Quality Standards and Certification Requirements for Mammography Facilities; General Facility Requirements

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 900

[Docket No. 93N-0351]

RIN 0910-AA24

Quality Standards and Certification Requirements for Mammography

Facilities; General Facility Requirements

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend

the facility standards established in the interim regulations

implementing the Mammography Quality Standards Act of 1992 (the MQSA).

This proposed rule would modify and add to the general requirements for

mammography facilities, including requirements for a medical reporting

and recordkeeping program, a medical outcomes audit program, special

methods for examining individuals with breast implants, a consumer

complaint mechanism, and a variance procedure for requesting FDA

approval of alternative standards. In addition to the statutory

framework and the expertise and research of FDA personnel, the agency

is proposing this rule based on advice from the National Mammography

Quality Assurance Advisory Committee (NMQAAC) and public comments

received in response to the interim regulations. This action is being

taken to ensure safe, accurate, and reliable mammography on a

nationwide basis. This is the third of five related proposed rules

being published concurrently.

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.

asis. This is the third of five related proposed rules

being published concurrently.

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, OMB, 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 third 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 all of these

proposed rules, a description of the information collection

requirements, proposed revisions to Sec. 900.1 Scope and Sec

65)

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 all of these

proposed rules, a description of the information collection

requirements, proposed revisions to Sec. 900.1 Scope and Sec. 900.2

Definitions, and proposed alternative approaches to mammography

standards and a request for comments on the proposed alternatives.

II. Provisions of the Proposed Rule

A. Development of the Proposed Regulations

This proposed rule establishes mammography facility standards for

recordkeeping and reporting, medical outcomes audit, quality assurance,

imaging of examinees with breast implants, and addressing consumer

complaints. The proposal also establishes general certification

requirements, and a procedure for any entity regulated under this rule

to request FDA approval of alternative standards. As in the development

of the interim regulations, FDA has been guided by the requirements of

the MQSA and its stated legislative intent to guarantee access to safe

and effective mammography services for all women in the United States

(Ref. 1).

In addition to the statutory framework and the expertise and

research of FDA personnel, the agency relied upon two major sources of

information in developing this proposed rule. The first source was the

written comments received on the interim regulations. FDA received 103

comments from individuals and organizations on the interim regulations.

Included among the written comments were responses from professional

organizations, medical facilities, State agencies, consumer groups,

manufacturers, and individual physicians, medical physicists, and

radiologic technologists.

e first source was the

written comments received on the interim regulations. FDA received 103

comments from individuals and organizations on the interim regulations.

Included among the written comments were responses from professional

organizations, medical facilities, State agencies, consumer groups,

manufacturers, and individual physicians, medical physicists, and

radiologic technologists.

The second outside source of information used to develop the

proposed regulations was the advice and recommendations of the NMQAAC.

Sections of these proposed regulations were discussed at the NMQAAC

meetings in February, May, July, and September 1994. All of these

proposed regulations, as then drafted, were reviewed again at the

January 1995 meeting of the NMQAAC. The 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 meetings in

recognition of their expertise in mammography also participated in the

discussions.

B. Applicability

Proposed Sec. 900.10 states that the provisions of subpart B apply

to all facilities under the jurisdiction of the United States that

provide mammography services, with the exception of the facilities of

the Department of Veterans Affairs (DVA).

Several comments objected to the exemption of DVA facilities from

the interim regulations. In response to these comments, the agency

notes that the DVA facilities are excluded from the requirements of the

MQSA by the statute itself (42 U.S.C. 263b(a)(3)(A)). However, since

the publication of the interim regulations, DVA has voluntarily

committed its facilities to a program consistent with the standards

issued under the MQSA.

C. Certification Requirements

Proposed Sec. 900.11 defines the two types of certificates,

provisional and

at the DVA facilities are excluded from the requirements of the

MQSA by the statute itself (42 U.S.C. 263b(a)(3)(A)). However, since

the publication of the interim regulations, DVA has voluntarily

committed its facilities to a program consistent with the standards

issued under the MQSA.

C. Certification Requirements

Proposed Sec. 900.11 defines the two types of certificates,

provisional and

full, that permit a mammography facility to operate lawfully after

October 1, 1994. This section states the length of time the

certificates will be valid and the circumstances under which the

certificates may be renewed or extended. In addition, proposed

Sec. 900.11(c) outlines reinstatement procedures for a facility that

has allowed its certificate to expire, has been refused a renewal of

its certificate, or has had its certificate revoked by FDA. It also

states that the owner or operator of a facility that has had its

certificate revoked by FDA may not apply for reinstatement until at

least 2 years have passed from the time of the revocation. This

additional restriction is required by the statute (42 U.S.C.

263b(i)(3)).

One comment on the interim regulations requested that FDA state

clearly that a provisional certificate can only be issued once.

FDA reviewed this issue in connection with implementation of the

interim regulations and concluded that the statute does not limit any

particular facility to receiving a provisional certificate only once.

Situations in which a subsequent provisional certificate might be

issued to a facility include cases where a facility was denied an

initial full certificate or renewal of its full certificate or has had

its certificate revoked by FDA but subsequently has made substantial

progress in correcting the problems that led to denial or revocation of

the certificate

provisional certificate only once.

Situations in which a subsequent provisional certificate might be

issued to a facility include cases where a facility was denied an

initial full certificate or renewal of its full certificate or has had

its certificate revoked by FDA but subsequently has made substantial

progress in correcting the problems that led to denial or revocation of

the certificate. In the case of a facility that failed to achieve

accreditation and certification during its initial 6-month provisional

time period, the regulations permit FDA to issue a second provisional

certificate if the facility applies for one after a corrective action

plan has been effectively implemented. At that point, a new 6-month

provisional certificate may be provided to the facility while the

accreditation process is underway. In the case of a revoked

certificate, as described previously, at least 2 years must pass before

the owner or operator of the facility can apply for a new provisional

certificate. A subsequent provisional certificate also might be issued

to a facility that allowed its previous certificate to expire but later

wishes to resume providing mammography services.

However, the comment is correct to the extent that FDA may not

issue two sequential, uninterrupted 6-month provisional certificates to

the same facility. The agency invites comments on whether its policy of

permitting a facility to obtain a subsequent 6-month provisional

certificate once the facility has effectively corrected its

deficiencies should be included in the final regulations and, if so,

what if any, conditions should be placed in the process.

The same comment expressed the opinion that provisional

certificates were only intended to aid facilities in meeting the

October 1, 1994, deadline

mitting a facility to obtain a subsequent 6-month provisional

certificate once the facility has effectively corrected its

deficiencies should be included in the final regulations and, if so,

what if any, conditions should be placed in the process.

The same comment expressed the opinion that provisional

certificates were only intended to aid facilities in meeting the

October 1, 1994, deadline.

Although it is true that the provisional certificates were valuable

in helping existing facilities meet the October 1, 1994, deadline, they

are also intended to provide a way for new facilities to commence

operation after the date became effective. To become accredited and

certified, a facility must pass clinical image review. However, without

provisional certification, a new facility would be unable to perform

the necessary mammographic examinations for presentation to the

accreditation body for review after October 1, 1994. The provisional

certificate allows such facilities lawfully to produce the images they

need to achieve full accreditation and certification.

Two comments suggested that other justifications, in addition to

avoiding an adverse impact on the availability of mammography, should

be considered in making a determination to grant a 90-day extension of

the provisional certificate.

Congress limited the possibility of a 90-day extension of a

provisional certificate under the MQSA to cases in which there would be

a significant reduction of access to mammography in the geographic area

served by the facility (42 U.S.C. 263b(c)(2)). Provisionally certified

facilities should make every effort to obtain full certification no

later than 6 months from the date the provisional certificate is

issued.

Other comments asked that the time periods for the provisional

certificates and the 90-day extensions be increased, primarily because

of the difficulty accreditation bodies experienced in meeting the

timeframes

S.C. 263b(c)(2)). Provisionally certified

facilities should make every effort to obtain full certification no

later than 6 months from the date the provisional certificate is

issued.

Other comments asked that the time periods for the provisional

certificates and the 90-day extensions be increased, primarily because

of the difficulty accreditation bodies experienced in meeting the

timeframes.

Again, the agency notes that the MQSA established these timeframes

and FDA cannot amend them. Although the number of applications for

accreditation submitted to meet the October 1, 1994, deadline did cause

some difficulties for accreditation bodies meeting the timeframes, the

accreditation bodies have increased their staffs to match the workload.

The agency believes that once the initial implementation period is

over, the accreditation bodies will be fully staffed to meet these

timeframes effectively and efficiently, provided that facilities

promptly submit the required information for evaluation. In addition,

accreditation bodies are taking steps to adjust the timeframes for

renewal of accreditation so that the workload is more evenly

distributed.

One comment suggested that some additional time be allowed for FDA

and facilities to gain experience with the interim standards before any

major changes are proposed. The comment stated that experience could

then serve as a guide in determining what revisions were needed.

When Congress gave FDA interim regulation authority, it intended

that FDA take prompt action to promulgate final regulations through

notice and comment rulemaking. Accordingly, FDA began work on the final

standards almost immediately after the interim regulations were

published. Because of the deliberative nature of the rulemaking

process, however, the agency will have had some experience with the

interim regulations before the final regulations are published

t FDA take prompt action to promulgate final regulations through

notice and comment rulemaking. Accordingly, FDA began work on the final

standards almost immediately after the interim regulations were

published. Because of the deliberative nature of the rulemaking

process, however, the agency will have had some experience with the

interim regulations before the final regulations are published. The

lessons learned during this interim period have been and will continue

to be applied in the development of the final regulations.

In addition, the passage of time has helped FDA identify concerns

that were not immediately apparent when the interim regulations were

drafted. For example, FDA has realized that there is a possibility

that, at some future time, particular facilities may not have access to

an accreditation body. If this event were to occur, FDA would have to

provide an alternative for accreditation or the facilities could not

lawfully operate. To be prepared for this possibility, the agency has

added the words ``or other entity as designated by FDA'' at every point

in Sec. 900.11, and elsewhere in the regulations, where facilities are

required to take some action with respect to their accreditation body.

D. Medical Records and Mammography Reports

Proposed Sec. 900.12(c) establishes certain requirements for the

content and terminology of the mammography examination report, the

manner of communicating results of the mammography examination to the

examinee and to health care providers, and the duties of the facility

for maintaining records of examinees.

1. Mammography Reporting

The information and assessment categories listed in proposed

Sec. 900.12(c)(1) are intended to establish a minimum national standard

that will permit the results of mammography examinations to be more

easily compared. This standardized format for presenting the results of

the

health care providers, and the duties of the facility

for maintaining records of examinees.

1. Mammography Reporting

The information and assessment categories listed in proposed

Sec. 900.12(c)(1) are intended to establish a minimum national standard

that will permit the results of mammography examinations to be more

easily compared. This standardized format for presenting the results of

the

examination will assist in preparation of the medical outcomes audit

that each facility is required to perform. The standard will also

facilitate communication about the risk of breast cancer from the

interpreting physician to the referring health care providers. The

categories proposed in the regulation are recommended by the American

College of Radiology and also recommended by the Agency for Health Care

Policy and Research (AHCPR) mammography practice guidelines, ``Quality

Determinants of Mammography.''

During discussions with NMQAAC, certain advisory committee members

suggested that FDA establish standard operating procedures that

facilities should follow for the production of mammography reports. FDA

believes that regulating a facility's internal procedures for

generating mammography reports would be overly intrusive. Interested

parties can find suggested guidelines for optimal facility operating

procedures for production and dissemination of mammography results in

the AHCPR's ``Quality Determinants of Mammography.''

FDA and NMQAAC discussed the collection of racial and ethnic data

as part of the recordkeeping requirements. Opinions of individual

committee members varied with respect to collection of such data. FDA

recognizes the value of these data in addressing such important issues

as the utilization and efficacy of mammography, as well as other

pertinent public health research questions

ammography.''

FDA and NMQAAC discussed the collection of racial and ethnic data

as part of the recordkeeping requirements. Opinions of individual

committee members varied with respect to collection of such data. FDA

recognizes the value of these data in addressing such important issues

as the utilization and efficacy of mammography, as well as other

pertinent public health research questions. However, after consultation

with other Public Health Service agencies that have experience in

attempting to collect racial and ethnic data from mammography

facilities, FDA determined that there is currently no effective

established method for collecting this information. Therefore, FDA is

not at this time proposing a requirement for facilities to collect

racial and ethnic data. FDA does encourage facilities to collect all

information, including racial and ethnic data, that will allow

facilities to better understand and serve their particular communities.

The items listed in proposed Sec. 900.12 (c)(1) and (c)(2)(i) are

minimum requirements and do not preclude the facility from including

additional information in mammography reports or in notifications to

examinees, including relevant public health messages to the health care

provider or to the examinee.

2. Signatures

Proposed Sec. 900.12(c)(1) would require the written mammography

report to be signed by the interpreting physician. FDA views the

signature on the report as an attestation of the signatory as the

individual who has read the mammogram and has rendered the

interpretation in the report. Therefore, in addition to handwritten

signatures on the mammography reports, FDA will accept other

``signatures,'' including those that are generated from computer

systems, typewritten, or name stamped, on the condition that these

signatures were personally authorized by the interpreting physician

as the

individual who has read the mammogram and has rendered the

interpretation in the report. Therefore, in addition to handwritten

signatures on the mammography reports, FDA will accept other

``signatures,'' including those that are generated from computer

systems, typewritten, or name stamped, on the condition that these

signatures were personally authorized by the interpreting physician.

NMQAAC advised FDA to adopt regulations to mandate that all

facilities have a written policy that ensures the integrity of the

signature on the mammography report as coming from the interpreting

physician, or a designated interpreting physician, if the interpreting

physician is unavailable. NMQAAC also encouraged FDA to mandate that

facilities assure that all personnel signatures, and other legally

binding equivalents in the medical record, include professional titles.

FDA encourages these practices but believes that it is unnecessary to

require them through regulation.

3. Communication With the Examinee and Health Care Providers

Communication responsibilities have long been a frustrating area in

mammography practice. All women who have mammography need to know the

results. Examinees without any health care providers need to have the

actual reports to show to subsequent health care providers, especially

in the case of abnormal findings. Many examinees believe no news is

good news. This fallacy contributes to delays in treatment when,

through communication problems, the significance of a finding is not

properly communicated to the examinee.

Currently, interim regulations provide that only women who have no

health care provider receive the actual medical report and a summary of

the mammography results in lay language. Two comments on the interim

regulations recommended that the final regulations be amended to ensure

that every examinee receives a written report signed by the

interpreting physician and presented in lay language

.

Currently, interim regulations provide that only women who have no

health care provider receive the actual medical report and a summary of

the mammography results in lay language. Two comments on the interim

regulations recommended that the final regulations be amended to ensure

that every examinee receives a written report signed by the

interpreting physician and presented in lay language. One comment on

the interim regulations suggested requiring the report to include all

elements previously required by the Health Care Financing

Administration's (HCFA's) screening mammography program.

Proposed Sec. 900.12(c)(2) would require that all examinees receive

notification of results expressed in lay terms. Examinees without

health care providers would receive the actual mammography report along

with the lay notification. If there is a health care provider, the lay

notification would go to the examinee and the actual report would go to

the health care provider, who, in turn, could communicate with the

examinee again or in greater detail, if necessary.

This proposal is in response to consumer complaints of failure to

communicate abnormal and normal results to examinees. The proposed

standard intends to maintain the examinee-provider relationship while

ensuring that results get communicated to the examinee. The lay

notification of results and recommendations vary in length and detail,

but may be as simple as ``Your mammogram reveals you need further

tests. Please contact your physician.'' FDA also believes that

notifications to examinees should be written in a way that is not

overly alarming. In addition, FDA believes that in those cases in which

an examination reveals the need for followup, notification directly to

the examinee is essential.

FDA recognizes there are some referring health care providers who

feel that they may be placed in an uncomfortable position if an

examinee is notified of results before the health care provider is

notified

a way that is not

overly alarming. In addition, FDA believes that in those cases in which

an examination reveals the need for followup, notification directly to

the examinee is essential.

FDA recognizes there are some referring health care providers who

feel that they may be placed in an uncomfortable position if an

examinee is notified of results before the health care provider is

notified. There is also a concern that the examinee may be unduly

alarmed by the facility's notification.

In response to these concerns, the agency notes that the main

purposes of the lay notification requirements are to provide another

safety mechanism to help to ensure that abnormal results are followed

up and to ensure that all examinees know their mammography results. If

facilities notify physicians and examinees simultaneously, the

referring doctor will have access to the results of the mammogram at

the time an examinee calls for clarification or followup. Those

physicians who prefer to handle all communication with their examinees

may continue that practice if procedures are properly coordinated with

the facility generating the reports. The proposed requirements would

not prohibit the mammography facility from providing standard lay

notifications, along with the mammography report, to a referring health

care provider who has agreed to issue these notices to his or her

examinees. This agreement should be documented by attestation

statements from the referring provider and should be on file at the

mammography facility for inspection purposes.

During discussions with NMQAAC, FDA heard diverse opinions

concerning the form and content of the notification that all examinees

will receive.

health

care provider who has agreed to issue these notices to his or her

examinees. This agreement should be documented by attestation

statements from the referring provider and should be on file at the

mammography facility for inspection purposes.

During discussions with NMQAAC, FDA heard diverse opinions

concerning the form and content of the notification that all examinees

will receive.

However, NMQAAC did favor some form of written notification to all

examinees, and that recommendation has been incorporated into the

proposal.

Section 900.12(e)(2)(ii)(A) of the interim regulations establishes

that the written report of any mammography examination shall be sent

directly to the patient if the patient's physician is not ``available''

or if the patient does not have a physician. Two comments stated that

the word ``available'' in this provision is ambiguous and could be

interpreted to mean that the physician will not be notified if he or

she is on vacation, at a meeting, or absent. One comment suggested

deleting this word. Another comment asked how one is to ascertain the

availability of the examinee's physician at the time a report is

generated.

FDA advises that, in the proposed regulation, communication of

mammography results to examinees and communication of results to health

care providers are addressed in separate sections. As with the interim

regulations, the proposed regulations require a facility to provide the

mammography report directly to the examinee if she does not have a

health care provider (Sec. 900.12(c)(2)(ii)). The issue of the

``availability'' of a physician is addressed in the section of the

proposed regulation that covers communications of results to health

care providers, Sec. 900.12(c)(3).

Proposed Sec. 900.12(c)(3)(ii) is intended to address the specific

concern that arises when a mammography report reveals possible

malignancy

she does not have a

health care provider (Sec. 900.12(c)(2)(ii)). The issue of the

``availability'' of a physician is addressed in the section of the

proposed regulation that covers communications of results to health

care providers, Sec. 900.12(c)(3).

Proposed Sec. 900.12(c)(3)(ii) is intended to address the specific

concern that arises when a mammography report reveals possible

malignancy. The proposed regulations would require the mammography

facility immediately to make reasonable attempts to communicate a

finding of possible malignancy directly to the health care provider or

a responsible designee, if the health care provider is not available.

``Not available'' is intended to mean ``not on call,'' ``not able to be

reached at this time,'' or other similar situations. Health care

providers normally have means of handling unexpected important health

matters concerning their examinees through coverage systems and the

proposed regulation recognizes this practice. The regulations are

intended to require reasonable attempts to notify the health care

provider or the entity designated by the referring health care provider

as responsible for patient care while the referring health care

provider is not available.

Questions were raised by the NMQAAC about retention of lay

notifications. Although the regulations do not require a facility to

keep a copy of the notification in the medical record, each facility

should have a system to monitor and verify that such a notice was sent

out for each examinee. In addition, samples of the lay notifications

which go to all examinees must be available for inspectors during

annual the MQSA inspections.

The results given in the lay notification are purposely labeled as

``results'' and not as ``assessment'' to avoid facilities having to use

one of the six assessment categories in proposed Sec. 900.12(c)(1)(iii)

and (c)(1)(iv)

ent

out for each examinee. In addition, samples of the lay notifications

which go to all examinees must be available for inspectors during

annual the MQSA inspections.

The results given in the lay notification are purposely labeled as

``results'' and not as ``assessment'' to avoid facilities having to use

one of the six assessment categories in proposed Sec. 900.12(c)(1)(iii)

and (c)(1)(iv). FDA encourages facilities to tailor these lay

notification letters of results to their clientele's literacy level,

and ethnic, cultural, and social sensibilities in order to maximize the

likelihood that these examinees will understand and appropriately

followup results.

Proposed Sec. 900.12(c)(2) recognizes that assessments indicating a

high probability of cancer need to be communicated with special care to

examinees, especially to those examinees without health care providers.

Examinees without a health care provider should receive person-to-

person communication, such as a telephone call, if it is at all

possible, when immediate followup is needed. In addition, in these and

other circumstances, such as when there are physical findings in the

absence of mammographic findings, when there are symptoms of breast

disease, or when a mammography report recommends further testing, the

proposed regulation requires each facility to have a formal system that

can refer an examinee who is without a health care provider. FDA

believes this proposed regulation codifies the role many radiologists

now assume with self-referred examinees.

The interim regulations require each facility to prepare a written

report of the results of each mammographic examination as soon as

possible. Two comments on the interim regulations stated that it is not

clear how a time limit of ``as soon as reasonably possible'' for

completing a report can be enforced. The comments suggested inclusion

of an actual time limit or replacing the word ``shall'' with

``should.''

FDA agrees that a timeframe should be specified. Proposed

Sec

results of each mammographic examination as soon as

possible. Two comments on the interim regulations stated that it is not

clear how a time limit of ``as soon as reasonably possible'' for

completing a report can be enforced. The comments suggested inclusion

of an actual time limit or replacing the word ``shall'' with

``should.''

FDA agrees that a timeframe should be specified. Proposed

Sec. 900.12(c)(3)(i) requires every mammography report to be prepared

and communicated to the health care provider as soon as possible, but

no later than 30 days from the date of the examination. Proposed

Sec. 900.12(c)(2) establishes the same timeframe for communication of

results to examinees. If the facility is gathering comparison films, an

initial report or notification can be sent to the examinee or health

care provider indicating preliminary results with an addendum to

follow.

4. Recordkeeping

One comment stated that the mammograms should be kept indefinitely,

noting particularly the need for retention of baseline mammograms.

FDA believes that the 10-year time period, which is set forth in

the statute itself, 42 U.S.C. 263b(f)(1)(G)(i), allows for adequate

prior information to be stored and used. The proposed regulations thus

adopt, in Sec. 900.12(c)(4)(i), the same retention periods required by

the interim regulations, which establish a minimum of 10 years in

situations where no additional mammography examinations are done for an

examinee. The time period may be longer, if required by State law.

One comment stated that the retention requirement in Sec. 900.12(e)

of the interim regulations requires facilities to retain all mammograms

for 10 years, because costs of determining after 5 years whether an

examinee has had additional mammograms will exceed storage costs.

FDA does not agree with this comment. One way to determine if

mammograms can be discarded is during filing of each new mammogram

ment stated that the retention requirement in Sec. 900.12(e)

of the interim regulations requires facilities to retain all mammograms

for 10 years, because costs of determining after 5 years whether an

examinee has had additional mammograms will exceed storage costs.

FDA does not agree with this comment. One way to determine if

mammograms can be discarded is during filing of each new mammogram. At

that time, prior mammograms over 5 years old can be discarded if

clinically appropriate and if permitted by State law. This policy

allows for a case by case determination of record retention for

individual examinees. A facility can keep images longer than the

minimum set forth in the proposed regulations.

The same comment further requested that FDA revise the interim

regulations to require that mammography records be retained for the

same time periods that are otherwise required by State law, or if any

State lacks such a requirement, for a period of 7 years, which is the

time period specified by California.

Because the MQSA specifies minimum retention periods, the proposed

change would be inconsistent with the statute. The MQSA permits States

to have more stringent regulations, including requirements relating to

record retention. However, the 7-year California requirement for

retention of a single mammography examination would not be a more

stringent requirement, because it is less than the 10 years required by

the MQSA.

One comment noted that two mammography studies taken on consecutive

days would allow a facility to circumvent the requirement for 10-year

record retention.

requirements relating to

record retention. However, the 7-year California requirement for

retention of a single mammography examination would not be a more

stringent requirement, because it is less than the 10 years required by

the MQSA.

One comment noted that two mammography studies taken on consecutive

days would allow a facility to circumvent the requirement for 10-year

record retention.

FDA does not believe this comment raises a valid concern. Although

the first mammograms would be exempt from the 10-year retention period,

the second study would not be. It is doubtful that a facility would

discard the first study while maintaining the second and highly

improbable that any facility would do double studies simply to avoid

retaining a set of images.

One comment suggested that examinees should only have a right to

copies of mammograms, not to the originals, because of the increased

risk of loss or misplacement associated with examinees permanently

taking possession of their original films and reports. Another comment

from an interpreting physician noted great difficulty in obtaining

original mammograms for comparison purposes. This comment stated that

copied films are of inadequate quality when assessing the need for

surgery.

The issue of whether to require copies or originals to be sent to

facilities for clinical use or for comparison studies was discussed

with NMQAAC. Although NMQAAC members did acknowledge problems with loss

or misplacement of original films, there was general concern that many

copies were of such poor quality that they did not provide adequate

information. Sometimes only original films can provide the information

that will prevent a woman from undergoing unnecessary invasive

procedures, or confirm the need for such procedures. Thus, the NMQAAC

agreed that FDA should require that originals be sent for comparison

studies, as proposed in Sec. 900.12(c)(4)(ii). Under the proposed

regulations, examinees would need to request any transfer of their

films

times only original films can provide the information

that will prevent a woman from undergoing unnecessary invasive

procedures, or confirm the need for such procedures. Thus, the NMQAAC

agreed that FDA should require that originals be sent for comparison

studies, as proposed in Sec. 900.12(c)(4)(ii). Under the proposed

regulations, examinees would need to request any transfer of their

films. Facilities could ask examinees to sign releases as part of the

request for the transfer of originals. A copy of the film could be kept

at the original facility until the original films are returned.

FDA and NMQAAC discussed the issue of facility closure and

disposition of the films and mammography reports. Members of the NMQAAC

advised FDA to require that facilities give the public notice of their

impending closure to allow a reasonable opportunity for examinees to

obtain or transfer films and reports; that facilities be required to

make financial plans to fulfill this notification requirement and to

transfer medical records in the event of cessation of mammography

activities; that facilities be required to notify the accreditation

bodies and FDA of the disposition of films and records; and that

facilities establish contingency locations for the transfer of

examinees' films and records.

The issue of medical record and film disposition in the event of a

closure is generic to the health care system. Facilities are required

under the interim and proposed regulations to report all changes in

status to their accreditation bodies, including plans to close. FDA

would encourage facilities to plan for an orderly transfer of records

in case of closure and to comply with applicable State laws concerning

record retention. However, FDA believes that additional Federal

regulations on this issue would be problematic with respect to

compliance and enforcement.

E. Quality Assurance--General

status to their accreditation bodies, including plans to close. FDA

would encourage facilities to plan for an orderly transfer of records

in case of closure and to comply with applicable State laws concerning

record retention. However, FDA believes that additional Federal

regulations on this issue would be problematic with respect to

compliance and enforcement.

E. Quality Assurance--General

The MQSA requires each facility to establish and maintain a quality

assurance and quality control program to ensure the reliability,

clarity, and accuracy of interpretation of mammograms.

Proposed Sec. 900.12(d) establishes general requirements for

quality assurance (QA) programs.

Proposed Sec. 900.12(d)(1) requires the facility to assign

responsibility for various components of its QA program to individuals

who are qualified for their assignments and who shall be given adequate

time to perform their duties. Proposed Sec. 900.12(d)(1) also

establishes QA responsibilities for the lead interpreting physician,

interpreting physician, medical physicist, and quality control

technologist.

The agency developed these regulations in response to several

comments that objected to the medical physicist having primary

responsibility for the QA program under the interim regulations. The

comments noted that, especially if the medical physicist is a contract

employee, he or she may not have the authority to ensure that all the

actions necessary for proper implementation of the QA program are

carried out. In addition, NMQAAC members advised FDA that some aspects

of the QA program fall outside the medical physicist's area of

expertise.

The agency believes that the division of responsibility under the

proposed regulations addresses these concerns and satisfies the

requirements under the MQSA that certain responsibilities be assigned

to the physicist.

Proposed Sec. 900.12(d)(1)(i) states that the lead interpreting

physician shall have general responsibility for assuring that all of

the QA requirements are met

of

expertise.

The agency believes that the division of responsibility under the

proposed regulations addresses these concerns and satisfies the

requirements under the MQSA that certain responsibilities be assigned

to the physicist.

Proposed Sec. 900.12(d)(1)(i) states that the lead interpreting

physician shall have general responsibility for assuring that all of

the QA requirements are met. The regulation is intended to recognize

that, in order to carry out this responsibility effectively, the lead

interpreting physician must have authority to ensure that the

individuals involved with the QA program are qualified for their duties

and that they perform them properly.

The proposed regulation requires each facility to designate a

qualified individual as lead interpreting physician for purposes of the

QA program. However, the actual administrative title of the individual

is left to the facility. Decisions to assign other supervisory duties,

unrelated to the QA program, to the lead interpreting physician are

left to the discretion of each facility.

NMQAAC felt strongly that the individual assigned overall

responsibility for the QA program should be an interpreting physician.

NMQAAC recognized that this may cause some difficulty for a facility

whose interpreting physician is not normally at the facility. However,

the committee believed, and FDA agrees, that the benefits to be gained

when the individual overseeing the QA program has the skills of an

interpreting physician outweighed the difficulties.

Proposed Sec. 900.12(d)(1)(ii) establishes that all interpreting

physicians have a responsibility to assist and participate in the QA

program.

Proposed Sec. 900.12(d)(1)(iii) establishes that the primary

responsibility of the medical physicist in the QA program is related to

mammography equipment.

Proposed Sec. 900.12(d)(1)(iv) is intended to recognize that many

aspects of the QA program should be assigned to quality control

technologists

l interpreting

physicians have a responsibility to assist and participate in the QA

program.

Proposed Sec. 900.12(d)(1)(iii) establishes that the primary

responsibility of the medical physicist in the QA program is related to

mammography equipment.

Proposed Sec. 900.12(d)(1)(iv) is intended to recognize that many

aspects of the QA program should be assigned to quality control

technologists. NMQAAC believed that it was essential that quality

control technologists be qualified to perform diagnostic radiology

examinations in order to be able to carry out adequately the

responsibilities normally assigned to them, including, for example,

responsibility for darkroom cleanliness, darkroom fog tests, processor

quality control, analysis of fixer retention in film, and retake

analysis. After some discussion, NMQAAC also concluded that the quality

control technologists need not be qualified to perform mammography

examinations specifically.

NMQAAC's position is reflected in the definition of quality control

technologist in proposed Sec. 900.2, published elsewhere in this issue

of the Federal Register. The definition would bar biomedical engineers,

manufacturer's service personnel, darkroom personnel, or individuals in

other positions from serving as quality control technologists unless

they were also qualified to perform diagnostic radiology examinations.

NMQAAC discussed the advisability of limiting performance of

certain QA

0.2, published elsewhere in this issue

of the Federal Register. The definition would bar biomedical engineers,

manufacturer's service personnel, darkroom personnel, or individuals in

other positions from serving as quality control technologists unless

they were also qualified to perform diagnostic radiology examinations.

NMQAAC discussed the advisability of limiting performance of

certain QA

tasks exclusively to quality control technologists. NMQAAC concluded

that there might be certain situations where the absence of the

technologist might require a medical physicist or interpreting

physician to step in and perform these tasks in order to avoid the

temporary closure of a facility. The proposed regulations, therefore,

do not assign specific QA duties to particular individuals, as do the

ACR manuals.

Proposed Sec. 900.12(d)(2) outlines the necessary QA records the

facility will be required to keep. These records include: A QA manual;

a list assigning responsibility for the various aspects of the QA

program; records to show the qualifications of the individuals involved

in the program; and records that monitor the facility's implementation

of its QA program and resolution of any problems that occur. FDA

believes that such records are necessary to ensure that all employees

are aware of their QA responsibilities and trained to perform them and

that appropriate actions are taken to meet the goal of providing high

quality mammography.

F. Medical Outcomes Audit

in the program; and records that monitor the facility's implementation

of its QA program and resolution of any problems that occur. FDA

believes that such records are necessary to ensure that all employees

are aware of their QA responsibilities and trained to perform them and

that appropriate actions are taken to meet the goal of providing high

quality mammography.

F. Medical Outcomes Audit

Proposed Sec. 900.12(f) requires a mammography medical outcomes

audit program to be part of each facility's QA program. A mammography

medical outcomes audit is a systematic collection and analysis of

mammography results and the comparison of those results with data from

biopsy results.

The intent of the mammography medical audit is to provide an

objective measure of the interpretive ability of the interpreting

physician. This information can be useful for determining how the

interpreting physician performs from year to year and in comparison

with other interpreting physicians in the same facility and serving the

same examinee population.

As the medical outcomes audit data are collected and analyzed, a

facility should acquire information that can improve the interpretive

skills of the physicians. Some examples of this type of information

include: positive predictive value (PPV), cancer detection rate, and

percent of minimal cancers found. The medical literature describes

these and other outcome data that may prove useful in assisting the

interpreting physician in assessing and continuing to develop and

improve his or her interpretive skills. If one interpreting physician

is not ``doing as well'' as his/her colleagues in the same practice,

he/she may obtain additional training.

Although audits can be as detailed as necessary, the proposed

requirements in Sec. 900.12(f) for the medical outcomes audit program

are general in nature. There are several reasons for this

continuing to develop and

improve his or her interpretive skills. If one interpreting physician

is not ``doing as well'' as his/her colleagues in the same practice,

he/she may obtain additional training.

Although audits can be as detailed as necessary, the proposed

requirements in Sec. 900.12(f) for the medical outcomes audit program

are general in nature. There are several reasons for this. In drafting

the MQSA, Congress recognized that there is not consensus on the most

desirable methodologies for such audit programs and provided

authorization in 42 U.S.C. 263b(p) for research grants to study the

most desirable methods for the collection and use of outcomes data.

These research grants are administered by the National Cancer Institute

(NCI). FDA believes it would be premature to require specific

methodologies in the regulations before these studies are complete. In

addition, some facilities may not be able to collect data that are

meaningful if specific methodologies are mandated. The agency also

believes that each facility should have flexibility to design an audit

program that best serves its needs.

There was also concern expressed during discussion with NMQAAC that

facilities may be reluctant to collect medical audit data because of

concerns relating to legal liability and malpractice litigation.

In response to these concerns, FDA advises that the MQSA requires

the agency to establish standards for a quality assurance and quality

control program at each facility (42 U.S.C. 263b(f)(1)(A)). The agency

believes that data generated and reviewed for mammography audits are to

be used internally by each facility to improve individual and group

performance and should not necessarily be viewed as information that is

accessible to third parties

MQSA requires

the agency to establish standards for a quality assurance and quality

control program at each facility (42 U.S.C. 263b(f)(1)(A)). The agency

believes that data generated and reviewed for mammography audits are to

be used internally by each facility to improve individual and group

performance and should not necessarily be viewed as information that is

accessible to third parties.

The MQSA inspectors are trained to verify that a facility has a

medical audits system that tracks positive mammograms, seeks followup

results of surgical procedures, correlates those results with the

mammogram, and interprets and evaluates the resulting data at least

yearly for both the facility as a whole and for individual interpreting

physicians. Inspectors ordinarily will not copy the data as part of the

inspection and FDA has no current plans to ask facilities to provide

the agency with the results of their medical audits. Accordingly, it is

unlikely that the agency will have records in its possession that would

be responsive to requests from the public for medical audit data.

If it does become necessary for an MQSA inspector to collect

specific medical audit data, or if FDA should wish to obtain such data

in the future, the agency would protect audit results from public

disclosure in accordance with the Freedom of Information Act, the Trade

Secrets Act, and the agency's implementing public information

regulations. Aggregate data that does not identify the medical audit

outcomes of any particular facility would be available to the public.

The agency recognizes that State laws with respect to medical audit

information vary considerably. The 1993 ACHPR guidelines on ``Quality

Determinants of Mammography'' noted that very few broadly drawn

statutes protecting audit information from discovery are in place at

this time. Accordingly, the agency's commitment to protect such data

may not prevent disclosure in state courts through discovery or other

procedures established by State law

to medical audit

information vary considerably. The 1993 ACHPR guidelines on ``Quality

Determinants of Mammography'' noted that very few broadly drawn

statutes protecting audit information from discovery are in place at

this time. Accordingly, the agency's commitment to protect such data

may not prevent disclosure in state courts through discovery or other

procedures established by State law. The agency believes, however, that

the medical audit requirements that are proposed in this rule are

general requirements that will not increase third-party requests for

medical audit data.

Proposed Sec. 900.12(f) requires each facility to establish and

maintain a mammography medical outcomes audit program that correlates

the results of biopsy and cytology examinations with the interpreting

physician's recommendations. A facility must correlate the biopsy or

cytology results of its positive mammograms with the interpreting

physician's recommendations and mammographic report. A positive

mammogram includes one that has an overall assessment of findings that

are suspicious or highly suggestive of malignancy, as set forth in

proposed Sec. 900.12(c)(1)(iii). The pathologist examines the tissue

sample and its cellular structure to determine whether or not the

tissue is cancerous.

Proposed Sec. 900.12(f)(4) requires each facility to designate at

least one interpreting physician to review the audit data at least

annually. This individual shall record the dates of the audit period(s)

and be responsible for identifying issues and analyzing results based

on this audit. This physician will notify other interpreting physicians

of these issues and results, and ensure that necessary corrective

actions are taken and documented. The proposal requires evaluations to

be made individually and collectively for all interpreting physicians

at the facility

dates of the audit period(s)

and be responsible for identifying issues and analyzing results based

on this audit. This physician will notify other interpreting physicians

of these issues and results, and ensure that necessary corrective

actions are taken and documented. The proposal requires evaluations to

be made individually and collectively for all interpreting physicians

at the facility.

One comment noted that the preamble to the interim regulations

discussed preventing false negative results, but the only quality

assurance issue actually addressed in the interim regulations was the

tracking of positive readings.

FDA believes that it would be too burdensome to require facilities

to identify all false negative exams because, at the current time,

adequate methods are not available to track all negative readings. The

research studies funded by NCI grants may prove helpful

in future development of adequate methods for tracking false negative

results.

A related comment expressed the belief that it was imperative that

FDA spell out specific audit standards in the regulations. Another

comment suggested that the final regulations should include a

requirement for keeping statistics on additional procedures ordered by

each radiologist.

Again, NCI's research program may aid in determining whether the

collection and analysis of specific statistics should be mandated.

However, FDA believes that currently there is inadequate data to

justify making these suggestions regulatory requirements. NMQAAC

supported the agency's position at its January 1995 meeting.

One comment suggested that, instead of correlating surgical biopsy

results with mammography reports, a similar result can be achieved by

requiring documentation of all erroneous or indistinguishable

mammography results through a complaint program.

FDA believes the complaint mechanism and audit are substantially

different in intent; therefore, one cannot replace the other

anuary 1995 meeting.

One comment suggested that, instead of correlating surgical biopsy

results with mammography reports, a similar result can be achieved by

requiring documentation of all erroneous or indistinguishable

mammography results through a complaint program.

FDA believes the complaint mechanism and audit are substantially

different in intent; therefore, one cannot replace the other.

One comment did not understand how the radiology department could

use outcomes data, such as pathology reports, to improve the quality of

mammography or the performance of technologists.

FDA believes that an audit program helps to provide quality

assurance for the interpretation component of mammography by reviewing

outcome data for each interpreting physician and monitoring how that

physician is performing over time with respect to other interpreting

physicians in the same facility and serving the same patient

population. This review and analysis provides physicians with an

opportunity to evaluate and improve performance. As mentioned

previously, a physician may learn from an audit that he or she needs

additional training in particular skills. Technologists' performance

may be better evaluated through the repeat analysis process.

One comment mistakenly perceived a deficiency in the interim audit

regulations because the comment believed that the interim regulations

did not require followup of positive screening examinations. In fact,

the interim regulations do require the facility's medical audit to

track all positive mammograms and this requirement has been maintained

in the proposed regulations at Sec. 900.12(f)(1).

One comment suggested that all mammograms should be read a second

time by a second qualified physician to avoid unnecessary surgery and

emotional distress that can be associated with a false positive

reading, and to avoid lack of appropriate followup and treatment in the

case of a false negative reading

nd this requirement has been maintained

in the proposed regulations at Sec. 900.12(f)(1).

One comment suggested that all mammograms should be read a second

time by a second qualified physician to avoid unnecessary surgery and

emotional distress that can be associated with a false positive

reading, and to avoid lack of appropriate followup and treatment in the

case of a false negative reading.

Although the proposed regulations do not preclude this practice,

FDA has not required it due to a lack of consensus within the medical

community as to whether the benefits of double reading outweigh the

costs. FDA solicits further comments on this issue.

G. Mammography of Examinees With Breast Implants

The MQSA specifically requires that standards be established

relating to special techniques for mammography of examinees with breast

implants (42 U.S.C. 263b(f)(1)(H)). FDA interprets this requirement to

mean mammography of the breast for the early detection of breast

cancer, and not for imaging of the implant for rupture, leakage, or

other problems. The agency recommends that women who have had breast

surgery for cancer, including reconstruction with breast implants,

consult with their physician as to the appropriateness of mammography

for their particular situation.

Proposed Sec. 900.12(g) requires facilities to establish

procedure(s) to identify examinees with breast implants. The regulation

also sets forth general techniques facilities should follow for

mammographic examinations of women with breast implants. The proposed

requirements are flexible enough to allow efficient adoption of newer

imaging techniques as they become available.

One comment suggested that facilities should simply establish an

intake procedure to identify examinees with implants and to indicate

that special techniques are necessary. Another comment expressed

concern that, if an examinee does not notify the technician that she

has an implant, the mammogram may have to be redone

w efficient adoption of newer

imaging techniques as they become available.

One comment suggested that facilities should simply establish an

intake procedure to identify examinees with implants and to indicate

that special techniques are necessary. Another comment expressed

concern that, if an examinee does not notify the technician that she

has an implant, the mammogram may have to be redone.

FDA agrees with these comments and has proposed in

Sec. 900.12(g)(1) that facilities have a procedure to inquire if an

examinee has a breast implant at the time of mammogram scheduling.

Another comment suggested that there be a requirement for

``Eklund'' views (four views per breast). A similar comment stated

that, in order to obtain an adequate image of a breast with an implant,

both the breast and implant should be carefully manipulated so that the

maximum amount of breast tissue is imaged. A third comment, however,

stated that FDA should not mandate medical procedures in regulations.

FDA and NMQAAC agree that currently the Eklund procedures,

including appropriate individualized views, provide the best

mammographic means to visualize breast tissue for most women with

implants. There was also recognition, however, that other methods may

exist that would be preferable in particular cases.

In addition, breast implant imaging is evolving, and the agency

believes that it would be premature to limit this imaging by regulation

to only one technique.

However, in response to the comment that stated FDA should not

require medical procedures in regulations, the agency notes that the

MQSA does require FDA to establish standards and that the codification

of certain procedures in regulations may be appropriate when there is

consensus that such procedures are necessary to protect women and

assure accurate and safe mammography.

Another comment suggested that mammography facilities provide an

excellent opportunity for further data collection and health assessment

of examinees with implants

ire FDA to establish standards and that the codification

of certain procedures in regulations may be appropriate when there is

consensus that such procedures are necessary to protect women and

assure accurate and safe mammography.

Another comment suggested that mammography facilities provide an

excellent opportunity for further data collection and health assessment

of examinees with implants.

In response to this comment, FDA notes that proposed Sec. 900.12(f)

requires mammography facilities to perform mammography medical outcomes

audits, and that these audits would include examinees with breast

implants.

Two comments were concerned about possible harm from the

compression of the implant.

To minimize this possibility, FDA has proposed in

Sec. 900.12(a)(2)(ii)(C) (published elsewhere in this issue of the

Federal Register) that the technologist have at least 5 hours of

training in imaging examinees with breast implants and in

Sec. 900.12(g)(3) that the supervising interpreting physician be

required to have training in mammography of examinees with breast

implants, including specialized mammographic techniques.

H. Facility Complaint Mechanism

In accordance with section 354(n)(3)(E) of the Public Health

Service Act (the PHS Act) as amended by the MQSA (42 U.S.C.

263b(n)(3)(E)), FDA has worked with the NMQAAC to develop mechanisms to

investigate consumer complaints about mammography services provided by

facilities. The preamble for proposed Sec. 900.4(g), published

elsewhere in this issue of the Federal Register, provides a thorough

discussion of the complaint mechanism, including the role of the

accreditation body in the process. In addition, FDA received a number

of written comments on the complaint

ndate such requirements.

Instead, FDA believes facilities should have the flexibility to promote

their own consumer complaint mechanism to their clientele in a manner

that is most appropriate. The agency notes that the name of the

accreditation body is listed on the facility certificate, which the

facility is required by statute to post prominently within view of the

examinees.

Proposed Sec. 900.12(h) is intended to ensure that ``serious''

complaints within the purview of the MQSA are adequately addressed.

``Serious'' complaints are defined in proposed Sec. 900.2. FDA has

worked extensively with the NMQAAC in developing the proposed consumer

complaint mechanism and believes the proposed requirements meet

important consumer needs without imposing an undue burden on

facilities. Proposed Sec. 900.12(h) establishes minimum requirements

for facilities and provides them with the flexibility to institute

their own complaint mechanism procedures. FDA encourages facilities to

design their complaint mechanism procedures to be responsive to the

language, ethnic, and literacy differences among consumers served by

the facility.

I. Additional Clinical Image Review and Examinee Notification

Proposed Sec. 900.12(i) requires a facility to cooperate with FDA

in the investigation of concerns about the quality of the images

produced by that facility and in notification of examinees or the

public, should the investigation justify such notification.

Proposed Sec. 900.12(i)(1) complements the requirements in proposed

Sec. 900.4(f) of the accreditation body regulations, which are

published elsewhere in this issue of the Federal Register. Proposed

Sec. 900.4(f), among other things, would require accreditation bodies,

or other entities as specified by FDA, to perform additional clinical

image reviews when there are concerns or complaints about the quality

of images produced at a facility. Proposed Sec. 900.12(i)(1) requires

the facility to provide the clinical images for this review

ewhere in this issue of the Federal Register. Proposed

Sec. 900.4(f), among other things, would require accreditation bodies,

or other entities as specified by FDA, to perform additional clinical

image reviews when there are concerns or complaints about the quality

of images produced at a facility. Proposed Sec. 900.12(i)(1) requires

the facility to provide the clinical images for this review.

If FDA determines that any activity related to the provision of

mammography at a facility presents a serious risk to human health,

proposed Sec. 900.12(i)(2) would require a facility to notify

examinees, their designees, or the public of actions that may be

necessary to minimize the risk. Such notification may be used in cases

where diagnoses of possible malignancy may have been missed due to the

grossly inadequate performance of the facility. Examinees, their

designees, health professionals, or the public may have to be notified

so that they may take appropriate remedial action. For example,

affected examinees may wish to repeat examinations at another facility

or a member of the public may be able to contact an otherwise

unreachable examinee.

J. Revocation of a Facility's Accreditation and Revocation of FDA

Approval of a Facility's Accreditation Body

Proposed Sec. 900.13 establishes procedures for revocation of

facility accreditation and accreditation body approval. No comments

were received on these requirements as promulgated under the interim

regulations. The agency is proposing to retain these procedures with

the exception of the following changes and additions:

Proposed Sec. 900.13(a) gives FDA the discretion to revoke or

suspend the certificate of a facility whose accreditation has been

revoked by its accreditation body while the agency investigates what

actions to take with respect to the facility as a result of the

revocation.

Proposed Sec

agency is proposing to retain these procedures with

the exception of the following changes and additions:

Proposed Sec. 900.13(a) gives FDA the discretion to revoke or

suspend the certificate of a facility whose accreditation has been

revoked by its accreditation body while the agency investigates what

actions to take with respect to the facility as a result of the

revocation.

Proposed Sec. 900.13(b)(1) gives the agency greater flexibility

with respect to facilities when FDA has revoked approval of the

accreditation body that accredited the facilities. Under the proposed

regulation, the certificates of the facilities would normally remain in

effect for up to 1 year after the accreditation body approval was

revoked. The change from the interim regulations, however, would allow

the agency to shorten this period if FDA determined that a facility had

been accredited fraudulently or posed a serious threat to public health

or safety.

Proposed Sec. 900.13(b)(2) incorporates the additional language the

agency has proposed in Sec. 900.11 in order to provide alternative

means of accreditation if the accreditation body cannot or will not

perform this function at some future date.

K. Suspension and Revocation of Certificates

FDA has revised Sec. 900.14 to set forth the bases for agency

action to suspend or revoke certificates and the procedural rights

available to facilities in these circumstances.

Proposed Sec. 900.14 tracks 42 U.S.C. 263b(i), the section of the

PHS Act that establishes provisions for suspension and revocation of

certificates. Proposed Sec. 900.14(a) provides that the agency may

suspend or revoke a certificate, following notice and opportunity for a

hearing in accordance with part 16 (21 CFR part 16), if FDA finds that

the owner, operator, or any employee of the facility: (1) Has been

guilty of misrepresentation in obtaining the certificate; (2) has

failed to comply with standards under Sec

cation of

certificates. Proposed Sec. 900.14(a) provides that the agency may

suspend or revoke a certificate, following notice and opportunity for a

hearing in accordance with part 16 (21 CFR part 16), if FDA finds that

the owner, operator, or any employee of the facility: (1) Has been

guilty of misrepresentation in obtaining the certificate; (2) has

failed to comply with standards under Sec. 900.12; (3) has failed to

comply with reasonable requests for records or information; (4) has

refused to permit duly authorized inspections; (5) has violated or

aided and abetted violations of the MQSA or implementing regulations;

or (6) has failed to comply with prior sanctions imposed under 42

U.S.C. 263b(h).

Proposed Sec. 900.14(b) sets forth the bases for FDA to suspend a

certificate prior to holding a hearing. Here, too, the regulation

tracks the statutory provision. FDA may dispense with a hearing if, in

addition to making one of the findings listed above, the agency also

determines that: (1) Failure to comply with the required standards

presents a serious risk to human health; (2) the refusal to permit

inspection makes immediate suspension necessary; or (3) there is reason

to believe that the violative acts were intentional or otherwise rise

to a level that presents a threat to the public. These three

aggravating factors create circumstances in which the need to protect

the public health outweighs the harm to the affected facility, which

will have to wait a period of time for an

to permit

inspection makes immediate suspension necessary; or (3) there is reason

to believe that the violative acts were intentional or otherwise rise

to a level that presents a threat to the public. These three

aggravating factors create circumstances in which the need to protect

the public health outweighs the harm to the affected facility, which

will have to wait a period of time for an

opportunity to demonstrate that the agency's determinations are

erroneous.

As set forth in the statute and in the proposed regulation at

Sec. 900.14(b)(1), FDA may take action before a hearing if the agency

determines that a facility's failure to comply with promulgated

standards presents a serious risk to human health.

FDA may also take such action following a determination that a

facility has refused reasonable requests for inspection. The agency

believes this provision is intended to provide discretion for the

agency to suspend a certificate in circumstances where recalcitrant

actions by a facility make it impossible for the agency to inspect and

investigate violations in order to determine whether the public is at

risk if the facility continues operation. Proposed Sec. 900.14(b)(2)

sets forth this basis for suspension prior to hearing.

The agency may also take action prior to hearing upon a

determination that a facility has violated or aided and abetted in the

violation of any provision of the statute or an implementing

regulation. FDA has interpreted this statutory provision to mean that

the agency may suspend prior to hearing when the compliance record of

the facility or other evidence demonstrates that responsible persons at

that facility are not disposed to comply with established standards or

with representations that were made during the certifying process.

Proposed Sec

the statute or an implementing

regulation. FDA has interpreted this statutory provision to mean that

the agency may suspend prior to hearing when the compliance record of

the facility or other evidence demonstrates that responsible persons at

that facility are not disposed to comply with established standards or

with representations that were made during the certifying process.

Proposed Sec. 900.14(b)(3) states that the agency may suspend a

certificate prior to hearing when the agency determines that there is

reason to believe that the violation, or aiding and abetting of the

violation, was intentional or associated with fraud. Such behavior

cannot be tolerated without undermining the entire regulatory system

and is sufficiently egregious to warrant immediate action by the

agency.

As required by the MQSA and proposed in Sec. 900.14(c)(1),

facilities whose certificates are suspended prior to hearing will have

an opportunity for a hearing within 60 days of the suspension.

As a matter of general policy, FDA will not suspend certificates

without a hearing unless the agency believes that violations at the

facility or misconduct by responsible persons present a serious risk to

human health. Furthermore, suspension of a certificate, with or without

a hearing, is not a regulatory action FDA intends to initiate as a

matter of course. The MQSA favors voluntary compliance over regulatory

sanctions, and FDA is committed to working with facilities to correct

deficiencies rather than eliminating services. Suspension will be

necessary only in those cases where voluntary action or lesser

sanctions have proven ineffective.

L. Appeals of Adverse Accreditation Decisions

ulatory action FDA intends to initiate as a

matter of course. The MQSA favors voluntary compliance over regulatory

sanctions, and FDA is committed to working with facilities to correct

deficiencies rather than eliminating services. Suspension will be

necessary only in those cases where voluntary action or lesser

sanctions have proven ineffective.

L. Appeals of Adverse Accreditation Decisions

The MQSA includes a provision that requires the Secretary of DHHS

(the Secretary) to provide particular appeal procedures to a facility

that has been denied certification. Section 263b(d)(2) of the PHS Act

requires the Secretary (FDA, by delegation) to provide the facility

with a statement of the grounds upon which the denial is based, and

``an opportunity for an appeal in accordance with procedures set forth

in regulations published at 42 CFR 498 and in effect on the date of the

enactment of [the MQSA].'' (42 U.S.C. 263b(d)(2).)

Because FDA may not certify a facility that has failed to become

accredited, appeal of an FDA decision not to certify a facility will

become, in actuality, a review of the accreditation body's

determination that the facility did not meet necessary standards. For

this reason, FDA believes that the procedural rights that are

referenced in the statute should be available to the facility at the

time it receives an adverse accreditation decision from the

accreditation body to which it has applied.

FDA also believes that accreditation bodies should establish and

implement impartial procedures for review and reconsideration of

adverse accreditation decisions. As discussed elsewhere in this issue

of the Federal Register, FDA is requiring each accreditation body to

establish such reconsideration procedures and to inform any facility

that receives an adverse accreditation decision of the opportunity to

seek reconsideration by the accreditation body

and

implement impartial procedures for review and reconsideration of

adverse accreditation decisions. As discussed elsewhere in this issue

of the Federal Register, FDA is requiring each accreditation body to

establish such reconsideration procedures and to inform any facility

that receives an adverse accreditation decision of the opportunity to

seek reconsideration by the accreditation body. Because it is the

accreditation body that has the most detailed knowledge of the facts

and alleged deficiencies of the facility's mammography practice, it is

the accreditation body that is in the best position to make suggestions

or review additional information that may result in accreditation.

FDA is proposing to require mammography facilities to seek

reconsideration by the accreditation body before appealing the adverse

decision to FDA. The agency believes this practice is in the best

interest of the facility, the agency, and the public. As discussed

above, the accreditation body will be in the best position to evaluate

any additional information the facility presents for reconsideration.

In addition, in order to perform an adequate evaluation of the adverse

accreditation decision, FDA will request and review materials provided

by the accreditation body as well as the facility. The internal

reconsideration process at the accreditation body level will permit the

areas of dispute to be clarified for FDA review and conserve the

limited resources of agency personnel.

A facility that is not satisfied with the result of the

accreditation body's reconsideration may appeal that determination to

the government. The regulations set forth at 42 CFR part 498, which are

referenced in the MQSA, are Health Care Financing Administration (HCFA)

regulations that were promulgated for appeals of decisions that among

other things deny providers of medical services the opportunity to

participate in Medicare

h the result of the

accreditation body's reconsideration may appeal that determination to

the government. The regulations set forth at 42 CFR part 498, which are

referenced in the MQSA, are Health Care Financing Administration (HCFA)

regulations that were promulgated for appeals of decisions that among

other things deny providers of medical services the opportunity to

participate in Medicare. In order to implement a certification appeals

process that is in accordance with those provisions and appropriate to

the review of mammography accreditation decisions, FDA has consulted

with other agencies of the Department of Health and Human Services

(DHHS) that utilize and apply those procedures on a regular basis. As a

result of those cooperative efforts, FDA and other agencies of DHHS

have agreed that FDA's Division of Mammography Quality and Radiation

Programs (DMQRP) will handle all appeals for reconsideration of an

accreditation body's decision to deny accreditation. Hearing officers

of the DHHS' Departmental Appeals Board (DAB) will conduct formal

hearings for facilities that wish to appeal the FDA's reconsideration

decision, and the DAB itself will hear appeals of the hearing officer's

decision.

The procedures to be followed for these various appeals are

detailed in 42 CFR part 498. However, as discussed above, because those

are HCFA regulations, references to HCFA should be read as FDA for

purposes of the MQSA program. In addition, references to the Social

Security Appeals Council in 42 CFR part 498 should be read as the DAB;

although 42 CFR part 498 has not been amended to reflect the delegation

of authority, administrative law judges of the DAB have been handling

adversarial HCFA hearings since 1992 and the DAB itself has been

handling appeals of those hearing decisions.

Although 42 CFR part 498 is referenced in the MQSA and in FDA's

implementing regulations, FDA is also proposing that its MQSA

regulations broadly summarize the way these HCFA regulations will be

applied by FDA

ion

of authority, administrative law judges of the DAB have been handling

adversarial HCFA hearings since 1992 and the DAB itself has been

handling appeals of those hearing decisions.

Although 42 CFR part 498 is referenced in the MQSA and in FDA's

implementing regulations, FDA is also proposing that its MQSA

regulations broadly summarize the way these HCFA regulations will be

applied by FDA. The agency believes that summary of the various appeal

levels will make the procedures more accessible to facilities that wish

to challenge adverse

decisions. Applicable details about the various appeal procedures that

are not codified in FDA's proposed regulations can be found at 42 CFR

part 498.

A facility that is appealing an adverse accreditation decision,

regardless of the level of appeal, may not perform mammography services

until the decision has been reversed and the facility has been

certified by FDA.

M. Alternative Requirements

In the interim rule published in the Federal Register of September

30, 1994 (59 FR 49808), FDA established procedures for approval of

alternatives to the quality standards of Sec. 900.12. Such alternatives

can be approved if, among other things, the alternatives provide at

least as great an assurance of quality mammography as the original

standards. These procedures were developed to permit flexibility in

appropriate individual circumstances and to encourage further

improvement in the practice of mammography. The alternative requirement

procedures will allow the agency to permit the practice of mammography

to benefit rapidly from improvements and advancements without the need

first to amend regulations, which is often a lengthy process. Approved

alternative requirements will be made available for review in the

public docket file in FDA's Dockets Management Branch (address above).

In addition, notices of approved alternative requirements with wide

applicability will be published in the Federal Register

fit rapidly from improvements and advancements without the need

first to amend regulations, which is often a lengthy process. Approved

alternative requirements will be made available for review in the

public docket file in FDA's Dockets Management Branch (address above).

In addition, notices of approved alternative requirements with wide

applicability will be published in the Federal Register.

The comment period on the interim regulations ended on December 29,

1994. No comments were received on the alternative requirements or, for

that matter, on any of the amendments. The agency has interpreted this

lack of response to indicate that members of the public did not object

to the content of the amendments.

NMQAAC discussed the alternative requirement regulation

(Sec. 900.18) at its February 1994 meeting. The regulation was

discussed again at NMQAAC's January 1995 meeting. The only suggestion

for change at the latter meeting came from a Federal liaison to NMQAAC

who recommended that Federal agencies be given the same opportunity as

State Governments to apply for approval of alternative requirements.

NMQAAC endorsed this suggestion and FDA has revised Sec. 900.18(b)(2)

accordingly.

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

this suggestion and FDA has revised Sec. 900.18(b)(2)

accordingly.

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 accreditation bodies, personnel requirements, and

quality standards for mammography equipment and quality assurance,

published elsewhere in this issue of the 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

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 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 collections. 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

New Executive Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC

20503, Attn: Desk Officer for FDA. Written comments on the information

collection should be submitted by May 3, 1996.

VI. Request for Comments

Interested persons may, on or before July 2, 1996, submit to the

Dockets Management Branch (address above) written comments regarding

this proposal. 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. Reference

ockets Management Branch (address above) written comments regarding

this proposal. 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. Reference

The following reference 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,'' S.

Rept. 102-448, October 1, 1992.

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. Section 900.10 is revised to read as follows:

Sec. 900.10 Applicability.

The provisions of subpart B are applicable to all facilities under

the regulatory jurisdiction of the United States that provide screening

or diagnostic mammography services, with the exception of the

facilities of the Department of Veterans Affairs.

3. Section 900.11 is revised to read as follows:

Sec. 900.11 Requirements for certification.

d to read as follows:

Sec. 900.10 Applicability.

The provisions of subpart B are applicable to all facilities under

the regulatory jurisdiction of the United States that provide screening

or diagnostic mammography services, with the exception of the

facilities of the Department of Veterans Affairs.

3. Section 900.11 is revised to read as follows:

Sec. 900.11 Requirements for certification.

(a) General. After October 1, 1994, a certificate issued by FDA is

required for

lawful operation of all mammography facilities subject to the

provisions of subpart B of this part. To obtain a certificate from FDA,

facilities are required to meet the quality standards in Sec. 900.12

and to be accredited by an approved accreditation body or other entity

as designated by FDA.

(b) Application--(1) Certificates. (i) In order to qualify for a

certificate, a facility must apply to an FDA-approved accreditation

body, or to another entity as designated by FDA. The facility shall

submit to such body or entity the information required in 42 U.S.C.

263b(d)(1).

(ii) Following the agency's receipt of the accreditation body's

decision to accredit a facility, or an equivalent decision by another

entity as designated by FDA, the agency will issue a certificate to the

facility, or renew an existing certificate, if the agency determines

that the facility has satisfied the requirements for certification or

recertification.

quired in 42 U.S.C.

263b(d)(1).

(ii) Following the agency's receipt of the accreditation body's

decision to accredit a facility, or an equivalent decision by another

entity as designated by FDA, the agency will issue a certificate to the

facility, or renew an existing certificate, if the agency determines

that the facility has satisfied the requirements for certification or

recertification.

(2) Provisional certificates. (i) New facilities beginning

operation after October 1, 1994, are eligible to apply for provisional

certificates. The provisional certificate will enable the facility to

perform mammography and to obtain the clinical images needed to

complete the accreditation process. To apply for and receive a

provisional certificate, a facility must meet the requirements of 42

U.S.C. 263b(c)(2) and submit the necessary information to an approved

accreditation body or other entity designated by FDA.

(ii) FDA will issue a provisional certificate to a facility upon

determination that the facility has satisfied the requirements of

paragraph (b)(2)(i) of this section. A provisional certificate shall be

effective for up to 6 months from the date of issuance. A provisional

certificate cannot be renewed, but a facility may apply for a 90-day

extension of the provisional certificate.

(3) Extension of provisional certificate. (i) To apply for a 90-day

extension to a provisional certificate, a facility shall submit to its

accreditation body, or other entity as designated by FDA, a statement

of what the facility is doing to obtain certification and evidence that

there would be a significant adverse impact on access to mammography in

the geographic area served if such facility did not obtain an

extension.

(ii) FDA will issue a 90-day extension for a provisional

certificate upon determination that the extension meets the criteria

set forth in 42 U.S.C. 263b(c)(2).

(iii) There can be no renewal of a provisional certificate beyond

the 90-day extension.

there would be a significant adverse impact on access to mammography in

the geographic area served if such facility did not obtain an

extension.

(ii) FDA will issue a 90-day extension for a provisional

certificate upon determination that the extension meets the criteria

set forth in 42 U.S.C. 263b(c)(2).

(iii) There can be no renewal of a provisional certificate beyond

the 90-day extension.

(c) Reinstatement policy. A previously certified facility that has

allowed its certificate to expire, that has been refused a renewal of

its certificate by FDA, or that has had its certificate revoked by FDA,

may apply to have the certificate reinstated.

(1) Unless prohibited from reinstatement under paragraph (c)(4) of

this section, a facility applying for reinstatement shall:

(i) Contact an FDA-approved accreditation body or other entity as

designated by FDA to determine the requirements for reapplication for

accreditation;

(ii) Fully document its history as a previously provisionally or

fully certified mammography facility, including the following

information:

(A) Name and address of the facility under which it was previously

provisionally or fully certified;

(B) Name of previous owner/lessor;

(C) FDA facility identification number assigned the facility under

its previous certification; and

(D) Expiration date of the most recent FDA provisional or full

certificate; and

(iii) Justify application for reinstatement of accreditation by

submitting to the accreditation body or other entity as designated by

FDA, a corrective action plan that details how the facility has

corrected deficiencies that contributed to the lapse of, denial of

renewal, or revocation of its certificate.

(2) FDA will issue a provisional certificate to the facility if:

ull

certificate; and

(iii) Justify application for reinstatement of accreditation by

submitting to the accreditation body or other entity as designated by

FDA, a corrective action plan that details how the facility has

corrected deficiencies that contributed to the lapse of, denial of

renewal, or revocation of its certificate.

(2) FDA will issue a provisional certificate to the facility if:

(i) The accreditation body or other entity as designated by FDA

notifies the agency that the facility has adequately corrected, or is

in the process of correcting, pertinent deficiencies; and

(ii) FDA determines that the facility has taken sufficient

corrective action since the lapse of, denial of renewal, or revocation

of its previous certificate.

(3) After receiving the provisional certificate, the facility may

lawfully resume performing mammography services while completing the

requirements for full certification.

(4) If a facility's certificate was revoked, that facility is not

eligible for reinstatement until at least 2 years from the date the

certificate was revoked if the facility is owned or operated by any

person who owned or operated the facility at the time of revocation.

4. Section 900.12 is amended by revising paragraphs (c) and (d) and

by adding new paragraphs (f), (g), (h), and (i) to read as follows:

Sec. 900.12 Quality standards.

* * * * *

(c) Medical records and mammography reports. (1) Contents and

terminology. Each facility shall prepare a written report signed by the

interpreting physician for each mammography examination performed under

its certificate. The mammography report shall include the following

information:

adding new paragraphs (f), (g), (h), and (i) to read as follows:

Sec. 900.12 Quality standards.

* * * * *

(c) Medical records and mammography reports. (1) Contents and

terminology. Each facility shall prepare a written report signed by the

interpreting physician for each mammography examination performed under

its certificate. The mammography report shall include the following

information:

(i) The name of the examinee;

(ii) Date of examination;

(iii) Overall final assessment of findings, classified in one of

the following categories:

(A) ``Negative:'' Nothing to comment upon. (If the interpreting

physician is aware of clinical findings or symptoms, despite the

negative assessment, these shall be explained);

(B) ``Benign:'' Also a negative assessment, but benign finding(s)

can be described at the discretion of the interpreter;

(c) ``Probably benign:'' Finding(s) has a high probability of being

benign;

(D) ``Suspicious:'' Finding(s) without all the characteristic

morphology of breast cancer but indicating a definite probability of

being malignant;

(E) ``Highly suggestive of malignancy:'' Finding(s) has a high

probability of being malignant;

(iv) In cases where no final assessment category can be assigned

due to incomplete work-up, ``Needs additional imaging evaluation''

shall be assigned as an assessment and reasons why no assessment can be

made shall be stated by the interpreting physician; and

finite probability of

being malignant;

(E) ``Highly suggestive of malignancy:'' Finding(s) has a high

probability of being malignant;

(iv) In cases where no final assessment category can be assigned

due to incomplete work-up, ``Needs additional imaging evaluation''

shall be assigned as an assessment and reasons why no assessment can be

made shall be stated by the interpreting physician; and

(v) Recommendations made to the health care provider about what

additional actions, if any, should be taken. All clinical questions

raised by the referring health care provider shall be addressed in the

report to the extent possible.

(2) Communication of mammography results to the examinee. Each

facility shall maintain a system for providing written notification of

results of each mammographic examination to the examinee. The written

notification issued by the facility or by its designee shall be

communicated to the examinee as soon as possible, but no later than 30

days from the date of the mammography examination. If assessments are

``Suspicious'' or ``Highly suggestive of malignancy'' and if the

examinee has not named a referring health care provider, the facility

shall make reasonable attempts to communicate results to the examinee

immediately.

(i) The written notification of results provided to the examinee

shall include:

(A) The date of the examination;

(B) The results of the examination in lay terms; and

(C) A recommendation to the examinee on followup actions.

(ii) Examinees who do not name a health care provider to receive

the mammography report shall be sent the report described in paragraph

to the examinee

immediately.

(i) The written notification of results provided to the examinee

shall include:

(A) The date of the examination;

(B) The results of the examination in lay terms; and

(C) A recommendation to the examinee on followup actions.

(ii) Examinees who do not name a health care provider to receive

the mammography report shall be sent the report described in paragraph

(c)(1) of this section, in addition to the written notification

described in paragraph (c)(2)(i) of this section.

(iii) Each facility that accepts examinees who do not have a

primary care provider shall maintain a system for referring such

examinees to a health care provider when clinically indicated.

(3) Communication of mammography results to health care providers.

When the examinee has a referring health care provider or the examinee

has named a health care provider, the facility shall:

(i) Provide a written report of the mammography examination,

including the items listed in paragraph (c)(1) of this section, to that

health care provider as soon as possible, but no later than 30 days

from the date of the mammography examination; and

(ii) If the assessment is ``Suspicious'' or ``Highly suggestive of

malignancy,'' make reasonable attempts to communicate with the health

care provider immediately, or if the health care provider is

unavailable, to a responsible designee of the health care provider.

(4) Recordkeeping. Each facility shall maintain mammography films

and reports in a permanent medical record of the examinee as follows:

f the assessment is ``Suspicious'' or ``Highly suggestive of

malignancy,'' make reasonable attempts to communicate with the health

care provider immediately, or if the health care provider is

unavailable, to a responsible designee of the health care provider.

(4) Recordkeeping. Each facility shall maintain mammography films

and reports in a permanent medical record of the examinee as follows:

(i) For a period of not less than 5 years, or of not less than 10

years if no additional mammograms of the examinee are performed at the

facility, or a longer period if mandated by State or local law; or

(ii) Until requested by an examinee to transfer the original

mammograms and copies of the examinee's reports to a medical

institution, or to a physician or health care provider designated by

the examinee, or to the examinee directly, and the records are so

transferred.

(iii) Any fee charged to examinees for providing the services in

paragraphs (c)(4)(ii) of this section shall not exceed the actual

documented costs associated with this service.

(d) Quality assurance--general. Each facility shall establish and

maintain a quality assurance program to ensure the safety, reliability,

clarity, and accuracy of mammography services performed at the

facility.

(1) Responsible individuals. Responsibility for the quality

assurance program and for each of its elements shall be assigned to

individuals who are qualified for their assignments and who shall be

given adequate time to perform these duties.

sh and

maintain a quality assurance program to ensure the safety, reliability,

clarity, and accuracy of mammography services performed at the

facility.

(1) Responsible individuals. Responsibility for the quality

assurance program and for each of its elements shall be assigned to

individuals who are qualified for their assignments and who shall be

given adequate time to perform these duties.

(i) Lead interpreting physician. The facility shall identify a lead

interpreting physician who shall have the general responsibility of

ensuring that the quality assurance program meets all requirements of

paragraphs (d) through (f) of this section. No other individual shall

be assigned or shall retain responsibility for quality assurance tasks

unless the lead interpreting physician has determined that the

individual's qualifications for, and performance of, the assignment are

adequate.

(ii) Interpreting physicians. All interpreting physicians

interpreting mammograms for the facility shall provide feedback on the

quality of the mammograms they interpret to the radiologic

technologists producing those mammograms and shall participate in the

facility's medical outcomes audit program.

(iii) Medical physicist. Each facility shall have available the

services of an individual or individuals, who meet the qualifications

of paragraph (a)(3) of this section, to survey mammography equipment

and oversee the equipment-related quality assurance practices of the

facility.

(iv) Quality control technologist. Responsibility for all

individual tasks within the quality assurance program not assigned to

the lead interpreting physician or the medical physicist shall be

assigned to quality control technologists.

(2) Quality assurance records. The facility shall maintain the

following documents related to its quality assurance program:

ance practices of the

facility.

(iv) Quality control technologist. Responsibility for all

individual tasks within the quality assurance program not assigned to

the lead interpreting physician or the medical physicist shall be

assigned to quality control technologists.

(2) Quality assurance records. The facility shall maintain the

following documents related to its quality assurance program:

(i) A quality assurance manual describing the procedures that are

to be followed in meeting the requirements of paragraphs (e) and (f) of

this section, including ``action levels'' for corrective actions, as

defined in Sec. 900.2. The manual shall be readily available to all

staff members. It shall contain a sign-off page documenting that it has

been read and approved by the lead interpreting physician and the

medical physicist.

(ii) A current list of the individuals to whom quality assurance

responsibilities have been assigned and the duties assigned to them.

This list shall be readily available to all staff members.

(iii) Records to show that all staff members assigned

responsibilities in the quality assurance program are qualified to

conduct their assigned duties.

(iv) Records to show the data obtained during monitoring of the

facility's performance, the analysis of the monitoring data, the

problems detected and corrective actions carried out, and the

effectiveness of the corrective actions in resolving the problems.

These records shall be kept for each test specified in paragraphs (e)

and (f) of this section for a minimum of 1 year or until the test has

been performed two additional times at the required frequency,

whichever is longer.

* * * * *

sis of the monitoring data, the

problems detected and corrective actions carried out, and the

effectiveness of the corrective actions in resolving the problems.

These records shall be kept for each test specified in paragraphs (e)

and (f) of this section for a minimum of 1 year or until the test has

been performed two additional times at the required frequency,

whichever is longer.

* * * * *

(f) Quality assurance--mammography medical outcomes audit. Each

facility shall establish and maintain a mammography medical outcomes

audit program for followup based on mammographic assessments and to

correlate biopsy or cytology results with interpreting physicians'

recommendations. This program shall be designed to ensure the

reliability, clarity, and accuracy of the interpretation of mammograms.

(1) General requirements. Each facility shall establish a system

for reviewing outcome data from all mammography performed, in order to

followup on the disposition of positive mammograms and to correlate

biopsy or cytology results with interpreting physician's mammography

report.

(2) Data collection. Data shall be collected on an ongoing basis

for all examinees with positive mammograms.

(3) Frequency of audit analysis. An initial audit analysis shall be

conducted no later than 12 months after the date the facility became

fully certified. Subsequent audit analyses shall be conducted at least

once every 12 months from the date of the initial analysis.

mography

report.

(2) Data collection. Data shall be collected on an ongoing basis

for all examinees with positive mammograms.

(3) Frequency of audit analysis. An initial audit analysis shall be

conducted no later than 12 months after the date the facility became

fully certified. Subsequent audit analyses shall be conducted at least

once every 12 months from the date of the initial analysis.

(4) Reviewing interpreting physician. The facility shall designate

at least one interpreting physician to review the audit data at least

once every 12 months. This individual shall record the dates of the

audit period(s) and shall be responsible for identifying issues and

analyzing results based on this audit, notifying the other interpreting

physicians of these issues and results, and ensuring that necessary

corrective actions are taken and documented. Evaluations shall be made

individually and collectively for all interpreting physicians at the

facility.

(g) Mammographic procedure and techniques for mammography of

examinees with breast implants. (1) Each facility shall have a

procedure to inquire whether an examinee has a breast implant at the

time of mammogram scheduling.

(2) Except where contraindicated, or unless modified by a

physician's directions, examinees with breast implants undergoing

mammography shall have mammographic views to maximize the visualization

of breast tissue and optimize breast cancer detection.

(3) These mammographic examinations shall be supervised by an

onsite interpreting physician who is trained in mammography of

examinees with breast implants, including training in specialized

mammographic techniques of these examinees and training in interpreting

the mammograms of these examinees.

phic views to maximize the visualization

of breast tissue and optimize breast cancer detection.

(3) These mammographic examinations shall be supervised by an

onsite interpreting physician who is trained in mammography of

examinees with breast implants, including training in specialized

mammographic techniques of these examinees and training in interpreting

the mammograms of these examinees.

(h) Consumer complaint mechanism. Each facility shall:

(1) Establish a written and documented system for collecting and

resolving consumer complaints;

(2) Maintain a record of each serious complaint received by the

facility for at least 3 years from the date the complaint was received;

(3) Provide the consumer with adequate directions for filing the

complaint with the facility's accreditation body, if the facility is

unable to resolve a serious complaint to the consumer's satisfaction;

(4) Report unresolved serious complaints to the accreditation body

in a manner and timeframe specified by the accreditation body.

(i) Additional clinical image review and examinee notification.

(1) If FDA believes that image quality at a facility has been

severely compromised and presents a serious risk to human health, the

facility shall provide clinical images, as specified by FDA, for review

by the accreditation body or other entity designated by FDA. This

additional clinical image review will help the agency to determine

whether there is a need to notify affected examinees and the public.

(2) If FDA determines that any activity related to the provision of

mammography at a facility presents a serious risk to human health such

that examinee notification is necessary, the facility shall notify

examinees, their designees, or the public of action that may be taken

to minimize the effects of the risk. Such notification shall occur

within a timeframe specified by FDA.

5. Section 900.13 is revised to read as follows:

Sec. 900.13 Revocation of accreditation, and revocation of

accreditation body approval.

man health such

that examinee notification is necessary, the facility shall notify

examinees, their designees, or the public of action that may be taken

to minimize the effects of the risk. Such notification shall occur

within a timeframe specified by FDA.

5. Section 900.13 is revised to read as follows:

Sec. 900.13 Revocation of accreditation, and revocation of

accreditation body approval.

(a) FDA action following revocation of accreditation. If a

facility's accreditation is revoked by an accreditation body, the

agency may conduct an investigation into the reasons for the

revocation. If FDA determines that the revocation was justified, FDA

may take action, revoke or suspend the facility's certificate, or

require the submission and implementation of a corrective action plan,

whichever action or combination of actions will best protect the public

health.

(b) Revocation of FDA approval of an accreditation body.

(1) If FDA revokes approval of an accreditation body under

Sec. 900.6, the certificates of facilities previously accredited by

such body shall remain in effect for up to 1 year from the date of

revocation, unless FDA determines, in order to protect human health or

because the accreditation body fraudulently accredited facilities, that

the certificates of some or all of the facilities should be revoked or

suspended or that a shorter time period should be established for the

certificates to remain in effect.

(2) After 1 year from the date of revocation of approval of an

accreditation body, or within any shorter period of time established by

the agency, the affected facilities must obtain accreditation from

another accreditation body, or from another entity designated by FDA.

6. Section 900.14 is revised to read as follows:

Sec. 900.14 Suspension or revocation of certificates.

to remain in effect.

(2) After 1 year from the date of revocation of approval of an

accreditation body, or within any shorter period of time established by

the agency, the affected facilities must obtain accreditation from

another accreditation body, or from another entity designated by FDA.

6. Section 900.14 is revised to read as follows:

Sec. 900.14 Suspension or revocation of certificates.

(a) FDA may suspend or revoke a certificate if FDA finds, after

providing the owner or operator of the facility with notice and

opportunity for an informal hearing in accordance with part 16 of this

chapter, that the owner, operator, or any employee of the facility:

(1) Has been guilty of misrepresentation in obtaining the

certificate;

(2) Has failed to comply with the standards of Sec. 900.12;

(3) Has failed to comply with reasonable requests of the agency for

records, information, reports, or materials that FDA believes are

necessary to determine the continued eligibility of the facility for a

certificate or continued compliance with the standards of Sec. 900.12;

(4) Has refused a reasonable request of a duly designated FDA

inspector, State inspector, or accreditation body representative for

permission to inspect the facility or the operations and pertinent

records of the facility;

(5) Has violated or aided and abetted in the violation of any

provision of or regulation promulgated pursuant to 42 U.S.C. 263b; or

(6) Has failed to comply with prior sanctions imposed by the agency

under 42 U.S.C. 263b(h).

(b) FDA may suspend the certificate of a facility before holding a

hearing if FDA makes a finding described in paragraph (a) of this

section and also determines that:

(1) The failure to comply with required standards presents a

serious risk to human health;

(2) The refusal to permit inspection makes immediate suspension

necessary; or

(3) There is reason to believe that the violation or aiding and

abetting of the violation was intentional or associated with fraud.

if FDA makes a finding described in paragraph (a) of this

section and also determines that:

(1) The failure to comply with required standards presents a

serious risk to human health;

(2) The refusal to permit inspection makes immediate suspension

necessary; or

(3) There is reason to believe that the violation or aiding and

abetting of the violation was intentional or associated with fraud.

(c) If FDA suspends a certificate in accordance with paragraph (b)

of this section:

(1) The agency shall provide the facility with an opportunity for

an informal hearing under part 16 of this chapter not later than 60

days from the effective date of the suspension;

(2) The suspension shall remain in effect until the agency

determines that:

(i) Allegations of violations or misconduct were not substantiated;

(ii) Violations of required standards have been corrected to the

agency's satisfaction; or

(iii) The facility's certificate is revoked in accordance with

Sec. 900.14(d).

(d) After providing a hearing in accordance with paragraph (c)(1)

of this section, the agency may revoke the facility's certificate if

the agency determines that the facility:

(1) Is unwilling or unable to correct violations that were the

basis for suspension; or

(2) Has engaged in fraudulent activity to obtain or continue

certification.

7. New Sec. 900.15 is added to subpart B to read as follows:

Sec. 900.15 Appeals of adverse accreditation and certification

decisions.

(a) The appeals procedures described in this section are available

only for adverse accreditation decisions that preclude certification or

recertification by FDA. Agency decisions to suspend or revoke

certificates that are already in effect will be handled in accordance

with Sec. 900.14.

(b) Upon learning that a facility has failed to become accredited,

FDA will notify the facility that the agency is unable to certify that

facility without proof of accreditation.

or adverse accreditation decisions that preclude certification or

recertification by FDA. Agency decisions to suspend or revoke

certificates that are already in effect will be handled in accordance

with Sec. 900.14.

(b) Upon learning that a facility has failed to become accredited,

FDA will notify the facility that the agency is unable to certify that

facility without proof of accreditation.

(c) A facility that has been denied accreditation is entitled to an

appeals process from the accreditation body, in accordance with

Sec. 900.7. A facility must avail itself of the accreditation body's

appeal process before requesting reconsideration from FDA.

(d) A facility that cannot achieve satisfactory resolution of an

adverse accreditation decision through the accreditation body's appeal

process is entitled to further appeal in accordance with procedures set

forth in this section and in regulations published at 42 CFR part 498.

(1) References to the Health Care Financing Administration (HCFA)

in 42

CFR part 498 should be read as the Division of Mammography Quality and

Radiation Programs, Center for Devices and Radiological Health, Food

and Drug Administration.

(2) References to the Appeals Council of the Social Security

Administration in 42 CFR part 498 should be read as references to the

Departmental Appeals Board.

(3) In accordance with the procedures set forth in subpart B of 42

CFR part 498, a facility that has been denied accreditation following

appeal to the accreditation body may request reconsideration of that

adverse decision from DMQRP.

(2) References to the Appeals Council of the Social Security

Administration in 42 CFR part 498 should be read as references to the

Departmental Appeals Board.

(3) In accordance with the procedures set forth in subpart B of 42

CFR part 498, a facility that has been denied accreditation following

appeal to the accreditation body may request reconsideration of that

adverse decision from DMQRP.

(i) A facility must make its request for reconsideration to DMQRP,

within 60 days of the accreditation body's adverse appeals decision, at

the following address: Division of Mammography Quality and Radiation

Programs (HFZ-240), Center for Devices and Radiological Health, Food

and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, Attn:

Facility Accreditation Review Committee.

(ii) The request for reconsideration shall include 3 copies of the

following records:

(A) The accreditation body's original denial of accreditation;

(B) All information the facility submitted to the accreditation

body as part of the appeals process;

(C) A copy of the accreditation body's adverse appeals decision;

and

(D) A statement of the bases for the facility's disagreement with

the accreditation body's decision.

(iii) DMQRP will conduct its reconsideration in accordance with the

procedures set forth in subpart B of 42 CFR part 498.

(4) A facility that is dissatisfied with DMQRP's decision following

reconsideration is entitled to a formal hearing in accordance with

procedures set forth in subpart D of 42 CFR part 498.

(5) Either the facility or FDA may request review of the hearing

officer's decision. Such review will be conducted by the Departmental

Appeals Board in accordance with subpart E of 42 CFR part 498.

(6) A facility cannot perform mammography services while an adverse

accreditation decision is being appealed.

8. Section 900.18 is revised to read as follows:

Sec. 900.18 Alternative requirements for 42 U.S.C. 263b quality

standards.

uest review of the hearing

officer's decision. Such review will be conducted by the Departmental

Appeals Board in accordance with subpart E of 42 CFR part 498.

(6) A facility cannot perform mammography services while an adverse

accreditation decision is being appealed.

8. Section 900.18 is revised to read as follows:

Sec. 900.18 Alternative requirements for 42 U.S.C. 263b quality

standards.

(a) Criteria for approval of alternative standards. Upon

application by a qualified party as defined under paragraph (b) of this

section, the Director, Division of Mammography Quality and Radiation

Programs (the Director), may approve an alternative to a quality

standard under Sec. 900.12, when the Director determines that:

(1) The proposed alternative standard will be at least as effective

in assuring quality mammography as the standard it proposes to replace,

and

(2) The proposed alternative:

(i) Is too limited in its applicability to justify an amendment to

the standard; or

(ii) Offers an expected benefit to human health that is so great

that the time required for amending the standard would present an

unjustifiable risk to the human health; and

(3) The granting of the alternative is in keeping with the purposes

of 42 U.S.C. 263b.

(b) Applicants for alternatives. (1) Mammography facilities and

accreditation bodies may apply for alternatives to the quality

standards of Sec. 900.12.

(2) Federal agencies and State governments that are not

accreditation bodies may apply for alternatives to the standards of

Sec. 900.12(a).

(3) Manufacturers and assemblers of equipment used for mammography

may apply for alternatives to the standards of Sec. 900.12 (b) and (e).

ammography facilities and

accreditation bodies may apply for alternatives to the quality

standards of Sec. 900.12.

(2) Federal agencies and State governments that are not

accreditation bodies may apply for alternatives to the standards of

Sec. 900.12(a).

(3) Manufacturers and assemblers of equipment used for mammography

may apply for alternatives to the standards of Sec. 900.12 (b) and (e).

(c) Applications for approval of an alternative standard. An

application for approval of an alternative standard or for an amendment

or extension of the alternative standard shall be submitted in an

original and two copies to the Director, Division of Mammography

Quality and Radiation Programs, Center for Devices and Radiological

Health (HFZ-240), Food and Drug Administration, 1350 Piccard Dr.,

Rockville, MD 20850. The application for approval of an alternative

standard shall include the following information:

(1) Identification of the original standard for which the

alternative standard is being proposed and an explanation of why the

applicant is proposing the alternative;

(2) A description of the manner in which the alternative is

proposed to deviate from the original standard;

(3) A description, supported by data, of the advantages to be

derived from such deviation.

(4) An explanation, supported by data, of how such a deviation

would assure equal or greater quality of production, processing, or

interpretation of mammograms than the original standard;

(5) The suggested period of time that the proposed alternative

standard would be in effect; and

(6) Such other information required by the Director to evaluate and

act on the application.

m such deviation.

(4) An explanation, supported by data, of how such a deviation

would assure equal or greater quality of production, processing, or

interpretation of mammograms than the original standard;

(5) The suggested period of time that the proposed alternative

standard would be in effect; and

(6) Such other information required by the Director to evaluate and

act on the application.

(d) Ruling on applications. (1) The Director may approve or deny,

in whole or in part, a request for approval of an alternative standard

or any amendment or extension thereof, and shall inform the applicant

in writing of this action. The written notice will state the manner in

which the requested alternative standard differs from the agency

standard and a summary of the reasons for approval or denial of the

request. If the request is approved, the written notice will also

include the effective date and the termination date of the approval and

a summary of the limitations and conditions attached to the approval

and any other information that may be relevant to the approved request.

Each approved alternative standard will be assigned an identifying

number.

(2) Notice of an approved request for an alternative standard or

any amendment or extension thereof will be placed in the public docket

file in the Dockets Management Branch and may also be in the form of a

notice published in the Federal Register. The notice will state the

name of the applicant, a description of the published agency standard,

and a description of the approved alternative standard, including

limitations and conditions attached to the approval of the alternative

standard.

(3) Summaries of the approval of alternative standards, including

information on their nature and number, will be provided to the

National Mammography Quality Assurance Advisory Committee.

applicant, a description of the published agency standard,

and a description of the approved alternative standard, including

limitations and conditions attached to the approval of the alternative

standard.

(3) Summaries of the approval of alternative standards, including

information on their nature and number, will be provided to the

National Mammography Quality Assurance Advisory Committee.

(4) All applications for approval of alternative standards and for

amendments and extensions thereof and all correspondence (including

written notices of approval) on these applications will be available

for public disclosure in the Dockets Management Branch, excluding

examinee identifiers and confidential commercial information.

(e) Amendment or extension of an alternative standard. An

application for amending or extending approval of an alternative

standard shall include the following information:

(1) The approval number and the expiration date of the alternative

standard;

(2) The amendment or extension requested and the basis for the

amendment or extension; and

(3) An explanation, supported by data, of how such an amendment or

extension would assure equal or greater quality of production,

processing, or

interpretation of mammograms than the original standard.

(f) Applicability of the alternative standards. Any approval of an

alternative standard, amendment, or extension may be implemented only

by the entity to which it was granted and under the terms under which

it was granted, except that when an alternative standard is approved

for a manufacturer of equipment, any facility using that equipment will

also be covered by the alternative standard. Other entities interested

in similar or identical approvals must file their own application

following the procedures of paragraph (c) of this section.

ty to which it was granted and under the terms under which

it was granted, except that when an alternative standard is approved

for a manufacturer of equipment, any facility using that equipment will

also be covered by the alternative standard. Other entities interested

in similar or identical approvals must file their own application

following the procedures of paragraph (c) of this section.

(g) Withdrawal of approval of alternative requirements. The

Director shall amend or withdraw approval of an alternative standard

whenever the Director determines that this action is necessary to

protect the human health or otherwise is justified by Sec. 900.12. Such

action will become effective on the date specified in the written

notice of the action sent to the applicant, except that it will become

effective immediately upon notification of the applicant when the

Director determines that such action is necessary to prevent an

imminent health hazard.

Dated: March 22, 1996.

David A. Kessler,

Commissioner of Food and Drugs.

Donna E. Shalala,

Secretary of Health and Human Services.

[FR Doc. 96-7830 Filed 3-29-96; 8:45 am]

BILLING CODE 4160-01-P