IT'S STARTED... THE WHEELS ARE IN MOTION THAT WILL BRING CAPR and their patented machine for MRI mammography forward in the years to come.... check this out...
Accuracy, quality control and mammography: new
federal regulations.
( Healthfacts )
New federal regulations have gone into effect recently to assure high- quality
mammograms. They differ in two significant ways from the accreditation program
initiated several years ago by the American College of Radiology (ACR). Quality
assurance measures are now mandated by the FDA for all mammography facilities in
the country, whereas participation in the ACR program was purely voluntary. The
radiologist's skill in interpreting mammography film will be assessed through a
tracking system--something that is omitted in the ACR program.
In another welcome--and long overdue--turn of events, the U.S. Agency for Health
Care Policy Research has advised all x-ray facilities to provide women with the
written summary of mammography results. Such improvements, of course, should be
in place for all x-ray examinations, but mammography is a good place to start. This
x-ray examination of the breasts has been promoted as a screening test for over 20
years.
Accuracy is all the more critical for a screening test which by definition is given to
healthy, symptomless people. Inaccurate information is the most worrisome risk, for
example, a benign lesion misidentified as cancerous. Odds of this occurring are highest
among women under age 50 because they have a lower rate of breast cancer and
denser breast tissue which makes for less accurate film reading.
Image quality has been an issue since the mid-1980s when the FDA conducted the
first randomized survey of the nation's mammography facilities and found nearly one
in three mammograms to be substandard. The agency' s findings led directly to the
establishment of the first accreditation program (ACR's) to oversee quality control.
The rate of substandard mammograms in the country has since been reduced to 14%.
Attention has now turned to another critical element, the radiologist' s interpretive skill,
which made news recently when a Yale study produced some disturbing findings .
This is a most unusual study because the physician's interpretation of x-rays is rarely
subjected to systematic review. Ten seasoned radiologists were asked to read
mammograms of 150 women with biopsy-proven breast cancer and 123 with no
evidence of breast cancer. The investigators concluded that radiologists differ,
sometimes substantially, in their mammographic interpretations and recommendations
for management (New England Journal of Medicine, 1 December 1994).
Outcomes Monitored
The new FDA regulations (Mammography Quality Standards Act) aim to improve
mammogram accuracy by requiring all facilities to initiate a system that will follow the
women who went on to have a biopsy. The facilities will be required to correlate
mammography findings to the biopsy reports. "Right now there is no accessible
measure of accuracy except these clinical outcomes," explained Florence Houn, MD,
MPH, director of the FDA's division of mammography quality and radiation
program. She acknowledged that it will take years to get an accurate picture of a
mammography facility's performance.
How and whether the public will learn the results remains open. At this point, Dr.
Houn assures that the public will at least be notified when a facility fails to have the
outcomes reporting system in place. The FDA regulations, initiated last year, are
actually interim guidelines that will not be finalized until later this year. As is usual for
the FDA, public comment will be sought before the regulations become final.
The FDA has no authority over physicians. It can mandate a tracking system which
presumably will have a self-correcting effect, especially when results are made public,
but the FDA cannot take action against the doctor with a poor record.
Dr. Houn said that the facilities already accredited by the ACR and those in states like
Iowa, Arkansas and California with strong accreditation programs in place are already
considered certified under the new regulations. "There are currently 10,352 facilities
that are FDA certified, out of 10,666 in the U.S." Continued certification will require
annual inspection and compliance with FDA quality standards.
Putting written mammography results directly in the hands of women is a priority of
another government agency. The Agency for Health Care Policy and Research
(AHCPR) "strongly recommends" the following: "The mammography facility
personnel should give the woman written notification of the results of her
mammography, either at site or by mail." This excellent suggestion appears in the
guidelines, entitled "Quality Determinants of Mammography," which are directed to
medical personnel. Unfortunately the AHCPR neglected to be as forceful in its written
recommendations aimed at women.
In the AHCPR's consumer brochure, women are rightly advised not to assume that
the mammogram is normal just because they haven't received the results. But women
are merely encouraged to ask for the results within ten days (a very long time). No
mention is made of asking for a copy of written results.
The AHCPR periodically issues practice guidelines for a wide variety of medical
treatments concentrating on problem areas, such as the undertreatment of
postoperative pain and the overtreatment of middle ear infection. The agency usually
publishes separate copies of its recommendations to professionals and to consumers.
In doing so, the AHCPR is alerting the public about appropriate care.
Past guidelines from this agency have been outstanding, and HealthFacts has often
encouraged readers to send for a free copy of the doctor' s version. The consumer's
version, on the other hand, is often superficial, omitting any reference to the research
people should be encouraged to seek when making any treatment decision. (A
notable exception was last year's consumer pamphlet on treatment options for
enlarged prostate.)
The consumer's version of the latest AHCPR guidelines on high- quality mammograms
is worse than usual, and the guide for professionals is too technical. Neither are
recommended this time, though referring physicians and x-ray facility personnel can
benefit from the High- Quality Mammography Information for Referring Providers
and Quality Determinants of Mammography, respectively from the AHCPR at
1(800) 358-9295.
COPYRIGHT 1995 Center for Medical Consumers Inc.
Accuracy, quality control and mammography: new federal regulations.., Vol. 20,
Healthfacts, 01-01-1995, pp 2(2).
US HHS: Clinton administration supports
Mammography Quality Standards Act
( M2 PressWIRE )
The Clinton Administration announced its support of
legislation introduced today by Sen. Mikulski, D-Md.,
to reauthorize the Mammography Quality Standards Act
(MQSA). The law, which requires all mammography
facilities nationwide to be certified as meeting
quality standards, and to be inspected annually, will
expire this year unless it is reauthorized.
"As a result of this law, the quality of mammography
has improved at practically all facilities that
perform mammography in this country -- whether in a
hospital, a doctor's office, a mobile van, or on a
military base," said Health and Human Services
Secretary Donna E. Shalala at a press conference
today. "This program has been very good news for
women, and we want to assure that its success
continues."
Currently, mammography (x-rays of the breast) is the
most effective technique for early detection of
breast cancer. Mammographies, when performed
correctly, can often locate small tumors earlier than
they can be detected by touch. Studies of screening
mammography show that regular mammography can
decrease the chance of dying from breast cancer.
Furthermore, the earlier breast cancer is detected
the less likely it is to have spread, giving a woman
the option of choosing treatments that preserve her
breasts.
Congress passed the MQSA in 1992 in response to
concerns that mammography practice did not meet
quality standards at all facilities. The law
established a number of requirements aimed at
strengthening the quality of mammography services
nationwide.
Today, facilities must meet quality standards set by
the U.S. Food and Drug Administration for personnel,
equipment and image quality in order to be certified
to perform mammography. In addition, they must be
inspected annually by an FDA-trained inspector to
assure continuing compliance with standards.
There are currently 10,025 certified facilities in
the United States.
A recent General Accounting Office study confirmed
that this law is having a positive effect in the
fight against breast cancer. The study, released Jan.
25, 1997, shows an even greater level of compliance
with the national standards set by the MQSA than an
earlier study and demonstrates that these standards
make a difference.
The names and locations of FDA certified mammography
facilities are available through the National Cancer
Institute's toll-free Cancer Information Service at
1-800-4-CANCER.
CONTACT: Sharon Snider
Tel: +1 301 443-3285
*M2 COMMUNICATIONS DISCLAIMS ALL LIABILITY FOR
INFORMATION PROVIDED WITHIN M2 PRESSWIRE. DATA
SUPPLIED BY NAMED PARTY/PARTIES.*
This is probably a couple of years old but the direction and the trends are unmistakable.... going forward better scanners and better diagnoses and better quality ...even though people chuckle.. 99.97% accuracy is the target... and that is why MRI mammography is going to fill a niche in fighting breast cancer and xrays will be made better or will be made obsolete...by their inacuraccy.
luis |
