical use of radioactive material › GENERAL TECHNICAL REQUIREMENTS › Section 246-240-125 - Provision of mobile medical service

Current through Register Vol. 24-14, July 15, 2024
(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.
Washington Administrative Code › Title 246 - Health, Department of › RADIATION › Chapter 246-240 - Radiation protection Medical use of radioactive material › GENERAL TECHNICAL REQUIREMENTS › Section 246-240-128 - Decay-in-storage

Current through Register Vol. 24-14, July 15, 2024
(1) A licensee may
				  hold radioactive material with a physical half-life of less than 120 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.
Washington Administrative Code › Title 246 - Health, Department of › RADIATION › Chapter 246-240 - Radiation protection Medical use of radioactive material › GENERAL TECHNICAL REQUIREMENTS › Section 246-240-151 - Use of unsealed radioactive material for uptake, dilution, and excretion studies for which a written directive is not required

Current through Register Vol. 24-14, July 15, 2024
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, producer,
				  or preparer licensed under WAC
				  246-235-100(1) or equivalent U.S. NRC or agreement state requirements; or
(2) Prepared by an authorized nuclear
				  pharmacist, or a physician who is an authorized user and who meets the
				  requirements specified in WAC
				  246-240-163, or
				  246-240-210 and
				  246-240-163(3)(a)(ii)(G),
				  or an individual under the supervision of either as specified in WAC
				  246-240-057; or
(3) Obtained from and prepared by an
				  agreement state or U.S. NRC licensee for use in research in accordance with a
				  radioactive drug research committee-approved protocol or an investigational new
				  drug (IND) protocol accepted by FDA; or
(4) Prepared by the licensee for use in
				  research in accordance with a radioactive drug research committee-approved
				  application or an investigational new drug (IND) protocol accepted by
				  FDA.
Statutory Authority:
						RCW
						70.98.050 and
						70.98.080. 09-06-003, §
						246-240-151, filed 2/18/09, effective 3/21/09. Statutory Authority:
						RCW
						70.98.050. 07-14-131, § 246-240-151,
						filed 7/3/07, effective 8/3/07; 06-05-019, § 246-240-151, filed 2/6/06,
						effective 3/9/06.
Washington Administrative Code › Title 246 - Health, Department of › RADIATION › Chapter 246-240 - Radiation protection Medical use of radioactive material › UNSEALED RADIOACTIVE MATERIAL - WRITTEN DIRECTIVE NOT REQUIRED › Section 246-240-154 - Training for uptake, dilution, and excretion studies

Current through Register Vol. 24-14, July 15, 2024
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, NRC, or an agreement state. The names of board
				  certifications that have been recognized by the department, NRC, or an
				  agreement state are posted on the NRC's medical uses licensee toolkit web page.
				  To have its certification process recognized, a specialty board shall require
				  all candidates for certification to:
(a)
				  Complete 60 hours of training and experience in basic radionuclide handling
				  techniques and radiation safety applicable to the medical use of unsealed
				  radioactive material for uptake, dilution, and excretion studies as described
				  in subsection (3)(a)(i) through (ii)(F) 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
Washington Administrative Code › Title 246 - Health, Department of › RADIATION › Chapter 246-240 - Radiation protection Medical use of radioactive material › UNSEALED RADIOACTIVE MATERIAL - WRITTEN DIRECTIVE NOT REQUIRED › Section 246-240-157 - Use of unsealed radioactive material for imaging and localization studies for which a written directive is not required

Current through Register Vol. 24-14, July 15, 2024
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, producer,
				  or preparer licensed under WAC
				  246-235-100(1) or equivalent agreement state or U.S. NRC requirements; or
(2) Prepared by an authorized nuclear
				  pharmacist, a physician who is an authorized user and who meets the
				  requirements specified in WAC
				  246-240-163, or
				  246-240-210 and
				  246-240-163(3)(a)(ii)(G),
				  or an individual under the supervision of either as specified in WAC
				  246-240-057;
(3) Obtained from and prepared by an
				  agreement state or U.S. NRC licensee for use in research in accordance with a
				  radioactive drug research committee-approved protocol or an investigational new
				  drug (IND) protocol accepted by FDA; or
(4) Prepared by the licensee for use in
				  research in accordance with a radioactive drug research committee-approved
				  application or an investigational new drug (IND) protocol accepted by
				  FDA.
Statutory Authority:
						RCW
						70.98.050 and
						70.98.080. 09-06-003, §
						246-240-157, filed 2/18/09, effective 3/21/09. Statutory Authority:
						RCW
						70.98.050. 07-14-131, § 246-240-157,
						filed 7/3/07, effective 8/3/07; 06-05-019, § 246-240-157, filed 2/6/06,
						effective 3/9/06.