[Congressional Record Volume 143, Number 160 (Thursday, November 13, 1997)]
[Senate]
[Pages S12562-S12563]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                   MAMMOGRAPHY QUALITY STANDARDS ACT

  Ms. MIKULSKI. Mr. President, I rise today to celebrate the Senate 
passage of the Mammography Quality Standards Act. I am delighted that 
the Senate acted on Sunday, November 9 to unanimously approve this 
important legislation. The bill that the Senate has now passed 
reauthorizes the original legislation which passed in 1992 with 
bipartisan support. This year's bill is presented to the Senate with 55 
cosponsors.
  What MQSA does is require that all facilities that provide mammograms 
meet key safety and quality-assurance standards in the area of 
personnel, equipment, and operating procedures. Before the law passed, 
tests were misread, women were misdiagnosed, and people died as a 
result of sloppy work. Since 1992, MQSA has been successful in bringing 
facilities into compliance with the federal standards.
  What are these national, uniform quality standards for mammography? 
Well, facilities are required to use equipment designed specifically 
for mammography. Only radiological technologists can perform 
mammography. Only qualified doctors can interpret the results of 
mammography. Facilities must establish a quality assurance and control 
program to ensure reliability, clarity and accurate interpretation of 
mammograms. Facilities must be inspected annually by qualified 
inspectors. Finally, facilities must be accredited by an accrediting 
body approved by the Secretary of Health and Human Services.
  This current reauthorization makes a few minor changes to the law to 
ensure the following: Patients and referring physicians must be advised 
of any mammography facility deficiency. Women are guaranteed the right 
to obtain an original of their mammogram. Finally, both state and local 
government agencies are permitted to have inspection authority.
  I like this law because it has saved lives. The front line against 
breast cancer is mammography. We know that early detection saves lives. 
But a mammogram is worse than useless if it produces a poor-quality 
image or is misinterpreted. The first rule of all medical treatment is: 
Above all things, do no harm. And a bad mammogram can do real harm by 
leading a woman and her doctor to believe that nothing is wrong when 
something is. The result can be unnecessary suffering or even a death 
that could have been prevented. That is why this legislation is so 
important. This law needs to be reauthorized so that we don't go back 
to the old days when women's lives were in jeopardy.
  A strong inspection program under MQSA is extremely important to 
ensure the public that quality standards are being met. In a GAO report 
which evaluated the MQSA inspection program, GAO praised the program. 
They also recommended changes to further strengthen the program. FDA is 
in the process of implementing these recommendations. The FDA has 
proposed to direct its attention to conducting comprehensive 
inspections on those facilities where problems have been identified in 
the past, while decreasing the extensiveness of inspections at those 
facilities with excellent compliance records. I think it is important 
for the FDA to move promptly in this direction. The best way to protect 
the public health is for the FDA to focus its resources on the problem 
facilities.
  I want to make sure that women's health needs are met 
comprehensively. It is expected that 180,000 new cases of breast cancer 
will be diagnosed and about 44,000 women will die from the disease in 
1997. This makes breast cancer the most common cancer among women. And 
only lung cancer causes more deaths in women.
  We must aggressively pursue prevention in our war on breast cancer. I 
pledge to fight for new attitudes and find new ways to end the needless 
pain and death that too many American women face. This bill is an 
important step in that direction.
  As the 105th Congress comes to a close, we can look back on some 
great bipartisan victories and other great partisan frustrations. But 
one area Republicans and Democrats have always worked together on is 
women's health. I am proud of this bill's broad bipartisan support. I 
want to take this opportunity to thank all the cosponsors for making 
this happen. A special thanks to Senator Jeffords for working with me 
on making passage of this bill a reality. As Dean of the Democratic

[[Page S12563]]

Women, I want to also thank the Dean of the Republican Women, Kay 
Bailey Hutchison, for always reaching out to work together on the 
issues that matter most to American women and their families.
  Still, Senate passage alone does not assure reauthorization. It is my 
hope that the strong show of bipartisan support for this bill here in 
the Senate will encourage the House of Representatives to promptly move 
forward on this bill. I hope they will follow our lead to ensure a 
quick reauthorization of MQSA. America's women are counting on it.
  Mr. HARKIN. Mr. President, I join Senator Mikulski and many of my 
colleagues today to support reauthorization of the Mammography Quality 
Standards Act. I want to especially commend Senator Mikulski for her 
invaluable leadership on this issue. She brought the problem of poor 
quality mammography screening to the Senate's attention several years 
ago and authored the historic legislation we are today reauthorizing.
  As many of you know, I lost my sisters at an early age because of 
breast cancer. This experience has helped to make me acutely aware of 
the need for research on and improved early detection of breast cancer. 
I've always thought if they had had access to quality mammography 
screening, they would be alive with us today.
  Starting in 1990, as chairman of the Labor, Health and Human Services 
Appropriations Subcommittee, I worked with Senator Mikulski and others 
to start and fund a program at the CDC to provide screening for lower 
income women without insurance. And in 1992, I offered an amendment to 
dedicate $210 million in the Defense budget for breast cancer research. 
Because of this legislation, funding for breast cancer research has 
been included in the Defense Department budget every year since 1992, 
and will be included again in Fiscal Year 1998.
  It is clear that if we are to win the war on breast cancer we must 
continue to support research on improved treatments, but we must also 
ensure that breast cancer is detected early enough to apply these 
treatments effectively. The need for legislating mammography quality 
standards is obvious--every year approximately 180,000 women will be 
diagnosed and 44,000 women will die of breast cancer. We can prolong 
and save the lives of millions of women if we can detect the cancer 
early in its development. The earlier we can diagnose breast cancer, 
the sooner a women can begin to receive appropriate treatment, and the 
more likely it is that she will survive. It is vital that all women 
have access to mammograms which are both properly performed and 
accurately analyzed. This screening is a very powerful weapon in the 
battle against cancer.
  Early diagnosis, and consequently early treatment, depend upon 
accurate evaluations of breast tissue. This means that the health care 
professionals taking mammograms and reading mammograms must be properly 
trained. This Act sets forth requirements that all mammography 
facilities meet stringent standards in terms of equipment used, 
personnel, and reporting of mammography findings.
  Congress must act quickly to pass this reauthorization so that women 
throughout our nation can be confident that they are receiving the 
safest, most reliable mammography available. Without these standards, 
women do not have such guarantees. They would be forced to place their 
lives in the hands of a random patchwork of Federal, State, and 
voluntary standards. This is unacceptable. We cannot return to the days 
before this law was passed, when women were misdiagnosed because 
mammography clinics did not have standards for quality control.
  Women also deserve the best technology available when it comes to 
early detection of cancer because advanced technology means more 
accurate, and therefore earlier diagnosis. One such advance is digital 
mammography. This screening technique involves the creation of digital 
images which are more easily visualized and can also be stored and 
forwarded to other medical sites. This can provide women in rural areas 
with vital access to expert medical diagnosticians.
  When women and their doctors have access to the best technology 
available, such as digital mammography, it can mean the difference 
between life and death. It can also mean money saved, because it is 
cheaper to treat a small, confined tumor than it is to treat a full-
blown metastactic cancer which has spread to other organ systems.
  Breast cancer is the most common cancer among American women, but it 
does not have to be the No. 1 cancer killer among women in the United 
States because we have ways to detect it early on. The National Cancer 
Institute advises that ``high-quality mammography combined with a 
clinical breast exam is the most effective technology presently 
available to detect breast tumors.'' We have an obligation to American 
women to ensure that the mammographies they receive meet high-quality 
federal standards. I am proud to be an original cosponsor of this 
legislation and I look forward to its speedy passage into law.
  Mrs. HUTCHISON. Mr. President, I rise today to commend my colleagues 
for passing the Mammography Quality Standards Act, assuring that 
national, uniform quality standards will be in place for this 
lifesaving, preventive procedure.
  Experts universally agree that mammography is one of the best ways to 
detect breast cancer early. Yet, statistics show that the majority of 
women who need mammograms are not getting them. Nearly 40 percent of 
women ages 40 to 49, 35 percent of women ages 50 to 64, and 46 percent 
of women 65 years of age and over have not received a mammogram in the 
past 2 years. With 44,000 women dying annually from breast cancer, one 
in three of these might be saved if her breast cancer is detected 
early.
  Since almost 10 percent of breast cancers are not detected by 
mammography, it's essential to remember breast self-examination and 
clinical screening as the other important early detection tools we have 
at our disposal.
  This was the first year that the National Cancer Institute joined the 
American Cancer Society and other breast cancer organizations in 
support of screening mammograms on a regular basis. Dr. Richard 
Klausner, NCI Director, announced in March that the mammography 
recommendations of the National Cancer Screening Board would be adopted 
by NCI.
  Dr. Klausner spoke movingly about NCI-conducted focus groups that 
found that many women are not aware that breast cancer risks increase 
with age and that most women who develop breast cancer have no family 
history of the disease. He is to be commended for launching a new 
education campaign featuring new breast health and mammogram fact 
booklets, and breast health information hotline and Internet website.
  The passage of the reauthorization of the Mammography Quality 
Standards Act dovetails nicely with these efforts. The original 
legislation passed in 1992 has been successful in bringing mammography 
screening facilities into compliance with a tough Federal standard. 
Patients can be assured that their mammography procedures and results 
are provided by qualified technical professionals and with annually 
inspected radiographic equipment and facilities.
  This reauthorization makes some needed improvements to existing law. 
Facilities are now required to inform the patient as well as the 
physician about the screening results, and patients may now obtain 
their original mammogram films and report. Consumers and physicians 
must now be advised of any mammography facility deficiencies, and both 
State and local government agencies are granted inspection authority. 
These improvements were recommended in a GAO report as ways to assure 
that this vital prevention program continues to protect the public 
health and address women's health needs.
  Last, I want to thank all the countless radiologists, radiologic 
technicians, and support workers who provide this very worthwhile 
service and make the time spent undertaking this procedure as pleasant 
as possible. These are the soldiers in our war against cancer, and 
their contributions are invaluable. I thank you all for your support.

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