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  1. MQSA Insights

2018 Scorecard Statistics


December 2018

Certified facilities, as of October 1, 2018 8,704
Certification statistics, as of December 1, 2018  
  Total certified facilities / Total accredited units 8,694 / 19,859
  Certified facilities with digital units2 / Accredited digital units 8,647 / 12,909
  Certified facilities with DBT3,4 units / Accredited DBT units 4,865 / 6,883
FY 2019 inspection statistics, as of December 1, 2018  
  Facilities inspected 1,239
  Total units at inspected facilities 2,768
  Percent of inspections where the highest noncompliance was a:  
    Level 1 violation 0.6%
    Level 2 violation 15.7%
  Percent of inspections with no violation 83.7%
Total annual mammography procedures reported, as of December 1, 20181 39,297,637

November 2018

Certified facilities, as of October 1, 2018 8,704
Certification statistics, as of November 1, 2018  
  Total certified facilities / Total accredited units 8,693 / 19,773
  Certified facilities with digital units2 / Accredited digital units 8,644 / 12,900
  Certified facilities with DBT3,4 units / Accredited DBT units 4,801 / 6,804
FY 2019 inspection statistics, as of November 1, 2018  
  Facilities inspected 522
  Total units at inspected facilities 1,218
  Percent of inspections where the highest noncompliance was a:  
    Level 1 violation 0.5%
    Level 2 violation 12.1%
  Percent of inspections with no violation 87.3%
Total annual mammography procedures reported, as of November 1, 20181 39,286,613

October 2018

Certified facilities, as of October 1, 2017 8,726
Certification statistics, as of October 1, 2018  
  Total certified facilities / Total accredited units 8,704 / 19,564
  Certified facilities with digital units2 / Accredited digital units 8,649 / 12,858
  Certified facilities with DBT3,4 units / Accredited DBT units 4,708 / 6,635
FY 2019 inspection statistics, as of October 1, 2018  
  Facilities inspected 8,477
  Total units at inspected facilities 17,822
  Percent of inspections where the highest noncompliance was a:  
    Level 1 violation .8%
    Level 2 violation 15.2%
  Percent of inspections with no violation 84%
Total annual mammography procedures reported, as of October 1, 20181 39,265,435

September 2018

Certified facilities, as of October 1, 2017 8,726
Certification statistics, as September 1, 2018  
  Total certified facilities / Total accredited units 8,693 / 19,381
  Certified facilities with digital units2 / Accredited digital units 8,636 / 12,827
  Certified facilities with DBT3,4 units / Accredited DBT units 4,609 / 6,478
FY2018 inspection statistics, as of September 1, 2018  
  Facilities inspected 7,764
  Total units at inspected facilities 16,264
  Percent of inspections where the highest noncompliance was a:  
    Level 1 violation .8%
    Level 2 violation5 15%
  Percent of inspections with no violation 84.2%
Total annual mammography procedures reported, as of September 1, 20181 39,207,473

August 2018

Certified facilities, as of October 1, 2017 8,726
Certification statistics, as August 1, 2018  
  Total certified facilities / Total accredited units 8,688 / 19,242
  Certified facilities with FFDM2 units / Accredited FFDM units 8,622 / 12,817
  Certified facilities with DBT3,4 units / Accredited DBT units 4,526 / 6,341
FY2018 inspection statistics, as of August 1, 2018  
  Facilities inspected 6,897
  Total units at inspected facilities 14,463
  Percent of inspections where the highest noncompliance was a:  
    Level 1 violation .8%
    Level 2 violation5 14.3%
  Percent of inspections with no violation 84.9%
Total annual mammography procedures reported, as of August 1, 20181 39,318,393

July 2018

Certified facilities, as of October 1, 2017 8,726
Certification statistics, as July 1, 2018  
  Total certified facilities / Total accredited units 8,692 / 19,094
  Certified facilities with FFDM2 units / Accredited FFDM units 8,621 / 12,806
  Certified facilities with DBT3,4 units / Accredited DBT units 4,423 / 6,200
FY2018 inspection statistics, as of July 1, 2018  
  Facilities inspected 6,175
  Total units at inspected facilities 12,985
  Percent of inspections where the highest noncompliance was a:  
    Level 1 violation .8%
    Level 2 violation5 13.7%
  Percent of inspections with no violation 85.5%
Total annual mammography procedures reported, as of July 1, 20181 39,346,545

June 2018

Certified facilities, as of October 1, 2017 8,726
Certification statistics, as June 1, 2018  
  Total certified facilities / Total accredited units 8,687 / 18,962
  Certified facilities with FFDM2 units / Accredited FFDM units 8,618 / 12,794
  Certified facilities with DBT3,4 units / Accredited DBT units 4,334 / 6,079
FY2018 inspection statistics, as of June 1, 2018  
  Facilities inspected 5,389
  Total units at inspected facilities 11,286
  Percent of inspections where the highest noncompliance was a:  
    Level 1 violation .7%
    Level 2 violation5 13.2%
  Percent of inspections with no violation 86.1%
Total annual mammography procedures reported, as of June 1, 20181 39,358,307

May 2018

Certified facilities, as of October 1, 2017 8,726
Certification statistics, as May 1, 2018  
  Total certified facilities / Total accredited units 8,691 / 18,852
  Certified facilities with FFDM2 units / Accredited FFDM units 8,617 / 12,768
  Certified facilities with DBT3,4 units / Accredited DBT units 4,272 / 5,990
FY2018 inspection statistics, as of May 1, 2018  
  Facilities inspected 4,676
  Total units at inspected facilities 9,700
  Percent of inspections where the highest noncompliance was a:  
    Level 1 violation .7%
    Level 2 violation5 12.7%
  Percent of inspections with no violation 86.7%
Total annual mammography procedures reported, as of May 1, 20181 39,328,699

April 2018

Certified facilities, as of October 1, 2017 8,726
Certification statistics, as April 1, 2018  
  Total certified facilities / Total accredited units 8,683 / 18,640
  Certified facilities with FFDM2 units / Accredited FFDM units 8,606 / 12,750
  Certified facilities with DBT3,4 units / Accredited DBT units 4,142 / 5,791
FY2018 inspection statistics, as of April 1, 2018  
  Facilities inspected 3,984
  Total units at inspected facilities 8,279
  Percent of inspections where the highest noncompliance was a:  
    Level 1 violation .7%
    Level 2 violation5 12.2%
    Level 3 violation %
  Percent of inspections with no violation 87.2%
Total annual mammography procedures reported, as of April 1, 20181 39,332,300

March 2018

Certified facilities, as of October 1, 2017 8,726
Certification statistics, as March 1, 2018  
  Total certified facilities / Total accredited units 8,699 / 18,551
  Certified facilities with FFDM2 units / Accredited FFDM units 8,614 / 12,754
  Certified facilities with DBT3,4 units / Accredited DBT units 4,074 / 5,691
FY2018 inspection statistics, as of March 1, 2018  
  Facilities inspected 3,221
  Total units at inspected facilities 6,697
  Percent of inspections where the highest noncompliance was a:  
    Level 1 violation .6%
    Level 2 violation5 10.9%
    Level 3 violation %
  Percent of inspections with no violation 88.5%
Total annual mammography procedures reported, as of March 1, 20181 39,208,365

February 2018

Certified facilities, as of October 1, 2017 8,726
Certification statistics, as February 1, 2018  
  Total certified facilities / Total accredited units 8,693 / 18,451
  Certified facilities with FFDM2 units / Accredited FFDM units 8,607 / 12,761
  Certified facilities with DBT3,4 units / Accredited DBT units 3,998 / 5,579
FY2018 inspection statistics, as of February 1, 2018  
  Facilities inspected 2,537
  Total units at inspected facilities 5,281
  Percent of inspections where the highest noncompliance was a:  
    Level 1 violation .7%
    Level 2 violation5 10.8%
    Level 3 violation %
  Percent of inspections with no violation 88.5%
Total annual mammography procedures reported, as of February 1, 20181 39,168,821

January 2018

Certified facilities, as of October 1, 2017 8,726
Certification statistics, as January 1, 2018  
  Total certified facilities / Total accredited units 8,715 / 18,352
  Certified facilities with FFDM2 units / Accredited FFDM units 8,623 / 12,774
  Certified facilities with DBT3,4 units / Accredited DBT units 3,915 / 5,462
FY2018 inspection statistics, as of January 1, 2018  
  Facilities inspected 1,963
  Total units at inspected facilities 4,020
  Percent of inspections where the highest noncompliance was a:  
    Level 1 violation .7%
    Level 2 violation5 10.6%
    Level 3 violation %
  Percent of inspections with no violation 88.6%
Total annual mammography procedures reported, as of January 1, 20181 39,216,125

1 This number is an aggregate of the total number of procedures performed annually as reported by facilities to their accreditation bodies at the time of their re-accreditation, which takes place once every three years. We have aggregated only the numbers reported by MQSA-certified, non-Veterans Hospital Administration facilities. The aggregate number may not reflect the current number of procedures performed at these facilities.

2 FFDM - Full Field Digital Mammography unit.

3 DBT - Digital Breast Tomosynthesis.

4 Facilities with DBT also have FFDM so the DBT facilities count is included within the FFDM facilities count.

5 Based on an analysis of the violation rates for all MQSA citations, the FDA has decided to elevate the five remaining Level 3 citations to Level 2 citations. This change took effect on October 27, 2016. Since all Level 3 citations, if repeated, could have been elevated to a Level 2 with a requirement of a 30 day response to FDA, they should not be viewed as minor in nature, and they should be initially cited as a Level 2. As a consequence, the Level 3 violation rates will approach zero, and the Level 2 violation rates may initially increase but should level off with time.