- Email: [email protected]
System Innovation: Veterans Health Administration National Center for Patient Safety
THE JOINT COMMISSION A common thread that runs through all Department of Veterans Affairs National Center for Patient Safety work is ensuring that the tools and products developed can be implemented in a straightforward manner to achieve the ultimate goal—the prevention of harm to patients. JOHN M. EISENBERG PATIENT SAFETY AWARDS
photo courtesy of Imijination Photography; www.imijphoto.com
System Innovation: Veterans Health Administration National Center for Patient Safety JEFFREY R. HEGET JAMES P. BAGIAN, MD, PE CARYL Z. LEE RN, MSN JOHN W. GOSBEE, MD, MS
James P. Bagian, MD, PE
wo years before the 1999 Institute of Medicine (IOM) report To Err Is Human: Building a Safer Health System,1 the Veterans Health Administration (VHA) recognized medical errors as a significant issue and preemptively inaugurated a number of patient safety initiatives to address these problems. One such effort involved the creation of the National Center for Patient Safety (NCPS) and the selection of this article’s coauthor—Dr James P. Bagian—as the center’s director in early 1999.
T
From the outset, NCPS recognized that individual human weakness is almost never the basic reason for adverse events. Such events are usually due to the complex collision of known or unknown vulnerabilities in any health care setting. Traditional efforts to fix problems focused on blaming the individual rather than on larger systems issues. These efforts resulted in perpetuation of the status quo. NCPS took a different approach. It developed and implemented and continues to refine an innovative systems approach to patient safety that is designed
Jeffrey R. Heget is Administrative Officer, Veterans Affairs (VA) National Center for Patient Safety, Ann Arbor, Michigan. James P. Bagian, MD, PE, is Director. Caryl Z. Lee, RN, MSN, is Program Manager. John W. Gosbee, MD, MS, is Director, Patient Safety Information Systems. The authors acknowledge the hard work, dedication, and contribution of the Veterans Health Administration (VHA) networks and facilities (from the first volunteer pilot sites and ongoing frontline RCA teams, to the facility and net-
work patient safety managers, to leaders at the facility, network, and central office levels, without whose team efforts progress would have been impossible.). The views expressed herein are those of the authors and do not represent the official position of the Department of Veterans Affairs. Please address requests for reprints to Jeffrey R. Heget, Administrative Officer, VA National Center for Patient Safety, 24 Frank Lloyd Wright Drive, Lobby M, P.O. Box 486, Ann Arbor, MI 48106-0486; phone 734/930-5890; fax 734/930-5877; email [email protected].
Copyright © 2002 by the Joint Commission on Accreditation of Healthcare Organizations
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Article-at-a-Glance Background: In 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. NCPS’s 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. A novel approach: To 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 nonpunitive 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
to reduce accidental or inadvertent harm to patients while they are under the VHA’s care and to be applicable beyond the Department of Veterans Affairs system in the United States and elsewhere.
Setting On the most basic level, NCPS’s aim is to foster a culture of safety in the VA. To this end, it develops and provides patient safety programs to the VHA and delivers standardized tools, methods, and initiatives. This foundation enables the 163 VHA facilities and the 21 Veterans Integrated Service Networks (VISNs)—into which the facilities are geographically and operationally grouped—to move forward with patient safety improvement programs much more rapidly than if they each had to start from scratch. Currently operating with a core budget of approximately $4 million, the NCPS program office is located in Ann Arbor, Michigan. NCPS also maintains a presence at the VA central office in Washington, DC, and a field office at the VA Medical Center in White River Junction, Vermont, which will focus on optimizing deployment strategies and determining the effectiveness of new patient safety initiatives. Thirty-one clinical, technical, and administrative professionals of various backgrounds and disciplines staff NCPS, including three physicians and five patient safety program managers, each with a unique area of expertise or specialization; these include anesthesia, internal medicine, psychiatry, human factors
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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. Key action items and results related to RCA: NCPS’s 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 aids. 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.
engineering, information systems, nursing, physical plant and fire safety engineering, business case development, clinical pharmacy, legal issues, and labor relations. Other staff members include an administrative officer, a biomedical engineer, a biostatistician, an instructional systems specialist, a communications officer, a psychologist, registered nurse, analytical and support staff, and information technology specialists.
A New Approach In its early years, NCPS’s major challenges revolved around the need to innovate in developing a patient safety program. No one had ever instituted a comprehensive systems-oriented safety program for large medical organizations or health systems. As a starting point, NCPS looked to high-reliability industrial settings, such as aviation and nuclear power, for models and lessons learned, and it combined these with theory and methods from human factors and safety engineering. At the front end, the learning curve was very steep. It was essential to get those in the field—that is, staff of individual facilities and networks—to recognize that there was a problem and then to involve them in the formulation and deployment of a solution. The “high touch” approach involved extensive and ongoing communication. To ensure the approach’s success, NCPS invited VA facilities and networks to participate but did not order them to do so. Some people in the VHA and beyond thought that NCPS would not be able to initiate and implement
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THE JOINT COMMISSION change in networks and facilities as rapidly as has been achieved because of the VHA’s size and complexity. Others thought that the patient safety program was a “flavor of the day” that could be waited out. The NCPS responded by communicating (a) its mission to serve the needs of the patient and the field networks and facilities and (b) a sense of urgency about identifying and solving patient safety problems. NCPS’s priority agenda item was (and still is) to create a culture of safety. Core concepts of the approach included a systemwide focus; a nonpunitive 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. The safety program sensitizes people to the frequency and severity of adverse events and close calls and encourages acceptance of the fact that humans can never be perfect and may err. However, the program also shows health care providers that systems can be changed to reduce the potential that harm will occur to patients during care provision.
Key Action Items A severity assessment code (SAC) matrix,2 developed in 1998 and rolled out throughout the VHA, allowed consistent handling of safety reports for either a close call or an adverse event and helped to prioritize such events. Enhanced reporting of close calls and adverse events was ensured systemwide by stating that safety investigations would not be used for punitive purposes as long as the event was not the result of an “intentionally unsafe act.”3 Next, NCPS developed an RCA system for use by caregivers at the front line to investigate adverse events or close calls. The analysis focuses on a systems approach rather than individual fault finding. Its comprehensive approach not only identifies underlying causes of system failures or potential failures but also links them to actions and outcomes. A computeraided tool leads the team through the various steps of the RCA in a user-centered way. In addition, a cognitive aid (triage and triggering question flipbook) guides the team members through key human factors questions and topics that must be fully understood if the RCA is to be thorough and credible. Triage ques-
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tions relate to six system-focused areas: human factors communication, human factors training, human factors fatigue/scheduling, environment and equipment, rules, policies and procedures, and barriers (safeguards). The final component of the patient safety system was to ensure that action would be taken based on what was learned during the RCA and that the action was verified to be effective. To this end, NCPS developed a step-by-step process involving, among other items, obtaining concurrence from the facility director (effectively the facility’s CEO) about each recommended corrective action to establish leadership endorsement and responsibility for ensuring that the corrective action is actually implemented. Sidebar 1 (p 663) provides a summary of key training programs, procedures, tools, and information systems developed by NCPS.
Implementation To implement the patient safety program throughout the VA system, NCPS leaders embarked on a mission with a success-oriented schedule calling for effective deployment of the program and rollout in all 163 VA medical facilities in less than 12 months (Nov 1999 to Aug 2000). A handbook with operational details was researched, drafted, tested, and revised. A full training curriculum was designed from scratch, with specific attention to interactive training and simulation that developed the skills needed for the patient safety program. A computer-aided RCA tool was also developed to facilitate the fields’ efforts. NCPS leaders felt that an incremental approach beginning with pilot programs would allow them to benefit from experience that could be employed in subsequent facility implementations. Pilots that began in November 1999 (six facilities) and February 2000 (five facilities) preceded a full-scale national rollout and implementation that began in April 2000 and concluded by the end of August 2000. During the implementation phase, NCPS staff supplied 3 days of training for individuals from each facility and network office before rolling it out. Training sessions were held for several networks at a time and typically included 70 to 80 participants in both plenary and small-group sessions. The training included ■ didactic components (for example, Patient Safety Improvement Handbook, SAC, RCA);
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Sidebar 1. Major NCPS Initiatives Root Cause Analysis of Adverse Events and Close Calls and Aggregate Reviews of Adverse Events and Close Calls These two interrelated methods are key to understanding and reducing adverse events. They involve review of real incidents by personnel where the incidents occurred. Their purpose is to determine the cause of events or close calls and to establish corrective actions to prevent or reduce the likelihood of recurrence at the facility. They then determine if the corrective actions were effective. Analyses are submitted to NCPS for review and dissemination of the knowledge gained. Aggregated reviews allow those on the facility review teams to see multiple events in the same topic area at the same time, potentially leading to identification of patterns and recurring problems that may lead to adverse events. Patient Safety Information Systems Software This database tool holds text-rich information from analyses of adverse events and close calls conducted throughout the VHA system. It assists facility patient safety personnel and RCA teams in documenting and analyzing adverse events and close calls on their personal and notebook computers. The software tool standardizes the RCA process throughout VHA facilities. It includes a unique NCPS-developed, easy-to-use flowcharting feature that is not available on any comparable software package. Patient Safety Alerts and Advisories Alerts and advisories expeditiously notify VHA health care providers about newly discovered process vulnerabilities or biomedical equipment issues that could adversely affect patient safety. Recent topics include blood tubing for dialysis, oxygen (compressed gas) cylinder hazard summary, and sterilization of medical devices. Patient Safety Cognitive Aids Designed for use by health care staff, these tools can be used both as training aids and to assist staff during busy or stressful times by reducing individual reliance on memory. Their use can lead to an improved level of care by standardizing and incorporating evidencebased medicine (eg, checklists and algorithms). Under NCPS’s direction, these tools have been developed internally by VHA subject matter experts and experts from other organizations. HFMEATM Healthcare Failure Mode and Effect Analysis (HFMEA)TM is a prospective risk analysis and mitigation tool that is designed to improve patient safety by identifying and correcting system vulnerabilities before adverse events occur. It enables the development of “fault tolerant” systems, in which component failures do not translate into harm to the patient. The tool is consistent with and will support compliance with the requirement of the Joint Commission on Accreditation of Healthcare Organizations for proactive risk assessment. HFMEATM training was conducted on national level in all VA medical facilities in 2002.4 VA/NASA Patient Safety Reporting System (PSRS) The PSRS is designed to improve patient safety in the VA system by creating and operating an external reporting system that is complementary to the VA’s internal RCA system. In functioning as a safety valve, it will identify vulnerabilities that would otherwise be impossible to know about because they were not reported to the internal system. The PSRS represents a collaborative project between VA and NASA that is independently operated by NASA to improve patient safety. It builds on NASA’s experience since 1976 in operating the Aviation Safety Reporting System for the Federal Aviation Administration. NASA stores data in a permanently “de-identified” format, which ensures that those accessing the data cannot “work backward” to identify individuals or facilities associated with specific adverse events or other incidents. Hence, in the spirit of a culture of safety that focuses on learning; the PSRS identifies what and why things happened, not who did it.5,6 Patient Safety Centers of Inquiry Initiated by VHA’s Under Secretary of Health in 1998, four patient safety centers of inquiry were selected for 4-year funding based on the review of formal proposals in 1999. Established shortly thereafter, NCPS became responsible for the center’s oversight. The aim of the centers is to provide valuable contributions to the improvement of patient safety within the VA and beyond through breakthrough collaboratives, safe patient movement and fall prevention initiatives, human factors evaluation, and fatigue and simulation modeling.
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THE JOINT COMMISSION an introduction to human factors engineering concepts; and ■ small-group and large-group simulation exercises. The didactic materials, many of which were available in both hard copy and electronic formats, were intended for just-in-time training for the RCA teams at their home facilities. All this was accomplished with a professional staff of less than half a dozen, and it was designed to be exportable to other health care organizations. ■
Patient Safety Impact One of the most telling measures of success of NCPS’s patient safety program is the dramatic increase in the number of adverse event and close call reports submitted to NCPS that result in effective preventive actions. Before program implementation, close call reports represented less than 0.10% of the total events reported in the VHA. Although many health care systems do not report close calls at all, safety experts maintain that a healthy system from a safety perspective will have a high percentage of reported close calls as a proportion of total events reported. Close calls can provide an accurate picture of what actually occurs in an organization and have been shown to be anywhere from 3 to 300 times more common than actual adverse events.7 Following program implementation, NCPS saw a 30-fold increase in all events reported to it and a 900-fold increase in reporting of close calls of high-priority events.8 There are many examples where the recognition of a problem through RCA of a close call had widespread, and even global, impact. One such example involved vulnerable design features of a pacemaker. Discovery of the vulnerability was made by a close call RCA report involving a VHA patient’s potential lifethreatening problem with a pacemaker. NCPS alerted all VHA facilities to the problem and its solution. The manufacturer was also persuaded to implement a fix that will affect products shipped worldwide. The replicability of the NCPS’s patient safety program in any health care setting is another key impact on worldwide patient safety. From the outset, NCPS aimed to develop a program that would be applicable within both the VA and the private sector and has been willing to actively share its work with those outside the VA. Key documents, training and mentoring modules, and related software were
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developed to be and are immediately transferable. To date, NCPS has trained not only more than 1,200 health care staff from the VA but also staff in nonfederal organizations such as M.D. Anderson Cancer Center, Dartmouth Medical School, and Henry Ford Health System and in organizations outside the United States. In addition, the U.S. Department of Defense is rolling out a patient safety system based on the NCPS model, as is the University of Michigan. In June 2002 the American Hospital Association distributed A Toolkit for Improving Patient Safety to more than 6,400 member and nonmember hospitals. The kit contains tools and educational material created by NCPS.
Future Efforts Still a young organization, the NCPS is shifting its focus from startup to maintenence and operation of high-quality initiatives. As the organization grows, it will continuously face the challenge of effectively branching out to design and implement new curricula, new alerts and advisories, and new collaborative efforts with other organizations to reach broader audiences. Areas for future emphasis have always derived from and will continue to derive largely from an analysis of the concerns expressed by VA network and facility staff. Guidance from external organizations and Congress also provides directions for the future. Within the next decade, NCPS leaders anticipate increased collaboration with other health care leaders in the United States and in other countries, systematic evaluation of software tools and Web sites for programming and enhancements, and increased involvement of leadership and physicians. Sidebar 2 (p 665) outlines projects under consideration. NCPS considers its greatest achievements to date the ability of all staff to learn new human factors– oriented skills and techniques that will make a difference, coupled with the development of an information database/system that leads to learning, sharing, and making things safer for patients worldwide. A key take-home message is that changing culture and improving patient safety are a marathon, not a sprint! All health care staffs in VA facilities and beyond will find inspiration in Margaret Meade’s words: “Never doubt that a small group of thoughtful committed people can change the world; indeed it’s the only thing that ever has!” J
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Sidebar 2. Ongoing and Future NCPS Projects ■ Additional field and facility leadership training programs. ■ Development and implementation of a pilot project and national guidance for ensuring correct surgery in collaboration with the Office of Patient Care Services. ■ Further programming and the addition of user-centered capabilities to NCPS information systems (including natural language processing and text mining). ■ Development of methods to target and disseminate alerts and advisories to specific groups of health care providers and staff. A feedback loop to learn how previous issues of alerts and advisories have been acted on (in view of possible message saturation) will be developed and implemented. ■ Development of a patient safety curriculum that emphasizes approaches used in human factors engineering. Geared initially to residents and medical students, the curriculum is currently in pilot stages of grassroots implementation at approximately 10 facilities. This initiative is built on the belief that it is much better to train individuals initially about a systems approach to safe care than to have them unlearn less-than-ideal habits and workarounds.
References 1. Institute of Medicine: To Err Is Human: Building a Safer Health System. Washington, DC: National Academy Press, 1999. 2. Bagian JP, Lee CA, Cole JF: A method for prioritizing safety related actions. In Proceedings of Enhancing Patient Safety and Reducing Errors in Health Care. Chicago: National Patient Safety
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Foundation, 1998, pp 176–179. 3. Department of Veterans Affairs, Veterans Health Adminsitration. www.va.gov/publ/direc/ health/handbook/1051-1hk1-3002.pdf (last accessed Nov 6, 2002). 4. DeRosier J, et al: Using Health Care Failure Mode and Effect AnalysisTM: The VA National Center for Patient Safety's prospective risk
analysis system. Jt Comm J Qual Improv 28:248-267, 2002. 5. Bagian JP, Gosbee, JW, Lee CZ: The VA-NASA Patient Safety Reporting System. Federal Practitioner 8:10-15, Mar 2001. 6. Patient Safety Reproting System. www.psrs.arc.nasa.gov (last accessed Nov 6, 2002). 7. Barach P, Small SD: Report-
ing and preventing medical mishaps: Lessons from non-medical near miss reporting systems. BMJ 320:759-763, 2000 8. Bagian JP, et al: Developing and deploying a patient safety program in a large health care delivery system: You can't fix what you don't know about. Jt Comm J Qual Improv 27:522-532, 2001.
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photo courtesy of Imijination Photography; www.imijphoto.com
System Innovation: Veterans Health Administration National Center for Patient Safety JEFFREY R. HEGET JAMES P. BAGIAN, MD, PE CARYL Z. LEE RN, MSN JOHN W. GOSBEE, MD, MS
James P. Bagian, MD, PE
wo years before the 1999 Institute of Medicine (IOM) report To Err Is Human: Building a Safer Health System,1 the Veterans Health Administration (VHA) recognized medical errors as a significant issue and preemptively inaugurated a number of patient safety initiatives to address these problems. One such effort involved the creation of the National Center for Patient Safety (NCPS) and the selection of this article’s coauthor—Dr James P. Bagian—as the center’s director in early 1999.
T
From the outset, NCPS recognized that individual human weakness is almost never the basic reason for adverse events. Such events are usually due to the complex collision of known or unknown vulnerabilities in any health care setting. Traditional efforts to fix problems focused on blaming the individual rather than on larger systems issues. These efforts resulted in perpetuation of the status quo. NCPS took a different approach. It developed and implemented and continues to refine an innovative systems approach to patient safety that is designed
Jeffrey R. Heget is Administrative Officer, Veterans Affairs (VA) National Center for Patient Safety, Ann Arbor, Michigan. James P. Bagian, MD, PE, is Director. Caryl Z. Lee, RN, MSN, is Program Manager. John W. Gosbee, MD, MS, is Director, Patient Safety Information Systems. The authors acknowledge the hard work, dedication, and contribution of the Veterans Health Administration (VHA) networks and facilities (from the first volunteer pilot sites and ongoing frontline RCA teams, to the facility and net-
work patient safety managers, to leaders at the facility, network, and central office levels, without whose team efforts progress would have been impossible.). The views expressed herein are those of the authors and do not represent the official position of the Department of Veterans Affairs. Please address requests for reprints to Jeffrey R. Heget, Administrative Officer, VA National Center for Patient Safety, 24 Frank Lloyd Wright Drive, Lobby M, P.O. Box 486, Ann Arbor, MI 48106-0486; phone 734/930-5890; fax 734/930-5877; email [email protected].
Copyright © 2002 by the Joint Commission on Accreditation of Healthcare Organizations
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DECEMBER 2002 JOURNAL Copyright 2002 Joint Commission on Accreditation of Healthcare Organizations
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Article-at-a-Glance Background: In 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. NCPS’s 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. A novel approach: To 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 nonpunitive 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
to reduce accidental or inadvertent harm to patients while they are under the VHA’s care and to be applicable beyond the Department of Veterans Affairs system in the United States and elsewhere.
Setting On the most basic level, NCPS’s aim is to foster a culture of safety in the VA. To this end, it develops and provides patient safety programs to the VHA and delivers standardized tools, methods, and initiatives. This foundation enables the 163 VHA facilities and the 21 Veterans Integrated Service Networks (VISNs)—into which the facilities are geographically and operationally grouped—to move forward with patient safety improvement programs much more rapidly than if they each had to start from scratch. Currently operating with a core budget of approximately $4 million, the NCPS program office is located in Ann Arbor, Michigan. NCPS also maintains a presence at the VA central office in Washington, DC, and a field office at the VA Medical Center in White River Junction, Vermont, which will focus on optimizing deployment strategies and determining the effectiveness of new patient safety initiatives. Thirty-one clinical, technical, and administrative professionals of various backgrounds and disciplines staff NCPS, including three physicians and five patient safety program managers, each with a unique area of expertise or specialization; these include anesthesia, internal medicine, psychiatry, human factors
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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. Key action items and results related to RCA: NCPS’s 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 aids. 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.
engineering, information systems, nursing, physical plant and fire safety engineering, business case development, clinical pharmacy, legal issues, and labor relations. Other staff members include an administrative officer, a biomedical engineer, a biostatistician, an instructional systems specialist, a communications officer, a psychologist, registered nurse, analytical and support staff, and information technology specialists.
A New Approach In its early years, NCPS’s major challenges revolved around the need to innovate in developing a patient safety program. No one had ever instituted a comprehensive systems-oriented safety program for large medical organizations or health systems. As a starting point, NCPS looked to high-reliability industrial settings, such as aviation and nuclear power, for models and lessons learned, and it combined these with theory and methods from human factors and safety engineering. At the front end, the learning curve was very steep. It was essential to get those in the field—that is, staff of individual facilities and networks—to recognize that there was a problem and then to involve them in the formulation and deployment of a solution. The “high touch” approach involved extensive and ongoing communication. To ensure the approach’s success, NCPS invited VA facilities and networks to participate but did not order them to do so. Some people in the VHA and beyond thought that NCPS would not be able to initiate and implement
12
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THE JOINT COMMISSION change in networks and facilities as rapidly as has been achieved because of the VHA’s size and complexity. Others thought that the patient safety program was a “flavor of the day” that could be waited out. The NCPS responded by communicating (a) its mission to serve the needs of the patient and the field networks and facilities and (b) a sense of urgency about identifying and solving patient safety problems. NCPS’s priority agenda item was (and still is) to create a culture of safety. Core concepts of the approach included a systemwide focus; a nonpunitive 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. The safety program sensitizes people to the frequency and severity of adverse events and close calls and encourages acceptance of the fact that humans can never be perfect and may err. However, the program also shows health care providers that systems can be changed to reduce the potential that harm will occur to patients during care provision.
Key Action Items A severity assessment code (SAC) matrix,2 developed in 1998 and rolled out throughout the VHA, allowed consistent handling of safety reports for either a close call or an adverse event and helped to prioritize such events. Enhanced reporting of close calls and adverse events was ensured systemwide by stating that safety investigations would not be used for punitive purposes as long as the event was not the result of an “intentionally unsafe act.”3 Next, NCPS developed an RCA system for use by caregivers at the front line to investigate adverse events or close calls. The analysis focuses on a systems approach rather than individual fault finding. Its comprehensive approach not only identifies underlying causes of system failures or potential failures but also links them to actions and outcomes. A computeraided tool leads the team through the various steps of the RCA in a user-centered way. In addition, a cognitive aid (triage and triggering question flipbook) guides the team members through key human factors questions and topics that must be fully understood if the RCA is to be thorough and credible. Triage ques-
662
tions relate to six system-focused areas: human factors communication, human factors training, human factors fatigue/scheduling, environment and equipment, rules, policies and procedures, and barriers (safeguards). The final component of the patient safety system was to ensure that action would be taken based on what was learned during the RCA and that the action was verified to be effective. To this end, NCPS developed a step-by-step process involving, among other items, obtaining concurrence from the facility director (effectively the facility’s CEO) about each recommended corrective action to establish leadership endorsement and responsibility for ensuring that the corrective action is actually implemented. Sidebar 1 (p 663) provides a summary of key training programs, procedures, tools, and information systems developed by NCPS.
Implementation To implement the patient safety program throughout the VA system, NCPS leaders embarked on a mission with a success-oriented schedule calling for effective deployment of the program and rollout in all 163 VA medical facilities in less than 12 months (Nov 1999 to Aug 2000). A handbook with operational details was researched, drafted, tested, and revised. A full training curriculum was designed from scratch, with specific attention to interactive training and simulation that developed the skills needed for the patient safety program. A computer-aided RCA tool was also developed to facilitate the fields’ efforts. NCPS leaders felt that an incremental approach beginning with pilot programs would allow them to benefit from experience that could be employed in subsequent facility implementations. Pilots that began in November 1999 (six facilities) and February 2000 (five facilities) preceded a full-scale national rollout and implementation that began in April 2000 and concluded by the end of August 2000. During the implementation phase, NCPS staff supplied 3 days of training for individuals from each facility and network office before rolling it out. Training sessions were held for several networks at a time and typically included 70 to 80 participants in both plenary and small-group sessions. The training included ■ didactic components (for example, Patient Safety Improvement Handbook, SAC, RCA);
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Sidebar 1. Major NCPS Initiatives Root Cause Analysis of Adverse Events and Close Calls and Aggregate Reviews of Adverse Events and Close Calls These two interrelated methods are key to understanding and reducing adverse events. They involve review of real incidents by personnel where the incidents occurred. Their purpose is to determine the cause of events or close calls and to establish corrective actions to prevent or reduce the likelihood of recurrence at the facility. They then determine if the corrective actions were effective. Analyses are submitted to NCPS for review and dissemination of the knowledge gained. Aggregated reviews allow those on the facility review teams to see multiple events in the same topic area at the same time, potentially leading to identification of patterns and recurring problems that may lead to adverse events. Patient Safety Information Systems Software This database tool holds text-rich information from analyses of adverse events and close calls conducted throughout the VHA system. It assists facility patient safety personnel and RCA teams in documenting and analyzing adverse events and close calls on their personal and notebook computers. The software tool standardizes the RCA process throughout VHA facilities. It includes a unique NCPS-developed, easy-to-use flowcharting feature that is not available on any comparable software package. Patient Safety Alerts and Advisories Alerts and advisories expeditiously notify VHA health care providers about newly discovered process vulnerabilities or biomedical equipment issues that could adversely affect patient safety. Recent topics include blood tubing for dialysis, oxygen (compressed gas) cylinder hazard summary, and sterilization of medical devices. Patient Safety Cognitive Aids Designed for use by health care staff, these tools can be used both as training aids and to assist staff during busy or stressful times by reducing individual reliance on memory. Their use can lead to an improved level of care by standardizing and incorporating evidencebased medicine (eg, checklists and algorithms). Under NCPS’s direction, these tools have been developed internally by VHA subject matter experts and experts from other organizations. HFMEATM Healthcare Failure Mode and Effect Analysis (HFMEA)TM is a prospective risk analysis and mitigation tool that is designed to improve patient safety by identifying and correcting system vulnerabilities before adverse events occur. It enables the development of “fault tolerant” systems, in which component failures do not translate into harm to the patient. The tool is consistent with and will support compliance with the requirement of the Joint Commission on Accreditation of Healthcare Organizations for proactive risk assessment. HFMEATM training was conducted on national level in all VA medical facilities in 2002.4 VA/NASA Patient Safety Reporting System (PSRS) The PSRS is designed to improve patient safety in the VA system by creating and operating an external reporting system that is complementary to the VA’s internal RCA system. In functioning as a safety valve, it will identify vulnerabilities that would otherwise be impossible to know about because they were not reported to the internal system. The PSRS represents a collaborative project between VA and NASA that is independently operated by NASA to improve patient safety. It builds on NASA’s experience since 1976 in operating the Aviation Safety Reporting System for the Federal Aviation Administration. NASA stores data in a permanently “de-identified” format, which ensures that those accessing the data cannot “work backward” to identify individuals or facilities associated with specific adverse events or other incidents. Hence, in the spirit of a culture of safety that focuses on learning; the PSRS identifies what and why things happened, not who did it.5,6 Patient Safety Centers of Inquiry Initiated by VHA’s Under Secretary of Health in 1998, four patient safety centers of inquiry were selected for 4-year funding based on the review of formal proposals in 1999. Established shortly thereafter, NCPS became responsible for the center’s oversight. The aim of the centers is to provide valuable contributions to the improvement of patient safety within the VA and beyond through breakthrough collaboratives, safe patient movement and fall prevention initiatives, human factors evaluation, and fatigue and simulation modeling.
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THE JOINT COMMISSION an introduction to human factors engineering concepts; and ■ small-group and large-group simulation exercises. The didactic materials, many of which were available in both hard copy and electronic formats, were intended for just-in-time training for the RCA teams at their home facilities. All this was accomplished with a professional staff of less than half a dozen, and it was designed to be exportable to other health care organizations. ■
Patient Safety Impact One of the most telling measures of success of NCPS’s patient safety program is the dramatic increase in the number of adverse event and close call reports submitted to NCPS that result in effective preventive actions. Before program implementation, close call reports represented less than 0.10% of the total events reported in the VHA. Although many health care systems do not report close calls at all, safety experts maintain that a healthy system from a safety perspective will have a high percentage of reported close calls as a proportion of total events reported. Close calls can provide an accurate picture of what actually occurs in an organization and have been shown to be anywhere from 3 to 300 times more common than actual adverse events.7 Following program implementation, NCPS saw a 30-fold increase in all events reported to it and a 900-fold increase in reporting of close calls of high-priority events.8 There are many examples where the recognition of a problem through RCA of a close call had widespread, and even global, impact. One such example involved vulnerable design features of a pacemaker. Discovery of the vulnerability was made by a close call RCA report involving a VHA patient’s potential lifethreatening problem with a pacemaker. NCPS alerted all VHA facilities to the problem and its solution. The manufacturer was also persuaded to implement a fix that will affect products shipped worldwide. The replicability of the NCPS’s patient safety program in any health care setting is another key impact on worldwide patient safety. From the outset, NCPS aimed to develop a program that would be applicable within both the VA and the private sector and has been willing to actively share its work with those outside the VA. Key documents, training and mentoring modules, and related software were
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developed to be and are immediately transferable. To date, NCPS has trained not only more than 1,200 health care staff from the VA but also staff in nonfederal organizations such as M.D. Anderson Cancer Center, Dartmouth Medical School, and Henry Ford Health System and in organizations outside the United States. In addition, the U.S. Department of Defense is rolling out a patient safety system based on the NCPS model, as is the University of Michigan. In June 2002 the American Hospital Association distributed A Toolkit for Improving Patient Safety to more than 6,400 member and nonmember hospitals. The kit contains tools and educational material created by NCPS.
Future Efforts Still a young organization, the NCPS is shifting its focus from startup to maintenence and operation of high-quality initiatives. As the organization grows, it will continuously face the challenge of effectively branching out to design and implement new curricula, new alerts and advisories, and new collaborative efforts with other organizations to reach broader audiences. Areas for future emphasis have always derived from and will continue to derive largely from an analysis of the concerns expressed by VA network and facility staff. Guidance from external organizations and Congress also provides directions for the future. Within the next decade, NCPS leaders anticipate increased collaboration with other health care leaders in the United States and in other countries, systematic evaluation of software tools and Web sites for programming and enhancements, and increased involvement of leadership and physicians. Sidebar 2 (p 665) outlines projects under consideration. NCPS considers its greatest achievements to date the ability of all staff to learn new human factors– oriented skills and techniques that will make a difference, coupled with the development of an information database/system that leads to learning, sharing, and making things safer for patients worldwide. A key take-home message is that changing culture and improving patient safety are a marathon, not a sprint! All health care staffs in VA facilities and beyond will find inspiration in Margaret Meade’s words: “Never doubt that a small group of thoughtful committed people can change the world; indeed it’s the only thing that ever has!” J
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Sidebar 2. Ongoing and Future NCPS Projects ■ Additional field and facility leadership training programs. ■ Development and implementation of a pilot project and national guidance for ensuring correct surgery in collaboration with the Office of Patient Care Services. ■ Further programming and the addition of user-centered capabilities to NCPS information systems (including natural language processing and text mining). ■ Development of methods to target and disseminate alerts and advisories to specific groups of health care providers and staff. A feedback loop to learn how previous issues of alerts and advisories have been acted on (in view of possible message saturation) will be developed and implemented. ■ Development of a patient safety curriculum that emphasizes approaches used in human factors engineering. Geared initially to residents and medical students, the curriculum is currently in pilot stages of grassroots implementation at approximately 10 facilities. This initiative is built on the belief that it is much better to train individuals initially about a systems approach to safe care than to have them unlearn less-than-ideal habits and workarounds.
References 1. Institute of Medicine: To Err Is Human: Building a Safer Health System. Washington, DC: National Academy Press, 1999. 2. Bagian JP, Lee CA, Cole JF: A method for prioritizing safety related actions. In Proceedings of Enhancing Patient Safety and Reducing Errors in Health Care. Chicago: National Patient Safety
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Foundation, 1998, pp 176–179. 3. Department of Veterans Affairs, Veterans Health Adminsitration. www.va.gov/publ/direc/ health/handbook/1051-1hk1-3002.pdf (last accessed Nov 6, 2002). 4. DeRosier J, et al: Using Health Care Failure Mode and Effect AnalysisTM: The VA National Center for Patient Safety's prospective risk
analysis system. Jt Comm J Qual Improv 28:248-267, 2002. 5. Bagian JP, Gosbee, JW, Lee CZ: The VA-NASA Patient Safety Reporting System. Federal Practitioner 8:10-15, Mar 2001. 6. Patient Safety Reproting System. www.psrs.arc.nasa.gov (last accessed Nov 6, 2002). 7. Barach P, Small SD: Report-
ing and preventing medical mishaps: Lessons from non-medical near miss reporting systems. BMJ 320:759-763, 2000 8. Bagian JP, et al: Developing and deploying a patient safety program in a large health care delivery system: You can't fix what you don't know about. Jt Comm J Qual Improv 27:522-532, 2001.
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