Mammography Facility Adverse Event and Action Report - July through December 2009

Mammography Quality Standards Act and Program
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Mammography Facility Adverse Event and Action Report - July through December 2009
1April 28, 2010

BACKGROUND

Congress enacted the Mammography Quality Standards Act (MQSA) in 1992, marking the first time mammography facilities were required by the federal government to meet strict quality standards. The intent of the MQSA is to assure the quality of mammography nationwide. Quality mammography can detect breast cancer in its earliest, most treatable stages. Studies show that widespread use of mammography can reduce deaths from breast cancer.

Congress charged the Food and Drug Administration (FDA) with implementing and enforcing MQSA. With the help of the National Mammography Quality Assurance Advisory Committee (NMQAAC), FDA developed interim regulations, initiated an inspection program, and issued comprehensive final regulations that became effective on April 28, 1999. The final regulations strengthen the 1994 interim standards for personnel, equipment, quality assurance and quality control activities, and reporting of examination results, as well as requirements for the accreditation bodies. To help providers and patients understand how MQSA affects them, FDA developed the Mammography web site (http://www.fda.gov/Radiation-EmittingProducts/ MammographyQualityStandardsActandProgram/Guidance/ PolicyGuidanceHelpSystem/default.htm2).

As of January 1, 2010, there were 8,692 facilities fully certified under the MQSA operating in the United States and its territories.

As part of the MQSA, Congress mandated there be annual reporting of adverse actions taken against mammography facilities. Congress stipulated that the report be made available to physicians and the general public and that it should include information that is useful in evaluating the performance of mammography facilities nationwide. To provide this important information in an even more timely manner, FDA commenced publishing the Mammography Facility Adverse Event and Action Report (MFAEAR) on a semi-annual reporting cycle in 2009 with the first mid-year report published in August 2009. The mid-year report identified adverse events and actions taken against mammography facilities that were completed in January through June 2009. The current report provides information on facilities that have had adverse events and subsequent actions taken against them that were completed in July through December 2009.

To gather data for this report, FDA consulted with and received reports from the following federal, State, and territorial agencies, as well as the American College of Radiology (ACR):

The Office of the Inspector General (OIG), Health and Human Services (HHS), Center for Medicare and Medicaid Services (CMS) for data about fraud, abuse, kickbacks and false billing under Medicare and Medicaid.

The HHS Inspector General lists no conviction data under Medicare or Medicaid for cases related to mammography facilities from July through December of calendar year 2009.

FDA’s Office of Criminal Investigations (OCI) for criminal prosecution against individuals associated with mammography facilities.

The Office of Criminal Investigations reported no criminal conviction cases related to mammography facilities from July through December of calendar year 2009.

FDA’s Office of Communication, Education, and Radiation Programs (OCER), Division of Mammography Quality and Radiation Programs (DMQRP), Diagnostic Devices Branch (DDB) for actions taken against mammography facilities.

The FDA reported one action taken against a mammography facility from July through December of calendar year 2009, as described in this report.

The MQSA Accreditation Bodies (ABs) for reports of revocation, suspension of accreditation, and cease and desist orders.

For July through December 2009, FDA asked all of the ABs approved under MQSA to report whether they suspended or revoked the accreditation of facilities that they accredit. Revocation and suspension are means used by the AB to withdraw a facility’s accreditation prior to its expiration date for reasons other than voluntary withdrawal by the facility. Currently, the FDA-approved Accreditation Bodies are the ACR and the States of Arkansas (SAR), Iowa (SIA) and Texas (STX).

The ABs reported no suspensions or revocations of facility accreditation from July through December of calendar year 2009.

The MQSA States as Certifiers (SAC) Certification Agencies (CAs) for actions taken against mammography facilities in their respective States.

For July through December 2009, FDA asked all of the State CAs approved under MQSA to report whether they took any actions against mammography facilities that they certify. Currently, the FDA-approved CAs are the States of Illinois (SIL), Iowa (SIA), South Carolina (SSC) and Texas (STX).

The State CAs of SIL, SIA, and SSC reported no actions against mammography facilities from July through December of calendar year 2009. The STX CA reported an adverse event and subsequent actions against one facility, as described in this report.

All States and U.S. Territories for actions they have taken under their own authority against mammography facilities.

MQSA does not preclude a State or U.S. Territory from having stricter mammography requirements than those of MQSA. In States that have additional requirements, facilities are required to comply with both State and MQSA regulations to operate lawfully.

One State reported an adverse event and subsequent actions from July through December of calendar year 2009, as described in this report.

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