S.C. Code Regs. § § 61-64.IV.RHB 4.4

Current through Register Vol. 48, No. 10, October 25, 2024

Section 61-64.IV.RHB 4.4 - Shielding

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.

4.4.2 Equipment Replacement.

4.4.2.1 A shielding plan is not required upon the replacement of an existing x-ray control or generator with like equipment and when there are no other changes which would render the original shielding plan inaccurate, as determined by a Class III, Class IV, Class VII, Class VIII, or Class IX vendor. The appropriate vendor shall notify the Department within thirty (30) calendar days of such replacement. Notification shall be made on the current version of the form provided by the Department and shall be exempt from RHB 2.3.2.

4.4.2.2 A shielding plan shall be required when a facility replaces an existing x-ray system. A shielding plan shall also be required when an x-ray control or generator is replaced with components with increased capabilities which would render the original shielding plan inaccurate, as determined by a Class III, Class IV, Class VII, Class VIII, or Class IX vendor, or when the original shielding plan is not available.

4.4.3 X-ray equipment shall not be installed or operated before a shielding plan for the unit has been reviewed and accepted by the Department. In addition, x-ray equipment shall be installed according to the accepted shielding plan. Deviations shall be documented in accordance with RHB 4.4.6.3 and 4.4.7.2.

4.4.4 Shielding Plan Requirements.

4.4.4.1 The registrant shall submit plans and a report, including any recommendations and all basic assumptions used, from the vendor to the Department. Applicable fees shall be submitted in accordance with RHB 2.3.2. In order for the Department to accept the submitted shielding plan, the information listed in Appendix B shall be submitted. The design considerations listed in Appendix C shall be followed.

4.4.4.2 Each installation shall be provided with such primary barriers and secondary barriers as are necessary to ensure compliance with RHB 3.3, RHB 3.4, and RHB 3.5. The requirement shall be deemed to be met if the thickness of such barriers is equivalent to the thickness as computed in accordance with the current version of the appropriate National Council of Radiation Protection and Measurements Reports as deemed by the Department.

4.4.4.3 All wall, floor, and ceiling areas exposed to the useful beam shall have primary barriers. Primary barriers in walls shall extend to a minimum height of 2.13 meters above the floor.

4.4.4.4 Secondary barriers shall be provided in all wall, floor, and ceiling areas not having primary barriers.

4.4.4.5 The operator's station at the control shall be behind a protective barrier either in a separate room, in a protected booth, or behind a shield which will intercept the useful beam and any radiation that has been scattered only once. The operator's station shall meet all applicable requirements of Appendix C of this Part.

4.4.4.6 Mobile and portable x-ray systems used in conjunction with a permanently installed cassette holder shall be considered a stationary radiographic system and shall meet the requirements for such an installation.

4.4.5 The acceptance of such plans shall not preclude the requirement of additional modifications should a subsequent analysis of operating conditions indicate the possibility of an individual receiving a dose in excess of the limits prescribed in Part III of this regulation.

4.4.6 Area Surveys. The registrant shall have a radiation area survey performed by a Class III, Class IV, Class VII, Class VIII, or Class IX vendor, registered with the Department.

4.4.6.1 The survey shall be submitted to the Department for review and shall include a scale drawing of the room indicating the composition of the walls, floor, ceiling, windows, and doors, and the placement of the x-ray equipment, including the table, control, and vertical cassette holder, if provided. If a film bin is used, the location and composition of the film bin shall also be included, if applicable. The survey shall include an evaluation of the adequacy of each protective barrier to include the ceiling and the floor, the operator's location, and if film is used, the film storage area. The survey shall include the date performed, the legible signature of the person performing the survey, and a certification that the shielding is adequate.

4.4.6.2 The survey shall be completed within thirty (30) calendar days of installation of the x-ray equipment. A copy of the radiation area survey shall be submitted to the Department within thirty (30) calendar days after the completion of the survey. The survey shall be submitted along with the completed, current version of forms provided by the Department.

4.4.6.3 Any deviation from the accepted shielding plan shall be documented and evaluated for adequacy.

4.4.6.4 The Department may determine that a survey is not required for some installations.

4.4.7 As-built Drawings.

4.4.7.1 After construction and installation are complete, the facility shall ensure that as-built drawings are submitted to the Department. The drawings shall indicate the composition of the walls, floor, ceiling, windows, and doors. The drawings shall indicate the placement of the x-ray equipment, including the table, control, and vertical cassette holder, if provided, as well as the location and composition of the film bin, if present.

4.4.7.2 A copy of the as-built drawing shall be submitted to the Department within thirty (30) calendar days after the date of installation of the x-ray equipment. The as-built drawing shall include the legible signature of the person submitting the drawing and the date it is submitted. The as-built drawings shall be submitted along with the completed, current version of forms provided by the Department.

4.4.7.3 Any deviation from the accepted shielding plan shall be documented and evaluated for adequacy by a Class III, Class IV, Class VII, Class VIII, or Class IX vendor.

4.4.8 Bone Density, Mammography, and Transportable Installations.

4.4.8.1 Bone Density and Mammography Installations. 4.4.8.1.1 Prior to installation of new or replacement equipment:

4.4.8.1.1.1 A shielding plan shall be submitted to the Department for review and acceptance or;

4.4.8.1.1.2 A written request shall be made by a Class III, Class VII, or Class IX vendor registered with the Department to perform a post-install survey in lieu of a shielding plan. All provisions of RHB 4.4.6 apply.

4.4.8.1.1.3 Notification shall be made on the current version of forms provided by the Department. Applicable fees shall be submitted in accordance with RHB 2.3.2.

4.4.8.2 Transportable X-ray Installations.

4.4.8.2.1 When transportable x-ray equipment is installed in the same location for thirty (30) calendar days, an area survey shall be performed in accordance with RHB 4.4.6.

4.4.8.2.2 Notification shall be made on the current version of forms provided by the Department. Applicable fees shall be submitted in accordance with RHB 2.3.2.

4.4.9 After installation of a radiation machine, the facility shall maintain for inspection by the Department:

4.4.9.1 A copy of the shielding plan, as required by RHB 4.4,

4.4.9.2 A copy of the Department's acceptance letter, and

4.4.9.3 A copy of the area survey or as-built drawing, as required by RHB 4.4.6 or 4.4.7.

S.C. Code Regs. § 61-64.IV.RHB 4.4

Replaced and amended by State Register Volume 40, Issue No. 06, eff. 6/24/2016; State Register Volume 47, Issue No. 05, eff. 5/26/2023.