Transforming Concepts

Patient Safety

Diane Pinakiewicz

Diane Pinakiewicz

President National Patient Safety Foundation USA.


The Institute of Medicine's 1999 report, To Err Is Human, sparked efforts to improve patient safety in the US. Recent data suggest, however, that adverse events persist. The Lucian Leape Institute at NPSF has outlined concepts that have the potential to transform the way healthcare is practised and delivered, and lead to safer care.


For the patient safety movement in the US, 2011 has been a year of paradox. Every month brings reports of progress through new tools, methods, or technology. With so many stakeholders working on improvements, we know we must be doing better. Yet recent studies suggest that medical errors continue to be a notable cause of extended hospital stays, preventable readmissions, and even premature deaths.

How can it be that much is being done, but not much progress is being made? That question was asked earlier this year at the National Patient Safety Foundation’s Annual Patient Safety Congress. During one plenary session, members of the Lucian Leape Institute, a think tank based at NPSF, continued ongoing discussions of transforming concepts that have the potential to significantly advance patient safety.

Most serious discussions of patient safety in the U.S. still cite the groundbreaking Institute of Medicine report, To Err Is Human, which estimated that between 44,000 and 98,000 deaths and more than 1 million injuries are caused each year by medical errors.

Experts can point to any number of reasons for the lag in progress, from a dysfunctional healthcare payment system to outdated medical education programs and an agonisingly slow adoption of fully functional electronic health records. The good news is that we know much more today than we did when the initial IOM report was released, and most hospitals and healthcare organizations now view patient safety as a critical competency.

More good news is that in April 2011, the U.S. Department of Health and Human Services and the Centers for Medicare and Medicaid Services (the branch of the federal government that provides health insurance coverage for the elderly and the poor) announced the Partnership for Patients, a public-private patient safety initiative that aims to improve the quality of the healthcare system while also reducing costs. Two specific goals are to reduce hospital readmissions and hospital-acquired conditions. But the larger goal is to reduce “all-cause harms.” Rather than focusing on specific actions or outcomes, as many measurement and accrediting bodies do, the initiative seeks to promote fundamental changes to healthcare as practised in the U.S.

In 2009, the Lucian Leape Institute published a paper outlining a number of transforming concepts that are necessary to bring significant and lasting improvements in patient safety. Since then, the Institute has organised a series of roundtable discussions with expert panels to map a path to improvement. Following are some of the transforming concepts that have been identified to date:

  • • Medical education reform
  • • Care integration
  • • Transparency
  • • Consumer engagement
  • • Joy and meaning in work and healthcare workforce safety

Medical education reform

One of the chief recommendations of  To Err Is Human was for physicians, nurses and other members of clinical teams to work together in redesigning flawed systems. In the US, however, physicians are primarily schooled in the science of medicine, not in the skills needed to manage and interact in constructive ways with other members of the healthcare team or their patients. Little or no attention is paid by most US medical schools to theories of human factors, safety science, communication skills, teaming or the other basic tenets of patient safety.

Progress in this area has begun, albeit slowly. The Accreditation Council for Graduate Medical Education and the American Board of Medical Specialties have formulated recommendations relative to the acquisition of knowledge, skills and attitudes that support desired behaviours for the delivery of safe care. The IOM has defined a group of “core competencies” that all healthcare professionals—physicians, nurses, and others--should endeavor to achieve in order to practice safe and effective care.

In considering medical education reform as a transforming concept, the Lucian Leape Institute also addressed the dysfunctional culture present in many teaching hospitals, noting that when students become physicians, they tend to perpetuate the bad behaviours they experienced during training. In 2010, the Institute published a report, Unmet Needs: Teaching Physicians to Provide Safe Patient Care, which was the result of a series of roundtable discussions by Institute members and a panel of experts with extensive experience in medical education.

In the US, we are beginning to see some of these thoughts applied. One recent example is of a medical school that weighs prospective students’ interpersonal and communications skills along with their academic achievements. Such examples represent a positive turn, but much reform is still needed.

Care integration

The U.S. healthcare system has been well served by remarkable innovation in medicine and medical technology, but similar innovations have not been brought to bear with respect to its care delivery models. The supporting processes for care delivery have not kept pace with the increasing complexities of clinical care and have evolved without proper aforethought, such that the “system” does not provide an integrated approach to patients. This is due, in part, to lack of appropriate incentives in the payment system and lack of research dollars for delivery system innovation. As a result, the infrastructure of the care system has evolved with a focus on acute care, has been designed to be provider-centric rather than patient-centric, and is disjointed in its design and functioning, Handoffs between practitioners and transitions in care have proven to provide significant opportunities for error. Patient safety work requires a system perspective and approach, and this, in combination with growing healthcare consumerism, calls for a complete re-examination of the way care is organised and delivered. Furthermore, the disjointed nature of the system, with independently practicing clinicians and hospitals, has not allowed for a rational and integrated deployment of health information technology, which holds great promise for integrating the care delivered to patients.

Much has been written in the US recently about accountable care organisations (ACOs), which essentially represent a financial integration strategy. Organisational integration associated with ACO formation would drive realignment of risk, and incentives would be provided for higher quality and safety at lower cost. The Leape Institute, while supportive of payment reform as a key strategy to incent for safe care, believes that the concept of integration as defined organisationally is insufficient and that true integration of care must occur around the patient experience rather than around organisational structures.  It is only in this manner that coordination of care across the continuum of a patient’s life can be optimised, as the patient is the only constant in that continuum. This, of course, will call for measurement to assess the effectiveness of new integration models from the perspective of the patient experience.

As a transforming concept to improve patient safety, care integration would encompass a reorganisation of care processes around well-defined consumer groups, with clinical resources better matched to care requirements, new and improved delivery components for the non-acute aspects of the care continuum, and a deployment of new technologies to support the care needs and preferences of the involved consumer. This will be critical, among other things, for dealing with the significant challenges of managing chronic illnesses. The system would, ideally, also link patients to community resources, and have an infrastructure robust enough (information technology, medical technology) to manage variations in care. This is a concept that will no doubt be widely discussed in the US over the next few years.


In the US, transparency in healthcare is usually thought of as an organisation’s willingness to participate in public reporting of outcomes. As an example, the Center for Medicare and Medicaid Services collects data from hospitals on specific practises (such as giving antibiotics to patients prior to surgery to prevent surgical site infections). At the state level, hospitals are required to report sentinel events. Although these methods can be helpful, they are widely acknowledged to still be flawed in significant ways. Moreover the “public” reports produced from them are extremely difficult for most nonclinical people to interpret.

Considering transparency as a transforming concept to promote patient safety requires a much broader focus, as it really lies at the heart of culture change. The Leape Institute defines transparency as a “moral imperative,” a precondition to safe care, and a foundational tenet of a learning culture. It defines full transparency as encompassing transparency among caregivers, between caregivers and patients, between organizations and to the public.

Hospital leaders must establish a culture that encourages staff to be open and honest in all of their interactions with patients. It is fundamental to effective provider-patient relationships, to safe care, and is a right that all patients deserve. Significant progress has been made with transparency around error, with “open disclosure” being practised around the country and showing results of decreased malpractice claims, dispelling the initial concerns with this strategy.

Perhaps the biggest challenge in this area is internal transparency among the members of the healthcare team. The U.S. Agency for Healthcare Research and Quality (AHRQ) conducts an annual survey on patient safety culture. The most recent results (2010) revealed that only 44 per cent of respondents felt free to report an error without risking some consequence. If the healthcare staff fears blame or scorn, they are less likely to report errors. If they do not report errors, systems that allow them to happen cannot be corrected.

Transparency between organisations is required in order to share learnings from incidents that can prevent their recurrence elsewhere, as well as to share evidence-based best practice to improve care processes.

In large part, the ability to practise transparency is dependent upon culture, and in this regard, many organisations still have a long way to go.

Patient and consumer engagement

In 1998, a Salzburg Global Seminar suggested that patient and consumer engagement could positively alter efforts to improve healthcare, and the phrase “nothing about me, without me,” was first used. Providing patient-centered care is one of the IOM’s recommended core competencies and is closely tied to care integration efforts. Evidence supports the benefit of engaging patients in their own care. When patients self-report their experience of adverse events in the hospital, for example, AEs come to light that were not reported by staff and do not appear in the medical record. In many hospitals, patients are serving on advisory committees as well as becoming more engaged as members of their own healthcare teams. Studies support the idea that patient-centeredness and engagement can foster greater patient satisfaction, better health outcomes, and reduced healthcare costs.

The Patient and Family Advisory Committee of the National Patient Safety Foundation developed the Universal Patient Compact: Principles for Partnership, to help providers and patients forge relationships that could lead to better, and safer, care. As a transforming concept, patient and consumer engagement requires healthcare organisations to consistently and proactively partner with patients in both their care delivery and planning. Family members need to be considered part of the team as well. Patients and their family caregivers need to be fully informed and able to participate in care decisions and in appropriate self-care.

Most research in this area has so far focused on patients’ engagement in their own care. AHRQ has recommended addressing patient and consumer engagement on multiple levels: in their own care; in the design of care processes; and in health policy decision making. This is a broad area, and while anecdotal evidence supports consumer engagement at all levels, future research is needed to document the benefits and demonstrate best practices.

The Leape Institute is also considering patient engagement with a continuum perspective, which encompasses consumer education and engagement – educating and supporting consumers on patient safety before, after, and between episodes with the healthcare system when they are not considered “patients.” This calls for addressing patient safety as a public health issue, a daunting challenge but one which part of the dialogue as levers to improve the pace of change are sought.

Restoration of Joy and Meaning in Work and Ensuring the Safety of the Healthcare Workforce

These two concepts go hand-in-hand, as no one could find joy and meaning while also feeling unsafe in the workplace. Like the other transforming concepts, these are complex issues that get to the very culture of the healthcare system.

Over the past two decades, healthcare in the US has experienced vast change in the form of medical and technological advances, and the challenges associated with an older and sicker population, and shortages of primary care physicians, experienced nurses, and other healthcare workers. Physicians have also felt the effects of a loss of control, increasing regulation, and a payment structure of vastly varying compensation levels. The healthcare workforce is under a lot of pressure, and there is a growing concern that they have lost touch with why they went into the caring profession in the first place. It is not uncommon for healthcare workers to experience disrespectful, disruptive or even threatening behaviours that prevent people from working effectively in teams. Although many US healthcare organisations espouse the belief that “our workers are our most valuable assets,” too few follow through with tools and leadership to make that belief a reality. We cannot expect our workforce to do the hard work associated with the patient safety if we do not take care of them, support them, and ensure that they are safe as well.

The Institute’s recommendation is for leaders to reassess their organizations as dynamic entities composed of skilled and committed people. Everyone working in healthcare should be able to answer “yes” to the following questions:

  1. • Are you treated with dignity and respect every day by everyone you encounter?
  2. • Are you given the things you need so that you can make the contribution to the organization that gives meaning to your life?
  3. • Are you recognized for what you do?

In essence, many of these transforming concepts begin with leadership and the successful transformation of culture. They are not easy concepts to pursue, particularly when dealing with the day-to-day requirements of taking care of patients. Taken together, however, they represent a vision for the future as articulated by the Lucian Leape Institute members:

“We envision a culture that is open, transparent, supportive and committed to learning; where doctors, nurses and all health workers treat each other and their patients competently and with respect; where the patient’s interest is always paramount; and where patients and families are fully engaged in their care.”

Full references are available at

This year’s Patient Safety Congress took place in the wake of new, but similarly disturbing, research:

  • • The Inspector General of the U.S. Department of Health and Human Services estimates that 13.5 percent of Medicare beneficiaries (senior citizens) experience adverse events during their hospitals stays. During the particular month studied, an estimated 1.5 percent experienced an event that contributed to their deaths. Projected nationally, the report estimates that 15,000 deaths per month may be attributed to adverse events.
  • • A study that used the Institute for Healthcare Improvement’s Global Trigger Tool estimates that one-third of U.S. hospital patients experience an adverse event.
  • • A similar study found 25 harms per 100 admissions in a review of 10 hospitals in one state.
    The report offers 12 recommendations for reforming medical education, grouped into three main categories:
  • • Setting the right organisational context: Recommendations in this area address cultural and leadership changes that could help medical schools promote patient safety understanding.
  • • Creating strategies for teaching patient safety: Recommendations in this area address the need for curricula change to include patient safety competencies.
  • • Leveraging change: This category addresses strategies such as linking accreditation standards to robust patient safety coursework, or applying financial incentives to schools that effectively implement patient safety training.

Author BIO

Diane Pinakiewicz is a President of The National Patient Safety Foundation, where she has served on the Board of Directors since its inception in 1997, the first five years as an officer. She also serves as President of the Lucian Leape Institute at NPSF. She has an extensive background in the healthcare industry with executive-level experience in hospital administration, healthcare consulting, disease management and pharma. She holds multiple appointments with national patient safety and quality improvement organizations and has served on the faculty of multiple programs, including Harvard’s program for Executives in Managed Care. She has published extensively on the topics of patient safety, value-based partnering and managed care financial strategies.