The 100,000 Lives Campaign: Crystallizing Standards of Care for Hospitals

The 100,000 Lives Campaign has the attention of U.S. hospitals, professional groups, and the media. Its aim has been endorsed, and its planks are being implemented, by more than 2,300 diverse hospitals in every state. We posit that the six planks of the campaign have become national standards of care and propose four theories of liability for hospitals that ignore the campaign or fail to implement its planks. As a result of the campaign, hospitals and their boards now face a legal incentive to reduce needless deaths through six specific interventions. I n december 2004 the Institute for Healthcare Improvement (IHI) announced a campaign aimed at avoiding 100,000 hospital deaths “over the next 18 months, and every year thereafter. ” The idea underlying the campaign is that if six evidence-based, proven interventions were reliably implemented in enough U.S. hospitals, 100,000 fewer patients would die each year. Endorsing the campaign immediately was an impressive array of organizations, including the American Medical Association (AMA), the American Nurses Association (ANA), the Centers for Medicare and Medicaid Services (CMS), the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), the Agency for Healthcare Research and Quality (AHRQ), the Association of American Medical Colleges (AAMC), and a large number of quality improvement organizations, state hospital associations, and other prominent associations and institutions. Initiated 14 December 2004 by Donald Berwick in a speech titled, “Some Is Not a Number, Soon Is Not a Time,” the campaign is unprecedented in its specific commitment to producing measurable results in quality within a time certain, on a national scale. The six “planks” of the campaign platform. Within five months after the campaign was announced, 2,300 of the nation’s 6,000 hospitals had enrolled, constituting by IHI’s count more than half of the hospital beds in the United States. By joining the campaign, hospitals committed to reducing the number of preventable 1 5 6 0 N o v e m b e r / D e c e m b e r 2 0 0 5 U s i n g E v i d e n c e DOI 10.1377/hlthaff.24. 6.1560 ©2005 Project HOPE–The People-to-People Health Foundation, Inc. Alice Gosfield (agosfield@gosfield.com), an attorney, is with Alice G. Gosfield and Associates in Philadelphia. James Reinertsen, a physician, is president of the Reinertsen Group in Alta, Wyoming. deaths in their institutions by using one or more of the following six interventions or “planks” that constitute the campaign “platform. ” (1) A system of rapid-response teams to immediately bring skilled resources to the bedside of any patient who is progressively failing outside the intensive care unit (ICU) whenever a nurse is worried that the patient might be heading toward a “code blue. ” (2) Reliable implementation of evidence-based care for acute myocardial infarction, including appropriate aspirin, beta-blocker, and angiotensin-converting enzyme (ACE) inhibitor administration and timely reperfusion, as measured by the JCAHO core measures and the CMS Seventh Scope of Work. (3) Prevention of adverse drug events by reconciling medications at all transitions in care. (4) Prevention of central line–associated bloodstream infection by reliably implementing a “bundle” of evidence-based services including hand hygiene, maximal barrier precautions, chlorhexidine skin antisepsis, appropriate care of the catheter site and administration system, and no routine replacement. (5) Prevention of ventilator-associated pneumonia by reliably implementing a “bundle” of evidence-based services including elevation of the head of the bed 30 degrees, daily sedation “vacations,” and daily readiness-to-wean assessments. (6) Prevention of surgical site infection using a “bundle” of evidence-based services including appropriate hair removal (clipping, not shaving), guideline-based timing and use of perioperative antibiotics, and tight perioperative glucose control. Basis of campaign planks. The planks were chosen based on four factors. First, each plank is strongly supported by evidence in the medical literature that it prevents avoidable deaths and injuries. With the possible exception of perioperative glucose control and the extent and types of surgical patients to which it should be applied, none of the interventions is particularly controversial. Many rest on evidence that has been in place for ten or more years. Second, each plank has been implemented in a variety of settings, not just in isolated research environments, with impressive results. In other words, the planks do not just apply to special circumstances and institutional systems. Third, these interventions deal with common problems that are associated with thousands of deaths. Implementing each plank widely and reliably would greatly reduce the number of deaths that occur in hospitals. Finally, implementation of none of the planks requires major capital investments or information system redesigns. For example, hospitals do not need to purchase new beds to elevate the head of the bed for all ventilator patients. Similarly, reconciling medications at each transition point in a patient’s care can be done with simple nursing processes, not expensive computer systems. Implementation and participants. Although implementation does not require capital, it does require investment of additional staff time, as well as reprioritization of resources, to support the measurement, change leadership, and other activities necessary to make these six practices reliable. So there are inevitably some costs associated with undertaking these efforts. That said, however, these interventions are practicable in virtually every hospital. H o s p i t a l s H E A L T H A F F A I R S ~ V o l u m e 2 4 , N u m b e r 6 1 5 6 1 The science supporting each plank and the evidence of success in their application are made known on the IHI Web site in a completely transparent manner; the names of hospitals and health care systems in the campaign also are posted there. Hospitals from all fifty states participate, and the institutions span the entire spectrum—from thirty-bed rural hospitals to community medical centers to large for-profit and not-for-profit hospital systems to the most prominent academic medical centers—in every kind of health care market. These hospitals are now implementing one or more planks, and the campaign has attracted considerable media attention. Legal accountability. Some may argue that the widespread emphasis on these six specific interventions might divert attention from other potentially more worthy quality initiatives. Our interest in this consideration is not the issue of priorities and choices among quality interventions; it is about the legal implications of the campaign itself, given that it already exists, and the potent effect of the 100,000 Lives Campaign on U.S. hospitals’ legal and malpractice risks. This campaign’s appeal is based on a clear, compelling set of moral, scientific, and practical drivers. In this paper we call attention to an additional driver—a legal argument—that supports both participation in the campaign and vigorous implementation of its planks. In our view, the mere fact of the campaign—the highly public nature of its announcement; the broad support of prominent national organizations; and the breadth, geographic dispersion, and diversity of its participating hospitals—raises the legal stakes for all hospitals, whether campaign participants or not, by bringing to the foreground and making highly visible six national standards of care, for which hospitals and their boards will now be held legally accountable. There is some precedent for our view. Some have considered that the purchasing principles of the Leapfrog Group have the potential to create legal liability for hospitals by becoming new standards of care, and this has raised concern. We believe, however, that instead of viewing the standards of care raised by the 100,000 Lives Campaign as a threat, hospitals and health care leaders should understand and harness these legal forces to help them drive the implementation of the planks throughout the country, as quickly as possible. We already know that moral, scientific, and even market forces have proved insufficient to compel all hospitals to make necessary improvements in safety. If health care leaders aim to reduce needless deaths, the question raised by this campaign might be, “Is it possible that malpractice liability could be a positive force for reducing needless deaths? ” Understanding Hospital Liability Four elements must be present and proven for a plaintiff to prevail on a medical malpractice cause of action: (1) a duty to act; (2) a breach of the applicable standard of care; (3) the occurrence of an injury; and (4) a causal connection between the breach of the standard and the injury. For many years, U.S. hospitals escaped 1 5 6 2 N o v e m b e r / D e c e m b e r 2 0 0 5 U s i n g E v i d e n c e