The HMO shall have a: Written procedure to assist and respond to enrollees, families, and providers on complaints concerning quality of care issues; and Designated department to handle complaints. Quality of care issues include, but are not necessarily limited to: Bad outcomes related to poor care; Failure to follow-up on diagnostic procedures; Failure to provide treatment for presenting complaints consistent with standard of care; Failure to appropriately document medical records; Confidentiality and privacy issues related to medical records or provision of care; General dissatisfaction with care; Qualifications of individuals who are: Employees of the HMO; or Under contract with the HMO to provide services to enrollees; Misdiagnosis; Inappropriate referral to meet enrollees' needs; Environmental issues related to infection control and hazardous medical waste; Failure of a provider to perform adequate medical screening, assessments, or timely care in emergency situations; Failure to provide an adequate internal enrollee complaint process concerning quality of care issues; Failure to comply with policies and procedures concerning delivery of care; or Inadequate credentialing and performance appraisal for physicians. The HMO shall: Submit the written procedure to the Department for approval before distributing to enrollees; Obtain Departmental approval of any revision to the written procedure before implementing the proposed change; and Distribute the approved written procedure to all enrollees. The written complaint procedure shall include, at a minimum, the: Department of the HMO that the enrollee or family member may contact if the enrollee wishes to make a complaint or obtain information concerning a complaint; Complaint department's address and telephone number; Procedure for investigating the complaint; Time frame in which the HMO shall provide a final response to or resolve the enrollee's complaint, not to exceed 60 days; and Telephone number of the Maryland Insurance Administration if the enrollee wishes to pursue a complaint regarding quality of care issues outside of the HMO's complaint system. The HMO shall treat the enrollee with dignity, courtesy, and due regard for the individual's privacy. The HMO shall maintain a written record of complaints and responses for at least 5 years following the date the complaint was received by the HMO. Investigation by the Department. The Maryland Insurance Administration is the single point of entry for all complaints to State government filed by an HMO enrollee. The Maryland Insurance Administration shall refer all quality of care complaints, as defined in §B of this regulation, to the Department for investigation. The Department may: Refer a complaint directly to an HMO for resolution; or Conduct an independent investigation. If the Department refers the complaint to an HMO, the HMO shall provide the following information in writing to the Department within 30 days of receipt of the complaint: The results of the investigation; Any change or proposed change to HMO policies or procedures as a result of the investigation; and The HMO's method to prevent recurrence of the problem. If the HMO has not completed the investigation within 30 days, the HMO shall send the Department an interim report with a summary of the investigation to date and the expected date of completion. The expected date of completion may not be longer than 60 days from receipt of the complaint.