Consumer Complaints: Mammography (Revised 02-06-2024)

Revision History

ACR-accredited facilities must:

• Have a written and documented system for collecting and resolving consumer complaints

• Maintain a record of each serious complaint received by the facility for at least 3 years from the date the complaint was received

• Provide the consumer with directions for filing serious complaints with the ACR if the facility is unable to resolve a serious complaint to the consumer’s satisfaction

• Report unresolved serious complaints to the ACR as soon as possible (the ACR does not specify a timeframe for facilities to report unresolved serious consumer complaints because we realize that every complaint is different and therefore that the amount of time facility staff will need to spend resolving a complaint may vary considerably)

A serious complaint is defined by the FDA as “a report of a serious adverse event, which means an event that significantly compromises clinical outcomes or one for which a facility fails to take appropriate corrective action in a timely manner.”

Serious Adverse Events: Examples

• Poor image quality

• The use of personnel that do not meet FDA qualifications

• Failure to send the mammography reports or lay summaries within 30 days

In addition, consumers may directly contact the ACR to report a serious complaint if they feel that their concerns have not been adequately addressed by the facility. All serious consumer complaints must be submitted to the ACR in writing and include:

• Consumer’s name, address and telephone number

• Consumer’s signature

• Name and location of the ACR-accredited facility where the mammogram was performed

• Description of the complaint

The ACR will:

• Acknowledge the receipt of the complaint by letter to the consumer (or facility)

• Obtain a signed Serious Consumer Complaint Inquiry Release Authorization and Consumer Complaint form from the patient

• Request a response from the facility in writing

• Provide a summary of its resolution to the patient

Consumer complaints may be mailed to:

The ACR is limited in what it can investigate by federal regulations. We are an FDA- approved accrediting body, but we are not a legal authority that can impose consequences on individuals. The ACR can only investigate the facility’s compliance with the FDA Mammography Quality Standards Act (MQSA) Final Rules and ACR Mammography Accreditation Program Requirements as they pertain to the complaint. MQSA law requires accrediting bodies to ensure that facilities meet all personnel, educational, and equipment requirements. It does not provide a method by which the ACR can evaluate the interpretation accuracy of a physician, billing practices, scheduling practices or compliance to state laws or regulations. Items such as these are beyond the legal authority of an accrediting body under federal law. Moreover, MQSA cannot assure that every examination will find all cancers early enough for successful treatment.

Although all consumer complaints are important, not all complaints submitted to the ACR are of a serious nature. These include patient waiting times, uncomfortable compression, and excessive fees charged by facilities for transferring images. The ACR will acknowledge the receipt of each complaint and advise the consumer which complaints can best be addressed directly by the facility. ACR staff will provide the consumer with links to FDA regulation and guidance supporting their complaint and alternative sources of assistance as appropriate. The ACR will not follow up any complaint that is submitted verbally or anonymously.

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