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  5. Mammography Facility Adverse Event and Action Report - September 13, 2021: Hoffman Medical Center, a/k/a Hoffman MRI, f/k/a Hope Imaging and Medical Center, Inc.
  1. MQSA Reports and Safety Notifications

Mammography Facility Adverse Event and Action Report - September 13, 2021: Hoffman Medical Center, a/k/a Hoffman MRI, f/k/a Hope Imaging and Medical Center, Inc.

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 (for example, Directed Plan of Correction, Patient and Provider Notifications, Civil Money Penalties, Suspension or Revocation of an MQSA Certificate, and Injunctions) taken against mammography facilities are concluded.

Mammography Facility Against Which There Was An Adverse Action

Hoffman Medical Center
a/k/a Hoffman MRI
f/k/a Hope Imaging and Medical Center, Inc.
2500 W. Higgins Road
Suite 830
Hoffman Estates, IL 60169

Facility ID Number

242701

Inspection/Reporting Entity

The State of Illinois Certification Agency

Adverse Event

On August 1, 2020, the State of Illinois Certification Agency (SIL CA) initiated an Additional Mammography Review (AMR) of mammograms performed by this facility, to be conducted by this facility's accreditation body, the American College of Radiology (ACR). The State initiated the AMR because the facility's accreditation and certification expired in October of 2019, and it was discovered that the facility continued to provide mammography services using an unaccredited unit and without a valid mammography certificate.

On October 14, 2020, the ACR notified the SIL CA that the AMR revealed serious deficiencies with the clinical image quality, and that the facility failed to meet the ACR's clinical image evaluation criteria.

On March 25, 2021, the SIL CA conducted an unannounced inspection at the facility. This inspection determined that the facility continued to perform mammography while unaccredited and uncertified.

Action Taken

On August 4, 2020, the SIL CA issued an "Emergency Order" under state law to the facility based on the discovery that the facility continued to provide mammography services without obtaining accreditation for the mammography unit or having a valid mammography certificate. The "Emergency Order" documented that the facility shall not perform mammography examinations until such a time that the facility is properly accredited with the American College of Radiology (ACR) and has been issued a certificate by the Illinois Emergency Management Agency (IEMA). 

On April 6, 2021, the SIL CA issued a second "Emergency Order" due to a change in ownership of the facility. The "Emergency Order" documented that the facility shall not perform mammography examinations until such a time that the facility is properly accredited with the American College of Radiology (ACR) and has been issued a certificate by the Illinois Emergency Management Agency (IEMA). 

On July 28, 2021, the SIL CA issued a public safety notification to the agency's website notifying patients to seek a second opinion on mammograms performed at the facility from October 2019 through March 2021.

Corrective Action

Based on the serious image quality deficiencies noted during the AMR, the SIL CA 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 healthcare providers of the mammography quality problems at the facility.

The facility was ordered to notify at-risk patients and their health care providers during the time period of October 17, 2019, up to and including March 25, 2021.

To date, the facility has not complied with the PPN order.

Status of the Facility

The facility is currently unaccredited and uncertified and cannot legally provide mammography services.

Additional Resources

For more information, see the MQSA Program webpage and States as Certifiers: Who They Are and What They Do.

 
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