LESSON 2
FEDERAL AND MILITARY REGULATIONS
2-1.
PURPOSE
How can we know when we have an excellent quality assurance program? We
follow some guidelines in order to standardize the established limits. How such a
program can be implemented has been outlined in detail in several regulations and, by
looking at these regulations, we can gain a better insight into the program. The federal
government has published recommendations for quality assurance programs in
diagnostic imaging facilities. In addition, most of the professional societies are
endorsing quality control and are publishing guidelines for quality assurance programs.
The Federal Title 21 presents guidelines that apply to all diagnostic radiology facilities,
but the regulation has no enforcement power. So, the Army incorporates the Title 21
guidelines into its Technical Bulletin (TB) MED 521, which does have enforcement
powers. We can see how both of these documents are important influences in all the
military quality assurance programs.
2-2.
TITLE 21, CODE OF FEDERAL REGULATIONS
a. Title 21 Guidelines. Title 21, Code of Federal Regulations (CFR) guidelines
are applicable to all diagnostic radiology facilities.
b. Definitions Representative of the Title 21, Code of Federal Regulations.
(1) Diagnostic radiology facility uses an x-ray system in any procedure
involving irradiation of any part of the human body for diagnosis or visualization.
(2) Quality assurance means planned and systematic actions to certify that
the diagnostic radiology facility will produce consistently high quality images with
minimum exposure to patients and personnel.
(3) A quality assurance program is organized and designed to provide
quality assurance for the diagnostic radiology facility.
(4) Quality control techniques are used to monitor (or test) and maintain
components of the x-ray system (concerned directly with the equipment).
(5)
Quality assurance administration procedures are intended to guarantee
that:
(a) Monitoring techniques are properly performed and evaluated.
(b) Necessary corrective measures are taken in response to the
monitoring results.
MD0062
2-2
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