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 percent1

, 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 48-

week treatment regimen.

VA estimates that about 800,000 veterans were screened for hepatitis C

during fiscal years 1999 and 20005

—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 veteransa

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 partnersb

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 alcoholc

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.

Chief

Financial

Officer

Hepatitis C

Program

Director

22 Network

Directors

145 Medical Facility

Directors

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