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Just how many infections are preventable? That’s the question with which every hospital grapples these days. While facilities are preventing more infections than ever before, the news still reports illnesses and deaths attributable to breaches in infection prevention and control, prompting infection preventionists to ask themselves, “How low can we go?”
That dialogue is one that has been repeated among practitioners, researchers and scholars, and was a part of a pro-fessional association’s initiative to eliminate healthcare-associated infections (HAIs) through improved education about evidence-based practices. In January 2008, the Association for Professionals in Infection Control and Prevention (APIC) launched its “Targeting Zero” campaign which was designed to “accelerate both learning and the delivery of practical tools for infection prevention professionals,” according to Kathy L. Warye, CEO of APIC. Warye says the program underscores APIC’s efforts to create a culture of zero tolerance for noncompliance with measures proven to prevent HAIs, as well as demonstrates to healthcare administrators and clinicians how they can implement effective strategies and simpler systems for protecting patients from HAIs.
The Origins and Drivers of Zero
So where did zero come from? The concept of zero tolerance emerged in 2000 when then-director of the CDC Julie Gerberding, MD, MPH, noted that the goal of elimination has been applied to other public health imperatives, according to Warye and Murphy (2008). A few years later, the idea of getting to zero surfaced when APIC published APIC Vision 2012, a strategic plan for the future. According to Warye and Murphy (2008) Goal 1 of the plan stated that APIC will “promote prevention and zero tolerance for healthcare-associated infections (HAIs).” They add, “Since that time, APIC's approach has evolved and focused instead on promoting a culture where targeting zero healthcare-associated infections is fully embraced.”
Edmond (2008) observes, “The ‘getting to zero’ movement is the product of three forces: the expansion of external pressures on infection control programs, the intrusion of suboptimal evidence, and the convergence of quality improvement and infection control.”
Edmond (2008) explains that consumers and consumer watchdog groups have priorities that may not be fully aligned with those of infection prevention experts, and that professional organizations may be allowing other stakeholders to dominate the agenda. He notes, “These external influences have arisen in response to the increasingly common perception that healthcare is a commodity and patients are consumers. Thus, the key stakeholders are demanding higher levels of accountability, increased transparency, and rapid solutions to highly complex problems.”
Edmond (2008) argues that getting to zero is a product of the convergence of quality improvement with infection control programs: “Until recently, infection control and quality improvement operated in different spheres, with quality im-provement focused on noninfectious adverse events. Today, that separation no longer exists, and, in some cases, infection control interventions are managed partially or entirely by quality improvement personnel. These groups have different strengths, perspectives, and approaches that, sometimes, lead to conflict ... Getting to zero is a concept that was intro-duced by the quality improvement community and embraced avidly by stakeholders, but it is a sound bite that represents suboptimal evidence. It is commonly interpreted to mean that the goal of reducing the number of HAIs to zero is attainable, and, therefore, all HAIs are preventable; this ultimately leads to the belief that the occurrence of an HAI must be someone’s fault.”
The Controversy Over Zero
The subject of getting to zero was a contentious one at last year’s meeting of the Society for Healthcare Epidemiolo-gists of America (SHEA). Michael Edmond, MD, MPH, MPA, hspital epidemiologist for Virginia Commonwealth University Medical Center in Richmond, Va. kicked up some intellectual dust, so to speak, when he suggested that zero tolerance regulations could set up practitioners for failure to deliver.
Edmond (2008) observes, “The ‘zero’ obsession has a number of worrisome, unintended consequences. It sets up unrealistic expectations on the part of the public and healthcare administrators, leading to unreasonable demands on infection control programs. It fosters a punitive culture, since someone must be at fault for causing infections. It separates infection control from safety and quality, when infection control concerns trump other important safety issues. It has shifted the development of interventions away from an approach based on local risk assessment to the promotion of a one-size-fits-all approach. Healthcare workers and hospital epidemiologists have become demoralized when the expectations for getting to zero persist but the elusive zero has not been attained. From a societal perspective, we continue to divert ever-increasing resources to marginal improvements in inpatient healthcare quality, while more people in the United States lose access to care.”
“Rather than setting us up for failure, I think getting to zero raises the bar for us and for continuing to promote HAI elimination wherever we can,” says Stephen Streed, MS, CIC, system director of epidemiology/infection control at Lee Memorial Health System in Ft. Meyers, Fla., and an APIC board member. “So rather than being content with being in the 25th percentile of the best rates or the 50th percentile as we compared to the NHSN rate – all of us now are trying to move toward zero as our goal.”
“At meetings it’s exciting to debate on an intellectual level, however, at the institutional level, it’s different,” Warye says. “They have seen that we can prevent more infections and that we don’t need to be content with the benchmarks. Institutions also understand that implementing bundles within a culture of change is very important. Many institutions have em-braced the concept that they can get lower, and that’s what getting to zero is about – ensuring that your infection rates are decreasing, or if you have already reached a very low level, that you are sustaining that the best you can. At the institu-tional level practitioners are not as concerned about the intellectual debate and the semantics.”
Streed points to an example at his facility: “We have two ICUs and one of our hospitals that have gone 27 consecutive months without a VAP. Now, five years ago, almost everybody said that was impossible but we embraced very warmly the IHI bundle process for VAP prevention, and so once we identified that those were the best practices we built them into our policies and procedures. Most importantly, we empowered the staff to ensure that those things actually happened all of the time. That is what helped us achieve those 27 straight months of zero VAP. Now in other infections at other sites we don’t know where zero is yet; we know where zero is, of course, but we don’t know what the best achievable level is yet because a lot of that work hasn’t been done. Some would have said five years ago, who can get to zero for VAP? Well, we did! We may have another one next week, but this success in keeping it down tells us these things can be done.”
Zero and the Irreducible Minimum
Just where zero is, exactly, is a matter up for further debate, as is a facility’s irreducible minimum.
“Rather than getting wrapped around the word zero, institutions need to strive for whatever their irreducible minimum is,” Warye emphasizes.
“If you look theoretically at all of the infections that occur, you could divide them up into two main groups: some that are preventable and some that are not,” Streed says. “The ones that are preventable are preventable through the implementation of practices, behaviors and procedures, and following a very strict clinical pathway. Others are not probably preventable, and that is the irreducible amount.”
Edmond says he isn’t convinced that zero is achievable.
“I would base that observation on the fact that the therapies we are using are more immunosuppressive and more invasive,” Edmond says. “So to expect that we are never going to have HAIs is not realistic. When we talk about getting to zero, there is the implication that we actually can get to zero. We are setting ourselves up for something I don’t think we can deliver, and it’s not an honest approach to use with the public. On the other hand, I would say I don’t think we have achieved, for the most part, the irreducible minimum, and we don’t really know what the irreducible minimum is at this point. We have a ways to go to get our rates down lower, but I don’t think that it’s zero. The question is, what exactly is zero – is it zero for a month, a quarter, a year? One of my ICUs has not had a VAP case for a year and a half, but that doesn’t mean that tomorrow they may not have one. So I would like us to be more realistic about what we can achieve. The problem with the getting-to-zero approach is the natural next step – if you believe that we can’t get to zero, then when we’re not achieving zero, it has to be someone’s fault; blame is not very productive.”
Victoria Fraser, MD, co-director of the Infectious Diseases Division of Washington University School of Medicine in St. Louis is in favor of adopting the term "zero" as an aggressive target to motivate people and institutions to move toward this goal even though it is not yet known what fraction of infections is preventable.
Fraser (2008) asks the rhetorical question, “But what is zero?” She notes, “Although zero actually has several definitions, most of us think of zero as an arithmetical symbol denoting the absence of all magnitude or quantity. Usually, epidemiologists don’t deal well with zero, because it lacks a denominator and a time frame for exposure risk. What about trying to eradicate HAIs? The CDC defines eradication as a permanent reduction to zero of the worldwide incidence of infection caused by a specific agent.”
Eradication requires buy-in from healthcare professionals, Streed says. “There is a longstanding history of silo behav-ior in healthcare and one of the things we have done to overcome that is interdisciplinary rounds, where we have infection prevention, clinical pharmacy, social services, intensivists and others making rounds at the same time and even involving the families in this process. By doing that, and it takes a awhile for comfort levels to develop, because we have people who are not used to saying, you know, this might not be the right antibiotic,’ but if you get that buy-in, success breeds success, and once people see that success, then they really embrace it.
The Bug-of-the-Month Mentality
A related issue is the danger of healthcare workers adopting a bug-of-the-month mentality. Edmond has said, for example, that some healthcare experts worry that putting an imbalanced amount of weight on the elimination of one pathogen in the hospital in response to legislation may contribute to conditions where another pathogen could flourish. “I think APIC has driven that to some degree by taking an organism and consistently bringing it into the limelight by having, for example, a press conference about MRSA, or MRSA grand rounds, or a study about C. diff... it brings more attention to it. I think the natural consequence is that someone is going to pass a law about it. You have to be more careful about what you do in terms of public activity -- it’s a double-edged sword.”
Fraser (2008) notes, “The concept of targeting zero HAIs is controversial because many people believe it sets unreal-istic or impossible expectations that all HAIs are preventable and that any HAI that may occur was due to an error or a broken process. To me, targeting zero is problematic because it does not address the variation in the risk of HAIs in dif-ferent patient populations or settings, it does not address the denominator or time frame that is necessary to understand rates of infection, and it inherently seems scientifically unrealistic. Although I believe now that many more HAIs are pre-ventable than I thought even a few years ago, I do not believe our science is yet robust enough to prevent all HAIs. When taken as a ‘big, hairy, audacious goal,’ trying to eliminate HAIs seems quite laudable, however.”
Edmond (2008) observes, “Getting to zero simply fails to capture the complexity of HAIs, seems to jettison more than three decades of research in healthcare epidemiology, and does not convey the important message that, although the majority of HAIs are preventable, some are not.” Edmond (2008) adds that suboptimal evidence is driving the process of getting to zero. “The consequences of suboptimal evidence in infection control include the use of administrative data to define and publicly report HAIs, smallpox vaccination of healthcare workers, annual fit testing of N95 masks, attempts to quantify hand hygiene compliance, and perseverating on methicillin-resistant Staphylococcus aureus while other impor-tant pathogens become increasingly prevalent.”
Warye says that healthcare facilities have not succumbed to a bug-of-the-month mentality. Instead, they are managing their programs properly and conducting risk assessment. They know what the issues they need to address in their facility. Where the bug-of-the-month mentality is dangerous is when you see state legislators and the public mobilizing around preventing just MRSA, and calling for active surveillance for MRSA. That forces the use of resources in ways that may or may not be beneficial for that patient population.”
Streed says that at his health system, the risk assessment process helped direct infection prevention practices, and that all important hospital pathogens received attention on a continuing basis. “The external forces that impinge upon us make us look at MRSA probably more than we would have otherwise. At my organization, less than 10 percent of our pathogens are MRSA. So that means if we focus just on MRSA, for instance, as our bug du jour, then we’re going to miss 90 percent of the rest, including E. coli, Klebsiella and Pseudomonas, etc. If we start losing focus on those then they will get out of hand. The external reporting mandates probably haven’t helped in that regard; they have probably forced us to reallocate resources away from prevention.”
One of the more controversial mandates that can swallow up precious resources is MRSA screening. “With regard to MRSA surveillance, we are still debating the evidence,” Edmond says. “We still don’t know how effective an active surveillance program can be or if it is effective... but before we have come to this conclusion, we have states mandating that patients be screened. I would say that a lot of what’s happening in the public policy arena is the fault of hospital infection control and epidemiology because I don’t think we have articulated very well what the evidence is, and I don’t think we’ve played enough of an active role in educating the public and shaping policy. I think there has been a void, and when there is a void, someone is going to step in and fill it. It’s unfortunate because the people with the most expertise may not be consulted.”
Understanding Why Rates Have Decreased
Fraser (2008) says that policy aside, it is critical to understand how and why HAI rates have declined: “In hospitals that have successfully reduced HAI rates, there has been an increased focus on the specific mechanics of HAI prevention. There has been a culture change in many institutions. HAI prevention has become more multidisciplinary and team based; there is more administrative support and accountability. In many settings, principles of patient safety, quality improvement, performance improvement, lean production, and Six Sigma have been incorporated into HAI prevention. Surveillance and feedback measuring processes and outcomes have gotten better and more timely. Enhanced reporting of HAI rates and enhanced transparency of reporting have helped focus attention on the problem, along with implementing multiple, itera-tive interventions, including education, evidenced-based policies and procedures, checklists, standardized orders, compe-tency assessments, and monitoring tools. Marketing campaigns, visual aids, rewards and incentives have also helped in our program. Additional measures suggested for fostering success in reducing HAIs include critical event analysis of each infection, engaging leadership and recruiting champions, daily assessment of devices, rapid response teams, infection control liaisons, weekly executive reports, focusing on systems reliability and simplification, and persistence.”
The CMS Angle
New pay-for-performance regulations from the Centers for Medicare & Medicaid Services (CMS) last October ushered in a new era of scrutiny for infections as well as a heightened awareness among clinical and administrative leadership about the value of infection prevention issues.
Richards (2008) explains that healthcare payment or regulation mandates help focus attention on prevention and that “current policy approaches to healthcare payment have focused on holding providers responsible for outcomes. In the future, healthcare epidemiologists must be engaged with [CMS] and healthcare insurers to develop appropriate ‘carrot and stick’ payment policies based on current evidence-based prevention recommendations.” Richards adds, “Healthcare providers should be accountable for reducing rates of infection by implementing evidence-based prevention practices. HAI public reporting can, ideally, be used to hold institutions and professionals accountable for their performance and out-comes if these data are transparent and accessible for consumers, payors and accreditors.”
Fraser (2008) warns against a “zero” slogan mentality that could give these aforementioned stakeholders the wrong message. “To some, the slogans seem like unrealistic, unfunded mandates that demand perfect outcomes without provid-ing the resources, the infrastructure, or the science to do the work or move the field forward,” Fraser (2008) writes. “In some instances, it has been perceived that the slogans have fueled the fire, by setting expectations that all HAIs are preventable. Thus, patients and the public might think that any HAI is the result of an error or suboptimal process; CMS and insurers could refuse payment for ‘never events.’”
Legal Ramifications of Zero
If a certain number of HAIs are considered to be preventable but still occur in healthcare facilities, could the legal pro-fession seize upon this?
Betsy McCaughey, PhD, chair of the Committee to Reduce Hospital Infection Deaths, observes, “Even where there is no evidence that a hospital overlooked infection prevention measures, the plaintiff's attorney could argue that infection is evidence enough that the hospital breached its duty. Every law student learns about the barrel that fell out of a merchant's second story window, injuring a customer below. The merchant is held liable because the accident was itself definitive evidence of negligence, a textbook example of res ipsa loquitur. Similarly, trial lawyers will claim that an infection speaks for itself and shifts the burden onto the hospital to offer evidence that it was not negligent.” McCaughey adds, “What must hospitals do to avoid liability for infections? That's still unknown ... In the early cases, plaintiffs may have to point to specific departures from best infection prevention practices ... to prevail. Exactly how the legal precedents will develop is unknown.”
Hsieh (2008) points to a number of verdicts on and settlements of claims based on hospital infections, including a case where a jury awarded $13.5 million to a Massachusetts woman who died of an infection caused by flesh-eating bacteria that she contracted during cancer treatment.
Warye says that she has not seen an increase in infection-related lawsuits that actually go to trial, but notes, “You will see patients not being content with letting this situation go. And that’s going to place additional requirements on the infection preventionist in terms of information, so we want to prepare them for what they could be facing down the road.”
“I think there is always the potential for the legal profession to be circling over us,” Streed says. “I have heard of some attorneys being alert for C. diff, and you see ads on TV telling people ‘If you or a loved one has gotten MRSA from a hos-pital, call so-and-so.’ If the general public felt that zero was achievable, which means that everything must be preventable, then if you don’t prevent it, is that sort of evidence of negligence?”
“I think institutions will have to concentrate more on what is defensible information,” Warye emphasizes. “And create that portfolio of information to defend the institution in these instances.”
Streed chimes in, “And the best way to do that, in my judgment, is not only having procedural things like the IHI bundles but validation that they took place – recording it in a chart or on a checklist. Because if you do all of the things that are evidence-based, that’s all you can do.”
Warye adds, “And that will keep the burden of proof on the patient as opposed to the institution.”
Culture of Change
If only one thing is certain, over the past decade, hospitals have discovered that it is possible to reduce HAI rates to levels lower than anyone thought possible years ago. Key to this change is promoting cultural change within healthcare institutions, according to Warye and Murphy (2008).
“Targeting zero places the emphasis on the need for institutions to create cultures and systems that would enable them to get closer to zero HAIs,” Warye says. “It’s a combination of many more organizations embracing the need to reduce their infections, putting interventions and programs into place to do that, and then measuring the success of those programs.”
Warye and Murphy (2008) say that “willful non-adherence by healthcare workers with proven infection prevention and control measures” should be unacceptable, and that a
culture of targeting zero HAIs and zero tolerance for unsafe practices is characterized by the following:
• Setting the theoretical goal of elimination of HAIs
• An expectation that infection prevention and control (IPC) measures will be applied consistently by all healthcare workers all of the time
• A safe environment for healthcare workers to pursue 100 percent adherence, where they are empowered to hold each other accountable for infection prevention
• Systems and administrative support that provide the foundation to successfully perform infection prevention meas-ures
• Transparency and continuous learning where mistakes and/or poor systems and processes can be openly discussed without fear of penalty
• Prompt investigation of HAIs of greatest concern to the organization and/or community
• Focus on providing real time data to front-line staff for the purpose of driving improvements.
Murphy, et al. (2008) describe some simple rules for an infection prevention system:
1. No patient should be harmed by an infection in the facility.
2. Everyone is responsible and accountable for HAI prevention.
3. Compliance with measures and adherence to behaviors that prevent HAI are expected.
4. The chief executives will clearly communicate expectations, set metrics to achieve goals, and provide necessary resources.
In the end, Fraser (2008) says that a number of challenges and limitations to the existing infection prevention and control knowledge base, but that “infection prevention research and data are often limited by lack of funding and suboptimal study designs.” Fraser (2008) also notes, “There are many unanswered questions about the best ways to prevent infections, the cost-effectiveness of different interventions, and which aspects of care bundles are the most important. Whether better risk prediction models can be developed to target prevention strategies to the patients at highest risk, whether bet-ter risk stratification can be used to more effectively predict which HAIs are preventable across populations and centers, and whether reductions in mortality can be demonstrated along with reduced HAI rates remain to be seen. Given the current scientific evidence in the field, it is unlikely that all HAIs are preventable. Currently, we can only guess what proportion is actually preventable. Even in error-free settings with perfect healthcare delivery and implementation of best practices, HAIs can still occur. If we want to move beyond this limitation, we need to advance the science in the field. Currently, the amount of federal and state resources dedicated to HAI prevention and research is not proportional to the esti-mated public health burden of HAIs. If we want to “eliminate HAIs, then we must work together to garner the additional resources for research and infection control programs, so that we can more effectively try to eliminate HAIs. Otherwise, as a good friend once told me, ‘a vision without resources is just a hallucination.’”
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