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Information
for mammography facility personnel, inspectors, and consumers
about the implementation of the Mammography Quality Standards Act of 1992
(MQSA) |
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Mammography Quality Standards Act Regulations
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Following are the quality standards developed under the Mammography Quality
Standards Act after incorporation of the amendments published on February
6, 2002 (67 FR 5446). The effective date for Subparts A and B was April
28, 1999, except for Sec.(b)(8)(i), (e)(4)(iii)(B), (e)(5)(i)(B), (e)(5)(iii),
and (e)(x), which become effective October 28, 2002. Subpart C became
effective on May 7, 2002.
PART 900--MAMMOGRAPHY
Subpart A--Accreditation
Sec.
900.1 Scope.
900.2 Definitions.
900.3 Application for approval as an accreditation body.
900.4 Standards for accreditation bodies.
900.5 Evaluation.
900.6 Withdrawal of approval.
900.7 Hearings.
900.8--900.9 [Reserved]
Subpart B--Quality Standards and Certification
900.10 Applicability.
900.11 Requirements for certification.
900.12 Quality standards.
900.13 Revocation of accreditation and
revocation of accreditation body approval.
900.14 Suspension or revocation of certificates.
900.15 Appeals of adverse accreditation or
reaccreditation decisions that preclude certification or recertification.
900.16 Appeals of denials of certification.
900.17 [Reserved]
900.18 Alternative requirements for Sec. 900.12 quality
standards.
Subpart C--States as Certifiers
900.20 Scope.
900.21 Application for approval as a certification
agency.
900.22 Standards for certification agencies.
900.23 Evaluation.
900.24 Withdrawal of approval.
900.25 Hearings and appeals.
AUTHORITY: 21 U.S.C. 360i, 360nn, 374(e); 42 U.S.C. 263b.
Subpart A--Accreditation
Sec. 900.1 Scope.
The regulations set forth in this part implement the Mammography Quality
Standards Act (MQSA) (42 U.S.C. 263b). Subpart A of this part establishes
procedures whereby an entity can apply to become a Food and Drug Administration
(FDA)-approved accreditation body to accredit facilities to be eligible
to perform screening or diagnostic mammography services. Subpart A further
establishes requirements and standards for accreditation bodies to ensure
that all mammography facilities under the jurisdiction of the United States
are adequately and consistently evaluated for compliance with national
quality standards for mammography. Subpart B of this part establishes
minimum national quality standards for mammography facilities to ensure
safe, reliable, and accurate mammography. The regulations set forth in
this part do not apply to facilities of the Department of Veterans Affairs.
Sec. 900.2 Definitions.
The following definitions apply to subparts A, B, and C of this part:
- (a) Accreditation body or body means an entity
that has been approved by FDA under Sec. 900.3(d) to accredit mammography
facilities.
- (b) 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.
- (c) Adverse event means an undesirable experience
associated with mammography activities within the scope of 42 U.S.C.
263b. 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 that do not meet the applicable
requirements of Sec. 900.12(a).
- (d) 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. In air, 1Gy of absorbed dose is delivered by 114
roentgens (R) of exposure.
- (e) Breast implant means a prosthetic device implanted
in the breast.
- (f) 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.
- (g) 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.
- (h) Certificate means the certificate described
in Sec. 900.11(a).
- (i) Certification means the process of approval
of a facility by FDA or a certification agency to provide mammography
services.
- (j) Clinical image means a mammogram.
- (k) 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).
- (l) Continuing education unit or continuing education
credit means one contact hour of training.
- (m) Contact hour means an hour of training received
through direct instruction.
- (n) 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).
- (o) 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.
- (p) 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.
- (q) 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, processing
of the 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.
- (r) 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.
- (s) FDA means the Food and Drug Administration.
- (t) 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.
- (u) Interpreting physician means a licensed physician
who interprets mammograms and who meets the requirements set forth
in Sec. 900.12(a)(1).
- (v) Kerma means the sum of the initial energies
of all the charged particles liberated by uncharged ionizing particles
in a material of given mass.
- (w) Laterality means the designation of either the
right or left breast.
- (x) 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 Sec. 900.12(d) through (f). The administrative title and other
supervisory responsibilities of the individual, if any, are left
to the discretion of the facility.
- (y) Mammogram means a radiographic image produced
through mammography.
- (z) Mammographic Modality means a technology, within
the scope of 42 U.S.C. 263b, for radiography of the breast. Examples
are screen-film mammography and xeromammography.
- (aa) Mammography means radiography of the breast,
but, for the purposes of this part, 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's investigational device exemption regulations
in part 812 of this chapter.
- (bb) 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 Sec. 900.12(b) and (e).
- (cc) Mammography medical outcomes audit means a
systematic collection of mammography results and the comparison
of those results with outcomes data.
- (dd) 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.
- (ee) 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.
- (ff) 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 Sec. 900.12(a)(3).
- (gg) MQSA means the Mammography Quality Standards
Act.
- (hh) Multi-reading means two or more physicians,
at least one of whom is an interpreting physician, interpreting
the same mammogram.
- (ii) 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.
- (jj) 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.
- (kk) Phantom image means a radiographic image of
a phantom.
- (ll) Physical science means physics, chemistry,
radiation science (including medical physics and health physics),
and engineering.
- (mm) Positive mammogram means a mammogram that has
an overall assessment of findings that are either "suspicious"
or "highly suggestive of malignancy."
- (nn) Provisional certificate means the provisional
certificate described in Sec. 900.11(b)(2).
- (oo) 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
Sec. 900.12(a) 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 regulations of this part include, but are not limited
to, instructors in a post-high school training institution and manufacturer's
representatives.
- (pp) Quality control technologist means an individual
meeting the requirements of Sec. 900.12(a)(2) who is responsible
for those quality assurance responsibilities not assigned to the
lead interpreting physician or to the medical physicist.
- (qq) Radiographic equipment means X-ray equipment
used for the production of static X-ray images.
- (rr) Radiologic technologist means an individual
specifically trained in the use of radiographic equipment and the
positioning of patients for radiographic examinations and who meets
the requirements set forth in Sec. 900.12(a)(2).
- (ss) 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.
- (tt) Serious complaint means a report of a serious
adverse event.
- (uu) Standard breast means a 4.2 centimeter (cm)
thick compressed breast consisting of 50 percent glandular and 50
percent adipose tissue.
- (vv) Survey means an onsite physics consultation
and evaluation of a facility quality assurance program performed
by a medical physicist.
- (ww) Time cycle means the film development time.
- (xx) 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 +/- 3 percent of the national
standard in the mammography energy range.
- (yy) Review physician means a physician who, by
meeting the requirements set out in Sec. 900.4(c)(5), is qualified
to review clinical images on behalf of the accreditation body.
- (zz) Certification agency means a State that has
been approved by FDA under § 900.21 to certify mammography facilities.
- (aaa) Performance indicators mean the measures used
to evaluate the certification agency's ability to conduct certification,
inspection, and compliance activities.
- (bbb) Authorization means obtaining approval from
FDA to utilize new or changed State regulations or procedures during
the issuance, maintenance, and withdrawal of certificates by the
certification agency.
Sec. 900.3 Application for approval as an accreditation
body.
- (a) Eligibility. Private nonprofit organizations
or State agencies capable of meeting the requirements of this subpart
A may apply for approval as accreditation bodies.
- (b) Application for initial approval.
- (1) An applicant seeking initial FDA approval as
an accreditation body shall inform the Division of Mammography
Quality and Radiation Programs (DMQRP), Center for Devices and
Radiology Health (HFZ-240), Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850, marked Attn: Mammography Standards
Branch, of its desire to be approved as an accreditation body
and of its requested scope of authority.
- (2) Following receipt of the request, FDA will provide
the applicant with additional information to aid in submission
of an application for approval as an accreditation body.
- (3) The applicant shall furnish to FDA, at the address
in Sec. 900.3(b)(1), three copies of an application containing
the following information, materials, and supporting documentation:
- (i) Name, address, and phone number of the
applicant and, if the applicant is not a State agency, evidence
of nonprofit status (i.e., of fulfilling Internal Revenue Service
requirements as a nonprofit organization);
- (ii) Detailed description of the accreditation
standards the applicant will require facilities to meet and
a discussion substantiating their equivalence to FDA standards
required under Sec. 900.12;
- (iii) Detailed description of the applicant's
accreditation review and decision making process, including:
- (A) Procedures for performing accreditation
and reaccreditation clinical image review in accordance with
Sec. 900.4(c), random clinical image reviews in accordance
with Sec. 900.4(f), and additional mammography review in accordance
with Sec. 900.12(j);
- (B) Procedures for performing phantom
image review;
- (C) Procedures for assessing mammography
equipment evaluations and surveys;
- (D) Procedures for initiating and performing
onsite visits to facilities;
- (E) Procedures for assessing facility
personnel qualifications;
- (F) Copies of the accreditation application
forms, guidelines, instructions, and other materials the applicant
will send to facilities during the accreditation process,
including an accreditation history form that requires each
facility to provide a complete history of prior accreditation
activities and a statement that all information and data submitted
in the application is true and accurate, and that no material
fact has been omitted;
- (G) Policies and procedures for notifying
facilities of deficiencies;
- (H) Procedures for monitoring corrections
of deficiencies by facilities;
- (I) Policies and procedures for suspending
or revoking a facility's accreditation;
- (J) Policies and procedures that will
ensure processing of accreditation applications and renewals
within a timeframe approved by FDA and assurances that the
body will adhere to such policies and procedures; and
- (K) A description of the applicant's
appeals process for facilities contesting adverse accreditation
status decisions.
- (iv) Education, experience, and training requirements
for the applicant's professional staff, including reviewers
of clinical or phantom images;
- (v) Description of the applicant's electronic
data management and analysis system with respect to accreditation
review and decision processes and the applicant's ability to
provide electronic data in a format compatible with FDA data
systems;
- (vi) Resource analysis that demonstrates that
the applicant's staffing, funding, and other resources are adequate
to perform the required accreditation activities;
- (vii) Fee schedules with supporting cost data;
- (viii) Statement of policies and procedures
established to avoid conflicts of interest or the appearance
of conflicts of interest by the applicant's board members, commissioners,
professional personnel (including reviewers of clinical and
phantom images), consultants, administrative personnel, and
other representatives of the applicant;
- (ix) Statement of policies and procedures established
to protect confidential information the applicant will collect
or receive in its role as an accreditation body;
- (x) Disclosure of any specific brand of imaging
system or component, measuring device, software package, or
other commercial product used in mammography that the applicant
develops, sells, or distributes;
- (xi) Description of the applicant's consumer
complaint mechanism;
- (xii) Satisfactory assurances that the applicant
shall comply with the requirements of Sec. 900.4; and
- (xiii) Any other information as may be required
by FDA.
- (c) Application for renewal of approval. An approved
accreditation body that intends to continue to serve as an accreditation
body beyond its current term shall apply to FDA for renewal or notify
FDA of its plans not to apply for renewal in accordance with the
following procedures and schedule:
- (1) At least 9 months before the date of expiration
of a body's approval, the body shall inform FDA, at the address
given in Sec. 900.3(b)(1), of its intent to seek renewal.
- (2) FDA will notify the applicant of the relevant
information, materials, and supporting documentation required
under Sec. 900.3(b)(3) that the applicant shall submit as part
of the renewal procedure.
- (3) At least 6 months before the date of expiration
of a body's approval, the applicant shall furnish to FDA, at the
address in Sec. 900.3(b)(1), three copies of a renewal application
containing the information, materials, and supporting documentation
requested by FDA in accordance with Sec. 900.3(c)(2).
- (4) No later than July 28, 1998, any accreditation
body approved under the interim regulations published in the Federal
Register of December 21, 1993 (58 FR 67558), that desires to continue
to serve as an accreditation body under the final regulations
shall apply for renewal of approval in accordance with the procedures
set forth in paragraphs (c)(1) through (c)(3) of this section.
- (5) Any accreditation body that does not plan to
renew its approval shall so notify FDA at the address given in
paragraph (b)(1) of this section at least 9 months before the
expiration of the body's term of approval.
- (d) Rulings on applications for initial and renewed
approval.
- (1) FDA will conduct a review and evaluation to determine
whether the applicant substantially meets the applicable requirements
of this subpart and whether the accreditation standards the applicant
will require facilities to meet are substantially the same as
the quality standards published under subpart B of this part.
- (2) FDA will notify the applicant of any deficiencies
in the application and request that those deficiencies be rectified
within a specified time period. If the deficiencies are not rectified
to FDA's satisfaction within the specified time period, the application
for approval as an accreditation body may be rejected.
- (3) FDA shall notify the applicant whether the application
has been approved or denied. That notification shall list any
conditions associated with approval or state the bases for any
denial.
- (4) The review of any application may include a meeting
between FDA and representatives of the applicant at a time and
location mutually acceptable to FDA and the applicant.
- (5) FDA will advise the applicant of the circumstances
under which a denied application may be resubmitted.
- (6) If FDA does not reach a final decision on a renewal
application in accordance with this paragraph before the expiration
of an accreditation body's current term of approval, the approval
will be deemed extended until the agency reaches a final decision
on the application, unless an accreditation body does not rectify
deficiencies in the application within the specified time period,
as required in paragraph (d)(2) of this section.
- (e) Relinquishment of authority. An accreditation
body that decides to relinquish its accreditation authority before
expiration of the body's term of approval shall submit a letter
of such intent to FDA, at the address in Sec. 900.3(b)(1), at least
9 months before relinquishing such authority.
- (f) Transfer of records. An accreditation body that
does not apply for renewal of accreditation body approval, is denied
such approval by FDA, or relinquishes its accreditation authority
and duties before expiration of its term of approval, shall:
- (1) Transfer facility records and other related information
as required by FDA to a location and according to a schedule approved
by FDA.
- (2) Notify, in a manner and time period approved
by FDA, all facilities accredited or seeking accreditation by
the body that the body will no longer have accreditation authority.
- (g) Scope of authority. An accreditation body's
term of approval is for a period not to exceed 7 years. FDA may
limit the scope of accreditation authority.
Sec. 900.4 Standards for accreditation bodies.
- (a) Code of conduct and general responsibilities.
The accreditation body shall accept the following responsibilities
in order to ensure safe and accurate mammography at the facilities
it accredits and shall perform these responsibilities in a manner
that ensures the integrity and impartiality of accreditation body
actions.
- (1) (i) When an accreditation body receives or
discovers information that suggests inadequate image quality,
or upon request by FDA, the accreditation body shall review a
facility's clinical images or other aspects of a facility's practice
to assist FDA in determining whether or not the facility's practice
poses a serious risk to human health. Such reviews are in addition
to the evaluation an accreditation body performs as part of the
initial accreditation or renewal process for facilities.
- (ii) If review by the accreditation body demonstrates
that a problem does exist with respect to image quality or other
aspects of a facility's compliance with quality standards, or
upon request by FDA, the accreditation body shall require or monitor
corrective actions, or suspend or revoke accreditation of the
facility.
- (2) The accreditation body shall inform FDA as soon
as possible but in no case longer than 2 business days after becoming
aware of equipment or practices that pose a serious risk to human
health.
- (3) The accreditation body shall establish and administer
a quality assurance (QA) program that has been approved by FDA
in accordance with Sec. 900.3(d) or paragraph (a)(8) of this section.
Such quality assurance program shall:
- (i) Include requirements for clinical image
review and phantom image review;
- (ii) Ensure that clinical and phantom images
are evaluated consistently and accurately; and
- (iii) Specify the methods and frequency of
training and evaluation for clinical and phantom image reviewers,
and the bases and procedures for removal of such reviewers.
- (4) The accreditation body shall establish measures
that FDA has approved in accordance with Sec. 900.3(d) or paragraph
(a)(8) of this section to reduce the possibility of conflict of
interest or facility bias on the part of individuals acting on
the body's behalf. Such individuals who review clinical or phantom
images under the provisions of paragraphs (c) and (d) of this
section or who visit facilities under the provisions of paragraph
(f) of this section shall not review clinical or phantom images
from or visit a facility with which such individuals maintain
a relationship, or when it would otherwise be a conflict of interest
for them to do so, or when they have a bias in favor of or against
the facility.
- (5) The accreditation body may require specific equipment
performance or design characteristics that FDA has approved. However,
no accreditation body shall require, either explicitly or implicitly,
the use of any specific brand of imaging system or component,
measuring device, software package, or other commercial product
as a condition for accreditation by the body, unless FDA determines
that it is in the best interest of public health to do so.
- (i) Any representation, actual or implied,
either orally, in sales literature, or in any other form of
representation, that the purchase or use of a particular product
brand is required in order for any facility to be accredited
or certified under Sec. 900.11(b), is prohibited, unless FDA
approves such representation.
- (ii) Unless FDA has approved the exclusive
use and promotion of a particular commercial product in accordance
with this section, all products produced, distributed, or sold
by an accreditation body or an organization that has a financial
or other relationship with the accreditation body that may be
a conflict of interest or have the appearance of a conflict
of interest with the body's accreditation functions, shall bear
a disclaimer stating that the purchase or use of such products
is not required for accreditation or certification of any facility
under Sec. 900.11(b). Any representations about such products
shall include a similar disclaimer.
- (6) When an accreditation body denies accreditation
to a facility, the accreditation body shall notify the facility
in writing and explain the bases for its decision. The notification
shall also describe the appeals process available from the accreditation
body for the facility to contest the decision.
- (7) No accreditation body may establish requirements
that preclude facilities from being accredited under Sec. 900.11(b)
by any other accreditation body, or require accreditation by itself
under MQSA if another accreditation body is available to a facility.
- (8) The accreditation body shall obtain FDA authorization
for any changes it proposes to make in any standards that FDA
has previously accepted under Sec. 900.3(d).
- (9) An accreditation body shall establish procedures
to protect confidential information it collects or receives in
its role as an accreditation body.
- (i) Nonpublic information collected from facilities
for the purpose of carrying out accreditation body responsibilities
shall not be used for any other purpose or disclosed, other
than to FDA or its duly designated representatives, including
State agencies, without the consent of the facility;
- (ii) Nonpublic information that FDA or its
duly designated representatives, including State agencies, share
with the accreditation body concerning a facility that is accredited
or undergoing accreditation by that body shall not be further
disclosed except with the written permission of FDA.
- (b) Monitoring facility compliance with quality standards.
- (1) The accreditation body shall require that each
facility it accredits meet standards for the performance of quality
mammography that are substantially the same as those in this subpart
and in subpart B of this part.
- (2) The accreditation body shall notify a facility
regarding equipment, personnel, and other aspects of the facility's
practice that do not meet such standards and advise the facility
that such equipment, personnel, or other aspects of the practice
should not be used by the facility for activities within the scope
of part 900.
- (3) The accreditation body shall specify the actions
that facilities shall take to correct deficiencies in equipment,
personnel, and other aspects of the practice to ensure facility
compliance with applicable standards.
- (4) If deficiencies cannot be corrected to ensure
compliance with standards or if a facility is unwilling to take
corrective actions, the accreditation body shall immediately so
notify FDA, and shall suspend or revoke the facility's accreditation
in accordance with the policies and procedures described under
Sec. 900.3(b)(3)(iii)(I).
- (c) Clinical image review for accreditation and reaccreditation.
- (1) Frequency of review. The accreditation
body shall review clinical images from each facility accredited
by the body at least once every 3 years.
- (2) Requirements for clinical image attributes.
The accreditation body shall use the following attributes for
all clinical image reviews, unless FDA has approved other attributes:
- (i) Positioning. Sufficient breast tissue
shall be imaged to ensure that cancers are not likely to be
missed because of inadequate positioning.
- (ii) Compression. Compression shall
be applied in a manner that minimizes the potential obscuring
effect of overlying breast tissue and motion artifact.
- (iii) Exposure level. Exposure level
shall be adequate to visualize breast structures. Images shall
be neither underexposed nor overexposed.
- (iv) Contrast. Image contrast shall
permit differentiation of subtle tissue density differences.
- (v) Sharpness. Margins of normal breast
structures shall be distinct and not blurred.
- (vi) Noise. Noise in the image shall
not obscure breast structures or suggest the appearance of structures
not actually present.
- (vii) Artifacts. Artifacts due to lint,
processing, scratches, and other factors external to the breast
shall not obscure breast structures or suggest the appearance
of structures not actually present.
- (viii) Examination identification. Each
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:
- (A) Name of the patient and an additional
patient identifier.
- (B) Date of examination.
- (C) 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 FDA in accordance with Sec. 900.3(d)
or paragraph (a)(8) of this section shall be used to identify
view and laterality.
- (D) Facility name and location. At a minimum, the location shall include the city, State,
and zip code of the facility.
- (E) Technologist identification.
- (F) Cassette/screen identification.
- (G) Mammography unit identification,
if there is more than one unit in the facility.
- (3) Scoring of clinical images. Accreditation
bodies shall establish and administer a system for scoring clinical
images using all attributes specified in paragraphs (c)(2)(i)
through (c)(2)(viii) of this section or an alternative system
that FDA has approved in accordance with Sec. 900.3(d) or paragraph
(a)(8) of this section. The scoring system shall include an evaluation
for each attribute.
- (i) The accreditation body shall establish
and employ criteria for acceptable and nonacceptable results
for each of the 8 attributes as well as an overall pass-fail
system for clinical image review that has been approved by
FDA in accordance with Sec. 900.3(d) or paragraph (a)(8) of
this section.
- (ii) All clinical images submitted by a facility
to the accreditation body shall be reviewed independently
by two or more review physicians.
- (4) Selection of clinical images for review.
Unless otherwise specified by FDA, the accreditation body shall
require that for each mammography unit in the facility:
- (i) The facility shall submit craniocaudal
(CC) and mediolateral oblique (MLO) views from two mammographic
examinations that the facility produced during a time period
specified by the accreditation body;
- (ii) Clinical images submitted from one such
mammographic examination for each unit shall be of dense breasts
(predominance of glandular tissue) and the other shall be
of fat-replaced breasts (predominance of adipose tissue);
- (iii) All clinical images submitted shall
be images that the facility's interpreting physician(s) interpreted
as negative or benign.
- (iv) If the facility has no clinical images
meeting the requirements in paragraphs (c)(4)(i) through (c)(4)(iii)
of this section, it shall so notify the accreditation body,
which shall specify alternative clinical image selection methods
that do not compromise care of the patient.
- (5) Review physicians. Accreditation bodies
shall ensure that all of their review physicians:
- (i) Meet the interpreting physician requirements
specified in Sec. 900.12(a)(1) and meet such additional requirements
as have been established by the accreditation body and approved
by FDA;
- (ii) Are trained and evaluated in the clinical
image review process, for the types of clinical images to
be evaluated by a review physician, by the accreditation body
before designation as review physicians and periodically thereafter;
and
- (iii) Clearly document their findings and
reasons for assigning a particular score to any clinical image
and provide information to the facility for use in improving
the attributes for which significant deficiencies were identified.
- (6) Image management. The accreditation body's
QA program shall include a tracking system to ensure the security
and return to the facility of all clinical images received and
to ensure completion of all clinical image reviews by the body
in a timely manner. The accreditation body shall return all clinical
images to the facility within 60 days of their receipt by the
body, with the following exceptions:
- (i) If the clinical images are needed earlier
by the facility for clinical purposes, the accreditation body
shall cooperate with the facility to accommodate such needs.
- (ii) If a review physician identifies a suspicious
abnormality on an image submitted for clinical image review,
the accreditation body shall ensure that this information
is provided to the facility and that the clinical images are
returned to the facility. Both shall occur no later than 10
business days after identification of the suspected abnormality.
- (7) Notification of unsatisfactory image quality. If the accreditation body determines that the clinical images
received from a facility are of unsatisfactory quality, the body
shall notify the facility of the nature of the problem and its
possible causes.
- (d) Phantom image review for accreditation and reaccreditation.
- (1) Frequency of review. The accreditation
body shall review phantom images from each facility accredited
by the body at least once every 3 years.
- (2) Requirements for the phantom used. The
accreditation body shall require that each facility submit for
review phantom images that the facility produced using a phantom
and methods of use specified by the body and approved by FDA in
accordance with Sec. 900.3(d) or paragraph (a)(8) of this section.
- (3) Scoring phantom images. The accreditation
body shall use a system for scoring phantom images that has been
approved by FDA in accordance with Sec. 900.3(b) and (d) or paragraph
(a)(8) of this section.
- (4) Phantom images selected for review. For
each mammography unit in the facility, the accreditation body
shall require the facility to submit phantom images that the facility
produced during a time period specified by the body.
- (5) Phantom image reviewers. Accreditation
bodies shall ensure that all of their phantom image reviewers:
- (i) Meet the requirements specified in Sec.
900.12(a)(3) or alternative requirements established by the
accreditation body and approved by FDA in accordance with Sec.
900.3 or paragraph (a)(8) of this section;
- (ii) Are trained and evaluated in the phantom
image review process, for the types of phantom images to be
evaluated by a phantom image reviewer, by the accreditation
body before designation as phantom image reviewers and periodically
thereafter; and
- (iii) Clearly document their findings and reasons
for assigning a particular score to any phantom image and provide
information to the facility for use in improving its phantom
image quality with regard to the significant deficiencies identified.
- (6) Image management. The accreditation body's
QA program shall include a tracking system to ensure the security
of all phantom images received and to ensure completion of all
phantom image reviews by the body in a timely manner. All phantom
images that result in a failure of accreditation shall be returned
to the facility.
- (7) Notification measures for unsatisfactory image
quality. If the accreditation body determines that the phantom
images received from a facility are of unsatisfactory quality,
the body shall notify the facility of the nature of the problem
and its possible causes.
- (e) Reports of mammography equipment evaluation, surveys,
and quality control. The following requirements apply to all
facility equipment covered by the provisions of subparts A and B:
- (1) The accreditation body shall require every facility
applying for accreditation to submit:
- (i) With its initial accreditation application,
a mammography equipment evaluation that was performed by a medical
physicist no earlier than 6 months before the date of application
for accreditation by the facility. Such evaluation shall demonstrate
compliance of the facility's equipment with the requirements
in Sec. 900.12(e).
- (ii) Prior to accreditation, a survey that
was performed no earlier than 6 months before the date of application
for accreditation by the facility. Such survey shall assess
the facility's compliance with the facility standards referenced
in paragraph (b) of this section.
- (2) The accreditation body shall require that all
facilities undergo an annual survey to ensure continued compliance
with the standards referenced in paragraph (b) of this section
and to provide continued oversight of facilities' quality control
programs as they relate to such standards. The accreditation body
shall require for all facilities that:
- (i) Such surveys be conducted annually;
- (ii) Facilities take reasonable steps to ensure
that they receive reports of such surveys within 30 days of
survey completion; and
- (iii) Facilities submit the results of such
surveys and any other information that the body may require
to the body at least annually.
- (3) The accreditation body shall review and analyze
the information required in this section and use it to identify
necessary corrective measures for facilities and to determine
whether facilities should remain accredited by the body.
- (f) Accreditation Body Onsite Visits and Random Clinical
Image Reviews. The accreditation body shall conduct onsite visits
and random clinical image reviews of a sample of facilities to monitor
and assess their compliance with standards established by the body
for accreditation. The accreditation body shall submit annually
to FDA, at the address given in Sec. 900.3(b)(1), 3 copies of a
summary report describing all facility assessments the body conducted
under the provisions of this section for the year being reported.
- (1) Onsite visits.
- (i) Sample size. Annually, each accreditation
body shall visit at least 5 percent of the facilities it accredits.
However, a minimum of 5 facilities shall be visited, and visits
to no more than 50 facilities are required, unless problems
identified in paragraph (f)(1)(i)(B) of this section indicate
a need to visit more than 50 facilities.
- (A) At least 50 percent of the facilities
visited shall be selected randomly.
- (B) Other facilities visited shall be
selected based on problems identified through State or FDA
inspections, serious complaints received from consumers or
others, a previous history of noncompliance, or any other
information in the possession of the accreditation body, inspectors,
or FDA.
- (C) Before, during, or after any facility
visit, the accreditation body may require that the facility
submit to the body for review clinical images, phantom images,
or any other information relevant to applicable standards
in this subpart and in subpart B of this part.
- (ii) Visit plan. The accreditation body
shall conduct facility onsite visits according to a visit plan
that has been approved by FDA in accordance with Sec. 900.3(d)
or paragraph (a)(8) of this section, unless otherwise directed
by FDA in particular circumstances. At a minimum, such a plan
shall provide for:
- (A) Assessment of overall clinical image
QA activities of the facility;
- (B) Review of facility documentation
to determine if appropriate mammography reports are sent to
patients and physicians as required;
- (C) Selection of a sample of clinical
images for clinical image review by the accreditation body.
Clinical images shall be selected in a manner specified by
the accreditation body and approved by FDA that does not compromise
care of the patient as a result of the absence of the selected
images from the facility;
- (D) Verification that the facility has
a medical audit system in place and is correlating films and
pathology reports for positive cases;
- (E) Verification that personnel specified
by the facility are the ones actually performing designated
personnel functions;
- (F) Verification that equipment specified
by the facility is the equipment that is actually being used
to perform designated equipment functions;
- (G) Verification that a consumer complaint
mechanism is in place and that the facility is following its
procedures; and
- (H) Review of all factors related to
previously identified concerns or concerns identified during
that visit.
- (2) Clinical image review for random sample of
facilities.
- (i) Sample size. In addition to conducting
clinical image reviews for accreditation and reaccreditation
for all facilities, the accreditation body shall conduct clinical
image reviews annually for a randomly selected sample as specified
by FDA, but to include at least 3 percent of the facilities
the body accredits. Accreditation bodies may count toward this
random sample requirement all facilities selected randomly for
the onsite visits described in paragraph (f)(1)(i)(A) of this
section. Accreditation bodies shall not count toward the random
sample requirement any facilities described in paragraph (f)(1)(i)(B)
of this section that were selected for a visit because of previously
identified concerns.
- (ii) Random clinical image review. In
performing clinical image reviews of the random sample of facilities,
accreditation bodies shall evaluate the same attributes as those
in paragraph (c) of this section for review of clinical images
for accreditation and reaccreditation.
- (iii) Accreditation bodies should not schedule
random clinical image reviews at facilities that have received
notification of the need to begin the accreditation renewal
process or that have completed the accreditation renewal process
within the previous 6 months.
- (iv) Selection of the random sample of clinical
images for clinical image review by the accreditation body. Clinical images shall be selected in a manner, specified by
the accreditation body and approved by FDA under Sec. 900.3(d)
or paragraph (a)(8) of this section, that does not compromise
care of the patient as a result of the absence of the selected
images from the facility.
- (g) Consumer complaint mechanism. The accreditation
body shall develop and administer a written and documented system,
including timeframes, for collecting and resolving serious consumer
complaints that could not be resolved at a facility. Such system
shall have been approved by FDA in accordance with Sec. 900.3(d)
or paragraph (a)(8) of this section. Accordingly, all accreditation
bodies shall:
- (1) Provide a mechanism for all facilities it accredits
to file serious unresolved complaints with the accreditation body;
- (2) Maintain a record of every serious unresolved
complaint received by the body on all facilities it accredits
for a period of at least 3 years from the date of receipt of each
such complaint;
- (h) Reporting and recordkeeping. All reports to
FDA specified in paragraphs (h)(1) through (h)(4) of this section
shall be prepared and submitted in a format and medium prescribed
by FDA and shall be submitted to a location and according to a schedule
specified by FDA. The accreditation body shall:
- (1) Collect and submit to FDA the information required
by 42 U.S.C. 263b(d) for each facility when the facility is initially
accredited and at least annually when updated, in a manner and
at a time specified by FDA.
- (2) Accept applications containing the information
required in 42 U.S.C. 263b(c)(2) for provisional certificates
and in Sec. 900.11(b)(3) for extension of provisional certificates,
on behalf of FDA, and notify FDA of the receipt of such information;
- (3) Submit to FDA the name, identifying information,
and other information relevant to 42 U.S.C. 263b and specified
by FDA for any facility for which the accreditation body denies,
suspends, or revokes accreditation, and the reason(s) for such
action;
- (4) Submit to FDA an annual report summarizing all
serious complaints received during the previous calendar year,
their resolution status, and any actions taken in response to
them;
- (5) Provide to FDA other information relevant to
42 U.S.C. 263b and required by FDA about any facility accredited
or undergoing accreditation by the body.
- (i) Fees. Fees charged to facilities for accreditation
shall be reasonable. Costs of accreditation body activities that
are not related to accreditation functions under 42 U.S.C. 263b
are not recoverable through fees established for accreditation.
- (1) The accreditation body shall make public its
fee structure, including those factors, if any, contributing to
variations in fees for different facilities.
- (2) At FDA's request, accreditation bodies shall
provide financial records or other material to assist FDA in assessing
the reasonableness of accreditation body fees. Such material shall
be provided to FDA in a manner and time period specified by the
agency.
Sec. 900.5 Evaluation.
FDA shall evaluate annually the performance of each accreditation body.
Such evaluation shall include an assessment of the reports of FDA or State
inspections of facilities accredited by the body as well as any additional
information deemed relevant by FDA that has been provided by the accreditation
body or other sources or has been required by FDA as part of its oversight
initiatives. The evaluation shall include a determination of whether there
are major deficiencies in the accreditation body's performance that, if
not corrected, would warrant withdrawal of the approval of the accreditation
body under the provisions of Sec. 900.6.
Sec. 900.6 Withdrawal of approval.
If FDA determines, through the evaluation activities of Sec. 900.5, or
through other means, that an accreditation body is not in substantial
compliance with this subpart, FDA may initiate the following actions:
- (a) Major deficiencies. If FDA determines that an
accreditation body has failed to perform a major accreditation function
satisfactorily, has demonstrated willful disregard for public health,
has violated the code of conduct, has committed fraud, or has submitted
material false statements to the agency, FDA may withdraw its approval
of that accreditation body.
- (1) FDA shall notify the accreditation body of the
agency's action and the grounds on which the approval was withdrawn.
- (2) An accreditation body that has lost its approval
shall notify facilities accredited or seeking accreditation by
it that its approval has been withdrawn. Such notification shall
be made within a time period and in a manner approved by FDA.
- (b) Minor deficiencies. If FDA determines that an
accreditation body has demonstrated deficiencies in performing accreditation
functions and responsibilities that are less serious or more limited
than the deficiencies in paragraph (a) of this section, FDA shall
notify the body that it has a specified period of time to take particular
corrective measures directed by FDA or to submit to FDA for approval
the body's own plan of corrective action addressing the minor deficiencies.
FDA may place the body on probationary status for a period of time
determined by FDA, or may withdraw approval of the body as an accreditation
body if corrective action is not taken.
- (1) If FDA places an accreditation body on probationary
status, the body shall notify all facilities accredited or seeking
accreditation by it of its probationary status within a time period
and in a manner approved by FDA.
- (2) Probationary status shall remain in effect until
such time as the body can demonstrate to the satisfaction of FDA
that it has successfully implemented or is implementing the corrective
action plan within the established schedule, and that the corrective
actions have substantially eliminated all identified problems.
- (3) If FDA determines that an accreditation body
that has been placed on probationary status is not implementing
corrective actions satisfactorily or within the established schedule,
FDA may withdraw approval of the accreditation body. The accreditation
body shall notify all facilities accredited or seeking accreditation
by it of its loss of FDA approval, within a time period and in
a manner approved by FDA.
- (c) Reapplication by accreditation bodies that have
had their approval withdrawn.
- (1) A former accreditation body that has had its
approval withdrawn may submit a new application for approval if
the body can provide information to FDA to establish that the
problems that were grounds for withdrawal of approval have been
resolved.
- (2) If FDA determines that the new application demonstrates
that the body satisfactorily has addressed the causes of its previous
unacceptable performance, FDA may reinstate approval of the accreditation
body.
- (3) FDA may request additional information or establish
additional conditions that must be met by a former accreditation
body before FDA approves the reapplication.
- (4) FDA may refuse to accept an application from
a former accreditation body whose approval was withdrawn because
of fraud or willful disregard of public health.
Sec. 900.7 Hearings.
- (a) Opportunities to challenge final adverse actions taken
by FDA regarding approval or reapproval of accreditation bodies,
withdrawal of approval of accreditation bodies, or rejection of
a proposed fee for accreditation shall be communicated through notices
of opportunity for informal hearings in accordance with part 16
of this chapter.
- (b) A facility that has been denied accreditation is entitled
to an appeals process from the accreditation body. The appeals process
shall be specified in writing by the accreditation body and shall
have been approved by FDA in accordance with Sec. 900.3(d) or Sec.
900.4(a)(8).
- (c) A facility that cannot achieve satisfactory resolution
of an adverse accreditation decision through the accreditation body's
appeals process may appeal to FDA for reconsideration in accordance
with Sec. 900.15.
Secs. 900.8--900.9 [Reserved]
Subpart B--Quality Standards and Certification
Sec. 900.10 Applicability.
The provisions of subpart B are applicable to all facilities under the
regulatory jurisdiction of the United States that provide mammography
services, with the exception of the Department of Veterans Affairs.
Sec. 900.11 Requirements for certification.
- (a) General. After October 1, 1994, a certificate
issued by FDA is required for lawful operation of all mammography
facilities subject to the provisions of this subpart. To obtain
a certificate from FDA, facilities are required to meet the quality
standards in Sec. 900.12 and to be accredited by an approved accreditation
body or other entity as designated by FDA.
- (b) Application.
- (1) Certificates.
- (i) In order to qualify for a certificate,
a facility must apply to an FDA-approved accreditation body,
or to another entity designated by FDA. The facility shall submit
to such body or entity the information required in 42 U.S.C.
263b(d)(1).
- (ii) Following the agency's receipt of the
accreditation body's decision to accredit a facility, or an
equivalent decision by another entity designated by FDA, the
agency may issue a certificate to the facility, or renew an
existing certificate, if the agency determines that the facility
has satisfied the requirements for certification or recertification.
- (2) Provisional certificates.
- (i) A new facility beginning operation after
October 1, 1994, is eligible to apply for a provisional certificate.
The provisional certificate will enable the facility to perform
mammography and to obtain the clinical images needed to complete
the accreditation process. To apply for and receive a provisional
certificate, a facility must meet the requirements of 42 U.S.C.
263b(c)(2) and submit the necessary information to an approved
accreditation body or other entity designated by FDA.
- (ii) Following the agency's receipt of the
accreditation body's decision that a facility has submitted
the required information, FDA may issue a provisional certificate
to a facility upon determination that the facility has satisfied
the requirements of Sec. 900.11(b)(2)(i). A provisional certificate
shall be effective for up to 6 months from the date of issuance.
A provisional certificate cannot be renewed, but a facility
may apply for a 90-day extension of the provisional certificate.
- (3) Extension of provisional certificate.
- (i) To apply for a 90-day extension to a provisional
certificate, a facility shall submit to its accreditation body,
or other entity designated by FDA, a statement of what the facility
is doing to obtain certification and evidence that there would
be a significant adverse impact on access to mammography in
the geographic area served if such facility did not obtain an
extension.
- (ii) The accreditation body shall forward the
request, with its recommendation, to FDA within 2 business days
after receipt.
- (iii) FDA may issue a 90-day extension for
a provisional certificate upon determination that the extension
meets the criteria set forth in 42 U.S.C. 263b(c)(2).
- (iv) There can be no renewal of a provisional
certificate beyond the 90-day extension.
- (c) Reinstatement policy. A previously certified
facility that has allowed its certificate to expire, that has been
refused a renewal of its certificate by FDA, or that has had its
certificate suspended or revoked by FDA, may apply to have the certificate
reinstated so that the facility may be considered to be a new facility
and thereby be eligible for a provisional certificate.
- (1) Unless prohibited from reinstatement under Sec.
900.11(c)(4), a facility applying for reinstatement shall:
- (i) Contact an FDA-approved accreditation body
or other entity designated by FDA to determine the requirements
for reapplication for accreditation;
- (ii) Fully document its history as a previously
provisionally certified or certified mammography facility, including
the following information:
- (A) Name and address of the facility
under which it was previously provisionally certified or certified;
- (B) Name of previous owner/lessor;
- (C) FDA facility identification number
assigned to the facility under its previous certification;
and
- (D) Expiration date of the most recent
FDA provisional certificate or certificate; and
- (iii) Justify application for reinstatement
of accreditation by submitting to the accreditation body or
other entity designated by FDA, a corrective action plan that
details how the facility has corrected deficiencies that contributed
to the lapse of, denial of renewal, or revocation of its certificate.
- (2) FDA may issue a provisional certificate to the
facility if:
- (i) The accreditation body or other entity
designated by FDA notifies the agency that the facility has
adequately corrected, or is in the process of correcting, pertinent
deficiencies; and
- (ii) FDA determines that the facility has taken
sufficient corrective action since the lapse of, denial of renewal,
or revocation of its previous certificate.
- (3) After receiving the provisional certificate,
the facility may lawfully resume performing mammography services
while completing the requirements for certification.
- (4) If a facility's certificate was revoked on the
basis of an act described in 41 U.S.C. 263b(i)(1), no person who
owned or operated that facility at the time the act occurred may
own or operate a mammography facility within 2 years of the date
of revocation.
Sec. 900.12 Quality standards.
- (a) Personnel. The following requirements apply to
all personnel involved in any aspect of mammography, including the
production, processing, and interpretation of mammograms and related
quality assurance activities:
- (1) Interpreting physicians. All physicians
interpreting mammograms shall meet the following qualifications:
- (i) Initial qualifications. Unless the
exemption in paragraph (a)(1)(iii)(A) of this section applies,
before beginning to interpret mammograms independently, the
interpreting physician shall:
- (A) Be licensed to practice medicine
in a State;
- (B) (1) Be certified in an
appropriate specialty area by a body determined by FDA to
have procedures and requirements adequate to ensure that physicians
certified by the body are competent to interpret radiological
procedures, including mammography; or
- (2) Have had at least 3
months of documented formal training in the interpretation
of mammograms and in topics related to mammography. The
training shall include instruction in radiation physics,
including radiation physics specific to mammography, radiation
effects, and radiation protection. The mammographic interpretation
component shall be under the direct supervision of a physician
who meets the requirements of paragraph (a)(1) of this section;
- (C) Have a minimum of 60 hours of documented
medical education in mammography, which shall include: Instruction
in the interpretation of mammograms and education in basic
breast anatomy, pathology, physiology, technical aspects of
mammography, and quality assurance and quality control in
mammography. All 60 of these hours shall be category I and
at least 15 of the category I hours shall have been acquired
within the 3 years immediately prior to the date that the
physician qualifies as an interpreting physician. Hours spent
in residency specifically devoted to mammography will be considered
as equivalent to Category I continuing medical education credits
and will be accepted if documented in writing by the appropriate
representative of the training institution; and
- (D) Unless the exemption in paragraph
(a)(1)(iii)(B) of this section applies, have interpreted or
multi-read at least 240 mammographic examinations within the
6-month period immediately prior to the date that the physician
qualifies as an interpreting physician. This interpretation
or multi-reading shall be under the direct supervision of
an interpreting physician.
- (ii) Continuing experience and education.
All interpreting physicians shall maintain their qualifications
by meeting the following requirements:
- (A) Following the second anniversary
date of the end of the calendar quarter in which the requirements
of paragraph (a)(1)(i) of this section were completed, the
interpreting physician shall have interpreted or multi-read
at least 960 mammographic examinations during the 24 months
immediately preceding the date of the facility's annual MQSA
inspection or the last day of the calendar quarter preceding
the inspection or any date in-between the two. The facility
will choose one of these dates to determine the 24-month period.
- (B) Following the third anniversary date
of the end of the calendar quarter in which the requirements
of paragraph (a)(1)(i) of this section were completed, the
interpreting physician shall have taught or completed at least
15 category I continuing medical education units in mammography
during the 36 months immediately preceding the date of the
facility's annual MQSA inspection or the last day of the calendar
quarter preceding the inspection or any date in between the
two. The facility will choose one of these dates to determine
the 36-month period. This training shall include at least
six category I continuing medical education credits in each
mammographic modality used by the interpreting physician in
his or her practice; and
- (C) Before an interpreting physician
may begin independently interpreting mammograms produced by
a new mammographic modality, that is, a mammographic modality
in which the physician has not previously been trained, the
interpreting physician shall have at least 8 hours of training
in the new mammographic modality.
- (D) Units earned through teaching a specific
course can be counted only once towards the 15 required by
paragraph (a)(1)(ii)(B) of this section, even if the course
is taught multiple times during the previous 36 months.
- (iii) Exemptions.
- (A) Those physicians who qualified as
interpreting physicians under paragraph (a)(1) of this section
of FDA's interim regulations prior to April 28, 1999, are
considered to have met the initial requirements of paragraph
(a)(1)(i) of this section. They may continue to interpret
mammograms provided they continue to meet the licensure requirement
of paragraph (a)(1)(i)(A) of this section and the continuing
experience and education requirements of paragraph (a)(1)(ii)
of this section.
- (B) Physicians who have interpreted or
multi-read at least 240 mammographic examinations under the
direct supervision of an interpreting physician in any 6-month
period during the last 2 years of a diagnostic radiology residency
and who become appropriately board certified at the first
allowable time, as defined by an eligible certifying body,
are otherwise exempt from paragraph (a)(1)(i)(D) of this section.
- (iv) Reestablishing qualifications.
Interpreting physicians who fail to maintain the required continuing
experience or continuing education requirements shall reestablish
their qualifications before resuming the independent interpretation
of mammograms, as follows:
- (A) Interpreting physicians who fail
to meet the continuing experience requirements of paragraph
(a)(1)(ii)(A) of this section shall:
- (1) Interpret or multi-read
at least 240 mammographic examinations under the direct
supervision of an interpreting physician, or
- (2) Interpret or multi-read
a sufficient number of mammographic examinations, under
the direct supervision of an interpreting physician, to
bring the physician's total up to 960 examinations for the
prior 24 months, whichever is less.
- (3) The interpretations
required under paragraph (a)(1)(iv)(A)(1) or (a)(1)(iv)(A)(2)
of this section shall be done within the 6 months immediately
prior to resuming independent interpretation.
- (B) Interpreting physicians who fail
to meet the continuing education requirements of paragraph
(a)(1)(ii)(B) of this section shall obtain a sufficient number
of additional category I continuing medical education credits
in mammography to bring their total up to the required 15
credits in the previous 36 months before resuming independent
interpretation.
- (2) Radiologic technologists. All mammographic
examinations shall be performed by radiologic technologists who
meet the following general requirements, mammography requirements,
and continuing education and experience requirements:
- (i) General requirements.
- (A) Be licensed to perform general radiographic
procedures in a State; or
- (B) Have general certification from one
of the bodies determined by FDA to have procedures and requirements
adequate to ensure that radiologic technologists certified
by the body are competent to perform radiologic examinations;
and
- (ii) Mammography requirements. Have,
prior to April 28, 1999, qualified as a radiologic technologist
under paragraph (a)(2) of this section of FDA's interim regulations
of December 21, 1993, or completed at least 40 contact hours
of documented training specific to mammography under the supervision
of a qualified instructor. The hours of documented training
shall include, but not necessarily be limited to:
- (A) Training in breast anatomy and physiology,
positioning and compression, quality assurance/quality control
techniques, imaging of patients with breast implants;
- (B) The performance of a minimum of 25
examinations under the direct supervision of an individual
qualified under paragraph (a)(2) of this section; and
- (C) At least 8 hours of training in each
mammography modality to be used by the technologist in performing
mammography exams; and
- (iii) Continuing education requirements.
- (A) Following the third anniversary date
of the end of the calendar quarter in which the requirements
of paragraphs (a)(2)(i) and (a)(2)(ii) of this section were
completed, the radiologic technologist shall have taught or
completed at least 15 continuing education units in mammography
during the 36 months immediately preceding the date of the
facility's annual MQSA inspection or the last day of the calendar
quarter preceding the inspection or any date in between the
two. The facility will choose one of these dates to determine
the 36-month period.
- (B) Units earned through teaching a specific
course can be counted only once towards the 15 required in
paragraph (a)(2)(iii)(A) of this section, even if the course
is taught multiple times during the previous 36 months.
- (C) At least six of the continuing education
units required in paragraph (a)(2)(iii)(A) of this section
shall be related to each mammographic modality used by the
technologist.
- (D) Requalification. Radiologic
technologists who fail to meet the continuing education requirements
of paragraph (a)(2)(iii)(A) of this section shall obtain a
sufficient number of continuing education units in mammography
to bring their total up to at least 15 in the previous 3 years,
at least 6 of which shall be related to each modality used
by the technologist in mammography. The technologist may not
resume performing unsupervised mammography examinations until
the continuing education requirements are completed.
- (E) Before a radiologic technologist
may begin independently performing mammographic examinations
using a mammographic modality other than one of those for
which the technologist received training under paragraph (a)(2)(ii)(C)
of this section, the technologist shall have at least 8 hours
of continuing education units in the new modality.
- (iv) Continuing experience requirements.
- (A) Following the second anniversary
date of the end of the calendar quarter in which the requirements
of paragraphs (a)(2)(i) and (a)(2)(ii) of this section were
completed or of April 28, 1999, whichever is later, the radiologic
technologist shall have performed a minimum of 200 mammography
examinations during the 24 months immediately preceding the
date of the facility's annual MQSA inspection or the last
day of the calendar quarter preceding the inspection or any
date in between the two. The facility will choose one of these
dates to determine the 24-month period.
- (B) Requalification. Radiologic
technologists who fail to meet the continuing experience requirements
of paragraph (a)(2)(iv)(A) of this section shall perform a
minimum of 25 mammography examinations under the direct supervision
of a qualified radiologic technologist, before resuming the
performance of unsupervised mammography examinations.
- (3) Medical physicists. All medical physicists
conducting surveys of mammography facilities and providing oversight
of the facility quality assurance program under paragraph (e)
of this section shall meet the following:
- (i) Initial qualifications.
- (A) Be State licensed or approved or
have certification in an appropriate specialty area by one
of the bodies determined by FDA to have procedures and requirements
to ensure that medical physicists certified by the body are
competent to perform physics survey; and
- (B) (1) Have a masters degree
or higher in a physical science from an accredited institution,
with no less than 20 semester hours or equivalent (e.g., 30
quarter hours) of college undergraduate or graduate level
physics;
- (2) Have 20 contact hours
of documented specialized training in conducting surveys
of mammography facilities; and
- (3) Have the experience
of conducting surveys of at least 1 mammography facility
and a total of at least 10 mammography units. No more than
one survey of a specific unit within a period of 60 days
can be counted towards the total mammography unit survey
requirement. After April 28, 1999, experience conducting
surveys must be acquired under the direct supervision of
a medical physicist who meets all the requirements of paragraphs
(a)(3)(i) and (a)(3)(iii) of this section; or
- (ii) Alternative initial qualifications.
- (A) Have qualified as a medical physicist
under paragraph (a)(3) of this section of FDA's interim regulations
and retained that qualification by maintenance of the active
status of any licensure, approval, or certification required
under the interim regulations; and
- (B) Prior to the April 28, 1999, have:
- (1) A bachelor's degree
or higher in a physical science from an accredited institution
with no less than 10 semester hours or equivalent of college
undergraduate or graduate level physics,
- (2) Forty contact hours
of documented specialized training in conducting surveys
of mammography facilities and,
- (3) Have the experience
of conducting surveys of at least 1 mammography facility
and a total of at least 20 mammography units. No more than
one survey of a specific unit within a period of 60 days
can be counted towards the total mammography unit survey
requirement. The training and experience requirements must
be met after fulfilling the degree requirement.
- (iii) Continuing qualifications.
- (A) Continuing education. Following the
third anniversary date of the end of the calendar quarter
in which the requirements of paragraph (a)(3)(i) or (a)(3)(ii)
of this section were completed, the medical physicist shall
have taught or completed at least 15 continuing education
units in mammography during the 36 months immediately preceding
the date of the facility's annual inspection or the last day
of the calendar quarter preceding the inspection or any date
in between the two. The facility shall choose one of these
dates to determine the 36-month period. This continuing education
shall include hours of training appropriate to each mammographic
modality evaluated by the medical physicist during his or
her surveys or oversight of quality assurance programs. Units
earned through teaching a specific course can be counted only
once towards the required 15 units in a 36-month period, even
if the course is taught multiple times during the 36 months.
- (B) Continuing experience. Following
the second anniversary date of the end of the calendar quarter
in which the requirements of paragraph (a)(3)(i) or (a)(3)(ii)
of this section were completed or of April 28, 1999, whichever
is later, the medical physicist shall have surveyed at least
two mammography facilities and a total of at least six mammography
units during the 24 months immediately preceding the date
of the facility's annual MQSA inspection or the last day of
the calendar quarter preceding the inspection or any date
in-between the two. The facility shall choose one of these
dates to determine the 24-month period. No more than one survey
of a specific facility within a 10-month period or a specific
unit within a period of 60 days can be counted towards this
requirement.
- (C) Before a medical physicist may begin
independently performing mammographic surveys of a new mammographic
modality, that is, a mammographic modality other than one
for which the physicist received training to qualify under
paragraph (a)(3)(i) or (a)(3)(ii) of this section, the physicist
must receive at least 8 hours of training in surveying units
of the new mammographic modality.
- (iv) Reestablishing qualifications.
Medical physicists who fail to maintain the required continuing
qualifications of paragraph (a)(3)(iii) of this section may
not perform the MQSA surveys without the supervision of a qualified
medical physicist. Before independently surveying another facility,
medical physicists must reestablish their qualifications, as
follows:
- (A) Medical physicists who fail to meet
the continuing educational requirements of paragraph (a)(3)(iii)(A)
of this section shall obtain a sufficient number of continuing
education units to bring their total units up to the required
15 in the previous 3 years.
- (B) Medical physicists who fail to meet
the continuing experience requirement of paragraph (a)(3)(iii)(B)
of this section shall complete a sufficient number of surveys
under the direct supervision of a medical physicist who meets
the qualifications of paragraphs (a)(3)(i) and (a)(3)(iii)
of this section to bring their total surveys up to the required
two facilities and six units in the previous 24 months. No
more than one survey of a specific unit within a period of
60 days can be counted towards the total mammography unit
survey requirement.
- (4) Retention of personnel records. Facilities
shall maintain records to document the qualifications of all personnel
who worked at the facility as interpreting physicians, radiologic
technologists, or medical physicists. These records must be available
for review by the MQSA inspectors. Records of personnel no longer
employed by the facility should not be discarded until the next
annual inspection has been completed and FDA has determined that
the facility is in compliance with the MQSA personnel requirements.
- (b) Equipment. Regulations published under Secs.
1020.30, 1020.31, and 900.12(e) of this chapter that are relevant
to equipment performance should also be consulted for a more complete
understanding of the equipment performance requirements.
- (1) Prohibited equipment. Radiographic equipment
designed for general purpose or special nonmammography procedures
shall not be used for mammography. This prohibition includes systems
that have been modified or equipped with special attachments for
mammography. This requirement supersedes the implied acceptance
of such systems in Sec. 1020.31(f)(3) of this chapter.
- (2) General. All radiographic equipment used
for mammography shall be specifically designed for mammography
and shall be certified pursuant to Sec. 1010.2 of this chapter
as meeting the applicable requirements of Secs. 1020.30 and 1020.31
of this chapter in effect at the date of manufacture.
- (3) Motion of tube-image receptor assembly.
- (i) 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.
- (ii) The mechanism ensuring compliance with
paragraph (b)(3)(i) of this section shall not fail in the event
of power interruption.
- (4) Image receptor sizes.
- (i) Systems using screen-film image receptors
shall provide, at a minimum, for operation with image receptors
of 18 x 24 centimeters (cm) and 24 x 30 cm.
- (ii) Systems using screen-film image receptors
shall be equipped with moving grids matched to all image receptor
sizes provided.
- (iii) Systems used for magnification procedures
shall be capable of operation with the grid removed from between
the source and image receptor.
- (5) Light fields. For any mammography 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 cm or the maximum source-image
receptor distance (SID), whichever is less.
- (6) Magnification.
- (i) Systems used to perform noninterventional
problem solving procedures shall have radiographic magnification
capability available for use by the operator.
- (ii) Systems used for magnification procedures
shall provide, at a minimum, at least one magnification value
within the range of 1.4 to 2.0.
- (7) Focal spot selection.
- (i) When more than one focal spot is provided,
the system shall indicate, prior to exposure, which focal spot
is selected.
- (ii) When more than one target material is
provided, the system shall indicate, prior to exposure, the
preselected target material.
- (iii) When the target material and/or focal
spot 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 and/or focal spot actually
used during the exposure.
- (8) Compression. All mammography systems shall
incorporate a compression device.
- (i) Application of compression. Effective
October 28, 2002, each system shall provide:
- (A) An initial power-driven compression
activated by hands-free controls operable from both sides
of the patient; and
- (B) Fine adjustment compression controls
operable from both sides of the patient.
- (ii) Compression paddle.
- (A) 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 the requirements of paragraphs (b)(8)(ii)(D)
and (b)(8)(ii)(E) of this section.
- (B) Except as provided in paragraph (b)(8)(ii)(C)
of this section, 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.
- (C) Equipment intended by the manufacturer's
design to not be flat and parallel to the breast support table
during compression shall meet the manufacturer's design specifications
and maintenance requirements.
- (D) The chest wall edge of the compression
paddle shall be straight and parallel to the edge of the image
receptor.
- (E) The chest wall edge may be bent
upward to allow for patient comfort but shall not appear on
the image.
- (9) Technique factor selection and display.
- (i) Manual selection of milliampere seconds
(mA's) or at least one of its component parts (milliampere (mA)
and/or time) shall be available.
- (ii) The technique factors (peak tube potential
in kilovolt (kV) and either tube current in mA and exposure
time in seconds or the product of tube current and exposure
time in mA's) to be used during an exposure shall be indicated
before the exposure begins, except when automatic exposure controls
(AEC) are used, in which case the technique factors that are
set prior to the exposure shall be indicated.
- (iii) Following AEC mode use, the system shall
indicate the actual kilovoltage peak (kVp) and mA's used during
the exposure. The mA's may be displayed as mA and time.
- (10) Automatic exposure control.
- (i) Each screen-film system shall provide an
AEC mode that is operable in all combinations of equipment configuration
provided, e.g., grid, nongrid; magnification, nonmagnification;
and various target-filter combinations.
- (ii) The positioning or selection of the detector
shall permit flexibility in the placement of the detector under
the target tissue.
- (A) The size and available positions
of the detector shall be clearly indicated at the X-ray input
surface of the breast compression paddle.
- (B) The selected position of the detector
shall be clearly indicated.
- (iii) The system shall provide means for the
operator to vary the selected optical density from the normal
(zero) setting.
- (11) X-ray film. The facility shall use X-ray
film for mammography that has been designated by the film manufacturer
as appropriate for mammography.
- (12) Intensifying screens. The facility shall
use intensifying screens for mammography that have been designated
by the screen manufacturer as appropriate for mammography and
shall use film that is matched to the screen's spectral output
as specified by the manufacturer.
- (13) Film processing solutions. For processing
mammography films, the facility shall use chemical solutions that
are capable of developing the films used by the facility in a
manner equivalent to the minimum requirements specified by the
film manufacturer.
- (14) Lighting. The facility shall make special
lights for film illumination, i.e., hot-lights, capable of producing
light levels greater than that provided by the view box, available
to the interpreting physicians.
- (15) Film masking devices. Facilities shall
ensure that film masking devices that can limit the illuminated
area to a region equal to or smaller than the exposed portion
of the film are available to all interpreting physicians interpreting
for the facility.
- (c) Medical records and mammography reports—
- (1) Contents and terminology. Each facility
shall prepare a written report of the results of each mammography
examination performed under its certificate. The mammography report
shall include the following information:
- (i) The name of the patient and an additional
patient identifier;
- (ii) Date of examination;
- (iii) The name of the interpreting physician
who interpreted the mammogram;
- (iv) Overall final assessment of findings,
classified in one of the following categories:
- (A) "Negative:" Nothing to
comment upon (if the interpreting physician is aware of clinical
findings or symptoms, despite the negative assessment, these
shall be explained);
- (B) "Benign:" Also a negative
assessment;
- (C) "Probably Benign:" Finding(s)
has a high probability of being benign;
- (D) "Suspicious:" Finding(s)
without all the characteristic morphology of breast cancer
but indicating a definite probability of being malignant;
- (E) "Highly suggestive of malignancy:"
Finding(s) has a high probability of being malignant;
- (v) In cases where no final assessment category
can be assigned due to incomplete work-up, "Incomplete:
Need additional imaging evaluation" shall be assigned as
an assessment and reasons why no assessment can be made shall
be stated by the interpreting physician; and
- (vi) 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.
- (2) Communication of mammography results to the
patients. Each facility shall send each patient a summary
of the mammography report written in lay terms within 30 days
of the mammographic examination. If assessments are "Suspicious"
or "Highly suggestive of malignancy," the facility shall
make reasonable attempts to ensure that the results are communicated
to the patient as soon as possible.
- (i) Patients who do not name a health care
provider to receive the mammography report shall be sent the
report described in paragraph (c)(1) of this section within
30 days, in addition to the written notification of results
in lay terms.
- (ii) Each facility that accepts patients who
do not have a health care provider shall maintain a system for
referring such patients to a health care provider when clinically
indicated.
- (3) Communication of mammography 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:
- (i) Provide a written report of the mammography
examination, including the items listed in paragraph (c)(1)
of this section, to that health care provider as soon as possible,
but no later than 30 days from the date of the mammography
examination; and
- (ii) 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.
- (4) Recordkeeping. Each facility that performs
mammograms:
- (i) Shall (except as provided in paragraph
(c)(4)(ii) of this section) maintain mammography films and
reports in a permanent medical record of the patient for a
period of not less than 5 years, or not less than 10 years
if no additional mammograms of the patient are performed at
the facility, or a longer period if mandated by State or local
law; and
- (ii) 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;
- (iii) Any fee charged to the patients for
providing the services in paragraph (c)(4)(ii) of this section
shall not exceed the documented costs associated with this
service.
- (5) 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:
- (i) Name of patient and an additional patient
identifier.
- (ii) Date of examination.
- (iii) 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 FDA in accordance with Sec. 900.3(b) or Sec. 900.4(a)(8)
shall be used to identify view and laterality.
- (iv) Facility name and location. At
a minimum, the location shall include the city, State, and
zip code of the facility.
- (v) Technologist identification.
- (vi) Cassette/screen identification.
- (vii) Mammography unit identification, if
there is more than one unit in the facility.
- (d) Quality assurance—general. 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.
- (1) 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.
- (i) 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 paragraphs
(d) through (f) of this section. 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.
- (ii) 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.
- (iii) 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 reports described in paragraphs (e)(9)
and (e)(10) of this section.
- (iv) 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
paragraph (e) of this section.
- (2) Quality assurance records. The lead interpreting
physician, quality control technologist, and medical physicist
shall ensure that records concerning 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, protection and
employee qualifications to meet assigned quality assurance tasks
are properly maintained and updated. These quality control records
shall be kept for each test specified in paragraphs (e) and (f)
of this section until the next annual inspection has been completed
and FDA 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.
- (e) Quality assurance—equipment—
- (1) Daily quality control tests. Film processors
used to develop mammograms shall be adjusted and maintained to
meet the technical development specifications for the mammography
film in use. A processor performance test shall be performed on
each day that clinical films are processed before any clinical
films are processed that day. The test shall include an assessment
of base plus fog density, mid-density, and density difference,
using the mammography film used clinically at the facility.
- (i) The base plus fog density shall be within
+ 0.03 of the established operating level.
- (ii) The mid-density shall be within +/-
0.15 of the established operating level.
- (iii) The density difference shall be within
+/- 0.15 of the established operating level.
- (2) Weekly quality control tests. Facilities
with screen-film systems shall perform an image quality evaluation
test, using an FDA-approved phantom, at least weekly.
- (i) The optical density of the film at the
center of an image of a standard FDA-accepted phantom shall
be at least 1.20 when exposed under a typical clinical condition.
- (ii) The optical density of the film at the
center of the phantom image shall not change by more than +/-
0.20 from the established operating level.
- (iii) The phantom image shall achieve at least
the minimum score established by the accreditation body and
accepted by FDA in accordance with Sec. 900.3(d) or Sec. 900.4(a)(8).
- (iv) The density difference between the background
of the phantom and an added test object, used to assess image
contrast, shall be measured and shall not vary by more than
+/- 0.05 from the established operating level.
- (3) Quarterly quality control tests. Facilities
with screen-film systems shall perform the following quality control
tests at least quarterly:
- (i) Fixer retention in film. The residual
fixer shall be no more than 5 micrograms per square cm.
- (ii) Repeat analysis. If the total repeat
or reject rate changes from the previously determined rate by
more than 2.0 percent of the total films included in the analysis,
the reason(s) for the change shall be determined. Any corrective
actions shall be recorded and the results of these corrective
actions shall be assessed.
- (4) Semiannual quality control tests. Facilities
with screen-film systems shall perform the following quality control
tests at least semiannually:
- (i) Darkroom fog. The optical density
attributable to darkroom fog shall not exceed 0.05 when a mammography
film of the type used in the facility, which has a mid-density
of no less than 1.2 OD, is exposed to typical darkroom conditions
for 2 minutes while such film is placed on the counter top emulsion
side up. If the darkroom has a safelight used for mammography
film, it shall be on during this test.
- (ii) Screen-film contact. Testing for
screen-film contact shall be conducted using 40 mesh copper
screen. All cassettes used in the facility for mammography shall
be tested.
- (iii) Compression device performance.
- (A) A compression force of at least 111
newtons (25 pounds) shall be provided.
- (B) Effective October 28, 2002, the maximum
compression force for the initial power drive shall be between
111 newtons (25 pounds) and 200 newtons (45 pounds).
- (5) Annual quality control tests. Facilities
with screen-film systems shall perform the following quality control
tests at least annually:
- (i) Automatic exposure control performance.
- (A) The AEC shall be capable of maintaining
film optical density within +/- 0.30 of the mean optical density
when thickness of a homogeneous material is varied over a
range of 2 to 6 cm and the kVp is varied appropriately for
such thicknesses over the kVp range used clinically in the
facility. If this requirement cannot be met, a technique chart
shall be developed showing appropriate techniques (kVp and
density control settings) for different breast thicknesses
and compositions that must be used so that optical densities
within +/- 0.30 of the average under phototimed conditions
can be produced.
- (B) After October 28, 2002, the AEC shall
be capable of maintaining film optical density (OD) within
+/- 0.15 of the mean optical density when thickness of a homogeneous
material is varied over a range of 2 to 6 cm and the kVp is
varied appropriately for such thicknesses over the kVp range
used clinically in the facility.
- (C) The optical density of the film in
the center of the phantom image shall not be less than 1.20.
- (ii) Kilovoltage peak (kVp) accuracy and
reproducibility.
- (A) The kVp shall be accurate within
+/- 5 percent of the indicated or selected kVp at:
- (1) The lowest clinical
kVp that can be measured by a kVp test device;
- (2) The most commonly
used clinical kVp;
- (3) The highest available
clinical kVp, and
- (B) At the most commonly used clinical
settings of kVp, the coefficient of variation of reproducibility
of the kVp shall be equal to or less than 0.02.
- (iii) Focal spot condition. Until October
28, 2002, focal spot condition shall be evaluated either by
determining system resolution or by measuring focal spot dimensions.
After October 28, 2002, facilities shall evaluate focal spot
condition only by determining the system resolution.
- (A) System Resolution.
- (1) Each X-ray system used
for mammography, in combination with the mammography screen-film
combination used in the facility, shall provide a minimum
resolution of 11 Cycles/millimeters (mm) (line-pairs/mm)
when a high contrast resolution bar test pattern is oriented
with the bars perpendicular to the anode-cathode axis,
and a minimum resolution of 13 line-pairs/mm when the
bars are parallel to that axis.
- (2) The bar pattern shall
be placed 4.5 cm above the breast support surface, centered
with respect to the chest wall edge of the image receptor,
and with the edge of the pattern within 1 cm of the chest
wall edge of the image receptor.
- (3) When more than one
target material is provided, the measurement in paragraph
(e)(5)(iii)(A) of this section shall be made using the
appropriate focal spot for each target material.
- (4) When more than one
SID is provided, the test shall be performed at SID most
commonly used clinically.
- (5) Test kVp shall be
set at the value used clinically by the facility for a
standard breast and shall be performed in the AEC mode,
if available. If necessary, a suitable absorber may be
placed in the beam to increase exposure times. The screen-film
cassette combination used by the facility shall be used
to test for this requirement and shall be placed in the
normal location used for clinical procedures.
- (B) Focal spot dimensions. Measured
values of the focal spot length (dimension parallel to the
anode cathode axis) and width (dimension perpendicular to
the anode cathode axis) shall be within the tolerance limits
specified in Table 1.
Table 1
Focal Spot Tolerance Limit
Nominal Focal Spot Size (mm) |
Maximum Measured Dimensions |
Width(mm) |
Length(mm) |
0.10 |
0.15 |
0.15 |
0.15 |
0.23 |
0.23 |
0.20 |
0.30 |
0.30 |
0.30 |
0.45 |
0.65 |
0.40 |
0.60 |
0.85 |
0.60 |
0.90 |
1.30 |
- (iv) Beam quality and half-value layer (HVL). The HVL shall meet the specifications of Sec. 1020.30(m)(1)
of this chapter for the minimum HVL. These values, extrapolated
to the mammographic range, are shown in Table 2. Values not
shown in Table 2 may be determined by linear interpolation or
extrapolation.
Table 2
X-ray Tube Voltage (kilovolt peak) and Minimum HVL
Designed Operating Range (kV) |
Measured Operating Voltage (kV) |
Minimum HVL (millimeters of aluminum) |
Below 50 |
20 |
0.20 |
|
25 |
0.25 |
|
30 |
0.30 |
- (v) Breast entrance air kerma and AEC reproducibility.
The coefficient of variation for both air kerma and mA's shall not exceed 0.05.
- (vi) Dosimetry. The average glandular dose delivered
during a single cranio-caudal view of an FDA-accepted phantom simulating a standard
breast shall not exceed 3.0 milligray (mGy) (0.3 rad) per exposure. The dose
shall be determined with technique factors and conditions used clinically for
a standard breast.
- (vii) X-ray field/light field/image receptor/compression
paddle alignment.
- (A) All systems shall have beam-limiting devices that allow
the entire chest wall edge of the x-ray field to extend to the chest wall edge
of the image receptor and provide means to assure that the x-ray field does
not extend beyond any edge of the image receptor by more than 2 percent of the
SID.
- (B) If a light field that passes through the X-ray beam
limitation device is provided, it shall be aligned with the X-ray field so that
the total of any misalignment of the edges of the light field and the X-ray
field along either the length or the width of the visually defined field at
the plane of the breast support surface shall not exceed 2 percent of the SID.
- (C) The chest wall edge of the compression paddle shall
not extend beyond the chest wall edge of the image receptor by more than one
percent of the SID when tested with the compression paddle placed above the
breast support surface at a distance equivalent to standard breast thickness.
The shadow of the vertical edge of the compression paddle shall not be visible
on the image.
- (viii) Uniformity of screen speed. Uniformity of screen
speed of all the cassettes in the facility shall be tested and the difference
between the maximum and minimum optical densities shall not exceed 0.30. Screen
artifacts shall also be evaluated during this test.
- (ix) System artifacts. System artifacts shall be evaluated
with a high-grade, defect-free sheet of homogeneous material large enough to
cover the mammography cassette and shall be performed for all cassette sizes
used in the facility using a grid appropriate for the cassette size being tested.
System artifacts shall also be evaluated for all available focal spot sizes
and target filter combinations used clinically.
- (x) Radiation output.
- (A) The system shall be capable of producing a minimum
output of 4.5 mGy air kerma per second (513 milli Roentgen (mR) per second)
when operating at 28 kVp in the standard mammography (moly/moly) mode at any
SID where the system is designed to operate and when measured by a detector
with its center located 4.5 cm above the breast support surface with the compression
paddle in place between the source and the detector. After October 28, 2002,
the system, under the same measuring conditions shall be capable of producing
a minimum output of 7.0 mGy air kerma per second (800 mR per second) when operating
at 28 kVp in the standard (moly/moly) mammography mode at any SID where the
system is designed to operate.
- (B) The system shall be capable of maintaining the required
minimum radiation output averaged over a 3.0 second period.
- (xi) Decompression. If the system is equipped with a
provision for automatic decompression after completion of an exposure or interruption
of power to the system, the system shall be tested to confirm that it provides:
- (A) An override capability to allow maintenance of compression;
- (B) A continuous display of the override status; and
- (C) A manual emergency compression release that can be
activated in the event of power or automatic release failure.
- (6) Quality control tests—other modalities. For systems
with image receptor modalities other than screen-film, the quality assurance
program shall be substantially the same as the quality assurance program recommended
by the image receptor manufacturer, except that the maximum allowable dose
shall not exceed the maximum allowable dose for screen-film systems in paragraph
(e)(5)(vi) of this section.
- (7) Mobile Units. The facility shall verify that mammography
units used to produce mammograms at more than one location meet the requirements
in paragraphs (e)(1) through (e)(6) of this section. In addition, at each
examination location, before any examinations are conducted, the facility
shall verify satisfactory performance of such units using a test method that
establishes the adequacy of the image quality produced by the unit.
- (8) Use of test results.
- (i) After completion of the tests specified in paragraphs (e)(1)
through (e)(7) of this section, the facility shall compare the test results
to the corresponding specified action limits; or, for nonscreen-film modalities,
to the manufacturer's recommended action limits; or, for post-move, preexamination
testing of mobile units, to the limits established in the test method used by
the facility.
- (ii) If the test results fall outside of the action limits,
the source of the problem shall be identified and corrective actions shall be
taken:
- (A) Before any further examinations are performed or any
films are processed using a component of the mammography system that failed
any of the tests described in paragraphs (e)(1), (e)(2), (e)(4)(i), (e)(4)(ii),
(e)(4)(iii), (e)(5)(vi), (e)(6), or (e)(7) of this section;
- (B) Within 30 days of the test date for all other tests
described in paragraph (e) of this section.
- (9) Surveys.
- (i) At least once a year, each facility shall undergo a survey
by a medical physicist or by an individual under the direct supervision of a
medical physicist. At a minimum, this survey shall include the performance of
tests to ensure that the facility meets the quality assurance requirements of
the annual tests described in paragraphs (e)(5) and (e)(6) of this section and
the weekly phantom image quality test described in paragraph (e)(2) of this
section.
- (ii) The results of all tests conducted by the facility in
accordance with paragraphs (e)(1) through (e)(7) of this section, as well as
written documentation of any corrective actions taken and their results, shall
be evaluated for adequacy by the medical physicist performing the survey.
- (iii) The medical physicist shall prepare a survey report that
includes a summary of this review and recommendations for necessary improvements.
- (iv) The survey report shall be sent to the facility within
30 days of the date of the survey.
- (v) 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.
- (10) Mammography equipment evaluations. Additional evaluations
of mammography units or image processors shall be conducted whenever a new
unit or processor is installed, a unit or processor is disassembled and reassembled
at the same or a new location, or major components of a mammography unit or
processor equipment are changed or repaired. These evaluations shall be used
to determine whether the new or changed equipment meets the requirements of
applicable standards in paragraphs (b) and (e) of this section. All problems
shall be corrected before the new or changed equipment is put into service
for examinations or film processing. The mammography equipment evaluation
shall be performed by a medical physicist or by an individual under the direct
supervision of a medical physicist.
- (11) Facility cleanliness.
- (i) The facility shall establish and implement adequate protocols
for maintaining darkroom, screen, and view box cleanliness.
- (ii) The facility shall document that all cleaning procedures
are performed at the frequencies specified in the protocols.
- (12) 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 2 years and each time the instrument is repaired. The instrument calibration
must be traceable to a national standard and calibrated with an accuracy of
+/- 6 percent (95 percent confidence level) in the mammography energy range.
- (13) 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:
- (i) Comply with all applicable Federal, State, and local regulations
pertaining to infection control; and
- (ii) Comply with the manufacturer's recommended procedures
for the cleaning and disinfection of the mammography equipment used in the facility;
or
- (iii) If adequate manufacturer's recommendations are not available,
comply with generally accepted guidance on infection control, until such recommendations
become available.
- (f) Quality assurance-mammography medical outcomes audit. Each
facility shall establish and maintain a mammography medical outcomes audit program
to followup positive mammographic assessments and to correlate pathology 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) General requirements. Each facility shall establish
a system to collect and review outcome data for all mammograms performed,
including followup on the disposition of all positive mammograms and correlation
of pathology results with the interpreting physician's mammography report.
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 followup on surgical
and/or pathology results and review of the mammograms taken prior to the diagnosis
of a malignancy.
- (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) Audit 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 for notifying other interpreting physicians of their results
and the facility aggregate results. If followup actions are taken, the audit
interpreting physician shall also be responsible for documenting the nature
of the followup.
- (g) Mammographic procedure 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 exam.
- (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.
- (h) 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 3 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 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 timeframe specified by the accreditation body.
- (i) 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.
- (j) Additional mammography review and patient notification.
- (1) If FDA 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 FDA, for review by the accreditation body or other entity designated by
FDA. This additional mammography review will help the agency to determine
whether the facility is in compliance with this section 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 FDA determines that the quality of mammography performed
by a facility, whether or not certified under Sec. 900.11, was so inconsistent
with the quality standards established in this section as to present a significant
risk to individual or public health, FDA may require such facility to notify
patients who received mammograms at such facility, and their referring physicians,
of the deficiencies presenting such risk, the potential harm resulting, appropriate
remedial measures, and such other relevant information as FDA may require.
Such notification shall occur within a timeframe and in a manner specified
by FDA.
Sec. 900.13 Revocation of accreditation and revocation
of accreditation body approval.
- (a) FDA action following revocation of accreditation.
If a facility's accreditation is revoked by an accreditation body,
the agency may conduct an investigation into the reasons for the
revocation. Following such investigation, the agency may determine
that the facility's certificate shall no longer be in effect or
the agency may take whatever other action or combination of actions
will best protect the public health, including the establishment
and implementation of a corrective plan of action that will permit
the certificate to continue in effect while the facility seeks reaccreditation.
A facility whose certificate is no longer in effect because it has
lost its accreditation may not practice mammography.
- (b) Withdrawal of FDA approval of an accreditation body.
- (1) If FDA withdraws approval of an accreditation
body under Sec. 900.6, the certificates of facilities previously
accredited by such body shall remain in effect for up to 1 year
from the date of the withdrawal of approval, unless FDA determines,
in order to protect human health or because the accreditation
body fraudulently accredited facilities, that the certificates
of some or all of the facilities should be revoked or suspended
or that a shorter time period should be established for the certificates
to remain in effect.
- (2) After 1 year from the date of withdrawal of approval
of an accreditation body, or within any shorter period of time
established by the agency, the affected facilities must obtain
accreditation from another accreditation body, or from another
entity designated by FDA.
Sec. 900.14 Suspension or revocation of certificates.
- (a) Except as provided in paragraph (b) of this section,
FDA may suspend or revoke a certificate if FDA finds, after providing
the owner or operator of the facility with notice and opportunity
for an informal hearing in accordance with part 16 of this chapter,
that the owner, operator, or any employee of the facility:
- (1) Has been guilty of misrepresentation in obtaining
the certificate;
- (2) Has failed to comply with the standards of Sec.
900.12;
- (3) Has failed to comply with reasonable requests
of the agency or the accreditation body for records, information,
reports, or materials that FDA believes are necessary to determine
the continued eligibility of the facility for a certificate or
continued compliance with the standards of Sec. 900.12;
- (4) Has refused a reasonable request of a duly designated
FDA inspector, State inspector, or accreditation body representative
for permission to inspect the facility or the operations and pertinent
records of the facility;
- (5) Has violated or aided and abetted in the violation
of any provision of or regulation promulgated pursuant to 42 U.S.C.
263b; or
- (6) Has failed to comply with prior sanctions imposed
by the agency under 42 U.S.C. 263b(h).
- (b) FDA may suspend the certificate of a facility before
holding a hearing if FDA makes a finding described in paragraph
(a) of this section and also determines that;
- (1) The failure to comply with required standards
presents a serious risk to human health;
- (2) The refusal to permit inspection makes immediate
suspension necessary; or
- (3) There is reason to believe that the violation
or aiding and abetting of the violation was intentional or associated
with fraud.
- (c) If FDA suspends a certificate in accordance with paragraph
(b) of this section:
- (1) The agency shall provide the facility with an
opportunity for an informal hearing under part 16 of this chapter
not later than 60 days from the effective date of this suspension;
- (2) The suspension shall remain in effect until the
agency determines that:
- (i) Allegations of violations or misconduct
were not substantiated;
- (ii) Violations of required standards have
been corrected to the agency's satisfaction; or
- (iii) The facility's certificate is revoked
in accordance with paragraph (d) of this section;
- (d) After providing a hearing in accordance with paragraph
(c)(1) of this section, the agency may revoke the facility's certificate
if the agency determines that the facility:
- (1) Is unwilling or unable to correct violations
that were the basis for suspension; or
- (2) Has engaged in fraudulent activity to obtain
or continue certification.
Sec. 900.15 Appeals of adverse accreditation
or reaccreditation decisions that preclude certification or recertification.
- (a) The appeals procedures described in this section are
available only for adverse accreditation or reaccreditation decisions
that preclude certification or recertification by FDA. Agency decisions
to suspend or revoke certificates that are already in effect will
be handled in accordance with Sec. 900.14.
- (b) Upon learning that a facility has failed to become
accredited or reaccredited, FDA will notify the facility that the
agency is unable to certify that facility without proof of accreditation.
- (c) A facility that has been denied accreditation or reaccreditation
is entitled to an appeals process from the accreditation body, in
accordance with Sec. 900.7. A facility must avail itself of the
accreditation body's appeal process before requesting reconsideration
from FDA.
- (d) A facility that cannot achieve satisfactory resolution
of an adverse accreditation decision through the accreditation body's
appeal process is entitled to further appeal in accordance with
procedures set forth in this section and in regulations published
in 42 CFR part 498.
- (1) References to the Health Care Financing Administration
(HCFA) in 42 CFR part 498 should be read as the Division of Mammography
Quality and Radiation Programs (DMQRP), Center for Devices and
Radiological Health, Food and Drug Administration.
- (2) References to the Appeals Council of the Social
Security Administration in 42 CFR part 498 should be read as references
to the Departmental Appeals Board.
- (3) In accordance with the procedures set forth in
subpart B of 42 CFR part 498, a facility that has been denied
accreditation following appeal to the accreditation body may request
reconsideration of that adverse decision from DMQRP.
- (i) A facility must request reconsideration
by DMQRP within 60 days of the accreditation body's adverse
appeals decision, at the following address: Division of Mammography
Quality and Radiation Programs (HFZ-240), Center for Devices
and Radiological Health, Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850, Attn: Facility Accreditation
Review Committee.
- (ii) The request for reconsideration shall
include three copies of the following records:
- (A) The accreditation body's original
denial of accreditation.
- (B) All information the facility submitted
to the accreditation body as part of the appeals process;
- (C) A copy of the accreditation body's
adverse appeals decision; and
- (D) A statement of the basis for the
facility's disagreement with the accreditation body's decision.
- (iii) DMQRP will conduct its reconsideration
in accordance with the procedures set forth in subpart B of
42 CFR part 498.
- (4) A facility that is dissatisfied with DMQRP's
decision following reconsideration is entitled to a formal hearing
in accordance with procedures set forth in subpart D of 42 CFR
part 498.
- (5) Either the facility or FDA may request review
of the hearing officer's decision. Such review will be conducted
by the Departmental Appeals Board in accordance with subpart E
of 42 CFR part 498.
- (6) A facility cannot perform mammography services
while an adverse accreditation decision is being appealed.
Sec. 900.16 Appeals of denials of certification.
- (a) The appeals procedures described in this section are available
only to facilities that are denied certification by FDA after they have been
accredited by an approved accreditation body. Appeals for facilities that have
failed to become accredited are governed by the procedures set forth in Sec.
900.15.
- (b) FDA may deny the application if the agency has reason to believe
that:
- (1) The facility will not be operated in accordance with standards
established under Sec. 900.12;
- (2) The facility will not permit inspections or provide access
to records or information in a timely fashion; or
- (3) The facility has been guilty of misrepresentation in obtaining
the accreditation.
- (c)
- (1) If FDA denies an application for certification by a facility that
has received accreditation from an approved accreditation body, FDA shall
provide the facility with a statement of the grounds on which the denial is
based.
- (2) A facility that has been denied accreditation may request
reconsideration and appeal of FDA's determination in accordance with the applicable
provisions of Sec. 900.15(d).
Sec. 900.17 [Reserved]
Sec. 900.18 Alternative requirements for Sec.
900.12 quality standards.
- (a) Criteria for approval of alternative standards.
Upon application by a qualified party as defined in paragraph (b)
of this section, FDA may approve an alternative to a quality standard
under Sec. 900.12, when the agency determines that:
- (1) The proposed alternative standard will be at
least as effective in assuring quality mammography as the standard
it proposes to replace, and
- (2) The proposed alternative:
- (i) Is too limited in its applicability to
justify an amendment to the standard; or
- (ii) Offers an expected benefit to human health
that is so great that the time required for amending the standard
would present an unjustifiable risk to the human health; and
- (3) The granting of the alternative is in keeping
with the purposes of 42 U.S.C. 263b.
- (b) Applicants for alternatives.
- (1) Mammography facilities and accreditation bodies
may apply for alternatives to the quality standards of Sec. 900.12.
- (2) Federal agencies and State governments that are
not accreditation bodies may apply for alternatives to the standards
of Sec. 900.12(a).
- (3) Manufacturers and assemblers of equipment used
for mammography may apply for alternatives to the standards of
Sec. 900.12(b) and (e).
- (c) Applications for approval of an alternative standard. An application for approval of an alternative standard or for an
amendment or extension of the alternative standard shall be submitted
in an original and two copies to the Director, Division of Mammography
Quality and Radiation Programs (HFZ-240), Center for Devices and
Radiological Health, Food and Drug Administration, 1350 Piccard
Dr., Rockville, MD 20850. The application for approval of an alternative
standard shall include the following information:
- (1) Identification of the original standard for which
the alternative standard is being proposed and an explanation
of why the applicant is proposing the alternative;
- (2) A description of the manner in which the alternative
is proposed to deviate from the original standard;
- (3) A description, supported by data, of the advantages
to be derived from such deviation;
- (4) An explanation, supported by data, of how such
a deviation would ensure equal or greater quality of production,
processing, or interpretation of mammograms than the original
standard;
- (5) The suggested period of time that the proposed
alternative standard would be in effect; and
- (6) Such other information required by the Director
to evaluate and act on the application.
- (d) Ruling on applications.
- (1) FDA may approve or deny, in whole or in part,
a request for approval of an alternative standard or any amendment
or extension thereof, and shall inform the applicant in writing
of this action. The written notice shall state the manner in which
the requested alternative standard differs from the agency standard
and a summary of the reasons for approval or denial of the request.
If the request is approved, the written notice shall also include
the effective date and the termination date of the approval and
a summary of the limitations and conditions attached to the approval
and any other information that may be relevant to the approved
request. Each approved alternative standard shall be assigned
an identifying number.
- (2) Notice of an approved request for an alternative
standard or any amendment or extension thereof shall be placed
in the public docket file in the Dockets Management Branch and
may also be in the form of a notice published in the Federal Register.
The notice shall state the name of the applicant, a description
of the published agency standard, and a description of the approved
alternative standard, including limitations and conditions attached
to the approval of the alternative standard.
- (3) Summaries of the approval of alternative standards,
including information on their nature and number, shall be provided
to the National Mammography Quality Assurance Advisory Committee.
- (4) All applications for approval of alternative
standards and for amendments and extensions thereof and all correspondence
(including written notices of approval) on these applications
shall be available for public disclosure in the Dockets Management
Branch, excluding patient identifiers and confidential commercial
information.
- (e) Amendment or extension of an alternative standard. An application for amending or extending approval of an alternative
standard shall include the following information:
- (1) The approval number and the expiration date of
the alternative standard;
- (2) The amendment or extension requested and the
basis for the amendment or extension; and
- (3) An explanation, supported by data, of how such
an amendment or extension would ensure equal or greater quality
of production, processing, or interpretation of mammograms than
the original standard.
- (f) Applicability of the alternative standards.
- (1) Except as provided in paragraphs (f)(2) and (f)(3)
of this section, any approval of an alternative standard, amendment,
or extension may be implemented only by the entity to which it
was granted and under the terms under which it was granted. Other
entities interested in similar or identical approvals must file
their own application following the procedures of paragraph (c)
of this section.
- (2) When an alternative standard is approved for
a manufacturer of equipment, any facility using that equipment
will also be covered by the alternative standard.
- (3) The agency may extend the alternative standard
to other entities when FDA determines that expansion of the approval
of the alternative standard would be an effective means of promoting
the acceptance of measures to improve the quality of mammography.
All such determinations will be publicized by appropriate means.
- (g) Withdrawal of approval of alternative requirements. FDA shall amend or withdraw approval of an alternative standard
whenever the agency determines that this action is necessary to
protect the human health or otherwise is justified by Sec. 900.12.
Such action will become effective on the date specified in the written
notice of the action sent to the applicant, except that it will
become effective immediately upon notification of the applicant
when FDA determines that such action is necessary to prevent an
imminent health hazard.
Subpart C--States as Certifiers
Sec. 900.20 Scope.
The regulations set forth in this part implement the Mammography Quality
Standards Act (MQSA) (42 U.S.C. 263b). Subpart C of this part establishes
procedures whereby a State can apply to become a FDA-approved certification
agency to certify facilities within the State to perform mammography services.
Subpart C of this part further establishes requirements and standards
for State certification agencies to ensure that all mammography facilities
under their jurisdiction are adequately and consistently evaluated for
compliance with quality standards at least as stringent as the national
quality standards established by FDA.
Sec. 900.21 Application for approval as a certification
agency.
- (a) Eligibility. State agencies may apply for approval as
a certification agency if they have standards at least as stringent as those
of Sec. 900.12, qualified personnel, adequate resources to carry out the States
as Certifiers' responsibilities, and the authority to enter into a legal agreement
with FDA to accept these responsibilities.
- (b) Application for approval.
- (1) An applicant seeking FDA approval as a certification agency
shall inform the Division of Mammography Quality and Radiation Programs (DMQRP),
Center for Devices and Radiological Health (HFZ-240), Food and Drug Administration,
Rockville, MD 20850, marked Attn: States as Certifiers Coordinator, in writing,
of its desire to be approved as a certification agency.
- (2) Following receipt of the written request, FDA will provide
the applicant with additional information to aid in the submission of an application
for approval as a certification agency.
- (3) The applicant shall furnish to FDA, at the address in paragraph
(b)(1) of this section, three copies of an application containing the following
information, materials, and supporting documentation:
- (i) Name, address, and phone number of the applicant;
- (ii) Detailed description of the mammography quality standards
the applicant will require facilities to meet and, for those standards different
from FDA's quality standards, information substantiating that they are at
least as stringent as FDA standards under Sec. 900.12;
- (iii) Detailed description of the applicant's review and
decisionmaking process for facility certification, including:
- (A) Policies and procedures for notifying facilities
of certificate denials and expirations;
- (B) Procedures for monitoring and enforcement of the
correction of deficiencies by facilities;
- (C) Policies and procedures for suspending or revoking
a facility's certification;
- (D) Policies and procedures that will ensure processing
certificates within a timeframe approved by FDA;
- (E) A description of the appeals process for facilities
contesting adverse certification status decisions;
- (F) Education, experience, and training requirements
of the applicant's professional and supervisory staff;
- (G) Description of the applicant's electronic data
management and analysis system;
- (H) Fee schedules;
- (I) Statement of policies and procedures established
to avoid conflict of interest;
- (J) Description of the applicant's mechanism for handling
facility inquiries and complaints;
- (K) Description of a plan to ensure that certified
mammography facilities will be inspected according to MQSA (42 U.S.C. 263b)
and procedures and policies for notifying facilities of inspection deficiencies;
- (L) Policies and procedures for monitoring and enforcing
the correction of facility deficiencies discovered during inspections or
by other means;
- (M) Policies and procedures for additional mammography
review and for requesting such reviews from accreditation bodies;
- (N) Policies and procedures for patient notification;
- (O) If a State has regulations that are more stringent
than those of Sec. 900.12, an explanation of how adverse actions taken against
a facility under the more stringent regulations will be distinguished from
those taken under the requirements of Sec. 900.12; and
- (P) Any other information that FDA identifies as necessary
to make a determination on the approval of the State as a certification
agency.
- (c) Rulings on applications for approval.
- (1) FDA will conduct a review and evaluation to determine whether
the applicant substantially meets the applicable requirements of this subpart
and whether the certification standards the applicant will require facilities
to meet are the quality standards published under subpart B of this part or
at least as stringent as those of subpart B.
- (2) FDA will notify the applicant of any deficiencies in the
application and request that those deficiencies be corrected within a specified
time period. If the deficiencies are not corrected to FDA's satisfaction within
the specified time period, FDA may deny the application for approval as a
certification agency.
- (3) FDA shall notify the applicant whether the application has
been approved or denied. The notification shall list any conditions associated
with approval or state the bases for any denial.
- (4) The review of any application may include a meeting between
FDA and representatives of the applicant at a time and location mutually acceptable
to FDA and the applicant.
- (5) FDA will advise the applicant of the circumstances under
which a denied application may be resubmitted.
- (d) Scope of authority. FDA may limit the scope of certification
authority delegated to the State in accordance with MQSA.
Sec. 900.22 Standards for certification agencies.
The certification agency shall accept the following responsibilities
in order to ensure quality mammography at the facilities it certifies
and shall perform these responsibilities in a manner that ensures the
integrity and impartiality of the certification agency's actions:
- (a) Conflict of interest. The certification agency
shall establish and implement measures that FDA has approved in
accordance with Sec. 900.21(b) to reduce the possibility of conflict
of interest or facility bias on the part of individuals acting on
the certification agency's behalf.
- (b) Certification and inspection responsibilities.
Mammography facilities shall be certified and inspected in accordance
with statutory and regulatory requirements that are at least as
stringent as those of MQSA and this part.
- (c) Compliance with quality standards. The scope,
timeliness, disposition, and technical accuracy of completed inspections
and related enforcement activities shall ensure compliance with
facility quality standards required under Sec. 900.12.
- (d) Enforcement actions.
- (1) There shall be appropriate criteria and processes
for the suspension and revocation of certificates.
- (2) There shall be prompt investigation of and appropriate
enforcement action for facilities performing mammography without
certificates.
- (e) Appeals. There shall be processes for facilities
to appeal inspection findings, enforcement actions, and adverse
certification decision or adverse accreditation decisions after
exhausting appeals to the accreditation body.
- (f) Additional mammography review. There shall be
a process for the certification agency to request additional mammography
review from accreditation bodies for issues related to mammography
image quality and clinical practice. The certification agency should
request additional mammography review only when it believes that
mammography quality at a facility has been compromised and may present
a serious risk to human health.
- (g) Patient notification. There shall be processes
for the certification agency to conduct, or cause to be conducted,
patient notifications should the certification agency determine
that mammography quality has been compromised to such an extent
that it may present a serious risk to human health.
- (h) Electronic data transmission. There shall be
processes to ensure the timeliness and accuracy of electronic transmission
of inspection data and facility certification status information
in a format and timeframe determined by FDA.
- (i) Changes to standards. A certification agency
shall obtain FDA authorization for any changes it proposes to make
in any standard that FDA has previously accepted under Sec. 900.21
before requiring facilities to comply with the changes as a condition
of obtaining or maintaining certification.
Sec. 900.23 Evaluation.
FDA shall evaluate annually the performance of each certification agency.
The evaluation shall include the use of performance indicators that address
the adequacy of program performance in certification, inspection, and
enforcement activities. FDA will also consider any additional information
deemed relevant by FDA that has been provided by the certification body
or other sources or has been required by FDA as part of its oversight
mandate. The evaluation also shall include a review of any changes in
the standards or procedures in the areas listed in Secs. 900.21(b) and
900.22 that have taken place since the original application or the last
evaluation, whichever is most recent. The evaluation shall include a determination
of whether there are major deficiencies in the certification agency's
regulations or performance that, if not corrected, would warrant withdrawal
of the approval of the certification agency under the provisions of Sec.
900.24, or minor deficiencies that would require corrective action.
Sec. 900.24 Withdrawal of approval.
If FDA determines, through the evaluation activities of Sec. 900.23,
or through other means, that a certification agency is not in substantial
compliance with this subpart, FDA may initiate the following actions:
- (a) Major deficiencies. If, after providing notice
and opportunity for corrective action, FDA determines that a certification
agency has demonstrated willful disregard for public health, has
committed fraud, has failed to provide adequate resources for the
program, has submitted material false statements to the agency,
has failed to achieve the MQSA goals of quality mammography and
access, or has performed or failed to perform a delegated function
in a manner that may cause serious risk to human health, FDA may
withdraw its approval of that certification agency. The certification
agency shall notify, within a time period and in a manner approved
by FDA, all facilities certified or seeking certification by it
that it has been required to correct major deficiencies.
- (1) FDA shall notify the certification agency of
FDA's action and the grounds on which the approval was withdrawn.
- (2) A certification agency that has lost its approval
shall notify facilities certified or seeking certification by
it, as well as the appropriate accreditation bodies with jurisdiction
in the State, that its approval has been withdrawn. Such notification
shall be made within a timeframe and in a manner approved by FDA.
- (b) Minor deficiencies. If FDA determines that a
certification agency has demonstrated deficiencies in performing
certification functions and responsibilities that are less serious
or more limited than the deficiencies in paragraph (a) of this section,
including failure to follow the certification agency's own procedures
and policies as approved by FDA, FDA shall notify the certification
agency that it has a specified period of time to take particular
corrective measures as directed by FDA or to submit to FDA for approval
the certification agency's own plan of corrective action addressing
the minor deficiencies. If the approved corrective actions are not
being implemented satisfactorily or within the established schedule,
FDA may place the agency on probationary status for a period of
time determined by FDA, or may withdraw approval of the certification
agency.
- (1) If FDA places a certification agency on probationary
status, the certification agency shall notify all facilities certified
or seeking certification by it of its probationary status within
a time period and in a manner approved by FDA.
- (2) Probationary status shall remain in effect until
such time as the certification agency can demonstrate to the satisfaction
of FDA that it has successfully implemented or is implementing
the corrective action plan within the established schedule, and
that the corrective actions have substantially eliminated all
identified problems, or
- (3) If FDA determines that a certification agency
that has been placed on probationary status is not implementing
corrective actions satisfactorily or within the established schedule,
FDA may withdraw approval of the certification agency. The certification
agency shall notify all facilities certified or seeking certification
by it, as well as the appropriate accreditation bodies with jurisdiction
in the State, of its loss of FDA approval, within a timeframe
and in a manner approved by FDA.
- (c) Transfer of records. A certification agency
that has its approval withdrawn shall transfer facility records
and other related information as required by FDA to a location and
according to a schedule approved by FDA.
Sec. 900.25 Hearings and appeals.
- (a) Opportunities to challenge final adverse actions taken by FDA
regarding approval of certification agencies or withdrawal of approval of
certification agencies shall be communicated through notices of opportunity
for informal hearings in accordance with part 16 of this chapter.
- (b) A facility that has been denied certification is entitled to
an appeals process from the certification agency. The appeals process shall
be specified in writing by the certification agency and shall have been approved
by FDA in accordance with Secs. 900.21 and 900.22.
Updated May 31, 2002