Sunday, November 24, 2013

Quality and Risk Management

Introducing Rational Risk

I was invited to give a presentation at the Biomedical Standards eXchange 2013 meeting sponsored by the Singapore Standards Council.  The meeting was held in conjunction with our International Organization for Standardization (ISO) meeting for Technical Committee 212.  As opposed to the ISO meeting, the eXchange was well organized, and provided a lot of interesting information that would likely form the basis of some future action.  [The ISO meeting was pretty much the opposite.] 
I was invited to give a presentation on the application of Risk Management for the medical laboratory.  The sub-title for my presentation was “Reducing Risk through Application of Standards”.  For those interested, the presentation slides will be available at by November 27, if not sooner.

The message from my presentation was not a traditional Risk Management message, but I think it was both realistic and appropriate, and therefore an effective message for medical laboratorians.  

I started with some basics from Frank Knight that Uncertainty is made of two components; measureable uncertainty (“risk”) and the unmeasurable component (the unknown unknowns).  I argued that in controlled situations, like manufacturing, one can expect to considerably reduce uncertainty variables (measureable>>unmeasureable), but when one thinks of all the variation associated with patient selection, test ordering, sample collection and transport, the unknown unknowns in medical laboratory testing are huge and the relationship is likely inverted.  

Then I introduced observations from medical laboratory error investigation which indicate the large impact and frequency of testing slips.  Game and Chaos theories say that all events have a cause and effect, but often the cause is unrecognized.  Causes may be unproportional, meaning that seemingly trivial causes are associated with major effects (downstreaming). 
My main argument was that while there is a role in using risk management tools to reduce bad outcomes, at the same time, we have to acknowledge that until many other control issues come to play in the medical laboratory, one needs to understand that the goal is to reduce risk of bad events rather than prevention. 

We are more likely to achieve success through the application of outcome oriented risk management tools (such as severity-occurrence grids) than we would with a static precision tools (like Failure Mode – Effects Analysis or FMEA).     

I demonstrated how to set up an S-O grid, and how to use one for setting priorities and further how an S-O grid helps in implementing risk mitigation strategies.  

I think that was a helpful message, and it seemed to be well appreciated.

I also pointed out a risk strategy flaw in ISO 15189:2012.  As good as this standard is it introduces risk management as a way to reduce error soley associated with patient safety.  That is a good message, but does not go far enough.  Risk in the medical laboratory has a much broader footprint than just patient safety.  We also have risks that impact clinical staff, laboratory staff, the community, the environment, and the institution.  Setting up risk reduction without taking these issues into consideration would likely leave the laboratory with all sorts of liability issues.  

One of the other speakers, coming from the cosmetic industry, also talked about risk, but from another perspective.  He introduced the following formula:


His point was extremely relevant to the microbiology laboratory.  Just because E. coli can produce exzymes and toxins and can cause infection (all examples of inherent hazard), this does not equate to risk level because exposure effects are moderated by handwashing, containment, packaging, laboratorization, antimicrobials, etc, etc, etc.  

The formula is critical in recognizing and understanding the differences between risk perception and risk reality.  It is the key issue that should distinguish the general public from what should be the knowledgeable public [politicians, regulators, biosafety officers].  

All too often, it seems that “knowledgeable public” see a microbial name and then based on that information alone make all sorts of inappropriate assumptions and judgements about risk to public, many of which are just wrong.   

Recently I tried to have a discussion on the subject with one of our Canadian transport regulators, who was clearly incapable in understanding the concept.  Too busy first protecting her right to write regulation to make sure that the regulations were rational or appropriate.  

  Write before being right.  

It was disappointing and sad comment on the ability and mindset of what should have been a responsible professional.  Tragic.


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    1. Many thanks. I really enjoy the topic and I love writing about it


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