61–64. X-RAYS (TITLE B). PART I - GENERAL PROVISIONS RHB 1.1 Scope RHB 1.2 Prohibited Use RHB 1.3 Inspections RHB 1.4 Test and Surveys RHB 1.5 Exemptions RHB 1.6 Additional Requirements RHB 1.7 Violations RHB 1.8 Enforcement RHB 1.9 Impounding RHB 1.10 Records RHB 1.11 Records and Reports of Misadministration RHB 1.12 Communications RHB 1.13 Administration of Civil Penalties RHB 1.14 Compliance with Other Laws RHB 1.15 Severability RHB 1.16 Appeals PART II - REGISTRATION OF X-RAY MACHINES AND SERVICES RHB 2.1 Scope RHB 2.2 Exemptions RHB 2.3 Application and Review Fees RHB 2.4 Facility Registration Approval RHB 2.5 Equipment Registration Requirements, Users of X-Ray Machines RHB 2.6 Registration Requirements-Servicing and Services (Vendors) RHB 2.7 Vendor Obligation RHB 2.8 Out-of-State Facilities RHB 2.9 Modification, Revocation, Termination of Registrants RHB 2.10 Annual Fees PART III - STANDARDS FOR PROTECTION AGAINST RADIATION RHB 3.1 Purpose and Scope RHB 3.2 Implementation RHB 3.3 Authority and Responsibility for the Radiation Protection Programs RHB 3.4 Occupational Dose Limits for Adults RHB 3.5 Compliance with Requirements for the Summation of External and Internal Doses RHB 3.6 Planned Special Exposures RHB 3.7 Occupational Dose Limits for Minors RHB 3.8 Dose to an Embryo/Fetus RHB 3.9 Dose Limits for Individual Members of the Public RHB 3.10 Compliance with Dose Limits for Individual Members of the Public RHB 3.11 Surveys RHB 3.12 Personnel Monitoring RHB 3.13 Control of Access to High Radiation Areas RHB 3.14 Control of Access to Very High Radiation Areas RHB 3.15 Caution Signs RHB 3.16 Posting Requirements RHB 3.17 General Provisions for records RHB 3.18 Records of Radiation Protection Programs RHB 3.19 Records of Surveys RHB 3.20 Determination and Records of Prior Occupational Dose RHB 3.21 Records of Planned Special Exposures RHB 3.22 Records of Individual Monitoring Results RHB 3.23 Records of Dose to Individual Members of the Public RHB 3.24 Notification of Incidents RHB 3.25 Reports of Exposures and Radiation Levels Exceeding the Limits RHB 3.26 Reports of Planned Special Exposures RHB 3.27 Reports of Individual Monitoring RHB 3.28 Notification and Reports to Individuals RHB 3.29 Storage and Control of Radiation Sources RHB 3.30 Reports of Stolen, Lost, or Missing Radiation Sources PART IV - USE OF X-RAYS IN THE HEALTH PROFESSIONS RHB 4.1 Scope RHB 4.2 General Safety Provisions RHB 4.3 General Requirements for all Diagnostic X-ray Systems RHB 4.4 Shielding RHB 4.5 Intraoral Dental Radiographic Installations RHB 4.6 Extraoral Dental Radiographic Installations RHB 4.7 Medical Radiographic Systems RHB 4.8 Mobile Radiographic Equipment RHB 4.9 Fluoroscopic X-ray Systems RHB 4.10 Bone Densitometry Systems RHB 4.11 Computed Tomography (CT) X-ray Systems RHB 4.12 Veterinary Radiographic Systems RHB 4.13 Medical Specimen Unit Appendix A Healing Arts Screening Appendix B Required Information for Plan Review Appendix C Design Requirements for Operator’s Booth Appendix D Average Patient Exposure Guide Appendix E Automatic Exemptions for Sterile Fields Appendix F Minimum Criteria for Performance Tests PART V - QUALITY STANDARDS AND CERTIFICATION REQUIREMENTS FOR FACILITIES PERFORMING MAMMOGRAPHY RHB 5.1 Scope RHB 5.2 Requirements for Certification RHB 5.3 Certificates RHB 5.4 Reinstatement Policy RHB 5.5 Appeals of Adverse Accreditation or Reaccreditation Decisions RHB 5.6 Fees RHB 5.7 Personnel Requirements RHB 5.8 Equipment Requirements RHB 5.9 Medical Records and Mammography Reports RHB 5.10 Quality Assurance Requirements RHB 5.11 Equipment Quality Assurance Tests RHB 5.12 Surveys RHB 5.13 Mammography Equipment Evaluations RHB 5.14 Calibration of Air Kerma Measuring Instruments RHB 5.15 Additional Administrative Requirements RHB 5.16 Facility Cleanliness RHB 5.17 Infection Control RHB 5.18 Mammography Procedures and Techniques for Mammography Patients with Breast Implants RHB 5.19 Consumer Compliant Mechanism RHB 5.20 Clinical Image Quality RHB 5.21 Mammography Medical Outcomes Audit RHB 5.22 Additional Mammography Review and Patient Notification RHB 5.23 Revocation of Accreditation RHB 5.24 Suspension or Revocation of Certificates RHB 5.25 Mammography Units Used for Localization or Stereotactic Breast Biopsy Procedures RHB 5.26 Shielding RHB 5.27 Operating Conditions RHB 5.28 Notification Requirements for Mobile Mammography Facilities Certified by Another Certifying Agency RHB 5.29 Failure of Mobile Mammography Facilities Certified by Another Certifying Entity to Meet Requirements Appendix A (Mammography Dose Measurement Protocol) Appendix B (Mammography Phantom Image Evaluation) Appendix C (Mammography Dose Evaluation Table) PART VI - USE OF THERAPEUTIC EQUIPMENT RHB 6.1 Scope RHB 6.2 Shielding Requirements for all Therapeutic X-ray Equipment RHB 6.3 General Provisions for all Therapeutic Equipment RHB 6.4 Therapeutic X-Ray Systems of Less than 1 MeV RHB 6.5 X-ray and Electron Therapy Systems with Energies of 1 MeV and Above RHB 6.6 Operational Requirements for X-ray and Electron Therapy Systems with Energies of 1 MeV and Above RHB 6.7 Misadministration Report Requirements of All Therapeutic X-ray Systems PART VII - RADIATION SAFETY REQUIREMENTS FOR ANALYTICAL X-RAY EQUIPMENT RHB 7.1 Scope RHB 7.2 Electron Microscopes RHB 7.3 Hand-Held Analytical X-ray Equipment RHB 7.4 General Requirements for All Analytical X-ray Equipment RHB 7.5 Additional Requirements for Open Beam Configuration X-ray Equipment RHB 7.6 Additional Requirements for Enclosed Beam X-ray Equipment RHB 7.7 Area Requirements for All Analytical X-ray Equipment RHB 7.8 Radiation Survey Instruments RHB 7.9 Minimum Personnel Radiation Safety Requirements for Radiation Safety Officers and Operators RHB 7.10 Operating Procedures RHB 7.11 Personnel Monitoring PART VIII - RADIATION SAFETY REQUIREMENTS FOR INDUSTRIAL USES OF RADIO- GRAPHIC SOURCES RHB 8.1 Scope RHB 8.2 Locking of X-ray Machines RHB 8.3 Permanent Storage Precautions RHB 8.4 Radiation Survey Instruments RHB 8.5 Labeling RHB 8.6 Registration and Posting Requirements RHB 8.7 Minimum Personnel Radiation Safety Requirements for Radiation Safety Officers and Operators RHB 8.8 Operating and Emergency Procedures RHB 8.9 Inspection and Maintenance RHB 8.10 Personnel Monitoring RHB 8.11 Minimum Subjects to be Covered in Training Radiation Safety Officers and Radiographers RHB 8.12 Special Requirements for Certain Industrial Radiographic Techniques PART IX - DEFINITIONS PART X - NOTICES, INSTRUCTIONS, AND REPORTS TO WORKERS: INSPECTIONS RHB 10.1 Purpose and Scope RHB 10.2 Posting of Notices to Workers RHB 10.3 Instructions to Workers RHB 10.4 Notification and Reports to Individuals RHB 10.5 Presence of Registrants and Workers During Inspections RHB 10.6 Consultation with Workers During Inspection RHB 10.7 Request by Workers for Inspections RHB 10.8 Inspections not Warranted. Informal Review RHB 10.9 Right to Inspect and Investigate PART XI - REGIONAL CALIBRATION LABORATORY RHB 11.1 Scope RHB 11.2 Operation RHB 11.3 Fees PART I GENERAL PROVISIONS Editor’s Note Unless noted otherwise, the following constitutes the history for part I. HISTORY: Amended by State Register Volume 24, Issue No. 6, eff June 23, 2000; State Register Volume 25, Issue No. 5, Part 2, eff May 25, 2001; State Register Volume 33, Issue No. 6, eff June 26, 2009. RHB 1.1. Scope. Except as otherwise specifically provided, these regulations apply to all persons who receive, possess, use, transfer, own, or acquire any x-ray producing machine. The provisions of these regulations shall not be interpreted as limiting the intentional exposure of patients to radiation for the purpose of diagnosis, analysis, or therapy by persons licensed to practice one or more of the health professions within the authority granted to them by statute or regulation. HISTORY: Amended by State Register Volume 40, Issue No. 6, Doc. No. 4595, eff June 24, 2016. RHB 1.2. Prohibited Use. 1.2.1 It shall be unlawful to operate or maintain fluoroscopic devices for fitting or selling footwear. 1.2.2 It shall be unlawful to intentionally apply radiation to human beings except by, or under the direct supervision of, persons licensed to practice the health professions and authorized to use such radiation. 1.2.3 It shall be unlawful to use, receive, own, or possess x-ray equipment unless the facility is registered with the Department and is operated in compliance with all applicable provisions. 1.2.4 It shall be unlawful to use hand-held non-image intensified fluoroscopic screens. 1.2.5 It shall be unlawful to use plastic pointed position indicating devices on intraoral dental systems. 1.2.6 The use of any source of radiation may be prohibited when it is determined by the Department to be detrimental to public health and safety. 1.2.7 It shall be unlawful to use hand-held radiographic or fluoroscopic imaging devices, or hand- held therapy units, except for contact therapy units operated according to Part VI of these regulations. 1.2.8 It shall be unlawful to use fluoroscopy for positioning a patient for radiographic imaging, except when done by a licensed practitioner of the healing arts, or except for radiation therapy simulators. 1.2.9 It shall be unlawful for a person other than a licensed practitioner of the healing arts as defined by the South Carolina Department of Labor, Licensing, and Regulation to use fluoroscopy when the licensed practitioner of the healing arts is not physically present in the room, except during therapy simulations, maintenance activities, and training courses.