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 III - STANDARDS FOR PROTECTION AGAINST RADIATION › Section 61-64.III.RHB 3.21 - Records of Planned Special Exposures

Current through Register Vol. 48, No. 6, June 28, 2024
3.21.1 For
				each use of the provisions of
				RHB 3.6 for planned special
				exposures, the registrant shall maintain records that describe:
3.21.1.1 The exceptional circumstances
				requiring the use of a planned special exposure;
3.21.1.2 The name of the management official
				who authorized the planned special exposure and a copy of the signed
				authorization;
3.21.1.3 What
				actions were necessary;
3.21.1.4
				Why the actions were necessary;
3.21.1.5 What precautions were taken to
				assure that doses were maintained ALARA;
3.21.1.6 What individual and collective doses
				were expected to result; and
3.21.1.7 The doses actually received in the
				planned special exposure.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part III - STANDARDS FOR PROTECTION AGAINST RADIATION › Section 61-64.III.RHB 3.22 - Records of Individual Monitoring Results

Current through Register Vol. 48, No. 6, June 28, 2024
3.22.1
				Record-keeping Requirement. Each registrant shall maintain records of doses
				received by all individuals for whom monitoring was required pursuant to
				RHB 3.12, and records of
				doses received during planned special exposures, accidents, and emergency
				conditions. These records shall include the deep dose equivalent to the whole
				body, eye dose equivalent, shallow dose equivalent to the skin, and shallow
				dose equivalent to the extremities.
3.22.2 Record-keeping Frequency. The
				registrant shall make entries of the records specified in
				RHB 3.22.1 at intervals not
				to exceed one (1) year.
3.22.3
				Record-keeping Format. The registrant shall maintain the records specified in
				RHB 3.22.1.
3.22.4 The registrant shall maintain the
				records of dose to an embryo/fetus with the records of dose to the declared
				pregnant woman. The declaration of pregnancy, including the estimated date of
				conception, shall also be kept on file, but may be maintained separately from
				the dose records.
3.22.5 The
				registrant shall retain each required form or record until the Department
				terminates each pertinent registration requiring the record.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part III - STANDARDS FOR PROTECTION AGAINST RADIATION › Section 61-64.III.RHB 3.23 - Records of Dose to Individual Members of the Public

Current through Register Vol. 48, No. 6, June 28, 2024
3.23.1 Each
				registrant shall maintain records sufficient to demonstrate compliance with the
				dose limit for individual members of the public in
				RHB 3.10.
3.23.2 The registrant shall retain the
				records required by
				RHB 3.23.1 until the
				Department terminates each pertinent registration requiring the
				record.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part III - STANDARDS FOR PROTECTION AGAINST RADIATION › Section 61-64.III.RHB 3.24 - Notification of Incidents

Current through Register Vol. 48, No. 6, June 28, 2024
3.24.1
				Immediate Notification. Notwithstanding other requirements for notification,
				each registrant shall immediately report each event involving a source of
				radiation possessed by the registrant that may have caused or threatens to
				cause an individual to receive:
3.24.1.1 A
				total effective dose equivalent of 25 rem (0.25 Sv) or more;
3.24.1.2 An eye dose equivalent of 75 rem
				(0.75 Sv) or more; or
3.24.1.3 A
				shallow dose equivalent to the skin or extremities or a total organ dose
				equivalent of 250 rad (2.5 Gy) or more.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part III - STANDARDS FOR PROTECTION AGAINST RADIATION › Section 61-64.III.RHB 3.25 - Reports of Exposures and Radiation Levels Exceeding the Limits

Current through Register Vol. 48, No. 6, June 28, 2024
3.25.1 In addition to the notification
				required by
				RHB 3.24, each registrant
				shall submit a written report within thirty (30) calendar days after learning
				of any of the following occurrences:
3.25.1.1
				Any incident for which notification is required by
				RHB 3.24;
3.25.1.2 Doses in excess of any of the
				following:
3.25.1.2.1 The occupational dose
				limits for adults in
				RHB 3.4;
3.25.1.2.2 The occupational dose limits for a
				minor in RHB
				3.7;
3.25.1.2.3 The limits for an embryo/fetus of
				a declared pregnant woman in
				RHB 3.8; or
3.25.1.2.4 The limits for an individual
				member of the public in
				RHB 3.9.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part III - STANDARDS FOR PROTECTION AGAINST RADIATION › Section 61-64.III.RHB 3.26 - Reports of Planned Special Exposures

Current through Register Vol. 48, No. 6, June 28, 2024
The registrant shall submit a written report to the
				  Department within thirty (30) calendar days following any planned special
				  exposure conducted in accordance with
				  RHB 3.6, informing the
				  Department that a planned special exposure was conducted and indicating the
				  date the planned special exposure occurred and the information required by RHB
				  3.21.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part III - STANDARDS FOR PROTECTION AGAINST RADIATION › Section 61-64.III.RHB 3.27 - Reports of Individual Monitoring

Current through Register Vol. 48, No. 6, June 28, 2024
The Department may require by registration condition, or
				  order pursuant to
				  RHB 1.6.1, annual reports of
				  the results of individual monitoring carried out by the registrant for each
				  individual for whom monitoring was required by RHB 3.12.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part III - STANDARDS FOR PROTECTION AGAINST RADIATION › Section 61-64.III.RHB 3.28 - Notifications and Reports to Individuals

Current through Register Vol. 48, No. 6, June 28, 2024
3.28.1
				Requirements for notification and reports to individuals of exposure to
				radiation are specified in
				RHB 11.4.
3.28.2 When a registrant is required pursuant
				to RHB 3.26
				to report to the Department any exposure of an individual to radiation, the
				registrant shall also notify the individual. Such notice shall be transmitted
				at a time not later than the transmittal to the Department, and shall comply
				with the provisions of
				RHB 11.4.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part III - STANDARDS FOR PROTECTION AGAINST RADIATION › Section 61-64.III.RHB 3.29 - Storage and Control of Radiation Sources

Current through Register Vol. 48, No. 6, June 28, 2024
3.29.1 The
				registrant shall secure all radiation equipment, including equipment in
				storage, from unauthorized removal.
3.29.2 The registrant shall maintain control
				of all radiation equipment, including equipment in storage, to prevent
				unauthorized use.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part III - STANDARDS FOR PROTECTION AGAINST RADIATION › Section 61-64.III.RHB 3.30 - Reports of Stolen, Lost, Abandoned, or Missing Radiation Sources

Current through Register Vol. 48, No. 6, June 28, 2024
3.30.1 Telephone Reports. Each registrant
				shall report to the Department by telephone, immediately after its occurrence
				becomes known to the registrant, a stolen, lost, abandoned, or missing
				radiation machine.
3.30.2 Written
				Reports. Each registrant required to make a report pursuant to
				RHB 3.30.1 shall, within
				thirty (30) calendar days after making the telephone report, make a written
				report to the Department setting forth the following information:
3.30.2.1 A description of the registered
				source of radiation involved, including the manufacturer, model and serial
				number, type and maximum energy of radiation emitted;
3.30.2.2 A description of the circumstances
				under which the loss or theft occurred;
3.30.2.3 A statement of disposition, or
				probable disposition, of the registered source of radiation involved;
3.30.2.4 Actions that have been taken, or
				will be taken, to recover the source of radiation; and
3.30.2.5 Procedures or measures that have
				been, or will be, adopted to ensure against a recurrence of the loss or theft
				of registered sources of radiation.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part IV - USE OF X-RAYS IN THE HEALTH PROFESSIONS › Section 61-64.IV.RHB 4.1 - Scope

Current through Register Vol. 48, No. 6, June 28, 2024
This Part establishes requirements for which a registrant is
				  responsible, for use of x-ray equipment by or under the supervision of an
				  individual authorized by and licensed in accordance with state statutes to
				  engage in the healing arts or veterinary medicine. This Part also establishes
				  requirements for shielding for all Parts of this regulation.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part IV - USE OF X-RAYS IN THE HEALTH PROFESSIONS › Section 61-64.IV.RHB 4.3 - General Requirements for all Diagnostic X-ray Systems

Current through Register Vol. 48, No. 6, June 28, 2024
All diagnostic x-ray systems shall meet the following
				  requirements.
4.3.1 Warning Label. The
				control panel containing the main power switch shall bear the warning
				statement: "WARNING: This x-ray unit may be dangerous to patient and operator
				unless safe exposure factors and operating instructions are observed."
4.3.1.1 The warning label shall be legible
				and its view unobstructed.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part IV - USE OF X-RAYS IN THE HEALTH PROFESSIONS › Section 61-64.IV.RHB 4.4 - Shielding

Current through Register Vol. 48, No. 6, June 28, 2024
The following requirements for shielding apply to all Parts
				  of this regulation.
4.4.1 Shielding
				Plan Required.
4.4.1.1 Each registrant and/or
				applicant shall ensure that prior to construction of a new facility,
				modification, or renovation of an existing x-ray facility, or replacement of an
				x-ray machine, the floor plans and equipment arrangement are reviewed by a
				Class III, Class IV, Class VII, Class VIII, or Class IX vendor and submitted to
				the Department for review and acceptance. Notification shall be made on the
				current version of the form provided by the Department and shall include
				shielding review fees as required by
				RHB 2.3.2.
4.4.1.2 A shielding plan shall be required
				for any space utilized as a radiation area for a period of five (5) or more
				consecutive days.
4.4.1.3 A
				shielding plan shall be required when the parameters, as required by Appendix B
				of this Part, of the original shielding plan change to an extent so as to
				render the original shielding plan inaccurate, as determined by a Class III,
				Class IV, Class VII, Class VIII, or Class IX vendor.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part IV - USE OF X-RAYS IN THE HEALTH PROFESSIONS › Section 61-64.IV.RHB 4.5 - Intraoral Dental Radiographic Systems

Current through Register Vol. 48, No. 6, June 28, 2024
In addition to the applicable provisions of this regulation,
				  the requirements of this Part apply to all stationary, transportable, mobile,
				  portable, and hand-held dental systems.
4.5.1 Source-to-Skin Distance (SSD). X-ray
				systems designed for use with an intraoral image receptor shall be provided
				with means to limit the source-to-skin distance, to not less than eighteen
				centimeters (18 cm).
4.5.2 Field
				Limitation. Radiographic systems designed for use with an intraoral image
				receptor shall be provided with means to limit the x-ray field such that:
4.5.2.1 The x-ray field at the minimum SSD
				shall be containable in a circle having a diameter of no more than seven
				centimeters (7 cm).
4.5.2.2 An
				open-ended Position Indication Device (PID) shall be used, and shall provide
				the same degree of protection as the housing. Pointed PIDs shall not be
				used.
4.5.2.3 The operator shall
				position the end of the PID as close as practicable to the skin of the
				patient.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part IV - USE OF X-RAYS IN THE HEALTH PROFESSIONS › Section 61-64.IV.RHB 4.6 - Extraoral Dental Radiographic Systems

Current through Register Vol. 48, No. 6, June 28, 2024
In addition to the applicable provisions of this regulation,
				  the requirements of this Part apply to all cephalometric, panoramic and dental
				  computed tomography (CT) systems.
4.6.1 Cephalometric Installations
4.6.1.1 Where applicable, all provisions of
				RHB 4.4 and 4.7
				apply.
4.6.1.2 The radiographic
				field shall be restricted to the area of the image receptor.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part IV - USE OF X-RAYS IN THE HEALTH PROFESSIONS › Section 61-64.IV.RHB 4.7 - Medical Radiographic Systems

Current through Register Vol. 48, No. 6, June 28, 2024
In addition to the applicable provisions of this regulation,
				  the requirements of this Part apply to x-ray equipment and associated
				  facilities used for radiography with stationary and transportable radiographic
				  systems other than intraoral dental, fluoroscopic, computed tomography (CT),
				  mammography, or veterinary medical systems.
4.7.1 Stationary and Transportable General
				Purpose Units. In addition to the other provisions of this Part, all stationary
				and transportable general purpose units must also meet the following
				requirements:
4.7.1.1 Means shall be provided
				for independent stepless adjustment of at least two (2) dimensions of the x-ray
				field.
4.7.1.2 Means shall be
				provided to indicate when the axis of the x-ray beam is perpendicular to the
				plane of the image receptor.
4.7.1.3 Means shall be provided for visually
				defining the perimeter of the x-ray field. The total misalignment of the edges
				of the visually defined field with the respective edges of the x-ray field
				along either the length or width of the visually defined field shall not exceed
				two percent (2%) of the distance from the source to the center of the visually
				defined field when the surface upon which it appears is perpendicular to the
				axis of the x-ray beam.
4.7.1.4 The
				beam limiting device shall indicate numerically the field size in the plane of
				the image receptor to which it is adjusted.
4.7.1.5 Indication of field size dimensions
				and SIDs used shall be specified in inches and/or centimeters on the
				collimator. The indications on the collimator shall be such that aperture
				adjustments result in x-ray field dimensions in the plane of the image receptor
				which correspond to those of the image receptor to within two percent (2%) of
				the SID when the beam axis is perpendicular to the plane of the image
				receptor.
4.7.1.6 The beam limiting
				device shall be provided with SID scales that reflect the actual SID(s) used
				for radiographic procedures.
4.7.1.7 Means shall be provided to align the
				center of the x-ray field with the center of the image receptor to within two
				percent (2%) of the SID.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part IV - USE OF X-RAYS IN THE HEALTH PROFESSIONS › Section 61-64.IV.RHB 4.8 - Mobile and Portable Radiographic Systems

Current through Register Vol. 48, No. 6, June 28, 2024
In addition to the applicable provisions of this regulation,
				  the requirements of this Part apply to all mobile and portable radiographic
				  systems.
4.8.1 All provisions of
				RHB 4.7.4 through
				4.7.14 apply, except 4.7.12 and
				4.7.4.2.2.
4.8.2 Means shall be
				provided for independent stepless adjustment of at least two (2) dimensions of
				the x-ray field.
4.8.3 Means shall
				be provided to indicate when the axis of the x-ray beam is perpendicular to the
				plane of the image receptor.
4.8.4
				Means shall be provided for visually defining the perimeter of the x-ray field.
				The total misalignment of the edges of the visually defined field with the
				respective edges of the x-ray field along either the length or width of the
				visually defined field shall not exceed two percent (2%) of the distance from
				the source to the center of the visually defined field when the surface upon
				which it appears is perpendicular to the axis of the x-ray beam.
4.8.5 If provided, the beam-limiting device
				shall indicate numerically the field size in the plane of the image receptor to
				which it is adjusted.
4.8.6 If
				collimator indications are provided, the indications shall be such that
				aperture adjustments result in x-ray field dimensions in the plane of the image
				receptor which correspond to those of the image receptor to within two percent
				(2%) of the SID when the beam axis is perpendicular to the plane of the image
				receptor.
4.8.7 Means shall be
				provided to measure SIDs, and shall be accurate to within two percent
				(2%).
4.8.8 Mobile and portable
				x-ray systems which are used in a single location for a period of five (5) or
				more consecutive days shall be considered a stationary radiographic system and
				shall meet the requirements of
				RHB 4.4.
4.8.9 Mobile and portable x-ray systems which
				are used at multiple locations shall be provided with an adequate protective
				barrier or protective apron for the operator and with a method of control which
				will permit the operator to be at least six feet (6 ft) from the tube head and
				the nearest edge of the useful beam during exposures.
4.8.10 Tube stands. A tube stand or other
				mechanical support shall be used for portable x-ray systems so that the x-ray
				tube housing assembly need not be hand-held during exposures.
4.8.11 All mobile or portable radiographic
				systems shall be provided with means to limit the source-to-skin distance to
				equal to or greater than thirty centimeters (30 cm).
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part IV - USE OF X-RAYS IN THE HEALTH PROFESSIONS › Section 61-64.IV.RHB 4.9 - Fluoroscopic X-ray Systems

Current through Register Vol. 48, No. 6, June 28, 2024
In addition to the applicable provisions of this regulation,
				  the requirements of this Part apply to all stationary, transportable, mobile,
				  portable, and C-Arm type fluoroscopes. All fluoroscopic x-ray systems shall be
				  image intensified or direct digital receptor, and meet the following
				  requirements.
4.9.1 Source-to-Skin
				Distance (SSD). The SSD shall not be less than:
4.9.1.1 Thirty-eight centimeters (38 cm) on
				stationary and transportable fluoroscopic systems manufactured on or after
				August 1, 1974;
4.9.1.2 Thirty-five
				and one half centimeters (35.5 cm) on stationary and transportable fluoroscopic
				systems manufactured prior to August 1, 1974;
4.9.1.3 Thirty centimeters (30 cm) on all
				mobile and portable fluoroscopes; and
4.9.1.4 Twenty centimeters (20 cm) for mobile
				fluoroscopes used for specific surgical procedures. If removable, the
				appropriate spacer shall be replaced after the specific surgical procedure
				application is complete.
4.9.1.4.1 For
				stationary, transportable, mobile, or portable fluoroscopes manufactured on or
				after June 10, 2006, having a maximum source-to-image receptor distance of less
				than forty-five centimeters (45 cm), means shall be provided to limit the
				source-to-skin distance (SSD) to not less than nineteen centimeters (19 cm).
				Such systems shall be labeled for extremity use only.
4.9.1.4.2 For those systems intended for
				specific surgical applications that would be prohibited at the source-skin
				distance specified above, provisions may be made for operation at shorter
				source-skin distances but in no case less than ten centimeters (10
				cm).
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part IV - USE OF X-RAYS IN THE HEALTH PROFESSIONS › Section 61-64.IV.RHB 4.10 - Bone Densitometry Systems

Current through Register Vol. 48, No. 6, June 28, 2024
In addition to the applicable provisions of this regulation,
				  the requirements of this Part apply to all stationary, transportable, mobile,
				  and portable x-ray bone densitometry systems.
4.10.1 Registration. All provisions of
				RHB 2.3 and 2.4
				apply.
4.10.2 Shielding.
4.10.2.1 Stationary units. The registrant
				shall submit a shielding plan, as required by
				RHB 4.4, to the Department for
				review and acceptance.
4.10.2.2
				Peripheral units are exempt from
				RHB 4.10.2.1.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part IV - USE OF X-RAYS IN THE HEALTH PROFESSIONS › Section 61-64.IV.RHB 4.11 - Computed Tomography (CT) X-ray Systems

Current through Register Vol. 48, No. 6, June 28, 2024
In addition to the applicable provisions of this regulation,
				  the requirements of this Part apply to all stationary, transportable, and
				  mobile CT X-ray systems.
4.11.1
				Equipment Requirements.
4.11.1.1 Tomographic
				Plane Indication and Alignment.
4.11.1.1.1 For
				any single tomogram system, means shall be provided to permit visual
				determination of the tomographic plane or a reference plane offset from the
				tomographic plane.
4.11.1.1.2 For
				any multiple tomogram system, means shall be provided to permit visual
				determination of the location of a reference plane. The reference plane can be
				offset from the location of the tomographic planes.
4.11.1.1.3 If a device using a light source
				is used to satisfy the requirements of
				RHB 4.11.1.1.1 or
				4.11.1.1.2, the light source shall provide illumination levels sufficient to
				permit visual determination of the location of the tomographic plane or
				reference plane under ambient light conditions.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part IV - USE OF X-RAYS IN THE HEALTH PROFESSIONS › Section 61-64.IV.RHB 4.12 - Veterinary Systems

Current through Register Vol. 48, No. 6, June 28, 2024
In addition to the applicable provisions of this regulation,
				  the requirements of this Part apply to all stationary, transportable, mobile,
				  portable, and hand-held X-ray systems for veterinary use.
4.12.1 Administrative Requirements. All
				provisions of
				RHB 4.2 apply, except 4.2.2,
				4.2.7, and 4.2.11. No person other than a licensed veterinarian or an
				adequately trained individual, as required by
				RHB 4.12.22, shall use
				equipment emitting ionizing radiation for diagnostic purposes.
4.12.2 Radiation Protection. All provisions
				of RHB 4.2.9
				apply, except 4.2.9.3.
4.12.3
				Holding of Patients and Films. All provisions of
				RHB 4.2.12 apply. In
				addition:
4.12.3.1 Each human holder in a
				veterinary facility shall utilize protective apparel.
4.12.3.2 Each veterinary facility that holds
				patients shall provide personnel monitoring devices. If the human holder's
				hands are in or near the primary beam and lead gloves are not utilized, then
				ring badges shall also be provided and worn.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part IV - USE OF X-RAYS IN THE HEALTH PROFESSIONS › Section 61-64.IV.RHB 4.13 - Medical Specimen Systems

Current through Register Vol. 48, No. 6, June 28, 2024
In addition to the applicable provisions of this regulation,
				  the requirements of this Part apply to all stationary, transportable, mobile,
				  and portable medical specimen systems.
4.13.1 Administrative Requirements. All
				provisions of
				RHB 4.2.2.7
				apply.
4.13.2 Radiation Protection.
				Upon installation, the medical specimen unit shall not be operated until a
				physical radiation survey of the unit and areas adjacent to the unit has been
				performed. A radiation survey of the unit and areas adjacent to the unit shall
				also be performed at least annually, and after any repair, modification, or
				maintenance on the system. Documentation of the surveys shall be maintained for
				inspection by the Department.
4.13.3 Tests of all safety devices such as
				interlocks shall be conducted annually for medical specimen units.
				Documentation of such tests shall be maintained for inspection by the
				Department.
4.13.4 Radiation
				emitted from the medical specimen unit shall not exceed 0.5 milliRoentgens per
				hour at any point five centimeters from the external surface.
4.13.5 When not in operation, the medical
				specimen unit shall be secured.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part IV - USE OF X-RAYS IN THE HEALTH PROFESSIONS › Appendix 61-64.IV.A - Information to be Submitted by Persons Proposing to Conduct Healing Arts Screening

Current through Register Vol. 48, No. 6, June 28, 2024
Persons requesting that the Department approve a healing arts
				  screening program shall submit the following information for review and
				  approval:
1. Name and address of the applicant, and where applicable,
				  the names and addresses of agents within the state.
2. Diseases or conditions for which the x-ray examinations
				  are to be used.
3. Description in detail of the x-ray examinations proposed
				  in the screening program.
4. Description of the population to be examined in the
				  screening program (i.e., age, sex, physical condition, and other appropriate
				  information).
5. An evaluation of any known alternate methods not involving
				  ionizing radiation which could achieve the goals of the screening program and
				  why these methods are not used in preference to the x-ray examinations.
6. An evaluation by a qualified expert of the x-ray system(s)
				  to be used in the screening program. The evaluation by the qualified expert
				  shall show that such system(s) do satisfy all requirements of this
				  regulation.
7. A description of the image quality control program.
8. A copy of the technique chart for the x-ray examinations
				  procedures to be used.
9. The qualifications of each individual who will be
				  operating the x-ray system(s).
10. The qualifications of the individual who will be
				  supervising the operators of the x-ray system(s).
11. The name and address of the individual who will interpret
				  the radiograph(s).
12. A description of the procedures to be used in advising
				  the individuals screened and their private practitioners of the healing arts of
				  the results of the screening procedure and any further medical needs
				  indicated.
13. A description of the procedures for the retention or
				  disposition of the radiographs and other records pertaining to the x-ray
				  examinations.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part IV - USE OF X-RAYS IN THE HEALTH PROFESSIONS › Appendix 61-64.IV.B - Information on Radiation Shielding Required for Plan Review

Current through Register Vol. 48, No. 6, June 28, 2024
The following information must be provided to the Department
				  for review and acceptance of a shielding plan:
1. Plans shall show, at a minimum, the following:
a) The normal location of the x-ray system's radiation port;
				  the port's travel and traverse limits; general direction(s) of the useful beam;
				  locations of any windows and doors; the location of the operator's
				  booth/station; the location of the x-ray control panel, and the location of the
				  wall bucky or chest board, if applicable.
b) The structural composition and thickness or lead
				  equivalent of all walls, doors, partitions, floor, and ceiling of the room(s)
				  concerned.
c) An accurate drawing of the room(s) concerned.
d) The type of occupancy of all adjacent areas subject to
				  primary and secondary scatter inclusive of space above and below the room(s)
				  concerned. If there is an exterior wall, show distance to the closest area(s)
				  where it is likely that individuals may be present.
e) The type of x-ray equipment and the maximum technique
				  factors.
f) Location of the darkroom and the area where the film will
				  be stored. Any shielding which will be used to protect the film must be noted.
				  The use of filmless systems shall be indicated in writing.
2. Information on the anticipated workload of the x-ray
				  system(s). Give the number of individual exposures per week. This is the total
				  number of exposures (not patients) taken each week. This figure should include
				  allowances for future growth so that the shielding will continue to remain
				  adequate.
3. Individual barrier radiation shielding specifications and
				  descriptions of all assumptions that were used in the shielding
				  calculations.
4. The date the plan was prepared and the printed name and
				  signature of the person preparing the plan.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part IV - USE OF X-RAYS IN THE HEALTH PROFESSIONS › Appendix 61-64.IV.D - Patient Exposure Guide

Current through Register Vol. 48, No. 6, June 28, 2024
Medical ESEs Compliance with
				  RHB 4.2.13.2 shall be
				  considered adequate if the patient's exposure at skin entrance (ESE) does not
				  exceed the limits for the anatomical thicknesses listed below. Facilities
				  utilizing digital imaging systems shall not exceed the ESE Limits as outlined
				  for a 200 speed system.
ESE Limits
Exam Type
Thickness
200 Speed/Digital (mR)
400 Speed (mR)
PA Chest - Grid - Non Grid
23 cm
38 23
23 8
AP Abdomen
23 cm
735
450
AP Lumbar Spine
23 cm
675
525
Full Spine (AP)
23 cm
390
218
AP Cervical Spine
13 cm
203
142
Lateral Skull
15 cm
218
105
Ret Pyelogram (AP)
23 cm
893
893
Thoracic Spine (AP)
23 cm
612
612
DP Foot
8 cm
111
111
Cephalometric
15 cm
45
45
Notes:
a) Patient thicknesses are expressed in centimeters
				  (cm).
b) All measurements are made in air (no phantom).
c) If the film/screen speed cannot be determined, it will be
				  assumed to be 200 speed.
Mammography ESEs: Refer to
				  RHB 5.13.5.10 Dental
				  Intraoral ESEs:
Compliance with
				  RHB 4.2.13.2 shall be
				  considered adequate if the patient's exposure at skin entrance (ESE) does not
				  exceed the limits listed below. Facilities utilizing digital imaging systems
				  shall not exceed the ESE Limits as outlined for a "D" speed film system.
kVp
"D" Speed Film and Digital
"E" and "F" Speed Film
ESE Limits (mR)
ESE Limits (mR)
50
690
384
55
600
324
60
528
276
65
480
240
70
420
204
75
312
168
80
276
144
85
240
126
90
216
108
95
192
64
100
168
56
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-64 - X-Rays (Title B) › Part IV - USE OF X-RAYS IN THE HEALTH PROFESSIONS › Appendix 61-64.IV.E - Automatic Exemptions for Sterile Fields

Current through Register Vol. 48, No. 6, June 28, 2024
Automatic exemptions to
				  RHB 4.9.8.2.2 will be
				  granted for the following procedures:
1. Myelograms
2. Arthrograms
3. Angiograms
4. Percutaneous nephrostomies
5. Biliary drainage procedures
6. Percutaneous cholangiograms
7. T-tube cholangiograms
8. Sinograms or fistulograms
9. Fluoroscopic biopsy 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 5.1 - Scope

Current through Register Vol. 48, No. 6, June 28, 2024
This Part establishes quality standards and certification
				  requirements for facilities performing mammography to ensure that all
				  mammography facilities are adequately and consistently evaluated for compliance
				  with the standards provided.
5.1.1 Any
				person proposing to conduct a healing arts screening program shall not initiate
				such a program without prior approval of the Department. When requesting such
				approval, that person shall submit the information outlined in Appendix A of
				Part IV. Approval to conduct a healing arts screening program shall be renewed
				on an annual basis if deemed necessary by the Department.
5.1.2 Exemptions.
5.1.2.1 Mammography units used only during
				invasive interventions for localization or biopsy procedures are exempt from
				the requirements of this Part, except that such systems shall satisfy the
				criteria specified in
				RHB 5.25, and all Parts to
				which RHB 5.25
				refers.
5.1.2.2 Each mobile
				mammography facility based outside of South Carolina that operates in South
				Carolina and which has not been certified by the Department is exempt from the
				requirements of
				RHB 5.4 and 5.8, provided that:
5.1.2.2.1 The mobile mammography facility is
				certified to perform mammography by the U.S. Food and Drug Administration (FDA)
				or other FDA-approved certifying agency at all times while conducting
				operations in South Carolina;
5.1.2.2.2 The mobile mammography facility
				meets the requirements of
				RHB 5.28;
5.1.2.2.3 The mobile mammography facility
				complies with all other requirements in Part V; and
5.1.2.2.4 The mobile mammography facility
				meets the requirements of
				RHB 2.3 and 2.4.
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 5.2 - Requirements for Certification

Current through Register Vol. 48, No. 6, June 28, 2024
A certificate issued by the Department is required for lawful
				  operation of all mammography facilities subject to the provisions of this Part.
				  Certificate-holding facilities shall meet the requirements of
				  RHB 5.8 and be accredited by an
				  FDA-approved 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 5.3 - Revocation of Accreditation

Current through Register Vol. 48, No. 6, June 28, 2024
If a facility's accreditation is revoked by an accreditation
				  body, the Department may conduct an investigation into the reasons for the
				  revocation. Following such investigation, the Department may suspend or revoke
				  the facility's certificate and take whatever action or combination of actions
				  to protect public health, including requiring the establishment and
				  implementation of a corrective plan of action that shall permit the certificate
				  to continue in effect while the facility seeks reaccreditation. A facility
				  whose certificate is suspended or revoked because it has lost its accreditation
				  may not practice mammography.
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 5.4 - Certificates

Current through Register Vol. 48, No. 6, June 28, 2024
5.4.1 In order to
				qualify for a certificate, a facility shall apply to an FDA-approved
				accreditation body.
5.4.2 Following
				the Department's receipt of the accreditation body's decision to accredit a
				facility, the Department may issue a certificate to the facility, or renew an
				existing certificate, if the Department determines that the facility has
				satisfied the requirements for certification or recertification.
5.4.3 Provisional Certificates.
5.4.3.1 A new facility is eligible to apply
				for a provisional certificate. The provisional certificate will enable the
				facility to perform mammography and to obtain the clinical images needed to
				complete the accreditation process.
5.4.3.2 Following the Department's receipt of
				the accreditation body's decision that a facility has submitted the required
				information, the Department may issue a provisional certificate to a facility
				upon determination that the facility has satisfied the requirements for
				provisional certification. A provisional certificate shall be effective for up
				to six (6) months from the date of issuance. A provisional certificate cannot
				be renewed, but a facility may apply for a ninety (90)-day extension of the
				provisional certificate.
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 5.5 - Suspension or Revocation of Certificates

Current through Register Vol. 48, No. 6, June 28, 2024
5.5.1
				Except as provided in RHB 5.5.2, the Department may suspend or revoke a
				certificate if the Department finds that the owner, operator, or any employee
				of the facility:
5.5.1.1 Has been guilty of
				misrepresentation in obtaining the certificate;
5.5.1.2 Has failed to comply with the
				standards of
				RHB 5.2 through
				5.24;
5.5.1.3 Has failed to comply with reasonable
				requests of the Department or the accreditation body 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
				RHB 5.2 through
				5.24;
5.5.1.4 Has refused a reasonable request of a
				duly designated FDA inspector, Department inspector, or accreditation body
				representative for permission to inspect the facility or the operations and
				pertinent records of the facility;
5.5.1.5 Has violated or aided and abetted in
				the violation of any provision of this regulation;
5.5.1.6 Has failed to comply with prior
				sanctions imposed by the Department; or
5.5.1.7 Has failed to pay any required
				fees.
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 5.6 - Reinstatement Policy

Current through Register Vol. 48, No. 6, June 28, 2024
A previously certified facility that has allowed its
				  certificate to expire, that has been refused a renewal of its certificate by
				  the FDA or the Department, or that has had its certificate suspended or revoked
				  by the FDA or the Department, may apply for reinstatement. If reinstated, the
				  facility will be eligible for a provisional certificate.
5.6.1 Unless prohibited from reinstatement
				under RHB 5.6.4,
				a facility applying for reinstatement shall:
5.6.1.1 Contact an FDA-approved accreditation
				body to determine the requirements for reapplication or
				accreditation;
5.6.1.2 Fully
				document its history as a previously provisionally certified or certified
				mammography facility, including the following information:
5.6.1.2.1 Name and address of the facility
				under which it was previously provisionally certified or certified;
5.6.1.2.2 Name of previous
				owner/lessor;
5.6.1.2.3 FDA
				facility identification number assigned to the facility under its previous
				certification; and
5.6.1.2.4
				Expiration date of the most recent FDA provisional certificate or
				certificate.
5.6.1.3
				Justify application for reinstatement of accreditation by submitting to the
				accreditation body a corrective action plan that details how the facility has
				corrected deficiencies that contributed to the lapse of, denial of renewal, or
				revocation of its certificate.
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 5.7 - Adverse accreditation or reaccreditation decisions

Current through Register Vol. 48, No. 6, June 28, 2024
The appeals procedures described in this Part are available
				  only for adverse accreditation or reaccreditation decisions that preclude
				  certification by the Department. Department decisions to suspend or revoke
				  certificates that are already in effect shall be conducted in accordance with
				  RHB 5.5.
5.7.1 Upon learning that a
				facility has failed to become accredited or reaccredited, the Department will
				notify the facility that the Department is unable to certify that facility
				without proof of accreditation.
5.7.2 A facility that has been denied
				accreditation or reaccreditation is entitled to an appeals process from the
				FDA.
5.7.3 A facility cannot
				perform mammography services while an adverse accreditation decision is being
				appealed.
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 5.8 - Fees

Current through Register Vol. 48, No. 6, June 28, 2024
5.8.1 The Department shall assess each
				certified mammography facility an annual certification fee of one thousand
				thirty-one dollars ($1031.00) in accordance with
				RHB 2.11. This certification
				fee includes one (1) mammographic tube. The Department shall assess each
				certified mammography facility an additional fee of two hundred thirty-one
				dollars ($231.00) per mammographic tube for each additional tube.
5.8.2 The annual fee described in
				RHB 5.8.1 applies to both
				fully and provisionally certified mammography facilities.
5.8.3 A new mammography facility issued an
				initial provisional certificate during the calendar year shall be issued a
				prorated fee for the remainder of the year, in accordance with
				RHB 2.11.
5.8.4 All fees shall be due and payable in
				accordance with
				RHB 2.11.
5.8.5 Follow-up Inspection Fees
5.8.5.1 In the event that the Department
				deems a follow-up inspection necessary, an inspection fee of five hundred
				dollars ($500.00) shall be assessed upon the completion of the follow-up
				inspection.
5.8.5.2 The follow-up
				inspection invoice shall be issued in conjunction with the follow-up inspection
				report.
5.8.5.3 Payment of the
				follow-up inspection fee shall be due within thirty (30) calendar days of the
				date of the follow-up inspection fee invoice.
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 5.9 - Personnel Requirements

Current through Register Vol. 48, No. 6, June 28, 2024
The following requirements apply to all personnel involved in
				  any aspect of mammography, including the production, processing, and
				  interpretation of mammograms and related quality assurance activities:
5.9.1 Interpreting physicians. All physicians
				interpreting mammograms shall meet the following qualifications:
5.9.1.1 Initial qualifications. Unless the
				exemption in
				RHB 5.9.1.3 applies, before
				beginning to interpret mammograms independently, the interpreting physician
				shall:
5.9.1.1.1 Be a licensed physician to
				practice medicine in this state;
5.9.1.1.2 Be certified in diagnostic
				radiology by either the American Board of Radiology, the American Osteopathic
				Board of Radiology, or Royal College of Physicians and Surgeons of Canada, or
				have had at least three (3) months of documented formal training in the
				interpretation of mammograms and in topics related to mammography. The training
				shall include instruction in radiation physics, including radiation physics
				specific to mammography, radiation effects, and radiation protection. The
				mammographic interpretation component shall be under the direct supervision of
				a physician who meets the requirements of RHB 5.9.1 of this Part.
5.9.1.1.3 Have a minimum of sixty (60) hours
				of documented medical education in mammography, which shall include instruction
				in the interpretation of mammograms and education in basic breast anatomy,
				pathology, physiology, technical aspects of mammography, and quality assurance
				and quality control in mammography. All sixty (60) of these hours shall be
				Category I and have at least fifteen (15) hours of the Category I hours shall
				have been acquired within three (3) years immediately prior to the date that
				the physician qualifies as an interpreting physician. Hours spent in residency
				specifically devoted to mammography will be considered as equivalent to
				Category I continuing medical education credits and will be accepted if
				documented in writing by the appropriate representative of the training
				institution; and
5.9.1.1.4 Unless
				the exemption in
				RHB 5.9.1.3.2 applies, have
				interpreted or multi-read at least two hundred forty (240) mammograms
				examinations within the six (6)-month period immediately prior to the date that
				the physician qualifies as an interpreting physician. The interpretation or
				multi-reading shall be under direct supervision of a qualified interpreting
				physician.