August 17, 2001 - The Office of the Inspector General (OIG) of the Health and Human Services (HHS) Department of the U.S. Government has released a report entitled:

"The Medicare Beneficiary Complaint Process: A Rusty Safety Valve". A report is available in pdf format.

According to the HHS web site, "This OIG inspection examines the effectiveness of the beneficiary complaint process administered by Medicare's peer review organizations (PROs). We found the complaint process to be an ineffective safety valve that has changed little since our inquiry 5 years ago. Its accessibility is questionable. The process rarely triggers any intervention beyond a letter to providers or physicians for substantiated complaints. It also fails to provide a meaningful response to complainants. The CMS' contract with the PROs treats complaints as a minor activity and PROs also tend to be more oriented toward the medical community than to the beneficiary community. We recommend that CMS provide beneficiaries with an effective complaint process by either fixing the current PRO system or creating a new system outside the PROs."

Page 12 of this report states, "We developed a template for an effective complaint process on prior inspection work on dialysis facility oversight. In testimony before Congress on dialysis facilities, CMS endorsed the elements as essential to an effective complaint system. We think it is just as relevant to the complaint process of Medicare PROs."

In June 2000, in conjuction with a Senate hearing on dialysis, three reports were released by government agencies about US dialysis facilities and their compliance with quality care regulations. These reports were:

A report from the Office of the Inspector General (OIG) of the Health and Human Resources Department entitled "External Quality Review of Dialysis Facilities: A Call for Greater Accountability" (pdf file)

This report contains the "Template for an Effective Complaint System":

• Accessibility - Makes efforts to inform potential users of the system and is easy to use.
  
  
• Objectivity - Respects the rights of all parties involved. Conducts unbiased investigations.
  
  
• Investigative Capacity - Has access to clinical expertise and has sufficient resources and authority to thoroughly review and evaluate complaints, including the ability to go on-site whenever necessary.
  
  
• Timeliness - Complaint investigations conclude within a reasonable time frame.
  
  
• Responsiveness to Complaints - Complainants receive substantive information about the process and any resulting actions.
  
  
• Enforcement Authority and Follow-up - Has the authority to hold facilities and individuals accountable when complaints are substantiated. Follows up with appropriate corrective actions.
  
  
• Improvement Orientation - Use complaints to help identify opportunities for improvement or prevention.
  
  
• Public Accountability - Facility specific complaint information is available to the public so that they can be aware of any disciplinary actions or any past problems at a particular facility

This template was created when investigators found that the complaint systems for dialysis "serve as unreliable means for identifying and resolving quality-of-care concerns." The report also identified these barriers to lodging complaints:

"Two basic barriers inhibit patient complaints about the quality of care. First, dialysis patients find it difficult to complain about an individual or facility providing treatment that their lives depend upon. Network officials, other renal professionals, and patient representatives stressed that fear of retribution deters patients from complaining. The second major barrier is limit patient information and understanding about the technical aspects of their care."

"In many respects, the staff in dialysis facilities are in the best position to lodge complaints about continuing problems with the quality of care in a facility. But as were were often reminded, staff also face significant deterents to lodging complaints; such actions could put their jobs at risk and brand them as troublemakers; thereby jeopardizing future employment in the field."

"(End-stage Renal Disease) Network (web site) officials are aware of and often sympathetic to these barriers. But, in general, their policies and practices make the barriers even more imposing."

(Paragraphs have been abridged.)

Another report from the OIG entitled "External Quality Review of Dialysis Facilities: Two Promising Approaches" (pdf file)

A General Accounting Office (GAO) document entitled "Oversight of Kidney Dialysis Facilities Needs Improvement" (pdf file) which reports that the number of dialysis facilities subjected to inspections each year has declined from 52 percent in 1993 to 11 percent in 1999. The report further states that of the 409 facilities inspected last year, 15 percent had deficiencies severe enough that, if uncorrected, would warrant expulsion from Medicare. In 1993, only 6 percent were found to have similar deficiencies.

One of the functions of the ESRD Networks to is handle dialysis patient grievances that can not be resolved at the facility level. According to the ESRD Network web site:

"All Networks maintain a grievance process, enabling patients to voice concerns about the care they receive to an objective third party. Many complaints are resolved at an early stage and never result in a formal grievance. Of an estimated 1200 patient contacts in 1994, only 106 complaints resulted in formal grievances. This mark of success shows that Networks have developed an expertise in resolving these concerns at an early stage, avoiding major conflicts, and often, litigation." (Italics added by RenalWEB.)

[This message has been edited by Gary Peterson (edited 12-28-2004).]