The message to shift quality improvement energies toward measuring harm is not new; it has roots as far back as 2000, in an IHI program co-sponsored by Premier, Inc., known as the “Idealized Design of the Medication System” (IDMS). A group of patient safety experts assembled in the IDMS project (30 physicians, nurses, pharmacists, and statisticians) focused on reducing adverse drug events (ADEs). In addressing this goal, the team started by acknowledging that the traditional system of self-reporting of errors, as a method for measuring medication and other types of errors, is ineffective. Public health researchers have established that only 10 to 20 percent of errors are ever reported and, of those, some 90 to 95 percent cause no harm to patients. For example, a wrong medication prepared and delivered to the patient may or may not cause harm.

 

The inadequacy of the error-reporting system stems from limitations in the process itself: it is voluntary and highly subjective; one person’s opinion about what constitutes an error may differ from another’s. It is often a cumbersome process, based on time-consuming paperwork required of over-burdened providers. Moreover, there is a punitive element that hinders reporting: we naturally look to blame individuals for errors, but harm is typically caused by system flaws or failures.

 

According to Roger Resar, MD, IHI Senior Fellow at the Mayo Health System’s Luther Midelfort physician group in northwest Wisconsin, and one of the participants in the IDMS initiative, “We’re not saying that clinicians shouldn’t record errors and work to reduce them. Just don’t spend all your time and energy on it, because it is only one piece of safety information. You could work forever trying to fix every error and not affect the level of harm.”

 

For example, standard postoperative narcotics given to ease pain often cause nausea and vomiting. Consider a case in which such nausea keeps a patient from eating well during recovery and delays the course of his or her physical therapy, ultimately adding an extra day or two of hospitalization. Although this outcome is harmful to the patient, the damage is rooted not in error but in a course of treatment that could be improved, for example, with standard anti-nausea protocols.

 

Similarly, when a patient admitted for routine surgery gets a staph infection while an inpatient, that hospital-induced illness is certainly harmful. The harm is caused not by individual error but by an institution’s inadequate germ-protection system.

 

Approaching adverse events from the perspective of harm experienced by patients inspired a team led by Carol Haraden, PhD, IHI Vice President and patient safety expert, to create a new tool now widely used by quality improvement teams to measure and quantify levels of harm within their institutions. The tool uses the concept of “triggers,” red flags in patient charts that could be signs of a harmful event.

 

While there are now modified Trigger Tools available for use in ICUs, surgical settings, and outpatient clinics, the original tool was designed to measure ADEs. The Trigger Tool for Measuring Adverse Drug Events lists 19 specific items in a medical chart that could be a sign of a harmful event; these include drugs ordered, lab results received, and patient symptoms noted. For example, Benadryl is one trigger, since the drug is a common antidote for an allergic reaction — possibly a reaction to a drug prescribed earlier in treatment. Other triggers are an abrupt medication stop, a rash, a fall, or lethargy experienced by a patient.

 

By going back through randomly selected patient charts, reviewers identify triggers and clinicians can verify where harm has occurred and ultimately produce valid and reliable measurements. According to Haraden, identifying triggers brings us to the really hard work: tracing the instances of harm to its systemic roots in an institution. This means tackling such issues as infrastructure redesign, IT investment, and adoption of best-practice standards. It also inevitably entails difficult cultural change: questioning of definitions of harm, accepted treatment complications, and standard assumptions about preventability. Such challenges offer genuine opportunities to reduce and prevent unintended harm to our patients — a goal that no one should pass up.