[Federal Register Volume 61, Number 65 (Wednesday, April 3, 1996)]
[Proposed Rules]
[Pages 14884-14898]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-7831]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 900
[Docket No. 95N-0192]
RIN 0910-AA24
Proposed Requirements for Accreditation Bodies of Mammography
Facilities
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
its interim regulations for application procedures for FDA approval as
an accreditation body under the Mammography Quality Standards Act of
1992 (the MQSA). FDA is proposing these amendments based on experience
gained in administering the interim regulations, advice from the
National Mammography Quality Assurance Advisory Committee (NMQAAC), and
public comments received in response to the interim regulations. This
proposal would also establish new requirements and responsibilities for
accreditation bodies. This proposal is the second of five proposed
rules published in this issue of the Federal Register regarding MQSA
requirements applicable to mammography facilities. These proposed rules
are being issued to ensure adequate and consistent evaluation of
mammography facilities on a nationwide basis.
DATES: Written comments on this proposed rule by July 2, 1996. Written
comments on the information collection requirements should be submitted
by May 3, 1996. The agency is proposing that any final rule based on
this proposed rule become effective 1 year after its date of
publication in the Federal Register.
ADDRESSES: Submit written comments on this proposed rule to the Dockets
Management Branch (HFA-305), Food and Drug Administration, 12420
Parklawn Dr., rm. 1-23, Rockville, MD 20857. The Regulatory Impact
Study (RIS) is available at the Dockets Management Branch for review
between 9 a.m. and 4 p.m., Monday through Friday. Requests for copies
of the RIS should be submitted to the Freedom of Information Staff
(HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm. 12A-16,
Rockville, MD 20857.
Submit written comments on the information collection requirements
to the Office of Information and Regulatory Affairs, Office of
Management and Budget, New Executive Office Bldg., 725 17th St. NW.,
rm. 10235, Washington, DC 20503, Attn: Desk Officer for FDA.
FOR FURTHER INFORMATION CONTACT: Charles K. Showalter, Center for
Devices and Radiological Health (HFZ-240), Food and Drug
Administration, 1350 Piccard Dr., Rockville, MD 20850, 301-594-3332.
SUPPLEMENTARY INFORMATION:
I. Background
This proposal is the second of five related proposed rules
published in this issue of the Federal Register to amend interim
regulations published on December 21, 1993 (58 FR 67558 and 58 FR
67565) implementing the MQSA (Pub. L. 102-539). The first proposed
rule, ``Quality Mammography Standards; General Preamble and Proposed
Alternative Approaches'' contains background information and a summary
of the preliminary analysis of the costs and benefits of the proposed
rules, a description of the information collection requirements,
proposed revisions to Secs. 900.1 Scope (21 CFR 900.1) and 900.2
Definitions (21 CFR 900.2), and proposed alternative approaches to
mammography quality standards and a request for comments on the
proposed alternatives.
II. Provisions of the Proposed Rule
A. Development of the Proposed Regulation
This proposed rule covers procedures for application to FDA for
approval as an accreditation body and the requirements and
responsibilities of such bodies. As with the interim regulations, FDA
was guided in the development of this proposed rule by the intent of
the legislation to guarantee access to safe and effective mammography
services for all women in the United States (Ref. 1). FDA also relied
upon three major sources of information, in addition to the expertise
and research of FDA personnel.
First, the agency considered public comments received on the
interim regulations. The agency received 103 comments from individuals
and organizations, including professional organizations, medical
facilities, State agencies, consumer groups, manufacturers, and
individual physicians, medical physicists, and radiologic
technologists. The proposed regulations were also discussed in a series
of quarterly meetings with the NMQAAC. Members of the NMQAAC include
interpreting physicians, medical physicists, radiologic technologists,
representatives of State agencies, and consumer representatives.
Consultants to the NMQAAC and guests invited to attend the committee
meetings in recognition of their expertise in mammography also
participated in these discussions of the proposed regulations. Finally,
the agency's experience over the last year with the four accreditation
bodies approved under the interim regulations also influenced the
development of the proposed regulations. A discussion of the proposed
amendments and a summary and analysis of both NMQAAC input and public
comments regarding the regulations are provided below.
B. Application for Approval as an Accreditation Body
In Sec. 900.3 (21 CFR 900.3) of the interim regulations, FDA
established standards for approving the applications of prospective
accreditation bodies. These standards are expanded in proposed
Sec. 900.3 to provide FDA with more thorough criteria for assessing a
[[Page 14885]]
prospective body's capabilities. FDA is also proposing regulations to
establish renewable terms of authority and the scope of authority of
accreditation bodies.
1. Accreditation Body Assessment Criteria
To identify more comprehensive criteria for evaluating prospective
accreditation bodies, FDA researched Federal oversight of other
accreditation organizations in the health care field. This included
review of HCFA regulations and of an assessment of those regulations by
GAO.
In the Federal Register of December 14, 1990 (55 FR 51434), HCFA
published a proposed regulation entitled ``Medicare Program: Granting
and Withdrawal of Deeming Authority to National Accreditation
Organizations.'' GAO reviewed that proposed regulation and stated in a
1991 report that, with only one exception, the proposed regulation met
all of the criteria that GAO considers important in the evaluation of
an accreditation organization (Ref. 2). This regulation was finalized
in the Federal Register of November 23, 1993 (58 FR 61816).
Based on GAO's review of the proposed HCFA regulation, and FDA's
experience with accreditation bodies under the interim regulations, FDA
considers it essential to require a complete description of a
prospective accreditation body's review and decisionmaking processes,
including policies and procedures used to notify facilities of
deficiencies and to monitor the correction of deficiencies. In
addition, FDA considers the following criteria to be important in
evaluating a prospective accreditation body's application: (1)
Qualifications of the body's professional staff; (2) adequacy of the
body's staffing level, finances, and other resources; (3) the body's
ability to provide data and reports in an electronic format compatible
with FDA data systems; and (4) adequacy of the body's consumer
complaint mechanism. These additional criteria, together with the
interim criteria, are reflected in proposed Sec. 900.3(b)(3).
Several comments on the interim regulations as well as members of
the NMQAAC noted the importance of timely processing of accreditation
applications. These comments requested that accreditation body
applications include satisfactory assurances that the applicant will be
able to complete the accreditation process for a given facility within
6 months if the facility submits the required information in a timely
manner.
FDA agrees that timely processing of accreditation materials is
necessary in order to: (1) Meet statutory requirements, that, in most
cases, allow new facilities to be provisionally certified for only 6
months, and (2) ensure that reaccreditation applications will be
processed before expiration of a facility's accreditation. Therefore,
FDA is proposing to add a requirement in Sec. 900.3(b)(3)(iii)(J) for
prospective accreditation bodies to submit such assurances with their
application for approval, along with a description of their policies
and procedures for ensuring timely processing of accreditation
materials.
To gain further insight regarding appropriate criteria for
evaluating prospective accreditation bodies, FDA reviewed a regulation
entitled ``Secretary's Procedures and Criteria for Recognition of
Accrediting Agencies,'' which was finalized by the U.S. Department of
Education in the Federal Register of April 29, 1994 (59 FR 22250).
Based on FDA's review of that regulation, along with the agency's
experience under the interim regulations and comments by NMQAAC
members, FDA is proposing to add new Sec. 900.3 (b)(3)(iii)(K),
(b)(3)(viii), and (b)(3)(ix). These sections would require each
prospective accreditation body to submit with its accreditation
application: (1) A description of the body's appeals process for
facilities contesting accreditation decisions; (2) a description of the
body's mechanism for ensuring against conflicts of interest; and (3)
information disclosing any commercial products used in mammography that
the body develops, sells, or distributes.
2. Term Limits and Scope of Authority
In Sec. 900.3(g), FDA is proposing to establish renewable 5-year
terms of approval for accreditation bodies. The agency believes that a
body should not be approved for an indefinite amount of time without
undergoing periodic comprehensive reviews. Although the interim
regulations addressed the possibility of withdrawing the approval of an
accreditation body for unsatisfactory performance, the interim
regulations did not establish a regular term limit for accreditation
body approval.
FDA is proposing in Sec. 900.3(c) a schedule and requirements for
application for renewal of an accreditation body's approval. These
schedule and renewal requirements would also apply to accreditation
bodies approved under the interim regulations that seek to continue
serving as accreditation bodies under the final regulations. FDA's
intention in establishing such a schedule is to ensure sufficient time
for the review and processing of applications in order to avoid
interruption in the availability of the services of the accreditation
body. The agency solicits comments on whether the 90-day timeframe for
application is appropriate.
Proposed Sec. 900.3(d) describes the process the agency would use
for reviewing accreditation body applications and renewals. The
proposed process includes a provision for extending an accreditation
body's previous approval if FDA has not reached a final decision on
renewal before the previous approval expires.
FDA is proposing new provisions in Sec. 900.3 (e) and (f) requiring
the accreditation body to notify facilities and FDA, and to transfer
records in instances where the body: (1) Voluntarily ceases its
accreditation functions before expiration of its 5-year term, (2)
decides not to reapply for an additional term of approval, or (3) fails
to become reapproved by FDA.
In addition to limiting the term of approval of accreditation
bodies, FDA believes that the agency should be permitted to limit the
scope of authority of an accreditation body (for example,
geographically, for State agencies). This is proposed in Sec. 900.3(g).
FDA plans to issue application guidance to prospective
accreditation bodies to assist them in preparing materials and
supporting documentation required by the revised accreditation
regulations, when finalized. It is expected that for accreditation
bodies applying for renewal, the supporting documentation will consist
primarily of updates of information previously provided to FDA.
C. Standards for Accreditation Bodies
In Sec. 900.4 (21 CFR 900.4), FDA is proposing expanded
requirements and responsibilities for accreditation bodies. These
standards are intended to ensure that accreditation bodies work
together with FDA and mammography facilities to achieve and maintain
high quality mammography at all facilities.
Proposed Sec. 900.4(a) establishes a code of conduct and general
responsibilities for accreditation bodies to assure the integrity and
impartiality of accreditation body actions and appropriate oversight of
the quality of mammography at all accredited facilities. Other proposed
paragraphs in Sec. 900.4 and the accreditation body requirements they
address include: Sec. 900.4(b)--standards that the accreditation body
must apply to
[[Page 14886]]
accredit facilities; Sec. 900.4 (c) and (d)--accreditation body review
of facility clinical and phantom images; paragraph (e)--accreditation
body review of reports of mammography equipment evaluation, physics
surveys, quality control records, and personnel updates at facilities;
Sec. 900.4(f)--accreditation body onsite visits to facilities and
performance of random clinical image reviews; Sec. 900.4(g)--consumer
complaint mechanisms; Sec. 900.4(h)--other reporting and recordkeeping
requirements; and Sec. 900.4(i)--fees that accreditation bodies may
charge facilities for accreditation. While most of these requirements
were addressed by the interim regulations, FDA is proposing additions
and modifications that are described in this preamble.
1. Code of Conduct and General Responsibilities
In Sec. 900.4(a)(1), FDA is proposing to require an accreditation
body to take certain actions if the agency believes that the clinical
image quality or other aspects of a facility's practice are seriously
compromised and would pose an unreasonable risk of substantial harm to
the public. The agency's intention is that this authority would only be
used in those situations, hopefully rare, where the mammography-
specific health hazard is serious enough to warrant actions beyond the
scope of those normally used to meet the facility quality standards. It
is not intended to replace the normal interaction between accreditation
bodies and facilities as they seek to meet the quality standards.
This section was added in response to discussions with the NMQAAC
and public comments requesting additional measures to ensure timely
compliance with regulatory requirements by facilities. For example, one
comment questioned whether the loss of a facility's certification would
assure termination of a facility's ability to provide mammography
services. Another comment stated that accreditation bodies should have
the authority to take action against miscreant facilities.
FDA advises that there are a number of mechanisms in place to
ensure that decertified facilities no longer provide mammography
services. When facilities lose their certification, they can no longer
provide mammography services lawfully and are required to return their
certificate to the agency. Consumers have been advised through various
publicity campaigns to check for the presence of an FDA certificate
when they go for a mammogram, so many consumers will be aware that they
should not have a mammogram performed at a facility that does not
display an FDA certificate. In addition, the statute provides for civil
money penalty and injunctive sanctions against facilities that practice
mammography without a certificate. Nonetheless, for circumstances where
FDA believes there is a risk of substantial harm to the public,
proposed Sec. 900.4(a)(1) would provide an additional means of
monitoring facility compliance with MQSA requirements and would allow
FDA to require accreditation bodies to assist the agency in taking
actions or requiring facilities to take actions that the agency deems
necessary to prevent harm to consumers. FDA solicits comments on the
nature and appropriateness of this proposed additional monitoring.
Similarly, Sec. 900.4(a)(2) and (a)(3) propose additional steps to
be taken by accreditation bodies in circumstances where a facility's
operations may compromise the quality of mammography or otherwise pose
a health or safety hazard that is within the scope of the MQSA but not
as severe as situations addressed by Sec. 900.4(a)(1). In accordance
with these proposed paragraphs, accreditation bodies would be required
to notify FDA any time the accreditation body becomes aware that there
has been actual loss of life or serious injury or illness associated
with facility noncompliance with MQSA requirements. Such notification
would have to be provided to FDA within 5 business days of the
accreditation body's learning of the event. The 5-business day interval
was chosen as a compromise between the agency's need to be informed as
soon as possible of serious mammography-specific health hazards and the
need for the accreditation body to have sufficient time to identify and
report the event. Comments are specifically invited upon the
appropriateness of the allowed length of time. Accreditation bodies
would also be required to obtain, review, and monitor plans of
correction from facilities not in compliance with the facility
standards. These provisions should further address the concerns of the
comments mentioned above.
One comment requested that all time period designations related to
requirements for action by accreditation bodies be specified in
``business'' days rather than ``calendar'' days.
FDA agrees that some time period designations should be specified
as business days and has proposed changes to the interim regulations
accordingly. Where proposed time periods are not explicitly specified
as business days, they should be interpreted as calendar days. In
addition, in order to afford accreditation bodies and facilities
increased flexibility, FDA is proposing to eliminate some of the
mandatory schedules specified under the interim regulations. For
example, FDA is eliminating the interim requirement that accreditation
bodies with minor deficiencies submit a plan of corrective action
within 90 days. Thus, under the proposed regulations, certain schedule
requirements would be left to the discretion of the accreditation body
or FDA or would be subject to FDA approval during the accreditation
body application process.
In Sec. 900.4(a)(4), FDA is proposing that accreditation bodies be
required to establish a quality assurance (QA) program that includes
clinical and phantom image review. This QA program would establish
policies and procedures to ensure consistent and accurate evaluation of
facility images with respect to both methods of review. The QA program
would also address training and evaluation of staff performing the
reviews.
In proposed Sec. 900.4(a)(5), FDA calls for new measures to reduce
the possibility of conflict of interest or bias on the part of an
accreditation body or anyone acting on an accreditation body's behalf
with regard to specific facilities. NMQAAC members and consultants
expressed concern about conflicts of interest or bias with regard to
clinical image reviewers evaluating images from their own States or
from geographically limited areas where the reviewers may know the
facilities and their interpreting physicians. Also, various comments
expressed concern that: (1) ``Innumerable `non-profit' health care
corporations'' could be approved as accreditation bodies and accredit
their own facilities as long as clinical image reviewers had no
financial interest in the facilities; (2) a professional organization
serving as an accreditation body has members with ``vested interests in
the outcome of the body's decisions;'' (3) individuals employed by a
professional organization that is an accreditation body have a conflict
of interest with regard to the establishment of standards by which
their facilities would be evaluated under the MQSA; and (4) members of
a professional organization that was an approved accreditation body
would be prevented from conducting clinical image reviews.
The proposed code of conduct in Sec. 900.4(a) is intended to
address the various concerns raised regarding conflict of interest
considerations for accreditation bodies. In addition, FDA notes that
all standards used by accreditation bodies to accredit facilities
[[Page 14887]]
are subject to review and approval by the agency. However, neither the
interim requirements nor the proposed code of conduct would preclude
members of a professional organization that is designated as an
accreditation body from conducting clinical image reviews for that
organization solely on the basis of membership in that organization. In
addition, the proposed standards include conflict of interest
provisions that would preclude other situations suggested by the
comments.
Several comments and presentations at the NMQAAC meetings, on
behalf of a trade association of software vendors, expressed concern
that a currently approved accreditation body that markets mammography
reporting software might have a sales advantage because of its MQSA
accreditation functions and a perceived ``imprimatur of government
approval'' for its products. In particular, this trade association
proposed that the following language be incorporated into FDA's
standards for approval of an accreditation body:
Satisfactory assurances that the body does not have any interest
in the development, sale, promotion, or distribution of any product
(including computer software) under circumstances where the product
will be the subject of inspection or review by the accreditation
body in facility quality assurance or quality control or other
aspects of the accreditation process. This restriction does not
apply to educational programs or educational material typically
prepared or disseminated by an accreditation body.
Although FDA has not proposed the standard suggested by this
comment, the agency specifically solicits public comment on this
alternative. This issue has been raised repeatedly during the open
public sessions of the NMQAAC meetings, and FDA wants to be certain
that there is full opportunity for the public to comment on the
underlying question: Is there an inherent conflict in an accreditation
body also being a product vendor for a mammography- related product? As
currently proposed, the requirements in Sec. 900.4(a)(6) minimize the
possibility of accreditation body conflict of interest with regard to
the marketing of commercial products by prohibiting an accreditation
body from representing in any way that the purchase of a particular
product is a condition of accreditation. However, proposed
Sec. 900.4(a)(6) would not require accreditation bodies to divest all
interests in commercial products. Moreover, the proposed regulation
would permit an accreditation body to require the use of a product by
facilities it accredits, even when there is the possibility of a
conflict of interest, if FDA determines that such use is in the best
interest of public health. As noted previously, FDA encourages further
public comment on the conflict of interest issue, including comment on
whether the outcome of any conflict of interest issue would be affected
by: (1) The cost of the product sold by an accreditation body, i.e., by
the magnitude of the financial interest; or (2) the number of
accreditation bodies available to choose from.
Proposed Sec. 900.4(a)(6) would require an accreditation body to
state the bases for denying accreditation in a written notification to
the affected facility. In accordance with proposed
Sec. 900.3(b)(3)(iii)(K), each accreditation body will establish
procedures for appeal of adverse accreditation decisions to the
accreditation body. The accreditation body's notification of denial of
accreditation also would be required to describe the appeals process
available from the body if the facility wishes to contest the adverse
decision.
Proposed Sec. 900.4(a)(8) would explicitly prohibit any State that
has been approved as an accreditation body from precluding any other
FDA-approved accreditation bodies from operating in that State. This
amendment is intended to codify what has been FDA policy and practice
under the interim regulations.
Several comments stated that FDA should allow only one
accreditation body to operate in a given State or should allow only
States to serve as accreditation bodies.
FDA disagrees with these comments. The statute itself does not
provide for such exclusivity. The MQSA allows FDA to approve either
State agencies or private nonprofit organizations to serve as
accreditation bodies, as long as they meet the standards established by
FDA. The agency believes that facilities, consumers, and the
professional community can benefit from the existence of more than one
accreditation body.
Consistent with the interim regulations, the proposed regulations
would require that accreditation bodies obtain FDA authorization before
changing accreditation body standards previously approved by FDA
(Sec. 900.4(a)(9)). Several comments expressed concern that this
requirement would preempt section 354(m) of the PHS Act, which permits
States to enact and enforce laws that are more stringent than those
mandated by the MQSA. There was also discussion during the January 1995
NMQAAC meeting as to whether accreditation bodies could have more
stringent requirements than those mandated under MQSA.
FDA requires State agencies and private nonprofit organizations
approved as accreditation bodies by FDA to establish and implement
facility standards that have been approved by FDA. FDA will approve
such standards only if FDA determines that they are substantially the
same as the standards required under MQSA. In addition, all
accreditation bodies, whether State agencies or private nonprofit
organizations, must determine the MQSA accreditation status of a
facility using only FDA-approved standards. However, accreditation
bodies may use more stringent standards under other (non-MQSA)
authorities for purposes other than that of determining the MQSA
accreditation status of facilities. For example, a State public health
agency approved as an MQSA accreditation body by FDA may require
facilities in the State to meet additional standards (beyond those
required by MQSA) under the body's authority as a State accreditation
agency. However, the body may not require facilities to meet these
additional standards in order to obtain MQSA accreditation. Similarly,
a private nonprofit organization approved as an accreditation body may
recommend compliance with more stringent standards than those mandated
under MQSA, but may not use such standards in determining the MQSA
accreditation status of a facility.
Proposed Sec. 900.4(a)(10) states the accreditation body's
obligation to protect the confidentiality of nonpublic information
acquired in connection with carrying out accreditation body
responsibilities. The accreditation body may not use or disclose
information it receives from facilities, other than to FDA or its
designated representatives, without the consent of the facility. The
accreditation body must also protect the confidentiality of nonpublic
information it receives from FDA or its duly designated
representatives.
2. Facility Standards
In proposed Sec. 900.4(b), FDA outlines the quality standards for
mammography that accreditation bodies would have to apply to facilities
they accredit (facility standards). The details of the facility
standards required under the MQSA are being proposed elsewhere in this
issue of the Federal Register. FDA is also proposing in Sec. 900.4(b)
actions to be required by the accreditation body with respect to
facilities not in compliance with the quality standards, such as
reviewing and monitoring the implementation of facility plans of
correction and revoking a facility's accreditation.
[[Page 14888]]
One comment recommended that a single quality standard be
implemented nationwide by all accreditation bodies.
FDA intends to ensure that each accreditation body's standards are
substantially the same as those promulgated by the agency, in
accordance with the requirements of section 354(e)(1) of the PHS Act
(42 U.S.C. 263b(e)). However, FDA notes that mammography standards are
unlikely to be identical across the country because the MQSA allows for
both private nonprofit organizations and State agencies to serve as
accreditation bodies, and also permits States to establish more
stringent mammography standards under their own authority. In addition,
FDA believes it is necessary to allow some flexibility in accreditation
body operations in order to provide for efficient accreditation
services for the more than 10,000 mammography facilities nationwide.
Nonetheless, the statute and proposed regulations are intended to
establish minimum nationwide facility standards, and proposed
Sec. 900.4(b) would require all accreditation bodies to adopt and apply
these standards.
3. Clinical Image Review
FDA believes that effective clinical image review is essential to
ensure high quality mammograms. A primary purpose of the MQSA is to
ensure that all mammography facilities have the benefit of such review
and that accreditation bodies be qualified to perform that function.
Accordingly, FDA is proposing to establish more specific requirements
with respect to clinical image review than were established under the
interim regulations. The requirements proposed are based on advice from
the NMQAAC and public comments.
The areas covered by the proposed standards in Sec. 900.4 for
clinical image review are as follows: Sec. 900.4(c)(1)--requirements
for the minimum frequency of review; Sec. 900.4(c)(2)--clinical image
attributes to be evaluated (with a provision for FDA approval of
alternatives, including ones that may be appropriate for new
technology); Sec. 900.4(c)(3)--scoring of clinical images;
Sec. 900.4(c)(4)--selection of clinical images for review;
Sec. 900.4(c)(5)--qualifications and procedures for clinical image
reviewers; Sec. 900.4(c)(6)--management of clinical images to ensure
their timely return to facilities and the reporting of unsuspected
abnormalities; and Sec. 900.4(c)(7)--corrective measures for
unsatisfactory image quality. With respect to this last paragraph, it
is FDA's intent that the accreditation process be a constructive one
that helps facilities improve mammography quality. Therefore, FDA is
proposing that clinical image reviewers be required to provide
information to facilities that can help them correct deficiencies
identified from their clinical images.
Several comments as well as NMQAAC discussions concerned the
interim requirements for clinical image review. Some NMQAAC members and
consultants expressed uncertainty about whether States would have the
expertise to perform clinical image reviews, because States had no
prior experience with such reviews. Some comments called for increased
standardization and the establishment of minimum requirements for
clinical image review. One comment believed that all clinical images
should be selected randomly in order to prevent facilities from merely
selecting their best images for accreditation body review. Two comments
questioned the need for clinical image review requirements at all.
These two comments believed that other requirements in the interim
regulations adequately addressed image quality. Another comment
believed that clinical images should be independently reviewed by more
than one radiologist.
In response to these comments, FDA notes first that the MQSA
mandates clinical image reviews and FDA fully supports the need for
such reviews. FDA does not intend to approve any entity as an
accreditation body, including a State agency, without first determining
that the prospective body will be capable of performing or providing
satisfactory clinical image reviews. The proposed regulations
concerning clinical image review add specific details and requirements
that are in addition to those set forth in the interim regulations. FDA
believes that these additions in the proposed regulations, as well as
anticipated agency guidance, will ensure that prospective accreditation
bodies understand what FDA expects of them regarding such reviews and
will be prepared to establish their ability to perform or provide these
reviews as part of their application to become accreditation bodies. In
addition, FDA will monitor accreditation bodies' compliance with the
agency's standards and expectations, including their clinical image
review functions. This will be done through annual performance
evaluations and other oversight mechanisms.
FDA agrees with the comment that clinical images should be
independently reviewed by more than one radiologist. Although such a
requirement was not explicitly established in the interim regulations,
it has been the practice established by FDA and the accreditation
bodies under those regulations. FDA is proposing to codify this policy
in Sec. 900.4(c)(3)(ii).
FDA disagrees with the comment that all clinical images submitted
by facilities should be selected completely at random. For example, it
is important in assessing the quality of a facility's mammography that
accreditation bodies evaluate, for each mammography unit in a facility,
mammograms for women with different types of breast composition (e.g.,
with predominantly glandular versus adipose tissue). FDA believes that
systems for clinical image review under the MQSA can be implemented
using random or nonrandom methods of image selection. FDA also notes
that nonrandom methods for clinical image review were used by the ACR
as part of its voluntary accreditation program before the passage of
the MQSA.
4. Phantom Image Review
FDA is proposing a new requirement in Sec. 900.4(d) for review of
phantom images by the accreditation body. This is being done on the
recommendation of the NMQAAC. To the extent that issues in the review
of phantom images parallel issues in the review of clinical images, the
requirements of this paragraph parallel those of Sec. 900.4(c).
However, a unique issue with respect to phantom images is determining
what constitutes acceptable phantom characteristics for
radiographically modeling aspects of breast disease and cancer.
FDA recognizes that a variety of phantoms may be useful for this
purpose, and that the desirable phantom characteristics may change over
time, particularly with the introduction of new technology.
Consequently, FDA is not proposing that any specific attributes, such
as specks, fibers, or masses, or their dimensions, be required by
regulation. However, to assure the adequacy of phantoms used, FDA is
proposing to require that accreditation bodies obtain FDA approval for
the phantoms and methods of use that the bodies specify for facilities
they accredit. This approach will provide needed flexibility for
accreditation bodies and facilities and will enable FDA to respond in a
timely manner to technological advances in this area.
5. Reports of Mammography Equipment Evaluation, Surveys, and Quality
Control
Consistent with the interim regulations and statutory requirements,
FDA is proposing to require in Sec. 900.4(e) that accreditation bodies
mandate submission of a survey by facilities in
[[Page 14889]]
order to obtain accreditation. ``Survey'' is defined in Sec. 900.2
(published elsewhere in this issue of the Federal Register) as an
onsite physics consultation and evaluation of a facility performed by a
medical physicist. This survey would have to demonstrate the facility's
compliance with the MQSA standards adopted by the accreditation body.
The statute does not require new facilities to submit a survey in
order to qualify for provisional certification from FDA. Therefore, new
facilities may perform mammography for up to 6 months without
undergoing a survey. Both the agency and the NMQAAC believe that
postponement of the survey required for full accreditation under MQSA
should not be interpreted as permitting the clinical use of equipment
that has not been evaluated for safety. Accordingly, FDA is proposing
that all facilities, whether seeking full or provisional certification,
be required to submit with their initial accreditation application a
mammography equipment evaluation demonstrating that the facility's
equipment is in compliance with the requirements in Sec. 900.12(e) (21
CFR 900.12)(e)) for equipment quality assurance (published elsewhere in
this issue of the Federal Register). This requirement would ensure that
provisionally certified facilities verify the proper functioning of
their mammography equipment prior to clinical use.
FDA will be developing a guidance document outlining the criteria
for an adequate equipment evaluation. The agency invites comments on
possible criteria for inclusion within this guidance document. A
complete survey, which includes reviews and information in addition to
equipment QA, would still have to be submitted in order for a
provisionally certified facility to obtain accreditation and full
certification.
There was some discussion with the NMQAAC regarding who should
perform the mammography equipment evaluation that is part of the
initial application for accreditation. In deference to comments from
rural health care providers, FDA has decided against requiring that
this evaluation be performed by a medical physicist. Rural health care
providers have indicated that, because of the limited availability of
medical physicists in rural areas, it might be difficult for a
physicist to visit a rural facility twice over a short time period in
order to perform the mammography equipment evaluation and, later, the
survey required for accreditation and full certification. In addition,
the agency's experience under the Radiation Control for Health and
Safety Act (Pub. L. 90-602) shows that the types of measurements being
requested for the mammography equipment evaluation can be performed
effectively by nonphysicists. Therefore, FDA believes it would not be
cost-effective or practical to require performance of the mammography
equipment evaluation by a medical physicist.
FDA is proposing specific time periods for facility submission and
accreditation body review of mammography equipment evaluations and
surveys. These requirements are being recommended as a result of FDA's
experience with MQSA over the last year and advice from the NMQAAC. In
particular, both the agency and the NMQAAC believe it is important that
facilities be required to submit survey and evaluation data that
reflects current practice in the facility at the time of application
for accreditation.
FDA is proposing to require in Sec. 900.4(e) that accreditation
bodies mandate annual submission of certain materials by the facility
to the accreditation body for review. These materials would include the
annual survey and quality control records, personnel updates, and other
information that the body may require. This requirement is intended to
assure continued compliance with the facility standards and to provide
continued accreditation body oversight of facilities' quality control
programs as they relate to such standards.
Several comments addressed issues related to accreditation and
certification of facilities with more than one mammography unit
(consisting of the x-ray generator and associated image receptor and
auxiliary equipment). In particular, clarification was requested
regarding the status of multiple-unit facilities that had not undergone
all tests to assure compliance with standards or that had failed to
meet all requirements. Some comments favored requiring the complete
evaluation of all units in a facility, with measures to ensure that
only equipment meeting the necessary requirements is used to perform
mammography.
FDA agrees that only equipment meeting necessary requirements
should be used to perform mammography. Under both the interim and
proposed regulations, all units that are used for mammography in a
facility must be reported to the accreditation body and meet applicable
standards. As discussed previously, FDA is proposing to require that
facilities submit the results of mammography equipment evaluations with
their initial application for accreditation. Those evaluations will
establish compliance with equipment QA standards under Sec. 900.12(e)
for every unit in the facility. In addition, surveys (Sec. 900.4(e)),
as well as clinical (Sec. 900.4(c)(4)(i)) and phantom images
(Sec. 900.4(d)(4)), would have to be submitted for each mammography
unit at a facility during specified time periods. FDA is also proposing
in Sec. 900.4(c)(2)(viii)(G) that facilities with multiple units have a
mechanism for identifying the unit used to produce each mammography
image. This would enable inspectors and accreditation body visitors to
check facility images against the compliance status of facility
equipment and would facilitate problem identification and corrective
measures, if necessary.
It is FDA's policy that similar requirements apply to new and
repaired equipment, i.e., such equipment may be used clinically after
the mammography equipment evaluation has demonstrated compliance of the
equipment with the requirements in Sec. 900.12(e). A survey and
clinical and phantom image reviews may be required after the initiation
of clinical use. Such image reviews and a survey are now, and would
continue to be, necessary for new equipment; however, the accreditation
body will specify, with FDA's approval, the circumstances under which
repaired equipment will require a survey or image reviews by the
accreditation body. Any facility that performs mammography with
equipment the facility has reason to believe does not meet MQSA
standards will be subject to sanctions under section 354(h)(2) of the
PHS Act, including civil money penalties.
One comment questioned the value of requiring annual submission of
all facility quality control records to both the accreditation body and
FDA. The comment also suggested that quality control records may be
useful for internal evaluations, but that documents that are to be
submitted to the accreditation body may be screened or amended by the
facility in order to avoid negative publicity or regulatory action.
FDA advises that no routine requirement exists to submit all
quality control records to FDA. In addition, the use of the phrase
``quality control records'' in Sec. 900.4(e)(2)(iii) of the interim
regulations is not intended to mandate submission of all quality
control records to the accreditation body every year. The records to be
submitted will depend on the specific requirements established by the
accreditation body, subject to FDA approval. FDA agrees that quality
control records can serve as an
[[Page 14890]]
important internal source of information for helping facilities
identify problems and appropriate solutions. However, FDA would regard
any purposeful alterations of records to be acts of fraud.
6. Accreditation Body Onsite Visits and Random Clinical Image Reviews
The MQSA requires that accreditation bodies make a ``sufficient
number'' of onsite visits to facilities they accredit ``to allow a
reasonable estimate of the performance'' of the body (42 U.S.C.
263b(e)(4)). The MQSA also requires the accreditation body to conduct
random reviews of clinical images from the facilities it accredits, in
addition to the clinical image reviews required for accreditation (42
U.S.C. 263b(e)(1)(B)). These requirements are listed in Sec. 900.4(f)
of the proposed regulations (corresponding to Sec. 900.4(e) in the
interim regulations). In the proposed regulations, the word ``visits''
is substituted for the previously used word ``inspections'' in order to
reduce any confusion between onsite visits by accreditation bodies and
annual inspections by State or FDA inspectors.
One comment disputed the need for onsite visits by accreditation
bodies and another comment questioned the need for the interim
requirement that the accreditation body submit a copy of the visit
report to FDA.
FDA disagrees with both of these comments. The need for onsite
visits is established by the statute. The purpose of the visits is to
provide a mechanism by which an accreditation body can both ensure
facility compliance with quality standards and monitor its own
performance of accreditation functions. The accreditation body would be
able to compare the results from visits for consistency with
information obtained through other accreditation body functions. Also,
because FDA is required to evaluate annually the performance of each
accreditation body, the reports of onsite visits would provide valuable
information on which to base such evaluations. Therefore, although the
agency is proposing to delete the requirement that a full copy of each
onsite visit report be provided to FDA at the conclusion of the
accreditation body's onsite visit, FDA would continue to require that a
summary of findings obtained as a result of accreditation body visits
to facilities be included in the accreditation body's annual report to
FDA. As discussed previously, notification about situations involving
health hazards and death or serious injury or illness cannot wait for
annual reports.
Several comments addressed the selection process, number, and need
for advance notification of facilities for accreditation body onsite
visits. Some comments stated that the percentage of visits performed by
accreditation bodies should be established by FDA (at perhaps 5 or 10
percent of accredited facilities). One comment suggested that a means
be established to ensure proportionate distribution of visits to
facilities with regard to facility size and geographic distribution.
Several comments believed that accreditation bodies should be required
to give facilities advance notice of a visit, although one comment
believed that FDA should specify certain circumstances for which
unannounced visits might be appropriate.
In response to these comments, FDA is proposing in Sec. 900.4(f)(1)
that accreditation bodies select some facilities for onsite visits on a
random basis and select other facilities based on specific reasons for
concern with those facilities, such as previous history of
noncompliance with quality standards. In general, each accreditation
body would have to visit annually at least 5 percent of facilities it
accredits, up to a maximum of 50 facilities, but no less than 5. The
number could exceed 50 if many facilities need to be visited because of
previously identified concerns.
Regarding advance notification of facilities by accreditation
bodies, FDA believes that accreditation bodies will need flexibility in
scheduling onsite visits. In some cases, particularly if an
accreditation body has serious concerns about a facility's ability to
meet quality standards, significant advance notice would not be
appropriate. In general, however, for facilities selected randomly for
onsite visits, FDA will encourage accreditation bodies to work with
facilities to schedule visits so as to minimize examinee inconvenience
and disruption to facility operations.
For random clinical image reviews, FDA is proposing that, on an
annual basis, 3 percent of facilities (but no less than five
facilities) accredited by an accreditation body would have to be chosen
randomly to submit clinical images for review. These clinical images
would be in addition to those submitted every 3 years as part of the
accreditation process. As the requirements have been proposed, the
accreditation body would be able to count toward this 3 percent
requirement all facilities that have undergone an additional clinical
image review because of random selection for the onsite visits in
Sec. 900.4(f)(1)(i)(A).
The requirement for selecting a 3 percent random sample of
facilities is changed from that in the interim regulations, which
required random clinical image review for each facility accredited by a
body. The change in the sampling requirement is based on FDA experience
with implementing the interim regulations. The agency believes that
annual random clinical image review for every facility in addition to
the clinical image reviews required for initial accreditation and
renewal is not an effective use of accreditation body resources. In
addition, accreditation bodies should not schedule random clinical
image reviews at facilities that have received their notification of
their need to begin the accreditation renewal process or at facilities
that have completed the accreditation renewal process within the
previous 6 months.
7. Consumer Complaint Mechanism
The interim regulations required accreditation bodies to establish
processes for receipt, investigation, and records maintenance of
consumer complaints about facilities they accredit. In accordance with
42 U.S.C. 263(n)(3)(E), FDA has worked with the NMQAAC to develop
mechanisms to investigate consumer complaints. The committee and FDA
agree that the investigation of ``serious complaints'' and the
correction of underlying problems that may have precipitated them can
help improve the practice of mammography. The proposed role of
accreditation bodies in this process is specified in Sec. 900.4(g).
A ``serious'' complaint is defined in proposed Sec. 900.2
(published elsewhere in this issue of the Federal Register) as a report
by a consumer of: (1) A ``serious adverse event'' that significantly
compromises, or has the potential to significantly compromise, clinical
outcomes, or (2) an ``adverse event'' for which the facility fails to
take appropriate corrective action. ``Consumer'' is defined in proposed
Sec. 900.2 as an individual who chooses to comment or complain in
reference to a mammography exam. Consumers, therefore, may include the
examinee or representatives of the examinee (e.g., family members or
referring physicians).
In the proposed regulations, the consumer complaint mechanism
focuses on serious complaints related to incidents over which FDA has
regulatory authority under MQSA. FDA acknowledges that there may be
additional kinds of serious complaints that are legitimate and worthy
of investigation, but that do not fall under the agency's regulatory
authority under MQSA (e.g., sexual harassment or discrimination). FDA
encourages the channeling and resolution of such complaints through
appropriate existing mechanisms, such as State oversight
[[Page 14891]]
organizations and professional licensing boards.
The proposed consumer complaint mechanism would set minimum
requirements for facilities and accreditation bodies. FDA has worked
extensively with NMQAAC in developing this mechanism and believes that
the proposed requirements meet the important needs of the consumer
without imposing undue burden on mammography facilities. The proposed
regulations would allow facilities flexibility in instituting their own
complaint resolution procedures. FDA encourages facilities to design
their complaint mechanisms to be responsive to language, ethnic, and
literacy differences among consumers served by the facility.
FDA believes that all comments and complaints should be directed
first to the facility, where there is the greatest opportunity for
resolution. FDA is proposing that facilities be required to establish
and administer a documented consumer complaint mechanism that complies
with standards in proposed Sec. 900.12(h), published elsewhere in this
issue of the Federal Register. However, FDA also recognizes that, under
certain circumstances, consumers may want to report serious complaints
that they have been unable to resolve with the facility to a more
impartial organization. FDA believes that a facility's accreditation
body should receive these complaints because the accreditation body has
the responsibility for assuring that facilities meet quality standards.
To fulfill this responsibility, accreditation bodies need data on
serious complaints related to mammography quality. Therefore, FDA is
proposing that the accreditation body be the second level in the
complaint process to receive, investigate, and resolve serious consumer
complaints.
The third level of the complaint process, should the complaint go
unresolved at the accreditation body level, would be FDA. The
accreditation body could recommend that FDA take regulatory action,
including inspections, sanctions, or revocation of the facility's
certificate. Some consumers might want to address complaints about
facilities directly to FDA, and this option is also open to them.
FDA is proposing to require accreditation bodies to review and
evaluate each facility's plan for handling consumer complaints. The
agency is also proposing that the accreditation body be required to
maintain a record of each serious complaint it receives regarding
facilities it accredits, whether or not the accreditation body is able
to resolve the complaint. All records of serious complaints would have
to be retained for at least 3 years after the date of receipt of the
complaint by the accreditation body. Accreditation bodies would also be
required to submit to FDA an annual report summarizing serious
complaints.
One comment on the interim regulations requested that complaint
information be shared with States and the public.
The MQSA does not include a provision requiring public disclosure
of individual consumer complaints or release of such information by
individual facilities to State authorities. However, the MQSA does
require in 42 U.S.C. 263b(l)(1) that information FDA determines to be
useful in evaluating the performance of mammography facilities be made
available to the general public no later than October 1, 1996, and
annually thereafter. This information must include a list of facilities
that have been convicted under Federal or State laws relating to fraud
and abuse, false billings, or kickbacks, have been subject to
sanctions, have had certificates revoked or suspended, or have had
accreditation revoked.
One comment on the interim regulations noted that the mechanism for
handling complaint information contains no provision for protecting
confidentiality and that unsubstantiated allegations should not be made
publicly available.
As discussed above, FDA does not believe the MQSA is intended to
authorize public disclosure of details concerning specific complaints
or allegations. FDA encourages all individuals involved in resolution
of complaints to protect the confidentiality of consumers and health
professionals to the full extent required by State law and professional
ethics. However, knowledge of the identity of individuals involved in
the complaint process may be necessary in order for the accreditation
body or FDA to investigate the complaint. The agency's own regulations
prohibit disclosure of information that would be an unwarranted
invasion of personal privacy and FDA will not release names or personal
identifiers without consent of the individuals involved (21 CFR 20.63
and 20.111).
8. Reporting and Recordkeeping
In Sec. 900.4(h), FDA is proposing to require that accreditation
body reports to FDA be submitted in the format and medium prescribed by
the agency. This requirement would facilitate the use of uniform
methods for efficient data management and analysis, including the use
of computer-based systems by FDA.
One comment stated that the timeframes specified in the interim
regulations (Sec. 900.4(g)) for accreditation body reporting were
unreasonable.
FDA agrees that changes in this area are needed and the proposed
regulations have been designed to allow greater flexibility in
specifying timeframes for reports to FDA, based on FDA and
accreditation body needs.
One comment expressed concern that the wording of the interim
requirement in Sec. 900.4(g)(6) might result in a request for
proprietary information not specifically required by or relevant to the
MQSA. Another comment indicated concern that the interim requirement in
Sec. 900.4(d)(1) for a facility to provide its accreditation body with,
``any other information the body may require, as a part of the annual
report about the facility'', was excessively broad.
FDA believes that the MQSA provides the agency with the authority
to determine the information that is necessary to meet the agency's
statutory responsibilities under MQSA (e.g., 42 U.S.C.
263b(d)(1)(B)(iii) and (e)(1)(C)(vi)). In addition, FDA has
considerable experience with receiving and protecting proprietary
information. However, in response to the comments, FDA has modified the
regulatory language to specify that any information collected by an
accreditation body from a facility should be relevant to the MQSA. In
addition, as part of FDA's approval and oversight responsibilities, the
agency will review the information required by accreditation bodies
with regard to its relevance to such bodies' responsibilities under
MQSA.
As discussed earlier, FDA has also addressed the issue of
confidentiality in the accreditation body code of conduct and general
responsibilities. Proposed Sec. 900.4(a)(9) states the obligation of
the accreditation body to keep confidential all nonpublic information
it acquires in connection with carrying out its accreditation body
responsibilities.
9. Fees
In proposed Sec. 900.4(i), FDA is continuing to require that
accreditation body fees charged to facilities be reasonable, as in
Sec. 900.4(c) of the interim regulations.
Several comments regarding accreditation fees mentioned the
relatively small amounts of various third party reimbursements for
screening mammography and hoped that FDA would consider this
information when establishing requirements for fees. Two comments
disagreed with the interim requirements for limiting fee increases to
adjustments in the consumer price index (CPI). A
[[Page 14892]]
few other comments raised additional issues related to determining the
reasonableness of fees, including expansion costs and accreditation
body activities specifically attributable to MQSA responsibilities. The
latter issue was raised with respect to State agencies with multiple
responsibilities in addition to those associated with MQSA.
FDA is proposing certain changes in the fee provisions in response
to comments. The proposed regulations would permit variation in
accreditation body fees, and adjustments would no longer be limited to
changes in the CPI. However, FDA is proposing that accreditation bodies
only be allowed to recover costs that are a result of MQSA-attributable
functions. Consequently, fee changes might be appropriate for changes
in accreditation body activities that have been approved by FDA.
However, accreditation body activities that are not FDA-approved
activities could not be considered in determining fees charged for MQSA
accreditation functions. Consequently, the relationship of fees to
costs incurred because of accreditation body responsibilities under
these regulations would be an important factor in determining the
reasonableness of fees.
One comment questioned whether providers would have an opportunity
to question the reasonableness of fees before they are approved by FDA.
Although there is no official provision for public comment on
accreditation fees, anyone who feels that fee increases are excessive
may raise these concerns with FDA at any time.
D. Evaluation of Accreditation Bodies
In proposed Sec. 900.5, FDA states that the agency will evaluate
all accreditation bodies at least annually and at other times if
specific circumstances warrant.
Two comments suggested the following additions to the factors
specified in the interim regulations for evaluating accreditation
bodies: (1) Responsiveness of the body to FDA and to complaints from
other sources, and (2) compliance of the body with requirements for
approval as an accreditation body. One of these comments also suggested
that more detail be added related to the sample size of facilities and
clinical images to be assessed by FDA as part of FDA's evaluation of
accreditation bodies.
In response to these comments, FDA advises that the proposed
regulations contain more extensive requirements (in Sec. 900.3) for
approval as an accreditation body than did the interim regulations. As
part of its annual evaluation of accreditation bodies, FDA will
consider compliance with these requirements, including the
responsiveness and timeliness with which accreditation bodies meet
their various responsibilities. In order to perform these evaluations,
FDA will have access to the results of annual inspections of facilities
by FDA or State inspectors, information from annual and other reports
from accreditation bodies, and visits to facilities or accreditation
bodies to evaluate their compliance with the standards specified under
subparts A and B of part 900 (21 CFR part 900). FDA also will be able
to request more data, such as additional clinical images, at any time
the agency determines that it needs further information to complete its
evaluation.
E. Withdrawal of Approval
In Sec. 900.6, FDA has proposed certain changes to the interim
criteria for withdrawal of approval of an accreditation body and the
addition of certain other actions the agency may take against
accreditation bodies, when warranted.
Under the interim regulations, FDA was precluded from reinstating
approval of an accreditation body if withdrawal of approval was based
on fraud or material false statements. FDA has reconsidered these
criteria in drafting these proposed rules and in light of the agency's
experience implementing the interim regulations.
FDA continues to believe that certain actions are so egregious that
they should automatically preclude an accreditation body from
continuing or ever resuming service as an accreditation body. The
agency believes that, in addition to the commission of fraud, willful
disregard of the public health constitutes an action by an
accreditation body that should permanently disqualify that body from
future approval. Accordingly, FDA has added willful disregard of the
public health as a bar to reinstatement as an accreditation body.
However, FDA is proposing to review on a case-by-case basis
applications from former accreditation bodies whose approval was
withdrawn due to the submission of material false statements. The
agency is persuaded that there may be instances where the submission of
material false statements was unintentional or had limited
consequences. FDA has drafted the proposed regulations to retain
discretion to reinstate accreditation bodies if the agency determines
there is evidence to demonstrate that such conduct will not recur.
The proposed regulations also clarify that FDA reserves the right
to withdraw approval or place an accreditation body on probationary
status, depending on the specific deficiencies involved. Unlike the
interim regulations, the proposal gives FDA discretion about how to
proceed, even with respect to accreditation bodies that have
demonstrated major deficiencies. FDA would make these determinations on
a case-by-case basis. In addition, FDA would have discretion to specify
particular corrective actions that the accreditation body must take or
to offer the accreditation body an opportunity to submit its own plan
of corrective action (including timetables) for FDA approval.
Two comments stated that the specification in the interim
regulations of a 90-day time period for submitting a corrective action
plan to FDA for minor deficiencies should be shortened from 30 to 60
days, and that FDA should respond to the proposed plan within the same
timeframe.
FDA has concluded that establishing fixed time periods for
submission or implementation of corrective action plans does not allow
the agency or accreditation bodies sufficient flexibility. Timeframes
for correction of minor deficiencies should be based on the specific
deficiencies that must be addressed. Therefore, the agency has not set
forth specific timeframes in proposed Sec. 900.6(b)(2). Instead, FDA
will determine the necessary implementation schedules on a case-by-case
basis.
F. Hearings
Under proposed Sec. 900.7 on hearings, a facility that has been
denied accreditation would be entitled to an appeals process from the
accreditation body (Sec. 900.7(b)). The facility could then appeal the
results of this process to FDA and the Department of Health and Human
Services in accordance with proposed Sec. 900.15, published elsewhere
in this issue of the Federal Register.
III. Environmental Impact
The agency has determined under 21 CFR 25.24(e)(3) that this action
is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
IV. Analysis of Impacts
FDA has examined together the impacts of this proposed rule and the
proposed rules on general facility requirements, personnel
requirements, and quality standards for mammography equipment and
quality assurance, published elsewhere in this issue of the
[[Page 14893]]
Federal Register, under Executive Order 12866, the Regulatory
Flexibility Act (Pub. L. 96-354), and under the Unfunded Mandates
Reform Act. The analysis has addressed the proposed requirements of
these four rules as one unit for purposes of determining their economic
impact. The preamble to the proposed rule ``Quality Mammography
Standards; General Preamble and Proposed Alternative Approaches,''
published elsewhere in this issue of the Federal Register, contains a
brief summary of the cost and benefit determination and the Regulatory
Impact Study that details the agency's calculation of these economic
impacts and is available at the Dockets Management Branch (address
above) for review. FDA recognized that these proposed regulations may
have a disproportionate effect on small volume mammography facilities
and is currently collecting additional information on the potential
impact on this industry sector. The agency requests comments that will
assist it in accounting for this impact.
V. Paperwork Reduction Act of 1995
This proposed rule contains information collections which are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (Pub. L. 104-13). The title,
description, and respondent description of the information collection
are contained in the proposed rule ``Quality Mammography Standards;
General Preamble and Proposed Alternative Approaches,'' published
elsewhere in this issue of the Federal Register, with an estimate of
the annual reporting and recordkeeping burden.
The agency has submitted a copy of this proposed rule to OMB for
its review and approval of these information collection requirements.
Other organizations and individuals desiring to submit comments
regarding this burden estimate or any aspect of these information
collection requirements, including suggestions for reducing the burden,
should direct them to the Office of Information and Regulatory Affairs,
OMB, rm. 10235, New Executive Office Bldg., Washington, DC 20503, Attn:
Desk Officer for FDA. Written comments on the information collection
requirements should be submitted by May 3, 1996.
VI. Comments
Interested persons may, on or before July 2, 1996, submit to the
Dockets Management Branch (address above) written commentsregarding
this proposed rule. Two copies of any comments are to be submitted,
except that individuals may submit one copy. Comments are to be
identified with the docket number found in brackets in the heading of
this document. Received comments may be seen in the office above
between 9 a.m. and 4 p.m., Monday through Friday.
VII. References
The following information has been placed on display in the Dockets
Management Branch (address above) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday.
1. ``Report on the Mammography Quality Standards Act of 1992,''
U.S. Senate, Report 102-448, October 1, 1992.
2. ``Health Care: Hospitals with Quality-of-Care Problems Need
Closer Monitoring,'' U.S. GAO, GAO/HRD-91-40, May 1991.
List of Subjects in 21 CFR Part 900
Electronic products, Health facilities, Mammography, Medical
devices, Radiation protection, Reporting and recordkeeping
requirements, X-rays.
Therefore, under the Federal Food, Drug, and Cosmetic Act, the
Public Health Service Act, and under authority delegated to the
Commissioner of Food and Drugs, it is proposed that 21 CFR part 900 be
amended as follows:
PART 900--MAMMOGRAPHY
1. The authority citation for 21 CFR part 900 continues to read as
follows:
Authority: Secs. 519, 537, and 704(e) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360i, 360nn, and 374(e)); sec. 354 of
the Public Health Service Act (42 U.S.C. 263b).
2. Sections Sec. 900.3 through 900.7 are revised to read as
follows:
Sec. 900.3 Application for approval as an accreditation body.
(a) Eligibility. Private nonprofit organizations or State agencies
capable of meeting the requirements of this subpart may apply for
approval as accreditation bodies.
(b) Application for initial approval. (1) An applicant seeking
initial FDA approval as an accreditation body shall inform the Division
of Mammography Quality and Radiation Programs, Center for Devices and
Radiology Health (HFZ-240), Food and Drug Administration, 1350 Piccard
Dr., Rockville, MD 20850, marked Attn: Mammography Standards Branch, of
its requested scope of authority.
(2) Following receipt of the request, FDA will send application
guidance to the applicant.
(3) In accordance with the guidance provided, the applicant shall
furnish to FDA at the address in paragraph (b)(1) of this section three
copies of an application containing the following information,
materials, and supporting documentation:
(i) Name, address, and phone number of the applicant and evidence
of nonprofit status (i.e., of fulfilling Internal Revenue Service
requirements as a nonprofit organization) if the applicant is not a
State agency;
(ii) Detailed description of the accreditation standards the
applicant will require facilities to meet and a discussion
substantiating their equivalence to FDA standards required under 42
U.S.C. 263b(e)(3);
(iii) Detailed description of the applicant's accreditation review
and decisionmaking process, including:
(A) Procedures for performing clinical image review;
(B) Procedures for performing phantom image review;
(C) Procedures for assessing mammography equipment evaluations and
surveys;
(D) Procedures for performing onsite visits to facilities;
(E) Procedures for assessing facility personnel qualifications;
(F) Copies of the accreditation application forms, guidelines,
instructions, and other materials the applicant will send to facilities
during the accreditation process;
(G) Policies and procedures for notifying facilities of
deficiencies;
(H) Procedures for monitoring corrections of deficiencies by
facilities;
(I) Policies and procedures for revoking a facility's
accreditation;
(J) Policies and procedures that will assure processing of
accreditation applications and renewals within a timeframe approved by
FDA and assurances that the body will adhere to such policies and
procedures; and
(K) A description of the applicant's appeals process for facilities
contesting adverse accreditation status decisions.
(iv) Education, experience, and training requirements for the
applicant's professional staff, including reviewers of clinical or
phantom images;
(v) Description of the applicant's electronic data management and
analysis system with respect to accreditation review and decision
processes and the applicant's ability to provide electronic data in a
format compatible with FDA data systems;
(vi) Resource analysis that demonstrates that the applicant's
staffing, funding, and other resources are adequate to perform the
required accreditation activities;
(vii) Fee schedules with supporting cost data;
[[Page 14894]]
(viii) Statement of policies and procedures established to avoid
conflicts of interest or the appearance of conflicts of interest by the
applicant's board members, commissioners, professional personnel
(including reviewers of clinical and phantom images), consultants,
administrative personnel, and other representatives of the applicant;
(ix) Disclosure of any specific brand of imaging system or
component, measuring device, software package, or other commercial
product used in mammography that the applicant develops, sells, or
distributes;
(x) Description of the body's documented consumer complaint
mechanism;
(xi) Satisfactory assurances that the applicant shall comply with
the requirements of Sec. 900.4; and
(xii) Any other information as may be required by FDA.
(c) Application for renewal of approval. An approved accreditation
body that intends to continue to serve as an accreditation body beyond
its current term shall apply to FDA for renewal or notify FDA of its
plans not to apply for renewal in accordance with the following
procedures and schedule:
(1) At least 9 months before the date of expiration of a body's
approval, an applicant for renewal shall inform FDA at the address
given in paragraph (b)(1) of this section.
(2) FDA will notify the applicant of the applicable information,
materials, and supporting documentation from paragraph (b)(3) of this
section that the applicant shall submit as part of the renewal
procedure.
(3) At least 6 months before the date of expiration of a body's
approval, the applicant shall furnish to FDA at the address in
paragraph (b)(1) of this section three copies of a renewal application
containing the information, materials, and supporting documentation
requested by FDA in accordance with paragraph (c)(2) of this section.
(4) No later than July 2, 1996, any accreditation body approved
under the interim regulations published in the Federal Register of
December 21, 1993 (58 FR 67558) that intends to continue to serve as an
accreditation body under the final regulations shall apply for renewal
of approval in accordance with the procedures set forth in paragraphs
(c)(1) through (c)(3) of this section.
(5) Any accreditation body that does not plan to renew its approval
shall so notify FDA at the address given in paragraph (b)(1) of this
section at least 90 days before the expiration of the body's term of
approval.
(d) Rulings on applications for initial and renewed approval. (1)
FDA will conduct a review and evaluation to determine whether the
applicant substantially meets the applicable requirements of this
subpart and whether the accreditation standards the applicant will
require facilities to meet are substantially the same as the quality
standards published under subpart B of this part.
(2) FDA will notify the applicant of any deficiencies in the
application and request that those deficiencies be rectified within a
specified time period. If the deficiencies are not rectified to FDA's
satisfaction within the specified time period, the application for
approval as an accreditation body will be rejected.
(3) The applicant will receive a formal notice from FDA stating
whether the application has been approved or denied and a statement of
the bases for any denial.
(4) The review of any application may include a meeting between FDA
and representatives of the applicant at a time and location mutually
acceptable to FDA and the applicant.
(5) FDA will advise the accreditation body of the circumstances
under which a denied application may be resubmitted.
(6) If FDA does not reach a final decision on a renewal application
in accordance with this paragraph before the expiration of an
accreditation body's approval, the approval will be deemed extended
until the agency reaches a final decision on the application, unless an
accreditation body does not rectify deficiencies in the application
within the specified time period, as required in paragraph (d)(2) of
this section.
(e) Relinquishment of authority. An accreditation body that decides
to relinquish its accreditation authority before expiration of the
body's term of approval shall submit a letter of such intent to FDA at
the address in paragraph (b)(1) of this section at least 90 days before
relinquishing such authority.
(f) Transfer of records. An accreditation body that does not apply
for renewal of accreditation body approval, is denied such approval by
FDA, or relinquishes its accreditation authority and duties before
expiration of its term of approval, shall:
(1) Transfer facility records and other related information as
required by FDA to a location and according to a schedule approved by
FDA.
(2) Notify, in a manner and time period approved by FDA in
accordance with Secs. 900.3(d) or 900.4(a)(9), all facilities
accredited or seeking accreditation by the body that the body will no
longer have accreditation authority.
(g) Scope of authority. The accreditation body's term of approval
is for a period of 5 years. FDA may limit the scope of accreditation
authority.
Sec. 900.4 Standards for accreditation bodies.
(a) Code of conduct and general responsibilities. The accreditation
body shall accept the following responsibilities in order to ensure
safe and accurate mammography at the facilities it accredits and shall
perform these responsibilities in a manner that ensures the integrity
and impartiality of accreditation body actions.
(1) Upon request by FDA, the accreditation body shall review a
facility's clinical images or other aspects of a facility's practice to
assist FDA in determining whether or not the facility's practice poses
an unreasonable risk of substantial harm to the public. Such reviews
would be in addition to the evaluation an accreditation body performs
as part of the initial accreditation or renewal process for facilities.
If FDA determines that a facility's practice poses an unreasonable risk
of substantial harm to the public:
(i) The accreditation body shall require the facility to take
appropriate corrective actions as determined by the accreditation body
or FDA, including, but not limited to, notifying examinees or referring
physicians; and
(ii) The accreditation body shall monitor the facility's
implementation of corrective actions in accordance with a schedule
specified by FDA.
(2) The accreditation body shall provide guidance to facilities
regarding reporting requirements for conditions within the scope of 42
U.S.C. 263b that arise at the facility and that pose a health hazard to
examinees, personnel, or others in the facility.
(i) The accreditation body shall require that such information and
a plan of correction addressing the conditions be submitted by the
facility in a manner and time period specified by the accreditation
body.
(ii) The accreditation body shall require the facility to cease use
of any equipment or to eliminate any practices that may contribute to
such potentially harmful conditions as soon as possible. In those
circumstances where the accreditation body has reason to believe a
hazard exists, the accreditation body shall notify the facility that
use of the equipment or continuation of the practice shall stop
immediately.
(iii) The accreditation body shall monitor the facility's
compliance with the plan of correction and progress
[[Page 14895]]
toward meeting applicable standards and minimizing health hazards.
(3) The accreditation body shall inform FDA within 5 business days
of becoming aware of equipment or practices that pose an unreasonable
risk of substantial harm to the public.
(4) The accreditation body shall establish and administer a quality
assurance (QA) program that has been approved by FDA in accordance with
Sec. 900.3(d) or paragraph (a)(8) of this section. Such quality
assurance program shall:
(i) Include requirements for clinical image review and phantom
image review;
(ii) Ensure that clinical and phantom images are evaluated
consistently and accurately; and
(iii) Specify the methods and frequency of training, evaluation,
and performance improvement for clinical and phantom image reviewers,
and the bases and procedures for removal of such reviewers.
(5) The accreditation body shall establish measures that FDA has
approved in accordance with Sec. 900.3(d) or paragraph (a)(8) of this
section to reduce the possibility of conflict of interest or facility
bias on the part of individuals acting on the body's behalf. Such
individuals who review clinical or phantom images under the provisions
of paragraphs (c) and (d) of this section or who visit facilities under
the provisions of paragraph (f) of this section shall not review
clinical or phantom images from or visit a facility with which such
individuals maintain a financial relationship, or when it would
otherwise be a conflict of interest for them to do so, or when they
have a bias in favor of or against the facility.
(6) The accreditation body may require specific equipment
performance or design characteristics that FDA has approved. However,
no accreditation body shall require, either explicitly or implicitly,
the use of any specific brand of imaging system or component, measuring
device, software package, or other commercial product as a condition
for accreditation by the body, unless FDA determines that it is in the
best interest of public health to do so.
(i) Any representation, actual or implied, either orally, in sales
literature, or in any other form of representation, that the purchase
or use of a particular product brand is required in order for any
facility to be accredited or certified under 42 U.S.C. 263b, is
prohibited, unless FDA approves such representation.
(ii) Unless FDA has approved the exclusive use and promotion of a
particular commercial product in accordance with this section, all
products produced, distributed, or sold by an accreditation body or an
organization that has a financial or other relationship with the
accreditation body that may be a conflict of interest or have the
appearance of a conflict of interest with the body's accreditation
functions, shall bear a disclaimer stating that the purchase or use of
such products is not required for accreditation or certification of any
facility under 42 U.S.C. 263b. Any representations about such products
shall include a similar disclaimer.
(7) When an accreditation body denies accreditation to a facility,
the accreditation body shall notify the facility in writing and explain
the bases for its decision. The notification shall also describe the
appeals process available from the accreditation body for the facility
to contest the decision.
(8) No State agency that is approved as an accreditation body may
require facilities in the State to be accredited under 42 U.S.C. 263b
only by the State agency and not by other FDA- approved accreditation
bodies.
(9) The accreditation body shall obtain FDA authorization for any
changes it proposes to make in any standards that FDA has previously
accepted under Sec. 900.3(d).
(10) An accreditation body shall protect confidential information
it collects or receives in its role as an accreditation body.
(i) Nonpublic information collected from facilities for the purpose
of carrying out accreditation body responsibilities shall not be used
for any other purpose or disclosed, other than to FDA or its duly
designated representatives, without the consent of the facility;
(ii) Nonpublic information that FDA or its duly designated
representatives share with the accreditation body concerning a facility
that is accredited or undergoing accreditation by that body shall not
be further disclosed except with the written permission of FDA.
(b) Facility standards. (1) The accreditation body shall require
that each facility it accredits meet standards for the performance of
quality mammography that are substantially the same as those in this
subpart and in subpart B of this part.
(2) The accreditation body shall notify a facility regarding
equipment, personnel, and other aspects of the facility's practice that
do not meet such standards and take reasonable steps to ensure that
such equipment, personnel, or other aspects of the practice are not
used by the facility for activities covered by 42 U.S.C. 263b.
(3) The accreditation body shall specify the actions that
facilities must take to correct deficiencies in equipment, personnel,
and other aspects of the practice to ensure facility compliance with
applicable standards.
(4) If deficiencies cannot be corrected to ensure compliance with
standards or if a facility is unwilling to take corrective actions, the
accreditation body shall revoke the facility's accreditation in
accordance with the policies and procedures in
Sec. 900.3((b)(3)(iii)(I).
(c) Clinical image review. (1) Frequency of review. The
accreditation body shall review clinical images from each facility
accredited by the body at least once every 3 years.
(2) Requirements for clinical image attributes. The accreditation
body shall use the following attributes for all clinical image reviews,
unless FDA has approved other attributes.
(i) Positioning. Sufficient breast tissue shall be imaged to ensure
that cancers are not likely to be missed because of inadequate
positioning.
(ii) Compression. Compression shall be applied in a manner that
minimizes the potential obscuring effect of overlying breast tissue and
motion artifact.
(iii) Tissue exposure. Tissue exposure shall be adequate to
visualize breast structures. Images shall be neither underexposed nor
overexposed.
(iv) Contrast. Image contrast shall permit differentiation of
subtle tissue density differences.
(v) Sharpness. Margins of normal breast structures shall be
distinct and not blurred.
(vi) Noise. Noise in the image shall not significantly obscure
breast structures or suggest the appearance of structures not actually
present.
(vii) Artifacts. Artifacts due to lint, scratches, and other
factors external to the breast shall not obscure breast structures or
suggest the appearance of structures not actually present.
(viii) Examination identification. Each image shall have the
following information indicated on it in a permanent and unambiguous
manner and placed so as not to obscure anatomic structures:
(A) Examinee identification.
(B) Date of examination.
(C) View and laterality. This information shall be placed on the
image in a position near the axilla. Standardized codes specified by
the accreditation body and approved by FDA in accordance with
Sec. 900.3(d) or
[[Page 14896]]
paragraph (a)(9) of this section shall be used to identify view and
laterality.
(D) Facility name and location. At a minimum, the location shall
include the city, state, and zip code number of the facility.
(E) Technologist identification.
(F) Cassette/screen identification.
(G) Mammography unit identification, if there is more than one unit
in the facility.
(3) Scoring of clinical images. Accreditation bodies shall
establish and administer a system for scoring clinical images using all
attributes specified in paragraphs(c)(2)(i) through (c)(2)(viii) of
this section or an alternative system that FDA has approved in
accordance with Sec. 900.3(d) or paragraph (a)(9) of this section. The
scoring system shall include an individual scoring scale for each
attribute. Each scoring scale shall cover the range from unacceptable
deficiencies that markedly reduce the clinical value of an image to no
significant deficiencies. Each clinical image submitted shall be scored
for each attribute.
(i) The accreditation body shall establish and employ criteria for
a pass-fail system for clinical image review that has been approved by
FDA in accordance with Sec. 900.3(d) or Sec. 900.4(a)(9).
(ii) All clinical images submitted by a facility to the
accreditation body shall be reviewed independently by two or more
clinical image reviewers.
(4) Selection of clinical images for review. Unless otherwise
specified by FDA, the accreditation body shall require that for each
mammography unit in the facility:
(i) The facility shall submit craniocaudal (CC) and mediolateral
oblique (MLO) views from two mammographic examinations that the
facility produced during a time period specified by the accreditation
body;
(ii) Clinical images submitted from one such mammographic
examination for each unit shall be of dense breasts (predominance of
glandular tissue) and the other shall be of fat-replaced breasts
(predominance of adipose tissue);
(iii) All clinical images submitted shall be images that the
facility's interpreting physician(s) interpreted as normal.
(iv) If the facility has no clinical images meeting the
requirements in paragraphs (c)(4)(i) through (c)(4)(iii) of this
section, it shall so notify the accreditation body, which shall specify
alternative clinical image selection methods that do not compromise
care of the examinee.
(5) Clinical image reviewers. Accreditation bodies shall ensure
that all of their clinical image reviewers:
(i) Meet the interpreting physician requirements specified in
Sec. 900.12(a)(1);
(ii) Are trained and evaluated in the clinical image review
process, for the types of clinical images to be evaluated by a clinical
image reviewer, by the accreditation body before designation as
clinical image reviewers and periodically thereafter; and
(iii) Clearly document their findings and reasons for assigning a
particular score to any clinical image and provide information to the
facility for use in improving the attributes for which significant
deficiencies were identified.
(6) Image management. The accreditation body's QA program shall
include a tracking system to assure the security and return to the
facility of all clinical images received and to assure completion of
all clinical image reviews by the body in a timely manner. The
accreditation body shall return all clinical images to the facility
within 60 days of their receipt by the body, with the following
exceptions:
(i) If the clinical images are needed earlier by the facility for
clinical purposes, the accreditation body shall work with the facility
to accommodate such needs.
(ii) If a clinical image reviewer identifies an abnormality on a
clinical image that the facility interpreted as normal, and this
finding is not clearly specified on mammography reports submitted with
the clinical images, the accreditation body shall ensure that this
information is provided and the clinical images returned to the
facility no later than 10 business days after identification of the
suspected abnormality.
(7) Corrective measures for unsatisfactory image quality. If the
accreditation body determines that the clinical images from a facility
it accredits are of insufficient quality, the body shall notify the
facility of the nature of the problem and its possible causes. The
accreditation body shall monitor facility progress in correcting the
problem and take appropriate action if the necessary corrective
measures are not implemented in a manner and time period satisfactory
to the body.
(d) Phantom image review. (1) Frequency of review. The
accreditation body shall review phantom images from each facility
accredited by the body at least once every 3 years.
(2) Requirements for the phantom used. The accreditation body shall
require that each facility submit for review phantom images that the
facility produced using a phantom and methods of use specified by the
body and approved by FDA in accordance with Sec. 900.3(d) or paragraph
(a)(9) of this section.
(3) Scoring phantom images. The accreditation body shall use a
system for scoring phantom images that has been approved by FDA in
accordance with Sec. 900.3(d) or paragraph (a)(9) of this section.
(4) Phantom images selected for review. For each mammography unit
in the facility, the accreditation body shall require the facility to
submit phantom images that the facility produced during a time period
specified by the body.
(5) Phantom image reviewers. Accreditation bodies shall ensure that
all of their phantom image reviewers:
(i) Meet the requirements specified in Sec. 900.12(a)(3) or
alternative requirements established by the accreditation body and
approved by FDA in accordance with Sec. 900.3(d) or paragraph (a)(9) of
this section;
(ii) Are trained and evaluated in the phantom image review process,
for the types of phantom images to be evaluated by a phantom image
reviewer, by the accreditation body before designation as phantom image
reviewers and periodically thereafter; and
(iii) Clearly document their findings and reasons for assigning a
particular score to any phantom image and provide information to the
facility for use in improving its phantom image quality with regard to
the significant deficiencies identified.
(6) Image management. The accreditation body's QA program shall
include a tracking system to assure the security and return to the
facility of all phantom images received and to ensure completion of all
phantom image reviews by the body in a timely manner.
(7) Corrective measures for unsatisfactory image quality. If the
accreditation body determines that any phantom images are of
insufficient quality, the body shall notify the facility of the nature
of the problem and its possible causes. The accreditation body shall
monitor facility progress in correcting the problem and take
appropriate action if the necessary corrective measures are not
implemented in a manner and time period satisfactory to the body.
(e) Reports of mammography equipment evaluation, surveys, and
quality control. The following requirements apply to all facility
equipment covered by the provisions of subparts A and B:
(1) The accreditation body shall require every facility applying
for accreditation to submit:
[[Page 14897]]
(i) With its initial accreditation application, a mammography
equipment evaluation performed no earlier than 6 months before the date
of application for accreditation by the facility. Such evaluation shall
demonstrate compliance of the facility's equipment with the
requirements in Sec. 900.12(e).
(ii) A survey which was performed no earlier than 6 months before
the date of application for accreditation by the facility. Such survey
shall assess the facility's compliance with the facility standards
referenced in paragraph (b) of this section.
(2) The accreditation body shall require that all facilities
undergo an annual survey to assure continued compliance with the
standards referenced in paragraph (b) of this section and to provide
continued oversight of facilities' quality control programs as they
relate to such standards. The accreditation body shall require for all
facilities that:
(i) Such annual surveys be conducted no later than 14 months after
the most recent prior survey;
(ii) Facilities take reasonable steps to ensure that they receive
reports of such surveys within 30 days of survey completion; and
(iii) Facilities submit the results of such surveys, together with
quality control records, personnel updates, and other information that
the body may require, to the body at least annually.
(3) The accreditation body shall review and analyze the information
required in this section and use it to determine the accreditation
status of a facility and to identify necessary corrective measures for
facilities.
(f) Onsite visits to facilities and random clinical image reviews.
The accreditation body shall conduct onsite visits and random clinical
image reviews of a sample of facilities to monitor and assess their
compliance with the facility standards imposed under Sec. 900.3. The
accreditation body shall submit annually to FDA, at the address given
in Sec. 900.3(b)(1), 3 copies of a summary report describing all
facility assessments the body conducted under the provisions of this
section for the year being reported.
(1) Onsite visits. (i) Sample size. Annually, each accreditation
body shall visit at least 5 percent of the facilities it accredits.
However, a minimum of 5 facilities shall be visited, and visits to no
more than 50 facilities are required, unless problems identified in
paragraph (f)(1)(i)(B) of this section indicate a need to visit more
than 50 facilities.
(A) At least 50 percent of the facilities visited shall be selected
randomly.
(B) Other facilities visited shall be selected based on problems
identified through State or FDA inspections, complaints received from
consumers or others, a previous history of noncompliance, or any other
information in the possession of the accreditation body, inspectors, or
FDA.
(C) Before, during, or after any facility visit, the accreditation
body may require that the facility submit to the body for review
clinical images, phantom images, or any other information relevant to
applicable standards in this subpart and in subpart B of this part.
(ii) Visit plan. The accreditation body shall conduct visits
according to a visit plan that has been approved by FDA in accordance
with Sec. 900.3(d) or paragraph (a)(9) of this section. At a minimum,
such plan shall address review of the following elements during visits
to facilities selected randomly and facilities selected because of
previously identified concerns:
(A) Assessment of overall clinical image QA activities of the
facility;
(B) Review of facility documentation to determine if appropriate
mammography reports are sent to examinees and physicians as required;
(C) Selection of a sample of clinical images for clinical image
review by the accreditation body. Clinical images shall be selected in
a manner that does not compromise care of the examinee as a result of
the absence of the selected images from the facility;
(D) Review of the facility's medical audit system and assessment of
correlation between film and pathology reports for positive cases;
(E) Verification that personnel specified by the facility are the
ones actually performing designated personnel functions;
(F) Verification that equipment specified by the facility is the
equipment that is actually being used to perform designated equipment
functions;
(G) Verification of facility compliance with its consumer complaint
mechanism; and
(H) Review of all factors related to previously identified concerns
or concerns identified during that visit.
(2) Clinical image review for random sample of facilities. (i)
Sample size. In addition to conducting clinical image reviews for
initial and renewed accreditation for all facilities, the accreditation
body shall conduct clinical image reviews annually for a randomly
selected sample of 3 percent of the facilities the body accredits.
However, a minimum of five facilities shall be selected for such random
clinical image review. Accreditation bodies may count toward this 3
percent requirement all facilities selected randomly for the onsite
visits described in paragraph (f)(1)(i)(A) of this section.
Accreditation bodies shall not count toward the 3 percent random sample
requirement any facilities selected for a visit because of previously
identified concerns described in paragraph (f)(1)(i)(B) of this
section.
(ii) Clinical image review. In performing clinical image reviews of
the 3 percent random sample of facilities, accreditation bodies shall
apply the same standards as those in paragraph (c) of this section for
review of clinical images for initial and renewed accreditation.
(iii) Accreditation bodies should not schedule random clinical
image reviews at facilities that have received notification of need to
begin the accreditation renewal process or that have completed the
accreditation renewal process within the previous 6 months.
(g) Consumer complaint mechanism. The accreditation body shall
develop and administer a written and documented system, including
timeframes, for collecting and resolving serious consumer complaints
that could not be resolved at a facility. Such system shall have been
approved by FDA in accordance with Sec. 900.3(d) or paragraph (a)(9) of
this section. Accordingly, all accreditation bodies shall:
(1) Provide a mechanism for filing a serious complaint with the
accreditation body if the complaint has not been resolved at the
facility;
(2) Maintain a record of every serious complaint received by the
body on all facilities it accredits for a period of at least 3 years
from the date of receipt of each such complaint;
(3) Submit to FDA, at the address in paragraph (b)(1) of this
section, in a manner and time period specified by FDA, an annual report
summarizing all serious complaints received during the previous
calendar year, their resolution status, and any actions taken in
response to them.
(h) Reporting and recordkeeping. All reports to FDA specified in
paragraphs (h)(1) through (h)(4) of this section shall be prepared and
submitted in a format and medium prescribed by FDA and shall be
submitted to a location and according to a schedule specified by FDA.
The accreditation body shall:
(1) Collect and submit to FDA the information required by 42 U.S.C.
263b(d) for each facility when the facility is initially accredited and
at least annually when updated, in a manner and at a time specified by
FDA.
[[Page 14898]]
(2) Accept applications containing the information required in 42
U.S.C. 263b(c)(2) for provisional certificates and in Sec. 900.12(b)(2)
for extension of provisional certificates, on behalf of FDA, and notify
FDA of the receipt of such information;
(3) Submit to FDA the name, identifying information, and other
information relevant to 42 U.S.C. 263b and specified by FDA for any
facility for which the accreditation body denies or revokes
accreditation, or for which the accreditation body denies submission to
FDA of information required from facilities for provisional
certification or for extension of provisional certification, as
described in paragraph (h)(3) of this section, and the reason(s) for
such action;
(4) Provide to FDA other information relevant to 42 U.S.C. 263b and
required by FDA about any facility accredited or undergoing
accreditation by the body.
(i) Fees. Fees charged to facilities for accreditation shall be
reasonable. Costs of accreditation body activities that are not related
to accreditation functions under 42 U.S.C. 263b are not recoverable
through fees established for accreditation.
(1) The accreditation body shall make public its fee structure,
including those factors, if any, contributing to variations in fees for
different facilities.
(2) At FDA's request, accreditation bodies shall provide financial
records or other material to assist FDA in assessing the reasonableness
of accreditation body fees. Such material shall be provided to FDA in a
manner and time period specified by the agency.
Sec. 900.5 Evaluation.
FDA will evaluate annually the performance of each accreditation
body. Such evaluation shall include an assessment of the reports of FDA
or State inspections of facilities accredited by the body as well as
any additional information deemed relevant by FDA that has been
provided by the accreditation body or other sources or has been
required by FDA as part of its oversight initiatives.
Sec. 900.6 Withdrawal of approval.
If FDA determines, through the evaluation activities of Sec. 900.5,
or through other means, that an accreditation body is not in
substantial compliance with this subpart, FDA shall initiate
enforcement actions as follows:
(a) Major deficiencies. If FDA determines that an accreditation
body has failed to perform a major accreditation function
satisfactorily, has demonstrated willful disregard for public health,
has violated the code of conduct, has committed fraud, or has submitted
material false statements to the agency, FDA may withdraw its approval
of that accreditation body.
(1) FDA will notify the accreditation body of the agency's action
and the grounds on which the approval was withdrawn.
(2) An accreditation body that has lost its approval shall notify
facilities accredited or seeking accreditation by it that its approval
has been withdrawn. Such notification shall be made within a time
period and in a manner approved by FDA.
(b) Minor deficiencies. If FDA determines that an accreditation
body has demonstrated deficiencies in performing accreditation
functions and responsibilities that are less serious or more limited
than the deficiencies in paragraph (a) of this section, FDA shall
notify the body that it has a specified period of time to take
particular corrective measures directed by FDA or to submit to FDA for
approval the body's own plan of corrective action addressing the minor
deficiencies. FDA may place the body on probationary status for a
period of time determined by FDA, or may withdraw approval of the body
as an accreditation body if corrective action is not taken.
(1) If FDA places an accreditation body on probationary status, the
body shall notify all facilities accredited or seeking accreditation by
it of its probationary status within a time period and in a manner
approved by FDA.
(2) Probationary status will remain in effect until such time as
the body can demonstrate to the satisfaction of FDA that it has
successfully implemented or is implementing the corrective action plan
within the established schedule, and that the corrective actions have
substantially eliminated all identified problems.
(3) If FDA determines that an accreditation body that has been
placed on probationary status is not implementing corrective actions
satisfactorily or within the established schedule, FDA may withdraw
approval of the accreditation body. The accreditation body shall notify
all facilities accredited or seeking accreditation by it of its loss of
approval authority, within a time period and in a manner approved by
FDA.
(c) Reapplication by accreditation bodies that have had their
approval withdrawn. (1) A former accreditation body that has had its
approval withdrawn may submit a new application for approval if the
body can provide information to FDA to establish that the problems that
were grounds for withdrawal of approval have been resolved.
(2) If FDA determines that the new application demonstrates that
the body satisfactorily has addressed the causes of its previous
unacceptable performance, FDA may reinstate approval of the
accreditation body.
(3) FDA may request additional information or establish additional
conditions that must be met by a former accreditation body before FDA
approves the reapplication.
(4) FDA will not accept an application from a former accreditation
body whose approval was withdrawn because of fraud or willful disregard
of public health.
Sec. 900.7 Hearings.
(a) Opportunities to challenge final adverse actions taken by FDA
regarding approval or reapproval of accreditation bodies, withdrawal of
approval of accreditation bodies, or rejection of a proposed fee shall
be communicated through notices of opportunity for informal hearings in
accordance with part 16 of this chapter.
(b) A facility that has been denied accreditation is entitled to an
appeals process from the accreditation body. The appeals process shall
be specified in writing by the accreditation body and shall have been
approved by FDA in accordance with Sec. 900.3(d) or Sec. 900.4(a)(9).
(c) A facility that cannot achieve satisfactory resolution of an
adverse accreditation decision through the accreditation body's appeals
process may appeal to FDA for reconsideration in accordance with
Sec. 900.15.
Dated: March 22, 1996.
David A. Kessler,
Commissioner of Food and Drugs.
Donna E. Shalala,
Secretary of Health and Human Services.
[FR Doc. 96-7831 Filed 3-29-96; 8:45 am]
BILLING CODE 4160-01-P
