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  1. Mammography Quality Standards Act and Program

Mammography Facility Adverse Event and Action Report - April 02, 2019: DMI Clinic - Carl J. Kubek

Mammography Facility Adverse Event and Action Report - April 02, 2019: DMI Clinic - Carl J. Kubek

Background

As part of the Mammography Quality Standards Act (MQSA), Congress mandated that 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 Michigan

Facility Name and Address:

MI Clinic - Carl J. Kubek
847 Parchment SE
Grand Rapids, MI 49546

Facility ID Number:

110213

Adverse Event:

On August 21, 2018, the facility’s accreditation body, the American College of Radiology (ACR), issued a Validation Image Check (VIC) to the facility as part of the ACR’s routine monitoring procedures for accredited facilities. The VIC revealed clinical image quality deficiencies, and a report of the findings was issued to the facility on December 14, 2018. Because of the deficient VIC, the ACR required the facility to complete a Corrective Action Plan (CAP) by December 28, 2018 with complete documentation due by February 12, 2019.

The ACR made multiple attempts to contact and assist the facility regarding the required CAP, and on March 05, 2019, the ACR issued an Intent to Revoke Accreditation letter to the facility; the letter requested that the facility submit all documentation relating to the CAP no later than March 15, 2019.

Action Taken:

As of March 18, 2019, the facility had not submitted a CAP plan or documentation to the ACR, and as such, the ACR issued an Accreditation Revocation letter to the facility due to non-compliance with completing the ACR’s required CAP process.

Furthermore, on March 19, 2019, the FDA declared the facility’s MQSA certificate to be no longer in effect until such time as the facility’s accreditation is reinstated and the facility has complied with all the requirements of the FDA.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:

As of the date of this posting, the facility has not completed the ACR required CAP to reinstate its accreditation.

Status of the Facility:

The facility is currently not performing mammography.