C.M.R. 10, 144, ch. 220, pt. F, app 144-220-F-G
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.
C.M.R. 10, 144, ch. 220, pt. F, app 144-220-F-G