Current through Register Vol. 46, No. 19, March 20, 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.
(2)
Registration and application standards and requirements.
a. Registration and certificates.
(1) Each radiation machine used to perform
mammography shall be registered according to 641-subrule 39.3(2).
(2) A certificate issued by the FDA or this
agency is required for lawful operation of all mammography facilities subject
to the provisions of this subrule. To obtain a certificate from the FDA or this
agency, facilities are required to meet the quality standards in 641-41.6
(136C) and to be accredited and approved by an approved accreditation
body.
b. Each facility
wishing to perform mammography shall apply for authorization by providing or
verifying the following information for each mammography machine:
(1) The mammography unit meets the criteria
for agency-approved mammography accreditation bodies.
(2) The mammography equipment and facility
meet the general requirements of these rules for radiation machines.
(3) The radiation machine is specifically
designed to perform mammography.
(4) The radiation machine is used according
to these rules on patient radiation exposure and radiation dose
levels.
(5) The radiation machine
is operated by individuals meeting the requirements of this subrule.
(6) The entire mammography system is
evaluated at least annually by a medical physicist.
(7) The equipment, personnel, procedures, and
records are evaluated annually by a physician consultant.
(8) Provisional or reinstatement
certification. A new facility beginning operation after September 30, 1994, is
eligible to apply for provisional or reinstatement certification. This will
enable the facility to perform mammography and to obtain the clinical images
needed to complete the accreditation process. To apply for and receive
provisional or reinstatement certification, a facility must meet the
requirements of 641-41.6 (136C). Provisional or reinstatement certification
shall be effective for up to six months from the date of issuance and cannot be
renewed. The facility may apply for one 90-day extension.
c. Suspension, revocation, or denial of
mammography certification.
(1) Mammography
certification may be suspended or revoked with cause if any facility or machine
does not meet one or more of the standards of these rules, will not permit
inspections or provide access to records or information in a timely fashion, or
has been guilty of misrepresentation in obtaining the certification.
(2) The facility shall have opportunity for a
hearing in connection with a denial, suspension or revocation of mammography
certification in accordance with 641-Chapter 173.
(3) An emergency order suspending or revoking
certification may be issued in accordance with
641-173.31 (17A) if the agency
finds the radiation unit or facility violates rules that seriously affect the
health, safety, and welfare of the public. An opportunity for hearing shall be
held within 20 working days after the issuance of the order. The order shall be
effective during the proceedings.
(4) If certification is revoked, the
radiation machine shall not be used for mammography until reinstated.
(5) If a facility's certification is revoked,
no person who owned or operated that facility at the time the act occurred may
own or operate a mammography facility in Iowa within two years of the date of
revocation.
d.
Reinstatement of mammography certification after revocation.
(1) An application for reinstatement shall be
submitted and processed as an initial application. Appropriate corrective
actions must be submitted with the application.
(2) The agency shall inspect the radiation
machine within 60 days of the approved reinstatement application.
(3) A full certificate shall be issued only
after the agency has inspected the radiation machine and determined that it
meets the requirements of these rules.
e. Inspections. The agency shall conduct an
inspection of each radiation machine no later than 14 months after initial
mammography certification and at least annually thereafter.
f. An application for authorization shall be
submitted to the department and processed for agency approval. A mammography
authorization is effective for three years.
g. A phantom image taken with the authorized
unit(s) shall be reviewed at the time of annual inspection by the
agency.
h. Federal mammography
regulations. All Iowa facilities performing mammography shall comply with the
applicable regulations found in 21 CFR Part 900 which has an effective date of
April 28, 1999. Persons certified to perform mammography in Iowa shall be
responsible for ensuring compliance with the appropriate CFR regulations or
Iowa administrative rules, whichever are more stringent.
i. Review workstation (RWS) requirements.
(1) RWS used for final interpretation of
mammogram images must meet the following criteria:
1. Have 5 megapixel resolution; or
2. Be approved by the United States Food and
Drug Administration 510K process and be intended for digital mammography
use.
(2) The workstation
must have a quality control program substantially the same as that outlined by
the mammography unit manufacturer's quality control manual, that outlined by
the RWS monitor manufacturer's quality control manual or the quality control
program outlined by an FDA-approved accrediting body.
(4)
Obtaining and preserving
records.
a. The facility performing
the current mammography examination must make all reasonable efforts to obtain
the patient's recent mammography records, including original images or films,
copies of written reports prepared by interpreting physicians, and other
relevant information pertinent to previous mammograms that might be available
from other facilities, for comparison with the current mammography
records.
b. The facility must make,
for each patient, a written report of each mammography examination performed.
This report shall include:
(1) The date the
mammography procedure was performed.
(2) The date of the interpretation.
(3) The name of the interpreting
physician.
(4) The name of the
patient and an additional patient identifier.
(5) A description of the procedures
performed.
(6) The name of the
referring physician (if any) or other physician (if any) identified by the
patient to receive the interpreting physician's written report.
(7) The date the interpreting physician's
written report was sent to the appropriate physician or patient.
(8) A separate and distinct section entitled,
"Assessment" with the appropriate assessment term. One of the following terms
in quotations or an approved equivalent must be included in the assessment:
1. "Negative": Nothing to comment upon (if
the interpreting physician is aware of clinical findings or symptoms, despite
the negative assessment, these shall be explained).
2. "Benign": Also a negative
assessment.
3. "Probably benign":
Finding(s) has a high probability of being benign.
4. "Suspicious": Finding(s) without all the
characteristic morphology of breast cancer but indicating a definite
probability of being malignant.
5.
"Highly suggestive of malignancy": Finding(s) has a high probability of being
malignant.
6. "Incomplete: Need
additional imaging evaluation" shall be assigned as an assessment in cases
where no final assessment category can be assigned due to incomplete workup,
and reasons why no assessment can be made shall be stated by the interpreting
physician.
(9)
Recommendations made to the health care provider about what additional actions,
if any, should be taken. All clinical questions raised by the referring health
care provider shall be addressed in the report to the extent possible, even if
the assessment is negative or benign.
(10) Information on a patient's breast
density, as categorized by an interpreting physician at the facility based on
standards as defined in nationally recognized guidelines or systems for breast
imaging reporting of mammography screening, including the breast imaging
reporting and data system of the American College of Radiology.
c. Preservation of records.
(1) The facility must provide satisfactory
assurances (as documented in its medical records) that the images or films of
the first and subsequent mammography procedures and the related written reports
of the interpreting physician for each patient are either placed in the
patient's medical record kept by the facility or sent for placement in the
patient's medical record as directed by the patient's physician or the
patient.
(2) Records retained by
the facility must be retained for at least 60 calendar months following the
date of service, as long as the patient continues consecutive mammograms. If no
additional mammograms of the patient are performed, the records must be
retained for at least ten years.
(3) If the facility should cease to exist
before the end of the retention period, the records must be transferred to the
patient or patient's physician or other mammographic facility.
(4) The facility shall upon request by, or on
behalf of, the patient, permanently or temporarily, transfer the original
mammograms and copies of the patient's reports to a medical institution, or to
a physician or health care provider of the patient, or to the patient
directly.
(5) Any fee charged to
the patient for providing the services in subparagraph (4) above shall not
exceed the documented costs associated with this service.
d. Communication of results to the patient.
Each facility shall maintain a system to ensure that the results of each
mammographic examination are communicated in lay terms to each patient in a
time period not to exceed 30 days from the date of the mammography examination.
If assessments are "Suspicious" or "Highly suggestive of malignancy" and the
patient has not named a health care provider, the facility shall make
reasonable attempts to ensure that the results are communicated to the patient
as soon as possible.
(1) As soon as possible,
but no later than 30 days from the date of the mammography examination,
patients who do not name a health care provider to receive the mammography
report shall be sent the report described in 41.6(4)"e"(1) in
addition to a written notification of results in lay terms.
(2) Each facility that accepts patients who
do not have a primary care provider shall maintain a system for referring such
patients to a health care provider when clinically indicated.
(3) The breast density information as
designated in the report pursuant to 41.6(4)"b"(10) shall be
included in the patient lay letter with a reference to a department-accepted
site or document where the patient can obtain more information about breast
density. For patients categorized as having heterogeneously dense breasts or
extremely dense breasts, or an equivalent determination by another nationally
recognized density gradient system, the notification to the patient shall
include evidence-based information on dense breast tissue, the increased risk
associated with dense breast tissue, and the effects of dense breast tissue on
screening mammography and shall be stated in language appropriate for the
facility's patient population.
e. Communication of results to health care
providers. When the patient has a referring health care provider or the patient
has named a health care provider, the facility shall:
(1) Provide a written report of the
mammography examination, including all of the items listed in
41.6(4)"b," to the health care provider as soon as possible,
but no later than 30 days from the date of the examination, and
(2) If the assessment is "Suspicious" or
"Highly suggestive of malignancy," make reasonable attempts to communicate with
the health care provider as soon as possible or, if the health care provider is
unavailable, to a responsible designee of the health care provider.
f. Mammographic image
identification. Each mammographic image shall have the following information
indicated on it in a permanent, legible, and unambiguous manner and placed so
as not to obscure anatomic structures:
(1)
Name of patient and an additional patient identifier.
(2) Date of examination.
(3) View and laterality. This information
shall be placed on the image in a position near the axilla. Standardized codes
specified by the accreditation body and approved by the FDA shall be used to
identify view and laterality.
(4)
Facility name and location. At a minimum, the location shall include the city,
state, and ZIP code of the facility.
(5) Technologist identification.
(6) Mammography unit identification, if there
is more than one unit in the facility.
(5)
Quality assurance
program.
a. The facility shall
ensure that the facility has an equipment quality assurance program specific to
mammography and covering all components of the system to ensure consistently
high-quality images with minimum patient exposure. 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, EQUIP included, meets all requirements of these
rules. 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:
1. Follow the facility
procedures for corrective action when the images they are asked to interpret
are of poor quality, and
2.
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(s) shall be
responsible for performing the surveys and mammography equipment evaluations
and providing the facility with the applicable reports.
(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(s). 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 41.6(5)"e"
through"j."
b. The facility shall ensure that a general
review of the program is conducted at least annually and have available the
services of a qualified medical physicist who is capable of establishing and
conducting the program.
c. Under
the direction of the lead interpreting physician, the medical physicist shall
have responsibility for establishing and conducting the equipment quality
assurance program. The program shall include:
(1) Conducting or training others to conduct
equipment performance monitoring functions.
(2) Analyzing the monitoring results to
determine if there are any problems requiring correction.
(3) Ensuring that the facility has procedures
in place for carrying out or arranging for the necessary corrective actions as
well as for the calibrations and other preventive maintenance.
d. Calibration of equipment. All
variable parameters of the equipment shall be calibrated:
(1) When the equipment is first
installed.
(2) After any major
changes or replacement of parts.
(3) At least annually during use based on
recommendations of the mammography imaging medical physicist.
(4) When quality assurance tests indicate
that calibration is needed.
e. Performance monitoring. The facility shall
routinely ensure that the performance of the mammography system is monitored.
The parameters to be monitored shall include all testing as outlined in the
manufacturer's mammography unit's quality control manual and the RWS quality
control requirements of 41.6(2)"i"(2).
f. Availability and use of technique charts
that shall include an indication of the kV-target-filter combination to be used
with each image receptor.
g.
Evaluation of monitoring results. FFDM and DBT mammography units must comply
with the quality control test requirements outlined by the performance criteria
in the appropriate manufacturer's quality control manual.
(1) Standards of image quality giving
acceptable ranges of values for each of the parameters tested shall be
established to aid in the evaluation. The standards of image quality related to
dose shall include a requirement that the mean glandular dose for one
craniocaudal view of a 4.2 cm compressed breast (50 percent adipose/50 percent
glandular) or equivalent phantom shall not exceed 300 millirad for full field
digital units.
(2) The monitoring
results shall be compared routinely by the facility staff to the standards of
image quality in 41.6(5)"j." If any test results fall outside
the performance criteria range listed for the unit, specific actions as
directed in the appropriate quality control manual shall be followed.
h. Medical outcomes audit. Each
facility shall establish a system for reviewing outcome data from all
mammography performed, including follow-up on the disposition of positive
mammograms and correlation of surgical biopsy results with the interpreting
physician's findings. This program shall be designed to ensure the reliability,
clarity, and accuracy of the interpretation of mammograms.
(1) Analysis of these outcome data shall be
made individually and collectively for all interpreting physicians at the
facility. In addition, any cases of breast cancer among women imaged at the
facility that subsequently become known to the facility shall prompt the
facility to initiate follow-up on surgical and pathology results, or both, and
review of the mammograms taken prior to the diagnosis of a malignancy.
Responsibility for each requirement for monitoring shall be assigned to
qualified personnel and documented in the facility's records.
(2) Frequency of audit analysis. The
facility's first audit analysis shall be initiated no later than 12 months
after the date the facility becomes certified, or 12 months after April 28,
1999, whichever date is the latest. This audit analysis shall be completed
within an additional 12 months to permit completion of diagnostic procedures
and data collection. Subsequent audit analyses will be conducted at least once
every 12 months.
(3) Reviewing
interpreting physician. Each facility shall designate at least one interpreting
physician to review the medical outcomes audit data at least once every 12
months. This individual shall record the dates of the audit period(s) and shall
be responsible for analyzing results based on this audit. This individual shall
also be responsible for documenting the results and notifying other
interpreting physicians of the results and the facility aggregate results. If
follow-up actions are taken, the reviewing interpreting physician shall also be
responsible for documenting the nature of the follow-up. The reviewing
physician shall sign the medical audit as proof of the evaluation of the
data.
i. 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
these rules until the next annual inspection has been completed and 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.
j. Quality
assurance-equipment.
(1) Daily, weekly,
biweekly, monthly, quarterly, semiannual and annual quality control tests.
Facilities shall perform quality control tests as required by the
manufacturer's mammography unit's quality control manual, the RWS quality
control requirements of 41.6(2)"i"(2) or the quality control
program outlined by an FDA-approved accrediting body.
(2) Surveys.
1. At least annually, each facility shall
undergo a survey by a medical physicist or by an individual under the direct
supervision of a medical physicist. The survey shall include testing as
required by the manufacturer's mammography unit's quality control manual, the
RWS quality control manual or the quality control program outlined by the
accrediting body.
2. The results of
the tests, any corrective actions taken and their results shall be evaluated
for adequacy by the medical physicist performing the survey.
3. The medical physicist shall prepare a
survey report that includes a summary of this review and recommendations for
necessary improvements.
4. The
survey report shall be sent to the facility within 30 days of the date of the
survey.
5. The survey report shall
be dated and signed by the medical physicist performing or supervising the
survey. If the survey was performed entirely or in part by another individual
under the direct supervision of the medical physicist, that individual and the
part of the survey that individual performed shall also be identified in the
survey report.
(3)
Mammography equipment evaluations. Additional evaluations of mammography units
or image processors or any other applicable mammography system ancillary parts
shall be conducted at new installations, at disassembly, at reassembly, at the
same or a new location, or when major components are changed or repaired. These
evaluations shall be used to determine whether the new or changed equipment
meets the requirements of applicable standards in 41.6(5) and 41.6(6). All
problems shall be corrected before the new or changed equipment is put into
service for examinations. The mammography equipment evaluation shall be
performed by a medical physicist or by an individual under the direct
supervision of an Iowa-approved medical physicist.
(4) Calibration of air kerma measuring
instruments. Instruments used by medical physicists in their annual survey to
measure the air kerma or air kerma rate from a mammography unit shall be
calibrated at least once every two years and each time the instrument is
repaired. The instrument calibration must be traceable to a national standard
and calibrated with an accuracy of plus or minus 6 percent (95 percent
confidence level) in the mammography energy range.
(5) Infection control. Facilities shall
establish and comply with a system specifying procedures to be followed by the
facility for cleaning and disinfecting mammography equipment after contact with
blood or other potentially infectious materials. This system shall specify the
methods for documenting facility compliance with the infection control
procedures established and shall:
1. Comply
with all applicable federal, state, and local regulations pertaining to
infection control; and
2. Comply
with the manufacturer's recommended procedures for the cleaning and
disinfecting of the mammography equipment used in the facility; or
3. If adequate manufacturer's recommendations
are not available, comply with generally accepted guidance on infection
control, until such recommendations become available.
k. Mammography procedures and
techniques for mammography of patients with breast implants.
(1) Each facility shall have a procedure to
inquire whether or not the patient has breast implants prior to the actual
mammographic examination.
(2)
Except where contraindicated, or unless modified by a physician's directions,
patients with breast implants undergoing mammography shall have mammographic
views to maximize the visualization of breast tissue.
l. Consumer complaint mechanism. Each
facility shall:
(1) Establish a written and
documented system for collecting and resolving consumer complaints;
(2) Maintain a record of each serious
complaint received by the facility for at least three years from the date the
complaint was received;
(3) Provide
the consumer with adequate directions for filing serious complaints with the
facility's accreditation body and any other appropriate regulatory entity if
the facility is unable to resolve a serious complaint to the consumer's
satisfaction.
(4) Report unresolved
serious complaints to the accreditation body in a manner and time frame
specified by the accreditation body.
m. Clinical image quality. Clinical images
produced by any certified facility must continue to comply with the standards
for clinical image quality established by that facility's accreditation
body.
n. Additional mammography
review and patient notification.
(1) If the
agency believes that mammography quality at a facility has been compromised and
may present a serious risk to human health, the facility shall provide clinical
images and other relevant information, as specified by the agency, for review
by the accreditation body or other entity designated by the agency. This
additional mammography review will help the agency to determine whether the
facility is in compliance with rule 641-41.6 (136C) and, if not, whether there
is a need to notify affected patients, their physicians, or the public that the
reliability, clarity, and accuracy of interpretation of mammograms has been
compromised.
(2) If the agency
determines that any activity related to the provision of mammography at a
facility may present a serious risk to human health such that patient
notification is necessary, the facility shall notify patients or their
designees, their physicians, or the public of action that may be taken to
minimize the effects of the risk. Such notification shall occur within a time
frame and a manner specified by the agency.
(6)
Equipment standards. The
equipment used to perform mammography shall meet the following standards:
a. Design: Be specifically designed for
mammography. This prohibits systems that have been modified or equipped with
special attachments for mammography.
b. Performance standards: Meet the Food and
Drug Administration (FDA) performance standards for diagnostic X-ray systems
and their major components found in
21 CFR
1020.30 and FDA standards for radiographic
equipment in
21 CFR
1020.31.
c. Image receptor systems:
(1) Have image receptor systems and
individual components which are appropriate for mammography and used according
to the manufacturer's recommendations.
(2) Systems used for magnification procedures
shall be capable of operation with the grid removed from between the source and
image receptor.
d. Light
fields: For any system with a light beam that passes through the X-ray
beam-limiting device, the light shall provide an average illumination of not
less than 160 lux (15 foot candles) at 100 centimeters or the maximum
source-image receptor distance (SID), whichever is less.
e. Magnification:
(1) Systems used to perform noninterventional
problem-solving procedures shall have radiographic magnification capability
available for use by the operator.
(2) Systems used for magnification procedures
shall provide, at a minimum, at least one magnification value within the range
of 1.4 to 2.0.
f.
Tube-image receptor assembly:
(1) The assembly
shall be capable of being fixed in any position where it is designed to
operate. Once fixed in any such position, it shall not undergo unintended
motion.
(2) The mechanism ensuring
compliance with this subrule shall not fail in the event of power
interruption.
g. Focal
spot: The focal spot size, magnification factor and source to image receptor
distance (SID) shall be appropriate for mammography.
(1) When more than one focal spot is
provided, the system shall indicate, prior to exposure, which focal spot is
selected.
(2) When more than one
target material is provided, the system shall indicate, prior to exposure, the
preselected target material.
(3)
When the target material or focal spot, or both, is selected by a system
algorithm that is based on the exposure or on a test exposure, the system shall
display, after the exposure, the target material or focal spot, or both,
actually used during the exposure.
h. Compression devices: Shall have
compression devices able to immobilize and compress the breast with a force of
at least 25 pounds per square inch and shall be capable of maintaining this
compression for at least three seconds. Each system shall provide:
(1) An initial power-driven compression
activated by hands-free controls operable from both sides of the patient;
and
(2) Fine adjustment compression
controls operable from both sides of the patient.
(3) Systems shall be equipped with different
sized compression paddles that match the sizes of all full field image
receptors provided for the system. Compression paddles for special purposes,
including those smaller than the full size of the image receptor (for "spot
compression"), may be provided. Such compression paddles for special purposes
are not subject to 41.6(6)"h"(6) and (7).
(4) Except as provided in
41.6(6)"h," the compression paddle shall be flat and parallel
to the breast support table and shall not deflect from parallel by more than
1.0 cm at any point on the surface of the compression paddle when compression
is applied.
(5) Equipment intended
by the manufacturer's design not to be flat and parallel to the breast support
table during compression shall meet the manufacturer's design specifications
and maintenance requirements.
(6)
The chest wall edge of the compression paddle shall be straight and parallel to
the edge of the image receptor. Equipment intended by the manufacturer's design
not to be straight and parallel to the edge of the image receptor shall meet
the manufacturer's design specifications and maintenance
requirements.
(7) The chest wall
edge of the compression paddle may allow for patient comfort but shall not
appear on the image.
i.
Grids: Shall have the capability for using antiscatter grids.
j. AEC: Shall have automatic exposure control
such that:
(1) The positioning or selection of
the detector shall permit flexibility in the placement of the detector under
the target tissue.
* The size and available positions of the detector shall be
clearly indicated at the X-ray input surface of the breast compression
paddle.
* The selected position of the detector shall be clearly
indicated.
(2) The system
shall provide means for the operator to vary the selected optical density from
the normal (zero) setting.
k. Control panel: Shall have a control panel
that:
(1) Gives a positive indication when
X-rays are being produced.
(2)
Gives an audible signal indicating termination of exposure.
(3) Has manual selection of milliampere
seconds (mAs) or at least one of its component parts (milliampere (mA) or time,
or both).
(4) Has the technique
factors (peak tube potential in kilovolts (kV) and either tube current in mA
and exposure time in seconds or the product of tube current and exposure time
in mAs) to be used during an exposure indicated before the exposure begins,
except when AEC is used, in which case the technique factors that are set prior
to the exposure shall be indicated.
(5) Has a system that, following AEC mode
use, shall indicate the actual kilovoltage peak (kVp) and mAs used during the
exposure.
l. mAs: Shall
indicate, or provide a means of determining, the mAs resulting from each
exposure made with automatic exposure control.
m. Mobile units and vans. Appropriate
manufacturer's quality control manual procedures and criteria shall be
met.
