The following procedure details the steps that are taken with a client/patient grievance or complaint is received.

After receiving the concern, the Compliance Officer will take the following steps:

Contact the person making the concern if contact has not already been established

• Record information regarding the concern on the Concern Log
• Date
• Time
• Description of concern. If equipment-related injury was involved refer to Product incident Procedure
• Name of individuals or description of products involved, and lot numbers if applicable.
• Determine what actions the caller feels should be initiated regarding the concern.
• Arrange for the replacement of defective items if the concern involves a product
• Speak with involved employees as appropriate
• Attempt to resolve the concern to the client/patient’s satisfaction
• Report status of activities to client patient within two days following receipt of concern

Each concern will be logged on a Concern Form. All completed Concern Forms are to be kept in a Concern Forms notebook at the location. When a concern cannot be resolved within five business days in the above stated manner the Concern Form should be forwarded to the Compliance Officer. The Compliance Officer will review the Concern Form and collect additional data as required for the resolution of the concern and will respond to the concern within three business days, after the receipt of the Concern Form has been received. 

Any concern received after normal business hours will be resolved the next business day if possible. If not, the concern will be reported to the Compliance Officer after receipt of the following morning. All concerns will be written up as soon as possible on the Concern Form. All concerns will be reviewed at the next QI meeting and reported to the owner quarterly.