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U.S. Department of Health and Human Services

Radiation-Emitting Products

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

PDF Printer VersionApril 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.htm).

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.

The following report provides information on facilities that have had an adverse event(s) and subsequent actions taken against them that were completed in July through December 2009. The format is in alphabetical order by State, local agency, and U.S. Territory. When a State is not listed, there were no adverse events reported by the State that were comparable to actions that would be taken under the MQSA.

MAMMOGRAPHY FACILITIES AGAINST WHICH THERE WERE ADVERSE ACTIONS

The State of Michigan

Professional Medical Center
3956 Mt. Elliott
Detroit , MI 48207

Facility ID: 236285

Adverse Event:

On August 4, 2009, Professional Medical Center’s medical physicist notified the State of Michigan that while performing a survey he found a Cease and Desist letter addressed to Professional Medical Center dated April 23, 2009; however, the facility had performed mammography after the date of the Cease and Desist letter.

The Professional Medical Center’s FDA MQSA facility certificate expired on November 14, 2008, and its Michigan Mammography Machine Authorization expired on March 1, 2009.

Action Taken:

On-site investigation - August 6-26, 2009: A joint investigation conducted by a State MQSA inspector and an FDA investigator revealed that Professional Medical Center performed mammography after both the MQSA certification and State Authorization had expired. Additionally, the investigation identified numerous MQSA and State regulation violations.

Mammography Quality Standards Act (MQSA) authority - FDA required the facility to undergo an additional mammography review (AMR) for the time period of November 15, 2008 through July 11, 2009 to assess the quality of mammography. The facility passed the AMR.

State of Michigan authority –

  • On September 2, 2009, the State of Michigan conducted a hearing with the facility at which time violations identified during the joint inspection were discussed. Records showed that mammography had been performed during 11 calendar weeks (April 23, 2009 through July 11, 2009) without State Authorization. A fine of $5,500 was imposed.
  • An inspection letter dated September 11, 2009 listing State violations and requiring a plan of correction be provided was sent to the facility.
Corrective Action :

State of Michigan authority –

  • The State imposed a fine of $5,500 on the facility.
  • In correspondence dated September 24, 2009, the State of Michigan received a corrective action letter from the facility that the State determined to be incomplete.
  • On October 13, 2009, the State of Michigan sent a letter to the facility asking for a more detailed plan of correction, as well as notifying the facility of the requirements to undergo a complete inspection, meet all federal requirements, and obtain an FDA MQSA facility certificate and Michigan Mammography Machine Authorization.
  • On February 16, 2010, the State sent a letter to the facility stating that Professional Medical Center is not in compliance with the Ionizing Radiation Rules of the State of Michigan.
  • The facility is currently not MQSA certified nor does it have State Authorization.
Status of Facility: Not performing mammography.

The State of Texas

TIDC - Irving, Inc
dba Texas Imaging & Diagnostic Center (TIDC)
3636 N. MacArthur Blvd.
Suite 170
Irving, TX 75062

FDA Facility ID: 215558

Adverse Event: In May 2008, the facility closed. On March 30, 2009, the State of Texas received a complaint from a former TIDC patient that mammography records were not available. A State investigation of the facility’s storage area found that mammography records were in disarray making retrieval of records nearly impossible.
Action Taken:

State of Texas Certification Agency (STX CA) authority -

  • On April 16, 2009, the State of Texas issued a Notice of Violation for failure to establish a means of providing mammography records and imposed a $4,000 penalty. Additionally, the State of Texas issued orders for the facility to protect the mammography records and patient database.
  • The case was referred to the Texas Attorney General.
  • A State inspection report dated July 9, 2009 indicated that the patient records storage location had been cleaned up with all the mammography records organized according to medical record numbers.
Corrective Action :

State of Texas Certification Agency (STX CA) authority -

  • In exchange for the facility owner’s cooperation, the Texas Attorney General dropped the $4,000 penalty but obtained an injunction to ensure that the mammography records would be made available to the patients.
  • Additionally, the State of Texas worked with the facility owner to establish a procedure whereby patients can request and obtain their mammography records.
  • Under the agreement, the State of Texas notified TIDC patients of the availability of the records and of the phone number to call to request the records.
  • Persons interested in obtaining their old mammography films may telephone the patient-call-in number (214)-577-2663 and pay a $15 fee. Upon receipt of payment, the mammography records are mailed to the requesting patient.
Status of Facility: Facility is closed. Patients have access to their mammograms.

HOW TO FIND AN FDA-CERTIFIED FACILITY

Cancer Information Service

To operate legally, a mammography facility must have and prominently display an FDA MQSA facility certificate or a similar certificate from an FDA-approved State certifying agency.  This certificate shows that the mammography facility is certified as meeting baseline quality standards for equipment, personnel, and practices under the MQSA. Consumers and health professionals can locate MQSA-certified facilities in their geographic area by calling the National Cancer Institute’s Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). Information specialists at this number are trained to answer questions about mammography and breast cancer.  Written documentation on mammography and breast cancer is also available on request.

Internet

The FDA Mammography Web Site, (http://www.fda.gov/Radiation-EmittingProducts/ MammographyQualityStandardsActandProgram/ Guidance/PolicyGuidanceHelpSystem/default.htm) provides a listing of all MQSA-certified facilities by selected State or U.S. territory and zip code.

National Technical Information Service

A list of all MQSA-certified mammography facilities is available on a computer diskette and sold as either a single issue (the most recent diskette) or a subscription (the diskette is updated quarterly) from:

National Technical Information Service (NTIS)
5285 Port Royal Road
Springfield, VA 22161
http://www.ntis.gov/

To order a single disk, call 1-800-553-6847. The NTIS order number is SUB-5386/Code D01.