reglab/statecodes huggingface dataset:
Virginia Administrative Code › Title 12 - HEALTH › Agency 5 - DEPARTMENT OF HEALTH › Chapter 481 - VIRGINIA RADIATION PROTECTION REGULATIONS › Part V - Radiation Safety Requirements For Industrial Radiographic Operations › Article 3 - Recordkeeping Requirements › Section 12VAC5-481-1440 - Utilization logs

Current through Register Vol. 40, No. 24, July 15, 2024
A. Each licensee or
					 registrant shall maintain utilization logs showing for each source of radiation
					 the following information:
1. A description,
					 including the make, model, and serial number of the radiation machine or the
					 radiographic exposure device, transport, or storage container in which the
					 sealed source is located;
2. The
					 identity and signature of the radiographer to whom assigned;
3. The location and dates of use, including
					 the dates removed and returned to storage; and
4. For permanent radiographic installations,
					 the dates each radiation machine is energized.
Virginia Administrative Code › Title 12 - HEALTH › Agency 5 - DEPARTMENT OF HEALTH › Chapter 481 - VIRGINIA RADIATION PROTECTION REGULATIONS › Part V - Radiation Safety Requirements For Industrial Radiographic Operations › Article 3 - Recordkeeping Requirements › Section 12VAC5-481-1450 - Records of inspection and maintenance of radiation machines, radiographic exposure devices, transport and storage containers, associated equipment, source changers, and survey instruments

Current through Register Vol. 40, No. 24, July 15, 2024
A. Each licensee or registrant shall maintain
					 records specified in
					 12VAC5-481-1270 of equipment
					 problems found in daily checks and quarterly inspections of radiation machines,
					 radiographic exposure devices, transport and storage containers, associated
					 equipment, source changers, and survey instruments, and retain each record for
					 three years after it is made.
B.
					 The record must include the date of check or inspection, name of inspector,
					 equipment involved, any problems found, and what repair and/or maintenance, if
					 any, was performed.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Virginia Administrative Code › Title 12 - HEALTH › Agency 5 - DEPARTMENT OF HEALTH › Chapter 481 - VIRGINIA RADIATION PROTECTION REGULATIONS › Part V - Radiation Safety Requirements For Industrial Radiographic Operations › Article 3 - Recordkeeping Requirements › Section 12VAC5-481-1460 - Records of alarm system and entrance control checks at permanent radiographic installations

Current through Register Vol. 40, No. 24, July 15, 2024
Each licensee or registrant shall maintain records of
						alarm system and entrance control tests required by
						12VAC5-481-1280 and retain each
						record for three years after it is made.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Virginia Administrative Code › Title 12 - HEALTH › Agency 5 - DEPARTMENT OF HEALTH › Chapter 481 - VIRGINIA RADIATION PROTECTION REGULATIONS › Part V - Radiation Safety Requirements For Industrial Radiographic Operations › Article 3 - Recordkeeping Requirements › Section 12VAC5-481-1470 - Records of training and certification

Current through Register Vol. 40, No. 24, July 15, 2024
Each licensee or registrant shall maintain the following
						records for three years:
1. Records of
					 training of each radiographer and each radiographer's assistant. The record
					 must include radiographer certification documents and verification of
					 certification status, copies of written tests, dates of oral and practical
					 examinations, the names of individuals conducting and receiving the oral and
					 practical examinations, and a list of items tested and the results of the oral
					 and practical examinations; and
2.
					 Records of annual refresher safety training and semi-annual inspections of job
					 performance for each radiographer and each radiographer's assistant. The
					 records must list the topics discussed during the refresher safety training,
					 the dates the annual refresher safety training was conducted, and names of the
					 instructors and attendees. For inspections of job performance, the records must
					 also include a list showing the items checked and any noncompliance observed by
					 the radiation safety officer or designee.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Virginia Administrative Code › Title 12 - HEALTH › Agency 5 - DEPARTMENT OF HEALTH › Chapter 481 - VIRGINIA RADIATION PROTECTION REGULATIONS › Part V - Radiation Safety Requirements For Industrial Radiographic Operations › Article 3 - Recordkeeping Requirements › Section 12VAC5-481-1480 - Copies of operating and emergency procedures

Current through Register Vol. 40, No. 24, July 15, 2024
Each licensee or registrant shall maintain a copy of
						current operating and emergency procedures until the agency terminates the
						license or registration. Superseded material must be retained for three years
						after the change is made.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Virginia Administrative Code › Title 12 - HEALTH › Agency 5 - DEPARTMENT OF HEALTH › Chapter 481 - VIRGINIA RADIATION PROTECTION REGULATIONS › Part V - Radiation Safety Requirements For Industrial Radiographic Operations › Article 3 - Recordkeeping Requirements › Section 12VAC5-481-1490 - Records of personnel monitoring

Current through Register Vol. 40, No. 24, July 15, 2024
Each licensee or registrant shall maintain the following
						exposure records specified in
						12VAC5-481-1350:
1. Direct reading dosimeter readings and
					 yearly operability checks required by
					 12VAC5-481-1350
					 B and
					 12VAC5-481-1350
					 C for three years after the record is made;
2. Records of alarming ratemeter calibrations
					 for three years after the record is made;
3. Personnel dosimeter results until the
					 agency terminates the license or registration; and
4. Records of estimates of exposures as a
					 result of off-scale personal direct reading dosimeters or lost or damaged
					 personnel dosimeters until the agency terminates the license or
					 registration.
Statutory Authority: §
													32.1-229
						  of the Code of Virginia.
Virginia Administrative Code › Title 12 - HEALTH › Agency 5 - DEPARTMENT OF HEALTH › Chapter 481 - VIRGINIA RADIATION PROTECTION REGULATIONS › Part V - Radiation Safety Requirements For Industrial Radiographic Operations › Article 3 - Recordkeeping Requirements › Section 12VAC5-481-1500 - Records of radiation surveys

Current through Register Vol. 40, No. 24, July 15, 2024
Each licensee shall maintain a record of each exposure
						device survey conducted before the device is placed in storage as specified in
						subdivision 3 of
						12VAC5-481-1360. Each record must
						be maintained for three years after it is made.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Virginia Administrative Code › Title 12 - HEALTH › Agency 5 - DEPARTMENT OF HEALTH › Chapter 481 - VIRGINIA RADIATION PROTECTION REGULATIONS › Part V - Radiation Safety Requirements For Industrial Radiographic Operations › Article 3 - Recordkeeping Requirements › Section 12VAC5-481-1510 - Form of records

Current through Register Vol. 40, No. 24, July 15, 2024
Each record required by this part must be legible
						throughout the specified retention period. The record may be the original or a
						reproduced copy or a microform provided that the copy or microform is
						authenticated by authorized personnel and that the microform is capable of
						reproducing a clear copy throughout the required retention period. The record
						may also be stored in electronic media with the capability for producing
						legible, accurate, and complete records during the required retention period.
						Records, such as letters, drawings, and specifications, must include all
						pertinent information, such as stamps, initials, and signatures. The licensee
						or registrant shall maintain adequate safeguards against tampering with and
						loss of records.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Virginia Administrative Code › Title 12 - HEALTH › Agency 5 - DEPARTMENT OF HEALTH › Chapter 481 - VIRGINIA RADIATION PROTECTION REGULATIONS › Part V - Radiation Safety Requirements For Industrial Radiographic Operations › Article 3 - Recordkeeping Requirements › Section 12VAC5-481-1520 - Location of documents and records

Current through Register Vol. 40, No. 24, July 15, 2024
A. Each licensee or registrant shall maintain
					 copies of records required by this part and other applicable parts of these
					 regulations at the location specified in
					 12VAC5-481-1200 A 11.
B. Each licensee or registrant shall also
					 maintain current copies of the following documents and records sufficient to
					 demonstrate compliance at each applicable field station and each temporary
					 jobsite;
1. The license or registration
					 authorizing the use of sources of radiation;
2. A copy of Parts I (12VAC5-481-10 et seq.); IV
					 (12VAC5-481-600 et seq.); V
					 (12VAC5-481-1170 et seq.); and X
					 (12VAC5-481-2250 et seq.) of this
					 chapter;
3. Utilization logs for
					 each source of radiation dispatched from that location as required by
					 12VAC5-481-1440.
4. Records of equipment problems identified
					 in daily checks of equipment as required by
					 12VAC5-481-1450 A;
5. Records of alarm system and entrance
					 control checks required by
					 12VAC5-481-1460, if
					 applicable;
6. Records of dosimeter
					 readings as required by
					 12VAC5-481-1490;
7. Operating and emergency procedures as
					 required by
					 12VAC5-481-1480;
8. Evidence of the latest calibration of the
					 radiation survey instruments in use at the site, as required by
					 12VAC5-481-1410;
9. Evidence of the latest calibrations of
					 alarming ratemeters and operability checks of dosimeters as required by
					 12VAC5-481-1490;
10. Survey records as required by
					 12VAC5-481-1500 and
					 12VAC5-481-1000 as applicable, for
					 the period of operation at the site;
11. The shipping papers for the
					 transportation of radioactive materials required by Part XIII (12VAC5-481-2950 et seq.) of this
					 chapter; and
12. When operating
					 under reciprocity pursuant to Part III (12VAC5-481-380 et seq.) of this
					 chapter, a copy of the applicable state license or registration, or NRC license
					 authorizing the use of sources of radiation.
Virginia Administrative Code › Title 12 - HEALTH › Agency 5 - DEPARTMENT OF HEALTH › Chapter 481 - VIRGINIA RADIATION PROTECTION REGULATIONS › Part V - Radiation Safety Requirements For Industrial Radiographic Operations › Article 4 - Notifications › Section 12VAC5-481-1530 - Notifications

Current through Register Vol. 40, No. 24, July 15, 2024
A. In addition to
					 the reporting requirements specified in
					 12VAC5-481-1110
					 and in Part IV (12VAC5-481-600
					 et seq.) of this chapter, each licensee or registrant shall provide a written
					 report to the agency within 30 days of the occurrence of any of the following
					 incidents involving radiographic equipment:
1. Unintentional disconnection of the source
					 assembly from the control cable;
2.
					 Inability to retract the source assembly to its fully shielded position and
					 secure it in this position;
3.
					 Failure of any component, which is critical to safe operation of the device, to
					 properly perform its intended function; or
4. An indicator on a radiation machine fails
					 to show that radiation is being produced, an exposure switch fails to terminate
					 production of radiation when turned to the off position, or a safety interlock
					 fails to terminate X-ray production.
Virginia Administrative Code › Title 12 - HEALTH › Agency 5 - DEPARTMENT OF HEALTH › Chapter 481 - VIRGINIA RADIATION PROTECTION REGULATIONS › Part V - Radiation Safety Requirements For Industrial Radiographic Operations › Article 5 - Jobsite Requirements › Section 12VAC5-481-1560 - Reciprocity

Current through Register Vol. 40, No. 24, July 15, 2024
A. All reciprocal
					 recognition of licenses and registrations by the agency will be granted in
					 accordance with Part III (12VAC5-481-380 et
					 seq.) of this chapter.
B.
					 Reciprocal recognition by the agency of an individual radiographer
					 certification will be granted provided that:
1. The individual holds a valid certification
					 in the appropriate category issued by a certifying entity, as defined in
					 12VAC5-481-10;
2. The requirements and procedures of the
					 certifying entity issuing the certification affords the same or comparable
					 certification standards as those afforded by
					 12VAC5-481-1320 A;
3. The applicant presents the certification
					 to the agency prior to entry into the state; and
4. No escalated enforcement action is pending
					 with the NRC or in any other agreement state.
Virginia Administrative Code › Title 12 - HEALTH › Agency 5 - DEPARTMENT OF HEALTH › Chapter 481 - VIRGINIA RADIATION PROTECTION REGULATIONS › Part V - Radiation Safety Requirements For Industrial Radiographic Operations › Article 5 - Jobsite Requirements › Section 12VAC5-481-1570 - Specific requirements for radiographic personnel performing industrial radiography

Current through Register Vol. 40, No. 24, July 15, 2024
A. At a job
					 site, the following shall be supplied by the licensee or registrant:
1. At least one operable, calibrated survey
					 instrument for each exposure device or radiation machine in use;
2. A current whole body personnel monitor
					 (TLD, OSL or film badge) for each person performing radiographic
					 operations;
3. An operable,
					 calibrated pocket dosimeter with a range of 0 to 2 mSv (200 mrem) for each
					 person performing radiographic operations;
4. An operable, calibrated, alarming
					 ratemeter for each person performing radiographic operations using a
					 radiographic exposure device; and
5. The appropriate barrier ropes and
					 signs.
Virginia Administrative Code › Title 12 - HEALTH › Agency 5 - DEPARTMENT OF HEALTH › Chapter 481 - VIRGINIA RADIATION PROTECTION REGULATIONS › Part VI - Use Of Diagnostic X-Rays In The Healing Arts › Section 12VAC5-481-1580

Current through Register Vol. 40, No. 24, July 15, 2024
Statutory Authority: § 32.1-229 of the Code of
						Virginia.
Virginia Administrative Code › Title 12 - HEALTH › Agency 5 - DEPARTMENT OF HEALTH › Chapter 481 - VIRGINIA RADIATION PROTECTION REGULATIONS › Part VI - Use Of Diagnostic X-Rays In The Healing Arts › Section 12VAC5-481-1581 - Purpose and scope

Current through Register Vol. 40, No. 24, July 15, 2024
This part establishes requirements, for which a registrant
					 is responsible, for use of diagnostic x-ray equipment and imaging systems by or
					 under the supervision of an individual authorized by and licensed in accordance
					 with Virginia law to engage in the healing arts or veterinary medicine. The
					 provisions of this part are in addition to and not in substitution for other
					 applicable provisions of this chapter.
Statutory Authority: § 32.1-229 of the Code of
						Virginia.
Virginia Administrative Code › Title 12 - HEALTH › Agency 5 - DEPARTMENT OF HEALTH › Chapter 481 - VIRGINIA RADIATION PROTECTION REGULATIONS › Part VI - Use Of Diagnostic X-Rays In The Healing Arts › Section 12VAC5-481-1590

Current through Register Vol. 40, No. 24, July 15, 2024
Statutory Authority: § 32.1-229 of the Code of
						Virginia.
Virginia Administrative Code › Title 12 - HEALTH › Agency 5 - DEPARTMENT OF HEALTH › Chapter 481 - VIRGINIA RADIATION PROTECTION REGULATIONS › Part VI - Use Of Diagnostic X-Rays In The Healing Arts › Section 12VAC5-481-1600

Current through Register Vol. 40, No. 24, July 15, 2024
Statutory Authority: § 32.1-229 of the Code of
						Virginia.
Virginia Administrative Code › Title 12 - HEALTH › Agency 5 - DEPARTMENT OF HEALTH › Chapter 481 - VIRGINIA RADIATION PROTECTION REGULATIONS › Part VI - Use Of Diagnostic X-Rays In The Healing Arts › Section 12VAC5-481-1610

Current through Register Vol. 40, No. 24, July 15, 2024
Statutory Authority: § 32.1-229 of the Code of
						Virginia.
Virginia Administrative Code › Title 12 - HEALTH › Agency 5 - DEPARTMENT OF HEALTH › Chapter 481 - VIRGINIA RADIATION PROTECTION REGULATIONS › Part VI - Use Of Diagnostic X-Rays In The Healing Arts › Section 12VAC5-481-1611 - Fluoroscopic equipment

Current through Register Vol. 40, No. 24, July 15, 2024
A. The
				  provisions of this section apply to equipment for fluoroscopic imaging or for
				  recording images from the fluoroscopic image receptor, except computed
				  tomography x-ray systems manufactured on or after November 29, 1984.
B. Primary protective barrier.
1. Limitation of useful beam. The
				  fluoroscopic imaging assembly shall be provided with a primary protective
				  barrier that intercepts the entire cross section of the useful beam at any SID.
				  The x-ray tube used for fluoroscopy shall not produce x-rays unless the barrier
				  is in position to intercept the entire useful beam. The AKR due to transmission
				  through the barrier with the attenuation block in the useful beam combined with
				  radiation from the fluoroscopic imaging receptor shall not exceed
				  3.34x10-3% of the entrance AKR, at a distance of 10
				  cm from any accessible surface of the fluoroscopic imaging assembly beyond the
				  plane of the image receptor. Radiation therapy simulation systems shall be
				  exempt from this requirement provided the systems are intended only for remote
				  control operation.
2. Measuring
				  compliance. The AKR shall be measured in accordance with subsection E of this
				  section. The AKR due to transmission through the primary barrier combined with
				  radiation from the fluoroscopic image receptor shall be determined by
				  measurements averaged over an area of 100 square cm with no linear dimension
				  greater than 20 cm. If the source is below the tabletop, the measurement shall
				  be made with the input surface of the fluoroscopic imaging assembly positioned
				  30 cm above the tabletop. If the source is above the tabletop and the SID is
				  variable, the measurement shall be made with the end of the beam-limiting
				  device or spacer as close to the tabletop as it can be placed, provided that it
				  shall not be closer than 30 cm. Movable grids and compression devices shall be
				  removed from the useful beam during the measurement. For all measurements, the
				  attenuation block shall be positioned in the useful beam 10 cm from the point
				  of measurement of entrance AKR and between this point and the input surface of
				  the fluoroscopic imaging assembly.
Virginia Administrative Code › Title 12 - HEALTH › Agency 5 - DEPARTMENT OF HEALTH › Chapter 481 - VIRGINIA RADIATION PROTECTION REGULATIONS › Part VI - Use Of Diagnostic X-Rays In The Healing Arts › Section 12VAC5-481-1620

Current through Register Vol. 40, No. 24, July 15, 2024
Statutory Authority: § 32.1-229 of the Code of
						Virginia.
Virginia Administrative Code › Title 12 - HEALTH › Agency 5 - DEPARTMENT OF HEALTH › Chapter 481 - VIRGINIA RADIATION PROTECTION REGULATIONS › Part VI - Use Of Diagnostic X-Rays In The Healing Arts › Section 12VAC5-481-1630

Current through Register Vol. 40, No. 24, July 15, 2024
Statutory Authority: § 32.1-229 of the Code of
						Virginia.
Virginia Administrative Code › Title 12 - HEALTH › Agency 5 - DEPARTMENT OF HEALTH › Chapter 481 - VIRGINIA RADIATION PROTECTION REGULATIONS › Part VI - Use Of Diagnostic X-Rays In The Healing Arts › Section 12VAC5-481-1631 - Intraoral dental radiographic equipment

Current through Register Vol. 40, No. 24, July 15, 2024
In addition to the applicable provisions of
					 12VAC5-481-1591,
					 12VAC5-481-1601, and
					 12VAC5-481-1621, the requirements
					 of this section apply to x-ray equipment and associated facilities used for
					 dental intraoral radiography. Requirements for extraoral dental radiographic
					 systems are in
					 12VAC5-481-1621.
1. Radiation exposure control. Means shall be
				  provided to initiate the radiation exposure by a deliberate action on the part
				  of the operator, such as the depression of a switch. Radiation exposure shall
				  not be initiated without such an action.
2. Exposure control location and operator
				  protection.
a. Stationary x-ray systems shall
				  be required to have the x-ray exposure control permanently mounted in a
				  protected area, so that the operator is required to remain in that protected
				  area during the entire exposure; and
b. Mobile and portable x-ray systems that
				  are:
(1) Used for greater than one week in the
				  same location that is , a room or suite, shall meet the requirements of
				  subdivision 2 a of this section.
(2) Used for less than one week in the same
				  location shall be provided with either a protective barrier at least two meters
				  (6.5 feet) high for operator protection, or means to allow the operator to be
				  at least 2.7 meters (nine feet) from the tube housing assembly while making
				  exposures.
Virginia Administrative Code › Title 12 - HEALTH › Agency 5 - DEPARTMENT OF HEALTH › Chapter 481 - VIRGINIA RADIATION PROTECTION REGULATIONS › Part VI - Use Of Diagnostic X-Rays In The Healing Arts › Section 12VAC5-481-1640

Current through Register Vol. 40, No. 24, July 15, 2024
Statutory Authority: § 32.1-229 of the Code of
						Virginia.
Virginia Administrative Code › Title 12 - HEALTH › Agency 5 - DEPARTMENT OF HEALTH › Chapter 481 - VIRGINIA RADIATION PROTECTION REGULATIONS › Part VI - Use Of Diagnostic X-Rays In The Healing Arts › Section 12VAC5-481-1641 - Computed tomography equipment

Current through Register Vol. 40, No. 24, July 15, 2024
A. Reserved.
B. Requirements for equipment.
1. Termination of exposure.
a. Means shall be provided to terminate the
				  x-ray exposure automatically by either de-energizing the x-ray source or
				  shuttering the x-ray beam in the event of equipment failure affecting data
				  collection. Such termination shall occur within an interval that limits the
				  total scan time to no more than 110% of its preset value through the use of
				  either a backup timer or devices that monitor equipment function.
b. A visible signal shall indicate when the
				  x-ray exposure has been terminated through the means required by subdivision 1
				  a of this subsection.
c. The
				  operator shall be able to terminate the x-ray exposure at any time during a
				  scan, or series of scans under CT x-ray system control, of greater than
				  one-half second duration.
Virginia Administrative Code › Title 12 - HEALTH › Agency 5 - DEPARTMENT OF HEALTH › Chapter 481 - VIRGINIA RADIATION PROTECTION REGULATIONS › Part VI - Use Of Diagnostic X-Rays In The Healing Arts › Section 12VAC5-481-1650

Current through Register Vol. 40, No. 24, July 15, 2024
Statutory Authority: § 32.1-229 of the Code of
						Virginia.
Virginia Administrative Code › Title 12 - HEALTH › Agency 5 - DEPARTMENT OF HEALTH › Chapter 481 - VIRGINIA RADIATION PROTECTION REGULATIONS › Part VI - Use Of Diagnostic X-Rays In The Healing Arts › Section 12VAC5-481-1651 - Mammography requirements

Current through Register Vol. 40, No. 24, July 15, 2024
A. Only
				  x-ray systems, pursuant to the Mammography Quality Standards Reauthorization
				  Act of 1998 ( Pub.L.
				  105-248 ) and 21 CFR Part 900, shall be used for
				  screening and diagnostic mammography.
B. A facility performing mammography shall
				  have a valid certificate issued by the U.S. Department of Health and Human
				  Services, pursuant to the Mammography Quality Standards Reauthorization Act of
				  1998 and 21 CFR Part 900.
C. A
				  facility performing mammography shall ensure that the additional mammography
				  activities of processing the x-ray film, interpreting the image, and
				  maintaining viewing conditions, wherever performed, meet all quality standards
				  pursuant to the Mammography Quality Standards Reauthorization Act of 1998 and
				  21 CFR Part 900.
D. The operator of
				  the mammography machine shall be certified by the American Registry of
				  Radiologic Technologists (ARRT) and shall have had specialized training in
				  mammography meeting the requirements set forth by the U.S. Food and Drug
				  Administration under the Mammography Quality Standards Reauthorization Act of
				  1998.
E. When film developing is
				  not available or the patient chooses not to wait, the patient shall be notified
				  within two business days if another mammogram is necessary. This requirement
				  does not imply or require that a diagnostic opinion be made at the time of the
				  mammogram. The interpreting physician may require that the mammogram be retaken
				  if, in the opinion of the physician, the study is of inadequate
				  quality.
F. Agency inspectors may
				  conduct unannounced inspections during normal business hours.
Statutory Authority: § 32.1-229 of the Code of
						Virginia.
Virginia Administrative Code › Title 12 - HEALTH › Agency 5 - DEPARTMENT OF HEALTH › Chapter 481 - VIRGINIA RADIATION PROTECTION REGULATIONS › Part VI - Use Of Diagnostic X-Rays In The Healing Arts › Section 12VAC5-481-1653 - Hand-held radiographic unit

Current through Register Vol. 40, No. 24, July 15, 2024
In addition to the applicable provisions found elsewhere
					 in this chapter, the following provisions apply to a hand-held radiographic
					 unit.
1. A hand-held radiograph unit
				  shall be:
a. Certified by the manufacturer
				  pursuant to 21 CFR Part 803, Medical Device Reporting of the Federal Food and
				  Drug Administration Modernization Act of 1997; 21 USC Chapter 9, Subchapter V,
				  Part C - Electronic Product Radiation Control (EPRC) (§ 360hh et seq.) of
				  the Federal Food, Drug and Cosmetic Act; and
				  21 CFR
				  1020.30, Diagnostic x-ray systems and their
				  major components.
b. Registered
				  with the agency in accordance with applicable parts of this chapter.
c. Maintained and operated in accordance with
				  the manufacturer's specifications.
Virginia Administrative Code › Title 12 - HEALTH › Agency 5 - DEPARTMENT OF HEALTH › Chapter 481 - VIRGINIA RADIATION PROTECTION REGULATIONS › Part VI - Use Of Diagnostic X-Rays In The Healing Arts › Section 12VAC5-481-1655 - Bone densitometry

Current through Register Vol. 40, No. 24, July 15, 2024
A. A bone
				  densitometry system shall be:
1. Certified by
				  the manufacturer pursuant to 21 CFR Part 803, Medical Device Reporting of the
				  Federal Food and Drug Administration Modernization Act of 1997; 21 USC Chapter
				  9, Subchapter V, Part C - Electronic Product Radiation Control (EPRC) (§
				  360hh et seq.) of the Federal Food, Drug and Cosmetic Act; and
				  21 CFR
				  1020.30, Diagnostic x-ray systems and their
				  major components.
2. Registered
				  with the agency in accordance with applicable parts of this chapter.
3. Maintained and operated in accordance with
				  the manufacturer's specifications.
Virginia Administrative Code › Title 12 - HEALTH › Agency 5 - DEPARTMENT OF HEALTH › Chapter 481 - VIRGINIA RADIATION PROTECTION REGULATIONS › Part VI - Use Of Diagnostic X-Rays In The Healing Arts › Section 12VAC5-481-1657 - Quality assurance program

Current through Register Vol. 40, No. 24, July 15, 2024
All registrants of diagnostic x-ray imaging equipment may
					 be required by the agency to establish and maintain a quality assurance program
					 consisting of quality control assessments.
Statutory Authority: § 32.1-229 of the Code of
						Virginia.
Virginia Administrative Code › Title 12 - HEALTH › Agency 5 - DEPARTMENT OF HEALTH › Chapter 481 - VIRGINIA RADIATION PROTECTION REGULATIONS › Part VII - Use of Radionuclides in the Healing Arts › Article 1 - Purpose and Scope › Section 12VAC5-481-1660 - Purpose and scope

Current through Register Vol. 40, No. 24, July 15, 2024
Part VII (12VAC5-481-1660 et
						seq.) of this chapter establishes requirements and provisions for the
						production, preparation, compounding and 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 Part VII (12VAC5-481-1660 et seq.) of this
						chapter are in addition to, and not in substitution for, others in these
						regulations. The requirements and provisions of these regulations apply to
						applicants and licensees subject to Part VII (12VAC5-481-1660 et seq.) of this
						chapter unless specifically exempted.
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Virginia Administrative Code › Title 12 - HEALTH › Agency 5 - DEPARTMENT OF HEALTH › Chapter 481 - VIRGINIA RADIATION PROTECTION REGULATIONS › Part VII - Use of Radionuclides in the Healing Arts › Article 2 - General Information › Section 12VAC5-481-1670 - General requirements

Current through Register Vol. 40, No. 24, July 15, 2024
A.
					 Licensees may conduct research involving human research subjects only if it
					 uses the radioactive materials specified on its license for the uses authorized
					 on its license.
B. If the research
					 is conducted, funded, supported, or regulated by another agency that has
					 implemented a policy for protection of human subjects, the licensee shall,
					 before conducting research:
1. Obtain review
					 and approval of the research from an authorized review board; and
2. Obtain informed consent, in writing, from
					 the human research subject.
Virginia Administrative Code › Title 12 - HEALTH › Agency 5 - DEPARTMENT OF HEALTH › Chapter 481 - VIRGINIA RADIATION PROTECTION REGULATIONS › Part VII - Use of Radionuclides in the Healing Arts › Article 2 - General Information › Section 12VAC5-481-1680 - Licensing and exemptions

Current through Register Vol. 40, No. 24, July 15, 2024
A. A
					 person may manufacture, produce, acquire, receive, possess, prepare, use, or
					 transfer radioactive material for medical use only in accordance with a
					 specific license issued by the agency, the NRC, or another agreement state, or
					 as allowed in subsection B of this section.
B. A specific license is not needed for an
					 individual who:
1. Receives, possesses, uses,
					 or transfers radioactive material in accordance with this part under the
					 supervision of an authorized user as provided in
					 12VAC5-481-1710,
					 unless prohibited by license condition; or
2. Prepares unsealed radioactive material for
					 medical use in accordance with this part under the supervision of an authorized
					 nuclear pharmacist or authorized user as provided in
					 12VAC5-481-1710,
					 unless prohibited by license condition.
Virginia Administrative Code › Title 12 - HEALTH › Agency 5 - DEPARTMENT OF HEALTH › Chapter 481 - VIRGINIA RADIATION PROTECTION REGULATIONS › Part VII - Use of Radionuclides in the Healing Arts › Article 2 - General Information › Section 12VAC5-481-1690 - Notifications

Current through Register Vol. 40, No. 24, July 15, 2024
A. Licensees shall
					 provide the agency the following information 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, an ophthalmic physicist, or
					 an authorized medical physicist:
1. A copy of
					 (i) the board certification, (ii) the written attestation signed by a
					 preceptor, and (iii) the NRC or another Agreement state license;
2. The permit issued by a NRC master material
					 licensee;
3. The permit issued by a
					 broad scope licensee;
4. The permit
					 issued by a NRC master material broad scope permittee; or
5. Documentation that only
					 accelerator-produced radioactive materials, discrete sources of radium-226, or
					 both, were used for medical use or in the practice of nuclear pharmacy at a
					 government agency or federally recognized Indian tribe before November 30,
					 2007, or at all other locations of use before August 8, 2009, or an earlier
					 date as noticed by the NRC.
6. For
					 individuals permitted to work within the 30-day time frame, the licensee shall
					 also provide, as appropriate, verification of completion of:
a. Any additional case experience required in
					 12VAC5-481-1980
					 2 b (7) for an authorized user under
					 12VAC5-481-1950;
b. Any additional training required in
					 12VAC5-481-2040
					 A 4 for an authorized user under
					 12VAC5-481-2040
					 A; or
c. Any additional training
					 required in
					 12VAC5-481-1760
					 A 3 for an authorized medical physicist.
Virginia Administrative Code › Title 12 - HEALTH › Agency 5 - DEPARTMENT OF HEALTH › Chapter 481 - VIRGINIA RADIATION PROTECTION REGULATIONS › Part VII - Use of Radionuclides in the Healing Arts › Article 3 - General Administrative Requirements › Section 12VAC5-481-1700 - Authority and responsibilities for the radiation protection programs and changes

Current through Register Vol. 40, No. 24, July 15, 2024
A. In addition to
					 the radiation protection program requirements of
					 12VAC5-481-630, a licensee's
					 management shall approve, in writing:
1.
					 Requests for a license application, renewal, or amendment before submittal to
					 the agency;
2. Any individual
					 before allowing that individual to work as an authorized user, authorized
					 nuclear pharmacist, or an authorized medical physicist; and
3. Radiation protection program changes that
					 do not require a license amendment and are permitted under subsection I of this
					 section.
Virginia Administrative Code › Title 12 - HEALTH › Agency 5 - DEPARTMENT OF HEALTH › Chapter 481 - VIRGINIA RADIATION PROTECTION REGULATIONS › Part VII - Use of Radionuclides in the Healing Arts › Article 3 - General Administrative Requirements › Section 12VAC5-481-1710 - Supervision

Current through Register Vol. 40, No. 24, July 15, 2024
A. Licensees that
					 permit the receipt, possession, use, or transfer of radioactive material by an
					 individual under the supervision of an authorized user, as allowed by
					 12VAC5-481-1680
					 B 1, shall:
1. In addition to the
					 requirements in
					 12VAC5-481-2270,
					 instruct the supervised individual in the licensee's written radiation
					 protection procedures, written directive procedures, regulations, and license
					 conditions with respect to the use of radioactive material; and
2. Require the supervised individual to
					 follow the instructions of the supervising authorized user for medical uses of
					 radioactive material, written radiation protection procedures established by
					 the licensee, written directive procedures, regulations, and license conditions
					 with respect to the medical use of radioactive material.
Virginia Administrative Code › Title 12 - HEALTH › Agency 5 - DEPARTMENT OF HEALTH › Chapter 481 - VIRGINIA RADIATION PROTECTION REGULATIONS › Part VII - Use of Radionuclides in the Healing Arts › Article 3 - General Administrative Requirements › Section 12VAC5-481-1720 - Written directives

Current through Register Vol. 40, No. 24, July 15, 2024
A. A
					 written directive shall be dated and signed by an authorized user before the
					 administration of I-131 sodium iodide greater than 30 microcuries (µCi)
					 (1.11 megabecquerels (MBq)), any therapeutic dose of unsealed radioactive
					 material, or any therapeutic dose of radiation from radioactive material.
If, because of the emergent nature of the patient's
						condition, a delay in order to provide a written directive would jeopardize the
						patient's health, an oral directive is acceptable. The information contained in
						the oral directive shall be documented as soon as possible in writing in the
						patient's record. A written directive shall be prepared within 48 hours of the
						oral directive.
B. The
					 written directive shall contain the patient or human research subject's name
					 and the following information:
1. For any
					 administration of quantities greater than 30 µCi (1.11 MBq) of sodium
					 iodide (I-131): the dosage;
2. For
					 an administration of a therapeutic dosage of unsealed radioactive material
					 other than sodium iodide (I-131): the radioactive drug, dosage, and route of
					 administration;
3. For gamma
					 stereotactic radiosurgery: the total dose, treatment site, and values for the
					 target coordinate settings per treatment for each anatomically distinct
					 treatment site;
4. For teletherapy:
					 the total dose, dose per fraction, number of fractions, and treatment
					 site;
5. For high dose-rate remote
					 afterloading brachytherapy: the radionuclide, treatment site, dose per
					 fraction, number of fractions, and total dose;
6. For permanent implant brachytherapy:
a. Before implantation: treatment site, the
					 radionuclide, and the total source strength; and
b. After implantation but before the patient
					 leaves the post-treatment recovery area: treatment site, number of sources
					 implanted, total source strength implanted, and the date; or
7. For all other brachytherapy,
					 including low, medium and pulsed dose rate remote afterloaders:
a. Before implantation: treatment site, the
					 radionuclide, and dose; and
b.
					 After implantation but before completion of the procedure: the radionuclide,
					 treatment site, number of sources, and total source strength and exposure time
					 (or the total dose) and date.
Virginia Administrative Code › Title 12 - HEALTH › Agency 5 - DEPARTMENT OF HEALTH › Chapter 481 - VIRGINIA RADIATION PROTECTION REGULATIONS › Part VII - Use of Radionuclides in the Healing Arts › Article 3 - General Administrative Requirements › Section 12VAC5-481-1730 - Procedures for administrations requiring a written directive

Current through Register Vol. 40, No. 24, July 15, 2024
For any administration requiring a written directive,
						licensees shall develop, implement, and maintain written directive procedures
						to provide high confidence that the patient's or human research subject's
						identity is verified before each administration and each administration is in
						accordance with the written directive. A licensee shall retain a copy of the
						procedures required by this section in accordance with
						12VAC5-481-2070. At a
						minimum, the procedures required by this section shall address the following
						items that are applicable to the licensee's use of radioactive material:
1. Verifying the identity of the patient or
					 human research subject;
2.
					 Verifying that the specific details of the administration are in accordance
					 with the treatment plan, if applicable, and the written directive;
3. Checking both manual and
					 computer-generated dose calculations;
4. Verifying that all computer-generated dose
					 calculations are correctly transferred into the consoles of therapeutic medical
					 units authorized by
					 12VAC5-481-2040
					 B and C and
					 12VAC5-481-2060;
5. Determining if a medical event, as defined
					 in
					 12VAC5-481-2080, has
					 occurred; and
6. Determining, for
					 permanent implant brachytherapy, within 60 calendar days from the date the
					 implant was performed, the total source strength administered outside of the
					 treatment site compared to the total source strength documented in the
					 post-implantation portion of the written directive unless a written
					 justification of patient unavailability is documented.
Statutory Authority: §
													32.1-229
						  of the Code of Virginia.
Virginia Administrative Code › Title 12 - HEALTH › Agency 5 - DEPARTMENT OF HEALTH › Chapter 481 - VIRGINIA RADIATION PROTECTION REGULATIONS › Part VII - Use of Radionuclides in the Healing Arts › Article 3 - General Administrative Requirements › Section 12VAC5-481-1740 - Suppliers for sealed sources or devices for medical use

Current through Register Vol. 40, No. 24, July 15, 2024
For medical use, licensees may only use the
						following:
1. Sealed sources or
					 devices manufactured, labeled, packaged, and distributed in accordance with a
					 license issued under this part or equivalent requirements of the NRC or another
					 agreement state;
2. Sealed sources
					 or devices non-commercially transferred from another medical use
					 licensee;
3. Teletherapy sources
					 manufactured and distributed in accordance with a license issued under Part III
					 (12VAC5-481-380
					 et seq.) of this chapter or equivalent requirements of the NRC or another
					 agreement state.
Statutory Authority: §
													32.1-229
						  of the Code of Virginia.
Virginia Administrative Code › Title 12 - HEALTH › Agency 5 - DEPARTMENT OF HEALTH › Chapter 481 - VIRGINIA RADIATION PROTECTION REGULATIONS › Part VII - Use of Radionuclides in the Healing Arts › Article 3 - General Administrative Requirements › Section 12VAC5-481-1760 - Training for an authorized medical physicist

Current through Register Vol. 40, No. 24, July 15, 2024
Except as provided in 12VAC5-481-1780, licensees shall
						require the authorized medical physicist (AMP) to be an individual who:
1. Is certified by a specialty board whose
					 certification process has been recognized by the agency, NRC, or an agreement
					 state and who meets the requirements of subdivision 3 of this section. The name
					 of board certifications that have been recognized by the NRC or an agreement
					 state are posted on the NRC's Medical Uses Licensee Toolkit web page. To have
					 its certification process recognized, a specialty board shall require all
					 candidates for certification to:
a. Hold a
					 master's or doctor's degree in physics, medical physics, other physical
					 science, engineering, or applied mathematics from an accredited college or
					 university;
b. Have two years of
					 full-time practical training or supervised experience in medical physics (i)
					 under the supervision of a medical physicist who is certified in medical
					 physics by a specialty board whose certification process has been recognized
					 under this section by the agency, the NRC, or an agreement state; or (ii) in
					 clinical radiation facilities providing high-energy, external beam therapy
					 (photons and electrons with energies greater than or equal to 1 million
					 electron volts) and brachytherapy services under the direction of physicians
					 who meet the requirements in 12VAC5-481-1780, 12VAC5-481-2018, or 12VAC5-481-
					 2040; and
c. Pass an examination,
					 administered by diplomates of the specialty board that assesses knowledge and
					 competence in clinical radiation therapy, radiation safety, calibration,
					 quality assurance, and treatment planning for external beam therapy,
					 brachytherapy, and stereotactic radiosurgery; or
Virginia Administrative Code › Title 12 - HEALTH › Agency 5 - DEPARTMENT OF HEALTH › Chapter 481 - VIRGINIA RADIATION PROTECTION REGULATIONS › Part VII - Use of Radionuclides in the Healing Arts › Article 3 - General Administrative Requirements › Section 12VAC5-481-1770 - Training for an authorized nuclear pharmacist

Current through Register Vol. 40, No. 24, July 15, 2024
Except as provided in
						12VAC5-481-1780, licensees shall
						require the authorized nuclear pharmacist (ANP) to be a pharmacist who:
1. Is certified by a specialty board whose
					 certification process has been recognized by the NRC, the agency, or an
					 agreement state. The names of board certifications that have been recognized by
					 the NRC or an agreement state are posted on the NRC's Medical Uses Licensee
					 Toolkit web page. To have its certification process recognized, a specialty
					 board shall require all candidates for certification to:
a. Have graduated from a pharmacy program
					 accredited by the Accreditation Council for Pharmacy Education (ACPE)
					 (previously named the American Council on Pharmaceutical Education) or have
					 passed the Foreign Pharmacy Graduate Examination Committee (FPGEC)
					 examination;
b. Hold a current,
					 active license to practice pharmacy;
c. Provide evidence of having acquired at
					 least 4000 hours of training or experience in nuclear pharmacy practice.
					 Academic training may be substituted for no more than 2000 hours of the
					 required training and experience; and
d. Pass an examination in nuclear pharmacy
					 administered by diplomates of the specialty board that assesses knowledge and
					 competency in procurement, compounding, quality assurance, dispensing,
					 distribution, health and safety, radiation safety, provision of information and
					 consultation, monitoring patient outcomes, research, and development;
					 or
Virginia Administrative Code › Title 12 - HEALTH › Agency 5 - DEPARTMENT OF HEALTH › Chapter 481 - VIRGINIA RADIATION PROTECTION REGULATIONS › Part VII - Use of Radionuclides in the Healing Arts › Article 3 - General Administrative Requirements › Section 12VAC5-481-1790 - Recentness of training

Current through Register Vol. 40, No. 24, July 15, 2024
The training and experience specified in this article
						and Articles 5 (12VAC5-481-1900
						et seq.), 6 (12VAC5-481-1950
						et seq.), 7 (12VAC5-481-2010
						et seq.), 8 (12VAC5-481-2020
						et seq.), and 9 (12VAC5-481-2040
						et seq.) of this part shall have been obtained within the seven years preceding
						the date of the application or the individual shall have had related continuing
						education and experience since the required training and experience was
						completed.
Statutory Authority: §
													32.1-229
						  of the Code of Virginia.
Virginia Administrative Code › Title 12 - HEALTH › Agency 5 - DEPARTMENT OF HEALTH › Chapter 481 - VIRGINIA RADIATION PROTECTION REGULATIONS › Part VII - Use of Radionuclides in the Healing Arts › Article 4 - General Technical Requirements › Section 12VAC5-481-1800 - Possession, use, and calibration of instruments used to measure the activity of unsealed radioactive material

Current through Register Vol. 40, No. 24, July 15, 2024
A.
					 For direct measurements performed in accordance with
					 12VAC5-481-1820,
					 licensees 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.
					 Licensees shall test the instrumentation required by subsection A of this
					 section in accordance with nationally recognized standards or the
					 manufacturer's instructions.
Statutory Authority: §
													32.1-229
						  of the Code of Virginia.
Virginia Administrative Code › Title 12 - HEALTH › Agency 5 - DEPARTMENT OF HEALTH › Chapter 481 - VIRGINIA RADIATION PROTECTION REGULATIONS › Part VII - Use of Radionuclides in the Healing Arts › Article 4 - General Technical Requirements › Section 12VAC5-481-1810

Current through Register Vol. 40, No. 24, July 15, 2024
Statutory Authority
§ 32.1-229 of the Code of Virginia.
Virginia Administrative Code › Title 12 - HEALTH › Agency 5 - DEPARTMENT OF HEALTH › Chapter 481 - VIRGINIA RADIATION PROTECTION REGULATIONS › Part VII - Use of Radionuclides in the Healing Arts › Article 4 - General Technical Requirements › Section 12VAC5-481-1820 - Determination of dosages of unsealed radioactive material for medical use

Current through Register Vol. 40, No. 24, July 15, 2024
A. Licensees 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 the
					 radioactivity; or
2. A decay
					 correction based on activity or activity concentration determined by:
a. A manufacturer or preparer licensed under
					 12VAC5-481-480
					 I or equivalent NRC or other agreement state requirements;
b. An agency, NRC, or another agreement state
					 licensee for use in research in accordance with Radioactive Drug Research
					 Committee-approved protocol or Investigational New Drug (IND) protocol accepted
					 by FDA; or
c. A PET radioactive
					 drug producer licensed under
					 12VAC5-481-440
					 H or equivalent NRC or other agreement state
					 requirements.