We are back. I wanted to talk to you about a couple of examples of projects which have been successfully sustained and some of the measures that were taken to help ensure that that happened. We're going to talk about hand hygiene or improving hand hygiene and we're going to talk about preventing central line associated bloodstream infections, something which perhaps originated at Johns Hopkins. The acronym is CLABSI, but people often now really are more likely to refer to bloodstream infections or catheter related bloodstream infections. The first global patient safety challenge of the World Health Organization's World Alliance for Patient Safety was launched in about 2005. That initiative was called Clean Care is Safer Care. And since that time, guidelines have been developed and promulgated for hand hygiene in health care. As many of you will be familiar, there are many opportunities to perform hand hygiene. And health care workers should perform adequate hand hygiene; hand washing with soap and water or even better with alcohol-based hand rub. And at least five points in patient care. The five moments are perhaps most obviously after touching a patient and this is something that somehow health care workers are most compliance at following. Perhaps even more important for the patients sake is before touching a patient, also important of course before performing an aseptic or sterile procedure, after touching materials that a patient might have touched, such as bedclothes or equipment and finally, if one comes in contact with body fluids. Compliance rate with hand hygiene historically were dismal. Ideally, every healthcare worker should perform hand cleaning at every one of those instances. Initial studies show that the rates range from perhaps 20 to 40, or to 50 percent in the best case when studies were done. It was obviously necessary to mount a major effort to improve this situation. In part because it was clearly demonstrable that better hand hygiene led to decreased health care related infections of all kinds. So thinking ahead, what outcomes are important and what measures might be used? The team at the World Health Organization, which also included the external lead Didier Pathé and his team at the hospital of the University of Geneva, considered measuring outcomes, the incidence of healthcare acquired infections and also processes where people were cleaning their hands. Processes that were considered included; Did people perform a hand hygiene for every opportunity that was presented? It turns out that the best way to measure that is by direct observation. And the measure would end up being, the proportion of appropriate hand hygiene behaviors per total number of hand hygiene opportunities. Additional measures were considered including indirect measurement, such as measuring the volume of alcohol-based hand rub that might be used on a particular units or area. Outcome as it turns out, is easy to measure so long as the microbiology lab is functioning. The incidence of health care acquired infection particularly bloodstream infections, is relatively easy to measure as the number of positive blood cultures. In the end, all of these measures have been used in one form or other. An additional measure was learning. This is perhaps a measure of process but in fact it is a measure of knowledge that precedes those processes. If you think about the four E's, has the second E, education of the trip model, been attained? One can measure staff knowledge of a policy or a program. One can measure staff knowledge of the presence of a problem and recognition or an attitude that the problem is important. If there is a policy, which is a structure put in place, do staff know that that policy or program is in fact in effect? One can then look at, thinking about execution, are they using that policy, are the observing or complying with that policy? And this is from direct observation. Yet another way to measure success might be in measuring something different, which is measuring safety culture. It turns out that safety culture as measured by among others the safety attitudes questionnaire, or the AHRQ safety culture questionnaire, is highly correlated with many outcomes including the rate of healthcare acquired infections. An annual assessment of the culture of safety could be performed and, in fact, is something which was instituted at Johns Hopkins. Among other things, this survey evaluates staff attitudes regarding safety problems, regarding teamwork, and even regarding their success at being able to execute those programs. These are correlated with and are predictive of additional outcomes and can provide an important indicator of success of a program. On a more global level, the first patient safety challenge had a number of objectives. The first was increasing awareness. And they were interested in increasing awareness at the global level. Certainly, perhaps a structure that could be important if achievable. They were interested in mobilizing nations, which required some politics. And in fact, politics with a small p is involved very often in sustaining any program. They're interested in providing technical guidelines and tools, and we will talk a bit more about this in a moment, but this was most relevant to healthcare settings. I only showed this slide because we have mostly been focusing on the healthcare setting. But this is an issue that, in fact, engages individual entire nations and perhaps even the greater healthcare community on a global level. By 2008, only a few years after the launch of the first global patient safety challenge, countries had signed on to reducing healthcare acquired infections that represented 74 percent of the world's population. Today, this includes the very large majority of countries across the globe. A continued annual program is run by WHO. The Save Lives: Clean Your Hands initiative has, as its national Worldwide Day, May 5th. May 5th, Five, five. Clean your hands. And much of what this is aimed at is moving from the worldwide and nation level to the point of care. Initially, and this was in about 2009 and 2010, over 5,000 health care facilities from 122 countries signed onto this initiative. And the program at WHO developed a set of tools and guidelines which are freely available in all of the six WHO languages as well as others, for system change, for training and education of healthcare workers, for evaluating using different methods, the success of hand hygiene initiatives, for providing feedback to healthcare workers, for assessing safety climate at institutions, and for providing reminders, posters, and other publicity materials in the workplace. All of these are relatively enduring and readily available and support the success and sustainment of this initiative. A second initiative is based on this very well known and highly cited article by Peter Pronovost and team from the New England Journal. An intervention to decrease catheter-related bloodstream infections in the ICU. This was based on work initially performed in ICUs at Johns Hopkins and was published in 2006 based on the experience of virtually all of the intensive care units in the state of Michigan. Without describing this entire project in detail, something which was considered very early is, what should be measured? Should we measure outcomes or perhaps processes? This is a key decision to be considered at the very beginning of a project. Part of the reason for this is technical. And part of this is socio-technical. It's important to get all of those ICUs and hospital leaders to buy-in to the capture and dissemination of these data about outcomes. Do they believe that these are meaningful measures? Do they believe that they can be collected fairly and that they will be cast in a positive light? So, ultimately, it was decided to choose infection rates, an outcome measure, because of a couple of factors. First of all, the CDC, the Centers for Disease Control in the US, provides standardized, scientifically rigorous definitions for health care infections, including bloodstream infections. This is something that did not need to be done or agreed upon. Secondly and very importantly in the US and in Michigan, hospitals are already required to collect data on health care infections, particularly about bloodstream infections and report them on a regular basis. These data were already being collected and this was already being supported. The second reason was it was really difficult to develop a valid and feasible measure of compliance with the key evidence-based practices for central line insertion. The main reason for this was that although many of these central lines were placed in intensive care units, many others were placed at other places in the hospital: in the emergency room, on the wards, even in the operating room. And it was very difficult and really proved impossible to monitor and collect these data. This required coordination in all of the hospitals in Michigan initially that really wound up being too difficult to achieve. Self-reported compliance could be used but, in general as one might imagine, this overestimates performance. In summary here, the key measure was an outcome measure. And this is relatively easily tracked. These are actually data from Johns Hopkins but they show that at the beginning of our journey in the early 2000s, the rate of catheter. The rate of infections per 1,000 catheter days on the vertical axis was something around 20 at Johns Hopkins, which was higher than the national mean of closer to 10. Over time, a variety of interventions were implemented and this outcome could be tracked downward. In preventing central line-associated bloodstream infections, it's been crucial to use data to assess progress. And in this case, as I mentioned previously, available data are best. Some of the tools that are used, currently both at Johns Hopkins and now nationwide, are a hospital survey on patient safety, which measures frontline observations and attitudes, those infection rates that I mentioned. Some process measures when they can be collected, perhaps, how often are these procedures followed in the ICU or in a specific ICU, particularly if an infection occurs. And organization and team culture. The reason we can zero in now more closely on particular units is that since the implementation of this protocol, the median number of bloodstream infections in our ICUs and in most of the ICUs across Michigan is zero per month. Many of the ICUs have never had another bloodstream infection. And when they do, this is treated as a sentinel event. It is investigated and it is feasible then to look more closely, for example, at whether processes are being followed in that unit. Some of the tools that were employed to help institutionalize best practices. A first step in this project was to summarize the voluminous evidence from the CDC on best practices for preventing central line infection. These were well-known before the 2000s even, but the guideline that the CDC put out was 150 pages long and was not usable at the bedside or perhaps anywhere else. These practices will remove unnecessary lines, perform hand hygiene, use maximum barrier precautions, when inserting a central line use chlorhexidine for skin antisepsis, and avoid femoral lines. An innovation was to convert those five points into evidence-based behaviors in a behavioral checklist, where it is possible to check off before the procedure. Did the healthcare worker or workers wash their hands? Sterilize the procedures that was chlorhexidine? And drape the entire patient in sterile fashion? Check, check, check. During the procedure did they use sterile gloves, mask, and gown? Did they maintain a sterile field? Check, check. Did all personnel assisting with the procedure follow these precautions? Check. These data could be monitored. And in fact, the checklist that is filled out, whether on paper or electronically, could be introduced into the record, kept, and audited. Another tool was a central line cart. This structure was found to be necessary after clinicians were observed inserting central lines. Interestingly, it was found that in order to put in a central line, clinicians would scramble around to collect all of the equipment necessary to comply with the guidelines including gloves, drapes, etc, in up to eight different locations in the hospital. This, of course, presented a barrier to them complying every time. And to make compliance easier, we introduced a central line cart where all of the necessary supplies were stored and which was available in the ICU or could be rolled over to someone who was putting in a central line. Additional tools which wound up being enduring elements within the healthcare organizations were the Comprehensive Unit Based Safety Program. You will hear more about this but this included several components including an initial safety culture assessment, training of healthcare workers in the science of safety, identification of safety hazards by staff members, executive leader, partnership with units using learning from a defect tool for improvement and reassessing safety culture after all these things had been done and then on a recurring basis. Some of the tools from CUSP include safety assessments that are done by units, daily goals sheet completed by health care workers perhaps at morning briefings, safety rounds dedicated to only safety rather than other concerns, shadowing of other providers to understand what they did and what they ought to be doing, and learning from defects. An important step in improving the likelihood of sustainments and then in sustainment, is to identify and address local barriers to compliance. It was found, for example, when we initially did this work at Johns Hopkins, that nurses were reluctant to question or challenge doctors even if they weren't following the practice as needed. Physicians as it turned out did not appreciate being questioned by nurses particularly in front of patients. They felt they lost face. Everyone agreed that the practices were necessary and should be followed, but there were cultural barriers that reduced the reliability of this being performed. To address barriers, besides implementing the CUSP program, a number of materials and tools were developed including videos and scripts which helped people and encouraged people to communicate more effectively.