By one measure of quality, mammography providers have increased their performance from a D grade in 2002 to a B grade this year.
An update issued today from the U.S. Food and Drug Administration on the Mammography Quality Standards Act and Program (MQSA) reveals that 86.9% of all facilities inspected by the FDA in February were free of violations, a vast improvement since 2002, when just 64.2% of facilities achieved that distinction.
Complying with MQSA adds to the cost of operating a mammography service line and may even have contributed to a decline in the number of mammography providers: In December of 2002, the FDA reported 9,235 accredited mammography facilities, and the latest update shows 8,710 accredited facilities.
A figure posted on the web site of the American College of Radiology, which administers the nation's largest mammography accreditation program, shows a 12.5% decline in the number of MQSA-certified facilities since 2000, but a .42% increase in the number of accredited units.
The current MQSA program, however, demonstrates a trend of continuous quality improvement since 2002, when just 64.2% of facilities inspected were violation free. In February of 2005, 67.9% were violation free; in February 2010, the figure was 79.4%, increasing to 86.9% in February 2014.
The percentage of facilities where the highest level of noncompliance was a level 1 violation, considered the most serious levied by inspectors, also has declined—from 2% of inspected facilities in 2002 to .4% of facilities in February 2014. Facilities receive a level 1 violation if they can’t produce a physicist report for two successive years.
Congress enacted MQSA in 1992 to ensure that all women had access to quality mammography, and the FDA was tasked with developing and implementing regulations. The first set of regulations became effective in 1994, with annual inspections beginning in January 1995. The FDA issued more comprehensive final regulations in 19197, effective April 1999. Subsequent reauthorizations made further updates to the requirements.
According to the update issued today from the U.S. Food and Drug Administration, there are 8,710 accredited facilities and 13,322 accredited units operating today. The reported statistics indicate that full-field digital mammography (FFDM) may be nearing complete market penetration. Of the 8,710 certified facilities, 8,088 have deployed 12,506 accredited full-field digital mammography units, up from 345 and 465 respectively in 2003.