Barbara M. Soule
Introduction
In the late 1950s and early 1960s, an epidemic of a new, virulent, antibiotic-resistant strain of Staphylococcus aureus infections swept through U.S. hospitals. There were rapid and dramatic increases in infections in newborns and obstetrical and surgical patients. Up to 25% of newborn infants developed superficial pyodermas or more serious deep infections and about 1% of healthy postpartum mothers died of S. aureus sepsis [1].
These infections highlighted the deficiencies in care practices for patients and focused the attention of healthcare providers on healthcare-associated infections (HAIs) [2]. Two influential national agencies came forward to assist hospitals in their efforts to prevent HAIs [3]. The collaboration between healthcare professionals, public health, governmental, and trade organizations established ties that shaped the early evolution of infection prevention and control programs (IC) and forged relationships that continue today.
This chapter describes the context, role, and influence of regulatory, voluntary, public, and professional entities on the practices and outcomes of IC and hospital epidemiology. A case-study illustrates the interplay among the entities using the development and implementation of hand hygiene evidence-based practices in healthcare.
Early History
The Centers for Disease Control (now the Centers for Disease Control and Prevention [CDC]) and the American Hospital Association (AHA) were the first to partner with healthcare organizations and professionals engaged in IC. During the height of the staphylococcal epidemic, the CDC created a small unit of epidemiologists to provide assistance to hospitals struggling to understand and contain HAIs [1]. The CDC hosted the first national Conference on the Prevention of Hospital-Acquired Staphylococcal disease in 1958 [4], published guidance on isolation techniques for hospitals [5] and began training nurses who were filling the new role of infection control nurse in 1968 [6]. In 1965, the CDC sponsored a pilot study of six community hospitals to evaluate the epidemiology of HAIs in nonuniversity hospitals [6,7]. This initial work evolved into the National Nosocomial Infections Surveillance (NNIS) system (now the National Healthcare Safety Network) (NHSN), the only national HAI database
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in the United States [8,9]. The CDC remains the primary governmental partner for infection control professionals (ICPs) and hospital epidemiologists.
In the late 1950s and early 60s, the AHA recognized the need to disseminate advice for controlling HAIs to its member hospitals [3,10,11]. They recommended that hospitals establish a committee on HAIs; create an HAI surveillance and reporting system; use strict aseptic practices in surgeries, delivery rooms, and nurseries; minimize the use of antibiotics; and identify which infections occurred in the hospital and the community. These recommendations served as early guidelines for IC programs. Later, reports and technical briefings addressed evolving issues such as Human Immunodeficiency Virus (HIV)/Acquired Immune Deficiency Syndrome (AIDS) and hepatitis B virus (HBV) [12,13]. The AHA established The Advisory Committee on Infections within Hospitals that evolved into the Technical Panel on Infections within Hospitals and remained in existence until 1995. Today, the AHA continues to advocate for IC issues through its state hospital associations.
The CDC, AHA, and others helped drive the IC agenda. By 1976, nearly 90% of hospitals were performing HAI surveillance and had an infection control committee, and close to half had an infection control nurse at least part-time [14]. Interestingly, there were no regulations or standards for IC at that time, so early IC efforts occurred voluntarily in hospitals [6].
As questions arose about the effectiveness and value of IC, the CDC performed a nationwide study over a 10-year period. The Study on the Efficacy of Nosocomial Infection Control (SENIC) project provided strong evidence that effective IC programs with specific surveillance, reporting, and staffing components could demonstrate a decrease in HAIs [15]. Through the decades, the CDC and the AHA have maintained the prominence of the prevention and control of HAIs on their agenda by sponsoring studies, programs, advocacy, and evidence-based guidelines to assist the field in defining the epidemiology of HAIs and using scientific practices to reduce HAI risk.
Voluntary and Regulatory Standard-Setting Organizations: Influence on Infection Prevention and Control
External evaluation and controls of health services involve setting standards against which organizational operations and programs can be measured. Florence Nightingale developed early standards for IC in her efforts to control the patient's environment, improve sanitation, and reduce infections during the Crimean War in the mid-1800s [16]. Today, some standards, such as those from the National Quality Forum [17] and the Agency for Healthcare Research and Quality (AHRQ) [18], are voluntary and developed by consensus. They are used by organizations for professional self-examination and determination of competence in program activities and outcomes. Other standards are used to determine reimbursement for care services. Those developed by the Joint Commission (JC) [19] and the American Osteopathic Association (AOA) [20] are voluntary whereas those from the Centers for Medicare and Medicaid Services (CMS) [21] are mandatory and required for healthcare licensure and/or payment. Regulatory standards, such as those from the Occupational Safety and Health Administration (OSHA) [22] or the Federal Drug Administration (FDA) [23] are promulgated based on federal and/or state statutes that delegate standard setting, interpretation, and oversight to a specific federal or state agency.
Three key steps characterize the external evaluation process [24]. First, formal standards are created and adopted to define a set of performance expectations for the programs that participate. Second, the standards are audited externally to determine the degree of compliance by the organization. Both Cruse and Haley recognized the positive effect of assessing surgical site infections (SSIs) using an external observer (the ICP and physician) and providing incidence data and trends on the SSI rates to the surgeons [1,25]. Accreditation and regulatory agencies also conduct both scheduled and unannounced surveys to monitor compliance with their standards and to respond to complaints. Third, rewards or sanctions are designated depending on the degree of compliance with the standards. This might include awarding, withholding, or revoking accreditation or licensure or issuing citations or fines and recommendations for improvement in care provided.
Many standard-setting organizations influence IC practices. Although it is not possible to discuss all in detail, a summary is provided in Table 12-1. Four that have been particularly important are covered here.
The Joint Commission (JC)
The JC is a voluntary, nongovernmental, not-for-profit organization that is a coalition of several major healthcare organizations. Historically, its standards originated from the American College of Surgeons' (ACS) Minimum Standards for Hospitals based on Ernest Codman's outcome-based monitoring system [26]. Codman's system was to track each patient to determine whether the treatment was effective and, if not, to determine why, so that subsequent patients could be treated more effectively. On-site hospital inspections using these standards were begun in 1918 by the ACS and in 1953 by the JCAH (now JC). In 1965, Congress passed the Social Security Amendment with a provision that JCAH-accredited hospitals were “deemed” to be in compliance with the Medicare Conditions of
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Participation and could receive Medicare and Medicaid funds [27].
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TABLE 12-1 |
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The JC published the first standards for IC in 1976 [28]. When the standards were published, some professionals noted the lack of a substantive body of scientific information to indicate whether, if followed, they would reduce HAIs [3]. The most recent standards have added requirements for risk assessment, evaluation of goals and strategies, assessment of IC data, and evidence of performance improvement efforts [19]. The infection control standards apply to all healthcare settings surveyed by the JC including hospitals; long-term care, home health, behavioral health, and ambulatory settings; laboratories; office-based surgeries; and others. The fourth iteration of IC standards became effective in 2005 after development with the input of an expert panel of infection control and epidemiology professionals from a variety of professional organizations [19].
American Osteopathic Association (AOA)
The AOA was founded in 1897 to advance the tenets of osteopathic medicine and provide support for doctors of osteopathy medicine [20]. The organization serves >50, 000 physician members, providing education, research, and guidance on providing cost-effective and ethical care. The AOA serves as the accrediting agency for all osteopathic medical colleges and healthcare facilities using a voluntary process.
For organizations not inclined to participate in the JC or AOA surveys, an alternative is to rely on the annual state surveys from the state health department for determining entitlement to Medicare and Medicaid reimbursement.
Centers for Medicare and Medicaid Services (CMS)
The CMS (formerly the Health Care Financing Administration [HCFA]) was established in 1977 by the U.S. Department of Health and Human Services (DHHS). This federal agency is responsible for administering and enforcing the Medicare and Medicaid reimbursement programs.
The CMS generates infection control standards under its Conditions of Participation (CoP) [21] for hospitals and long-term care and home care agencies. In contrast to the JC and AOA voluntary standards, those from CMS are mandatory for continued participation/reimbursement from Medicare and Medicaid. The regulations require the hospital to develop, implement, and maintain an IC program for the prevention, control, and investigation of HAIs [21]. The JC standards and the CMS CoP for IC are similar but not identical. When differences exist and healthcare organizations voluntarily participate in JC accreditation, the organization must adhere to both sets of standards.
Occupational Health and Safety Administration (OSHA)
OSHA is a governmental agency organized under the U.S. Department of Labor [22]. Its mission is to ensure the safety and health of U.S. workers by setting and enforcing standards; providing training, outreach, and education; establishing partnerships; and encouraging continual improvement in workplace safety and health [22]. In 1991, OSHA issued the Bloodborne Pathogens Standard (BBP) to protect healthcare workers (HCWs) from exposures and subsequent infections [29]. Under the general Duty Clause of the standard, employers are required to provide a work environment “free from recognized hazards that are causing or are likely to cause death or serious physical harm to his employees” [29]. The BBP Standard has been well integrated into IC programs and healthcare organizations with policies, education and training, administrative controls, and safe practices. In January 2001, OSHA revised the BBP standard in conformance with the requirements of the federal Needlestick Safety and Prevention Act of 2000 [30], requiring healthcare organizations to redefine engineering controls to include safer medical devices and systems in concert with the users of the devices and to involve frontline HCWs in device evaluation and selection. A subsequent study in one hospital indicated significant decreases in sharps injuries [31]. The influence of these two OSHA standards has had a positive effect on reducing HCW infections in the United States. Some states (called “state-plan states”) have retained authority for occupational safety standards; the state can exceed but not lessen protections required by federal OSHA.
Other Standard-Setting Organizations
Many other organizations issue standards that affect IC in some way. These include the Environmental Protection Agency (EPA) standards for the disposal and transportation of medical waste and a registry of liquid chemical products used for surface disinfection and sterilization in hospitals [32]. The FDA regulates antiseptics and medical devices through the Safe Medical Device Act, the reuse of single-use devices, the safety of the blood supply, and most food safety [23]. The Government Accountability Office (GAO) has published standards for the minimum elements of an IC program with a focus on economic issues [33]. Recently, the National Fire Protection Association (NFPA) participated with ICPs and others in a lengthy debate about the placement of alcohol-based hand hygiene products in egress corridors of facilities [34]. This is later described further. These and other organizations are listed in Table 12-1.
Infection Control Health Policy: The Role of Science and Politics
The public health policy process is complex. It reflects the heterogeneity of participants, their pluralistic interests, and
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the policy process itself. Policy formulation and adoption do not occur in a vacuum, nor do they occur in an orderly manner [35]. The public, interest groups, government agencies, and policy makers bring to bear their personal, political, ideological, and cultural values as they determine which policies they will consider, support, or oppose [36]. Not all HAI issues become candidates for public policy. The subject must generate anxiety or dissatisfaction or be perceived as a problem by the public or the policy makers [37]. Those that involve personal fear, urgency, or threats are more likely to reach the policy agenda. Some issues describe actual risks; others escalate public fear through sensationalism or misperceptions based on lack of scientific knowledge. Often, the process reflects a combination of these elements.
In the 1980s, HIV/AIDS first became a policy issue due to public fear and uncertainty regarding its transmission, the persons affected by it, and the lack of adequate information about it [38,39]. Medical waste disposal then became a related policy issue. Medical waste had rarely been demonstrated to pose a risk of human disease if managed in a reasonable manner [40], yet the advent of AIDS intensified the fear about transmission of HIV from used hospital supplies, hospitals, or clinics, which reached policy discussion [40]. The potential for an avian influenza pandemic has found a place on the policy agenda because of the anxiety, scientific uncertainty, and alarm it has generated about potential morbidity and mortality. On the other hand, significant matters (e.g., antimicrobial resistance, immunizations, and device-related infections) have until recently been largely managed by the health professionals without becoming politically charged health policy issues.
Health issues must be articulated to attract the attention of policy makers. Some problems are difficult to quantify because of their “invisible” nature [37]. One strategy to gain attention is to collect and share data that characterize the magnitude of a problem; another is to publicize unfortunate events. Infections among the homeless, immigrants, or other politically underpowered populations are largely left to health professionals to manage. In contrast, the increasing availability of HAI data has amplified visibility and resulted in increased public awareness and concern. Consumer groups have successfully articulated the need for mandatory public reporting of HAI data and lobbied state legislatures to enact HAI reporting statutes (Table 12-1). Infection control societies, the CDC, and others have joined the conversation, and the media have kept the issue before the public.
Both science and politics contribute to health policy formulation. Science is essential but often not sufficient. It contributes a relatively impartial and rational aspect to policy making, but political factors, such as economics, social values, and public perception, may be more powerful in policy determination [36]. The 2005 update of the CDC Tuberculosis (TB) Guidelines involved extensive negotiations and lobbying between ICPs, agencies such as the CDC and its National Institute for Occupational Safety and Health (NIOSH) to focus on science to determine respiratory policies for TB protection [41]. The revised CDC's Hospital Infection Control Practices Advisory Committee (HICPAC) Guidelines on Isolation have been in development for several years while professionals debated the science, politics, and costs of managing multidrug-resistant organisms (MDROs) in healthcare organizations [42]. The balance between the forces that determine the infection prevention agenda is a continuing challenge.
The Era of Partnerships: Consensus, and Collaboration
Patient Safety and Quality Organizations
In 1999, the landmark Institute of Medicine (IOM) report, To ERR Is Human, generated intense media, policy, and provider discussion about the safety of U.S. healthcare and its impact on morbidity, mortality, and cost of medical errors [43]. A subsequent report in 2001, Crossing the Quality Chasm, discussed the necessary redesign of the healthcare system to improve patient safety [44]. Finally, the third report, Leadership by Example: Coordinating Government Roles in Improving Healthcare Quality, not only discussed immunization but also estimated that >40,000 lives could be saved annually through wider implementation of CDC guidelines [45].
Such reports have led to the development of numerous patient safety and quality organizations and have spurred the development of various pay-for-performance quality programs and large state and national collaboratives designed to improve healthcare quality and prevent HAIs. As with regulatory agencies, it is not possible to discuss all patient safety and quality organizations; therefore, several will be highlighted.
The Agency for Healthcare Research and Quality (AHRQ)
Previously known as the Agency for Healthcare Policy and Research (AHCPR), AHRQ, as it is known today, arose out of the Healthcare Research and Quality Act of 1999 [18]. As such, it is the lead federal agency on quality-of-care research with responsibility to coordinate all federal quality improvement efforts and health services research. It is organized under the U.S. Department of Health and Human Services, and, through its 12 evidence-based practice centers, it supports scientific quality research and maintains the National Guideline Clearinghouse, a Web site devoted to collecting and organizing various evidence-based practice guidelines developed by other agencies and professional societies [46]. Through its web site, the AHRQ provides inpatient quality indicators that can be abstracted from administrative data in order to assist hospitals to identify
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problem areas that need further improvement [18]. In addition, AHRQ's patient safety indicators include postoperative sepsis, wound dehiscence, and selected infections [18]. In a compendium of quality recommendations published by AHRQ, 28% of recommendations are infection-control related, and 5 of 11 “clear opportunities for improvement,” including the use of full barriers for central venous catheter insertion and appropriate use of surgical prophylaxis, are infection related [47]. Using patient safety indicator data, Zhan identified excess charges, mortality, and length of stay associated with various infection indicators [48]. The AHRQ Web site contains numerous free resources that can be used for improvement efforts, including information for consumers.
National Quality Forum (NQF)
The NQF is a public-private not-for-profit partnership composed of approximately 170 organizations that was established in 1999 as part of the President's Commission on Quality [17]. Its goal is to standardize healthcare performance measures that can be used to compare healthcare across the United States. This includes voluntary measures for inpatient and outpatient settings, standardization of patient safety taxonomy, and incorporation of evidence-based recommendations [17]. The first set of 39 measures included SSI prophylaxis, immunizations for selected conditions, and device-associated HAIs.
In early 2006, the NQF named a steering team that will develop by February 2007 national voluntary consensus standards for reporting HAIs [17]. The steering team will receive reports from six technical advisory panels including experts on intravascular catheters and bloodstream infections (BSIs), urinary tract infections (UTIs), ventilator-associated pneumonia (VAP), SSIs, pediatric infections, and reporting and implementation [17]. Many of the NQF measures have been subsequently adopted by CMS and JC as hospital performance measures.
The Institute for Healthcare Improvement (IHI)
The IHI is a not-for-profit organization founded in 1991 with the goal to improve the quality of healthcare delivered to patients around the world [49]. In January, 2005, the IHI initiated a nationwide voluntary collaborative, the Save 100,000 Lives campaign, with the goal of reducing healthcare-related deaths by 100,000 in 18 months [49]. Three of six campaign initiatives involve reducing HAIs through implementation of ventilator and central line “bundles” (groups of evidence-based practices shown to reduce infection risk) and appropriate SSI prophylaxis. To date, >3000 hospitals have voluntarily signed on to participate in one or more campaign initiatives. The campaign provides access to best practices sharing and frequent conference calls and tracks progress on its Web site countdown [49]. In addition to information regarding the Save 100,000 lives campaign, the Web site provides many other resources designed to improve quality of care.
Table 12-2 lists selected consensus documents that influence IC and HAI prevention practices.
Evidence-Based Practices
Evidence-based practices are defined as practices supported by some level of scientific review, which can range from scales using a weighted scheme (e.g., the CDC methodology that gives the highest weight to randomized, controlled clinical trials) to expert consensus. The AHRQ National Guideline Clearinghouse provides descriptions of different evidence rating techniques [46].
For IC, the most widely used evidence-based guidelines originate from the CDC's Healthcare Infection Control Practices Advisory Committee (HICPAC) [50] (Table 12-3), the Association for Professionals in Infection Control and Epidemiology (APIC) [51], and the Society for Healthcare Epidemiology of America (SHEA) [52], which all use a weighted rating scale for evidence determination.
HICPAC consists of 14 members serving overlapping four-year terms and nonvoting liaisons from APIC, SHEA, CMS, and other representatives as necessary [53]. The committee advises the CDC on needed guideline updates and drafts new guidelines as necessary. All meetings are open to the public, and draft guidelines are published in the Federal Register in order to solicit additional broad input before finalization [53]. The final step includes peer review through the Office of Management and Budget (OMB).
In contrast, professional society guidelines often are developed by committees with deep experience in infection control and healthcare epidemiology with final approval by SHEA's board of directors.
The Influence of Professional Organizations on Infection Control and Healthcare Epidemiology Practice
The Association for Professionals in Infection Control and Epidemiology (APIC)
The APIC [51] was founded in 1972 as the first U.S. professional organization dedicated to reducing HAIs [54]. The organization is composed of >10,000 ICPs and healthcare epidemiologists who manage IC programs in multiple healthcare settings throughout the world [51]. In 1978, APIC emphasized the need for trained ICPs [55] and encouraged professionals to use epidemiological principles and methods to address infection, quality, and risk issues [56], and more recently, patient safety challenges [56]. APIC publishes a comprehensive text of IC [57] and professional and practice standards [58]. The Certification Board of Infection Control (CBIC), established by APIC in 1980, offers certifying examinations for ICPs and epidemiologists [59]. A major focus of
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APIC is to translate the HAI science and guideline recommendations into practice.
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TABLE 12-2 |
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The Society of Healthcare Epidemiology of America (SHEA)
In 1980, a group of physicians, mainly specialists in infectious diseases, founded the SHEA [60]. This professional organization is dedicated to developing and applying the science of healthcare epidemiology to the study and improvement of HAIs and other adverse outcomes. One of the organization's goals is to translate knowledge into effective policy and practice [52]. SHEA has approximately 2000 members with a large international membership component. SHEA changed its name to substitute “Healthcare” for “Hospital” in recognition that the skills of healthcare epidemiologists should be applied to the broader context of healthcare in areas beyond IC and settings outside of the hospital. Later, SHEA expanded its membership to include ICPs. A major focus of SHEA is to develop and disseminate the science on which IC practices are designed.
SHEA and APIC have both actively and successfully advocated for sensible and pragmatic IC policies and the resources necessary to sustain an active program. Both organizations publish position papers, consensus documents (Table 12-2), scientific research studies in peer-reviewed journals, and thoughtful articles about the state of the art and policy issues for the field. The associations create or endorse guidelines from other organizations, such as the Infectious Diseases Society of America (IDSA) or the Institute of Healthcare Improvement (IHI), to add strength to recommendations that promote best practices. Both APIC and SHEA proactively educate their members and engage lawmakers, regulatory agencies, the CDC, and others in the development of infection control regulations and standards, as well as the response to emerging issues. Their participation in developing the CDC HICPAC guidelines (Table 12-3) is invaluable. SHEA, APIC, and the CDC have worked together on a number of projects, for example, the Communications Network, which is designed to quickly and efficiently disseminate critical IC information to their members [61]. These efforts have greatly influenced IC practice and policies.
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TABLE 12-3 |
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The Interplay and Influence of Professionals and Agencies on Practice: Hand Hygiene: A Case Study
Efforts to increase hand hygiene compliance illustrate the interplay between various guidelines, accreditation standards, professional societies, and regulatory bodies.
Hand hygiene has been recognized since the time of Ignaz Semmelweis to be one of the most important interventions to prevent the transmission of infections among patients. Although the evidence to support hand hygiene practices has been known for >150 years, actual compliance has been poor, ranging from 5%–81% [62], prompting the CDC in its Hand Hygiene Guideline to recommend the broad use of alcohol-based hand rubs (ABHR) in an effort to increase compliance and thus reduce HAIs [62]. APIC and SHEA quickly embraced the guidelines.
Shortly after publication, questions were raised about whether the use of ABHR would be compliant with OSHA Bloodborne Pathogens Standard [63], which required “hand washing” after exposure to blood or other potentially infectious material (OPIM) [63]. In March 2003, OSHA issued a standard interpretation [64], noting that ABHR would be appropriate when no actual contact with blood or OPIM had occurred but that soap and running water would still be required when actual exposure had taken place [64]. This was just the tip of the iceberg in terms of regulatory interplay.
In 2004, the JC added compliance with the CDC IA, IB, and IC Hand Hygiene recommendations to its National Patient Safety Goals [65]. This elevated CDC's voluntary guidelines to the level of a national standard of care because most U.S. healthcare inpatient facilities are accredited by JC.
The next hurdle to overcome related to ABHR dispenser placement; CMS requires adherence to the national Life Safety Code as part of Medicare/Medicaid conditions of participation [21]. It was not until April 15, 2004, that professional societies acting in conjunction with the American Institute of Architects (AIA) [66], the American Society for Healthcare Engineering (ASHE) [67], the EPA [32], the FDA [23], JC [65], and the CDC collaborated with CMS to adopt a temporary interim amendment to the 2000 edition of the National Fire Protection Life Safety Code that would allow ABHR dispensers to be placed in egress corridors under certain specified conditions [68]. Finally, in late 2005, the NFPA adopted the 2006 Life Safety Code after approval by the International Code Council, settling the issue of dispenser placement [68].
That is still not the end of the story of interagency cooperation and collaboration. The World Health Organization's Global Patient Safety Challenge for 2005–2006 addresses HAI reduction through its “Clean Care Is Safer Care” program focusing international attention on improving hand hygiene, including the use of ABHR when appropriate [69,70].
Finally, IHI has recently adopted the improving hand hygiene challenge, developing support tools in collaboration with CDC, APIC, and SHEA to improve implementation of CDC evidence-based recommendations in healthcare facilities [71]. The campaign goal is to galvanize healthcare facilities to implement recommendations with the same enthusiasm with which they participated in the Save 100,000 Lives campaign.
Conclusions
A wide variety of regulatory, accrediting, and not-for-profit state, national, and international collaborating partners are now paying attention to HAIs and working with the CDC and IC professional societies to prevent infections in patients and healthcare workers. As never before, ICPs, epidemiologists, and standard-setting and advisory groups have the ground support to be able to reduce HAI to the irreducible minimum.
References
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