The modern patient safety field was built on a foundation of “systems thinking,” namely, that we should avoid assigning individual blame for errors, instead focusing on identifying and fixing dysfunctional systems. While this approach is largely correct and is responsible for many of the field’s successes, it needs to be balanced with a need for accountability.

Today, while there is an increasing appreciation of the importance of achieving such balance, leaders of health care delivery systems are unsure about how and when to enforce certain safety standards and rules. We believe that the time has come to articulate criteria for “must do” safety practices: practices that have sufficiently compelling supportive evidence that clinicians should not have the right of individual veto.

In the following blog post, we offer proposed criteria for “must do” practices and argue that two practices—hand hygiene and influenza vaccination for health care workers—should currently qualify. We believe that these practices, if more widely adopted, will help ensure patient safety.

The Patient Safety Movement

The patient safety movement has embraced as its central thesis that most medical errors are the result of bad systems, not bad people. This thesis has resulted in efforts to create a “no blame” culture, in which clinicians are encouraged to report their errors and near misses, after which organizations seek to deeply understand the underlying “latent conditions” that contributed to the errors and develop programs to shore up faulty systems. Particularly when compared with the previously dominant “blame and shame” approach, this paradigm has been useful, empirically validated, and inspirational.

While some recent studies are encouraging, the relatively slow progress in improving safety has prompted a search for new directions. Our sluggish progress can be explained by several factors, including competing priorities, the difficulty of culture change, immature information technology systems, inadequate research funding, and relatively weak incentives.

We are convinced, however, that another obstacle has been a uniform invocation of the “no blame” mantra. While “no blame” remains the correct reaction to most mistakes, it is not the appropriate response when clinicians are disruptive, incompetent, or willfully choose to ignore evidence-based safety rules. The latter category is this paper’s focus.

We, the board members of the National Patient Safety Foundation’s Lucian Leape Institute, believe it is time to require that clinicians follow certain well-established safety practices. We applaud efforts to promote a “Just Culture” (whose algorithm differentiates innocent from blameworthy mistakes) and to characterize some quality and safety standards as “accountability measures.” Yet few health care organizations consistently enforce meaningful sanctions for the either “blameworthy” mistakes (for example, willful failure to complete a required surgical checklist) or missed accountability measures (such as failure to perform hand hygiene), partly because neither they nor regulators have enumerated practices that require universal adherence.

We believe that the time has come to set out practices for which clinician compliance is not elective — a “Must Do” list. In this blog post, we offer a series of criteria to determine when a practice should be placed on the “Must Do” list (Exhibit 1). We also propose two evidence-based, relatively inexpensive, and highly effective practices for initial inclusion.

The Two Initial “Must Do” Practices

Hand hygiene and influenza vaccination for health care workers meet all five criteria enumerated in Exhibit 1. Both practices address significant safety problems. Substantial literature has demonstrated that widespread adherence with hand hygiene and influenza vaccination is associated with major reductions in harm. Universal compliance is feasible; indeed, compliance rates close to 100 percent have already been achieved in some institutions, though such rates are far from typical. Both practices have been endorsed by the National Quality Forum, relevant specialty societies, and broad professional consensus.

Setting Standards And Penalties

We should expect 100 percent adherence to “must do” practices. Of course, there will be exceptions, such as emergency procedures in which there isn’t time for hand hygiene, or legitimate medical reasons to forego influenza vaccination, but such circumstances are rare and should not weaken the general expectation for compliance. Central to this argument is that clinicians cannot choose, as individuals, to forego “must do” practices.

Our hope is that the creation and dissemination of a “Must Do” list will drive more professionalism than enforcement. In other words, once organizations educate clinicians about such practices and build systems to promote adherence, clinicians will universally comply because of their commitment to keeping patients safe. For example, at the University of California, San Francisco, a robust campaign that included clinician education, audit and feedback, and strategic use of financial incentives led to improvements in rates of hand hygiene adherence from the 50 percent range to more than 90 percent.

Yet exhortation may not be enough. Many organizations have had less success with similar campaigns, putting patients at risk because of low rates of hand hygiene and similarly important practices. Because of this, leaders must hold clinicians accountable by setting up effective monitoring and disciplinary systems. Organizations must include the expectation of universal compliance in bylaws, clinician compacts, and, where appropriate, individual or group contracts. Moreover, they must be willing to terminate clinicians for deliberate and repetitive non-compliance.

Monitoring Compliance

We recognize that auditing adherence to “must do” practices may create a burden for health care organizations and clinicians, but we believe this can be overcome. Some practices, such as rates of influenza vaccination, can be measured through the electronic health record, although modifications may be required. Others may require strengthening of existing measurement systems, such as antiquated human resources or employee health databases.

Still others may need new technologies, such as video cameras or hand hygiene dispenser sensors. We believe that a mandate for adherence will catalyze the development of relatively inexpensive and acceptable methods to track adherence to “must do” practices.

The Role Of Accreditors

Just as we believe that individual clinicians will be driven to universal compliance out of professionalism, we believe that health care leaders will create systems to facilitate and measure compliance out of their desire to do the right thing. Yet we also recognize the need for a stronger regulatory framework or business case to promote these politically challenging steps.

Therefore, we call on the Joint Commission, the Centers for Medicare and Medicaid Services, and other accreditors and payers to adopt these standards. The processes used to achieve these standards should not be overly prescriptive; individual organizations should be free to develop creative solutions to reach full compliance.

For example, the Joint Commission might require that hospitals achieve 100 percent hand hygiene compliance (with only rare, well-documented exceptions), verified by an unbiased, reliable auditing system. We also call on funders, such as the Agency for Healthcare Research and Quality, payers, and foundations, to support research in this area, so that these diverse approaches can be rigorously tested and the results disseminated.

Concerns About This Policy

We recognize that thoughtful people may harbor concerns about a policy that moves us from a full-throated embrace of the “no blame” paradigm to one that identifies certain inviolable safety standards and holds clinicians and health care organizations accountable for adherence. One concern is that the pendulum may swing too far in the direction of blame. This is why we begin with only two safety practices, ones that unambiguously meet the criteria in Exhibit 1.

We initially considered including a third practice, the use of surgical checklists, but removed it after studies illustrated that universal adherence can be challenging and is not uniformly associated with improved outcomes. Its removal illustrates our preference for a very high bar, at least initially, for the designation of “must do” practices.

Moreover, this approach does not mean that we are rejecting the systems thinking paradigm. Quite the contrary: clearly defining “must do” practices and enforcing accountability defends health care organizations and clinicians against charges that “no blame” is being reflexively invoked for acts (of commission or omission) that are clinically and morally indefensible.

Some may raise concerns about the challenges that certain types of institutions—safety-net, rural, or teaching hospitals, for example—will have in achieving full compliance. We see no reason that such hospitals should have an especially difficult time with universal hand hygiene or influenza vaccination compliance, nor why these practices are any less important to their patients than others. Of course, such institutions may need additional resources to support robust auditing systems.

We are even less sympathetic to the frequently heard argument that these standards will put hospitals (or clinicians) out of business. Hospitals or clinicians unable to achieve uniform adherence with “must do” practices should not be in the business of delivering health care. We are confident that this new paradigm will have just the opposite effect: promoting healthy conversations between policymakers, leaders, and clinicians about the best ways to achieve adherence to lifesaving practices.

Progress For Patient Safety

We continue to believe that the “no blame,” systems thinking paradigm has been an essential centerpiece of the patient safety movement. Such thinking has led to the elevation and implementation of effective practices such as checklists, computerization, teamwork training, standardization, and simulation. Continued progress in safety will depend on our ongoing efforts to create and strengthen safe systems of care.

Yet, as the saying goes, if all you have is a hammer, everything looks like a nail. Fifteen years into the patient safety movement, the “no blame” approach has become our hammer, yet certain safety practices are not nails. An approach in which “no blame” is invoked for innocent mistakes but there is blame (and penalties) for willful failure to follow evidence-based safety practices is crucial to promoting progress in patient safety, and to retaining the trust of key stakeholders.

It is time to label such practices as “must do,” and to get on with the business of ensuring universal adherence.

Exhibit 1