For Release on Delivery

Expected at 10:00 a.m.

Thursday, July 27, 2000

GAO/T-HEHS-00-167

VA PATIENT SAFETY

Initiatives Promising but

Continued Progress

Requires Culture Change

Statement of Cynthia A. Bascetta, Associate Director

Veterans’ Affairs and Military Health Care Issues

Health, Education, and Human Services Division

Testimony

Before the Subcommittee on Oversight and Investigations,

Committee on Veterans’ Affairs, House of Representatives

United States General Accounting Office

GAO
Page 1 GAO/T-HEHS-00-167

Mr. Chairman and Members of the Subcommittee:

We are pleased to be here today to discuss the Department of Veterans

Affairs’ (VA) effort to improve patient safety, an integral part of VA’s

overall strategy to improve the quality of health care. VA’s quality

management strategy is multidimensional and includes programs and

internal and external review processes to improve health outcomes, to

ensure that providers are competent and well-trained, and to optimize the

use of technology to achieve health outcome goals. In this overall system,

the role of patient safety activities is to prevent injuries related to care

and, when they do occur, identify the causes and countermeasures to

prevent them in the future.

My comments today will focus on VA’s effort to reduce and prevent patient

adverse events in VA health care facilities through its new patient safety

initiatives, part of its internal review processes. 1 Adverse events, which

occur in both public and private health care facilities, can have tragic

consequences, including permanent disability and death. A number of

studies have shown that serious injuries sustained from medical care are

common and often preventable. A 1997 poll of 1,500 Americans conducted

for the National Patient Safety Foundation showed that 42 percent felt that

they or a close friend or relative had experienced a preventable adverse

event.2 A 1999 report by the Institute of Medicine (IOM) estimated that

44,000 to 98,000 Americans die each year as a result of medical errors. 3

These findings were widely reported in the media, further heightening the

public’s awareness of the need to improve patient safety in health care.

As you know, in mid-1997 VA began an effort to improve patient safety in

VA facilities. Specifically, the effort aims to reduce adverse events by

focusing on system weaknesses instead of assigning blame to individuals.

A growing body of evidence shows that adverse events are commonly

caused by problematic systems and processes rather than human

performance problems. Consequently, many experts believe that crafting

1VA defines adverse events as untoward incidents, therapeutic misadventures, iatrogenic injuries, or

other adverse occurrences directly associated with care or services provided within the jurisdiction of

a medical center, outpatient clinic, or other Veterans Health Administration (VHA) facility. These

include events such as falls, medication errors, missing patient events, and suicides. Adverse events

may result from acts of commission or omission.

2Error Reduction in Health Care: A Systems Approach to Improving Patient Safety, P. L. Spath, ed.

(San Francisco, Calif.: Jossey-Bass Publishers, 2000).

3IOM, To Err Is Human: Building a Safer Health System (Washington, D.C.: National Academy Press,

Nov. 1999).

VA Patient Safety: Initiatives Promising but

Continued Progress Requires Culture Change
VA Patient Safety: Initiatives Promising but

Continued Progress Requires Culture

Change

Page 2 GAO/T-HEHS-00-167

solutions that make it more difficult for human errors to occur holds the

most promise for reducing adverse events. In fact, the premise of the

systems approach is that human error is to be expected and that errors

can be reduced by changing the conditions under which humans work. For

example, changing the system of gas connectors can prevent a gas hose or

cylinder from being installed at the wrong site, and differentiating similar

names and packaging of drugs can reduce the likelihood of giving a patient

the wrong medication.

VA has set out to implement this approach so that health care

professionals will feel able to openly acknowledge and report adverse

events as part of their daily work. VA created the National Center for

Patient Safety (NCPS) in 1998 to take the lead in integrating its patient

safety efforts and to develop and nurture a culture of safety in VA medical

facilities so that adverse events and close calls (situations in which

adverse events are narrowly averted) can be reduced and prevented.

Given the importance of VA’s patient safety effort and the IOM report

highlighting the need to improve patient safety, you asked us for this

hearing to (1) determine the status of VA’s initiatives to detect and prevent

adverse events and (2) describe the challenges VA may face as it

establishes a culture of safety. Our work is based on discussions with

officials at VA headquarters, the NCPS, and four Patient Safety Centers of

Inquiry funded by VA; participation in VA’s Patient Safety Improvement

Handbook training; reviews of VA’s patient safety policies and reports, the

IOM study on patient safety, and other relevant literature; and visits to VA

facilities in California, Florida, and Washington, D.C.

In summary, VA has developed a number of initiatives that indicate it is

moving toward a culture of safety in which systems are developed or

revised to better detect and prevent adverse events. Some of VA’s systems

have been cited as potential models for other health care organizations.

For example, VA has established systems that incorporate the use of bar

code technology to prevent blood product and medication administration

errors. VA introduced bar code technology in operating rooms to ensure

that patients receive the correct blood product. Bar code technology is

also being used when medications are administered to inpatients to verify

that the right patient is receiving the right drug in the right dose at the

right time. VA is currently completing its implementation of a revised

mandatory adverse event reporting and prevention process, which will

allow VA to identify systems and processes that require redesign. This

initiative is perhaps the most challenging because its success is dependent

on VA establishing a culture in which employees feel safe to openly report

actual adverse events as well as close calls.
VA Patient Safety: Initiatives Promising but

Continued Progress Requires Culture

Change

Page 3 GAO/T-HEHS-00-167

In implementing its initiatives, VA used strategies that mirror some of

those suggested by IOM for creating a culture of safety. However, we

believe VA can benefit if it increases its emphasis on several leadership

strategies cited by IOM. In fact, VA agrees that it is appropriate to measure

its progress against the IOM recommended strategies. These include

making patient safety a more prominent goal, establishing clear

responsibilities and expectations, and communicating the importance of

patient safety to all staff. VA’s interim draft strategic plan for fiscal years

2001 through 2006 better highlights patient safety as a goal than the

current strategic plan, but does not yet include outcome measures for

determining the effectiveness of its patient safety initiatives. VA could also

better ensure success if it prepared a detailed implementation plan that

identifies how and when VA’s various patient safety initiatives will be

implemented, how they are aligned to support improved patient safety,

and what contribution each initiative can be expected to make toward the

goal of improved patient safety. In addition, VA could raise staff awareness

and understanding of the importance of this effort by better

communicating its commitment to establishing patient safety as a top

priority. Taking such steps should help VA progress further in the

development of its patient safety culture and convey the commitment

necessary to sustain a lasting change.

In 1996, a conference on Examining Medical Errors in Health Care brought

together for the first time leaders from medicine, nursing, pharmacology,

and hospitals as well as accreditors and regulators to talk and learn more

about medical errors—a subject usually not openly discussed in health

care organizations.4 At the conference, it was acknowledged that there

was a need to improve patient safety by addressing medical errors. In

1997, VA’s Under Secretary for Health initiated a revised risk management

policy that he believed “would place VA at the forefront of efforts

everywhere to provide safer medical care.” According to the Under

Secretary, VA’s modified program was based on research findings showing

that preventable medical errors resulted from poorly designed systems or

processes and that analyses of systems could often lead to process or

system redesign that would reduce the likelihood of errors.

Before VA’s new patient safety effort, adverse events were investigated by

the health care facilities where they occurred and the findings were

4Annenberg Center for Health Sciences, Examining Errors in Healthcare: Developing a Prevention,

Education and Research Agenda (Rancho Mirage, Calif.: Oct. 1996).

Background
VA Patient Safety: Initiatives Promising but

Continued Progress Requires Culture

Change

Page 4 GAO/T-HEHS-00-167

submitted to regional quality management staff for their review; they

forwarded the results to headquarters officials. In 1997, VA required that

reported events that resulted in serious injury or death be included in a

registry maintained by VA’s chief network officer. In 1999, VA’s Office of

the Medical Inspector analyzed the adverse events reported to the registry

over a 19-month period beginning June 1997. In its report, issued in

December 1999, the Medical Inspector found that VA’s registry data

showed wide variation in the number and types of events reported by VA’s

22 Veterans Integrated Services Networks (VISN).5

In an effort to help ensure adequate oversight of its investigation and

reporting procedures, VA established the NCPS in 1998 to lead and

integrate VA’s patient safety effort. Under NCPS’ direction, VA’s Patient

Safety Improvement Handbook was revised to include new adverse event

investigation and reporting procedures and tools.6 In November 1999,

NCPS began training representatives from VA facilities to use the new

procedures and tools. Adverse events are now reported to NCPS, which

enters them into VA’s new mandatory adverse event reporting system

database, replacing the system maintained by the chief network officer.

Since VA began its patient safety effort in 1997, it has taken a number of

important steps to reduce and prevent adverse events by evaluating and

then modifying or redesigning the systems that allow them to occur. These

initiatives are at various stages of development, and only a few are fully

implemented.

VA reports that it has fully implemented two patient safety initiatives—

each of which eliminates identified hazards that can have fatal

consequences. First, to ensure that a patient will not receive the wrong

blood type during surgery and die, VA requires that blood products

administered to patients in an operating room be verified through

independent computer bar code technology. This check is made in

addition to VA’s standard verification procedure of having two people

visually match information about the patient’s identity and information on

the blood product. VA’s second initiative eliminated an identified lethal

5Office of the Medical Inspector, VHA, VA Patient Safety Event Registry: First Nineteen Months of

Reported Cases Summary and Analysis, June 1997 through December 1998. The Office of the Medical

Inspector is currently reviewing the causes of underreporting and the reasons for variations in

reporting.

6The Patient Safety Improvement Handbook, developed in January 1998, effectively replaced VA’s risk

management policy.

Patient Safety

Initiatives Are at

Various States of

Development and

Implementation
VA Patient Safety: Initiatives Promising but

Continued Progress Requires Culture

Change

Page 5 GAO/T-HEHS-00-167

medication error. Specifically, VA reports that it has removed

concentrated potassium chloride and other concentrated injectable

solutions from patient care areas—such as patient wards, intensive care

units, and surgical suites—and instead now requires that a facility’s

pharmacy dilute concentrated injectable solutions before sending them to

patient care areas for administration. This system change virtually

eliminates the possibility for human error to result in accidental

administration of a lethal dose of concentrated potassium chloride.

Several other major initiatives addressing adverse events are under way in

VA health care facilities. These include using bar code technology when

administering medications; implementing a new internal mandatory

process for analyzing and reporting adverse events; and collaborating with

the National Aeronautics and Space Administration (NASA) to develop an

external voluntary adverse event reporting system.

In October 1999, VA began implementing a bar code medication

administration (BCMA) system for inpatient medications. BCMA is

designed to help caregivers avert potential medication administration

errors by verifying that the right patient is receiving the right drug, in the

right dose, at the right time. The system also screens for other potential

problems such as drug interactions. VA reported that during a BCMA pilot

test at the Topeka, Kansas, VA medical center, medication errors were

reduced by about 70 percent. Systemwide implementation of BCMA was

scheduled for June 30, 2000. However, only 79 of 137 facilities have fully

implemented BCMA in all inpatient care areas excluding intensive care

units; 9 facilities have not implemented BCMA in any area.7 According to

VA officials, these delays are due to technical and administrative

difficulties, including computer hardware being delivered damaged or late;

the need for hardware upgrades; and renegotiations of union labor

agreements, which do not include BCMA use. VA expects the BCMA

system to be fully operational in all inpatient care areas except intensive

care units by September 2000.

VA’s Patient Safety Improvement Handbook specifies new processes that

VA staff at health care facilities must use when reporting adverse events

and close calls that pose safety risks to patients. The handbook details the

use of the Safety Assessment Code matrix, a tool facility staff can use to

assess the actual and potential probability and severity of the adverse

event or close call—measured on a scale of one through three, with three

7As of July 7, 2000.
VA Patient Safety: Initiatives Promising but

Continued Progress Requires Culture

Change

Page 6 GAO/T-HEHS-00-167

reflecting the highest severity. An adverse event or close call with a score

of three requires that a team be assembled to conduct an analysis to

identify the root causes of the event. Once the causes have been identified,

the team makes recommendations for reducing or eliminating the

occurrence of such an event in the future. Representatives from each

medical center must receive 24 hours of training in the use of the new

approach before the facility can begin using the revised reporting and

analysis system outlined in the handbook. According to VA’s schedule,

training of facility staff in the use of the new procedures is scheduled for

completion by the end of August 2000.

To complement its internal mandatory reporting system, VA is also

establishing an external voluntary adverse event reporting system that will

allow VA employees to report errors confidentially. Specifically, at the end

of May 2000, VA signed a 4-year, $8.2-million agreement with NASA to

develop a voluntary Patient Safety Reporting System (PSRS), which will be

modeled after NASA’s Aviation Safety Reporting System (ASRS).8 PSRS

will collect and analyze voluntarily submitted reports of adverse events or

close calls that occur in VA health care facilities. To ensure confidentiality,

reports will be stripped of any identifying information—that is, all

personal and organizational names and dates, times, and related

information that could be used to infer an identity—before they are

entered into the database. Some organizations expect a system that

protects the identity of the person reporting a potential or actual adverse

event to yield more complete data because it helps remove the fear of

reprisal. However, it will take time to determine if a system similar to

ASRS will be successful in a health care setting. PSRS is scheduled to be

fully operational sometime in 2001.

VA’s initiatives to improve patient safety mirror some of those suggested

by IOM, but VA will face significant challenges to ensure the success of its

patient safety effort. In particular, establishing a culture of safety using

strategies such as ones described by IOM will be unprecedented in a

health care system of VA’s size and will require sustained commitment to

effect permanent change. After reviewing lessons from aviation, nuclear

power, and other high-risk industries—as well as reviewing evidence of

practices that can improve health care safety—IOM identified various

strategies related to five principles for achieving safe health care (see table

8ASRS was established in 1975 under an agreement between the Federal Aviation Administration

(FAA) and NASA. NASA administers the program and sets its policies in consultation with FAA and the

aviation community.

VA Faces Challenges

as It Implements Its

Patient Safety

Initiatives
VA Patient Safety: Initiatives Promising but

Continued Progress Requires Culture

Change

Page 7 GAO/T-HEHS-00-167

1). These strategies essentially lay out a framework within which VA’s

progress can be monitored as it attempts to create a patient safety culture.

Table 1: IOM’s Five Principles and Strategies for Achieving Safe Health

Care

Principle Strategy

Make patient safety a priority corporate objective

Establish clear responsibilities and set expectations for safety

Make patient safety everyone’s responsibility

Provide resources, human and financial, for error analysis and

system redesign

Leadership

Develop effective mechanisms for identifying and dealing with unsafe

practitioners

Design jobs for safety

Avoid reliance on memory

Use constraints and forcing functions

Avoid reliance on vigilance

Simplify key processes

Respect human

limits in process

design

Standardize work processes

Promote effective Train in teams those who are expected to work in teams

team functioning Include the patient in safety design and the process of care

Adopt a proactive approach: examine new technologies and

processes of care for threats to safety and redesign them before

accidents occur

Design for recovery—make errors visible

Anticipate the

unexpected

Improve access to accurate, timely information

Use simulation whenever possible

Encourage recognizing and reporting of errors and hazardous

conditions

Ensure no reprisals for reporting errors

Develop a working culture in which communication flows freely

regardless of authority gradient; improve verbal communication

Create a learning

environment

Implement mechanisms of feedback and learning from error

Source: IOM, 1999.

Because VA is just beginning its initiative to create a culture of safety, we

conducted our assessment by comparing its efforts to the IOM leadership

principle. Successful leadership strategies create the foundation on which

all other patient safety strategies are built. Experts agree that a culture

change can take several years to effect, and VA officials have estimated 5

to 7 years are needed to implement their effort. Moreover, such profound

change is largely dependent on leadership and staff having a common

understanding and unequivocal commitment to the goal of improved

patient safety. Our review identified several strategies under IOM’s

leadership principle that could help VA better achieve such a common
VA Patient Safety: Initiatives Promising but

Continued Progress Requires Culture

Change

Page 8 GAO/T-HEHS-00-167

understanding and commitment in this early phase of the culture change.

These include (1) making patient safety a priority organizational goal (with

measurable outcomes); (2) developing a detailed and integrated patient

safety plan with clear lines of responsibility and expectations; and (3)

ensuring, through effective communication, that all employees understand

that patient safety is their personal responsibility as well as a collective

responsibility. While VA has made significant strides so far toward

improving patient safety through the implementation of its various

initiatives, emphasis in these three areas would assist them in creating a

culture of safety throughout the organization.

VA is three years into its patient safety effort and it has dedicated

approximately $478 million over 3 years to support its national patient

safety initiatives. Although its fiscal year 1998-2003 strategic plan did not

include patient safety as a specific goal, VA’s draft interim fiscal year 2001-

2006 strategic plan takes an important step in the right direction by

articulating improved patient safety as an objective. However, the plan

does not yet identify measurable outcomes so that progress can be

assessed.9 For example, VA’s strategic plan does not incorporate outcome

measures related to reducing medication administration errors through

the use of BCMA. Outcome measures are another way to emphasize the

importance of patient safety because collecting the data to measure

outcomes underscores the importance of the goal for all staff.

VA has not yet developed an overall implementation plan that establishes

clear responsibilities, sets expectations, and explains linkages between the

offices accountable for patient safety. Such a plan would help VA explain

how and when VA’s patient safety initiatives will be implemented, how

they are aligned to support improved patient safety, and how each

initiative is expected to contribute to improved patient safety. Currently,

primary responsibility for patient safety improvement is distributed across

NCPS and two headquarters offices—the Office of Quality and

Performance and the Office of the Medical Inspector. NCPS was created to

lead and integrate VA’s patient safety efforts, the Office of Quality and

Performance coordinates the design and implementation of performance

measures related to patient safety, and the Office of the Medical Inspector

explores how and why patient care systems failed and resulted in an

9The fiscal year 2001-2006 plan includes what VA calls “6 for 2006”—referring to six strategic

objectives that represent the highest priorities for providing health care to veterans. One objective

refers to patient safety. Specifically, the objective “put quality first until first in quality” lists “improve

the safety of the care environment for patients and employees” as a strategy for achieving this

objective.
VA Patient Safety: Initiatives Promising but

Continued Progress Requires Culture

Change

Page 9 GAO/T-HEHS-00-167

adverse event. The three offices’ physician leaders are core members of

VA’s Patient Safety Improvement Oversight Committee, which meets at

least once a month to review national trends in adverse events and

analyses that have implications for department policy development.

During our discussions with these officials, they told us that the linkages

between the three offices were still being developed. For example, prior to

1998, patient safety was under the purview of the Office of Quality and

Performance. When NCPS was created, many patient safety functions

were realigned, but VA has not yet finalized how the two offices will work

together.

An overall implementation plan could also clarify the role of the four

Patient Safety Centers of Inquiry, which VA created to function as learning

laboratories for the development and dissemination of evidence-based

patient safety practices. The plan would also lay out linkages between the

four centers and either NCPS or the Office of Quality and Performance.

The centers all concentrate on identifying and preventing avoidable

adverse events and each has a different focus. The primary areas include

but are not limited to reduction in medication errors, risk assessment for

falls, issues related to human-machine interfaces, and anesthesia/operating

room simulation training. Although NCPS and these Patient Safety Centers

of Inquiry have developed informal relationships to work on projects of

mutual interest, such as the pilot testing of the new adverse event analysis

and reporting procedures at one of the Centers, each of the four centers

formally reports to a VA medical center or network director. Establishing

formal linkages could facilitate rapid and systematic dissemination of

findings that could improve patient safety across the entire VA health care

system. In addition, as the patient safety effort matures, VA could consider

whether linking the results of the centers’ findings to national

performance measures would help send a clear mandate to improve

patient safety throughout VA.10

In addition, IOM reported that ensuring that all employees understand that

patient safety is their responsibility is key to a successful effort. Although

VA has issued policies regarding many of its patient safety initiatives, it

has not communicated its commitment to establishing patient safety as a

top priority to all of its employees. Clear and unambiguous communication

from leadership that patient safety is a serious priority of the organization

is crucial to gaining the trust and support of employees, which IOM

10VISN 1 Patient Safety Center of Inquiry, VA Collaborative Breakthrough Series on Reducing Adverse

Drug Events, September 1999 to April 2000 (May 25, 2000).
VA Patient Safety: Initiatives Promising but

Continued Progress Requires Culture

Change

Page 10 GAO/T-HEHS-00-167

identified as an important component of a successful patient safety

program. A physician with the Institute for Healthcare Improvement—

which contracted with VA to help coordinate its patient safety education

efforts for one Center of Inquiry—similarly describes a successful

management system for safety as needing processes for encouraging and

maintaining a participative culture.11 Moreover, some employees voiced

the opinion that VA medical center management staff could benefit from a

better understanding of the new adverse event reporting and review

process as well as the need to move from a culture of blame to a

nonpunitive environment. When we asked VA officials about the

leaderships’ exposure to the new adverse event reporting and analysis

process, they did not have a plan to ensure that all VISN and medical

center leaders would receive the information needed to understand the

shift in paradigm. We believe VA leadership could do more to build agency

management and employee awareness of and support for the patient

safety effort by communicating openly and frequently about the effort.

In conclusion, it is too early in VA’s implementation of its various patient

initiatives to predict if it will be successful in creating a patient safety

culture. Doing so could be of significant benefit to veterans and could lead

the way for private sector health care providers to improve patient safety.

The patient safety objective VA outlines in its draft interim strategic plan is

a critical step toward making patient safety a more prominent goal in the

organization. Articulating ways to measure progress toward reaching this

goal, developing an explicit implementation plan, and stepping up

communication with staff should further advance the coherence and

visibility necessary for an effort of this magnitude.

11Donald F. Phillips, “New Look Reflects Changing Style of Patient Safety Enhancement,” Journal of

the American Medical Association, vol. 281, no. 3 (Jan. 20, 1999).
Page 1 GAO/T-HEHS-00-167

Mr. Chairman, this concludes my prepared statement. I will be happy to

answer any questions that you or Members of the Subcommittee may have.

(406190)
Orders by Internet

For information on how to access GAO reports on the Internet, send

an e-mail message with “info” in the body to:

Info@www.gao.gov

or visit GAO’s World Wide Web home page at:

http://www.gao.gov

Contact one:

Web site: http://www.gao.gov/fraudnet/fraudnet.htm

E-mail: fraudnet@gao.gov

1-800-424-5454 (automated answering system)

Ordering Information

To Report Fraud,

Waste, and Abuse in

Federal Programs