16 Del. Admin. Code § 4465-B-5.0
Current through Register Vol. 28, No. 7, January 1, 2025
Section 4465-B-5.0 - Shielding Plan Review5.1 Radiation machine facilities proposed for construction, renovation, or equipment installation after the effective date of this regulation that are designed to house x-ray machines with the potential to generate radiation dose to members of the public equal to or greater than 100 millirem per year, or expose a member of the public to an exposure rate equal to or greater than 2 milliroentgen per hour shall be required to submit a radiation shielding plan prepared by a Qualified Expert who is registered with the Office of Radiation Control as a Radiation Service Provider (see Section 9.0 of this part). 5.1.1 Radiation Machine Facilities or rooms which require a shielding plan include the following modalities: | * | Dental panoramic or cephalometric x-ray |
| * | Dental Cone Beam Computed Tomography (CT) |
| * | Stationary radiographic or fluoroscopic x-ray |
| * | Mobile x-ray machine used routinely in one location |
| * | Computed Tomography (CT) scanner |
| * | Linear Accelerator or other therapy machine |
5.2 New radiation machine facilities or rooms designed to house only x-ray machines that operate at maximum energy less than or equal to 70 kVP shall be exempt from the radiation shielding plan requirement; such devices include but are not limited to the following modalities: 5.2.1 Radiation Machine Facilities or rooms which generally do not require a shielding plan include the following modalities: | * | Dental intraoral (eg. bitewing, periapicals) |
| * | Mini C-Arm (eg. Orthopedic) |
5.3 Prior to construction, the floor plans, shielding specifications and equipment arrangement of all new installations, or modifications of existing installations utilizing ionizing radiation sources with maximum energy greater than 70 kVP shall be submitted to the Division of Public Health Office of Engineering for review and approval. The required information is listed in Appendices A and B of this Part and Regulation 4465 Part X, Appendix A, for radiation therapeutic sources.5.4 The Agency shall require the applicant to utilize the services of a Qualified Expert who is registered with the Agency see Section 9.0 of this Part to determine the shielding requirements prior to the plan review and approval. The registered consultant shall provide the shielding information on Form R15A or equivalent to the Office of Engineering, Division of Public Health, which will review the shielding plan and if determined acceptable, will issue a Certificate of Approval to Construct letter to the applicant.5.5 The issuance of a Certificate of Approval to Construct by the Office of Engineering for radiation shielding 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 Regulations 4465 Part D, Sections 6.0, 11.0, 12.0, and 13.0 of these regulations.5.6 The Office of Radiation Control, Division of Public Health shall conduct a pre-operational, on-site inspection to evaluate shielding and/or operating conditions prior to issuance of the radiation machine registration permit and Certificate of Approval to Operate.5.7 The Certificate of Approval to Operate issued by the Office of Radiation Control reflects regulatory compliance at the time of the pre-operational inspection of a new facility, and does not imply or certify the facility beyond the scope of that specific inspection.5.8 After installation of any radiation machine, the registrant shall maintain for inspection by the Agency: 5.8.1 The maximum rated technique factors of each machine;5.8.2 A scale drawing of the room in which a stationary radiation machine system is located with such drawing indicating the use of areas adjacent to the room and an estimation of the extent of occupancy by an individual in such areas. In addition, the drawing shall include: 5.8.2.1 The results of a survey for radiation levels present at the operator's position and at pertinent points outside the room at specified test conditions; or5.8.2.2 The type and thickness of materials, or lead equivalency, of each protective barrier.5.9 Radiation machine facilities that initiated design, construction or installation of dental panoramic, cephalometric, or cone beam CT devices prior to the effective date of this regulation shall maintain records of radiation surveys of exposure rate (milliroentgen per hour) levels present in uncontrolled public areas (ie. corridors or alcoves) where members of the public or employees may be present in the facility. If such surveys indicate an exposure rate equal to or greater than 2 millroentgen per hour is possible in uncontrolled public areas while x-ray equipment is in operation the facility shall provide administrative controls to limit the dose to members of the public with a visible barrier to delineate the controlled area.16 Del. Admin. Code § 4465-B-5.0
17 DE Reg. 983(4/1/2014)
22 DE Reg. 401( 11/1/2018) (Final)