Techniques for Clinical Quality Improvement and Error Reduction Techniques

Gregory B. Seymann

BACKGROUND

Generations of physicians have been raised with the notion that the practice of medicine is based on science as well as art. This traditional thesis suggests that science provides an understanding of pathophysiology, justifies its application to technology and pharmacology, and enables clinicians to heal patients. The “art of medicine” has been relegated to the individual practitioner who forges a unique relationship with his or her patient, and chooses how best to apply the scientific data to each case. This process has been deemed an “art” ideally practiced by a seasoned clinician who is capable of creating a customized treatment plan.

This conception of the practice of medicine has changed markedly since the Institute of Medicine (IOM) published its seminal report in 1999, To Err Is Human, declaring, “medicine is not as safe as it should be—and can be.” It referenced two studies suggesting, “At least 44,000 people, and perhaps as many as 98,000 people, die in hospitals each year as a result of medical errors that could have been prevented…,” an annual mortality rate that exceeded AIDS or breast cancer. This information awakened the public and the medical community to the fact that despite the exponential increase in the volume of scientific discoveries, the US healthcare system was not performing optimally for all patients.

The early advocates of the patient safety and quality improvement movements realized that the data from the IOM might represent only the tip of the iceberg and suggested that many more nonfatal errors resulting in temporary harm or in “near misses” must go unreported. Subsequently, a follow-up study by the Office of the Inspector General (OIG) in the Department of Health and Human Services disclosed that during the month of October 2008, the adverse event rate among hospitalized Medicare beneficiaries was 27%. Of these events, only 1.5% led to death. The remainder of the events led to serious or temporary harm, or prolongation of the hospital stay. Most importantly, physician reviewers in this study determined that 44% of the events were clearly or likely preventable. These events impacted 270,000 patients per month, at an additional annual cost to Medicare of $4.4 billion.

The nature and frequency of the events defined as “errors” are fairly broad. The OIG study confirmed that, despite significant media attention, drastic errors such as wrong-site surgery remain exceedingly rare. The majority were attributed to medications (e.g., excessive bleeding due to anticoagulants, delirium due to psychoactive drugs, and renal insufficiency due to nephrotoxins). Other studies consistently demonstrate that medical errors commonly involve underuse of interventions proven to be beneficial. McGlynn and colleagues reviewed the care provided to a large, geographically diverse group of patients over a 2-year period. They found that overall adherence to a group of well-developed, standardized measures of quality (e.g., vaccination for influenza in the elderly, treatment of uncontrolled hypertension, treatment of elevated cholesterol in patients with known coronary artery disease) was 54.9%. In other words, patients received evidence-based standard of care approximately half the time. The majority of the deficiencies involved underuse of proven interventions.

The fiscal impact of these errors alone is staggering and has energized the entities that pay for healthcare to call for change. In addition to the $4 billion in expenditures for inpatient medical errors, preventable hospital readmissions cost the US healthcare system $25 billion annually. Increasingly, healthcare advocacy groups, private and public payers have created incentives for hospitals and physicians to improve the quality and safety of patient care.

SYSTEMS IMPROVEMENT: EXAMPLES

Revisiting the concept of the “art of medicine” reveals that its role is more limited than physicians who have been trained to believe. In reviewing some examples of the errors listed above, it is apparent that many interventions that are well-supported by evidence don’t reliably reach the patients who need them. Why can’t the scientific method be applied to the “art of medicine” too? In other words, rigorous investigation to discover better ways to ensure consistent application of appropriate medical interventions to eligible patients may add as much benefit to patient outcomes as the discovery of new knowledge. The adage becomes: “We don’t need to do better things, we need to do things better.”

It was clear to the authors of the IOM report that high error rates in healthcare are not linked primarily to negligent or poorly trained physicians. Other industries, notably the automotive and aviation industries, have achieved decades of success in improving the reliability of their products and services, and offer excellent models for medicine. In contrast to medicine, these industries have not put the primary culpability for error on the individual employee. Instead, they have accepted the inherent fallibility of the individual worker, and have sought ways to improve their systems to account for it. Leaders in the fields of patient safety and quality improvement have spent the past two decades exploring ways to apply such concepts to medicine, and to energize the healthcare community to accept this approach.

There have been many success stories among those who embrace the idea that we can transform healthcare into a highly reliable industry. It is instructive to review several examples of how the scientific method was employed to yield innovative changes in local hospitals.

The Keystone Project focused on the application of a simple intervention to eliminate central venous catheter (CVC)-related bloodstream infections in their intensive care unit (ICU). Data suggested that CVCs were responsible for 80,000 bloodstream infections annually and up to 28,000 deaths in ICUs, at a cost of $2.3 billion. Secondly, they identified a set of evidence-based best practices to reduce CVC-related bloodstream infections:

1. Strict adherence to handwashing

2. Full sterile barrier precautions during CVC insertion (cap, gown, mask, drape)

3. Skin preparation with chlorhexidine

4. Avoidance of the femoral insertion site when possible

5. Prompt removal of unnecessary catheters.

These best practices were known to most clinicians who practiced in the ICU at the time of the study, but it was unclear how strict adherence would improve outcomes. More importantly, the investigators recognized that a systematic change was needed to ensure that these practices were followed reliably; counting on physicians and nurses to remember each step every time was not sufficient to effect a change in practice technique.

As part of the study, a physician and nurse champion were recruited for every ICU. These local leaders were tasked with educating their colleagues about the changes, and exerted influence in their units to facilitate acceptance of the intervention. A procedure cart with necessary equipment was created to ensure that compliance with sterile precautions was easy for physicians, and a checklist was created to facilitate adherence with all five steps. Unit staff was empowered to stop practitioners in non-emergent situations if the listed practices were not being followed, and daily rounds included a discussion of catheter removal on every patient. Teams were given feedback on a regular basis about their rates of CVC-related bloodstream infection.

Using this straightforward model, the median number of ICU bloodstream infections in the study hospitals dropped from 2.7 infections per 1,000 catheter days to 0 within 3 months of implementation. Remarkably, the median infection rate remained at 0 for a full 18 months of observation. The overall incidence of bloodstream infections was reduced by 66%. The study population encompassed 85% of the available ICU beds in the state of Michigan, and thus the impact was widespread. Extrapolation of these practices to ICU’s across the country has major implications for patient safety.

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