reglab/statecodes huggingface dataset:
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart D - UNSEALED RADIOACTIVE MATERIAL...WRITTEN DIRECTIVE NOT REQUIRED › Section 61-63.IV.D.RHA 4.38 - Permissible Molybdenum-99, Strontium-82, and Strontium-85 Concentrations

Current through Register Vol. 48, No. 6, June 28, 2024
4.38.1 A licensee may not administer to humans a
				  radiopharmaceutical that contains:
4.38.1.1 More
				  than 0.15 kilobecquerel of molybdenum-99 per megabecquerel of technetium-99m (0.15
				  microcurie of molybdenum-99 per millicurie of technetium-99m); or
4.38.1.2 More than 0.02 kilobecquerel of
				  strontium-82 per megabecquerel of rubidium-82 chloride injection (0.02 microcurie of
				  strontium-82 per millicurie of rubidium-82 chloride); or more than 0.2 kilobecquerel
				  of strontium-85 per megabecquerel of rubidium-82 chloride injection (0.2 microcurie
				  of strontium-85 per millicurie of rubidium-82).
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart D - UNSEALED RADIOACTIVE MATERIAL...WRITTEN DIRECTIVE NOT REQUIRED › Section 61-63.IV.D.RHA 4.39 - Training for Imaging and Localization Studies

Current through Register Vol. 48, No. 6, June 28, 2024
Except as provided in RHA 4.23, the licensee shall require an
					 authorized user of unsealed radioactive material for the uses authorized under
					 RHA 4.37 to be a physician
					 who-
4.39.1 Is certified by a medical
				  specialty board whose certification process has been recognized by the Nuclear
				  Regulatory Commission or an Agreement State. The names of board certifications that
				  have been recognized by the Nuclear Regulatory Commission 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:
4.39.1.1 Complete 700 hours of
				  training and experience in basic radionuclide handling techniques and radiation
				  safety applicable to the medical use of unsealed radioactive material for imaging
				  and localization studies that includes the topics listed in paragraphs RHA 4.39.3
				  through 4.39.3.2.7; and
4.39.1.2 Pass an
				  examination, administered by diplomats of the specialty board, which assesses
				  knowledge and competence in radiation safety, radionuclide handling, and quality
				  control; or
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart E - UNSEALED RADIOACTIVE MATERIAL-WRITTEN DIRECTIVE REQUIRED › Section 61-63.IV.E.RHA 4.40 - Use of Unsealed Radioactive Material for Which a Written Directive is Required

Current through Register Vol. 48, No. 6, June 28, 2024
A licensee may use any unsealed radioactive material identified
					 in RHA 4.43.2.2.7 prepared for medical use and for which a written directive is
					 required that is-
4.40.1 Obtained from:
4.40.1.1 A manufacturer or preparer licensed under
				  RHA 2.7.5 or equivalent Agreement State requirements; or
4.40.1.2 A PET radioactive drug producer licensed
				  under Part 2 of this Regulation or equivalent Agreement State requirements;
				  or
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart E - UNSEALED RADIOACTIVE MATERIAL-WRITTEN DIRECTIVE REQUIRED › Section 61-63.IV.E.RHA 4.41 - Safety Instruction

Current through Register Vol. 48, No. 6, June 28, 2024
In addition to the requirements of RHA 6.4 of these
					 regulations,
4.41.1 A licensee shall
				  provide radiation safety instruction, initially and at least annually, to personnel
				  caring for patients or human research subjects who cannot be released under RHA
				  4.32. To satisfy this requirement, the instruction must be commensurate with the
				  duties of the personnel and include--
4.41.1.1
				  Patient or human research subject control;
4.41.1.2 Visitor control, including--
4.41.1.2.1 Routine visitation to hospitalized
				  individuals in accordance with RHA 3.13.1.1 of these regulations; and
4.41.1.2.2 Visitation authorized in accordance
				  with RHA 3.13.3 of these regulations;
4.41.1.3 Contamination control;
4.41.1.4 Waste control; and
4.41.1.5 Notification of the Radiation Safety
				  Officer, or his or her designee, and the authorized user if the patient or the human
				  research subject has a medical emergency or dies.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart E - UNSEALED RADIOACTIVE MATERIAL-WRITTEN DIRECTIVE REQUIRED › Section 61-63.IV.E.RHA 4.42 - Safety Precautions

Current through Register Vol. 48, No. 6, June 28, 2024
4.42.1 For each patient
				  or human research subject who cannot be released under RHA 4.32, a licensee shall--
4.42.1.1 Quarter the patient or the human research
				  subject either in--
4.42.1.1.1 A private room with
				  a private sanitary facility; or
4.42.1.1.2 A room, with a private sanitary
				  facility, with another individual who also has received therapy with unsealed
				  radioactive material and who also cannot be released under RHA
				  4.32;
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart E - UNSEALED RADIOACTIVE MATERIAL-WRITTEN DIRECTIVE REQUIRED › Section 61-63.IV.E.RHA 4.43 - Training for Use of Unsealed Radioactive Material for Which a Written Directive is Required

Current through Register Vol. 48, No. 6, June 28, 2024
Except as provided in
					 RHA 4.23, the licensee shall
					 require an authorized user of unsealed radioactive material for the uses
					 authorized under
					 RHA 4.40 to be a physician
					 who-
4.43.1 Is certified by a medical
				  specialty board whose certification process has been recognized by the Nuclear
				  Regulatory Commission or an Agreement State and who meets the requirements in
				  paragraphs 4.43.2.2.7 of this section. The names of board certifications that
				  have been recognized by the Nuclear Regulatory Commission or an Agreement State
				  are posted on the NRC's Medical Uses Licensee Toolkit Web page. To be
				  recognized, a specialty board shall require all candidates for certification
				  to:
4.43.1.1 Successfully complete residency
				  training in a radiation therapy or nuclear medicine training program or a
				  program in a related medical specialty. These residency training programs must
				  include 700 hours of training and experience as described in paragraphs
				  4.43.2.1 through 4.43.2.2.5 of this section. Eligible training programs must be
				  approved by the Residency Review Committee of the Accreditation Council for
				  Graduate Medical Education, the Royal College of Physicians and Surgeons of
				  Canada, or the Council on Postdoctoral Training of the American Osteopathic
				  Association; and
4.43.1.2 Pass an
				  examination, administered by diplomats of the specialty board, which tests
				  knowledge and competence in radiation safety, radionuclide handling, quality
				  assurance, and clinical use of unsealed radioactive material for which a
				  written directive is required; or
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart F - MANUAL BRACHYTHERAPY › Section 61-63.IV.F.RHA 4.46 - Use of Sources for Manual Brachytherapy

Current through Register Vol. 48, No. 6, June 28, 2024
4.46.1 A
				  licensee must use only brachytherapy sources:
4.46.1.1 Approved in the Sealed Source and Device
				  Registry for manual brachytherapy medical use. The manual brachytherapy sources may
				  be used for manual brachytherapy uses that are not explicitly listed in the Sealed
				  Source and Device Registry, but must be used in accordance with the radiation safety
				  conditions and limitations described in the Sealed Source and Device Registry;
				  or
4.46.1.2 In research to deliver
				  therapeutic doses for medical use in accordance with an active Investigational
				  Device Exemption (IDE) application accepted by the U.S. Food and Drug Administration
				  provided the requirements of RHA 4.19.1 are met.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart F - MANUAL BRACHYTHERAPY › Section 61-63.IV.F.RHA 4.47 - Surveys After Source Implant and Removal

Current through Register Vol. 48, No. 6, June 28, 2024
4.47.1 Immediately after
				  implanting sources in a patient or a human research subject, the licensee shall make
				  a survey to locate and account for all sources that have not been
				  implanted.
4.47.2 Immediately after
				  removing the last temporary implant source from a patient or a human research
				  subject, the licensee shall make a survey of the patient or the human research
				  subject with a radiation detection survey instrument to confirm that all sources
				  have been removed.
4.47.3 A licensee
				  shall retain a record of the surveys required by RHA 4.47.1 and 4.47.2 in accordance
				  with RHA 4.103.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart F - MANUAL BRACHYTHERAPY › Section 61-63.IV.F.RHA 4.48 - Brachytherapy Sources Accountability

Current through Register Vol. 48, No. 6, June 28, 2024
4.48.1 A
				  licensee shall maintain accountability at all times for all brachytherapy sources in
				  storage or use.
4.48.2 As soon as
				  possible after removing sources from a patient or a human research subject, a
				  licensee shall return brachytherapy sources to a secure storage area.
4.48.3 A licensee shall maintain a record of the
				  brachytherapy source accountability in accordance with RHA 4.104.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart F - MANUAL BRACHYTHERAPY › Section 61-63.IV.F.RHA 4.49 - Safety Instruction

Current through Register Vol. 48, No. 6, June 28, 2024
4.49.1 In addition to
				  the requirements of RHA 6.4 of these regulations, the licensee shall provide
				  radiation safety instruction, initially and at least annually, to personnel caring
				  for patients or human research subjects who are receiving brachytherapy and cannot
				  be released under RHA 4.32. To satisfy this requirement, the instruction must be
				  commensurate with the duties of the personnel and include the--
4.49.1.1 Size and appearance of the brachytherapy
				  sources;
4.49.1.2 Safe handling and
				  shielding instructions;
4.49.1.3 Patient
				  or human research subject control;
4.49.1.4 Visitor control, including both:
4.49.1.4.1 Routine visitation of hospitalized
				  individuals in accordance with RHA 3.13.1.1 of these regulations; and
4.49.1.4.2 Visitation authorized in accordance
				  with RHA 3.13.3 of these regulations; and
4.49.1.5 Notification of the Radiation Safety
				  Officer, or his or her designee, and an authorized user if the patient or the human
				  research subject has a medical emergency or dies.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart F - MANUAL BRACHYTHERAPY › Section 61-63.IV.F.RHA 4.50 - Safety Precautions

Current through Register Vol. 48, No. 6, June 28, 2024
4.50.1 For each patient
				  or human research subject who is receiving brachytherapy and cannot be released
				  under RHA 4.32, a licensee shall--
4.50.1.1 Not
				  quarter the patient or the human research subject in the same room as an individual
				  who is not receiving brachytherapy;
4.50.1.2 Visibly post the patient's or human
				  research subject's room with a "Radioactive Materials" sign; and
4.50.1.3 Note on the door or in the patient's or
				  human research subject's chart where and how long visitors may stay in the patient's
				  or human research subject's room.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart F - MANUAL BRACHYTHERAPY › Section 61-63.IV.F.RHA 4.51 - Calibration Measurements of Brachytherapy Sources

Current through Register Vol. 48, No. 6, June 28, 2024
4.51.1 Before the first
				  medical use of a brachytherapy source on or after the effective date of these
				  regulations, a licensee shall have--
4.51.1.1
				  Determined the source output or activity using a dosimetry system that meets the
				  requirements of RHA 4.63.1;
4.51.1.2
				  Determined source positioning accuracy within applicators; and
4.51.1.3 Used published protocols currently
				  accepted by nationally recognized bodies to meet the requirements of RHA 4.51.1.1
				  and 4.51.1.2.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart F - MANUAL BRACHYTHERAPY › Section 61-63.IV.F.RHA 4.52 - Strontium-90 Sources for Ophthalmic Treatments

Current through Register Vol. 48, No. 6, June 28, 2024
4.52.1 Licensees who
				  use strontium-90 for ophthalmic treatments must ensure that certain activities as
				  specified in 4.52.2 of this section are performed by either:
4.52.1.1 An authorized medical physicist;
				  or
4.52.1.2 An individual who:
4.52.1.2.1 Is identified as an ophthalmic
				  physicist on a specific medical use license issued by the Nuclear Regulatory
				  Commission or an Agreement State; permit issued by a Nuclear Regulatory Commission
				  or Agreement State broad scope medical use licensee; medical use permit issued by a
				  Nuclear Regulatory Commission master material licensee; or permit issued by a
				  Nuclear Regulatory Commission master material licensee broad scope medical use
				  permittee; and
4.52.1.2.2 Holds a
				  master's or doctor's degree in physics, medical physics, other physical sciences,
				  engineering, or applied mathematics from an accredited college or university;
				  and
4.52.1.2.3 Has successfully
				  completed 1 year of full-time training in medical physics and an additional year of
				  full-time work experience under the supervision of a medical physicist;
				  and
4.52.1.2.4 Has documented training
				  in:
4.52.1.2.4.1 The creation, modification, and
				  completion of written directives;
4.52.1.2.4.2 Procedures for administrations
				  requiring a written directive; and
4.52.1.2.4.3 Performing the calibration
				  measurements of brachytherapy sources as detailed in
				  RHA
				  4.51.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart F - MANUAL BRACHYTHERAPY › Section 61-63.IV.F.RHA 4.53 - Therapy-Related Computer Systems

Current through Register Vol. 48, No. 6, June 28, 2024
4.53.1 The licensee
				  shall perform acceptance testing on the treatment planning system of 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:
4.53.1.1 The source-specific
				  input parameters required by the dose calculation algorithm;
4.53.1.2 The accuracy of dose, dwell time, and
				  treatment time calculations at representative points;
4.53.1.3 The accuracy of isodose plots and graphic
				  displays; and
4.53.1.4 The accuracy of
				  the software used to determine sealed source positions from radiographic
				  images.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart F - MANUAL BRACHYTHERAPY › Section 61-63.IV.F.RHA 4.54 - Training for Use of Manual Brachytherapy Sources

Current through Register Vol. 48, No. 6, June 28, 2024
Except as provided in
					 RHA 4.23, the licensee shall
					 require an authorized user of a manual brachytherapy source for the uses
					 authorized under
					 RHA 4.46 to be a physician
					 who-
4.54.1 Is certified by a medical
				  specialty board whose certification process has been recognized by the Nuclear
				  Regulatory Commission or an Agreement State. The names of board certifications
				  that have been recognized by the Nuclear Regulatory Commission 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:
4.54.1.1
				  Successfully complete a minimum of 3 years of residency training in a radiation
				  oncology program approved by the Residency Review Committee of the
				  Accreditation Council for Graduate Medical Education or the Royal College of
				  Physicians and Surgeons of Canada or the Council on Postdoctoral Training of
				  the American Osteopathic Association; and
4.54.1.2 Pass an examination, administered by
				  diplomats of the specialty board, that tests knowledge and competence in
				  radiation safety, radionuclide handling, treatment planning, quality assurance,
				  and clinical use of manual brachytherapy; or
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart F - MANUAL BRACHYTHERAPY › Section 61-63.IV.F.RHA 4.55 - Training for Ophthalmic Use of Strontium-90

Current through Register Vol. 48, No. 6, June 28, 2024
Except as provided in RHA 4.23, the licensee shall require the
					 authorized user of strontium-90 for ophthalmic radiotherapy to be a physician
					 who-
4.55.1 Is an authorized user under
				  RHA 4.54 or equivalent NRC
				  requirements; or
4.55.2 Has completed 24
				  hours of classroom and laboratory training applicable to the medical use of
				  strontium-90 for ophthalmic radiotherapy. The training must include-
4.55.2.1 Radiation physics and
				  instrumentation;
4.55.2.2 Radiation
				  protection;
4.55.2.3 Mathematics
				  pertaining to the use and measurement of radioactivity; and
4.55.2.4 Radiation biology;
				  and
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart G - SEALED SOURCES FOR DIAGNOSIS › Section 61-63.IV.G.RHA 4.56 - Use of Sealed Sources and Medical Devices for Diagnosis

Current through Register Vol. 48, No. 6, June 28, 2024
4.56.1 A licensee must use only sealed sources that are not in
					 medical devices for diagnostic medical uses if the sealed sources are approved in
					 the Sealed Source and Device Registry for diagnostic medicine. The sealed sources
					 may be used for diagnostic medical uses that are not explicitly listed in the Sealed
					 Source and Device Registry but must be used in accordance with the radiation safety
					 conditions and limitations described in the Sealed Source and Device
					 Registry.
4.56.2 A licensee must only use medical devices containing
					 sealed sources for diagnostic medical uses if both the sealed sources and medical
					 devices are approved in the Sealed Source and Device Registry for diagnostic medical
					 uses. The diagnostic medical devices may be used for diagnostic medical uses that
					 are not explicitly listed in the Sealed Source and Device Registry but must be used
					 in accordance with the radiation safety conditions and limitations described in the
					 Sealed Source and Device Registry.
4.56.3 Sealed sources and devices for diagnostic medical uses
					 may be used in research in accordance with an active Investigational Device
					 Exemption (IDE) application accepted by the U.S. Food and Drug Administration
					 provided the requirements of RHA 4.19.1 are met.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart G - SEALED SOURCES FOR DIAGNOSIS › Section 61-63.IV.G.RHA 4.57 - Training for Use of Sealed Sources and Medical Devices for Diagnosis

Current through Register Vol. 48, No. 6, June 28, 2024
Except as provided in RHA 4.23, the licensee shall require the
					 authorized user of a diagnostic sealed source for use in a device authorized under
					 RHA 4.56 to be a physician,
					 dentist, or podiatrist who-
4.57.1 Is
				  certified by a medical specialty board whose certification process includes all of
				  the requirements in RHA 4.57.3 and 4.57.4 of this section and whose certification
				  has been recognized by the Nuclear Regulatory Commission or an Agreement State. The
				  names of board certifications that have been recognized by the Nuclear Regulatory
				  Commission or an Agreement State are posted on the NRC's Medical Uses Licensee
				  Toolkit Web page; or
4.57.2 Is an
				  authorized user for uses listed in RHA 4.37 or equivalent Nuclear Regulatory
				  Commission or Agreement State requirements; or
4.57.3 Has had 8 hours of classroom and laboratory
				  training in basic radionuclide handling techniques specifically applicable to the
				  use of the device. The training must include-
4.57.3.1 Radiation physics and
				  instrumentation;
4.57.3.2 Radiation
				  protection;
4.57.3.3 Mathematics
				  pertaining to the use and measurement of radioactivity;
4.57.3.4 Radiation biology;
				  and
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart H - PHOTON EMITTING REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS › Section 61-63.IV.H.RHA 4.58 - Use of a Sealed Source in a Remote Afterloader Unit, Teletherapy Unit, or Gamma Stereotactic Radiosurgery Unit

Current through Register Vol. 48, No. 6, June 28, 2024
4.58.1 A licensee must
				  only use sealed sources:
4.58.1.1 Approved and as
				  provided for in the Sealed Source and Device Registry in photon emitting remote
				  afterloader units, teletherapy units, or gamma stereotactic radiosurgery units to
				  deliver therapeutic doses for medical uses: or
4.58.1.2 In research involving photon-emitting
				  remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery
				  units in accordance with an active Investigational Device Exemption (IDE)
				  application accepted by the U.S. Food and Drug Administration provided the
				  requirements of RHA 4.19.1 are met.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart H - PHOTON EMITTING REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS › Section 61-63.IV.H.RHA 4.59 - Surveys of Patients and Human Research Subjects Treated With a Remote Afterloader Unit

Current through Register Vol. 48, No. 6, June 28, 2024
4.59.1 Before releasing a patient or a human
				  research subject from licensee control, a licensee shall survey the patient or the
				  human research subject and the remote afterloader unit with a portable radiation
				  detection survey instrument to confirm that the source(s) has been removed from the
				  patient or human research subject and returned to the safe shielded
				  position.
4.59.2 A licensee shall retain
				  a record of these surveys in accordance with RHA 4.103.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart H - PHOTON EMITTING REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS › Section 61-63.IV.H.RHA 4.60 - Installation, Maintenance, Adjustment, and Repair

Current through Register Vol. 48, No. 6, June 28, 2024
4.60.1 Only a person
				  specifically licensed by the NRC or an Agreement State shall install, maintain,
				  adjust, or repair a remote afterloader unit, teletherapy unit, or gamma stereotactic
				  radiosurgery unit that involves work on the source(s) shielding, the source(s)
				  driving unit, or other electronic or mechanical component that could expose the
				  source(s), reduce the shielding around the source(s), or compromise the radiation
				  safety of the unit or the source(s).
4.60.2 Except for low dose-rate remote afterloader
				  units, only a person specifically licensed by the NRC or an Agreement State shall
				  install, replace, relocate, or remove a sealed source or source contained in other
				  remote afterloader units, teletherapy units, or gamma stereotactic radiosurgery
				  units.
4.60.3 For a low dose-rate remote
				  afterloader unit, only a person specifically licensed by the NRC or an Agreement
				  State or an authorized medical physicist shall install, replace, relocate, or remove
				  a sealed source(s) contained in the unit.
4.60.4 A licensee shall retain a record of the
				  installation, maintenance, adjustment, and repair of remote afterloader units,
				  teletherapy units, and gamma stereotactic radiosurgery units in accordance with RHA
				  4.107.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart H - PHOTON EMITTING REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS › Section 61-63.IV.H.RHA 4.61 - Safety Procedures and Instructions for Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units

Current through Register Vol. 48, No. 6, June 28, 2024
4.61.1 A licensee
				  shall--
4.61.1.1 Secure the unit, the console, the
				  console keys, and the treatment room when not in use or unattended;
4.61.1.2 Permit only individuals approved by the
				  authorized user, Radiation Safety Officer, or authorized medical physicist to be
				  present in the treatment room during treatment with the source(s);
4.61.1.3 Prevent dual operation of more than one
				  radiation producing device in a treatment room if applicable; and
4.61.1.4 Develop, implement, and maintain written
				  procedures for responding to an abnormal situation when the operator is unable to
				  place the source(s) in the shielded position, or remove the patient or human
				  research subject from the radiation field with controls from outside the treatment
				  room. These procedures must include--
4.61.1.4.1
				  Instructions for responding to equipment failures and the names of the individuals
				  responsible for implementing corrective actions;
4.61.1.4.2 The process for restricting access to
				  and posting of the treatment area to minimize the risk of inadvertent exposure;
				  and
4.61.1.4.3 The names and telephone
				  numbers of the authorized users, the authorized medical physicist, and the Radiation
				  Safety Officer to be contacted if the unit or console operates
				  abnormally.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart H - PHOTON EMITTING REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS › Section 61-63.IV.H.RHA 4.62 - Safety Precautions for Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units

Current through Register Vol. 48, No. 6, June 28, 2024
A licensee shall control access to the treatment room by a door
					 at each entrance. [FN*]
4.62.2 A licensee
				  shall equip each entrance to the treatment room with an electrical interlock system
				  that will--
4.62.2.1 Prevent the operator from
				  initiating the treatment cycle unless each treatment room entrance door is
				  closed;
4.62.2.2 Cause the source(s) to
				  be shielded when an entrance door is opened; and
4.62.2.3 Prevent the source(s) from being exposed
				  following an interlock interruption until all treatment room entrance doors are
				  closed and the source(s) on-off control is reset at the console.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart H - PHOTON EMITTING REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS › Section 61-63.IV.H.RHA 4.63 - Dosimetry Equipment

Current through Register Vol. 48, No. 6, June 28, 2024
4.63.1 Except for low
				  dose-rate remote afterloader sources where the source output or activity is
				  determined by the manufacturer, a licensee shall have a calibrated dosimetry system
				  available for use. To satisfy this requirement, one of the following two conditions
				  must be met.
4.63.1.1 The system must have been
				  calibrated using a system or source traceable to the National Institute of Science
				  and Technology (NIST) and published protocols accepted by nationally recognized
				  bodies; or by a calibration laboratory accredited by the American Association of
				  Physicists in Medicine (AAPM). The calibration must have been performed within the
				  previous 2 years and after any servicing that may have affected system calibration;
				  or
4.63.1.2 The system must have been
				  calibrated within the previous 4 years. Eighteen to thirty months after that
				  calibration, the system must have been intercompared with another dosimetry system
				  that was calibrated within the past 24 months by NIST or by a calibration laboratory
				  accredited by the AAPM. The results of the intercomparison must indicate that the
				  calibration factor of the licensee's system had not changed by more than 2 percent.
				  The licensee may not use the intercomparison result to change the calibration
				  factor. When intercomparing dosimetry systems to be used for calibrating sealed
				  sources for therapeutic units, the licensee shall use a comparable unit with beam
				  attenuators or collimators, as applicable, and sources of the same radionuclide as
				  the source used at the licensee's facility.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart H - PHOTON EMITTING REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS › Section 61-63.IV.H.RHA 4.64 - Full Calibration Measurements on Teletherapy Units

Current through Register Vol. 48, No. 6, June 28, 2024
4.64.1 A licensee
				  authorized to use a teletherapy unit for medical use shall perform full calibration
				  measurements on each teletherapy unit--
4.64.1.1
				  Before the first medical use of the unit; and
4.64.1.2 Before medical use under the following
				  conditions:
4.64.1.2.1 Whenever spot-check
				  measurements indicate that the output differs by more than 5 percent from the output
				  obtained at the last full calibration corrected mathematically for radioactive
				  decay;
4.64.1.2.2 Following replacement
				  of the source or following reinstallation of the teletherapy unit in a new
				  location;
4.64.1.2.3 Following any
				  repair of the teletherapy unit that includes removal of the source or major repair
				  of the components associated with the source exposure assembly; and
4.64.1.3 At intervals not exceeding 1
				  year.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart H - PHOTON EMITTING REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS › Section 61-63.IV.H.RHA 4.65 - Full Calibration Measurements on Remote Afterloader Units

Current through Register Vol. 48, No. 6, June 28, 2024
4.65.1 A
				  licensee authorized to use a remote afterloader unit for medical use shall perform
				  full calibration measurements on each unit--
4.65.1.1 Before the first medical use of the
				  unit;
4.65.1.2 Before medical use under
				  the following conditions:
4.65.1.2.1 Following
				  replacement of the source or following reinstallation of the unit in a new location
				  outside the facility; and
4.65.1.2.2
				  Following any repair of the unit that includes removal of the source or major repair
				  of the components associated with the source exposure assembly; and
4.65.1.3 At intervals not exceeding 1
				  quarter for high dose-rate, medium dose-rate, and pulsed dose-rate remote
				  afterloader units with sources whose half-life exceeds 75 days; and
4.65.1.4 At intervals not exceeding 1 year for low
				  dose-rate remote afterloader units.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart H - PHOTON EMITTING REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS › Section 61-63.IV.H.RHA 4.66 - Full Calibration Measurements on Gamma Stereotactic Radiosurgery Units

Current through Register Vol. 48, No. 6, June 28, 2024
4.66.1 A licensee authorized to use a gamma
				  stereotactic radiosurgery unit for medical use shall perform full calibration
				  measurements on each unit--
4.66.1.1 Before the
				  first medical use of the unit;
4.66.1.2
				  Before medical use under the following conditions--
4.66.1.2.1 Whenever spot-check measurements
				  indicate that the output differs by more than 5 percent from the output obtained at
				  the last full calibration corrected mathematically for radioactive decay;
4.66.1.2.2 Following replacement of the sources or
				  following reinstallation of the gamma stereotactic radiosurgery unit in a new
				  location; and
4.66.1.2.3 Following any
				  repair of the gamma stereotactic radiosurgery unit that includes removal of the
				  sources or major repair of the components associated with the source assembly;
				  and
4.66.1.3 At intervals not
				  exceeding 1 year, with the exception that relative helmet factors need only be
				  determined before the first medical use of a helmet and following any damage to a
				  helmet.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart H - PHOTON EMITTING REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS › Section 61-63.IV.H.RHA 4.67 - Periodic Spot-Checks for Teletherapy Units

Current through Register Vol. 48, No. 6, June 28, 2024
4.67.1 A licensee
				  authorized to use teletherapy units for medical use shall perform output spot-checks
				  on each teletherapy unit once in each calendar month that include determination of--
4.67.1.1 Timer accuracy, and timer linearity over
				  the range of use;
4.67.1.2 On-off
				  error;
4.67.1.3 The coincidence of the
				  radiation field and the field indicated by the light beam localizing
				  device;
4.67.1.4 The accuracy of all
				  distance measuring and localization devices used for medical use;
4.67.1.5 The output for one typical set of
				  operating conditions measured with the dosimetry system described in RHA 4.63.2;
				  and
4.67.1.6 The difference between the
				  measurement made in RHA 4.67.1.5 and the anticipated output, expressed as a
				  percentage of the anticipated output (i.e., the value obtained at last full
				  calibration corrected mathematically for physical decay).
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart H - PHOTON EMITTING REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS › Section 61-63.IV.H.RHA 4.68 - Periodic Spot-Checks for Remote Afterloader Units

Current through Register Vol. 48, No. 6, June 28, 2024
4.68.1 A licensee
				  authorized to use a remote afterloader unit for medical use shall perform
				  spot-checks of each remote afterloader facility and on each unit--
4.68.1.1 Before the first use of a high dose-rate,
				  medium dose-rate, or pulsed dose-rate remote afterloader unit on a given
				  day;
4.68.1.2 Before each patient
				  treatment with a low dose-rate remote afterloader unit; and
4.68.1.3 After each source
				  installation.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart H - PHOTON EMITTING REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS › Section 61-63.IV.H.RHA 4.69 - Periodic Spot-Checks for Gamma Stereotactic Radiosurgery Units

Current through Register Vol. 48, No. 6, June 28, 2024
4.69.1 A
				  licensee authorized to use a gamma stereotactic radiosurgery unit for medical use
				  shall perform spot-checks of each gamma stereotactic radiosurgery facility and on
				  each unit--
4.69.1.1 Monthly;
4.69.1.2 Before the first use of the unit on a
				  given day; and
4.69.1.3 After each
				  source installation.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart H - PHOTON EMITTING REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS › Section 61-63.IV.H.RHA 4.70 - Additional Technical Requirements for Mobile Remote Afterloader Units

Current through Register Vol. 48, No. 6, June 28, 2024
4.70.1
				  A licensee providing mobile remote afterloader service shall--
4.70.1.1 Check survey instruments before medical
				  use at each address of use or on each day of use, whichever is more frequent;
				  and
4.70.1.2 Account for all sources
				  before departure from a client's address of use.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart H - PHOTON EMITTING REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS › Section 61-63.IV.H.RHA 4.71 - Radiation Surveys

Current through Register Vol. 48, No. 6, June 28, 2024
4.71.1 In addition to
				  the survey requirement in RHA 3.16, a person licensed under this subpart shall make
				  surveys to ensure that the maximum radiation levels and average radiation levels
				  from the surface of the main source safe with the source(s) in the shielded position
				  do not exceed the levels stated in the Sealed Source and Device Registry.
4.71.2 The licensee shall make the survey required
				  by RHA 4.71.1 at installation of a new source and following repairs to the source(s)
				  shielding, the source(s) driving unit, or other electronic or compromise the
				  radiation safety of the unit or the source(s).
4.71.3 A licensee shall retain a record of the
				  radiation surveys required by RHA 4.71.1 in accordance with RHA 4.115. mechanical
				  component that could expose the source, reduce the shielding around the source(s),
				  or
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart H - PHOTON EMITTING REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS › Section 61-63.IV.H.RHA 4.72 - Full-inspection Servicing for Teletherapy and Gamma Stereotactic Radiosurgery Units

Current through Register Vol. 48, No. 6, June 28, 2024
4.72.1 A licensee shall have each teletherapy unit
				  and gamma stereotactic radiosurgery unit fully inspected and serviced during each
				  source replacement to assure proper functioning of the source exposure mechanism and
				  other safety components. The interval between each full-inspection servicing shall
				  not exceed 5 years for each teletherapy unit and shall not exceed 7 years for each
				  gamma stereotactic radiosurgery unit.
4.72.2 This inspection and servicing may only be
				  performed by persons specifically licensed to do so by the NRC or an Agreement
				  State.
4.72.3 A licensee shall keep a
				  record of the inspection and servicing in accordance with RHA 4.116.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart H - PHOTON EMITTING REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS › Section 61-63.IV.H.RHA 4.73 - Therapy-Related Computer Systems

Current through Register Vol. 48, No. 6, June 28, 2024
4.73.1 The licensee
				  shall perform acceptance testing on the treatment planning system of 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:
4.73.1.1 The source-specific
				  input parameters required by the dose calculation algorithm;
4.73.1.2 The accuracy of dose, dwell time, and
				  treatment time calculations at representative points;
4.73.1.3 The accuracy of isodose plots and graphic
				  displays;
4.73.1.4 The accuracy of the
				  software used to determine sealed source positions from radiographic images; and
4.73.1.5 The accuracy of electronic
				  transfer of the treatment delivery parameters to the treatment delivery unit from
				  the treatment planning system.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart H - PHOTON EMITTING REMOTE AFTERLOADER UNITS, TELETHERAPY UNITS, AND GAMMA STEREOTACTIC RADIOSURGERY UNITS › Section 61-63.IV.H.RHA 4.74 - Training for Use of Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units

Current through Register Vol. 48, No. 6, June 28, 2024
Except as provided in
					 RHA 4.23, the licensee shall
					 require an authorized user of a sealed source for a use authorized under
					 RHA 4.58 to be a physician
					 who-
4.74.1 Is certified by a medical
				  specialty board whose certification process has been recognized by the Nuclear
				  Regulatory Commission or an Agreement State and who meets the requirements in
				  paragraph 4.74.3 of this section. The names of board certifications that have
				  been recognized by the Nuclear Regulatory Commission 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:
4.74.1.1
				  Successfully complete a minimum of 3 years of residency training in radiation
				  therapy program approved by the Residency Review Committee of the Accreditation
				  Council for Graduate Medical Education or the Royal College of Physician and
				  Surgeons of Canada or the Council on Postdoctoral Training of the American
				  Osteopathic Association; and
4.74.1.2 Pass an examination, administered by
				  diplomats of the specialty board, which tests knowledge and competence in
				  radiation safety, radionuclide handling, treatment planning, quality assurance,
				  and clinical use of stereotactic radiosurgery, remote afterloaders and external
				  beam therapy; or
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart K - OTHER MEDICAL USES OF RADIOACTIVE MATERIAL OR RADIATION FROM RADIOACTIVE MATERIAL › Section 61-63.IV.K.RHA 4.88 - Other Medical Uses of Radioactive Material or Radiation From Radioactive Material

Current through Register Vol. 48, No. 6, June 28, 2024
4.88.1 A licensee may use radioactive material or
				  a radiation source approved for medical use which is not specifically addressed in
				  subparts D through H of this part if--
4.88.1.1
				  The applicant or licensee has submitted the information required by RHA 4.7.2
				  through 4.7.4; and the applicant or licensee has received written approval from the
				  Department or the NRC in a license or license amendment and uses the material in
				  accordance with the regulations and specific conditions the Department or the NRC
				  considers necessary for the medical use of the material.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-63 - Radioactive Materials (Title A) › Part IV - USE OF RADIONUCLIDES IN THE HEALTH PROFESSIONS › Subpart L - RECORDS › Section 61-63.IV.L.RHA 4.89 - Records of Authority and Responsibilities for Radiation Protection Programs

Current through Register Vol. 48, No. 6, June 28, 2024
4.89.1 A licensee shall retain a record of actions
				  taken by the licensee's management in accordance with RHA 4.13.1 for 5 years. The
				  record must include a summary of the actions taken and a signature of licensee
				  management.
4.89.2 The licensee shall
				  retain a copy of both authority, duties, and responsibilities of the Radiation
				  Safety Officer as required by RHA 4.13.5, and a signed copy of each Radiation Safety
				  Officer's agreement to be responsible for implementing the radiation safety program,
				  as required by RHA 4.13.2, for the duration of the license. The records must include
				  the signature of the Radiation Safety Officer and licensee management.
4.89.3. For each Associate Radiation Safety
				  Officer appointed under RHA 4.13.2, the licensee shall retain, for 5 years after the
				  Associate Radiation Safety Officer is removed from the license, a copy of the
				  written document appointing the Associate Radiation Safety Officer signed by the
				  licensee's management.