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Reflections on Safety is a monthly column presenting the insights of Tejal K. Gandhi, MD, MPH, CPPS, Chief Clinical and Safety Officer, Institute for Healthcare Improvement (IHI). Dr. Gandhi was president and CEO of the National Patient Safety Foundation prior to its merger with IHI in May 2017.


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Five Notable Developments in Patient Safety in 2016

Posted By Administration, Tuesday, December 20, 2016

Progess was made in 2016, but there is much work to do in the patient safety field.

By Tejal K. Gandhi, MD, MPH, CPPS

Tejal K. Gandhi


Just about a year ago, the National Patient Safety Foundation released Free from Harm: Accelerating Patient Safety Improvement Fifteen Years After To Err Is Human, a report offering eight recommendations for elevating national focus on patient safety. These recommendations continued to reverberate within the field in 2016, and guided my picks for five notable developments in patient safety this year.

  1. Developing a culture of safety (Recommendation 1): One of the chief messages of the Free from Harm report is that without a culture of safety, it is difficult for any organization to advance patient safety and sustain improvements. The report defines a culture of safety as one in which “health care professionals and leaders are held accountable for unprofessional conduct yet not punished for human mistakes; errors are identified and mitigated before they harm patients; and strong feedback loops enable frontline staff to learn from previous errors and alter care processes to prevent recurrences.”

    NPSF is currently collaborating with the American College of Healthcare Executives on a resource to help leaders create a culture of safety in their organizations. But perhaps most notable this year is the number of other organizations also working on this issue. The American Nurses Association addressed safety culture and leadership in monthly installments of resources this year, and a culture of safety was the theme of National Nurses Week. Meanwhile, the number of research studies and articles addressing the importance of culture is on the rise.

  2. Recognizing the need for improved safety metrics (Recommendation 3): In May, BMJ published a paper suggesting that medical errors are the third-leading cause of death in the U.S. The paper received wide attention, including some counter-arguments that the methodology was flawed. Ultimately, however, this article should spark broad agreement that there is a great need for improvements in the way we measure patient safety. Right now, too many of our methods are retrospective, reporting is inconsistent, and metrics are not uniformly used and analyzed. This year we began to see that the true toll of preventable harm in health care will only be known once we establish consistent and robust metrics in all settings.

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  3. Adding to our knowledge about ambulatory safety (Recommendation 5): Free from Harm points out that, while most of the patient safety work done thus far has been done in acute care hospitals, the vast amount of health care delivered in the U.S. happens in the outpatient arena. For example, the Office of the Inspector General released a report this year estimating that 29 percent of Medicare recipients experience an adverse event or temporary harm while in a rehabilitation setting, with almost half of them deemed preventable.

       Some of Dr. Gandhi's picks for notable developments
    in patient safety this year reflect recommendations of
    the NPSF report, Free from Harm.
    We have so much to learn about risks and strategies to prevent harm in ambulatory or other settings. One notable development this year has been increased research in this topic. Most recently, AHRQ issued a technical brief that combined interviews with key informants as well as a literature review. The brief identifies medication safety, diagnosis, transitions, referrals, and testing as important ambulatory care safety topics. Communications, health IT, teaming, patient engagement, organizational approaches, and safety culture are flagged as the most important areas in which to seek improvement.

    This is not just a U.S. concern, however, and it is encouraging to see the World Health Organization convene experts to develop ways to “bridge knowledge gaps” in primary care.

  4. Increasing emphasis on workforce safety (Recommendation 6): NPSF considers the physical, psychological, and emotional safety of clinicians and staff to be a precondition to patient safety. This year we have seen growing recognition that burnout is a huge issue for the health care workforce, with more than half of physicians reporting at least one symptom of burnout. This has a direct impact on patient safety, as we know that clinicians experiencing burnout are not only more likely to make an error, but also less likely to take the steps necessary to engage patients, families, and the health care team.

    In encouraging signs, the American Medical Association, the National Academy of Medicine, and other entities are beginning to take a hard look at solutions. There is now wide acknowledgment that we need to look beyond the toll on individuals and begin addressing burnout as a system-wide issue and even as a quality measure.

    Related to this, fatigue can be a significant contributor to burnout. This year, the Accreditation Council for Graduate Medical Education has been exploring changes to duty hour limits, despite the evidence that fatigued residents are more likely to make errors that harm patients or themselves. NPSF and others are opposed to any change and, instead, argue for improving handoffs and communication.

  5. Partnering with patients and families (Recommendation 7): Communication and resolution programs (CRPs) promote open communication after an adverse event is discovered, comprehensive analysis of the event, implementation of improvement initiatives, emotional support for patients and providers, and appropriate resolution. In 2016, we saw progress in the number of organizations putting CRPs into practice.

    In April, NPSF offered a complimentary webinar on this topic in partnership with the Collaborative for Accountability and Improvement. The following month, the NPSF Patient Safety Congress featured an all-day immersion workshop on implementing CRPs.

    Also this year, the Agency for Healthcare Research and Quality released the CANDOR Toolkit, designed to help expand use of an AHRQ-developed process called Communication and Optimal Resolution, or CANDOR. This program gives hospitals and health systems the tools to respond immediately when a patient is harmed and to promote candid, empathetic communication and timely resolution for patients and caregivers.

If you have not had a chance to read the Free from Harm report, I encourage you to do so. These developments show that the issues discussed in the report remain vital to patient safety and are sure to be important as we move in to 2017.

What are your thoughts on the top developments in patient safety this year? Comment on this post below. Note: To comment, you must first register on the website. If you are already registered, you must log in to comment.

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Tejal K. Gandhi, MD, MPH, CPPS, is president and chief executive officer of the National Patient Safety Foundation and of the NPSF Lucian Leape Institute.

Tags:  culture  Health IT  leadership  workforce safety 

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The Many Roads to Medication Adherence

Posted By Administration, Tuesday, November 15, 2016

Medication adherence is a major challenge, particularly in outpatient settings.
We need a multipronged approach to improvement.

By Tejal K. Gandhi, MD, MPH, CPPS


Tejal K. Gandhi

Last month in this column I wrote about the importance of addressing patient safety across the continuum of care. As an example of how challenging this is, let’s take a look at one aspect of outpatient safety: medication adherence.

Medication adherence problems are not simply a matter of patients accidentally missing a dose. Primary nonadherence occurs when patients do not take the step of filling or picking up a prescription. But nonadherence also includes taking a lower or higher dose than prescribed; stopping a prescription early; taking an old medication for a new problem without consulting a doctor; taking medication prescribed for someone else; and forgetting whether a medication has been taken.

These are major problems in the ambulatory arena, where patients or their family members serve the vital role of administering medication.

Most health professionals recognize the challenges involved when patients do not take medications as directed—or at all—whether intentionally or unintentionally. In one study of 195,000 newly prescribed e-prescriptions, only 72% were filled. Nonadherence was common for medications for chronic conditions such as hypertension, diabetes, and hyperlipidemia.


When medication is not taken as prescribed, health problems may worsen, requiring more intervention. Nonadherence not only poses risks to patients’ health, it also costs our health care system an estimated $100 billion annually in avoidable hospitalizations.

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Medication Adherence in Practice

The issue of not taking medications—and how to improve it—is linked to several major themes in patient safety:

  1. Patient and family engagement. As noted in the NPSF report Free from Harm: Accelerating Patient Safety Improvement Fifteen Years After To Err Is Human, most definitions of patient engagement include ideas such as partnership, communication, information exchange, and respect. Health care practitioners can help improve adherence by making sure patients understand why the medication has been prescribed and how to take it properly, and by answering questions and addressing concerns.

  2. Health literacy. More than one-third of US adults have below basic or basic health literacy skills. Health literacy involves the ability to not only read and follow instructions, but also work with numbers and understand what to do if something goes wrong, if a dose is missed, or if an adverse event occurs.

  3. Transitions in care. Patients recently discharged face challenges in adhering to medication regimens that may have changed since they entered the hospital. In one study, 29% of patients were not taking a medication on their discharge list, were taking a different does or frequency, or taking an additional medication.

There is no easy solution and, in fact, a multipronged approach is likely needed to improve medication adherence. Zullig and colleagues note that greater research and evaluation of strategies, similar to the drug development process, is needed to encourage adherence. Furthermore, they note that the success of each strategy may differ between patient populations and settings, and that efforts are needed for wide dissemination and adoption of proven interventions.


Other interventions are currently being tested:

  • Mobilizing pharmacists to answer patients’ questions and be sure they know how to take medication properly.
  • Encouraging the use of patient portals by patients to become familiar with their medications, order refills, or ask questions.
  • Exploring pill monitoring technology, such as electronic pill caps and “smart” blister packaging.
  • Using innovative options such as electronic monitors (for example, biometric monitors or activity monitors) and mobile health strategies (such as text messaging and smartphone apps) to alert health practitioners about medication adherence and remind patients to take their medication. One of the eight recommendations of the NPSF Free from Harm report is to ensure that technology is safe and optimized to improve patient safety. There is much promise in the drive to use technology to improve medication adherence.

We still have work to do to determine the best strategies to improve this area of patient safety, and we need to match interventions to each patient’s individual needs. But we are at a point where innovations in technology, coupled with increased education among providers about the issue, may converge to help improve medication adherence across the continuum of care.

What strategies do you think will encourage medication adherence? Comment on this post below. Note: To comment, you must first register on the website. If you are already registered, you must log in to comment.

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Tejal K. Gandhi, MD, MPH, CPPS, is president and chief executive officer of the National Patient Safety Foundation and of the NPSF Lucian Leape Institute.

Tags:  ambulatory  medication  patient engagement 

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Patients, Patients—Everywhere

Posted By Administration, Friday, October 14, 2016

Why we must improve patient safety in all settings.

By Tejal K. Gandhi, MD, MPH, CPPS

Tejal K. Gandhi


According to publicly reported data, about half of all adults in the U.S. have a chronic illness, 60% take at least one prescription medication, and more than 1 billion health care encounters take place each year in ambulatory settings such as doctor’s offices, emergency departments, and hospital-based outpatient clinics. By comparison, there are roughly 35 million hospital admissions in the U.S. each year.


Despite the much greater utilization of outpatient health services, patient safety research and advances have largely taken place in hospitals. Today, when only the very sickest patients are hospitalized, and many patients with chronic illnesses are treated in ambulatory care or even in the home, it is past time to focus research dollars and efforts toward the epidemiology of medical errors, lapses, and near misses in other settings, and in finding solutions to effectively prevent them.

What do we know about medical errors in outpatient care? A 2011 study that looked at paid medical malpractice claims found that 43% of the events took place in ambulatory settings, and another 9% involved both inpatient and outpatient settings. The most common reason for a paid claim in outpatient care was for misdiagnosis, and the most common outcomes in either setting were “major injury” and “death.”

Outcomes associated with malpractice claims may be the most shocking, but they are far from the only instances of safety lapses. A systematic review of patient safety incidents in primary care published earlier this year found that errors occur fairly frequently, although most do not result in serious harm. Medication errors and diagnostic errors were found to be most common, but the authors note that lack of a “standardized taxonomy for classifying incidents and harm” make it difficult to compare results across settings and over time.

About 9 million people in the U.S. receive home health care or care in nursing homes, rehabilitation centers, and other residential care facilities. The lack of care coordination between these settings and the risk of miscommunication or lack of communication between providers is another gaping opportunity for error. A 2014 analysis by the Department of Health & Human Services Office of the Inspector General (OIG) reviewed records of Medicare patients who transitioned from acute care hospitals to skilled nursing facilities. According to the OIG report, 22% of the patients sampled experienced an adverse event with serious harm, and another 11% experienced temporary harm. Physician reviewers determined that 59% of the events and harms were “clearly or likely preventable.”

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Safety in home care is another largely unexplored territory. According to the Family Caregiver Alliance, in 2015, some 43 million people provided care to an adult or child in the U.S. Unlike a hospital or physician’s office, a patient’s home is an uncontrolled environment with unique hazards that can potentially harm both the patient and the home health care worker or family caregiver.

We are only at the very beginning stages of grasping how to address patient safety under these circumstances, and the need for improvement grows in proportion to our aging population.

Addressing safety across the care continuum is among the key recommendations of an NPSF report released late last year. In order to advance safety in all settings we need to better understand the epidemiology of medical errors and safety lapses in those settings, which will require more funding for research and creation of better metrics for tracking and improvement.

In addition, while most hospitals today have patient safety officers, departments, or committees, many outpatient and residential care facilities lack the infrastructure and expertise so necessary to make improvements. The NPSF report recommends expanding safety expertise, reporting mechanisms, collaboratives for sharing experiences and insights, and other methods of identifying and implementing best practices for all settings across the care continuum.

Of course, this is easier said than done. I have written here recently about the importance of federal funding for the Agency for Healthcare Research and Quality, which does so much to support patient safety research. But we also need health care leaders to recognize the importance of safety issues in all settings and prioritize developing the safety science and expertise to drive improvement.

What are your ideas for improving patient safety across the continuum of care? Comment on this post below. Note: To comment, you must first register on the website. If you are already registered, you must log in to comment.

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Tejal K. Gandhi, MD, MPH, CPPS, is president and chief executive officer of the National Patient Safety Foundation and of the NPSF Lucian Leape Institute.

Tags:  ambulatory 

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Resident Work Hours and Patient Safety

Posted By Administration, Tuesday, September 20, 2016

Putting limits on the number of hours that physicians-in-training can work makes good sense—
for patients and for trainees.

By Tejal K. Gandhi, MD, MPH, CPPS

Tejal K. Gandhi


Most people would agree that they do not perform at their best when tired.

For physicians in training, overwork and exhaustion has been shown to lead to motor vehicle accidents, needle sticks, burnout, and depression. It can also lead to medical errors and adverse events.

And yet, we are still debating work hour limits for resident physicians.

The Accreditation Council for Graduate Medical Education (ACGME) sets duty hour limits for physicians-in-training and this year conducted a planned five-year review of limits set back in 2011. For now, duty hour limits will remain at the current standard: first-year residents (interns) may work no more than 16 hours straight, while more senior residents may work up to 24 hours (and in some specialty areas, up to 28 hours). Other requirements include a maximum of 80 hours per week, averaged over a four-week period, and mandatory one day free of duty each week. Exceptions may be made on a case by case basis, for example, if a resident wishes to extend his or her hours to ensure continuity of care, but other patients must be appropriately handed off and the reasons for the extended hours must be documented.

A number of physician groups have lobbied to have duty hour standards relaxed, the argument being that shorter hours lead to more handoffs and a less comprehensive learning experience for trainees. ACGME granted waivers for residents participating in two research trials comparing outcomes between a group that followed the duty hour restrictions and another group that worked flexible, that is extended, hours. The FIRST trial found that outcomes were “no worse” with extended hours among surgical resident. The iCOMPARE trial, which looks at internal medicine residents, has yet to release results.

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Based on what we know, the National Patient Safety Foundation strongly advises maintaining duty hour limits for residents at all levels. In a statement given at the ACGME Congress on the Resident Learning and Working Environment held earlier this year, NPSF recommended that discussions of duty hours be held in the context of a drive to total systems safety; that residents be trained in effective handoff methods, such as I-PASS; and that meaningful measures of safety be applied in research on this issue. We should not have to choose between patient safety (that is, by limiting handoffs) and workforce safety (by increasing handoffs to allow residents sufficient rest) because, in fact, both are critically important, and we now have good methods available to ensure safe handoffs.


Recently the public has weighed in as well. A national poll conducted by Public Citizen, a nonprofit advocacy organization, found that 86% of respondents were opposed to lifting duty hour restrictions, and 80% support a 16-hour limit on all residents, not just first-year residents (interns).

Duty hours and patient safety are two of the areas that fall under the Clinical Learning Environment Review (CLER) program that ACGME announced earlier this year. The program was created to help “improve how clinical sites engage resident and fellow physicians in learning to provide safe, high quality patient care,” and among the first steps was to conduct site visits. The first program brief, released in July, shows that in the area of fatigue management and duty hours, many sites reported fatigue from volume of patients and increased fatigue among faculty.


The fact is that fatigue and burnout are serious issues among all members of the health care workforce that endanger both patients and health care workers. It will not be an easy issue on which to achieve consensus, but we must do better for those who care for the most vulnerable among us. We must see that they are afforded adequate rest and respite, while also receiving the training they need to deliver the highest quality care. This must be achievable—we need to creatively and rigorously determine how.

Do you agree that fatigue and burnout among health professionals is a problem? Comment on this post below. Note: To comment, you must first register on the website. If you are already registered, you must log in to comment.

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Tejal K. Gandhi, MD, MPH, CPPS, is president and chief executive officer of the National Patient Safety Foundation and of the NPSF Lucian Leape Institute.

Tags:  medical education  workforce safety 

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Research: At the Heart of Patient Safety Improvement

Posted By Administration, Friday, August 12, 2016
Updated: Friday, August 12, 2016

The National Patient Safety Foundation has joined with 250 other organizations in the Friends of AHRQ
to voice our support for the agency and its mission.

By Tejal K. Gandhi, MD, MPH, CPPS

Tejal K. Gandhi


As noted in the recent NPSF report Free from Harm, the scientific process does not always move in a straight line. This can be illustrated by conflicting studies. For example, in a 2009 paper, Haynes and colleagues demonstrated a benefit from the use of surgical safety checklists. Several years later, Urbach and others were not able to replicate the results.


Researchers wisely recognize that the latter studies illustrate the need for both safety science research (the development of the checklist) and implementation science research (how best to put them into use). Because of this, one of the NPSF report’s eight recommendations to accelerate patient safety calls for increased research funding for both safety science and implementation research.


Since 1999, the U.S. Agency for Healthcare Research and Quality (AHRQ), has played an essential role in funding, conducting, and sharing results of patient safety research. A section of the federal Department of Health & Human Services, AHRQ was created by Congress with the purpose of “producing evidence to make health care safer; higher quality; more accessible, equitable, and affordable; and to ensure that the evidence is understood and used.”


In addition to compiling the National Healthcare Quality and Disparities Reports, AHRQ has funded and helped promulgate numerous evidence-based tools and resources. Among these are the Comprehensive Unit-Based Safety Program (CUSP), which is now being used in hospitals throughout the country; Team STEPPS®, developed in collaboration with the Department of Defense to improve teamwork in clinical settings; and the new CANDOR Toolkit, which provides a roadmap for organizations to learn how to communicate with patients about medical errors and adverse events.

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My own entrée to the patient safety field was as a researcher with a focus on ambulatory safety and the use of technology to improve quality and safety. AHRQ funded key research that my colleagues and I conducted on missed and delayed diagnosis errors and their causes, and the impact of barcode technology on medication safety, among many other topics. This critical research really helped advance our understanding of ambulatory safety and the benefits of technology. And it likely would never have happened without AHRQ providing the funding.


Regrettably, AHRQ recently saw its budget reduced to $280.24 million, a $54 million reduction from current levels, even though the AHRQ budget has historically represented less than 1% of all federally funded research. (See AHRQ: 15 Years of Transforming Care and Improving Health.) The National Patient Safety Foundation has joined with 250 other organizations in the Friends of AHRQ, which is being led by Academy Health, a leading health services research organization, to voice our support for the agency and its mission.


Now is not the time to reverse course in patient safety research. We need to expand patient safety research throughout all health settings if we are going to continue to make progress in ensuring safety care.


To read more about the NPSF report Free from Harm and the tactics recommended for increasing research funding, visit   Comment on this post below. Note: To comment, you must first register on the website. If you are already registered, you must log in to comment.

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Tejal K. Gandhi, MD, MPH, CPPS, is president and chief executive officer of the National Patient Safety Foundation and of the NPSF Lucian Leape Institute.

Tags:  AHRQ  research 

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