John Gosbee

The Veterans Affairs Root Cause Analysis System in Action

BACKGROUNDnThe patient safety program in the Department of Veterans Affairs (VA) began in 1998, when the National Center for Patient Safety (NCPS) was established to lead the effort on a day-to-day basis. NCPS provides the structure, training, and tools, and VA facilities provide front-line expertise, feedback about the process, and root cause analysis (RCA) of adverse events and close calls.nnnMONITORING THE PROCESSnFacility patient safety managers determine the disposition of adverse events and close calls occurring at their facilities. They use a safety assessment code (SAC) to prioritize the actual and potential severity and frequency of an event. BEFORE-AND-AFTER STUDY: Before the new RCA system was implemented in 2000, the VA used another adverse event reporting system, focused review (FR). A comparison of the two processes indicates that the RCA process has shifted analyses of adverse events toward a human factors engineering approach-entailing a search for system vulnerabilities rather than human errors and other less actionable root causes.nnnCASE EXAMPLESnTwo case examples--on hazards in the magnetic resonance imaging (MRI) room and on a cardiac pacemaker malfunction--illustrate how the RCA system works in actual operation. The cases illustrate that broadly applicable, high-impact actions can result from a thorough RCA process.nnnDISCUSSIONnNCPS monitors the quality and completeness of RCAs through the immediate review and feedback process. Still to be investigated is the effectiveness of RCA actions addressing the hypothesized root causes and contributing factors of the close calls and adverse events.

System Innovation: Veterans Health Administration National Center for Patient Safety

BACKGROUNDnIn 1998 the Veterans Health Administration (VHA) created the National Center for Patient Safety (NCPS) to lead the effort to reduce adverse events and close calls systemwide. NCPSs aim is to foster a culture of safety in the Department of Veterans Affairs (VA) by developing and providing patient safety programs and delivering standardized tools, methods, and initiatives to the 163 VA facilities.nnnA NOVEL APPROACHnTo create a system-oriented approach to patient safety, NCPS looked for models in fields such as aviation, nuclear power, human factors, and safety engineering. Core concepts included a non-punitive approach to patient safety activities that emphasizes systems-based learning, the active seeking out of close calls, which are viewed as opportunities for learning and investigation, and the use of interdisciplinary teams to investigate close calls and adverse events through a root cause analysis (RCA) process. Participation by VA facilities and networks was voluntary. NCPS has always aimed to develop a program that would be applicable both within the VA and beyond.nnnKEY ACTION ITEMS AND RESULTS RELATED TO RCAnNCPSs full patient safety program was tested and implemented throughout the VA system from November 1999 to August 2000. Program components included an RCA system for use by caregivers at the front line, a system for the aggregate review of RCA results, information systems software, alerts and advisories, and cognitive acids. Following program implementation, NCPS saw a 900-fold increase in reporting of close calls of high-priority events, reflecting the level of commitment to the program by VHA leaders and staff.

How to Make the Most of Failure Mode and Effect Analysis

Current accreditation standards issued by the Joint Commission for the Accreditation of Healthcare Organizations (JCAHO) require hospitals to carry out a proactive risk assessment on at least 1 high-risk activity each year for each accredited program. Because hospital risk managers and patient safety managers generally do not have the knowledge or level of comfort for conducting a proactive risk assessment, they will appreciate the expertise offered by biomedical equipment technicians (BMETs), occupational safety and health professionals, and others. The skills that have been developed by BMETs and others while conducting job safety analyses or failure mode effect analysis can now be applied to a health care proactive analysis. This article touches on the Health Care Failure Mode and Effect Analysis (HFMEA) model that the Department of Veterans Affairs (VA) National Center for Patient Safety developed for proactive risk assessment within the health care community. The goal of this article is to enlighten BMETs and others on the growth of proactive risk assessment within health care and also on the support documents and materials produced by the VA. For additional information on HFMEA, visit the VA website at www.patientsafety.gov/HFMEA.html.

Conclusion: You need human factors engineering expertise to see design hazards that are hiding in "plain sight!".

BACKGROUNDnThe Human Factors Engineering (HFE) series was launched to share the ideas and methods to aid deeper analyses of adverse events and provide tools to ensure more effective and lasting therapies. Articles in the series showed how human limitations and capabilities were important design issues in a variety of areas, ranging from labels and warnings to work place design and complex decision support systems.nnnREMAINING QUESTIONSnAfter reading all the articles, one might ask a number of questions, such as who made all our puzzle rooms? How did it happen that so many device components masquerade as each other yet perform very distinct functions? What are the procurement systems that gave us medication containers, tubing, and connectors that are hard to see and easy to misconnect? Behind all those questions remains a key query: what stands in the way of developing or hiring the expertise to see and fix these catastrophic design hazards hiding in plain sight?nnnSUMMARY AND CONCLUSIONnHFE has already found its way into health care organizations and industry. As with most large changes in professions and industries, many small steps will need to be taken toward applying HFE methods and principles to the large problems of patient safety. But there already ample incentives and tools to start transforming your health care delivery or manufacturing organization.

Who Left the Defibrillator On

BACKGROUNDnTwo related scenarios involving defibrillator devices reveal how inadvertent hazardous design can go unnoticed until engineers or patient safety personnel use human factors engineering (HFE) analysis. The first adverse event, in which the device was inadvertently turned off while being used to externally pace the patients heart, resulted in an increased length of stay. The second scenario describes a similar close call and the useless acts of sanctioning the nurse and firing the engineer technician.nnnCOMMENTS AND RECOMMENDATIONSnFeedback to the end user about a devices status is an important design issue. It does not take much expertise to detect when there are problems with dialogue from the device to the person (that is, feedback). Many HFE issues have been cited in emergency care areas, and many medical devices--not just defibrillators--do not have readable and understandable feedback to the end user or the kind of automation that would make the wrong action harder to accomplish. All the interactions of multifunction devices with end users in a hectic, noisy, and dynamic environment need to be usability tested and validated. Nurses and engineering personnel can be trained to more easily see HFE design issues--and not dismiss them as individual failings or someone elses job. Medical device companies are starting to follow the guidelines and regulations that should help prevent adverse events.nnnCONCLUSIONnThe defibrillators design problems had successfully masqueraded as expected glitches with hospital electrical utilities, personnel shortcomings, and personality problems. Adverse events related to seemingly simple devices can be prevented with HFE analysis.

Federal Patient Safety Initiatives Panel Summary

The participants in this panel described major federal initiatives aimed at improving patient safety. Summaries of the panelists remarks follow in the order of presentation at the Symposium.nn### Food and Drug Administration (FDA)nnMedication errors have multiple causes including: poor communication, name confusion, abbreviations, poor techniques, knowledge deficit, inexperience, and confirmation bias. In addition to the patient, hospitals, practitioners, manufacturers, and governments can also be victims of medication errors. The FDA has collected more than 20,000 medication errors since 1993 and data reflect a 10% mortality rate. In order to combat medication errors, the FDA has initiatives in the area of pre-marketing, post-marketing, risk management, and research (Table 1). For more information see .nnView this table:nnTable 1 nExamples of Pre- and Post-Marketing FDA Activities Related to Patient Safety and Medication Error PreventionnnnnThe FDA is involved in numerous risk communication activities including publishing in professional journals such as AHSP, JAMA, and NEJM and through the consumer-oriented FDA Today. Other risk minimization activities include improved labeling, letters to physicians, education, restricted access to a particular drug, and withdrawal from the market. In addition, the FDA collaborates with other organizations such as the AMA, AHSP, USP, and Institute for Safe Medication practices.nnComputer-based order entry is …