Ill. Admin. Code tit. 32, § 370.100 - Quality Assurance Requirements
Each facility shall establish and maintain a quality assurance program to ensure the safety, reliability, clarity and accuracy of mammography services performed at the facility.
a)
Responsible individuals. Responsibility for the quality assurance program and
for each of its elements shall be assigned to individuals who are qualified for
their assignments and who shall be allowed adequate time to perform these
duties.
1) Lead interpreting physician. The
facility shall identify a lead interpreting physician who shall have the
general responsibility of ensuring that the quality assurance program meets all
requirements of this Section and Sections
370.110,
370.120(b)
and (c) and
370.130
of this Part. No other individual shall be assigned or shall retain
responsibility for quality assurance tasks unless the lead interpreting
physician has determined that the individual's qualifications for, and
performance of, the assignment are adequate.
2) Interpreting physicians. All interpreting
physicians interpreting mammograms for the facility shall:
A) Follow the facility procedures for
corrective action when the images they are asked to interpret are of poor
quality; and
B) Participate in the
facility's medical outcomes audit program.
3) Medical physicist. Each facility shall
have the services of a medical physicist available to survey mammography
equipment and oversee the equipment-related quality assurance practices of the
facility. At a minimum, the medical physicist shall be responsible for
performing the surveys and mammography equipment evaluations and providing the
facility with the reports described in Section
370.110(i)
of this Part.
4) Quality control
technologist. Responsibility for all individual tasks within the quality
assurance program not assigned to the lead interpreting physician or the
medical physicist shall be assigned to a quality control technologist. The
tasks are to be performed by the quality control technologist or by other
personnel qualified to perform the tasks. When other personnel are utilized for
these tasks, the quality control technologist shall ensure that the tasks are
completed in such a way as to meet the requirements of Section
370.110
of this Part.
b)
Personnel quality assurance records. The lead interpreting physician, quality
control technologist and medical physicist shall ensure that records concerning
employee qualifications to meet assigned quality assurance tasks, mammography
technique and procedures, quality control (including monitoring data, problems
detected by analysis of that data, corrective actions and the effectiveness of
the corrective actions), safety, and protection are properly maintained and
updated. These quality control records shall be kept for each test specified in
Section
370.110
of this Part until the next annual inspection has been completed and the Agency
has determined that the facility is in compliance with the quality assurance
requirements or until the test has been performed two additional times at the
required frequency, whichever is longer.
Notes
Amended at 29 Ill. Reg. 20963, effective December 16, 2005
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