Welcome to Episode 4: Models for Change. How care we begin to address significant patient safety problems facing healthcare today? One key is to focus on those harms or errors that can be shown to be fully or at least partly preventable. In order for an error to be classified as preventable, it must first be identifiable and measurable. Second, the process or intervention that resulted in the error must have been shown to be modifiable. And third, there must be one or more modifications that can actually be implemented and tested in a given setting to prove that the intervention does indeed lead to fewer errors. An example of a clearly preventable error is having two vials of a medication that look exactly the same but have vastly different concentrations of the medication. Twins born to an actor in the US, Dennis Quaid, were given 10,000 units per milliliter of heparin instead of 10, and both children suffered life-threatening harm as a result. A major reason for this error was that the vials with different concentrations of heparin looked exactly the same. Changing the shape, the color, or some other major characteristic of the vials would have eliminated at least this source of error. Medication errors such as the ones just noted are one of the most common causes of harms to patients. Another common problem is healthcare related infections, especially infections from central lines. On a hopeful note, some recent studies have shown that central line infections in hospitals can be drastically reduced, or perhaps eliminated, by modifying the care process related to the insertion and monitoring of central lines to include the diligent use of a simple checklist. The challenge is now to have the simple technology of a checklist adopted by all healthcare facilities. Another frequent cause of medical error is delayed or misdiagnosis. Now this type of medical error has been more difficult to recognize, specify, measure, or modify. In 2015, the Institute of Medicine, or IOM in the United States, released a report focusing on misdiagnosis. While there have been few or no studies that have adequately quantified the problem, there is evidence that misdiagnosis occurs frequently in every clinical setting. Indeed it is likely that every one of us will at some time in our life experience delayed or misdiagnosis. While there are no widely used interventions to improve diagnostic accuracy at this point, the results of some computer-based programs that assist or provide feedback to clinicians about the likely accuracy of the diagnoses they make provides some hope that misdiagnosis may also be preventable. Likewise, studies that revealed traps that clinicians sometimes fall into, like premature closure on a single diagnosis before we have all the evidence, or ignoring evidence that's contrary to our initial diagnosis, may also lead to future improvements in diagnostic accuracy. In seeking to improve healthcare quality and safety, it is useful to examine successes and failures from other industries. In contrast to healthcare, a number of other industries have made major strides by combining technologies engineered from the outset to be safe and effective. And using training and education to ensure that people use those technologies in a reliable and consistent manner. For example, the airline industry has achieved major gains in safety through systematic and thorough investigation of both near misses and accidents. And by using information acquired from these investigations to improve both the technologies and the human interface with those technologies. The airline industry is fortunate in that it has at least one compelling and fairly simple to understand measure of major harm, the rate of fatal accidents per unit of air travel. There are, of course, many other tools used in aviation, such as studies of near misses, of accidents without fatalities, and of careful monitoring of processes, such as those used to maintain aircraft and to train staff. In addressing areas that could result in fatal accidents, the airline industry requires pilots to complete extensive training, including ongoing work in simulators, in order to both obtain and maintain a commercial pilot's license. In addition, the entire flight crew participates in ongoing exercises and simulations to help ensure high levels of teamwork and function in emergency situations. Flight crews and maintenance crews also employ an extensive system of checklists and inspections that increase the likelihood that the crew and equipment works in the expected way every time. While, as we have noted, healthcare presents some unique challenges. Lessons from the airline industry that seem relevant for healthcare include, first, the use of systems engineering and rigorous testing of technologies for safety defects. And indeed, engineering into the technology, safety from the beginning. Full and thorough investigations of all near misses, as well as actual errors and accidents. The systematic use of information from these error investigations to improve quality. Developing and applying measures and checklists to improve care, and recognition of the need for ongoing training, including simulation or procedures to emulate crisis situations. Each of these approaches can also be applied to improve healthcare. For example, frequent and consistent testing, including the use of simulations, especially of all healthcare staff likely to be involved in emergent care, has the potential to reduce errors and improve performance in actual emergency situations. Another industry that has made significant advances in safety that could be relevant to the healthcare industry is the food industry. While there are numerous government regulations concerning food safety at all points of production, the food industry itself is responsible for the safety of the public's food. The food industry has developed a hazard analysis and critical control point, or HACCP approach to ensure food safety. As defined by the Food and Drug Administration, HACCP is a systematic preventive approach to ensure food safety by protecting food from biological, chemical, and physical hazards in the production processes that could cause the finished product to be unsafe, including the design of measurements to reduce those risks to minimal safe levels. The key elements include conducting a hazard appraisal, identifying critical control points, establishing the upper and lower limits of those control points, establishing critical control point monitoring, establishing corrective actions, and ensuring that the HACCP procedures work, and in establishing record-keeping processes. While there are occasional breakdowns, especially where there are inadequate staff, the system in the past has worked in food safety. It is likely that healthcare quality can be improved by integrating some of these quality control checkpoints and procedures at critical points in healthcare processes as well. Given continued increases in healthcare costs, the actual cost of safety and quality interventions and improvements must also be considered. Calculating the cost versus the benefits of improving safety is often complex. The cost of a death of a loved one does not neatly fit into economic calculations. In addition, there actually can be significant costs associated with the infrastructure needed to help develop and implement improvements, such as implementing an electronic medical record or increasing staff levels. However, the cost of medical errors, even aside from the difficult to measure suffering of patients and families, is substantial. In 2008, one estimate was that medical errors cost about $20 billion just for those costs associated with the additional care due to the harm caused. A more recent calculation by Angel and his colleagues estimates that the overall economic impact of medical errors is a staggering $1 trillion a year. The general consensus at this point is that most careful efforts aimed at improving safety and quality are likely to be cost effective given the extraordinarily high economic and human impact of errors. However, choosing interventions that are fairly simple to implement and that effectively address major causes of error and poor quality, along with monitoring both the cost of the work of improvement, as well as the benefits of safety and quality is still critical. Clearly, we are at an early stage in creating and continuing proven safety within our healthcare system. But even at this early stage, we must already be asking critical questions about how best to invest our scarce time and resources in creating the greatest advances and fostering ever more safe and high quality healthcare.
