Looking for Safety in all the Wrong Places

Safety is the number one concern of hospitalized patients and their families. Safety is also the number one “product” that hospitals sell. Yet these two synergistic goals are rarely met. Other than sporadic instances of exceptional hospital safety performance, data from multiple sources suggest a dismal record of safety with little improvement nationally. For example, a recent issue of Consumer Reports (“Safety still lags in US hospitals”) documents continuing overall poor performance.¹ Using a scoring system 0-100, the average score for all reporting US hospitals is 49/100. Parenthetically, this level of performance is similar to that of the YUGO, one of the least safe automobiles ever manufactured. The hospital with the best score, Bellin Memorial Hospital (Green Bay WI), only achieved a 74/100. However, nearly two thirds of all US teaching hospitals ranked below the national average. As a matter of fact, 27of 28 teaching hospitals in the New York City region also received a poor score. For example, John Dempsey Hospital (University of Connecticut) received only 17/100. Other databases (e.g., Hospital Compare, Leapfrog, US News and World Reports) support these numbers. As Consumer Reports notes, the only good news in this arena is an almost doubling of the number of hospitals reporting safety data (probably on the basis of regulatory requirements), 2,031 in 2013 versus 1,151 in 2012. Author Rosemary Gibson categorizes the safety data as an “…epidemic of health-care harm.”² Dr. Peter Pronovost, an internationally recognized patient-safety authority, states, “Hospitals haven’t given safety the attention it deserves. Medical harm is probably one of the three leading causes of death in the U.S., but the government doesn’t adequately track it as it does deaths from automobiles, plane crashes and cancer. It is appalling.”²

Why is safety so difficult to improve? First, there is a taxonomy deficit, in which there is no standard, reliable definition of the term that is used across various organizations working in this area.^3-5 Not only is a definition required, but also a classification system must be part of the nomenclature. Although the World Health Organization International Patient Safety Classification attempts to ‘harmonize’ these concepts, it has certainly not been met with universal acceptance.⁴ The second area of concern is the tendency of “blaming” the frontline clinician for an adverse safety outcome. This overlooks a multitude of organizational issues, which are also at play, e.g., production pressure, inadequate work area design, ineffective ergonomic equipment design, operator fatigue, and multiple procedures occurring simultaneously (diverting the clinician’s attention). Both James Reason and Charles Perrow have developed paradigms to investigate the occurrence of accidents. Reason’s famous “Swiss Cheese Model” states that the ‘holes in the cheese’ must all line up for an accident to transpire. In other words, a series of lapses of vigilance must occur to observe tragic manifestations of latent safety deficiencies.⁶ I prefer Perrow’s approach, which emphasizes that in high-risk environments accidents are the “normal state.”⁷ Accidents are never removed from a system; only the interval between them is altered, e.g., increased or decreased. Furthermore, accidents unfold in unpredictable ways. One only has to look at the Three Mile Island Nuclear Power Plant Disaster, The Apollo 13 mishap, or the sinking of the ferry, the Herald of Free Enterprise, to see validation of Perrow’s hypothesis. Of these, perhaps the sinking of the ferry, which resulted in the greatest loss of life on a British civilian vessel since the sinking of the Titanic, is most analogous to deviations from safety protocols seen in the hospital.⁸ The sailor, who had responsibility to ensure that the watertight doors were closed and notify the Captain before debarkation, was found guilty of causing the sinking and loss of life. However, using the Perrow paradigm, inadequacies were also noted in vessel design, vessel operation, docking design and procedures, significant change in docking protocols, crew working patterns, and unsafe heuristics.⁹

With this as background, the Scientific Statement entitled “Patient Safety in the Cardiac Operating Room: Human Factors and Teamwork” becomes an important initiative for the American Heart Association (AHA).¹⁰ It is obvious why the AHA should promulgate this document. The cardiac OR, the iconic image of cardiovascular care employed by the media, is a site of major advances in diagnostic and therapeutic management of patients with cardiovascular diseases. As the authors point out, significant improvement in patient outcomes have already been seen in this venue. But, as Wahr and colleagues state “ …the highly skilled and dedicated personnel in cardiac ORs are human and will make errors.” Importantly, they define and classify terms in a workable manner, which will not only facilitate programmatic development of safety protocols but also quantify outcome. By focusing on non-technical skills, the authors appropriately attack the area that potentially will have the greatest impact on safety improvement. This is based upon data, which for example, documents the deterioration in performance from something as “small” as the number of times an hour a door to the OR is opened (between 19-23/hr)!¹¹ Increased door opening frequency not only increases the risk of infection, but also disrupts workflow and communication between team members. As part of the solution, the Statement also emphasizes the 6 C’s of teamwork (communication, cooperation, coordination, cognition, conflict resolution, and coaching).

Critical to the success of any safety initiative is the institution’s organizational culture. Medical and administrative leadership must be supportive with both behaviors and resources. Espousing safety in the absence of supplying resources will actually result in a further deterioration in creating a safe environment.

In no other endeavor in medicine is teamwork as critical as in the cardiac OR. Thus, the authors not only pinpoint areas for development, but also significantly discuss training observers to measure team performance. Only through objective data collection and analysis can this key variable be improved.

Finally the major strength of this Scientific Statement is the composition of the Committee, which included experts in the entire spectrum of clinical care provided in cardiac ORs, as well as authorities in psychology and human factors.

In summary, as we move to new hybrid ORs, where cardiac surgeons, cardiac anesthesiologists, cardiac nurses, and perfusionists will work with interventional cardiologists, the Statement assumes even greater importance as a roadmap or “GPS” for the future.