Radiation-Emitting Products

What is an example of an acceptable system for collecting and resolving consumer complaints?

Policy Guidance Help System logo

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).

  1. 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.
  2. 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).
  3. 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.
  4. 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).
  5. FDA suggests that facilities analyze the complaints to determine if persistent/recurrent problems exist and use this information to help improve their mammography services.
  6. 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.

Back to Consumer Complaints

Page Last Updated: 08/12/2014
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.