Iowa Administrative Code › Agency 641 - Public Health Department › Chapter 41 - Safety Requirements for the Use of Radiation Machines and Certain Uses of Radioactive Materials › Rule 641-41.6 - X-ray Machines Used for Screening and Diagnostic Mammography

Current through Register Vol. 47, No. 3, July 24, 2024
(1)
Definitions.
In addition
			 to the definitions provided in
			 641-38.2 (136C),
			 641-40.2 (136C), and
			 641-41.1 (136C), the following
			 definitions shall be applicable to this rule.
"Accreditation body"
means an entity that has
				been approved by FDA to accredit mammography facilities.
"Acquisition workstation"
or
"AWS"
means the soft copy display workstation used in
				conjunction with the mammography unit.
"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 must 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. Adverse events include but
				are not limited to:
1. Poor image
			 quality;
2. Failure to send
			 mammography reports within 30 days to the referring physician or in a timely
			 manner to the self-referred patient; and
3. Use of personnel who do not meet the
			 applicable requirements of this chapter.
"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 Gray of absorbed
				dose is delivered by 114 roentgens (R) of exposure.
"Annually"
means within 10 to 14 months of
				previous occurrence.
"Artifact"
means a substance or structure not
				naturally present in living tissue but of which an authentic image appears in a
				radiograph.
"Automatic exposure control systems"
means
				automatic exposure control systems, often referred to as phototimers, which are
				designed to automatically determine and provide the exposure needed to produce
				an adequate density image by sampling the X-ray intensity after passage through
				the patient and image receptor.
"Average glandular dose"
means the energy
				deposited per unit mass of glandular tissue averaged over all the glandular
				tissue in the breast, calculated from values of entrance exposure in air, the
				X-ray beam quality (half-value layer), and compressed breast thickness. For a
				50 percent-50 percent adipose and glandular 4.2 centimeter breast, the average
				glandular dose shall not exceed 300 millirad (3 mGy). See also: "Dose."
"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 1"
means medical education
				activities that have been designated as Category 1 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 41.6(2)
"a"
(2).
"Certification"
means the process of approval
				of a facility by the FDA or this agency to provide mammography services.
"Clinical image"
means a mammogram.
"Compression device"
means a firm plastic
				paddle used to help hold the breast stationary and eliminate blurring due to
				motion, to help separate structures within the breast, and to decrease the
				thickness of breast tissue, minimizing the amount of radiation used and the
				amount of scattered radiation reaching the film.
"Computed radiography mammography"
means a
				type of digital mammography in which the digital image receptor must be removed
				from the X-ray unit for the image to be read and processed by a separate image
				receptor reader.
"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).
"Contact hour"
means an hour of training
				received through direct instruction.
"Continuing education unit"
or
"continuing education credit"
means one contact hour of
				training.
"Craniocaudal view"
means one of two routine
				views for mammography. The detector system is placed caudad to (below) the
				breast and the vertical X-ray beam is directed from cranial to caudad
				(downward) through the breast.
"Dedicated mammography equipment"
means X-ray
				systems designed specifically for breast imaging, providing optimum imaging
				geometry, a device for breast compression and low dose exposure that can
				generate reproducible images of high quality.
"Digital breast tomosynthesis"
or
"DBT"
means mammography that uses reconstructions to create
				three-dimensional images of the breasts.
"Direct detector technology"
means a digital
				mammogram captured using a material which converts the X-ray energies directly
				to an electric signal.
"Direct instruction"
means:
1. Face-to-face interaction between
			 instructor(s) and student(s), as when the instructor provides a lecture,
			 conducts demonstrations, or reviews student performance; or
2. The administration and correction of
			 student examinations by an instructor(s) with subsequent feedback to the
			 student(s).
"Direct supervision"
means that:
1. 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
2. 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.
"Dose"
means the amount of energy deposited
				per unit mass of tissue due to X-radiation. The newer unit of absorbed dose is
				the Gray: 1 Gray=1 Joule of energy deposited per kilogram of tissue. The older
				unit of absorbed dose is the rad: 1 rad=0.01 Gray, 1 centiGray, or 10
				milliGray.
"EQUIP"
means Enhancing Quality Using the
				Inspection Program and uses inspection questions related to the image quality
				regulations of MQSA to emphasize the significance of continuous clinical image
				quality.
"Exposure"
means the amount of X-radiation,
				quantitated by measuring the amount of ionization in air caused by the
				radiation. The units of exposure are Coulombs of charge ionized per kilogram of
				air. The older unit of exposure is the Roentgen: 1 Roentgen=2.58 x 10E-4
				Coulombs of charge per kilogram of air.
"Facility"
means a hospital, outpatient
				department, clinic, radiology practice, mobile unit, office of a physician, or
				other facility that conducts mammography activities, including the following:
				operation of equipment to produce a mammogram, initial interpretation of the
				mammogram, and maintaining viewing conditions for that interpretation. This
				term does not include a facility of the Department of Veterans Affairs.
"FDA"
means the Food and Drug
				Administration.
"First allowable time"
means the earliest time
				a resident physician is eligible to take the diagnostic radiology boards from
				an FDA-designated certifying body. The "first allowable time" may vary with the
				certifying body.
"Full field digital mammography"
or
"FFDM"
means radiographic imaging of the breast using a
				digital image receptor with minimum dimensions of 18x23 cm to allow imaging the
				average size breast in a single exposure.
"Grids"
means a set of thin lead strips spaced
				close to one another, interspaced by carbon fiber for mammographic grids. The
				grid is placed between the breast and the screen-film image receptor to reduce
				scattered radiation reaching the image receptor.
"Image noise."
See "Radiographic
				noise."
"Image receptor support device"
means, for
				mammography X-ray systems, that part of the system designed to support the
				image receptor during a mammographic examination and to provide a primary
				protective barrier.
"Inspection"
means to assess and determine
				compliance with regulations.
"Interpreting physician"
means a licensed
				radiologist who interprets mammograms and who meets the requirements set forth
				in 41.6(3)
"a."
"Kerma"
means the sum of the initial energies
				of all the charged particles liberated by uncharged ionizing particles in a
				material of given mass.
"Laterality"
means the designation of either
				the right or left breast.
"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 this
				chapter. The administrative title and other supervisory responsibilities of the
				individual, if any, are left to the discretion of the facility.
"Mammogram"
means a radiographic image
				produced through mammography.
"Mammographic modality"
means a technology for
				radiography of the breast. Examples are screen-film mammography, full field
				digital mammography and digital breast tomosynthesis.
"Mammography"
means radiography of the breast
				but, for the purposes of 641-41.6 (136C), does not include:
1. Radiography of the breast performed during
			 invasive interventions for localization or biopsy procedures; or
2. Radiography of the breast performed with
			 an investigational mammography device as part of a scientific study conducted
			 in accordance with FDA investigational device exemption regulations;
			 or
3. Radiography of the breast
			 performed as part of either a breast localization procedure or a
			 post-stereotactic clip placement localization procedure.
"Mammography equipment evaluation"
means an
				on-site assessment of the mammography unit or review workstation by a medical
				physicist for the purpose of making a preliminary determination as to whether
				the equipment meets all of the applicable standards.
"Mammography medical outcomes audit"
means a
				systematic collection of mammography results and the comparison of those
				results with outcomes data.
"Mammography unit(s)"
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 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 for a medical physicist set
				forth in 41.6(3)
"c."
"Mediolateral view"
means one of the routine
				views for mammography in addition to the craniocaudal view. The detector system
				is placed lateral to the breast and the horizontal X-ray beam is directed from
				medial to lateral aspect through the breast.
"MQSA"
means the Mammography Quality Standards
				Act of 1992.
"Multi-reading"
means two or more physicians,
				at least one of whom is an interpreting physician, interpreting the same
				mammogram. A radiologist may count the current mammographic examination and one
				prior mammographic examination, provided the radiologist was not the
				interpreter of the prior mammographic examination. A separate tally shall be
				kept for the prior examinations.
"Oblique mediolateral view"
means one of the
				standard two views of the breast. The detector system is angled 30-60 degrees
				from horizontal so that the detector system is parallel to the pectoral muscle
				and the corner of the detector system fits comfortably into the axilla. The
				X-ray beam is directed from the supero-medial to the infero-lateral aspect of
				the breast.
"Patient"
means any individual who undergoes a
				mammography evaluation in a facility, regardless of whether the person is
				referred by a physician or is self-referred.
"Phantom"
means an artificial test object used
				to simulate radiographic characteristics of compressed breast tissue and
				containing components that radiographically model aspects of breast disease and
				cancer.
"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 certification"
means the
				six-month certification time period in which a facility has to complete the
				accreditation/certification process.
"Qualified instructor"
means individuals whose
				training and experience adequately prepare them to carry out specified training
				assignments. Interpreting physicians, radiologic technologists, or medical
				physicists who meet the requirements of 41.6(3) would be considered qualified
				instructors in their respective areas of mammography. Radiological
				technologists who meet the requirements of 41.6(3) and have passed a
				state-approved mammography examination such as the examination given by the
				American Registry of Radiography Technologists would be considered qualified
				instructors in their respective areas of mammography. The examination would
				include, but not necessarily be limited to: breast anatomy and physiology,
				positioning and compression, quality assurance/quality control techniques, and
				imaging of patients with breast implants. Other examples of individuals who may
				be qualified instructors for the purpose of providing training to meet the
				regulations of this chapter include, but are not limited to, instructors in a
				post-high school training institution and manufacturers'
				representatives.
"Quality control technologist"
means an
				individual meeting the requirements of 41.6(5)
"a"
(4) who is
				responsible for those quality assurance responsibilities not assigned to the
				lead interpreting physician or to the medical physicist.
"Radiographic equipment"
means X-ray equipment
				used for the production of static X-ray images.
"Radiologic technologist"
means an individual
				specifically trained in the use of radiographic equipment and in the
				positioning of patients for radiographic examinations and who meets the
				requirements set forth in 41.6(3)
"b."
"Radiologist continuing experience"
means the
				number of mammograms interpreted by a radiologist in the past 24-month period.
				For the purpose of counting, a radiologist may count the current mammographic
				examination and one prior mammographic examination, provided the radiologist
				was not the interpreter of the prior mammographic examination. A separate tally
				shall be kept for the prior examinations.
"Reinstatement"
means the process of
				recertification of a facility that has lost or voluntarily given up previous
				accreditation/certification.
"Review workstation"
or
"RWS"
means soft copy display device intended for use in mammography
				interpretations.
"Screen-film mammography"
means mammography
				performed with high-detailed intensifying screen(s) in close contact with the
				film.
"Screening mammography"
means X-ray breast
				examination of asymptomatic individuals in an attempt to detect breast cancer
				when it is small, nonpalpable, and confined to the breast.
"Serious adverse event"
means an adverse event
				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 on-site 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 two years and the results of
				the proficiency test conducted within 24 months of calibration show agreement
				within ±plusmn; 3 percent of the national standard in the mammography
				energy range.
"Written report"
means interpreting
				physician's technical narrative of a mammography evaluation.
"Written statement"
means interpreting
				physician's description of a mammography examination written in lay
				terms.