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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 - January through June 2010

PDF Printer VersionSeptember 3, 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 September 1, 2010, there were 8,713 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 current report provides information on facilities that have had adverse events and subsequent actions taken against them that were completed in January through June 2010.

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 reported one conviction under Medicare or Medicaid cases related to mammography facilities from July through December of calendar year 2009, described in this report.

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

    The Office of Criminal Investigations reported no criminal convictions related to mammography facilities from January through June of calendar year 2010.

  • 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 four actions taken against mammography facilities from January through June of calendar year 2010, described in this report.

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

    For January through June 2010, FDA asked 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. The FDA-approved accreditation bodies are the ACR and the States of Arkansas (SAR), Iowa (SIA) and Texas (STX).

    The ABs reported three suspensions or revocations of facility accreditation from January through June of calendar year 2010, described in this report.

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

    For January through June, 2010, FDA asked all of the State CAs approved under MQSA to report whether they took any actions against mammography facilities that they certify. The FDA-approved CAs are the States of Illinois (SIL), Iowa (SIA), South Carolina (SSC) and Texas (STX).

    The State CAs of SIL, SIA, SSC, and STX reported no actions against mammography facilities from January through June of calendar year 2010. 

  • 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.

    Three States reported adverse events and subsequent actions from January through June of calendar year 2010, as described in this report.

The following report provides inform ation on facilities th at have had an adverse event(s) and subsequent actions taken against them that were completed in January through June 2010. The format is in alphabetical order by St ate, 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 th at would be taken under the MQSA.

MAMMOGRAPHY FACILITIES AGAINST WHICH THERE WERE ADVERSE ACTIONS

The State of Arizona

Arcadia Radiology and Breast Center
4440 N 36th Street, Suite 110
Phoenix, Arizona 85018

Facility ID: 101246
 

Adverse Event:

On January 26, 2010, an MQSA inspection resulted in the facility being cited for not having a medical physicist survey within the required 14-month timeframe.

Action Taken:

Because this was a repeat of the same violation within five years, the State of Arizona imposed a $1500 civil penalty, which the facility paid.

Corrective Action :

On April 30, 2010, the State of Arizona deemed the facility’s corrective action and response adequate.

Status of Facility: The facility is providing mammography services.

The State of Florida

Medisound, Inc.
301 North John Young Parkway
Kissimmee, Florida 34741

Facility ID: 23639

Adverse Event:

On June 11, 2010, The American College of Radiology (ACR) initiated an additional mammography review (AMR) because of quality issues noted on films submitted for accreditation.

On July 14, FDA notified Medisound that ACR had denied the facility accreditation, that it was no longer certified, and that it must stop performing mammography.

On July 20, 2010, ACR notified FDA that the facility failed the AMR at a level considered a serious risk to human health.

Action Taken:

On July 26, 2010, the FDA required the facility to notify patients and their referring healthcare providers of the facility’s quality issues. This notification included those patients who had mammograms performed during the time period June 10, 2008 through June 10, 2010.

Corrective Action :

Because the facility was unwilling to perform the notification, FDA posted a safety notification on its website on August 27, 2010, notifying women who had mammograms performed at the facility from June 10, 2008 through June 10, 2010 of the mammography quality issues at Medisound.

The facility ceased its mammography services on July 20, 2010.

Status of Facility: Not performing mammography.

The State of Florida

Med Pro Imaging
7050 NW 4 Street
Ste. 202
Plantation, Florida 33317

Facility ID: 168732
 

Adverse Event: During the additional mammography review (AMR) required of the Rivero Diagnostic Center (see Rivero case below), which took over business from the Med Pro facility, quality issues were noted for mammograms performed when the facility operated as Med Pro. Additionally, because Med Pro was no longer in business, women who had mammograms at Med Pro could not obtain their mammograms.
Action Taken: Because the Rivero AMR, which failed at a level considered a serious risk to human health, included films from Med Pro, Med Pro was required to notify its patients and referring providers of its quality issues.
Corrective Action: Because Med Pro was now out of business and the new Rivero facility did not have access to Med Pro records, Rivero could not individually notify Med Pro patients and their health care providers of the quality issues with the Med Pro films. Consequently, FDA posted a safety notification on its website on August 17, 2010, notifying women who had mammograms performed at the facility from May 21, 2008 – September 20, 2009, of the problems associated with the quality of mammograms performed at Med Pro Imaging. The safety notification also provided Med Pro patients with information on obtaining their mammogram films.
Status of Facility: Not performing mammography

The State of Florida

Rivero Diagnostic Center, Inc.
7050 NW 4 Street
Ste. 202
Plantation, Florida 33317

Facility ID: 168732

Adverse Event: On March 23, 2010, the American College of Radiology (ACR) determined that Rivero Diagnostic Center’s mammography unit could not be accredited due to unacceptable image quality
Action Taken:

On March 23, 2010, the ACR required the facility to undergo an additional mammography review (AMR).

On May 4, 2010, the ACR notified FDA that the facility failed the AMR at a level considered a serious risk to human health.

On May 12, 2010, ACR revoked the facility’s accreditation, and FDA subsequently declared the facility’s MQSA certificate no longer in effect due to the accreditation revocation.

On May 26, 2010, FDA required the facility to notify all patients and their referring healthcare providers of the facility’s quality issues. This notification included those patients who had mammograms performed at the facility during the time period May 21, 2008 through May 21, 2010. .

Corrective Action: The patient and provider notification (PPN) was completed.
Status of Facility: Not performing mammography

The State of Georgia

Perry Hospital
1120 Morningside Drive
Perry, Georgia 31069

FDA Facility ID: 142802

Adverse Event: On 5/10/2010, Perry Hospital made a public announcement that it had discovered that over 900 mammograms had not been interpreted by a qualified interpreting physician. Rachael Michelle Rapraeger, a radiologic technologist at the facility, accessed the facility's mammography reporting computer system and coded negative assessments for these women's mammograms. Since the system indicated that these mammograms had been read, they were not referred to a physician for interpretation. An FDA investigative inspection was performed to ensure that the facility's actions were appropriate to address the problem. A final assessment revealed that 1300 patient's mammograms were involved. Perry Hospital notified all these women and offered them new mammograms free of charge.
Action Taken:

Ms. Rapraeger was terminated by the facility. On 9/7/2010, the Houston County District Attorney's office announced that Ms. Rapraeger was indicted on 20 charges of submitting false mammogram results.

Corrective Action: All affected women were notified and offered free mammograms.
Status of Facility: Performing mammography.

The State of Maryland

Baltimore Imaging Centers
4000 Old Court Road
Ste 103
Pikesville, MD 21208

Facility ID: 106401

Adverse Event: The American College of Radiology (ACR) initiated an additional mammography review (AMR) for mammograms done at this facility, based on a complaint it received from another facility. On April 30, 2010, the ACR informed FDA that the facility failed the AMR at a level considered a serious risk to human health.
Action Taken: On May 12, 2010, FDA required the facility to notify patients and their health care providers of the facility’s quality problems. This notification included patients who had a mammogram performed during the time period May 12, 2008 through May 12, 2010.

ACR revoked the facility’s accreditation on May 10, 2010, and FDA subsequently declared the facility’s MQSA certificate no longer in effect due to the accreditation revocation.

Corrective Action: The patient and provider notification was completed.
Status of Facility: Not performing mammography.

The State of Pennsylvania

Carlisle Regional Medical Center
361 Alexander Spring Road
Carlisle, Pennsylvania, 17015.

FDA Facility ID: 105569

Adverse Event: Carlisle Regional Medical Center failed to provide a patient’s lay summary mammography report within the required timeframe.
Action Taken: The State’s investigation concluded with a fee settlement, agreed upon by both parties.
Corrective Action: The facility paid the agreed upon fee on April 12, 2010.
Status of Facility: The facility is providing mammography services

The State of South Dakota

Spearfish Regional Hospital
1440 N. Main
Spearfish, SD 57783

FDA Facility ID: 121004

Adverse Event: Spearfish Regional Hospital submitted claims for reimbursement for mammography services provided by a technologist who did not have ARRT credentials for the years 2000 to 2008. The technologist performed mammograms during that timeframe without the required ARRT certification, causing false submissions to be presented to Medicare for payment.
Action Taken: As part of a False Claims settlement, the technologist agreed to pay the sum of $6,082.17.

The facility owed $10,414.49 to Medicare, $1,791.65 to Medicaid, and $1,236.81 to other public and private programs, for a total amount of $13,442.95.
 

Corrective Action: The facility terminated the employment of the technologist and paid $13,442.95 to Medicare, Medicaid and other public and private programs.
Status of Facility: 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 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)
5301 Shawnee Road
Alexandria, VA 22312
http://www.ntis.gov/

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