Monday, December 17, 2012
Risk Benefit analysis in the Medical Laboratory
A few years back I was involved in the writing of an ISO technical specification on the role of Risk Management in the medical laboratory. The thesis of the TS was that managing Risk interfaced with Quality Management principally through Preventive Action. By examining for potential events before they occur, adverse events can be prevented or at least contained. I still think that is true. Although the revision of the document will point out a much broader view of what constitutes Risk in the medical laboratory, the core of the link will be through preventive action.
One of the major tools that is used in Risk Assessment is an Occurrence – Outcome grid, where a potential event is either qualitatively or semi-quantitatively assessed from never occurring (0) through to always occurring (100) . The contrasting concern assesses outcome from never significant (0) through to potentially fatal (100). The point of the exercise is to determine the controls and the degree of risk aversion or avoidance or tolerance need to be considered and applied with regard to the event. This sort of tool can be used in a variety of situations that could potentially have an adverse effect on the patient, the clinicians, the staff, the laboratory or the community.
An important characteristic and perspective of that approach is its singular view that outcome falls on a negative gradation, which starts at neutral (no impact) and goes to bad and then to worse.
But as I read and think about risk and the medical laboratory I see one variance between the traditional view of medical laboratory risk and risk literature. In risk theory and in its applications to finance, to innovation, and to discovery, there is an also a positive side to risk, which is on the risk-reward side.
Consider in the world of gambling and investment. One looks at potential outcome as either leading to profit or loss, and weighs the balance of circumstance and evidence and comes to a decision. Either the potential benefit is worth putting money on the line or it is not, and through to a certain point, the greater the potential benefit, then the more that the person is prepared to risk. At a certain point either the opportunity for benefit is either so low or the likelihood of major success is so small that the exceeding a level of risk is no longer rational or appropriate. Consider the common phrase: if a deal seems too good to be true, then it probably is.
And so I have to ask, is there a place in the medical laboratory where Risk and Quality come together where the potential positive side of Risk and Benefit comes to play? It seems intuitive that the right answer is clearly “no”.
Many would agree that over the last many years hospitals have had policies that say that the only level of acceptable risk is risk aversion, where there is absolutely no tolerance for any level of risk. An outcome, even with a frequency of 1:10,000,000 is unacceptable. That clearly has not been a workable or financially viable policy.
What makes more sense is to make a measured, objective calculation of tolerable risk where patients are protected, perhaps to an arbitrary risk of perhaps 1:1,000,000.
But to get back to the question at hand, the health care system, and the laboratory in specific cannot and must not make risk-reward decisions that provide benefit to the hospital or the laboratory or the laboratorians that may put patients at risk of harm which would include the risk of faulty diagnosis.
Similarly in a public pay health care system, one should similarly argue that the hospital should not be making decisions that put public money at risk for loss if the benefits accrue only to the health community. We see that often enough in the news when people get caught. The newspaper calls that abuse of public office, and people sometimes can go to jail. (In Canada we have seen a really good example of this in area of building Electronic Medical Records systems.)
But let me argue that there are situations, such as implementing green energy systems, or error tracking systems, or high efficiency operating rooms to allow for more laparoscopic or other accepted minimal invasive surgical techniques that have the potential of resulting in better or improved service.
Given an option I prefer this to be part of the private care system when the owners and decision makers carry the liability of poor outcome, but the reality is that at a certain point in the public system, there needs to still be an institution that has to go first.
I think that the point that I am trying to make is that in my experience, many institutions make arguments more by impression than by calculation of measured risk. Measuring risk in most situations is an exercise to reduce error and negative outcome. But sometimes, risk can be a positive concept where the point of the laboratory and the institution can benefit from positive reward.
A standard on medical laboratory risk needs to recognize and address both sides of the topic,