# Quality Mammography Standards

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URL: https://www.frixlaw.com/law-library/documents/fr%3A97-26351

## Record

- **Collection:** Federal Register
- **Document type:** Rule
- **Published:** October 28, 1997
- **Citation:** 62 FR 55852

## Text

SUMMARY: The Food and Drug Administration (FDA) is amending its
regulations governing mammography. Amendments are being made to the
requirements for accreditation bodies; procedures for facility
certification; and quality standards for mammography personnel,
equipment and practices, including quality assurance. This action is
being taken to provide increased assurance of adequate and consistent
evaluation of mammography facilities on a nationwide level and
compliance of the facilities with quality standards. It also carries
out the intent of Congress that FDA replace the existing interim rules
with more comprehensive final regulations.

DATES: This regulation is effective April 28, 1999; except
Secs. 900.12(b)(8), 900.12(e)(4)(iii), 900.12(e)(5)(i),
900.12(e)(5)(iii), and 900.12(e)(5)(x), which become effective October
28, 2002.

FOR FURTHER INFORMATION CONTACT: Roger Burkhart, Center for Devices and
Radiological Health (HFZ-240), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20850, 301-594-3332, FAX 301-594-3306.

SUPPLEMENTARY INFORMATION:

I. Background

The Mammography Quality Standards Act (the MQSA) (Pub. L. 102-539)
was passed on October 27, 1992, to establish national quality standards
for mammography. The MQSA required that, to provide mammography
services legally after October 1, 1994, all facilities, except
facilities of the Department of Veterans Affairs, shall be accredited
by an approved accreditation body and certified by the Secretary of
Health and Human Services (the Secretary). The authority to approve
accreditation bodies and to certify facilities was delegated by the
Secretary to FDA.
The MQSA was enacted in response to the growing incidence of breast
cancer and its associated mortality rate. Breast cancer is now the most
common nonskin cancer and is the second leading cause of cancer deaths
among women, after lung cancer. Early detection of breast cancer,
typically involving breast physical examination and mammography, is the
best means of preventing deaths that can result if the diagnosis is
delayed until the onset of more advanced symptoms. Mammograms can
reveal breast cancer up to 2 years before a woman or her doctor can
feel a lump. In addition, over 90 percent of these early stage cancers
can be cured (Ref. 1).
However, according to the General Accounting Office (GAO), a
mammogram is among the most difficult radiographic images to read. It
must be of high quality for the image to be interpreted correctly. If
the image quality is poor, the interpreter may miss an incipient
cancerous lesion. This false negative diagnosis could delay early
treatment and result in an avoidable death or increased morbidity. It
is equally true that poor quality images or faulty interpretations can
lead to a false positive diagnosis when normal tissue is misread as
abnormal. This can lead to needless anxiety for the patient, costly
additional testing, and painful biopsies.
The Senate Committee on Labor and Human Resources held hearings on
breast cancer in 1992 and found a wide range of problems with
mammography practice in the United States including: (1) Poor quality
equipment, (2) a lack of quality assurance procedures, (3) poorly
trained radiologic technologists and interpreting physicians, and (4) a
lack of facility inspections or consistent governmental oversight.

A. Provisions of the MQSA

The MQSA was enacted to address these deficiencies in mammography
practice. Under the MQSA, Congress established a comprehensive
statutory scheme for the certification and inspection of mammography
facilities to ensure that only those facilities that comply with
minimum Federal standards for safe, high-quality mammography services
would lawfully continue to operate after October 1, 1994. Operation
after that date would be contingent on receipt of an FDA certificate
attesting that the facility meets the mammography quality standards
issued under section 354(f) of the Public Health Services Act (the PHS
Act) (42 U.S.C. 263b(f)).
Specifically, the MQSA required the following:
(1) Accreditation of mammography facilities by private, nonprofit
organizations or State agencies that have been approved by FDA as
meeting the standards established by FDA for accreditation bodies and
that continue to pass annual FDA reviews of their activities. The MQSA
also requires that, as part of the overall accreditation process,
actual clinical mammograms from each facility be evaluated for quality
by the accreditation body.
(2) An annual mammography facility physics survey, consultation,
and evaluation performed by a qualified medical physicist.
(3) Annual inspection of mammography facilities, to be performed by
FDA-certified Federal or State inspectors. If State inspectors are
used, the MQSA requires a Federal audit of the State inspection program
by direct Federal inspections of a sample of State-inspected
facilities.
(4) Establishment of initial and continuing qualification standards
for interpreting physicians, radiologic technologists, medical
physicists, and mammography facility inspectors.
(5) Specification of boards or organizations eligible to certify
the adequacy of training and experience of mammography personnel.
(6) Establishment of quality standards for mammography equipment
and practices, including quality assurance and quality control (QC)
programs.
(7) Standards governing recordkeeping for patient files and
requirements for mammography reporting and patient notification by
physicians.
(8) Establishment by the Secretary of a National Mammography
Quality Assurance Advisory Committee (NMQAAC). Among other things,
NMQAAC is required to advise FDA on appropriate quality standards for
mammography facilities and accreditation bodies.
The MQSA replaced a patchwork of Federal, State, and private
standards. Its purpose is to guarantee sufficient oversight of
mammography facilities to ensure that all women nationwide receive
adequate quality mammography services.

B. Interim Regulations

On December 14, 1993, the President signed legislation (H. Rept.
2202) granting authority to the Secretary (and by delegation, to FDA)
to issue temporary interim regulations setting forth standards for
approving accreditation bodies and establishing quality standards for
mammography facilities. This authorization was provided in recognition
of the fact that FDA certification of the approximately 10,000
mammography facilities in the United States could not be accomplished
by the October 1, 1994, statutory deadline without streamlining

[[Page 55853]]

the rulemaking process for issuing initial standards. Because of the
urgent public health need for national mammography standards, Congress
decided to grant this interim rule authority rather than extend the
deadline to develop standards.
In the Federal Register of December 21, 1993 (58 FR 67558 and 58 FR
67565), FDA issued interim rules establishing requirements for entities
applying to serve as accreditation bodies and for facilities applying
to obtain FDA certification in order to continue the legal provision of
mammography services after October 1, 1994. These interim rules became
effective on February 22, 1994. They were amended by another interim
rule published in the Federal Register on September 30, 1994 (59 FR
49808).

C. Accreditation and Certification

Operating under the interim regulations, FDA approved the American
College of Radiology (the ACR) and the State of Iowa as accreditation
bodies and issued certificates to more than 5,000 facilities accredited
by these 2 bodies before the October 1, 1994, statutory deadline. Over
4,500 of the remaining facilities were actively involved in becoming
accredited on that date. In the fall of 1994, FDA also approved the
States of Arkansas and California as accreditation bodies.
In recognition of the fact that a large number of facilities were
working to meet accreditation standards at the same time, and cognizant
of the extremely heavy demands this placed upon the accreditation
bodies, FDA used authority provided by the MQSA to issue 6-month
provisional certificates on October 1, 1994, to facilities whose
applications for accreditation were sufficiently complete for review
and which, on preliminary examination, appeared reasonably likely to
receive accreditation. This avoided the major reduction in access to
mammography that would have resulted had several thousand facilities
been forced to close their doors until the accreditation and
certification process could be completed.
By March 31, 1995, the expiration date for the 6-month provisional
certificates issued on October 1, 1994, over 8,200 facilities had
become fully accredited and certified. Most of the facilities whose
accreditation was still in progress satisfied the criteria for the 1-
time 90-day extension of the provisional certificate provided by the
MQSA and were granted such extensions.
By June 30, 1995, approximately 9,400 facilities had become fully
accredited and certified. Several hundred more, primarily facilities
that had begun operation after October 1, 1994, or facilities that had
previously failed accreditation and were seeking approval after having
taken corrective actions, were operating under provisional certificates
or 90-day extensions of these certificates. FDA estimates that
approximately 800 facilities closed between October 1993 and June 1995.
The closings were due to a number of reasons, including failure to
apply for certification, voluntary closure, and failure to meet the
standards for accreditation, and other reasons unrelated to the MQSA,
such as retirement.

D. Onsite Inspection of Facilities

At the same time FDA was working with the four accreditation bodies
to accredit and certify facilities, the agency was also meeting the
MQSA requirement to establish an annual onsite inspection program to
monitor facility compliance with the MQSA standards. The bulk of these
inspections are performed by State inspectors operating under the
contracts that FDA has with 49 States, Puerto Rico, the District of
Columbia, and New York City. Federal inspectors inspect Federal
facilities and facilities in the remaining States and do audits of the
State inspections. FDA has trained and certified approximately 250
Federal and State inspectors for this program. All facilities that
completed the certification process had received their first
inspections by September 1996 and approximately 70 percent had received
their second inspections by the end of March 1997. FDA was pleased to
find widespread compliance with the quality standards during these
inspections. Only 2 percent of the facilities had one or more of the
most serious findings (referred to by FDA as Level 1 findings) during
the first round of inspections and that proportion has dropped to less
than 1 percent of the facilities inspected so far in the second round.

E. Development of Proposed Regulations

In granting interim rule authority to FDA, Congress made clear its
intention that the agency replace the interim regulations with more
comprehensive regulations as soon as possible. These more extensive
regulations were to be developed using the normal ``notice and
comment'' rulemaking process and consultation with the NMQAAC.
Apart from the strong congressional encouragement, there were also
other reasons why it was important to replace the existing interim
regulations for quality mammography with more comprehensive final
regulations. The interim regulations were based primarily on the
voluntary standards of the ACR's Mammography Accreditation Program
(MAP). Utilization of the MAP standards aided greatly in meeting the
October 1, 1994, deadline for accreditation and certification of
facilities. The application of these standards to all facilities,
instead of just those that had sought voluntary accreditation from the
ACR, had a significant impact on mammography nationwide. However, the
MAP provisions did not cover all areas that required standards under
the MQSA, such as mammography of patients with breast implants and
experience requirements for some personnel of mammography facilities.
Furthermore, in many situations where MAP voluntary standards were
relevant, their wording needed to be changed and clarified for use as
part of a regulatory program.
One especially significant gap was in the equipment area where the
standards under the interim regulations were minimal. To provide
greater assurances of quality equipment performance, the ACR, with the
Centers for Disease Control and Prevention (CDC), had previously
convened expert committees to develop specifications for mammography
equipment. The reports of these expert committees were an important
basis for the equipment provisions of the proposed regulations.
In addition, the interim standards were required to be issued and
implemented prior to FDA developing any significant experience
regulating mammography. Because the statute was new and the regulatory
scheme it established presented a different and innovative approach,
the agency would inevitably develop ideas for improvement in quality
and efficiency of implementation as the program developed.
For all of these reasons, it was necessary to replace the interim
regulations with more comprehensive final regulations in order to
obtain the highest quality mammography that is reasonably achievable.
Coincident with the implementation of the interim rules, work was
proceeding on the development of final regulations. This effort was
aided by the agency's ongoing experience under the interim rules and
the advice of members of the NMQAAC. The NMQAAC membership includes
health professionals whose work focuses significantly on mammography
and representatives of consumer groups. NMQAAC was chartered on July 7,

[[Page 55854]]

1993. Nominations for members were accepted until September 7, 1993.
The first meeting of the NMQAAC was held February 17 through 18, 1994.
At that meeting, and in subsequent meetings in April, July, and
September 1994, the NMQAAC reviewed and commented on drafts of portions
of the proposed regulations developed by FDA. At its January 1995
meeting, the NMQAAC reviewed the entire body of draft proposed
regulations. Many of the requirements in the proposed regulations were
based on advice obtained from the members of NMQAAC during these
meetings.
Another valuable resource utilized by FDA in the development of the
proposed regulations was the guideline entitled, Quality Determinants
of Mammography (Ref. 2). This guideline was developed by the Quality
Determinants of Mammography Panel, with support from the Agency for
Health Care Policy and Research (AHCPR), to help eliminate low quality
mammography and, thereby, eliminate the adverse consequences it causes.
The Panel consisted of a diverse group representing many medical
specialties and consumer representatives knowledgeable about
mammography.
Proposed regulations were published in the Federal Register of
April 3, 1996 (61 FR 14856). To facilitate review by the public, they
were published in 5 separate documents, as described in the
introduction to section III of this document.

F. Development of the Final Regulations

A 90-day public comment period ending July 3, 1996, was provided
for the proposed regulations. During that time, extensive efforts were
made to encourage public comments. Approximately 17,000 copies of the
proposed regulations were mailed to the organizations and individuals
on FDA's MQSA mailing list, including 1 to every certified mammography
facility. The availability of the proposal was announced in Mammography
Matters, the newsletter of FDA's Division of Mammography Quality and
Radiation Programs (DMQRP), and in the newsletters of professional
groups. Copies were also distributed by FDA personnel at professional
meetings. By the end of the comment period, approximately 1,900
responses, containing approximately 8000 individual comments, had been
received from organizations and individuals. NMQAAC also provided
additional comments on the proposal during an April 1996 meeting.
Analysis of the many comments began after the end of the comment
period. At the October 1996 meeting, FDA consulted the NMQAAC for
advice with respect to some of the more controversial issues raised by
the comments. During the January 1997 meeting, the Committee reviewed
the entire set of regulations in light of the comments received. The
public comments and the advice received from the NMQAAC were used to
develop a draft of final regulations, which the members of the NMQAAC
had an opportunity to review individually in March 1997.
The majority of the final regulations will become effective April
28, 1999. The interim rules will continue to apply until that date.
Certain equipment-related regulations, in Sec. 900.12(b) and (e), will
become effective October 28, 2002. This delay in the effective date for
certain equipment requirements is intended to minimize the costs
associated with equipment improvements. The cost savings are achieved
by permitting facilities to implement the improvements as they follow
their normal equipment replacement schedule instead of requiring an
immediate purchase of new equipment or equipment upgrades.

II. Highlights of the Final Rule

This section highlights the major features of the final
regulations, as compared to the interim and the proposed regulations,
and their potential for achieving the MQSA goals of establishing
nationwide quality standards for mammography, while maintaining a broad
patient access to mammography services. A detailed discussion of the
public comments and FDA's response to them is provided under section
III of this document.
These final regulations fulfill FDA's responsibility under the MQSA
to establish national quality standards for mammography services, with
extensive input from NMQAAC. These Federal regulations will be
implemented under the MQSA framework whereby mammography facilities are
accredited once every 3 years by FDA-approved State or private not-for-
profit accreditation bodies, and inspected once every year by FDA-
trained and certified State (or in some cases Federal) inspectors. The
Federal-State-private sector partnership provides the necessary tools
to successfully implement these regulations and realize the MQSA's goal
of assuring high quality mammography services for every American woman.
Accordingly, these regulations establish rigorous criteria designed
to enhance the quality of mammography services in a manner that is
reasonably achievable by mammography facilities. The regulations
provide facilities with flexibility in needed areas to meet the
important public health goals of these standards. Taken as a whole, the
regulations are expected to provide substantial consumer benefits in a
reasoned and cost-effective manner.
The final regulations consist of two subparts. Subpart A is
composed primarily of the requirements to be met by the accreditation
bodies who perform the crucial initial screening of mammography
facilities for quality, including clinical image review, subpart B
establishes quality standards to be met by the mammography facilities
and administrative procedures.

A. Accreditation Body Requirements

The final regulations refine and codify policies FDA had developed
under the interim regulations for the initial approval of accreditation
bodies by FDA, and for defining the ongoing responsibilities of these
bodies and the agency's oversight of them. The primary goal of the
accreditation body requirements is to ensure that there is nationwide
consistency, both within and between accreditation bodies, in the
evaluation of mammography units and procedures to determine if they
meet the standards for quality mammography.
The major change made from proposed Secs. 900.3 through 900.7 was
the removal of several provisions that would have assigned compliance
responsibilities to the accreditation bodies. Removal of these
provisions ensures that the activities of the accreditation bodies will
have their proper focus, which is to identify facilities that are not
performing adequate quality mammography and to advise such facilities
on the nature of their problems and how to correct them. Compliance
activities under the MQSA are reserved for FDA.

B. Facility Quality Standards

1. Personnel Standards
The personnel standards of Sec. 900.12(a) cover interpreting
physicians, radiologic technologists, and medical physicists who
provide services to mammography facilities. The goals of the standards
are to ensure that personnel: (1) Have general qualifications in
radiology; (2) possess specific qualifications in mammography; and (3)
keep their qualifications up-to-date.
Most of the proposed changes in the personnel area were intended to
clarify general statements in the interim regulations that have caused
confusion in interpretation. A major step to improve quality of
personnel

[[Page 55855]]

performance, however, was the proposed establishment of initial and
continuing experience requirements for radiologic technologists and
medical physicists. These requirements are parallel to requirements
already in the interim regulations for physicians and, like the
physician requirements, are intended to make sure that individuals have
supervised clinical experience before they begin to provide mammography
services independently, and that they maintain their skills through
regular performance of their duties. These new experience requirements
have been codified in the final rule after some adjustments in the
amount of experience required due to practical considerations, such as
the difficulties that medical physicists under contract to one facility
would face in attempting to meet the proposed requirement to do surveys
in several facilities.
Another significant change from the proposed personnel standards is
that the final rule ``grand parents'' technologists who met the
personnel requirements under the interim regulations. Without grand
parenting technologists already in the system, there was the
possibility that localized shortages of technologists would occur,
resulting in a serious, short-term impact on access to mammography.
Because the agency believes that most technologists presently providing
mammography services either meet, or have qualifications comparable to
the final requirements, grand parenting could be permitted to relieve
these concerns without any significant impact on quality.
2. Equipment
The equipment standards in Sec. 900.12(b) are intended to ensure
that mammography equipment has the capability of producing quality
mammograms over the full range of clinical conditions. The equipment
area was addressed only briefly in the interim regulations. To better
define the equipment capabilities needed for high quality mammography,
equipment specification standards were proposed for all equipment
components of the mammography system from the X-ray generator to the
view box. These proposals relied heavily upon the recommendations of
the equipment focus groups convened in the early part of the decade by
the ACR, with the support of CDC.
After reviewing the information provided in the public comments and
by the NMQAAC, FDA revisited the question of the proper balance between
the economic impact of new standards and the associated gains to the
public health. This reconsideration led the agency to conclude that the
expected benefits from some of the proposed equipment specifications
would not compensate for the cost to replace or retrofit mammography
systems to meet them. The agency has concluded that, in some cases, the
same public health goals could be accomplished through specified
quality assurance procedures. Accordingly, specifications related to
source-image receptor distance (SID), focal spot location, filtration,
and film processors have been eliminated and specifications related to
compression and radiation output are being treated as performance
standards under the quality assurance section of the regulations.
Similarly, performance outcome aspects of the requirements for
alignment have been moved to the quality assurance section. Finally,
requirements related to system resolution were eliminated as
duplicating performance standards already in the quality assurance
section, and the requirements related to the examination of disabled
patients were eliminated in part because of a lack of consensus about
the need for such requirements.
In an effort to reduce costs, FDA is phasing in the equipment
requirements, with some becoming effective the same time (18 months) as
the rest of the regulations and others within 5 years. However, based
on the desire not to impede technological advances, the uncertainty in
estimating needs further in the future, and an assessment of the
associated costs, the agency has eliminated the proposed 10-year phase-
in requirements and some of the 5-year phase-in requirements. The
agency intends to reassess the need for the deleted requirements at a
future time.
3. Recordkeeping and Reporting Requirements
The recordkeeping and reporting requirements of Sec. 900.12(c) are
intended to: (1) Ensure that all patients and their referring
physicians receive timely and adequate notification of the results of
examinations, and (2) assist in diagnosis by ensuring that records of
past examinations, including the original mammograms, are available
when needed for comparison with the images produced during new
examinations.
With respect to patient notification of examination results, the
final rule codified this essential reporting requirement as a
performance outcome standard. The proposed rule would have required the
facilities to have a system to ensure that all patients received
written notification of their examination results, and further
specified what should be included in that notification. The final rule
requires that each facility have a system to ensure that the results of
each mammographic examination are communicated to the patient in a
timely manner. Thus, the focus is placed on the desired performance
outcome, the notification of the patient in a timely manner, and not on
the method or specific conduit of the notification. Under the final
rule, the facility has the flexibility to use the method of
notification that is most effective in its situation and to convey the
information to the patient that it deems to be most important. In the
part of the preamble discussing this provision, FDA continues to
endorse the use of written notification as the most reliable way to
guarantee that each patient is notified of results and that any
necessary followup will occur and recommends that facilities follow the
AHCPR guidelines on direct written notification to all patients. The
agency also describes other methods that may achieve the desired
outcome equally well in specific situations.
With respect to providing patients with original mammograms upon
request, the final rule was modified to make it clear that the original
mammograms must be made available to other medical facilities, at the
patient's request, whether the transfer is permanent or temporary. It
is expected that this change will end the difficulties in obtaining
previous original mammograms for comparison with new mammograms (an
essential aid to diagnosis) that many patients have experienced under
the interim regulations.
4. Quality Assurance
The goal of the quality assurance requirements of Sec. 900.12(d),
(e), and (f) are to ensure that equipment and personnel continue to
perform at adequate levels. Section 900(d) defines staff
responsibilities and recordkeeping requirements for the quality
assurance program, Sec. 900.12(e) establishes equipment QC
requirements, and Sec. 900.12(f) outlines the requirements for
mammography medical outcome audits.
The proposed equipment QC requirements represented a major
transition towards performance outcome standards. The interim
regulations had referenced the ACR quality assurance manuals and thus
specified not only the performance outcomes to be achieved but the test
procedures to be followed. The proposed rule was intended to establish
the desired performance outcomes and the required frequency of testing
at levels nearly identical to those in the interim regulations, but
sought to give the mammography facilities some

[[Page 55856]]

flexibility in the testing procedures to be used.
The final rule leaves the testing frequencies and the performance
outcomes largely unchanged from the proposal, with the exception that
standards have been added for radiation output, alignment, and
compression, parameters previously considered under the equipment
specifications. The provisions related to retesting after equipment
failure and taking equipment out-of-service until problems are solved
have also been modified to give the facility more flexibility in
determining when performance is compromised sufficiently to warrant
such actions.
5. Medical Outcomes Audit
A comprehensive mammography medical outcomes audit program can
ensure that a facility is providing its patients with accurate
mammography examinations and followup care and has the potential to
provide the basis for performance outcome standards. However, the
public comments made it clear that more research is needed before the
state-of-the-art will be sufficiently advanced to support regulatory
performance outcome requirements based on audits. FDA did move a step
beyond the interim requirement that each facility have a system for
reviewing outcome data by codifying requirements related to the
analysis of the data collected.
6. Consumer Complaint Mechanism
Under the interim regulations, accreditation bodies have developed
mechanisms for addressing consumer complaints about the quality of
mammography services received. Requirements for such mechanisms have
been continued in Sec. 900.4(g) of the final regulations. FDA
recognized, however, that consumer complaints usually can be addressed
most effectively at the facility level. For this reason, FDA proposed
to require each facility to develop a system for collecting and
resolving consumer complaints, with special emphasis placed on the
resolution of serious complaints. This requirement has been codified
with little change in Sec. 900.12(h). The accreditation body and FDA
retain the responsibility for addressing complaints that cannot be
resolved at the facility level.
7. Alternative Requirements
The alternative requirements in Sec. 900.18 provide a mechanism for
implementing advances in mammography that meet quality standards more
rapidly than would be possible through amending the regulations. This
mechanism will be used only when the potential public health benefits
justify such actions.
This section was incorporated into the proposed rule from the
interim regulations with little change. Before codification in the
final rule, the section was modified to give the agency the authority
to allow an approved alternative to be used by entities other than the
entity that applied for approval. This change was made in response to
concerns that it would be an unnecessary duplication of effort for the
agency and for the applicants if multiple applications were required
for the approval of the same advance in mammography.
8. Performance Outcomes
FDA's proposed rule invited comments on the possibility of taking a
performance outcomes approach to mammography quality standards.
Suggestions and comments on possible performance outcome indicators
were also invited. As discussed in more detail elsewhere in this
document, the consensus of the public comments was that while the
performance outcome concept was attractive in theory, much additional
research will be needed before a performance outcome system to ensure
mammography quality can be issued. The agency agrees with this
consensus but also believes that it is possible to start moving in that
direction in certain areas as noted in the previous discussion.

III. Provisions of the Final Rule

The proposed regulations that published in the Federal Register of
April 3, 1996, consisted of five separate documents. The first,
``Quality Mammography Standards; General Preamble and Proposed
Alternative Approaches'' (61 FR 14856 (Docket No. 95N-0192)): (1)
Surveyed the history of efforts to implement the MQSA; (2) summarized
FDA's analysis of the environmental, economic, and paperwork impacts of
the final regulations; and (3) set out the agency's proposed ``scope''
and ``definitions'' sections (Secs. 900.1 and 900.2). In that document,
the agency also invited public comments on the concept of performance-
based outcomes regulations and the feasibility of recasting the
proposed design and process requirements into performance-based
outcomes requirements.
The second, ``Quality Standards and Certification Requirements for
Mammography Facilities; General Facility Requirements'' (61 FR 14870
(Docket No. 93N-0351)), proposed regulations covering a variety of
areas, including: (1) Applicability (Sec. 900.10); (2) requirements for
certification (Sec. 900.11); (3) procedures for suspension or
revocation of accreditation; (4) accreditation body approval; (5)
facility certificates (Secs. 900.13 and 900.14); (6) the process for
appealing agency decisions (Sec. 900.15); and (7) an alternative
requirement process (Sec. 900.18). Some aspects of the facility
standards were also covered. These included medical records and
recordkeeping (Sec. 900.12(c)); general quality assurance requirements
(Sec. 900.12(d)); mammography medical outcome audits (Sec. 900.12(f));
mammography of examinees with breast implants (Sec. 900.12(g)); the
consumer complaint process (Sec. 900.12(h)); and additional clinical
image review and patient notification (Sec. 900.12(I)).
The third, ``Proposed Requirements for Accreditation Bodies of
Mammography Facilities'' (61 FR 14884 (Docket No. 95N-0192)), covered
the approval, responsibilities, and withdrawal of approval of
accreditation bodies (Secs. 900.3 to 900.7).
The fourth, ``Quality Standards and Certification Requirements for
Mammography Facilities; Personnel Requirements'' (61 FR 14898 (Docket
No. 95N-0215)), proposed standards to be met by interpreting physicians
(Sec. 900.12(a)(1)), radiologic technologists (Sec. 900.12(a)(2)), and
medical physicists (Sec. 900.12(a)(3)) working in mammography
facilities.
The fifth, ``Proposed Quality Standards for Mammography Equipment
Quality Assurance'' (61 FR 14908 (Docket No. 95N-0195)), proposed
equipment specifications (Sec. 900.12(b)) and requirements for the
equipment quality assurance program (Sec. 900.12(e)).
The proposed regulations were published in these five segments to
facilitate review and make it easier for members of the public to focus
on the sections of most interest to them. Because the final regulations
are being issued as a single document, the comments received in
response to the proposed regulations are addressed as part of this
single preamble rather than in separate documents relating to each of
the five proposal documents. General comments are treated first,
followed by a discussion of the public response to the concept of
performance outcome requirements and their feasibility. Then comments
on the individual components of the final regulations are discussed in
the order that each component appears in the final regulations.
Finally, the comments on the FDA's analyses of impact are discussed
in sections V of this document, and section VI covers the Paperwork
Reduction Act of 1995 provisions. Citations for individual provisions
of the regulations

[[Page 55857]]

generally have remained the same; the preamble clearly notes any
instance in which a provision has been codified under a new citation.
Each of the five proposed regulations was preceded by a preamble
containing a wide range of information intended as background and
information for the final regulations. Comments that the agency
received relating to preamble discussions have been addressed either
with the general comments or with the specific regulation sections to
which they are most closely related.

A. General Comments

Many comments received on the proposed regulations raised issues or
concerns that were broader in scope than any specific provision. These
more general comments are responded to first, before turning to the
more specific comments.
1. The Overall Value of the Quality Standards
(Comment 1). A number of the comments stated opposing positions on
the overall value of the quality standards established by these
regulations. Seventeen comments supported the quality standards with
only minor modifications, noting that they would strengthen radiology
practices and enhance the quality of mammography. Twenty-six comments,
on the other hand, opposed the quality standards in their entirety.
Reasons given included concern about costs and the resultant impact on
access, opposition to the regulation of medicine, a characterization of
the standards as unnecessary micro-management, belief that more
stringent standards were unnecessary or ineffective in improving
quality, and an opposition to ``international'' requirements for
mammography practice.
The agency recognizes the need to balance the benefits to be
achieved from improved quality of mammography with the cost of those
improvements and the impact such cost might have on access to
mammography. Congress addressed the concern with that balance in
drafting the MQSA and has guided the agency in its efforts to implement
the statute. An independent evaluation of the program performed by GAO
determined that the interim regulations had a positive effect on the
quality of mammography without a serious adverse impact on access (Ref.
2). Although, as previously mentioned, a number of facilities did close
for various reasons, service from another provider was generally
available within 25 miles. Newly established facilities have continued
to be certified, further mitigating any impact on access. Based upon
its experience with the interim regulations and advice from NMQAAC
members, FDA believes that the proposed regulations will achieve
further improvements in quality at a cost that will not impact access
significantly. The public comments on the proposal led to a further
refinement of the regulations, including removal of requirements when
the comments persuaded the agency that the requirement was not
essential. These changes, and the associated reduction in cost, should
provide an even more favorable ratio of benefit to cost.
In answer to concerns about micro-management, many of the specific
provisions added in the final regulations reflect practices and
policies that were developed under the interim regulations. These
policies were developed in response to requests from mammography
facilities for information on how to meet the requirements of interim
regulations and are already being followed by most facilities.
Incorporating these policies into the final regulations gave interested
parties the opportunity to comment on them. In response to the
comments, requirements have been refined to achieve the most favorable
balance between benefit and cost.
Finally, FDA notes that the system for ensuring quality mammography
established by the MQSA and these regulations is unique to the United
States and is not a duplicate of, or related to any international
requirements or systems established in any other country.
(Comment 2). Two comments, while apparently not in total opposition
to the regulations, did express their authors' opinions that the
personnel and recordkeeping and reporting requirements went ``far
beyond FDA's medical device mandate.''
FDA notes that the authors of these comments have overlooked the
fact that these regulations are issued under the MQSA, which amended
the Public Health Service Act, not under the Medical Device Amendments
to the Federal Food, Drug, and Cosmetic Act (the act). The MQSA
specifically requires the agency to develop standards for personnel
qualifications and for reporting and recordkeeping (42 U.S.C. 263b(f)).
(Comment 3). Several comments, while expressing varying degrees of
support or opposition to the requirements, asked why mammography has
been singled out for such attention. Some suggested that other diseases
were as serious or more serious than breast cancer, while one comment
pointed out that the radiation levels in mammography are quite low.
Although a case might be made for developing similar programs for
diagnosis of other diseases, Congress decided that mammography should
be the subject of this legislation. Congress found the evidence
sufficiently convincing that breast cancer was a significant public
health risk that could be reduced by improved mammography and,
furthermore, that the performance of mammography nationwide was in need
of improvement. Congress responded with the MQSA, and FDA is carrying
out the mandate of that statute. FDA agrees with the comment that
observed that the radiation levels in mammography are much lower than
they were 20 years ago (largely as a result of a cooperative
government, industry, and facility effort) and lower than those used in
many other examinations. However, the primary concerns addressed by the
MQSA are not radiation levels but poor image quality and
interpretation.
(Comment 4). One comment criticized the proposed regulations for
not sufficiently recognizing local facility condition variations,
indicating that standards appropriate for some facilities might be
unduly burdensome to others. In contrast, another comment strongly
supported the application of uniform standards in both rural and
nonrural areas. It stated that this would ensure that women in rural
areas received optimum care.
FDA believes that all women are entitled to high quality
mammography, no matter where they live, and so has not issued lesser
standards for rural areas or any other subset of facilities. The agency
further notes that the fear that applying uniform minimum standards
would cause an undue burden to rural facilities is refuted by the
experience of Michigan, where such uniform standards have been applied
to all facilities in that State since 1989 (Ref. 3), and by experience
under the Federal interim regulations.
(Comment 5). Ten comments stated that ``the regulations and the
complaint process may confuse the public by bringing up more issues
than it is necessary for them to be concerned with and confusing the
role of mammography in the overall diagnosis and treatment of breast
cancer.''
The purpose of the MQSA is to ensure adequate quality mammography
for all patients. If this purpose is achieved, members of the public
will be able to receive mammography at any facility in the country
without having to be concerned about the issues covered by the
regulations. Thus, public

[[Page 55858]]

``confusion'' should decrease rather than increase as a result of these
regulations. Without additional details, FDA cannot respond further to
the concern expressed by the comments about confusion over the role of
mammography. The agency assumes, however, that any such problems could
be handled through educational efforts.
2. Division of Responsibility
The MQSA established a system of checks and balances involving the
interaction of several groups, including FDA, the States, and the
accreditation bodies. A number of comments expressed varied concerns
about the division of responsibility established by the proposal.
(Comment 6). One of these comments stated that oversight and review
of mammography facilities is the backbone of the MQSA program. Along
with a second comment, it noted that FDA, not the accreditation bodies,
should be responsible for enforcement actions.
FDA agrees with this comment and believes that the final
regulations clearly give the agency the primary responsibility for this
function. However, the regulations also establish that the
accreditation bodies have responsibility for notifying FDA when they
have information that enforcement actions may be needed and for
assisting in related investigations.
(Comment 7). Two comments stated that the regulations should allow
States to eliminate overlapping functions if they are serving as both
accreditation bodies and inspection agencies. A third comment stated
that more leeway should be given to State accreditation bodies, which
have enforcement capability, than to non-State accreditation bodies. A
fourth comment recommended eliminating some unspecified requirements if
a State agency holds both accreditation body status and an inspection
contract.
FDA agrees that states that are both accreditation bodies and
inspection agencies may be able to combine some functions and, in fact,
some steps have been taken under the interim regulations. However, it
is important that all facilities meet the same accreditation and
inspection requirements. The agency believes it is unlikely that any
requirements pertaining to accreditation bodies or facility standards
can be eliminated entirely in States with dual status. The need for
consistency also explains why FDA disagrees with the third comment;
State accreditation bodies may have enforcement capability under State
law but this capability could vary greatly from State to State. As the
author of the fourth comment did not give specific examples of
requirements to be eliminated, the agency cannot respond further to
that comment.
(Comment 8). Three comments suggested that to reduce costs there
should be one comprehensive system to accomplish all the necessary
accreditations within any State that already has in place a mechanism
for accreditation of facilities and licensure of technologists. The
comment observed that the Federal Government would have to subsidize
States for this work.
States are permitted under the MQSA to apply to become FDA-approved
accreditation bodies (42 U.S.C. 263b(e)(1)(A)) and three States have
already done so. FDA disagrees that the agency should merely substitute
existing State accreditation and licensing systems for the MQSA
standards. States may have widely different accreditation standards
under their State laws, while the drafters of the MQSA envisioned a
system that would establish uniform, minimum national standards for all
mammography facilities. The MQSA, however, expressly permits State laws
relating to mammography that are more stringent to be issued or to
remain in effect (42 U.S.C. 263b(m)). Furthermore, the drafters of the
MQSA did not provide for Federal subsidies for any accreditation body;
the statute instead expects those bodies to be supported by their
accreditation fees.
(Comment 9). One comment recommended the adoption of only one set
of rules, whether it be established by the State, ACR, or FDA, to
govern mammography, while a second recommended combining FDA and ACR
into one ``accreditation body'' to reduce the problems of complying
with the requirements of both. Another comment objected to FDA
permitting States to pass additional laws and regulations governing
mammography in addition to the MQSA requirements. It stated that this
would prevent the establishment of consistent nationwide standards.
Another comment objected to the absence of a preemption clause in the
MQSA, fearing that would lead to overlapping State and Federal
regulations.
FDA notes that, within the limits of the authority given to it by
the MQSA, it has worked towards the goal of one set of rules. The MQSA
authorizes FDA to establish one set of uniform baseline standards and
to require that all approved accreditation bodies, including ACR,
enforce standards substantially the same as these. The agency has taken
this step. FDA also notes that the Health Care Financing Administration
(HCFA) has agreed to accept the MQSA regulations and inspections in
lieu of the regulations and inspection system it had previously
established to govern mammography under Medicare, thus reducing
duplication. The MQSA also requires State standards to be at least as
rigorous as those of FDA. However, as noted by the comment that there
is no preemption clause in the statute, the MQSA explicitly gives
States authority to develop additional regulations governing
mammography, as long as they are more stringent than the MQSA
requirements (42 U.S.C. 263b(m)). The intention of the MQSA was to
create a uniform nationwide baseline quality level for mammography,
while permitting individual States to strive for higher levels. Only
Congress can make changes in this approach, not FDA.
(Comment 10). One comment expressed concern that the nature of the
State/Federal agency relationship may be an impediment to ensuring
quality mammography. The author cited two GAO reports criticizing the
oversight of State programs by other Federal agencies. FDA notes that
the agency has a long history of Federal-State cooperative programs,
especially with respect to educational efforts and inspections in the
medical X-ray area, and that, in general, these programs have been very
successful. As the agency moves into new areas of cooperation with the
States, it is studying the experiences of other Federal agencies in an
effort to avoid any difficulties they may have experienced in working
with the States.
(Comment 11). One comment recommended that FDA's mammography
oversight be limited to equipment standards and requiring that
facilities be accredited and that oversight of the accreditation bodies
by FDA be reduced. Another comment suggested limiting FDA's oversight
only to ensuring that facilities are accredited properly by the
accreditation bodies.
FDA notes that the MQSA gives FDA far greater responsibilities than
either of these comments would permit and the regulations are intended
to help the agency continue to fulfill its obligations under the
statute.
(Comment 12). Similarly, two comments made the general
recommendation that the accreditation bodies be given expanded
responsibilities. Other comments had more specific opinions, for or
against, certain expanded responsibilities for the accreditation
bodies. Two comments stated that the accreditation body should be the
sole evaluator of the annual physicist survey, with the MQSA inspector
merely accepting the

[[Page 55859]]

accreditation body's review. A third comment argued, however, that
valuable information would be lost if the inspector accepted the
accreditation body's review of the report and a fourth comment agreed
that, if duplicate review is not cost effective, it would be more
appropriate for the inspector to review the survey than the
accreditation bodies. Three comments stated that the accreditation body
should be responsible for tracking all personnel requirements for a
facility, while a fourth would give the accreditation body
responsibility for review of continuing education credentials.
Similarly, a fifth comment would limit the inspections to review of the
physicist survey and the QC program, plus taking a phantom image,
leaving oversight of the other areas to some unspecified group. Another
comment on the appropriate division of responsibilities stated that FDA
should not have inspectors performing tests that have already been
conducted by medical physicists and technologists.
FDA has utilized, and plans to continue utilizing, the expertise of
the accreditation bodies to the maximum extent permitted by the
statute. The agency also realizes that the checks and balances system
required by the MQSA leads to some duplication of effort between the
accreditation body and the inspectors or the inspectors and the medical
physicists. However, one of the weaknesses of the pre-MQSA oversight
system for mammography was the lack of an onsite evaluation of the
facility programs by an individual independent of the facility.
Experience with the interim regulations has demonstrated the value of
such inspections; the great majority of findings were for situations
that had not been identified by the accreditation bodies or the medical
physicists. On the other hand, there is no doubt that the accreditation
bodies and the medical physicists have prompted the correction of many
problems before the inspections took place. These activities and
results demonstrate the strength of the program. The agency believes
that the drafters of the MQSA were correct in concluding that a checks
and balances system, involving two or more entities, would be more
effective in ensuring the continued maintenance of high quality
mammography than the use of only one entity or the other.
(Comment 13). Two comments recommended that the information
obtained by either the accreditation bodies or the inspectors should be
shared with the other groups to cut down on unnecessary duplication of
information collection activities or submission requirements for the
facilities.
FDA agrees with this comment and the statute itself supports
elimination of collection of duplicative information (42 U.S.C.
263b(d)). Under the interim regulations, the agency has been working
with the accreditation bodies on the electronic exchange of information
and will continue to do so under the final regulations.
3. Inspections and Inspectors
A number of the more general comments addressed various aspects of
the annual and audit inspections.
(Comment 14). Two comments suggested that the FDA facility
inspections should be reduced or eliminated in order to reduce the
costs to facilities or because annual inspections are not needed. A
third comment urged that inspection frequencies not be included in
regulations.
Annual onsite inspections are required by the MQSA (42 U.S.C.
263b(g)); that requirement cannot be changed by the agency, even if it
is not in regulations. The agency is evaluating alternative ways for
conducting inspections in the hopes of reducing costs for facilities.
(Comment 15). One comment stated that it was inconsistent for FDA
to inspect every facility every year while the accreditation bodies are
required to visit a much smaller number of facilities annually. The
comment further maintained that the MQSA inspections duplicated other
inspections.
The FDA inspections and the accreditation body visits serve two
different purposes. The MQSA inspections, which are required to be
annual, are intended to ensure that all facilities continue to meet the
MQSA quality standards. The MQSA requirement that accreditation bodies
visit a sample of their facilities each year serves an additional
purpose, which is to have accreditation bodies evaluate their own
performance and the effectiveness of their accreditation procedures (42
U.S.C. 263b(e)(4)(A)). In addition, accreditation bodies, at FDA's
request or on their own authority, will visit facilities that have been
identified as potential problem facilities for the purpose of
identifying the problems and assisting the facility in correcting them.
(Comment 16). Eleven comments suggested that ACR be designated as
the inspection organization in New Mexico.
FDA is unable to consider this suggestion because the MQSA
specifically limits inspectors to Federal or State personnel (42 U.S.C.
263b(g)).
(Comment 17). Three comments were concerned about the standards for
FDA inspectors and two more urged additional training for inspectors.
Another comment was very complimentary of inspectors in Iowa. Fifteen
other comments expressed various concerns about the inspection fees.
These issues are beyond the scope of these regulations, which cover
requirements for accreditation bodies and quality standards for
facilities only. FDA has referred these comments directly to the
components of FDA that deal with inspector training and inspection
fees.
4. Public Participation in the Process
(Comment 18). Three comments expressed concern that not enough
public input has been obtained during the regulation development
process and suggested that facilities, manufacturers, and personnel
should be interviewed.
The NMQAAC is composed of representatives of the mammography
community and consumer groups and has been a valuable conduit of public
input during the eight meetings at which it discussed the final
regulations before and after they were published. Furthermore, each
meeting included an open session during which members of the public
could make statements and many individuals took advantage of these
opportunities. Finally, there were three public comment periods during
the development of the regulations. The first of these was for comments
on the interim regulations. A great deal of information was gained for
use in the development of the final regulations from comments received
at this time. The second was after preliminary drafts of the equipment
and medical physicist standards were released and again valuable
information was obtained from the public. The third opportunity to
comment was after the publication of the proposed regulations and, as
previously discussed, approximately 1,900 responses covering every area
of the regulations were received from a broad spectrum of organizations
and individuals. FDA believes that the public has had ample opportunity
to participate in the regulation development and reiterates that this
public participation had a significant impact on its final form.
(Comment 19). Another comment recommended prohibiting NMQAAC
members from also serving on advisory boards or as consultants to
accreditation bodies in order to avoid the possibility that a limited
number of people will have disproportionate influence on the program.
In forming the NMQAAC and its other advisory panels, FDA has
complied with the Federal Advisory Committee

[[Page 55860]]

Act (the FACA), the agency's implementing regulations at 21 CFR part
14, and the MQSA. The FACA requires each advisory committee to be
fairly balanced in terms of the points of view represented and the MQSA
expressly describes the constituent segments of the affected community
that are to have representatives on the Committee (42 U.S.C. 263b(n)).
Because advisory committees enlist the expertise of outside consultants
to advise the government, it is frequently the case that well-qualified
members are nationally recognized experts who are also called upon to
play leadership and consultant roles for private groups. The agency
does not prohibit such individuals from providing government service if
the agency determines that such participation is in the best interest
of the government because the need for such participation outweighs the
potential conflict of interest. The existence of any potential
conflicts are stated for the public record at the beginning of each
advisory committee meeting and panel members who have conflicts on
particular matters may be prohibited from voting on those issues.
5. Double Reading
In the preamble to the proposed rule (61 FR 14870 at 14876, April
13, 1996), FDA noted that one of the comments received on the interim
regulations suggested that all mammograms be read a second time by a
second qualified physician. The author of the comment stated that this
would avoid unnecessary surgery and emotional stress that can arise
from a false positive reading and the lack of appropriate followup in
the case of a false negative reading. The agency did not include such a
requirement in the final regulations but asked for further comments on
the issue.
(Comment 20). Twenty four comments argued against a double reading
requirement, basing their opposition on such reasons as the cost, the
difficulty of achieving double reading, the delays in reporting to the
referring physician leading to patient dissatisfaction, and the belief
that it would be a meaningless exercise and only a few abnormalities
would be picked up. Comments asserted that the burden would be
especially great in rural and isolated areas and could reduce access to
mammography services. Twelve of these comments also questioned where
the notion of double reading would lead; and would there be a press for
triple and quadruple reading. One of these comments urged that the
focus be on training for the first reader so that double reading is not
necessary. On the other hand, three comments offered strong support for
the use of double reading and one comment went so far as to say that
all films should be double read in order to eliminate the trauma and
psychological stress associated with false positives. One comment
suggested requiring double reading for all positive mammograms.
FDA has determined not to include a double reading requirement in
the final regulations. Double or multi-reading (as it is now called by
the agency for reasons discussed with the comments on Sec. 900.2) is
referenced in the regulations only as a way for interpreting physicians
at low-workload facilities to meet their continuing experience
requirements. Although this practice is not being required, the
regulations do not preclude double reading. FDA encourages facilities
that believe their services will benefit from such procedures to
establish the practice as a quality assurance measure.
6. The Organization of the Final Regulation
(Comment 21). A number of comments were extremely critical of the
organization of the proposal, finding it difficult to read and to see
the relationship between the five separate divisions, each with its own
docket number, preamble, and regulatory content. Several of these
comments stated that information on the organization of the proposal
should have been provided, while others made suggestions for
reorganization of the material when it was published as a final
regulation.
FDA adopted the method of presentation in the preamble of the
proposals in an effort to make it easier for readers to focus on the
provisions that were of most concern to them. Readers interested
primarily in the personnel requirements, for example, would need
consider only the fourth division, while those whose concerns were
primarily equipment-related, could focus on the last division. Although
the summary section of each of the five divisions identified the
material being provided in the other divisions, it is clear from the
comments that further explanation would have been helpful.
The final regulations are being published in a single document.
This single document follows the usual Federal Register format of a
preamble and a regulation section. The regulation section combines the
regulations from the five divisions of the proposal in numerical order
from Secs. 900.1 to 900.18, with some sections reserved for later use.
For the convenience of the reader, a table of contents is provided.
7. Other Comments
(Comment 22). Additional comments were received on widely varied
topics. One comment noted that mammography services are provided for
men and women, and suggested that any mention of ``women'' should be
replaced by ``women and men.''
FDA agrees that men are also consumers of mammography services.
However, because breast disease and diagnosis overwhelmingly affects
women, that word seems more appropriate. However, the agency notes that
in the regulations themselves and at many places in the preamble, the
term ``patient'' is used. FDA believes this terminology addresses the
comment's concern.
(Comment 23). Four comments took issue with statements in the
preamble to the proposed regulations concerning the expected benefits
from improved mammography and the number of expected deaths from breast
cancer.
FDA is aware that several aspects of these issues are unsettled and
that authorities may draw different conclusions from the same data.
However, the authors of the comments did not appear to challenge the
statute's underlying assumption that mammography can be valuable in
combating a serious public health threat, even though they might
disagree on the quantification of that value.
(Comment 24). Three comments urged FDA to delay the final
regulations until a study of the impact of the interim regulations
could be conducted to determine what changes were needed or even if the
MQSA itself were necessary. Congress intended that final regulations be
in place before October 1, 1994, so that the benefits of improved
mammography could be realized as soon as possible. Recognizing the
magnitude of the task, Congress provided FDA with interim rule
authority that would require regulations to be issued in two steps. The
first step was the interim regulations, which led to significant
benefits. Neither Congress nor the agency believes that any further
delay in completing the second stage and achieving the increased
benefits of the final regulations can be justified. The agency notes,
however, that facilities have been operating under the interim rules
for over 2\1/2\ years and inspections against the interim regulations
have been occurring for over 2 years. This experience with the interim
regulations and the problem areas that were identified have contributed
significantly to the provisions of the final regulations.
(Comment 25). One comment asked the agency to clarify who makes the
decisions about the MQSA regulations.

[[Page 55861]]

FDA assumes that the author is referring to decisions about
interpretations of the regulations, including decisions about the
adequacy of particular training programs for mammography personnel.
These decisions are made primarily in FDA's DMQRP (address above).
(Comment 26). Four comments expressed concern that the more unique
mammography regulations become, the greater the likelihood that
generalists will be forced out of the field.
Many of the personnel requirements, such as licensing and
certification, are general requirements of the medical field. In
addition, Congress determined, and FDA agrees, that mammography is a
sufficiently unique and difficult examination to require specialized
training and experience in the production and interpretation of the
images and in the testing and maintenance of the equipment. However, it
does not require a full-time mammography practice to meet the
experience requirements specific to mammography and the specific
training requirements are only a fraction of what is required for other
purposes, such as completing a residency program or maintaining
certification from the American Registry of Radiologic Technologists
(ARRT). Thus, individuals will be able to meet the MQSA requirements
without limiting their activities to mammography and so there will
still be room for generalists.
(Comment 27). A number of comments expressed a variety of concerns
about matters outside the scope of these regulations or beyond FDA's
authority. These concerns included: (1) Questions about the appropriate
frequency for screening mammography and the levels of Medicare
reimbursement; (2) a recommendation that a State advisory board be
created to monitor each State's mammography program; and (3) a concern
about the perceived domination of medicine by big business. Because
these comments are beyond the scope of these regulations, these
comments will not be addressed.

B. Alternative Approaches to Quality Mammography

Executive Order 12866 requires Federal agencies to identify and
assess alternative forms of regulation and, where feasible, specify
performance objectives (performance or outcome-based standards), rather
than specifying the behavior and manner of compliance that regulated
entities must adopt (design-specification standards). In addition,
Executive Order 12866 requires each agency to avoid regulations that
duplicate other regulations. In response to this Executive Order, under
Docket No. 95N-0192, in the Federal Register of April 3, 1996 (61 FR
14856 at 14859) FDA invited comments on the feasibility of developing
performance-based regulations. Although the agency did not propose
specific regulations in this area, it did suggest several possible
performance measures for mammography and requested comments on their
value and feasibility. The agency also invited the public to suggest
other performance outcomes that might provide a basis for performance-
based standards. FDA also invited comments on suggestions for other
possible alternative approaches. While the standards that were proposed
were not designed to be performance-based standards, there are elements
of performance requirements throughout the final regulations. For
example, most of the QC standards in the final regulations are
performance based. The discussion in the proposal was to consider
extending such performance criteria to areas not now covered by that
type of requirement and to make the performance standards that had been
proposed more general, thereby possibly reducing the burden on
facilities.
1. General Comments
(Comment 28). Sixteen comments asserted that the goal of the
quality mammography efforts by FDA should be to reduce burdens on the
medical community by not requesting comments and review of additional
regulations. Some of the comments stated that ACR should be the entity
designated to define performance standards and that compliance with
such standards should be voluntary. Five additional comments suggested
that it was more appropriate for ACR and ARRT to oversee and govern
mammography quality.
FDA notes that these comments are in conflict with the statutory
provisions of the MQSA (42 U.S.C. 263b)), which mandate that the
government have authority and responsibility to establish standards for
the performance of quality mammography. However, in carrying out that
mandate, FDA has solicited and considered comments from the members of
the mammography community, including comments from ACR, ARRT, and
members of NMQAAC.
(Comment 29). Several individual comments addressed the general
issue of alternative approaches for quality mammography. One comment
favored FDA's role in establishing and strengthening standards for
quality mammography. Another suggested that FDA work with volunteers
who have an interest in alternative compliance options in order to
learn what is best.
Although FDA intends to continue to gather ideas and information
from experts in the field, the agency believes that the opportunity for
public review and comment on proposed regulations that will affect
members of the mammography community is the most equitable approach and
will minimize potential problems of ``standardization without
representation.''
(Comment 30). Four comments addressed the issue of FDA establishing
another set of interim rules, to be in effect while necessary research
on performance outcomes-based standards was conducted, or simply going
forward with the final regulations as proposed. These comments
supported finalizing the proposed regulations and suggested change only
if new technologies or alternative compliance options are identified at
a later time.
Three comments focused on the cost of changing the regulations and
discouraged change to the final regulations if any additional costs
were to be borne by the mammography facilities.
FDA is sensitive to the issue of costs associated with the
regulations and will keep this issue in mind whenever considering
changes to the regulations.
(Comment 31). Two comments expressed concerns that the general aim
of alternative approaches to achieve compliance would result in
loopholes that would allow facilities not performing at acceptable
levels to continue to perform substandard mammography.
The agency recognizes the importance of issuing performance
standards that do not allow loopholes. As with provisions that specify
the manner of compliance facilities must adopt, FDA intends to review
performance-based approaches for potential gaps that could defeat
efforts to achieve quality mammography.
(Comment 32). One comment stated that the ideas presented in the
alternative approaches section are unworkable and were not discussed
with the members of NMQAAC.
FDA acknowledges that NMQAAC did not have the opportunity to
discuss the alternative approaches material before publication (61 FR
14856). However, NMQAAC members did have the opportunity to review this
material and to make comments and recommendations at two meetings after
the proposal was published.
Generally, the NMQAAC comments did not support increasing the
number of performance-based standards at this time. They pointed out
that the

[[Page 55862]]

proposed regulations were actually a mix of performance- and
specification-based standards. While NMQAAC agreed that increased
reliance on performance-based standards might have promise for the
future, after further research is done, there are insufficient data at
this time to base the entire set of standards on performance criteria.
(Comment 33). One comment stated that the current tests specified
in the existing regulations are more thorough and complete than
alternative performance approaches that were identified in the preamble
to the proposed rules. A similar comment stated that the current tests
should be used by all facilities, with the exception of those
facilities that might develop improved, innovative strategies or
methods. The comment recommended that these facilities apply to FDA for
exemptions to use the innovative strategies or alternative methods. FDA
notes that a process for accepting and reviewing such applications is
provided by Sec. 900.18.
An additional comment expressed support for the intent of Executive
Order 12866, but at the same time argued that it is in the best
interests of FDA to be more specific in the final rules about those
instances where there are multiple methods or procedures to accomplish
the same task. The comment further stated that it was unclear how the
agency decided whether to use a performance outcome-based or a design-
based requirement in a particular situation. A second comment expressed
a similar opinion.
FDA notes that the comments on performance outcome-based standards
discussed above and in the following pages point out many difficulties
at the present time in establishing regulatory requirements to ensure
quality mammography that are based totally on performance outcomes.
However, the agency believes that in certain areas, for example,
quality assurance, performance outcome standards can and should be
established. In developing standards in a particular area, the agency
first considered whether it was feasible to ensure quality in that area
with performance-outcome standards. If it was not possible to issue
adequate performance-outcome standards in that area, the agency then
turned to design standards. Along those lines, FDA disagrees with the
statement in the comment that specific-design standards should always
be issued in cases where there are multiple ways of adequately
achieving a particular task or goal. On the contrary, the agency
believes that performance-outcome standards should be strongly
considered in such areas in order to give facilities the flexibility to
chose the method of achieving the goal that bests fits its particular
circumstances, instead of requiring that all facilities follow the same
path.
One other general comment similar to those of NMQAAC, asserted that
it was premature to try to identify alternative performance-based
approaches due to inadequate research and testing of these alternative
methods at this time. Another comment indicated that FDA did not comply
with Executive Order 12866 because the agency did not make a real
effort to identify alternative approaches. Similarly, one comment
argued that the FDA regulations ignored duplication with other
regulations, although no examples were given.
FDA notes that it did include a number of possible performance
outcomes measures in the proposal. There may be other possibilities of
which the agency is unaware, but the fact that no alternatives were
suggested by the author of these comments, or in any other comment,
suggests that few, if any, other options are currently available. FDA
further notes that the attempt to elicit public comment,
recommendations, and opinions concerning performance-based standards
through the proposal will not end its efforts to identify such
alternatives. FDA is unable to respond to the criticism that its
efforts duplicate other regulations in the absence of information on
where the author of the comment believes this has occurred. However,
HCFA has agreed to set aside its regulations in the mammography area
and to accept FDA-certified facilities as meeting its requirements for
reimbursement under Medicare and Medicaid. This eliminated one possible
source of regulation duplication.
FDA strongly supports the use of performance standards, however, it
recognizes that additional research is needed in the scientific
community before it can support additional regulations based on
performance outcomes. FDA encourages continued research in this area,
and will actively work to develop performance standards in the future.
2. Performance Standards and Outcomes Measures Suggested in the
Proposal
A large number of comments were received on the various performance
outcomes measures identified as possible alternatives by FDA. These are
reviewed in the following narrative in connection with the identified
alternative.
3. Mammography Medical Outcomes Audit
(Comment 34). FDA in the preamble to the proposed rules, FDA
suggested that the results of a mammography medical outcomes audit
might be used as the basis for a performance-based standard for each
mammography facility. A significant number of comments expressed
concerns about one particular aspect of the audit, namely, requirements
for patient followup that might be necessary to obtain outcomes data.
The major issues raised were the cost of such followup and the lack of
evidence that feedback about outcomes improves practitioner
performance. The authors of the 10 comments believed that individual
practitioners would never have sufficient cases to calculate meaningful
statistical outcomes.
Concerns were also expressed that there were no protections for the
confidentiality of outcomes data and that medical outcomes-based
standards could motivate practitioners to avoid challenging or
difficult cases. Eleven comments expressed objections to any
performance standard that would require mammography facilities and
interpreting physicians to collect followup data on films interpreted
as negative or to require the calculation of statistics relating to
sensitivity, specificity, or minimal cancer detection rates. One
comment objected on the basis that requiring the collection of such
data would imply that standards were required to force physicians to do
the best possible job and that this was necessary because it was the
norm for physicians to cheat or be dishonest. One comment expressed the
view that use of cancer registries to accumulate data for monitoring
outcomes was clumsy and expensive.
A related set of comments directed toward use of the positive
predictive value (PPV) statistic as a measure of quality mammography
performance was overwhelmingly negative. Nine comments pointed out that
there are varying definitions of PPV and that this is not a measure
familiar and understandable to the general public. The general
consensus was that this statistic was not useful and should not be
required to be published outside the physician's practice. Six
respondents argued that it was completely unacceptable to use the
physician's outcomes data as a measure of performance. Two comments
expressed the viewpoint that collection of information about PPV was
not appropriate because it was affected by many factors beyond the
control of the facility. Three comments vehemently opposed the public
disclosure of outcomes data, arguing that there would be a high
likelihood of misinterpretation by the public and incentives for

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facilities to falsify data. Two comments stated that data collection
and review alone would not have any significant influence on
radiologists' behavior, and consequently, that collection of
statistical data was not worth the effort. Finally, one comment agreed
that it would be valuable to find valid process and outcomes measures
for mammography but concluded that it would be premature to focus on
PPV, which is subject to influence by so many factors external to the
radiologist.
In contrast to these negative comments on using the results of the
mammography medical outcomes audit as the basis for performance
standards, one comment strongly supported the idea of the medical audit
as the basis for a performance standard and argued for the publication
of such findings in order to ensure that the public had access to
information that would allow them to select a reputable institution.
Another supportive comment asserted that the agency should develop
performance standards for medical outcomes audit statistics, which
could then be used to evaluate physician performance. A third
respondent urged that medical outcomes could and should be used as more
comprehensive measures of competence and compliance. Another comment
suggested that standardized values for sensitivity and specificity
could support a reduction in personnel requirements for facilities that
met the performance standards for these two statistics. One final
comment applauded the possibility of change from specification of the
manner of compliance to specification of performance objectives.
FDA observes that the majority of the comments received oppose the
use of the results of the mammography medical outcomes audit as the
basis for performance-based standards, at least at this time. The
agency recognizes that the issues of the confidentiality of data
collected and the limitations of PPV as an indicator of performance,
and the other problems identified in the comments, are concerns that
would have to be addressed before the audit could become the basis for
performance-based standards. The agency has concluded that it is
premature to establish performance standards based upon the mammography
medical outcomes audit, primarily because the necessary data to
establish such standards and to resolve the concerns expressed in the
comments are not yet available.
FDA is aware that the National Cancer Institute's Breast Cancer
Surveillance Consortium (NCI BCSC) has been actively engaged in
research to understand the full effect of breast cancer screening on
cancer outcomes through a collaborative effort with academic and
community-based mammography facilities. Through linkages of data from
mammography facilities with pathology data on cancer outcomes from
population-based cancer registries, outcomes data will be correlated to
interpretation. One of the goals of this research is to help establish
realistic targets for mammography performance. FDA participates with
the NCI BCSC and has staff expertise in the medical outcomes audit area
to further assist standards development of outcomes measures. FDA will
evaluate results from this research project as well as other projects
to determine the best approach to promote improved mammography
performance through performance-based outcome measures. FDA anticipates
issuing regulations in the future that would have appropriate medical
outcomes-based measures.
To this end, facilities are actively encouraged to develop their
medical audit programs and pursue outcomes-based measures. Information
to assist facilities in conducting and interpreting the mammography
medical outcomes audit can be found in the medial literature. In
addition, in 1994 the Agency for Health Care Policy and Research
published, ``Quality Mammography: Clinical Practice Guidelines.'' This
primer has a complete discussion of issues surrounding the medical
audit and has references to aid facilities. Meanwhile, the suggestions
contained in the comments to FDA's proposed rule supporting the use of
the audit as a basis for performance standards will be considered by
FDA in further efforts to develop performance-based standards. In
addition, FDA specifically invites comments on this issue for future
consideration. Please submit comments on this issue to the contact
person listed above.
4. Performance-based or Proficiency Testing
With respect to personnel, FDA raised the possibility in the
proposal that standards based on successfully passing proficiency tests
might be the basis for replacement of design specification standards
requiring certain levels of training and experience.
(Comment 35). The general consensus of 34 comments on proficiency
testing was that such requirements would be excessive, unnecessary,
costly, impractical, and duplicative of examinations already in place,
such as those administered by the American Board of Medical Physics,
the American Board of Radiology (ABR), and the American Board of Health
Physics. Twenty comments criticized the use of performance-based
standards in this area because they asserted that such standards are
not yet developed to a level where they can substitute for current
requirements. Two comments stated that it is better if FDA does not
become involved in personnel performance-based standards as part of the
MQSA. Rather, continuing medical education (CME) requirements as they
currently exist should be satisfactory for this part of the education
process. Three respondents indicated that the term ``performance-based
testing'' is too vague and could include even such simple things as the
radiologist's observation of the technologist performing an
examination.
After reviewing these general comments and the specific ones that
are discussed later in this document, FDA has concluded that it would
be premature to establish general performance standards based on
proficiency testing because there is no consensus among experts about
what those standards should be or how they should be measured. The
topic of proficiency testing for specific professional groups drew a
number of responses varying in their level of support for such testing.
Specific comments are noted and discussed as follows:
a. Proficiency testing for radiologists
(Comment 36). Proficiency testing for radiologists drew divergent
responses. Three comments urged that FDA, in collaboration with NMQAAC,
develop a proficiency test that physicians must pass prior to
initiating the practice of mammography interpretation. Four additional
comments favored proficiency testing for radiologists, but only as an
initial requirement. Thirteen comments indicated unqualified support
for proficiency testing for physicians. In contrast, five comments
maintained that board certification could replace proficiency testing
with intermittent retesting at 5- to 8-year intervals. Such
examinations could be handled by the accreditation bodies. Another
comment stated that random clinical image review at the time of the
MQSA annual inspection could substitute for proficiency testing. Six
comments agreed with the basic premise that performance evaluation is
important in order to determine accurate standards but that more time
is required to determine appropriate testing devices and standards. One
comment stated that training and experience requirements for
interpreting physicians should be sufficient and there was no need for
periodic testing. Similarly, one comment stated that the

[[Page 55864]]

medical audit could function as a proficiency test for radiologists.
Two comments expressed a total lack of support for proficiency testing,
arguing that such testing is time consuming, costly, unnecessary,
redundant, and not done in any other area of medicine. One comment
stated that periodic proficiency testing is appropriate for
nonradiologists reading mammograms but not for trained radiologists. In
lieu of proficiency testing, this comment suggested a special
certificate as part of designated continuing education courses as a
simpler way to establish a measure of proficiency. One final comment
stated that proficiency testing would impose undue hardship on the
radiologist whose practice is not exclusively devoted to mammography. A
total of 79 respondents argued that the cost of proficiency testing
would be too high and that the additional expenses would be passed
along to consumers.
FDA observes that support for proficiency testing for interpreting
physicians is somewhat stronger than for proficiency testing in
general, but that the majority of respondents still opposed the idea.
Given the diversity of response to the possible use of proficiency
testing for radiologists, and the fact that no existing tests were
identified in the comments, FDA has concluded that it is not in the
interest of quality mammography to mandate such testing at this time.
The agency believes that proficiency testing for physicians, if
feasible at all, would have to undergo further development before it
could be the basis of a performance standard.
b. Proficiency testing for technologists
(Comment 37). Three respondents stated that proficiency testing
every 3 to 5 years would be beneficial to technologists. One additional
comment concurred, but recommended testing every 2 years. Overall,
however, there was a general lack of support in the comments for
proficiency testing of technologists.
Sixty-one comments stated that such testing for technologists
cannot be conducted objectively and also indicated that the final
requirements were adequate to ensure the qualifications of
technologists. Ten additional comments claimed that proficiency testing
for technologists is impractical because of the lack of established
criteria and the absence of an appropriate body to administer such
tests. Three respondents argued that the medical audit served as a
proxy proficiency test for technologists. Twenty comments stated that
the proposed continuing education requirements were sufficient and it
was not necessary to administer recertification examinations. Thirty-
seven comments argued that technologist proficiency testing was
redundant with the other initial and continuing education requirements.
One comment stated that at one time, the ARRT had considered adding
a practical exam to its evaluation of mammography competency but
deferred doing so until credible analyses would establish that such an
examination would result in improved quality of performance. Four
comments stated that proficiency testing for technologists would drive
technologists away from the field of mammography. One comment expressed
the view that annual testing was unnecessary because mammography does
not change that rapidly. Another comment stated that a requirement for
proficiency testing for technologists would have a negative impact on
the availability of mammography in rural and mountainous regions. An
additional respondent argued that the annual requirements for
technologists are already excessive and the addition of competency or
proficiency testing would simply raise costs or close mammography
facilities. Four other comments expressed similar sentiments, stating
that technologists already have to meet sufficient requirements, and
the addition of proficiency testing would be excessive. Concerns also
were raised about who would administer such testing and the method of
payment. One comment urged that, if proficiency testing became a
requirement for recertification, it should be offered at no cost to the
technologist.
One comment argued that incompetent technologists could pass a
proficiency test and further stated that proficiency testing was a
measure of test-taking skills, not of mammographic competency. Two
comments expressed the point of view that proficiency testing is
useless and insulting. Several comments stated that recertification, if
required in addition to continuing education, is redundant, time-
consuming, and costly. These comments asserted that retesting is
valuable only in instances of significant changes in the mammography
modality. One comment pointed out that the ARDMS (a sonographer's
organization not further identified) had tried to offer a practical
examination, but abandoned the project because it proved too costly.
The remaining comments were all generally opposed to proficiency
testing for technologists. One comment suggested that a better way to
evaluate technologists would be to require performance at a seminar
that would assess their clinical competence. Another comment concurred
with this viewpoint, saying that a written exam cannot measure
competence in a hands-on field such as mammography. Finally, one
comment argued that further examination is not necessary if the
technologist remains active in the field of mammography and maintains
proper licensure.
The agency is persuaded that regulations requiring such testing
would be premature. FDA believes some of the objections raised, as with
the objections to radiologist testing, can be addressed and overcome;
e.g., to the extent comments argued that proficiency testing was
duplicative of current training, education, and experience
requirements, FDA could consider eliminating some of those
requirements. However, the agency agrees with the general consensus
expressed by the comments and concludes that proficiency testing for
technologists currently cannot provide the basis for a performance
standard.
c. Proficiency testing for physicists
(Comment 38). The agency received 17 comments about this topic. Of
the 17, 3 were in favor of proficiency testing for physicists, with 1
additional comment asserting that is would be possible to conduct such
a test, but only at great cost. Other comments stated that proficiency
testing for physicists was simply a bad idea. Two comments argued that
the proposed standards of a written examination and a practical survey
test were sufficient proficiency measures for physicists. Two comments
stated that a doctorate in physical science and board certification in
an appropriate medical physics sub-specialty provided a better
assurance of professional integrity than written and practical
examinations. Another comment suggested that it would be more
appropriate for physicists' accreditation bodies to administer such
tests because FDA lacked the necessary experience and knowledge in this
area. One comment expressed concern about the possibility of computer
errors if the examinations relied on computer programs for test
administration and scoring. One comment recommended that the idea of a
qualifying examination for physicists should be further explored,
especially because the proposed regulations do not adequately address
the issue of how detailed an annual survey should be.
One comment asked whether a performance-based standard would help
physicists working at small institutions to meet the training
requirements. Although it is possible that proficiency

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testing could alleviate difficulties involving access to training for
some physicists, FDA notes that it is not possible to determine whether
such an approach would permit these physicists to qualify until such a
time as the form and nature of a possible proficiency test is better
known.
As with proficiency testing for interpreting physicians and
radiologic technologists, the comments have persuaded FDA that it would
be premature to require such testing for physicists as the basis of a
performance standard. The agency, however, will continue to explore the
feasibility of such testing for radiologists, technologists, and
physicists.
5. Mammography Equipment and QC
The preamble to the proposals (61 FR 14860) suggested possible
performance-based substitutes for equipment specification and QC
testing in the proposed rule. One general comment recommended that FDA
retain the existing QC tests as proposed to ensure adequate mammography
equipment and QC. The author was of the opinion that one or two
performance-based criteria would not be adequate to serve as QC
measures.
a. Phantom image testing
FDA suggested that one possibility was that a more sophisticated
phantom might be developed for use in a single QC test that would
provide the same information on equipment performance as some or all of
the separate tests and specifications. A performance-based standard
predicated on test results using this phantom and falling within
defined limits might provide the same assurance of image quality as a
number of the design specifications and, therefore, could replace the
design specifications in the regulations.
(Comment 39). One comment stated that it was possible to develop a
single system test with an alternative phantom. The comment stated that
one distinct advantage of a single system test would be to replace the
present daily processor quality control (QC) test with sensitometry
based on the actual light emission of the radiographic screen and at
the same time check the performance of the rest of the imaging system.
The comment stated that the final regulations should allow facilities
and accreditation bodies to work together to adopt a suitable phantom
to be used as a daily total system test. The majority of the comments
received, however, were opposed to using phantom image testing as a
comprehensive equipment test, even if such testing would permit
alternative tests to be performed less frequently. There was strong
support for FDA to implement the mammography performance and design
requirements described in the proposed rules. Overall, a total of nine
comments opposed use of the phantom as a daily test that would replace
other QC tests. It was noted that more frequent use of the phantom
would increase costs, would not yield an adequate measure of quality,
would be useful only as a supplement to other QC tests, and would yield
results that were highly variable. Three comments remarked that phantom
testing is a good measure of quality but cannot replace all other QC
tests. Finally, it was noted that the STEP test should be added to the
phantom image analysis.
FDA observes that the general consensus of these comments is that
it is unlikely that testing with a more sophisticated phantom, if one
is made available through further research, will be an adequate
substitute for other QC tests.
b. Repeat rate
Another measure that was suggested as a possible performance
standard was the facility's repeat rate. Under the final regulations, a
repeat rate is to be analyzed every 3 months, and include up to 250
examinations. In the preamble to the proposal (61 FR 14860), FDA asked
for comments on the possibility of using the repeat analysis rate in
some modified form, such as conducting the test continuously, as the
basis for a performance standard. The agency also noted that such a use
would have to take into account the possibility that the repeat rate
could be altered through the acceptance by a mammography facility of
all images of any quality performed.
(Comment 40). Responses to this possible alternative were generally
negative. Three comments contended that the repeat rate could not serve
as an alternative to existing equipment and QC tests. Specifically, it
was noted that ongoing repeat analyses could not substitute for QC
tests. Four comments raised concerns about the possibilities for
altering or falsifying findings and lack of consistency within and
between mammography facilities in performing repeat analyses. A related
comment stated that technologists will not repeat images that should be
redone if they think the repeated images will affect their job. This
means poorer images may be submitted to radiologists for
interpretation.
FDA recognizes the validity of the concerns raised by these
comments and has concluded that a performance standard based on repeat
rate analyses is not likely to enhance quality mammography nationwide.
c. Clinical image review
FDA identified clinical image review as a possible basis for
performance-based standards. General comments regarding clinical image
review for this purpose were largely unfavorable.
(Comment 41). Nine respondents argued that random selection of
images for review is unnecessary because the review is conducted by the
accreditation body. It is better therefore, these comments continued,
to select previous images of the same patients to document improvements
in image quality between examinations rather than random selection of
images. Thirteen comments stated that the supervising radiologist
ultimately is responsible for assessment of clinical image quality.
Four comments questioned who would do the clinical image reviews for
all facilities and suggested that this would require a new government
agency in a time when government has been directed to downsize. Two
comments stated that clinical image review is only useful as a learning
tool in difficult cases and is not useful as a general test of
proficiency.
Additional comments were received on the possibility of using
clinical image review to evaluate the performance of the radiologic
technologist. Twelve comments were openly opposed to clinical image
review for assessment of technologists, arguing that it would require a
large investment of effort and financial resources. One comment said
that the radiologist, not the technologist, is responsible for the
quality of images and, consequently, it would be inappropriate to use
this as a performance assessment for technologists. Another comment
expressed the point of view that clinical image review was unnecessary
if technologists remain active in performing mammography and also
maintain proper licensure.
The question of who would do the image reviews drew a number of
comments. One comment said that clinical image review by technologists
had been tried previously with poor success, although specifics about
the problems were not mentioned. Nine comments asserted that clinical
image review to assess technologist performance should be done under
physician review, rather than by sending images to an outside
bureaucracy, which would be very costly for facilities. Cost was raised
as an issue by another respondent who argued that a facility with many
mammography technologists would have many images out for review, which
would be both costly and a threat to patient confidentiality. One
comment suggested that the FDA inspector review

[[Page 55866]]

clinical images at the time of the annual MQSA inspection, rather than
the facility submitting the images to some central point. Under this
approach, technologists and radiologists would complete critique forms
of their images to explain any difficulties or problems in taking or
reading the films.
On the more positive side, twelve comments stated that clinical
image review under the MQSA, combined with additional actions, would
ensure proper mammography performance sufficient to assess
technologists' clinical skills. The additional action suggested by 10
of these comments was yearly attendance at hands-on workshops, while
another comment suggested periodic recertification examinations, and
the 12th advocated use of repeat analysis. This last comment also
suggested that such an evaluation could even substitute for the
practice volume requirement for technologists in the proposal.
FDA observes that opinion is divided more evenly on the feasibility
of using clinical image review as a performance standard for
technologists than on the feasibility of the other possible bases for
performance standards mentioned in the proposal. The major problem
seems to be how to establish an effective system at a reasonable cost.
Although clinical image review will not substitute for the radiologic
technologist requirements being finalized in the regulations, FDA will
continue to evaluate this issue in collaboration with the members of
NMQAAC and other agencies involved with mammography QC.
6. General Observations
As discussed above, FDA sought public comment on the possibility of
taking an alternative approach to assuring the quality of mammography
nationwide. The alternative approach would be the greater use of
performance-based standards in place of the primarily design
specification standards established in the interim regulations and
proposed for the final regulations. Several possible measures or
mechanisms that could form the basis for performance-based standards
were identified and the public was invited to comment on their
feasibility and also to suggest other options. The agency also asked
for comments on how it should proceed with regulation development if
performance-based standards were considered feasible. If such standards
could be developed relatively quickly, FDA could consider maintaining
the interim standards and delaying the issuance of final regulations
until performance-based standards were developed. Conversely, if the
expected time for the development of performance-based standards was
lengthy, in the interest of achieving additional improvement in
mammography more rapidly, the agency might appropriately proceed with
finalizing the proposed rules (as modified in response to public
comment) and replace them at a later date with performance-based
standards after the necessary research for those standards was
complete.
(Comment 42). Only four comments addressed these questions directly
and, as noted above, they urged FDA to proceed with publication of the
final regulations. FDA also notes, as described above, that the
comments on the possible mechanisms for performance-based standards
identified by the agency were predominantly negative. Furthermore, none
of the comments suggested any other possibilities for performance-based
standards. This would seem to support the view that performance-based
standards, if feasible, will require further research. Based on this,
FDA concluded that it should proceed with the publication of these
final regulations. If further research and development suggest that
performance-based standards can replace these regulations, FDA will
propose amendments to the MQSA rules.

C. Scope Sec. 900.1

This section briefly summarized the content of the following
regulatory sections. No comments were received and it was codified
unchanged.

D. Definitions Sec. 900.2

This section defines terms used in the regulations whose meaning
would not be common knowledge or for which there exists more than one
definition, making it necessary to specify which is to be used for the
purposes of these regulations. Comments received on the definitions in
the proposal are discussed first. This is followed by a consideration
of comments that recommended adding new definitions or made other more
general comments on the proposed definitions. Discussed third are
definitions that have been added to, or changed from, those in the
proposal due to changes in other parts of the regulations.
1. Comments on the Proposed Definitions
a. General comments on several related definitions
The following closely related definitions were included in the
proposal in order to identify which consumer complaints must be
considered by the facility and the accreditation bodies in the
complaint process required by the MQSA:
Adverse event
Consumer
Serious adverse event
Serious complaint
The purpose of these definitions, as explained in the preamble to the
proposal (61 FR 14863), is to ensure that serious complaints about the
quality of the MQSA-related mammography services are adequately
addressed without placing an undue burden on facilities and
accreditation bodies by requiring extensive consideration for
relatively minor complaints.
``Adverse event'' is defined to mean an undesirable experience
associated with mammography activities within the scope of 42 U.S.C.
263b. Examples were included in the definition.
The definition of a ``consumer'' is intended to make it clear that
a patient or a representative of the patient (for example, family
members or referring physicians) can file complaints.
``Serious adverse event'' is defined to mean an adverse event that
could significantly compromise clinical outcomes or for which a
facility failed to take appropriate corrective action in a timely
manner. Finally, ``serious complaint'' is defined to mean a report of a
serious adverse event. Facilities, under Sec. 900.12(h), and
accreditation bodies, under Sec. 900.4(g), are required to carry out
specified activities in response to serious complaints.
(Comment 43). A number of general comments were received on these
related definitions. One comment stated that using the severity levels
outlined in current inspection procedures would be more applicable for
complaint activities than the proposed definitions.
FDA disagrees with this comment. The severity levels used for the
MQSA inspection program were developed for use by inspectors. They are
too technical and not necessarily relevant for consumer complaint
purposes.
(Comment 44). One comment recommended removing the terms ``adverse
event'' and ``serious adverse event'' and the addition of the
definition of ``complaint'' to mean the report of any undesirable
experience associated with mammography activities. These experiences
may include poor image quality, failure to send mammography reports
within 30 days, or the use of personnel who do not meet regulatory
requirements. Another comment also suggested adding a definition for
complaint without specifying what it should be.
FDA believes that the definition offered by the first comment could
result in complaints unrelated to the

[[Page 55867]]

MQSA (e.g., billing procedures) and complaints that would not
ordinarily be considered serious by most patients (e.g., facility
temperature) being forwarded to the accreditation bodies and FDA when
they have the greatest chance for resolution at the facility. The final
regulations require facilities to record all serious complaints. The
facility will forward unresolved serious complaints to the
accreditation body and/or FDA for further action. In addition, the
agency notes that the definitions of ``adverse event'' and ``serious
adverse event'' give examples of the kind of complaints that are within
the parameters of the consumer complaint mechanism. All of the examples
noted in the comment would fall within the scope of consumer complaints
subject to further accreditation body and FDA review.
b. Adverse event
(Comment 45). One comment agreed that the definition of ``adverse
event'' should include failure to send mammography reports in a timely
fashion to the referring physician or self-referred patient, but argued
that 30 days is an unreasonably long time for communication of adverse
events. FDA notes that the 30-day period referenced in the definition
is intended as the maximum amount of time that may elapse and that the
regulations state that the results should be communicated as soon as
possible.
This is discussed further in section III.L.3 of this document,
where FDA's responses to comments received on Secs. 900.12(c)(2)
Communication of mammography results to the patient, and 900.12(c)(3)
Communication of mammography results to health care providers, are
given.
(Comment 46). Several comments requested greater clarity or
additional explanation for the term ``poor image quality'' (used in the
definition of adverse event), and FDA's criteria to determine when
image quality is poor. The comment observed that the definition of poor
image quality is likely to be very subjective.
FDA agrees that a single definition for poor image quality would be
subjective and, therefore, has not included such a definition in order
to give facilities and accreditation bodies the flexibility to evaluate
such performance in a particular situation on a case-by-case basis.
However, criteria to be considered by accreditation bodies in
evaluating acceptable image quality are specified in Sec. 900.4(c)(2).
Consumers who decide to complain about poor image quality would
generally have assistance from health professionals (for example,
referring or consulting physicians, or accreditation body) in making
this determination. In situations in which FDA has reason to believe
image quality at a particular facility is poor, FDA may consult with
accreditation bodies for additional mammography review in order to
determine whether corrective or enforcement actions are appropriate.
c. Serious adverse event
The regulation defines ``serious adverse event'' as ``an adverse
event that may significantly compromise clinical outcomes, or an
adverse event for which a facility fails to take appropriate corrective
action in a timely manner.''
(Comment 47). Four comments recommended that the definition of
``serious adverse event'' should be revised. They stated that failure
to take action on a nonserious event should not turn the event into a
serious complaint. The comments recommended that ``serious complaint''
should be written to preclude common and potentially unavoidable
complaints about mammography (e.g., compression hurts, room too cold).
FDA disagrees that the definition should be revised. Failure to
take action on certain nonserious events may indeed result in a serious
adverse event. For example, it is generally accepted that most
compression complaints are considered to be minor. However, there may
be instances in which compression is unusually severe and, therefore,
the complaint would be considered serious. FDA believes the definition
should remain flexible to allow for this type of situation.
(Comment 48). One comment suggested changing ``may significantly
compromise clinical outcomes'' to ``has significantly compromised
clinical outcomes.''
FDA disagrees. A primary goal of the consumer complaint mechanism
is to improve mammography services by providing facilities with data
and information they might not otherwise receive or analyze. It is
preferable to correct a potentially serious situation before harm
occurs, rather than after the harm has affected the patient.
d. Serious complaint
(Comment 49). A ``serious complaint'' is defined as ``a report of a
serious adverse event.'' Two comments suggested that descriptions of
the type of serious complaints to be reported to the accreditation body
should be specified.
FDA agrees that additional descriptions will be helpful and intends
to make such information available through guidance. The agency
believes that making this information available in guidance, rather
than in regulations, will give facilities, accreditation bodies, and
FDA the flexibility to determine on a case-by-case basis whether or not
an event should be classified as serious.
e. Contact hour
``Contact hour'' was defined in the proposal as an hour of training
received through direct instruction.
(Comment 50). One comment recommended that it be defined as 50
minutes.
FDA is aware that in academic institutions an hour of didactic
training is frequently only 50 minutes long. However, in clinical and
continuing education situations, an hour of instruction is usually a
full 60 minutes. Reducing the figure from 60 to 50 minutes would reduce
the training requirements 16 percent. Because those training
requirements were proposed at what are believed to be the minimum
adequate levels, the agency did not change the definition.
f. Direct instruction
Direct instruction requires instructor-student interaction, either
face-to-face or through examination.
(Comment 51). One comment stated that the definition is too vague,
especially when compared to mammography equipment evaluation.
FDA disagrees. The agency believes the definition is sufficiently
specific to give a clear idea of what is required, while also
preserving the flexibility to accept possible new approaches to
instruction.
g. Direct supervision
The definition of direct supervision was designed to permit
``trainees'' to lawfully obtain the experience in interpreting or
producing mammograms or surveying mammography units that they needed to
become qualified or requalified. At the same time, by having the
trainee's work checked and, if necessary, corrected before any clinical
care might be jeopardized, the patient's right to adequate quality
mammography is protected.
(Comment 52). One comment supported this definition. A second
comment asked if direct supervision was needed for ``nonqualified''
people doing the QC tests.
In accordance with 42 U.S.C. 263b(f)(1), personnel qualifications
were established only for interpreting physicians, radiologic
technologists, and medical physicists. As a result, tests performed by
medical physicist ``trainees'' would have to be done under this
definition of direct supervision, although tests performed by QC
technologist ``trainees'' would not. However, the agency notes that
Sec. 900.12(d)(1)(iv) makes the QC technologist responsible for
ensuring the quality of performance of those

[[Page 55868]]

doing QC tests. The definition of QC technologist in Sec. 900.2(pp)
requires the QC technologists to meet the requirements for a radiologic
technologist, including training in quality assurance/QC. Taken
together, these requirements provide for a level of supervision similar
to that provided under this definition.
h. Facility
The definition of ``facility'' is provided by the law itself in 42
U.S.C. 263b(a)(3). It includes a variety of types of locations where
mammograms are produced, processed, or interpreted.
(Comment 53). Three comments either inquired if processing and
interpreting facilities would have to be certified and inspected or
asked that these facilities be excluded from the requirements. The law
defines locations where mammograms are processed or interpreted, and
where mammograms are produced, as facilities (42 U.S.C. 263b(a)(3)).
The agency's approach under the interim regulations, which is expected
to continue under the final regulations, has been a systems approach.
The facility producing the mammograms receives the certificate and is
responsible for ensuring that the facilities at which their mammograms
are processed and interpreted, if separate, meet the applicable quality
standards. This is consistent with the statutory provision that
requires the facility performing the mammography to be responsible for
meeting quality standards (42 U.S.C. 263b(a)(3)(B)). FDA has not set up
a separate certification and inspection system for facilities that
process or interpret only. However, because a certification system for
``partial'' providers may have some advantages for such facilities, the
agency may consider such an approach in the future.
(Comment 54). Two comments requested that the definition be
expanded to address situations involving multiple locations under the
same certificate or temporary locations where a unit (stationary,
portable, or mobile) is used more than a minimum number of days.
FDA's experience under the interim regulations shows there is wide
variety in the locations at which mammography is performed and in the
corporate and business relationships among these locations. Presently,
such situations are handled on a case-by-case basis in consultation
with the facilities and accreditation bodies involved. The agency
believes that it is essential that this flexibility be maintained and
that it would be unduly restrictive to prescribe permissible locality
arrangements in regulation.
i. First allowable time
The proposal defined ``first allowable time'' as the earliest time
a physician is eligible to take the diagnostic radiology boards of an
eligible certifying body. Because the ``first allowable time'' a
resident physician becomes eligible to take the boards may vary with
the certifying body, the definition cannot be more specific. If a
resident physician wishes to use the exemption from the initial
experience requirement described in Sec. 900.12(a)(1)(iii)(B), it is
the physician's responsibility to ascertain the requirements of the
body by which he or she wishes to become certified and to seek that
certification as soon as he or she becomes eligible to do so.
(Comment 55). Three comments stated that this definition was
unclear and were unsure how or why this related to resident physicians
who would be interpreting 240 mammograms during a 6-month period.
NMQAAC also stated that the concept of ``first allowable time''
required further explanation.
This term is used in Sec. 900.12(a)(1)(iii)(B). That provision is
an exemption that allows resident physicians to interpret the 240
mammograms required for initial experience in any 6-month period during
the last 2 years of their residency program (rather than during the
last 6 months immedi

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A97-26351. Public record. Not legal advice.