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Mammography Facility Adverse Event and Action Report - October 24, 2017: Tarrant County Hospital District dba John Peter Smith Hospital

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:
Tarrant County Hosp. District dba John Peter Smith Hosp.
1050 W. Arkansas
Suite150
Arlington, TX 76013

Facility ID Number:
232480

Adverse Event:
In May 2017, the American College of Radiology (ACR), the facility's accrediting body, 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 ACR’s MQSA-required process for random clinical image review.

On June 2, 2017, the ACR notified the facility that it failed the AMR because the images reviewed did not meet the ACR’s criteria for clinical image quality and that it believed the deficiencies posed a serious risk to human health.

Action Taken:
The ACR revoked the facility’s accreditation effective June 13, 2017. After evaluating the information leading up to the ACR’s revocation decision, the State of Texas Certification Agency (STX CA) determined that the facility’s MQSA certificate should be place in a “no longer in effect status” until such time as the facility’s accreditation was reinstated and the facility complied with all requirements under the MQSA.

Corrective Action:
On June 27, 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 $4,000 in administrative penalty fees.

The facility completed the PPN and was notified of such by the STX CA on September 6, 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.