Answers
09/29/1994

<TITLE>MAMMOGRAPHY QUALITY DEADLINE:  OCT. 1, 1994</TITLE>
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T94-47                                       Sharon Snider
Sept. 29, 1994                               (301) 443-3285

                           Talk Paper

           MAMMOGRAPHY QUALITY DEADLINE:  OCT. 1, 1994

     By Oct. 1, mammography facilities in the United States must
meet quality standards established by the Food and Drug
Administration or cease operation.  The new standards are designed
to ensure that all women have access to mammography facilities that
provide top quality mammograms.
     No mammography facility--whether in a hospital, doctor's
office, mobile van, military base or any other public or private
enterprise--will be able to operate legally after Oct. 1 unless it
is FDA certified.
     Almost 90 percent of the 11,000 mammography facilities in the
United States have taken steps to meet the deadline.  To date,
5,337 (49%) have been fully certified.  Another 4,425 (40%) have
received provisional certificates.
     Quality standards for mammography facilities were required by
Congress in 1992 in response to concerns that mammography practice
did not meet uniformly high standards at all facilities.  The new
standards, developed under the Mammography Quality Standards Act of
1992, require that x-ray images be of high quality and that they be
read by physicians proficient in interpreting them.
                             -MORE-

                                       Page 2, T94-47, Mammography
     Implementing regulations published by FDA in December 1993
require that:
     *  personnel who perform mammography and physicians who
interpret the mammograms must have adequate training and experience
     *  facilities be inspected annually by FDA-trained inspectors
     *  mammography units be monitored closely to ensure radiation
levels and overall operation
     *  facilities set up quality assurance programs to ensure that
mammograms are as clear as possible, and that positive results are
followed up properly
     To be FDA certified, facilities must first show an
accreditation body approved by FDA that they meet these standards. 
To date, the American College of Radiology and the states of Iowa,
California and Arkansas have been approved as accreditation bodies.
     FDA has issued certificates to certified mammography
facilities and they must be prominently displayed so that women
will know the facility is certified and has met the required
standards.  Facilities that have applied for, but not yet received, 
accreditation have been issued a provisional certificate, valid for
six months, allowing them to legally provide mammography services
for six months while their application is being reviewed.
     Congress exempted the Veterans Administration from the
Mammography Quality Standards Act, but the Veterans Administration
is implementing its own high quality mammography program.
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