Avoiding patient harm has been healthcare’s goal from the days of Hippocrates. Yet achieving this goal remains elusive. Despite years of attention to the Universal Protocol, patient identification, escalation of clinical concerns, medication reconciliation and other thoughtful approaches to patient safety, there is little evidence that the incidence of harm has diminished.
Greeley will describe the organizational capabilities necessary to enhance reliability and reduce harm over the course of four blog posts.
This first post describes the overall model, Greeley’s “Framework for High Reliability.” In subsequent contributions we will:
- Describe “Care Facilitation,” a highly effective approach to monitoring and improving problem-prone systems across an organization;
- Share game-changing strategies for oversight, enabling organizations to get much more done in far less time; and
- Describe practical methods to simplify and streamline policy expectations and untangle complex and burdensome clinical documentation.
How Greeley’s Framework for High Reliability Evolved
Patient safety, regulatory compliance, and healthcare quality have been important parts of Greeley’s consultation portfolio for decades. But things got very serious eight years ago when we were asked to become the CMS-approved consulting group for a Systems Improvement Agreement (or “SIA”) involving a 600-bed safety-net hospital in the Southeast. Although Greeley led the industry in achieving and maintaining CMS and Joint Commission compliance, we had never coalesced our approach into a single model of high reliability. Yet such a model was essential if we were to organize and focus our client, a truly excellent institution that had fallen victim to a series of unfortunate patient safety events.
Our Framework for High Reliability became the concrete synthesis of many longstanding safety, compliance and quality principles and was used to guide progress over the next year of the SIA. In the end, CMS and the state were delighted with the hospital’s progress. More importantly, the number of harm events diminished markedly during and after the SIA. Errors and adverse situations were more frequently identified before they had a chance to harm patients.
Greeley has lived the Framework ever since, on hundreds of compliance and safety engagements, including more hospital SIAs than any other consulting firm in the nation. What you are about to learn is not a theory, it is a field-tested and effective model for high reliability. It is not a dream devised in a conference room, it is a very real family of mechanisms, each of which has been stress tested in the field again and again and again. The approaches we will share over the next few months are exceedingly practical and, we believe, essential to the wellbeing of hospitals and the patients they serve.
Understanding the Fabric of Healthcare
Before we address Greeley’s Framework, we must first describe the Fabric of Healthcare.
A hospital is a collection of settings that function semi-autonomously alongside one another. A typical hospital has emergency departments, operating room suites, critical care units, telemetry units, ambulatory care clinics and a host of other diagnostic and therapeutic departments. Although these settings interface with one another, they are highly specialized and methods used in one setting, such as the operating room, are often different from the methods for similar functions in critical care, the emergency department or the cardiac catheterization laboratory. The principles may be the same, but the details often differ due to differences in staffing, the environment and how the setting accesses other hospital services. These hospital settings are depicted by the black vertical bars in Figure 1. Some view these settings as silos. We prefer to think of them as “cylinders of excellence.”
There are many, many processes that must take place safely and consistently across all hospital settings. The ED, OR, critical care and diagnostic testing must all complete assessments, plan and provide treatment or testing, and safely perform high-risk interventions. These cross-setting, multi-departmental processes are represented by the horizontal arrows going from left to right in Figure 1.
For many years Greeley used this “Fabric of Healthcare” to identify trends and patterns across an organization. Did one department or setting tend to have more problems than others? Did a particular process, like procedure-related sedation or disinfection, tend to be problematic across the various hospital settings?
The Framework for High Reliability
Knowing the pattern of safety issues within the Fabric of Healthcare is not enough, however. Only by bounding the weave of settings and processes with certain fundamental organizational capabilities can a hospital hope to achieve and sustain quality, efficiency, and safety.
There are four fundamental capabilities that should be effective and efficient if an organization hopes to reduce harm:
- Process Implementation
- Process Monitoring
Safe processes must be well designed and effectively implemented. We’ve identified four distinct functions that fall under the Process Implementation capability: Policy, Documentation, Education, and Resources.
Policies and procedures must be designed to account for the differences and complexities of each department or setting that has a role to play. The process and the document that describes it (e.g. the “policy and procedure”) must make clinical and operational sense to each involved setting or department. Policy expectations should never be based on regulatory myths (of which there are many). To be successfully implemented and sustained the policy must balance customer experience, safety, and efficiency. It must be concisely described in a way that will make sense to a new practitioner on his or her first day after orientation. And it must be readily available to front line managers, educators, and caregivers.
No hospital can afford a 10-page or longer restraint policy, or a 5-page policy on EMTALA that may make sense to an attorney but does not connect with clinicians. Policies and procedures must be well designed, succinct and as simple as possible. Any process that dissatisfies patients, physicians or staff members will not last. An overly complex or inefficient process soon vanishes.
Even before electronic medical records, patient documentation was a mess. It has now grown into a monster, with thousands of “clicks” and menu choices that rarely describe the patient or their condition. Like policies and procedures, clinical documentation must be succinct and promote efficient and accurate communications about the patient. Although clinical documentation, like the care process it records, is complex by its nature, there is no need to increase complexity by adding hundreds and hundreds of unnecessary and non-contributory entries.
We will devote a separate detailed blog post on these first two capabilities, “Policy” and “Documentation.”
It is essential that education extends beyond the classroom to the point of care or service. Didactic education soon fades unless it is reinforced “on the job.” Our next post on Care Facilitation will expand upon our approach to combining point-of-care education, change management, and metrics monitoring.
The first thing on the chopping block during a reduction in force (“RIF”) seems to be middle management, education, and quality. Yet, without a credible middle management structure or enough frontline care and services providers, it is truly impossible to consistently implement important processes across an institution.
There must be a credible feedback mechanism for important hospital processes. Too often we experience a flood of new processes without any data to suggest that they are effective. The Framework includes four essential monitoring functions: Metrics, Events, Issues, and Improvement.
It is often, but not always, possible to develop meaningful data-based measures of performance with helpful and accurate numerators, denominators and rates. However, hospitals cannot afford “deep dives” into invalid data. Our upcoming article on Care Facilitation will show how to efficiently combine education and change management into a rich data set to track improvement.
Adverse events and at-risk situations are a rich source of performance information. However, they must be reported quickly and comprehensively, and they must be appropriately analyzed. It is important to remember, however, that mitigating the impact of these events is not the goal for the purpose of patient safety. (It is an important risk management function, however.) The patient safety goal for events analysis is to understand why the event happened. We cannot solve the “what,” only the “why.” In a separate series of blog posts, we will describe some of the reasons incident reporting systems and “root cause analysis” activities frequently come up short.
All organizations have many, many issues on their improvement agendas; too many to successfully address. An issue can become apparent through performance on a metric or a single or cluster of adverse events. For example, a hospital may recognize that it has a problem with falls prevention because its falls rate is too high, or, instead, because of a single catastrophic fall event. All issues, whether apparent from metrics, events or both, should be captured and prioritized. Even “low priority” issues should land on a list maintained and reviewed by the hospital’s Oversight core capability.
There are many reasons improvements fail. One such reason is that hospitals try to improve too many things at once. A wise person once said, “the best way to do nothing is to try to do too much.” A second reason improvements fail is that the goal of the improvement was never clearly defined at the beginning. It is important to solve these and other performance improvement challenges as a hospital progresses toward zero harm.
Too often a significant change in process is communicated inconsistently across the organization. That is why it is essential that each complex or important change is accompanied by a plan to effectively communicate, reinforce and monitor implementation. The Care Facilitation process in our next blog post plays an important role in implementing important changes.
We’ve known the importance of a culture of safety, and just culture, for many years. Yet, developing a culture of safety is a journey, not a destination, and we cannot afford to let “just culture” algorithms or safe communication practices become empty promises.
The hospital’s Chief Executive Officer should never hear about a serious adverse event from a reporter or state surveyor. Instead, hospital executives should know the details of truly significant adverse events immediately and oversee steps to protect patients while longer-term fixes are designed and implemented.
Hospitals have scores of oversight committees, very few of which actually provide oversight. There are three important features of Oversight, the Framework’s fourth and final capability: Structure, Action Orientation, and Accountability.
There is often a dissonance between the organization’s leadership structure and the quality and safety improvement structure. These two structures must be brought into alignment if oversight is to be efficient and effective.
All presentations to oversight groups must be action-oriented. Each presentation must have a conclusion, a recommendation, and sufficient analysis to support both. Yet the issue must also be presented in a concise format during a well-planned and efficiently conducted meeting.
Promised and assigned actions must be tracked to completion.
Although these three features of Oversight seem intuitive, we’ve designed practical approaches to each of them over the years, from effective oversight structures to model agendas, quick and meaningful minutes, action-focused presentations and issue, IOU and responsibility tracking tools, all of which will be explained of an upcoming blog post.
The Framework is Not a Theory
The Framework for High Reliability works. It is used in many hospitals across the country as you read this. We are very pleased to be given the opportunity to share this model with our colleagues across the country as we all endeavor to “do no harm.”
Bud Pate, VP of Compliance Content
Mr. Pate has been with Greeley for 16 years. Before joining Greeley he spent 15 years as the Southern California Regional Director of Licensing and Accreditation for Kaiser Foundation Hospitals and, prior to that, as a regulator involved with Medicare Certification and state licensing for non-long-term care institutions in Los Angeles County.