Previously I mentioned Management Mythbuster by David Axson as a great read. I still support that. But it is important to say that David Axson is not a laboratorian and he did not write the book as a guide to medical laboratory quality. So that creates a challenge; how to find useful information that has applicability across the broad spectrum.
Take the topic of risk.
Medical laboratories carry all sorts of risk. Although Axson does not classify risks in this way, I can, by extension from the chapter, put together the following:
- Patient risk: for example when a test is easy to perform and is repeatable (verifiable) but the test results have no discrimination value to document or diagnose pathology or wellness (not validated). This would also apply to the opposite (validated but unverifiable, or insensitive or non-specific).
- Innovation risk: if a new piece of equipment obtained to perform the test proves to be unstable or unreliable or inefficient. (Another version of innovation risk is when you sink a lot of money into a piece of equipment or assay only to find that the next new-and-improved version comes out two years later)
- Organizational risk: when inappropriate policies get introduced, or the very opposite.
- Community risk: where a procedure or a reagent or equipment can constitute a safety risk to staff or the public.
- Reputational risk: Even in the public sector a black eye is a still a black eye. Think about those jurisdictions that have been tainted by tumor marker or HIV and Hepatitis B or infection control scandals. All too often the reputation damage goes on for years making it tough to get but public confidence or to recruit the staff that you want. And the staff whose names get tied to a mess can pretty much shrink their expectations for an upward career.
- Financial risk: associated with investing in equipment to perform a specific test only to find out that either the test has no interest for users, or there is lots of interest but the insurance bodies decide that the test will not be reimbursed.
- Fiduciary risk: when things go sufficiently wrong to the point where all sorts of bad legal things happen.
- And risk from the unknowns: (Think Donald Rumsfelt – there are the known risks, there are the risks you know but don’t have information, and then there are the unknown unknowns where you don’t know what you don’t know).
Taken as a whole you could argue that taking on new tests and new equipment and new personnel can generate enormous risk, but in my experience many laboratories create all sorts of problems for themselves by being attracted to new tests or procedures based more on the number of bells and whistles than on risk assessment. Business cases rarely take into consideration any acknowledgement or awareness of potential downside risk.
With respect to the unknown and unplanned, Axson writes that bad things happen all the time and “success …is more about how [organizations] deal with the unplanned adverse events than how you execute when everything is going smoothly”.
Axson makes a number of points that I think not only apply to the business world, they apply to medical laboratories as well.
- If you are taking on a new project, try to plan not only for traditional risk, but think also about non traditional considerations as well (reputation, environmental impact).
- Risk management is more about preparation than it is about reaction. If you aren't looking for bad outcomes, then you probably won’t find them until it is way too late. You may not know why problems are developing but if you know the problems are occurring (and increasing?) you can jump into action.
- When bad things happen, success can be much about quickly identifying and correcting bad decisions. Have some sort of contingency plan structure available. Have the courage to admit mistakes and quickly take corrective action.
All in all a fresh new look and an old problem.
Originally written December 26, 2011. Updated July 10, 2012