Code of Massachusetts Regulations
105 CMR - DEPARTMENT OF PUBLIC HEALTH
Title 105 CMR 127.000 - Licensing Of Mammography Facilities
Requirements
Section 127.018 - Quality Assurance Program
Universal Citation: 105 CMR 127.000 MA Code of Regs 127.018
Current through Register 1531, September 27, 2024
(A) General Provisions. The quality assurance program must include the following:
(1) The Responsible
Physician of each facility in which mammographic x-ray procedures are performed
shall establish and maintain an ongoing quality assurance program specific to
mammographic imaging, covering all components of the mammography facility, to
ensure consistently high-quality images with minimum patient
exposure.
(2) The Responsible
Physician shall conduct a review, at least annually, of the effectiveness of
the quality assurance program and maintain a written report of such review. The
most recent copy of such reports shall be available for inspection by
Department inspectors at the machine use location.
(3) The Medical Physicist has the
responsibility for establishing and conducting the ongoing equipment quality
assurance program, as specified in
105 CMR
127.019(C), including:
(a) Conducting the initial setup optimization
procedures on all the equipment used in producing mammograms prior to use on
patients;
(b) Conducting or
training others to conduct equipment performance monitoring
functions;
(c) Conducting or
training others to perform the analysis of the monitoring results to determine
if there are problems requiring correction; and
(d) Carrying out or arranging for the
necessary corrective actions, prior to continuing mammographic operations, when
quality assurance test results indicate the need.
(4) The Medical Physicist shall routinely
perform the equipment quality assurance measurements, when equipment is
initially installed, after major changes or replacement of parts, and according
to the frequency specified in
105 CMR
127.019.
(5) The licensee is responsible for ensuring
that the mammographic x-ray equipment under his or her jurisdiction has been
inspected and that quality assurance tests are performed by an individual as
indicated:
(a) Quality assurance tests
outlined in
105 CMR 127.019(C)
may be performed by a Medical
Physicist;
(b) Quality assurance
tests outlined in
105 CMR 127.019(C)(1)
through (4) and (10) may be performed by a
licensed Mammography Radiologic Technologist.
(6) Any individual who performs the quality
assurance tests required in
105 CMR 127.019(C)
shall verify in writing that the
mammographic x-ray equipment is in safe operating condition, and is being
operated at optimum performance criteria to yield the optimal quality mammogram
that is adequate for clinical requirements:
(a) Prior to initial use of the equipment;
and
(b) At least yearly after the
initial verification.
(B) Quality Assurance Procedures Manual. Each mammography x-ray facility shall have a Quality Assurance Procedures Manual. The Quality Assurance Procedures Manual shall include at least the following:
(1) List of names and
qualifications of individuals responsible for:
(a) Supervision;
(b) Performance of each of the quality
assurance tests; and
(c) Repairing
or servicing of mammographic x-ray equipment.
(2) Control limits or parameters of
acceptability for each quality assurance test.
(3) Brief description of the quality
assurance tests to be performed.
(4) Frequency of each quality assurance
test.
(5) Forms to be used for each
quality assurance test.
(6) A
protocol for correcting each quality assurance finding that does not fall
within the acceptable limits as specified in
105 CMR
127.017.
(7) A list of equipment to be used for
performing quality assurance tests.
Disclaimer: These regulations may not be the most recent version. Massachusetts may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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