216 R.I. Code R. 216-RICR-40-20-5.4

Current through December 26, 2024

Section 216-RICR-40-20-5.4 - General Technical Requirements for Facilities Using Therapeutic Radiation Machines

5.4.1Shielding and Safety Designs Requirements

A. Each therapeutic radiation machine subject to §§ 5.6, 5.7, 5.8, 5.12 or 5.13 of this Part must be provided with such primary and/or secondary barriers as are necessary to ensure compliance with Part 1 of this Subchapter.

1. Facility shielding and safety designs must be performed in accordance with current published recommendations from a recognized national professional association with expertise in the use of therapeutic radiation technologies; and

2. By, or under the direction of, a Qualified Medical Physicist or a Medical Health Physicist.

3. Facility design information for all new installations of a therapeutic radiation machine, or installations of a therapeutic radiation machine of a different model with a different isocenter or higher energy or workload into a room not previously approved for that energy or isocenter or planned workload, must be submitted for Agency approval prior to actual installation of the therapeutic radiation machine. The minimum facility design information that must be submitted is contained in § 5.14 of this Part.

B. Radiation Shielding Surveys

1. The registrant must ensure that radiation shielding surveys of all new facilities, and existing facilities not previously surveyed are performed:

a. With an operable radiation measurement survey instrument calibrated in accordance with § 5.11 of this Part; and

b. In accordance with current published recommendations from a recognized national professional association with expertise in the use of therapeutic radiation technologies. In the absence of a protocol published by a recognized national professional association, the manufacturer's protocol or equivalent quality, safety, and security protocols, must be followed; and

c. By, or under the direction of, a Qualified Medical Physicist or a Medical Health Physicist; and

d. Must verify that radiation levels in restricted and unrestricted areas are not likely to cause personnel exposures in excess of the limits specified in Part 1 of this Subchapter.

C. In addition to the requirements of §5.4.1(A) of this Part, a radiation shielding survey must also be performed prior to any subsequent medical use and:

1. After making any change in the treatment room shielding;

2. After making any change in the location of the therapeutic radiation machine within the treatment room;

3. After replacing or relocating the therapeutic radiation machine; or

4. Before using the therapeutic radiation machine in a manner that could result in increased radiation levels in areas outside the external beam radiation therapy treatment room.

D. The survey record must indicate all instances where the facility, in the opinion of the Qualified Medical Physicist or Medical Health Physicist, is in violation of applicable regulations. The survey record must also include the date of the measurements, the reason the survey is required, the manufacturer's name, model number and serial number of the therapeutic radiation machine, the instrument(s) used to measure radiation levels in accordance with § 5.11 of this Part, a plan of the areas surrounding the treatment room that were surveyed, the measured dose rate at several points in each area expressed in microsieverts or millirems per hour, the calculated maximum level of radiation over any one (1) hour for each restricted and unrestricted area, the calculated maximum level of radiation over a period of one (1) week for each restricted and unrestricted area, the signature of the individual responsible for conducting the survey, and date signed.

E. If the results of the surveys required by §§5.4.1(A) or (B) of this Part indicate any radiation levels in excess of the respective limit specified in §5.4.1(A) of this Part, the registrant must lock the control in the "OFF" position and not use the unit:

1. Except as may be necessary to repair, replace, or test the therapeutic radiation machine, the therapeutic radiation machine shielding, or the treatment room shielding; or

2. Until the registrant has received a specific exemption from the Agency.

5.4.2Modification of Radiation Therapy Unit or Room Before Beginning a Treatment Program

A. If the survey required by §5.4.1 of this Part indicates that an individual in an unrestricted area may be exposed to levels of radiation greater than those permitted by § §1.8.1(A) and (B) of this Subchapter, before beginning the treatment program the registrant must:

1. Either equip the unit with beam direction interlocks or add additional radiation shielding to ensure compliance with §§1.8.1(A) and (B) of this Subchapter;

2. Perform the survey required by §5.4.1 of this Part again; and

3. Include in the report required by §5.4.4 of this Part the results of the initial survey, a description of the modification made to comply with §5.4.2(A) of this Part and the results of the second (2nd) survey; or

4. Request and receive a registration amendment that authorizes radiation levels in unrestricted areas greater than those permitted by §§1.8.1(A) and (B) of this Subchapter.

5.4.3Radiation Measuring Equipment

The registrant must have appropriate and operable radiation measuring equipment available for use and calibrated in accordance with § 5.11 of this Part. Radiation measuring equipment includes, but is not limited to, dosimetry systems, survey instruments, and other radiation measuring devices used in planning, guiding, and administering radiation.

5.4.4Reports of External Beam Radiation Therapy Surveys and Measurements

The registrant for any therapeutic radiation machine subject to §§ 5.6, 5.7, 5.8, 5.12 or 5.13 of this Part must furnish a copy of the records of surveys required in §§5.4.1 and 5.4.2 of this Part to the Agency within thirty-six (36) days following completion of the action that initiated the record requirement.

216 R.I. Code R. 216-RICR-40-20-5.4

Adopted effective 1/1/2019
Amended effective 5/25/2022
Amended effective 11/27/2023