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

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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 federalgovernment to meet strict quality standards. The intent of MQSA is to assure thequality of mammography nationwide. Quality mammography can detect breast

cancer in its earliest, most treatable stages. Studies show that widespread use ofmammography 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 aninspection 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 helpproviders 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 MQSAoperating in the United States.

As part of MQSA, Congress mandated there be annual reporting of adverseactions taken against mammography facilities. Congress stipulatedthat the report bemade available to physicians and the general public and that it should include

information that is useful in evaluating the performance of mammographyfacilities nationwide. Beginning this year, to provide this important informationin a more timely manner, FDA will publish the Mammography Facility AdverseEvent and Action Report (MFAEAR) on a semi-annual reporting cycle. This firstmid-year report identifies adverse events and actions taken against mammographyfacilities that were completed January through June 2009.

Food and Drug Administration1350 Piccard DriveRockville MD 20850


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

The Office of the Inspector General (OIG), Health and Human Services

(HHS), Center for Medicare and Medicaid Services (CMS) for data aboutfraud, abuse, kickbacks and false billing under Medicare and Medicaid.

The HHS Inspector General lists no conviction data under Medicare orMedicaid for cases related to mammography facilities during Januarythrough June of calendar year 2009.

FDAs Office of Criminal Investigations (OCI) for criminal prosecutionagainst individuals associated with mammography facilities.

The Office of Criminal Investigations reported two criminal conviction casesrelated to mammography facilities from January through June of calendaryear 2009, as described in this report.

FDAs Office of Communication, Education, and Radiation Programs(OCER), Division of Mammography Quality and Radiation Programs(DMQRP), Inspection and Compliance Branch (ICB) for actions takenagainst mammography facilities.

The FDA reported one occasion when actions were taken against amammography 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 whetherthey suspended or revoked the accreditation of facilities that they accredit.Revocation and suspension are means used by the AB to withdraw a facilitysaccreditation prior to its expiration date for reasons other than voluntarywithdrawal 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 accreditationduring January through June of calendar year 2009.


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

Each year, FDA asks all of the State CAs approved under MQSA to reportwhether they took any actions against mammography facilities that they

certify. Currently, the FDA-approved certification agencies are the States ofIllinois (SIL), Iowa (SIA), South Carolina (SSC) and Texas (STX).

The States of Illinois, Iowa, and South Carolina reported no actions againstmammography facilities during January through June of calendar year 2009.The STX CA reported an adverse event and required corrective action against1 facility, as described in this report.

All States and U.S. territories for actions they have taken under their ownauthority against mammography facilities.

MQSA does not preclude a State or U.S. territory from having strictermammography requirements than those of MQSA. In States that haveadditional requirements, facilities are required to comply with both State andMQSA regulations to operate lawfully.

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

The following report provides information on facilities that have had adverseevents and subsequent corrective actions taken against them that were

completed in January through June 2009. The format is in alphabetical order byState, local agency, and U.S. Territory. When a State is not listed, there were noadverse events reported by the State that were comparable to actions that wouldbe taken under MQSA.

MAMMOGRAPHY FACILITIES AGAINST WHICH THERE WEREADVERSE ACTIONS

The State of Delaware

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

FDA Facility ID: 129767


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Adverse Event:

Action Taken: On July 30, 2008, Ms. Clements was suspended byPapastavros Associates Medical Imaging andsubsequently resigned.

FDAs Office of Criminal Investigations (OCI)authority - Ms. Clements was criminally prosecutedfor four felony counts and one misdemeanor.

Mammography Quality Standards Act (MQSA)authority -FDA required the facility to undergo anadditional mammography review (AMR) for mammograms

performed by Ms. Clements during the time period May 13,

2007 through July 30, 2008 to assess the quality ofmammography. The facility passed the AMR.

Corrective Action: On April 14, 2009, Ms. Clements signed a pleaagreement in which she agreed to plead guilty to 3rddegree forgery and to pay a $2,000 fine, with thefelony counts dismissed. Also on April 14, 2009, Ms.Clements was sentenced to one year of incarceration,which was suspended for one year of probation. Shewas also fined $2000 plus court costs.

Status of Facility: Performing mammography.

Puerto Rico

Barranquitas Ultrasound and Mammography CenterCalle Hermandad #3Barranquitas, PR 00794

Facility ID: 216036

Adverse Event: On February 16, 2009, the American College ofRadiology (ACR) conducted a scheduled on-sitesurvey (SOSS) at the facility. An SOSS is available tofacilities when extensive corrective action is requiredin order to pass accreditation.

Due to repeated certification failures and operatingwithout an MQSA certificate, as well as findings of


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QC program failures, FDA asked the ACR to performa full additional mammography review (AMR)during the SOSS, rather than the ABs standardreview performed during an SOSS. The interpretingphysician for the survey team reviewed clinical

images to assess the quality of mammography andfailed the AMR at a serious risk to human health.

Action Taken: Mammography Quality Standards Act (MQSA)authority On March 10, 2009, based on the failedAMR performed during the SOSS, FDA required thefacility to notify patients and their referringphysicians of the findings of serious risk to humanhealth (patient and physician notification, "PPN") forthose patients who had mammograms performed

during the time period March 10, 2007 throughSeptember 29, 2008.

The American College of Radiology (ACR) ABauthority Based on the deficiencies identifiedduring the SOSS, ACR required the facility toundergo a corrective action plan.

Corrective Action: The corrective action plan was successfully completedand ACR reinstated the facility on May 26, 2009.

The PPN is completed.


The State of South Dakota

Spearfish Regional Hospital1440 North MainSpearfish, SD 57783


Adverse Event: Jill Jeanette Ericsson falsified AmericanRegistry of Radiologic Technologists (ARRT)credentials from 2000 to 2008. Ms. Ericssonperformed hundreds of mammograms from


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2000 to 2008 without the required ARRTregistration.

Action Taken: Spearfish Regional Hospital terminatedemployment of Ms. Ericsson.

FDAs Office of Criminal Investigations (OCI)

authority - Criminal prosecution of Ms.Ericsson for one felony count of forgeryresulted in a plea agreement.

Mammography Quality Standards Act(MQSA) authority -FDA required the facility toundergo 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 ofmammography. The facility passed the AMR.

Corrective Action: On April 29, 2009, Ms. Ericsson was sentencedto two years supervised probation andpayment of restitution to Spearfish RegionalHospital in the amount of $11,046.46, courtcosts of $73.00, and costs of prosecution to theSouth Dakota Medicaid Fraud Control Unit inthe amount of $408.65.


The State of Texas

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


Adverse Event: The facility closed in February 2008 and sold itsmedical records to a salvage company on June 9, 2008.The salvage company separated the mammographyrecords from the rest of medical records and heldthe mammography records aside in case the facilitymight 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 therequired 10 years (minimum) resulting in anAttorney General legal fee of $6,000 and anadministrative penalty of $4,000.

At the Texas Department of State Health Services(DSHS) request, the Texas Attorney General filedan injunction requiring the facility to re-takepossession of the mammography records from thesalvage company and make them available to

patients. At a hearing on March 10, 2009, the StateCourt issued an order that required the facility to:

1. take possession of the mammography recordsby April 9, 2009 and provide the mammograms inaccordance with the Texas Administrative Code,

2. notify the certified mammography facilities inBrownsville of the availability of the records, and

3. allow periodic inspections of the storage locationand records of mammography record transfers.

Corrective Action: The facility complied with the court order.

The mammography records are currently being stored inBrownsville, TX. Persons interested in obtaining their

records may fax a request to (956) 541-9393 or send an e-

mail message to [email protected].

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 displayan FDA MQSA certificate or a similar certificate from a State certifying body.


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

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