Fw: Subject Reference: MQSA Audit for 2001 completed by FDA

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----- Original Message ----- From: Martha Murdock & gigi* Lawrence

BreastImplantNews

Sent: Friday, March 29, 2002 8:01 AM

Subject: Subject Reference: MQSA Audit for 2001 completed by FDA

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Governmental Entity Audit Completed for 2001

In Fall 2001, the Food and Drug Administration's (FDA) Center for Devices and Radiological Health conducted its fourth 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 the 812 mammography facilities claiming to be GE's, FDA audited 393 randomly selected facilities in the 2001 audit. These results validated FDA's belief that there is confusion among mammography facilities regarding the requirements that must be met to be considered a GE. FDA identified 41 mammography facilities that had inappropriately claimed GE status. One of the problems encountered during the audit was difficulty in contacting facilities to verify their status as governmental entities.

Within the next few months, FDA will contact and bill facilities that were found to be ineligible for GE status. If a facility needs additional information about the requirements to be met to qualify as a GE, it may access the FDA/MQSA website www.fda.gov/cdrh/mammography and PGHS www.fda.gov/mammography/guidance-rev.html. A facility may also call the FDA Facility Hotline at 1/800-838-7715.

FDA will conduct its next Governmental Entity Audit in 2003.

Back to CDRH Mammography Home

(Updated 3/28/02)==^================================================================

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