216-40-20 R.I. Code R. § 3.5

Current through June 20, 2024

Section 216-RICR-40-20-3.5 - General Regulatory Requirements

3.5.1Shielding Plan Review

A. Except as otherwise provided in §3.5.1(C) of this Part, all new X-ray equipment (as defined by Part 4 of this Subchapter, Diagnostic X-Rays and Associated Imaging Systems in the Healing Arts) facilities and modifications of existing X-ray equipment facilities utilizing ionizing radiation machines shall require shielding plan review by the Agency.

B. Prior to construction, the floor plans, shielding specifications, and equipment arrangement shall be submitted to the Agency for review and approval. The required information for all ionizing radiation machines, except therapeutic radiation machines, is denoted in § 3.13 of this Part. The required information for therapeutic radiation machines is contained in § 5.13 of this Subchapter.

C. The Agency may require the applicant to utilize the services of a person registered to provide General Radiation Physics Services in developing the information required by § 3.13 of this Part.

D. Shielding plan review by the Agency is not required for the following type of X-ray equipment facilities:

1. Any type of X-ray equipment which provides sufficient self-shielding to reduce the radiation levels at all external surfaces of the equipment below those levels required by §§1.7.1, 1.7.7 and 1.8.1 of this Subchapter.

2. Any X-ray equipment facility performing only dental intraoral and/or panoramic procedures whose estimated workload has been evaluated in accordance with NCRP Report 145 ["Radiation Protection in Dentistry" (2003)], and it has been documented that existing structural configuration will provide sufficient shielding to reduce the radiation levels to those required by §§1.7.1, 1.7.7 and 1.8.1 of this Subchapter.

3.5.2Submission of Application

A. Each person who owns or possesses and administratively controls an X-ray equipment facility, unless specifically exempted in § 3.3 of this Part, shall apply for registration of such facility with the Agency prior to the operation of an X-ray equipment facility. Application for registration shall be completed on forms furnished by the Agency and shall contain all the information required by the form and accompanying instructions, including a designated e-mail address for receipt of official Agency correspondence in electronic format. The issuance of a Certificate of Registration for an X-ray equipment facility shall not preclude the Agency from subsequently reassigning the registered X-ray equipment to a more appropriate registration category and/or requiring the facility to periodically reregister all X-ray equipment at the facility. The registration category for an X-ray equipment facility will be determined in accordance with the provisions of §15.4.6 of this Subchapter.

B. Designation of Individual Responsible for Radiation Protection. An individual to be responsible for radiation protection shall be designated on each application form. The qualifications of that individual shall be submitted to the Agency with the application. The Radiation Safety Officer (RSO) shall meet the applicable requirements of § 3.15 of this Part and carry out the responsibilities in § 3.16 of this Part.

C. Designation of Facility Supervisor

1. An individual responsible for directing the operation of the X-ray equipment facility shall be designated on each application form.

2. The designation of a licensed practitioner of the healing arts shall be required on each healing arts application.

3. The designation of an individual licensed in accordance with R.I. Gen. Laws Chapter 5-25 to engage in veterinary medicine shall be required on each veterinary medicine application.

D. Additional Requirements for Medical Research on Humans. In addition to the requirements of §§3.5.2(A), (B) and (C) of this Part, the applicant shall submit, as a minimum, the following information:

1. A detailed description of the proposed medical research, including a copy of the form that will be used to obtain informed consent from the human subjects and an evaluation of the potential radiation exposure to individuals participating in the medical research; and

2. The following documentation:

a. Documentation that the research is conducted, funded, supported, or regulated by a Federal Agency which has implemented the Federal Policy for the Protection of Human Subjects; or

b. Documentation of prior review and approval of the research activities by an "Institutional Review Board" as required by 45 C.F.R. Part 46 and 21 C.F.R. Part 56.

E. Additional Requirements for Mobile Service Operations. In addition to the requirements of §§3.5.2(A), (B) and (C) of this Part, the applicant shall submit the following information:

1. The location where the X-ray equipment, records, etc. will be maintained for inspection. This shall be a street address, not a post office box number.

2. A sketch or description of the normal configuration of each radiation machine's use, including the operator's position and any ancillary personnel's location during exposures. If a mobile van is used with a fixed unit inside, furnish the floor plan indicating protective shielding and the operator's location; and

3. A current copy of the applicant's operating and safety procedures including radiological practices for protection of patients, operators, employees, and the general public.

F. Signature. Each application shall be signed by the applicant or a person duly authorized to act on their behalf.

3.5.3Shielding Evaluation Required

A. Prior to routine use, but in no case later than thirty (30) days subsequent to installation of the radiation producing equipment and/or modification of the existing facility, the shielding shall be reviewed and evaluated by a person registered with the Agency to provide General Radiation Physics Services.

B. A written report of the shielding evaluation shall be provided to the facility within ten (10) days of the evaluation. The report shall specifically address any shielding and/or radiation protection deficiencies that were discovered during the evaluation and shall include recommendations for correcting these deficiencies. Any noted deficiencies shall be adequately addressed by the facility.

C. Facilities shall provide the Agency with a copy of the shielding evaluation report within ten (10) days of receipt of said report.

D. An Agency finding that an X-ray equipment facility meets appropriate radiation protection standards shall not preclude the requirement of additional modifications, should a subsequent analysis of operating conditions and/or a radiation survey indicate that an individual is likely to receive a dose in excess of the limits prescribed in §§1.7.1, 1.7.7 and 1.8.1 of this Subchapter.

E. Retention of Information Used to Develop Shielding Plan. After installation of radiation producing equipment, the registrant shall maintain for inspection by the Agency:

1. The maximum rated technique factors of each machine;

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:

a. 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; or

b. The type and thickness of materials, or lead equivalency, of each protective barrier.

3. All information required by §3.5.3(E) of this Part shall be retained until disposal is authorized by the Agency. All required information shall be retained in an active file from at least the time of generation until the next Agency inspection. Information generated prior to the last Agency inspection may be microfilmed or otherwise archived as long as a complete copy of said information can be retrieved until such time as the Agency authorizes final disposal.

216 R.I. Code R. § 216-RICR-40-20-3.5

Adopted effective 1/1/2019
Amended effective 5/25/2022