Governmental Entity Audit Completed for 2006

In Spring 2006, the Food and Drug Administration's (FDA) Center for Devices and Radiological Health conducted its sixth biennial audit of mammography facilities claiming status as a governmental entity (GE). Under the Mammography Quality Standards Act (MQSA), all certified mammography facilities except GEs, are subject to an annual inspection fee. To be eligible for GE status, a facility must either:

• Be owned and/or operated and have all their personnel salaries entirely paid by some level of government,

The level of government may be federal, state, district, territory, possession, federally recognized Indian tribe, city, county, town, village, municipal corporation or similar political organization.

Or

• Be providing at least 50% of their mammography screenings, during the preceding 12 months, under the Center for Disease Control and Prevention (CDC) grant program supporting the Breast and Cervical Cancer Mortality Prevention Act of 1990, (www.cdc.gov/cancer/nbccedp).

As part of the MQSA oversight responsibilities, FDA conducts its audits of mammography facilities claiming GE status to verify facilities' declarations that they qualify as GE's and are, therefore, exempt from paying inspection fees.

Of approximately 800 mammography facilities claiming to be GE’s, FDA randomly selected 77 mammography facilities to participate in this GE audit who claimed GE status between the dates of October 1, 2004 through December 31, 2005. There were 69 facilities that responded to the audit (90%) all of which FDA determined to be eligible for the GE exemptions. Therefore, FDA concludes that most of the GE mammography facilities are in compliance.

If a facility needs additional information about the requirements to be met to qualify as a GE, it may access the FDA/MQSA website and PGHS. A facility may also call the FDA Facility Hotline at 1/800-838-7715.

FDA will conduct its next Governmental Entity Audit in 2008.