reglab/statecodes huggingface dataset:
Louisiana Administrative Code › Title 33 - ENVIRONMENTAL QUALITY › Part XV - Radiation Protection › Chapter 7 - Use of Radionuclides in the Healing Arts › Section XV-701 - Purpose and Scope

Current through Register Vol. 50, No. 6, June 20, 2024
A. This Chapter
				establishes requirements and provisions for the use of radionuclides in the
				healing arts and for issuance of licenses authorizing the medical use of this
				material. These requirements and provisions provide for the protection of the
				public health and safety. The requirements and provisions of this Chapter are
				in addition to, and not in substitution for, other applicable provisions of LAC
				33:XV.Chapters 1, 3, 4, and 10. The requirements and provisions of these
				regulations apply to applicants and licensees subject to this Chapter unless
				specifically exempted. The definitions of some terms used in this Chapter may
				be found in LAC 33:XV.Chapters 1 and 6. Nothing in this Chapter relieves the
				licensee from complying with applicable FDA, other federal and state
				requirements governing radioactive drugs or devices.
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  30:2001 et
				  seq.
Louisiana Administrative Code › Title 33 - ENVIRONMENTAL QUALITY › Part XV - Radiation Protection › Chapter 7 - Use of Radionuclides in the Healing Arts › Section XV-702 - License Required and Exemptions

Current through Register Vol. 50, No. 6, June 20, 2024
A. No person shall manufacture, produce,
				acquire, receive, possess, use, or transfer radioactive material for medical
				use except in accordance with a specific license issued by the department, the
				Nuclear Regulatory Commission, or an agreement state or as allowed in
				Subsections B and C of this Section.
B. Unless prohibited by license condition, an
				individual may receive, possess, use, or transfer radioactive material in
				accordance with the regulations in this Chapter under the supervision of an
				authorized user as provided in LAC 33:XV.709.
C. An individual may prepare unsealed
				radioactive material for medical use in accordance with the regulations in this
				Chapter under the supervision of an authorized nuclear pharmacist or authorized
				user, as provided in LAC 33:XV.709, unless prohibited by license
				condition.
D. Exemptions Regarding
				Specific Licenses of Broad Scope. A licensee possessing a specific license of
				broad scope for medical use is exempt from the following:
1. the provisions of LAC
				33:XV.703.A.2;
2. the provisions of
				LAC 33:XV.703.A.5 regarding additions to or changes in the areas of use only at
				the addresses specified in the license;
3. the provisions of LAC 33:XV.704.A;
				and
4. the provisions of LAC
				33:XV.704.B.1 for an authorized user or an authorized nuclear
				pharmacist.
Louisiana Administrative Code › Title 33 - ENVIRONMENTAL QUALITY › Part XV - Radiation Protection › Chapter 7 - Use of Radionuclides in the Healing Arts › Section XV-703 - License Amendments and Provisions for Research Involving Human Subjects

Current through Register Vol. 50, No. 6, June 20, 2024
A. A licensee shall
				apply for and receive a license amendment:
1.
				before using radioactive material for a method or type of medical use not
				permitted by the license issued under this Chapter;
2. before permitting anyone to work as an
				authorized user, authorized medical physicist, or authorized nuclear pharmacist
				under the license, except an individual who is:
a. an authorized user certified by the
				organizations specified in LAC 33:XV.763.C.1, D.1, E.1, F.1, H.1, or
				I.1;
b. an authorized nuclear
				pharmacist certified by the organization specified in LAC
				33:XV.763.K.1;
c. identified as an
				authorized user, an authorized medical physicist, or an authorized nuclear
				pharmacist on a department, Nuclear Regulatory Commission, licensing state, or
				agreement state license that authorizes the use of radioactive material in
				medical use or in the practice of nuclear pharmacy, respectively; or
d. identified as an authorized user, an
				authorized medical physicist, or an authorized nuclear pharmacist on a permit
				issued by a department, Nuclear Regulatory Commission, licensing state, or
				agreement state specific licensee of broad scope that is authorized to permit
				the use of radioactive material in medical use or in the practice of nuclear
				pharmacy, respectively;
3. before changing a radiation safety
				officer, authorized medical physicist, or teletherapy physicist;
4. before receiving radioactive material in
				excess of the amount authorized on the license;
5. before adding to or changing the areas of
				use or address or addresses of use identified in the application or on the
				license; and
6. before changing
				statements, representations, and procedures incorporated into the
				license.
Louisiana Administrative Code › Title 33 - ENVIRONMENTAL QUALITY › Part XV - Radiation Protection › Chapter 7 - Use of Radionuclides in the Healing Arts › Section XV-704 - Notifications

Current through Register Vol. 50, No. 6, June 20, 2024
A. A licensee shall
				provide to the Office of Environmental Compliance a copy of the board
				certification, the Nuclear Regulatory Commission or agreement state license, or
				the permit issued by a licensee of broad scope for each individual no later
				than 30 days after the date that the licensee permits the individual to work as
				an authorized user, an authorized nuclear pharmacist, or an authorized medical
				physicist in accordance with LAC 33:XV.703.A.2.
B. A licensee shall notify the Office of
				Environmental Compliance by letter no later than 30 days after:
1. an authorized user, an authorized nuclear
				pharmacist, a radiation safety officer, or an authorized medical physicist
				permanently discontinues performance of duties under the license or has a name
				change; or
2. the licensee's
				mailing address changes.
Louisiana Administrative Code › Title 33 - ENVIRONMENTAL QUALITY › Part XV - Radiation Protection › Chapter 7 - Use of Radionuclides in the Healing Arts › Section XV-705 - ALARA Program

Current through Register Vol. 50, No. 6, June 20, 2024
A. Each
				licensee shall develop and implement a written program to maintain radiation
				doses and releases of radioactive material in effluents to unrestricted areas
				as low as reasonably achievable in accordance with LAC 33:XV.401.B.
B. To satisfy the requirement of LAC
				33:XV.705.A:
1. the management, radiation
				safety officer, and all authorized users shall participate in the
				establishment, implementation, and operation of the program as required by
				these regulations or the radiation safety committee; or
2. for licensees that are not medical
				institutions, management and all authorized users shall participate in the
				program as required by the radiation safety officer.
Louisiana Administrative Code › Title 33 - ENVIRONMENTAL QUALITY › Part XV - Radiation Protection › Chapter 7 - Use of Radionuclides in the Healing Arts › Section XV-706 - Radiation Safety Officer

Current through Register Vol. 50, No. 6, June 20, 2024
A. A
				licensee-us management shall appoint a radiation safety officer, who agrees, in
				writing, to be responsible for implementing the radiation protection program.
				The licensee, through the radiation safety officer, shall ensure that radiation
				safety activities are being performed in accordance with licensee-approved
				procedures and regulatory requirements. A licensee's management may appoint, in
				writing, one or more associate radiation safety officers to support the
				radiation safety officer. The radiation safety officer, with written agreement
				of the licensee's management, shall assign the specific duties and tasks to
				each associate radiation safety officer. These duties and tasks are restricted
				to the types of use for which the associate radiation safety officer is listed
				on a license. The radiation safety officer may delegate duties and tasks to the
				associate radiation safety officer but shall not delegate the authority or
				responsibilities for implementing the radiation protection program.
B. The radiation safety officer shall do the
				following.
1. Investigate overexposures,
				accidents, spills, losses, thefts, unauthorized receipts, uses, transfers, and
				disposals, and other deviations from approved radiation safety practice and
				implement appropriate corrective actions as necessary.
2. Implement written policy and procedures
				for:
a. authorizing the purchase of
				radioactive material;
b. receiving
				and opening packages of radioactive material;
c. storing radioactive material;
d. keeping an inventory record of radioactive
				material;
e. using radioactive
				material safely;
f. taking
				emergency action if control of radioactive material is lost;
g. performing periodic radiation
				surveys;
h. performing checks and
				calibrations of survey instruments and other safety equipment;
i. disposing of radioactive
				material;
j. training personnel who
				work in or frequent areas where radioactive material is used or stored;
				and
k. keeping a copy of all
				records and reports required by the department regulations (LAC 33:XV), a copy
				of these regulations, a copy of each licensing request and license and
				amendments, and the written policy and procedures required by these
				regulations.
3. For
				medical use not sited at a medical institution, approve or disapprove radiation
				safety program changes with the advice and consent of management prior to
				submittal to the department for licensing action.
4. For medical use sited at a medical
				institution, assist the radiation safety committee in the performance of its
				duties.
Louisiana Administrative Code › Title 33 - ENVIRONMENTAL QUALITY › Part XV - Radiation Protection › Chapter 7 - Use of Radionuclides in the Healing Arts › Section XV-707 - Radiation Safety Committee

Current through Register Vol. 50, No. 6, June 20, 2024
A. Each
				medical institution licensee shall establish a radiation safety committee to
				oversee the use of radioactive material.
1.
				The committee shall meet the following administrative requirements.
a. Membership must consist of at least three
				individuals and shall include an authorized user of each type of use permitted
				by the license, the radiation safety officer, a representative of the nursing
				service, and a representative of management who is neither an authorized user
				nor a radiation safety officer. Other members may be included as the licensee
				deems appropriate.
b. The committee
				shall meet at least once each calendar quarter.
c. To establish a quorum and to conduct
				business, one-half of the committee's membership shall be present, including
				the radiation safety officer and the management's representative.
d. The minutes of each radiation safety
				committee meeting shall include:
i. the date
				of the meeting;
ii. members
				present;
iii. members
				absent;
iv. summary of
				deliberations and discussions;
v.
				recommended actions and the numerical results of all ballots; and
vi. documentation of any reviews required in
				LAC 33:XV.705.C and 707.A.1.b.
e. The committee shall provide each member
				with a copy of the meeting minutes and retain one copy until the department
				authorizes its disposition.
Louisiana Administrative Code › Title 33 - ENVIRONMENTAL QUALITY › Part XV - Radiation Protection › Chapter 7 - Use of Radionuclides in the Healing Arts › Section XV-708 - Statement of Authorities and Responsibilities

Current through Register Vol. 50, No. 6, June 20, 2024
A. A licensee shall provide sufficient
				authority, organizational freedom, time, resources, and management prerogative
				to the radiation safety officer and the radiation safety committee to:
1. ...
2. initiate, recommend, or provide corrective
				actions;
3. stop unsafe operations;
				and
4. verify implementation of
				corrective actions.
Louisiana Administrative Code › Title 33 - ENVIRONMENTAL QUALITY › Part XV - Radiation Protection › Chapter 7 - Use of Radionuclides in the Healing Arts › Section XV-709 - Supervision

Current through Register Vol. 50, No. 6, June 20, 2024
A. A licensee who
				permits the receipt, possession, use, or transfer of radioactive material by an
				individual under the supervision of an authorized user as allowed by LAC
				33:XV.702 shall:
1. instruct the supervised
				individual in the principles of radiation safety appropriate to that
				individual's use of radioactive material;
2. require the supervised individual to
				follow the instructions of the supervising authorized user, 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;
3. review the supervised individual's use of
				radioactive material, provide reinstruction as needed, and review records kept
				to reflect this use;
4. require the
				authorized user to be immediately available to communicate with the supervised
				individual;
5. require the
				authorized user to be able to be physically present and available to the
				supervised individual on one hour's notice (The supervising authorized user
				need not be present for each use of radioactive material.); and
6. require that only those individuals
				specifically trained, and designated by the authorized user, shall be permitted
				to administer radionuclides or radiation to patients.
Louisiana Administrative Code › Title 33 - ENVIRONMENTAL QUALITY › Part XV - Radiation Protection › Chapter 7 - Use of Radionuclides in the Healing Arts › Section XV-710 - Report and Notification of a Dose to an Embryo/Fetus or a Nursing Child

Current through Register Vol. 50, No. 6, June 20, 2024
A. A licensee shall
				report any dose to an embryo/fetus that is greater than 50 mSv (5 rem) dose
				equivalent that is a result of an administration of byproduct material or
				radiation from byproduct material to a pregnant individual unless the dose to
				the embryo/fetus was specifically approved, in advance, by the authorized
				user.
B. A licensee shall report
				any dose to a nursing child that is a result of an administration of byproduct
				material to a breast-feeding individual that:
1. is greater than 50 mSv (5 rem) total
				effective dose equivalent; or
2.
				has resulted in unintended permanent functional damage to an organ or a
				physiological system of the child, as determined by a physician.
Louisiana Administrative Code › Title 33 - ENVIRONMENTAL QUALITY › Part XV - Radiation Protection › Chapter 7 - Use of Radionuclides in the Healing Arts › Section XV-711 - Mobile Nuclear Medicine Service Administrative Requirements

Current through Register Vol. 50, No. 6, June 20, 2024
A. The department will only license mobile
				nuclear medicine services in accordance with this Chapter and other applicable
				requirements of these regulations to serve clients who do not have a department
				license.
B. Mobile nuclear medicine
				service licensees shall retain for the duration of service a letter signed by
				the management of each location where services are rendered that authorizes use
				of radioactive material.
C. A
				mobile nuclear medicine service shall not have radioactive material delivered
				directly from the manufacturer or the distributor to the client's address of
				use.
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  30:2001 et
				  seq.
Louisiana Administrative Code › Title 33 - ENVIRONMENTAL QUALITY › Part XV - Radiation Protection › Chapter 7 - Use of Radionuclides in the Healing Arts › Section XV-712 - Notifications, Reports, and Records of Medical Events

Current through Register Vol. 50, No. 6, June 20, 2024
A. A licensee shall report any event as a
				medical event, except for an event that results from patient intervention, in
				which the administration of byproduct material or radiation from byproduct
				material, except permanent implant brachytherapy, results in:
1. a dose that differs from the prescribed
				dose, or the dose that would have resulted from the prescribed dosage, by more
				than 0.05 Sv (5 rem) effective dose equivalent, 0.5 Sv (50 rem) to an organ or
				tissue, or 0.5 Sv (50 rem) shallow dose equivalent to the skin, and:
a. the total dose delivered differs from the
				prescribed dose by 20 percent or more;
b. the total dosage delivered differs from
				the prescribed dosage by 20 percent or more or falls outside the prescribed
				dosage range; or
c. the
				fractionated dose delivered differs from the prescribed dose, for a single
				fraction, by 50 percent or more;
Louisiana Administrative Code › Title 33 - ENVIRONMENTAL QUALITY › Part XV - Radiation Protection › Chapter 7 - Use of Radionuclides in the Healing Arts › Section XV-713 - Suppliers

Current through Register Vol. 50, No. 6, June 20, 2024
A. For medical use,
				a licensee may only use:
1. sealed sources or
				devices, manufactured, labeled, packaged, and distributed in accordance with a
				license issued in accordance with these regulations or the equivalent
				regulations of another agreement state, a licensing state, or the Nuclear
				Regulatory Commission;
2. sealed
				sources or devices non-commercially transferred from a Nuclear Regulatory
				Commission Medical Licensee, a licensing state medical use licensee, or an
				agreement state medical use licensee; and
3. teletherapy sources manufactured and
				distributed in accordance with a license issued pursuant to these regulations
				or the equivalent regulations of another agreement state, a licensing state, or
				the U.S. Nuclear Regulatory Commission.
Louisiana Administrative Code › Title 33 - ENVIRONMENTAL QUALITY › Part XV - Radiation Protection › Chapter 7 - Use of Radionuclides in the Healing Arts › Section XV-714 - Quality Control of Imaging Equipment

Current through Register Vol. 50, No. 6, June 20, 2024
A.
				Each licensee shall establish written quality control procedures for all
				equipment used to obtain images from radionuclide studies. As a minimum, the
				procedures shall include quality control procedures recommended by equipment
				manufacturers or procedures that have been approved by the department. The
				licensee shall conduct quality control procedures in accordance with written
				procedures.
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  30:2001 et
				  seq.
Louisiana Administrative Code › Title 33 - ENVIRONMENTAL QUALITY › Part XV - Radiation Protection › Chapter 7 - Use of Radionuclides in the Healing Arts › Section XV-715 - Possession, Use, Calibration, and Checking of Dose Calibrators and of Instruments to Measure Dosages of Alpha-Emitting or Beta-Emitting Radionuclides

Current through Register Vol. 50, No. 6, June 20, 2024
A. For
				direct measurements performed in accordance with LAC 33:XV.717, 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 do the following.
1. Check each dose
				calibrator for constancy with a dedicated check source at the beginning of each
				day of use. To satisfy the requirements of this Section, the check shall be
				done on a frequently used setting with a sealed source of not less than 10
				microcuries (370 kBq) of radium-226 or 50 microcuries (1.85 MBq) of any other
				photon-emitting radionuclide with a half-life greater than 90 days.
2. Test each dose calibrator for accuracy
				upon installation and at intervals not to exceed 12 months thereafter by
				assaying at least two sealed sources containing different radionuclides, the
				activity of which the manufacturer has determined within 5 percent of the
				stated activity, with minimum activity of 10 microcuries (370 kBq) for
				radium-226 and 50 microcuries (1.85 MBq) for any other photon-emitting
				radionuclide, and at least one of which has a principal photon energy between
				100 keV and 500 keV.
3. Test each
				dose calibrator for linearity upon installation and at intervals not to exceed
				three months thereafter over the range of use between 10 microcuries (370 kBq)
				and the highest dosage that will be administered.
4. Test each dose calibrator for geometry
				dependence upon installation over the range of volumes and volume
				configurations for which it will be used. The licensee shall keep a record of
				this test for the duration of the use of the dose calibrator.
Louisiana Administrative Code › Title 33 - ENVIRONMENTAL QUALITY › Part XV - Radiation Protection › Chapter 7 - Use of Radionuclides in the Healing Arts › Section XV-716 - Calibration and Checking of Survey Instruments

Current through Register Vol. 50, No. 6, June 20, 2024
A. A licensee shall ensure that the survey
				instruments used to show compliance with this Chapter have been calibrated
				before first use, annually, and following repair.
B. To satisfy the requirements of Subsection
				A of this Section, the licensee shall:
1.
				calibrate all required scale readings up to 1,000 milliroentgens (10 mSv) per
				hour with a radiation source;
2.
				for each scale that shall be calibrated, calibrate two readings separated by at
				least 50 percent of the scale rating; 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.
Louisiana Administrative Code › Title 33 - ENVIRONMENTAL QUALITY › Part XV - Radiation Protection › Chapter 7 - Use of Radionuclides in the Healing Arts › Section XV-717 - Assay of Radiopharmaceutical Dosages

Current through Register Vol. 50, No. 6, June 20, 2024
A. A licensee shall determine and record the
				activity of each dosage before medical use.
B. For a unit dosage, this determination
				shall 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
				LAC 33:XV.328.J or equivalent agreement state requirements; or
b. a U.S. Nuclear Regulatory Commission or
				agreement state 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
c. a
				PET radioactive drug producer license as specified in LAC 33:XV.324.D,
				equivalent agreement state requirements or equivalent Nuclear Regulatory
				Commission requirements.
Louisiana Administrative Code › Title 33 - ENVIRONMENTAL QUALITY › Part XV - Radiation Protection › Chapter 7 - Use of Radionuclides in the Healing Arts › Section XV-718 - Authorization for Calibration, Transmission, and Reference Sources

Current through Register Vol. 50, No. 6, June 20, 2024
A. Any person
				authorized by LAC 33:XV.702 for medical use of byproduct material may receive,
				possess, and use the following byproduct material for check, calibration,
				transmission, and reference use:
1. sealed
				sources manufactured and distributed by persons specifically licensed in
				accordance with Chapter 3 of these regulations or equivalent provisions of the
				U.S. NRC, an agreement state, or a licensing state, and that do not exceed 30
				millicuries (1.11 GBq) each;
2.
				sealed sources redistributed by a licensee authorized to redistribute the
				sealed sources manufactured and distributed by a person licensed under LAC
				33:XV.328.L or equivalent agreement state regulations, providing the
				redistributed sealed sources are in the original packaging and shielding and
				are accompanied by the manufacturer's approved instructions and do not exceed
				30 mCi (1.11 GBq) each;
3. any
				byproduct material with a half-life of 120 days or less in individual amounts
				not to exceed 15 millicuries (0.56 GBq);
4. any byproduct material with a half-life
				greater than 120 days in individual amounts not to exceed the smaller of 200
				microcuries (7.4 MBq) or 1000 times the quantities in LAC 33:XV.499.Appendix C;
				or
5. technetium-99m in amounts as
				needed.
Louisiana Administrative Code › Title 33 - ENVIRONMENTAL QUALITY › Part XV - Radiation Protection › Chapter 7 - Use of Radionuclides in the Healing Arts › Section XV-719 - Requirements for Possession of Sealed Sources and Brachytherapy Sources

Current through Register Vol. 50, No. 6, June 20, 2024
A. Each licensee
				shall do the following.
1. Follow radiation
				safety and handling instructions approved by the department, the U.S. Nuclear
				Regulatory Commission, an agreement state, or a licensing state, and furnished
				by the manufacturer on the label attached to the source, device, or permanent
				container thereof, or in the leaflet or brochure that accompanies the source or
				device, and maintain such instruction in a legible and conveniently available
				form.
2. Assure that needles or
				standard medical applicator cells containing cobalt-60 as wire, radium-226, or
				cesium-137 are not opened while in the licensee's possession unless
				specifically authorized by the department.
Louisiana Administrative Code › Title 33 - ENVIRONMENTAL QUALITY › Part XV - Radiation Protection › Chapter 7 - Use of Radionuclides in the Healing Arts › Section XV-720 - Syringe Shields

Current through Register Vol. 50, No. 6, June 20, 2024
A. A licensee
				shall keep syringes that contain radioactive material to be administered in a
				radiation shield.
B. A licensee
				shall require each individual who prepares or administers radiopharmaceuticals
				to use a syringe radiation shield unless the use of the shield is
				contraindicated for that patient or human research subject.
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  30:2001 et
				  seq.
Louisiana Administrative Code › Title 33 - ENVIRONMENTAL QUALITY › Part XV - Radiation Protection › Chapter 7 - Use of Radionuclides in the Healing Arts › Section XV-721 - Syringe Labels

Current through Register Vol. 50, No. 6, June 20, 2024
A. Unless it is
				utilized immediately, a licensee shall conspicuously label each syringe, or
				syringe radiation shield that contains a syringe with a radiopharmaceutical,
				with the radiopharmaceutical name or its abbreviation, the type of diagnostic
				study or therapy procedure to be performed, or the patient's or human research
				subject's name.
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  30:2001 et
				  seq.
Louisiana Administrative Code › Title 33 - ENVIRONMENTAL QUALITY › Part XV - Radiation Protection › Chapter 7 - Use of Radionuclides in the Healing Arts › Section XV-722 - Vial Shields

Current through Register Vol. 50, No. 6, June 20, 2024
A. A licensee
				shall require each individual preparing or handling a vial that contains a
				radiopharmaceutical to keep the vial in a vial radiation shield.
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  30:2001 et
				  seq.
Louisiana Administrative Code › Title 33 - ENVIRONMENTAL QUALITY › Part XV - Radiation Protection › Chapter 7 - Use of Radionuclides in the Healing Arts › Section XV-723 - Vial and Vial Shield Labels

Current through Register Vol. 50, No. 6, June 20, 2024
A. Each
				vial that contains a radiopharmaceutical 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.
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  30:2001 et
				  seq.
Louisiana Administrative Code › Title 33 - ENVIRONMENTAL QUALITY › Part XV - Radiation Protection › Chapter 7 - Use of Radionuclides in the Healing Arts › Section XV-724 - Surveys for Contamination and Ambient Radiation Dose Rate

Current through Register Vol. 50, No. 6, June 20, 2024
A. A licensee shall survey with a radiation
				detection survey instrument at the end of each day of use all areas where
				radiopharmaceuticals are routinely prepared for use or administered.
B. A licensee shall survey with a radiation
				detection survey instrument at least once each week all areas where
				radiopharmaceuticals or radioactive wastes are stored.
C. A licensee shall conduct the surveys
				required by LAC 33:XV.724.A and B so as to be able to measure rates as low as
				0.1 milliroentgens (1 [MICRO]Sv) per hour.
D. A licensee shall establish dose rate
				action levels for the surveys required by LAC 33:XV.724.A and B and shall
				require that the individual performing the survey immediately notify the
				radiation safety officer if a rate exceeds an action level.
E. A licensee shall survey for removable
				contamination each week of use all areas where radiopharmaceuticals are
				routinely prepared for use or administered and each week where radioactive
				materials are stored.
F. A licensee
				shall conduct the surveys required by LAC 33:XV.724.E so as to be able to
				detect contamination on each wipe sample of 2,000 disintegrations per minute
				(33.3 Bq).
G. A licensee shall
				establish removable contamination action levels for the surveys required by LAC
				33:XV.724.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 required by LAC 33:XV.724.A, B, and E for two years.
				The record must include the date of the survey, a sketch of each area surveyed,
				action levels established for each area, the measured dose rate at several
				points in each area expressed in milliroentgens per hour or the removable
				contamination in each area expressed in disintegrations per minute (becquerels)
				per 100 square centimeters, the serial number and the model number of the
				instrument used to make the survey or analyze the samples, and the initials of
				the individual who performed the survey.
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  30:2001 et
				  seq.
Louisiana Administrative Code › Title 33 - ENVIRONMENTAL QUALITY › Part XV - Radiation Protection › Chapter 7 - Use of Radionuclides in the Healing Arts › Section XV-725 - Release of Individuals Containing Radiopharmaceuticals or Permanent Implants

Current through Register Vol. 50, No. 6, June 20, 2024
A. A licensee
				may authorize the release from its control of any individual who has been
				administered unsealed byproduct material or implants containing byproduct
				material if the total effective dose equivalent to any other individual from
				exposure to the released individual is not likely to exceed 5 millisieverts
				(0.5 rem).
NOTE: The current revision of NUREG1556, Vol. 9,
				  "Consolidated Guidance About Materials Licenses: Program-Specific Guidance
				  About Medical Licenses," describes methods for calculating doses to other
				  individuals and contains tables of activities not likely to cause doses
				  exceeding 5 mSv (0.5 rem).
B. A licensee shall provide the released
				individual, or the individual's parent or guardian, with instructions,
				including written instructions, on actions recommended to maintain doses to
				other individuals as low as is reasonably achievable if the total effective
				dose equivalent to any other individual is likely to exceed 1 millisievert (0.1
				rem). If the total effective dose equivalent to a breast-feeding infant or
				child could exceed 1 millisievert (0.1 rem) assuming there were no interruption
				of breast-feeding, the instructions shall 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 the guidance.
Louisiana Administrative Code › Title 33 - ENVIRONMENTAL QUALITY › Part XV - Radiation Protection › Chapter 7 - Use of Radionuclides in the Healing Arts › Section XV-726 - Mobile Medical Service Technical Requirements

Current through Register Vol. 50, No. 6, June 20, 2024
A. A licensee providing mobile medical
				services shall do the following.
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 shall include a constancy check.
3. Check survey instruments for proper
				operation with a dedicated check source before use at each client's
				address.
4. Before leaving a
				client's address, survey all areas of use to ensure compliance with the
				requirements in LAC 33:XV.Chapter 4.
Louisiana Administrative Code › Title 33 - ENVIRONMENTAL QUALITY › Part XV - Radiation Protection › Chapter 7 - Use of Radionuclides in the Healing Arts › Section XV-727 - Storage of Volatiles and Gases

Current through Register Vol. 50, No. 6, June 20, 2024
A. A
				licensee shall store volatile radiopharmaceuticals and radioactive gases in the
				shippers' radiation shield and container.
B. A licensee shall store and use a multidose
				container in a properly functioning fume hood.
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  30:2001 et
				  seq.
Louisiana Administrative Code › Title 33 - ENVIRONMENTAL QUALITY › Part XV - Radiation Protection › Chapter 7 - Use of Radionuclides in the Healing Arts › Section XV-728 - Decay-in-Storage

Current through Register Vol. 50, No. 6, June 20, 2024
A. A licensee shall
				hold radioactive material with a physical half-life of less than 120 days for
				decay-in-storage before disposal in ordinary trash and is exempt from the
				requirements of LAC 33:XV.460 of these regulations if the licensee:
1. holds radioactive material for decay a
				minimum of 10 half-lives;
2.
				monitors radioactive material at the container surface before disposal as
				ordinary trash and determines that its radioactivity cannot be distinguished
				from the background radiation level with an appropriate radiation detection
				survey instrument set on its most sensitive scale and with no interposed
				shielding;
3. 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; and
4. separates and monitors each generator
				column individually with all radiation shielding removed to ensure that its
				contents have decayed to background radiation level before disposal.
Louisiana Administrative Code › Title 33 - ENVIRONMENTAL QUALITY › Part XV - Radiation Protection › Chapter 7 - Use of Radionuclides in the Healing Arts › Section XV-729 - Use of Radiopharmaceuticals for Uptake, Dilution, or Excretion Studies

Current through Register Vol. 50, No. 6, June 20, 2024
A. A licensee may
				use the following prepared radiopharmaceuticals for diagnostic studies
				involving the measurement of uptake, dilution, or excretion:
1. iodine-131 as sodium iodide, iodinated
				human serum albumin (IHSA), labeled rose bengal, or sodium
				iodohippurate;
2. iodine-125 as
				sodium iodide or iodinated human serum albumin (IHSA);
3. cobalt-57 as labeled
				cyanocobalamin;
4. cobalt-58 as
				labeled cyanocobalamin;
5.
				chromium-51 as sodium chromate or labeled human serum albumin;
6. iron-59 as citrate; and
7. any radioactive material in a
				radiopharmaceutical for a diagnostic use involving measurements of uptake,
				dilution, or excretion for which the Food and Drug Administration (FDA) has
				accepted a "Notice of Claimed Investigational Exemption for a New Drug" (IND)
				or approved a "New Drug Application" (NDA).
Louisiana Administrative Code › Title 33 - ENVIRONMENTAL QUALITY › Part XV - Radiation Protection › Chapter 7 - Use of Radionuclides in the Healing Arts › Section XV-730 - Possession of Survey Instrument

Current through Register Vol. 50, No. 6, June 20, 2024
A. 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 0.1 milliroentgen
				(1.0 [MICRO]Sv) per hour to 50 milliroentgens (500 [MICRO]Sv) per hour. The
				instrument shall be operable and calibrated in accordance with LAC
				33:XV.716.
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  30:2001 et
				  seq.
Louisiana Administrative Code › Title 33 - ENVIRONMENTAL QUALITY › Part XV - Radiation Protection › Chapter 7 - Use of Radionuclides in the Healing Arts › Section XV-731 - Use of Radiopharmaceuticals, Generators, and Reagent Kits for Imaging and Localization Studies

Current through Register Vol. 50, No. 6, June 20, 2024
A. A licensee
				may use the following radiopharmaceuticals, generators, and reagent kits for
				imaging and localization studies:
1.
				molybdenum-99/technetium-99mm generators for the elution or extraction of
				technetium-99m as pertechnetate;
2.
				technetium-99m as pertechnetate;
3.
				prepared radiopharmaceuticals and reagent kits for the preparation of the
				following technetium-99m labeled radiopharmaceuticals:
a. sulfur colloid;
b. pentetate sodium;
c. human serum albumin
				microspheres;
d.
				polyphosphate;
e. macroaggregated
				human serum albumin;
f. etidronate
				sodium;
g. stannous
				pyrophosphate;
h. human serum
				albumin;
i. medronate
				sodium;
j. gluceptate
				sodium;
k. oxidronate
				sodium;
l. disofenin; and
m. succimer;
4. iodine-131 as sodium iodide, iodinated
				human serum albumin, macroaggregated iodinated human serum albumin, colloidal
				(macroaggregated) iodinated human serum albumin, rose bengal, or sodium
				iodohippurate;
5. iodine-125 as
				sodium iodide or fibrinogen;
6.
				chromium-51 as human serum albumin;
7. gold-198 in colloidal form;
8. gallium-67 as citrate;
9. indium-111 as chloride or DTPA;
10. thallium-201 as chloride;
11. iodine-123 as sodium iodide or
				iodohippurate; and
12. any
				radioactive material in a diagnostic radiopharmaceutical, except aerosol or
				gaseous form, or any generator or reagent kit for preparation and diagnostic
				use of a radiopharmaceutical containing radioactive material for which the Food
				and Drug Administration has accepted a "Notice of Claimed Investigational
				Exemption for a New Drug" (IND) or approved a "New Drug Application"
				(NDA).
Louisiana Administrative Code › Title 33 - ENVIRONMENTAL QUALITY › Part XV - Radiation Protection › Chapter 7 - Use of Radionuclides in the Healing Arts › Section XV-732 - Permissible Molybdenum-99, Strontium-82, and Strontium-85 Concentrations

Current through Register Vol. 50, No. 6, June 20, 2024
A. A licensee shall
				not administer to humans a radiopharmaceutical containing:
1. more than 0.15 microcurie of molybdenum-99
				per millicurie of technetium-99m (0.15 kilobecquerel of molybdenum-99 per
				megabecquerel of technetium-99m);
2. more than 0.02 kilobecquerel of
				strontium-82 per megabecquerel of rubidium-82 chloride injection (0.02
				microcurie of strontium-82 per millicurie of rubidium-82 chloride);
				or
3. more than 0.2 kilobecquerel
				of strontium-85 per megabecquerel of rubidium-82 chloride injection (0.2
				microcurie of strontium-85 per millicurie of rubidium-82).
Louisiana Administrative Code › Title 33 - ENVIRONMENTAL QUALITY › Part XV - Radiation Protection › Chapter 7 - Use of Radionuclides in the Healing Arts › Section XV-733 - Control of Aerosols and Gases

Current through Register Vol. 50, No. 6, June 20, 2024
A. A
				licensee who administers radioactive aerosols or gases shall do so with a
				system that will keep airborne concentrations within the limits prescribed by
				LAC 33:XV.412 and 416 of these regulations.
B. The system shall either be directly vented
				to the atmosphere through an air exhaust or provide for collection and decay or
				disposal of the aerosol or gas in a shielded container.
C. Reserved.
D. Before receiving, using, or storing a
				radioactive gas, the licensee shall calculate the amount of time needed after a
				release to reduce the concentration in the area of use to the occupational
				limit listed in these regulations. The calculation shall be based on the
				highest activity of gas handled in a single container and the measured
				available air exhaust rate.
E. A
				licensee shall post the time calculated in LAC 33:XV.733.D at the area of use
				and require that, in case of a gas spill, individuals evacuate the room until
				the posted time has elapsed.
F. A
				licensee shall check the operation of collection systems monthly and measure
				the ventilation rates in areas of use at intervals not to exceed six months.
				Records of these checks and measurements shall be maintained for two
				years.
G. A copy of the
				calculations required in LAC 33:XV.733.D shall be recorded and retained for the
				duration of the license.
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  30:2001 et
				  seq.
Louisiana Administrative Code › Title 33 - ENVIRONMENTAL QUALITY › Part XV - Radiation Protection › Chapter 7 - Use of Radionuclides in the Healing Arts › Section XV-734 - Possession of Survey Instruments

Current through Register Vol. 50, No. 6, June 20, 2024
A. 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 0.1 milliroentgen per hour to 50
				milliroentgens per hour, or a portable radiation measurement survey instrument
				capable of measuring dose rates over the range of 1 milliroentgen per hour to
				1,000 milliroentgens per hour. The instruments shall be operable and calibrated
				in accordance with LAC 33:XV.716.
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  30:2001 et
				  seq.
Louisiana Administrative Code › Title 33 - ENVIRONMENTAL QUALITY › Part XV - Radiation Protection › Chapter 7 - Use of Radionuclides in the Healing Arts › Section XV-735 - Use of Radiopharmaceuticals for Therapy

Current through Register Vol. 50, No. 6, June 20, 2024
A. A licensee may use the following prepared
				radiopharmaceuticals:
1. iodine-131 as iodide
				for treatment of hyperthyroidism, cardiac dysfunction, and thyroid
				carcinoma;
2. phosphorus-32 as
				soluble phosphate for treatment of polycythemia vera, leukemia, and bone
				metastases;
3. phosphorus-32 as
				colloidal chromic phosphate for intracavitary treatment of malignant
				effusions;
4. any radioactive
				material in a radiopharmaceutical and for a therapeutic use for which the Food
				and Drug Administration has accepted a "Notice of Claimed Investigational
				Exemption for a New Drug" (IND), or approved a "New Drug Application" (NDA).
				The licensee shall comply with the package insert instructions regarding
				indications and method of administration.
Louisiana Administrative Code › Title 33 - ENVIRONMENTAL QUALITY › Part XV - Radiation Protection › Chapter 7 - Use of Radionuclides in the Healing Arts › Section XV-736 - Safety Instruction

Current through Register Vol. 50, No. 6, June 20, 2024
A. A
				licensee shall provide oral and written radiation safety instruction for all
				personnel caring for patients or human research subjects undergoing
				radiopharmaceutical therapy. Refresher training shall be provided at intervals
				not to exceed one year.
B. To
				satisfy Subsection A of this Section, the instruction shall describe the
				licensee's procedures for:
1. patient or
				human research subject control;
2.
				visitor control, including:
a. routine
				visitation to hospitalized individuals in accordance with LAC 33:XV.421.A.1;
				and
b. visitation authorized in
				accordance with LAC 33:XV.421.C;
3. contamination control;
4. waste control;
5. notification of the radiation safety
				officer, or his or her designee, and an authorized user, in the case of the
				patient's or human research subject's death or medical emergency; and
6. LAC 33:XV.Chapter 10 training
				requirements.
Louisiana Administrative Code › Title 33 - ENVIRONMENTAL QUALITY › Part XV - Radiation Protection › Chapter 7 - Use of Radionuclides in the Healing Arts › Section XV-737 - Safety Precautions

Current through Register Vol. 50, No. 6, June 20, 2024
A. For each
				patient or human research subject receiving radiopharmaceutical therapy and
				hospitalized for compliance with LAC 33:XV.725, a licensee shall do the
				following:
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 LAC 33:XV.725;
Louisiana Administrative Code › Title 33 - ENVIRONMENTAL QUALITY › Part XV - Radiation Protection › Chapter 7 - Use of Radionuclides in the Healing Arts › Section XV-738 - Possession of Survey Instruments

Current through Register Vol. 50, No. 6, June 20, 2024
A. A
				licensee authorized to use radioactive material for radiopharmaceutical therapy
				shall possess a portable radiation detection survey instrument capable of
				detecting dose rates over the range 0.1 milliroentgen per hour to 50
				milliroentgens per hour, and a portable radiation measurement survey instrument
				capable of measuring dose rates over the range of 1 milliroentgen per hour to
				1,000 milliroentgens per hour. The instruments shall be operable and calibrated
				in accordance with LAC 33:XV.716.
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  30:2001 et
				  seq.
Louisiana Administrative Code › Title 33 - ENVIRONMENTAL QUALITY › Part XV - Radiation Protection › Chapter 7 - Use of Radionuclides in the Healing Arts › Section XV-739 - Use of Sealed Sources and Medical Devices for Diagnosis

Current through Register Vol. 50, No. 6, June 20, 2024
A. A licensee shall use only sealed sources
				that are not in medical devices for diagnostic medical uses if the sealed
				sources are approved in the Sealed Source and Device Registry for diagnostic
				medicine. The sealed sources may be used for diagnostic medical uses that are
				not explicitly listed in the Sealed Source and Device Registry but shall be
				used in accordance with the radiation safety conditions and limitations
				described in the Sealed Source and Device Registry.
B. A licensee shall only use medical devices
				containing sealed sources for diagnostic medical uses if both the sealed
				sources and medical devices are approved in the Sealed Source and Device
				Registry for diagnostic medical uses. The diagnostic medical devices may be
				used for diagnostic medical uses that are not explicitly listed in the Sealed
				Source and Device Registry but shall be used in accordance with the radiation
				safety conditions and limitations described in the Sealed Source and Device
				Registry.
C. Sealed sources and
				devices for diagnostic medical uses may be used in research in accordance with
				an active Investigational Device Exemption (IDE) application accepted by the
				U.S. Food and Drug Administration provided the requirements of LAC
				33:XV.713.A.1 are met.
AUTHORITY NOTE:
				  Promulgated in accordance with
				  R.S.
				  30:2001 et seq. and
				  2104.B.