STATEMENT FOR THE RECORD
FOOD AND DRUG ADMINISTRATION
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOR THE SENATE COMMITTEE ON HEALTH, EDUCATION,
LABOR AND PENSIONS, SUBCOMMITTEE ON PUBLIC HEALTH
AND THE SENATE APPROPRIATIONS SUBCOMMITTEE
ON LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATON
February 28, 2002
Chairman Mikulski and Chairman Harkin:
The Food and Drug Administration (FDA or the Agency)
welcomes this opportunity to present this statement for
the record regarding Mammography Quality Standards Act
The Mammography Quality Standards Act (MQSA) of 1992
was enacted in response to serious concerns about the
quality of mammography. This procedure is an aid in combating
the mortality associated with the growing incidence of
breast cancer. In spite of the current controversy about
the studies showing the benefits of mammography screening
and in the absence of consensus about the scientific issues,
the Department of Health and Human Services (HHS) and
FDA support the conclusion reached by the U.S. Preventive
Services Task Force. High quality mammography continues
to be the best available tool for the early detection
of breast cancer and MQSA provides our best assurance
of that quality.
Mammography can reveal cancerous lesions up to 2 years
before a woman or her doctor can feel a lump, and is a
significant contributor to the current 5-year survival
rate of 86%. Mammography represents life-saving ammunition
in the war on breast cancer which is the most common non-skin
cancer and, after lung cancer, the second leading cause
of cancer deaths among women.
To achieve these benefits, all elements of the mammography
system must be of high quality. Mammography is a highly
challenging radiographic examination of the breast. The
equipment must be capable of producing quality images
and be maintained and operated by qualified individuals.
Physicians who interpret these images must also be highly
skilled. If the quality of mammography is poor, an incipient
cancerous lesion may be missed. False negative diagnoses
can delay early treatment and result in avoidable deaths.
Poor quality mammography can also lead to false positive
diagnoses, in which normal tissue is judged to be abnormal,
resulting in needless anxiety for patients, costly additional
testing, and unnecessary biopsies.
In the mid-1980s, indications of problems with the quality
of mammography began to appear. Significant evidence came
from a 1985 study known as the Nationwide Evaluation of
X-ray Trends (NEXT), which was conducted by State radiation
control agencies in cooperation with the FDA. Based on
a survey of a representative national sample of mammography
facilities, this study found that the image quality produced
in perhaps as many as one-third of the facilities was
less than desirable.
The findings from the NEXT study catalyzed efforts by
the American College of Radiology (ACR), a private, non-profit
association of radiologists, to create a voluntary mammography
accreditation program. Begun in 1987, this program included
an evaluation of the quality of clinical mammograms provided
by facilities seeking accreditation. Although it is reasonable
to surmise that facilities participating in this voluntary
program were among the better facilities, ACR found that
approximately 30 percent of the applicants failed on their
first attempt to achieve accreditation.
Other evidence came from a 1990 General Accounting Office
(GAO) study that reported that many mammography providers
lacked adequate quality assurance programs. In 1992, hearings
held by the Senate Committee on Labor and Human Resources
revealed a wide range of problems with mammography services
in the United States. These problems included poor quality
equipment, lack of quality assurance procedures, poorly
trained facility personnel, and inconsistent governmental
oversight. At the same time, several States instituted
programs to ensure that their residents were being provided
with high quality mammography.
Despite these efforts, no national standards for providing
safe, reliable, and accurate mammography were in place
for the over 25 million American women who undergo the
procedure annually. To rectify this situation, Congress
enacted the MQSA on October 27, 1992, to ensure uniform
high standards for mammography facilities, their equipment
and personnel, and the quality of their mammograms. This
law required all mammography facilities be certified by
the Federal government after October 1, 1994, except for
those facilities operated by the Department of Veterans
Affairs (DVA). A separate law mandating a similar program
governs DVA facilities. Responsibility for implementing
MQSA was delegated to FDA by the Secretary of HHS on June
Faced with the task of certifying approximately 10,000
mammography facilities in less than 2 years, FDA published
interim regulations in December 1993, which became effective
in February 1994. As a prerequisite to certification,
facilities had to be accredited by an FDA-approved accreditation
body, the first of which was ACR approved in March 1994.
Subsequently, four States, Arkansas, California, Iowa,
and Texas, achieved approval as accreditation bodies.
FDA successfully met its demanding statutory deadline
of certifying all qualified mammography facilities by
October 1, 1994. While the interim regulations were in
effect, FDA developed more exacting regulations, and the
MQSA final regulations were published in October 1997,
and became effective on April 28, 1999.
Another hurdle was obtaining qualified personnel to annually
inspect the nearly 10,000 mammography facilities. FDA
developed special training courses for both FDA and State
personnel, and trained and eventually deployed 250 inspectors
to conduct annual facility inspections. These inspections
began in January, 1995. During this time, FDA also designed
and implemented a dynamic, interactive data system, the
Mammography Program Reporting and Information System (MPRIS),
to tie the pieces of the program together. MPRIS provides
and tracks information on accreditation and certification
of facilities, facility inspections, inspection violations,
and the billing of inspection fees. MPRIS also allows
inspectors to use uniform software on a laptop computer
while in the field, and to directly upload inspection
results to the headquarters database, thus streamlining
the inspection process and facilitating data analysis.
In addition, the database transmits certification information
to the Centers for Medicare and Medicaid Services each
day, thereby facilitating efficient facility reimbursement,
and allowing consumers to search for certified mammography
facilities by zip code.
In order to educate facilities about the regulations
and how to comply with them, FDA published a quarterly
newsletter that was mailed to facilities and other interested
parties. A mammography web site www.fda.gov/cdrh/mammography
was then created, a principal component of which is an
extensive policy guidance help system. The print newsletter
eventually evolved into web page updates and articles
on matters of importance to facilities.
III. DEVELOPING PROGRAMS
MQSA allowed States that desired to do so to take on
the role of a certifying body, with FDA approval and oversight.
In August 1998, the States as Certifiers (SAC) pilot was
initiated with two participating States. During this time,
regulations were promulgated and published in February
2002. These regulations will become effective in May 2002.
Several additional States have expressed interest in the
SAC program, and FDA expects this program to expand.
IV. PROGRAM COMPLIANCE
Compliance with the final regulations continues to improve.
Currently, 60% of all certified facilities are in total
compliance with MQSA. The Government Performance Results
Act goal for most serious violations is less than 3%.
At this time, only 2.4% of facilities are exceeding the
goal. This exemplary compliance rate can in large part
be attributed to the programís extensive outreach efforts,
including facility education by inspectors, and the availability,
both on the web and in hard copy, of all guidance and
V. PROGRAM ASSESSMENT
In 1995 and 1997, the GAO evaluated aspects of the MQSA
program. These favorable reports found that the initial
impact of the new federal law had been positive, while
the report that looked at mammography inspections found
that facility compliance was continuing to improve.
FDA performed facility satisfaction surveys under both
the interim and the final regulations. The purpose of
those surveys was to look at how facilities perceive the
inspection process and the programís educational and guidance
materials. Based on these results, it is clear that the
vast majority of facilities see the MQSA inspection program
as beneficial, particularly the educational approach of
the inspectors that helps facilities identify areas for
FDA continues to fine-tune the MQSA program to better
serve the mammography community, leading to higher quality
care for the women of America.
MQSA was reauthorized in October 1998, with the enactment
of the Mammography Quality Standards Reauthorization Act
(MQSRA). MQSRA mandated that patients be directly notified
of their mammogram results, in lay language. The regulations
were amended to reflect this mandate. Facilities quickly
complied, and currently, there are almost no inspection
violations in this area. In addition, a study published
in the American Journal of Roentgenology in February 2002
surveyed patients before and after this requirement went
into effect. The study found that there was a substantial
increase in the number of screening patients who reported
timely receipt of mammography results, and a substantial
decrease in patients dissatisfied with their results,
all without an appreciable increase in patient anxiety.
Congress also requested FDA to look at whether or not
the best-performing mammography facilities can maintain
their high standards without the scrutiny of annual inspections.
With input from the conference of Radiation Control Program
Directors, FDA designed a demonstration program whereby
citation-free facilities from States who agreed to participate
were randomly assigned to study and control groups, with
the study group facilities skipping their next annual
inspection, beginning in May 2002. After data collection
is completed in the summer of 2004, data analysis will
be performed and a report will be presented to Congress
Reauthorization of the appropriations authority for the
Certification of Mammography Facilities would allow the
Federal Government to continue to ensure that all mammography
facilities provide high quality mammograms as an aid in
the early detection of breast cancer.
FDA has been successfully implemented the MQSA program
and have improved the overall quality of mammography by
constructing and implementing an effective program that
holds all providers of mammography to the same standard.
The MQSA program in an invaluable tool in promoting public
health and merits reauthorization.
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revised: March 7, 2002