GAO-01-123R VA Patient Safety

United States General Accounting Office

Washington, DC 20548

October 13, 2000

The Honorable Terry Everett

Chairman

Subcommittee on Oversight

and Investigations

Committee on Veterans’ Affairs

House of Representatives

Subject: Response to Questions From Hearing on Patient Safety and Quality of

Care at VA Facilities

Dear Mr. Chairman:

The enclosed information responds to your follow-up questions on our July 27,

2000, testimony for the Subcommittee on Oversight and Investigations hearing

concerning VA’s Patient Safety and Quality of Care. We will make copies of this

correspondence available to other interested parties upon request.

If you have any questions or would like to discuss this information further, please

contact me at (202) 512-7101.

Sincerely yours,

Cynthia A. Bascetta

Director, Health Care – Veterans' Health and

Benefits Issues

Enclosure
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2 GAO-01-123R VA Patient Safety

SUPPLEMENTAL INFORMATION ON VA’S PATIENT SAFETY INITIATIVES

This enclosure presents your questions and our responses, which supplement

information in our testimony before the Subcommittee on Oversight and

Investigations, VA Patient Safety: Initiatives Promising but Continued Progress

Requires Culture Change (GAO/T-HEHS-00-167, July 27, 2000).

1. Regarding VA’s four Patient Safety Centers of Inquiry, how does

their role and research focus relate to the work conducted by VA’s

Office of Research and Development? In what way does the work of

the centers address the principal adverse and sentinel events that

were disclosed in VA’s 1999 Office of the Medical Inspector’s

report?

The Patient Safety Centers of Inquiry and VA’s Office of Research and

Development are not directly linked organizationally. The four Centers of Inquiry

do not report to and are not funded by the Office of Research and Development.

Rather, the Directors of the four centers report to either the Veterans Integrated

Service Networks (VISN) or Medical Center manager where they are located. The

Office of Research and Development staff assisted the Under Secretary for Health

in developing the Centers of Inquiry request for proposals and subsequently

helped in rating and ranking the proposals submitted. The centers were then

chosen by the Under Secretary for Health and received $500,000 per year in

funding from medical care funds. Some staff associated with the Centers of

Inquiry also have active projects funded by Health Services Research and

Development (HSR&D), which is part of the Office of Research and Development.

In addition to these projects, HSR&D funds other patient safety research projects

that are not directed by the centers and is currently funding four projects that

overlap with the work of the centers. Two of these focus on selected aspects of

adverse drug reactions, and the other two address fall prevention in the hospital

and home environments. As the patient safety effort develops, VA told us that it

expects to articulate clear linkages between these efforts to maximize the

efficiency of this research effort.

The work at the Centers of Inquiry address some but not all of the known

principal adverse and sentinel events at VA medical facilities. In December 1999,

a report by VA’s Medical Inspector disclosed that between June 1997 and

December 1998, the top five categories of adverse events reported by VA facilities

were patient falls, suicide and attempted suicide, other unplanned occurrences,

and patient abuse (not in rank order). Adverse events in these five categories

account for 69 percent of reported events during the timeframe reviewed by the

Medical Inspector. The Patient Safety Center of Inquiry at the Tampa VA medical

center is studying fall prevention and injury reduction related to patient falls in

high-risk populations that have mobility problems. The Center in White River

Junction is currently working to reduce medication errors (ranked seventh on the

Medical Inspector’s list) using a collaborative technique. Not targeted by the
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3 GAO-01-123R VA Patient Safety

centers are unplanned occurrences, patient abuse, and suicide and suicidal

behavior.

Although none of the centers is currently studying suicide prevention, VA has

undertaken a variety of suicide prevention efforts since the 1970s, including most

recently its March 1, 2000, suicide summit called "Suicide: Recognizing Risks

Across Treatment Settings."1

This program was designed to encourage caregivers

to screen patients for risk of suicide; share resources regarding suicide

awareness, prevention, and treatment; and recommend proper treatment and

referral. Suicide risk assessment pocket cards were also printed and distributed

to clinicians to use in their daily activities. VA has also implemented depression

screening in nonmental health care settings to identify veterans at risk for suicide

and to get them help from a mental health professional. There are also 12 VA

facilities with active projects related to improved prevention and management of

suicidal behavior.

“Unplanned occurrences” is a general category for events that do not fit neatly

into one of the other categories used by VA. To work in this area, the events

would need to be further categorized. VA is no longer handling cases of alleged

patient abuse under the patient safety program and instead has mandated that

facilities take immediate administrative steps to investigate these incidents.

2. Given GAO’s early assessment of VA’s efforts to improve patient

safety, what obstacles or other problems might VA have to overcome to

ensure continued progress?

As we testified, VA’s initiatives to improve patient safety mirror some of those

suggested by the Institute of Medicine (IOM), but VA faces significant challenges

to ensure the success of its patient safety efforts. The key challenges include

setting goals, planning, and communicating the priority of patient safety to its

employees. Beyond that, VA needs to overcome obstacles that impede the move

from a “blame and shame” way of handling adverse events to a culture of safety

that looks openly at how and why adverse events occur and how systems can be

improved to prevent them in the future. To make a major change in patient safety,

VA must convey the message to all its employees that patient safety is everyone’s

responsibility and then put this belief into practice by making it an integral part of

everyday work. Safety experts agree that management officialsmany of whom

have been trained to look for the person responsible for an error—need to focus

instead on the systems that allowed the adverse event to occur. They must also be

able to create a nonpunitive work environment in which employees feel safe

enough to report and investigate adverse events and, even more important, close

calls (situations in which an adverse event could have occurred but did not).

Because successful culture change takes years, we believe that patience and

sustained commitment in the event of leadership changes should also be a top

priority. Also, once the culture change has taken root, VA leadership at all levels

1

In VA, a summit is a series of educational and networking events designed to share best practices

across the VA health care system.
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4 GAO-01-123R VA Patient Safety

of the organization must remain committed to continuous improvement in the

effort to drive the medical error rate to zero.

It is also important to point out that, in the short run, if the culture change is

successful, we would expect to see an increase in the number of reported adverse

events, and we should view this increase as a positive result of VA’s efforts. As

reports of adverse events increase and more errors come to light, managing the

potential negative reaction of skeptics and highlighting the fact that staff are able

to learn from these errors will be critical to ensuring that the patient safety

program stays on track.

3. Much has been said about VA’s patient safety program and some

people point to it as a model for the private sector to follow. Does

GAO believe that it is a model program?

Because VA’s patient safety program has not been fully implemented, it is too

early to predict whether, in the final analysis, it will be a model for other health

care organizations. While some of VA’s patient safety initiatives are clearly

exemplary, such as removing concentrated potassium chloride from wards and

bar-coding medications, these initiatives preceded the broader patient safety

program that VA is now trying to put in place. In other words, more fundamental

than such stand-alone initiatives is VA’s effort to create a systemwide culture of

safety. In this key endeavor, VA is not yet a model. While VA leads the rest of the

health care sector in adopting the right concepts and consulting with appropriate

experts, we believe that it is too early to predict if VA will be successful in

creating a culture that promotes patient safety. Until VA demonstrates results

attributable to the processes it is putting in place, others will be unable to emulate

them. In our view, therefore, calling VA a model would be premature.

4. VA’s National Center for Patient Safety promises to have a pivotal role

in the development of new systems that will be used to analyze and

report on sentinel and adverse events. If the Center’s new processes

are successful, what will be the likely impact on the number of patient

safety events that are reported?

In the short run, if the processes instituted by the National Center for Patient

Safety are successful, there should be a rise in the number of reported adverse

events at VA facilities. We believe an increase in reported events will reflect a

willingness on the part of employees to report events that have been occurring all

along, not a real increase in the number of adverse or sentinel events. In fact, we

would be suspicious that the system is not working well if the number of events is

too low. The magnitude of this potential increase is unknown but could be steep.

Increased reporting will offer employees a chance to learn from adverse events,

especially close calls, and will provide an opportunity to propose changes that can

prevent such events from happening again in the future. In the long run, more

reports should lead to a drop in preventable adverse events as proposed solutions

and action plans are disseminated systemwide to reduce or prevent occurrences.
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5. In addition to more definitive goal setting and measurement,

comprehensive planning, and communicating the importance of the

program to all its employees, are there other actions VA can take to

ensure the success of its patient safety program?

Reporting adverse eventsone of the most important steps VA is taking to

improve patient safetydepends on the cooperation and participation of VA

employees. However, a reporting system is not enough. In its training for

employees on VA’s new method for reporting and analyzing the root causes of

patient safety problems, the National Center for Patient Safety emphasizes the

importance of feedback to all employees who are participating in the

processfrom the individual who reports the adverse event or close call to the

team of employees selected to perform the root cause analysis or aggregate

review. We believe that motivating employees by involving them in these

processes will enhance the success of VA’s efforts even more than setting goals

and communicating patient safety as a top priority. The importance of providing

feedback to teams and disseminating findings throughout VA cannot be

overemphasized. Managers must be willing not only to find time for employees to

participate in the root cause analysis but must also support the implementation of

recommendations made by the teams. We believe that only when these processes

run smoothly and employees participate fully as part of their everyday work will

the full benefits of the culture of safety be realized.

6. The VA Office of Inspector General’s Combined Assessment Program

(CAP) reports often identify critical nursing staff shortages. Can you

comment on how these shortages have an impact on patient safety?

The nursing shortagea national problem affecting VA and private sector

hospitals alikeis projected to worsen in the coming years. GAO has not

conducted an evaluation of the adequacy of nursing staff ratios in VA. We

therefore cannot comment directly on the potential effect that any nursing

shortage may have on patient safety. However, in 1998, VA and Kaiser Permanente

jointly sponsored a public/private sector focus group of health care professionals

to identify perceived barriers to patient safety. These care providers, including

VA participants, identified inadequate staffing as the largest barrier to patient

safety. Not surprisingly, they reported that inadequate staffing leads to employee

fatigue and frustration. Other industries, such as aviation, have established strict

rules that prevent flight crews, for instance, from working without adequate rest

periods. VA is currently doing research in this area to determine the applicability

of this preventive measure in health care delivery situations.

7. The VA points to its bar-coding system for medications as one of its

great success stories. I understand the implementation of this system

has encountered problems in operating rooms and in interfacing with

VA’s computerized patient record system. Would you please elaborate

on these difficulties?
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VA reports that it has implemented bar code medication administration (BCMA)

in over 60 percent of its inpatient care areas. For BCMA to work, the physician

order entry package, which is part of the Computerized Patient Record System

(CPRS), must be functioning. One reason for the slippage in the BCMA schedule

is that CPRS is not uniformly available in all facilities, even though VA tells us that

the software has been installed at all VA facilities. We are unaware of any specific

interface problems between BCMA and CPRS, but VA has experienced hardware

and training problems in some locations that have prevented full implementation

of CPRS.

VA did not indicate that problems in operating rooms were occurring. However,

there are some problems in intensive care units (ICUs), where the situation is

more complex. VA told us that ICUs, in which about 70 percent of medications

are administered intravenously, are further behind other inpatient care areas in

implementing BCMA. Specifically, only about 40 ICUs had implemented BCMA,

as of the end of June 2000. According to VA officials, the original BCMA computer

package was intended primarily for administration of oral medications and not for

intravenous therapy. VA tells us that the Version 2 upgrade of the software,

scheduled for 2001, will resolve this problem.

8. What evidence have you seen of VA’s senior management participation

or commitment to the ambitious safety training programs being

conducted throughout the VA system?

There has been little participation by VA senior management in its safety training

programs. We asked the National Center for Patient Safety to provide a breakout

of the job titles of those employees who attended one of the 3-day patient safety

improvement training sessions. On July 19, 2000, VA told us that, until then, no

VISN or medical center director had participated in the training sessions. The

highest level managers who did attend included 41 chiefs of staff, 49 service

chiefs, and 83 associate directors for patient care services or nurse executives.

According to VA, of the nearly 600 employees trained, the majority were facility

risk managers or quality managers.

9. Has VA identified the highest priority areas for medical errors, and

have they developed a standardized system for measuring the

reduction of these errors?

VA can use its adverse event registry to categorize adverse events that occur most

frequently and that would merit priority attention, such as falls, suicides, and

medication errors. VA has not yet developed a standardized system for

measuring a reduction in medical errors, and we are not aware of any VA plans to

do so. However, before VA can target the patient safety problems that most need

attention, it will have to put in place a well-functioning reporting system and

establish an accurate baseline from which to measure change systemwide. Until

VA’s new system is fully in place and operating for some time, VA will use the root
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cause analysis process to provide a standardized tool for assessing the causes of

errors and to compare analyses across all VA facilities.

10.The IOM report uses the Harvard Medical Practice Study in New York,

which states that adverse events occurred in 2.9 percent of

hospitalizations. This is a widely respected peer reviewed study. The

VA reported 2,927 adverse events in a 19-month period. The July 17,

2000, U.S. News and World Report cited the Johns Hopkins Hospital in

Baltimore, Maryland, as the highest rated hospital in America for

several years running. Johns Hopkins had 69,603 inpatients in FY

1999. If you use IOM’s 2.9 percent times 69,603, Johns Hopkins would

have had just over 2,000 adverse events. This is just one hospital.

How can the entire VA hospital system only report 2,927 adverse

events? Using the same formula, one would predict 21,802 possible

adverse events. Can GAO try to explain this phenomenal

discrepancy?

We do not know if Johns Hopkins has a reporting system, or, if it does, the

number of adverse events it contains. Nevertheless, this example underscores the

growing consensus in the health care industry, including the VA system, that

underreporting of adverse events is a serious problem. The percentage reported

by the IOM is based on limited research in two states and represents a national

estimate not intended for application to individual health care systems. Moreover,

other researchers have made compelling but contradictory arguments that the

IOM report overstates and understates the extent of underreporting.

Nevertheless, experts agree that underreporting is a problem and that there is

inadequate data to estimate the degree of underreporting with much precision.

So, whether 22,000 adverse events is the “right” number or not is impossible to

say. During fiscal year 2000, VA will be conducting a survey to establish a

baseline measurement of how employees feel about reporting adverse events. If

employees report that they do not feel safe enough to report adverse events, then

we can assume that underreporting will continue to be a problem. However,

determining the magnitude of this problem will continue to be difficult.

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