reglab/statecodes huggingface dataset:
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart A - GENERAL INFORMATION › Section 144-220-G-A-15 - Exemptions regarding Type A specific licenses of broad scope

Current through 2024-29, July 17, 2024
A licensee possessing a Type A specific license of broad
						scope for medical use is exempt from:
A. The provisions of G.12.C regarding the
					 need to file an amendment to the license for medical use of radioactive
					 material, as described in G.1000;
B. The provisions of G.13.B;
C. The provisions of G.13.E regarding
					 additions to or changes in the areas of use at the addresses identified in the
					 application or on the license;
D.
					 The provisions of G.14.A;
E. The
					 provisions of G.14.B(1) for an authorized user, an authorized nuclear
					 pharmacist, or an authorized medical physicist, or an ophthalmic
					 physicist;
F. The provisions of
					 G.14.B.4 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 G.100 or G.200; and
G. The provisions of G.49.A.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart A - GENERAL INFORMATION › Section 144-220-G-A-16 - Reserved

Current through 2024-29, July 17, 2024
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart A - GENERAL INFORMATION › Section 144-220-G-A-17 - Reserved

Current through 2024-29, July 17, 2024
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart A - GENERAL INFORMATION › Section 144-220-G-A-18 - License issuance

Current through 2024-29, July 17, 2024
A. The Agency shall
					 issue a license for the medical use of radioactive material if:
(1) The applicant has filed HHE Form 850,
					 Application for a Radioactive Material License, in accordance with the
					 instructions in G.12;
(2) The
					 applicant has paid any applicable fee as provided in Part C;
(3) The Agency finds the applicant equipped
					 and committed to observe the safety standards established by the Agency in this
					 rule for the protection of the public health and safety; and
(4) The applicant meets the requirements of
					 Part C.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart A - GENERAL INFORMATION › Section 144-220-G-A-19 - Specific Exemptions

Current through 2024-29, July 17, 2024
The Agency may, upon application of any interested person
						or upon its own initiative, grant exemptions from the regulations in this Part
						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.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart B - GENERAL ADMINISTRATIVE REQUIREMENTS › Section 144-220-G-B-24 - Authority and responsibilities for the radiation protection program

Current through 2024-29, July 17, 2024
A. In addition to the radiation protection
					 program requirements of Part D, a licensee's management shall approve in
					 writing:
(1) Requests for a license
					 application, renewal, or amendment before submittal to the Agency;
(2) Any individual before allowing that
					 individual to work as an authorized user, authorized nuclear pharmacist, or
					 authorized medical physicist; and
(3) Radiation protection program changes that
					 do not require a license amendment and are permitted under G.26.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart B - GENERAL ADMINISTRATIVE REQUIREMENTS › Section 144-220-G-B-26 - Radiation protection program changes

Current through 2024-29, July 17, 2024
A. A
					 licensee may revise its radiation protection program without Agency approval
					 if:
(1) The revision does not require a
					 license amendment under G.13;
(2)
					 The revision is in compliance with the regulations and the license;
(3) The revision has been reviewed and
					 approved by the radiation safety officer, licensee management, and the
					 radiation safety committee (if applicable); and
(4) The affected individuals are instructed
					 on the revised program before the changes are implemented.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart B - GENERAL ADMINISTRATIVE REQUIREMENTS › Section 144-220-G-B-27 - Supervision

Current through 2024-29, July 17, 2024
A. 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 G.11.B.(1) shall:
(1) In addition to the requirements in Part
					 J, instruct the supervised individual in the licensee's written radiation
					 protection procedures, written directive procedures, regulations of this
					 Chapter, and license conditions with respect to the use of radioactive
					 material; and
(2) 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 this Chapter, and license conditions with respect to the medical
					 use of radioactive material.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart B - GENERAL ADMINISTRATIVE REQUIREMENTS › Section 144-220-G-B-28 - Duties of authorized user and authorized medical physicist

Current through 2024-29, July 17, 2024
A. A licensee shall assure that only
					 authorized users for the type of radioactive material used:
(1) Prescribe the radiopharmaceutical dosage
					 and/or dose to be administered through the issuance of a written directive or
					 reference to the diagnostic clinical procedures manual; and
(2) Direct, as specified in G.27 and G.40, or
					 in license conditions, the administration of radioactive material for medical
					 use to patients or human research subjects;
(3) Prepare and administer, or supervise the
					 preparation and administration of radioactive material for medical use, in
					 accordance with G.11.B. and G.11.C. and G.27;
(4) Perform the final interpretation of the
					 results of tests, studies, or treatments
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart B - GENERAL ADMINISTRATIVE REQUIREMENTS › Section 144-220-G-B-29-39 - Reserved

Current through 2024-29, July 17, 2024
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart B - GENERAL ADMINISTRATIVE REQUIREMENTS › Section 144-220-G-B-40 - Written directives

Current through 2024-29, July 17, 2024
A. A written
					 directive must be dated and signed by an authorized user before the
					 administration of sodium iodide I-131 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.
(1) 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.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart B - GENERAL ADMINISTRATIVE REQUIREMENTS › Section 144-220-G-B-41 - Procedures for administrations requiring a written directive

Current through 2024-29, July 17, 2024
A. For any administration requiring a written
					 directive, the licensee shall develop, implement, and maintain written
					 procedures to provide high confidence that:
(1) The patient's or human research subject's
					 identity is verified before each administration; and
(2) Each administration is in accordance with
					 the written directive.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart B - GENERAL ADMINISTRATIVE REQUIREMENTS › Section 144-220-G-B-49 - Suppliers for radioactive material, sealed sources or devices for medical use

Current through 2024-29, July 17, 2024
For medical use, a licensee may only use:
A. Radioactive material, sealed sources or
					 devices manufactured, labeled, packaged, and distributed in accordance with a
					 license issued pursuant to this rule or the equivalent regulations of the NRC
					 or an Agreement State.
B. Reagent
					 kits that have been manufactured, labeled, packaged, and distributed in
					 accordance with an approval issued by the U.S. Department of Health and Human
					 Services, Food and Drug Administration.
C. Sealed sources or devices non-commercially
					 transferred from a Part G licensee; or
D. Teletherapy sources manufactured and
					 distributed in accordance with a license issued pursuant to this rule, or the
					 equivalent regulations of the NRC or an Agreement State.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart B - GENERAL ADMINISTRATIVE REQUIREMENTS › Section 144-220-G-B-50 - Training for radiation safety officer

Current through 2024-29, July 17, 2024
Except as provided in G.57, 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, as provided in G.24, to be an individual who:
A. Is certified by a specialty board whose
					 certification process includes all of the requirements in G.18.B and whose
					 certification has been recognized by the Agency, the Nuclear Regulatory
					 Commission, or an Agreement State, and who meets the requirements in paragraphs
					 D and E of this section. The names of boards whose certification processes have
					 been recognized by the Agency, the NRC or an Agreement State will be posted on
					 the NRC's Medical Uses Licensee Toolkit Web page. To be recognized, a specialty
					 board shall require all candidates for certification to:
(1)
(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 20
					 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 required experience) including 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
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart B - GENERAL ADMINISTRATIVE REQUIREMENTS › Section 144-220-G-B-51 - Training for an authorized medical physicist

Current through 2024-29, July 17, 2024
Except as provided in G.21, the licensee shall require
						the authorized medical physicist to be an individual who -
A. Is certified by a specialty board whose
					 certification has been recognized by the Agency, Nuclear Regulatory Commission,
					 or an Agreement State and who meets the requirements in G.51.C of this section.
					 The names of board certifications that have been recognized by the Agency,
					 Nuclear Regulatory Commission, or an Agreement State are posted on the Nuclear
					 Regulatory Commission's Medical Uses Licensee Toolkit Web page. To have its
					 certification process recognized, a specialty board shall require all
					 candidates for certification to:
(1) 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;
(2) Have two years of
					 full-time practicable 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 Agency, the NRC, or an Agreement State, or
(b) 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 definition of an
					 authorized user in Part A.2 or who meet the requirements for authorized users
					 in G.57, G.490 or G.690; and
(3) Pass an examination, administered by
					 diplomates of the specialty board, that 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
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart B - GENERAL ADMINISTRATIVE REQUIREMENTS › Section 144-220-G-B-55 - Training for an authorized nuclear pharmacist

Current through 2024-29, July 17, 2024
Except as provided in G.57, the licensee shall require
						the authorized nuclear pharmacist to be a pharmacist who:
A. Is certified by a specialty board whose
					 certification process has been recognized by the Agency, the Nuclear Regulatory
					 Commission, or an Agreement State. The names of board certifications that have
					 been recognized by the Agency, the NRC, or an Agreement State are posted on the
					 NRC's Medical Uses License Toolkit Web Page. To have its certification process
					 recognized, a specialty board shall require all candidates for certification
					 to:
(1) 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;
(2) Hold a current,
					 active license to practice pharmacy;
(3) Provide evidence of having acquired at
					 least 4000 hours of training/experience in nuclear pharmacy practice. Academic
					 training may be substitutes for no more than 2000 hours of the required
					 training and experience;
(4) 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
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart B - GENERAL ADMINISTRATIVE REQUIREMENTS › Section 144-220-G-B-59 - Recentness of training

Current through 2024-29, July 17, 2024
The training and experience specified in Subparts B, D,
						E, F, G, and H, of Part G 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.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart C - GENERAL TECHNICAL REQUIREMENTS › Section 144-220-G-C-60 - Possession, use, and calibration of instruments used to measure the activity of unsealed radioactive material

Current through 2024-29, July 17, 2024
A. For direct
					 measurements performed in accordance with G.60, 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.
B. A licensee shall calibrate the
					 instrumentation required in G.60.A in accordance with nationally recognized
					 standards or the manufacturer's instructions.
C. The tests shall at a minimum include tests
					 for constancy, linearity, accuracy and geometry dependence, as appropriate to
					 demonstrate proper operation of the instrument.
D. A licensee shall retain a record of each
					 instrument calibration required by this section in accordance with
					 G.2060.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart C - GENERAL TECHNICAL REQUIREMENTS › Section 144-220-G-C-61 - Calibration of survey instruments

Current through 2024-29, July 17, 2024
A. A licensee
					 shall calibrate the survey instruments used to show compliance with this Part
					 and Part D before first use, annually, and following a repair that affects the
					 calibration. A licensee shall:
(1) Calibrate
					 all required scales with readings up to 10 mSv (1000 mrem) per hour with a
					 radiation source;
(2) Have each
					 radiation survey instrument calibrated:
(a) At
					 energies appropriate for use and intervals not to exceed 12 months or after
					 instrument servicing, except battery changes;
(b) For linear scale instruments, at two
					 points located approximately one- third and two-thirds of full-scale on each
					 scale; for logarithmic scale instruments, at mid-range of each decade, and at
					 two points of at least one decade; and for digital instruments, at three points
					 between 0.02 and 10 millisieverts (2 and 1000 mrem) per hour; and
(c) For dose rate instruments, so that an
					 accuracy within plus or minus 20 percent of the true radiation dose rate can be
					 demonstrated at each point checked.; and
(3) Conspicuously note on the instrument the
					 apparent dose rate from a dedicated check source as determined at the time of
					 calibration, and the date of calibration.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart C - GENERAL TECHNICAL REQUIREMENTS › Section 144-220-G-C-62 - Quality control of diagnostic equipment. Each licensee shall establish written quality control procedures for all diagnostic equipment used for radionuclide studies

Current through 2024-29, July 17, 2024
As a minimum, quality control procedures and frequencies
						shall be those recommended by equipment manufacturers or procedures which have
						been approved by the Agency. The licensee shall conduct quality control
						procedures in accordance with written procedures.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart C - GENERAL TECHNICAL REQUIREMENTS › Section 144-220-G-C-63 - Determination of dosages of unsealed radioactive material for medical use

Current through 2024-29, July 17, 2024
A. A licensee shall determine and record the
					 activity of each dosage within 30 minutes before medical use.
B. For a unit dosage, this determination must
					 be made by:
(1) Direct measurement of
					 radioactivity; or
(2) A decay
					 correction, based on the activity or activity concentration determined by:
(a) A manufacturer or preparer licensed under
					 Part C or equivalent Nuclear Regulatory Commission, or Agreement State
					 requirements;
(b) An Agency,
					 Nuclear Regulatory Commission, or an Agreement State licensee for use in
					 research in accordance with a approved protocol or an (IND) protocol accepted
					 by the FDA; or
(c) A PET
					 radioactive drug producer licensed under Part C of this rule or equivalent
					 provisions of the NRC, or an Agreement State.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart C - GENERAL TECHNICAL REQUIREMENTS › Section 144-220-G-C-65 - Authorization for calibration, transmission, and reference sources

Current through 2024-29, July 17, 2024
Any person authorized by G.11 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 GBq (30 mCi) each, manufactured and distributed by persons licensed
					 pursuant to Part C of this rule or equivalent Nuclear Regulatory Commission, or
					 Agreement State regulations.
B.
					 Sealed sources, not exceeding 1.11 GBq (30mCi) each, redistributed by a person
					 licensed under Part C.11.K, 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 GBq (15 mCi).
D. Any radioactive material with a half-life
					 longer than 120 days in individual amounts not to exceed the smaller of 7.4 MBq
					 (200 µCi) or 1000 times the quantities in Appendix C of Part D of this
					 rule.
E. Technetium-99m in amounts
					 as needed.
F. Byproduct material in
					 sealed sources authorized by this provision shall not be:
(1) Used for medical use as defined in G.2
					 except in accordance with the requirements in G.500; or
(2) Combined (i.e., bundled or aggregated) to
					 create an activity greater than the maximum activity of any single sealed
					 source authorized under this section.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart C - GENERAL TECHNICAL REQUIREMENTS › Section 144-220-G-C-67 - Requirements for possession of sealed sources and brachytherapy sources

Current through 2024-29, July 17, 2024
A. A licensee in possession of any sealed
					 source or brachytherapy source shall follow the radiation safety and handling
					 instructions supplied by the manufacturer.
B. A licensee in possession of a sealed
					 source shall:
(1) 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
(2) Test the source
					 for leakage at intervals not to exceed six months or at other intervals
					 approved by the Agency, the Nuclear Regulatory Commission, or an Agreement
					 State in the Sealed Source and Device Registry.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart C - GENERAL TECHNICAL REQUIREMENTS › Section 144-220-G-C-69 - Labeling of Vials and Syringes

Current through 2024-29, July 17, 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. Furthermore, a licensee shall require each individual
						preparing or handling a vial that contains a radioactive drug to keep the vial
						in a vial radiation shield.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart C - GENERAL TECHNICAL REQUIREMENTS › Section 144-220-G-C-70 - Surveys for ambient radiation dose rate

Current through 2024-29, July 17, 2024
A. In addition to the surveys required by
					 Part D, 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 was prepared for use or administered.
B. A licensee does not need to perform the
					 surveys required by G.70.A in an area(s) where patients or human research
					 subjects are confined when they cannot be released under G.75.
C. A licensee shall conduct the surveys
					 required by G.70.A and B so as to able to measure dose rates as low as 1
					 microsievert (0.1 mrem) per hour.
D. A licensee shall establish dose rate
					 action levels for the surveys required by G.70.A and G.70.B and shall require
					 that the individual performing the survey immediately notify the radiation
					 safety officer if a dose rate exceeds an action level.
E. A licensee shall survey for removable
					 contamination each week of use all areas where radioactive materials are
					 prepared for use, used, administered or stored.
F. A licensee shall conduct the surveys
					 required by G.70.E so as to be able to detect contamination on each wipe sample
					 of 33.3 becquerels (2000 dpm) for restricted areas and 3.33 becquerels (200
					 pdm) for unrestricted areas.
G. A
					 licensee shall establish removable contamination action levels for the surveys
					 required by G.70.E and shall require that the individual performing the survey
					 immediately notify the radiation safety officer if contamination exceeds action
					 levels.
H. A licensee shall retain
					 a record of each survey in accordance with G.2070.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart C - GENERAL TECHNICAL REQUIREMENTS › Section 144-220-G-C-75 - Release of individuals containing unsealed radioactive material or implants containing radioactive material

Current through 2024-29, July 17, 2024
A. 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).1
B. The 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:
(1) Guidance
					 on the interruption or discontinuation of breast-feeding; and
(2) Information on the potential
					 consequences, if any, of failure to follow guidance.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart C - GENERAL TECHNICAL REQUIREMENTS › Section 144-220-G-C-80 - Provision of mobile nuclear medicine service

Current through 2024-29, July 17, 2024
A. A licensee providing mobile nuclear
					 medicine service shall --
(1) Obtain a letter
					 signed by the management of each client for which 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;
(2) 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
					 paragraph must include a constancy check;
(3) Check survey instruments for proper
					 operation with a dedicated check source before use at each client's address;
					 and
(4) Before leaving a client's
					 address, survey all areas of use to ensure compliance with the requirements in
					 Part D of this rule.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart C - GENERAL TECHNICAL REQUIREMENTS › Section 144-220-G-C-92 - Decay-in-storage

Current through 2024-29, July 17, 2024
A. 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 the licensee:
(1) Monitors radioactive material at the
					 surface before disposal and determines that its radioactivity cannot be
					 distinguished from the background radiation level with a radiation detection
					 survey instrument set on its most sensitive scale and with no interposed
					 shielding; and
(2) 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.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart D - UNSEALED RADIOACTIVE MATERIAL WRITTEN DIRECTIVE NOT REQUIRED › Section 144-220-G-D-100 - Use of unsealed radioactive material for uptake, dilution, and excretion studies for which a written directive Is not required

Current through 2024-29, July 17, 2024
Except for quantities that require a written directive
						under G.40, a licensee may use any unsealed radioactive material, prepared for
						medical use for uptake, dilution, or excretion studies that is:
A. Obtained from a manufacturer or preparer
					 licensed pursuant to Part C or equivalent Nuclear Regulatory Commission or
					 Agreement State requirements; or from a PET radioactive drug producer licensed
					 under Part C of this rule or equivalent provisions of the NRC Agreement
					 State,
B. Excluding production of
					 PET radionuclides prepared by:
(1) An
					 authorized nuclear pharmacist;
(2)
					 A physician who is an authorized user and who meets the requirements specified
					 in G.290 or G.390, and G.290.C.(1)(b)(vii); or
(2) An individual under the supervision, as
					 specified in Part G.27, of the authorized nuclear pharmacist in G.100.B(1) or
					 the physician who is an authorized user in G.100.B(2); and
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart D - UNSEALED RADIOACTIVE MATERIAL WRITTEN DIRECTIVE NOT REQUIRED › Section 144-220-G-D-110 - Possession of survey instrument

Current through 2024-29, July 17, 2024
A licensee authorized to use radioactive material for
						uptake, dilution, and excretion studies shall possess a portable radiation
						detection survey instrument capable of detecting dose rates over the range of 1
						microsievert (0.1 mrem) per hour to 500 microsieverts (50 mrems) per hour. The
						instrument shall be operable and calibrated in accordance with G.61.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart D - UNSEALED RADIOACTIVE MATERIAL WRITTEN DIRECTIVE NOT REQUIRED › Section 144-220-G-D-111-189 - Reserved

Current through 2024-29, July 17, 2024
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart D - UNSEALED RADIOACTIVE MATERIAL WRITTEN DIRECTIVE NOT REQUIRED › Section 144-220-G-D-190 - Training for uptake, dilution, and excretion studies

Current through 2024-29, July 17, 2024
Except as provided in G.57, the licensee shall require an
						authorized user of unsealed radioactive material for the uses authorized under
						G.100 to be a physician who:
A. Is
					 certified by a medical specialty board whose certification process has been
					 recognized by the Agency, the Nuclear Regulatory Commission, or an Agreement
					 State and who meets the requirements in G.190.C(2). The names of board
					 certifications which have been recognized by the Agency, the 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:
(1)
					 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 that includes
					 the topics listed in paragraphs G.190.C(1)(a) and G.190.C(1)(b) and
(2) Pass an examination, administered by
					 diplomates of the specialty board, that assesses knowledge and competence in
					 radiation safety, radionuclide handling, and quality control; or
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart D - UNSEALED RADIOACTIVE MATERIAL WRITTEN DIRECTIVE NOT REQUIRED › Section 144-220-G-D-200 - Use of unsealed radioactive material for imaging and localization studies for which a written directive is not required

Current through 2024-29, July 17, 2024
Except for quantities that require a written directive
						under G.40, a licensee may use for any unsealed radioactive material prepared
						for medical use for imaging and localization studies that is:
A. Obtained from a manufacturer or preparer
					 licensed pursuant to Part C or equivalent Nuclear Regulatory Commission or
					 Agreement State requirements, or a PET radioactive drug producer licensed under
					 Part C of this rule or equivalent provisions of the NRC, Agreement State, or
B. Excluding production of PET
					 radionuclides prepared by:
(1) An authorized
					 nuclear pharmacist;
(2) A physician
					 who is an authorized user and who meets the requirements specified in G.290 or
					 G.390 and G.290.C(1)(b)(vii); or
(3) An individual under the supervision, as
					 specified in G.27, of the authorized nuclear pharmacist in G.200.B(1) or the
					 physician who is an authorized user in G.200.B(2);
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart D - UNSEALED RADIOACTIVE MATERIAL WRITTEN DIRECTIVE NOT REQUIRED › Section 144-220-G-D-204 - Permissible Molybdenum-99 Concentration

Current through 2024-29, July 17, 2024
A. A
					 licensee may not administer to humans a radioactive drug containing:
(1) More than 0.15 kilobecquerel of
					 molybdenum-99 per megabecquerel of technetium-99m (0.15 µCi of
					 molybdenum-99 per mCi of technetium-99m);
(2) More than 0.02 kilobecquerel of
					 strontium-82 per megabecquerel of rubidium-82 (0.02 µCi of Sr-82 per mCi
					 of Rb-82 chloride); or
(3) More
					 than 0.2 kilobecquerel of strontium-85 per megabecquerel of rubidium-82
					 chloride injection (0.2 µCi of Sr-85 per 1 mCi of Rb-82).
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart D - UNSEALED RADIOACTIVE MATERIAL WRITTEN DIRECTIVE NOT REQUIRED › Section 144-220-G-D-220 - Possession of survey instrument

Current through 2024-29, July 17, 2024
A licensee authorized to use radioactive material for
						imaging and localization studies shall possess a portable radiation detection
						survey instrument capable of detecting dose rates over the range of 1
						microsievert (0.1 mrem) per hour to 500 microsieverts (50 mrems) per hour, and
						a portable survey instrument capable of measuring dose rates over the range of
						10 microsieverts (1 mrem) per hour to 10 microsieverts (1000 mrems) per hour.
						The instrument shall be operable and calibrated in accordance with G.61.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart D - UNSEALED RADIOACTIVE MATERIAL WRITTEN DIRECTIVE NOT REQUIRED › Section 144-220-G-D-290 - Training for imaging and localization studies

Current through 2024-29, July 17, 2024
Except as provided in G.57, the licensee shall require an
						authorized user of unsealed radioactive material for the uses authorized under
						G.200 to be a physician who:
A. Is
					 certified by a medical specialty board whose certification process has been
					 recognized by the Agency, the NRC, or an Agreement State. The names of board
					 certifications which have been recognized by the Agency, the NRC, or an
					 Agreement State, will be 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:
(1) Complete 700 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 that includes the topics listed in paragraphs
					 G.290.C(1)(a) through (2) Pass an examination, administered by diplomates of
					 the specialty board, that assesses knowledge and competence in radiation
					 safety, radionuclide handling, and quality control;
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart E - UNSEALED RADIOACTIVE MATERIAL WRITTEN DIRECTIVE REQUIRED › Section 144-220-G-E-300 - Use of unsealed radioactive material for which a written directive is required

Current through 2024-29, July 17, 2024
A licensee may use any unsealed radioactive material
						identified in G.390.B(1)(b)(vii) prepared for medical use and for which a
						written directive is required that is:
A. Obtained from a manufacturer or preparer
					 licensed pursuant to Part C or equivalent Nuclear Regulatory Commission or
					 Agreement State requirements; or from a PET radioactive drug producer licensed
					 under Part C of this rule or equivalent provisions of the NRC, Agreement State,
					 or
B. Excluding production of PET
					 radionuclides prepared by;
(1) An authorized
					 nuclear pharmacist;
(2) A physician
					 who is an authorized user and who meets the requirements specified in G.290 or
					 G.390; or
(3) An individual under
					 the supervision, as specified in Part G.27, of the authorized nuclear
					 pharmacist in G.300.B(1); or the physician who is an authorized user in
					 G.300.B(2); or
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart E - UNSEALED RADIOACTIVE MATERIAL WRITTEN DIRECTIVE REQUIRED › Section 144-220-G-E-310 - Safety instruction

Current through 2024-29, July 17, 2024
In addition to the requirements of Part J.3,
A. A licensee shall provide radiation safety
					 instruction initially and at least annually, to one personnel caring for
					 patients or human research subjects who cannot be released under G.75. To
					 satisfy this requirement, the instruction must be commensurate with the duties
					 of the personnel and include:
(1) Patient or
					 human research subject control;
(2)
					 Visitor control, including:
(a) Routine
					 visitation to hospitalized individuals in accordance with Part D.27.A(1), and
(b) Visitation authorized in
					 accordance with Part D.27.C;
(3) Contamination control;
(4) Waste control; and
(5) Notification of the radiation safety
					 officer or his or her designee, and the authorized user if the patient or human
					 research subject has a medical emergency or dies.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart E - UNSEALED RADIOACTIVE MATERIAL WRITTEN DIRECTIVE REQUIRED › Section 144-220-G-E-315 - Safety precautions

Current through 2024-29, July 17, 2024
A. For each patient
					 or human research subject who cannot be released under G.75, a licensee shall:
(1) Quarter the patient or human research
					 subject either in:
(a) A private room with a
					 private sanitary facility; or
(b) 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 G.75.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart E - UNSEALED RADIOACTIVE MATERIAL WRITTEN DIRECTIVE REQUIRED › Section 144-220-G-E-320 - Possession of survey instrument

Current through 2024-29, July 17, 2024
A licensee authorized to use radioactive material for
						which a written directive is required shall possess a portable radiation
						detection survey instrument capable of detecting dose rates over the range of 1
						microsievert (0.1 mrem) per hour to 500 microsieverts (50 mrems) per hour, and
						a portable survey instrument capable of measuring dose rates over the range of
						10 microsieverts (1 mrem) per hour to 10 microsieverts (1000 mrems) per hour.
						The instrument shall be operable and calibrated in accordance with
						G.61.
Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part G - MEDICAL USE OF RADIOACTIVE MATERIAL › Subpart E - UNSEALED RADIOACTIVE MATERIAL WRITTEN DIRECTIVE REQUIRED › Section 144-220-G-E-390 - Training for use of unsealed radioactive material for which a written directive is required

Current through 2024-29, July 17, 2024
Except as provided in G.57, the licensee shall require an
						authorized user of unsealed radioactive material for the uses authorized under
						G.300 to be a physician who:
A. Is
					 certified by a medical specialty board whose certification process has been
					 recognized by the Agency, the Nuclear Regulatory Commission, or an Agreement
					 State, and who meets the requirements in G390.B(1)(b)(vii) and G.390.B(2).
					 Specialty Boards whose certification processes have been recognized by the
					 Agency, the NRC or an Agreement State will be posted on the NRC's Medical Uses
					 Licensee Toolkit Web page. To be recognized, a specialty board shall require
					 all candidates for certification to:
(1)
					 Successfully complete residency training in a radiation therapy or nuclear
					 medicine training program or a program in a related medical specialty. These
					 residency training programs must include 700 hours of training and experience
					 as described in G.390.B(1)(a) through G.390.B(2). 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 Council on Postdoctoral Training of the American Osteopathic
					 Association; and
(2) Pass an
					 examination, administered by diplomates of the specialty board, which assesses
					 knowledge and competence in radiation safety, radionuclide handling, and
					 quality control; and clinical use of unsealed radioactive material for which a
					 written directive is required; or