Illinois Administrative Code › Title 32 - ENERGY › Part 370 - QUALITY STANDARDS AND CERTIFICATION REQUIREMENTS FOR FACILITIES PERFORMING MAMMOGRAPHY › Section 370.20 - Definitions

Current through Register Vol. 48, No. 28, July 12, 2024
As used in this Part, the following definitions apply:
"Accreditation body" or "body" means an entity that has been
				approved by FDA to accredit mammography facilities.
"Action limits" or "action levels" means the minimum and
				maximum values of a quality assurance measurement that can be interpreted as
				representing acceptable performance with respect to the parameter being tested.
				Values less than the minimum or greater than the maximum action limit or level
				indicate that corrective action shall be taken by the facility. Action limits
				or levels are also sometimes called control limits or levels.
"Adverse event" means an undesirable experience associated with
				mammography activities that include but are not limited to:
Poor image quality;
Failure to send mammography reports within 30 days to the
				referring physician or in a timely manner to the self-referred patient;
				and
Use of personnel that do not meet the requirements of Section
				370.70 of
				this Part.
"Agency" means the Illinois Emergency Management Agency.
"Air kerma" means kerma in a given mass of air. The unit used
				to measure the quantity of air kerma is the Gray (Gy). For x-rays with energies
				less than 300 kiloelectronvolts (keV), 1 Gy = 100 rad.
"Breast implant" means a prosthetic device implanted in the
				breast.
"Calendar quarter" means any one of the following time periods
				during a given year: January 1 through March 31, April 1 through June 30, July
				1 through September 30 or October 1 through December 31.
"Category I" means medical educational activities that have
				been designated as Category I by the Accreditation Council for Continuing
				Medical Education (ACCME), the American Osteopathic Association (AOA), a state
				medical society or an equivalent organization.
"Certificate" means the certificate described in Section
				370.50
				of this Part.
"Certification" means the process of approval of a facility by
				the Agency to provide mammography services.
"Clinical image" means a mammogram.
"Consumer" means an individual who chooses to comment or
				complain in reference to a mammography examination, including the patient or
				representative of the patient (e.g., family member or referring
				physician).
"Continuing education unit" or "continuing education credit"
				means one contact hour of training.
"Contact hour" means an hour of training received through
				direct instruction.
"Diagnostic mammography" means mammography performed on a
				patient with: clinical signs, symptoms or physical findings suggestive of
				breast cancer;
an abnormal or questionable screening mammogram;
a history of breast cancer with breast conservation surgery
				regardless of absence of clinical breast signs, symptoms or physical findings;
				or
augmented breasts regardless of absence of clinical breast
				signs, symptoms or physical findings.
AGENCY NOTE: Diagnostic mammography is also called
				problem-solving mammography or consultative mammography. This definition
				excludes mammography performed during invasive interventions for localization
				or biopsy procedures.
"Direct instruction" means:
Face-to-face interaction between instructor and students, as
				when the instructor provides a lecture, conducts demonstrations or reviews
				student performance; or
The administration and correction of student examinations by an
				instructor with subsequent feedback to the students.
"Direct supervision" means that:
During joint interpretation of mammograms, the supervising
				interpreting physician reviews, discusses, and confirms the diagnosis of the
				physician being supervised and signs the resulting report before it is entered
				into the patient's records; or
During the performance of a mammography examination or survey
				of the facility's equipment and quality assurance program, the supervisor is
				present to observe and correct, as needed, the performance of the individual
				being supervised who is performing the examination or conducting the
				survey.
"Director" means the Director of the Illinois Emergency
				Management Agency.
"Established operating level" means the value of a particular
				quality assurance parameter that has been established as an acceptable normal
				level by the facility's quality assurance program.
"Facility" or "mammography installation" means a hospital,
				outpatient department, clinic, radiology practice, mobile unit, office of a
				physician or other facility that conducts mammography activities, including
				operation of equipment to produce a mammogram, processing of the mammogram,
				initial interpretation of the mammogram and maintaining viewing conditions for
				that interpretation.
"First allowable time" means the earliest time a resident
				physician is eligible to take the diagnostic radiology boards from an
				FDA-designated certifying body.
"FDA" means the U.S. Food and Drug Administration.
"Interim regulations" means the regulations entitled
				"Requirements for Accrediting Bodies of Mammography Facilities" (58 FR
				67558-67565) and "Quality Standards and Certification Requirements for
				Mammography Facilities" (58 FR 67565-67572), published by FDA on December 21,
				1993, and amended on September 30, 1994 (59 FR 49808-49813). These regulations
				established the standards that had to be met by mammography facilities in order
				to lawfully operate between October 1, 1994 and April 28, 1999.
"Interpreting physician" means a licensed physician who
				interprets mammograms and who meets the requirements of Section
				370.70(a)
				of this Part.
"Lead interpreting physician" means the interpreting physician
				assigned the general responsibility for ensuring that a facility's quality
				assurance program meets all of the requirements of Sections
				370.100,
				370.110,
				370.120(b)
				and (c) and
				370.130
				of this Part. The administrative title and other supervisory responsibilities
				of the individual, if any, are left to the discretion of the facility.
"Mammogram" means radiographic image produced through
				mammography.
"Mammographic modality" means a technology for radiography of
				the breast. Examples are screen-film mammography and digital
				mammography.
"Mammography" means radiography of the breast.
"Mammography equipment evaluation" means an onsite assessment
				of mammography unit or image processor performance by a medical physicist for
				the purpose of making a preliminary determination as to whether the equipment
				meets all of the applicable standards in this Part.
"Mammography medical outcomes audit" means a systematic
				collection of mammography results and the comparison of those results with
				outcomes data.
"Mammography unit" or "units" means an assemblage of components
				for the production of x-rays for use during mammography, including, at a
				minimum, an x-ray generator, an x-ray control, a tube housing assembly, a beam
				limiting device and the supporting structures for these components.
"Mean optical density" means the average of the optical
				densities (OD) measured using phantom thicknesses of 2, 4 and 6 centimeters
				with values of kilovolt peak (kVp) clinically appropriate for those
				thicknesses.
"Medical physicist" means a person trained in evaluating the
				performance of mammography equipment and facility quality assurance programs
				and who meets the qualifications set forth in Section
				370.70(c)
				of this Part.
"MQSA" means the federal Mammography Quality Standards Act of
				1992, as amended by the Mammography Quality Standards Reauthorization Act of
				1998.
"Multi-reading" means two or more physicians, at least one of
				whom is an interpreting physician, interpreting the same mammogram.
"Patient" means any individual who undergoes a mammography
				evaluation in a facility.
"Phantom" means a test object used to simulate radiographic
				characteristics of compressed breast tissue and containing components that
				radiographically model aspects of breast disease and cancer. It is equivalent
				to a nominal 4.2 centimeter compressed breast of average density (i.e., 50
				percent adipose and 50 percent glandular tissue) and shall contain the
				following objects:
Spherical masses, composed of phenolic plastic, with
				thicknesses of: 2.00, 1.00, 0.75, 0.50 and 0.25 millimeter;
Specks, composed of aluminum oxide, with diameters of: 0.54,
				0.40, 0.32, 0.24 and 0.16 millimeter;
Fibers, composed of nylon, with thicknesses of: 1.56,
				1.12,
				0.89, 0.75, 0.54 and 0.40 millimeter.
AGENCY NOTE: The Mammographic Accreditation Phantom Model 156,
				manufactured by Radiation Measurements, Inc., meets the above criteria and was
				chosen for use by the American College of Radiology's Mammography Accreditation
				Program.
"Phantom image" means a radiographic image of a phantom.
"Physical science" means physics, chemistry, radiation science
				(including medical physics and health physics) and engineering.
"Positive mammogram" means a mammogram that has an overall
				assessment of findings that are either "suspicious" or "highly suggestive of
				malignancy."
"Provisional certificate" means the provisional certificate
				described in Section
				370.50(b)
				of this Part.
"Qualified instructor" means an individual whose training and
				experience adequately prepares him or her to carry out specified training
				assignments. Interpreting physicians, radiologic technologists or medical
				physicists who meet the requirements of Section
				370.70 of
				this Part would be considered qualified instructors in their respective areas
				of mammography. Other examples of individuals who may be qualified instructors
				for the purpose of providing training to meet the requirements of this Part
				include, but are not limited to, instructors in a post-high school training
				institution and manufacturer's representatives.
"Quality control technologist" means an individual meeting the
				requirements of Section
				370.100(a)(4)
				of this Part who is responsible for those quality assurance responsibilities
				not assigned to the lead interpreting physician or to the medical
				physicist.
"Radiologic technologist" means an individual specifically
				trained in the use of radiographic equipment and the positioning of patients
				for radiographic examinations and when performing mammography without direct
				supervision, also meets the requirements set forth in Section
				370.70(b)
				of this Part.
"Screening mammography" means mammography performed on an
				asymptomatic patient to detect the presence of breast cancer at an early
				stage.
"Serious adverse event" means an adverse advent that may
				significantly compromise clinical outcomes, or an adverse event for which a
				facility fails to take appropriate corrective action in a timely manner.
"Serious complaint" means a report of a serious adverse
				event.
"Standard breast" means a 4.2 centimeter (cm) thick compressed
				breast consisting of 50 percent glandular and 50 percent adipose tissue.
"Survey" means an onsite physics consultation and evaluation of
				a facility quality assurance program performed by a medical physicist.
"Time cycle" means the film development time.
"Traceable to a national standard" means an instrument is
				calibrated at either the National Institute of Standards and Technology (NIST)
				or at a calibration laboratory that participates in a proficiency program with
				NIST at least once every 2 years and the results of the proficiency test
				conducted within 24 months of calibration show agreement within plus or minus 3
				percent of the national standard in the mammography energy
				range.