VA Patient Safety: Initiatives Promising but Continued Progress Requires
Culture Change (Testimony, 07/27/2000, GAO/T-HEHS-00-167).

Pursuant to a congressional request, GAO discussed the Department of
Veterans Affairs' (VA) effort to reduce and prevent patient adverse
events in VA health care facilities through its new patient safety
initiative.

GAO noted that: (1) 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; (2)
some of VA's systems have been cited as potential models for other
health care organizations; (3) for example, VA has established systems
that incorporate the use of bar code technology to prevent blood product
and medication administration errors; (4) VA introduced bar code
technology in operating rooms to ensure that patients receive the
correct blood product; (5) bar code technology is also being used when
medications are administered to in patients to verify that the right
patient is receiving the right drug in the right dose at the right time;
(6) VA is 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; (7) 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; (8) in implementing its
initiatives, VA used strategies that mirror some of those suggested by
the Institute of Medicine (IOM) for creating a culture of safety; (9)
however, GAO believes VA can benefit if it increases its emphasis on
several leadership strategies cited by IOM; (10) in fact, VA agrees that
it is appropriate to measure its progress against the IOM recommended
strategies; (11) these include making patient safety a more prominent
goal, establishing clear responsibilities and expectations, and
communicating the importance of patient safety to all staff; (12) 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; (13) 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; and (14) 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.

--------------------------- Indexing Terms -----------------------------

 REPORTNUM:  T-HEHS-00-167
     TITLE:  VA Patient Safety: Initiatives Promising but Continued
	     Progress Requires Culture Change
      DATE:  07/27/2000
   SUBJECT:  Veterans hospitals
	     Hospital care services
	     Medical equipment
	     Health care personnel
	     Patient care services
	     Management information systems
	     Reporting requirements
	     Safety standards
	     Health statistics
IDENTIFIER:  VA Veterans Integrated Service Network

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GAO/T-HEHS-00-167

   * 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

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

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. 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. 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. 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 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.

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.

Background

Before VA's new patient safety effort, adverse events were investigated by
the health care facilities where they occurred and the findings were
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).

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. 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.

Patient Safety Initiatives Are at Various States of Development and
Implementation

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 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. 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
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). 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 Faces Challenges as It Implements Its Patient Safety Initiatives

Table 1: IOM's Five Principles and Strategies for Achieving Safe Health Care
 Principle        Strategy
 Leadership       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
                  Develop effective mechanisms for identifying and dealing
                  with unsafe practitioners
 Respect human
 limits in        Design jobs for safety
 process design
                  Avoid reliance on memory
                  Use constraints and forcing functions
                  Avoid reliance on vigilance
                  Simplify key processes
                  Standardize work processes
 Promote
 effective team   Train in teams those who are expected to work in teams
 functioning
                  Include the patient in safety design and the process of
                  care

 Anticipate the   Adopt a proactive approach: examine new technologies and
 unexpected       processes of care for threats to safety and redesign them
                  before accidents occur
                  Design for recovery-make errors visible
                  Improve access to accurate, timely information
 Create a
 learning         Use simulation whenever possible
 environment
                  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
                  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 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.
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 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.

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 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. 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.

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)

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