Attachment 3: Consumer Complaint Policy
The ACR is required under FDA's Quality Mammography Standards; Final Rule to have a system to collect and resolve serious consumer complaints that could not be resolved at their accredited mammography facilities. If a facility cannot resolve a serious consumer complaint to the satisfaction of the patient, the facility must report the complaint to the ACR as soon as possible. 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.
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. Examples of serious adverse events include: poor image quality, missed cancers, the use of personnel that do not meet the applicable requirements of 900.12(a), and failure to send to the appropriate person(s) mammography reports or lay summaries within 30 days." All serious consumer complaints must be submitted to the ACR in writing. The complaint should include the consumer's name, address, telephone number, the name and location of the ACR-accredited mammography facility where the examination was performed, a description of the complaint and the consumer's signature (if reported by the consumer). The complaint should also include copies of any supporting documentation that would be helpful in addressing this complaint. Follow-up will not occur with any complaint that is submitted verbally or anonymously. The complaint may be either faxed, e-mailed, or mailed to the following address:
Assistant Director, Breast Imaging Accreditation Programs
American College of Radiology
1891 Preston White Drive
Reston, VA 20191-4397
Fax: (703) 648-9176
mamm-accred@acr.org
ACR staff will acknowledge the receipt of the complaint by letter to the patient (or facility), obtain a signed Serious Consumer Complaint Inquiry Release Authorization from the patient, request a response from the facility in writing and provide a summary of its resolution to the patient. Unresolved complaints will be forwarded to the senior director of the Breast Imaging Accreditation Programs for further investigation, FDA notification or other action as appropriate.
Although all consumer complaints are important, not all complaints submitted to the ACR may be of a serious nature. These include patient waiting times, uncomfortable compression and excessive fees charged by facilities for transferring films. ACR will acknowledge the receipt of each complaint and advise the patient that their complaint can best be addressed directly by the facility. ACR staff will provide the patient with copies of FDA regulation and guidance supporting their complaint and alternative sources of assistance as appropriate.