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U.S. Department of Health and Human Services

Radiation-Emitting Products

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2010 Scorecard Statistics

December 2010

Certified facilities, as of October 1, 20108,652
Certification statistics, as of December 1, 2010 
  Total certified facilities / Total accredited units8,619 / 12,412
 Certified facilities with FFDM2 units / Accredited FFDM units6,174 / 8,957
FY 2011 inspection statistics, as of December 1, 2010 
 Facilities inspected1,205
 Total units at inspected facilities1,672
 Percent of inspections where the highest noncompliance was a: 
   Level 1 violation0.7%
  Level 2 violation13.5%
  Level 3 violation3.1%
 Percent of inspections with no violation82.7%
Total annual mammography procedures reported, as of December 1, 2010138,965,863

November 2010

Certified facilities, as of October 1, 20108,652
Certification statistics, as of November 1, 2010 
  Total certified facilities / Total accredited units8,643 / 12,427
 Certified facilities with FFDM2 units / Accredited FFDM units6,106 / 8,874
FY 2011 inspection statistics, as of November 1, 2010 
 Facilities inspected538
 Total units at inspected facilities723
 Percent of inspections where the highest noncompliance was a: 
   Level 1 violation0.4%
  Level 2 violation13.6%
  Level 3 violation2.4%
 Percent of inspections with no violation83.6%
Total annual mammography procedures reported, as of November 1, 2010138,945,731

October 2010

Certified facilities, as of October 1, 20098,713
Certification statistics, as of October 1, 2010 
  Total certified facilities / Total accredited units8,652 / 12,445
 Certified facilities with FFDM2 units / Accredited FFDM units6,004 / 8,748
FY 2010 inspection statistics, as of October 1, 2010 
 Facilities inspected8,371
 Total units at inspected facilities11,686
 Percent of inspections where the highest noncompliance was a: 
   Level 1 violation0.8%
  Level 2 violation14.5%
  Level 3 violation3.4%
 Percent of inspections with no violation81.3%
Total annual mammography procedures reported, as of October 1, 2010138,924,837

September 2010

Certified facilities, as of October 1, 20098,713
Certification statistics, as of September 1, 2010 
  Total certified facilities / Total accredited units8,646 / 12,412
 Certified facilities with FFDM2 units / Accredited FFDM units5,903 / 8,614
FY 2010 inspection statistics, as of September 1, 2010 
 Facilities inspected7,605
 Total units at inspected facilities10,625
 Percent of inspections where the highest noncompliance was a: 
   Level 1 violation0.8%
  Level 2 violation14.5%
  Level 3 violation3.4%
 Percent of inspections with no violation81.2%
Total annual mammography procedures reported, as of September 1, 2010138,808,689

August 2010

Certified facilities, as of October 1, 20098,713
Certification statistics, as of August 1, 2010 
  Total certified facilities / Total accredited units8,651 / 12,432
 Certified facilities with FFDM2 units / Accredited FFDM units5,826 / 8,514
FY 2010 inspection statistics, as of August 1, 2010 
 Facilities inspected6,844
 Total units at inspected facilities9,602
 Percent of inspections where the highest noncompliance was a: 
   Level 1 violation0.9%
  Level 2 violation14.5%
  Level 3 violation3.5%
 Percent of inspections with no violation81.1%
Total annual mammography procedures reported, as of August 1, 2010138,823,849

July 2010

Certified facilities, as of October 1, 20098,713
Certification statistics, as of July 1, 2010 
  Total certified facilities / Total accredited units8,649 / 12,437
 Certified facilities with FFDM2 units / Accredited FFDM units5,748 / 8,412
FY 2010 inspection statistics, as of July 1, 2010 
 Facilities inspected6,164
 Total units at inspected facilities8,671
 Percent of inspections where the highest noncompliance was a: 
   Level 1 violation0.8%
  Level 2 violation14.6%
  Level 3 violation3.6%
 Percent of inspections with no violation81.1%
Total annual mammography procedures reported, as of July 1, 2010138,822,632

June 2010

Certified facilities, as of October 1, 20098,713
Certification statistics, as of June 1, 2010 
  Total certified facilities / Total accredited units8,655 / 12,492
 Certified facilities with FFDM2 units / Accredited FFDM units5,663 / 8,312
FY 2010 inspection statistics, as of June 1, 2010 
 Facilities inspected5,351
 Total units at inspected facilities7,536
 Percent of inspections where the highest noncompliance was a: 
   Level 1 violation0.9%
  Level 2 violation14.6%
  Level 3 violation3.6%
 Percent of inspections with no violation81.0%
Total annual mammography procedures reported, as of June 1, 2010138,384,929

May 2010

Certified facilities, as of October 1, 20098,713
Certification statistics, as of May 1, 2010 
  Total certified facilities / Total accredited units8,664 / 12,519
 Certified facilities with FFDM2 units / Accredited FFDM units5,582 / 8,193
FY 2010 inspection statistics, as of May 1, 2010 
 Facilities inspected4,626
 Total units at inspected facilities6,549
 Percent of inspections where the highest noncompliance was a: 
   Level 1 violation0.8%
  Level 2 violation14.7%
  Level 3 violation3.7%
 Percent of inspections with no violation80.8%
Total annual mammography procedures reported, as of May 1, 2010138,353,211

April 2010

Certified facilities, as of October 1, 20098,713
Certification statistics, as of April 1, 2010 
  Total certified facilities / Total accredited units8,669 / 12,562
 Certified facilities with FFDM2 units / Accredited FFDM units5,508 / 8,105
FY 2010 inspection statistics, as of April 1, 2010 
 Facilities inspected3,934
 Total units at inspected facilities5,592
 Percent of inspections where the highest noncompliance was a: 
   Level 1 violation0.9%
  Level 2 violation14.6%
  Level 3 violation3.7%
 Percent of inspections with no violation80.8%
Total annual mammography procedures reported, as of April 1, 2010138,135,035

March 2010

Certified facilities, as of October 1, 20098,713
Certification statistics, as of March 1, 2010 
  Total certified facilities / Total accredited units8,681 / 12,623
 Certified facilities with FFDM2 units / Accredited FFDM units5,402 / 7,963
FY 2010 inspection statistics, as of March 1, 2010 
 Facilities inspected3,162
 Total units at inspected facilities4,493
 Percent of inspections where the highest noncompliance was a: 
   Level 1 violation0.9%
  Level 2 violation15.2%
  Level 3 violation3.6%
 Percent of inspections with no violation80.2%
Total annual mammography procedures reported, as of March 1, 2010138,057,377

February 2010

Certified facilities, as of October 1, 20098,713
Certification statistics, as of February 1, 2010 
  Total certified facilities / Total accredited units8,681 / 12,630
 Certified facilities with FFDM2 units / Accredited FFDM units5,327 / 7,864
FY 2010 inspection statistics, as of February 1, 2010 
 Facilities inspected2,444
 Total units at inspected facilities3,494
 Percent of inspections where the highest noncompliance was a: 
   Level 1 violation0.9%
  Level 2 violation15.9%
  Level 3 violation3.8%
 Percent of inspections with no violation79.4%
Total annual mammography procedures reported, as of February 1, 2010137,975,545

January 2010

Certified facilities, as of October 1, 20098,713
Certification statistics, as of January 1, 2010 
  Total certified facilities / Total accredited units8,692 / 12,705
 Certified facilities with FFDM2 units / Accredited FFDM units5,246 / 7,755
FY 2010 inspection statistics, as of January 1, 2010 
 Facilities inspected1,888
 Total units at inspected facilities2,668
 Percent of inspections where the highest noncompliance was a: 
   Level 1 violation1.0%
  Level 2 violation15.7%
  Level 3 violation3.7%
 Percent of inspections with no violation79.6%
Total annual mammography procedures reported, as of January 1, 2010137,477,657

 

1 This number is an aggregate of the total number of procedures performed annually as reported by facilities to their accreditation bodies. Facilities are asked to disclose this information at their initial accreditation, and then at the time of their re-accreditation, which takes place once every three years. FDA began collecting these data in 1998. The aggregate does not reflect the current number of procedures performed at these facilities, but only the numbers reported by them during the three-year period prior to the current date. We have aggregated only the numbers reported by certified, non-Veterans Administration facilities.
2 FFDM - Full Field Digital Mammography unit.
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