Veterans' Health Care: Standards and Accountability Could Improve
Hepatitis C Screening and Testing Performance (14-JUN-01,
GAO-01-807T).
Three years ago, the Department of Veterans Affairs (VA)
characterized hepatitis C as a serious national health problem
that needs early detection to reduce transmission risks, ensure
timely treatment, and prevent progression of liver disease. In a
1988 information letter the Under Secretary for Health outlined
the process clinicians should use when (1) screening veterans for
known risk factors for exposure to hepatitis C and (2) ordering
tests to detect antibodies and diagnose hepatitis C infection as
part of a plan to evaluate and assess risk factors for VA
patients. As part of an ongoing assessment of VA's testing and
screening for hepatitis C. This testimony discusses VA's progress
in screening and testing veterans for hepatitis C during fiscal
years 1999 and 2000. GAO found that VA (1) missed opportunities
to screen as many as three million veterans when they visited
medical facilities during fiscal years 1999 and 2000, potentially
leaving as many as 200,000 veterans unaware that they have
hepatitis C infections, (2) of those screened, an unknown number
likely remain undiagnosed because of flawed procedures, (3)
although the pace of screening and testing appears to be
improving, many currently undiagnosed veterans may not be
identified expeditiously unless VA (a) establishes early
detection of hepatitis C as a standard for care and (b) holds
facility managers accountable for timely screening and testing of
veterans who visit VA medical facilities.
-------------------------Indexing Terms-------------------------
REPORTNUM: GAO-01-807T
ACCNO: A01175
TITLE: Veterans' Health Care: Standards and Accountability Could
Improve Hepatitis C Screening and Testing Performance
DATE: 06/14/2001
SUBJECT: Disease detection or diagnosis
Health care programs
Infectious diseases
Veterans
Accountability
Health care services
******************************************************************
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GAO-01-807T
Testimony Before the Subcommittee on National Security, Veterans Affairs,
and International Relations, Committe on Government Reform, House of
Representatives
United States General Accounting Office
GAO For Release on Delivery Expected at 10: 00 a. m. Thursday, June 14, 2001
VETERANS' HEALTH
CARE Standards and Accountability Could Improve Hepatitis C Screening and
Testing Performance
Statement of Cynthia A. Bascetta Director, Health Care- Veterans' Health and
Benefits Issues
GAO- 01- 807T
Page 1 GAO- 01- 807T
Mr. Chairman and Members of the Subcommittee: We are pleased to be here
today to discuss the Department of Veterans Affairs? (VA) efforts to
identify veterans who have hepatitis C- a chronic bloodborne virus that can
cause potentially fatal liver- related conditions. This year, VA expects 3.8
million veterans to use its health care system, which consists of over 700
facilities located in 22 service delivery networks.
Three years ago, VA characterized hepatitis C as a serious national health
problem that needs early detection to reduce transmission risks, ensure
timely treatment, and prevent progression of liver disease. In a 1998
information letter, the Under Secretary for Health provided background
information on hepatitis C and stated that all patients will be evaluated
for risk factors and have assessments documented in their patient charts. He
also outlined the process clinicians should use when (1) screening veterans
for known risk factors for exposure to hepatitis C and (2) ordering tests to
detect antibodies and diagnose hepatitis C infection. He also recommended
testing of those with the presence or history of any risk factor or at the
patient?s request.
Subsequently, VA included a request for $195 million and $340 million for
hepatitis C screening, testing, and antiviral drug treatment in its fiscal
year 2000 and 2001 budget submissions, respectively. In doing so, VA noted
that hepatitis C has particular importance because of its prevalence among
VA?s enrolled population. Specifically, VA cited its one- day survey of over
26,000 veterans (on March 17, 1999) that documented an infection rate of 6.6
percent 1 , compared with 1.8 percent in the general population.
My comments today will focus on VA?s progress in screening and testing
veterans for hepatitis C during fiscal years 1999 and 2000 and ways that
performance could be enhanced. Our assessment of VA?s efforts to treat
infected veterans remains ongoing and results will be available early next
year.
1 Department of Veterans Affairs, Office of the Assistant Secretary for
Financial Management, FY 2001 Budget Submission, Medical Programs (Volume 2
of 6, February 2000), p. 2- 28.
Page 2 GAO- 01- 807T
Our review of VA?s hepatitis C screening and testing was conducted from
November 2000 through May 2001 in accordance with generally accepted
government auditing standards. It included:
reviews of relevant VA documents, including a sample of electronic medical
records, budget justifications, policy documents and practice guidelines;
interviews with over 100 VA officials, including the Under Secretary for
Health, the former and current Hepatitis C Directors, and officials in seven
VA health care networks; and
visits to seven medical facilities that conducted hepatitis C screening
and testing.
In summary, VA missed opportunities to screen as many as 3 million veterans
when they visited medical facilities during fiscal years 1999 and 2000,
potentially leaving as many as 200,000 veterans unaware that they have
hepatitis C infections. Most remain undiagnosed primarily because local
managers adopted restrictive hepatitis C screening practices. Moreover, of
those screened, an unknown number likely remain undiagnosed because of
flawed procedures. Clinicians at facilities we visited, for example,
frequently did not (1) order blood tests for screened veterans who had known
hepatitis C risk factors or (2) follow up to ensure that ordered tests were
completed.
During fiscal year 2001, VA has taken important steps to enhance hepatitis C
screening and testing performance, such as a better communication process
that includes lead clinicians at each medical facility. Although the pace of
screening and testing appears to be improving, many currently undiagnosed
veterans may not be identified expeditiously unless VA (1) establishes early
detection of hepatitis C as a standard for care and (2) holds managers
accountable for timely screening and testing of veterans who visit VA
medical facilities. Communicating more effectively with local managers about
the availability of funding for screening, testing, and treatment could also
reduce concerns about resources as a barrier to improved performance.
Hepatitis C virus infection is the most common chronic bloodborne infection
in the United States. 2 It develops into a chronic infection in 85
2 Miriam Alter, et al.,? The Prevalence of Hepatitis C Virus Infection in
the United States, 1988 Through 1994,? New England Journal of Medicine (Vol.
341, August 19, 1999), p. 560. Background
Page 3 GAO- 01- 807T
percent of the cases, through a slow process that is often without symptoms
for 20 years or more. Hepatitis C antibodies, however, generally appear in
the blood within 3 months of infection. Undiagnosed hepatitis C can
eventually lead to liver cancer, cirrhosis (scarring of the liver), or end
stage liver disease, which is the leading indication for liver
transplantation. 3
Hepatitis C (previously referred to as non- A, non- B hepatitis) was first
recognized as a unique disease in 1989. In 1992, blood tests became
available to detect the antibody. This discovery helped curb the rapid
spread of the virus by allowing effective screening of blood products to
virtually eliminate contamination. 4 Many, however, had already become
infected through transfusions and were unaware of their infection because
they had no symptoms.
Early detection is important for several reasons. Those who have hepatitis C
infections could unknowingly behave in ways that speed up the progression of
the disease. For example, alcohol use can hasten the onset of cirrhosis and
liver failure. Equally important, undiagnosed persons are missing
opportunities to safeguard their health. For example, vaccinations could
help those with hepatitis C avoid contracting hepatitis A and B. In
addition, some could benefit from antiviral drug therapies.
Early detection is also important because persons carrying the virus could
infect others, posing a serious public health threat. Specifically, as a
bloodborne virus, hepatitis C can be spread between family members through
sharing of razors; to health care workers through unequivocal blood
exposure, such as needlestick injuries; and to others who come in contact
with contaminated blood such as intravenous drug abusers. The Centers for
Disease Control and Prevention also reported potential risks associated with
tattooing under certain circumstances, such as in unregulated settings.
Given that the prevalence of hepatitis C may be 3 times greater in the
veteran population than the general population, this disease has particular
3 R. Cheung, ?Epidemiology of Hepatitis C Virus Infection in American
Veterans ,? The American Journal of Gastroenterology (Vol. 95, March 2000),
p. 740. 4 Centers for Disease Control and Prevention, U. S. Department of
Health and Human Services, ?Recommendations for Prevention and Control of
Hepatitis C Virus (HCV) Infection and HCV- Related Chronic Disease,? MMWR
(Vol. 47, October 16, 1998), p. 1.
Page 4 GAO- 01- 807T
importance for VA?s health care system. For example, hepatitis C now
accounts for over half of the liver transplants needed by VA patients-
costing as much as $140, 000 per transplant. In addition, VA treats many
other veterans for hepatitis C- related conditions, including some which
frequently require hospital stays, costing as much as $40,000 per patient.
Also, drug therapy to treat hepatitis C is costly- about $13,000 for a
48week treatment regimen.
VA estimates that about 800,000 veterans were screened for hepatitis C
during fiscal years 1999 and 2000 5 -about 20 percent of all veterans (4
million) making outpatient visits to VA medical facilities in those years.
Moreover, screening and testing practices were sometimes flawed. As a
result, the majority of veterans with hepatitis C who visited VA facilities
may remain undiagnosed. For example, while the true hepatitis C prevalence
rate for the 3.2 million unscreened veterans is unknown, as many as 200,000
could have hepatitis C infections if VA?s estimated 6.6 percent prevalence
rate is accurate. 6 By contrast, VA has identified about 75,000 veterans
with hepatitis C during this time period.
During VA?s hepatitis C screening process, providers are to determine,
generally through a series of questions, whether veterans who visit VA
facilities have any risk factors for hepatitis C. Figure 1 shows the 11 risk
factors, as stated in VA?s guidelines to providers.
5 Department of Veterans Affairs, Veterans Health Administration, White
Paper to Inform Congress of Decisions for Hepatitis C Funding (April 10,
2001), p. 7. 6 During congressional testimony last year, VA representatives
and others informed members that the prevalence rate could be as high as 10
percent. VA is conducting a study over the next year to determine the
prevalence of hepatitis C in its veteran population. Most Infected
Veterans Likely Remain Undiagnosed
Restrictive Screening Practices
Page 5 GAO- 01- 807T
Figure 1: VA?s Risk Factors for Hepatitis C
1. Vietnam- era veterans a 2. Blood transfusion before1992 3. Past or
present intravenous drug use 4. Unequivocal blood exposure of skin or mucous
membranes 5. History of multiple sexual partners b 6. History of
hemodialysis 7. Tattoo or repeated body piercing (circumstances most
important) 8. History of intranasal cocaine use 9. Unexplained liver disease
10. Unexplained/ abnormal ALT (alanine transaminase) 11. Intemperate or
immoderate use of alcohol c
a As currently determined by dates of service or in the age range of 40 to
55 years b Defined as more than 10 lifetime sexual partners c Defined as
more than 50g of alcohol per day for ten or more years (roughly 10- 14 grams
of alcohol = 1 beer) Source: U. S. Department of Veterans Affairs, Veterans
Health Administration, Hepatitis C Testing and Prevention Counseling -
Guidelines for VA Health Care Practitioners.
Local facility managers often adopted restrictive hepatitis C screening
practices, limiting screenings to primary care clinics or certain days of
the week or letting individual providers use their own judgment regarding
who should be screened. At most of the seven facilities we visited, managers
stated that their decisions regarding screening practices were based, in
part, on concerns about the availability of funding for screening, testing,
and treating services.
For example, at four of the seven sites we visited, screenings were almost
exclusively limited to veterans who used primary care clinics. However, as
many as a third of veterans visiting individual VA outpatient facilities may
not use primary care clinics. Instead, they receive care from specialists
who work in other clinics such as cardiology, substance abuse, or mental
health. Most specialty clinics at the sites we visited did not routinely
screen veterans for hepatitis C.
In addition, some facilities opted to limit hepatitis C screenings within
primary care clinics. For example, one facility rotated hepatitis C
screening among its five primary care clinics so that each clinic conducted
screenings only 1 day each week, due in part to concerns about the
availability of funding for laboratory services. Another facility phased- in
screenings, so that only one of its three primary care clinics screened
veterans for hepatitis C during fiscal year 2000, with the other clinics
Page 6 GAO- 01- 807T
beginning to screen in early fiscal year 2001, due in part to concerns about
the availability of funding for pharmaceuticals.
Moreover, facility managers told us that, during most of fiscal years 1999
and 2000, they left it to the discretion of individual providers to decide
who should be screened for hepatitis C. As a result, rather than screening
everyone, some providers only screened veterans who had symptoms associated
with liver disease or obvious risk factors.
Also, screening procedures used at the sites we visited could result in some
veterans with hepatitis C not being identified as at risk. For example,
providers at some sites frequently required veterans to identify their
specific risk behavior rather than allowing them to generally acknowledge
that at least one risk factor applied to them. Such a procedure could
embarrass veterans, which could result in some not identifying that they had
a risk factor. For example, several staff members responsible for screening
at facilities we visited noted that veterans were hesitant to discuss
stigmatizing risk behaviors associated with hepatitis C- especially when
they were asked to admit their history of sexual behavior and substance
abuse- such as alcohol, intranasal cocaine, or intravenous drug use.
In some locations, screening was conducted in areas that lacked sufficient
privacy, adding another barrier to obtaining accurate information. For
instance, a staff member at one clinic told us that interviews were
conducted near the general patient waiting area. She believed this to be
problematic when screening veterans, especially those elderly veterans who
might be reluctant to answer questions regarding intemperate alcohol use and
sexual conduct.
Testing procedures at the sites we visited resulted in many at- risk
veterans not being tested despite their being screened. Sometimes tests were
not ordered and other times ordered tests were not completed. As a result,
any of these veterans with hepatitis C infections would remain undiagnosed.
At four of the seven facilities we visited, we reviewed a random sample of
375 medical records for veterans identified as having at least one risk
factor. On average, we found that about 50 percent of those patients were
not tested. The percentage of sampled veterans who were not tested at the
four facilities ranged between 38 and 84 percent. Flawed Screening
Procedures Flawed Testing Procedures
Page 7 GAO- 01- 807T
Tests were not ordered for a variety of reasons. For example, at one
facility, providers thought that veterans would not be eligible for
antiviral hepatitis C treatment because of age, psychiatric illness, or
substance abuse. At another facility, tests were not ordered for some at-
risk veterans who were seen at outlying clinics where providers had not been
able to attend training sessions about hepatitis C screening. Also, some
screeners were unsure of their authority to order tests. Nursing staff, who
were charged with screening veterans at yet another facility, did not order
blood tests because they did not think they had the authority to order
tests, when in fact they did.
Also, we found that about 7 percent of ordered tests were not completed at
the facilities. Staff at those facilities told us that sometimes veterans do
not show up at the laboratory to have their blood tested and providers often
do not follow up with these veterans during their next visit to reschedule
the blood test. These facilities lacked a mechanism for tracking at- risk
veterans to ensure that they were tested.
During fiscal year 2001, VA has taken important steps to improve hepatitis C
screening and testing performance. For example, VA modified its computerized
patient record system to remind providers to screen and document screening
results during patients? visits. 7 Also, a new hepatitis C program director
was appointed in November 2000 who, among other things, has (1) improved
communication processes through the identification of lead clinicians at
local medical facilities and (2) convened regional workgroups to identify
procedural weaknesses and share best practices.
In VA?s management structure, the hepatitis C program director does not have
line authority over the providers who screen veterans. Rather, he serves as
a catalyst to stimulate ideas and facilitate problem solving. In doing so,
he may communicate directly with local managers, but his ability to affect
change depends primarily on the level of support provided by managers who
have line authority.
7 When a provider enters a patient name into the computer during a patient
visit, the reminder for hepatitis C screening automatically appears on the
computer monitor as part of the patient?s electronic medical record. When a
patient has been screened for hepatitis C, that reminder no longer appears
to prompt the physician to screen the veteran, and the provider notes
documenting the screening become part of the patient?s record. Standards and
Accountability Could Improve Hepatitis C Screening and Testing Performance
Page 8 GAO- 01- 807T
In that regard, the size and breadth of VA?s health care system poses a
significant challenge, when trying to address the types of procedural
weaknesses noted earlier. As figure 2 shows, policies and guidance must be
communicated from the Under Secretary for Health through 22 network
directors and 145 facility directors to over 15,000 health care providers
who conduct hepatitis C screenings in over 700 locations nationwide.
Figure 2: VA?s Management Structure for Hepatitis C Screening and Testing
From our perspective, the pace of screenings appears to be improving,
although VA has been unable to provide reliable nationwide data on the
number of veterans who were screened this year. Nonetheless, procedural
weaknesses noted earlier still persist. This suggests that a more systematic
approach may be warranted if all veterans using VA?s system are to be
screened appropriately and expeditiously. Key steps could include
welldefined standards for care and accountability, as well as enhanced
communications concerning funding availability.
Chi ef Financial
Offi cer Hepatitis C
Program Direct or
22 Network Direct ors
145 Medical Facility Direct ors
Over 15,000 Providers
VA Under Secretary for Health
Page 9 GAO- 01- 807T
VA?s hepatitis C initiative has operated for almost 3 years with a general
policy objective- evaluate all veterans for risk factors and conduct blood
tests for the hepatitis C antibody for those with a history of risk factors
or who request testing. VA?s stated policy, however, does not specify a
timeframe for achieving this objective.
Managers at the seven facilities we visited interpreted VA?s policy as
encouraging, but not requiring, screening and testing each veteran who
visits a VA medical facility. As discussed earlier, these managers, when
exercising their discretion, frequently adopted restrictive practices for
screening and testing veterans, resulting in relatively limited progress.
Establishing early detection of hepatitis C as a standard for care could
convey the higher priority that headquarters would expect local managers to
place on hepatitis C screening and testing. VA, for example, could direct
clinicians to screen veterans during their next visit to any VA medical
facility. Likewise, VA could direct clinicians to order blood tests in a
timely manner for all at- risk veterans as well as others requesting such
tests.
VA?s hepatitis C program has operated for almost 3 years without performance
targets or adequate management oversight information. Local managers told us
that if such targets had been set, and tracked, they would have taken steps
to achieve them. Last year, VA told this subcommittee that performance
targets for screening were under development. In April of this year, VA
stated that performance targets will be available for use in fiscal year
2003.
To motivate local managers to aggressively implement other health screening
and prevention initiatives, such as smoking cessation or reducing the risk
of colorectal cancer, VA has set performance targets and included them in
network managers? performance plans. Also, VA has developed processes for
collecting information to measure and report results so that managers can be
held accountable.
From our perspective, performance targets are most effective when they are
results- oriented and time- sensitive. Specifically, such targets should
communicate the percent of a target population that is expected to achieve a
desired outcome within a prescribed time period. For example, because the
use of tobacco products is the single most preventable cause of disease and
death, VA set a national goal to reduce the percentage of patients who use
tobacco products to 16 percent by 2004. VA has steadily Establishing Early
Detection As A Standard For Care
Establishing Accountability For Timely Detection of Hepatitis C
Page 10 GAO- 01- 807T
reduced the percentage of patients using tobacco each year from 32 percent
in 1997 to 25 percent in 2000, heading toward the strategic target of 16
percent.
A comparable performance target could be established to guide hepatitis C
screenings. For example, during fiscal year 2002, VA expects almost 3. 8
million veterans to visit VA facilities over 40 million times. With these
veterans visiting VA facilities so frequently, setting a target to screen 90
percent or more of these veterans during the next 12 months seems
reasonable. Such a goal, if achieved, could enable VA to identify most of
the previously undiagnosed veterans.
Likewise, a performance target relating to the timeliness of testing could
also help improve hepatitis C detection results. Testing, for example,
involves electronic ordering of a laboratory analysis, the drawing of a
blood sample from a veteran, assessment of the blood sample for hepatitis C
antibodies, and electronic reporting of the results to the ordering
provider. This process would be considered timely if completed within a
specified time frame from the date of initial screening for risk factors.
If VA managers are to be held accountable for achieving such performance
targets, timely information on screening and testing results are needed.
Currently, VA has no system to provide essential information. To date, when
collecting hepatitis C data, VA has relied primarily on its Emerging
Pathogens Initiative surveillance system which was designed for the limited
purpose of monitoring trends in rates of infectious diseases.
Through this system, VA began to track the number of people tested for
hepatitis C and the number with positive tests in 1997. However, it was not
able to systematically collect data on the number of veterans screened for
hepatitis C until VA?s electronic clinical reminder process was implemented
last year. Nonetheless, information remains unavailable on the numbers of
veterans who should have been screened and tested- information that is
essential to hold managers accountable for performance.
Moreover, only one of the seven facilities we visited used the clinical
reminder system to track provider performance in screening and testing
veterans for hepatitis C. This facility distributed screening results
periodically to managers and providers to motivate them to more aggressively
screen veterans. While this facility has had great success in increasing the
number of veterans screened, managers at the six other facilities had not
capitalized on the system?s capabilities.
Page 11 GAO- 01- 807T
VA agrees that its current sources of data on hepatitis C are inadequate.
The new hepatitis C program director is working to address the situation by
developing standardized hepatitis C- specific reports to track progress at
individual facilities. 8
VA told us the $195 million requested for hepatitis C screening, testing and
antiviral therapy for fiscal year 2000 and $340 million for this fiscal year
were allocated to network managers as part of its general medical care
resource distribution; in turn, network managers made allocations to local
facilities. However, VA did not clearly communicate how much of each
network?s allocation it expected would be spent for screening and testing
veterans for hepatitis C infections.
Network budget officers, facility managers, and providers we interviewed
were generally unaware that they had received funding to screen and test for
hepatitis C. Those who thought funds were available were unsure of how much
money was available. As noted earlier, such perceived funding inadequacies
resulted in some local managers adopting restrictive screening practices, as
well as some providers deciding that blood tests were not warranted for
certain at- risk veterans.
Our assessment shows that amounts distributed to networks were sufficient to
allow local facilities to screen all previously unscreened veterans when
they visited VA facilities during those years. 9 Thus, clearer communication
regarding available funding could eliminate local managers? and providers?
perceptions that resources are a barrier to accelerating their screening and
testing efforts.
VA established a high priority for hepatitis C screening and testing but
failed to follow through, even though funding was sufficient to get the job
done. In short, managers and providers at local facilities were afforded too
much discretion to decide who and when to screen and test without
8 Also, VA is designing an electronic database, referred to as a registry,
to manage the care and treatment of veterans who, after testing, are
diagnosed with hepatitis C infections. This registry, according to VA?s
hepatitis C program director, will not help managers assess the progress of
screening and testing efforts, as it will not contain information on the
numbers of veterans who need either screening or testing.
9 Veterans? Health Care: Observations on VA?s Assessment of Hepatitis C
Budgeting and Funding (GAO- 01- 661T, April 25, 2001). Communicating Funding
Available for Detection of Hepatitis C
Concluding Observations
Page 12 GAO- 01- 807T
adequate senior management oversight. Faced with the serious health care
needs of thousands of veterans who remain at risk of having hepatitis C- as
well as the urgent public health implications of hepatitis C- senior
managers can no longer afford to take a hands- off approach to its screening
and testing efforts.
From our perspective, veterans using VA?s health care system should be
screened and tested as quickly as possible in order to ensure timely
prevention of the progression of liver disease as well as to reduce
transmission risks to others. Toward that end, senior managers should take
immediate action to establish early detection of hepatitis C as a standard
for care, set aggressive performance targets, and hold local managers
accountable for achieving them.
Last week, we shared our findings with the Under Secretary for Health and
the hepatitis C program director. In general, they agreed that additional
management action could improve the pace and quality of hepatitis C
screening and testing. In that regard, they indicated that VA would take the
results of our work into consideration as they modify their national
hepatitis C program.
Mr. Chairman, this concludes my prepared statement. I will be happy to
answer any questions that you or Members of the Subcommittee may have.
For more information regarding this testimony, please contact me at (202)
512- 7101. Key contributors to this testimony include Paul Reynolds, Cheryl
Brand, Patricia Jones, and Irene Barnett.
(290013) GAO Contact and
Staff Acknowledgements
*** End of document. ***