Healthcare–associated infections (HAIs) are infections that patients acquire during the course of treatment in healthcare settings.1 HAIs can be acquired in any setting in which healthcare is delivered, including acute care hospitals, ambulatory care settings, and long-term care facilities, such as nursing homes and skilled nursing facilities. HAIs are associated with a variety of risk factors, including the use of indwelling medical devices such as bloodstream and urinary catheters, surgical procedures, injections, environmental contamination, and transmission of diseases between patients and healthcare personnel. Widespread use of antimicrobial drugs also helps account for the increase in HAIs, including infections by antibiotic-resistant organisms. HAIs may be caused by any type of infectious agent, including bacteria, fungi, and viruses.
The public health burden of HAIs is staggering. For example, hospital-acquired infections alone are among the leading causes of preventable death in the United States, accounting for an estimated 1.7 million infections and 99,000 associated deaths in 2002.2 According to more recent data, at any given time, approximately 1 in 20 patients will contract an HAI in US hospitals.3 Another 1.6 to 3.8 million infections are estimated to occur annually in long-term care facilities.4 There are currently no reliable overall estimates of the total burden of infections that occur as a result of treatment in ambulatory care settings.
The cost to the American economy due to HAIs is also steep. Hospital-acquired infections alone are responsible for $28–$33 billion dollars in preventable healthcare expenditures annually.5 A 2010 report from the US Department of Health and Human Services (HHS) Office of the Inspector General estimated that hospital care associated with adverse events and temporary harm events (ie, an event that requires intervention, but does not cause lasting harm), including hospital-acquired infections, cost Medicare an estimated $324 million for 1 month alone.6
Despite the health burden and costs associated with HAIs, infections associated with medical treatment were once considered to be an acceptable and unavoidable “cost of doing business” in the healthcare delivery system. However, over the past 15 years, experts in the field of patient safety have discussed the concept and feasibility of not just reducing, but eliminating HAIs. In 1999, the Institute of Medicine released its landmark report, “To Err is Human: Building a Safer Health System,” which served as a clear call for national improvements in the healthcare delivery system to improve awareness of the problem of adverse events in healthcare, and as a call for the alignment of payment and liability systems to encourage improvements in safety.7 Indicative of the increasing focus on improving healthcare quality and patient safety, pockets of success in addressing certain types of HAIs have been seen across the country. For example, activities in southwestern Pennsylvania by the Pittsburgh Regional Health Initiative with involvement from the Centers for Disease Control and Prevention (CDC) have shown that implementation of prevention recommendations can reduce healthcare–associated bloodstream infections by as much as 68% through targeted approaches.8 Scientific advances, an enhanced culture of safety within the healthcare system, and the proven success of smaller-scale prevention initiatives have now led to a consensus among experts that the elimination of HAIs is a worthy aspirational goal, as well as one that may be possible to achieve.9,10
National-level efforts to reduce and eliminate HAIs have been underway for decades across HHS agencies, including CDC and the Agency for Healthcare Research and Quality (AHRQ). However, beginning in early 2008, the US Government Accountability Office (GAO) completed a review of HAIs in American hospitals. Although the review and subsequent report acknowledged HHS-supported efforts, the GAO noted a lack of leadership and centralized coordination of activities to optimally leverage federal resources to address HAIs.11 The report encouraged HHS to increase its leadership through enhanced coordination of all interventions and other related activities. In particular, the report directed HHS to (1) prioritize the numerous existing recommended infection control practices to facilitate their implementation in healthcare facilities and (2) reduce “silos” across its agencies with regard to the various information technology systems used to measure HAIs. Although there are numerous systems and databases that collect HAI-related data across HHS, GAO noted a need for greater consistency and compatibility of data, including information used to obtain reliable national estimates of the major types of HAIs.
In response to the GAO report, HHS has used a multipronged public health approach to address HAIs, with a renewed emphasis in the last 5 years on improving the quality and safety of US healthcare. Owing to the increasing complexity of healthcare delivery and the multiple causal factors that contribute to the occurrence of HAIs, HHS is pursuing a multifaceted solution grounded in an appropriate understanding of the biological, social/behavioral, and cultural/environmental determinants of health and disease.
HHS’s approach for addressing HAIs, which is the focus of this paper, is part of a broader emphasis within the federal government and HHS to improve the quality, value, and cost-effectiveness of US healthcare. The Affordable Care Act in 201012 seeks to transform the quality of US healthcare services. Concurrently, the HHS Office of the Assistant Secretary for Health initiated a new focus on using a systems approach to improve the quality of healthcare and public health in the United States. Also, in 2011, HHS launched the Partnership for Patients, a public-private partnership focused on reducing all-cause harms in hospitals and improving the care provided to patients as they transition from acute care hospitals to other settings.13
In this paper, we describe the key components of HHS’s National Action Plan to Prevent Healthcare-associated Infections: Roadmap to Elimination and many of the activities that have been implemented in relation to the plan. In particular, we describe the multipronged public health approach taken by the HAI Action Plan; discuss key initiatives at the national, state, and regional levels; and describe some of the general approaches used to support the HAI Action Plan, as well as some challenges. This paper is intended to establish the foundation for further discussion of the HAI Action Plan in this volume.
NATIONAL ACTION PLAN TO PREVENT HAIs
In the summer of 2008, the senior-level Federal Steering Committee for the Prevention of Healthcare-associated Infections was established.14 Members of the Steering Committee include clinicians, scientists, and public health leaders from across HHS and other federal departments. The charge to the Steering Committee was to develop the National Action Plan to Prevent Healthcare-associated Infections: Roadmap to Elimination.15 The HAI Action Plan would serve as a comprehensive policy document establishing national 5-year reduction goals, outlining key actions for coordinating and enhancing efforts, and providing a “roadmap” to eliminate HAIs in the United States.
The initial version of the HAI Action Plan was finalized in June 2009. This version focused on hospital-acquired infections, specifically catheter-associated urinary tract infections, central line–associated bloodstream infections, surgical site infections, and ventilator-associated pneumonia, as well as infections with methicillin-resistant Staphylococcus aureus and Clostridium difficile.16
The HAI Action Plan prioritized current infection prevention recommendations from CDC. The plan also prioritized a research agenda and established criteria for assigning priorities to proposed research projects; outlined projects for integrating HAI-related data collection across HHS surveillance systems; outlined policy options for connecting payment incentives or disincentives to quality of care and enhancing regulatory oversight of healthcare facilities; and delineated a national outreach plan to raise awareness of the problem of HAIs and of preventive steps to reduce the risk of contracting or transmitting an infection.
A critical step in the HAI Action Plan development process was the identification and establishment of priority measures and 5-year national targets for assessing progress in HAI reduction and prevention.17 Measure identification and target setting was coordinated with existing HHS initiatives, including Healthy People 2020, an evidence-based, 10-year list of national objectives for promoting health and preventing disease.18 It was important to coordinate the establishment of the national initiative’s measures and goals with other programs to reduce confusion and duplicative efforts (eg, collecting and analyzing data). The original HAI Action Plan included priority areas, measures, 5-year reduction targets, and national baseline periods. It should be noted that a measure and corresponding reduction goal could not be identified and established in 2009 for ventilator-associated pneumonia due to the lack of consensus on a clinical and surveillance definition for the infection.
A draft of phase 2 of the HAI Action Plan was released in 2011. The revised HAI Action Plan included strategies on addressing HAIs in ambulatory surgical centers, and end-stage renal disease facilities, as well as a strategy to increase seasonal influenza vaccination of healthcare personnel to protect the health of workers and reduce the risk of influenza transmission to patients. Since then, the HAI Action Plan has expanded to include additional content on reducing HAIs and enhancing infection control and prevention in long-term care facilities. Additional sections are being considered that would address HAIs occurring in various ambulatory care settings.
Since the development and issuance of the HAI Action Plan in 2009, a number of activities have been carried out to better understand HAIs and interventions to prevent HAIs at the national, regional, and state levels. We describe examples of some key initiatives here.
At the national level, each of the HHS component agencies conducts programs in accord with its individual mission for the prevention of HAIs. One example is the establishment of a new supply chain of HAI data within the last 4 years. As a first step in implementing the Affordable Care Act, data from CDC’s National Healthcare Safety Network (NHSN) are being supplied to Centers for Medicare & Medicaid Services’ (CMS’s) Hospital Inpatient Quality Reporting Program.19 Currently, >5000 hospitals are enrolled in NHSN and many states have laws mandating that facilities publicly report facility-specific HAI data and use NHSN for implementation of mandatory reporting laws.20 The HAI data supplied from CDC to CMS is included in the healthcare quality measurement data made publicly available on the CMS Hospital Compare website. Other federal efforts, such as those by the Office of the National Coordinator for Health Information Technology, are supporting adoption of electronic health records across the country.21 The long-term goal is to transition from manual methods of HAI detection and reporting to methods relying on electronic capture of information from electronic health records.
Another activity at the national level is the collaboration between AHRQ and CDC to ensure that HAI data standards are applied to AHRQ’s patient safety reporting program. This is consistent with the HAI Action Plan’s goal of aligning and standardizing data definitions across as many systems and programs as possible. Standardized definitions are intended to ease downstream efforts, including data analysis, reporting, and interpretation.
At the state level, there have been substantial federal investments to build and enhance capacity to address HAIs. The American Recovery and Reinvestment Act (ARRA) of 2009 provided a total of $50 million in funding for state-level HAI-related activities.22 The CDC-administered ARRA program invested in building state health departments’ HAI prevention capacity.23 CDC provided technical assistance to states for surveillance and prevention activities, collaboration initiatives, workforce training, and measurement of outcomes. Federal investments have also been used to support states’ HAI ongoing prevention efforts in acute care settings and to establish programs to address HAIs in other facility types, such as end-stage renal disease facilities.
The CMS-administered ARRA program was designed to support State Survey Agencies in their efforts to enhance the inspection process of Medicare-participating ambulatory surgical centers, specifically to include case tracer methodology and a more robust infection control assessment tool in surveys and to increase surveying frequency. Through CMS policy setting mechanisms, all states are now required to use the enhanced inspection process and survey one third of ambulatory surgical centers.24 Before the federally funded program, ambulatory surgical centers were inspected at an average frequency of every 10 years. The goal of the program is to inspect facilities every 3 years.
Also at the state level, AHRQ involves State Hospital Associations in implementing the HAI Action Plan. Funds from AHRQ have been used to award projects that address critical implementation science gaps and demonstrate generalizability and feasibility for widespread implementation.25 An integral program funded mostly by AHRQ is the Comprehensive Unit-based Safety Program (CUSP). The CUSP approach was designed to improve the culture of safety and help clinical teams learn from mistakes by integrating safety practices into the daily work of a unit or clinical area.26 The program combines clinical guidelines and recommendations for care with practical and explicit implementation approaches for use by hospitals and other healthcare delivery organizations.27,28 CUSP was first shown to be effective in reducing central line–associated bloodstream infections in intensive care units through the Keystone Project in Michigan; it has subsequently been implemented at a large number of organizations and has achieved significant reductions in central line–associated bloodstream infections. The program has expanded to address other types of HAIs (eg, catheter-associated urinary tract infections, ventilator-associated pneumonia) and other areas of the hospital besides intensive care units, and additional areas of the country.
In addition to national-level and state-level activities, a small amount of federal funds has been used over the past 4 years to support regional projects implemented by the HHS Regional Offices. The projects include development of a state website to display HAI rates for the consumer audience, enhancement of HAI surveillance in dialysis facilities, and development of training curricula for healthcare personnel working in ambulatory surgical centers and small rural critical-access hospitals.29
GENERAL APPROACHES USED IN THE HAI ACTION PLAN
The agencies leading the HAI Action Plan’s implementation have used several approaches to support the program’s success. We summarize some of those here.
With the HAI Action Plan, government leaders have chosen to pursue a public health, holistic approach to controlling HAIs in the United States. The approach involves engaging multidisciplinary stakeholders and implementing multidimensional components, including payment reform, implementation of evidence-based practices, articulation of research priorities, and partnership development, among others. A holistic approach focuses on the upstream factors that may be the real and underlying determinants of the problem, such as perverse financial incentives that counter the delivery of quality care or a culture in healthcare facilities that does not put patient safety at the forefront.
Emphasis has also been given to involving states in HAI prevention efforts. Indeed, some public health researchers have emphasized the vital role of the state over other program components, including effective interventions and sophisticated research methods–as a key determinant of the success of public health efforts in the 21st century.30 Over the past 5 years, significant federal funding has been allocated to build state capacity to monitor and address HAIs.
The HAI Action Plan emphasizes the need for rigorous data, especially upon which to base policymaking, and promotes strategies to support the generation of rigorous data at the national, state, and local levels. Even though quality improvement projects have traditionally received fewer resources than traditional (eg, basic science) research projects to collect and ensure the quality of the data, quality improvement projects also need to be rigorously designed, executed, and assessed.31,32 As the patient safety and quality improvement field matures and as data quality from quality improvement projects and surveillance systems increase, higher-quality data will be available with which to assess progress for public health initiatives similar to the national effort to reduce HAIs. To the extent possible, the program has sought to use strategies that are based on scientific evidence. This is true of unit-level and facility-level interventions, such as CUSP, which are being implemented across the United States. It is also true of state-level and national-level interventions, although evidence to support the higher-level or broader activities is limited.
Another focus of the program is the alignment of programs and policy incentives to the HAI Action Plan. Alignment of policies and programs is vital because proper alignment can reduce duplicative efforts and confusion. At the same time, HAI Action Plan leaders recognize that it is also important not to strictly control HAI prevention efforts, especially at every level. Local-level adaptation and customization of interventions to local practice and culture are vital to the effectiveness of the overall program.
NEED FOR FORMAL EVALUATION OF THE HAI ACTION PLAN
In the fall of 2009, HHS contracted with IMPAQ International and the RAND Corporation to produce an independent, formal evaluation of activities in support of the HAI Action Plan. It was important for the plan’s leaders to understand the impact of the program and to attempt to record the implications of the HAI Action Plan. It was also crucial to obtain continuous feedback from the external evaluation team on what was working well and not working well, in order to improve the program’s effectiveness.
Within the healthcare and public health communities, the emphasis on healthcare quality, patient safety, and particularly on the prevention and elimination of HAIs continues to grow in prominence. The past 5 years have seen dramatic growth in efforts to address this important public health problem. Achieving the goal of HAI prevention and progressing toward elimination will require sustained commitments of action and resources on the part of all the stakeholders involved in the initiative. Significant challenges, such as limited scientific evidence, lack of a national measurement strategy, and lack of stable funding sources for the initiative, need to be mitigated to ensure progress in reducing the burden of HAIs in the United States.
2. Klevens RM, Edwards JR, Richards CL, et al..Estimating healthcare-associated infections and deaths in U.S. hospitals, 2002.Public Health Rep.2007;122:160–166.
4. Smith PW, Bennett G, Bradley S, et al..SHEA/APIC guideline: infection prevention
and control in the long-term care facility.Infect Control Hosp Epidemiol.2008;29:785–814.
5. Scott RD.The Direct Medical Costs of Healthcare-associated Infections in U.S. Hospitals and the Benefits of Prevention.2009.Atlanta, GA:Centers for Disease Control and Prevention.
6. .Adverse Events in Hospitals: National Incidence Among Medicare Beneficiaries. OEI-06-09-00090.2010.Washington, DC:US Department of Health and Human Services.
7. Kohn LT, Corrigan JM, Donaldson MS.To Err is Human: Building a Safer Health System.2000.Washington, DC:National Academy Press.
8. .Reduction in central line-associated bloodstream infections among patients in intensive care units—Pennsylvania, April 2001–March 2005.MMWR Morb Mortal Wkly Rep.2005;54:1013–1016.
9. Cardo D, Dennehy PH, Halverson P, et al..Moving Toward elimination of healthcare-associated infections: a call to action.Infect Control Hosp Epidemiol.2010;38:671–675.
10. Frieden TR.Maximizing infection prevention
in the next decade: defining the unacceptable.Infect Control Hosp Epidemiol.2010;31:S1–S3.
11. .Healthcare-associated infections in hospitals: leadership needed from HHS to prioritize prevention practices and improve data on these infections. GAO-08-283. Washington, DC (March 31, 2008).
12. .The Patient Protection and Affordable Care Act. U.S. Government Printing Office (March 23, 2010).
15. U.S. Department of Health and Human Services, Office of the Secretary, Office of the Assistant Secretary for Health. National Action Plan to Prevent Healthcare-Associated Infections: Roadmap to Elimination. Available at: http://www.hhs.gov/ash/initiatives/hai/actionplan/
. Accessed May 10, 2013.
26. .Using a comprehensive unit-based safety program to prevent healthcare-associated infections. Available at: http://www.ahrq.gov/qual/cusp.htm
. Accessed September 26, 2011.
27. Pronovost P, Needham D, Berenholtz S, et al..An intervention to decrease catheter-related bloodstream infections in the ICU.N Engl J Med.2006;355:2725–2732.
28. .Reduction in central line-associated bloodstream infections among patients in intensive care units—Pennsylvania, April 2001–March 2005.MMWR Morb Mortal Wkly Rep.2005;54:1013–1016.
30. McKinlay JB, Marceau LD.To boldly go….Am J Public Health.2000;1:25–33.
31. Needham DM, Sinopoli DJ, Dinglas VD, et al..Improving data quality control in quality improvement
projects.Int J Qual Healthcare.2009;2:145–150.
32. Berenholtz SM, Needham DM, Lubomski LH, et al..Improving the quality of quality improvement
projects.Jt Comm J Qual Patient Saf.2010;10:468–473.