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Patient Safety Imperative for Health Care Reform
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Building Safe, Effective Health Care

[Position statement issued in October 2009 by the Lucian Leape Institute at the National Patient Safety Foundation. Institute members call for health care reform and outline specific recommendations designed to bring about transformational change in the health care system.]

Never before in the history of the US healthcare system has there been a more opportune time to engage the full spectrum of stakeholders in a comprehensive effort to improve the manner in which we deliver health care to our citizens. The commitment of the Administration to health care reform affords a welcome opportunity to accelerate improvements in patient safety, a discipline that utilizes a systems approach to improving health care processes and, therefore, outcomes.

The patient safety effort has provided new insights into our work processes and new tools to target our improvement efforts. We have come to understand that our exceptional advances in medicine and clinical technology need to be coupled with innovation in the delivery system models we use to support and deliver patient care. We also understand that these efforts can no longer be postponed, as the lack of attention to delivery model and process is compromising the quality of care.

As a result of the patient safety work, we now know that waste, overuse, and preventable injury are major causes of undue harm and the unnecessarily high cost of health care. Unless we deal with them, adding tens of millions of new patients to our already overburdened health care system will only make the problems worse. If health care reform addresses these issues within a systems-based approach, we will have ample resources to assure that all Americans have access to care and the system will be safer and perform at a higher level of responsiveness and effectiveness.

We know a great deal about what needs to be done. Since the Institute of Medicine (IOM) reports To Err Is Human in 1999 and Crossing the Quality Chasm in 2001, there has been a tremendous effort in both private and public sectors, collectively referred to as the patient safety movement. The Federal Government has provided resources for improving safety through the Agency for Healthcare Research and Quality (AHRQ), Centers for Medicare and Medicaid Services (CMS), the Veteran’s Health Administration (VA), and the Department of Defense (DOD). In the private sector, the National Quality Forum (NQF), The Joint Commission, the Institute for Healthcare Improvement (IHI), the National Patient Safety Foundation (NPSF), state coalitions, major health care systems, hospitals, and virtually every professional society have made significant contributions.

The major insight from this experience is that transformational change in health care system outcomes requires a shift from a focus on individual performance to the application of systems thinking, safety science and human factors engineering. Essential to this shift will be the inclusion of patients and their families in all aspects of the design, delivery, and evaluation of care. Making this change needs to be a central objective of the reform effort.

Our health care system has evolved over the last 50 years to provide episodic care for patients with acute, time-limited conditions. It is ill-equipped to meet the needs of 21st century care. Foremost among these are many patients with complex chronic disease, who consume over 75% of health care expenditures yet fail to get coordinated and preventive care. Our system also fails those needing urgent care – our emergency rooms are overcrowded and expensive – and provides little help for patients to navigate the complex array of providers and services. Even routine and preventive care for the well and palliative care for the dying are poorly served. For all of these patients, care must be organized, integrated, and delivered by multidisciplinary teams.

Multidisciplinary teams are also essential for improving patient safety. The major safety breakthroughs of recent years, such as the dramatic success of hospitals in Michigan in eliminating blood stream infections and ventilator-associated pneumonia, and the impressive reduction in surgical complications associated with briefing and debriefing check lists, are only possible when doctors, nurses, technicians, and others work together in multidisciplinary teams.

Our current system is unable to provide this care and places unnecessary barriers in the way of our health care professionals. Few professionals are trained to work in teams, most patient records are not computerized, and we lack methods for measuring most of the important quality and safety outcomes and for making that information available to patients and for quality improvement. The fee-for-service payment system provides strong incentives for overuse, does not appropriately reward for quality, pays for care even when outcomes are poor and penalizes the team-based care needed for safety and prevention.
A major restructuring of how health care is delivered is required. We need new models of care delivery that relieve the burden on the acute care system, provide evidence-based integrated care for all patients, and restore joy and meaning to work for our professionals.

Hospitals, doctors, and health care systems have to be held accountable for continuous improvement in quality and safety and to provide information through a real-time information system that demonstrates that they are doing so. They need to be provided the tools and support to allow this to happen. All patients and providers should have access to computerized patient records. Financing and payment must be aligned with these objectives.

In order to accelerate learning across the healthcare systems and better serve the public and patient interests it should be mandatory for hospitals, doctors and health systems to submit real-time “safety learning reports” of adverse medical events and outcomes information such as disease-specific mortality, infection rates, and patient satisfaction. Such reports should be used for learning and system improvement in health-care facilities and, in the interest of transparency, should be made public, to encourage continuous improvement, to facilitate exchange of ideas and examples among institutions and to enable consumers and patients to have the benefit of provider-specific information. In each case, safety learning reports should explore associated underlying factors and systemic dynamics for the purpose of preventing such events and generally reducing risks in the future.

The mandatory reporting system must be meaningful, accurate, and complete, with stringent data quality oversight mechanisms, periodic audits and other means to ensure the completeness and accuracy of the reporting. The trustees of health-care institutions should be legally responsible and liable for accurate and timely reporting. We recognize that many organizations and professionals will need assistance and advice to improve their skills and capacities for developing and fielding meaningful reporting systems and for engaging in effective learning and improvement activities based on those systems.

Strong conflict of interest guidelines should apply to advisory panels and governing bodies and other governmental health-related entities – whether for comparative effectiveness research, Medicare policy, health insurance exchanges, or any other such panels. Consistent with the IOM report on conflict of interest issued in April 2009 – which concludes that “the central goal of conflict of interest policies in medicine is to protect the integrity of professional judgment and to preserve public trust rather than to try to remediate bias or mistrust after it occurs” – conflict of interest should be “prohibited” rather than “avoided” or “managed” or “taken into consideration.” We recognize there may be exceptional situations where crucial expertise is needed and is not available from an un-conflicted expert; in such situations any direct or indirect financial or personal interest must be fully and publicly disclosed and the member should be recused from consideration or decision-making on issues where there is a conflict.

To achieve these goals, we make the following recommendations:

  • Delivery systems need to develop models of team-based care that support the integration of care across all services and venues. Different delivery models are required for acute care, chronic care, prevention, and palliation. 
  • Patients and families should be involved as full members of their care teams and in critical stages of planning for their care. 
  • Hospitals, doctors and health systems should be required to submit real-time “safety learning reports” of adverse medical events and outcomes information such as disease-specific mortality, infection rates, and patient satisfaction. Such reports should be made public. 
  • Health professional education needs to be reformed to integrate patient safety education and training throughout the entire curriculum, and extend this emphasis longitudinally across the educational continuum to create life-long patient safety learners. 
  • Payment systems, both public and private, must be aligned with these two objectives and must encourage organizations to take responsibility for comprehensive, integrated care. Global or “bundled” payments should be provided to provider networks (also known as “accountable care organizations”) that can deliver coordinated, integrated care to all patients, particularly those with chronic or complex conditions. 
  • We applaud the recent funding of comparative effectiveness research and cost-effectiveness of all treatments, drugs, and devices, and urge also the establishment of an independent body to set evidence-based standards for payment. 
  • Strong conflict of interest guidelines should apply to advisory panels and governing bodies and other governmental health-related entities. 
  • Increased support is needed to explore new organizational models for care delivery and to teach practitioners how to integrate evidence-based safe practices into their existing care processes. We recommend raising the appropriation for AHRQ each year by 50% for at least five years. 
  • The plans under way to achieve comprehensive adoption of electronic health records within five years must receive continuing support. These records should be accessible to patients and across all providers, with appropriate provision for privacy and security protections.


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