American Journal of Law & Medicine

System and responsibility: three readings of the IOM Report on medical error.(Institute of Medicine)


The most publicized finding of the Institute of Medicine (IOM) report is that between 44,000 and 98,000 patients die each year as a result of "adverse events" in medical care.(1) The core concern of the report is to argue that a "systems" approach to medical practice holds out considerable promise for the elimination of the subset of those "adverse events" which are the result of medical error.(2) The report outlines the "systems" approach and proposes various public policies which might encourage the adoption of that approach, enhance its effectiveness and protect it from potentially undermining legal assaults.(3)

This paper is an inquiry into the nature of the "systems" approach to human error. It is particularly concerned with the fate of the idea of personal responsibility in systems theory. Part II outlines the IOM's systems approach. Part III casts the approach as an aspect of management theory. Part IV casts it as an effort to "medicalize" a previously "legal" problem. Part V is a speculative philosophical conclusion.

II. Error Happens

   The common initial reaction when an error occurs is to find and blame 
   someone. However, even apparently single events or errors are due most 
   often to the convergence of multiple contributing factors. Blaming an 
   individual does not change these factors and the same error is likely to 
   recur. ... The problem is not bad people; the problem is that the system 
   needs to be made safer. 
      --Institute of Medicine, To Err is Human(4) 

"To err is human," the Institute of Medicine tells us in its title--and yet it turns out that it is not humans who err. Let us follow the reasoning that leads to this conclusion. This will involve, first, a brief review of the IOM's vocabulary and then the application of that vocabulary to an IOM-supplied example.(5)

Patients are harmed by their diseases, but too often are also independently harmed by the medical care they receive.(6) The IOM terms any injury caused "by medical management rather than by the underlying condition of the patient" an adverse event.(7) An adverse event attributable to error is a preventable adverse event.(8) Preventable adverse events may result either from errors in execution (failures to complete planned actions as intended), or errors in planning use of a wrong plan to achieve an aim).(9) The IOM report focuses primarily on errors in execution, reserving errors in planning for later treatment,(10) Of preventable adverse events, only some are the result of legally cognizable negligence.(11) Not all preventable medical harms, in other words, result from failure to meet the medical standard of care; not all error is negligent error.(12)

Error occurs within systems.(13) Systems include equipment, people, and the procedures designed to govern their interaction (i.e., interactions between pieces of equipment, among people and between people and equipment).(14) When systems fail, the most obvious part of that failure "occurs at the level of the frontline operator [and] its effects are felt almost immediately."(15) This is active error. But active error often flows from such background systemic features as poor design, incorrect installation, bad management and poorly structured organizations. This is latent error.(16) When a pilot loses control of a plane and it crashes, that is active error. The faulty balancing equipment that causes the pilot to lose control and the faulty testing procedure that fails to isolate an equipment problem are instances of latent error.(17)

The IOM offers a "core case" of medical error to which these terms may be applied:

   A nurse, new to a hospital, sets up a series of three IV-drip machines, the 
   design of one of which is new to her. The anesthesiologist arrives at 
   surgery a bit late--too late to give her set-up anything more than a 
   cursory review. During surgery, through a combination of events involving 
   failure of one of the drips and the anesthesiologist's attempts to 
   understand and respond to that failure, medication begins to flow freely 
   from one of the infusion devices, instead of in metered drips, and the 
   patient receives an overdose.(18) 

This is an adverse effect. It was preventable; the case is thus one of medical error. The error was one of execution--the IV-drip machines did not operate as planned. Leaving aside the question of negligence, we may ask, where shall we locate this medical error?

The IOM wants to persuade us to locate the error in a system, and not simply in a person.(19) The system in this case is the "medication administration system"--the IV equipment, the people, their interactions with each other and with the equipment, the procedures in place, and even the physical design of the surgical suite in which the equipment and people function. The "medication administration system" is riven with latent error: the fact that multiple infusion devices were used, each requiring many steps to set up, thus presenting multiple opportunities for failure; scheduling problems that may have contributed to the anesthesiologist's lack of time; training problems may have contributed to the nurse's unfamiliarity with the infusion devices; the lack of any fixed "checklist" for the nurse and the anesthesiologist to run through; and so on.(20)

And now we come to the core IOM move, the isolation of the active error in the case, the error that "occurs at the level of the front-line operator" and whose effects are felt immediately.(21) The "active error" in this case was--as the IOM puts it--"the free flow of medication from the infusion device."(22)

An ordinary person might guess that the active error was that the nurse didn't set up the equipment properly, or that the anesthesiologist didn't allow himself sufficient time to check the setup carefully enough to make well-informed, quick adjustments to it in the event of an emergency. But no. The "error" was the "flow of medication;" this error "occurs at the level" of the nurse and the anesthesiologist, but their actions are no part of the IOM's description of the error here. Their faulty scheduling and faulty training acted through them--"at their level"--creating an error in the world; unplanned free-flow.

The doctor and the nurse--the humans--do not err in this case; they are merely the instrumentalities of error. Error happens through them. They are the helpless victims of their circumstances; blame does not lie with them but with the systems at whose "sharp edge" they are unfortunate enough to find themselves standing. But, perhaps this is too swift a move. Perhaps there are, in this case, humans who have erred; the medication administration system designers--management.


   In the past the man has been first; in the future the system must be first. 
   --Frederick Winslow Taylor, The Principles of Scientific Management(23) 

The IOM report is not simply an empirical report on medical error, coupled with proposals for that error's elimination. It is also a brief for a certain form of medical management; it speaks, literally, in favor of managed care. I refer here not to the managed care industry,(24) but to the (technological) phenomenon of the increasing subordination of clinical medical practice to scientific managerial principles, whether these principles are developed and applied to clinical practice by physicians or by frontline managers of large health insurance firms. The IOM report, bearing as it does the imprimatur of medical authority, marks an important incursion of contemporary general management theory into medical practice.

American management theory begins with Frederick Winslow Taylor's Principles of Scientific Management.(25) Taylor's ideas transformed American industry, particularly the manufacturing and construction sectors that dominated the economy at the beginning of the 20th century.(26) Taylorite management theory made an attempt to enter 20th-century medicine as early as the Teens and Twenties, when some of Taylor's students--notably Frank Gilbreth, author of the successful memoir (later film) Cheaper by the Dozen--tried to make hospitals and surgical suites more efficient by tinkering with the arrangement of instruments, beds and so on.(27) Taylor's influence on medicine remained minimal in his own era, however. Medicine simply did not involve the repetitive physical procedures that Taylor's approach was so obviously good at optimizing; there was nowhere for the Taylorite college-boys to stand, stopwatches in hand, conducting their efficiency studies. It was not until the managed care revolution of the late twentieth century that Taylor's early-twentieth-century ideas began to work a transformation of American medicine. That transformation of medicine has proceeded in a decidedly more subtle, but no less decisive, fashion than did Taylor's earlier transformation of industrial manufactures. It will be worth examining some of Taylor's central themes and tracing their manifestations in managed care. After this examination the IOM report will emerge as advancing a post-Taylorite view of proper medical management--an incremental improvement upon Taylor, unthinkable without him, parallel with post-Taylorite improvements touted in the general business management literature.

Taylor conceived the goal of American industry as efficiency; the achievement of maximum prosperity through the complete elimination of waste.(28) This achievement, in Taylor's view, involved getting men to do the highest class of work for which their natural abilities fitted them at the fastest pace possible.(29) Taylor imagined that the primary source of inefficiency in the industry of his day was "soldiering" on the part of workmen; deliberate failure to work at top speed. …

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