Current through Register Vol. 48, No. 12, March 22, 2024
a) Each operator of
a Class D radiation installation shall utilize the services of an individual,
registered with the Agency pursuant to 32 Ill. Adm. Code 410, to implement and
maintain a comprehensive radiation protection program. Activities related to
diagnostic radiation producing machines shall be performed by a registered
diagnostic imaging specialist. Activities related to therapeutic radiation
machines shall be performed by a registered therapeutic radiological physicist.
Each operator shall ensure that registered individuals:
1) Conduct an annual performance evaluation
of all radiation machines.
2)
Determine and document in a report to the facility that the radiation machines
evaluated are being maintained and operated in accordance with standards
established by the Agency to protect the public health as set forth in 32 Ill.
Adm. Code: Chapter II, Subchapters b and d. Noncompliance items shall be
readily identified in the report.
3) Establish and oversee the
equipment-related quality assurance practices. Specifically, these quality
assurance practices shall include as a minimum:
A) For therapeutic radiation machines,
compliance with the quality assurance requirements specified in 32 Ill. Adm.
Code
360.110(d)
or
360.120(e).
B) For computed tomography machines,
compliance with the quality assurance requirements specified in 32 Ill. Adm.
Code
360.75.
C) For mammography machines, compliance with
the quality assurance requirements specified in 32 Ill. Adm. Code
370.100.
4) Establish and oversee a quality
assurance program for the film processors. The program shall include
specifications for processor cleaning and maintenance and procedures to ensure
the processor is optimized and properly maintained.
AGENCY NOTE: The Agency recommends daily sensitometry and
densitometry evaluation for processors used in facilities with heavy workloads.
However, the diagnostic imaging specialist or therapeutic radiological
physicist is the individual best qualified to determine the appropriate quality
assurance program for each processor, based on its workload and conditions of
use.
5) Users of digital
imaging acquisition systems shall follow a quality assurance/quality control
protocol for image processing established by the manufacturer and:
A) The registrant shall include the protocol
in its operating and safety procedures.
B) The registrant shall document the
frequency at which the quality assurance/quality control protocol is performed.
Documentation shall include the date and initials of the individual completing
the document and shall be maintained at the site where performed for inspection
by the Agency.
C) The protocol
shall include but not be limited to the following:
i) Cleaning and erasure of all imaging
plates;
ii) Quality control phantom
analysis;
iii) Evaluation of
repeat/retake x-ray examinations;
iv) Review of dose index values.
b) Each
operator of a Class D radiation installation shall maintain and have available
for review by the Agency:
1) Accurate and
thorough radiation machine evaluation reports.
2) Records of quality assurance testing
performed.
3) Records of
calibrations, maintenance or repair.
4) Records of corrective action taken for
items of non-compliance.
5) Records
of film processor cleaning and maintenance.
6) Records of digital imaging quality
control.
c) The records
and reports required by this Section shall be maintained for a period of at
least one inspection cycle.