FROM: FOOD AND DRUG ADMINISTRATION
MQSA National Statistics
In this section of the MQSA Scorecard, we present the most commonly requested national statistics regarding the MQSA program. These statistics are updated on the first of each month.
Certified facilities, as of October 1, 2013
8,691
Certification statistics, as of February 1, 2014
Total certified facilities / Total accredited units
8,712 / 13,234
Certified facilities with FFDM2 units / Accredited FFDM units
8,060 / 12,374
FY 2014 inspection statistics, as of February 1, 2014
Facilities inspected
2,465
Total units at inspected facilities
3,676
Percent of inspections where the highest noncompliance was a:
Level 1 violation
0.4%
Level 2 violation
11.2%
Level 3 violation
1.5%
Percent of inspections with no violation
86.9%
Total annual mammography procedures reported, as of February 1, 20141
38,735,379
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.
FACILITY VIOLATIONS AS DEFINED BY FDA
Level 1 Survey Observations
The FDA issues an L1 citation if the facility did not have an annual medical physicist survey for two successive years.
Level 2 Survey Observations
The FDA issues an L2 citation to the facility for any of the following observations:
Time interval between the current and previous survey exceeds 14 months
Time interval between inspection date and the most recent survey exceeds 14 months
Unsigned report or one without the ID of the person who conducted or supervised the survey
Incomplete survey, e.g., any of the following tests are missing or incomplete:
spatial resolution
AEC performance
phantom image
dose
system artifacts
new modality QC tests
We evaluated inspection results over the date range of 10/1/99 to 3/31/03 for items under each of the 4 main bullets. First, violations regarding the third bullet (unsigned report, etc.) were very rare, e.g., only 2 facilities in FY01 and none since then.
Level 3 Survey Observations
Although Level 3 (L3) violations are considered not as serious as Level 2 and Level 1 violations and do not require a facility response, the FDA views all violations as detrimental for the quality of mammography and expects facilities to take corrective action regarding these violations as soon as possible.
The FDA issues an L3 citation to the facility for any of the following observations:
Incomplete survey (e.g., any of the following tests/tasks are missing or incomplete):
pass/fail list in the report
recommendations for failed items
physicist’s evaluation of the technologist’s QC tests
any of the tests not listed under L2
collimation assessment
kVp accuracy
kVp reproducibility
beam quality (HVL) measurement
uniformity of screen speed
radiation output
decompression (compression release)
Not taking timely corrective actions for items that failed in the survey.
