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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

• FY 2010
• FY 2011
• FY 2012
• All

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 - 2012

Time	Target	Number
Oct 2011	N/A	493
Nov 2011	N/A	675
Dec 2011	N/A	691
Jan 2012	N/A	594
Feb 2012	N/A	682
Mar 2012	N/A	768
Apr 2012	N/A	658
May 2012	N/A	717
Jun 2012	N/A	827
Jul 2012	N/A	674
Aug 2012	N/A	761
Sep 2012	N/A	744

FY 2012 Total: 8,284

Total number of domestic mammography facility inspections completed during the month

Fiscal Year - 2012

Time	Target	Number
Oct 2011	N/A	499
Nov 2011	N/A	682
Dec 2011	N/A	697
Jan 2012	N/A	598
Feb 2012	N/A	687
Mar 2012	N/A	775
Apr 2012	N/A	663
May 2012	N/A	723
Jun 2012	N/A	834
Jul 2012	N/A	679
Aug 2012	N/A	768
Sep 2012	N/A	749

FY 2012 Total: 8,354