[Congressional Record Volume 144, Number 132 (Monday, September 28, 1998)]
[Senate]
[Page S11057]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]


[[Page S11057]]
         THE MAMMOGRAPHY QUALITY STANDARDS REAUTHORIZATION ACT

 Ms. MIKULSKI. Mr. President, I rise today to celebrate the 
Senate passage of the Mammography Quality Standards Reauthorization Act 
(MQSA). It is timely and appropriate that the Senate took action on 
this important legislation in time for Breast Cancer Awareness Month in 
October and on the eve of the march against cancer right here in 
Washington. The bill that the Senate passed reauthorizes the original 
legislation which passed in 1992 with bipartisan support.
  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 raising 
the quality of mammography services that women receive.
  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 some improvements to the current 
law. It ensures that women will receive direct written notification of 
their mammogram results. MQSA already requires written notification of 
mammography results to self-referred women. Now this provision will 
apply to all women. Women won't assume that ``no news is good news'' 
when this isn't always the case. They will know what their results are, 
so that they can get any follow up care they need. The Agency for 
Health Care Policy Research has cited studies that show that direct 
communication with patients, which is in addition to written 
communication to health care providers, dramatically increases 
compliance with follow up recommendations. Women are entitled to know 
the results of their exams. This new provision will ensure that women 
are informed and active participants in their health care decisions.
  This legislation also allows the Secretary of Health and Human 
Services to establish a demonstration program for less than annual 
inspections for facilities that have excellent track records. This 
program will not be implemented before April 1, 2001, which is almost 
two years after the final regulations implementing MQSA go into effect. 
The facilities that participate in this program will continue to be 
inspected to ensure that they continue to comply with MQSA standards. A 
strong inspection program under MQSA is extremely important to assure 
the public that quality standards are being met. In a 1997 GAO report 
which evaluated the MQSA inspection program, GAO praised the program. I 
am very interested in the results of this demonstration. This 
demonstration program will provide us with an important opportunity to 
see if less than annual inspections are just as effective in making 
high-quality facilities comply with MQSA. It should allow the FDA to 
focus more of its attention on ensuring compliance with MQSA standards 
by facilities where problems have been identified in the past. The best 
way to protect the public health is for the FDA to focus its resources 
on the problem facilities.
  This bill also contains a few minor changes to the law to ensure 
that: patients and referring physicians be advised of any mammography 
facility deficiency; women are guaranteed the right to obtain an 
original of their mammogram; physicians who review facility images on 
behalf of accreditation bodies are highly qualified and subject to high 
ethical standards; and both state and local government agencies are 
permitted to have inspection authority.
  I like MQSA 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. And 
that is why I am so pleased that this law is being reauthorized, so 
that we don't go back to the old days when women's lives were in 
jeopardy.
  I want to make sure that women's health needs are met 
comprehensively. It is expected that 178,700 new cases of breast cancer 
will be diagnosed and about 43,900 women will die from the disease in 
1998. 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 to 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 bipartisan 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 56 cosponsors of my MQSA 
bill here in the Senate for their support. I also want to recognize 
Congresswoman Nancy Johnson and Delegate Eleanor Holmes Norton as the 
original sponsors of the House MQSA bill. I applaud the Democrats and 
Republicans of the House Commerce Committee, especially Congressmen 
Bliley, Dingell, Bilirakis, and Brown for their leadership on MQSA. A 
special thanks also goes to Senator Jeffords for working with me to 
make reauthorization of MQSA a reality. As Dean of the Democratic 
Women, I want to also thank the Dean of the Republican Women, Kay 
Bailey Hutchinson, for always reaching out to work together on the 
issues that matter most to American women and their families. MQSA is a 
shining example of what the U.S. Congress can accomplish when both 
Republicans and Democrats work together for the good of the American 
people.

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