Theory, Philosophy & Justification for Root Cause Analysis in Healthcare Organizations: Why Bother?

 

The move to conduct root cause analysis is largely motivated by a growing recognition that the complexity of health

care and health care delivery drives the incidence of adverse events uncomfortably and unacceptably high (Brennan

et al, 1991). Consistent with this, the National Patient Safety Foundation (NPSF) maintains as its philosophy that:

 

Most errors result from faulty systems rather than human error, e.g., poorly designed processes that put people in

situations where errors are more likely to be made. Those people are in essence "set up" to make errors for which

they are not truly responsible.

 

Root cause analysis is a set of processes by which the underlying causes of adverse outcomes may be identified,

with the goal in mind of preventing the reoccurrence of such events. There are many different processes by which

root cause analyses are performed; the engineering and industrial risk management literature is rife with arguments

for and against the different approaches. It is not the purpose of this current writing to explore those

differences. Comments pertinent to root cause analyses performed outside the health care industry will not

distinguish among such approaches, but will address as much as possible those areas of commonality.

 

Root Cause Analysis in Health Care. One area of undisputed agreement is the observation that without strong support

by upper management, root cause analyses will be performed in a perfunctory manner, with the singular purpose of

meeting JCAHO regulatory requirements. In order to be effective, it must be accepted throughout the organization

that the result of any given root cause analysis will be for improvement purposes, not for assignation of blame.

This is in keeping with basic philosophy and tenet of continuous improvement in any area of endeavor. Because,

however, root cause analysis has been accepted for some two decades in industries other than health care, the level

of acceptance by management and personnel is much greater in those industries than can be reasonably expected in

health care organizations. Similarly, the value in this analytic procedure is already accepted in other industries

and government, being part and parcel of policies pertinent to Departments of Energy and Transportation, Nuclear

Regulatory Commission, etc. In the health care industry, root cause analysis is for the most part still viewed as

yet another regulatory requirement which is neither value-added nor inexpensive.

 

As a consequence, there is resistance to the performance of root cause analyses, resistance to learning about their

performance, and lack of support at all levels for their effective usage. Lack of familiarity with pertinent

literature from other industries compounds this systemic and generally passive-aggressive though at times actively

aggressive attitude against root cause analysis in all its aspects. Regrettably, a passing familiarity with such

literature will in fact increase the above resistance for two reasons.

 

1. Among health care administrators, the fact that it is not uncommon to spend substantial sums of money on a single

root cause analysis raises the question of cost-effectiveness.

 
2. Among health care providers the emphasis on human error in the root cause analysis literature of other industries

raises the specter of blame, personal financial liability and the National Practitioner Databank, the last having

no equivalent in other industries. Non-practitioners appear to have a tendency to underestimate the real impact of

Databank reporting, as well as practitioners' emotional reactions to possibility of such reporting. In sum, even if

the risk manager and/or continuous improvement personnel at a given health care facility is convinced of the value

of appropriately performed root cause analyses, there are very difficult obstacles to their effective and

acceptable performance.

 

Clearly, education throughout the health care organization is the optimal means by which to address these problems.

There are critical philosophical differences in error reduction in other industries versus the health care

industry. These differences are not universal, but are very common. It has been our experience in discussions with

root cause analysis experts in other industries that these differences are usually not appreciated, and in fact are

at times considered to be antithetical to understanding of how an effective root cause analyses should be

approached and conducted. Significantly and similarly, we have seen no awareness of these differences in the

literature pertaining to medical applications of root cause analysis. These philosophical differences have impact

upon both the process and outcome of root cause analyses. We have identified three basic philosophical differences:

 

■issues of blame, responsibility, and emphasis upon human error,
 
■contributing versus causative factors, and,
 
■degree of efficacy of corrective action or solutions.

It is significant to note at this juncture that the experts with whom we spent the greatest amount of time

discussing these and related issues were representatives of firms offering software designed to facilitate the root

cause analysis process. It is largely their responses which are reflected in the following paragraphs, when

expert's opinions are reported. Regarding the first of these, we offer an assertion made by a prominent expert in

root cause analysis outside of the health care arena, "All sentinel events are the result of human errors that

queue up in a particular sequence." This writer has just guaranteed that any health care provider who reads this

line will adamantly oppose any efforts to institute root cause analytic processes, and has therefore devastated any

provider, any hospital counsel and any risk manager who is trying to gain the trust of his or her provider staff in

such an endeavor. That the above quotation may or may not be accurate is irrelevant of the fact of its extremely

negative emotional impact.

 

That such comments are not uncommon in the root cause analysis literature means that very careful educational

groundwork must be established prior to even encouraging health care personnel to read such literature; reality is

not necessarily good if the recipient has not been adequately prepared to deal with it.

Going further, litigation for sentinel events may result from the root cause analysis in any industry if a

plaintiff secures the product of such an analysis. Personal liability, however, is a far greater risk in the health

care industry than in other industries. Issues of personal fear are correspondingly more prominent. Regarding the

validity of the above assertion, it is interesting to note that Lucian L. Leape, MD, one of the foremost proponents

of root cause analysis in medicine articulates his views thusly,

 

Errors must be accepted as evidence of systems flaws, not character flaws" (Leape, 1994, 1997).

 

In the area of risk management in general: (not limited to health care), James Reason asserts, "Indeed it could be

argued that for certain complex, automated, well-defended systems, such as nuclear power plants, chemical process

plants, modern commercial aircraft and various medical activities (emphasis added), organizational accidents are

really the only kind left to happen. Such systems are largely proof against single failures, either human or

technical....Perhaps the greatest risk to these high technology systems is the insidious accumulation of latent

failures, hidden behind computerized, "intelligent" interfaces, obscured by layers of management, or lost in the

interstices between various specialized departments" (Reason, 1994).

 

Cook and Woods (1994) present four distinct reasons that failures or accidents are attributed to human error,

especially in "complex systems" when in fact this largely constitutes a mis-attribution. Moray (1994) asserts that,

"...the systems of which humans are a part call forth errors from humans, not the other way around."

 

The foremost experts in risk management both within and without the health care industry emphasize system failures

and system-driven errors over direct human error, and the philosophy guiding the process of root cause analysis, be

it manual or automated, should reflect this emphasis. In our research into root cause analysis in aviation,

aerospace, transportation, electronics, security and energy industries, we found a nearly ubiquitous underlying

assumption that causative factors had to be:

 

■necessary and sufficient,
 
■necessary but not sufficient, or,
 
■irrelevant.

Of note is the fact that such rigidity in the rejection of contributing factors is directly contrary to views

expressed by the most recognized experts in the fields of human behavior and risk management (Grandjean, 1980;

Norman, 1981, 1988; Reason, 1990). As Reason eloquently describes, "... a detailed examination of the causes of

these accidents reveals the insidious concatenation of often relatively banal factors, hardly significant in

themselves, but devastating in their combination" (Reason, 1994). A partial solution to an identified root cause is

worth consideration and implementation. It appears to be assumed that any root cause can be either "corrected" or

is "non-correctable," though the exact terminology varied with different consultant writers. Not only would we

challenge this assumption in the health care arena, but we would likewise challenge the assumption in all areas of

application. The difficulty appears to reside with the recognized requirement to monitor the results of any

corrective action implemented. With sentinel events, we are generally discussing very low frequency occurrences,

which means rate of occurrence may be a relatively meaningless metric. Every occurrence is critical, is sentinel,

and anything less than a complete correction is less than adequate, e.g., is perceived by certain of these

consultants and possibly by both internal and external customers to be a failure.

 

This perception belies, however, the underlying philosophy and guiding principles of continuous improvement;

improvements are incremental and ongoing; perfection is targeted, but not attained.

 

Regrettably, sentinel events occur with certain "acceptable" levels of incidence, though for most sentinel events

which result in an actual adverse outcome, even one instance is indeed unacceptable. It is our goal to

progressively reduce the frequency of all classes of adverse events, knowing that many will not be eliminated. This

does not necessarily define a failure. We would argue that this applies within and outside the health care

industry.

 

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Table of References

Brennan, T.A., Leape, L.L., Laird, N.M., Hebert, L., Localio, A.R., Lathers, A.G., Newhouse, J.P., Weiler, P.C., &

Hiatt, H.H. (1991). Incidence of adverse events and negligence in hospitalized patients: Results from the Harvard

Medical Practice Study I. New England Journal of Medicine, 324, 370-376.

Cook, R.I. & Woods, D.D. (1994). Operating at the Sharp End. In Human Error in Medicine, Marilyn Sue Bogner (Ed).,

Hillsdale, NJ: Lawrence Erlbaum Associates, Inc.

Grandjean, E. (1980). Fitting the Task to the Man. London: Taylor and Francis.

Healthcare Risk Management. Sentinel event policy changed, but it's still a 'lawsuit kit' for attorneys. Healthcare

Risk Management, July 1998.

JCAHO (1996). Conducting a Root Cause Analysis in Response to a Sentinel Event.

Leape, L.L., Brennan, T.A., Laird, N.M., Lawthers, A.G., Localio, A.R., Barnes, B.A., Herbert, L., Newhouse, J.P. &

Hiatt, H.H. (1991). The nature of adverse events in hospitalized patients. New England Journal of Medicine, 324,

377-384.

Leape, L.L. (1994). Preventability of Medical Injury. In Human Error in Medicine, Marilyn Sue Bogner (Ed).,

Hillsdale, NJ: Lawrence Erlbaum Associates, Inc.

Moray, N. (1994). Error Reduction as a Systems Problem. In Human Error in Medicine, Marilyn Sue Bogner (Ed).,

Hillsdale, NJ: Lawrence Erlbaum Associates, Inc.

Norman, D.A. (1981). Categorization of action slips. Psychological Review, 88, 1-55.

Norman, D.A. (1988). The Psychology of Everyday Things. New York: Basic Books.

Prager, L.O. (1998). Keeping clinical errors out of criminal courts. American Medical News, March 16, 41-11, p. 1.

Reason, James T. (1990).Human Error. Cambridge, England: Cambridge University Press.

Reason, James T. (1994). Foreword to Human Error in Medicine, Marilyn Sue Bogner (Ed)., Hillsdale, NJ: Lawrence

Erlbaum Associates