Proposed Requirements for Accreditation Bodies of Mammography Facilities

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