The widespread prevalence and enormous cost of healthcare–associated infections (HAIs) have been recognized as major public and personal-level health problems.1–3 As described in this special issue and elsewhere,4–6 the Government Accountability Office (GAO) released a 2008 report critical of the Department of Health and Human Services’ (HHS) leadership on the issue of HAIs and of coordination of HAI-related activities across operating divisions within the department.7 This report was followed by congressional hearings on the subject. In response, in 2009 HHS developed and launched the HHS Action Plan to Prevent Healthcare-associated Infections, an interdepartmental national strategy to address the HAI epidemic.
Going beyond the formal recommendations of the GAO report, the initial Action Plan identified metrics and 5-year reduction targets for the most common and burdensome infections in acute care inpatient settings and later for other areas of care. These targets made HHS accountable for system change and presented the department with its primary implementation challenge: how to effect change across multiple levels and stakeholders of the healthcare system over which federal agencies have no direct control and, in many cases, limited authority.
This paper examines the unique infrastructure developed through the HHS Action Plan (later renamed National Action Plan) to stimulate and support changes in healthcare needed to improve adoption of HAI prevention practices and reduce the national prevalence of HAIs. This type of change requires attending to the context and structure of systems, which in healthcare in the United States is notoriously complex and multifaceted.8,9 A range of factors, including cultural norms and attitudes, organizational structure and processes, and resources, affect the willingness and ability of stakeholders to implement and maintain new practices. Similarly, factors such as policies and incentives, networks and linkages, and media and change agents represent sources of information and influence through which potential adopters learn about, assess, and receive reinforcement for innovations.10–12 These factors and processes also manifest at multiple levels—from the wider policy, cultural and economic environment to the layers of regulatory agencies, interest groups, payment systems, and the community and social networks in which healthcare organizations are embedded and in turn which provide context for healthcare providers and individual patients.10,13
Our evaluation tracked implementation of the Action Plan through multiple methods, including interviews with federal and other stakeholders representing multiple perspectives, ongoing review of articles and other documents relevant to the Action Plan and HAI prevention, observations of interagency meetings and national stakeholder conferences, and an inventory of HHS programs and projects.4 (See also the supplemental Online Methods Appendix, Supplemental Digital Content 1, http://links.lww.com/MLR/A619, for additional detail). This analysis of infrastructure development relies primarily on the semistructured interviews of federal (n=32) and other stakeholders (n=38) at 2 time points over 3 years, as well as reviews of reports and agency documents and journal articles (n=260) collected over the evaluation period, and observations of interagency meetings (n=17) and national multistakeholder conferences related to the Action Plan initiative (n=17).
For the analysis, we extracted key progress and challenges in the development of infrastructure related to the Action Plan and national HAI improvement from each data source. Our evaluation framework specifically defined infrastructure as 1 of the 4 system functions representing governance and other structures that support the adoption of HAI prevention practices at various levels of the healthcare system. The infrastructure function encompasses such categories as regulation and oversight, funding and payment systems, quality and safety culture, and dissemination and technical assistance programs (including education and training). We focused on infrastructure for HAI improvement related to the Action Plan developed at the federal level and that intended to stimulate change within the healthcare system across regional, state, and local levels. We then identified the system properties from our evaluation framework—for example, coordination and alignment, accountability and incentives, resources, etc.—implicated in each progress and challenge area that enabled or hindered progress on infrastructure development.4
Goals and Inputs of the Action Plan
In response to the 2008 GAO report and congressional hearings described above, HHS established a Steering Committee for the Prevention of Healthcare-associated Infections, which was charged with developing a comprehensive strategy to prevent and reduce HAIs. The Steering Committee was composed of senior-level representatives from HHS offices and operating divisions, chaired by the Deputy Assistant Secretary for Healthcare Quality and supported by his staff in the Office of Healthcare Quality within the Office of the Assistant Secretary for Health (OASH).14
The Steering Committee developed the Action Plan, which outlined specific actions to enhance the ability of HHS to coordinate the prevention efforts of its various operating divisions.15 As part of those actions, the Plan incorporated a variety of goals related to infrastructure development, which are shown in Table 1.
To accomplish these goals, the Steering Committee formed a working group structure, which initially involved 6 subcommittees focused on different functional areas of HAI prevention in acute care hospital settings, as shown in Figure 1.
Subsequent to the initial Action Plan, the Steering Committee approved a Phase II expansion that included ambulatory surgical centers (ASCs), end-stage renal disease (ESRD) facilities, and influenza vaccination of healthcare personnel, and a Phase III extension focusing on long-term care facilities.16
Inputs From Federal Agencies
Four HHS agencies have assumed lead roles in the Action Plan: the Office of Healthcare Quality within OASH, the Agency for Healthcare Research and Quality (AHRQ), the Centers for Disease Control and Prevention (CDC), and Centers for Medicare and Medicaid Services (CMS). In addition to chairing and supporting the Steering Committee, OASH has primary responsibility for coordinating Action Plan activities and outreach to engage external stakeholders. OASH also directly manages several HAI programs and projects, including a national media campaign and a series of HAI prevention projects proposed by HHS Regional Health Administrator offices.17
AHRQ manages a broad portfolio of dissemination and implementation research addressing HAI prevention for the range of infections and healthcare settings in the Action Plan.18 It has received substantial appropriations for projects targeting HAI improvement, including the Comprehensive Unit-based Safety Program, a nationally disseminated intervention to reduce CLABSI in hospital ICUs that has since been adapted for CAUTI, SSI, and other HAI conditions.19,20
CDC has a long history of epidemiological research into HAI prevention, manages core HAI data and surveillance (most notably the National Healthcare Safety Network or NHSN),21,22 and works closely with state health departments. CDC led a $40 million funding and technical assistance program supported by the American Reinvestment and Recovery Act (ARRA) from 2009 to 2011 to build state-level HAI prevention capacity.23,24
CMS has several lead functions related to stimulating HAI improvement, including requiring standards for HAI prevention in facility certification Conditions of Participation in Medicare, providing technical assistance to healthcare facilities through its Quality Improvement Organization program,25,26 and establishing initiatives to incentivize improvement in healthcare services through value-based purchasing (VBP) and public reporting programs.27,28 The latter incentives include ceasing to pay hospitals for specific “never events” that are considered reasonably preventable; instituting reimbursement penalties for low-tier safety performance through the Inpatient Prospective Payment System; and reporting facility-level performance indicators on CMS’s Hospital Compare Web site for specific hospital-acquired conditions, including several HAIs. CMS also launched a department-wide, $500 million patient safety initiative in 2011—the Partnership for Patients (PfP)—to engage hospitals across the country toward reducing hospital-acquired conditions (including several HAIs) by 40% and hospital readmissions by 20% over 2 years.29
A number of other federal agencies with interests and programs in HAI prevention also participate in the Action Plan, including the Assistant Secretary for Planning and Evaluation, Office of the National Coordinator for Health Information Technology, Indian Health Service, National Institutes of Health, Food and Drug Administration, Health Resources and Services Administration, Office of the Secretary, Assistant Secretary for Public Affairs, Administration on Community Living, and 3 non-HHS agencies, the Veterans Health Administration, Department of Defense, and Department of Labor.
Inputs From Other Existing Stakeholders
Many external stakeholder groups have been involved in HAI prevention before the release of the Action Plan. These included accreditation and survey bodies, such as the Joint Commission, which have incorporated HAI prevention policies and practices in their requirements7; and the epidemiological community, consumer groups, and patient safety movement, which played catalyzing roles in the lead-up to the Action Plan.6 Other stakeholder assets and potential contributions to the Action Plan are shown in Table 2.
Progress in Infrastructure for HAI Prevention
Our assessment identified a number of areas in which the Action Plan has facilitated progress in infrastructure for HAI prevention both to implement a model of interagency coordination at the federal level and to stimulate change throughout the wider healthcare system.
The Action Plan Model for Interagency Coordination
More important than the structure of the organizational chart of the Action Plan has been the creation of a coordinative “home” for addressing HAIs, and the development of a culture of cooperation among federal agencies and their staff.
Consistent leadership support and accountability: Federal stakeholders cited the importance of consistent support of the Action Plan and its activities by leadership across HHS. This visible support has provided a sense of accountability for agencies and staff to participate more genuinely in the Action Plan. For example, 1 agency member noted, “Without that emphasis from the leadership level, the people involved in the Action Plan would have just continued in the same way they were working on HAIs before.”
Collaborative leadership and “home” for coordination: Federal stakeholders commented that an essential facilitator of the Action Plan has been HHS’s establishment and support of dedicated roles and a “funded home for coordination,” namely in the form of OASH’s Deputy Assistant Secretary for Healthcare Quality and OASH staff. Of particular note has been their effective use of a consensus-driven, collaborative form of leadership that is able to manage and facilitate “thorny discussions about roles and responsibilities of the agencies [in a way that] didn’t take sides but tried to get us all together to think creatively on how we can work together.” Continuing challenges with coordination reported by federal stakeholders, including competing metrics for certain HAIs despite standardization of many measures, persistent “data silos” among federal HAI data collection programs, protracted coordination of basic science into prioritization of HAI research, and naturally ongoing competing priorities of “multiple agencies with different missions,”30 indicate that such “thorny” issues of interagency collaboration are not trivial and require constant management. This coordinative “home” does not have direct authority over the other participating agencies in the Action Plan, rather, as described by another federal stakeholder, “the key is having someone such as the Deputy Assistant Secretary for Healthcare Quality who is accountable” for managing and facilitating interagency cooperation.
Leveraging complementary strengths: OASH and other leaders of the Action Plan have emphasized relevant agency strengths and the leveraging of complementary assets across the “federal family.” Another federal stakeholder described the pooling of resources as a “two-way benefit in that we get a knowledge base and professionals that we could never hire ourselves, and [other agencies] get… discretionary money we have beyond what they would otherwise.”
Culture of cooperation: The recognition of complementary agency contributions and the collaborative form of leadership have been key features in developing a “culture of cooperation” among agencies. In 1 agency representative’s words, the collaboration has provided “a forum to come together, whereas 10 years ago they wouldn’t necessarily have done so.” A number of other federal stakeholders similarly pointed to how the Action Plan has created opportunities, “space,” and a “neutral environment” for regularized, robust interagency coordination. Interacting both within and outside of working groups and formal committees was viewed by federal participants as helping “lay a foundation for staff relationships across agencies” that has been useful for supporting other cross-department initiatives, such as the PfP.
External stakeholders also remarked on the uniqueness of this interagency environment. For example, a leader of an accreditation/improvement organization commented that “The Action Plan was one of the first times I saw several Federal agencies (all of those under HHS and a few others) coming together and focusing on a target.” According to a healthcare industry representative, the Plan “really brought them together with other folks they had not previously worked with on these issues.”
Infrastructure for Stimulating Healthcare System Change
Transparency (public reporting) and financial incentives: Efforts of federal agencies have contributed to an increase in HAI reporting. State-level reporting systems were described as having pioneered the way: “It was only when 30 states passed [mandatory HAI reporting] legislation that the Federal Government got interested.” Other stakeholders noted roles played by private initiatives, such as the collaboration among the Leapfrog Group, Consumers Union, and Commonwealth Fund to report facility-specific CLABSI and other HAI rates. However, national reporting of NHSN and other facility-level HAI data by Medicare through its Hospital Compare Web site31 was felt to have had a strong impact on accountability of healthcare organizations, as noted by a healthcare industry representative: “Just the fact that people are paying attention now and things are being spotlighted stands to change the care.”
Federal stakeholders described the final publication of Medicare’s VBP penalty rule to implement financial incentives for HAI performance as a major “step of progress”: “If you think about what we did, we took the best quality measures and turned them into a payment rule, and got all the best hospital organizations to approve it.” External stakeholders commented on the impact of the VBP rule, such as a representative of an accreditation/improvement organization who noted it has led to “more incentivization to hospitals” while a member of a payer/insurer group noted, “One of the drivers for [improvements] is CMS’s authority to change the payment policy. That got everyone’s attention.” Although CMS’ Hospital Compare and VBP did not originate with the Action Plan, the coordinated use of measures and data from CDC’s NHSN system has helped reduce overall reporting burden on healthcare facilities, while raising both the credibility of the CMS programs among clinical stakeholders and the participation of hospitals in NHSN.31
Support of state and regional HAI prevention capacity: Federal and state-level stakeholders emphasized the critical role of ARRA funding and other federal programs in developing infrastructure for HAI prevention within states, including support for multidisciplinary state HAI advisory boards, state HAI coordinators, and improvement collaboratives. Internal stakeholders described the ARRA funding as an “important step for Congress to think about. That is—how states would meet those [Action Plan] goals and give states funding.”
Concurrent with the ARRA funding, Congress required states to develop statewide HAI plans consistent with the federal Action Plan to receive Preventive Health and Health Services block grants.32 The state HAI plan requirements were focused on stimulating collaboration among state-level stakeholders, participation in HAI surveillance by healthcare facilities, and improvement capacity and activity.
External and internal stakeholders attributed these programs and other policies, such as CMS’s requirement for Quality Improvement Organizations in the 10th Scope of Work to collaborate with other improvement entities, as encouraging greater coordination among stakeholders at the state and local levels. Regional projects sponsored by OASH, although more modest in scope, similarly stimulated infrastructure for HAI prevention at the regional level, much of which did not previously exist. These initiatives provided HAI training to ASCs and helped form a nexus of interactions and relationships spanning state HAI coordinators, other state-level stakeholders, HHS regional staff, and staff and subject matter experts from several HHS agencies (eg, CDC, CMS, AHRQ, HRSA).33
Changes in safety culture—greater acceptance of the preventability of HAIs and the goal of elimination: Many external stakeholders noted a general change in this “softer” yet critical element of infrastructure. A number of stakeholders reported a more recent emphasis on elimination (compared with only reduction), reflected as well in the 2012 revision to the Action Plan (subtitled “Roadmap to Elimination”). Although some consumer group representatives were eager for even greater change, they also noted that an important shift had occurred, “it represents some major leaps for the hospitals and agencies to even just get past the cultural barriers of accepting these infections as something that’s inevitable.”
Engagement and feedback mechanisms with stakeholder groups: Federal agencies have collaboratively conducted various national meetings to engage nongovernment stakeholders in Action Plan goals and HAI improvement. Examples have included periodic national meetings on Action Plan progress, a healthcare executive roundtable, meetings for state-level stakeholders, focused meetings for specific HAI conditions (eg, VAP, SSI) and healthcare settings (eg, ASCs and ESRDCs), and a national summit on HAI data and measurement.30,31,34 OASH in particular has actively sought to increase engagement of key stakeholder groups, including production of video HAI trainings for healthcare students and sponsorship of award programs with professional societies to recognize exceptional examples of HAI prevention. A number of federal stakeholders believed these engagement efforts to have broadened acceptance and ownership beyond the federal government to the point that the initiative now can credibly be called a “national” plan.
Challenges in Developing Infrastructure for HAI Improvement
Our evaluation also identified a variety of significant challenges for the Action Plan to developing HAI prevention infrastructure, many related to the same areas of progress noted above.
Lack of Infrastructure for Prevention Practice Adoption in New Healthcare Settings Targeted by the Action Plan
Both internal and external stakeholders noted a relative lack of infrastructure for prevention adoption, particularly in the new settings targeted in Phases II and III of the Action Plan (ie, ASCs, ESRDCs, and long-term care).
“[Patients] move to a variety of care sites, either with their infection or incubating an infection. Everyone has been struck by the limited capacity of these types of facilities to do the kinds of things that are necessary to reduce infection.” (professional association)
As this quote alludes, there is a need for coordinated HAI interventions across healthcare settings and the continuum of care.20 Internal and external stakeholders noted that local infrastructure, particularly local health departments, could be better developed and leveraged to facilitate such community-wide HAI efforts.
Unintended Consequences of Payment and Transparency Incentives
A range of stakeholders raised concerns that as HAI surveillance data become more extensively used for public reporting and payment incentives, there is greater motivation for healthcare organizations to underreport or “game the system,” especially as independent validation of these data are currently limited.31 Any substantial loss of confidence in the data risks reducing the support and viability of these systems. For example, a healthcare industry representative noted that penalties might drive “down reporting of infections, but not the actual occurrence of infections,” whereas a consumer group representative stated the concern that “hospitals are figuring out ways to get around” payment penalties.
Constrained Funding Environment
In many areas, such as HAI data collection, the activities that the Action Plan is asking stakeholders to perform may exceed available resources. In the words of a federal stakeholder, “There is a disconnect between what we are asking and the effort it actually takes.” This is especially the case for stakeholders in the state and private sectors, who are understandably hesitant to take on additional uncompensated burden.
Internal and external stakeholders also pointed to the increasingly constrained funding environment across the federal, state, and private sectors and its implications for sustainability of HAI prevention infrastructure and activities.
Both internal and external stakeholders stressed the significant challenges in terms of the greater decline and instability in resources posed by the current “backlash against additional spending,” at both the federal and other levels of government. Federal stakeholders also noted the difficulty of maintaining a dedicated, funded home for coordination, and emphasized the need for resources “that don’t necessarily fit into other agencies,” such as resources for coordination.
Continuing Disjoint, Lack of Clarity Over Agency Roles and Between Federal Initiatives
Although the Action Plan leaders made progress in coordination as noted earlier, a number of comments from external stakeholders highlighted how the roles of specific agencies seem to be unclear and how the plethora of HAI activities, at the federal, state, and other levels, sometimes made it difficult to understand responsibilities:
“There’s so much going on that it’s still difficult to coordinate and get a clear sense of who all is involved and who is doing what, and then the concern about duplication.” (professional association)
A lack of perceived alignment was especially noted between the Action Plan and the PfP initiative. Several federal respondents commented on how the overall objectives of the initiatives are complementary, how much time and resources have been consumed in attempting to align specific goals and framing with the PfP, and how doing so “definitely has slowed down implementation of the Action Plan.”
However, as other federal stakeholders described, “the alignment is not complete” and there is still need “to make sure the hospital stuff we [Action Plan] have done pulls under the umbrella of the Partnership.” Specific challenges to coordination mentioned include “so much overlap” in structures, different strategies of engagement and accountability, and competition for attention (“the PfP kind of swallows us up”). External stakeholders had even more trouble “seeing where the coordination is. If [the Action Plan and PfP] came out with a map of how they relate to each other and that they’re not incompatible, that would be helpful.” This perception harbors “the danger that [both initiatives] could look ‘schizophrenic’ and may ultimately lose support.”
The National Action Plan developed a unique infrastructure to coordinate HAI prevention activities among federal agencies and to stimulate HAI improvement through the healthcare system to the point of care. In addition, the progress and challenges involved in developing this infrastructure highlight the importance of attending to system properties to implement change, including prioritization of goals and activities, coordination and alignment processes, accountability and incentive systems, stakeholder engagement, and resource availability and use.
For example, the Action Plan’s establishment of national targets and the visible support of HHS leadership and Congress created accountability for agencies to collaborate, whereas a dedicated office for coordination and recognition of complementary capabilities and strengths of agencies encouraged a positive “space” to build relationships among staff and manage inherent tensions across agencies. Efforts of the dedicated coordinating office and other federal agencies to engage stakeholder groups in HAI prevention has been extensive, although external stakeholders’ familiarity with the extent of the Action Plan activities was limited until the second year of the initiative, indicating the importance of constant communication and feedback.
It was also clear that infrastructure for prevention capacity was greatly aided by substantial Congressional appropriations, especially funding from the ARRA economic stimulus aimed at state-level efforts. However, the end of ARRA funding and budget constraints in both the public and private sectors has created uncertainty on how to sustain HAI-related efforts. Regulatory infrastructure in the form of CMS’s VBP is expected to generate strong incentives for healthcare organizations to prevent HAIs. At the same time, there are calls for greater practical assistance on how to implement prevention practices and for consolidating strategies across HAIs.
Although some components of this infrastructure were a direct outgrowth of the Action Plan (eg, the Regional projects sponsored by OASH), many of the federal HAI prevention programs included in the scope of the plan have been activities initiated by individual agencies or even Congress itself. As illustrated by the use of NHSN data for CMS’ transparency and financial incentive programs, cross-use of HAI prevention expertise, resources, and tools among various agency programs, and collaborative engagement of external stakeholders, the Action Plan has added particular value in coordinating, prioritizing, and filling gaps in this infrastructure.
The experience of the Action Plan in developing a robust and effective infrastructure for national HAI improvement indicates that broad-scale change requires attention across multiple healthcare system functions and properties at different levels of the healthcare system. In some ways, HAI prevention has unique characteristics as a domain of healthcare quality—particularly in terms of the range and types of stakeholders involved, for instance the early and strong roles of consumer groups and the epidemiological community, and the high visibility given to many infections by the public media.6 However, many of the structures and strategies for coordinating federal efforts and engaging these stakeholders to stimulate national action are applicable beyond to other areas of public health and patient safety. The Action Plan has built a foundation of infrastructure to expand prevention of HAIs and presents useful lessons for other large-scale improvement initiatives.
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