Washington, D.C.
The Workgroup on Quality of the Subcommittee on Populations of the National Committee on Vital and Health Statistics held hearings on December 12, 2001 at the Hubert H. Humphrey Building in Washington, D.C. The meeting was open to the public.
· John R. Lumpkin, M.D., M.P.H.
The Workgroup on Quality of the Subcommittee on Populations held hearings December 12, 2001 in an ongoing process focused on addressing information needs related to improving the quality of care and services provided by the U.S. healthcare delivery system. Members listened to five perspectives concerning public and private sector patient safety initiatives.
Public/Private Sector Patent Safety Initiatives
As the lead agency responsible for establishing a patient safety initiative and research program, Dr. Battles reported the Agency for Health Care Research and Quality (AHRQ) developed a portfolio of 94 grants and contracts: (1) addressing the reporting of errors, health systems error reporting analysis, and funding 24 improvement demonstration projects that tackle issues concerning: public disclosure for error reporting systems, confidential versus mandatory, analysis, administrative data, and malpractice claims; (2) funding 23 centers of excellence and developing centers projects to build infrastructure and conduct patient safety research; (4) supporting potential innovations in clinical informatics that might promote patient safety, (5) funding 20 working condition projects including eight specifically addressing issues of patient safety; and (6) disseminating patient safety research and education programs to the community.
Mr. Eldridge emphasized that the VA’s National Center for Patient Safety (NCPS) was designed for learning and applications that reduce future occurrences, rather than punishing individuals associated with adverse events. NCPS uses multidisciplinary root cause analysis (RCA) teams to study close calls that Mr. Eldridge said served as “a canary in a coal mine” and identified system vulnerabilities that could then be reduced or eliminated. The challenge, he said, was to capture the best things learned within the facilities and act upon them nationwide.
Ms. Corrigan reported on developments related to building the data infrastructure needed for safety and quality, touching on four efforts: (1) a national safety and quality tracking system, (2) the project on patient safety data standards (3) a federal quality oversight project, and (4) development efforts for building a national health information infrastructure (NHII). She noted major barriers Institute of Medicine (IOM) identified to development of NHII.
Dr. Vaida said the Institute for Safe Medication Practices’ mission is to encourage voluntary reporting, translate errors in education, promote a non-punitive culture, and help prevent medication errors by productively interacting with regulatory and professional agencies, practitioners and industry. The core of their efforts is the medication errors reporting program operated by the United States Pharmacopoeia (USP) in cooperation with ISMP. Information is disseminated to some two million people each month through journals and newsletters. ISMP sends a medication safety self-assessment to every hospital in the United States and works with American Hospital Association (AHA), American Society of Health System Pharmacists (ASHSP), and physician organizations to provide educational programs addressing shortcomings.
Ms. Delbanco described The Leapfrog Group as an effort initiated by the Business Roundtable and a mix of Fortune 500 companies, leading business coalitions, and the U.S. Office of Personnel Management who use their role as health benefits purchasers to drive improvement in the healthcare system. Members commit to a set of purchasing principles and agree to compare performance at the hospital or physician level. Comparison initially focuses on promoting the use of hospital computerized physician order entry (CPOE) systems, focusing on intensive care units’ (ICUs) physician staffing, and evidence-based hospital referrals (EHRs). Hospitals are asked to share information on their progress implementing these safety “leaps” via an online Web survey. Members agree to reward and recognize hospitals implementing these steps.
Public/Private Sector Patent Safety Initiatives
Responding to the avalanche of activity on patient safety triggered by the IOM report, To Err is Human, AHRQ became the lead agency in the federal government responsible for establishing a patient safety initiative and research program. Dr. Battles noted the goal of patient safety is to reduce the risk of iatrogenic injury to patients and, in order to accomplish this, hazards increasing this risk must be identified and removed or minimized.
Congress, in appropriating $50 million for this patient safety initiative, was fairly specific in its intent to: develop guidelines in the collection of uniform data, establish competitive demonstration programs for healthcare facilities and organizations, and determine ways to improve provider training. Congress called for: a close look at the causes of medical errors, models and mechanisms that encourage reporting them, and health systems and providers participation in demonstration programs that utilize all available technologies to reduce error.
The agency name was changed from AHCPR to AHRQ and it was charged with the mission of patient safety. The appropriations language focused the research agenda and AHRQ’s national advisory committee outlined the direction to proceed. AHRQ issued the report, Doing What Counts for Patient Safety, held a national research summit, and continued interactions with other national organizations and partners. User-driven input from agencies funding patient safety and the private sector helped formulate an agenda. People wanted AHRQ to look at the epidemiology of error, infrastructure needed to improve safety within organizations, and the kind of information these systems need. AHRQ had to determine innovations to adopt, what would facilitate implementation, and then disseminate this information.
AHRQ took what Congress mandated and that user-driven research agenda and created a series of requests for applications (RFAs). The first and largest RFA focused on the reporting of errors, health systems error reporting analysis, and improvement demonstration projects. Recognizing some organizations lacked a stable source of funding to conduct patient safety research, AHRQ issued an RFA for centers of excellence in patient safety. Noting that a significant number of institutions with the capacity to carry out research needed funding to build infrastructures, AHRQ added an RFA for the developing centers program. CLIPS focuses on potential innovations in informatics that promote patient safety. Also of interest to Congress were the working conditions that surround quality of care and patient safety. And clearly there was a need to disseminate patient safety research and education programs throughout the community. These opportunities shaped AHRQ’s pantheon of RFAs.
AHRQ has funded 24 reporting demonstration projects totaling $24.7 million that tackle issues concerning: public disclosure for error reporting systems, confidential versus mandatory, analysis, administrative data, and malpractice claims. The projects look at changes in information systems and improved data. With so many projects and levels of finding, AHRQ strove for a multi-dimensional approach to collecting and analyzing information about reported events.
CLIPS funded 22 projects, totaling $5.3 million, to: develop state of the art applications including hand-held computers with decision support, simulation tools, and to examine how to improve tools (e.g. infusion pumps) and assess other technologies for improvement.
A total of 20 working-condition projects were funded for about $3 million with eight specifically addressing issues looking at patient safety: staffing and also fatigue, stress, and sleep deprivation and their relationship to quality of care.
Some 23 centers of excellence and developing centers projects were funded to help disseminate information, providing a variety of programs, activities, and types of institutions in developing centers and three established centers in Boston, Philadelphia and Houston. Seven projects look at different types of dissemination and demonstrate and evaluate new approaches to provider education, explore new ways of applying applications including simulation, utilize national organizations such as the American College of Surgeons, and look at dissemination of information about medical errors and patient safety.
Additional activities included in the $50 million include: (1) meetings with state and local officials to advance the patient safety initiative through a user-liaison program, (2) a feasibility study to determine the background knowledge and experience level required for the patient safety managers the Joint Commission mandated every institution must have and ways to provide training, and (3) contracts to look at uniform vocabulary and standards.
AHRQ funded the Stanford UCSF EPC report (available on the AHRQ Web site) on the evidence base for a variety of patient safety practices. AHRQ is working with the Department of Defense (DoD) to evaluate training programs and develop patient safety measures. Noting the need for common assessments (e.g. safety culture organizations), AHRQ is evaluating various ways grantees might build on activities already underway with VA, DoD and others to make available valid, reliable public-domain instruments.
Given this substantial portfolio of 94 grants and contracts, AHRQ is striving to maximize interaction and support among grantees. A coordinating center for patient safety research: (1) provides additional support, (2) facilitates grantee communications and interactions through Web-based and list serve communications, annual meetings, and teleconferences, (3) provides technical assistance in methodology and design, (4) looks at common instrumentation across multiple grants, (5) collects and coordinates data sharing amongst grantees, and (6) disseminates information. AHRQ’s goal is a uniform portfolio with diverse projects moving together as a unit.
Another major activity is coordinating the existing federal reporting system. AHRQ created the patient safety task force to bring CDC, CMS and FDA together and consider how existing reporting activities amongst HHS agencies can be integrated, providing both front end and integration of the data. Medstat is conducting an implementation feasibility-planning study to identify opportunities and possibilities for integration of the data, requirements for providing necessary linkage, and plans. IOM is providing data guidance on aspects of patient safety.
Dr. Battles noted the importance of studying all three categories of errors as they relate to reporting; (1) sentinel events and misadventures at the top of the iceberg involving actual harm to patients; (2) no-harm events where (due to luck or human physiology’s robust nature) events never reached fruition, but potential for harm was there; and (3) near misses where somebody intervened. Dr. Battles observed that there were many opportunities beyond specific harm events to study the dimension. He noted a first step in error management was detection and that undetected errors could have disastrous consequences. He emphasized that the number of reports would increase dramatically. Managing was about reducing the risk associated with events reported--not the number of events reported. Success meant knowing a lot more about errors.
Next steps involve coordinating the 94 separate projects while communicating and sharing the data. Partnerships need to be built with state and local institutions. Dr. Battles said the major aspect was to implement the agenda and set the priority for things already funded.
Dr. Starfield remarked that patient safety was more than errors: it was also unanticipated or adverse effects. She asked how AHRQ and its grantees conceptualize this work--did they deal with the broad field of patient safety or mostly errors? Dr. Battles said the term medical error was useful, because people understood it--but that they looked at more than just error. Their research dimension was a close interrelationship between patient safety and quality of care and the structure within the activity. Looking only at a narrow definition, he said they’d probably miss most the important areas. The goal was to reduce injury to patients, however they were injured.
Dr. Battles noted Jim Reson's term: latent failures. Mr. Reson claimed that the higher one was on the organizational ladder, the greater his or her capacity to create latent error. Both the sharp and blunt ends were accountable; everyone in the system could produce iatrogenic injury.
Public/Private Sector Patent Safety Initiatives
Following up on the previous discussion, Mr. Eldridge said NCPS tried to scrub out the word errors, which meant different things to different people. Looking beyond “errors”, NCPS studied attempted suicides, patient “elopements,” falls, and adverse drug events, including those not associated with errors.
Mr. Eldridge emphasized that NCPS’s system was designed for learning and applications to reduce future occurrences, rather than punishing individuals associated with adverse events. An external panel advised that error-reporting programs had to be viewed as confidential and non-punitive by people in the healthcare setting, and he noted shame and embarrassment were punishments.
NCPS set up a multidisciplinary root cause analysis (RCA) team comprised of healthcare professionals with diverse perspectives, backgrounds and knowledge bases. Noting that NCPS focused on close call (rather than near-miss) analysis, Mr. Eldridge emphasized the semantics was important: people were more willing to talk about close calls than actual adverse events.
Mr. Eldridge emphasized that close calls served as “a canary in a coal mine” giving timely warning that “bad things could happen.” He described how, in following up on one reported close call involving an MRI machine, NCPS realized how often metal objects near an MRI’s powerful magnet became projectiles. NCPS put out an alert within VHA and suggestions for prevention.
Mr. Eldridge noted that NCPS narrowed the scope of reporting, centering the program on learning rather than accountability or punishment. Intentionally unsafe acts were reviewed by other systems within VA. Reporting adverse events and close calls was not part of the quality or occupational safety program, but a separate patient safety program and its director reported to the chief of the organization.
NCPS developed a prioritization scoring method: the safety assessment code. Two aspects of events were evaluated: the severity of the event and its probability of reoccurring. A scale enabled standardizing report handling. The facility must establish a team and do an RCA for events beyond a set level. Front-line caregivers received initial reports and conduct analyses, communicating findings to the facility director and the person who initially reported the event. Mr. Eldridge emphasized the importance of timely, relevant feedback that demonstrated the value of reporting. Reports include corrective actions teams recommend implementing to prevent reoccurrences and specify individuals responsible for changes and end dates. The director must document if he or she doesn’t concur.
The RCA was also sent to the central office and kept in a database available for searches and determinations about when alerts should be developed and information disseminated throughout the VA healthcare system. The VA saw a 30-fold increase in the number of adverse events (90 percent close calls) and corrective actions reported. Mr. Eldridge noted the biggest challenge was determining recommendations (patient safety alerts and advisories) to the whole organization. The system focused on making changes within the facility; but Mr. Eldridge underscored NCPS’s belief that the primary value of reporting was the subsequent analysis that led to identification of systems vulnerabilities, which could then be reduced or eliminated. The major emphasis wasn’t on numbers, but on difficult-to-count attitudinal changes that brought about a heightened ability to increase patient safety.
NCPS trained over 1,000 people in a three-day course in RCA and other aspects of patient safety. NCPS’s director, Dr. James Bajian leads each course. NCPS has developed cognitive tools including computer-aided software and a flipbook of triage questions that lead RCA teams through the analysis. Each of the VA’s 22 networks and every hospital was to allocate a patient safety manager; 150 out of 163 managers have been hired.
The VA also set up a complementary, external patient safety reporting system (PSRS) in concert with NASA. People submit reports of adverse events and close calls to NASA. A team of physicians, pharmacists and nurses review and disseminate the de-identified reports. The memorandum of agreement states the VA can’t ask for information that isn’t in the memo. Mr. Eldridge said this channel offered potential to gain insight from anyone hesitant to report through the regular system. He noted that after 25 years and more than half-a-million reports, NASA hadn’t had a single disclosure. PSRS is currently employed at three networks; full implementation is scheduled for the middle of fiscal year 2002.
DoD and a number of other organizations have implemented programs modeled on NCPS. And AHA is disseminating NCPS training materials and assessment tools along with the training module to member hospitals. Several new JCAHO standards in Patient Safety are based on NCPS practices. Healthcare systems in Japan, Denmark, Canada, and the United Kingdom sought details for use in their systems. NCPS was one of five winners in the Innovations in American Government Award Program administered by the Harvard University Kennedy School of Government.
Mr. Eldridge explained that VA measured suicide to look at the safety of the patient, the error, and to see if the person received appropriate treatment. Asked the proportion of events that didn’t fit within their error categories and if VA envisioned emerging classifications, Mr. Eldridge said they were working on that and would meet with IOM staff doing terminology work for patient safety. The system was set up for aggregated reviews of most common events. Every facility quarterly reviewed all their falls, medication errors, adverse drug events, missing patient events, parasuicides and completed suicides. Mr. Eldridge clarified that NASA “scrubbed out” information that could enable anyone to work backwards and identify an event. Information would be available on the Internet.
Noting VA’s scope was broader than medically- or doctor-related interactions, Dr. Starfield suggested VA needed a different term than iatrogenic. Asked if the PSRS required filling out two sets of forms, Mr. Eldridge said people could chose to report both ways, but there wasn’t a form for VA. Each hospital had a contact. Some used forms; others relied on e-mail or phone calls. He said the NASA PSRS already was in the Southern California network and was moving into two others. Within two months, it would be nationwide. Representatives from each hospital would attend a January training session.
Asked how this came together at VA and not at other moderately large organizations, Mr. Eldridge said the catalysts were individuals like Dr. Ken Kaiser who directed VA and Dr. Bajian. He noted it was a huge, uniform system. And he added there were legal reasons: a VA doctor could end up in the national practitioner data bank, but wasn’t going to be sued personally for malpractice.
Ms. Peterson asked if information about changes hospitals put in place post RCA were shared within the system. Mr. Eldridge said VA was developing software to disseminate that data nationwide. There were concerns about confidentiality and the NCPS was setting up permissions so someone in one hospital could review all adverse events that happened in others and how reoccurrences were prevented.
Public/Private Sector Patent Safety Initiatives
IOM views safety as a component of quality; Ms. Corrigan reported on developments related to building the data infrastructure needed for both. She focused on the data infrastructure aspects of projects underway, touching on four efforts: (1) the National Safety and Quality Tracking System, (2) the project on patient safety data standards that Dr. Battles mentioned, (3) a federal quality oversight project, and (4) development efforts for building NHII.
An extensive effort is underway in HHS to put together the IOM’s National Health Care Quality Report, which has components on safety, effectiveness, patient centeredness, and timeliness and views equity as a crosscutting issue. A workshop this spring will examine underlying data sources and measures to view dimensions of safety as they relate to subpopulations likely to face less than sufficient care and other health disparities issues. A report to be released in September on the workshop’s preliminary findings might provide input for the disparities report that is part of the National Health Care Quality effort. Emphasis is on measuring the magnitude of safety and quality concerns and the direction of change over time. In terms of the source data sets, they will be looking at the three potential areas identified in the National Health Care Quality Report, including the potential to draw useful information from survey data, namely MEPS. Ms. Corrigan noted that an earlier committee on the National Health Care Quality Report concluded that the limited clinical richness of administrative data and differences across programs made comparability difficult.
Ms. Corrigan said the Patient Safety Data Standards project grew out of the attention given to patient safety issues and reporting systems set up within CDC, DoD, Medicare and other federal and state programs. The National Academy for State Health Policy documents what state-level systems are collecting and more states are expected to follow the IOM’s recommendation (for the most egregious, serious events that result in death or serious permanent injuries) and initiate patient safety reporting systems. Ms. Corrigan said the task was to envision what should be standardized throughout these systems, so there could be comparability and useful information.
In the case of adverse events, the IOM committee will look at the ability to define events and data sources in order to calculate rates. Part of the emphasis is on analyzing individual events, to understand root causes and contributing factors. While different kinds of reporting systems have distinct objectives, in this two-year effort the committee intends to identify basic data sources used and standardizations reported in both events. The team is meeting with people who have extensive reporting systems in place, to gain an understanding of the types of events being reported, forms being used, and major standardization issues. The committee is moving a potential slate through the internal structures of the National Academies. Their final report is due in the fall of 2003.
The third effort, the Federal Quality Oversight Project, is a congressionally mandated project that looks at comparative quality information across federal healthcare programs and what needs to be done if this is to be publicly reported. There is a broad scope to this project that evaluates whether these oversight programs (which include certification, accreditation, licensure requirements, and other basic capabilities) encompass the full variety of quality measurement and oversight programs in place. It looks at the extent to which these programs move toward direct measurement of clinical quality and safety and the measures used. And it evaluates the extent to which they currently are or soon will likely produce publicly available information.
Most these federal programs have moved extensively toward direct measures of safety and clinical quality and a focus on a subset of chronic conditions. Beyond surface variables, there is considerable commonality in the conditions and clinical measures--raising issues about standardization of performance measures. The committee is looking at infrastructure issues and ways to encourage development of the more sophisticated information infrastructure needed to support technical measures of safety and quality in oversight and reporting activities.
Noting that consistent requirements for the reporting of various performance measures would put pressure on delivery systems to automate clinical data, Ms. Corrigan said there was a great deal of discussion about minimum requirements for clinical information systems. One approach mentioned at a recent workshop was conditions of participation requiring things like automation medication order entry systems. She added that achieving a 70-80 percent reduction in adverse medication events (as David Bateman's studies show) signals this is part of the necessary infrastructure a hospital or medical group must have to deliver safe, high-quality care.
Ms. Corrigan pointed out that development efforts for building NHII (all products of the IOM and the Quality of Care in America Committee that released the Crossing the Quality Chasm report) reflect the realization that healthcare has moved past the phase where one could rely solely on administrative and billing data. The Healthcare and Record Committee concluded there was a need to move to automated clinical data--not only for reporting, measuring and monitoring quality, but because safe and effective care couldn't be delivered without decision-support systems that automated clinical data. The first major barrier to development of that infrastructure that IOM identified was the absence of leadership and public will. Ms. Corrigan emphasized the need to cultivate strong leadership that addresses clinical information infrastructure issues, builds public awareness of the magnitude of safety and quality-of-care issues, and bolsters the public will to put investments in place necessary for an infrastructure and automated clinical information systems.
Ms. Corrigan identified standards as the second barrier and noted NCVHS’s contributions in this area. The National Quality Forum's summit on March 6 and 7 will focus attention on the standards issue and vendors’ and others’ perspectives on barriers in this area.
The third barrier is work force issues: the ability of health professionals and others to function in an information-rich environment, and their willingness to be part of what it takes to automate clinical data and engage decision-support systems. IOM sponsors a health professions summit June 17-18 with ASPI, COGME, and NACNAP (the nursing counterpart for the Council on Graduate Medical Education) focusing on how to better prepare health professionals to work in this different environment, feel comfortable with its technology, and realize its benefits.
The fourth major barrier the committee identified concerns financing and incentive systems: not only the issue of how much capital is required, where it will come from, and how to ensure it goes toward building the NHII--but, also, what are the incentives for health institutions and professional groups to improve quality in a way that builds on a strong NHII.
A broader project IOM plans for this spring looks at how all four efforts fit together to build a NHII that serves both research needs and public health. Ms. Corrigan said IOM is making every effort to ensure that the right groups and expertise are involved.
Noting she was sure Ms. Corrigan was aware of NCVHS’s efforts to develop thinking about an NHII, Dr. Starfield asked how she saw both groups working together. Hopefully closely, Ms. Corrigan replied. She said the Board on Health Care Services, which oversees this work, complimented NCVHS on its work. IMO seeks to find ways to build on the Committee’s message and, as a group, push this shared agenda forward. IMO was identifying potential members well versed in the work and wanted to talk to the Committee about collaborating on workshops and ensuring both groups were aware of the other’s agenda.
Noting that the NHII report had three parts (computerized patient record, population, and personal), Dr. Starfield asked how much IOM focused on the others. Ms. Corrigan said all were on the table, but they were still sorting through the beginning of a draft and descriptive documents.
Dr. Vaida remarked that the Institute for Safe Medication Practices, a non-profit organization, began medication error reporting and disseminating safety recommendations a year before NASA's aviation program took flight and it, too, never had a breach in confidentiality. ISMP is a totally independent agency with a multidisciplinary board of trustees and advisors from the health professions, academia, consumers, and industry. Its mission is to encourage voluntary reporting, translate errors in education, promote a non-punitive culture, and help prevent medication errors by productively interacting with regulatory and professional agencies, practitioners and the industry. The foundation of their efforts is the medication errors reporting program operated by USP in conjunction with ISMP. Practitioners, consumers, and health professionals report in confidence via toll-free numbers, a self-mailing ISMP MERP reporting form, and on their Web site.
ISMP and USP are USDA Medwatch partners and USP and FDA share reports dealing with medications. Information is disseminated among two million people each month through journals and newsletters. Another publication, ISMP Medication Safety Alert, circulates biweekly to every hospital and 600,000 readers in the United States and about 30 foreign countries. Both pride themselves on not waiting until an error happens, and several times a year a national alert goes out, not just to subscribers, but also to every hospital. E-mails, faxes, and press releases on hazardous conditions are sent to associations’ and other professional organizations’ mailing lists. ISMP’s Web site offers other publications including a book, Medication Errors; testimonies on reporting programs and voluntary-versus-mandatory reporting; patient information; and a reporting program for consumers.
Dr. Vaida told a number of ISMP’s success stories. Several years ago, over 70 deaths were reported with an injectable lidocaine bolus product. ISMP worked with the manufacturers and FDA to have this product pulled from the market. Recently ISMP was instrumental in having labeling changed on another product used for seizures that led to seven deaths because of labeling issues. ISMP worked with the Joint Commission to have concentrated potassium chloride injection almost entirely removed from hospitals. One national alert involved two vials--one that lowers blood pressure, analoprilate; the other a neuromuscular blocking (and paralyzing) agent, pancaronium. When analoprilate came on the market, hospitals (which were spending tens of thousands of dollars for the brand name) were eager to get this generic brand. But a major group purchasing organization notified ISMP that these vials looked exactly the same. Within about two hours ISMP had an alert on their Web site. Within 12 hours they’d e-mailed and faxed every hospital in the United States. And within 24 hours they’d sent out a press release and mailing.
USP has a national coordinating council that includes FDA, AMA, and several pharmacy and nursing organizations. USP publishes labeling changes and abbreviations widely disseminated through journals and different media. The Joint Commission has picked up on a number of recommendations and put them in their sentinel event alert.
An ISMP interdisciplinary team (pharmacist, nurse, risk manager and physician) from ISMP does two-and-a-half day safety consults with hospitals. The team goes through the entire hospital medication-use process and system, talking with both administration and medical staff. Recently, ISMP formed a partnership with AHA and, with funding from the Commonwealth Fund, received a grant to send the medication safety self-assessment to every hospital in the United States. A consortium of hospitals in Australia also uses this self-assessment; Canada and the United Kingdom plan to adopt it.
Hospitals were asked to form a multidisciplinary team to critically evaluate where they stand on these recommendations. Despite internal pressure to complete the assessment but not report the information, 23 percent or 1,435 acute care hospitals responded. De-identified preliminary comparative results are on the Web site and hospitals can compare themselves nationally to similar demographic hospitals. Hospitals that haven’t participated can download the self-assessment. The maximum score was 1,294. The raw score for hospitals below 100 beds was 692; hospital above 100 beds scored 709. Scores didn't significantly depend on the number of beds, whether the hospital was rural or urban, teaching or non-teaching.
When seeking a root cause for medication errors, ISMP looks for a breakdown in ten system elements, which include patient information, how information is communicated, medical devices, quality, staff competency, and the environment. Mr. Vaida said doing hospital consults and reports in this way helps promote a non-punitive environment.
ISMP identified areas (e.g. patient information, communication, patient education) where hospitals could use help and works with AHA, ASHSP, and physician organizations to provide educational programs addressing these shortcomings. Only 14 percent of hospitals had a list of dangerous abbreviations that should never be used in a hospital. Just 24 percent said staff investigated a patient’s questions before administering. And only 21 percent provided patients with full written information upon discharge. ISMP is providing information nationally on simple, low-cost things health systems can do immediately to help prevent problems or medication errors. Noting the need for leadership, Mr. Vaida said that partnering with AHA helps ISMP gain buy-in from hospital administration, involving more than just front-line staff.
With a seed grant American Pharmaceutical Association and National Association of Chain Drug Stores, ISMP produced a community ambulatory self-assessment, which is available (along with results) on the Web site. In conjunction with AHA, a number of purchasing alliances use the self-assessments internally. ISMP collaborated with the Institute for Health Care Improvement on their breakthrough series on medication errors; they are now working together on a redesign project. ISMP also prepared the benchmarking project for the Massachusetts coalition. Michigan Blue Cross/Blue Shield (BCBS) provides an incentive bonus to hospitals that fill out the medication safety self assessment.
Mr. Vaida noted reporting programs, especially on the state level, were still steeped in a punitive environment. ISMP frequently received phone calls from physicians and nurses called in front of state boards. Practitioners found to have committed spent time in a safe hospital, but Mr. Vaida pointed out that people weren’t going to want to report and that time in a safe hospital didn’t do much for front-line practitioners reentering environments without safety features. He emphasized there were problems with litigation and that peer review was needed to share errors.
Addressing the issue of fragmented reporting systems, Mr. Vaida noted Mr. Eldridge’s presentation and commended the VA. ISMP has a national voluntary reporting program with USP and sought to share information with 5,000 hospitals, not just 180. USP and ISMP already shared information with ECRI, which had a medical device reporting program for 30 years, and worked with blood banks so, hopefully, practitioners will have a national spot to report errors.
Mr. Vaida noted the need for a clearer understanding of accountability: many state licensing boards struggled to balance accountability issues with submitting error reports.
Noting Mr. Vaida talked about fragmented reporting systems and that the day’s hearings indicated there were many, Dr. Cohn asked about ways to de-fragment so they might come to conclusions. Mr. Vaida pointed out that ISMP had a national volunteer reporting program for over 25 years. ECRI had a similar program for 30 years and Blood Bank had another. Now, many states felt pressed to start their own reporting programs. He expressed concern about 50 reporting programs and no plan for what anyone would do with that information. He suggested that they utilize existing reporting programs--or at least share information with national programs. He noted that, with the Safe Medical Device Act of 1990, the Congress legislated that medical device problems had to be reported--but he said he didn’t know of any learning perspective that came from that. ISMP always asked: How will you share this information--How will you get it back--And what will you do with it?
Mr. Vaida reported that 10 percent of the hospitals stated in their assessments that they had CPOE systems. The percentage reporting 100 percent of the physicians enter all their orders was significantly lower.
Ms. Delbanco said Leapfrog Group started informally over three years ago as an effort initiated by the Business Roundtable and a mix of Fortune 500 companies, leading business coalitions, and the U.S. Office of Personnel Management (which oversees the Federal Employees Benefits Program). Members use their role as health benefits purchasers to drive improvement in the healthcare system. Today, the group consists of more than 90 large healthcare purchasers who represent over 26 million Americans, not including Medicare beneficiaries and those receiving benefits through DoD. Members include many state agencies and a growing number of unions and business coalitions. Together they spend over $46 billion in healthcare expenditures each year.
Leapfrog’s founders, frustrated with healthcare costs that rose ad infinitum, while quality remained low, realized that they hadn't been buying right. They recognized a fiduciary responsibility to ensure that the care they provide employees, retirees and their families was of the utmost quality--but their decisions had been based on cost. Members wanted to make gains in patient safety and leapfrog the gridlock experienced in the healthcare system that blocked taking advantage of the know-how and technology available for major improvements in the quality and safety of care.
Ms. Delbanco said health plans, while doing many things to drive quality improvement, knew more about the differences among providers than they shared with purchasers and consumers. So, it was hard for those buying healthcare, whether employers or individual healthcare consumers, to use information on differences among providers to advantage themselves and signal that they, too, value quality. And it was hard for providers to reengineer the way they provide care: without seeing a business case, it was difficult to convince a hospital board to invest millions of dollars in CPOE systems. Because healthcare purchasers, who had the greatest opportunity to provide that business case, hadn’t done so, breakthroughs providers also want hadn’t been possible. And individuals hadn’t been engaged in considering quality information when making their healthcare choices.
Ms. Delbanco said for years, consumers had been given information that focused on the wrong unit of analysis--health plans. She said the emphasis had been on topics too remote (e.g. the proportion of women who should have gotten pap smears, but didn’t) for consumers to relate to meaningfully. Leapfrog sought the equivalent of how people respond when they hear, “There’ll be a lightening storm within minutes.” Focusing on preventable medical mistakes, the group hoped to strike that rod and engage consumers. Remarking that she was sure everyone had heard the statistics from IOM’s report many times, Ms. Delbanco noted Leapfrog's focus, right now, was on hospitals: the groupwe knows more about how errors occur in that setting and the kinds of interventions successful in reducing hospital-based errors.
Ms. Delbanco said Leapfrog is not so much another organization as it is an action plan used to leapfrog gridlock. It consists of a two-pronged approach: 1) an organized effort on the part of healthcare purchasers to buy right, signaling the healthcare marketplace that they want breakthroughs made in terms of quality and safety, and 2) about engaging and activating consumers to become part of the solution.
By joining the group, members commit publicly to a common set of purchasing principles. They agree to inform and educate their enrollees about the fact that preventable mistakes happen, and that certain practices they can look for in hospitals might indicate that their care would be safer. Members also agree to compare performance at the hospital or physician level, as more information becomes available. Comparison initially will focus on the group’s three safety “leaps.” Members also agree to reward and recognize hospitals that implement these three steps proven to reduce preventable mistakes. Ms. Delbanco said members spread across the country face different healthcare markets, where different incentives or rewards were valued, and they were encouraged to confer with hospitals what would make their business case.
Members agree to highlight a few discrete practices the group believes can make a big difference in patient safety. Observing that employers don’t have a track record for sticking to such programs, Ms. Delbanco said an “insurance clause” is built in asking members, if their first efforts don't change things, to intensify their efforts until they actually see changes.
Ms. Delbanco said safety “leaps” were chosen with careful thought. Quality improvement experts were asked to help them devise “the equivalent of antilock brakes, air bags and seat belts” for the healthcare system--practices proven to make a big difference for patients that would be understandable to the average American consumer. She said consumers needed to understand their choices, and that practices highlighted by the group must bewhat was feasible today, and what was readily ascertainable by others outsiders like consumers and purchasers in order to determine that appropriate practices were in place.
The first safety “leap” is promoting the use of CPOE systems in hospitals. Ms. Delbanco noted research indicating these systems can prevent up to eight in ten serious medication errors. and that Leapfrog had developed clinical decision-support tools for physicians.
The second safety step leap focuseds on intensive care unit (ICU) and physician staffing. Research suggestsed there could be a ten percent mortality reduction with CCM-trained physicians overseeing ICU care and telemonitoring. Ms. Delbanco said that, as more areas participated in publicly reported risk adjustment outcomes programs in the ICU, outcomes data would replace the structural standard created around staffing. Ultimately, Leapfrog wanted to identify for consumers hospitals with the best ICUs.
Leapfrog’s third safety step leap is promoting EHRs. Research indicated that referring patients with certain high-risk neonatal conditions or needing certain high-risk surgeries to hospitals where their outcomes were likely to be better could result in at least a 20 percent mortality reduction for seven complex treatments. In the absence of outcomes data, Leapfrog believed there was strong enough evidence to rely on volume as a proxy. Leapfrog was eager to move more toward outcomes data reporting rather than the structural measures set up for both the ICU and EHR standards. Meanwhile, members felt they could help patients seek safer care by informing them about these relationships.
Realizing purchasers couldn't actualize such an initiative alone, Leapfrog reaches out to health plans; individual hospitals; and hospital, physician and consumer groups exploring how to collaborate toward these goals. Hospitals are asked to share information on their progress implementing the three safety leaps via an online voluntary Web survey created with the help of the The Medstat groupGroup. Those data will be reported in January, initiating an ongoing public repository of information consumers can turn to when making healthcare choices. Initially, five six regional roll-outs (where employers made the biggest effort to get hospitals to report) will be featured. Leapfrog also looks to hospitals for help in understanding what makes a business case and how to realign incentives to reward hospitals going the extra mile to protect patients.
Noting many members delegate much of their purchasing responsibilities to health plans, Ms. Delbanco said Leapfrog hopes these plans, which are more privy than employers to information about when patients are about to make a hospital choice, will help educate consumers. Most national carriers have been supportive and plan to educate members and designate in their directories hospitals that meet Leapfrog’s standards. Many carriers wrote letters encouraging their hospital CEOs to fill out the survey. Ms. Delbanco expressed confidence they would find other opportunities to work together.
Research Leapfrog conducted last summer with consumers, employees and retirees clearly indicated that people want physicians input on hospital choices. Ms. Delbanco said Leapfrog reached is reaching out to physician groups to inform them about its initiatives and find ways they might work together to enhance shared decision making. She acknowledged the three “leaps” they promoted weren’t the only factors consumers considered in choosing a hospital; they also want familiar places where their families can easily visit and other features. She encouraged physicians to help patients think through all these factors.
Ms. Delbanco reiterated Leapfrog’s belief that patients are part of the solution they strive toward. She noted that, while public awareness had grown about the issue of preventable medical mistakes, there was still much to communicate so patients could determine what they needed to protect themselves and be part of the solution.
Leapfrog workgroups focused focus on designing financially based incentives and reward-models members could adopt in their communities to help participating hospitals gain a preferential position in the marketplace. With a grant from the Robert Wood Johnson Foundation, Leapfrog conducted focus groups for consumer testing that led to the development of an enrollee communications tool kit, available free on Leapfrog’s Web site.
Although Leapfrog is a national effort, Ms. Delbanco noted a special focus on regional roll-outs. They started with seven roll-outs and plan more next year. Emphasis is on turning Leapfrog from a purchaser initiative into one that is community wide and collaborative with all the stakeholders in the healthcare system. Plans call for adding 10-15 regions in a concerted effort to bring everyone to the table, get hospitals to report to the survey, educate consumers, and carry out other elements of Leapfrog's action plan.
Ms. Delbanco noted they were starting to see some impact. Experts estimated that the number of hospitals meeting Leapfrog’s CPOE system standard would more than double next year. Bear Stearns considers Leapfrog a fundamental change agent in the healthcare system. In New York, IBM, Pepsi, Xerox, Empire BCBS and other employers agreed to give financial bonuses to hospitals meeting Leapfrog’s standards. In Atlanta, major employers struck a deal with the largest, eight-hospital system to implement these standards.
Ms. Delbanco said members were confident this effort would make a big difference for patients. Leapfrog commissioned researchers at Dartmouth to estimate the potential benefit if all non-rural hospitals implemented these standards. The conservative estimate was that, with these three standards alone, each year more than half-a-million serious medication errors could be prevented and close to 60,000 lives saved. Research suggested that, for every preventable death, there were many more preventable disabilities.
Dr. Cohn said he was sympathetic to many of Leapfrog’s views but, with health plan dues being raised 10-15 percent, he questioned where the money would come from. He said members seemed resistant to the idea that the system needed more money. Ms. Delbanco said Leapfrog was about helping consumers make better choices and there were hospitals across the country that met the standards. Leapfrog at least wanted to share that information. The next step was finding a way in this “zero-sum game” to realign how payment was structured, so they paid for quality. Now, no matter what a hospital or physician did, they were paid the same. Unless the hospital was paid the way Medicare paid, if something went wrong the employer paid for those extra days. No other industry was like that. There was no way for a hospital or physician who worked hard to be rewarded--and that was part of the solution.
Some members were interested in becoming co-investors with healthcare systems where their employees received care. Models might crop up where members provided capital up front for CPOE. Different approaches would be taken: Leapfrog wouldn’t dictate solutions, but encouraged innovation. Members knew they needed to create the business case, and she said everyone was going to see creativity.
Responding to a question, Ms. Delbanco said two-to-seven-percent of hospitals had in place Brigham and Women’s model order-entry systems where the physician did the entry. She noted Leapfrogs standard didn't just ask if a hospital had a system, but focused on its ability to intercept serious medication errors, whether physicians used it, and if it took a written acknowledgement to override a warning. She said they’d know more about how many hospitals met the standard as more participated; current estimates were small, but were expected to more than double next year.
Ms. Delbanco said Leapfrog’s standards were stretch goals--not requirements. Fortune 500 companies and other large purchasers didn't feel there was a need to set easily attainable standards already widespread. Leapfrog was a voluntary program: hospitals voluntarily shared information and consumers voluntarily provided positive incentives or rewards based on practices not already in place that they believed could make a big difference.
Noting they’d heard from presenters that reporting systems needed to be non-punitive, Ms. Coltin asked if Leapfrog had considered a more recognition-based approach (e.g. American Diabetes Association’s physician recognition program or the top-100-hospitals approach) that recognized those with systems in place without embarrassment. Ms. Delbanco said they’d considered different approaches and settled on one where hospitals could voluntarily report. They didn't just ask if they met the standards, but asked about their intentions and progress. Few hospitals met the standards, but Leapfrog wanted to commend hospitals willing to report and would share information about hospitals on the path. Leapfrog worked nationally and locally to make that story heard. Consumer testing and discussions with different stakeholders indicated it would be most helpful to have a complete list of hospitals that report and the information provided couched in an easily understood form.
Dr. Starfield asked how the buy-right strategy worked with Leapfrog’s focus on hospitals, when they were buying health plans rather than hospital care. Ms. Delbanco said the idea was to create a more direct relationship between employers and hospitals. Their members, especially the large employers, had relationships where they could work with the health plans to set up pass-through bonus payment arrangements to hospitals, similar to what Empire BCBS’s approach. Most major national health plans wouldn’t do these things without the backing of employers, but with backing they’d like to do them. For years, plans had collected information on how quality varied among providers; they’d like to make that more transparent, but without employer support that was hard to do.
Deferring further discussion to the next meeting, Ms. Coltin adjourned the meeting at 4:30 p.m.
I hereby certify that, to the best of my knowledge, the foregoing summary of minutes is accurate and complete.
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