Galvanized by the seminal publication of the Institute of Medicine’s report To Err Is Human: Building a Safer Health System in 1999, the patient-safety movement has resulted in substantial improvements in the safety and quality of the care delivered by hospitals. A number of techniques and process-improvement tools from inside and outside the industry have been brought to bear: lean engineering to simplify and standardize care, Crew Resource Management to improve teamwork, checklists to help teams focus and improve reliability, and so on. Human factors science, which studies the relationship between human beings and systems in order to improve efficiency, safety, and effectiveness, is now being applied broadly in health care in everything from information management to the design of operating rooms.
Yet preventable harmful events — called “never events” because they are considered largely preventable — are still occurring. In fact, in Minnesota, where reporting of never events is required, there
been little change in the frequency over the past decade. The patient-safety movement seems to have plateaued. Or has it really?
Counting the frequency of never events (and other health-care-acquired harms) is important but won’t ever be an adequate way to measure the progress of patient safety over time. In fact, following the frequency of never events (the ratio of never events to opportunities to have the event) over time will provide a distorted picture of the progress in improving patient safety for several reasons:
- The definition of never events in the numerator has changed over time.
- The complexity and severity of inpatients’ illnesses, on average, is higher than ever and such patients are more likely to suffer pressure ulcers or falls.
- The entire context of care has changed: Many of the current procedures, operations, and treatments were not performed a decade ago.
- Not all never events are associated with significant patient harm, and many other events that are associated with serious levels of harm are not defined as never events.
The science of patient-safety measurement has simply not kept up. Consequently, even though some measures suggest there has been little change in the frequency of never events or other hospital-acquired conditions over time, many providers feel that their hospital care is much safer today than two decades ago. So how do we know if we are making progress, and how do we move to the next level? Here are some ways that Mayo Clinic is trying to address these challenges.
To look for opportunities to improve care, we examine all aspects of care rendered for every patient who dies in our facility — even those whose death was anticipated due to grave illness. We look for trends in opportunities in order to prioritize improvement work across our hospitals. Toward that end, we produce metrics on a quarterly basis concerning how frequently we saw care issues or improvement opportunities. In addition, we display a Pareto chart to graphically depict the most prevalent opportunities for improvement. We use these measures help us focus our improvement efforts.
For example, some years ago we noted that there was a growing prevalence in problems with smooth and safe direct admissions and transfers into our hospital. Due to inadequate information, patients would occasionally arrive too ill to be cared for in the area where they were first bedded and would soon need to be transferred to an area that could provide a higher level of care. Consequently, we developed a much better system that ensures that patients will receive safer transport and will arrive in the area most appropriate for their needs.
When we started this mortality-review process, we found care issues or opportunities for improvement approximately 23% of the time. More recently, that figure has declined to around 13% of the time. This is a reliable sign of progress in patient safety.
Every safety incident associated with serious harm, whether voluntarily reported or found through our mortality-review process, is examined to determine whether we deviated from our own standards of care that should have prevented its occurrence. When such a deviation happens, we count those incidents as “preventable harm” events. (Our board of trustees focuses on their frequency.) This is a meaningful way to measure progress in patient safety, because it measures something we feel we can influence — i.e., how reliably we follow our best practices to prevent harm.
As we learn from these and other reviews, and develop standard care methods to prevent harm, we codify those safe practices into our “Mayo Clinic Patient Safety Essentials” and ensure implementation across each of our facilities. Implementation is simple in some instances but in others requires a diffusion process equipped with project managers, systems engineers, communications experts, clinical experts, and the oversight of a high-level champion.
By acting in this way, we have reduced our surgical and procedural never-event frequency to less than 0.030 per 1,000 patient days (5.51 sigma), our advanced pressure ulcer rate to 1/60th the national average, and our overall never-event frequency to 5.24 sigma. (Six sigma — or no more than 3.4 defects per million opportunities — is generally considered high reliability.) Nonetheless, patients still suffer unintended harm. So we looked for additional improvement opportunities.
Technology has been very useful in compensating for human limitations and has been critical in approaching our goal of 0 never events. For example, to ensure that the correct medicine is administered to the correct patient at the correct time, all 22 Mayo Clinic hospitals have done three things:
- Instead of handwriting prescriptions, clinicians enter all them via a computerized menu directly into an information system that automatically checks for errors (e.g., related to drug interactions, allergies, and dose adjustments due to kidney disease).
- We’ve adopted an advanced pharmacy-preparation and packaging system that attaches a bar code to each medication with patient-specific information and dosing instructions.
- The person dispensing the medicine uses a bar-code reader that compares the patient’s code with the medicine’s code.
Thanks to these measures, there have been no harmful incidents due to medication errors at our largest campus (in Rochester, Minnesota) for the past 13 months, and the combined rate of harm from medication errors at all 22 Mayo hospitals during the same period has averaged less than 0.021 per 1,000 patient days.
Increasing staff engagement through a combination of checklists and the application of new technologies has also produced much better levels of safety in other areas. Before 2005, there were about 74 surgical sponges left in patients per 1 million procedures at our Rochester hospital. Thanks to the use of checklists and a bar-coding system to help count the sponges, we now have fewer than 5 per 1 million procedures (5.9 sigma).
In contrast, we continue to struggle to further reduce the frequency of pressure ulcers, we still perform procedures at the wrong body site, we sometimes perform the wrong procedure, and we have not figured out how to eliminate patient falls that result in injuries. In each of these categories, we already perform at or better than most health care centers, but zero events eludes us. Why?
The main reason is we’ve picked the low-hanging fruit. We are now mostly dealing with minute details, not gross errors. For example, most “wrong-site” procedures occur when the surgeon operates on a vertebra just above or below the intended spinal level and are often associated with abnormal anatomy or difficulties isolating the correct spinal location in obese patients. The wrong type of procedure is no longer an appendectomy when a cholecystectomy was planned; rather it is insertion of one type of central catheter instead of one that was marginally different than the intended one, or it is the unintentional biopsy taken when only a diagnostic procedure was ordered. The retained foreign objects are minuscule pieces of implantable devices, ones that actually rarely cause harm — for example, a small fragment of an elastic piece that broke off from an endoscope during a procedure. (Since clinicians judged that it was not causing harm and retrieving it might, they left it in.) And most pressure ulcers in our institution are now suffered by critically ill patients for whom all known prevention methods have been employed and failed. Just as they may suffer lung, kidney, and heart failure, they are suffering skin failure.
To continue to make progress and completely eliminate never events, we need new approaches, some of which will require new investment in tools, care environment, and our caregivers. For example, to tackle fall prevention, one of the most costly events in terms of both human suffering and financial impact, we need to invest in a redesign of hospital rooms. To get to the next level of patient safety, larger, private rooms with properly designed beds, built-in and efficient patient-lift devices, bathrooms large enough to accommodate ambulatory-assist devices, and contrasting colors to enhance the vision of the elderly and ill may all be required.
Some of the surgical and procedural events are closely tied to communication lapses. These usually occur when the communication channel is unclear: e.g., when procedures are scheduled by someone other than the person who actually performs the procedure, or when there are changes in the patient’s condition or needs between the decision for and performance of the procedure. These could be significantly reduced by development of an embedded information system — a bar code of sorts — that would register all of the requisite information wherever patients went in their care journey. Such a system has not yet been developed, but it could be.
Such information systems must be designed to organize pertinent information that is easily accessible for clinicians. To combat the cognitive overload, our clinical researchers have developed such “heads up” data displays for the critical care and the operating room environment. We are now striving to deploy advanced display systems for all patient rooms.
Finally, despite the unprecedented rise of technology in health care, patient care is ultimately delivered by humans who are having to work in increasingly complex and hurried environments. Care involves more team members, a faster pace, higher caseloads, and higher stakes. We studied the root causes for over 60 surgical near-miss and safety events and found that cognitive factors such as channeled attention on a single issue, overconfidence or confirmation bias, inadequate vigilance, errors made based on inaccurate information, and distractions underlay many of them. Until we can find the right technological tools to aid clinicians, the only satisfactory improvement tool in some cases may be to slow down and do less, have more time to think and deliver care. This is probably not the most popular option in an environment that is resource constrained and competitive.
So there is still much to do, and we providers must do it. Zero never events should not simply be an aspirational goal if we want to be true to our creed of “do no harm.”