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Percent of domestic mammography facilities inspected that were free of Level 1 (serious) inspection observations during the month (1)
Dictionary: Approximately 8,800 mammography facilities are inspected annually by FDA-certified MQSA inspectors (comprised of both FDA inspectors and State inspectors). MQSA inspections ensure that quality standards are met. Inspection findings are graduated from Level 1, 2, 3 to “no observation,” which reflects the degree of the facility’s violation from most serious to fully compliant, respectively.
A Level 1 finding represents a deviation from MQSA standards that may seriously compromise the quality of mammography services offered by the facility (i.e. sufficient objects in phantom image not visible). Gross adherence to MQSA standards is a valuable indicator of the efficacy of breast cancer diagnoses in the United States.
Information is current as of September 30, 2012
Fiscal Year - 2010
| Time | Target | Percent |
|---|---|---|
| Oct 2009 | N/A | 98.80 |
| Nov 2009 | N/A | 99.48 |
| Dec 2009 | N/A | 98.62 |
| Jan 2010 | N/A | 98.94 |
| Feb 2010 | N/A | 99.10 |
| Mar 2010 | N/A | 98.89 |
| Apr 2010 | N/A | 99.09 |
| May 2010 | N/A | 99.13 |
| Jun 2010 | N/A | 99.03 |
| Jul 2010 | N/A | 99.26 |
| Aug 2010 | N/A | 99.26 |
| Sep 2010 | N/A | 99.22 |
FY 2010 Overall: 99.07%
Footnotes
- (1) Level 1 inspection observations are considered the most serious - those that may have a detrimental effect on the quality of mammography services. An example is a facility that has mammography personnel who do not meet FDA’s minimum qualification standards. Level 1 violation require FDA to issue a warning letter; the facility must begin correcting problems immediately and respond in writing to FDA within 15 work days of receiving the warning letter about the corrective actions taken.
Number of domestic mammography facilities inspected that were free of Level 1 (serious) inspection observations during the month
Fiscal Year - 2010
| Time | Target | Number |
|---|---|---|
| Oct 2009 | N/A | 741 |
| Nov 2009 | N/A | 571 |
| Dec 2009 | N/A | 644 |
| Jan 2010 | N/A | 654 |
| Feb 2010 | N/A | 551 |
| Mar 2010 | N/A | 710 |
| Apr 2010 | N/A | 765 |
| May 2010 | N/A | 686 |
| Jun 2010 | N/A | 718 |
| Jul 2010 | N/A | 807 |
| Aug 2010 | N/A | 675 |
| Sep 2010 | N/A | 760 |
FY 2010 Total: 8,282
Total number of domestic mammography facility inspections completed during the month
Fiscal Year - 2010
| Time | Target | Number |
|---|---|---|
| Oct 2009 | N/A | 750 |
| Nov 2009 | N/A | 574 |
| Dec 2009 | N/A | 653 |
| Jan 2010 | N/A | 661 |
| Feb 2010 | N/A | 556 |
| Mar 2010 | N/A | 718 |
| Apr 2010 | N/A | 772 |
| May 2010 | N/A | 692 |
| Jun 2010 | N/A | 725 |
| Jul 2010 | N/A | 813 |
| Aug 2010 | N/A | 680 |
| Sep 2010 | N/A | 766 |
FY 2010 Total: 8,360
Glossary
Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.
