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Mammography Facility Adverse Event and Action Report - October 24, 2017: Clinics of North Texas L.L.P.

Background
As part of the Mammography Quality Standards Act (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. In order to provide this information in the timeliest manner, we now post the following information in "real time," as actions taken against mammography facilities are concluded:

Mammography Facility Against Which There Was An Adverse Action

The State of Texas

Facility Name and Address:
Clinics of North Texas L.L.P.
501 Midwestern Parkway East
Wichita Falls, TX 76302

Facility ID Number:
146787

Adverse Event:
On June 30, 2017, the State of Texas Accreditation Body (STX AB) initiated an Additional Mammography Review (AMR) of mammograms performed by this facility due to serious image quality problems identified during a review of clinical images submitted as part of STX AB’s MQSA-required process for random clinical image review.

On August 14, 2017, STX AB notified the facility that it failed the AMR because the images reviewed did not meet STX AB’s criteria for clinical image quality and that it believed the deficiencies posed a serious risk to human health.

Action Taken:
Under State authority, the facility voluntarily suspended its accreditation, effective August 14, 2017. After evaluating the information leading up to serious risk to human health determination, the State of Texas Certification Agency (STX CA) suspended the facility’s MQSA certificate until such time as the facility’s accreditation was reinstated and the facility complied with all requirements under the MQSA.

Corrective Action:
On August 18, 2017, the STX CA required the facility to perform a Patient and Referring Healthcare Provider Notification (PPN) to alert all at-risk patients and their providers of the mammography quality problems at the facility. In addition, under State authority, the facility was assessed $9,000 in administrative penalty fees.

The facility completed the PPN and was notified of such by the STX CA on October 13, 2017.

Status of the Facility:
The facility’s accreditation was reinstated and the facility was issued an MQSA certificate. The facility is currently performing mammography.