Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 220 - Rules Relating to Radiation Protection › Part F - X-RAYS IN THE HEALING ARTS › Appendix 144-220-F-G - QUALITY ASSURANCE FOR FACILITIES PERFORMING DIAGNOSTIC X-RAY

Current through 2024-29, July 17, 2024
I. Introduction
A. Purpose
1. This rule describes a basic radiation safety/quality
					 assurance program and represents only a portion of the Quality Assurance tests
					 your facility may choose to perform as part of an individualized program. The
					 Department of Health and Human Services has implemented this program to reduce
					 radiation exposure and optimize diagnostic x-ray image quality. The goal to
					 assist facilities to be more actively involved and responsible for quality
					 assurance.
2. All hospitals, outpatient clinics, chiropractic, and
					 private medical facilities, to include State-approved screening programs, that
					 are performing diagnostic x-rays on humans, shall establish an active quality
					 assurance program. The QA program will be reviewed throughout the year and
					 inspected by the Department at the same frequency stated in section
					 F.3.C.
B. General Concepts
1. Quality control and quality assurance are not well
					 defined and are often incorrectly used. Quality control is a series of distinct
					 technical procedures, which ensure the production of a satisfactory product.
					 Its aim is to provide quality that is not only satisfactory and diagnostic, but
					 also dependable and economic.
2. Quality assurance is an all-encompassing program,
					 including quality control that extends to administrative, educational and
					 preventive maintenance methods. It includes a continuing evaluation of the
					 adequacy and effectiveness of the overall imaging program, with a view to
					 initiating corrective measures when necessary.
C. ALARA principle (As Low As Reasonably Achievable)
This QA requirement has been established on the ALARA
					 principle to assure that the benefits of using ionizing radiation exceeds the
					 risks to the individual and the public.
D. Authority.
This program is authorized by 22 MRS §674.
II. Radiation safety/quality assurance
					 programs
A. Radiation safety/quality assurance committee
1. Each diagnostic facility should establish a committee of
					 individuals to be responsible for radiation safety and quality assurance. The
					 committee should be composed of a minimum of one trained licensed professional,
					 the chief technologist, and/or the QC technologist. Other individuals, such as
					 hospital administrators and representatives of contracted service companies may
					 also be valuable.
2. This oversight committee shall convene on a frequency
					 adequate to meet their responsibilities, with a minimum of one meeting
					 annually. More frequent meetings will probably be important in the initial
					 stages of this program. The minutes of these meetings shall be kept for a
					 minimum of three years.
3. It is the responsibility of this committee to provide
					 direction to the program, assure that proper documentation and testing is
					 maintained, review the program's effectiveness and determine any changes which
					 should be made.
4. The committee shall establish a quality assurance manual
					 with assigned responsibilities recorded in the manual. The responsible
					 individuals must be properly instructed.
III. Quality assurance manual
A. Records facilities should include are:
1. List of the individuals or companies responsible for
					 testing, supervising and repairing/or servicing the equipment;
2. List of the tests to be performed and the frequency of
					 performance;
3. Acceptability limits for each test;
4. Description of the procedures to be used for each
					 test;
5. List of the equipment to be tested;
6. Protocol for correction;
7. Reference materials and their location;
8. List of the equipment to be used for testing;
9. Sample forms to be used for each test;
10. Committee organization and duties in writing;
11. Equipment records shall be maintained for each x-ray
					 room and mobile x-ray unit to include exposure ranges;
12. Processor and sensitometer logs to regulate proper
					 processor function to include preventive maintenance;
13. Radiation safety policies and procedures;
14. Repeat/reject analysis yearly;
15. Internal audit to self-assess the quality of
					 mammographic interpretations.
IV. General monitoring requirements for all
					 equipment
A. Each facility shall conduct the following tests, at the
					 frequency specified, and maintain records of the data. The type of tests and
					 the frequency of the tests may be modified if the facility can show that
					 alternate tests or schedules will assure good diagnostic image quality.
Daily
Processor - Speed, contrast, base + fog, solution
					 temperatures
Monthly
Replenishments rates, phantom image quality
					 check-mammography only
Semi-annually
Safelights
Interlocks
Viewboxes
Aprons, gloves and drapes
Annually
SID indicators
Film/screen contact
Exposure switches
Fluoroscopic image receptor/x-ray field alignment
Fluoroscopic image resolution
Fluoroscopic timers
Fluoroscopic tabletop rates
Pixel size - CT only
Noise - CT only
Linearity and contrast scale - CT only
Water value - CT only
Spatial uniformity -CT only
Scan width - CT only
Tabletop travel - CT only
Laser alignment - CT only
Dose measurements - CT only
Light field/x-ray field alignment
Positive beam limitation sizing
X-ray field/image receptor alignment
Tomographic equipment
* Radiographic Timers including AEC
* kVp - for all tubes
* mA linearity - for all tubes
* HVL - for all tubes
* Average glandular dose - mammography
* This test is to be conducted yearly for hospital and
					 non-hospital mammographic facilities. For all other radiographic facilities the
					 test frequency shall be the same as the mandatory inspection in accordance with
					 Part F.3.C.3.
V. Additional test for mammography
					 equipment
A. Mammographic equipment. Each mammographic facility shall
					 evaluate the following:
1. Image quality phantom to identify masses and
					 calcifications on a monthly basis. Mobile mammographic units shall perform
					 these tests after each relocation.
2. Average glandular dose calculation yearly.
3. Focal spot size measurement annually.