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U.S. Department of Health and Human Services

Radiation-Emitting Products

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2011 Scorecard Statistics


December 2011

Certified facilities, as of October 1, 20118,620
Certification statistics, as of December 1, 2011 
  Total certified facilities / Total accredited units8,617 / 12,287
 Certified facilities with FFDM2 units / Accredited FFDM units6,988 / 10,117
FY 2012 inspection statistics, as of December 1, 2011 
 Facilities inspected1,181
 Total units at inspected facilities1,654
 Percent of inspections where the highest noncompliance was a: 
   Level 1 violation1.1%
  Level 2 violation14.9%
  Level 3 violation2.5%
 Percent of inspections with no violation81.5%
Total annual mammography procedures reported, as of December 1, 2011139,245,668

November 2011

Certified facilities, as of October 1, 20118,620
Certification statistics, as of November 1, 2011 
  Total certified facilities / Total accredited units8,624 / 12,301
 Certified facilities with FFDM2 units / Accredited FFDM units6,942 / 10,050
FY 2012 inspection statistics, as of November 1, 2011 
 Facilities inspected499
 Total units at inspected facilities681
 Percent of inspections where the highest noncompliance was a: 
   Level 1 violation1.2%
  Level 2 violation13.4%
  Level 3 violation2.2%
 Percent of inspections with no violation83.2%
Total annual mammography procedures reported, as of November 1, 2011139,203,398

October 2011

Certified facilities, as of October 1, 20108,652
Certification statistics, as of October 1, 2011 
  Total certified facilities / Total accredited units8,620 / 12,299
 Certified facilities with FFDM2 units / Accredited FFDM units6,895 / 9,976
FY 2011 inspection statistics, as of October 1, 2011 
 Facilities inspected8,328
 Total units at inspected facilities11,481
 Percent of inspections where the highest noncompliance was a: 
   Level 1 violation0.5%
  Level 2 violation13.8%
  Level 3 violation2.6%
 Percent of inspections with no violation83.0%
Total annual mammography procedures reported, as of October 1, 2011139,098,089

September 2011

Certified facilities, as of October 1, 20108,652
Certification statistics, as of September 1, 2011 
  Total certified facilities / Total accredited units8,614 / 12,277
 Certified facilities with FFDM2 units / Accredited FFDM units6,837 / 9,875
FY 2011 inspection statistics, as of September 1, 2011 
 Facilities inspected7,618
 Total units at inspected facilities10,505
 Percent of inspections where the highest noncompliance was a: 
   Level 1 violation0.6%
  Level 2 violation13.7%
  Level 3 violation2.7%
 Percent of inspections with no violation83.0%
Total annual mammography procedures reported, as of September 1, 2011139,271,233

August 2011

Certified facilities, as of October 1, 20108,652
Certification statistics, as of August 1, 2011 
  Total certified facilities / Total accredited units8,620 / 12,270
 Certified facilities with FFDM2 units / Accredited FFDM units6,766 / 9,760
FY 2011 inspection statistics, as of August 1, 2011 
 Facilities inspected6,813
 Total units at inspected facilities9,433
 Percent of inspections where the highest noncompliance was a: 
   Level 1 violation0.5%
  Level 2 violation13.6%
  Level 3 violation2.5%
 Percent of inspections with no violation83.4%
Total annual mammography procedures reported, as of August 1, 2011138,844,222

July 2011

Certified facilities, as of October 1, 20108,652
Certification statistics, as of July 1, 2011 
  Total certified facilities / Total accredited units8,624 / 12,274
 Certified facilities with FFDM2 units / Accredited FFDM units6,714 / 9,674
FY 2011 inspection statistics, as of July 1, 2011 
 Facilities inspected6,151
 Total units at inspected facilities8,540
 Percent of inspections where the highest noncompliance was a: 
   Level 1 violation0.5%
  Level 2 violation13.6%
  Level 3 violation2.5%
 Percent of inspections with no violation83.5%
Total annual mammography procedures reported, as of July 1, 2011138,849,021

June 2011

Certified facilities, as of October 1, 20108,652
Certification statistics, as of June 1, 2011 
  Total certified facilities / Total accredited units8,627 / 12,288
 Certified facilities with FFDM2 units / Accredited FFDM units6,654 / 9,571
FY 2011 inspection statistics, as of June 1, 2011 
 Facilities inspected5,365
 Total units at inspected facilities7,440
 Percent of inspections where the highest noncompliance was a: 
   Level 1 violation0.5%
  Level 2 violation13.3%
  Level 3 violation2.4%
 Percent of inspections with no violation83.8%
Total annual mammography procedures reported, as of June 1, 2011138,882,880

May 2011

Certified facilities, as of October 1, 20108,652
Certification statistics, as of May 1, 2011 
  Total certified facilities / Total accredited units8,636 / 12,305
 Certified facilities with FFDM2 units / Accredited FFDM units6,586 / 9,477
FY 2011 inspection statistics, as of May 1, 2011 
 Facilities inspected4,639
 Total units at inspected facilities6,457
 Percent of inspections where the highest noncompliance was a: 
   Level 1 violation0.4%
  Level 2 violation13.3%
  Level 3 violation2.5%
 Percent of inspections with no violation83.8%
Total annual mammography procedures reported, as of May 1, 2011138,803,773

April 2011

Certified facilities, as of October 1, 20108,652
Certification statistics, as of April 1, 2011 
  Total certified facilities / Total accredited units8,641 / 12,313
 Certified facilities with FFDM2 units / Accredited FFDM units6,523 / 9,387
FY 2011 inspection statistics, as of April 1, 2011 
 Facilities inspected3,931
 Total units at inspected facilities5,484
 Percent of inspections where the highest noncompliance was a: 
   Level 1 violation0.4%
  Level 2 violation13.4%
  Level 3 violation2.5%
 Percent of inspections with no violation83.7%
Total annual mammography procedures reported, as of April 1, 2011139,211,644

March 2011

Certified facilities, as of October 1, 20108,652
Certification statistics, as of March 1, 2011 
  Total certified facilities / Total accredited units8,636 / 12,338
 Certified facilities with FFDM2 units / Accredited FFDM units6,421 / 9,269
FY 2011 inspection statistics, as of March 1, 2011 
 Facilities inspected3,082
 Total units at inspected facilities4,318
 Percent of inspections where the highest noncompliance was a: 
   Level 1 violation0.4%
  Level 2 violation13.7%
  Level 3 violation2.5%
 Percent of inspections with no violation83.4%
Total annual mammography procedures reported, as of March 1, 2011139,132,016

February 2011

Certified facilities, as of October 1, 20108,652
Certification statistics, as of February 1, 2011 
  Total certified facilities / Total accredited units8,636 / 12,344
 Certified facilities with FFDM2 units / Accredited FFDM units6,349 / 9,163
FY 2011 inspection statistics, as of February 1, 2011 
 Facilities inspected2,447
 Total units at inspected facilities3,427
 Percent of inspections where the highest noncompliance was a: 
   Level 1 violation0.4%
  Level 2 violation13.6%
  Level 3 violation2.5%
 Percent of inspections with no violation83.4%
Total annual mammography procedures reported, as of February 1, 2011139,090,923

January 2011

Certified facilities, as of October 1, 20108,652
Certification statistics, as of January 1, 2011 
  Total certified facilities / Total accredited units8,639 / 12,394
 Certified facilities with FFDM2 units / Accredited FFDM units6,275 / 9,074
FY 2011 inspection statistics, as of January 1, 2011 
 Facilities inspected1,900
 Total units at inspected facilities2,635
 Percent of inspections where the highest noncompliance was a: 
   Level 1 violation0.5%
  Level 2 violation13.5%
  Level 3 violation2.5%
 Percent of inspections with no violation83.5%
Total annual mammography procedures reported, as of January 1, 2011139,028,464
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.