216 R.I. Code R. 216-RICR-40-20-4.10

Current through December 26, 2024

Section 216-RICR-40-20-4.10 - Quality Assurance Program

4.10.1Quality Assurance

A. Except where otherwise specified by the provisions of §4.10.1(A)(7) of this Part, all registrants of diagnostic X-ray imaging equipment shall establish and maintain a quality assurance program consisting of quality control assessments addressing at least the following items:

1. Administration

a. Written standard operating procedures on radiation protection are reviewed and updated by management at intervals not to exceed twelve (12) months (± thirty (30) days);

b. Employee review and written acknowledgement of standard operating procedures and policies on radiation protection at intervals not to exceed twelve (12) months (± thirty (30) days);

c. Maintenance of documentation of minimum qualifications for practitioners, medical physicists, and X-ray equipment operators; and d. Record retention in accordance with applicable Rhode Island statutes and Regulations, but in no case less than three (3) years.

2. Image Processing

a. Facilities Using Analog Image Receptors

(1) Facilities shall establish and implement a quality assurance program for X-ray film developing, whether developing is manual or automatic, in accord with the recommendations of a Qualified Medical Physicist, the system manufacturer, or a nationally recognized organization.

(2) Facilities other than dental, podiatry, and veterinary shall have a continuous and documented sensitometric quality control program, including quality control tests for speed, contrast and fog. These tests shall be performed according to specifications of a Qualified Medical Physicist, the manufacturer, or a nationally recognized organization.

b. Facilities Using Computed Radiography (CR) or Direct Digital Radiography (DDR).

(1) Facilities shall establish and follow an image quality control program in accordance with the recommendations of a Qualified Medical Physicist, the system manufacturer, or a nationally recognized organization;

(2) Facilities other than dental, podiatric and veterinary, shall quarterly complete phantom image evaluation using a phantom approved by a Qualified Medical Physicist, system manufacturer, or the Agency. At a minimum the analysis shall include: artifacts, spatial resolution, contrast/noise, workstation monitors, and exposure indicator constancy.

c. Dental Facilities

(1) Facilities using analog image receptors shall maintain a lighttight darkroom, use proper safelighting and safeguards, and evaluate darkroom integrity and daylight loading systems for film fog every six (6) months and after a change that may impact film fog.

(2) Facilities using a filmless system shall maintain and operate PSP and DDR systems according to manufacturer specifications.

3. Radiographic Equipment

a. Facilities other than dental, podiatry, and veterinary shall have their digital radiographic systems evaluated by a Qualified Medical Physicist prior to initial clinical use after installation or relocation and by or under the direction of a Qualified Medical Physicist at intervals not to exceed twelve (12) months (± thirty (30) days) unless otherwise determined by the Agency. The evaluation shall follow nationally recognized procedures or those recognized by the Agency and shall include a review of any required QC tests.

b. Dental, podiatry, and veterinary facilities shall have their digital radiographic systems evaluated by a Qualified Medical Physicist prior to initial clinical use after installation or relocation. The evaluation shall follow nationally recognized procedures or those recognized by the Agency.

c. Measurement of the radiation output shall be performed at a specified distance and over a range of clinical kVp values and shall be made at intervals not to exceed twelve (12) months (± thirty (30) days) or after any maintenance of the system which might affect the radiation output. These measurements shall be performed in-air with minimum scatter conditions. Results of the measurements shall include the µGy/mAs (mR/mAs), as well as the technique factors used to determine such results.

(1) These measurements may be used to estimate entrance skin exposure (ESE) for the average adult patient for selected routine radiographic procedures. These values should be compared with available national reference values.

(2) The name and signature of the Qualified Medical Physicist performing the measurements, and the date the measurements were performed, shall be included in the results.

4. Fluoroscopic Equipment

a. Fluoroscopic equipment shall be evaluated by a Qualified Medical Physicist within thirty (30) days of installation and of any maintenance of the system that may affect the exposure rate. Thereafter, the measurements shall be made annually or at intervals not to exceed twelve (12) months (± thirty (30) days) from the date of the prior measurement by or under the direction of a Qualified Medical Physicist. The evaluation shall include a review of any required QC tests. At a minimum these evaluations shall include:

(1) A measurement of entrance exposure rates that covers the full range of patient thicknesses, including those that are expected to drive the system to maximum output in all modes clinically used, including fluoroscopy, high-level control, acquisition, digital subtraction and CINE, when available. For systems without automatic exposure control, these measurements shall be made utilizing a milliamperage and kVp typical of the clinical use of the fluoroscopic system. For systems with automatic exposure control, these measurements shall be made utilizing sufficient attenuating material in the useful beam to produce a milliamperage and kVp typical of the clinical use of the fluoroscopic system.

(2) A measurement and verification of compliance of maximum AKR for fluoroscopy and high-level control, if available. Measurements shall be made in accordance with §4.5.7(A) of this Part.

(3) An evaluation of high contrast resolution and low contrast resolution in both fluoroscopic and spot-film modes.

(4) An evaluation of the operation of the five (5) minute timer, warning lights, interlocks, and collision sensors.

(5) An evaluation of the beam quality and collimation in the fluoroscopy and spot-film modes.

(6) An evaluation of the availability and accuracy of technique indicators and integrated radiation dose displays.

(7) An evaluation of any changes that may impact patient and personnel protection devices.

b. Results of these measurements shall be posted where any fluoroscopist may have ready access to such results during the fluoroscopic procedure and in the record required in §4.3.13(A)(5) of this Part. Results of the measurements shall include the mGy per minute (R/min exposure rate), as well as the technique factors used to determine such results. The name of the Qualified Medical Physicist performing the measurements and the date the measurements were performed shall be included in the results.

5. Computerized Tomography Equipment

a. The evaluation of a CT X-ray system shall be performed after initial installation and before use on human patients, and at intervals not to exceed twelve (12) months (± thirty (30) days). In addition, the Qualified Medical Physicist shall complete an evaluation of the CT system within thirty (30) days or after any change or replacement of components which, in the opinion of the Qualified Medical Physicist, could cause a change in the radiation output or image quality;

b. The annual testing of the CT X-ray system shall be performed by, or under the personal supervision of, a Qualified Medical Physicist who assumes the responsibility and signs the final performance evaluation report;

c. Evaluation standards and tolerances shall be established by the Qualified Medical Physicist and maintained by the facility. These standards and tolerances shall meet nationally recognized standards and tolerances for the CT X-ray system;

d. The evaluation shall include but not be limited to:

(1) Geometric factors and alignment including alignment light accuracy and table increment accuracy;

(2) Image localization from scanned projection radiograph (localization image);

(3) Radiation beam width;

(4) Image quality including high-contrast (spatial) resolution and low-contrast resolution

(5) Image uniformity;

(6) Noise;

(7) Artifact evaluation;

(8) CT number accuracy;

(9) Image quality for acquisition workstation display devices;

(10) A review of the results of the routine QC required under §4.7.3(B) of this Part;

(11) A safety evaluation of audible and visual signals, posting requirements;

(12) Dosimetry.

e. Cone Beam CT (CBCT) Systems

(1) Facilities other than dental shall have an evaluation performed by, or under the direct supervision of, a Qualified Medical Physicist. The evaluation shall follow nationally recognized standards and tolerances or those recognized by the Agency. The evaluation shall be performed within thirty (30) days of initial installation, at intervals not to exceed twelve (12) months (± thirty (30) days), and within thirty (30) days after any change or replacement of components which, in the opinion of the Qualified Medical Physicist, could cause a change in the radiation output or image quality. The facility shall maintain documentation of the established standards and tolerances and testing results. Exemption. A Qualified Medical Physicist performance evaluation on CBCT systems capable of operating at no greater than one hundred (100) kV or twenty (20) mA shall be performed at intervals not to exceed twenty-four (24) months, or an interval approved by the Agency.

(2) Facilities other than dental shall follow the QC recommendations provided by the CBCT manufacturer. In the absence of manufacturer provided QC recommendations, the registrant shall implement and document QC guidelines established by a Qualified Medical Physicist in accordance with nationally recognized guidelines or those recognized by the Agency.

(3) Dental facilities shall have an evaluation performed by, or under the direct supervision of, a Qualified Medical Physicist. The evaluation shall be performed within thirty (30) days of initial installation, at intervals not to exceed twelve (12) months (± thirty (30) days), and within thirty (30) days after any change or replacement of components which, in the opinion of the Qualified Medical Physicist, could cause a change in the radiation output or image quality. The evaluation shall include, at a minimum, the following elements (if applicable to the CBCT system):

Test	Standard
Scan Increment Accuracy	±1 mm
Scan Localization Light Accuracy	±5 mm
Patient Dose	CBCT equipment manufacturer's specifications and scan protocol or phantom manufacturer' s specifications
Pre-Patient Collimation Accuracy	Manufacturer' s specifications
Contrast Scale	CBCT equipment or phantom manufacturer' s specifications
CT Number for Water	CBCT equipment or phantom manufacturer' s specifications
Slice Thickness	CBCT equipment or phantom manufacturer' s specifications
Field Uniformity	CBCT equipment or phantom manufacturer' s specifications
Low Contrast Resolution	CBCT equipment or phantom manufacturer' s specifications
High Contrast Resolution	CBCT equipment or phantom manufacturer' s specifications
Noise	CBCT equipment or phantom manufacturer' s specifications
Scan Protocol Review	As required by §4.3.4 of this Part
Review of facility and technologist's QC test	Review QC tests for proper procedure and corrective action
Medical physicist report and recommendations	Communicate results and recommendations to registrant

6. DXA Systems

a. Conform to the DXA system manufacturer recommendations and recommendations of recognized professional societies such as the International Society for Clinical Densitometry or the American College of Radiology.

7. Clarification of required quality assurance program elements for certain mammography X-ray facilities.

a. The requirements in § 4.10 of this Part do not pertain to diagnostic X-ray imaging equipment subject to the Mammography Quality Standards Reauthorization Act of 1998, Pub. Law 105-248, and 21 C.F.R. Part 900.

4.10.2Availability of Quality Assurance Program

The registrant shall establish and maintain written quality assurance (QA) and quality control (QC) procedures, including evaluation frequencies and tolerances. The QA/QC procedures shall be available for review by the Agency.

4.10.3Implementation of Quality Assurance Program

A. The registrant shall designate an appropriately trained individual to manage the quality assurance program. Quality control assessments for §§4.10.1(A)(2), (3), (4) and (5) of this Part shall be conducted by, or under the direction of, a Qualified Medical Physicist.

B. A Qualified Medical Physicist shall determine the frequency and nature of QA/QC procedures, except when the frequency for a specific QA/QC procedure is defined by this Subchapter.

C. A Qualified Medical Physicist shall perform a review of the Quality Assurance Program at an interval not to exceed twelve (12) months (± thirty (30) days) and shall provide a written report which documents the results of this review.

D. The registrant shall maintain documentation showing the testing instruments used in determining compliance with the provisions of this Part are properly calibrated in accordance with §4.4.13 of this Part and maintained in accordance with the Agency minimum standard or accepted professional standards when no Agency minimum is defined.

E. The registrant shall perform repeat/reject analysis of radiographic images at least quarterly following specifications of a nationally recognized organization.

F. The registrant shall complete preventative maintenance on the X-ray systems in accordance with manufacturer specifications at intervals not to exceed twelve (12) months.

G. The registrant shall check each study for artifacts. If an artifact is present, the source shall be identified, and appropriate action taken.

H. The registrant shall retain QA/QC records of evaluations and reviews in accordance with applicable provisions of the Rhode Island General Laws and this Subchapter, but in no case less than three (3) years.

I. Exemptions

1. Dental facilities. Dental facilities performing only intra-oral, panoramic, cephalometric or volumetric dental imaging are exempt from the following provisions of §§ 4.3 and 4.10.3 of this Part:

a. §4.3.1(C) of this Part - information available to referring physician;

b. §4.10.3(E) of this Part - repeat analysis

2. Podiatry facilities. Podiatry facilities are exempt from the following provisions of §§ 4.3 and 4.10.3 of this Part:

a. §4.3.1(C) of this Part - information available to referring physician;

b. §4.10.3(E) of this Part - repeat analysis

3. Veterinary facilities. Veterinary facilities are exempt from the following provisions of §§ 4.3 and 4.10.3 of this Part:

a. §4.3.1(C) of this Part - information available to referring physician;

b. §4.3.1(D) of this Part - use of reference levels;

c. §4.3.1(E) of this Part - use of dose reduction techniques;

d. §4.3.1(F) of this Part - patient identification;

e. §4.3.6(A)(3) of this Part (routine holding of patient);

f. §§4.3.10(E)(8)(a) through (c) of this Part - use of sensitometric equipment;

g. §4.3.12 of this Part - healing arts screening); and

h. §4.10.3(E) of this Part - repeat analysis.

216 R.I. Code R. 216-RICR-40-20-4.10

Adopted effective 1/1/2019
Amended effective 5/25/2022
Amended effective 11/28/2023