reglab/statecodes huggingface dataset:
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part V - QUALITY STANDARDS AND CERTIFICATION REQUIREMENTS FOR FACILITIES PERFORMING MAMMOGRAPHY › Section 61-64.V.RHB 5.10 - Equipment Requirements

Current through Register Vol. 48, No. 6, June 28, 2024
The equipment requirements of this Part are intended to
				  ensure that mammography equipment is capable of producing quality mammograms
				  over the full range of clinical conditions.
5.10.1 Prohibited equipment. Xeromammography
				equipment shall not be used for mammography procedures. Radiographic equipment
				designed for general purpose or special non-mammography procedures shall not be
				used for mammography. This prohibition includes systems that have been modified
				or equipped with special attachments for mammography. This requirement
				supersedes the implied acceptance of such systems in
				21 CFR, Section
				1020.31(f)(3).
5.10.2 General. Only special purpose
				equipment designed for mammography shall be specifically used for mammography
				and shall be certified pursuant to
				21 CFR, Section
				1010.2 as meeting the applicable requirements
				of 21 CFR, Section
				1020.30, effective as of April 1,
				1997.
5.10.3 Motion of tube-image
				receptor assembly.
5.10.3.1 The assembly shall
				be capable of being fixed in any position where it is designed to operate. Once
				fixed in any such position, it shall not undergo unintended motion.
5.10.3.2 The mechanism ensuring compliance
				with RHB
				5.10.3.1 shall not fail in the event of power
				interruption.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part V - QUALITY STANDARDS AND CERTIFICATION REQUIREMENTS FOR FACILITIES PERFORMING MAMMOGRAPHY › Section 61-64.V.RHB 5.11 - Medical Records and Mammography Reports

Current through Register Vol. 48, No. 6, June 28, 2024
5.11.1 Contents
				and terminology. Each facility shall prepare a written report of the results of
				each mammography examination performed under its certificate. The mammography
				report shall include the following information:
5.11.1.1 The name of the patient and an
				additional patient identifier;
5.11.1.2 Date of examination;
5.11.1.3 The name of the interpreting
				physician who interpreted the mammogram;
5.11.1.4 Overall final assessment of
				findings, classified in one of the following categories:
5.11.1.4.1 "Negative." Nothing to comment
				upon (if the interpreting physician is aware of clinical findings or symptoms,
				despite the negative assessment, these shall be explained);
5.11.1.4.2 "Benign." Also a negative
				assessment;
5.11.1.4.3 "Probably
				Benign." Finding(s) has a high probability of being benign;
5.11.1.4.4 "Suspicious." Finding(s) without
				all the characteristic morphology of breast cancer but indicating a definite
				probability of being malignant;
5.11.1.4.5 "Highly suggestive of malignancy."
				Finding(s) has a high probability of being malignant;
5.11.1.5 In cases where no final assessment
				category can be assigned due to incomplete work-up, "Incomplete: Need
				additional imaging evaluation" shall be assigned as an assessment and reasons
				why no assessment can be made shall be stated by the interpreting physician;
				and
5.11.1.6 Recommendations made
				to the health care provider about what additional actions, if any, should be
				taken. All clinical questions raised by the referring health care provider
				shall be addressed in the report to the extent possible, even if the assessment
				is negative or benign.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part V - QUALITY STANDARDS AND CERTIFICATION REQUIREMENTS FOR FACILITIES PERFORMING MAMMOGRAPHY › Section 61-64.V.RHB 5.12 - Quality Assurance Requirements

Current through Register Vol. 48, No. 6, June 28, 2024
Each facility shall establish and maintain a quality
				  assurance program to ensure the safety, reliability, clarity, and accuracy of
				  mammography services performed at the facility.
5.12.1 Responsible individuals.
				Responsibility for the quality assurance program and for each of its elements
				shall be assigned to individuals who are qualified for their assignments and
				who shall be allowed adequate time to perform these duties.
5.12.1.1 Lead interpreting physician. The
				facility shall identify a lead interpreting physician who shall have the
				general responsibility of ensuring that the quality assurance program meets all
				requirements of this Part. No other individual shall be assigned or shall
				retain responsibility for quality assurance tasks unless the lead interpreting
				physician has determined that the individual's qualifications for, and
				performance of, the assignment are adequate.
5.12.1.2 Interpreting physicians. All
				physicians interpreting mammograms for the facility shall:
5.12.1.2.1 Follow the facility procedures for
				corrective action when the images that they are asked to interpret are of poor
				quality; and
5.12.1.2.2 Participate
				in the facility's medical outcomes audit program.
5.12.1.3 Medical physicist. Each facility
				shall have the services of a medical physicist available to survey mammography
				equipment and oversee the equipment-related quality assurance practices of the
				facility. At a minimum, the medical physicist(s) shall be responsible for
				performing the surveys and mammography equipment evaluations and providing the
				facility with the reports described in
				RHB 5.14 and 5.15.
5.12.1.4 Quality control technologist.
				Responsibility for all individual tasks within the quality assurance program
				not assigned to the lead interpreting physician or the medical physicist shall
				be assigned to a quality control technologist(s). The tasks are to be performed
				by the quality control technologist or by other personnel qualified to perform
				the tasks. When other personnel are utilized for these tasks, the quality
				control technologist shall ensure that the tasks are completed in such a way as
				to meet the requirements of
				RHB 5.13.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part V - QUALITY STANDARDS AND CERTIFICATION REQUIREMENTS FOR FACILITIES PERFORMING MAMMOGRAPHY › Section 61-64.V.RHB 5.13 - Equipment Quality Assurance Tests

Current through Register Vol. 48, No. 6, June 28, 2024
5.13.1 Daily
				quality control tests. Film processors used to develop mammograms shall be
				adjusted and maintained to meet the technical development specifications for
				the mammography film in use. A processor performance test shall be performed on
				each day that examinations are performed before any clinical films are
				processed that day. The test shall include an assessment of base plus fog
				density, mid- density, and density difference, using the mammography film used
				clinically at the facility.
5.13.1.1 The base
				plus fog density shall be within plus 0.03 of the established operating
				level.
5.13.1.2 The mid-density
				shall be within plus or minus 0.15 of the established operating
				level.
5.13.1.3 The density
				difference shall be within plus or minus 0.15 of the established operating
				level.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part V - QUALITY STANDARDS AND CERTIFICATION REQUIREMENTS FOR FACILITIES PERFORMING MAMMOGRAPHY › Section 61-64.V.RHB 5.14 - Surveys

Current through Register Vol. 48, No. 6, June 28, 2024
5.14.1 At least once a year, each facility
				shall undergo a survey by a medical physicist or by an individual under the
				direct supervision of a medical physicist. At a minimum, this survey shall
				include the performance of tests and numerical values to ensure that the
				facility meets the quality assurance requirements of the annual tests described
				in RHB
				5.13.5 and 5.13.6 or 5.13.7; and the weekly phantom
				image quality test described in
				RHB 5.13.2.
5.14.2 The results of all these tests
				conducted by the facility in accordance with
				RHB 5.13.1 through
				5.13.8, as well as written
				documentation of any corrective actions taken and their results, shall be
				evaluated for adequacy by the medical physicist performing the
				survey.
5.14.3 The medical
				physicist shall prepare a survey report that includes a summary of this review
				and recommendations for necessary improvements.
5.14.4 The survey report shall be sent to the
				facility within thirty (30) calendar days of the date of the survey.
5.14.5 The survey report shall be dated and
				signed by the medical physicist performing and/or supervising the survey. If
				the survey was performed entirely or in part by another individual under the
				direct supervision of the medical physicist, that individual and the part of
				the survey that individual performed shall also be identified in the survey
				report.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part V - QUALITY STANDARDS AND CERTIFICATION REQUIREMENTS FOR FACILITIES PERFORMING MAMMOGRAPHY › Section 61-64.V.RHB 5.15 - Mammography equipment evaluations

Current through Register Vol. 48, No. 6, June 28, 2024
Additional evaluations of mammography units or image
				  processors shall be conducted whenever a new unit or processor is installed, a
				  unit or processor is disassembled and reassembled at the same or a new
				  location, or major components of a mammography unit or processor equipment are
				  changed or repaired. These evaluations shall be used to determine whether the
				  new or changed equipment meets the applicable standards in
				  RHB 5.10 and 5.13. All problems
				  shall be corrected before the new or changed equipment is put into service for
				  examinations or film processing. The mammography equipment evaluation shall be
				  performed by a medical physicist or an individual under the direct supervision
				  of a medical physicist.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part V - QUALITY STANDARDS AND CERTIFICATION REQUIREMENTS FOR FACILITIES PERFORMING MAMMOGRAPHY › Section 61-64.V.RHB 5.16 - Calibration of air kerma measuring instruments

Current through Register Vol. 48, No. 6, June 28, 2024
Instruments used by medical physicists in their annual survey
				  to measure the air kerma or air kerma rate from a mammography unit shall be
				  calibrated at least once every two (2) years and each time the instrument is
				  repaired. The instrument calibration must be traceable to a national standard
				  and calibrated with an accuracy of plus or minus six percent (6%) (ninety-five
				  percent (95%) confidence level) in the mammography energy
				  range.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part V - QUALITY STANDARDS AND CERTIFICATION REQUIREMENTS FOR FACILITIES PERFORMING MAMMOGRAPHY › Section 61-64.V.RHB 5.17 - Additional Administrative Requirements

Current through Register Vol. 48, No. 6, June 28, 2024
Each facility where mammography services are provided shall
				  ensure the availability for each mammography patient:
5.17.1 Instructions on how to perform breast
				self-examination;
5.17.2
				Information that early detection of breast cancer is maximized through a
				combined approach, using monthly breast self-examination, a thorough physical
				examination performed by a physician, and mammography performed at recommended
				intervals; and
5.17.3 Information
				that mammography is the most accurate method for making an early detection of
				breast cancer, however, no diagnostic tool is one hundred percent (100%)
				effective.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part V - QUALITY STANDARDS AND CERTIFICATION REQUIREMENTS FOR FACILITIES PERFORMING MAMMOGRAPHY › Section 61-64.V.RHB 5.18 - Facility Cleanliness

Current through Register Vol. 48, No. 6, June 28, 2024
5.18.1 The facility
				shall establish and implement written procedures for maintaining darkroom,
				screen, and view box cleanliness.
5.18.2 The facility shall document that all
				cleaning procedures are performed at the frequencies specified in the written
				procedures.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part V - QUALITY STANDARDS AND CERTIFICATION REQUIREMENTS FOR FACILITIES PERFORMING MAMMOGRAPHY › Section 61-64.V.RHB 5.19 - Infection Control

Current through Register Vol. 48, No. 6, June 28, 2024
Facilities shall establish and comply with a system
				  specifying procedures to be followed by the facility for cleaning and
				  disinfecting mammography equipment after contact with blood or other
				  potentially infectious materials. This system shall specify the methods for
				  documenting facility compliance with the infection control procedures
				  established and shall:
5.19.1 Comply
				with the manufacturer-recommended procedures for the cleaning and disinfection
				of the mammography equipment used in the facility; or
5.19.2 If adequate manufacturer's
				recommendations are not available, comply with generally accepted guidance on
				infection control, until such recommendations become available.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part V - QUALITY STANDARDS AND CERTIFICATION REQUIREMENTS FOR FACILITIES PERFORMING MAMMOGRAPHY › Section 61-64.V.RHB 5.20 - Mammography procedures and techniques for mammography patients with breast implants

Current through Register Vol. 48, No. 6, June 28, 2024
5.20.1 Each facility shall have a procedure
				to inquire whether or not the patient has breast implants prior to the actual
				mammographic exam.
5.20.2 Except
				where contraindicated, or unless modified by a physician's directions, patients
				with breast implants undergoing mammography shall have mammographic views to
				maximize the visualization of breast tissue.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part V - QUALITY STANDARDS AND CERTIFICATION REQUIREMENTS FOR FACILITIES PERFORMING MAMMOGRAPHY › Section 61-64.V.RHB 5.21 - Consumer Complaint Mechanism

Current through Register Vol. 48, No. 6, June 28, 2024
Each facility shall:
5.21.1 Establish a written and documented
				system for collecting and resolving consumer complaints;
5.21.2 Maintain a record of each serious
				complaint received by the facility for at least three (3) years after the date
				the complaint was received;
5.21.3
				Provide the consumer with adequate directions for filing serious complaints
				with the facility's accreditation body if the facility is unable to resolve a
				serious complaint to the consumer's satisfaction; and
5.21.4 Report unresolved serious complaints
				to the accreditation body in a manner and time frame specified by the
				accreditation body.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part V - QUALITY STANDARDS AND CERTIFICATION REQUIREMENTS FOR FACILITIES PERFORMING MAMMOGRAPHY › Section 61-64.V.RHB 5.22 - Clinical image quality

Current through Register Vol. 48, No. 6, June 28, 2024
Clinical images produced by any certified facility shall
				  continue to comply with the standards for clinical image quality established by
				  that facility's accreditation body.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part V - QUALITY STANDARDS AND CERTIFICATION REQUIREMENTS FOR FACILITIES PERFORMING MAMMOGRAPHY › Section 61-64.V.RHB 5.23 - Mammography Medical Outcomes Audit

Current through Register Vol. 48, No. 6, June 28, 2024
Each facility shall establish and maintain a mammography
				  medical outcomes audit program to follow-up positive mammographic assessments
				  and to correlate pathology results with the interpreting physician's findings.
				  This program shall be designed to ensure the reliability, clarity, and accuracy
				  of the interpretation of mammograms.
5.23.1 General Requirements. Each facility
				shall establish a system to collect and review outcome data for all mammograms
				performed, including follow-up on the disposition of all positive mammograms
				and correlation of pathology results with the interpreting physician's
				mammography report. Analysis of these outcome data shall be made individually
				and collectively for all interpreting physicians at the facility. In addition,
				any cases of breast cancer among patients imaged at the facility that
				subsequently become known to the facility shall prompt the facility to initiate
				follow-up on surgical and/or pathology results and review of the mammograms
				taken prior to the diagnosis of a malignancy.
5.23.2 Frequency of audit analysis. The
				facility's first audit analysis shall be initiated no later than twelve (12)
				months after the date the facility becomes certified, or twelve (12) months
				after April 28, 1999, whichever is later. This audit analysis shall be
				completed within an additional twelve (12) months to permit completion of
				diagnostic procedures and data collection. Subsequent audit analyses shall be
				conducted at least once every twelve (12) months.
5.23.3 Reviewing interpreting physician. Each
				facility shall designate at least one (1) interpreting physician to review the
				medical outcomes audit data at least once every twelve (12) months. This
				individual shall record the dates of the audit period(s) and shall be
				responsible for analyzing results based on this audit. This individual shall
				also be responsible for documenting the results, notifying other interpreting
				physicians of their results and the facility aggregate results. If follow-up
				actions are taken, the reviewing interpreting physician shall also be
				responsible for documenting the nature of the follow-up.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part V - QUALITY STANDARDS AND CERTIFICATION REQUIREMENTS FOR FACILITIES PERFORMING MAMMOGRAPHY › Section 61-64.V.RHB 5.24 - Additional Mammography Review and Patient Notification

Current through Register Vol. 48, No. 6, June 28, 2024
5.24.1 If the Department believes that
				mammography quality at a facility has been compromised and may present a
				serious risk to human health, the facility shall provide clinical images and
				other relevant information, as specified by the Department, for review by the
				accreditation body. The Department will determine whether the facility is in
				compliance with this Part and if not, whether there is a need to notify
				affected patients, their physicians, or the public that the liability, clarity,
				and accuracy of interpretation of mammograms has been compromised.
5.24.2 If the Department determines that the
				quality of mammography performed by a facility, whether or not certified under
				RHB 5.4, was so inconsistent
				with the quality standards established in this Part as to present a significant
				risk to individual or public health, the Department may require such facility
				to notify patients who received mammograms at such facility, and their
				referring physicians, of the deficiencies presenting such risk, the potential
				harm resulting, appropriate remedial measures, and such other relevant
				information as the Department may require.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part V - QUALITY STANDARDS AND CERTIFICATION REQUIREMENTS FOR FACILITIES PERFORMING MAMMOGRAPHY › Section 61-64.V.RHB 5.25 - Mammography Units Used for Localization or Stereotactic Breast Biopsy Procedures

Current through Register Vol. 48, No. 6, June 28, 2024
5.25.1 Personnel. The following requirements
				apply to all personnel involved in localization or biopsy procedures performed
				with mammography units:
5.25.1.1 Interpreting
				Physicians. The interpreting physician shall:
5.25.1.1.1 Be responsible for quality
				assurance activities including medical audit (tracking of number of biopsies
				done, cancers found, benign lesions, biopsies needing repeat, and
				complications);
5.25.1.1.2 Be
				responsible for oversight of all quality control;
5.25.1.1.3 Be responsible for the supervision
				of the radiologic technologist and the medical physicist;
5.25.1.1.4 Be responsible for post-biopsy
				management of the patient; and
5.25.1.1.5 Provide documentation of
				compliance with this Part to the Department upon request.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part V - QUALITY STANDARDS AND CERTIFICATION REQUIREMENTS FOR FACILITIES PERFORMING MAMMOGRAPHY › Section 61-64.V.RHB 5.26 - Shielding

Current through Register Vol. 48, No. 6, June 28, 2024
All mammography facilities shall meet the shielding
				  requirements specified in RHB 4.4.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part V - QUALITY STANDARDS AND CERTIFICATION REQUIREMENTS FOR FACILITIES PERFORMING MAMMOGRAPHY › Section 61-64.V.RHB 5.27 - Operating conditions

Current through Register Vol. 48, No. 6, June 28, 2024
All mammography facilities shall meet the requirements of RHB
				  4.2.3.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part V - QUALITY STANDARDS AND CERTIFICATION REQUIREMENTS FOR FACILITIES PERFORMING MAMMOGRAPHY › Section 61-64.V.RHB 5.28 - Notification Requirements for Mobile Mammography Facilities Certified by Another Certifying Agency

Current through Register Vol. 48, No. 6, June 28, 2024
Mobile mammography facilities that operate in South Carolina
				  and are certified under MQSA by the FDA, or another state authorized by FDA to
				  certify mammography facilities under MQSA, shall:
5.28.1 Notify the Department by telephone,
				facsimile, or letter of each date and location of operation of the mobile
				mammography facility in South Carolina prior to conducting such operation as
				required by
				RHB 2.4.2.1.4.
5.28.2 At all times while operating in South
				Carolina, have the following documentation available for review and inspection
				by the Department:
5.28.2.1 A copy of the
				mammography facility certificate issued by the FDA or another state, showing
				that the facility is currently certified;
5.28.2.2 A summary of the most recent physics
				survey of the mammography machine(s) and documentation of any corrective
				actions recommended by the medical physicist who performed the physics survey;
				and
5.28.2.3 Documentation that
				personnel meet the qualifications of
				RHB 5.9.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part V - QUALITY STANDARDS AND CERTIFICATION REQUIREMENTS FOR FACILITIES PERFORMING MAMMOGRAPHY › Section 61-64.V.RHB 5.29 - Failure of Mobile Mammography Facilities Certified by Another Certifying Entity to Meet Requirements

Current through Register Vol. 48, No. 6, June 28, 2024
The Department shall notify the certifying entity of the
				  facts and circumstances and may take other actions as may be appropriate under
				  the Atomic Energy and Radiation Control Act and regulations thereunder if the
				  Department has reason to believe that the owner, operator, or any employee of a
				  mobile facility certified by another certifying entity:
5.29.1 Has been guilty of misrepresentation
				in obtaining the certificate;
5.29.2 Has failed to comply with the
				standards of this Part;
5.29.3 Has
				failed to comply with reasonable requests of the Department for records,
				information, reports, or materials that the Department believes are necessary
				to determine the continued eligibility of the facility for a certificate or
				continued compliance with the standards of this Part; or
5.29.4 Has refused a reasonable request of a
				Department representative for permission to inspect the facility or the
				operations and pertinent records of the facility.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part VI - USE OF THERAPEUTIC EQUIPMENT › Section 61-64.VI.RHB 6.1 - Scope

Current through Register Vol. 48, No. 6, June 28, 2024
This Part establishes requirements, for which the registrant
				  is responsible, for use of therapeutic radiation equipment. The provisions of
				  this Part are in addition to, and not in substitution for, other applicable
				  provisions of this regulation. All provisions of this Part also apply to
				  therapeutic veterinary installations.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part VI - USE OF THERAPEUTIC EQUIPMENT › Section 61-64.VI.RHB 6.2 - Shielding Requirements for all Therapeutic X-ray Equipment

Current through Register Vol. 48, No. 6, June 28, 2024
6.2.1 All facilities utilizing therapy
				equipment shall meet the shielding requirements specified in
				RHB 4.4.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part VI - USE OF THERAPEUTIC EQUIPMENT › Section 61-64.VI.RHB 6.3 - General Provisions for all Therapeutic Equipment

Current through Register Vol. 48, No. 6, June 28, 2024
6.3.1
				Radiation Safety Officer.
6.3.1.1 The
				registrant shall designate an individual who will be responsible for radiation
				protection for the therapeutic equipment. Such individual may be a radiological
				physicist, and shall:
6.3.1.1.1 Be qualified
				by training and experience concerning all hazards and precautions involved in
				operating the therapeutic equipment for which he or she is
				responsible;
6.3.1.1.2 Recommend a
				detailed program of radiation safety for effective compliance with the
				applicable requirements of this regulation;
6.3.1.1.3 Give instructions concerning
				hazards and safety practices to individuals who may be exposed to radiation
				from the therapeutic equipment; and
6.3.1.1.4 Ensure surveys are performed and
				carry out other procedures as required by this regulation.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part VI - USE OF THERAPEUTIC EQUIPMENT › Section 61-64.VI.RHB 6.5 - X-ray and Electron Therapy Systems with Energies of 1 MeV and Above

Current through Register Vol. 48, No. 6, June 28, 2024
These rules shall apply to facilities using therapy systems
				  with energies 1 MeV and above. The records shall be maintained and available
				  for review.
6.5.1 Leakage Radiation to
				the Patient Area. Equipment shall meet the following requirements:
6.5.1.1 For operating conditions producing
				maximum leakage radiation, the absorbed dose in rads (Grays) due to leakage
				radiation, including x-rays and electrons, at any point in a circular plane of
				two meters (2 m) radius centered on and perpendicular to the central axis of
				the beam at the isocenter or nominal treatment distance and outside the maximum
				useful beam size shall not exceed 0.1 percent of the maximum absorbed dose in
				rads (Grays) of the unattenuated useful beam measured at the point of
				intersection of the central axis of the beam and plane surface. Measurements
				excluding those for neutrons shall be averaged over an area up to, but not
				exceeding, one hundred square centimeters (100 cm2)
				at the positions specified. Measurements of the portion of the leakage
				radiation dose contributed by neutrons shall be averaged over an area up to,
				but not exceeding, two hundred square centimeters (200
				cm2).
6.5.1.2 For each system, the registrant shall
				determine or obtain from the manufacturer the leakage radiation existing at the
				positions specified in
				RHB 6.5.1.1 for the
				specified operating conditions. Records on leakage radiation measurements shall
				be maintained for inspection by the Department.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part VI - USE OF THERAPEUTIC EQUIPMENT › Section 61-64.VI.RHB 6.6 - Operational Requirements for X-ray and Electron Therapy Systems with Energies of 1 MeV and Above

Current through Register Vol. 48, No. 6, June 28, 2024
6.6.1 Radiological
				Physics Support. The services of a radiological physicist shall be utilized in
				facilities having therapy systems with energies of one megaelectron volt (1
				MeV) and above. The radiological physicist shall be responsible for:
6.6.1.1 Calibration;
6.6.1.2 Supervision and review of patient
				dosimetry;
6.6.1.3 Beam data
				acquisition and storage for computer dosimetry, and supervision of its
				use;
6.6.1.4 Quality assurance,
				including spot check review;
6.6.1.5 Consultation with the radiation
				therapist in treatment planning, as needed; and
6.6.1.6 Availability and responsiveness to
				immediate problems or emergencies.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part VI - USE OF THERAPEUTIC EQUIPMENT › Section 61-64.VI.RHB 6.7 - Misadministration Report Requirements of all Therapeutic X-ray Systems

Current through Register Vol. 48, No. 6, June 28, 2024
All facilities utilizing therapeutic x-ray systems are
				  subject to the misadministration reporting requirements in RHB
				  1.11.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part VII - RADIATION SAFETY REQUIREMENTS FOR ANALYTICAL X-RAY EQUIPMENT › Section 61-64.VII.RHB 7.1 - Scope

Current through Register Vol. 48, No. 6, June 28, 2024
This Part establishes special requirements for analytical
				  x-ray equipment. The provisions of this Part are in addition to, and not in
				  substitution for, other applicable provisions of this
				  regulation.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part VII - RADIATION SAFETY REQUIREMENTS FOR ANALYTICAL X-RAY EQUIPMENT › Section 61-64.VII.RHB 7.2 - Electron Microscopes

Current through Register Vol. 48, No. 6, June 28, 2024
Electron microscopes shall be exempt from the other
				  requirements of Part VII except that they:
7.2.1 Shall be registered with the
				Department; and
7.2.2 Shall be
				installed, shielded, and operated in such a manner that no one shall be exposed
				beyond the limits defined in
				RHB 3.4.1 of this
				regulation.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part VII - RADIATION SAFETY REQUIREMENTS FOR ANALYTICAL X-RAY EQUIPMENT › Section 61-64.VII.RHB 7.3 - Hand-Held Analytical X-ray Equipment

Current through Register Vol. 48, No. 6, June 28, 2024
Hand-held analytical x-ray equipment shall be exempt from the
				  other requirements of Part VII except that they:
7.3.1 Shall be registered with the
				Department;
7.3.2 Shall only be
				operated by personnel who have completed documented training as outlined in
				RHB 7.9;
7.3.3 Shall have an interlock system that
				prevents the operation of the unit unless the x-ray exit port is in contact
				with or in close proximity to the item being irradiated;
7.3.4 Shall be operated in accordance with
				the manufacturer's specifications; and
7.3.5 Shall have operating procedures in
				accordance with
				RHB 7.10.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part VII - RADIATION SAFETY REQUIREMENTS FOR ANALYTICAL X-RAY EQUIPMENT › Section 61-64.VII.RHB 7.4 - General Requirements for all Analytical X-ray Equipment

Current through Register Vol. 48, No. 6, June 28, 2024
7.4.1
				Registration. All requirements of
				RHB 2.3 and 2.4
				apply.
7.4.2 Posting. Each area or
				room containing analytical x-ray equipment shall be conspicuously posted with a
				sign or signs bearing the radiation symbol and the words "CAUTION- X-RAY
				EQUIPMENT," or words having similar intent.
7.4.3 Labeling. All analytical x-ray
				equipment shall be labeled with a readily discernible sign or signs bearing the
				radiation symbol, and
7.4.3.1 A label bearing
				the words "Caution - Radiation - This Equipment Produces Radiation When
				Energized," or words having a similar intent, shall be placed near any switch
				which energizes an x-ray tube.
7.4.3.2 A sign bearing the words "Caution-
				High Intensity X-ray Beam," or words having a similar intent, shall be placed
				in the area immediately adjacent to each tube head or on the x-ray tube
				housing. The sign shall be so located that it is clearly visible to any person
				operating, aligning, or adjusting the unit, or handling or changing a
				sample.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part VII - RADIATION SAFETY REQUIREMENTS FOR ANALYTICAL X-RAY EQUIPMENT › Section 61-64.VII.RHB 7.5 - Additional Requirements for Open-Beam Configuration X-ray Equipment

Current through Register Vol. 48, No. 6, June 28, 2024
7.5.1 Safety Device. A device which prevents
				the entry of any portion of an individual's body into the primary beam path, or
				which causes the beam to be shut off upon entry into its path, shall be
				provided on all open-beam configuration x-ray equipment. A registrant may apply
				to the Department for an exemption from the requirement of a safety device.
				Such application shall include:
7.5.1.1 A
				description of the various safety devices that have been evaluated;
7.5.1.2 The reason each of these devices
				cannot be used;
7.5.1.3 A
				description of the alternative methods that will be employed to minimize the
				possibility of an accidental exposure, including procedures to assure that
				operators and others in the area will be informed of the absence of the safety
				devices; and
7.5.1.4 The procedure
				for notifying proper persons in the event of an accident. This list shall
				include the names, addresses, and telephone numbers.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part VII - RADIATION SAFETY REQUIREMENTS FOR ANALYTICAL X-RAY EQUIPMENT › Section 61-64.VII.RHB 7.6 - Additional Requirements for Enclosed Beam X-ray Equipment

Current through Register Vol. 48, No. 6, June 28, 2024
To include stationary, transportable, mobile, and portable
				  units.
7.6.1 The radiation source,
				sample, detector, and analyzing crystal (if used) shall be enclosed in a
				chamber or coupled chambers that cannot be entered by any part of the body
				during normal operation.
7.6.2 The
				sample chamber closure shall be interlocked with the x-ray tube high voltage
				supply or a shutter in the primary beam so that no x-ray beam can enter the
				sample chamber while it is open unless the interlock has been conspicuously and
				deliberately defeated. The interlock required by this section shall be of
				fail-safe design or adequate administrative controls shall be exercised to
				ensure operations will not continue without a properly functioning
				interlock.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part VII - RADIATION SAFETY REQUIREMENTS FOR ANALYTICAL X-RAY EQUIPMENT › Section 61-64.VII.RHB 7.7 - Area Requirements for all Analytical X-ray Equipment

Current through Register Vol. 48, No. 6, June 28, 2024
7.7.1
				Radiation Levels. The local components of an analytical x-ray system shall be
				located and arranged and shall include sufficient shielding or have access
				control such that no radiation in any area surrounding the local component
				group could result in a dose to an individual present therein in excess of the
				dose limits given in
				RHB 3.4. These levels shall be
				met at any specified tube rating.
7.7.2 Surveys, Tests, and Inspections.
				Radiation surveys, as required by
				RHB 1.4, of all analytical
				x-ray systems to show compliance with
				RHB 7.7.1 shall be performed
				and records kept and available for review:
7.7.2.1 Upon installation of the equipment
				and at least once every twelve (12) months thereafter;
7.7.2.2 Following any change in the initial
				arrangement, number, or type of local components in the system;
7.7.2.3 Following any change in operating
				parameters;
7.7.2.4 Following any
				maintenance requiring the disassembly or removal of a local component of the
				system;
7.7.2.5 During the
				performance of maintenance and alignment procedures if the procedures require
				the presence of a primary x-ray beam when any local component in the system is
				disassembled or removed;
7.7.2.6
				Any time a visual inspection of the local components in the system reveals an
				abnormal condition; and
7.7.2.7
				Whenever a monitoring device shows a significant increase over the previous
				monitoring period or the readings are approaching the radiation dose limits
				specified in
				RHB 3.4.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part VII - RADIATION SAFETY REQUIREMENTS FOR ANALYTICAL X-RAY EQUIPMENT › Section 61-64.VII.RHB 7.8 - Radiation Survey Instruments

Current through Register Vol. 48, No. 6, June 28, 2024
All provisions of
				  RHB 1.4.4
				  apply.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part VII - RADIATION SAFETY REQUIREMENTS FOR ANALYTICAL X-RAY EQUIPMENT › Section 61-64.VII.RHB 7.9 - Minimum Personnel Radiation Safety Training Requirements for Radiation Safety Officers and Operators

Current through Register Vol. 48, No. 6, June 28, 2024
7.9.1 No
				registrant shall permit any individual to act as a Radiation Safety Officer
				until such person:
7.9.1.1 Has been
				instructed in the subjects outlined in
				RHB 7.9.2 of this
				Part;
7.9.1.2 Has received copies
				of and instruction in: the regulations contained in this Part, Part XI, the
				applicable sections of Part III, and the registrant's operating and emergency
				procedures, and shall have demonstrated understanding thereof; and
7.9.1.3 Has demonstrated competence to use
				the x-ray machine, related handling tools, and survey instruments which will be
				employed in the assignment.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part VII - RADIATION SAFETY REQUIREMENTS FOR ANALYTICAL X-RAY EQUIPMENT › Section 61-64.VII.RHB 7.10 - Operating Procedures

Current through Register Vol. 48, No. 6, June 28, 2024
7.10.1 The
				registrant shall create and make available to x-ray operators written operating
				procedures. The procedures shall include, but not be limited to:
7.10.1.1 Policies and procedures for
				personnel and/or area monitoring;
7.10.1.2 Policies and procedures for pregnant
				employees;
7.10.1.3 Policies and
				procedures for training new employees;
7.10.1.4 Methods and occasions for conducting
				radiation surveys, tests, and inspections;
7.10.1.5 Methods for controlling access to
				restricted and radiation areas;
7.10.1.6 Methods for locking and securing
				x-ray machines, when not in use or in storage; and
7.10.1.7 Maintenance of records.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part VII - RADIATION SAFETY REQUIREMENTS FOR ANALYTICAL X-RAY EQUIPMENT › Section 61-64.VII.RHB 7.11 - Personnel Monitoring

Current through Register Vol. 48, No. 6, June 28, 2024
7.11.1 Personnel
				monitoring shall be required as outlined in
				RHB 3.12.
7.11.2 Finger or wrist dosimetric devices
				shall be provided to and shall be used by:
7.11.2.1 Analytical x-ray equipment workers
				using systems having an open-beam configuration and not equipped with a safety
				device; and
7.11.2.2 Personnel
				maintaining analytical or research and development x-ray equipment, if the
				maintenance procedures required the presence of a primary x-ray beam when any
				local component in the analytical or research and development x-ray system is
				disassembled or removed.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part VIII - RADIATION SAFETY REQUIREMENTS FOR INDUSTRIAL USES OF RADIOGRAPHIC SOURCES › Section 61-64.VIII.RHB 8.1 - Scope

Current through Register Vol. 48, No. 6, June 28, 2024
This Part establishes radiation safety requirements for
				  industrial uses of x-ray machines. The requirements of this Part are in
				  addition to, and not in substitution for, the other requirements of this
				  regulation.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part VIII - RADIATION SAFETY REQUIREMENTS FOR INDUSTRIAL USES OF RADIOGRAPHIC SOURCES › Section 61-64.VIII.RHB 8.2 - Locking of X-ray Machines

Current through Register Vol. 48, No. 6, June 28, 2024
Each x-ray machine shall be provided with a locking device
				  designed to prevent unauthorized or accidental production of radiation, and
				  shall be kept locked at all times except when under the direct surveillance of
				  a radiographer, a Radiation Safety Officer, or an operator, as
				  applicable.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part VIII - RADIATION SAFETY REQUIREMENTS FOR INDUSTRIAL USES OF RADIOGRAPHIC SOURCES › Section 61-64.VIII.RHB 8.3 - Permanent Storage Precautions

Current through Register Vol. 48, No. 6, June 28, 2024
Radiation machines shall be secured while in storage to
				  prevent tampering or removal by unauthorized individuals.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part VIII - RADIATION SAFETY REQUIREMENTS FOR INDUSTRIAL USES OF RADIOGRAPHIC SOURCES › Section 61-64.VIII.RHB 8.4 - Radiation Survey Instruments

Current through Register Vol. 48, No. 6, June 28, 2024
All provisions of
				  RHB 1.4.4
				  apply.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part VIII - RADIATION SAFETY REQUIREMENTS FOR INDUSTRIAL USES OF RADIOGRAPHIC SOURCES › Section 61-64.VIII.RHB 8.5 - Warning Devices

Current through Register Vol. 48, No. 6, June 28, 2024
Warning devices shall be labeled so that their purpose is
				  easily identified. An easily visible warning device light labeled with the
				  words "X-RAY ON," or words having a similar intent, shall be located near any
				  switch that energizes an x-ray tube and shall be illuminated only when the tube
				  is energized. This warning light shall be of a fail-safe
				  design.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part VIII - RADIATION SAFETY REQUIREMENTS FOR INDUSTRIAL USES OF RADIOGRAPHIC SOURCES › Section 61-64.VIII.RHB 8.6 - Labeling

Current through Register Vol. 48, No. 6, June 28, 2024
There shall be a durable permanent label indicating the
				  maximum operating current, kVp, the standard radiation symbol, and a caution
				  notice which shall read as follows or similarly: "CAUTION-RADIATION; THIS
				  EQUIPMENT PRODUCES RADIATION WHEN ENERGIZED." In addition, a label which reads,
				  "CAUTION-RADIATION; THIS EQUIPMENT PRODUCES RADIATION WHEN ENERGIZED" shall be
				  located near or adjacent to each switch that controls the production of
				  x-rays.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part VIII - RADIATION SAFETY REQUIREMENTS FOR INDUSTRIAL USES OF RADIOGRAPHIC SOURCES › Section 61-64.VIII.RHB 8.7 - Posting Requirements

Current through Register Vol. 48, No. 6, June 28, 2024
Areas in which radiography is being performed shall be
				  conspicuously posted as required by
				  RHB 3.15 and
				  3.16.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part VIII - RADIATION SAFETY REQUIREMENTS FOR INDUSTRIAL USES OF RADIOGRAPHIC SOURCES › Section 61-64.VIII.RHB 8.8 - Minimum Personnel Radiation Safety Training Requirements for Radiation Safety Officers, Radiographers, and Operators

Current through Register Vol. 48, No. 6, June 28, 2024
8.8.1 No
				registrant shall permit any individual to act as a Radiation Safety Officer
				until such person:
8.8.1.1 Has been
				instructed in the subjects outlined in
				RHB 8.12 of this
				Part;
8.8.1.2 Has received copies
				of and instruction in: the regulations contained in this Part, Part XI, the
				applicable sections of Part III, and the registrant's operating and emergency
				procedures, and shall have demonstrated understanding thereof; and
8.8.1.3 Has demonstrated competence to use
				the x-ray machine, related handling tools, and survey instruments which will be
				employed in the assignment.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part VIII - RADIATION SAFETY REQUIREMENTS FOR INDUSTRIAL USES OF RADIOGRAPHIC SOURCES › Section 61-64.VIII.RHB 8.9 - Operating and Emergency Procedures

Current through Register Vol. 48, No. 6, June 28, 2024
The registrant shall have written operating and emergency
				  procedures. These procedures shall include instruction in:
8.9.1 The handling and use of x-ray machines
				to be employed such that no person is likely to be exposed to radiation doses
				in excess of the limits established in Part III of this regulation;
8.9.2 Methods and occasions for conducting
				radiation surveys;
8.9.3 Methods
				for controlling access to radiographic areas;
8.9.4 Methods for locking and securing x-ray
				machines, when not in use or in storage;
8.9.5 Personnel monitoring and the use of
				personnel monitoring equipment, including steps that must be taken by
				radiography personnel in the event a pocket dosimeter is found to be
				off-scale;
8.9.6 The proper
				handling of exposed personnel;
8.9.7 Minimizing exposure of individuals in
				the event of an accident;
8.9.8 The
				procedure for notifying proper persons in the event of an accident, including a
				list of names, addresses, and telephone numbers; and
8.9.9 Maintenance of records.