1. Eastman, Peggy

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WASHINGTON-When it was released 15 years ago, "To Err Is Human: Building a Safer Health System" created shock waves in the U.S. medical community and in the general public.

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That landmark Institute of Medicine (IOM) report found that up to 98,000 Americans die in hospitals every year from preventable medical errors-surpassing deaths from car crashes, breast cancer, and AIDS.


The report concluded that the total costs of preventable medical errors (including the additional care they cause, lost income and household productivity, and disability) add up to approximately $17 billion to $29 billion in U.S. hospitals every year.


"To Err Is Human" launched a series of IOM reports on improving quality and reducing errors in the U.S. health care system, including the recent "Improving Diagnosis in Health Care" (OT 10/25/15 issue).


Top health leaders recently gathered here at the National Academy of Sciences building to mark the progress since "To Err Is Human" was released, and to discuss challenges and opportunities in patient safety for the future.


The all-day meeting was the 2015 Richard & Hinda Rosenthal Symposium, held under the auspices of the National Academy of Medicine (formerly known as the IOM).


'Literally Could Not Raise a Nickel''

Undertaking the report 15 years ago, which was self-initiated and self-funded by the IOM, "was a relatively unusual activity," said Kenneth I. Shine, MD, Chair of the symposium's planning committee, past president of the IOM, Professor of Medicine at Dell Medical School, and Professor of Medicine Emeritus at UCLA.


Shine said no one outside the IOM would fund the report: "We literally could not raise a nickel." People told him that the report would undermine the confidence of both physicians and patients, he recalled.


Problematic System

Fifteen years ago, "the general belief was that medical errors came about because of impaired physicians," said William C. Richardson, PhD, MBA, President Emeritus of Johns Hopkins University. But, in contrast to that belief, "To Err Is Human" found instead that medical errors occur because of a problematic health care system (or "nonsystem," as the report called it) marked by decentralization, fragmentation, faulty processes, or conditions that cause people to make mistakes.


Since medical errors are not a "bad apple problem," the report concluded, medical errors could be prevented by specifically designing the health system at all levels to make it safer.


'Turning Point'

In many ways, efforts to achieve that goal have been effective-even though there is a long way to go, speakers said.


"This was a transformative report for health care... it was a turning point," said Donald M. Berwick, MD, MPP, President Emeritus and Senior Fellow at the Institute for Healthcare Improvement, former administrator of the Centers for Medicare & Medicaid Services (CMS), former member of the IOM's Governing Council, and a member of the committee that wrote "To Err Is Human."


'If Had to Do It Over Again'

Berwick added that the committee could have gone further to encompass patient injury in addition to medical error, and said that if he had it to do over he would have included patients injured by mistakes made by the medical system and their families on the IOM committee. When it comes to patient safety, "In oncology it's crucial; this is an area where tremendous potential [for improvement] exists," Berwick told OT.


Also agreeing was Peter J. Pronovost, MD, Senior Vice President of for Patient Safety & Quality and Director of the Armstrong Institute for Patient Safety and Quality at Johns Hopkins Schools of Medicine, Nursing, and Public Health, and a member of the planning committee of the Rosenthal symposium.


Taking a systems approach to reduce errors, especially diagnostic errors, is especially important in the era of genomics and proteomics, an era in which breast cancer, for example, is not one disease but a number of different diseases, he said.


Berwick is co-author of a new report from the National Patient Safety Foundation (NPSF) called "Free from Harm: Accelerating Patient Safety Improvement Fifteen Years after To Err Is Human." That report calls for a total systems approach and a culture of safety in all settings to reduce avoidable medical errors (see box above).


'Abundantly Clear...'

Statistics on patient safety support speakers' assertion that preventable medical errors are declining, in large part due to the impact of "To Err Is Human."


The report opened up "a massive opportunity for improvement," said Brent C. James, MD, Chief Quality Officer and Executive Director of the Institute for Health Care Delivery Research at Intermountain Healthcare and a member of the planning committee of the Rosenthal symposium. "I think it is abundantly clear that patient safety is better is than it was 15 years ago," he added.


From 2010 to 2014 there was a 17 percent reduction in U.S. hospital adverse events, said Richard G. Kronick, PhD, Director of the Agency for Healthcare Research and Quality (AHRQ). During that same time period, there were 87,000 lives saved from medical errors and 2.1 million incidents of harm to patients avoided for a savings of $19.8 billion.


He noted that AHRQ is now expanding its focus on medical errors into settings other than hospitals, such as ambulatory settings (physician offices, outpatient clinics and laboratories).


In fiscal year 2015 alone at Ascension, the largest U.S. nonprofit health care delivery system, there was a mortality reduction of 9,041 lives due to efforts to improve patient safety, said David B. Pryor, MD, Ascension's Executive Vice President and Chief Clinical Officer.


Since 2004, a total of 57,123 lives have been saved at Ascension by efforts to reduce preventable medical harm, he said, noting that the company had initiated a specific campaign called "Healing without Harm" by 2014.


Hospitals that serve the most vulnerable U.S. populations are also focusing on reducing preventable medical errors, said Kirk A. Calhoun, MD, President of the University of Texas Health Science Center at Tyler, a rural hospital that serves as a safety net for Texans in the northeast part of the state. His hospital is considered one of America's essential hospitals-i.e., those that care for the most vulnerable citizens.


'All about the Culture'

According to data from the Essential Hospitals Engagement Network (EHEN), from 2012 to 2014, a total of 4,051 harmful events were avoided in these hospitals, at a cost savings of $40 million, Calhoun said. "I must say there was a bit of disbelief when 'To Err is Human' came out, because we were doing good things." But, he added, he realized that there was room for improvement. "It's all about culture. There's no way you can improve things if your people do not feel comfortable coming forward when there are adverse events."


Despite demonstrable improvements in reducing medical errors, speakers agreed that there is a long way to go to make the U.S. health system as safe as it should be. Kronick said there are still about 121 adverse events per 1,000 U.S. hospitalizations.


"The truth is that 'first do no harm' is a bedrock of medical care," said Carolyn M. Clancy, MD, Chief Medical Officer of the Veterans Health Administration and a member of the planning committee of the Rosenthal symposium. While progress has been made, "We have not reached a place where health care is consistently safe-or not yet," she added.


"I think expectations are higher, and that's a good thing," said Margaret E. O'Kane, MHA, founder and President of the National Committee for Quality Assurance (NCQA). She described how concerns about patient safety brought her to concerns about quality in medical care. She said personal experiences have shown her that there is still much room for improvement in patient safety, including the case of a family member treated for cancer in a "blue ribbon cancer hospital." The patient was plagued with infections, and the care was uncoordinated-"so I think there's a lot of work to do."


In his closing remarks, Victor J. Dzau, MD, President of the National Academy of Medicine, urged symposium attendees to take the lessons from what he called an "inspiring and stimulating" day and apply them to improve patient safety and the quality of care, especially in diagnosis.


"Let's not miss that opportunity."


9 Specific Suggestions

Speakers at the wide-ranging discussion during the all-day symposium suggested the following specific approaches to further improve patient safety.


1. Establish a federal agency for safety in medical care similar to the Federal Aviation Agency (FAA) for airline safety;


2. Include patients and families in efforts to improve patient safety. For example, noted Patrick H. Conway, MD, CMS Acting Principal Deputy Administrator, Deputy Administrator for Innovation & Quality and Chief Medical Officer, CMS now involves patients and families in all its quality measurement and development work; and Carolyn M. Clancy, MD, Chief Medical Officer of the Veterans Health Administration, said id the VA is sponsoring a focus group with patients and families to help develop a guideline on pain management;


3. Ensure that medical governing entities, such as CEOs and boards of directors, make patient safety and quality care top priorities;


4. Standardize quality-of-care metrics and their transparency, so there is agreement on how much and what needs to be reported;


5. Extend efforts to improve quality and safety beyond hospitals to ambulatory and long-term care settings;


6. Create a non-punitive, supportive culture that fosters patient safety, especially by including nurses in the planning and implementation of patient safety campaigns.


"In many places nurses do not feel empowered to speak up," said Matthew McHugh, RN, PhD, MPH, JD, the Rosemarie Greco Term Endowed Associate Professor in Advocacy at the University of Pennsylvania School of Nursing. "The chief nursing officers are not always taken seriously... Nurses see everything. Nursing is kind of the canary in the coal mine";


7. Establish more coordination of care to prevent medical errors, including interoperability of electronic medical records. "A lot of the errors that we deal with are errors of coordination; who is the quarterback?" said Farzad Mostashari, MD, co-founder and CEO of Aledade, a start-up company he founded to help primary care physicians transform their practices and form Accountable Care Organizations (ACOs);


8. Use a systems-engineering approach to health care delivery, which-just as in the aviation industry-strives to prevent potential errors through safety-oriented design; and


9. Take advantage of physicians' intrinsic motivation to improve patient safety and quality of care, which depends on internal peer review, enthusiasm, and commitment.


National Patient Safety Foundation Report on Patient Safety

Shortly before the symposium at the National Academy of Sciences (NAS) building in Washington to review progress on patient safety, the not-for-profit National Patient Safety Foundation (NPSF) released its own report calling for heightened efforts to reduce medical harm: "Free from Harm: Accelerating Patient Safety Improvement 15 Years after To Err Is Human."


"We've had progress, but nowhere near enough," Donald M. Berwick, MD, MPP, coauthor of the NPSF report and President Emeritus and Senior Fellow at the Institute for Healthcare Improvement, told OT. Berwick, a former administrator of the Centers for Medicare & Medicaid Services, a member of the committee that wrote "To Err Is Human" and a lecturer at Harvard Medical School, said the NPSF report is a "gap analysis" which looks toward making strides over the next 15 years in patient safety.


Berwick added that while there has been success in reducing patient harm, "far too many people still suffer from avoidable injuries in health care."


The NPSF report calls for a total systems approach in U.S. health care and a culture of safety to reduce preventable medical errors. "The field of patient safety has not achieved enough, despite definite progress having been made," said NPSF President and CEO Tejal K. Gandhi, MD, MPH, CPPS, in a statement accompanying the release the report.


Much of the research in patient safety up to now has been done in hospital care, whereas most care today is provided in the outpatient setting, the report notes. In addition, the concept of patient harm encompasses morbidity as well as headline-making deaths: lasting effects of harm, additional care; and lengthier hospitalizations. These, too, need attention, the report emphasizes.

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8 Recommendations

The NSPF report makes the following eight recommendations:


1. Ensure that leaders establish and sustain a culture of safety;


2. Create centralized and coordinated oversight of patient safety;


3. Create a common set of safety metrics that reflect meaningful outcomes;


4. Increase funding for research in patient safety and implementation science;


5. Address safety across the entire care continuum;


6. Support the health care workforce;


7. Partner with patients and families for the safest care; and


8. Ensure that technology is safe and optimized to improve patient safety.



-Peggy Eastman