Radiation-Emitting Products

Does the complaint mechanism have to be posted?

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No. The final regulations do not require facilities to post a sign describing how consumers can file complaints. The MQSA certificate includes the name and address of the facility’s accreditation body, and filing a complaint with the accreditation body is the next step for consumers registering a complaint. The facility is required to post their MQSA certificate prominently within the view of patients.

The final regulations also require the facility to give consumers with serious unresolved complaints directions for filing such complaints with the facility's accreditation body.

While not required, FDA encourages facilities to post a sign informing their patients of the presence of its complaint mechanism. Facilities can use messages such as, "We care about our patients. If you have comments, compliments, and/or concerns, please direct them to (the name of the person at the facility who is responsible for complaints)."

Additional suggestions for making patients aware of the complaint mechanism include: providing information about the complaint mechanism on the patient information sheet filled out before the exam, and requesting that patients complete a comment card following the mammography exam. FDA also encourages the facility to train its staff to be receptive to patient concerns so that the patient will feel comfortable in expressing those concerns.

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Page Last Updated: 07/11/2014
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