reglab/statecodes huggingface dataset:
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64E - Division of Environmental Health › Chapter 64E-5 - CONTROL OF RADIATION HAZARDS › Section 64E-5.506 - Intraoral Dental Radiographic Systems

Current through Reg. 50, No. 138; July 16, 2024
(1) Source-to-Skin Distance. X-ray systems
				designed for use with an intraoral image receptor shall be provided with means
				to limit source-to-skin distance to not less than:
(a) Eighteen centimeters if operable at or
				above 50 kVp, or
(b) Ten
				centimeters if not operable above 50 kVp.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64E - Division of Environmental Health › Chapter 64E-5 - CONTROL OF RADIATION HAZARDS › Section 64E-5.507 - Therapeutic X-Ray Systems of Less Than 1 MeV

Current through Reg. 50, No. 138; July 16, 2024
(1) Equipment Requirements.
(a) Leakage Radiation. When the tube is
				operated at its leakage technique factors, the leakage radiation shall not
				exceed the value specified at the distance specified for the following
				classification of that x-ray system:
1.
				Contact Therapy Systems. Leakage radiation shall not exceed 100 milliroentgens
				(25.8 uC per kg) per hour at 5 centimeters from the surface of the tube housing
				assembly.
2. Zero to One Hundred
				Fifty kVp Systems. Leakage radiation shall not exceed 100 milliroentgens (25.8
				uC per kg) in 1 hour at 1 meter from the source.
3. One Hundred Fifty-one to Nine Hundred
				Ninety-nine kVp Systems. The leakage radiation shall not exceed 0.1 percent of
				the useful beam 1 meter from the source, for any of its operating
				conditions.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64E - Division of Environmental Health › Chapter 64E-5 - CONTROL OF RADIATION HAZARDS › Section 64E-5.509 - Veterinary Medicine X-Ray Operations

Current through Reg. 50, No. 138; July 16, 2024
(1)
				Applicable Regulations. Veterinary medical x-ray operations shall conform with
				requirements of the following sections of these regulations:
(a) Rule
				 64E-5.502, F.A.C., General
				Requirements, except subparagraphs
				 64E-5.502(1)(a) 
				5., 6., 7., 8., F.A.C.
(b) Rule
				 64E-5.503, F.A.C., General
				Requirements for all Diagnostic X-Ray Systems.
(c) Rule
				 64E-5.504, F.A.C., Fluoroscopic
				X-Ray Systems.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64E - Division of Environmental Health › Chapter 64E-5 - CONTROL OF RADIATION HAZARDS › Section 64E-5.510 - Mammographic Systems

Current through Reg. 50, No. 138; July 16, 2024
(1) Mammographic
				medical x-ray systems shall meet the requirements of Rules
				 64E-5.502 and
				 64E-5.503, F.A.C. Registrants
				who provide mammography services shall:
(a)
				Have a written quality assurance program specific to mammography imaging that
				includes an equipment quality control program for performance monitoring and an
				evaluation of all components of the equipment from the x-ray generator to the
				image processor.
(b) Establish
				standards for clinical image evaluations that include breast positioning,
				compression and overall image quality.
(c) Assign qualified and trained personnel to
				each part of the quality assurance program.
(d) Conduct a general review of the
				effectiveness of the quality assurance program annually and maintain a written
				report of the review.
(e) Have
				available the services of a medical physicist to furnish diagnostic x-ray
				physics support who is able to establish and conduct the equipment quality
				control program and who meets the requirements specified in subsection (12),
				below. The specific duties of the medical physicist must include:
1. Monitoring equipment performance or
				verifying the qualifications and training of others to monitor equipment
				performance.
2. Evaluating the
				monitoring results to identify problems.
3. Verifying that corrections are effective
				and meet regulatory requirements.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64E - Division of Environmental Health › Chapter 64E-5 - CONTROL OF RADIATION HAZARDS › Section 64E-5.511 - Registration of Radiation Machines

Current through Reg. 50, No. 138; July 16, 2024
(1)
				Exemptions.
(a) Electronic equipment that
				produces radiation incidental to its operation for other purposes is exempt
				from registration registration requirements if the dose equivalent rate
				averaged over an area of 10 square centimeters does not exceed 0.5 mR (5
				µSv) per hour at 5 centimeters from any accessible surface of the
				equipment. The production, testing or factory servicing of such equipment shall
				not be exempt.
(b) Radiation
				machines that are non-operational and under the control of a registered vendor
				prior to final installation are exempt from the registration and fee
				requirements of this section.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64E - Division of Environmental Health › Chapter 64E-5 - CONTROL OF RADIATION HAZARDS › Section 64E-5.601 - License Required

Current through Reg. 50, No. 138; July 16, 2024
(1) Radioactive
				materials shall not be manufactured, produced, acquired, received, possessed,
				prepared, used, or transferred for medical use except as provided in a specific
				license.
(2) Any licensee who is
				licensed for one or more of the medical uses in Rule
				 64E-5.626,
				 64E-5.627,
				 64E-5.630, or
				 64E-5.632, F.A.C., also is
				authorized to use radioactive material under a general license in subsection
				 64E-5.206(8),
				F.A.C., for specified in vitro uses without filing the certificate required by
				paragraph  64E-5.206(8)(b),
				F.A.C., but is subject to the other provisions of subsection
				 64E-5.206(8),
				F.A.C.
(3)
(a) Unless prohibited by license condition, a
				physician, in training may receive, possess, acquire, prepare, use, or transfer
				radioactive materials as provided in these regulations under the supervision of
				an authorized user as provided in subsections
				 64E-5.608(1) 
				and  64E-5.608(3),
				F.A.C.
(b) Current and active
				certified radiologic technologists as authorized in Part IV, Chapter 468, F.S.,
				may receive, possess, acquire, prepare, use, or transfer radioactive materials
				as provided in these regulations under the supervision of an authorized user as
				provided in paragraph
				 64E-5.607(3)(e) 
				and subsection  64E-5.608(3),
				F.A.C.
(c) Unless prohibited by
				license condition, a medical physicist in training may receive, acquire,
				prepare, use, possess, or transfer radioactive materials as provided in these
				regulations under the supervision of an authorized medical physicist as
				provided in subsections
				 64E-5.608(2) 
				and  64E-5.608(3),
				F.A.C.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64E - Division of Environmental Health › Chapter 64E-5 - CONTROL OF RADIATION HAZARDS › Section 64E-5.6011 - Definitions

Current through Reg. 50, No. 138; July 16, 2024
(1) "Authorized medical physicist" means an
				individual who meets the requirements:
(a)
				Specified in subsection
				 64E-5.656(1) 
				and Rule  64E-5.658, F.A.C., or
(b) Is identified as an authorized medical
				physicist or teletherapy physicist on:
1. A
				specific medical use license issued by the NRC or an agreement state,
2. A medical use permit issued by
				a NRC master material licensee,
3.
				A permit issued by a NRC or agreement state broad scope medical use licensee,
				or
4. A permit issued by a NRC
				master material license broad scope medical use
				permittee.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64E - Division of Environmental Health › Chapter 64E-5 - CONTROL OF RADIATION HAZARDS › Section 64E-5.602 - License Amendments

Current through Reg. 50, No. 138; July 16, 2024
A licensee shall apply for and receive a license amendment or
				  departmental approval:
(1) Before
				using radioactive material for a method or type of medical use not permitted by
				the license;
(2) Before permitting
				anyone, except a visiting authorized user, visiting authorized medical
				physicist, or visiting authorized nuclear pharmacist described in Rule
				 64E-5.609, F.A.C., to work as an
				authorized user, authorized nuclear pharmacist, or authorized medical
				physicist.
(3) Before changing a
				RSO or authorized medical physicist;
(4) Before ordering or receiving radioactive
				material in excess of the amount, in a different form, or receiving a different
				radionuclide than is 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 which are incorporated into the
				license.
Rulemaking Authority
					  404.022,
					 404.051,
					 404.061,
					 404.071,
					 404.081,
					 404.141 FS. Law Implemented
					 404.022,
					  404.051(1), (4), (5), (6), (8), (9), (10),
					 (11),
					  404.061(2),
					 (3),
					  404.071(1),
					  404.081,
					  404.141 FS.
New 8-25-91, Formerly 10D-91.708, Amended
					 2-11-10.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64E - Division of Environmental Health › Chapter 64E-5 - CONTROL OF RADIATION HAZARDS › Section 64E-5.603 - Notification

Current through Reg. 50, No. 138; July 16, 2024
A licensee shall notify the department in writing within 30
				  days when the licensee changes its mailing address or when an authorized user,
				  RSO, authorized nuclear pharmacist, or authorized medical physicist permanently
				  discontinues performance of their duties under the licensee.
Rulemaking Authority
					  404.022,
					 404.051,
					 404.061,
					 404.071,
					 404.081,
					 404.141 FS. Law Implemented
					 404.022,
					  404.051(1), (4), (5), (6), (8), (9), (10),
					 (11),
					  404.061(2),
					 (3),
					  404.071(1),
					  404.081,
					  404.141 FS.
New 8-25-91, Formerly 10D-91.709, Amended 8-6-01,
					 2-11-10.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64E - Division of Environmental Health › Chapter 64E-5 - CONTROL OF RADIATION HAZARDS › Section 64E-5.604 - ALARA Program

Current through Reg. 50, No. 138; July 16, 2024
(1) 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 as provided in Rule
				 64E-5.303, F.A.C.
(2) 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.
(3) For licensees that are not required to
				have a radiation safety committee, medical institutions, management and all
				authorized users shall participate in the program as required by the
				RSO.
(4) The ALARA program shall
				include an annual review by the radiation safety committee for medical
				licensees required to have a radiation safety committee, or by management and
				the RSO for licensees that are not required to have a radiation safety
				committee. The review shall include summaries of the types, amounts and
				purposes of radioactive material used; occupational dose reports; and
				continuing education and training of all personnel who work with or in the
				vicinity of radioactive material. The purpose of the review is to ensure that
				individuals make every reasonable effort to maintain occupational doses, doses
				to the general public, and releases of radioactive material as low as
				reasonably achievable, taking into account the state of technology and the cost
				of improvements in relation to benefits.
(5) The licensee shall retain a current
				written description of the ALARA program for the duration of the license. The
				written description shall include:
(a) A
				commitment by management to keep occupational doses as low as reasonably
				achievable;
(b) A requirement that
				the radiation safety officer annually report to management in writing on the
				radiation safety program; and,
(c)
				Categories of personnel exposure levels that, when exceeded, will initiate
				investigation by the radiation safety officer of the cause of the exposure and
				actions taken to reduce the probability of
				recurrence.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64E - Division of Environmental Health › Chapter 64E-5 - CONTROL OF RADIATION HAZARDS › Section 64E-5.605 - Radiation Safety Officer

Current through Reg. 50, No. 138; July 16, 2024
(1) A licensee
				shall appoint a RSO who agrees in writing to be responsible for implementing
				the radiation safety program. The licensee, through the RSO, shall ensure that
				radiation safety activities are performed with approved procedures and
				regulatory requirements in the daily operation of the licensee's radioactive
				materials program.
(2) The
				radiation safety officer shall promptly investigate and implement corrective
				actions as necessary regarding:
(a)
				Overexposures;
(b)
				Accidents;
(c) Spills;
(d) Losses;
(e) Thefts;
(f) Unauthorized receipts, uses, transfers,
				and disposals; and,
(g) Other
				deviations from approved radiation safety practice. A written report of these
				investigations and the corrective actions taken shall be given to
				management.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64E - Division of Environmental Health › Chapter 64E-5 - CONTROL OF RADIATION HAZARDS › Section 64E-5.606 - Radiation Safety Committee

Current through Reg. 50, No. 138; July 16, 2024
(1) Each
				license listed below shall establish a radiation safety committee to oversee
				the use of radioactive materials;
(a) Medical
				institutions as defined in Rule
				 64E-5.101, F.A.C., or
(b) Other licenses authorized for any of the
				following medical uses:
1. Subsection
				 64E-5.627(2),
				F.A.C., and any subsection of Rule
				 64E-5.632 or
				 64E-5.634, F.A.C.,
2. Subsection
				 64E-5.627(3),
				F.A.C., and any subsection of Rule
				 64E-5.632 or
				 64E-5.634, F.A.C.,
3. Subsection
				 64E-5.627(4),
				F.A.C., and any subsection of Rule
				 64E-5.632 or
				 64E-5.634, F.A.C.,
4. Any subsection of Rule
				 64E-5.630, F.A.C., and any
				subsection of Rule  64E-5.632 or
				 64E-5.634, F.A.C.,
5. Subsections
				 64E-5.634(1) 
				and  64E-5.634(2),
				F.A.C.,
6. Subsections
				 64E-5.634(1) 
				and  64E-5.634(3),
				F.A.C., or
7. Subsections
				 64E-5.634(2) 
				and  64E-5.634(3),
				F.A.C.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64E - Division of Environmental Health › Chapter 64E-5 - CONTROL OF RADIATION HAZARDS › Section 64E-5.607 - Authority and Responsibilities

Current through Reg. 50, No. 138; July 16, 2024
(1) A
				licensee shall provide sufficient authority and organizational freedom to the
				radiation safety officer and the radiation safety committee to:
(a) Identify radiation safety
				problems;
(b) Initiate, recommend,
				or provide solutions;
(c) Require
				and verify implementation of corrective actions; and,
(d) Stop unsafe
				operations.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64E - Division of Environmental Health › Chapter 64E-5 - CONTROL OF RADIATION HAZARDS › Section 64E-5.608 - Supervision

Current through Reg. 50, No. 138; July 16, 2024
(1) Supervision of a physician in training to
				become an authorized user:
(a) A licensee who
				permits the receipt, acquisition, possession, use, preparation, or transfer of
				radioactive material by a physician in training under the supervision of an
				authorized user as allowed by paragraph
				 64E-5.601(3)(a),
				F.A.C., shall:
1. Instruct the supervised
				individual in the principles of radiation safety appropriate to that
				individual's use of radioactive material and in the licensee's written quality
				management program,
2. Review the
				supervised individual's use of radioactive material, provide reinstruction as
				needed and review records kept to reflect this use,
3. Require the preparation of radioactive
				materials use only under the supervision of an authorized user or authorized
				nuclear pharmacist,
4. Require the
				authorized user to be immediately available to communicate with the supervised
				individual; and,
5. Require that
				only those individuals specifically designated by the authorized user be
				permitted to administer radionuclides or radiation to
				patients.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64E - Division of Environmental Health › Chapter 64E-5 - CONTROL OF RADIATION HAZARDS › Section 64E-5.609 - Visiting Authorized User, Visiting Authorized Medical Physicist, or Visiting RSO

Current through Reg. 50, No. 138; July 16, 2024
(1) A licensee may
				permit any visiting authorized user to use licensed material for medical use
				under the terms of the licensee's license for 60 days each year if:
(a) The licensee has a copy of a license
				issued by the department, the NRC, or an agreement state that identifies the
				visiting authorized user by name as an authorized user for medical use; and,
(b) The visiting authorized user
				performs only those procedures for which he is specifically authorized by the
				license described in paragraph
				 64E-5.609(1)(a),
				F.A.C., above.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64E - Division of Environmental Health › Chapter 64E-5 - CONTROL OF RADIATION HAZARDS › Section 64E-5.611 - Quality Management Program and Notifications, Records and Reports of Medical Events

Current through Reg. 50, No. 138; July 16, 2024
(1) Each applicant or
				licensee under this part, as applicable, shall establish and maintain a written
				quality management program to provide a high confidence that radioactive
				material or radiation from radioactive material will be administered as
				directed by the authorized user. The quality management program must include
				written policies and procedures to meet the following objectives:
(a) Except where a delay to provide a written
				directive would jeopardize the patient's health as specified in paragraphs (b)
				and (c), of this rule, a written directive is prepared prior to administration
				for the following:
1. Any teletherapy
				radiation dose,
2. Any gamma
				stereotactic radiosurgery radiation dose,
3. Any brachytherapy radiation dose,
4. Any administration of iodine
				131 as sodium iodide in quantities greater than 30 microcuries (1.11
				megabecquerels),
5. Any therapeutic
				administration of a radiopharmaceutical other than iodine 131 as sodium iodide,
				or
6. Any high dose rate remote
				afterloader radiation dose.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64E - Division of Environmental Health › Chapter 64E-5 - CONTROL OF RADIATION HAZARDS › Section 64E-5.612 - Suppliers

Current through Reg. 50, No. 138; July 16, 2024
A licensee shall use for medical use only:
(1) Radioactive material manufactured,
				labeled, packaged, and distributed as specified in a license issued by the
				department or by another agreement state, a licensing state or the U.S. Nuclear
				Regulatory Commission;
(2)
				Generators and reagent kits that have been manufactured, labeled, packaged, and
				distributed as specified in an approval issued by the U.S. Department of Health
				and Human Services, Food and Drug Administration unless the kits are not
				subject to the Federal Food, Drug, and Cosmetics Act and the Public Health
				Services Act;
(3) Teletherapy
				sources manufactured and distributed as specified in a license issued by the
				department or by another agreement state, a licensing state or the NRC,
				or
(4) Sealed sources or devices
				containing radioactive materials that are either;
(a) Manufactured, labeled, packaged, and
				distributed as specified in a license issued by the department or by another
				agreement state, a licensing state or the NRC, or
(b) Noncommercially transferred from a
				medical use licensee authorized by Chapter 64E-5, Part VI, F.A.C., or
				equivalent medical use license issued by another agreement state or the
				NRC.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64E - Division of Environmental Health › Chapter 64E-5 - CONTROL OF RADIATION HAZARDS › Section 64E-5.613 - Quality Control of Diagnostic Instrumentation

Current through Reg. 50, No. 138; July 16, 2024
Each licensee shall establish written quality control
				  procedures for all equipment used to obtain images or information from
				  radionuclide studies. The procedures shall be recommended by equipment
				  manufacturers or be approved by the department. The licensee shall perform
				  quality control as specified in written procedures and retain a copy of the
				  quality control results for 3 years.
Rulemaking Authority
					  404.022,
					 404.051,
					 404.061,
					 404.071,
					 404.081,
					 404.141 FS. Law Implemented
					 404.022,
					  404.051(1), (4), (5), (6), (8), (9), (10),
					 (11),
					  404.061(2),
					 (3),
					  404.071(1),
					  404.081,
					  404.141 FS.
New 8-25-91, Amended 5-13-93, Formerly
					 10D-91.719.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64E - Division of Environmental Health › Chapter 64E-5 - CONTROL OF RADIATION HAZARDS › Section 64E-5.614 - Possession, Use, Calibration, and Check of Dose Calibrators in the Use of Unsealed Radiopharmaceuticals

Current through Reg. 50, No. 138; July 16, 2024
(1) A
				medical use licensee authorized to administer radiopharmaceuticals shall
				possess a dose calibrator and use it to measure the amount of activity
				administered to each patient or human research subject.
(2) A licensee shall check each dose
				calibrator before use each day of use, or during an assigned shift for
				facilities operating continuously, for constancy with a dedicated check source.
				The check shall be performed 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. A record shall be made of each check, which shall include:
(a) The model and serial number of the dose
				calibrator;
(b) The identity and
				decay corrected activity of the radionuclide contained in the check
				source;
(c) The date of the
				check;
(d) The activity
				measured;
(e) The percent
				error;
(f) The instrument settings;
				and,
(g) The name or initials of
				the individual performing the check.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64E - Division of Environmental Health › Chapter 64E-5 - CONTROL OF RADIATION HAZARDS › Section 64E-5.615 - Use, Calibration and Check of Survey Instruments

Current through Reg. 50, No. 138; July 16, 2024
A licensee shall ensure that the survey instruments used to
				  comply with this part have been calibrated before first use, at least every 12
				  months, and after repair.
(1) A record
				shall be made of each calibration, which shall include:
(a) A description of the source
				used;
(b) The certified dose rates
				from the source;
(c) The rates
				indicated by the instrument being calibrated;
(d) The correction factors deduced from the
				calibration data;
(e) The name of
				the individual who performed the calibration;
(f) The date of calibration;
(g) The model number and serial number of the
				instrument being calibrated; and,
(h) The results of the
				calibration.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64E - Division of Environmental Health › Chapter 64E-5 - CONTROL OF RADIATION HAZARDS › Section 64E-5.616 - Determination of Dosages of Unsealed Radioactive Material for Medical Use

Current through Reg. 50, No. 138; July 16, 2024
(1) The licensee shall determine by assay or
				direct measurement within 30 minutes before each radiopharmaceutical dosage and
				record the activity of each dosage before medical use. A record of the assay
				shall be made which shall include:
(a) The
				generic name, trade name, or abbreviation of the radiopharmaceutical; its lot
				number; expiration date; and the radionuclide;
(b) The patient's or human research subject's
				name or identification number if one has been assigned;
(c) The prescribed dosage and activity of the
				dosage at the time of assay or a notation that the total activity assayed is
				less than 10 microcuries (370 kBq);
(d) The date and time of the assay and
				administration; and,
(e) The name
				of the individual who performed the assay.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64E - Division of Environmental Health › Chapter 64E-5 - CONTROL OF RADIATION HAZARDS › Section 64E-5.617 - Authorization for Calibration, Transmission and Reference Sources

Current through Reg. 50, No. 138; July 16, 2024
Any person authorized by Rule
				   64E-5.601, F.A.C., for medical
				  use of radioactive material may receive, possess, and use the following
				  radioactive material for check, calibration, transmission and reference
				  use:
(1) Sealed sources that:
(a) Do not exceed 1.11 GBq (30 mCi) each,
				manufactured and distributed by a person licensed by the department, the NRC,
				an agreement state, or
(b) Do not
				exceed 1.11 GBq (30 mCi) each, which are redistributed by a licensee that is
				authorized to redistribute sealed sources that are manufactured and distributed
				by a person licensed by the department, the NRC, or an agreement state,
				provided the redistributed sealed sources are in the original packaging and
				shielding, and are accompanied by the manufacturer's approved
				instructions;
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64E - Division of Environmental Health › Chapter 64E-5 - CONTROL OF RADIATION HAZARDS › Section 64E-5.618 - Requirements for Possession of Sealed Sources and Brachytherapy Sources

Current through Reg. 50, No. 138; July 16, 2024
(1) A licensee who possesses any sealed
				source or brachytherapy source shall follow the radiation safety and handling
				instructions supplied by the manufacturer or equivalent instructions approved
				by the department and shall maintain the instructions for the duration of
				source use in a legible form and convenient to users.
(2) A licensee in possession of a sealed
				source shall assure that:
(a) The source is
				tested for leakage before its first use unless the licensee has a certificate
				from the supplier indicating that the source was tested within 6 months before
				transfer to the licensee; and,
(b)
				The source is tested for leakage at least every 6 months or at intervals
				approved by the department, another agreement state, a licensing state or the
				U.S. Nuclear Regulatory Commission.
(c) Leak tests are capable of detecting the
				presence of 0.005 microcurie (185 Bq) of radioactive material on the test
				sample, or, in the case of radium, the escape of radon at the rate of 0.001
				microcurie (37 Bq) each 24 hours;
(d) Test samples are taken from the source or
				from the surfaces of the device in which the source is mounted or stored on
				which radioactive contamination might be expected to accumulate; and,
(e) Teletherapy and other device
				source samples are taken when the source is in the off position.
(f) Leak tests are analyzed by individuals
				who are licensed by the department, U.S. Nuclear Regulatory Commission, an
				agreement state or licensing state to perform leak test
				services.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64E - Division of Environmental Health › Chapter 64E-5 - CONTROL OF RADIATION HAZARDS › Section 64E-5.619 - Syringe Shields and Labels

Current through Reg. 50, No. 138; July 16, 2024
(1) A
				licensee shall keep syringes that contain radioactive material to be
				administered in a radiation shield. Each individual who prepares or administers
				radiopharmaceuticals shall use a syringe radiation shield unless the use of the
				shield is contraindicated for that patient.
(2) Unless used immediately, a licensee shall
				label conspicuously each syringe or syringe radiation shield that contains a
				syringe with a radiopharmaceutical with the patient's name or the
				radiopharmaceutical name or its abbreviation and the type of diagnostic study
				or therapy procedure to be performed.
Rulemaking Authority
					 404.051,
					 404.061,
					 404.081,
					 404.141 FS. Law Implemented
					  404.022,
					  404.051(1), (4), (6), (10),
					 (11),
					  404.061(2),
					 (3),
					  404.081,
					  404.141 FS.
New 8-25-91, Amended 5-15-96, Formerly
					 10D-91.725.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64E - Division of Environmental Health › Chapter 64E-5 - CONTROL OF RADIATION HAZARDS › Section 64E-5.620 - Vial Shields and Labels

Current through Reg. 50, No. 138; July 16, 2024
A licensee shall require each individual preparing or
				  handling a vial that contains a radiopharmaceutical to keep the vial in a vial
				  radiation shield and conspicuously label each vial with the radiopharmaceutical
				  name or its abbreviation.
Rulemaking Authority
					  404.022,
					 404.051,
					 404.061,
					 404.081,
					 404.141 FS. Law Implemented
					 404.022,
					  404.051(1), (4), (6), (10),
					 (11),
					  404.061(2),
					 (3),
					  404.081,
					  404.141 FS.
New 8-25-91, Amended 5-15-96, Formerly
					 10D-91.727.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64E - Division of Environmental Health › Chapter 64E-5 - CONTROL OF RADIATION HAZARDS › Section 64E-5.621 - Surveys for Contamination and Ambient Radiation Dose Rate

Current through Reg. 50, No. 138; July 16, 2024
(1) A licensee shall survey with a radiation
				survey instrument at the end of each day of use, or during an assigned shift
				for facilities operating continuously, all areas where radiopharmaceuticals are
				routinely prepared for use or administered.
(2) A licensee shall survey all areas where
				radiopharmaceuticals or radioactive wastes are stored with a radiation survey
				instrument at least once each week.
(3) A licensee shall conduct the surveys
				required by subsections
				 64E-5.621(1) and
				(2), F.A.C., with an instrument capable of
				measuring dose rates as low as 0.1 millirem (1 µSv) per hour.
(4) A licensee shall establish dose rate
				action levels for the surveys required by subsections
				 64E-5.621(1) and
				(2), F.A.C., and shall require that the
				individual performing the survey immediately notify the radiation safety
				officer if a dose rate exceeds an action level.
(5) A licensee shall perform a wipe survey
				for removable contamination weekly of all areas where radiopharmaceuticals are
				routinely prepared for use, administered or stored.
(6) A licensee shall analyze the wipe surveys
				required by subsection
				 64E-5.621(5),
				F.A.C., with an instrument capable of detecting contamination of 2, 000
				disintegrations per minute (33.3 Bq) or shall monitor each wipe sample in a low
				background area with a radiation survey instrument using a probe with a maximum
				window thickness of 2.0 mg/cm2 and a minimum probe
				diameter of 1.5 inches.
(7) A
				licensee shall establish removable contamination action levels for the wipe
				surveys required by subsection
				 64E-5.621(5),
				F.A.C., and shall require that the individual performing the survey immediately
				notify the radiation safety officer if contamination exceeds action
				levels.
(8) A licensee shall retain
				a record of each survey required by subsections
				 64E-5.621(1), (2), and
				(5), F.A.C., for 3 years. The record shall
				include:
(a) The date of the survey;
(b) A diagram of each area
				surveyed;
(c) Action levels
				established for each area;
(d) The
				measured dose rate at several points in each area expressed in millirems
				(microsieverts) per hour or the removable contamination in each area expressed
				in disintegrations per minute (becquerels) per 100 square centimeters, or
				counts per minute if performed with a radiation survey instrument as described
				in subsection  64E-5.621(6),
				F.A.C.;
(e) The serial number and
				the model number of the instrument used to make the survey or analyze the
				samples; and,
(f) The name of the
				person who performed the survey.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64E - Division of Environmental Health › Chapter 64E-5 - CONTROL OF RADIATION HAZARDS › Section 64E-5.622 - Release of Patients or Human Research Subjects Treated with Radiopharmaceuticals, Implants or Remote Afterloader Units

Current through Reg. 50, No. 138; July 16, 2024
(1) Except as authorized by subsection
				 64E-5.622(4),
				F.A.C., a licensee shall not authorize release from confinement for medical
				care any patient administered a radiopharmaceutical until:
(a) The dose rate from the patient is less
				than 5 millirems (50 µSv) per hour at a distance of 1 meter, or
(b) The activity in the patient is less than
				30 millicuries (1.11 GBq).
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64E - Division of Environmental Health › Chapter 64E-5 - CONTROL OF RADIATION HAZARDS › Section 64E-5.623 - Storage of Volatiles and Gases

Current through Reg. 50, No. 138; July 16, 2024
A licensee shall store volatile radiopharmaceuticals and
				  radioactive gases in the shippers' radiation shield and container or an
				  equivalent shield and container. A licensee shall store and use a multidose
				  container in a properly functioning fume hood.
Rulemaking Authority
					  404.022,
					 404.051,
					 404.061,
					 404.071,
					 404.081,
					 404.141 FS. Law Implemented
					 404.022,
					  404.051(1), (4), (5), (6), (8), (9), (10),
					 (11),
					  404.061(2),
					 (3),
					  404.071(1),
					  404.081,
					  404.141 FS.
New 8-25-91, Formerly
					 10D-91.731.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64E - Division of Environmental Health › Chapter 64E-5 - CONTROL OF RADIATION HAZARDS › Section 64E-5.624 - Decay in Storage

Current through Reg. 50, No. 138; July 16, 2024
(1) A licensee
				shall hold radioactive material with a physical half life of less than 120 days
				for decay in storage before disposal as ordinary trash. A licensee is exempt
				from the requirements of paragraph
				 64E-5.331(1)(c),
				F.A.C., of these regulations if:
(a) The
				radioactive material is held for decay a minimum of 10 half-lives;
(b) The radioactive material is monitored at
				the container surface before disposal as ordinary trash and its radioactivity
				cannot be distinguished from the background radiation level in a low background
				radiation area with a radiation survey instrument set on its most sensitive
				scale and with no interposed shielding;
(c) All radiation labels are removed or
				obliterated; and,
(d) Each
				generator column is separated and monitored individually with all radiation
				shielding removed to ensure that its contents have decayed to background
				radiation levels before disposal.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64E - Division of Environmental Health › Chapter 64E-5 - CONTROL OF RADIATION HAZARDS › Section 64E-5.625 - Safety Instructions and Precautions for Liquid Iodine, Radiopharmaceutical Therapy, Manual Brachytherapy, Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery

Current through Reg. 50, No. 138; July 16, 2024
(1) A
				licensee shall provide oral and written radiation safety instructions to all
				personnel caring for patients or human research subjects, who cannot be
				released under Rule  64E-5.622, F.A.C., undergoing
				radiopharmaceutical therapy or manual brachytherapy. This training shall be
				provided initially prior to caring for patients and refresher training shall be
				provided at least every 12 months. The instruction shall describe the
				licensee's procedures for notification of the RSO and an authorized user in
				case of the patient's death or medical emergency.
(2) The instruction for radiopharmaceutical
				therapy shall be commensurate with the duties of the personnel and describe the
				procedures for:
(a) Patient or human research
				subject control;
(b) Visitor
				control, including;
1. Routine visitation to
				hospitalized individuals in accordance with paragraph
				 64E-5.312(1)(a),
				F.A.C.; and,
2. Visitation
				authorized in accordance with subsection
				 64E-5.312(5),
				F.A.C.
(c) Contamination
				control; and,
(d) Waste
				control.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64E - Division of Environmental Health › Chapter 64E-5 - CONTROL OF RADIATION HAZARDS › Section 64E-5.6251 - Manual Brachytherapy Therapy Related Computer Systems

Current through Reg. 50, No. 138; July 16, 2024
The licensee shall perform acceptance testing on the
				  treatment planning system of manual brachytherapy therapy-related computer
				  systems in accordance with published protocols accepted by nationally
				  recognized bodies. At a minimum, the acceptance testing must include, as
				  applicable, verification of:
(1) The
				source-specific input parameters required by the dose calculation
				algorithm;
(2) The accuracy of
				dose, dwell time, and treatment time calculations at representative
				points;
(3) The accuracy of isodose
				plots and graphic displays; and,
(4) The accuracy of the software used to
				determine sealed source positions from radiographic images.
The licensee shall maintain records of this acceptance
				  testing and protocols used in performing these tests for inspection by the
				  department.
Rulemaking Authority
					 404.051,
					 404.061,
					 404.081,
					 404.141 FS. Law Implemented
					  404.022,
					  404.051(1), (4), (6), (10),
					 (11),
					  404.061(2),
					 (3),
					  404.081,
					  404.141 FS.
New 2-11-10, Amended
					 12-26-13.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64E - Division of Environmental Health › Chapter 64E-5 - CONTROL OF RADIATION HAZARDS › Section 64E-5.626 - Use of Radiopharmaceuticals for Uptake, Dilution, or Excretion Studies

Current through Reg. 50, No. 138; July 16, 2024
A licensee is allowed to use any unsealed radioactive
				  material in a radiopharmaceutical for a diagnostic use involving measurements
				  of uptake, dilution, or excretion for medical use under the following
				  conditions:
(1) When a written
				directive is not required by subsection
				 64E-5.607(3),
				F.A.C., the licensee must satisfy the following:
(a) Radioactive material is obtained from a
				manufacturer or pharmacy licensed as specified in subsection
				 64E-5.210(10),
				F.A.C., or in equivalent NRC or agreement state regulations, or
(b) Radioactive material is obtained from and
				prepared by a NRC or agreement state licensee for use in research in accordance
				with a Radioactive Drug Research Committee-approved protocol, or a Notice of
				Claimed Investigational Exemption for a New Drug (IND) protocol accepted by
				U.S. Food and Drug Administration (FDA), or
(c) Radioactive material is prepared by the
				licensee for use in research in accordance with a Radioactive Drug Research
				Committee-approved application, or an IND protocol accepted by FDA,
				or
(d) Radioactive material is
				prepared by:
1. An authorized nuclear
				pharmacist,
2. Except for sodium
				iodide I-131 in quantities greater than 30 microcuries (1.11 MBq), a physician
				who is an authorized user and meets the training requirements specified in Rule
				 64E-5.650 or
				 64E-5.660, and sub-subparagraph
				 64E-5.650(3)(a) 
				2.g., F.A.C., or
3. An individual
				under the supervision of a physician who is an authorized user under
				subparagraph  64E-5.626(1)(d) 
				2., F.A.C., and as specified in paragraphs
				 64E-5.601(3)(a) and
				(b),
				 64E-5.607(3)(e),
				or subsection  64E-5.608(1),
				F.A.C., or
(e) The
				authorized user must satisfy the training and experience specified in Rule
				 64E-5.649 or
				 64E-5.657,
				F.A.C.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64E - Division of Environmental Health › Chapter 64E-5 - CONTROL OF RADIATION HAZARDS › Section 64E-5.627 - Use of Unsealed Radiopharmaceuticals, Generators, and Reagent Kits for Imaging and Localization Studies

Current through Reg. 50, No. 138; July 16, 2024
A licensee is allowed to use any radioactive material in a
				  diagnostic radiopharmaceutical, or any generator, or reagent kit, for
				  preparation and diagnostic use of a radiopharmaceutical containing radioactive
				  material for medical use under the following conditions:
(1) When a written directive is not required
				by subsection  64E-5.607(3),
				F.A.C., the licensee must satisfy the following:
(a) Obtained from a manufacturer or pharmacy
				licensed as specified in subsection
				 64E-5.210(10),
				F.A.C., or in equivalent U.S. Nuclear Regulatory Commission or Agreement State
				regulations, or
(b) Radioactive
				material is obtained from and prepared by a NRC or agreement state licensee for
				use in research in accordance with a Radioactive Drug Research
				Committee-approved protocol or an IND protocol accepted by FDA, or
(c) Radioactive material is prepared by the
				licensee for use in research in accordance with a Radioactive Drug Research
				Committee-approved application or an IND protocol accepted by FDA, or
(d) Radioactive material is prepared by:
1. An authorized nuclear
				pharmacist,
2. Except for sodium
				iodide I-131 in quantities greater than 30 microcuries (1.11 MBq), a physician
				who is an authorized user and meets the training requirements specified in
				Rules  64E-5.650 or
				 64E-5.660 and sub-subparagraph
				 64E-5.650(3)(a) 
				2.g., F.A.C., or
3. An individual
				under the supervision of a physician who is an authorized user under
				subparagraph  64E-5.626(1)(d) 
				2., F.A.C., and as specified in paragraphs
				 64E-5.601(3)(a) and
				(b),
				 64E-5.607(3)(e) 
				or subsection  64E-5.608(1),
				F.A.C., or
(e) The
				authorized user must satisfy the training and experience specified in Rule
				 64E-5.650 or
				 64E-5.657,
				F.A.C.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64E - Division of Environmental Health › Chapter 64E-5 - CONTROL OF RADIATION HAZARDS › Section 64E-5.628 - Generators

Current through Reg. 50, No. 138; July 16, 2024
(1) Permissible Molybdenum/Technetium
				Concentration.
(a) A licensee shall not
				administer a radiopharmaceutical containing more than 0.15 microcurie of
				molybdenum 99 per millicurie of technetium 99m (5.55 kilo-becquerel of
				molybdenum 99 per 37 megabecquerel of technetium 99m).
(b) A licensee preparing technetium 99m
				radiopharmaceuticals from molybdenum 99/technetium 99m generators shall measure
				the molybdenum 99 concentration in each eluate or extract.
(c) A licensee who is required to measure
				molybdenum concentrations shall retain a record of each measurement for 3
				years. The record shall include for each elution or extraction of technetium
				99m:
1. The measured activity of the
				technetium expressed in millicuries (megabecquerels),
2. The measured activity of molybdenum
				expressed in microcuries (kilobecquerels),
3. The ratio of the measures expressed as
				microcuries of molybdenum per millicurie of technetium (kilobecquerels of
				molybdenum per megabecquerel of technetium),
4. The date of the test; and,
5. The initials of the individual who
				performed the test.
(d) A
				licensee shall report immediately to the department each occurrence of
				molybdenum 99 concentration exceeding the limits specified in subsection
				 64E-5.628(1),
				F.A.C.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64E - Division of Environmental Health › Chapter 64E-5 - CONTROL OF RADIATION HAZARDS › Section 64E-5.629 - Control of Aerosols and Gases

Current through Reg. 50, No. 138; July 16, 2024
(1) A
				licensee shall only administer radioactive aerosols or gases when airborne
				concentrations are within the limits prescribed by State of Florida Bureau of
				Radiation Control ALIs, DACs, and Effluent Concentrations, June 2012, (see Rule
				 64E-5.101, F.A.C.) Table I,
				Column 3, and Table II.
(2) 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.
(3) A 1icensee
				shall only administer radioactive gases in rooms that are at negative pressure
				compared to surrounding rooms.
(4)
				Before receiving, using, or storing radioactive gas, the licensee shall
				calculate the time needed after a release to reduce the concentration in the
				area of use to the occupational limit listed in State of Florida Bureau of
				Radiation Control ALIs, DACs, and Effluent Concentrations, June 2012. The
				calculation shall be based on the highest activity of gas handled in a single
				container and the measured available air exhaust rate.
(5) A licensee shall post the time calculated
				in subsection  64E-5.629(4),
				F.A.C., at the area of use and require that individuals evacuate the room until
				the posted time has elapsed if a gas spill occurs.
(6) A licensee shall check the operation of
				collection systems prior to use each month of use and measure the ventilation
				rates in areas of use every 6 months. Records of these checks and measurements
				shall be maintained for 3 years.
(7) A copy of the calculations required in
				subsection  64E-5.629(4),
				F.A.C., shall be recorded and retained for the duration of the
				license.
Rulemaking Authority
					 404.051,
					 404.061,
					 404.071,
					 404.081,
					 404.141 FS. Law Implemented
					  404.022,
					  404.051(1), (4), (5), (6), (8), (9), (10),
					 (11),
					  404.061(2),
					 (3),
					  404.071(1),
					  404.081,
					  404.141 FS.
New 8-25-91, Amended 1-1-94, Formerly 10D-91.737, Amended
					 2-11-10, 12-26-13.
Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64E - Division of Environmental Health › Chapter 64E-5 - CONTROL OF RADIATION HAZARDS › Section 64E-5.630 - Use of Radiopharmaceuticals for Therapy

Current through Reg. 50, No. 138; July 16, 2024
A licensee is allowed to use any unsealed radioactive
				  material in a radiopharmaceutical that requires a written directive as
				  described in subsection
				   64E-5.607(3),
				  F.A.C., and for a therapeutic medical use provided the following is met:
(1) For any unsealed radiopharmaceutical
				including parenteral use listed in subsection
				 64E-5.630(4),
				F.A.C., and sodium iodide I-131 use listed in subsections
				 64E-5.630(2) and
				(3), F.A.C., the licensee must satisfy the
				following:
(a) Radioactive material is
				obtained from a manufacturer or pharmacy licensed as specified in subsection
				 64E-5.210(10),
				F.A.C., or in equivalent NRC or agreement state regulations, or
(b) Radioactive material is obtained from and
				prepared by an NRC or agreement state licensee for use in research in
				accordance with a Radioactive Drug Research Committee-approved protocol or an
				IND protocol accepted by FDA, or
(c) Radioactive material is prepared by the
				licensee for use in research in accordance with a Radioactive Drug Research
				Committee-approved application or an IND protocol accepted by FDA, or
(d) Radioactive material is prepared by:
1. An authorized nuclear
				pharmacist;
2. A physician who is
				an authorized user and meets the training requirements specified in Rule
				 64E-5.650 or
				 64E-5.660, F.A.C., or
3. An individual under the supervision of a
				physician who is an authorized user under subparagraph
				 64E-5.630(1)(d) 
				2., F.A.C., as specified in paragraphs
				 64E-5.601(3)(a) and
				(b),
				 64E-5.607(3)(e) 
				or subsection  64E-5.608(1),
				F.A.C.
(e) The authorized
				user must satisfy the applicable training and experience specified in Rule
				 64E-5.660 or
				 64E-5.657,
				F.A.C.