Department of Health and Human Services 
OFFICE OF 
 
INSPECTOR GENERAL 
 
 
 
 
 
 
 
 
T ESRD B
H  E    ENEFICIARY 
 
G P  
  RIEVANCE  ROCESS 
 
 
Daniel R. Levinson   
Inspector General  
 
December 2013 
OEI-01-11-00550   
   
EXECUTIVE SUMMARY:  THE ESRD BENEFICIARY GRIEVANCE PROCESS  
OEI-01-11-00550 
 
WHY WE DID THIS STUDY 
 
Over 5,000 dialysis facilities provide life-sustaining treatment to more than 
340,000 End-Stage Renal Disease (ESRD) Medicare beneficiaries.  Medicare regulations 
require that dialysis facilities implement a process for beneficiaries to file grievances 
without reprisal or denial of services.   Beneficiaries also have the option of filing 
grievances with ESRD Network Organizations, which are Medicare contractors that 
oversee dialysis facilities. Previous Office of Inspector General work found that the 
ESRD beneficiary grievance process was unreliable in identifying and resolving 
quality-of-care concerns. 
 
HOW WE DID THIS STUDY  
 
We sent a questionnaire to a random sample of 150 dialysis facilities and had an  
80-percent response rate. We sent a questionnaire to 17 of the 18 ESRD networks and 
had a 100-percent response rate. (We conducted a site visit to the 18th network, during 
which we pretested the questionnaire.) We also made site visits to 13 facilities and  
3 networks in 5 States, where we conducted structured interviews with staff and reviewed 
documentation, including the facility grievance logs. 
 
WHAT WE FOUND 
 
Dialysis facilities have latitude in what they record as a grievance, and two-thirds of  
facilities recorded five or fewer grievances in 2011.  The most common grievances 
recorded concerned the comfort or appearance of the physical environment and 
interactions with staff. Anonymous grievance processes can be difficult to implement, 
and fear of reprisal may be difficult for facilities to measure.  The Centers for Medicare 
& Medicaid Services (CMS) has begun to require that facilities use a standardized 
satisfaction survey that does not assess patient fear of reprisal for filing a grievance.  
ESRD networks involvement with beneficiary grievances are constrained by limited data 
and reporting. They analyze grievances for trends, but the database they use is of limited 
utility. CMS is unable to readily provide network-specific grievance and complaint data. 
 
WHAT WE RECOMMEND  
 
We recommend that CMS (1) define grievance for facilities, (2) require that facilities  
report grievances regularly to their respective networks, (3) provide guidance to facilities 
on what constitutes a robust process for anonymous grievances, (4) work with the 
Agency for Healthcare Research and Quality to add a question to the standardized 
satisfaction survey to assess ESRD beneficiaries fear of reprisal, and (5) provide 
networks with better technical support for their grievance database.  CMS concurred with 
three of our five recommendations. 
   
TABLE OF CONTENTS 
 
Objective......................................................................................................1 

Background..................................................................................................1 

Methodology................................................................................................5 

Findings........................................................................................................8 

Two-thirds of facilities recorded five or fewer grievances in 
 
2011 ..................................................................................................8 

Anonymous grievance processes can be difficult to implement, 

and fear of reprisal may be difficult for facilities to measure ........12 

ESRD networks involvement with beneficiary grievances is 

constrained by limited data and reporting ......................................13 

Conclusion and Recommendations ............................................................15 

Agency Comments and Office of Inspector General Response .................17 

Appendixes ................................................................................................19 

A: Nonrespondent Analysis ..........................................................19 

B: Point Estimates and Confidence Intervals Based on the  

Facility Questionnaire....................................................................20 

C: Agency Comments  ...................................................................21 

Acknowledgments......................................................................................25 

 
 
   
   
OBJECTIVE 
To describe the grievance processes that dialysis facilities and End Stage 
Renal Disease (ESRD) Network Organizations have in place for 
beneficiaries. 
BACKGROUND 
ESRD, characterized by a permanent loss of kidney function, entitles 
individuals to Medicare coverage based solely on the presence of a 
specific medical diagnosis.1  Most patients with ESRD rely on lengthy, 
uncomfortable dialysis treatment several times a week to compensate for 
kidney failure. Medicare pays for treatment for eligible Americans 
diagnosed with ESRD.2 In 2009, Medicare spent $9.2 billion on dialysis 
services for 340,000 ESRD beneficiaries.3    
Effective oversight of dialysis facilities, including robust processes for 
handling beneficiary grievances, is necessary to protect the vulnerable 
ESRD beneficiary population. The Centers for Medicare & Medicaid 
Services (CMS) divides oversight between State Agencies (SAs) and 
ESRD Network Organizations (networks).  SAs, networks, and dialysis 
facilities all can handle beneficiary grievances; the grievance processes of 
networks and facilities are the subject of this report.  
Dialysis  
Treatment options for ESRD include dialysis or kidney transplantation.  
The most common treatment is hemodialysis, 4 in which a machine 
functions as an artificial kidney and pumps blood from the patient and 
removes toxins and excess fluid as it flows through a filter called a 
dialyzer.  The cleansed blood is returned to the patients body through a 
vein. Peritoneal dialysis is a less common method, which drains toxins 
and excess fluid through the abdominal cavity using the patients natural 
peritoneal membrane as a filter.     
More than 5,500 facilities provide dialysis to ESRD Medicare 
beneficiaries.   The majority of facilities are freestanding (90 percent), as 
opposed to hospital-based units. Most facilities are for-profit (82 percent) 
 
1 Medicare also  covers patients with amyotropic lateral sclerosis. 

2 Social Security Act (SSA),  1881(a).  

3 Medicare Payment Advisory Commission (MedPAC),  Report to the Congress: 
 
Medicare Payment Policy, ch. 6, March 2011. 
 
4 Government Accountability Office, End-Stage Renal  Disease:  CMS Should  Monitor 

Access to and  Quality of  Dialysis Care Promptly after Implementation  of New Bundled 
 
Payment System, GAO-10-295, March 2010. 

The ESRD Beneficiary  Grievance Process (OEI-01-11-00550)   1 
   
   
and operated by a chain organization (80 percent).5  Almost two-thirds of 
facilities are operated by just two chain organizations.6  
Oversight of Dialysis Facilities  
ESRD Networks.  CMS contracts with 18 ESRD Network Organizations 
(networks) to evaluate and resolve beneficiary grievances, identify 
facilities not providing appropriate medical care, and measure and 
improve the quality of care through quality improvement projects.7 Each 
network covers a specific geographic region.8 On average, networks 
oversee 322 facilities in their regions.  The largest network has  
590 facilities in its region, and the smallest has 170.  Each networks staff 
includes clinical personnel and a medical review board with dialysis 
provider and beneficiary representation.9 CMS withholds 50 cents per 
patient per dialysis treatment from facilities to fund the networks.  
Funding for networks in 2010 was about $28 million.10  
Consumer Assessment of Healthcare Providers and Systems Survey. As of 
2012, as part of CMSs quality incentive program (QIP) for dialysis 
facilities, facilities must use the Consumer Assessment of Healthcare 
Providers and Systems (CAHPS) survey to measure patient satisfaction.11   
Monitoring patient satisfaction can identify concerns about the care 
provided. The Agency for Healthcare Research and Quality (AHRQ), 
which developed CAHPS, recommends that a third party administer the 
survey.12  Under the QIP, facilities failing to meet certain quality-of-care 
performance standards had their Medicare payments reduced between  
0.5 and 2 percent.13  In December 2011, CMS announced that 30 percent 
 
5 MedPAC, Report to the Congress: Medicare Payment Policy, ch. 6, March 2011. 
6 Ibid. Fresenius Medical Care North America and DaVita  together  own 60 percent of all 
 
dialysis facilities and  70  percent of freestanding dialysis facilities. 
 
7 SSA,    1881(c) and 42 CFR    405.2112. 

8 The statute at  SSA,  1881(c) requires the establishment of only 17  networks, but CMS 
 
ultimately established  18. See CMS, Medicare ESRD Network Organizations Manual.  
Pub.  100-14, ch. 1,  20. 

9  SSA,  1881(c)(1), 42  CFR  405.2113,  and CMS, Medicare ESRD Network 

Organizations Manual.   Pub. 100-14, ch. 2,   40  and 60. 

10 CMS, ESRD  Network Organization Program 2010 Summary Annual Report, p. 6. 
 
11  76  Fed.  Reg. 70228, 7026970270 (Nov. 10, 2011). 

12 AHRQ, Fielding the CAHPS In-Center Hemodialysis Survey, May, 2009. 

13 P.L.  100-275   153(c), which added subsection (h) to SSA,  1881.   42 CFR  

413.177;  76 Fed. Reg. 628 (Jan. 5, 2011).  The regulations set forth the QIP incentive 

program in general terms; the specifics can  be found in the Federal Register entry.  CMS 

determines the payment reduction  on the basis of calculated  facility performance scores. 

The ESRD Beneficiary  Grievance Process (OEI-01-11-00550)   2 
   
   
of dialysis facilities would have their payments reduced in 2012 based on 
their QIP scores.14    
Medicare Conditions for Coverage for Dialysis Facilities.  Facilities must 
meet 16 Conditions for Coverage (CfCs) to participate in the Medicare 
program. 15   The CfCs address topics such as patient rights, safety, and 
quality assessment and performance improvement. 16   Each CfC includes 
standards that facilities must meet.  For example, under the CfC for 
infection control is a requirement that facilities monitor staff members and 
ensure that they comply with aseptic techniques.  SAs oversee the CfCs 
through onsite certification surveys of facilities.  
Beneficiary Grievances 
Beneficiaries can file grievances with their respective facilities, networks, 
or SAs. CMS has declined to define what constitutes a grievance at the 
facility level.17  Facilities may instead define the term for themselves.  This  
contrasts with other parts of Medicare, such as Medicare Advantage (MA),  
for which CMS defines a grievance as any complaint or dispute... 
expressing dissatisfaction with any aspect of an MA organizations or 
providers operations, activities, or behavior, regardless of whether 
remedial action is requested.18  
Facility Processes for Handling Grievances 
Facilities must implement an internal grievance procedure for 
beneficiaries to file oral or written grievances without reprisal or denial of 
services.19  Beneficiaries may file internal grievances personally, 
anonymously, or through a representative of the patients choosing.20   
Furthermore, the CfCs state that beneficiaries have the right to privacy and  
confidentiality in all aspects of treatment.21  Facilities must prominently 
display a copy of patients rights, including the right to file a grievance, 
where it can be easily seen and read by patients.22  
 
14 CMS could not calculate performance scores for 625 facilities because they did  not 
meet the minimum  threshold for cases.  Their payments were not  reduced.  CMS, CMS  
Announces First Results for Program to Improve Care for Dialysis Patients, December 
15, 2011. Accessed at http://www.cms.gov on December 15, 2011. 
15 42 CFR pt. 494. 
16 CMS first issued CfCs for ESRD dialysis facilities in 1976, revising them in  2008. See 

73 Fed. Reg. 20370  (April  15, 2008). 
 
17 73 Fed. Reg. at 20392 (April 15, 2008). 

18 42 CFR   422.561.  

19 42 CFR   494.180(e). 

20 42 CFR   494.70(a)(17). 

21 42 CFR   494.70(a)(3).  

22  42  CFR  494.70(c).  

The ESRD Beneficiary  Grievance Process (OEI-01-11-00550)   3 
   
   
Facilities must inform beneficiaries of both the facility-level internal 
grievance process and the network- and SA-level grievance options.23   
Facilities must also measure, analyze, and track patient satisfaction and 
grievances as part of the CfC for quality assessment and performance 
improvement (QAPI).24  Facilities typically track grievances in a written or 
electronic log. 
ESRD Network Processes for Handling Grievances 
Beneficiaries can also file grievances with their respective networks.25   
Beneficiaries do not need to first file grievances with their facilities before  
contacting the networks; however, CMS instructs networks to encourage 
beneficiaries to use the facility-level grievance process before contacting 
the network. 26  Some beneficiaries may find it difficult to approach facility  
staff and reach resolution at the facility level.  
Networks must keep confidential the grievants identity unless given 
specific permission.27 When networks receive grievances, they gather 
information via telephone, letter, email, and onsite reviews.  Networks can 
make referrals to Quality Improvement Organizations, Managed Care 
Organizations, or other such entities if the networks identify concerns 
those entities could more appropriately handle.28 Networks immediately 
refer allegations to SAs and CMS when they involve a potential life-
threatening situation.29    
If networks determine that an instance or pattern of care exists that has 
affected or might affect the health or well-being of one or more 
beneficiaries, networks can require facilities to develop and implement 
improvement plans.  Networks monitor how facilities implement plans and 
expect facilities to complete the plans within 1 to 3 months.  If networks 
determine that facilities failed to correct the problem, networks may 
request a revised improvement plan, refer the grievance to SAs, or 
recommend sanctions to CMS regional offices.30  
 
23 42 CFR   494.70(a)(14)(17). 

24 42 CFR   494.110(a)(2)(viii). 

25 CMS, Medicare  ESRD Network Organizations Manual, ch. 7,   130.  Beneficiaries can 

also file a complaint with the network.  The network complaint process is less formal 

than the network grievance process.  The beneficiary decides whether to use the network 

complaint or grievance process.  In this report, we use the term grievance to refer to
  
both grievances and complaints at the network level. 
 
26 CMS, Medicare  ESRD Network Organizations Manual, ch. 7,   130.2. 

27 Ibid., ch. 7,   130.4. 
 
28 Ibid., ch. 7,   130.6. 
 
29 Ibid., ch. 7,   130.9. 
 
30 Ibid., ch. 7,  150. 

The ESRD Beneficiary  Grievance Process (OEI-01-11-00550)   4 
   
   
Networks must track and process all grievances in an electronic database.31   
Networks have recently switched to a new database as part of a larger data 
system  migration to the Consolidated Renal Operations in a Web-enabled 
Network (CROWNWeb).  Facilities use CROWNWeb to submit clinical  
quality measures to the networks.  The database that networks use to track 
grievances is called the Network Contact Utility.  This database also 
includes information on other types of requests made to networks, such as 
facilities asking for help with noncompliant patients or beneficiaries 
asking for information about their dialysis care. 
Previous Work 
In 2000, the Office of Inspector General (OIG) found major shortcomings 
in the oversight of dialysis facilities.32 Oversight focused on overall 
quality improvement rather than enforcing minimum requirements that 
protect beneficiaries from harm, and it lacked coordination and 
accountability on the part of the networks, SAs, and facilities.  The report 
also found that the ESRD beneficiary grievance process was unreliable in 
identifying and resolving quality-of-care concerns.  OIG recommended 
that CMS hold facilities more fully accountable for the quality of care they 
provide and hold the networks and SAs more fully accountable for their 
performance in overseeing the quality of care provided by facilities.  CMS 
generally agreed with OIGs recommendations and specifically stated that 
it would strengthen procedures for anonymous grievances to avoid the 
possibility of retaliation against patients. 
METHODOLOGY 
Scope 
This inspection is national in scope.  It examined network and facility 
grievance data for 2011. 
Data Sources and Collection 
Questionnaire for networks. We surveyed 17 of the 18 networks using an 
online questionnaire. (We pretested the questionnaire during a site visit to 
the 18th network.) The questionnaire asked about challenges that networks 
face in investigating grievances, how they use grievance data to identify 
quality improvement opportunities, and how they share facility-specific 
data with SAs and CMS.  We conducted the survey from   
JuneSeptember 2012, and had a 100-percent response rate.   
 
31 Ibid., ch. 7,   130. 
  
32 OIG,  External Quality Review of  Dialysis Facilities:  A Call for Greater 

Accountability, OEI-01-99-00050, June 2000. 

The ESRD Beneficiary  Grievance Process (OEI-01-11-00550)   5 
   
   
Questionnaire for dialysis facilities. We surveyed a simple random sample 
of 150 facilities (of the 5,571 facilities operating in 2011) using an online 
questionnaire.  The questionnaire covered facility grievance procedures, 
the number of grievances that facilities received, how facilities use 
grievances as part of their overall QAPI efforts, and whether facilities 
would record hypothetical concerns as formal grievances.  As part of the 
questionnaire, we asked facilities to provide us with copies of the survey 
instrument they used in 2011 to measure patient satisfaction.  We  
conducted the survey from JulyOctober 2012.  Two facilities we 
attempted to contact had closed.  We received responses from  
120 facilities, an 80-percent response rate.  Because of this response rate, 
our results apply to an estimated 4,457 of the 5,571 facilities in our 
sampling frame.  See Appendix A for an analysis of nonrespondents and 
Appendix B for confidence intervals and point estimates for key data 
points from the facility questionnaire. 
Site visits to dialysis facilities and networks. We conducted site visits at a 
purposive sample of 3 networks in 3 States and 13 facilities in 5 States.  
We selected the networks on the basis of geographic diversity and size of 
patient population, and we selected the facilities on the basis of their 
proximity to the networks, as well as ownership status and QIP results.  At 
the networks and facilities, we conducted structured interviews with staff 
members and reviewed policies and procedures, including those for how 
staff members investigate beneficiary grievances.  We conducted the site 
visits from JuneAugust 2012. 
Dialysis facility grievance logs. While onsite, we obtained the 
2011 grievance logs from the 13 facilities we visited.  The logs contained a 
total of 103 grievances. 
Analysis  
Questionnaires and site visits. We performed qualitative data analysis on 
responses from the interviews and questionnaires.  For example, we 
reviewed the responses for common themes.  We also analyzed network 
and facility questionnaire responses by performing frequency counts of 
responses. 
Dialysis facility grievance logs. We abstracted and categorized the nature 
of each grievance and the facilitys response to it, and performed 
frequency counts of those categories. 
Limitations 
We did not independently verify the data that facilities and networks 
reported to us in their questionnaires.   We also could not confirm whether 
facilities recorded all 2011 grievances in their logs; we could analyze only 
The ESRD Beneficiary  Grievance Process (OEI-01-11-00550)   6 
   
   
the grievances that were in the logs.  The conclusions we drew from our 
site visits are limited to the facilities and networks we visited. 
Standards 
This study was conducted in accordance with the Quality Standards for 
Inspection and Evaluation issued by the Council of the Inspectors General 
on Integrity and Efficiency. 
 
   
The ESRD Beneficiary  Grievance Process (OEI-01-11-00550)   7 
   
   
FINDINGS 
Two-thirds of facilities recorded five or fewer 
grievances in 2011 
Facilities recorded 25,032 beneficiary grievances in 2011.  However,   
28 percent of facilities recorded no grievances, and 38 percent recorded 
between one and five grievances. Because CMS does not define what a 
grievance is, facilities have latitude in defining what they record as a 
grievance; this may explain the variation across facilities in the number of 
reported grievances. The low number recorded in any one facility makes 
it difficult for a facility to analyze grievances for patterns.  
CMS requires facilities to prominently display a copy of patients rights, 
including the right to file a grievance, where it can be easily seen and read 
by patients.33  On our site visits, we generally observed these postings in 
facilities waiting areas.  Furthermore, we obtained documentation from  
the facilities we visited detailing the information given to patients 
regarding facility grievance procedures.  Facilities typically gave this 
information to patients when they began treatment.  
 
The most common grievances that facilities recorded 
concerned the comfort or appearance of the physical 
environment and interactions with staff 
About one in four grievances that facilities reported in response to our 
questionnaire concerned the comfort or appearance of the physical 
environment (see Table 1).  Because dialysis patients spend so much time 
at facilities receiving treatment (typically three treatments per week lasting 
3 to 4 hours each), the environment and comfort are of obvious 
importance to them.  Examples of such grievances included the facilitys 
temperature (most often, too cold), working order of televisions, and 
condition of dialysis treatment chairs.     
Facility staff also can be the subject of grievances (17 percent of recorded 
grievances).  Patients frequently interact with technicians, nurses, 
physicians, and social workers during treatment.  These grievances might 
involve a patient reporting that he or she had been treated rudely or 
unfairly by staff. For example, in one facility a patient complained that 
the receptionist was rude, and the patient left without receiving treatment.  
The facility resolved the grievance by counseling that staff member on 
how to be more sensitive to patients needs.  
 
33 42 CFR   494.70(c). 
The ESRD Beneficiary  Grievance Process (OEI-01-11-00550)   8 
   
   
Another type of recorded grievances concerned quality of care.  Examples  
of these grievances included instances of patients losing either too much 
or too little fluid during treatment.34 In response to these grievances, 
facility staff and the patients physician would monitor the patient during 
treatment, and make adjustments as necessary.  
Table 1: Nature of Grievances Recorded by Facilities in 2011  
Percentage of  
Nature of Grievance  
Recorded Grievances  
Physical Environment  26%  
Staff Interactions  17%  
Scheduling  11%  
Quality of Care   10%  
Staff Competence  5%  
Patient-to-Patient Conflicts  3%  
Other   22%  
Facility Could Not Categorize   6%  
Total   100%  
 
 Source: OIG  analysis of data from facility questionnaires, 2012. 
 
Facilities have latitude in what they decide to record as a 
grievance 
Although there is no expectation for any volume of grievances, the limited 
number that are recorded may result from the latitude that facilities have in  
determining what they record in their grievance logs.  Because facility 
staff determine for themselves what to record as a grievance, it is possible 
that some concerns could be omitted from grievance records.  
We asked facilities to provide their definitions of a grievance, and those 
definitions ranged from the very broad any problem a patient has to the 
more narrowly defined a request for an investigation of a complaint about 
a possible risk to the health, safety, or well-being of a patient; or a 
situation where the patient is unnecessarily at high risk.  Many facilities 
did not offer a definition beyond that of having a process to resolve 
grievances; some merely defined grievance as a patient complaint, and 
others defined it as a problem that cannot be resolved quickly. 
Our questionnaire provided facilities with potential concerns and asked 
whether the facilities would record them as grievances if they were to 
receive those concerns from beneficiaries.  Most facilities recorded many 
of the concernsparticularly quality-of-care-related concernsas formal 
 
34 Dialysis removes harmful  waste, extra salt, and water from blood.    
The ESRD Beneficiary  Grievance Process (OEI-01-11-00550)   9 
   
   
grievances. However, 20 percent of facilities reported that they would not 
record at least one of the following quality-of-care-related concerns:  a 
technician is not properly cleaning dialysis machines between shifts; a 
nurse is being rough when connecting the patient to the dialyzer; a nurse is 
not changing gloves before connecting the patient to the dialysis machine.  
This last concern could be a violation of the CfC on infection control, but 
because the facility would choose not to record it as a beneficiary 
grievance, State surveyors may not be aware of the potential violation 
unless a patient contacted them or the network directly.  See Table 2 for 
concerns that facilities would and would not record as grievances. 
At the 13 facilities we visited, staff told us that they generally record 
grievances only when they cannot resolve the concern immediately.  In 
four of those facilities, staff told us that beneficiaries can request that their 
grievances be recorded regardless of subject or severity, which can lead to  
the elevation of seemingly minor problems.    
 
Table 2  Concerns That Facilities Would and Would Not Record As 
Grievances 
Percentage of  
Percentage of  
Facilities That 
Facilities That Would 
Concern   Would Record  
Not Record Concern 
Concern as a 
as a Grievance  
Grievance  
Technician is not properly cleaning 
13%  87%  
dialysis machines between shifts 
Nurse is rough when connecting the 
12%   88%  
patient to the dialyzer  
Nurse does not change gloves 
before connecting the patient to the  12%  88%  
dialysis machine 
Staff make the patient feel 
15%   85%  
unwelcome 
Facility is too cold  24%  76% 
Patient demands to move to another 
dialysis chair because the patient 
23%   77%  
next to him/her makes him/her feel 
uncomfortable  
Patient submits written request to fix 
28%  72%  
the television  
   Source:  OIG  analysis of data from facility questionnaires, 2012.  
 
However, in some cases, grievances are not recorded at all.  For example, 
at one facility we visited, a beneficiary complained over several months 
both about quality-of-care-related issues and his comfort during treatment.  
The facility did not record these as grievances. These unrecorded 
The ESRD Beneficiary  Grievance Process (OEI-01-11-00550)   10 
   
   
grievances could present a missed opportunity to analyze trends and 
identify opportunities to improve quality.   
Facilities generally resolve grievances directly with the staff 
involved, rather than through systemic improvements 
Facilities have a number of tools available to resolve grievances.  In their 
survey responses, facilities told us that these tools include staff training, 
implementing quality improvement plans, disciplining employees, and 
contacting their respective networks. 
However, when we examined grievance logs in the facilities we visited, 
we observed that most grievances are resolved by talking to the 
beneficiaries and specific staff directly involved in the incident.  On only a 
few occasionswhen grievances addressed broad quality-of-care issues 
did facilities hold training sessions for all staff.   For example, one such 
grievance concerned a patient who experienced painful cannulation 
(insertion of a needle into the venous access point).  As a result, the 
facility trained its nursing staff  on communicating with patients during 
difficult interactions (the log did not note whether the facility also trained  
staff on cannulating). Another grievance concerned one patient who felt 
that some staff members were not proficient in using his dialysis machine.  
The facility held an in-service training on proper use of the machine. 
Facility staff typically tried to resolve common grievances about the 
physical environment, such as temperature or broken equipment, 
immediately, for example by adjusting the thermostat or calling in the 
appropriate repair people. 
Furthermore, facilities analysis of grievances rarely results in systemic 
improvements.  About half the facilities that we visited hold monthly 
meetings focused on facilitywide quality and performance improvement.  
During these meetings, facility staff might discuss trends gleaned from  
grievances; however, staff told us that their grievance volume is so low 
that they almost never have any grievances to discuss.  For grievances that 
staff do not record, such as issues with televisions or temperature, staff do 
not conduct any formal trend analysis.  Instead, the facilitys point person 
for resolving grievances tries to informally track and identify patterns.  
All but 3 percent of facilities reported that they analyze grievances to 
identify trends, but they are unable to see an actual trend because of the 
low number of cases.  Of the facilities that do analyze for trends, almost 
all look for trends related to the physical environment, specific employees, 
quality of care, facility procedures, and activities of specific patients, but 
they were able to identify trends in fewer than a third of these areas, as 
Table 3 shows. 
The ESRD Beneficiary  Grievance Process (OEI-01-11-00550)   11 
   
   
 
Table 3: Grievances That Facilities Analyzed for Trends 
 
Percentage of   Percentage of  
       
Nature of Grievance   Facilities That  Facilities That 
 
Analyze for Trends   Identified Trends  
 
 
Physical environment or appearance   98%   30%  
 
Sp ecific employee   97%   26%  
 
Qu ality of care   97%   19%  
 
Facility procedures  96%   20%  
 
Sp ecific patient   94%   27%  
 
Source: OIG analysis of data from facility questionnaires, 2012.  
 
Anonymous grievance processes can be difficult to 
implement, and fear of reprisal may be difficult for 
facilities to measure 
Almost all facilities reported that they offer methods for beneficiaries to 
submit grievances anonymously.  Anonymous processes at facilities we 
visited included submission by telephone, to corporate headquarters or to a 
third party, and to suggestion boxes.  However, 5 of the 13 facilities we 
visited did not offer anonymity.  At these facilities, staff told us that, 
although they keep confidential the identity of patients who submit 
grievances, the patients must give their names. 
Anonymous grievances can be difficult for facilities to address.  For 
example, if a grievance concerns a particular staff interaction, it may be 
difficult to obtain details about the incident when staff do not know which 
patient was involved. One staff person told us that an adequate 
resolution is usually dependent on identifying the complainant.  Ensuring  
anonymity is also difficult because, as facility staff told us, even when 
patients submit grievances anonymously, staff can often deduce the 
patients identities because of the nature of the grievances.   
On the other hand, it is important that patients who file grievances feel 
safe from reprisals, as OIG and patient advocates have documented.35   
Staff at one network told us that they sometimes must stop a grievance 
investigation when the patients anonymity becomes threatened, and 13 of 
the 18 networks said in response to our questionnaire that when they are 
resolving grievances, it is a challenge to assure patients that they will not 
face reprisals for complaining.   
 
35 OIG,  External Quality Review of  Dialysis Facilities:  A Call for Greater 
Accountability, OEI-01-99-00050, June 2000. 
The ESRD Beneficiary  Grievance Process (OEI-01-11-00550)   12 
   
   
Two-thirds of the patient satisfaction  surveys that facilities submitted to us  
include a question to measure fear of reprisals; such questions show 
facilities awareness that fear of reprisal may exist.  Facilities can use 
these data to assess how well they create an environment in which patients  
feel comfortable raising questions or grievances about their care.  
These patient satisfaction surveys were developed by the facilities.  
However, as part of its QIP, CMS mandated that facilities administer the 
CAHPS survey to measure patient satisfaction.  CAHPS includes 
questions that address patient satisfaction with common concerns, such as 
facility cleanliness, insertion of needles with as little pain as possible, and 
the timeliness of starting treatment. However, CAHPS does not include a 
question to measure a patients fear of reprisal for lodging a grievance.  
Because of the time and expense involved, it is unlikely that facilities will 
administer both the CAHPS survey and a survey of their own.  As a result, 
facilities may discontinue conducting their own surveys, and the chance to 
learn about fear of reprisal among patients will be limited. 
ESRD networks involvement with beneficiary 
grievances is constrained by limited data and 
reporting  
Although the networks serve as an external option for resolving 
beneficiary grievances with dialysis care, that role is constrained by 
limited data and reporting on grievances.  In addition to investigating 
grievances, networks also collect data and provide technical assistance to 
providers and beneficiaries.36  We found that communication between 
networks and facilities primarily concerned these latter areas, not 
grievances. Networks communicated with facilities primarily through 
email reminders promoting network initiatives, such as flu vaccination, 
and through other educational materials. Most networks reported that they 
visited at least one facility in 2011, most often to provide training rather 
than to assist in resolving a grievance. Similarly, facilities reported that 
networks rarely visit them, and when  networks do go onsite at a facility it 
is for reasons such as providing training, not to resolve grievances.  
All networks analyze grievances for trends, but the database 
they use is of limited utility  
Networks analyze grievances for trends at individual facilities and within 
chain organizations, as well as to identify opportunities to improve quality 
networkwide. All 18 networks run reports from the CMS-developed 
Network Contact Utility database to analyze grievances for trends.  All but 
 
36 SSA,    1881(c)(2) and  42 CFR   405.2112.  The Network areas are determined by  
number and concentration of  beneficiaries.  
The ESRD Beneficiary  Grievance Process (OEI-01-11-00550)   13 
   
   
two networks reported that they had developed their own programs (e.g., 
using Excel or SAS) to conduct additional analysis.  Most networks 
worked to identify systemic concerns at individual facilities and 
opportunities for networkwide projects to improve quality. 
The networks we visited raised concerns about the usefulness of the 
Contact Utility database for analyzing grievance data.  One network 
reported that its understanding and use of the Contact Utility database is 
limited because the database lacks a data dictionary or user manual.  
Another network that we visited duplicated all the data from the database 
into its own system to more accurately and specifically categorize 
grievances. In doing so, this network identified a lack of historical data as 
a problem; because the database retains only 18 months of data, its value 
is limited.  Furthermore, the broad categories in the database make it 
difficult to compare grievance trends across networks, as networks can 
interpret category labels differently.   
Facilities rarely contact networks for assistance with 
grievances 
Facilities rarely contact the network for assistance in dealing with 
grievances. Only 1 of the 13 facilities we visited had contacted its 
network for such help. Sixty-one percent of dialysis facilities responding 
to our survey said that they do not report to their respective networks the 
number and types of grievances they receive.  Of the facilities that did, 
most did so only upon the networks request or on an as-needed basis, 
rather than on a regular basis. Only eight networks reported in our survey 
that they conducted an onsite investigation of a facility.   
Facilities that we visited generally contacted their respective networks for 
assistance with difficult patients rather than for help with the grievance 
process. Recently, facilities have been contacting networks for assistance 
with the transition to CMSs CROWNWeb data system.  Many of the 
facilities we visited voiced frustration with the transition and have often 
contacted their networks for help in using the new system. 
CMS is unable to readily provide network-specific grievance 
data 
We asked CMS to provide us with information on network-specific data 
on grievances for 2011, including the nature of grievances and their 
disposition. After 8 months, CMS was able to provide only high-level 
summary data, apparently because of the networks inability to extract the 
data from the Contact Utility database.  This raises questions about CMSs 
ability to effectively oversee the networks role in investigating 
grievances. 
The ESRD Beneficiary  Grievance Process (OEI-01-11-00550)   14 
   
   
CONCLUSION AND RECOMMENDATIONS 
Medicare regulations require dialysis facilities to measure, analyze, and 
track beneficiary grievances.  When promulgating its ESRD regulations, 
CMS declined to define grievance on the grounds that the term was 
commonly understood.37  However, we found that facilities define 
grievances differently and as a result, they vary in how they measure and 
track them.  Some facilities are likely not recording important, quality-of-
care-related grievances, such as a nurse not changing gloves before 
connecting a patient to the dialysis machine, and other facilities are 
recording trivial grievances, such as televisions with poor reception.   
This variation, coupled with facilities not routinely reporting their 
grievance data to networks, means that networks do not get an accurate, 
complete picture of the grievances occurring in their respective regions.  
Furthermore, limitations with networks own data make it difficult for 
them to conduct their own analyses of grievance data.  
Therefore, we recommend that CMS:  
Define grievance for facilities 
CMS could offer a strict definition of a grievance.  Alternatively, it could 
define a grievance in terms of what facilities would be required to record 
in their logs. For example, CMS could require facilities to record only 
those grievances related to quality of care or staff interactions, rather than 
grievances related to temperature or broken television sets.  CMS could 
work with the networks to create a definition. 
Provide guidance to facilities on what constitutes a robust 
process for anonymous grievances 
CMS, either directly or via the networks, could provide facilities with 
guidance that explains the difference between a confidential process and 
an anonymous process.  Networks could also offer facilities guidance on 
effective strategies for investigating a grievance when the beneficiary 
chooses to remain anonymous. 
Require facilities to report grievances regularly to their 
respective networks 
CMS already requires facilities to regularly report certain clinical data to 
their respective networks. As part of this reporting, CMS could require 
facilities to periodically provide a summary of grievances.  For example, 
facilities could send quarterly reports to their networks with the number 
and nature of any grievances the facilities recorded.  CMS, together with 
 
37 73 Fed. Reg. at 20392 (April 15, 2008). 
The ESRD Beneficiary  Grievance Process (OEI-01-11-00550)   15 
   
   
the networks, could define which types of grievances facilities could 
report, omitting grievances concerning broken television sets and focusing 
on more serious concerns related to quality of care and staff interactions.  
Such regular reporting would give networks more data with which to 
analyze trends, and thus give them a better sense of the types of grievances 
that beneficiaries in their regions are raising with facilities.  
Work with AHRQ to add a question to CAHPS to assess 
beneficiaries fear of reprisal 
Once facilities transition to the CAHPS survey, it is unlikely that they will 
also conduct their own surveys. As a result, far fewer facilities will 
capture data from beneficiaries regarding fear of reprisal.  CMS could 
work with AHRQ on adding a small number of questions designed to elicit 
this information.  CMS would then be able to better measure the extent to 
which ESRD beneficiaries throughout the country fear reprisal for voicing 
grievances about their care. 
Provide networks with better technical support for the Contact 
Utility database 
CMS could provide networks with a data dictionary and user manual 
detailing the elements of the database.  It could also standardize for 
networks the definitions for types of grievances; such standardization is 
essential for cross-network analysis.  Furthermore, CMS could add 
additional standard reports and more historical data to the database so that 
networks would not need to create their own duplicative tools for data 
analysis.  
We understand that the entire network data system is in a state of 
transition as CMS implements the new CROWNWeb system.  Better 
support to networks will ease this transition and allow networks to best use 
grievance data to identify concerns in their regions.   
 
 
 
 
 
The ESRD Beneficiary  Grievance Process (OEI-01-11-00550)   16 
   
   
AGENCY RESPONSE AND OFFICE OF INSPECTOR GENERAL  
RESPONSE 
CMS concurred with our first, second, and fifth recommendations. 
Regarding the first recommendation, CMS no longer distinguishes 
between grievances and complaints at  the network level, and will consider  
proposing to define grievance in the ESRD CfCs during the next 
rulemaking cycle.  
In concurring with our second recommendation, CMS references its 
addition of a requirement in 2008, in response to an earlier OIG report 
(2000), that facilities inform beneficiaries of the right to file grievances 
personally, anonymously, or through a representative of the beneficiary's 
choosing. CMS noted that the networks are responsible for ensuring that 
facilities are aware of this requirement, and for informing beneficiaries of 
their right to decide whether to begin the grievance process at the facility 
or network level. CMS stated that it is working with beneficiaries, 
families, and other stakeholders to get direct input on making the 
grievance system more robust.  However, our report shows that some  
facilities either do not have an anonymous process in place, or that they do 
not understand what an anonymous process is.  CMS notes that networks 
must inform beneficiaries of their right to file a grievance either at their 
facility or their network, although CMSs guidance to networks 
encourages beneficiaries to use the facility-level grievance process before 
contacting the network. This policy reinforces how important it is that 
facilities have a robust process for anonymous grievances. 
Regarding our fifth recommendation, CMS held training sessions with the 
networks to assist them in learning the Contact Utility database, and 
included a copy of the technical manual. 
CMS did not concur with our third and fourth recommendations. 
Regarding the third recommendation, the agency agreed that although 
such data may be useful, safeguards exist to ensure that grievances are 
resolved. For example, the CfCs require that facilities have grievance 
policies and procedures in place, as well as include beneficiary satisfaction 
and grievances as part of their QAPI activities; that networks inform  
beneficiaries of the network's role in receiving, reporting, resolving, and 
tracking patient grievances; and that State surveyors assess the QAPI 
program and grievance component during their onsite inspections of 
facilities.   
 
The ESRD Beneficiary  Grievance Process (OEI-01-11-00550)   17 
   
   
Additionally, CMS stated that the recommendation did not take into 
account its costs and that further assessment of need and a benefit analysis 
would have to be performed.  However, our recommendation is meant to 
enhance the networks statutory responsibility to monitor facilities by 
providing another indicator the networks can use to identify poor 
performers.  With respect to the benefit analysis, we invite CMS to 
conduct such an analysis, including its assumptions of the costs and 
benefits of requiring reporting of such data. 
Regarding our fourth recommendation, CMS stated that it needs to 
consider additional costs for revising the survey, as well as the change in 
burden for the beneficiaries because of the increased number of survey 
questions. CMS is also concerned whether an ESRD beneficiary would 
honestly answer a question about fear of reprisal.  The ESRD Network 
Coordinating Center is exploring ways to obtain information on patient 
satisfaction with grievance resolution, and CMS plans to conduct a small 
number of interviews with beneficiaries and will look into this issue. 
OIG questions CMSs assumption that beneficiaries would not honestly 
answer a question about fear of reprisal on an anonymous survey 
administered by a third party.  That assumption calls into question whether 
beneficiaries would answer any of the questions honestly.   Furthermore, if 
beneficiaries are in fact too fearful to honestly answer such a question 
from a third party, it underscores the importance of measuring and 
addressing that fear.  
For the full text of CMSs comments, see Appendix C. 
 
 
   
The ESRD Beneficiary  Grievance Process (OEI-01-11-00550)   18 
   
   
APPENDIX A 
Nonrespondent Analysis 
Our findings are based on estimates made solely from data collected from  
sample respondents, and we did not statistically adjust our results because 
of any assumptions about how the nonrespondents may have answered our 
questions. Consequently, our results pertain to approximately 80 percent 
of the population of all dialysis facilities. We performed a nonresponse 
analysis to see if these results for 80 percent of the population might 
substantially differ from those of the entire population. We compared 
whether the respondents and nonrespondents differ in certain 
characteristics and examined whether the time of response affected the 
results. 
Comparisons of Respondents and Nonrespondents 
The characteristics we had available for both respondents and 
nonrespondents were facility type (chain or nonchain) and nonprofit status 
(for-profit or nonprofit). We estimated the proportion of respondents and 
nonrespondents with these characteristics and performed Wald Chi-Square 
tests of significance. We found no statistically significant differences at 
the 95-percent confidence level between the respondents and 
nonrespondents for either of these facility characteristics. 
Analysis of Late Respondents 
Survey researchers have found some evidence thatin generallate 
respondents may provide answers more similar to those that 
nonrespondents would have provided than to those provided by early 
respondents. We categorized the respondents as either early or late by 
whether they responded to the questionnaire within three written attempts 
(early) or only after we contacted them by telephone (late). We then 
compared estimates of early and late respondents on key survey questions, 
i.e., questions as to whether facilities recorded grievances, analyzed 
grievances for trends, or had a method for patients to complain 
anonymously.  We found no statistically significant differences at the  
95-percent confidence level between estimates by early and late 
respondents. 
Although we found no statistically significant differences on the basis of 
this analysis, we cannot conclude that no differences exist. The magnitude 
of any potential differences is a product of both the nonresponse rate and 
the extent to which nonrespondents actually would have answered the 
questions differently from respondents. However, our results based only 
on responding facilities may reasonably be expected not to differ 
substantially from those based on all facilities in the sample. 
The ESRD Beneficiary  Grievance Process (OEI-01-11-00550)   19 
   
   
APPENDIX B 
Point Estimates and Confidence Intervals Based on the Facility  
Questionnaire 
We calculated confidence intervals for key data points in the facility 
questionnaire. The sample size, point estimates, and 95-percent confidence 
intervals are given for each of the following: 
 
 
Data Element Description   Sample Size   Point Estimate   95-Percent Confidence Interval  
Number of Grievances Recorded   120  25,032   18,37031,695  
Percentage of Facilities That Recorded No Grievances   120  28%   20%36%  
Percentage of Facilities That Recorded 15 Grievances  120  38%   30%47%  
Grievances Related to Physical Environment   120  26%   15%37%  
Grievances Related to Staff Interactions  120  17%   11%23%  
Grievances Related to Scheduling  120  11%   8%13%  
Grievances Related to Quality of Care   120  10%   6%14%  
Grievances Related to Staff Competence  120  5%   3%7%  
Grievances Related to Patient-to-Patient Conflicts  120  3%   1%5%  
Facility Would Record as a Grievance That Technician Is Not 
120  87%   79%92%  
Cleaning Machine 
Facility Would Record as a Grievance That Nurse Is Rough 
120  88%   81%93%  
When Connecting Patient to Machine 
Facility Would Record as a Grievance That Nurse Did Not 
120  88%   81%93%  
Change Gloves 
Facility Would Record as a Grievance That Staff Makes 
120  85%   77%90%  
Patient Feel Unwelcome 
Facility Would Record as a Grievance That Temperature Is 
120  76%   67%83%  
Too Cold  
Facility Would Record as a Grievance Patient Request To  
120  77%   68%83%  
Move Chairs 
Facility Would Record as a Grievance Patient Written Request 
120  72%   64%80%  
To Fix TV  
Facilities That Analyze Grievances for Trends   120  97%   93%99%  
Facilities That Analyze for Trends About Physical Environment   117  98%   93%100%  
Facilities That Analyze for Trends About Specific Employees   117  97%   91%99%  
Facilities That Analyze for Trends About Quality  of Care   117  97%   91%99%  
Facilities That Analyze for Trends About Procedures   117  96%   90%98% 
 Facilities That Analyze for Trends About Specific Patients  117  94%   88%97%  
Facility Identified Trends About Physical Environment  117  30%   22%38%  
Facility Identified Trends About Specific Employees  117  26%   18%34%  
Facility Identified Trends About Quality of Care   117  19%   13%27%  
Facility Identified Trends About Procedures  117  20%   13%28%  
Facility Identified Trends About Specific Patients   117  27%   19%35%  
Source: OIG analysis of facility questionnaire data, 2012.  
 
The ESRD Beneficiary  Grievance Process (OEI-01-11-00550)   20 
  APPENDIXC 
Agency Comments 
*'fP."lC~.~ 
~ 
(  DEPARTMENT OF HEALTH & HUMAN SERVICES  Centers for Medicare & Medicaid Services 
,~,. 
Administrator 
Washington, DC 20201 
DATE:  OCT 3 0 2013 
TO:  Daniel R. Levinson 
Inspe~tor General 
FROM:  Mar~nTavenner 
Adminl'stratO. 
SUBJECT:  Office of Inspector General (OIG) Draft Report: The ESRD Beneficiary 
Grievance Process (OEI-0 I -I I -00550) 
Thank you for the opportunity to review and comment on the above subject OIG draft report. 
The Centers for Medicare & Medicaid Services (CMS) appreciates the recommendations for 
improving the End Stage Renal Disease (ESRD) Beneficiary grievance process and views this 
report as a means to reassess progress, and to highlight recent changes we have implemented to 
improve the ESRD Network grievance process and to improve dialysis care.  OIG's objective for 
this study was to describe the grievance processes that dialysis facilities and ESRD Network 
Organizations have in place for beneficiaries. 
The investigation and resolution ofgrievances is an opportunity to focus on meeting the needs of 
ESRD patients and to create change by listening to, and learning from, the patient's perspective. 
In January 2013, CMS implemented a redesigned ESRD Network Statement of Work (SOW) to 
improve alignment with the Department of Health and Human Services National Quality 
Strategy and the three aims ofbetter health, better care, and lower costs. The new approach 
facilitates a heightened focus on patient and family centered concerns and aims to promote better 
access to care. 
The OIG recommendations and CMS responses to those recommendations are provided below. 
OIG Recommendation 
The OIG recommends that CMS define "grievances" for facilities. 
CMS Response 
The CMS concurs with the recommendation. CMS was already in the process of implementing a 
standard definition prior to this review. The ESRD Network is responsible for using 
standardized procedures to collect data and address grievances to promote consistency. The 
Networks now adhere to the definition of grievances and the grievance resolution processes 
described in the revised Chapter 9, "Grievances and Patient-Appropriate Access to Care," of the 
The ESRD Beneficiary Grievance Process (OEI-01-11-00550)  21   
   
 
 
 
 
 
 
 
The ESRD Beneficiary  Grievance Process (OEI-01-11-00550)   22 
   
   
 
 
 
 
 
 
 
The ESRD Beneficiary  Grievance Process (OEI-01-11-00550)   23 
   
   
 
 
 
 
 
 
 
The ESRD Beneficiary  Grievance Process (OEI-01-11-00550)   24 
   
   
 
ACKNOWLEDGMENTS 
This report was prepared under the direction of Joyce M. Greenleaf, 
Regional Inspector General for Evaluation and Inspections in the Boston 
regional office; Russell Hereford, Deputy Regional Inspector General; and 
Kenneth Price, Deputy Regional Inspector General. 
Ivan Troy served as team leader for this study.  Other Office of Evaluation 
and Inspections staff from the Boston regional office who conducted the 
study include Elizabeth Havener and Kimberly Yates.  Central office staff 
who provided support include Althea Hosein, Kevin Farber, Meghan 
Kearns, and Christine Moritz. 
The ESRD Beneficiary  Grievance Process (OEI-01-11-00550)   25 
   
Office of Inspector General
http://oig.hhs.gov  
 
The mission of the Office of Inspector General (OIG), as mandated by Public Law 95-452, as  
amended, is  to protect the integrity of the Department of  Health and Human Services  
(HHS)  programs, as well as the health and welfare of beneficiaries  served by those 
programs.  This statutory mission  is  carried  out through  a nationwide network  of  audits, 
investigations, and inspections conducted by the  following operating components: 
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The Office  of  Audit Services  (OAS) provides auditing services  for HHS, either by  conducting  
audits  with its own audit resources or by  overseeing  audit work done by others.  Audits  
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The Office  of  Evaluation and Inspections (OEI)  conducts national evaluations to  provide 
HHS, Congress, and the public with timely, useful, and reliable information on significant 
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Office of Investigations 
The Office of Investigations (OI) conducts criminal, civil, and administrative investigations  
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by actively  coordinating with the Department  of Justice  and other Federal, State, and local 
law enforcement authorities.  The investigative efforts of OI often lead to  criminal 
convictions, administrative sanctions,  and/or  civil monetary  penalties.  
Office of Counsel to the Inspector General 
The Office of Counsel to the  Inspector  General (OCIG) provides general legal services to 
OIG, rendering  advice and opinions on HHS programs and operations and  providing all  
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