Food and Drug Administration

1350 Piccard Drive

Rockville MD 20850

August 27, 2009

MAMMOGRAPHY FACILITY ADVERSE EVENT AND ACTION REPORT –

January through June 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/Radiation-
EmittingProducts/MammographyQualityStandardsActandProgram/Guidance/PolicyG
uidanceHelpSystem/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.

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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):

¾ 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.

¾ 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.

¾ 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.

¾ 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.

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¾ 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 2009.
The STX CA reported an adverse event and required corrective action against
1 facility, as described in this report.

¾ 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

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Adverse Event:

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

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 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

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 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.

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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.

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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/PolicyG
uidanceHelpSystem/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.