Consumer Complaint Policy
Consumer Complaint Mechanism
The consumer Complaint Mechanism must address the following items:
§ Establish 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; (this means you will need to record the date the complaint was received and state that you will do so within your policy)
§ Provide the consumer with adequate directions for filing serious complaints with the facility's accreditation body if the facility is unable to resolve a serious complaint to the consumer's satisfaction;
§ Report unresolved serious complaints to the accreditation body in a manner and time frame specified by the accreditation body (the ACR states ASAP, thereby leaving it to the facility to state this time frame, usually 30, 60, or 90 days)
Referenced from the ACR website:
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:
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.
Referenced from the Policy Guidance Help System:
Question 9: What is an example of an acceptable system for collecting and resolving consumer complaints?
The MQSA final regulations require facilities to have a written and documented standard operating procedure for responding to consumer complaints. The facility may select its own format. An example of an acceptable system for collecting and documenting the consumer complaint is described below:
1. The facility designates a facility contact person with whom consumers, the accreditation body, and FDA or the State Certifying Agency can interact regarding serious consumer complaints. The contact person and other health professionals at the facility develop a clear understanding of the definitions of "consumer," "adverse event," "serious adverse event," and "serious complaint" so all parties are knowledgeable about the requirements of the consumer complaint mechanism.
2. If the facility cannot resolve a complaint to the consumer’s satisfaction, the facility provides the consumer with directions for filing serious complaints with the facility’s accreditation body. These directions are to be provided in writing.
The facility may wish to post a sign to explain how to file complaints. In this case, the facility could use messages such as, "We care about our patients. If you have comments and/or concerns, please direct them to (the name of the person in the facility who is responsible for complaints)."
This would be in addition to the name and address of the accreditation body, which is listed on the facility’s MQSA certificate. The facility is required by law to post the MQSA certificate prominently in the facility. 42 U.S.C. 263b(b)(1)(A)(iii).
3. The facility keeps documentation of the complaint on file for a period of three years from the date the complaint was received. The facility may develop a form to record, at a minimum, the following items concerning "serious complaints": name, address and telephone number of the person making the complaint; date of the complaint; date the serious adverse event occurred; precise description of the serious adverse event (including the name(s) of the individual(s) involved); how the complaint was resolved; and the date the complaint was resolved. This record can be either manual (written) or computerized, depending on the facility’s preference.
4. The facility acknowledges the consumer’s complaint, investigates the complaint, makes every effort to resolve the complaint, and responds to the individual filing the complaint within a reasonable time frame (these steps can usually be accomplished within 30 days).
5. The facility assures that the complaint and any information regarding the complaint or its followup will be shared only with those needed to resolve the complaint. In addition, facilities should design their complaint procedures to be responsive to the particular needs of the patients they serve. Patients or their representatives may complain in person or in writing.
6. The facility reports unresolved serious complaints to its accreditation body in a manner and timeframe specified by the body. The facility may wish to contact its accreditation body regarding this requirement. For easy reference, facilities may want to keep a separate listing of unresolved serious complaints, with the date of referral, summary and date of response, if any, from the accreditation body. (This would be in addition to the record described in number 3, above).
FDA suggests that facilities analyze the complaints to determine if persistent/recurrent problems exist and use this information to help improve their mammography services.
The primary responsibility for the consumer complaint mechanism is with the facility. However, for complaints that cannot be resolved at the facility, the consumer may choose to report the complaint to the accreditation body.