Dialysis Facilities
Problems Remain in Ensuring Compliance with Medicare Quality Standards Gao ID: GAO-04-63 October 8, 2003Most patients with end-stage renal disease (ESRD) must rely on dialysis treatments to compensate for kidney failure. Currently, over 222,000 ESRD patients visit dialysis centers several times a week to have toxins removed from their bloodstreams. While dialysis care has improved overall, questions remain regarding the quality of care provided by some of the nation's roughly 4,000 ESRD facilities. We examined (1) the extent and nature of quality of care problems identified at dialysis facilities, (2) the effectiveness of state survey agencies in ensuring that quality issues are uncovered, corrected, and stay corrected, and (3) the extent to which the Centers for Medicare & Medicaid Services (CMS) funds, monitors, and assists state survey activities related to dialysis care.
A substantial number of ESRD facilities do not achieve minimum patient outcomes specified in clinical practice guidelines, with significant proportions of their patients receiving inadequate dialysis or treatment for anemia. Similarly, inspections of dialysis facilities by state survey agencies have uncovered numerous problems that put patient health at risk. Between fiscal years 1998 and 2002, these inspections, commonly called surveys, revealed that 15 percent of facilities surveyed had serious quality problems that, if left uncorrected, would warrant termination from the Medicare program. Serious deficiencies commonly found during surveys included medication errors, contamination of water used for dialysis, and insufficient physician involvement in patient care. Infrequent, poorly targeted, and inadequate inspections allow facilities' quality of care problems to go undetected or remain uncorrected. Although ESRD survey activity has increased in recent years, only nine state survey agencies consistently met CMS's goal to inspect 33 percent of ESRD facilities annually. A substantial number of facilities go many years between inspections. In fiscal year 2002, 216 facilities nationwide went 9 or more years without an inspection. Deficiencies may not have been detected during an inspection if the surveyors had little experience in assessing dialysis quality. Even when deficiencies are identified and facilities take corrective action, little incentive exists for these facilities to remain in compliance. Data show a pattern of repeated serious deficiencies in successive inspections of an individual facility. No effective sanctions are available to enforce compliance, short of terminating the facility from the Medicare program, which is rarely done. Federal monitoring of state agencies' performance of surveys and technical assistance provided is uneven across CMS regions. CMS substantially increased its funding for ESRD surveys from an estimated $3.1 million in fiscal year 1998 to $8.2 million in fiscal year 2002. At the same time, several CMS regional offices in our study did not actively oversee how the state agencies used these funds to improve survey activities. CMS has not taken steps needed to facilitate information sharing between federally funded ESRD networks and state agencies on the performance of individual dialysis facilities--information that could help states to target their inspection resources. In addition, CMS has not offered adequate training opportunities for surveyors inspecting ESRD facilities.
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Director: Team: Phone:GAO-04-63, Dialysis Facilities: Problems Remain in Ensuring Compliance with Medicare Quality Standards
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Report to the Chairman, Committee on Finance, U.S. Senate:
United States General Accounting Office:
GAO:
October 2003:
Dialysis Facilities:
Problems Remain in Ensuring Compliance with Medicare Quality Standards:
Dialysis Facility Compliance:
GAO-04-63:
GAO Highlights:
Highlights of GAO-04-63, a report to the Chairman, Committee on
Finance, U.S. Senate
Why GAO Did This Study:
Most patients with end-stage renal disease (ESRD) must rely on
dialysis treatments to compensate for kidney failure. Currently, over
222,000 ESRD patients visit dialysis centers several times a week to
have toxins removed from their bloodstreams. While dialysis care has
improved overall, questions remain regarding the quality of care
provided by some of the nation‘s roughly 4,000 ESRD facilities. We
examined (1) the extent and nature of quality of care problems
identified at dialysis facilities, (2) the effectiveness of state
survey agencies in ensuring that quality issues are uncovered,
corrected, and stay corrected, and (3) the extent to which the Centers
for Medicare & Medicaid Services (CMS) funds, monitors, and assists
state survey activities related to dialysis care.
What GAO Found:
A substantial number of ESRD facilities do not achieve minimum patient
outcomes specified in clinical practice guidelines, with significant
proportions of their patients receiving inadequate dialysis or
treatment for anemia. Similarly, inspections of dialysis facilities by
state survey agencies have uncovered numerous problems that put
patient health at risk. Between fiscal years 1998 and 2002, these
inspections, commonly called surveys, revealed that 15 percent of
facilities surveyed had serious quality problems that, if left
uncorrected, would warrant termination from the Medicare program.
Serious deficiencies commonly found during surveys included medication
errors, contamination of water used for dialysis, and insufficient
physician involvement in patient care.
Infrequent, poorly targeted, and inadequate inspections allow
facilities‘ quality of care problems to go undetected or remain
uncorrected. Specifically:
* Although ESRD survey activity has increased in recent years, only
nine state survey agencies consistently met CMS‘s goal to inspect 33
percent of ESRD facilities annually.
* A substantial number of facilities go many years between
inspections. In fiscal year 2002, 216 facilities nationwide went 9 or
more years without an inspection.
* Deficiencies may not have been detected during an inspection if the
surveyors had little experience in assessing dialysis quality.
Even when deficiencies are identified and facilities take corrective
action, little incentive exists for these facilities to remain in
compliance. Data show a pattern of repeated serious deficiencies in
successive inspections of an individual facility. No effective
sanctions are available to enforce compliance, short of terminating
the facility from the Medicare program, which is rarely done.
Federal monitoring of state agencies‘ performance of surveys and
technical assistance provided is uneven across CMS regions. CMS
substantially increased its funding for ESRD surveys from an estimated
$3.1 million in fiscal year 1998 to $8.2 million in fiscal year 2002.
At the same time, several CMS regional offices in our study did not
actively oversee how the state agencies used these funds to improve
survey activities. CMS has not taken steps needed to facilitate
information sharing between federally funded ESRD networks and state
agencies on the performance of individual dialysis facilities”
information that could help states to target their inspection
resources. In addition, CMS has not offered adequate training
opportunities for surveyors inspecting ESRD facilities.
What GAO Recommends:
GAO suggests that Congress consider authorizing CMS to impose
immediate sanctions, such as monetary penalties or denying payment for
new Medicare patients, on dialysis facilities cited with serious
deficiencies in consecutive surveys. GAO recommends that the CMS
Administrator create incentives for facilities to maintain compliance
with quality standards, increase use of expert staff in conducting
ESRD facility surveys, and enhance the support and monitoring of state
survey agencies. CMS did not indicate an intention to implement five
of our six recommendations.
www.gao.gov/cgi-bin/getrpt?GAO-04-63.
To view the full product, including the scope and methodology, click
on the link above. For more information, contact Leslie G. Aronovitz
at (312) 220-7600.
[End of section]
Contents:
Letter:
Results in Brief:
Background:
Quality Problems Prevalent among Dialysis Facilities and Put Patient
Health at Risk:
Limitations in the ESRD Survey Process Leave Quality Problems
Undetected or Inadequately Addressed:
CMS Has Increased Funding for State Surveys, but Monitoring and
Technical Support Are Uneven:
Conclusions:
Matter for Congressional Consideration:
Recommendations for Executive Action:
Agency Comments and Our Evaluation:
Appendix I: Scope and Methodology:
Appendix II: Medicare Conditions for Coverage for Dialysis Facilities:
Appendix III: State Agencies' Progress toward Meeting CMS Survey Goals:
Appendix IV: Comments from the Centers for Medicare & Medicaid Services:
Appendix V: GAO Contact and Staff Acknowledgments:
GAO Contact:
Acknowledgments:
Related GAO Products:
Tables:
Table 1: Proportion of ESRD Facilities Recertified Within 3, 6, 9, or
More Years, Fiscal Years 1998 to 2002:
Table 2: Association between Surveyor Specialization and Rate of
Condition-and Standard-Level Deficiencies Cited in Fiscal Years 2001
and 2002:
Table 3: Rates of Repeated Deficiencies in Consecutive Surveys
Conducted from Fiscal Years 1998 through 2002:
Table 4: Federal Support for Provider Surveys, Fiscal Years 1998 to
2001:
Table 5: ESRD Facilities Recertified Annually by State, Fiscal Years
1998 to 2002:
Table 6: Facilities to Be Recertified to Meet CMS 3-Year Goal, by
State:
Figures:
Figure 1: Projected Growth in the ESRD Population and Medicare Costs:
Figure 2: Number of Facilities Where Some Patients Receive Inadequate
Dialysis Treatment and Anemia Management, 2000:
Figure 3: State Variation in the Rate of Condition-Level Deficiencies
Cited in Recertification Surveys Conducted from Fiscal Year 1998
through 2002:
Figure 4: ESRD Facility Survey Rate Compared to CMS Goal, Fiscal Years
1998 to 2002:
Figure 5: State Variation in the Proportion of Dialysis Facilities
Surveyed for Recertification, Fiscal Year 2002:
Abbreviations:
CMS: Centers for Medicare & Medicaid Services:
DFC: Dialysis Facility Compare Web site:
EPO: erythropoietin:
ESRD: end-stage renal disease:
ICF/MR: intermediate care facilities for the mentally retarded:
LTC: long-term care:
OSCAR: Online Survey Certification and Reporting system:
United States General Accounting Office:
Washington, DC 20548:
October 8, 2003:
The Honorable Charles E. Grassley
Chairman
Committee on Finance:
United States Senate:
Dear Mr. Chairman:
Most patients with end-stage renal disease (ESRD)--a life-shortening,
chronic illness--must rely on dialysis treatments to compensate for
kidney failure. Currently, over 222,000 ESRD patients spend 3 to 5
hours at dialysis centers three times a week, where dialysis machines
remove toxins from their bloodstreams. In addition to having permanent
kidney failure, ESRD patients are likely to suffer from diabetes or
heart disease and are at risk for developing illnesses during their
course on dialysis. Therefore, the care of ESRD patients requires
expertise in both the medical and technical aspects of maintaining
patients on dialysis.
While dialysis care has improved overall, according to a 2002
Department of Health and Human Services report, questions remain
regarding the quality of care provided to Medicare beneficiaries by
some of the nation's roughly 4,000 dialysis facilities. The HHS report
noted that many ESRD patients do not receive treatment meeting the
minimum standards established in the National Kidney Foundation's
clinical practice guidelines, which, when not met, have documented
adverse effects on patient outcomes. In 2001, 16 percent of dialysis
patients did not have an adequate amount of toxins removed from their
blood, 24 percent had anemia that was not brought under control, and 19
percent of patients were dialyzed for extended periods using catheters,
the least effective and most risky method for connecting patients to
dialysis machines.[Footnote 1]
ESRD is the one medical condition that confers eligibility regardless
of age to the Medicare program, which otherwise pays for health care
provided to people who are over 65 years of age or to those with
disabilities. The Centers for Medicare & Medicaid Services (CMS), which
oversees the Medicare program, has responsibility for ensuring that
dialysis patients receive quality care. For this purpose, CMS contracts
with state survey agencies that conduct onsite inspections. Following
up on a report we issued in June 2000,[Footnote 2] you asked us to
review CMS's system for enforcing Medicare's minimum quality and safety
standards for ESRD facilities and to assess whether and how it might be
strengthened. Specifically, we examined (1) the extent and nature of
quality of care problems identified at dialysis facilities, (2) the
effectiveness of state survey agencies in ensuring that quality issues
are uncovered, corrected, and stay corrected, and (3) the extent to
which CMS funds, monitors, and assists state survey activities related
to dialysis care.
To address these issues, we obtained data from existing national
databases and original data from 10 states. We analyzed facility-
specific information about quality measures reported on CMS's Dialysis
Facility Compare, a consumer guide available on the Internet. For the
nation as a whole and each of the states,[Footnote 3] we also analyzed
data from CMS's Online Survey Certification and Reporting (OSCAR)
system for the last 5 fiscal years, 1998 through 2002. This database
provides information on the dates when surveys took place, the
deficiencies cited, and the time spent conducting various survey
activities. In addition, we interviewed cognizant officials at CMS's
central office and reviewed changes in the CMS budget devoted to survey
activities from fiscal years 1998 to 2002.
To supplement available national data, we obtained additional
information from 10 states--Alabama, California, Florida, Kansas,
Maryland, Mississippi, Missouri, Nevada, New York, and Pennsylvania--
which together accounted for more than one-third of all facilities in
fiscal year 2001. They were selected to provide variation across a
range of dimensions, including the proportion of ESRD facilities
surveyed and deficiencies cited, number of ESRD facilities, and
geographic diversity. We interviewed state surveyors and
administrators, representatives from ESRD networks (organizations that
promote quality improvement in ESRD services), and federal regional
office officials responsible for monitoring ESRD facility surveys. In
addition, we collected detailed information on several states' corps of
ESRD surveyors, including their background, training, and experience.
We also examined the written reports from numerous facility surveys
conducted within the last 2 years. (App. I contains more detail on our
scope and methodology.) Our work was conducted from August 2002 to
September 2003 in accordance with generally accepted government
auditing standards.
Results in Brief:
A substantial number of dialysis facilities do not achieve the minimum
patient outcomes specified in clinical practice guidelines for a
significant proportion of their patients. Data reported on Dialysis
Facility Compare show that, in 2000, 512 facilities had 20 percent or
more of their patients receiving inadequate dialysis treatment, and
nearly 1,700 facilities had 20 percent or more of their patients
receiving inadequate care for anemia. In addition, the CMS-funded
system of on-site inspections of facility conditions, equipment, and
staffing has uncovered numerous problems that put patient health at
risk. From fiscal year 1998 through 2002, these inspections, generally
called surveys, revealed that 15 percent of facility surveys identified
serious quality problems that, if left uncorrected, would warrant
termination from the Medicare program. Serious deficiencies commonly
found during surveys included medication errors, contamination of water
used for dialysis, and insufficient physician involvement in patient
care.
Infrequent, poorly targeted, and inadequate inspections by state survey
agencies allow facilities' quality of care problems to go undetected or
remain uncorrected. Specifically:
* Although ESRD survey activity has increased in recent years, state
compliance with CMS's goal to resurvey 33 percent of ESRD facilities
annually has been inconsistent. While 33 states met the goal in at
least 1 of the last 2 fiscal years, only 9 of the 33 states surveyed a
third or more of their facilities in both years. Eighteen states failed
to meet the goal in either fiscal year 2001 or 2002.
* A substantial number of facilities go many years between inspections.
In fiscal year 2002, 216 facilities nationwide (5.4 percent) went 9 or
more years without an inspection, up from 53 facilities (1.6 percent)
in fiscal year 1998.
* Deficiencies may not have been detected during a survey if the
surveyors who inspected the facilities had little experience in
assessing dialysis quality. Data from several states showed that survey
agencies where designated staff specialized in performing ESRD surveys
uncovered a substantially larger number of deficiencies than agencies
without such staff expertise.
Even when deficiencies are identified and facilities take corrective
action, little incentive exists for these facilities to remain in
compliance with Medicare's minimum quality standards on a continuing
basis. As shown in nationwide data, when quality problems were cited,
the problems were corrected but often did not stay corrected. For
example, from fiscal years 1998 through 2002, 18 percent of facilities
found to have serious deficiencies were cited again for the same
deficiencies in successive inspections. At present, there is no
effective sanction to encourage a facility to avoid repeating prior
deficiencies, short of terminating the facility from the Medicare
program, which is rarely done.
CMS has expanded funding to support state ESRD survey activities, but
its monitoring of state agencies' performance of surveys and providing
technical assistance is uneven across CMS regions. CMS substantially
increased its aggregate funding for ESRD surveys from an estimated $3.1
million in fiscal year 1998 to $8.2 million in fiscal year 2002. At the
same time, several regional offices in our study did not actively
oversee or assist in improving ESRD survey activities. In addition, CMS
has not removed barriers between federally funded ESRD networks and
state agencies that inhibit the sharing of information on the
performance of individual dialysis facilities--information that could
assist states in targeting their inspection resources. Furthermore,
surveyors in several states reported that CMS has not offered adequate
training opportunities for surveyors inspecting ESRD facilities.
To encourage ESRD facilities to adhere to Medicare quality standards,
we suggest that Congress consider authorizing CMS to impose immediate
sanctions, such as monetary penalties or denying payment for new
Medicare patients, on dialysis facilities cited with serious
deficiencies in consecutive surveys. We are also recommending that CMS:
conduct more frequent surveys of facilities with serious deficiencies;
publicize facilities' survey results; encourage state agencies to use
ESRD-specialized surveyors; expand ESRD surveyor training
opportunities; require periodic, routine sharing of information between
ESRD networks and state survey agencies; and enhance oversight of state
agency performance.
In its comments on a draft of this report, CMS affirmed its commitment
to strengthening oversight of dialysis facilities and state survey
agencies, but did not indicate an intention to implement five of our
six recommendations. Instead, the agency highlighted its efforts to
develop tools to assist states in selecting facilities for inspection
and to make the survey process more uniform. We continue to believe
that more focused efforts to evaluate compliance with Medicare
requirements and stronger actions against poor performers are needed to
ensure an effective, consistent, and timely ESRD survey and
certification program.
Background:
Individuals with ESRD, characterized by permanent kidney failure, must
undergo either regular dialysis treatment or a kidney transplant to
stay alive. In 2000, about 248,000 individuals received one of two
modes of dialysis treatment--hemodialysis or peritoneal dialysis--both
of which can be performed at a facility or at home.[Footnote 4] Most
ESRD patients undergo hemodialysis.[Footnote 5] The number of
hemodialysis patients enrolled in Medicare has risen sharply, from
about 118,000 in 1991 to over 222,000 in 2000. With anticipated annual
growth of over 7 percent, the dialysis population is projected to reach
more than 520,000 by 2010.[Footnote 6] (See fig. 1.) This growth in
enrollment has been attributed largely to improvements in the survival
rate for people with ESRD and an increase in the number of Americans
with conditions, such as diabetes or high blood pressure, that often
lead to kidney failure.
Figure 1: Projected Growth in the ESRD Population and Medicare Costs:
[See PDF for image]
[End of figure]
Growth in the ESRD population has been matched by growth in the number
of dialysis facilities. In the decade between 1991 and 2001, the number
of outpatient dialysis facilities doubled from about 2,000 to more than
4,000 facilities. In 2001, 83 percent of all facilities were
freestanding (nonhospital-based) and 79 percent of all facilities were
for-profit. In 2001, the four largest for-profit dialysis chains
accounted for about two-thirds of all freestanding facilities.
The rise in the ESRD population has been accompanied by an even more
rapid increase in program spending. Medicare not only provides coverage
to most beneficiaries with ESRD for all ESRD-related services but for
their other health care needs as well.[Footnote 7] From 1990 to 2001,
Medicare expenditures for beneficiaries with ESRD rose from about $5
billion to over $15 billion, and are forecast to grow to $28 billion in
2010. Spending growth has been fueled by an expansion of enrollees with
greater medical needs--older beneficiaries and those with chronic
comorbidities[Footnote 8]--and the program's inclusion of new
treatments, particularly erythropoietin (EPO)--a synthetic hormone
widely used to manage anemia--and other injectable medications. While
Medicare pays ESRD providers a set amount--a composite rate--including
the nursing services provided and supplies used in each dialysis
treatment, it pays separately for injectable drugs.[Footnote 9] The
composite rate for dialysis services has remained virtually unchanged
since the program's inception. However, payments to freestanding
dialysis facilities for injectable drugs have grown considerably in
recent years, increasing from 33 percent of total payments in 1997 to
40 percent in 2001.
In 1976, CMS established minimum requirements that dialysis facilities
must meet in order to receive Medicare payments. The regulations,
referred to as "conditions for coverage," address 11 general areas,
including the facility's physical environment and overall management by
a governing body, as well as the adequacy of patient treatment
plans.[Footnote 10] (See app. II.) One condition covers the detailed
procedures that facilities must follow if they choose to reuse certain
supplies, such as dialyzers, rather than replace them for each
treatment.[Footnote 11] Under each condition are related "standards."
For example, under the condition "physical environment," there are
specific standards to maintain the purity of water used for dialysis.
Even deficiencies found solely at the standard level indicate potential
harm to patients. But, deficiencies cited at the condition level are
the most egregious, as they indicate a problem that is widespread at a
facility or serious in terms of its harm, or potential to harm
patients. Typically, they are accompanied by multiple standard-level
deficiencies under that condition.
To ensure provider compliance with dialysis quality standards, Medicare
contracts with state survey agencies.[Footnote 12] These agencies
conduct initial on-site surveys of dialysis facilities when providers
seek enrollment in the Medicare program. Subsequently, state agencies
periodically conduct unannounced inspections, referred to as
recertification surveys, to ensure that facilities are maintaining
compliance with Medicare standards. Although no statutory or regulatory
requirements exist regarding the frequency of recertification surveys,
CMS has established goals for state survey agencies to ensure that
facilities are surveyed within certain intervals. States are expected
to survey 33 percent of their dialysis facilities annually, and each
facility every 3 years. In addition, state survey agencies must respond
to complaints that they receive concerning dialysis facilities and,
when warranted, conduct on-site investigations.
If the state agency determines that a facility is out of compliance
with any condition or standard, CMS requires that the facility develop
a plan to correct the deficiency. The state agency is then responsible
for determining if the plan of correction is adequate to address the
quality problems identified. Facilities that do not correct condition-
level deficiencies within a reasonable amount of time, generally within
90 days, are subject to termination from the program. A much shorter
time frame for termination applies in situations where a facility's
noncompliance poses an immediate and serious threat to patient health
or safety.
CMS also contracts with 18 ESRD network organizations that are
responsible for helping providers improve the quality of care patients
receive in dialysis facilities. Rather than enforcing compliance with
federal quality regulations, the networks recruit facility
participation in national and regional quality improvement projects
that focus on enhancing specific clinical outcomes of dialysis
patients. Networks collect data from individual facilities on numerous
clinical indicators and provide them feedback on their performance. The
networks also provide technical assistance to facilities and handle
grievances concerning patient care. Each network has a medical review
board composed of dialysis facility representatives, physicians, and
dialysis patients, that oversees network operations.
To assist beneficiaries with ESRD in deciding where to get dialysis
services, CMS reports certain information on Dialysis Facility Compare,
an Internet Web site. Initiated in 2001, the site provides information
on specific characteristics--such as the location, operating hours, and
size--of all Medicare-certified facilities. It also provides data on
clinical outcomes related to several quality measures, but does not
contain the results of state agency surveys. In contrast, CMS routinely
posts survey results for nursing homes on a similar but separate
Internet Web site called Nursing Home Compare.
Quality Problems Prevalent among Dialysis Facilities and Put Patient
Health at Risk:
Data made public by CMS reveals that poor care is a problem at many
facilities, with large numbers of patients receiving inadequate
hemodialyis or treatment for anemia. Similarly, inspections of ESRD
facilities continue to find evidence that serious health and safety
problems exist for dialysis patients. From fiscal year 1998 through
2002, as many as one out of seven surveys identified problems
sufficiently severe to initiate the process of terminating the facility
from the Medicare program. These deficiencies, such as medication
errors and contamination of water used for dialysis, put the health of
patients at risk.
Many Facilities Do Not Provide Adequate Care to Their Hemodialysis
Patients:
Data reported on the Dialysis Facility Compare Web site provides
evidence that the care delivered at many facilities is substandard. The
most recent information available indicates that, in 2000, a
substantial number of facilities did not provide all of their Medicare
patients with a level of care that meets minimum clinical practice
guidelines. Figure 2 shows the extent to which facilities did not
achieve two commonly accepted quality benchmarks based on the National
Kidney Foundation guidelines: (1) the percent of the facility's
patients not receiving adequate hemodialysis and (2) the percent of the
facility's patients receiving EPO whose anemia was not adequately
managed.[Footnote 13] Despite some measurement limitations, both of
these indicators are considered characteristics of patient care that
reflect dialysis facility quality.
Figure 2: Number of Facilities Where Some Patients Receive Inadequate
Dialysis Treatment and Anemia Management, 2000:
[See PDF for image]
Notes: Adequacy of dialysis is measured as the percentage of the
facility's hemodialysis patients that had the minimum recommended urea
reduction ratio--a measure of the waste products removed from the
blood--of 65 or more. Data were reported for 3,158 facilities.
[End of figure]
Anemia management is measured as the percentage of the facility's
patients who received EPO that had a hematocrit level--a measure of low
red blood count--of 33 or greater. Data were reported for 3,325
facilities.
Relatively few dialysis facilities reported meeting these two national
guidelines for 100 percent of their patients. At about half of the
facilities, fewer than 10 percent of their patients fell short of the
hemodialysis guideline, but at 512 facilities, 20 percent or more of
their patients received inadequate hemodialysis. Results for anemia
treatment were less favorable overall. Nearly 1,700 facilities fell
short of meeting the guideline for anemia management for 20 percent or
more of the patients in their care; at 135 facilities, more than 50
percent of patients received inadequate treatment for anemia. Research
has shown that variation in such patient outcomes as dialysis adequacy
is largely attributable to factors at the facility--its policies
governing dialysis care, associated practice patterns, and attention to
individual patient problems--as opposed to patient-specific
causes.[Footnote 14]
Facility Inspections Identify an Unacceptable Level of Serious Quality
Problems:
The cumulative results of surveys conducted from fiscal years 1998
through 2002 suggest that condition-level deficiencies--quality
problems severe enough to warrant termination from the Medicare program
unless corrected within 90 days--are still far from rare. Fifteen
percent of recertification surveys conducted nationwide from fiscal
year 1998 through 2002 reported one or more condition-level
deficiencies. The distribution across states of condition-level
deficiencies cited was substantially uneven. Several states reported no
condition-level deficiencies during that 5-year period, whereas other
states found such deficiencies in roughly 60 percent of their surveys.
As shown in figure 3, most states were at the lower end of the range,
with 39 states citing condition-level deficiencies in fewer than 20
percent of their surveys, and 21 states, in fewer than 10 percent of
their surveys.
Figure 3: State Variation in the Rate of Condition-Level Deficiencies
Cited in Recertification Surveys Conducted from Fiscal Year 1998
through 2002:
[See PDF for image]
[End of figure]
Problems Cited at ESRD Facilities Create the Potential for Harm to
Patients:
Our review of recertification survey reports from fiscal years 2001 and
2002, collected from the 10 states in our study, identified condition-
level deficiencies that were commonly cited among noncompliant
facilities. Multiple instances were found of inadequate clinical
management, medication errors, improper use of reusable dialysis
equipment, contamination of water used for dialysis, and insufficient
professional medical involvement in the dialysis patients' care. State
surveyors documented these problems after reviewing facility personnel
files, policies, procedures, and the facility's overall environment. In
addition, surveyors reviewed a random sample of medical records from 10
percent of the facility's patients.[Footnote 15] The vignettes
presented below--which illustrate the types of problems found in 35
percent of all surveys conducted from fiscal year 1998 through 2002--
were extracted from surveyors' findings reports. Registered nurses with
substantial ESRD survey experience, who we asked to comment on the
clinical implications of these findings, indicated that the
deficiencies could lead in some cases to severely adverse patient
outcomes.
* Failure to monitor laboratory values and medication supply. A
Maryland surveyor found that for 31 days, one facility did not provide
any of its patients with EPO, a medication routinely used to stimulate
the production of red blood cells that are compromised by chronic
kidney disease. Upon reviewing patients' medical records, 8 out of 10
sampled records indicated that the patient's red blood cell count was
below normal, thus requiring EPO. In addition, 5 of these records
showed that the patient's red blood cell level decreased over a 4-month
period. The facility's head nurse did not monitor and report the
patients' abnormal laboratory values to the physicians and did not
respond to the patients' complaints of feeling tired and lacking
energy.
According to our nurse reviewers, patients who have a diminished red
blood cell count for an extended period of time can develop health-
related complications, including heart irregularities and a decrease in
brain function.
* Failure to administer medication as prescribed. A California surveyor
cited a condition-level deficiency when she found that physician orders
were not being followed. One patient's medical record documented that
6,000 units of EPO were prescribed for each dialysis treatment but that
the patient received only 600 units at each treatment for 20
treatments. Staff confirmed that the patient was receiving the wrong
dose, and when questioned by the surveyors, could not provide an
explanation. Another patient's medical record revealed that, despite a
physician-ordered increase in EPO, the patient received an incorrect
dosage of the medication for almost 2 months. Again, staff acknowledged
that the order to increase the dosage was not carried out. A review of
two more patients' medical records showed written orders for Venofer, a
medication to treat iron deficiency. The records documented that both
patients failed to receive this medication for a week or more. Staff
acknowledged that there was a period of time during which the facility
ran out of the medication.
Our nurse reviewers reported that a reduction of Venofer or EPO could
increase the dialysis patients' risk for anemia, a condition that, as
noted above, can cause a patient to experience extreme fatigue and
eventually clinical impairments to the heart and brain.
* Failure to administer dialysis treatments as prescribed. A
recertification survey in Pennsylvania discovered that, for over half
of the medical records reviewed, the facility did not ensure that
diagnostic and therapeutic orders were followed. Specifically,
documentation in patients' medical records revealed that the duration
of dialysis treatments deviated from the amount of time prescribed by a
physician. One patient's medical record indicated that dialysis
treatments were ordered for 3.5 hours in duration. However, actual
treatment periods were all less than the prescribed amount--by 20 to 90
minutes. Similarly, another patient's record indicated that dialysis
treatments were ordered for a duration of 3 hours and 45 minutes but
most treatments were for shorter duration--as much as an hour less.
Nurse reviewers indicated that when the dialysis treatment period is
reduced, the patient retains toxins and other fluids that have not been
removed adequately from the blood stream. This condition can adversely
affect the patient's overall general health and lead to loss of
appetite, swelling, fatigue, shortness of breath, and possibly heart
failure.
* Failure to monitor concentration of chemicals in the water system. A
New York surveyor found that a facility did not monitor the purity of
water used for dialysis. The water used to prepare dialysate, a
solution that removes wastes from the blood during dialysis, contained
chemical contaminates in excess of allowed concentrations. For at least
8 months, fluoride levels were 1.0--five times greater than the maximum
allowable limit of 0.2. In addition, two water tests showed that
calcium levels were above 5.25, well above the maximum allowable limit
for calcium of 2.0. The facility medical director did not monitor the
results of water tests conducted and did not ensure that the facility's
staff took appropriate action, such as reporting abnormal values or
resampling the water.
Nurse reviewers told us that excessive amounts of fluoride could cause
a dialysis patient's red blood cells to rupture and clot and that
excessive amounts of calcium in the blood could increase the incidence
of bone disease.
* Failure to involve a transplant surgeon in the review of patients'
long-term care plans. A recertification survey in Mississippi revealed
that the facility did not involve a transplant surgeon, as required, in
the review of patients' long-term care plans. All of the medical
records reviewed in that facility had long-term care plans that were
not updated within the required 6-month time frame. The surveyor
interview with the facility's medical director confirmed that a
transplant surgeon or his designee had not examined patients' long-term
care plans.
Nurse reviewers commented that, until screened by a transplant surgeon,
the dialysis patient's potential for kidney transplantation cannot be
properly assessed.
Limitations in the ESRD Survey Process Leave Quality Problems
Undetected or Inadequately Addressed:
Infrequent or poorly targeted inspections allow facilities' quality of
care problems to go undetected or remain uncorrected. Although state
survey activity increased from fiscal year 1998 to 2002, numerous state
agencies did not meet the goal currently set by CMS to survey 33
percent of all ESRD facilities annually. An increasing number of
facilities continued to operate 9 or more years between inspections. In
addition, states that relied primarily on surveyors with limited
experience in conducting inspections of ESRD facilities tended to
report substantially fewer deficiencies than states using more
experienced surveyors, suggesting that surveyors in the first group of
states may have missed some quality problems. We also found patterns of
repeated condition-level deficiencies, and particularly, citations for
the same problem in successive inspections of an individual facility.
Finally, facilities had little incentive to ensure continued adherence
to Medicare's minimum quality standards in the absence of sanctions for
noncompliance other than termination from the Medicare program--which,
historically, has been rarely used.
Increased CMS Goals Have Led to Greater Survey Activity, but Many
States Fall Short:
In recent years, CMS has underscored the importance of conducting
recertification surveys of ESRD facilities by raising its expectations
for the state agencies regarding the frequency with which such surveys
should take place. In fiscal year 2001, CMS increased the
recertification goal for states to 33 percent of facilities each year,
up from 10 percent in fiscal year 1999 and 17 percent in fiscal year
2000. Moreover, since fiscal year 2001, there has been a parallel goal
for states to survey every dialysis facility within a 3-year period.
Thus, by the end of fiscal year 2003, no dialysis facility should have
gone more than 3 years since its last recertification survey.
In response to CMS's heightened expectations, state agencies surveyed
more ESRD facilities, but not enough to fully meet CMS's current goals.
As shown in figure 4, the percentage of ESRD facilities undergoing
recertification surveys annually grew substantially from fiscal year
1998 to 2001. However, collectively, state agencies did not achieve the
current goal, effective in 2001, of surveying 33 percent of all ESRD
facilities each year. In fact, after increasing to over 28 percent in
fiscal year 2001, the survey frequency rate declined to about 27
percent in fiscal year 2002.
Figure 4: ESRD Facility Survey Rate Compared to CMS Goal, Fiscal Years
1998 to 2002:
[See PDF for image]
[End of figure]
Underlying this aggregate trend are wide disparities in survey
frequency rates across the individual state agencies, as shown in
figure 5. State recertification survey rates ranged from zero to 89
percent in fiscal year 2002. Even among the 13 states with the largest
number of ESRD facilities,[Footnote 16] recertification survey rates
varied widely--from 10 percent to 40 percent.
Figure 5: State Variation in the Proportion of Dialysis Facilities
Surveyed for Recertification, Fiscal Year 2002:
[See PDF for image]
[End of figure]
While 33 state survey agencies met the expanded CMS survey frequency
goal in at least 1 of the last 2 fiscal years--sometimes by substantial
margins--only 9 of those states met the 33 percent goal in both years.
(See table 5 in app. III.) By contrast, 18 state agencies failed to
reach 33 percent in either of the two most recent fiscal years,
including some of the largest ESRD states, such as California,
Michigan, Pennsylvania, and Virginia.
As a result, many states may have difficulty meeting CMS's second goal
for state recertification activity, to survey all their ESRD facilities
within a 3-year period. Because this goal was established in fiscal
year 2001, the first test of state compliance will come at the end of
fiscal year 2003. Based on the facilities surveyed in fiscal year 2001
and 2002, 35 states will have to inspect more than a third of their
ESRD facilities in fiscal year 2003 if they are to meet the 3-year
goal. (See table 6 in app. III.) About one in five states has more than
60 percent of facilities left to survey. Alabama has the most
facilities--89 percent--that need to be surveyed in the current fiscal
year. Among the largest states, California and Virginia have the
largest backlogs to overcome--around 76 percent.
Despite improvement in the overall rate of ESRD facility surveys, a
significant proportion of dialysis facilities continue to operate for
long periods without inspections. For example, as of September 30,
2002, 466 facilities had not been surveyed for 6 or more years, of
which 216 had not been inspected for recertification in 9 or more
years. Most of the effort to shorten the interval between
recertification surveys has focused on reducing the number of
facilities surveyed within 3 to 6 years. (See table 1.) From fiscal
year 1998 to 2000, the proportion of facilities not surveyed for more
than 6 years rose sharply (from 9.8 to 17.4 percent) and then declined
(to 11.6 percent). Those that operated 9 or more years without a
recertification survey steadily increased from 1.6 percent (53
facilities) in fiscal year 1998 to 5.4 percent (216 facilities) in
fiscal year 2002. This aggregate result reflected highly variable
survey rates across states. Four states--California, Texas, New York,
and Missouri--accounted for 174 facilities that had not been surveyed
within 9 years by the end of fiscal year 2002.
Table 1: Proportion of ESRD Facilities Recertified Within 3, 6, 9, or
More Years, Fiscal Years 1998 to 2002:
Length of time since last recertification survey: Less than 3 years;
Percentage of facilities subject to a recertification survey: 1998
(n=3,250): 51.6; Percentage of facilities subject to a recertification
survey: 1999 (n=3,462): 51.2; Percentage of facilities subject to a
recertification survey: 2000 (n=3,679): 49.8; Percentage of facilities
subject to a recertification survey: 2001 (n=3,882): 62.5; Percentage
of facilities subject to a recertification survey: 2002 (n=4,011):
72.4.
Length of time since last recertification survey: 3 to
