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 Kansas

Facility Name and Address:

Allen County Kansas Hospital dba Allen County Regional Hospital
3066 North Kentucky
Iola, KS 66749

Facility ID Number:

171611

Adverse Event:

On March 28, 2017, The American College of Radiology (ACR) initiated a Full Additional Mammography Review (AMR) of mammograms performed by this facility based on deficiencies noted with the clinical images submitted by the facility during the accreditation renewal process.

The ACR notified the facility on May 16, 2017, that the results of the AMR revealed that fifteen (15) out of thirty (30) clinical cases reviewed failed to meet the ACR's clinical image evaluation criteria.

Action Taken:

Based on the failed AMR results, on May 22, 2017, the ACR revoked the facility's accreditation.

After evaluating the reasons for the accreditation revocation, on May 23, 2017, the Food and Drug Administration (FDA) declared the facility's MQSA certificate to be no longer in effect until such time as the facility's accreditation is reinstated and the facility has complied with all the requirements of the FDA.

Corrective Action:

Based on the serious image quality deficiencies noted during the AMR, the FDA declared the mammography performed at this facility to be a serious risk to human health and therefore 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.

The facility successfully completed the PPN and was notified of such by the FDA on August 11, 2017.

As part of the ACR's post-revocation protocol, the facility was required to participate in a post revocation follow-up AMR, a more extensive clinical image review for accreditation reinstatement. On October 16, 2017, the FDA issued a provisional certificate to the facility for the facility to lawfully obtain the clinical images needed to complete the accreditation reinstatement process.

On January 26, 2018, the ACR informed the facility and the FDA that the results of the post revocation follow-up AMR revealed that twenty-two (22) out of thirty (30) clinical cases reviewed failed to meet the ACR's clinical image evaluation criteria.  Based on the failed results, the ACR revoked the facility's accreditation on February 6, 2018.

The FDA again declared the mammography performed at this facility to be a serious risk to human health and therefore required the facility to perform a second PPN to alert all at-risk patients and their providers of the mammography quality problems at the facility. On February 28, 2018, the FDA suspended the facility's certificate until such time as the facility's accreditation is reinstated and the facility has complied with all the requirements of the FDA.

The facility successfully completed the second PPN and was notified as such by the FDA on April 4, 2018.

Status of the Facility:

The facility is currently not practicing mammography.