The Many Worlds of Patient Safety in Anesthesiology

The Special Article by Kanjia et al.  in this issue of Anesthesiology provides an interesting analysis of the role of various theories of safety, drawn mostly from those primarily created for nonmedical arenas. Some of these theories have been adapted in part by various medical organizations and institutions, mostly addressing experienced personnel and their work. This article extends notions of other authors about ordering the theories, promoting a climb from Safety 0, which is aimed at clinicians’ capabilities; to Safety 1, in part using “high reliability organization theory”; Safety 2, which entails largely concentrating not on “errors” but on how things work well; and Safety 3, which concentrates more on the entire “system.” The notion of a strict hierarchy of theories is relatively new, although the hierarchy presented here acknowledges that beyond presenting novel issues, safety does require merging the levels.

Overall, the authors’ analysis is useful, especially to alert the anesthesia community to this specific collection of theories. Some components of the theories, especially for Safety 0, are already known to anesthesiologists, but many aspects of Safety 1, 2, and 3 are not. In particular, they call special attention to the 2020 publication about the new Safety 3 by Massachusetts Institute of Technology (Cambridge, Massachusetts) Professor Nancy Leveson in a very long (110 page) internal article, “Safety III: A Systems Approach to Safety and Resilience” (https://sunnyday.mit.edu/safety-3.pdf). This author, known best for earlier work on software safety, provides a conception of Safety 3 as the need to simultaneously address and unify safety approaches of complex hardware, software complexity, and a variety of human factors issues.

Scholars inside and outside health care have for a long time investigated and written about patient safety, especially in anesthesiology, and have analyzed or created a variety of “organizational safety theories” (some included in the article by Kanjia et al.¹  but also many others)  There are too many to describe, with most originally applied in domains like aviation, human spaceflight, aircraft carrier flight deck, nuclear power, open-water oil drilling, chemical manufacturing, and so forth.

Health care overall seeks to provide excellent care for all patients, but anesthesiology is unusual in many ways. It is highly dynamic (things happen in seconds, minutes, hours) while also being of “high intrinsic hazard,” with risks arising by its very nature, even without errors. For example, evolution did not intend for human beings to be rendered (1) deeply unconscious, (2) insensitive to pain, (3) substantially amnestic, or (4) having deep neuromuscular blockade.

Other unique aspects of anesthesiology are that (1) many anesthetic cases require special and careful attention to complex surgeries or to serious pre-existing medical condition(s) or both; (2) anesthesia care is often conducted by a single anesthesiologist, sometimes without a guarantee of help if needed; (3) anesthesiologists are typically their own pharmacist, technician, cardiologist, and so forth; (4) many medications used in anesthesia can be lethal; and (5) the work often has intense production pressure for speed. Yes, anesthesia care has become remarkably safe, but it is never simple.

These aspects apply to the “sharp end” of clinical care in anesthesiology, but additional system issues arise from the surgery–anesthesia–institution organization. In fact, every level of an organization has its many sharp ends—things that need to be accomplished—under the control of its own “blunt end” that oversees/drives the work. This goes all the way from the clinicians caring for patients through various levels of institutional systems, even to those imposed by national or state politics. Moreover, healthcare systems themselves differ in a number of ways from systems outside of health care, including the following:

• I.Knowledge about the system’s primary target(s). In all but health care, the most relevant objects and devices are designed and produced by human beings and are well understood. In health care, we do not “design” or “build” human beings, nor do we ever receive a complete “instruction manual.”
• II.Underlying characteristics of organizations
  • a.Centralization versus decentralization. Many nonhealthcare endeavors have substantial centralization. Taking nuclear power for example, there are only 94 reactors in the United States, operated by 54 plants, in 28 states (with approximately 20,000 nuclear technicians and nuclear engineers in the United States or ~250 at each plant). As another example, each day U.S. commercial aviation flies many thousands of aircraft (each with two cockpit crew members) between hundreds of major airports; yet, only 10 U.S. airlines account for nearly all of the passengers carried annually; the top five alone carried 84%. In contrast, health care, despite a growing amalgamation of institutions, is extremely decentralized. On any given day in the United States, there are millions of patients cared for by millions of clinicians and others in approximately 6,000 hospitals and a far larger set of clinics and independent sites.
  • b.Control by and of the firms. Most industries use commercial “firms,” each of which exercises substantial control over many aspects of how the work is done, while staying within the oversight rules from regulatory bodies (some federal, some state, some nongovernmental). In decentralized health care, the exact number of “firms” is unknown but certainly very high. The different firms and their subordinate units, if any, create policies and procedures, but primarily physicians control the diagnosis and treatment of patients. Some rules are imposed by accrediting bodies, or state and federal agencies, but here too, clinicians retain the bulk of the authority.
  • c.Harm to the means of production. All arenas of high intrinsic risk fear harm to life safety for their participants and workers and consider the financial burdens of litigation and “bad press.” However, for example, no airplane is ever “supposed” to crash. Most industries also fear that an accident might seriously harm or destroy one or more critical parts of its “means of production.,” e.g., no more passengers can ever be carried on an airplane that has crashed. Collectively, the multiple concerns provide substantial, albeit imperfect, financial incentives to pursue safety.

On the other hand, all humans will die, and in high-resource places, most will die in connection to health care. It can be difficult to tease out which events were avoidable errors versus inevitable due to clinical condition. However, drawing conclusions of unavoidability may mask situations in which better attention to safety might have saved someone, or at least reduced the risk for others in the future. In addition, somewhat cynically, I posit that health care may see fewer incentives to pursue maximal safety efforts in part because we rarely, if ever, harm the institution’s means of production.

In summary, the article by Kanjia et al.  provides one entry into the complex arenas of patient safety. All of the various theories they discuss are meaningful, whether created for healthcare settings or adapted from nonhealthcare settings. I urge everyone involved significantly in patient safety to read this article but also to dig deeper into the many other safety theories that have been developed or adapted by a wider cohort of scholars from outside and inside health care. A detailed discussion of applications to anesthesiology of human factors and many patient safety theories can be found in Miller’s Anesthesia.  Additional relevant work includes Gaba et al., Tamuz and Harrison and Leveson et al. 

The more each of us can learn about why, what, where, and how to deploy the various patient safety approaches—singly or in conjunction with others—the more likely we will be able to better serve our patients and our institutions. In doing so, we pursue the vision statement of the Anesthesia Patient Safety Foundation: That no one shall be harmed by anesthesia care.