State Operations Manual (Pub. 100-07), Ch. 5 § 5160
Investigating Complaints Against ESRD Suppliers
5160 - Investigating Complaints Against ESRD Suppliers
(Rev. 88, Issued: 08-27-13, Effective: 07-19-13, Implementation: 7-19-13)
1. General
Refer to the guidance for investigation of complaints against non-deemed providers and
suppliers. See SOM §5200.
The ESRD Networks are required to have a complaint /grievance resolution system.
Networks (NW) and the SA are frequently contacted by the same complainant with the
same or similar allegations. If the allegations require an onsite investigation or allege
potential risk to patient health or safety, the SA is responsible for the investigation. If the
allegations are primarily focused on relationship or communication issues, the NW may
assume primary responsibility for the investigation. If the focus of the allegations is a
medical practice issue, the SA and NW may need to collaborate on the investigation. The
NWs and SA are encouraged to communicate and collaborate to reduce or prevent
redundant investigations.
2. Conducting the ESRD Investigation
The SA surveyors must use the ESRD survey protocol in Appendix H to investigate
complaints. The allegations of the complaint will determine the tasks needed. For
example, an allegation of inadequate patient care staffing would require use of the
following tasks, at a minimum:
• Pre survey activities;
• Entrance Conference: Provide an overview of the complaint allegations and the
planned agenda for your survey time;
• Tour and observations;
• Patient interviews;
• Staff interviews;
• Record reviews;
• Review of quality management materials; and
• Exit conference.
Conduct each of the identified survey tasks in Appendix H, “Guidance to Surveyors:
End-Stage Renal Disease Facilities.”
3. Pre-survey Task for ESRD Complaint Investigations
Review the allegations of the complaint to identify needed survey tasks. Review the
State Outcomes List and the Dialysis Facility Report to determine if there are data
outliers related to the allegations. For example, if the complaint alleges staff members do
not wash their hands, the surveyor should review the facility’s rate of hospitalization and
hospitalizations related to septicemia, and consider this information in the survey process.
To facilitate meeting the requirement of surveying each ESRD facility every 3 years, the
SA evaluates all available information (outcome list rank, Dialysis Facility Report, time
since last survey, complaint history, NW information, etc.) to determine whether a
recertification survey should be conducted at the time of the complaint investigation.