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Presentation to the National Committee on Vital and Health StatisticsSubcommittee on PopulationsWorkgroup on Quality

December 12, 2001

The Department of Veterans Affairs National Center for Patient Safety Noel Eldridge

Executive Assistant to the DirectorNational Center for Patient Safety (10X)

Department of Veterans Affairs810 Vermont Ave, NW

Washington, DC 20420phone: 202 273-8878

fax: 202 273-9282e-mail: noel.eldridge@mail.va.gov

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The Origin of the VHA Patient Safety Improvement Program VHA identified patient safety as a high priority issue in 1997 and began a

Patient Safety Improvement Initiative throughout its entire health care system.

In 1998 VHA’s External Panel on Patient Safety System Design recommended that to be effective for learning, a reporting system needed to possess a number of characteristics: 

– Viewed as non-punitive by those from which reports were desired. Therefore, the reports need to be confidential.

– Multidisciplinary teams should analyze the reports in order to increase the likelihood that the true causes of the adverse event, and most effective responses, will be identified.

– Timely and relevant feedback to the community of reporters is necessary to show the value of reporting and demonstrate that reports do not enter a “black hole.”

– Close call analysis is critical in any strategy to prevent adverse events. • Close calls occur far more frequently than adverse events but identify many of the same

vulnerabilities.• Since close calls result in no harm it can be easier to get them reported.

A reporting system should not be evaluated primarily by the number of reports it receives. The relationship between the number of events reported and those occurring is unclear, but it is clear that fewer reports does not mean fewer events.

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The Value of Close Calls in Safety

Close calls can provide “sentinel” information without or before the “sentinel event.”

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The Current VA National Center for Patient Safety (NCPS) and System for Reporting Adverse Events and Close Calls

In 1998 VHA management recognized that the patient safety effort needed to be led on a day-to-day basis by a dedicated National Center for Patient Safety (NCPS). The Office was established and Dr. James Bagian was hired as Director. The NCPS Director reports directly to the VA Under Secretary for Health.

To make clear that the NCPS system was for learning rather than for accountability or punishment the VHA issued strict directions that intentionally unsafe acts were not to be dealt with by the NCPS but should be reported to the facility director and other authorities.

 – An “intentionally unsafe act” is defined as a criminal act; a purposefully

unsafe act; an act related to alcohol or substance abuse by an impaired provider and/or staff; or events involving alleged or suspected patient abuse of any kind.

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Classifying Events and Deciding Whether to Conduct an RCA

NCPS developed a prioritization scoring method, The Safety Assessment Code, which allows any report, whether close call or adverse event, to be classified for disposition consistent with VHA policies and JCAHO standards.

The NCPS method requires the classifier to assess:

1) the actual or potential severity of the event and,

2) the probability of occurrence according to specific definitions.

Both parameters are rated as one of four possible levels:

For severity the scale is catastrophic, major, moderate, and minor.

For probability the scale is frequent, occasional, uncommon, and remote.

Use of the SAC score standardized handling of reports throughout VHA system and permits a rational selection of cases to be considered.

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The SAC Matrix (excerpted from VHA Patient Safety Improvement Handbook)

  

Severity & Probability

 Catastrophic

 Major

 Moderate

 Minor

 Frequent

 3

 3

 2

 1

 Occasional

 3

 2

 1

 1

 Uncommon

 3

 2

 1

 1

 Remote

 3

 2

 1

 1

 

How the SAC Matrix Works When you pair a severity category with a probability category for either an actual event or Close Call, you will get a ranked matrix score (3 = highest risk, 2 = intermediate risk, 1 = lowest risk). These ranks, or Safety Assessment Codes (SACs) can then be used for doing comparative analysis, and, for deciding who needs to be notified about the event.

Notes 1. All known reporters of events, regardless of SAC score (1,2, or 3), will receive appropriate and timely feedback. 2. The Patient Safety Manager (or designee) will refer Adverse Events or Close Calls related solely to staff, visitors or equipment/facility damage to relevant facility experts or services on a timely basis, for assessment and resolution of those situations.  3. A quarterly Aggregated Root Cause Analysis may be used for four types of events (this includes all events or Close Calls other than actual SAC score of 3, since all actual SAC score of 3 require an individual RCA). These four types are falls, medication errors, missing patients, and parasuicidal behavior. The use of aggregated analysis serves two important purposes. First it provides greater utility of the analysis as trends or patterns not noticeable in individual case analysis are more likely to show up as the number of cases increases. Second, it makes wise use of the RCA team's time and expertise.

Of course, the facility may elect to perform an individual RCA rather than Aggregated Review on any Adverse Event or Close Call that they think merits that

attention, regardless of the SAC score.

(See attached documents defining Severity and Probability categories.)

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Design and Implementation of the VA NCPS Reporting and RCA Systems

NCPS decided to implement a system that would depend on caregivers at the frontline to receive initial reports of adverse events and close calls and to conduct subsequent RCAs.

There have been two main focuses in implementing the NCPS reporting and RCA systems: 1) pilot testing methods and systems prior to their widespread use, and 2) rigorous and widespread training of VHA staff.

  The foundations of the RCA system are training that introduces human factors engineering

concepts, safety mindfulness and usability testing, and a computer-aided software tool (“SPOT”) that leads an RCA team through the steps of the RCA process.

(See screen shot on next page.)

  NCPS also developed a cognitive aid, “Triage Questions for Root Cause Analysis,” which

includes a series of questions that help the identification of root causes in six major areas:

1) Human Factors – Communication; 2) Human Factors – Training; 3) Human Factors – Fatigue/ Scheduling; 4) Environment/Equipment; 5) Rules/ Policies; and 6) Barriers.

(See hard copy of flipbook.)

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Screen Shot of Start of SPOT Program

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Using RCAs to Prevent or Reduce Adverse Events

To ensure feedback, we built a step into our RCA process where the RCA team communicates their findings back to the reporter.

The process requires the facility Director to “concur” or “non-concur” on each recommended corrective action in the RCA. In the event that there is a non-concur the Director must furnish a written rationale for this decision that remains a part of the official record. The RCA team then proposes an alternative corrective action and this process continues until concurrence is achieved.

  The RCA team also outlines what parties are responsible for enacting the

corrective actions by what date.   The RCA team outlines how the effectiveness of the corrective actions will be

evaluated to verify that the actions had the intended effect.   Once the RCA is completed and entered into the SPOT database, the

information is available to NCPS for consideration for widespread dissemination throughout VHA health care system.

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Results to Date

We have seen, on an annualized basis, a 30-fold increase in events reported and an even larger increase in close calls reported. Close calls now make up a large majority of all events reported, rather than a negligible fraction, as was previously the case.

– The NCPS believes that the main value of reporting is in the subsequent analysis that leads to identification of systems vulnerabilities that can then be reduced or eliminated.

– It is important to note that in the VA, the reporting of adverse events and close calls does not emphasize numbers. The major emphasis is, and will continue to be, on the difficult-to-count attitudinal changes that we believe are expanding awareness of the need for, and new ability to implement, improvements to increase patient safety.

Patient Safety Managers have been hired or assigned for each of 163 VA hospitals and each of 22 VA networks.

The NCPS system presently focuses primarily on making changes based directly on the results of the RCA at the facility where the adverse event or close call took place, and on the generalization and widespread dissemination of individual findings.

NCPS, working with other VHA offices, has also very selectively issued Patient Safety Alerts and Advisories to the entire VHA healthcare system based on information from RCAs in cases where the vulnerabilities appear especially dangerous and for which specific measures have been identified to prevent or reduce occurrence of adverse events.

 

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NASA/VA Patient Safety Reporting System

Led by the NCPS, the VA formalized an agreement with NASA in May 2000 to develop a Patient Safety Reporting System (PSRS). The PSRS is designed to be a complementary external system to our current internal reporting system described above.

We began pilot testing of PSRS in March 2001 at a selected VA medical center. It is currently being implemented at 3 of the 22 networks. We plan to have it implemented nationwide by the middle of FY 2002.

  NASA is using its experience from developing and running its highly successful

Aviation Safety Reporting System (ASRS), which NASA developed and has been running for the Federal Aviation Administration since 1976.

  PSRS identifies vulnerabilities, but does not provide detailed solutions. Data is

de-identified by NASA and will be widely available.  The VA is paying NASA to independently operate the PSRS according to a

Memorandum of Agreement between the two agencies.

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Application of VA Patient Safety Developments Elsewhere

The DoD is currently implementing a program modeled on the NCPS.

Private healthcare institutions such as the University of Michigan and others have adopted all or many aspects of the NCPS program.

Several of the new JCAHO standards in Patient Safety are based on practices implemented in the VA.

The American Hospital Association has ordered 6,000 NCPS-developed “Triage Cards for Root Cause Analysis” for distribution to all its member hospitals. They have also ordered copies of other NCPS training materials, including those for Healthcare Failure Modes and Effects Analysis and the Safety Assessment Code.

  Representatives from the health care systems of Japan, the United Kingdom, Denmark,

and Canada have sought out detailed information on the VA program for use in their systems.

  In 2000 NCPS was chosen as a finalist in the Innovations in American Government

Awards Program for initiating a systems approach to ensuring the safety of VA patients. This recognition was given to only 5 programs in the Federal Government – and only 1.6% of applicants in 2000. In 2001, NCPS has been selected as a one of five winners of the Innovations Award, and was the only Federal program selected. We expect that this will add to the interest in applying VA NCPS innovations elsewhere.

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Additional Information

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Promoting a Culture of Safety

A major emphasis throughout the work that NCPS has done has been in developing a “culture of safety” in VHA. The term “safety culture” was first used in the aftermath of the Chernobyl accident when it was used to describe what was missing from the nuclear engineering and management community in the Soviet Union. A definition of safety culture taken from the electrical engineering[1] industry follows:

 The safety culture of an organization is the product of the individual and group values, attitudes, competencies and patterns of behavior that determine the commitment to, and the style and proficiency of, an organization’s health and safety programs. Organizations with a positive safety culture are characterized by communications founded on mutual trust, by shared perceptions of the importance of safety, and by confidence in the efficacy of preventative measures.

 A positive safety culture implies that the whole is more than the sum of the parts. The different aspects interact together to give added effect in a collective commitment. In a negative safety culture the opposite is the case, with the commitment of some individuals strangled by the cynicism of others. From various studies it is clear that certain factors appear to characterize organizations with a positive safety culture. These factors include:

– ·         The importance of leadership and the commitment of the chief executive– ·         The executive safety role of line management – ·         The involvement of all employees – ·         Effective communications and commonly understood and agreed goals – ·         Good organizational learning and responsiveness to change – ·         Manifest attention to workplace safety and health – ·         A questioning attitude and a rigorous and prudent approach by all individuals

– A recent publication describes the work the VHA related to fostering a safety culture.[2] In addition, working with other groups in VHA, the NCPS has formally surveyed over 6,000 VHA employees to better understand staff attitudes related to patient safety. The results are being analyzed and will be published subsequently.

[1] The Institution of Electrical Engineers [United Kingdom]; Health and Safety Briefings; Safety Culture: http://www.iee.org.uk/Policy/Areas/Health/hsb07.cfm [2] Weeks WB, Bagian JP. Developing a culture of safety in the Veterans Health Administration. Effective Clinical Practice 2000;6:270-276.

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SPOT Screen Shots on Safety Assessment Code

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