• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Radiation-Emitting Products

  • Print
  • Share
  • E-mail

Mammography Facility Adverse Event and Action Report - January through June 2009

PDF Printer Version

August 27, 2009

 

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 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/RadiationEmittingProducts/MammographyQuality StandardsActandProgram/Guidance/PolicyGuidanceHelpSystem/default.htm).

As of August 1, 2009, there were 8,711 facilities fully certified under the MQSA operating in the United States.

As part of 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.  Beginning this year, to provide this important information in a more timely manner, FDA will publish the Mammography Facility Adverse Event and Action Report (MFAEAR) on a semi-annual reporting cycle.  This first mid-year report identifies adverse events and actions taken against mammography facilities that were completed January through June 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 during January through June 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 two criminal conviction cases related to mammography facilities from January through June of calendar year 2009, as described in this report.

  • FDA’s Office of Communication, Education, and Radiation Programs (OCER), Division of Mammography Quality and Radiation Programs (DMQRP), Inspection and Compliance Branch (ICB) for actions taken against mammography facilities.

The FDA reported one occasion when actions were taken against a mammography facility during January through June 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.

Each year, FDA asks 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 during January through June of calendar year 2009

  • The MQSA States as Certifiers (SAC) certification agencies (CAs) for actions taken against mammography facilities in their respective States.

Each year, FDA asks 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 certification agencies are the States of Illinois (SIL), Iowa (SIA), South Carolina (SSC) and Texas (STX).

The States of Illinois, Iowa, and South Carolina reported no actions against mammography facilities during January through June of calendar year 2009The STX CA reported an adverse event and required corrective action against 1 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.

No States or U.S. territories reported adverse events and subsequent corrective actions during January through June of calendar year 2009.

The following report provides information on facilities that have had adverse events and subsequent corrective actions taken against them that were completed in January through June 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 MQSA.

 

 

MAMMOGRAPHY FACILITIES AGAINST WHICH THERE WERE ADVERSE ACTIONS

 

The State of Delaware


Papastavros Associates Medical Imaging, L.L.C.
1701 Augustine Cut-Off
Building IV, Suite 100
Wilmington, DE  19803

 

FDA Facility ID: 129767

 

 

Adverse Event:

 

Martine Clements falsified American Registry of Radiologic Technologists (ARRT) credentials in order to obtain her Delaware Radiologic Technologist (RT license. Clements conducted approximately 300 mammograms at Papastavros Associates Medical Imaging from 2001 to 2008.

 

Action Taken:

On July 30, 2008, Ms. Clements was suspended by Papastavros Associates Medical Imaging and subsequently resigned.

 

FDA’s Office of Criminal Investigations (OCI) authority - Ms. Clements was criminally prosecuted for four felony counts and one misdemeanor

 

Mammography Quality Standards Act (MQSA) authority - FDA required the facility to undergo an additional mammography review (AMR) for mammograms performed by Ms. Clements during the time period May 13, 2007 through July 30, 2008 to assess the quality of mammography. The facility passed the AMR.

 

 

Corrective Action:

 

On April 14, 2009, Ms. Clements signed a plea agreement in which she agreed to plead guilty to 3rd degree forgery and to pay a $2,000 fine, with the felony counts dismissed. Also on April 14, 2009, Ms. Clements was sentenced to one year of incarceration, which was suspended for one year of probation. She was also fined $2000 plus court costs.

 

 

Status of Facility:

 

Performing mammography.

 

 

Puerto Rico

Barranquitas Ultrasound and Mammography Center
Calle Hermandad #3
Barranquitas, PR  00794

Facility ID: 216036

 

 

Adverse Event:

 

On February 16, 2009, the American College of Radiology (ACR) conducted a scheduled on-site survey (SOSS) at the facility.  An SOSS is available to facilities when extensive corrective action is required in order to pass accreditation.

 

Due to repeated certification failures and operating without an MQSA certificate, as well as findings of QC program failures, FDA asked the ACR to perform a full additional mammography review (AMR) during the SOSS, rather than the AB’s standard review performed during an SOSS.  The interpreting physician for the survey team reviewed clinical images to assess the quality of mammography and failed the AMR at a serious risk to human health.

 

 

Action Taken:

 

Mammography Quality Standards Act (MQSA) authority – On March 10, 2009, based on the failed AMR performed during the SOSS, FDA required the facility to notify patients and their referring physicians of the findings of serious risk to human health (patient and physician notification, "PPN") for those patients who had mammograms performed during the time period March 10, 2007 through September 29, 2008.


The American College of Radiology (ACR) AB authority – Based on the deficiencies identified during the SOSS, ACR required the facility to undergo a corrective action plan.

 

 

Corrective Action:

 

The corrective action plan was successfully completed and ACR reinstated the facility on May 26, 2009.

 

The PPN is completed.

 

 

Status of Facility:

 

Performing mammography.

 

 

The State of South Dakota


Spearfish Regional Hospital
1440 North Main
Spearfish, SD  57783

FDA Facility ID: 121004

 

 

Adverse Event:

 

Jill Jeanette Ericsson falsified American Registry of Radiologic Technologists (ARRT) credentials from 2000 to 2008. Ms. Ericsson performed hundreds of mammograms from 2000 to 2008 without the required ARRT registration.

 

 

Action Taken: 

 

Spearfish Regional Hospital terminated employment of Ms. Ericsson.

 

FDA’s Office of Criminal Investigations (OCI) authority - Criminal prosecution of Ms. Ericsson for one felony count of forgery resulted in a plea agreement.

 

Mammography Quality Standards Act MQSA) authority - FDA required the facility to undergo an additional mammography review (AMR) for mammograms performed by Ms. Ericsson during the time period October 2, 2006 through October 2, 2008 to assess the quality of mammography. The facility passed the AMR.

 

 

Corrective Action:

 

On April 29, 2009, Ms. Ericsson was sentenced to two years supervised probation and payment of restitution to Spearfish Regional Hospital in the amount of $11,046.46, court costs of $73.00, and costs of prosecution to the South Dakota Medicaid Fraud Control Unit in the amount of $408.65.

 

 

Status of Facility:  

 

Performing mammography.

 

 

The State of Texas


Newco Imaging, L.L.C.
864 Central Boulevard, Suite 600
Brownsville, TX  78520

FDA Facility ID: 211581

 

 

Adverse Event: 

 

The facility closed in February 2008 and sold its medical records to a salvage company on June 9, 2008.

 

The salvage company separated the mammography records from the rest of medical records and held the mammography records aside in case the facility might want them back.

 

 

Action Taken:

 

State of Texas Certification Agency (STX CA) authority –

  • The State of Texas issued a Notice of Violation for failing to maintain mammography records for the required 10 years (minimum) resulting in an Attorney General legal fee of $6,000 and an administrative penalty of $4,000.
  • At the Texas Department of State Health Services (DSHS) request, the Texas Attorney General filed an injunction requiring the facility to re-take possession of the mammography records from the salvage company and make them available to patients. At a hearing on March 10, 2009, the State Court issued an order that required the facility to:
  1. take possession of the mammography records by April 9, 2009 and provide the mammograms in accordance with the Texas Administrative Code,
  2. notify the certified mammography facilities in Brownsville of the availability of the records, and
  3. allow periodic inspections of the storage location and records of mammography record transfers.

 

 

Corrective Action:

 

The facility complied with the court order.

 

The mammography records are currently being stored in Brownsville, TX. Persons interested in obtaining their records may fax a request to (956) 541-9393 or send an e-mail message to newcoimaging5123@yahoo.com.  

 

 

Status of Facility: 

 

Not performing mammography.

 

 

HOW TO FIND AN FDA-CERTIFIED FACILITY

Cancer Information Service

To operate legally, a mammography facility must have and prominently display an FDA MQSA certificate or a similar certificate from a State certifying body.  This certificate shows that the mammography facility is certified as meeting baseline quality standards for equipment, personnel, and practices under the Mammography Quality Standards Act (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.