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SafetyLeaders.org Page 1 of 26 Accelerating Healthcare-Associated Infection Elimination: Health System, Hospital, and Government Leadership Collaboration October 28, 2010 Webinar Transcript Charles Denham: It gives me great pleasure to welcome all of those on the webinar today. We have over 1,000 hospitals that will be listening to this broadcast from The National Press Club in Washington, D.C. I have to tell you that I am sitting in a room with some of the greatest talent in U.S. healthcare, and [we] also have a representative from Switzerland: the former Health Minister from Switzerland. Our charge today is to address this month's webinar, and the title is "Accelerating Healthcare-Associated Infection Elimination: Health System, Hospital, and Government Leadership Collaboration.” I am with a group of role-model hospital leaders from all over the country, as well as government leaders who are both dedicated to eliminating healthcare-associated infections, and in the spirit of the documentary that many of our attendees of the webinar have participated in, the Chasing Zero documentary is also about chasing zero, not incremental change. So we'd like to welcome the many hospital leaders from around the country, front-line caregivers who are nurses and infection control professionals, as well as so many in the C-suite: CEOs and CFOs and chief operating officers and then a huge contingent of our safety officers who are really the unsung heroes, as well as the caregivers on the front line. If you have any challenges getting the slides and would like to get them later and get a written transcript of the presentations today, please go to Safetyleaders.org, where, as we do in every webinar, we generate transcriptions of all the presenters as well as the slides and audio recordings. You may also download a number of assets that have been provided so graciously by the National Quality Forum, the Journal of Patient Safety, and a number of other organizations that have allowed us to have the opportunity to use those resources at no charge and no cost. The toolboxes and the other concepts, tools, and resources that are made available are constantly being updated, so within two or three business days, a transcript of this session with slides and audio recording will all be available to you. I have before you the disclosure statement of the groups that are presenting today, and I will not go into them in detail because we have such an esteemed group of speakers. We have a roundtable set of panelists that you see before you on the slide. We have Assistant Secretary Don Wright sitting in this room with me with a number of other leaders from a number of the agencies, all dedicated to eliminating healthcare-associated infections. We have had a wonderful session this morning with leaders and role-model leaders from all over the country. We have Dr. Michael Rapp, Thomas Hamilton, Dr. David Hunt, Dr. William Munier, and Dr. Arjun Srinivasan. I probably got that name wrong, but I'll do my best for Arjun, who is sitting here in the room, and at least he smiled at me. So we have an absolutely terrific set of speakers today. We also have a group in the room of leading role models, CEOs and leaders, physician leaders, quality leaders from a number of our organizations. Dr. Gary Gottlieb, who is the CEO of Partners HealthCare in Boston; Dr. Robert Cima, who is the Vice-Chairman of Surgery at the Mayo Clinic in Rochester and leads the quality effort in surgery; Dr. Stephen Grossbart with Catholic Healthcare Partners, who has shared with us this morning some terrific information which he will be sharing later today in terms of cost of harm; Dr. Michael Henderson from the Cleveland Clinic, who is the Chief of Quality for the Cleveland Clinic system; and last but not least, and especially not least, are our patient advocates. As is our approach in every webinar, we start with a voice of patients and we end with a voice of patients. We actually have two patient advocates that are going to share their voices with you today. The movie actor Dennis Quaid has become a real international champion for patient safety, to whom we owe tremendous thanks. He always laughs about his day job being a movie actor, and then that his passion is behind helping save lives. I have to share with you that Dennis Quaid wishes that he could be here with
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Accelerating Healthcare-Associated Infection Elimination: Health System, Hospital, and Government Leadership Collaboration

October 28, 2010 Webinar Transcript

Charles Denham: It gives me great pleasure to welcome all of those on the webinar today. We have over 1,000 hospitals that will be listening to this broadcast from The National Press Club in Washington, D.C. I have to tell you that I am sitting in a room with some of the greatest talent in U.S. healthcare, and [we] also have a representative from Switzerland: the former Health Minister from Switzerland. Our charge today is to address this month's webinar, and the title is "Accelerating Healthcare-Associated Infection Elimination: Health System, Hospital, and Government Leadership Collaboration.” I am with a group of role-model hospital leaders from all over the country, as well as government leaders who are both dedicated to eliminating healthcare-associated infections, and in the spirit of the documentary that many of our attendees of the webinar have participated in, the Chasing Zero documentary is also about chasing zero, not incremental change. So we'd like to welcome the many hospital leaders from around the country, front-line caregivers who are nurses and infection control professionals, as well as so many in the C-suite: CEOs and CFOs and chief

operating officers – and then a huge contingent of our safety officers who are really the unsung heroes,

as well as the caregivers on the front line. If you have any challenges getting the slides and would like to get them later and get a written transcript of the presentations today, please go to Safetyleaders.org, where, as we do in every webinar, we generate transcriptions of all the presenters as well as the slides and audio recordings. You may also download a number of assets that have been provided so graciously by the National Quality Forum, the Journal of Patient Safety, and a number of other organizations that have allowed us to have the opportunity to use those resources at no charge and no cost. The toolboxes and the other concepts, tools, and resources that are made available are constantly being updated, so within two or three business days, a transcript of this session with slides and audio recording will all be available to you. I have before you the disclosure statement of the groups that are presenting today, and I will not go into them in detail because we have such an esteemed group of speakers. We have a roundtable set of panelists that you see before you on the slide. We have Assistant Secretary Don Wright sitting in this room with me with a number of other leaders from a number of the agencies, all dedicated to eliminating healthcare-associated infections. We have had a wonderful session this morning with leaders and role-model leaders from all over the country. We have Dr. Michael Rapp, Thomas Hamilton, Dr. David Hunt, Dr. William Munier, and Dr. Arjun Srinivasan. I probably got that name wrong, but I'll do my best for Arjun, who is sitting here in the room, and at least he smiled at me. So we have an absolutely terrific set of speakers today. We also have a group in the room of leading role models, CEOs and leaders, physician leaders, quality leaders from a number of our organizations. Dr. Gary Gottlieb, who is the CEO of Partners HealthCare in Boston; Dr. Robert Cima, who is the Vice-Chairman of Surgery at the Mayo Clinic in Rochester and leads the quality effort in surgery; Dr. Stephen Grossbart with Catholic Healthcare Partners, who has shared with us this morning some terrific information which he will be sharing later today in terms of cost of harm; Dr. Michael Henderson from the Cleveland Clinic, who is the Chief of Quality for the Cleveland Clinic system; and last but not least, and especially not least, are our patient advocates. As is our approach in every webinar, we start with a voice of patients and we end with a voice of patients. We actually have two patient advocates that are going to share their voices with you today. The movie actor Dennis Quaid has become a real international champion for patient safety, to whom we owe tremendous thanks. He always laughs about his day job being a movie actor, and then that his passion is behind helping save lives. I have to share with you that Dennis Quaid wishes that he could be here with

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us in Washington to help catalyze awareness. We laughingly call him our "chief awareness officer," and he does this in a wonderful way, and he has a message for this group. So we'll start with the voice of advocacy for patients, not tokenism; our patient advocates are absolutely passionate. They are national and international leaders in building awareness, as is Dennis. I am going to share now a video clip for the group here in Washington, an audio with the attendees of the webinar. Dennis Quaid: [pre-recorded] We have some of the greatest leaders in the country who are in this room. All of you out there who are watching this webinar, I want to challenge you, after it's over, to do something extra. You can have a real impact on one little soul at a time, and one little soul adds up to hundreds and thousands and millions of lives. But as you go into your day and go back to your lives, know that you yourself have a chance to be a hero, and we support you. May God bless you. Charles Denham: And I'll be returning to the webinar slide set, so for those in the audience, the message that you just heard from Dennis Quaid will be available as a video and will be available on our website as well for those who want to log on and be able to actually download that video. We also have a message from Dr. Howard Koh, who joined us this morning, the Assistant Secretary of Health. Howard Koh: [pre-recorded] We are very proud of the leadership of so many hospital CEOs, so many hospital COOs, who have made quality outcomes and true attention to continued quality improvement a true mission of their work. So we are here to congratulate the leaders. We also want to empower and mentor future leaders going forward, and we also want leaders who view these efforts in the broadest perspective, taking their work in the healthcare setting and applying it to population health, because the health of the individual is almost inseparable from the health of the greater community, and that's the message of public health moving forward. Charles Denham: So I will give a brief overview of why this group is being convened here in Washington, D.C., before we hear from our speakers today. We remind our audience that the TMIT mission is to accelerate performance solutions that save lives, save money, and build value in the communities that we serve, and the group today and this morning focused on not only the clinical and operational issues, but the financial issues. The objective of the Greenlight Program is to take the National Quality Forum Safe Practices for Better Healthcare, 34 Safe Practices, and build impact calculators that can help us focus our attention in a more patient-centered way and be able to look at the intersection of leadership, practices, and technologies, then enable them in the spheres of clinical, operational, and financial performance. Not so much that we can just build a business case for patient safety, but that we can prudently and effectively be good stewards of the resources and the choices that we make as we move from a silo-centered system that is production-focused to one that is patient-centered. The hospitals and organizations in the room with me today include great brands in American healthcare: the Mayo Clinic, the Cleveland Clinic, Vanderbilt Medical Center, the Brigham and Women's Hospital, Ascension Health, Catholic Healthcare Partners,

and on and on – a tremendous group of, really, what we would say role-model leaders who have been

interacting with the government leaders here in Washington, D.C., to discuss ways that we can bring alignment and focus into eliminating healthcare-associated infections. Yesterday we had a group of our collaborators in the Greenlight Program who are focused on looking at patient trajectories and following clinical, operational, and financial performance, and identifying what we really need to know about our patients who are flowing through the system so that we can make good decisions. You will hear from Dr. Robert Cima regarding a process that we are undertaking, as part of the Greenlight Program, to map standardized patients in order to tie clinical and operational issues and be able to help us understand how we can make choices for things like skin preps for surgical-site infection, normothermia, and the other interventions that we think may hold promise to reduce surgical-site infections. We draw your attention to the Safetyleaders.org website in order to download a lot of the assets that will be developed there.

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One last housekeeping detail before I move to Dr. Don Wright, the Deputy Assistant Secretary of Health here in Washington, is to draw your attention to the fact that the Chasing Zero documentary has now been seen by 3.4 million viewers. It has been screened on the Discovery Channel and is likely soon to be rescreened because of demand. A toolbox has now been created with another hour and a half to two hours of content that helps viewers understand how to enable and how to equip themselves to be able to adopt innovations like those that were discussed, such as Share Rounds, and high-contact surface measurements at the Mayo Clinic, and other activities that we have seen that have been undertaken. More than 10,000 of the DVDs have been given away, and a new set of toolbox DVDs will be given away to all U.S. hospitals. Four will be delivered in the course of the next 60-90 days to the Chairman of the Board, the CEO, the Chief Quality or Safety Officer, and the Chief Nursing Officer. We are probably about 20% done on the next documentary, called Out of the Danger Zone*. It will highlight the Brigham and Women's Hospital as we did the Mayo Clinic in the first documentary, and in the series of documentaries, each of the outstanding organizations that are role models, such as the Vanderbilt Medical Center and Johns Hopkins, will be participating, and be highlighted. We'd also like to draw your attention to a grassroots effort that is being led by Sue Sheridan, the patient safety advocate who is also the leader of the World Health Organization Patient Advocacy Program globally, called CareMoms. It was announced on the Joy Behar Show by Dennis Quaid and me, and this is a grassroots effort to help encourage support and positive support of hospitals in communities across the country. What I'd like to do now is – it gives me great pleasure to introduce Dr. Don Wright, who I like to say is the general leading the war on healthcare-associated infections. He is the leader of a newly formed Office of Quality in the Secretary of Health's office and works very closely with Assistant Secretary Koh. Dr. Wright? Don Wright: Thank you, Chuck, for that very generous introduction. Let me say, it's a pleasure to lead off this webinar focused on accelerating healthcare-associated infection elimination. I want to begin by telling you a little bit about the office that I lead – the Office of Healthcare Quality, which is a new office within the Department of Health and Human Services. The purpose of our office is to coordinate activities across the department, to improve the quality of healthcare in this country. In reality, healthcare quality is addressed by a number of the operating and staff divisions within the U.S. Department of Health and Human Services, from the CDC to AHRQ to CMS to HRSA to the Office of the National Coordinator. They all have very important roles in improving the quality of health. And it's my office that is asked to bring these various operating divisions and staff divisions together, to leverage all their tools in a consistent manner to reduce healthcare-associated infections. We are a newly created office, and our priorities are healthcare quality and public health quality, but clearly, our number 1 priority is now, and has been for the last two years, reducing healthcare-associated infections. A new initiative that we will roll out in the next several months is an effort to improve the quality of public health delivery systems in this country. I want to begin with this introductory slide, and I realize it's redundant information for many of you, but healthcare-associated infections are those infections that patients acquire when receiving medical or surgical care in this country. They take many forms, from bloodstream infections to urinary tract infections to pneumonia to surgical-site infections. I think it's always important for us to get a perspective of how large a problem this is, and it's significant. It's estimated that there are 1.7 million healthcare-associated infections in hospitals alone each and every year. And regrettably, our surveillance systems are not robust enough to determine the impact in outpatient facilities. In addition to the 1.7 million cases, we have about 100,000 lives lost in hospitals to hospital-acquired infections, so clearly this is a very important issue in terms of patient safety and in human terms. But I also want to point out it's clearly an important issue in economic terms. It is estimated that the cost of treating healthcare-associated infections is between 28 and 33 billion dollars each and every year. So that's the bad news, but there is good news. It has also been estimated that if we just consistently implemented the existing infection-control practices that we now know about, we could reduce these infections 70% or more. I want to say, as the department *N.B.: The documentary is now titled Surfing the Healthcare Tsunami: Bring Your Best Board™. [01-25-12]

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lead for reducing healthcare-associated infections, we have taken very much a public-health approach to this problem. Patients move freely throughout the U.S. health system from their homes to outpatient facilities to acute-care hospitals and long-term care facilities, and therefore, a public-health approach is warranted. At this time, I want to take just a little bit and tell you about the departmental effort to reduce healthcare-associated infections and our chief work product to date, which is the HHS Action Plan to Prevent Healthcare-Associated Infections. I think historically HHS has always had a great emphasis and been heavily invested in reducing healthcare-associated infections, but, quite frankly, our efforts were enhanced, our commitment and our focus were enhanced, after the release of a GAO report in March of 2008. As you can see, the title of this report is "Healthcare-Associated Infections in Hospitals: Leadership Needed from HHS.” If you read this 85-page report, you would see that they acknowledge the great deal of good work at HHS, from the prevention guidelines out of the CDC, to some of the research from AHRQ, to payment policies and other incentives out of CMS, and yet they were critical in a number of areas. Certainly one of the recurrent themes in their criticism was that our efforts lack central coordination to ensure that what we do across the department works in a coordinated fashion to reduce these infections. We leverage all the resources HHS has at its disposal to reduce these infections. There is also a criticism as it relates to the prevention guidelines. Many of you know that there are 13 guidelines to prevent healthcare-associated infections, but in those guidelines, there are over 1,200 recommended clinical practices. We were encouraged from the GAO to try to prioritize those guidelines so that hospitals would know which practices have the highest impact. We were also asked to consider inclusion of conditions of participation and conditions for coverage in these guidelines moving forward. And the third area of criticism revolved around health IT. It was pointed out that we were not maximizing the use of health information technology to reduce these infections; and furthermore, at the time the report was issued, there was not an adequate system to give a reliable national estimate of healthcare-associated infections. On the basis of the GAO report and congressional hearings that followed, the question at the department was, in light of this criticism, where to from here? And ultimately, the secretary created a senior-level steering committee for the prevention of healthcare-associated infections. Our charge was simple: We were asked to develop an action plan to reduce, prevent, and ultimately eliminate healthcare-associated infections. In addition to the major charge, we were told to establish measurable national goals that would benchmark our success. Again, we were asked to improve the coordination to ensure that all of HHS's tools worked in a cohesive manner to reduce these infections. And lastly, we were encouraged to partner with external stakeholders to maximize our chance of success. And clearly, at HHS, we realize that government alone cannot solve this problem, that we must interact and partner with healthcare consumers, healthcare institutions, and healthcare providers. The initial Action Plan was considered a living document. We are, and continue to be, committed to updating that document periodically to reflect the evolving science, and also to highlight which strategies have been most effective in reducing healthcare-associated infections. This slide outlines the overall structure of our work. The blue square at the top of this diagram shows the senior-level steering committee that oversees and directs all the work across the department in this area. We have a number of workgroups. The middle group reflects our tier 1 effort, the prevention and implementation group led by the CDC that looks at the prevention guidelines, and how can we ensure that those guidelines are translated into bedside care; the research working group, led by AHRQ, identifying our research gaps, information in systems and technology, looking at how we can maximize the use of health IT to reduce these infections; incentives and oversight, looking at incentives broadly, from value-based purchasing to market-driven incentives, led by CMS; and then a messaging campaign led out of my office, as well as an evaluation group.

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When we took on this challenge, we recognized we needed a tiered approach. To try to address all healthcare-associated infections in all settings at one time was a daunting task. So our tier 1 effort focused on reducing these infections in hospitals alone, and we focused on the big 4: catheter-associated urinary tract infections, central line-associated bloodstream infections, surgical-site infections, ventilator-associated pneumonia, and two organism specific infections – that of MRSA and C. difficile. As I mentioned earlier, we were determined to create a scorecard, some national targets by which we could benchmark our success. I'm not going to go through the slide in detail, but if you'll notice for bloodstream infections, we set a national goal of reducing these infections 50% over a five-year period of time. Further on the chart, you'll note surgical-site infections. We hope to reduce those 25% over that same five-year target. We are encouraged. We certainly have seen some successful implementation of evidence-based guidelines to prevent bloodstream infections, and I think many of you on the line and watching this webinar are very aware of the Keystone Study, the landmark study in Michigan that involved 103 ICUs, where the use of a checklist over an 18-month period of time reduced the infection rate almost to zero. I think it's important to note that that has been sustained for 5 years since the completion of the study. It's this type of work that will certainly move us a long way towards our goal of reducing central line-associated bloodstream infections by 50% over the next 5 years. I want to end my presentation by talking about the intersection of healthcare-associated infections and the Patient Protection and Affordable Care Act. This particular element was directly mentioned in the Health Reform Bill, in particular in Title III on Improving the Quality and Efficiency of the Healthcare System. In one area, there was direct reference to healthcare-associated infections, and a direction to the secretary to link payment to quality or value-based purchasing. Particularly it said, "For fiscal year 2013, the Secretary shall select measures that cover at least the five following conditions: acute myocardial infarction, heart disease, pneumonia, surgeries," and then the topic of today, "healthcare-associated infections as measured by the prevention metrics and targets established in the HHS Action Plan to Prevent Healthcare-Associated Infections.” So you can see that this has garnered a great deal of interest at the national level as an incentive to reduce healthcare-associated infections. At this point, I want to turn the podium over to another representative from HHS, Dr. Thomas Hamilton from CMS. Thomas Hamilton: Thank you, Don. This afternoon, I'd like to talk about the role of the Survey and Certification Program, and in particular about how we enforce the conditions of participation and how those can be used effectively to promote the cause of patient safety. From my office, we contract with state public health departments to conduct on-site surveys of hospitals, as well as complaint investigations of hospitals. And we coordinate that function from the Medicare side and Medicaid side together with state licensure authorities, so that we can have as integrated an approach as possible, and we also work closely with the accrediting organizations that also do accreditation surveys on-site, whose accreditation we have approved as equivalent to CMS's accreditation. We publish in the Federal Register certain clear expectations for outcomes and for processes in a hospital setting that we call "conditions of participation," and that helps fulfill our responsibility as major purchases to protect beneficiaries and to share a basic level of acceptability. If you are one of the people who labor every day with a particular focus on patient safety, I hope that you will look at those conditions of participation as your allies in that cause. With regard to healthcare-associated infections, there are four conditions of participation that particularly stand out. Those are the responsibilities for effective infection control; the responsibilities for a governing body to ensure safety and the overall hospital responsibility to provide care in a safe setting; and the responsibility for an organization to have, as part of its integrated processes of care, an effective quality assurance and performance improvement system that can regularly be mindful of the organization's performance, stream performance information back to management in real time on a regular basis, so as to not only protect patients, but also to continually improve the processes of care. It is that last requirement, that last condition to participation, to which I would particularly like to speak, because I see it as singularly important. I see it as the leverage point where quality assurance, the survey and certification processes, effectively meets quality improvement. It is a leverage point. And I think every day, everyone in government needs to ask themselves, and I ask myself every day, how can I make my

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work less necessary? And the question that arises with regard to survey and certification is, why do we need so many surveys? How could we arrange things so that external surveys would be less and less necessary? I think part of the solution to that is to try to strengthen the internal capability of every type of organization to monitor its own performance and act on that information. For this reason, I call the QAPI requirement in our regulations the smartest requirement in the room. If our conditions of participation could speak and could have mottos, I think the motto of the QAPI requirement is really the old medical adage: if you lose the patient, don't lose the lesson. If you look at our requirements for an effective QAPI program, there are really five different functionalities that we expect each such system to have. First is a level of mindfulness, effective feedback systems, and we focus especially on the adverse event with the obligation for every hospital to have a comprehensive inventory of adverse events, to investigate those adverse events, and to act on that information – not necessarily to accept the recommendations of the quality committee, but to ensure that top management is effectively analyzing the causes of performance problems and acting on the information that is received. Secondly, that the organization have a system of quality indicators that are specified by the governing body that can focus on the high-risk, high-volume, or problem-prone areas, and can track those on an ongoing basis. Thirdly, that the organization undertake regular performance improvement projects that are scaled to the scope and complexity of the hospital by which the organization can then achieve measurable progress in outcomes improvement over time. And fourthly, on the basis of these first three functionalities, to take systemic action – that is, to analyze root causes and to make those changes in the system of care such that adverse events can be prevented in the future. Lastly, there are certain executive responsibilities, particularly with regard to the governing body. I've been spending the morning with a very knowledgeable and dedicated group of hospital officials who are inspiring in their work to promote quality, and we've learned about some of the tensions between the finance end of things and patient safety. What people do not necessarily fully appreciate is that the Medicare regulations oblige the governing body to pay attention to quality, and oblige the overall organization to make sure that its internal quality assurance and performance improvement system is adequately resourced and adequately functioning to address quality improvement and safety priorities; and that it is the responsibility of the governing body to set clear expectations for safety within that organization. So if we find, for example, that an organization has failed in its responsibilities to have an effective internal QAPI initiative or program, that deficiency, if you will, also redounds to the governing body, because the failure of QAPI can reflect on the failure of governance. So these are linked and are quite important. Over the course of the next two years, what we intend to do is to develop further the attention that we are focusing on the hospital's QAPI requirements, so that hopefully we could look more at those functionalities within a hospital and reduce the need for surveyors to be looking at the other areas, so that we can have the confidence going into an organization that if there are problems, that organization is mindful of the problems and is taking prompt and effective action. I would like to invite your thoughts on that future direction, and if you have concerns or thoughts about it, please write in to our website at bettercareatcms.hhs.gov, and give us the benefit of your thoughts. That's bettercare (one word) @cms.hhs.gov. Thank you very much. Charles Denham: It gives me great pleasure to have Dr. David Hunt, who has been a frequent speaker on the webinar series addressing the Safe Practices for Better Healthcare, as a committee member whom we adopted long ago when we started with the Practices, and as he moved from CMS to the Office of the National Coordinator of Health Information Technology, he graciously stayed with us and has been a wonderful contributor to the development and the ongoing update of the Safe Practices. However, we'll ask Dr. Hunt to really address health information technology and let him off the hook on Safe Practices today.

David Hunt: Thank you so much, Chuck. I'm thrilled to be here. First, let me extend greetings from Dr. David Blumenthal, the National Coordinator for Health IT. You know, as an office largely seen as a geek shop that deals with the arcane world of software requirements, standards, network protocols, and IT service architectures, it is critical that we really get an opportunity to tell our story to the people who make

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a real difference every day – those who practice the art and lay hands on patients every day. You see, Dr. Blumenthal is not the National Coordinator because his résumé is stocked with expertise in XML style sheets or Internet transfer protocols. No, he's the National Coordinator because he's a clinician with an abiding interest in the quality of healthcare in the United States. Likewise, I stand before you as a practicing surgeon, not a software developer. A clinician who, like so many others, took an oath to practice – an oath that subsumes the primary tenet of patient safety. And that tenet is expressed right here. Expressed by Hippocrates in Epidemics I, he wrote, "As to diseases, make a habit of two things – to help, or at least, do no harm.” Now, as a fundamental rule, this one has it all. First, it firmly establishes the upper and lower bounds: to help at the high end, and to do no harm at the lower end. When Hippocrates says, "Make a habit," today we would say, "Make a system.” And wonderfully, this rule provides an answer to a question we hear a lot at HHS: What is the relationship between patient safety and quality? Well, here's how we read it. And this model is the model that we used when I was at CMS to develop the Surgical Care Improvement Program, a model that was actually validated in 2003 in an IOM report on Patient Safety Data Standards, when Paul Tang and his team wrote that "patient safety is indistinguishable from the delivery of quality healthcare.” You see, in this model, all elements of safety are within the domain of quality, but there are aspects of quality outside of the domain of safety. But where exactly does health IT in meaningful use fit into this picture? We know that life in the real world is a lot more complicated. In fact, if you wanted to list just a small [number] of the influences affecting our nation's healthcare, it might look something like this. Now, in the center, we see our primary focus at HHS: to improve both individual and population health outcomes, to increase the efficiency and transparency of the entire system, and to improve our ability to study and improve healthcare delivery. These are some pretty wonderful goals, but surrounding this, you'll see just a fraction of the factors that influence the health of our nation. And no one at ONC would begin to suggest that any one of these challenges can be solved with an electronic health record alone. But, if in looking at this montage of challenges you can begin to consider which of these might be mitigated through the exchange of patient-level information, you can see that some of these challenges really are surmountable. The questions we have to answer in patient safety are particularly soluble with the effective application of information technology. Remember that primary rule of Hippocrates? "As to diseases, make a habit of two things – to help, or at least do no harm.” I mentioned earlier that in today's vernacular, the Greek term "make a habit" would translate into "make a system." And what better way to routinize a safe and effective set of processes than to support it with information technology. Now, I don't want to give the impression that I'm an uncritical cheerleader for health IT in any and all circumstances. The fact of the matter is that unsafe and ineffective processes can also be routinized with mind-numbing accuracy with the aid of software, which is exactly why we at ONC are doing everything possible to provide the technical assistance [that] the clinical community needs to ensure that we are not simply taking the workflow of a paper-based system and encoding it into information systems. Debbie Hattery, a good friend of mine at CMS, said that we can't just electrify our current system of healthcare delivery. So what will we at ONC do to help? Seen at the 50,000-foot level – and this is an overview of all of our major programs – I like to point out that our programs for meaningful use are about a lot more than just incentives. But to be a meaningful user, you first must be a user, which means adopting an electronic health record. To support the adoption of EHRs, we have announced and established the Health IT Regional Extension Center Program, and a national program of workforce training. Now in February, we announced the first of what would be 62 grant awardees for regional extension centers. Their specific mandate is to provide technical assistance to providers, and disseminate best practices, particularly to those providers who are less likely to be able to do this on their own. The workforce includes some über-geeks who like to install software and hardware and set up networks, but it also includes folks who are trained in the nuance of clinical work, who know how to lead practices through the steps of changing the way patients flow through hospitals. Some of these people will come from our

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workforce program; that's totaling over $70 million through a consortium of 82 community colleges across the country and throughout the staff. Now these programs will benefit from a comprehensive curriculum developed with the aid of the Department of Education. Now on the other side of meaningful use, after adoption, we focus on exchange of information. We have three big programs designed to support health information exchange, and we are providing over $600 million in grants to support these programs. Obviously, for exchange to occur, we have to continue to advance health IT standards and certification, but in relative importance, those two topics pale in comparison to privacy and security. Privacy is foundational, and I'm sure that you understand that better than I. Now I could go on for some time regarding the details of all of these programs, but time won't allow. I should point out, though, that these investments have already begun to leverage the over $20 billion of incentives from CMS. And this integrated set of programs and policies is designed to get everyone possible to step onto the meaningful-use escalator. The three stages of meaningful use, the first of which begins in 2011, is roughly analogous to the Donabedian model of quality measures. The first period in which we emphasize the adoption and data capture: that's structure. For stage two, the Health IT Policy Council has indicated that meaningful use will include emphasis on more processes of care. And finally, we are looking to achieving some real outcomes in the third stage of meaningful use. But let's get back to patient safety and stage one of meaningful use. We have three strong drug safety pillars for patient safety: CPOE, drug interaction checking, and finally, maintaining an active list of allergies. And here you can see a rough schematic of where these drug safety features can truly have an impact. One thing I love about the patient safety features in the first stage of meaningful use is that they are imminently quantifiable, both on the inpatient side, as well as on the outpatient side. So you can see, this is just the start – a start to really improve the quality of care for all Americans. And it's a program that we expect to extend and expand over these next few years. But finally, on our part, I want to make sure that we ask you right here, right now, from ONC's standpoint, to make some of the tacit assumptions that are on either side of health IT, make them a little bit more real. We need you to work with us. We need you to share your wisdom and your experience with us, as we all consider health IT and electronic health records. I'm here because your help is critical; it's crucial. We're trying to change a lot of things. We're changing it with old principles and new tools. Regardless of how inartful some of our meaningful-use rules may read, we can't begin to make these things better without everyone in this room and everyone on this webinar. So at ONC, we're trying to do what has never been done before, and we're all working toward the same end: service to others. Thank you very much. Charles Denham: Thank you, Dr. Hunt. We really appreciate the help that you've given us in health information technology, and now we'll be shifting gears to Dr. Bill Munier, who will be talking about the work at the Agency for Healthcare Research and Quality. Bill? Bill Munier: Thanks very much, Chuck. I'm Dr. Bill Munier, and I head the Center for Quality Improvement in Patient Safety at the Agency for Healthcare Research and Quality. Dr. Carolyn Clancy, who heads the agency, brings her regards to everybody this afternoon, and I'm certainly very pleased to be here and have a chance to talk to you. I'll see if I can get these slides working right. AHRQ's central role in this effort is to promote the wide-scale application of evidence-based approaches to prevent healthcare-associated infections. We derive our evidence from the Centers for Disease Control, from NIH, and from our own research. Based on that evidence, we tried to get hospitals and other doctors' offices and so on to implement these evidence-based practices and to reduce the number of healthcare-associated infections. We also spend a fair amount of money and we collaborate with the CDC and CMS in direct research ourselves. We don't do basic research, but we do do research in epidemiology, infection control interventions, and implementation and impact. That last one really deals with human factors, which are often the most important in terms of getting things that we know about that work to be accepted and adopted in institutions.

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In terms of our role within the department, we have a very active role working with our federal partners. We serve on the overall steering committee and participate in the development of the National Action Plan and its revision. We also chair the research working group for the department, and we facilitate the overall evaluation effort to see whether what we're doing is actually having an impact across the country. Dr. Don Wright in his remarks referred to the Keystone Project. That was an AHRQ project, which was relatively modest in its investment – $454,000 – and led by Dr. Peter Pronovost. As mentioned, it was the first sentinel study that really proved that these infections could be – at least a certain type – could be reduced and held to nearly zero over a prolonged period of time, and really changed the mindset about what we could do about this. Since that time, AHRQ has – and you'll see on the previous slide, that was a 2003 study – the next major investment that was made wasn't until 2007, when the results of that study were in and we knew it was having an impact. We then moved relatively rapidly to increase our investments over the years. Graphically represented, you can see what's happened since 2003, and I would add that from 2008 on, the large percentage of those big increases are actually congressionally appropriated funds that are directed to AHRQ for the specific purposes of investing in healthcare-associated infections, their reduction, research, and so on. The specific areas that we have addressed are the ones that are listed there: the four major infection sites and the two major organisms that we're trying to reduce – and those are both mentioned in the congressional appropriations and in the National Action Plan, and they are obviously the highest priorities. We also have made the approach of site-specific/setting-specific, if you will, so we are addressing hospitals, ambulatory settings, and long-term care facilities sequentially. Measurement has to be done in a given setting. It's one thing to talk about healthcare-associated infections over the broad range and say we want to reduce them across the country, but it's actually institutions that have to do it. So the measurement happens at an institutional level and in specific settings, and the quality improvement activities have to happen in those settings, so our efforts are directed at those different settings. Specifically, since we started in hospitals, we have set up an infrastructure in partnership with the American Hospital Association's Health Research and Educational Trust, or HRET, and we have funded HRET to turn around and work with the state hospital associations across the country, which also work with the state health departments and the local QIOs. This is effectively establishing infrastructure at the state level, which can then reach out and work with hospitals in all 50 states, and we hope, eventually over the next couple of years, all hospitals in the United States. Interestingly, there were Stimulus Act funds that came in to both CDC and CMS for the same purpose – $50 million to address reducing healthcare-associated infections – and those agencies built in and reinforced that same state-level infrastructure. So where are we going to go as we move forward? We're planning to build on prior-year activities, and we moved last year, for the first time, from just contracts to contracts and grants, and we plan to expand research and projects in high-priority areas and to continue to enhance the implementation efforts of working both across the different agencies within the department and increasingly reaching out to the private sector, because it is, after all, in the institutions that deliver care where change is going to occur. It's not going to occur in Washington, D.C. What I would say is, if those of you who are listening who are interested in becoming part of that growing graph of increasing AHRQ funds – and we don't know, of course, whether that's going to level off at some point; it certainly will, it's not going to keep going up – but if you're interested in participating in AHRQ funding, look on AHRQ's website for opportunities going forward. We do expect that the funding will continue, although we are uncertain of the level at this time. So we're very excited about our participation in this whole effort. I would say, in my experience in the government, this has represented one of the most rapid mobilizations of federal agencies and engagement of the private sector that I've seen, and I think when we have some early results, which ought to be out in the next few months, I think you'll see some dramatic improvements in our performance with reducing healthcare-associated infections. So thank you very much. Charles Denham: Thank you, Dr. Munier. We're blessed today with between 5,000 and 6,000 people. We have more than 1,330 hospitals that are online right now. What we'd like to do is now introduce Dr.

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Arjun Srinivasan, who is going to address the CDC's position. He is the leader who helps coordinate the internal and external activities related to healthcare-associated infections. Arjun Srinivasan: Thank you, Chuck. It's a pleasure for me to be here today, and I bring you greetings from Dr. Denise Cardo, the Division Director of the Division of Healthcare Quality Promotion from CDC. A group of partner organizations recently published a paper describing the four principle pillars upon which HAI elimination efforts should be built. These include adherence to evidence-based prevention practices; the alignment of incentives; innovation for research in emerging issues; and data for action; all of which must be underpinned by financial investment and resources. What I will do is describe to you a little bit about CDC activities in some of these important areas, as they support HHS activities to eliminate healthcare-associated infections. First, one of CDC's most important roles is in the provision of data for action on healthcare-associated infections. CDC's surveillance systems have long set the national standard for monitoring healthcare-associated infections, and our current web-based system, The National Healthcare Safety Network, is building on that reputation. The National Healthcare Safety Network has a number of important features and advantages. It uses standardized definitions, has built-in analytic tools for users. CDC provides user training and support for all users of the system at no charge. There is a developing infrastructure for electronic reporting so data can be submitted electronically to NHSN, thus alleviating some of the data-collection burdens; and there are more than 3,000 facilities that submit data to NHSN from all 50 states, which allows NHSN to serve as a useful tool for facility benchmarking. The strengths of the National Healthcare Safety Network have led to its adoption by a number of different organizations. First and foremost, it's used by individual facilities. And I'll be the first to acknowledge that a lot of the facilities that submit data to NHSN do so because they are required to, either under a state or now maybe a federal incentive program or requirement; but it's important to note that there are a lot of facilities that use NHSN voluntarily as a quality improvement tool. It has been adopted by a number of state health departments and state legislatures, more than 20 now, as a foundation for public reporting of healthcare-associated infections. It's being used by national and local HAI prevention projects. For example, as you've heard about, Dr. Pronovost's-led CUSP national effort is using the National Healthcare Safety Network as a platform for reporting information on bloodstream infections. HHS is using NHSN to help measure our progress towards meeting the HAI Action Plan goals for HAI elimination, and the Centers for Medicare & Medicaid Services are now also using NHSN, most importantly now as part of the inpatient prospective payment system, where facilities will be asked to report information on central line-associated bloodstream infections as part of the IPPS systems starting in January of 2011. But measurement is not CDC's only function when it comes to HAI elimination. We also play a key role in responding to emerging threats to healthcare safety. We respond to outbreaks in healthcare settings, both to individual facilities where we do send teams in support of efforts of state health departments to help facilities control outbreaks, and we also work nationally – for example, during the recent H1 influenza pandemic, when we worked to develop infection control guidance to prevent the transmission of H1 influenza in healthcare. Over the last several years, we have sent teams to facilities in more than 27 states to directly work with facilities and assist them, both on epidemiologic investigations to determine why outbreaks are occurring and help them stop the outbreaks, but also with our reference laboratories at the Centers for Disease Control to help characterize the pathogens associated with these outbreaks. CDC plays a key role in identifying and disseminating priority practices. As you've heard, CDC hosts the Healthcare Infection Control Practices Advisory Committee, or HICPAC, which is the federal committee that's responsible for advising the federal agencies on developing national evidence-based guidelines to prevent healthcare-associated infections. And as you've already seen and heard, these guidelines do form the foundation for a number of the checklists that have been so effective in reducing healthcare-associated infections, in particular, central line-associated bloodstream infections. How effective? You've already seen this data. They have reduced central-line associated bloodstream infections both in a project in Pennsylvania, and then, in the work published by Dr. Pronovost in Michigan, by more than 60% in each of those settings – very highly effective.

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We also are working at CDC to support new ways to prevent healthcare-associated infections and [to] address gaps in our current understanding of how to prevent them. You've heard that 70% of infections may well be preventable by what we know already, but that still leaves the 30% that we don't yet know how to prevent, and CDC is playing a role in trying to understand how to address that other 30%. We're working with a number of state health departments on multi-facility prevention projects to try and get better understanding of implementing HAI prevention efforts, and we also collaborate with and fund a number of academic centers to identify new strategies to promote HAI prevention. Taken together, we've seen that the dissemination of these practices has led to dramatic decreases, particularly in central line-associated bloodstream infections in intensive care units in this country; and this data is data from the National Healthcare Safety Network over the past decade, showing a significant reduction across intensive care units in central line-associated bloodstream infections, with thousands of infections being averted. So we know we're making progress, but we know we also have work left to do. And finally, CDC plays a key role as a lead federal agency for direct subject matter expertise in healthcare-associated infections. There is no question that there's an increasing awareness of the importance of HAI prevention, and because also of investments from the American Recovery and Reinvestment Act, there has been a surge of interest and demand for this type of subject matter expertise from CDC. The Division of Healthcare Quality Promotion at CDC is working to support a lot of these efforts, particularly a number of new state-based prevention efforts for healthcare-associated infections, with the development of resource materials for these types of prevention initiatives that are going on, a lot of them being led now by state health departments and involving multiple facilities in various states, and many of you on the call may be involved in some of those efforts. In recognition and support of those, we recently published, as Dr. Wright mentions, our first state-specific report on healthcare-associated infections in recognition of the important role that state health departments are now playing in leading HAI prevention efforts. That report did show an 18% reduction over the period from January through June 2009 in central line-associated bloodstream infections, and we're happy about that and want to build on that success. Finally, I'll close with the acknowledgment of the paradigm shift that all of you have heard about as part of this initiative, and that is to move our thinking away from accepting healthcare-associated infections as an inevitable part of providing care, towards an attitude that each healthcare-associated infection is potentially preventable. Thank you. Charles Denham: Thank you, Arjun. We'd like to remind the listeners to the webinar today that we have more than 5,000 to 6,000 attendees. Also, if you've come on late, there will be an audio transcript, both an audio recording tied to the slides, as well as a transcript, that will be available within 2 business days, so that whatever you may have missed, you may be able to take advantage of again. It gives me great pleasure to introduce Dr. Gary Gottlieb, well-known for great leadership of the Brigham and Women's Hospital, and in the last year now, the CEO of the entire Partners System. We've asked Gary to share with us some of the lessons learned in healthcare-associated infections and perhaps some insights as a CEO speaking to CEOs here nationally. Thank you, Gary. Gary Gottlieb: Thank you, Chuck. And it is a pleasure to be able to work in collaboration with other leaders in healthcare, as well as with terrifically motivated government officials to try to create a partnership to be able to totally eliminate healthcare-associated infections and a variety of the other challenges that exist within the system, to really try to seek perfect care ultimately. The work that I'm reflecting with you is work that has been done across the Partners Healthcare System in our safety programs, in our safety research programs, infection control, and reflects work at Partners at the Brigham and Women's Hospital and at Mass General Hospital. I'll specifically describe the experience at the Brigham over the last several years.

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Over the course of the last 10 years, we've become particularly interested in central line-associated bloodstream infections in the intensive care units. We were focusing our attention when it was observed by our providers in 1999 and started activities first in our medical intensive care units, then expanded to our surgical and other intensive care units at a hospital with about 130 ICU beds. Together the medical directors and nursing directors focused on standardized training that was mandatory for all providers. All incoming interns, because of the teaching nature of the hospital and the turnover, and key providers were required to have appropriate training. It was then extended to our simulator so that all interns who moved into our programs, who would be credentialed to provide central lines, would have to essentially have simulator training. A team-oriented approach was undertaken, and essentially the place was reorganized so that all supplies were immediately accessible to be able to have ease of process. Ultimately, a standardized central-line checklist for all insertion procedures was undertaken. And you can see over the course of the 10 years, there has been a remarkable reduction in central-line rates, with the only spike coming when we changed the way in which we were measuring so that we could compare outcomes across the system and across our area. Clearly, the notion to continue is to seek zero here in terms of these infection rates in our ICUs. You can see that there are substantial reductions from the perspective of the hospital in both unit costs associated with the management of these patients, as well as improvement in opportunity costs associated with a reduction in unnecessary bed-days to care for this patient population. One of the things we have talked about here today is the tension between investing in various kinds of safety in the pursuit of this kind of perfection and the tension that exists now in terms of healthcare cost reduction. Here there's a synergy that's obvious, and the ROI is extraordinary regardless of the perspective – from the perspective of the payer or from the perspective of the provider – in regard to both savings as well as improved margins. We also focused on preventing MRSA transmission within the hospital. We had a multi-pronged strategy. First, we focused on hospital-wide hand-hygiene rates – another area that we thought we'd never be able to improve adequately. With surveillance with a variety of programs around really marketing our programs as well as feedback to provide us in all areas, we increased hand-hygiene rates among our providers from just under 75% to close to 92% persistently over the course of two years. Similarly, we also worked together with those folks who are managing the environment, people in infection control as well as the clinicians, to really focus with every bit of attention on trying to reduce the exposure of the environment to the possibility of greater infection. We performed active surveillance cultures and we used contact precautions for infected and colonized patients, and you can see that each of these interventions had a substantial effect in ultimately reducing the MRSA rates within the hospital. Clearly there's more to go, but we're moving in the right direction here as well. Additionally, we've had several interventions that are focused on healthcare-associated Clostridium difficile infection rates, first with enhanced CDI precautions, and then with a set of treatment guidelines as well, again reducing the number of CDI cases per 1,000 patient-days in the hospital. So overall, these efforts, which have been team efforts that have cut across disciplines, which have had consistent feedback and really persistent sets of intervention, have allowed us to have an 80% reduction in central line-associated bloodstream infection rates, a 50% reduction in MRSA acquisition rates, and about a 40% reduction in C. difficile infection rates. Across the system, across Partners, you can see our efforts in central-line infection rates, as an example, have gone down in parallel. We've used each other as benchmarks and have used best practices across the system, and have been able to achieve rates of zero in our community hospitals for several quarters persistently, which is really the outcome that we expect in the rest of the system. Thank you. Charles Denham: Gary, you have done wonderfully on time. If you had the opportunity to speak to CEOs across the country and can tell them one thing about healthcare-associated infections and your advice to other CEOs, what would that be? Gary Gottlieb: The people who are working at the bedside have brilliant and wonderful ideas as to how to really redesign the process of care. It's our responsibility to facilitate the great works of people who are

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much more talented than we are, and if we look at the environments that we have, we've made them unduly complex and difficult for people to function in. If we help them to help those areas become simplified, our ability to do no harm increases remarkably. Charles Denham: Thank you. Wonderful. We will now shift to the Mayo Clinic, from one great role model to another, and I'd like to introduce Dr. Robert Cima. Dr. Cima is the Vice-Chairman of Quality and Safety at the Department of Surgery in the Mayo Clinic in Rochester. He works hand-in-glove with Dr. Steve Swensen, another one of our great leaders in quality, and will be sharing with us now a deep dive into surgical-site infections and some focus on the financial aspects when one pulls out comorbidities, and uncomplicates and unwraps some of the issues that pertain to surgical-site infections. Dr. Cima? Robert Cima: Thank you, Chuck. I want to thank everyone for participating and allowing me to participate with this. We're going from a very high level to basically down in the trenches. As a practicing colorectal surgeon, I'm acutely aware of surgical-site infections, as colorectal surgery is associated with probably the highest rate of surgical-site infections in acute-care hospitals right now. And the problem is, the data that's out there to drive change is quite confusing. It's quite vague in the sense of very large numbers about dollars spent on surgical-site infections. When you're trying to drive change, you need to have some specificity. That was one of the things I was looking for in our project. Difficulty in colorectal surgery, as in any acute-care hospital right now, is that it's a heterogeneous patient population. We are not dealing with the standard patient that we can base policy and payment on. There are heterogeneous types of procedures, from very minor procedures to very complex procedures in patients who have high acuity. And there are multiple postoperative confounders that make attribution of cost difficult. Our patients are sicker, they're older, they have multiple comorbidities – so how do you know, from administrative data or billing data, that what you're dealing with in excess cost per hospitalization isn't something do so with their underlying illness that is exacerbated, or other acute conditions that may arise that are not directly associated with the surgical-site procedure? I wanted to look at trying to find a clean data set, a set that I could look at and say, "What is the actual cost in my setting?" I looked at one hospital, the Mayo Clinic, Rochester. We have a group of colorectal surgeons and we have a high volume of colectomies performed. I wanted to tie that with data that was very reliable on outcomes based, using the National Surgical Quality Improvement data set, which many hospitals are aware of or using as a systemic sampling of procedures. I collected only those that were colectomies by CPT. That data was extracted by impartial and trained nurse abstractors that collect extensive pre-op, intra-op, and post-op variables, including 30-day outcomes. So it's not just in-hospital infections, but 30-day outcomes, which are collected with over 95% completion. I just wanted to look at those patients who had no bad outcomes – not just surgical-site infections, but any adverse outcome – versus those who similarly had no other adverse outcomes save one: surgical-site infection. We compared almost 2,000 patients to about 160, and just looked at what was the cost of care. It was a very simple study just to look at what was the cost and broke it down by both aggregate as well as by the three main definitions of surgical-site infections as outlined by the CDC. The median cost increase for surgical-site infection was around $4,000, and these are all statistically significant differences. When you start breaking it down into whether it was superficial, a deep-incisional, or organ space, the cost goes up dramatically, with ranges from a few hundred dollars all the way up to thousands of dollars. Deep organ-space infection that may require re-intervention in the operating room can increase the cost of care to almost $45,000 on average. So what this really showed is that you need some specificity and you need to eliminate confounders, but what it does show you is that no matter which way you do it, it costs money if these outcomes are adverse for the patient. So what we looked at, basically, in summary, was that at a high-volume institution with a standardized process for colectomies, even in what we think are very good hands and a good system, a surgical-site infection is associated with a significantly increased cost. The most common ones, even the ones that people think are superficial and don't have a huge impact, on average are very expensive for patient care and morbidity – almost $2,000 per event. And obviously, if we are able to reduce these, it would have a

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significant decrease in postoperative patient morbidity, of course, which is the primary goal, but secondarily, cost. Thank you. Charles Denham: Thank you, Dr. Cima. And so the approach of taking a standardized patient approach to identify clinical, operational, financial issues, the givens and variables and assumptions that are really important to making decisions along the trajectories of patients, now we'll be handed to the other Greenlight participants in the collaborative, and those would include Vanderbilt University Medical Center, the Cleveland Clinic, the Brigham and Women's Hospital, and others in our Greenlight collaborative, with the goal of identifying a common set of givens and assumptions that CFOs at front-line hospitals in our test bed might be able to use. So we're very grateful for the collaborative group in this room here at the National Press Club, who have committed to do that work on behalf of the rest of the nation to help identify what those costs really are and the opportunity. The same standardized patient approach is being undertaken with the CPOE Flight Simulator. We had Dr. David Hunt talk about CPOE, and the CPOE Flight Simulator developed with great leadership on behalf of Dr. David Bates and his team, who are here today, and Dr. David Classen, was the approach of creating a standardized patient who could be downloaded by an organization process through their CPOE system and then identify where the gaps are. So this standardized-patient approach has really been very helpful in illuminating choices – not necessarily the granular detail about very, very uncommon things, but very common things – and understanding where those opportunities are. What we'd like to do now is move to Dr. Stephen Grossbart. Dr. Grossbart is the Chief Quality Officer of Catholic Healthcare Partners, and is going to really focus in on the cost of harm. One of the really important and often left unattended areas is to identify, what does it really cost us when we do harm to a patient, and what implications might that have on how many patients we have to take care of appropriately to pay for our harmful event, which we really haven't been able to identify the way that we would like to. Steve will go ahead and walk us through that. Stephen Grossbart: Thank you, Chuck. And I'd like to thank you and the Texas Medical Institute of Technology for inviting Catholic Health Partners to join you today, and ... we have technical difficulties ... a sneak preview there for the next presentation. Is this going to cost me my time, too? Charles Denham: It won't cost you your time, Steve, because we know you have your notes. Go ahead and speak from your notes, and we'll get you ... Stephen Grossbart: Well, I'll get going. First of all, just a little background. Catholic Healthcare Partners is a 34-hospital system with our headquarters in Cincinnati, and for those of you participating on the webinar, I can assure you that we have a hospital just like your hospital. We range from rural, critical-access hospitals, to programs with significant graduate medical education programs and level-1 traumas. I want to take this time to talk about how we've initiated our journey to eliminating harm, and then more recently turned it into a chase, chasing zero, to borrow from the documentary. We have made a commitment as an organization, and we have accountability to our Board of Trustees to eliminate preventable harm as part of our five-year strategic plan. This accountability is key to our approach to improving patient safety. We've also embraced the NQF Safe Practices; we run internal learning collaboratives among our 34 hospitals, and we have robust measurement systems, and we've adopted Lean and Six Sigma techniques to improve care. One of the things we needed to do when we initiated this objective was to focus on building will. This slide is real compelling. One out of every four of our patients who dies in our hospitals has some evidence of potentially preventable harm, and we are actually among one of the top lowest-mortality-rate hospitals in the nation, so this is probably typical of your hospital. If you look at your patients, pull the charts, you're going to find harm, or compare your mortalities to existing known types of harm, such as hospital-acquired infections and so on. We've also done extensive data analysis to get a sense of – what does it cost us to harm a patient? I want to focus on two measures of harm: central line-associated bloodstream infections, we've talked a lot about that today. In our system, we lose $16,000 per patient when they

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acquire a central-line infection. That's compared to patients who have a central line without an infection. Those patients have a 10-extra-day length of stay in our hospitals. I also want to talk briefly about surgical-site infections. We had about 250 last year in our system of just hospital-acquired, identified before discharge, out of some 240,000 patients and about 60,000 to 70,000 surgeries. Average losses on a patient with a surgical-site infection – $2,700 – adds 8 days to the length of stay. With this kind of information, we decided to build a goal to reduce five common in the nation preventable events: pressure ulcers, central-line infections, post-op DVT, post-op sepsis, and falls and trauma. And we have a goal to eliminate these to zero in four years. This year our goal was 25%, and we've actually reduced about 33% during the year. The next few slides show some data about that improvement, so we have reduced our rate of harm, yet we can't lose sight that we're still harming over 40 patients a month, and it's important that you present this kind of information to your Board of Trustees to keep that will alive. In the area of central-line infections, we've seen a good reduction, resulting in about $600,000 of increased margin; yet again, we need to keep a human face on harm. And then surgical-site infections – again, some improvements, resulting in about $125,000 in increased margin. If we look at – and I call this slide "the Full Monty" – we have gone through our data systems and identified every type of harm there is – infections, pressure ulcers, falls, etc. – and we identified about 4,000 patients who have some form of harm in our system. We lost over $3,800 per patient on those patients. The length of stay increased 20,000 excess hospital days, $26,000,000 in excess, variable cost $15,000,000 negative impact on margin. We only make $57 on the patients we don't harm. It takes us 68 patients to offset one harmed patient. So in closing, I just want to emphasize that this is the right thing to do, and there is a profound financial case for addressing this. Charles Denham: Steve, thank you very much, and could you give us the number of discharges in a year and the footprint of your organization? Stephen Grossbart: We average about 250,000 discharges a year. Charles Denham: Fantastic. And so we really congratulate you for this work. Our approach with the Greenlight Program is to build impact calculators, which we'll actually be distributing fairly soon, in partnership with APIC and other organizations that will allow groups to take different data sets to be able to get a good feel for their cost. But this kind of analysis down to the cost per harm, and then into the detail on specific categories of patients, has been very helpful. Stephen Grossbart: And those calculators will accelerate this work, because not everyone has the capacity to do this kind of analysis at home. Charles Denham: Thanks very much. We'll now move to Dr. Mike Henderson from the Cleveland Clinic, another one of our Greenlight collaborators. Dr. Henderson is a practicing surgeon, and has been a leader in the surgical department of the Cleveland Clinic, and is now the Chief Quality Officer; and I think he exhibits the kind of leadership that we need to see across the country, where he's engaging physicians and helping the organization make engagement of physicians and physician leadership really a positive thing. Where historically, the quality and patient safety may not have been the most attractive area to be involved, Dr. Henderson has made it cool to be in quality and safety. Michael Henderson: Thanks, Chuck. I'd like to have that reputation. Really, I could probably stop just with the title here and not go much further, because I think it is, in my book, how we do get physicians engaged? I think that's often the hardest part of your workforce for quality improvement, and then the team-building to drive quality improvement overall ... sorry, going backwards. And really, three to four brief points: Do we set the right agendas, don't do everything at once, develop the team, get the results, and then celebrate the successes as you move on through. The agenda is about identifying the gaps and having very specific goals and targets. I think these are lessons we all know and learn, but I would emphasize again that something I found particularly important as I looked at how we worked at the clinic

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in developing how we moved forward: never forget your front line. We can sit in rooms, we can develop the best plans, but that reality check out there to your front-line people who are going to implement these for you – don't move forward until you've really given them the chance to comment on it. Then leadership commitment and ultimate communication. So the teams really are, I believe, much better if one can have them physician-driven. So the physician leadership gives a lot of credibility. But you've got to build the right balance to the team. Yes, the nursing projects are nursing-driven, but for a lot of the quality improvement, the kind of things we're talking about, particularly around the HAIs, get your physician leadership in there. Then the breadth of the stakeholders, who really are the people you need as part of that team. Good project management, and we've heard this talked about a bit already today, is how do we manage things through to get the jobs completed and the tasks done? Give people the time to do this. This isn't something you do in your spare time. So making a commitment up-front, so people really can get involved in it. Getting the results – I think it is about some of the clarity of the metrics. It is having clear definitions. I think this is particularly important when we look at some of the HAIs where some of the definitions have not been totally clear, and I think working with ... across the hospitals in our system, certainly one of my eye-openers was a recognition that not everyone had the same definitions on their radar screen. So making sure that we all work in the same way and have clear definitions, and consistent data management analysis are important. Priority on the timelines – look for those short-term wins. I think getting things up-front so people really think something is happening early on, again a critical step. But then setting those, as I said, those long-term annual targets, very specific targets that you're going to drive for. Don Wright brought up 50% reduction over four years. Again, that became for us one of the major targets around our central line-associated bloodstream infections. Let's get there, but Don, we only took one year as our target, and we're 40% of the way there with a few months to go yet. So hopefully we'll hit that in that time frame. And then accountability. Again, this is one of the things I know that we struggle with. Who really owns the project? Certainly when we started down our quality path, I felt I owned everything. How do you get it so that the people who are really doing the work understand this is part of what they do, that they have the ownership for it? How do we provide the right support for that? I think for many of the quality improvement teams out there, you are the enablers. And I use this term a lot, of providing the umbrella oversight to support the local ownership for the quality projects going forward. And again, I think that is particularly important with this group of initiatives as you move on through. As a surgeon, you know, I worked in the quick-fix arena. We'll fix it, and then next year it will look the same again. So how does one develop that sustainability? And again, I think this is where good project management is one of the key things that I learned, certainly as I moved from my research academic career to my longer-term quality career, this is something that I think is critically important in developing the projects as you move forward. I don't want them just fixed now; this is something that's got to stay there long term. So as for the success, number one, it is for the patients. It is for the patients, absolutely. But celebrate for the teams. You develop the teams. Don't just assume. Say thank you. Get them up there. Give them the credit. Make sure they are getting support, and celebrate their successes as they come through. And within that, I think recognizing the individuals who really drive it. By celebrating these successes, there is no question it helps inspire that group to want to do more of it. Whereas the list of hospital-acquired infections is a long list, I think picking them off one at a time – and I agree with the agenda out there – I think we need to build the success from project to project, from infection to infection, really along the lines. Again, I believe in the physician leadership parts of these, I believe in building the right teams, and then building it on good data that really can help drive the initiatives. So thank you very much. Charles Denham: Thank you very much. We really appreciate your help, and the Cleveland Clinic has been a terrific contributor to the Greenlight Program. I'd like to shift gears now and have a question-and-answer opportunity from our panel here at the National Press Club, and I'd like to invite Thomas Hamilton to come back up to the podium. We have a question for him and would like him to kind of explore a couple of the issues that are really pertinent to our challenges that we face out at the front line. The question that we have, Thomas, is that patient investigations are increasing in some states like Ohio. Is this a trend, to see these increased patient investigations, and are there any changes in the strategy? Is

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field accreditation changing from the HHS perspective? So we're seeing an increased number of investigations. Is that a trend, and can you give us some insights as to maybe any strategic focus areas as you go forward? Thomas Hamilton: We are trying to be more responsive to complaints that we receive, and we have an obligation to do so. We have noticed some increase in complaints, but not a very substantial one. It may change from state to state, and there will be a natural variation that occurs every year, but apart from being particularly as responsive as we can, there's no special agenda on that, other than over time, as I indicated, to be focusing more on the quality assurance and performance improvement. We are doing more work with the accrediting organizations, we're doing more validation surveys, and over the course of the next few years, we are increasingly trying to align the work of the accreditation organizations with us, so that's something that you could hear more about in the future. Charles Denham: Do you have any advice for our organizations at the front line when such an investigation is undertaken? In working with you over the last four or five years, I have had a great appreciation of your appreciation of the systems issues, and you've constantly emphasized the behaviors that are so key that you're looking for after these specifications, and what you're looking for in improvement plans. Can you address that? Thomas Hamilton: Well, I would hope that every organization that has a survey can use any of the survey results that come by as a form of feedback. We are all on the same page, working towards the same goals, and that is good quality of care, good patient safety. I appreciate that it is often very difficult to have an external group come in and assess the quality in an organization, particularly with the authority that we have to insist that, if there are quality-of-care problems, they be corrected. But I would encourage everyone to use the surveys as a tool, and if you approach it from that direction, we can really be your ally in trying to make sure that you have good quality of care. Charles Denham: Anything that you can share with us regarding some of the lessons that you're learning from the recent investigations? Thomas Hamilton: Well, one of the areas that I'm especially encouraged in is in the area of solid organ transplant, where we have new conditions of participation, and we're discovering that most solid organ transplant programs did not have their own internal quality assurance and performance improvement system. And in that area, we also have very good data where we can calculate risk-adjusted expected outcomes. And in our regulations, we establish a certain threshold, which says there's great room for internal quality improvement, but at a certain level – where death rates, for example, are more than 150% of the expected number – that transcends a certain level of acceptability, where it is no longer acceptable. And then we've been working with those hospitals to say, you have access to this data all the time – what are you doing to pay attention to the data, develop your internal improvement systems? And we're seeing some very good transformations where organizations have developed their QA/PI programs, where they have been able to turn around what has been maybe a four- or five-year history where patient deaths have been twice the number expected, and they've been able to bring those down into an acceptable range, and everyone is better off. And they've been pleased with the results, and we have as well. And that's exactly the kind of work that we just love to see. Charles Denham: One final question as we transition back to Dr. Rapp, who has been able to come back from a prior speech and now address our group, and that is: Thomas, could you address the issue of governance, and the fact that there really are linkages and there are expectations of CMS of governance oversight, accountability, and a direct linkage. You and I have had that conversation three or four times, and I think it's not known generally out in the marketplace, the expectations of governance oversight beyond the administrative executive team. Thomas Hamilton: And that, in our regulations, is indeed an expectation, that the governing body will have an agenda for patient safety and quality of care, and that they have a very direct role. So if the

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governing body, if the trustees, the executive group, is not paying attention to the quality-of-care agenda, then that will increasingly be an issue in the future. And we will be doing our utmost to encourage that kind of attention, mainly to make sure that the systems of care are being paid attention to. Charles Denham: Thank you, Thomas. As always, you're a wealth of information, and we understand that CMS has a carrot and a stick group, and we know that you sometimes need hugs because you're in the stick department. So thank you very much. Dr. Michael Rapp has just come back from a speech here in Washington, and fortunately, everything is close and he has made the effort to come back and speak to our national audience. We have over 5,000, almost 6,000 people, and about 1,350 hospitals that are on, and we'd like to remind them that if they've missed anything in the slides or in the audio, because we are transmitting from the National Press Club, that everything will be available within 2 business days in an audio recording as well as a transcript. Dr. Rapp? Michael Rapp: Great. OK. Well, it's a pleasure to be here and to speak to people near and far. So you've just heard the stick, and I'm the carrot. Sometimes our carrots seem like sticks, though, because sometimes we consider an incentive the absence of a penalty. So we'll talk a little bit about that. We like to think in terms of overall objectives, though, as we put forth our incentives for our quality reporting program, so the Triple Aim is something that we've begun to talk more about since Don Berwick has joined as the administrator for CMS. The Triple Aim identifies really three things at once. We frequently have talked about quality, but haven't as much talked about cost being an essential part of what we're trying to accomplish. Here you see on this slide, the Triple Aim of better healthcare for the individual, better population health – so not just interaction on a one-by-one basis, but thinking of the population as a whole – and lower per capita cost, but lower per capita cost that's done without sacrificing quality. As a matter of fact, we wanted to be based on improved quality rather than some adverse impact on the patients. So those quality aims, if we look a little bit deeper into that, we have better care for individuals. You, I'm sure, are aware of the six IOM Aims that describe the aims for better healthcare – it's effective, safe, patient-centered, timely, efficient, and equitable – so as we think about better care for individuals and as we adopt measures for this, we think about those. And then, better health for the population is seeking to address such things as prevention, but just look at what you're doing from a population standpoint as opposed to just the individual. And then again, reducing per capita cost – reducing cost while improving healthcare and population health. Now, at CMS, as I mentioned, we do have the stick on here as one of our available tools, but we work – at least in the area that I'm involved with – more with the carrot, or encouragement, or information and technical assistance. Some of the tools we have to improve quality and value are listed here. Contemporary quality improvement – we have the QIO program that's available all over the country. All states have a QIO that works to improve quality in that area. We are in the ninth Statement of Work currently, and there will be a tenth coming out soon. Transparency – by that, we're referring to public reporting of quality measure results. We have many websites on which we put quality information – the Hospital Compare website, Dialysis Facility Compare, Nursing Home Compare, Home Health Compare – and as a result of the Affordable Care Act, we're required to have, starting January 1, 2011, a Physician Compare website that will be expanded over the course of several years and contain a wealth of information. And then, in mentioning the carrot, we have financial incentives to try to encourage people to report the quality information to us. Many times, quality information is submitted on a voluntary basis, but what is purely voluntary, with no encouragement financially, a lot of times is not done. For example, with the Hospital Inpatient Quality Reporting Program, when we had a pure voluntary program, only about 400 hospitals reported. When it was changed to even as low as a 0.4% incentive, it increased. It now is 2%, and we have virtually every hospital that is paid under the Inpatient Perspective Payment System – they report these measures. So we have a broad array of measures on that, and we also have incentives for the other arenas, including dialysis facilities, home health, and so forth. In the Affordable Care Act, and actually before that, we are now moving to not just paying for reporting, but paying for better performance. The ESRD area was the first value-based purchasing program, which

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in 2008 was authorized by the Medicare legislation passed that summer; but as a result of the Affordable Care Act, we will have a hospital value-based purchasing program where hospitals will be differentially paid on the basis of quality, accountable care organizations, which is a new type of concept, really, but it deals with integration of care, and that really does focus on a population. In that instance, those organizations that meet the qualifications and meet certain performance standards for quality will be able to share in the savings. So it's a completely new way of paying for services. They will get the basic fee-for-service payments, but in addition, will [also] share in the savings that are the result of better quality. And then for physicians, we have the physician value modifier that by 2017 will apply to all physicians, being a combination measurement of cost and quality. The regulatory vehicles you've heard about – the national and local coverage decisions, demonstrations, pilots, and research – all that we bring together to try to work on improving quality. What this has to do with the HHS HAI Action Plan is, we can bring all those vehicles together, and by having all of them focused on a single goal, we make a lot more progress and we leverage our capabilities. You're familiar with the HHS HAI Action Plan and the seven measures in there. I think this probably was already discussed. Six of those are collected through the CDC, and one of them, the Surgical Care Improvement Project, is captured through our Hospital Quality Inpatient Reporting Program. That has been on our website for several years. And the central-line bloodstream infections, as I will indicate, and the surgical-site infection -- we are partnering with the CDC to capture that in a single way. If we look at our contemporary quality improvement, as it relates to HAIs, we have, in the ninth Statement of Work, the goal of reducing MRSA infections. These are, again, encouragements where the quality improvement organizations engage participants within the community to address this issue. And we'll have a tenth Statement of Work, and in that, we would expect to have more attention to the healthcare-associated infections. As far as transparency, this is a big area of alignment and overlap, and, really, an opportunity to make a big difference. In the CDC data collection system with CLABSI and SSI, again, that is completely voluntary, although in quite a number of states, it's required by the state. As I mentioned, virtually every hospital, if we put it in the Hospital Inpatient Quality Reporting Program, will report these measures. What the promise for this is, since we included the requirement for hospitals for their 2% incentive to report the CLABSI measure to the NHSN, then we would get the information from them to be able to post on the website. Starting January 1, 2012, the SSI, we're going to leverage and take advantage of that excellent collection system and not burden the hospitals with having to do things two different ways. So we'll in effect be able to have the benefit of the public health submission plus our ability to publish this information on the website; and once we do that, any measure in our Hospital Inpatient Reporting Program has to be published there, and that helps drive not only quality improvement, but also helps the consumers have better information about the hospitals. In the Affordable Care Act, we have the ability, as I mentioned, to take it one step further, in that measures that are on our Hospital Compare can then be ... there can be a differential payment on the basis of performance, and so all of the measures on Hospital Compare are available for that. As a matter of fact, they have to be on it and have to be in our inpatient reporting program. You've already heard about the conditions of participation, so I won't go into that, but that's just another vehicle that aligns with what we do. I thank you for the opportunity to speak to you. Charles Denham: Dr. Rapp, because we are moving into our Q&A session, I'm going to ask you a couple of questions that will allow you to answer for our national web audience and also for the Discovery Channel documentary. So we'll ask you just a couple of questions. The current models for value-based purchasing use the core measures and HGAP scores for calculation. Could you address stratification, hospital size, and those implications? And then we'll have one more question for you. Michael Rapp: OK. Well, as I mentioned, for the value-based purchasing for hospitals, the measures have to be on Hospital Compare. There are ... in terms of how the value-based purchasing is exactly going to work, that will be the subject of rule-making, so CMS speaks better in the past tense than we do in the future tense, unless it's in formal rule-making context or the Secretary sets forth what they're going to do, so I can't really probably give all the details. I wouldn't even know them, because they have to be

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developed. Suffice it to say, though, the way we do it on Hospital Compare, we look for differences. So we, for example, on our mortality measures, we basically don't consider hospitals that have a small number of cases, because we don't believe that they are sufficiently discriminatory in terms of performance. So I would think, without stating exactly what will happen, those sorts of things will be taken into consideration in a value-based purchasing as well. Charles Denham: A number of our audience are hospital CEOs who are nonclinical folks, but they allocate resources and they allocate their sticks and their carrots in their organization. Can you give us some insights as to the HACs? Just quickly, what they are and why they might be really important to our administrative and professional administrators who are nonclinical, and anything that you can share with us, that you're able to, about the timeline of HACs and implications? Michael Rapp: Well, actually, the healthcare-associated conditions that started off as a payment – not penalty, exactly – but, for their complications, most of them were started off as "never events" as identified by the National Quality Forum, so things that shouldn't happen ordinarily, such as leaving instruments behind at surgery, having blood transfusion reactions, and so forth. So most of them are that. Some of them overlap with healthcare-associated infections – specifically, central-line bloodstream infections and catheter-associated urinary tract infections. We adopted or incorporated eight of these into the Hospital Inpatient Quality Reporting Program for this next go-round, the rule that was finalized in August. So what that means is, these measures will be calculated from claims, will be published on the Hospital Compare website. As such, they would be potentially available for value-based purchasing. So I think from the CEO's standpoint, at the inception of this policy, the hospitals would not be paid for those complications. So if you leave an instrument behind, one wouldn't be paid to take it out, in effect. But now, the potential is there – well, first of all, we need to publish this information on the website, which will help drive improvement – but in addition, it would be available for value-based purchasing, so there would be a differential, potentially, with that if that were to happen. Charles Denham: Thank you very much, Dr. Rapp. Michael Rapp: You're welcome. Charles Denham: We're going to ask Dr. Arjun Srinivasan to come back and step up to the podium and speak on behalf of CDC, and help us with some of the challenging questions that we have. One of them is, in healthcare reform documentation information, there are three different definitions for central-line infections. This issue of definitions becomes very, very important to us now as we're heading into the next 24 months. Can you share with us what we should know about those definitions and what's important, practically speaking, as we have a number of quality leaders across the country who are online today? Arjun Srinivasan: Yeah, absolutely. I think that consistency in definitions, as has been pointed out, is vitally important. I think the CDC, the NHSN definitions – and it's important to note that those NHSN definitions are the same ones that are now going to be used for the IPPS by the Centers for Medicare & Medicaid Services – so I think you are seeing some alignment with the CDC's NHSN definitions. These are standard definitions, have been used by a number of organizations, have been used from the prevention perspective, by the CUSP Project – that's the definitions that they used as well – so I think you are seeing some convergence, at least on this from CDC's NHSN perspective and from some of the quality improvement initiatives using these NHSN standard definitions. Charles Denham: So as we go forward and we start to talk about some of the controversial definitions that include ventilator-associated pneumonias, can you give us some insight as to where we're heading on some of these really controversial areas? Arjun Srinivasan: So ventilator-associated pneumonia is a very important topic, and it was the subject of one of the discussion groups at a recent meeting that was convened by the Department of Health and Human Services. And I think that we're not there yet with respect to finalizing a new definition for

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ventilator-associated pneumonia, but I think that that discussion was critical in bringing together stakeholders, including folks who do critical care, bringing intensivists to the table, to have people give us information, give feedback, and provide thoughts on what the right definition would be. So there is a lot of active discussion about what's the best definition for ventilator-associated pneumonia, looking at data that's applicable to that, and then trying to move forward on what the right definition needs to be. Charles Denham: As the Co-Chair of the National Quality Forum on Safe Practices, and we have specific Practices for each and every one of the HAIs of these infections, we found ourselves with ventilator-associated pneumonias in a little bit of a dilemma. The national collaborative effort on the HAI compendium was very helpful to us, because we had national societies working together with great front-line organizations and experts. Do you see that as something that is valuable to you as you go forward – these kinds of national collaborative input areas – and could we expect to have more collaboration with CDC since you're the internal/external? Arjun Srinivasan: Yeah, absolutely. Without question. So these types of collaborative efforts, these types of partnerships, they are definitely critical in getting experts, just like we're doing here today, to get advice and the wisdom of people who have been on the front lines, who have implemented these types of systems, to hear from them what works, what doesn't work, what has been really effective, what has been most cost-effective. Those types of collaborations I think are critical moving forward. Charles Denham: Terrific. Thank you very much. We'll now turn to Dr. David Hunt and have him return to the podium, and we'll be talking about healthcare information technologies. Specifically, David, this issue of meaningful use. You're still a practicing surgeon. I think you have great credibility with us out at the front line. If you were at a St. Elsewhere Hospital today and had to really understand meaningful use, its implications, and have the best shot at getting these incentives, what would you tell your team with what you know today, being in the Office of the National Coordinator? What practical things and advice would you share with a front-line hospital that didn't have a big IT infrastructure? David Hunt: Well, the first thing I would say is, they've got to go out and reach out to their Regional Extension Center. They probably, hopefully, have already heard from or have been touched by their REC already, to have some input in terms of the technical support and assistance that they can give. That's probably the single best thing that you can do. There are feet on the ground – there are boots on the ground, if you would – from ONC that can really help in terms of helping practices and providers of all sizes, but particularly those who are in areas that are a little bit more challenging, like rural areas, for example, to really figure out and work their way through all of these meaningful use rules. They really are becoming quickly, and have already been able to demonstrate, that they're the experts in the field on meaningful use, and that's what I would say is the first big thing. Charles Denham: Can you define what one of these organizations is? Just give us a ... David Hunt: Sure. A Regional Extension Center is a group of about 60 ... actually, now we have 62 grantees who have been specifically charged with being able to go out and provide technical assistance in terms of helping providers, hospitals, practices, actually navigate to meaningful use. These groups are a somewhat eclectic group. That is to say, in some situations, they are university-based groups, some are QIO-based groups, and others are consortia of stakeholders within the community who actually came together to help locally the providers in one local area in a state or in an area within a state, actually ramp up, adopt, implement, and begin to meaningfully use this new technology. Charles Denham: A final question is regarding structured and unstructured data. You and I have had this conversation before. How soon will unstructured data and mining of unstructured data that may not be in just defined structural elements that we use every day and the linear record of patients start to become of value and of interest as we look over the horizon to the next three to five years?

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David Hunt: First, we should all work from, I think, pretty reasonable assumptions that structured data is valuable, particularly if we want to be able to mine or be able to actually analyze it, although we do have a very, very realistic view of where we are currently within health IT, and recognize that it will take some time before we're able to have a full compendium of structured data elements that are available for the electronic health record. The biggest thing that I would say in moving forward is we'll need the input of the community. We need to hear the voices of the community in terms of what will be the best uses and the best elements for structured data, and which elements are just too soon to actually be able to begin to use that. To that end, the Health IT Policy Council is constantly seeking testimony from groups of stakeholders within the medical community to help inform decisions around that. It's tough to say exactly when that will come to be, but we do have three major periods for meaningful use: the 2011 period is the first stage that begins, and then we'll have 2013, and then 2015. I think that you'll begin to see a progression or an elevation of the thresholds of what we should be including within the definition of meaningful use over that period of time. Charles Denham: Great. Thank you, Dr. Hunt. Final question – here I tempted you by saying you're almost done. The CPOE Flight Simulator is a tool that allows us now to really verify performance of health information technologies. It has now been used by The Leapfrog Group to help organizations download a standardized patient, assess the processing of their CPOE systems, and upload that. Are these kinds of tools that verify HIT performance going to be the wave of the future, one, and then number two is, what is the concern or how do we deal with the concern of potential HIT technology accidents? Whenever we introduce a new technology, when we've done it in aviation, nuclear power, and submarines, you know, we always have a risk management scenario that we kind of build under it as we adopt new technology, and we've not been good at that at healthcare. So CPOE Flight Simulator – wave of the future? And second question is, this issue about HIT accidents, and is that foremost in mind or part of that mindset? David Hunt: I think tools such as the Flight Simulator or the simulation tools are going to show us a great deal about the implementation of this technology, so I can see us growing in a number of ways. You know, I often use a quote from Mark Twain, that "a man who carries a cat by the tail learns something he'll learn in no other way," at the end of my presentations. And I do that to point out that we're going to learn things that we can learn in no other way through the implementation of this widespread, robust technology. So I think what we'll do is, we'll learn to innovate and find a number of different resources, and I think the simulation has got to be at the top of the list, because it has already been a relatively proven technology. Now to that end, the office has actually implemented or let out a number of resources to look at the questions of how can we make these systems safer – just the IT systems themselves safer – and how can we begin to actively continue to innovate along these lines? We are looking forward to the results of – they call them our Sharp Grant – investigators who are looking into ways to actually begin to innovate around health IT, as well as some of the grants around patient safety and EHRs that we expect to have come in. Charles Denham: Great. Now I know that Dr. Wright will be tugging on my leg to go, "Wait a minute! Healthcare-associated infections ... ,” you know, so we can kind of conclude on the note of what the subject matter is. So I'm going to ask even one more question, and that is regarding the AIIM Systems – the Automated Infection Identification and Mitigation Systems – these systems that are now available that allow us to integrate laboratory data and clinical data to identify new patterns and not look in the rearview mirror and say, "Oh, well we had an infection," but actually identifying on a more real-time basis in a real dynamic process, identify infections and be able to mitigate them. What's your take on those so I can have Dr. Wright give me a good nod and a smile that we finished on an HIT focus on infections? David Hunt: Well, I think systems like that are some of the really new and promising things that are on the horizon, and they all really have a predicate of a robust critical mass of information technology throughout that the clinicians actually can use. So I think all of the systems such as that type of technology, and a number of things coming down the pike, are looking very, very promising; but the stumbling block for all of this has always been, "Well, not enough folks use it. We don't have enough to really see whether or not it's useful across the board.” With this initiative around meaningful use, I think

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we'll be able to overcome that threshold, and as I said before, we're going to learn so many new ways and so many new things about how to best implement this. It's really one of the most interesting times that I can imagine.

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Charles Denham: Thank you. Thank you, David. I really appreciate it. We'll now close with a couple of questions for Dr. Bill Munier from AHRQ, from the Agency for Healthcare Quality and Research. We'd like to have him answer a few questions regarding a very hot topic to a lot of our patient safety officers who are across the network, and that is the patient safety organizations. Bill, can you share with us where we are, the common formats, where we are with patient safety organizations, and just give us maybe some insights into the next year ahead? William Munier: Sure. I think most people know, patient safety organizations are a relatively new phenomenon that provide uniform protection nationally for both privilege ... in other words, results of review at the local level are privileged – they can't be used in malpractice cases – and also impose confidentiality provisions, so the information is protected, supposedly allowing a culture of safety to flourish. There are two aspects of the program from our standpoint. One is operationally getting PSOs going across the country, and we now have 84 PSOs in 30 states. The other aspect of it is trying to aggregate the information, so we PSOs can learn from each other and we can learn from PSOs nationally. Obviously, if one is going to aggregate information on quality and safety, it has to be comparable. So we have been issuing what are called "common formats," which are common reporting definitions that are both clinically defined and electronically defined. And we now have the third release out for Hospital Common Formats, a beta, then two actual versions. There's a whole process that I won't go into, but it involves public comment, and we've had lots of feedback and worked with the agencies on that. Where we are with that now is that the software developers are currently – and not just software developers, but organizations that do their own software – are actually incorporating common formats into their automated systems right now. We expect to be receiving data nationally, probably in the second quarter of next year, which is very exciting because we'll begin to be able to learn from each other at that point. So if you go to AHRQ's website, it will lead you on a path that takes you to where the common formats are laid out, and it's all the way from English language descriptions of what we're collecting, to what the reports will look like, what the actual questions are that one should program into an automated system, and then the detailed computer specifications that allow these things to be programmed in a way that makes them interoperable. It's very interesting. One of the things that I think we've discovered as we come into the computer age is that people can have the same measures put down on paper, but then when different people program them, they become not only electronically not interoperable, but they also become clinically different, because there's a lot of play between what's on the paper and what gets programmed in. So we're trying to leave very little to the imagination and actually specify things in great detail. Charles Denham: Great. Bill, thank you very much. Terrific work, and I think we're really looking forward to being able to share the data using the PSO mechanism with safety. Well, we're in our last few minutes of our webinar, and we do have a moment to invite one of our guests from Switzerland, Dr. Thomas Zeltner, to offer 30 seconds or a minute of insights before we close with Sue Sheridan. We always close our webinars with the voice of the patient, which we really take very, very seriously. So we'll close with a couple of comments from Dr. Zeltner and insights coming from Switzerland, who was one of the most well-respected health ministers in the world, 19 years in Switzerland. They deliver terrific outcomes at 60% of what we spend here in the U.S., and took care of all 7,000,000 people in their population, and had a cost inflation rate of 2.1% per year. So I'm not going to ask how he did it, because that would be longer than 30 seconds. But then we'll close with Sue Sheridan, and I'll make a few closing comments and Sue will be the last one who will speak. So, Thomas, could you come up to the podium? We didn't warn him about that, but he's used to that with me. Thomas, your reflections on healthcare-associated infections and your perspective on the world? Maybe just a quick insight as to what we're looking at globally. Thomas Zeltner: Looking globally again, I mean, it's obvious that bugs and germs do not know borders, so we are actually confronted with the same problems you are having here in the U.S., all over the world. Talking about the difficulties and challenges, actually one of the major challenges we are facing in the future when it comes to infectious diseases is antibiotic resistance, because we do not have a pipeline of new antibiotics. So whatever you do to reduce infections in the hospital, you do a wonderful job. And you don't do it just for your patients, not only for your finances, but you do it actually for the global community. The second thing I really would like to say here is, I'm very impressed, very impressed about what you're achieving here. It is – and I'm not talking now as a Swiss, but as a European – and Hippocrates said, "Do

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not do any harm and do good," and I think you're on an incredibly amazing track. And the amazing thing is that you do have very good examples to follow up and to take as examples how to do it. And the second thing, and that is really what I'm impressed about, that your government is really taking this question very seriously and helping that you can make the next step forward and be really an example for the global community, and that is really great. Charles Denham: Thank you very much, Thomas. We really appreciate your insights. I'm going to just close the webinar. We're right on time, and we'll have Sue Sheridan, our patient advocate, share her final words. But it's been a real pleasure to have such a wonderful group here in the room at the National Press Club. We have national role models, and they come from all over the United States, but there's one common denominator, and that is core values. They're all here to help support the national community. They had no other reason to be here other than to collaborate with our government leaders, to help do the right thing, and we're very grateful for that. So I will just remind everyone that the audio recording of the entire webinar will be available, and if there are any slides that may not be on – we're broadcasting from the National Press Club and not our usual system, which may be a little more reliable – that they all will be there in the next couple of days. But we are very pleased to have you, Thomas, share your insights from Switzerland, and we realize that this is a global problem. And the numbers are pretty consistent around the world in the industrialized world, and the leading hospitals that are in this room today, which have done a great job at reducing them, have shown the way that you don't have to be a rich hospital with a great infrastructure. There are many front-line hospitals here that have done a fabulous job. So we just want to thank you so much for being here at the Press Club, for sharing your time with our national audience. We have between 5,000 and 6,000 people on the webinar, and we want to thank you. So I'd like to introduce Sue Sheridan. Sue is going to be the last one to speak on the webinar. We've asked Sue to speak to us. She's working with us at TMIT, helping develop a grassroots effort that can target that center of gravity that are ... we have one CFO in the room here, but we also have thousands of CFOs across the country, and we call them our chief family officers. Seventy percent of the healthcare decisions in America are made by women. One in four Americans is a caregiver of someone else and 80% are women, so we know the nuclear glue and the fabric that holds together so many of our communities are women and parents – CareMoms and CareDads. So Sue will be launching that effort and leading that. Sue has been ranked in the top 25 most powerful women in healthcare. Sue is the leader of the World Health Organization’s Patients for Patient Safety. She is also a founder and leader of CAPS. But she comes to us, as we describe in the documentary Chasing Zero, after having not one but two catastrophic errors that led to a total change in her family – losing her husband and having one child with disabilities. Yet she's been able to marshal that energy and channel it to do great things that we never thought were possible that consumers can do. So I think she's a fitting person to close this meeting. Sue? Sue Sheridan: Thank you, Chuck. I often close for Chuck. I was just thinking about this, Chuck, and one time when I was getting on stage, I was closing at the National Patient Safety Foundation, and he whispered in my ear, "Drive it home.” So I'm going to drive this home. I get to speak about the largest untapped resource in preventing hospital-acquired infection, and that is the patient population. So thank you, Dr. Denham, thank you, HHS, thank you, participants, for welcoming me, the patient voice, into this event. It's actually pretty courageous of you, but I think it's potentially very transformational in the battle against HAIs. Patient engagement is no longer a buzzword. It is not simply the politically correct thing to be saying in presentations anymore. It is – well, our national leaders – Don Berwick, Carolyn Clancy, Lucian Leape – are now identifying patient engagement as one of the top key concepts for transforming healthcare. We've talked a lot about patient-centered care here. There are a lot of different definitions of patient-centered care, so I'd like to give you the evolved definition that our leaders are now using at HHS and other places, that patient-centered care is not just healthcare for the patient – it is healthcare with the patient. So as we think about reducing and eliminating HAIs, let's think about that with the patient population.

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Chuck mentioned that I'm the voice of patients globally, so we encourage you to seize, to celebrate, and [to] value the wisdom, the power, and the role of the patient. We envision a different world in which healthcare errors are not harming people. We are partners in the effort to prevent all avoidable harm in healthcare. So we come together in dialogue, participating in care with you, uniting our strength as advocates for care without harm. Like Thomas said, recognizing that harm from healthcare-associated infections knows no borders, I'm here to give voice to those who know and have lived the aftermath of an HAI. I am the voice of Victoria, whose son Josh survived a tragic skydiving accident, yet died from an HAI when in the hospital recovering. Victoria has since created the Safe Care Campaign and has partnered with the CDC and has created an admission video to help activate, ignite, educate patients and providers, so everybody can get involved as partners. I am the voice of Evangelina Vasquez from Mexico, whose newborn son Uriel suffered permanent brain injury from a nosocomial infection and sepsis soon after birth. Evangelina now is collaborating with local hospitals and the Mexican government, going from hospitals to communities, talking about the importance of hand hygiene, and the campaign is called "En Sus Manos," or "In Your Hands.” I am also the voice of countless others who are now unheard as a result of an HAI. So we share our stories to illuminate, to teach, to inspire, and as a call to action. We bring your data to life. We are real people. We are not just statistics. We are committed to spread the word from town to town, from person to person, [from] country to country. Going forward, can we all commit to uniting patients, patient organizations, providers, hospitals, professional groups, and our government agencies, to embark on new initiatives that will inspire healthcare workers and empower, invite, learn how to activate and educate the patient population, regarding HAI? Can we teach the population about the real risk and how to participate in mitigating those risks? Because, quite frankly, it will save lives, and patients are the greatest at stake. Just imagine what we could do working together. So we invite you all and challenge you to bring your knowledge, your power, your wisdom, your strength, and your passion to the prevention of HAIs. Today we have a unique and powerful opportunity to embrace and implement safe practices, and to engage patients to help make the reduction and maybe the elimination of HAIs a reality. For Victoria, it might have meant that Josh would be home in their cabin in North Carolina right now. For Evangelina, it might have meant having a son who could speak, who could drag her around to soccer matches and worry her to death when he got his driver's license. So in honor of those who have died, those left disabled, our loved ones today, and our world's children yet to be born, let us all strive for excellence so that all involved in healthcare are as safe as possible, as soon as possible. So as we leave this event, let's commit, let's act, let's believe, let's be bold, let's be persistent, let's stand for preventing HAIs, let's be transparent, let's engage, let's create a new normal. Let's chase zero, and let's be safe. Thank you. Charles Denham: Thank you, Sue.