Quality Mammography Standards

SUMMARY: The Food and Drug Administration (FDA) is amending its

regulations governing mammography. Amendments are being made to the

requirements for accreditation bodies; procedures for facility

certification; and quality standards for mammography personnel,

equipment and practices, including quality assurance. This action is

being taken to provide increased assurance of adequate and consistent

evaluation of mammography facilities on a nationwide level and

compliance of the facilities with quality standards. It also carries

out the intent of Congress that FDA replace the existing interim rules

with more comprehensive final regulations.

DATES: This regulation is effective April 28, 1999; except

Secs. 900.12(b)(8), 900.12(e)(4)(iii), 900.12(e)(5)(i),

900.12(e)(5)(iii), and 900.12(e)(5)(x), which become effective October

28, 2002.

FOR FURTHER INFORMATION CONTACT: Roger Burkhart, Center for Devices and

Radiological Health (HFZ-240), Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20850, 301-594-3332, FAX 301-594-3306.

SUPPLEMENTARY INFORMATION:

I. Background

The Mammography Quality Standards Act (the MQSA) (Pub. L. 102-539)

was passed on October 27, 1992, to establish national quality standards

for mammography. The MQSA required that, to provide mammography

services legally after October 1, 1994, all facilities, except

facilities of the Department of Veterans Affairs, shall be accredited

by an approved accreditation body and certified by the Secretary of

Health and Human Services (the Secretary). The authority to approve

accreditation bodies and to certify facilities was delegated by the

Secretary to FDA.

The MQSA was enacted in response to the growing incidence of breast

cancer and its associated mortality rate. Breast cancer is now the most

common nonskin cancer and is the second leading cause of cancer deaths

among women, after lung cancer. Early detection of breast cancer,

typically involving breast physical examination and mammography, is the

best means of preventing deaths that can result if the diagnosis is

delayed until the onset of more advanced symptoms. Mammograms can

reveal breast cancer up to 2 years before a woman or her doctor can

feel a lump. In addition, over 90 percent of these early stage cancers

can be cured (Ref. 1).

However, according to the General Accounting Office (GAO), a

mammogram is among the most difficult radiographic images to read. It

must be of high quality for the image to be interpreted correctly. If

the image quality is poor, the interpreter may miss an incipient

cancerous lesion. This false negative diagnosis could delay early

treatment and result in an avoidable death or increased morbidity. It

is equally true that poor quality images or faulty interpretations can

lead to a false positive diagnosis when normal tissue is misread as

abnormal. This can lead to needless anxiety for the patient, costly

additional testing, and painful biopsies.

The Senate Committee on Labor and Human Resources held hearings on

breast cancer in 1992 and found a wide range of problems with

mammography practice in the United States including: (1) Poor quality

equipment, (2) a lack of quality assurance procedures, (3) poorly

trained radiologic technologists and interpreting physicians, and (4) a

lack of facility inspections or consistent governmental oversight.

A. Provisions of the MQSA

The MQSA was enacted to address these deficiencies in mammography

practice. Under the MQSA, Congress established a comprehensive

statutory scheme for the certification and inspection of mammography

facilities to ensure that only those facilities that comply with

minimum Federal standards for safe, high-quality mammography services

would lawfully continue to operate after October 1, 1994. Operation

after that date would be contingent on receipt of an FDA certificate

attesting that the facility meets the mammography quality standards

issued under section 354(f) of the Public Health Services Act (the PHS

Act) (42 U.S.C. 263b(f)).

Specifically, the MQSA required the following:

(1) Accreditation of mammography facilities by private, nonprofit

organizations or State agencies that have been approved by FDA as

meeting the standards established by FDA for accreditation bodies and

that continue to pass annual FDA reviews of their activities. The MQSA

also requires that, as part of the overall accreditation process,

actual clinical mammograms from each facility be evaluated for quality

by the accreditation body.

(2) An annual mammography facility physics survey, consultation,

and evaluation performed by a qualified medical physicist.

(3) Annual inspection of mammography facilities, to be performed by

FDA-certified Federal or State inspectors. If State inspectors are

used, the MQSA requires a Federal audit of the State inspection program

by direct Federal inspections of a sample of State-inspected

facilities.

(4) Establishment of initial and continuing qualification standards

for interpreting physicians, radiologic technologists, medical

physicists, and mammography facility inspectors.

(5) Specification of boards or organizations eligible to certify

the adequacy of training and experience of mammography personnel.

(6) Establishment of quality standards for mammography equipment

and practices, including quality assurance and quality control (QC)

programs.

(7) Standards governing recordkeeping for patient files and

requirements for mammography reporting and patient notification by

physicians.

(8) Establishment by the Secretary of a National Mammography

Quality Assurance Advisory Committee (NMQAAC). Among other things,

NMQAAC is required to advise FDA on appropriate quality standards for

mammography facilities and accreditation bodies.

The MQSA replaced a patchwork of Federal, State, and private

standards. Its purpose is to guarantee sufficient oversight of

mammography facilities to ensure that all women nationwide receive

adequate quality mammography services.

B. Interim Regulations

On December 14, 1993, the President signed legislation (H. Rept.

2202) granting authority to the Secretary (and by delegation, to FDA)

to issue temporary interim regulations setting forth standards for

approving accreditation bodies and establishing quality standards for

mammography facilities. This authorization was provided in recognition

of the fact that FDA certification of the approximately 10,000

mammography facilities in the United States could not be accomplished

by the October 1, 1994, statutory deadline without streamlining

[[Page 55853]]

the rulemaking process for issuing initial standards. Because of the

urgent public health need for national mammography standards, Congress

decided to grant this interim rule authority rather than extend the

deadline to develop standards.

In the Federal Register of December 21, 1993 (58 FR 67558 and 58 FR

67565), FDA issued interim rules establishing requirements for entities

applying to serve as accreditation bodies and for facilities applying

to obtain FDA certification in order to continue the legal provision of

mammography services after October 1, 1994. These interim rules became

effective on February 22, 1994. They were amended by another interim

rule published in the Federal Register on September 30, 1994 (59 FR

49808).

C. Accreditation and Certification

Operating under the interim regulations, FDA approved the American

College of Radiology (the ACR) and the State of Iowa as accreditation

bodies and issued certificates to more than 5,000 facilities accredited

by these 2 bodies before the October 1, 1994, statutory deadline. Over

4,500 of the remaining facilities were actively involved in becoming

accredited on that date. In the fall of 1994, FDA also approved the

States of Arkansas and California as accreditation bodies.

In recognition of the fact that a large number of facilities were

working to meet accreditation standards at the same time, and cognizant

of the extremely heavy demands this placed upon the accreditation

bodies, FDA used authority provided by the MQSA to issue 6-month

provisional certificates on October 1, 1994, to facilities whose

applications for accreditation were sufficiently complete for review

and which, on preliminary examination, appeared reasonably likely to

receive accreditation. This avoided the major reduction in access to

mammography that would have resulted had several thousand facilities

been forced to close their doors until the accreditation and

certification process could be completed.

By March 31, 1995, the expiration date for the 6-month provisional

certificates issued on October 1, 1994, over 8,200 facilities had

become fully accredited and certified. Most of the facilities whose

accreditation was still in progress satisfied the criteria for the 1-

time 90-day extension of the provisional certificate provided by the

MQSA and were granted such extensions.

By June 30, 1995, approximately 9,400 facilities had become fully

accredited and certified. Several hundred more, primarily facilities

that had begun operation after October 1, 1994, or facilities that had

previously failed accreditation and were seeking approval after having

taken corrective actions, were operating under provisional certificates

or 90-day extensions of these certificates. FDA estimates that

approximately 800 facilities closed between October 1993 and June 1995.

The closings were due to a number of reasons, including failure to

apply for certification, voluntary closure, and failure to meet the

standards for accreditation, and other reasons unrelated to the MQSA,

such as retirement.

D. Onsite Inspection of Facilities

At the same time FDA was working with the four accreditation bodies

to accredit and certify facilities, the agency was also meeting the

MQSA requirement to establish an annual onsite inspection program to

monitor facility compliance with the MQSA standards. The bulk of these

inspections are performed by State inspectors operating under the

contracts that FDA has with 49 States, Puerto Rico, the District of

Columbia, and New York City. Federal inspectors inspect Federal

facilities and facilities in the remaining States and do audits of the

State inspections. FDA has trained and certified approximately 250

Federal and State inspectors for this program. All facilities that

completed the certification process had received their first

inspections by September 1996 and approximately 70 percent had received

their second inspections by the end of March 1997. FDA was pleased to

find widespread compliance with the quality standards during these

inspections. Only 2 percent of the facilities had one or more of the

most serious findings (referred to by FDA as Level 1 findings) during

the first round of inspections and that proportion has dropped to less

than 1 percent of the facilities inspected so far in the second round.

E. Development of Proposed Regulations

In granting interim rule authority to FDA, Congress made clear its

intention that the agency replace the interim regulations with more

comprehensive regulations as soon as possible. These more extensive

regulations were to be developed using the normal ``notice and

comment'' rulemaking process and consultation with the NMQAAC.

Apart from the strong congressional encouragement, there were also

other reasons why it was important to replace the existing interim

regulations for quality mammography with more comprehensive final

regulations. The interim regulations were based primarily on the

voluntary standards of the ACR's Mammography Accreditation Program

(MAP). Utilization of the MAP standards aided greatly in meeting the

October 1, 1994, deadline for accreditation and certification of

facilities. The application of these standards to all facilities,

instead of just those that had sought voluntary accreditation from the

ACR, had a significant impact on mammography nationwide. However, the

MAP provisions did not cover all areas that required standards under

the MQSA, such as mammography of patients with breast implants and

experience requirements for some personnel of mammography facilities.

Furthermore, in many situations where MAP voluntary standards were

relevant, their wording needed to be changed and clarified for use as

part of a regulatory program.

One especially significant gap was in the equipment area where the

standards under the interim regulations were minimal. To provide

greater assurances of quality equipment performance, the ACR, with the

Centers for Disease Control and Prevention (CDC), had previously

convened expert committees to develop specifications for mammography

equipment. The reports of these expert committees were an important

basis for the equipment provisions of the proposed regulations.

In addition, the interim standards were required to be issued and

implemented prior to FDA developing any significant experience

regulating mammography. Because the statute was new and the regulatory

scheme it established presented a different and innovative approach,

the agency would inevitably develop ideas for improvement in quality

and efficiency of implementation as the program developed.

For all of these reasons, it was necessary to replace the interim

regulations with more comprehensive final regulations in order to

obtain the highest quality mammography that is reasonably achievable.

Coincident with the implementation of the interim rules, work was

proceeding on the development of final regulations. This effort was

aided by the agency's ongoing experience under the interim rules and

the advice of members of the NMQAAC. The NMQAAC membership includes

health professionals whose work focuses significantly on mammography

and representatives of consumer groups. NMQAAC was chartered on July 7,

[[Page 55854]]

1993. Nominations for members were accepted until September 7, 1993.

The first meeting of the NMQAAC was held February 17 through 18, 1994.

At that meeting, and in subsequent meetings in April, July, and

September 1994, the NMQAAC reviewed and commented on drafts of portions

of the proposed regulations developed by FDA. At its January 1995

meeting, the NMQAAC reviewed the entire body of draft proposed

regulations. Many of the requirements in the proposed regulations were

based on advice obtained from the members of NMQAAC during these

meetings.

Another valuable resource utilized by FDA in the development of the

proposed regulations was the guideline entitled, Quality Determinants

of Mammography (Ref. 2). This guideline was developed by the Quality

Determinants of Mammography Panel, with support from the Agency for

Health Care Policy and Research (AHCPR), to help eliminate low quality

mammography and, thereby, eliminate the adverse consequences it causes.

The Panel consisted of a diverse group representing many medical

specialties and consumer representatives knowledgeable about

mammography.

Proposed regulations were published in the Federal Register of

April 3, 1996 (61 FR 14856). To facilitate review by the public, they

were published in 5 separate documents, as described in the

introduction to section III of this document.

F. Development of the Final Regulations

A 90-day public comment period ending July 3, 1996, was provided

for the proposed regulations. During that time, extensive efforts were

made to encourage public comments. Approximately 17,000 copies of the

proposed regulations were mailed to the organizations and individuals

on FDA's MQSA mailing list, including 1 to every certified mammography

facility. The availability of the proposal was announced in Mammography

Matters, the newsletter of FDA's Division of Mammography Quality and

Radiation Programs (DMQRP), and in the newsletters of professional

groups. Copies were also distributed by FDA personnel at professional

meetings. By the end of the comment period, approximately 1,900

responses, containing approximately 8000 individual comments, had been

received from organizations and individuals. NMQAAC also provided

additional comments on the proposal during an April 1996 meeting.

Analysis of the many comments began after the end of the comment

period. At the October 1996 meeting, FDA consulted the NMQAAC for

advice with respect to some of the more controversial issues raised by

the comments. During the January 1997 meeting, the Committee reviewed

the entire set of regulations in light of the comments received. The

public comments and the advice received from the NMQAAC were used to

develop a draft of final regulations, which the members of the NMQAAC

had an opportunity to review individually in March 1997.

The majority of the final regulations will become effective April

28, 1999. The interim rules will continue to apply until that date.

Certain equipment-related regulations, in Sec. 900.12(b) and (e), will

become effective October 28, 2002. This delay in the effective date for

certain equipment requirements is intended to minimize the costs

associated with equipment improvements. The cost savings are achieved

by permitting facilities to implement the improvements as they follow

their normal equipment replacement schedule instead of requiring an

immediate purchase of new equipment or equipment upgrades.

II. Highlights of the Final Rule

This section highlights the major features of the final

regulations, as compared to the interim and the proposed regulations,

and their potential for achieving the MQSA goals of establishing

nationwide quality standards for mammography, while maintaining a broad

patient access to mammography services. A detailed discussion of the

public comments and FDA's response to them is provided under section

III of this document.

These final regulations fulfill FDA's responsibility under the MQSA

to establish national quality standards for mammography services, with

extensive input from NMQAAC. These Federal regulations will be

implemented under the MQSA framework whereby mammography facilities are

accredited once every 3 years by FDA-approved State or private not-for-

profit accreditation bodies, and inspected once every year by FDA-

trained and certified State (or in some cases Federal) inspectors. The

Federal-State-private sector partnership provides the necessary tools

to successfully implement these regulations and realize the MQSA's goal

of assuring high quality mammography services for every American woman.

Accordingly, these regulations establish rigorous criteria designed

to enhance the quality of mammography services in a manner that is

reasonably achievable by mammography facilities. The regulations

provide facilities with flexibility in needed areas to meet the

important public health goals of these standards. Taken as a whole, the

regulations are expected to provide substantial consumer benefits in a

reasoned and cost-effective manner.

The final regulations consist of two subparts. Subpart A is

composed primarily of the requirements to be met by the accreditation

bodies who perform the crucial initial screening of mammography

facilities for quality, including clinical image review, subpart B

establishes quality standards to be met by the mammography facilities

and administrative procedures.

A. Accreditation Body Requirements

The final regulations refine and codify policies FDA had developed

under the interim regulations for the initial approval of accreditation

bodies by FDA, and for defining the ongoing responsibilities of these

bodies and the agency's oversight of them. The primary goal of the

accreditation body requirements is to ensure that there is nationwide

consistency, both within and between accreditation bodies, in the

evaluation of mammography units and procedures to determine if they

meet the standards for quality mammography.

The major change made from proposed Secs. 900.3 through 900.7 was

the removal of several provisions that would have assigned compliance

responsibilities to the accreditation bodies. Removal of these

provisions ensures that the activities of the accreditation bodies will

have their proper focus, which is to identify facilities that are not

performing adequate quality mammography and to advise such facilities

on the nature of their problems and how to correct them. Compliance

activities under the MQSA are reserved for FDA.

B. Facility Quality Standards

1. Personnel Standards

The personnel standards of Sec. 900.12(a) cover interpreting

physicians, radiologic technologists, and medical physicists who

provide services to mammography facilities. The goals of the standards

are to ensure that personnel: (1) Have general qualifications in

radiology; (2) possess specific qualifications in mammography; and (3)

keep their qualifications up-to-date.

Most of the proposed changes in the personnel area were intended to

clarify general statements in the interim regulations that have caused

confusion in interpretation. A major step to improve quality of

personnel

[[Page 55855]]

performance, however, was the proposed establishment of initial and

continuing experience requirements for radiologic technologists and

medical physicists. These requirements are parallel to requirements

already in the interim regulations for physicians and, like the

physician requirements, are intended to make sure that individuals have

supervised clinical experience before they begin to provide mammography

services independently, and that they maintain their skills through

regular performance of their duties. These new experience requirements

have been codified in the final rule after some adjustments in the

amount of experience required due to practical considerations, such as

the difficulties that medical physicists under contract to one facility

would face in attempting to meet the proposed requirement to do surveys

in several facilities.

Another significant change from the proposed personnel standards is

that the final rule ``grand parents'' technologists who met the

personnel requirements under the interim regulations. Without grand

parenting technologists already in the system, there was the

possibility that localized shortages of technologists would occur,

resulting in a serious, short-term impact on access to mammography.

Because the agency believes that most technologists presently providing

mammography services either meet, or have qualifications comparable to

the final requirements, grand parenting could be permitted to relieve

these concerns without any significant impact on quality.

2. Equipment

The equipment standards in Sec. 900.12(b) are intended to ensure

that mammography equipment has the capability of producing quality

mammograms over the full range of clinical conditions. The equipment

area was addressed only briefly in the interim regulations. To better

define the equipment capabilities needed for high quality mammography,

equipment specification standards were proposed for all equipment

components of the mammography system from the X-ray generator to the

view box. These proposals relied heavily upon the recommendations of

the equipment focus groups convened in the early part of the decade by

the ACR, with the support of CDC.

After reviewing the information provided in the public comments and

by the NMQAAC, FDA revisited the question of the proper balance between

the economic impact of new standards and the associated gains to the

public health. This reconsideration led the agency to conclude that the

expected benefits from some of the proposed equipment specifications

would not compensate for the cost to replace or retrofit mammography

systems to meet them. The agency has concluded that, in some cases, the

same public health goals could be accomplished through specified

quality assurance procedures. Accordingly, specifications related to

source-image receptor distance (SID), focal spot location, filtration,

and film processors have been eliminated and specifications related to

compression and radiation output are being treated as performance

standards under the quality assurance section of the regulations.

Similarly, performance outcome aspects of the requirements for

alignment have been moved to the quality assurance section. Finally,

requirements related to system resolution were eliminated as

duplicating performance standards already in the quality assurance

section, and the requirements related to the examination of disabled

patients were eliminated in part because of a lack of consensus about

the need for such requirements.

In an effort to reduce costs, FDA is phasing in the equipment

requirements, with some becoming effective the same time (18 months) as

the rest of the regulations and others within 5 years. However, based

on the desire not to impede technological advances, the uncertainty in

estimating needs further in the future, and an assessment of the

associated costs, the agency has eliminated the proposed 10-year phase-

in requirements and some of the 5-year phase-in requirements. The

agency intends to reassess the need for the deleted requirements at a

future time.

3. Recordkeeping and Reporting Requirements

The recordkeeping and reporting requirements of Sec. 900.12(c) are

intended to: (1) Ensure that all patients and their referring

physicians receive timely and adequate notification of the results of

examinations, and (2) assist in diagnosis by ensuring that records of

past examinations, including the original mammograms, are available

when needed for comparison with the images produced during new

examinations.

With respect to patient notification of examination results, the

final rule codified this essential reporting requirement as a

performance outcome standard. The proposed rule would have required the

facilities to have a system to ensure that all patients received

written notification of their examination results, and further

specified what should be included in that notification. The final rule

requires that each facility have a system to ensure that the results of

each mammographic examination are communicated to the patient in a

timely manner. Thus, the focus is placed on the desired performance

outcome, the notification of the patient in a timely manner, and not on

the method or specific conduit of the notification. Under the final

rule, the facility has the flexibility to use the method of

notification that is most effective in its situation and to convey the

information to the patient that it deems to be most important. In the

part of the preamble discussing this provision, FDA continues to

endorse the use of written notification as the most reliable way to

guarantee that each patient is notified of results and that any

necessary followup will occur and recommends that facilities follow the

AHCPR guidelines on direct written notification to all patients. The

agency also describes other methods that may achieve the desired

outcome equally well in specific situations.

With respect to providing patients with original mammograms upon

request, the final rule was modified to make it clear that the original

mammograms must be made available to other medical facilities, at the

patient's request, whether the transfer is permanent or temporary. It

is expected that this change will end the difficulties in obtaining

previous original mammograms for comparison with new mammograms (an

essential aid to diagnosis) that many patients have experienced under

the interim regulations.

4. Quality Assurance

The goal of the quality assurance requirements of Sec. 900.12(d),

(e), and (f) are to ensure that equipment and personnel continue to

perform at adequate levels. Section 900(d) defines staff

responsibilities and recordkeeping requirements for the quality

assurance program, Sec. 900.12(e) establishes equipment QC

requirements, and Sec. 900.12(f) outlines the requirements for

mammography medical outcome audits.

The proposed equipment QC requirements represented a major

transition towards performance outcome standards. The interim

regulations had referenced the ACR quality assurance manuals and thus

specified not only the performance outcomes to be achieved but the test

procedures to be followed. The proposed rule was intended to establish

the desired performance outcomes and the required frequency of testing

at levels nearly identical to those in the interim regulations, but

sought to give the mammography facilities some

[[Page 55856]]

flexibility in the testing procedures to be used.

The final rule leaves the testing frequencies and the performance

outcomes largely unchanged from the proposal, with the exception that

standards have been added for radiation output, alignment, and

compression, parameters previously considered under the equipment

specifications. The provisions related to retesting after equipment

failure and taking equipment out-of-service until problems are solved

have also been modified to give the facility more flexibility in

determining when performance is compromised sufficiently to warrant

such actions.

5. Medical Outcomes Audit

A comprehensive mammography medical outcomes audit program can

ensure that a facility is providing its patients with accurate

mammography examinations and followup care and has the potential to

provide the basis for performance outcome standards. However, the

public comments made it clear that more research is needed before the

state-of-the-art will be sufficiently advanced to support regulatory

performance outcome requirements based on audits. FDA did move a step

beyond the interim requirement that each facility have a system for

reviewing outcome data by codifying requirements related to the

analysis of the data collected.

6. Consumer Complaint Mechanism

Under the interim regulations, accreditation bodies have developed

mechanisms for addressing consumer complaints about the quality of

mammography services received. Requirements for such mechanisms have

been continued in Sec. 900.4(g) of the final regulations. FDA

recognized, however, that consumer complaints usually can be addressed

most effectively at the facility level. For this reason, FDA proposed

to require each facility to develop a system for collecting and

resolving consumer complaints, with special emphasis placed on the

resolution of serious complaints. This requirement has been codified

with little change in Sec. 900.12(h). The accreditation body and FDA

retain the responsibility for addressing complaints that cannot be

resolved at the facility level.

7. Alternative Requirements

The alternative requirements in Sec. 900.18 provide a mechanism for

implementing advances in mammography that meet quality standards more

rapidly than would be possible through amending the regulations. This

mechanism will be used only when the potential public health benefits

justify such actions.

This section was incorporated into the proposed rule from the

interim regulations with little change. Before codification in the

final rule, the section was modified to give the agency the authority

to allow an approved alternative to be used by entities other than the

entity that applied for approval. This change was made in response to

concerns that it would be an unnecessary duplication of effort for the

agency and for the applicants if multiple applications were required

for the approval of the same advance in mammography.

8. Performance Outcomes

FDA's proposed rule invited comments on the possibility of taking a

performance outcomes approach to mammography quality standards.

Suggestions and comments on possible performance outcome indicators

were also invited. As discussed in more detail elsewhere in this

document, the consensus of the public comments was that while the

performance outcome concept was attractive in theory, much additional

research will be needed before a performance outcome system to ensure

mammography quality can be issued. The agency agrees with this

consensus but also believes that it is possible to start moving in that

direction in certain areas as noted in the previous discussion.

III. Provisions of the Final Rule

The proposed regulations that published in the Federal Register of

April 3, 1996, consisted of five separate documents. The first,

``Quality Mammography Standards; General Preamble and Proposed

Alternative Approaches'' (61 FR 14856 (Docket No. 95N-0192)): (1)

Surveyed the history of efforts to implement the MQSA; (2) summarized

FDA's analysis of the environmental, economic, and paperwork impacts of

the final regulations; and (3) set out the agency's proposed ``scope''

and ``definitions'' sections (Secs. 900.1 and 900.2). In that document,

the agency also invited public comments on the concept of performance-

based outcomes regulations and the feasibility of recasting the

proposed design and process requirements into performance-based

outcomes requirements.

The second, ``Quality Standards and Certification Requirements for

Mammography Facilities; General Facility Requirements'' (61 FR 14870

(Docket No. 93N-0351)), proposed regulations covering a variety of

areas, including: (1) Applicability (Sec. 900.10); (2) requirements for

certification (Sec. 900.11); (3) procedures for suspension or

revocation of accreditation; (4) accreditation body approval; (5)

facility certificates (Secs. 900.13 and 900.14); (6) the process for

appealing agency decisions (Sec. 900.15); and (7) an alternative

requirement process (Sec. 900.18). Some aspects of the facility

standards were also covered. These included medical records and

recordkeeping (Sec. 900.12(c)); general quality assurance requirements

(Sec. 900.12(d)); mammography medical outcome audits (Sec. 900.12(f));

mammography of examinees with breast implants (Sec. 900.12(g)); the

consumer complaint process (Sec. 900.12(h)); and additional clinical

image review and patient notification (Sec. 900.12(I)).

The third, ``Proposed Requirements for Accreditation Bodies of

Mammography Facilities'' (61 FR 14884 (Docket No. 95N-0192)), covered

the approval, responsibilities, and withdrawal of approval of

accreditation bodies (Secs. 900.3 to 900.7).

The fourth, ``Quality Standards and Certification Requirements for

Mammography Facilities; Personnel Requirements'' (61 FR 14898 (Docket

No. 95N-0215)), proposed standards to be met by interpreting physicians

(Sec. 900.12(a)(1)), radiologic technologists (Sec. 900.12(a)(2)), and

medical physicists (Sec. 900.12(a)(3)) working in mammography

facilities.

The fifth, ``Proposed Quality Standards for Mammography Equipment

Quality Assurance'' (61 FR 14908 (Docket No. 95N-0195)), proposed

equipment specifications (Sec. 900.12(b)) and requirements for the

equipment quality assurance program (Sec. 900.12(e)).

The proposed regulations were published in these five segments to

facilitate review and make it easier for members of the public to focus

on the sections of most interest to them. Because the final regulations

are being issued as a single document, the comments received in

response to the proposed regulations are addressed as part of this

single preamble rather than in separate documents relating to each of

the five proposal documents. General comments are treated first,

followed by a discussion of the public response to the concept of

performance outcome requirements and their feasibility. Then comments

on the individual components of the final regulations are discussed in

the order that each component appears in the final regulations.

Finally, the comments on the FDA's analyses of impact are discussed

in sections V of this document, and section VI covers the Paperwork

Reduction Act of 1995 provisions. Citations for individual provisions

of the regulations

[[Page 55857]]

generally have remained the same; the preamble clearly notes any

instance in which a provision has been codified under a new citation.

Each of the five proposed regulations was preceded by a preamble

containing a wide range of information intended as background and

information for the final regulations. Comments that the agency

received relating to preamble discussions have been addressed either

with the general comments or with the specific regulation sections to

which they are most closely related.

A. General Comments

Many comments received on the proposed regulations raised issues or

concerns that were broader in scope than any specific provision. These

more general comments are responded to first, before turning to the

more specific comments.

1. The Overall Value of the Quality Standards

(Comment 1). A number of the comments stated opposing positions on

the overall value of the quality standards established by these

regulations. Seventeen comments supported the quality standards with

only minor modifications, noting that they would strengthen radiology

practices and enhance the quality of mammography. Twenty-six comments,

on the other hand, opposed the quality standards in their entirety.

Reasons given included concern about costs and the resultant impact on

access, opposition to the regulation of medicine, a characterization of

the standards as unnecessary micro-management, belief that more

stringent standards were unnecessary or ineffective in improving

quality, and an opposition to ``international'' requirements for

mammography practice.

The agency recognizes the need to balance the benefits to be

achieved from improved quality of mammography with the cost of those

improvements and the impact such cost might have on access to

mammography. Congress addressed the concern with that balance in

drafting the MQSA and has guided the agency in its efforts to implement

the statute. An independent evaluation of the program performed by GAO

determined that the interim regulations had a positive effect on the

quality of mammography without a serious adverse impact on access (Ref.

2). Although, as previously mentioned, a number of facilities did close

for various reasons, service from another provider was generally

available within 25 miles. Newly established facilities have continued

to be certified, further mitigating any impact on access. Based upon

its experience with the interim regulations and advice from NMQAAC

members, FDA believes that the proposed regulations will achieve

further improvements in quality at a cost that will not impact access

significantly. The public comments on the proposal led to a further

refinement of the regulations, including removal of requirements when

the comments persuaded the agency that the requirement was not

essential. These changes, and the associated reduction in cost, should

provide an even more favorable ratio of benefit to cost.

In answer to concerns about micro-management, many of the specific

provisions added in the final regulations reflect practices and

policies that were developed under the interim regulations. These

policies were developed in response to requests from mammography

facilities for information on how to meet the requirements of interim

regulations and are already being followed by most facilities.

Incorporating these policies into the final regulations gave interested

parties the opportunity to comment on them. In response to the

comments, requirements have been refined to achieve the most favorable

balance between benefit and cost.

Finally, FDA notes that the system for ensuring quality mammography

established by the MQSA and these regulations is unique to the United

States and is not a duplicate of, or related to any international

requirements or systems established in any other country.

(Comment 2). Two comments, while apparently not in total opposition

to the regulations, did express their authors' opinions that the

personnel and recordkeeping and reporting requirements went ``far

beyond FDA's medical device mandate.''

FDA notes that the authors of these comments have overlooked the

fact that these regulations are issued under the MQSA, which amended

the Public Health Service Act, not under the Medical Device Amendments

to the Federal Food, Drug, and Cosmetic Act (the act). The MQSA

specifically requires the agency to develop standards for personnel

qualifications and for reporting and recordkeeping (42 U.S.C. 263b(f)).

(Comment 3). Several comments, while expressing varying degrees of

support or opposition to the requirements, asked why mammography has

been singled out for such attention. Some suggested that other diseases

were as serious or more serious than breast cancer, while one comment

pointed out that the radiation levels in mammography are quite low.

Although a case might be made for developing similar programs for

diagnosis of other diseases, Congress decided that mammography should

be the subject of this legislation. Congress found the evidence

sufficiently convincing that breast cancer was a significant public

health risk that could be reduced by improved mammography and,

furthermore, that the performance of mammography nationwide was in need

of improvement. Congress responded with the MQSA, and FDA is carrying

out the mandate of that statute. FDA agrees with the comment that

observed that the radiation levels in mammography are much lower than

they were 20 years ago (largely as a result of a cooperative

government, industry, and facility effort) and lower than those used in

many other examinations. However, the primary concerns addressed by the

MQSA are not radiation levels but poor image quality and

interpretation.

(Comment 4). One comment criticized the proposed regulations for

not sufficiently recognizing local facility condition variations,

indicating that standards appropriate for some facilities might be

unduly burdensome to others. In contrast, another comment strongly

supported the application of uniform standards in both rural and

nonrural areas. It stated that this would ensure that women in rural

areas received optimum care.

FDA believes that all women are entitled to high quality

mammography, no matter where they live, and so has not issued lesser

standards for rural areas or any other subset of facilities. The agency

further notes that the fear that applying uniform minimum standards

would cause an undue burden to rural facilities is refuted by the

experience of Michigan, where such uniform standards have been applied

to all facilities in that State since 1989 (Ref. 3), and by experience

under the Federal interim regulations.

(Comment 5). Ten comments stated that ``the regulations and the

complaint process may confuse the public by bringing up more issues

than it is necessary for them to be concerned with and confusing the

role of mammography in the overall diagnosis and treatment of breast

cancer.''

The purpose of the MQSA is to ensure adequate quality mammography

for all patients. If this purpose is achieved, members of the public

will be able to receive mammography at any facility in the country

without having to be concerned about the issues covered by the

regulations. Thus, public

[[Page 55858]]

``confusion'' should decrease rather than increase as a result of these

regulations. Without additional details, FDA cannot respond further to

the concern expressed by the comments about confusion over the role of

mammography. The agency assumes, however, that any such problems could

be handled through educational efforts.

2. Division of Responsibility

The MQSA established a system of checks and balances involving the

interaction of several groups, including FDA, the States, and the

accreditation bodies. A number of comments expressed varied concerns

about the division of responsibility established by the proposal.

(Comment 6). One of these comments stated that oversight and review

of mammography facilities is the backbone of the MQSA program. Along

with a second comment, it noted that FDA, not the accreditation bodies,

should be responsible for enforcement actions.

FDA agrees with this comment and believes that the final

regulations clearly give the agency the primary responsibility for this

function. However, the regulations also establish that the

accreditation bodies have responsibility for notifying FDA when they

have information that enforcement actions may be needed and for

assisting in related investigations.

(Comment 7). Two comments stated that the regulations should allow

States to eliminate overlapping functions if they are serving as both

accreditation bodies and inspection agencies. A third comment stated

that more leeway should be given to State accreditation bodies, which

have enforcement capability, than to non-State accreditation bodies. A

fourth comment recommended eliminating some unspecified requirements if

a State agency holds both accreditation body status and an inspection

contract.

FDA agrees that states that are both accreditation bodies and

inspection agencies may be able to combine some functions and, in fact,

some steps have been taken under the interim regulations. However, it

is important that all facilities meet the same accreditation and

inspection requirements. The agency believes it is unlikely that any

requirements pertaining to accreditation bodies or facility standards

can be eliminated entirely in States with dual status. The need for

consistency also explains why FDA disagrees with the third comment;

State accreditation bodies may have enforcement capability under State

law but this capability could vary greatly from State to State. As the

author of the fourth comment did not give specific examples of

requirements to be eliminated, the agency cannot respond further to

that comment.

(Comment 8). Three comments suggested that to reduce costs there

should be one comprehensive system to accomplish all the necessary

accreditations within any State that already has in place a mechanism

for accreditation of facilities and licensure of technologists. The

comment observed that the Federal Government would have to subsidize

States for this work.

States are permitted under the MQSA to apply to become FDA-approved

accreditation bodies (42 U.S.C. 263b(e)(1)(A)) and three States have

already done so. FDA disagrees that the agency should merely substitute

existing State accreditation and licensing systems for the MQSA

standards. States may have widely different accreditation standards

under their State laws, while the drafters of the MQSA envisioned a

system that would establish uniform, minimum national standards for all

mammography facilities. The MQSA, however, expressly permits State laws

relating to mammography that are more stringent to be issued or to

remain in effect (42 U.S.C. 263b(m)). Furthermore, the drafters of the

MQSA did not provide for Federal subsidies for any accreditation body;

the statute instead expects those bodies to be supported by their

accreditation fees.

(Comment 9). One comment recommended the adoption of only one set

of rules, whether it be established by the State, ACR, or FDA, to

govern mammography, while a second recommended combining FDA and ACR

into one ``accreditation body'' to reduce the problems of complying

with the requirements of both. Another comment objected to FDA

permitting States to pass additional laws and regulations governing

mammography in addition to the MQSA requirements. It stated that this

would prevent the establishment of consistent nationwide standards.

Another comment objected to the absence of a preemption clause in the

MQSA, fearing that would lead to overlapping State and Federal

regulations.

FDA notes that, within the limits of the authority given to it by

the MQSA, it has worked towards the goal of one set of rules. The MQSA

authorizes FDA to establish one set of uniform baseline standards and

to require that all approved accreditation bodies, including ACR,

enforce standards substantially the same as these. The agency has taken

this step. FDA also notes that the Health Care Financing Administration

(HCFA) has agreed to accept the MQSA regulations and inspections in

lieu of the regulations and inspection system it had previously

established to govern mammography under Medicare, thus reducing

duplication. The MQSA also requires State standards to be at least as

rigorous as those of FDA. However, as noted by the comment that there

is no preemption clause in the statute, the MQSA explicitly gives

States authority to develop additional regulations governing

mammography, as long as they are more stringent than the MQSA

requirements (42 U.S.C. 263b(m)). The intention of the MQSA was to

create a uniform nationwide baseline quality level for mammography,

while permitting individual States to strive for higher levels. Only

Congress can make changes in this approach, not FDA.

(Comment 10). One comment expressed concern that the nature of the

State/Federal agency relationship may be an impediment to ensuring

quality mammography. The author cited two GAO reports criticizing the

oversight of State programs by other Federal agencies. FDA notes that

the agency has a long history of Federal-State cooperative programs,

especially with respect to educational efforts and inspections in the

medical X-ray area, and that, in general, these programs have been very

successful. As the agency moves into new areas of cooperation with the

States, it is studying the experiences of other Federal agencies in an

effort to avoid any difficulties they may have experienced in working

with the States.

(Comment 11). One comment recommended that FDA's mammography

oversight be limited to equipment standards and requiring that

facilities be accredited and that oversight of the accreditation bodies

by FDA be reduced. Another comment suggested limiting FDA's oversight

only to ensuring that facilities are accredited properly by the

accreditation bodies.

FDA notes that the MQSA gives FDA far greater responsibilities than

either of these comments would permit and the regulations are intended

to help the agency continue to fulfill its obligations under the

statute.

(Comment 12). Similarly, two comments made the general

recommendation that the accreditation bodies be given expanded

responsibilities. Other comments had more specific opinions, for or

against, certain expanded responsibilities for the accreditation

bodies. Two comments stated that the accreditation body should be the

sole evaluator of the annual physicist survey, with the MQSA inspector

merely accepting the

[[Page 55859]]

accreditation body's review. A third comment argued, however, that

valuable information would be lost if the inspector accepted the

accreditation body's review of the report and a fourth comment agreed

that, if duplicate review is not cost effective, it would be more

appropriate for the inspector to review the survey than the

accreditation bodies. Three comments stated that the accreditation body

should be responsible for tracking all personnel requirements for a

facility, while a fourth would give the accreditation body

responsibility for review of continuing education credentials.

Similarly, a fifth comment would limit the inspections to review of the

physicist survey and the QC program, plus taking a phantom image,

leaving oversight of the other areas to some unspecified group. Another

comment on the appropriate division of responsibilities stated that FDA

should not have inspectors performing tests that have already been

conducted by medical physicists and technologists.

FDA has utilized, and plans to continue utilizing, the expertise of

the accreditation bodies to the maximum extent permitted by the

statute. The agency also realizes that the checks and balances system

required by the MQSA leads to some duplication of effort between the

accreditation body and the inspectors or the inspectors and the medical

physicists. However, one of the weaknesses of the pre-MQSA oversight

system for mammography was the lack of an onsite evaluation of the

facility programs by an individual independent of the facility.

Experience with the interim regulations has demonstrated the value of

such inspections; the great majority of findings were for situations

that had not been identified by the accreditation bodies or the medical

physicists. On the other hand, there is no doubt that the accreditation

bodies and the medical physicists have prompted the correction of many

problems before the inspections took place. These activities and

results demonstrate the strength of the program. The agency believes

that the drafters of the MQSA were correct in concluding that a checks

and balances system, involving two or more entities, would be more

effective in ensuring the continued maintenance of high quality

mammography than the use of only one entity or the other.

(Comment 13). Two comments recommended that the information

obtained by either the accreditation bodies or the inspectors should be

shared with the other groups to cut down on unnecessary duplication of

information collection activities or submission requirements for the

facilities.

FDA agrees with this comment and the statute itself supports

elimination of collection of duplicative information (42 U.S.C.

263b(d)). Under the interim regulations, the agency has been working

with the accreditation bodies on the electronic exchange of information

and will continue to do so under the final regulations.

3. Inspections and Inspectors

A number of the more general comments addressed various aspects of

the annual and audit inspections.

(Comment 14). Two comments suggested that the FDA facility

inspections should be reduced or eliminated in order to reduce the

costs to facilities or because annual inspections are not needed. A

third comment urged that inspection frequencies not be included in

regulations.

Annual onsite inspections are required by the MQSA (42 U.S.C.

263b(g)); that requirement cannot be changed by the agency, even if it

is not in regulations. The agency is evaluating alternative ways for

conducting inspections in the hopes of reducing costs for facilities.

(Comment 15). One comment stated that it was inconsistent for FDA

to inspect every facility every year while the accreditation bodies are

required to visit a much smaller number of facilities annually. The

comment further maintained that the MQSA inspections duplicated other

inspections.

The FDA inspections and the accreditation body visits serve two

different purposes. The MQSA inspections, which are required to be

annual, are intended to ensure that all facilities continue to meet the

MQSA quality standards. The MQSA requirement that accreditation bodies

visit a sample of their facilities each year serves an additional

purpose, which is to have accreditation bodies evaluate their own

performance and the effectiveness of their accreditation procedures (42

U.S.C. 263b(e)(4)(A)). In addition, accreditation bodies, at FDA's

request or on their own authority, will visit facilities that have been

identified as potential problem facilities for the purpose of

identifying the problems and assisting the facility in correcting them.

(Comment 16). Eleven comments suggested that ACR be designated as

the inspection organization in New Mexico.

FDA is unable to consider this suggestion because the MQSA

specifically limits inspectors to Federal or State personnel (42 U.S.C.

263b(g)).

(Comment 17). Three comments were concerned about the standards for

FDA inspectors and two more urged additional training for inspectors.

Another comment was very complimentary of inspectors in Iowa. Fifteen

other comments expressed various concerns about the inspection fees.

These issues are beyond the scope of these regulations, which cover

requirements for accreditation bodies and quality standards for

facilities only. FDA has referred these comments directly to the

components of FDA that deal with inspector training and inspection

fees.

4. Public Participation in the Process

(Comment 18). Three comments expressed concern that not enough

public input has been obtained during the regulation development

process and suggested that facilities, manufacturers, and personnel

should be interviewed.

The NMQAAC is composed of representatives of the mammography

community and consumer groups and has been a valuable conduit of public

input during the eight meetings at which it discussed the final

regulations before and after they were published. Furthermore, each

meeting included an open session during which members of the public

could make statements and many individuals took advantage of these

opportunities. Finally, there were three public comment periods during

the development of the regulations. The first of these was for comments

on the interim regulations. A great deal of information was gained for

use in the development of the final regulations from comments received

at this time. The second was after preliminary drafts of the equipment

and medical physicist standards were released and again valuable

information was obtained from the public. The third opportunity to

comment was after the publication of the proposed regulations and, as

previously discussed, approximately 1,900 responses covering every area

of the regulations were received from a broad spectrum of organizations

and individuals. FDA believes that the public has had ample opportunity

to participate in the regulation development and reiterates that this

public participation had a significant impact on its final form.

(Comment 19). Another comment recommended prohibiting NMQAAC

members from also serving on advisory boards or as consultants to

accreditation bodies in order to avoid the possibility that a limited

number of people will have disproportionate influence on the program.

In forming the NMQAAC and its other advisory panels, FDA has

complied with the Federal Advisory Committee

[[Page 55860]]

Act (the FACA), the agency's implementing regulations at 21 CFR part

14, and the MQSA. The FACA requires each advisory committee to be

fairly balanced in terms of the points of view represented and the MQSA

expressly describes the constituent segments of the affected community

that are to have representatives on the Committee (42 U.S.C. 263b(n)).

Because advisory committees enlist the expertise of outside consultants

to advise the government, it is frequently the case that well-qualified

members are nationally recognized experts who are also called upon to

play leadership and consultant roles for private groups. The agency

does not prohibit such individuals from providing government service if

the agency determines that such participation is in the best interest

of the government because the need for such participation outweighs the

potential conflict of interest. The existence of any potential

conflicts are stated for the public record at the beginning of each

advisory committee meeting and panel members who have conflicts on

particular matters may be prohibited from voting on those issues.

5. Double Reading

In the preamble to the proposed rule (61 FR 14870 at 14876, April

13, 1996), FDA noted that one of the comments received on the interim

regulations suggested that all mammograms be read a second time by a

second qualified physician. The author of the comment stated that this

would avoid unnecessary surgery and emotional stress that can arise

from a false positive reading and the lack of appropriate followup in

the case of a false negative reading. The agency did not include such a

requirement in the final regulations but asked for further comments on

the issue.

(Comment 20). Twenty four comments argued against a double reading

requirement, basing their opposition on such reasons as the cost, the

difficulty of achieving double reading, the delays in reporting to the

referring physician leading to patient dissatisfaction, and the belief

that it would be a meaningless exercise and only a few abnormalities

would be picked up. Comments asserted that the burden would be

especially great in rural and isolated areas and could reduce access to

mammography services. Twelve of these comments also questioned where

the notion of double reading would lead; and would there be a press for

triple and quadruple reading. One of these comments urged that the

focus be on training for the first reader so that double reading is not

necessary. On the other hand, three comments offered strong support for

the use of double reading and one comment went so far as to say that

all films should be double read in order to eliminate the trauma and

psychological stress associated with false positives. One comment

suggested requiring double reading for all positive mammograms.

FDA has determined not to include a double reading requirement in

the final regulations. Double or multi-reading (as it is now called by

the agency for reasons discussed with the comments on Sec. 900.2) is

referenced in the regulations only as a way for interpreting physicians

at low-workload facilities to meet their continuing experience

requirements. Although this practice is not being required, the

regulations do not preclude double reading. FDA encourages facilities

that believe their services will benefit from such procedures to

establish the practice as a quality assurance measure.

6. The Organization of the Final Regulation

(Comment 21). A number of comments were extremely critical of the

organization of the proposal, finding it difficult to read and to see

the relationship between the five separate divisions, each with its own

docket number, preamble, and regulatory content. Several of these

comments stated that information on the organization of the proposal

should have been provided, while others made suggestions for

reorganization of the material when it was published as a final

regulation.

FDA adopted the method of presentation in the preamble of the

proposals in an effort to make it easier for readers to focus on the

provisions that were of most concern to them. Readers interested

primarily in the personnel requirements, for example, would need

consider only the fourth division, while those whose concerns were

primarily equipment-related, could focus on the last division. Although

the summary section of each of the five divisions identified the

material being provided in the other divisions, it is clear from the

comments that further explanation would have been helpful.

The final regulations are being published in a single document.

This single document follows the usual Federal Register format of a

preamble and a regulation section. The regulation section combines the

regulations from the five divisions of the proposal in numerical order

from Secs. 900.1 to 900.18, with some sections reserved for later use.

For the convenience of the reader, a table of contents is provided.

7. Other Comments

(Comment 22). Additional comments were received on widely varied

topics. One comment noted that mammography services are provided for

men and women, and suggested that any mention of ``women'' should be

replaced by ``women and men.''

FDA agrees that men are also consumers of mammography services.

However, because breast disease and diagnosis overwhelmingly affects

women, that word seems more appropriate. However, the agency notes that

in the regulations themselves and at many places in the preamble, the

term ``patient'' is used. FDA believes this terminology addresses the

comment's concern.

(Comment 23). Four comments took issue with statements in the

preamble to the proposed regulations concerning the expected benefits

from improved mammography and the number of expected deaths from breast

cancer.

FDA is aware that several aspects of these issues are unsettled and

that authorities may draw different conclusions from the same data.

However, the authors of the comments did not appear to challenge the

statute's underlying assumption that mammography can be valuable in

combating a serious public health threat, even though they might

disagree on the quantification of that value.

(Comment 24). Three comments urged FDA to delay the final

regulations until a study of the impact of the interim regulations

could be conducted to determine what changes were needed or even if the

MQSA itself were necessary. Congress intended that final regulations be

in place before October 1, 1994, so that the benefits of improved

mammography could be realized as soon as possible. Recognizing the

magnitude of the task, Congress provided FDA with interim rule

authority that would require regulations to be issued in two steps. The

first step was the interim regulations, which led to significant

benefits. Neither Congress nor the agency believes that any further

delay in completing the second stage and achieving the increased

benefits of the final regulations can be justified. The agency notes,

however, that facilities have been operating under the interim rules

for over 2\1/2\ years and inspections against the interim regulations

have been occurring for over 2 years. This experience with the interim

regulations and the problem areas that were identified have contributed

significantly to the provisions of the final regulations.

(Comment 25). One comment asked the agency to clarify who makes the

decisions about the MQSA regulations.

[[Page 55861]]

FDA assumes that the author is referring to decisions about

interpretations of the regulations, including decisions about the

adequacy of particular training programs for mammography personnel.

These decisions are made primarily in FDA's DMQRP (address above).

(Comment 26). Four comments expressed concern that the more unique

mammography regulations become, the greater the likelihood that

generalists will be forced out of the field.

Many of the personnel requirements, such as licensing and

certification, are general requirements of the medical field. In

addition, Congress determined, and FDA agrees, that mammography is a

sufficiently unique and difficult examination to require specialized

training and experience in the production and interpretation of the

images and in the testing and maintenance of the equipment. However, it

does not require a full-time mammography practice to meet the

experience requirements specific to mammography and the specific

training requirements are only a fraction of what is required for other

purposes, such as completing a residency program or maintaining

certification from the American Registry of Radiologic Technologists

(ARRT). Thus, individuals will be able to meet the MQSA requirements

without limiting their activities to mammography and so there will

still be room for generalists.

(Comment 27). A number of comments expressed a variety of concerns

about matters outside the scope of these regulations or beyond FDA's

authority. These concerns included: (1) Questions about the appropriate

frequency for screening mammography and the levels of Medicare

reimbursement; (2) a recommendation that a State advisory board be

created to monitor each State's mammography program; and (3) a concern

about the perceived domination of medicine by big business. Because

these comments are beyond the scope of these regulations, these

comments will not be addressed.

B. Alternative Approaches to Quality Mammography

Executive Order 12866 requires Federal agencies to identify and

assess alternative forms of regulation and, where feasible, specify

performance objectives (performance or outcome-based standards), rather

than specifying the behavior and manner of compliance that regulated

entities must adopt (design-specification standards). In addition,

Executive Order 12866 requires each agency to avoid regulations that

duplicate other regulations. In response to this Executive Order, under

Docket No. 95N-0192, in the Federal Register of April 3, 1996 (61 FR

14856 at 14859) FDA invited comments on the feasibility of developing

performance-based regulations. Although the agency did not propose

specific regulations in this area, it did suggest several possible

performance measures for mammography and requested comments on their

value and feasibility. The agency also invited the public to suggest

other performance outcomes that might provide a basis for performance-

based standards. FDA also invited comments on suggestions for other

possible alternative approaches. While the standards that were proposed

were not designed to be performance-based standards, there are elements

of performance requirements throughout the final regulations. For

example, most of the QC standards in the final regulations are

performance based. The discussion in the proposal was to consider

extending such performance criteria to areas not now covered by that

type of requirement and to make the performance standards that had been

proposed more general, thereby possibly reducing the burden on

facilities.

1. General Comments

(Comment 28). Sixteen comments asserted that the goal of the

quality mammography efforts by FDA should be to reduce burdens on the

medical community by not requesting comments and review of additional

regulations. Some of the comments stated that ACR should be the entity

designated to define performance standards and that compliance with

such standards should be voluntary. Five additional comments suggested

that it was more appropriate for ACR and ARRT to oversee and govern

mammography quality.

FDA notes that these comments are in conflict with the statutory

provisions of the MQSA (42 U.S.C. 263b)), which mandate that the

government have authority and responsibility to establish standards for

the performance of quality mammography. However, in carrying out that

mandate, FDA has solicited and considered comments from the members of

the mammography community, including comments from ACR, ARRT, and

members of NMQAAC.

(Comment 29). Several individual comments addressed the general

issue of alternative approaches for quality mammography. One comment

favored FDA's role in establishing and strengthening standards for

quality mammography. Another suggested that FDA work with volunteers

who have an interest in alternative compliance options in order to

learn what is best.

Although FDA intends to continue to gather ideas and information

from experts in the field, the agency believes that the opportunity for

public review and comment on proposed regulations that will affect

members of the mammography community is the most equitable approach and

will minimize potential problems of ``standardization without

representation.''

(Comment 30). Four comments addressed the issue of FDA establishing

another set of interim rules, to be in effect while necessary research

on performance outcomes-based standards was conducted, or simply going

forward with the final regulations as proposed. These comments

supported finalizing the proposed regulations and suggested change only

if new technologies or alternative compliance options are identified at

a later time.

Three comments focused on the cost of changing the regulations and

discouraged change to the final regulations if any additional costs

were to be borne by the mammography facilities.

FDA is sensitive to the issue of costs associated with the

regulations and will keep this issue in mind whenever considering

changes to the regulations.

(Comment 31). Two comments expressed concerns that the general aim

of alternative approaches to achieve compliance would result in

loopholes that would allow facilities not performing at acceptable

levels to continue to perform substandard mammography.

The agency recognizes the importance of issuing performance

standards that do not allow loopholes. As with provisions that specify

the manner of compliance facilities must adopt, FDA intends to review

performance-based approaches for potential gaps that could defeat

efforts to achieve quality mammography.

(Comment 32). One comment stated that the ideas presented in the

alternative approaches section are unworkable and were not discussed

with the members of NMQAAC.

FDA acknowledges that NMQAAC did not have the opportunity to

discuss the alternative approaches material before publication (61 FR

14856). However, NMQAAC members did have the opportunity to review this

material and to make comments and recommendations at two meetings after

the proposal was published.

Generally, the NMQAAC comments did not support increasing the

number of performance-based standards at this time. They pointed out

that the

[[Page 55862]]

proposed regulations were actually a mix of performance- and

specification-based standards. While NMQAAC agreed that increased

reliance on performance-based standards might have promise for the

future, after further research is done, there are insufficient data at

this time to base the entire set of standards on performance criteria.

(Comment 33). One comment stated that the current tests specified

in the existing regulations are more thorough and complete than

alternative performance approaches that were identified in the preamble

to the proposed rules. A similar comment stated that the current tests

should be used by all facilities, with the exception of those

facilities that might develop improved, innovative strategies or

methods. The comment recommended that these facilities apply to FDA for

exemptions to use the innovative strategies or alternative methods. FDA

notes that a process for accepting and reviewing such applications is

provided by Sec. 900.18.

An additional comment expressed support for the intent of Executive

Order 12866, but at the same time argued that it is in the best

interests of FDA to be more specific in the final rules about those

instances where there are multiple methods or procedures to accomplish

the same task. The comment further stated that it was unclear how the

agency decided whether to use a performance outcome-based or a design-

based requirement in a particular situation. A second comment expressed

a similar opinion.

FDA notes that the comments on performance outcome-based standards

discussed above and in the following pages point out many difficulties

at the present time in establishing regulatory requirements to ensure

quality mammography that are based totally on performance outcomes.

However, the agency believes that in certain areas, for example,

quality assurance, performance outcome standards can and should be

established. In developing standards in a particular area, the agency

first considered whether it was feasible to ensure quality in that area

with performance-outcome standards. If it was not possible to issue

adequate performance-outcome standards in that area, the agency then

turned to design standards. Along those lines, FDA disagrees with the

statement in the comment that specific-design standards should always

be issued in cases where there are multiple ways of adequately

achieving a particular task or goal. On the contrary, the agency

believes that performance-outcome standards should be strongly

considered in such areas in order to give facilities the flexibility to

chose the method of achieving the goal that bests fits its particular

circumstances, instead of requiring that all facilities follow the same

path.

One other general comment similar to those of NMQAAC, asserted that

it was premature to try to identify alternative performance-based

approaches due to inadequate research and testing of these alternative

methods at this time. Another comment indicated that FDA did not comply

with Executive Order 12866 because the agency did not make a real

effort to identify alternative approaches. Similarly, one comment

argued that the FDA regulations ignored duplication with other

regulations, although no examples were given.

FDA notes that it did include a number of possible performance

outcomes measures in the proposal. There may be other possibilities of

which the agency is unaware, but the fact that no alternatives were

suggested by the author of these comments, or in any other comment,

suggests that few, if any, other options are currently available. FDA

further notes that the attempt to elicit public comment,

recommendations, and opinions concerning performance-based standards

through the proposal will not end its efforts to identify such

alternatives. FDA is unable to respond to the criticism that its

efforts duplicate other regulations in the absence of information on

where the author of the comment believes this has occurred. However,

HCFA has agreed to set aside its regulations in the mammography area

and to accept FDA-certified facilities as meeting its requirements for

reimbursement under Medicare and Medicaid. This eliminated one possible

source of regulation duplication.

FDA strongly supports the use of performance standards, however, it

recognizes that additional research is needed in the scientific

community before it can support additional regulations based on

performance outcomes. FDA encourages continued research in this area,

and will actively work to develop performance standards in the future.

2. Performance Standards and Outcomes Measures Suggested in the

Proposal

A large number of comments were received on the various performance

outcomes measures identified as possible alternatives by FDA. These are

reviewed in the following narrative in connection with the identified

alternative.

3. Mammography Medical Outcomes Audit

(Comment 34). FDA in the preamble to the proposed rules, FDA

suggested that the results of a mammography medical outcomes audit

might be used as the basis for a performance-based standard for each

mammography facility. A significant number of comments expressed

concerns about one particular aspect of the audit, namely, requirements

for patient followup that might be necessary to obtain outcomes data.

The major issues raised were the cost of such followup and the lack of

evidence that feedback about outcomes improves practitioner

performance. The authors of the 10 comments believed that individual

practitioners would never have sufficient cases to calculate meaningful

statistical outcomes.

Concerns were also expressed that there were no protections for the

confidentiality of outcomes data and that medical outcomes-based

standards could motivate practitioners to avoid challenging or

difficult cases. Eleven comments expressed objections to any

performance standard that would require mammography facilities and

interpreting physicians to collect followup data on films interpreted

as negative or to require the calculation of statistics relating to

sensitivity, specificity, or minimal cancer detection rates. One

comment objected on the basis that requiring the collection of such

data would imply that standards were required to force physicians to do

the best possible job and that this was necessary because it was the

norm for physicians to cheat or be dishonest. One comment expressed the

view that use of cancer registries to accumulate data for monitoring

outcomes was clumsy and expensive.

A related set of comments directed toward use of the positive

predictive value (PPV) statistic as a measure of quality mammography

performance was overwhelmingly negative. Nine comments pointed out that

there are varying definitions of PPV and that this is not a measure

familiar and understandable to the general public. The general

consensus was that this statistic was not useful and should not be

required to be published outside the physician's practice. Six

respondents argued that it was completely unacceptable to use the

physician's outcomes data as a measure of performance. Two comments

expressed the viewpoint that collection of information about PPV was

not appropriate because it was affected by many factors beyond the

control of the facility. Three comments vehemently opposed the public

disclosure of outcomes data, arguing that there would be a high

likelihood of misinterpretation by the public and incentives for

[[Page 55863]]

facilities to falsify data. Two comments stated that data collection

and review alone would not have any significant influence on

radiologists' behavior, and consequently, that collection of

statistical data was not worth the effort. Finally, one comment agreed

that it would be valuable to find valid process and outcomes measures

for mammography but concluded that it would be premature to focus on

PPV, which is subject to influence by so many factors external to the

radiologist.

In contrast to these negative comments on using the results of the

mammography medical outcomes audit as the basis for performance

standards, one comment strongly supported the idea of the medical audit

as the basis for a performance standard and argued for the publication

of such findings in order to ensure that the public had access to

information that would allow them to select a reputable institution.

Another supportive comment asserted that the agency should develop

performance standards for medical outcomes audit statistics, which

could then be used to evaluate physician performance. A third

respondent urged that medical outcomes could and should be used as more

comprehensive measures of competence and compliance. Another comment

suggested that standardized values for sensitivity and specificity

could support a reduction in personnel requirements for facilities that

met the performance standards for these two statistics. One final

comment applauded the possibility of change from specification of the

manner of compliance to specification of performance objectives.

FDA observes that the majority of the comments received oppose the

use of the results of the mammography medical outcomes audit as the

basis for performance-based standards, at least at this time. The

agency recognizes that the issues of the confidentiality of data

collected and the limitations of PPV as an indicator of performance,

and the other problems identified in the comments, are concerns that

would have to be addressed before the audit could become the basis for

performance-based standards. The agency has concluded that it is

premature to establish performance standards based upon the mammography

medical outcomes audit, primarily because the necessary data to

establish such standards and to resolve the concerns expressed in the

comments are not yet available.

FDA is aware that the National Cancer Institute's Breast Cancer

Surveillance Consortium (NCI BCSC) has been actively engaged in

research to understand the full effect of breast cancer screening on

cancer outcomes through a collaborative effort with academic and

community-based mammography facilities. Through linkages of data from

mammography facilities with pathology data on cancer outcomes from

population-based cancer registries, outcomes data will be correlated to

interpretation. One of the goals of this research is to help establish

realistic targets for mammography performance. FDA participates with

the NCI BCSC and has staff expertise in the medical outcomes audit area

to further assist standards development of outcomes measures. FDA will

evaluate results from this research project as well as other projects

to determine the best approach to promote improved mammography

performance through performance-based outcome measures. FDA anticipates

issuing regulations in the future that would have appropriate medical

outcomes-based measures.

To this end, facilities are actively encouraged to develop their

medical audit programs and pursue outcomes-based measures. Information

to assist facilities in conducting and interpreting the mammography

medical outcomes audit can be found in the medial literature. In

addition, in 1994 the Agency for Health Care Policy and Research

published, ``Quality Mammography: Clinical Practice Guidelines.'' This

primer has a complete discussion of issues surrounding the medical

audit and has references to aid facilities. Meanwhile, the suggestions

contained in the comments to FDA's proposed rule supporting the use of

the audit as a basis for performance standards will be considered by

FDA in further efforts to develop performance-based standards. In

addition, FDA specifically invites comments on this issue for future

consideration. Please submit comments on this issue to the contact

person listed above.

4. Performance-based or Proficiency Testing

With respect to personnel, FDA raised the possibility in the

proposal that standards based on successfully passing proficiency tests

might be the basis for replacement of design specification standards

requiring certain levels of training and experience.

(Comment 35). The general consensus of 34 comments on proficiency

testing was that such requirements would be excessive, unnecessary,

costly, impractical, and duplicative of examinations already in place,

such as those administered by the American Board of Medical Physics,

the American Board of Radiology (ABR), and the American Board of Health

Physics. Twenty comments criticized the use of performance-based

standards in this area because they asserted that such standards are

not yet developed to a level where they can substitute for current

requirements. Two comments stated that it is better if FDA does not

become involved in personnel performance-based standards as part of the

MQSA. Rather, continuing medical education (CME) requirements as they

currently exist should be satisfactory for this part of the education

process. Three respondents indicated that the term ``performance-based

testing'' is too vague and could include even such simple things as the

radiologist's observation of the technologist performing an

examination.

After reviewing these general comments and the specific ones that

are discussed later in this document, FDA has concluded that it would

be premature to establish general performance standards based on

proficiency testing because there is no consensus among experts about

what those standards should be or how they should be measured. The

topic of proficiency testing for specific professional groups drew a

number of responses varying in their level of support for such testing.

Specific comments are noted and discussed as follows:

a. Proficiency testing for radiologists

(Comment 36). Proficiency testing for radiologists drew divergent

responses. Three comments urged that FDA, in collaboration with NMQAAC,

develop a proficiency test that physicians must pass prior to

initiating the practice of mammography interpretation. Four additional

comments favored proficiency testing for radiologists, but only as an

initial requirement. Thirteen comments indicated unqualified support

for proficiency testing for physicians. In contrast, five comments

maintained that board certification could replace proficiency testing

with intermittent retesting at 5- to 8-year intervals. Such

examinations could be handled by the accreditation bodies. Another

comment stated that random clinical image review at the time of the

MQSA annual inspection could substitute for proficiency testing. Six

comments agreed with the basic premise that performance evaluation is

important in order to determine accurate standards but that more time

is required to determine appropriate testing devices and standards. One

comment stated that training and experience requirements for

interpreting physicians should be sufficient and there was no need for

periodic testing. Similarly, one comment stated that the

[[Page 55864]]

medical audit could function as a proficiency test for radiologists.

Two comments expressed a total lack of support for proficiency testing,

arguing that such testing is time consuming, costly, unnecessary,

redundant, and not done in any other area of medicine. One comment

stated that periodic proficiency testing is appropriate for

nonradiologists reading mammograms but not for trained radiologists. In

lieu of proficiency testing, this comment suggested a special

certificate as part of designated continuing education courses as a

simpler way to establish a measure of proficiency. One final comment

stated that proficiency testing would impose undue hardship on the

radiologist whose practice is not exclusively devoted to mammography. A

total of 79 respondents argued that the cost of proficiency testing

would be too high and that the additional expenses would be passed

along to consumers.

FDA observes that support for proficiency testing for interpreting

physicians is somewhat stronger than for proficiency testing in

general, but that the majority of respondents still opposed the idea.

Given the diversity of response to the possible use of proficiency

testing for radiologists, and the fact that no existing tests were

identified in the comments, FDA has concluded that it is not in the

interest of quality mammography to mandate such testing at this time.

The agency believes that proficiency testing for physicians, if

feasible at all, would have to undergo further development before it

could be the basis of a performance standard.

b. Proficiency testing for technologists

(Comment 37). Three respondents stated that proficiency testing

every 3 to 5 years would be beneficial to technologists. One additional

comment concurred, but recommended testing every 2 years. Overall,

however, there was a general lack of support in the comments for

proficiency testing of technologists.

Sixty-one comments stated that such testing for technologists

cannot be conducted objectively and also indicated that the final

requirements were adequate to ensure the qualifications of

technologists. Ten additional comments claimed that proficiency testing

for technologists is impractical because of the lack of established

criteria and the absence of an appropriate body to administer such

tests. Three respondents argued that the medical audit served as a

proxy proficiency test for technologists. Twenty comments stated that

the proposed continuing education requirements were sufficient and it

was not necessary to administer recertification examinations. Thirty-

seven comments argued that technologist proficiency testing was

redundant with the other initial and continuing education requirements.

One comment stated that at one time, the ARRT had considered adding

a practical exam to its evaluation of mammography competency but

deferred doing so until credible analyses would establish that such an

examination would result in improved quality of performance. Four

comments stated that proficiency testing for technologists would drive

technologists away from the field of mammography. One comment expressed

the view that annual testing was unnecessary because mammography does

not change that rapidly. Another comment stated that a requirement for

proficiency testing for technologists would have a negative impact on

the availability of mammography in rural and mountainous regions. An

additional respondent argued that the annual requirements for

technologists are already excessive and the addition of competency or

proficiency testing would simply raise costs or close mammography

facilities. Four other comments expressed similar sentiments, stating

that technologists already have to meet sufficient requirements, and

the addition of proficiency testing would be excessive. Concerns also

were raised about who would administer such testing and the method of

payment. One comment urged that, if proficiency testing became a

requirement for recertification, it should be offered at no cost to the

technologist.

One comment argued that incompetent technologists could pass a

proficiency test and further stated that proficiency testing was a

measure of test-taking skills, not of mammographic competency. Two

comments expressed the point of view that proficiency testing is

useless and insulting. Several comments stated that recertification, if

required in addition to continuing education, is redundant, time-

consuming, and costly. These comments asserted that retesting is

valuable only in instances of significant changes in the mammography

modality. One comment pointed out that the ARDMS (a sonographer's

organization not further identified) had tried to offer a practical

examination, but abandoned the project because it proved too costly.

The remaining comments were all generally opposed to proficiency

testing for technologists. One comment suggested that a better way to

evaluate technologists would be to require performance at a seminar

that would assess their clinical competence. Another comment concurred

with this viewpoint, saying that a written exam cannot measure

competence in a hands-on field such as mammography. Finally, one

comment argued that further examination is not necessary if the

technologist remains active in the field of mammography and maintains

proper licensure.

The agency is persuaded that regulations requiring such testing

would be premature. FDA believes some of the objections raised, as with

the objections to radiologist testing, can be addressed and overcome;

e.g., to the extent comments argued that proficiency testing was

duplicative of current training, education, and experience

requirements, FDA could consider eliminating some of those

requirements. However, the agency agrees with the general consensus

expressed by the comments and concludes that proficiency testing for

technologists currently cannot provide the basis for a performance

standard.

c. Proficiency testing for physicists

(Comment 38). The agency received 17 comments about this topic. Of

the 17, 3 were in favor of proficiency testing for physicists, with 1

additional comment asserting that is would be possible to conduct such

a test, but only at great cost. Other comments stated that proficiency

testing for physicists was simply a bad idea. Two comments argued that

the proposed standards of a written examination and a practical survey

test were sufficient proficiency measures for physicists. Two comments

stated that a doctorate in physical science and board certification in

an appropriate medical physics sub-specialty provided a better

assurance of professional integrity than written and practical

examinations. Another comment suggested that it would be more

appropriate for physicists' accreditation bodies to administer such

tests because FDA lacked the necessary experience and knowledge in this

area. One comment expressed concern about the possibility of computer

errors if the examinations relied on computer programs for test

administration and scoring. One comment recommended that the idea of a

qualifying examination for physicists should be further explored,

especially because the proposed regulations do not adequately address

the issue of how detailed an annual survey should be.

One comment asked whether a performance-based standard would help

physicists working at small institutions to meet the training

requirements. Although it is possible that proficiency

[[Page 55865]]

testing could alleviate difficulties involving access to training for

some physicists, FDA notes that it is not possible to determine whether

such an approach would permit these physicists to qualify until such a

time as the form and nature of a possible proficiency test is better

known.

As with proficiency testing for interpreting physicians and

radiologic technologists, the comments have persuaded FDA that it would

be premature to require such testing for physicists as the basis of a

performance standard. The agency, however, will continue to explore the

feasibility of such testing for radiologists, technologists, and

physicists.

5. Mammography Equipment and QC

The preamble to the proposals (61 FR 14860) suggested possible

performance-based substitutes for equipment specification and QC

testing in the proposed rule. One general comment recommended that FDA

retain the existing QC tests as proposed to ensure adequate mammography

equipment and QC. The author was of the opinion that one or two

performance-based criteria would not be adequate to serve as QC

measures.

a. Phantom image testing

FDA suggested that one possibility was that a more sophisticated

phantom might be developed for use in a single QC test that would

provide the same information on equipment performance as some or all of

the separate tests and specifications. A performance-based standard

predicated on test results using this phantom and falling within

defined limits might provide the same assurance of image quality as a

number of the design specifications and, therefore, could replace the

design specifications in the regulations.

(Comment 39). One comment stated that it was possible to develop a

single system test with an alternative phantom. The comment stated that

one distinct advantage of a single system test would be to replace the

present daily processor quality control (QC) test with sensitometry

based on the actual light emission of the radiographic screen and at

the same time check the performance of the rest of the imaging system.

The comment stated that the final regulations should allow facilities

and accreditation bodies to work together to adopt a suitable phantom

to be used as a daily total system test. The majority of the comments

received, however, were opposed to using phantom image testing as a

comprehensive equipment test, even if such testing would permit

alternative tests to be performed less frequently. There was strong

support for FDA to implement the mammography performance and design

requirements described in the proposed rules. Overall, a total of nine

comments opposed use of the phantom as a daily test that would replace

other QC tests. It was noted that more frequent use of the phantom

would increase costs, would not yield an adequate measure of quality,

would be useful only as a supplement to other QC tests, and would yield

results that were highly variable. Three comments remarked that phantom

testing is a good measure of quality but cannot replace all other QC

tests. Finally, it was noted that the STEP test should be added to the

phantom image analysis.

FDA observes that the general consensus of these comments is that

it is unlikely that testing with a more sophisticated phantom, if one

is made available through further research, will be an adequate

substitute for other QC tests.

b. Repeat rate

Another measure that was suggested as a possible performance

standard was the facility's repeat rate. Under the final regulations, a

repeat rate is to be analyzed every 3 months, and include up to 250

examinations. In the preamble to the proposal (61 FR 14860), FDA asked

for comments on the possibility of using the repeat analysis rate in

some modified form, such as conducting the test continuously, as the

basis for a performance standard. The agency also noted that such a use

would have to take into account the possibility that the repeat rate

could be altered through the acceptance by a mammography facility of

all images of any quality performed.

(Comment 40). Responses to this possible alternative were generally

negative. Three comments contended that the repeat rate could not serve

as an alternative to existing equipment and QC tests. Specifically, it

was noted that ongoing repeat analyses could not substitute for QC

tests. Four comments raised concerns about the possibilities for

altering or falsifying findings and lack of consistency within and

between mammography facilities in performing repeat analyses. A related

comment stated that technologists will not repeat images that should be

redone if they think the repeated images will affect their job. This

means poorer images may be submitted to radiologists for

interpretation.

FDA recognizes the validity of the concerns raised by these

comments and has concluded that a performance standard based on repeat

rate analyses is not likely to enhance quality mammography nationwide.

c. Clinical image review

FDA identified clinical image review as a possible basis for

performance-based standards. General comments regarding clinical image

review for this purpose were largely unfavorable.

(Comment 41). Nine respondents argued that random selection of

images for review is unnecessary because the review is conducted by the

accreditation body. It is better therefore, these comments continued,

to select previous images of the same patients to document improvements

in image quality between examinations rather than random selection of

images. Thirteen comments stated that the supervising radiologist

ultimately is responsible for assessment of clinical image quality.

Four comments questioned who would do the clinical image reviews for

all facilities and suggested that this would require a new government

agency in a time when government has been directed to downsize. Two

comments stated that clinical image review is only useful as a learning

tool in difficult cases and is not useful as a general test of

proficiency.

Additional comments were received on the possibility of using

clinical image review to evaluate the performance of the radiologic

technologist. Twelve comments were openly opposed to clinical image

review for assessment of technologists, arguing that it would require a

large investment of effort and financial resources. One comment said

that the radiologist, not the technologist, is responsible for the

quality of images and, consequently, it would be inappropriate to use

this as a performance assessment for technologists. Another comment

expressed the point of view that clinical image review was unnecessary

if technologists remain active in performing mammography and also

maintain proper licensure.

The question of who would do the image reviews drew a number of

comments. One comment said that clinical image review by technologists

had been tried previously with poor success, although specifics about

the problems were not mentioned. Nine comments asserted that clinical

image review to assess technologist performance should be done under

physician review, rather than by sending images to an outside

bureaucracy, which would be very costly for facilities. Cost was raised

as an issue by another respondent who argued that a facility with many

mammography technologists would have many images out for review, which

would be both costly and a threat to patient confidentiality. One

comment suggested that the FDA inspector review

[[Page 55866]]

clinical images at the time of the annual MQSA inspection, rather than

the facility submitting the images to some central point. Under this

approach, technologists and radiologists would complete critique forms

of their images to explain any difficulties or problems in taking or

reading the films.

On the more positive side, twelve comments stated that clinical

image review under the MQSA, combined with additional actions, would

ensure proper mammography performance sufficient to assess

technologists' clinical skills. The additional action suggested by 10

of these comments was yearly attendance at hands-on workshops, while

another comment suggested periodic recertification examinations, and

the 12th advocated use of repeat analysis. This last comment also

suggested that such an evaluation could even substitute for the

practice volume requirement for technologists in the proposal.

FDA observes that opinion is divided more evenly on the feasibility

of using clinical image review as a performance standard for

technologists than on the feasibility of the other possible bases for

performance standards mentioned in the proposal. The major problem

seems to be how to establish an effective system at a reasonable cost.

Although clinical image review will not substitute for the radiologic

technologist requirements being finalized in the regulations, FDA will

continue to evaluate this issue in collaboration with the members of

NMQAAC and other agencies involved with mammography QC.

6. General Observations

As discussed above, FDA sought public comment on the possibility of

taking an alternative approach to assuring the quality of mammography

nationwide. The alternative approach would be the greater use of

performance-based standards in place of the primarily design

specification standards established in the interim regulations and

proposed for the final regulations. Several possible measures or

mechanisms that could form the basis for performance-based standards

were identified and the public was invited to comment on their

feasibility and also to suggest other options. The agency also asked

for comments on how it should proceed with regulation development if

performance-based standards were considered feasible. If such standards

could be developed relatively quickly, FDA could consider maintaining

the interim standards and delaying the issuance of final regulations

until performance-based standards were developed. Conversely, if the

expected time for the development of performance-based standards was

lengthy, in the interest of achieving additional improvement in

mammography more rapidly, the agency might appropriately proceed with

finalizing the proposed rules (as modified in response to public

comment) and replace them at a later date with performance-based

standards after the necessary research for those standards was

complete.

(Comment 42). Only four comments addressed these questions directly

and, as noted above, they urged FDA to proceed with publication of the

final regulations. FDA also notes, as described above, that the

comments on the possible mechanisms for performance-based standards

identified by the agency were predominantly negative. Furthermore, none

of the comments suggested any other possibilities for performance-based

standards. This would seem to support the view that performance-based

standards, if feasible, will require further research. Based on this,

FDA concluded that it should proceed with the publication of these

final regulations. If further research and development suggest that

performance-based standards can replace these regulations, FDA will

propose amendments to the MQSA rules.

C. Scope Sec. 900.1

This section briefly summarized the content of the following

regulatory sections. No comments were received and it was codified

unchanged.

D. Definitions Sec. 900.2

This section defines terms used in the regulations whose meaning

would not be common knowledge or for which there exists more than one

definition, making it necessary to specify which is to be used for the

purposes of these regulations. Comments received on the definitions in

the proposal are discussed first. This is followed by a consideration

of comments that recommended adding new definitions or made other more

general comments on the proposed definitions. Discussed third are

definitions that have been added to, or changed from, those in the

proposal due to changes in other parts of the regulations.

1. Comments on the Proposed Definitions

a. General comments on several related definitions

The following closely related definitions were included in the

proposal in order to identify which consumer complaints must be

considered by the facility and the accreditation bodies in the

complaint process required by the MQSA:

Adverse event

Consumer

Serious adverse event

Serious complaint

The purpose of these definitions, as explained in the preamble to the

proposal (61 FR 14863), is to ensure that serious complaints about the

quality of the MQSA-related mammography services are adequately

addressed without placing an undue burden on facilities and

accreditation bodies by requiring extensive consideration for

relatively minor complaints.

``Adverse event'' is defined to mean an undesirable experience

associated with mammography activities within the scope of 42 U.S.C.

263b. Examples were included in the definition.

The definition of a ``consumer'' is intended to make it clear that

a patient or a representative of the patient (for example, family

members or referring physicians) can file complaints.

``Serious adverse event'' is defined to mean an adverse event that

could significantly compromise clinical outcomes or for which a

facility failed to take appropriate corrective action in a timely

manner. Finally, ``serious complaint'' is defined to mean a report of a

serious adverse event. Facilities, under Sec. 900.12(h), and

accreditation bodies, under Sec. 900.4(g), are required to carry out

specified activities in response to serious complaints.

(Comment 43). A number of general comments were received on these

related definitions. One comment stated that using the severity levels

outlined in current inspection procedures would be more applicable for

complaint activities than the proposed definitions.

FDA disagrees with this comment. The severity levels used for the

MQSA inspection program were developed for use by inspectors. They are

too technical and not necessarily relevant for consumer complaint

purposes.

(Comment 44). One comment recommended removing the terms ``adverse

event'' and ``serious adverse event'' and the addition of the

definition of ``complaint'' to mean the report of any undesirable

experience associated with mammography activities. These experiences

may include poor image quality, failure to send mammography reports

within 30 days, or the use of personnel who do not meet regulatory

requirements. Another comment also suggested adding a definition for

complaint without specifying what it should be.

FDA believes that the definition offered by the first comment could

result in complaints unrelated to the

[[Page 55867]]

MQSA (e.g., billing procedures) and complaints that would not

ordinarily be considered serious by most patients (e.g., facility

temperature) being forwarded to the accreditation bodies and FDA when

they have the greatest chance for resolution at the facility. The final

regulations require facilities to record all serious complaints. The

facility will forward unresolved serious complaints to the

accreditation body and/or FDA for further action. In addition, the

agency notes that the definitions of ``adverse event'' and ``serious

adverse event'' give examples of the kind of complaints that are within

the parameters of the consumer complaint mechanism. All of the examples

noted in the comment would fall within the scope of consumer complaints

subject to further accreditation body and FDA review.

b. Adverse event

(Comment 45). One comment agreed that the definition of ``adverse

event'' should include failure to send mammography reports in a timely

fashion to the referring physician or self-referred patient, but argued

that 30 days is an unreasonably long time for communication of adverse

events. FDA notes that the 30-day period referenced in the definition

is intended as the maximum amount of time that may elapse and that the

regulations state that the results should be communicated as soon as

possible.

This is discussed further in section III.L.3 of this document,

where FDA's responses to comments received on Secs. 900.12(c)(2)

Communication of mammography results to the patient, and 900.12(c)(3)

Communication of mammography results to health care providers, are

given.

(Comment 46). Several comments requested greater clarity or

additional explanation for the term ``poor image quality'' (used in the

definition of adverse event), and FDA's criteria to determine when

image quality is poor. The comment observed that the definition of poor

image quality is likely to be very subjective.

FDA agrees that a single definition for poor image quality would be

subjective and, therefore, has not included such a definition in order

to give facilities and accreditation bodies the flexibility to evaluate

such performance in a particular situation on a case-by-case basis.

However, criteria to be considered by accreditation bodies in

evaluating acceptable image quality are specified in Sec. 900.4(c)(2).

Consumers who decide to complain about poor image quality would

generally have assistance from health professionals (for example,

referring or consulting physicians, or accreditation body) in making

this determination. In situations in which FDA has reason to believe

image quality at a particular facility is poor, FDA may consult with

accreditation bodies for additional mammography review in order to

determine whether corrective or enforcement actions are appropriate.

c. Serious adverse event

The regulation defines ``serious adverse event'' as ``an adverse

event that may significantly compromise clinical outcomes, or an

adverse event for which a facility fails to take appropriate corrective

action in a timely manner.''

(Comment 47). Four comments recommended that the definition of

``serious adverse event'' should be revised. They stated that failure

to take action on a nonserious event should not turn the event into a

serious complaint. The comments recommended that ``serious complaint''

should be written to preclude common and potentially unavoidable

complaints about mammography (e.g., compression hurts, room too cold).

FDA disagrees that the definition should be revised. Failure to

take action on certain nonserious events may indeed result in a serious

adverse event. For example, it is generally accepted that most

compression complaints are considered to be minor. However, there may

be instances in which compression is unusually severe and, therefore,

the complaint would be considered serious. FDA believes the definition

should remain flexible to allow for this type of situation.

(Comment 48). One comment suggested changing ``may significantly

compromise clinical outcomes'' to ``has significantly compromised

clinical outcomes.''

FDA disagrees. A primary goal of the consumer complaint mechanism

is to improve mammography services by providing facilities with data

and information they might not otherwise receive or analyze. It is

preferable to correct a potentially serious situation before harm

occurs, rather than after the harm has affected the patient.

d. Serious complaint

(Comment 49). A ``serious complaint'' is defined as ``a report of a

serious adverse event.'' Two comments suggested that descriptions of

the type of serious complaints to be reported to the accreditation body

should be specified.

FDA agrees that additional descriptions will be helpful and intends

to make such information available through guidance. The agency

believes that making this information available in guidance, rather

than in regulations, will give facilities, accreditation bodies, and

FDA the flexibility to determine on a case-by-case basis whether or not

an event should be classified as serious.

e. Contact hour

``Contact hour'' was defined in the proposal as an hour of training

received through direct instruction.

(Comment 50). One comment recommended that it be defined as 50

minutes.

FDA is aware that in academic institutions an hour of didactic

training is frequently only 50 minutes long. However, in clinical and

continuing education situations, an hour of instruction is usually a

full 60 minutes. Reducing the figure from 60 to 50 minutes would reduce

the training requirements 16 percent. Because those training

requirements were proposed at what are believed to be the minimum

adequate levels, the agency did not change the definition.

f. Direct instruction

Direct instruction requires instructor-student interaction, either

face-to-face or through examination.

(Comment 51). One comment stated that the definition is too vague,

especially when compared to mammography equipment evaluation.

FDA disagrees. The agency believes the definition is sufficiently

specific to give a clear idea of what is required, while also

preserving the flexibility to accept possible new approaches to

instruction.

g. Direct supervision

The definition of direct supervision was designed to permit

``trainees'' to lawfully obtain the experience in interpreting or

producing mammograms or surveying mammography units that they needed to

become qualified or requalified. At the same time, by having the

trainee's work checked and, if necessary, corrected before any clinical

care might be jeopardized, the patient's right to adequate quality

mammography is protected.

(Comment 52). One comment supported this definition. A second

comment asked if direct supervision was needed for ``nonqualified''

people doing the QC tests.

In accordance with 42 U.S.C. 263b(f)(1), personnel qualifications

were established only for interpreting physicians, radiologic

technologists, and medical physicists. As a result, tests performed by

medical physicist ``trainees'' would have to be done under this

definition of direct supervision, although tests performed by QC

technologist ``trainees'' would not. However, the agency notes that

Sec. 900.12(d)(1)(iv) makes the QC technologist responsible for

ensuring the quality of performance of those

[[Page 55868]]

doing QC tests. The definition of QC technologist in Sec. 900.2(pp)

requires the QC technologists to meet the requirements for a radiologic

technologist, including training in quality assurance/QC. Taken

together, these requirements provide for a level of supervision similar

to that provided under this definition.

h. Facility

The definition of ``facility'' is provided by the law itself in 42

U.S.C. 263b(a)(3). It includes a variety of types of locations where

mammograms are produced, processed, or interpreted.

(Comment 53). Three comments either inquired if processing and

interpreting facilities would have to be certified and inspected or

asked that these facilities be excluded from the requirements. The law

defines locations where mammograms are processed or interpreted, and

where mammograms are produced, as facilities (42 U.S.C. 263b(a)(3)).

The agency's approach under the interim regulations, which is expected

to continue under the final regulations, has been a systems approach.

The facility producing the mammograms receives the certificate and is

responsible for ensuring that the facilities at which their mammograms

are processed and interpreted, if separate, meet the applicable quality

standards. This is consistent with the statutory provision that

requires the facility performing the mammography to be responsible for

meeting quality standards (42 U.S.C. 263b(a)(3)(B)). FDA has not set up

a separate certification and inspection system for facilities that

process or interpret only. However, because a certification system for

``partial'' providers may have some advantages for such facilities, the

agency may consider such an approach in the future.

(Comment 54). Two comments requested that the definition be

expanded to address situations involving multiple locations under the

same certificate or temporary locations where a unit (stationary,

portable, or mobile) is used more than a minimum number of days.

FDA's experience under the interim regulations shows there is wide

variety in the locations at which mammography is performed and in the

corporate and business relationships among these locations. Presently,

such situations are handled on a case-by-case basis in consultation

with the facilities and accreditation bodies involved. The agency

believes that it is essential that this flexibility be maintained and

that it would be unduly restrictive to prescribe permissible locality

arrangements in regulation.

i. First allowable time

The proposal defined ``first allowable time'' as the earliest time

a physician is eligible to take the diagnostic radiology boards of an

eligible certifying body. Because the ``first allowable time'' a

resident physician becomes eligible to take the boards may vary with

the certifying body, the definition cannot be more specific. If a

resident physician wishes to use the exemption from the initial

experience requirement described in Sec. 900.12(a)(1)(iii)(B), it is

the physician's responsibility to ascertain the requirements of the

body by which he or she wishes to become certified and to seek that

certification as soon as he or she becomes eligible to do so.

(Comment 55). Three comments stated that this definition was

unclear and were unsure how or why this related to resident physicians

who would be interpreting 240 mammograms during a 6-month period.

NMQAAC also stated that the concept of ``first allowable time''

required further explanation.

This term is used in Sec. 900.12(a)(1)(iii)(B). That provision is

an exemption that allows resident physicians to interpret the 240

mammograms required for initial experience in any 6-month period during

the last 2 years of their residency program (rather than during the

last 6 months immediately prior to the date that the physician

qualifies as an interpreting physician as required under

Sec. 900.12(a)(1)(D)). This exemption is available as long as these

physicians become board certified the first time they are eligible.

This provision allows residency programs to be flexible in scheduling

training for their resident physicians and eliminates the need to put

all senior resident physicians on their mammography rotation during the

last 6 months of their program.

(Comment 56). Two comments stated that because the ``first

allowable time'' may vary with the certifying body, a more uniform

standard would be preferable.

FDA believes that the term ``first allowable time'' must be defined

as proposed in order to allow flexibility, because certifying bodies

differ in the scheduling of their examinations. Anything more

proscriptive could penalize future resident physicians if the

certifying body wished to change its examination schedule.

j. Lead interpreting physician

This term was included in the proposal to identify the interpreting

physician who has the general responsibility for ensuring that the

facility meets the quality assurance requirements.

(Comment 57). One comment stated that the definition was not needed

because this person is easily identified, while a second comment wanted

the term changed to supervising interpreting physician.

FDA agrees that in most facilities the person with this

responsibility can be easily identified, but also believes there is an

advantage in having a term that can be used to designate and reference

this individual, both for the benefit of the employee and patients of

the facilities and for the accreditation bodies and the government

regulators. The possibility of using ``supervising'' was discussed with

NMQAAC but was rejected out of concern about possible confusion between

this individual and administrative supervisors who may have different

responsibilities.

k. Mammographic modality

``Modality,'' as proposed, means a technology, within the scope of

42 U.S.C. 263b, for radiography of the breast. Screen-film and

xeromammography were given as examples of a modality. In fact, at

present, they are the only examples in general use.

(Comment 58). Two comments stated that the term modality has other

uses in medicine and that the definition could be confusing to

facilities. Twelve other comments also found the term unclear.

FDA notes that NMQAAC spent some time discussing other possible

terms that could be used before concluding that this was the most

appropriate. The agency is aware that the term modality is used in

different ways in different areas, which is why a definition of its

meaning with respect to the MQSA is needed. In an effort to distinguish

it further from the other meanings of modality, FDA has changed the

name of the term being defined from ``modality'' to ``mammographic

modality.'' The definition now appears in the final regulations at

Sec. 900.2(z).

(Comment 59). Two comments recommended that the term ``modality''

be replaced with ``specialized techniques in mammography.''

FDA did not accept this suggestion because both ``techniques'' and

``specialized techniques'' already have a variety of meanings in

radiology and the agency concluded that the recommended change would

increase rather than reduce confusion.

(Comment 60). Nine comments suggested that the definition be

broadened to include other technology. Stereotactic, ultrasound,

digital, nuclear medicine, Magnetic Resonance Imaging (MRI), and CT

were all suggested for addition.

[[Page 55869]]

FDA does not believe that the definition should be broadened. The

definition is intended to clarify training requirements for personnel

providing mammography services. These individuals are required to have

training in each mammographic modality with which they work. Because

ultrasound, nuclear medicine, and MRI fall outside the statutory

definition of mammography as radiography of the breast, the agency

cannot include training related to those technologies as part of the

regulatory requirements. Digital, CT, and stereotactic do fall under

the authority granted by 42 U.S.C. 263b but have been temporarily

exempted from the regulatory requirements. When and if training and

other requirements related to these technologies are issued, the

proposed definition will not delay such requirements from taking effect

for those modalities.

(Comment 61). One comment recommended that xeromammography be

excluded from the definition because it produced less than optimal

mammograms at a higher dose.

FDA agrees that there have been problems with the use of

xeromammography and notes that these problems have led to its near

disappearance. However, the effect of removing xeromammography from the

definition would be to exempt those who use the technology from having

to obtain training. FDA expects such a change would increase, not

decrease, the problems with the modality.

l. Mammography

This definition incorporates the definition of mammography as

``radiography of the breast'' provided by 42 U.S.C. 263b(a)(6), but

temporarily excludes from the quality standards radiography of the

breast performed in interventional mammography or with an

investigational mammography device during a scientific study conducted

in accordance with FDA's investigational device exemption regulations.

(Comment 62). One comment suggested that ``for the purposes of

these regulations'' should be inserted in this definition.

FDA believes that it is well understood that all definitions that

appear with any regulation are for the purposes of those regulations.

(Comment 63). Another comment suggested expanding the wording of

the definition to specifically mention X-ray radiation and several

types of image receptors. FDA notes that the term radiography implies

the use of X-rays.

The agency further notes that if the changes were made, and a new,

yet unimagined type of image receptor was approved following

investigational device studies, the definition would have to be amended

before the new device could be put into general use. To avoid such a

delay in the use of an advance in image receptor technology, the agency

has retained the proposed general definition.

m. Exclusion of interventional mammography

In the proposal (61 FR 14862), FDA temporarily excluded

interventional mammography (radiography performed during invasive

interventions for localizations or biopsy procedures) from the

definition of mammography. This had the effect of exempting such

mammography from the requirements of the regulations. A similar

exemption has been in effect under the September 30, 1994, amendments

to the interim regulations (59 FR 49808-49813). The basis for the

exclusion, as explained in the preamble to the proposal (61 FR 14862),

was the agency's belief that science had not advanced to the point

where effective national quality standards could be developed for these

devices.

(Comment 64). Over 90 comments supported the exclusion of

interventional mammography. Many of these agreed that there currently

is no consensus with respect to appropriate standards for stereotactic

units, and until regulations based on scientific data can be developed,

it is inappropriate to include interventional procedures within the

scope of the regulations. In addition, the comments stated that

surgeons have extensive experience in dealing with breast disease and

breast biopsy and they are best suited to manage the patient. These

comments noted that many surgeons have had extensive experience

performing stereotactically guided breast biopsies and have achieved

good results with this procedure. Others wrote that in this procedure,

the surgeon knows that the lesion is present and is merely using

stereotactic images to guide the needle to the proper position for

biopsy. Other comments stated that while radiologists have only one

method to biopsy the breast, surgeons have several options and can

offer the patient the best biopsy option for her clinical status. Some

comments stated that surgeons have a long history of providing followup

care for patients and for many years have used radiographic equipment

in the operating room and are familiar with its use. Several comments

said that surgeons have used mammography for many years in the

diagnosis and treatment planning for breast cancer patients. Still

others said that these biopsy procedures will evolve into therapeutic

procedures that are best handled by the surgeon and that surgeons are

best equipped to handle any followup or complications associated with

these biopsy procedures.

NMQAAC and over 100 comments opposed the exclusion of

interventional mammography. Many of these asserted that it is

counterproductive to set quality standards for mammographic diagnosis

while having none for mammographically guided invasive breast

procedures and that only interpreting physicians have the expertise and

experience necessary to perform this procedure. Authors of other

comments wrote that interpreting physicians have experience dealing

with the quality assurance and QC issues necessary to maintain

stereotactic biopsy equipment and that the failure to regulate this

procedure places the public at risk. Some said that the lack of

adequate mammographic training could lead to the lesion in question

being missed during tissue sampling and that the abilities and training

required to localize a small subtle suspicious area are the same as

those for interpreting a mammogram. Other comments stated that only

interpreting physicians will be able to interpret the original

mammograms to determine if a needle biopsy is appropriate.

FDA agrees with the comments stating that interventional

mammography can be of great use in the evaluation of breast disease,

but only if optimally performed. Until recently, the science had not

advanced to the point where effective national quality standards could

be developed for these procedures. Since the publication of the

proposed regulations on April 3, 1996, significant progress has

occurred in the professional community and FDA now believes that there

is enough information to begin the development of interventional

mammographic regulations. However, that development requires a

comprehensive and careful approach that addresses all the factors

involved in such procedures. The agency has already begun the

development process by bringing this issue before NMQAAC during its

October 1996 meeting and is continuing to gather information and data.

Although the agency has concluded that the final regulations should

exclude coverage of interventional mammography, FDA expects to propose

regulations covering all aspects of interventional mammography in the

near future.

n. Exclusion of investigational devices

In the proposal, FDA also excluded from the definition of

mammography,

[[Page 55870]]

and thus from the regulatory requirements, investigational mammography

devices that were being evaluated in accordance with FDA's

investigational device exemption regulations in 21 CFR part 812. This

provision extended the exclusion for investigational devices previously

established under the September 30, 1994, amendments to the interim

regulations. The agency believes that it is obvious that it would be

premature to establish standards for devices still in the experimental

stage. FDA also believes that the precautions built into the agency's

general investigational device exemption regulations provide adequate

protection for the public health during the use of these devices.

However, the agency made clear in the preamble to the proposal (61 FR

14862) that any conventional mammography device used during the

scientific study to provide baseline data for evaluating the safety and

efficacy of the investigational device was not within the scope of the

exclusion and would have to meet the MQSA requirements.

(Comment 65). Two comments stated that the wording of this section

would make MRI for mammography investigations or use of full field

digital mammography illegal, unless they are performed by a radiologist

specializing in mammography.

MRI is not radiography of the breast and, therefore, does not come

under the definition of mammography. Similarly, investigational

studies, such as those involving full field digital mammography, are

specifically excluded under the definition of mammography in

Sec. 900.2(z)(2) of the final regulations. FDA concludes, therefore,

that the regulations will not prevent such research from occurring.

However, any conventional mammography performed as part of a study is

not excluded and does have to meet all the requirements of the final

regulations. FDA has modified the definition to clarify this issue.

o. Mammography medical outcomes audit

``Mammography medical outcomes audit'' means a systematic

collection of mammography results and the comparison of those results

with outcomes data.

(Comment 66). One comment stated that the term ``medical audit''

was self-explanatory and did not need a definition.

FDA disagrees. There are many different working definitions of this

term being used in the professional community. FDA's definition of what

minimally constitutes a mammography medical outcomes audit is for the

purposes of the MQSA requirements and may be different from recommended

guidelines and definitions of other organizations.

p. Mammography unit or units

The definition for ``mammography unit or units'' is an assemblage

of components for the production of X-rays for use during mammography.

Several components were listed.

(Comment 67). Two comments suggested that compression device,

breast support, and components associated with the image receptor and

grid be added to the list.

These suggestions would not fit the general criterion of a

component for the production of X-rays and the agency is not adding

them to the list.

q. Mean optical density

``Mean optical density'' was defined as the average of the optical

densities measured for phantom thicknesses of 2 to 6 centimeters (cm)

using kilovolt peak (kVp) values clinically appropriate for the

thicknesses.

(Comment 68). Three comments were received on this definition. One

suggested that the thickness range should be changed to 3 to 7 cm. A

second also supported a 3 to 7 cm range, but stated it would be prudent

to check at 2 and 8 cm as well. The third comment stated that, because

the thicknesses chosen could influence the result, the definition

should specify the thicknesses to be used. The comment further

suggested that 2, 4, and 6 cm should be used.

This definition is used in connection with a QC test of Automatic

Exposure Control performance. The test procedures recommended by the

ACR manuals and incorporated by reference into the interim regulations

requires the use of 2, 4, and 6 cm thicknesses. The agency agrees with

the third comment that it would be of value to add the exact

thicknesses to the definition and has done so. FDA does not believe

there is justification for changing the range of thicknesses used in

this standard test, as suggested by the other two comments.

r. Medical physicist

``Medical physicist'' is defined as a person trained in evaluating

the performance of mammography equipment and quality assurance programs

and who meets the requirements of Sec. 900.12(a)(3).

(Comment 69). One comment stated that the MQSA does not provide

statutory authority to FDA to define the profession of medical

physicist.

It is not FDA's intention to define the profession of medical

physicist in general and the agency also agrees that it lacks the

authority to do so. However, the MQSA requires that the agency

establish qualifications for those medical physicists providing

mammography services to mammography facilities (42 U.S.C. 263b(f)(1)(E)

and (F)). This provides both the authority and responsibility to define

``medical physicist'' for the purpose of these regulations. Again, this

definition applies only to medical physicists who wish to provide

services to mammography facilities under the MQSA and not to the

profession as a whole.

s. Multi-reading

``Double reading,'' defined as two or more interpreting physicians

interpreting the same clinical image, was included in the proposal to

describe one of the options that interpreting physicians can use to

meet the experience requirements.

(Comment 70). Several comments, including a consensus of NMQAAC,

requested further clarification of this term. Confusion apparently has

arisen due to the fact that ``double reading'' commonly is used to

describe the situation where a mammogram is read by two interpreting

physicians in an attempt to improve the accuracy of the interpretation.

Two comments, including a consensus comment from NMQAAC, suggested that

another term be used to describe multiple interpretation as it applies

to the final regulations.

In response to these comments, FDA has substituted the term

``multi-read'' to describe interpretation of mammograms by two or more

physicians. Multi-reading can be used by physicians to meet continuing

experience requirements. Multi-reading can also be used by physicians

to meet initial and/or requalification requirements if it is done under

direct supervision.

(Comment 71). Some of the comments incorrectly assumed that FDA was

forcing facilities to have all their mammograms read by two

interpreting physicians.

While facilities are free to perform this type of ``multi-reading''

as a means to improve accuracy, FDA does not require that any mammogram

be read by more than one interpreting physician.

(Comment 72). One comment suggested adding the words ``that has not

been marked as to possible pathology'' at the end of the definition of

``double read'' (now changed to multi-read).

FDA disagrees and believes that an interpreting physician benefits

from reviewing mammograms, even those that have been marked by another

physician. Requiring the removal of such marks would be overly

burdensome and might even be

[[Page 55871]]

detrimental to the patient if the original marks were not put back on

the images.

(Comment 73). One comment requested clarification as to whether

physicians must independently interpret the same clinical image, or is

it within the intent of the definition to include two or more

physicians in consultation interpreting the image together.

FDA intends the concept of ``multi-reading'' to include both

independent and consultative reading. If the multi-reading is done

under direct supervision, there must be a consultative component to the

supervision.

t. Patient

In the proposal, FDA used ``examinee'' to refer to any individual

undergoing a mammography examination. This was a change from the term

``patient,'' which was used in the interim regulations. As explained in

the preamble to the proposal (61 FR 14862), the change was made in

recognition of the fact that most individuals who undergo mammography

are not ill and do not have a condition requiring medical care.

(Comment 74). Eighteen comments stated that it was not necessary to

replace ``patient'' with ``examinee,'' because patient is a term used

universally. One comment objected to the proposed use of ``examinee''

and preferred ``patient'' because ``patient'' conveys the ethical

protections of a doctor-patient relationship, confers malpractice

protection, and ensures that third party payers recognize the

examination as required care. One comment agreed with the definition of

examinee and the inclusion of self-referred persons.

NMQAAC discussed these comments and there was general consensus to

recommend that FDA use the term ``patient,'' provided the definition

would include people who did not have health care providers and people

without medical symptoms. Finally it should be noted that the MQSA uses

the term patient. In light of these comments, FDA has decided to return

to the use of ``patient,'' which is defined in the final regulations as

anyone undergoing a mammographic procedure.

u. Phantom

``Phantom'' is defined as a test object used to simulate

radiographic characteristics of compressed breast tissue and containing

components that radiographically model aspects of breast tissue and

disease.

(Comment 75). One comment on this definition requested that FDA

specify the phantom contents and measurements. A second comment urged

FDA not to change the current phantom unless the new phantom decreased

the frequency of other testing.

FDA believes that the accreditation bodies should establish the

phantom specifications and related performance criteria, rather than

the agency establishing them through regulation. However, as part of

its responsibilities for accreditation body approval and oversight, FDA

will examine each body's phantom specifications and performance

requirements to ensure that they are substantially the same among

different accreditation bodies.

FDA believes that the second comment was in response to the

suggestion that a more sophisticated phantom might facilitate the

establishment of performance outcomes standards based on the new

phantom's use that would take the place of several of the existing

tests. This issue was discussed previously with other comments on that

subject under section III.B of this document, where the agency

concluded that performance standards based on a new phantom were not

practical at this time.

v. Physical science

``Physical science'' means physics, chemistry, radiation science

(including medical physics and health physics), and engineering.

(Comment 76). One comment received on this definition stated that

the engineering part of this definition should be limited to electrical

and nuclear engineering only, while a second comment opposed the

inclusion of engineering and chemistry at all.

FDA notes that this term is used to establish the qualifications to

be met by medical physicists, which include a degree in the physical

sciences on an appropriate level. The purpose of that part of the

requirements is to ensure that the individual has a general familiarity

with the scientific concepts, calculations, and techniques that provide

a basis for understanding and completing more specialized work in

medical physics, not that he or she has already achieved the training

in medical physics. The agency further notes that this general

requirement is reinforced with a more specific requirement for training

in physics. Because meeting these two requirements provides an adequate

foundation for meeting the more specialized medical physics

requirements, the agency does not believe the definition needs to be

narrowed by eliminating the fields suggested in the comments.

w. Positive mammogram

``Positive mammogram'' means a mammogram that has an overall

assessment of findings that are either ``suspicious'' or ``highly

suggestive of malignancy.''

(Comment 77). One comment stated that the term positive mammogram

was self-explanatory and did not need a definition. FDA disagrees.

There are many different working definitions of this term being used in

the professional community. Because the final regulations require all

positive mammograms to be entered into the facility's medical audit

system, it is necessary to retain a definition of ``positive

mammogram'' in order to clarify the scope of the audit.

x. QC technologist

This term was defined to mean the individual who is responsible for

the segments of the quality assurance program that are not the

responsibility of the lead interpreting physician or the medical

physicist. In general, this responsibility consists of the routine QC

testing and some data analysis and corrective actions related to the

results of that testing.

(Comment 78). One comment stated that it is not necessary to

identify or define this position because the person with this

responsibility is easily identified.

FDA does not agree with this comment for the same reason it

disagreed with the similar comment about the definition of lead

interpreting physician. In addition, the title of QC technologist is

already widely used in mammography facilities.

This definition was changed, however, as a result of discussions at

the January 1997 NMQAAC meeting. It is often possible for a single

individual to perform the duties of a QC technologist for an entire

radiology facility. That individual ordinarily is a technologist, but

may not meet the qualifications to do mammography. At early meetings,

NMQAAC had agreed that this person should be a qualified technologist,

but did not necessarily have to be qualified to perform mammography.

This would avoid the possibility that the mammography department of a

radiology facility might have to have its own QC technologist, thus

forcing the facility to assign two persons to meet the responsibilities

previously handled by one. NMQAAC reconsidered its position at the

January 1997 meeting, however, and concluded that the advantages of

having the QC technologist in the mammography department be qualified

to do mammography outweighed the possible extra costs. FDA accepted

NMQAAC's advice on this matter and changed the wording in the

definition to require the QC technologist to meet all the

qualifications in Sec. 900.12(a)(2) for

[[Page 55872]]

radiologic technologists doing mammography.

(Comment 79). Three comments disagreed with the proposed definition

because it barred qualified biomedical engineers, manufacturer's

representatives, and other individuals the authors believed were

qualified from serving as QC technologists. Although NMQAAC has changed

its position from time to time on whether the QC technologist must be

qualified to do mammography, it has never wavered from its advice that

the individual in this position should be a radiologic technologist.

FDA concurs with that view. However, as discussed below in connection

with the quality assurance requirements under Sec. 900.12(d)(1)(iv),

the final regulations permit nontechnologists to perform certain QC

tasks as long as the QC technologist ensures that the performance is

adequate.

y. Traceable to a national standard

Traceability refers to the ability to show that an instrument has

been calibrated by a process that eventually led back to a standard

established by the National Institute of Standards and Technology

(NIST).

(Comment 80). A number of comments requested further clarification

of traceability. A few comments requested that the requirement for

annual calibration be changed to every 3 years.

In response to these comments and after discussion with calibration

experts, FDA has revised the definition of traceability. The term

itself has been changed to ``traceable to a national standard'' to more

clearly reflect what is needed. Other changes have clarified that the

ultimate source of the calibration may be either NIST or a calibration

facility that participates in a proficiency program with NIST at least

once every 2 years during which the calibration facility achieves

agreement within + 3 percent of the NIST standard at mammography energy

levels.

2. New Definitions Suggested by the Comments

a. Category I

(Comment 81). Several comments suggested that the meaning of the

term ``Category I,'' as used in the regulations, was unclear.

In response, FDA has defined Category I, at Sec. 900.2(g), to mean

medical educational activities that have been designated as Category I

by the Accreditation Council for Continuing Medical Education, the

American Osteopathic Association, a State medical society, or an

equivalent organization.

b. Contact mammography

(Comment 82). One comment recommended that this term from the final

regulations should be defined. However, in the revisions of the

regulations following the public comments, this term has been

eliminated, so a definition is no longer needed.

c. Continuing education unit

(Comment 83). One comment warned that it would be difficult to

interpret the personnel training requirements if the term continuing

education unit was not defined.

FDA agrees with this comment and has added a new Sec. 900.2(l),

which states that continuing education unit or continuing education

credit means 1 contact hour.

d. Diagnostic and screening mammography

(Comment 84). Over 30 comments stated that diagnostic and screening

mammography should be defined and asserted that vacillation over these

definitions only confuses the public and those who are to measure

outcomes.

As explained in the proposed rule (61 FR 14862), FDA is eliminating

these terms from the definitions section because differences of opinion

within the professional community regarding the distinction between

these two types of mammography procedures remain unresolved. These

terms can have different meanings depending upon their context. For

example, HCFA has defined screening and diagnostic mammography for

claim processing purposes. AHCPR has defined these terms in their

guidelines for medical audits. On the other hand, some facilities do

not distinguish between screening and diagnostic mammography.

Facilities also differ on categorizing certain circumstances as

screening or diagnostic, as in the example of a healthy, asymptomatic

woman with breast implants who has diagnostic views performed during

``routine screening.'' The terms screening and diagnostic mammography,

along with other terms and definitions associated with the medical

audit, are in the process of obtaining consensus within the scientific

community. At present, FDA recommends that each facility choose and

consistently utilize HCFA, AHCPR, or other definitions in the medical

literature for medical audit purposes.

e. Established operating level

(Comment 85). One comment noted that this term was used in

connection with a number of QC tests and suggested that it be defined

as ``the single point for a particular quality assurance parameter set

by the lead interpreting physician.''

FDA agrees that a definition of established operating level is

needed and has added, at Sec. 900.2(p), that ``established operating

level means the value of a particular quality assurance parameter that

has been established as acceptable by the facility's quality assurance

program.'' This definition indicates that the level should not be

merely set but also should be determined to be acceptable. The

responsibility for making that determination will belong primarily to

the lead interpreting physician, as the comment suggested. However, the

definition being issued refers to acceptance as part of the entire

quality assurance program because additional facility and FDA personnel

also may be consulted when the level is established.

f. Image receptor

(Comment 86). Two comments suggested that a definition of image

receptor be included in the final regulations. FDA notes that there is

a general understanding within the radiology and general medical

community of what this means and if a specific definition is needed,

one is already available in 21 CFR 1020.30(b). The agency does not

believe that it needs to be repeated here.

g. Image receptor support device

(Comment 87). One comment suggested that a definition of image

receptor support device as that part of the mammography X-ray unit that

is designed by the manufacturer to hold the cassette be added to

clarify Sec. 900.12(b)(5).

FDA agrees that this is a useful suggestion. However, as a result

of other revisions that have been made to the proposal, the term

``image receptor support device'' is no longer used in the regulations

and, therefore, a definition is no longer needed.

h. Laterality

(Comment 88). Several comments found the meaning of the term

``laterality,'' as used in the regulations, to be unclear.

In response to these comments, FDA has defined laterality, at

Sec. 900.2(w), to mean the designation of either the right or left

breast.

i. Mammography equipment

(Comment 89). One comment suggested that a definition of

``mammography equipment'' should be added and further suggested that

the definition include all physical components of a mammography

facility needed to produce an interpretable film. The author believed

that this would more clearly define the components that the physicist

would need to include in the required ``survey'' of ``mammography

equipment'' for which

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he or she has been assigned responsibility under

Sec. 900.12(d)(1)(iii).

FDA considered the possibility of adding this definition, but notes

that Sec. 900.12(e)(9) already establishes the evaluations that, at a

minimum, are to be included in the survey. Because of this, the agency

decided that an additional definition was not needed.

j. Mobile unit

(Comment 90). Three comments suggested that mobile units should be

defined in such a way as to clarify when mammography units used under a

variety of different circumstances are to be included in this category.

FDA notes that the term mobile unit is relevant to compliance with

these regulations only in determining when the additional testing

required by Sec. 900.12(e)(7) needs to be performed. Under

Sec. 900.12(e)(7), a mobile unit is one that is used to produce

mammograms at more than one location. The agency believes

Sec. 900.12(e)(7) makes it sufficiently clear when the additional

testing is needed.

k. Quality assurance, quality assurance program, and QC

(Comment 91). Two comments recommended that these terms be defined.

FDA notes that one or more of these terms have been defined in 21 CFR

1000.55, in the ACR Quality Assurance manuals, or by various other

authorities. While the wording of these definitions may vary, the basic

concepts are the same and are widely understood. The agency does not

believe that they need to be defined again.

l. Technique chart

(Comment 92). One comment among those that suggested that a

technique chart should be part of the quality assurance manual also

noted that this would require defining technique chart. The comment

also made some suggestions for the definition.

FDA notes that, as will be discussed with other comments related to

quality assurance records required under Sec. 900.12(d)(2), a technique

chart is not being required to be included in the facility's quality

assurance manual. Because the term is not used in the regulations, a

definition is not needed.

m. Other comments on the proposed definitions

(Comment 93). Thirteen identical comments wanted the quality

assurance definitions changed, stating that, ``it is objectionable to

have the FDA creating definitions of medical terms not agreed on by

physicians.''

Quality assurance is not defined in the regulations and, as

discussed above, the agency does not believe such a definition is

needed. From other information in the letters containing the comments,

it appears that they are actually referring to specific definitions

discussed under the heading of ``Quality Assurance'' in the preamble to

the proposal. There were four such definitions: ``lead interpreting

physician,'' ``QC technologist,'' ``time cycle,'' and ``traceability.''

FDA agrees that, to the extent possible, the agency should adopt

definitions for medical terms that have widespread agreement among

physicians. In fact, QC technologist, as discussed above, is already a

title widely used in facilities and in the ACR manuals. It appears that

medical facilities have already reached consensus on its use as an

administrative title, although there may be differences on the

necessary qualifications of such individuals.

The agency does not agree that the other three terms are medical

terms whose definitions require agreement among physicians. ``Time

cycle'' and ``traceability'' are technical terms related to the film

development time and the calibration of radiation measuring

instruments. These are not terms that physicians use regularly or about

which they are likely to discuss and reach consensus. The remaining

term, lead interpreting physician, is an administrative term, not a

medical one. As discussed previously, this term has been defined as the

designation of an individual physician at each facility who has certain

responsibilities under these regulations; that identification will make

it easier for facilities, accreditation bodies, and government

regulators to ensure and monitor compliance with the MQSA standards.

3. New or Changed Definitions Made Necessary by Changes in the

Regulations

a. Air kerma and kerma

The Omnibus Trade and Competitiveness Act of 1988 amended the

Metric Conversion Act of 1975 to require each Federal agency to use the

International Systems of Units (SI) in its activities. The SI is also

known as the metric system although it makes use of only some of the

metric quantities and units. In accordance with this requirement, a

memorandum dated March 19, 1990, from FDA's Associate Commissioners of

Regulatory Affairs and Public Affairs, established the FDA policy for

the use of SI metric measurement. Since 1990, FDA has been undergoing a

transition to SI quantities and units in its regulatory activities. To

this end, air kerma, which is an SI quantity, has been introduced as a

replacement for the quantity of exposure previously referenced in

Sec. 900.12(e)(5)(v). Definitions of ``air kerma'' and ``kerma'' were

also added as Secs. 900.2(d) and 900.2(v), respectively, in the final

regulations.

b. Calendar quarter

To give facilities more flexibility in maintaining their records on

personnel qualifications, changes were made in several provisions of

Sec. 900.12(a). These changes allow the facility to use a variety of

methods to calculate the time periods necessary to establish compliance

with personnel requirements. In calculating these time periods, the

facility may designate any one of the following as the endpoint for the

period of time used to determine if their staff met the continuing

education and experience requirements: (1) The date of the inspection;

(2) the last day of the last calendar quarter before the inspection; or

(3) any date in between those two. To avoid any misunderstandings, FDA

added a definition of calendar quarter, under Sec. 900.2(f), that

establishes the endpoints of the 4 quarters as March 31, June 30,

September 30, and December 31.

c. Interim regulations

Reference was made to the interim regulations several times in the

final regulations. For the benefit of those unfamiliar with those

regulations, FDA defined them by citing, under Sec. 900.2(t) of the

final regulations, the Federal Register publication of December 21,

1993, as amended on September 30, 1994.

d. Interpreting physician

This definition was modified from the proposed definition by adding

the term ``licensed'' in order to clarify the intent of the statute

that the physician maintain a valid State license to practice med

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