Sunday, November 6, 2011

Pitfalls to Innovation in the medical laboratory.

I have been reading a new and interesting book entitled HBR’s 10 Must Reads: The Essentials: An introduction to the most enduring ideas on management for Harvard Business Review.  (Harvard Business School Publishing 2011).  I don’t expect it will be on the reading list of most medical laboratory Qualitologists.  Most of it is pretty hard-core profit and loss, but one chapter that I found thought provoking (and comprehensible for a neophyte) is on Innovation: The Classic Traps. 

Innovation is concept of considerable interest to me.  We have built and grown our CMPT Proficiency Testing program around innovation, and are trying to do the same thing with our Program Office for Laboratory Quality Management.  Almost by definition, university-based programs must be engaged in innovation.

There are lots of definitions of Innovation; most agree that it is the process by which new ideas in product, service and process are developed that result in an enriching experience through new or improved products and services with improved efficiency and effectiveness, including greater profit.  The customer may not always be aware of innovation, but either directly or indirectly they always benefit.

“Innovation: the Classic Traps” talks about some of the killers of innovation, such as inappropriate development teams, inflexible budgets and performance reviews, and the expectations that innovation should only focus on major “out-of-the-park” change. 
There have always been medical laboratorians that are interested in innovation and improvement.  My first thought always goes to Bauer, Kirby, Sherris and Turk for developing and standardizing disk-diffusion method for antibiotic susceptibility testing some 45 years ago.  The Kirby-Bauer assay allowed laboratories large and small to detect antibiotic resistance that otherwise would have been missed.  Their simple assay changed the diagnosis and treatment of infectious diseases world wide.  I have always been astounded that the Nobel Prize committee has overlooked the significance of their work.

But anyways, all this thinking about innovation got me reflecting upon changes that have occurred in medical laboratories over the years.  There is no doubt there has been a lot of positive change.  Better environment, better staff safety, faster test turnaround, and better standardization.  Some of this has been the result of newer safer equipment, and more consistent reagent quality.  A lot more is due to better knowledge and competence levels of staff.  Progress has not been in a straight line, or always positive and we still make far too many errors.  Quality partners have contributed more to the positive than to the negative. 

Like most profession groups we have learned through trial and error about what we do well, and what we don’t.  I present four pitfalls to innovation and positive change.

1: Don’t fool around with Quality Control. 
A common, recurring idea is that laboratories can be innovative and save money by fiddling with reagents and quality control.  If we reduce down the control on reagents, we will speed up the testing process and save money to boot.  This is a genuinely dumb idea.  Lots have tried, and all have failed.   More money gets lost on poor quality when tests results have to be stopped, or worse, recalled because the checks on equipment and reagents were reduced or stopped.  Any changes that you introduce to save time or money are far more likely to make things far, far worse.

2: Inventing your own procedure is rarely successful and never appropriate.
We do this all the time (including me!).  We dream up a new assay, or a modification of an old assay, and put it into operation without actually validating that the new procedure provides appropriate and meaningful information.  It’s all very satisfying to the inventive part of the soul, but creating bogus and uninterpretable information is never a good idea.  For me it was a type of time-kill modification to the serum-cidal assay.  (Clinical microbiologists with 25 years of experience will be the only ones that will know what I am talking about). 
ISO 15189 is very clear about the dangers of introducing un-validated tests.

3: Bells and Whistles are not innovations.
Laboratory equipment has a long track record of introducing “new” advances that solves one problem and creates another, all too often resulting in either a net zero, or sometimes a negative score, usually all done using public monies.  It always seems like a good idea (“everybody has one.  If we don’t get it we will be left behind”) until the new problems start to emerge.  It is another example of the FAD-FADE-FAIL or FAD-FAIL-FIND curve (see MMLQR Quality Anxiety)
It is no wonder that hospital administrators have trouble with laboratorian credibility.

4:  Arrogance is the innovation killer.
Actually there are tons of good ideas that get created in medical laboratories all the time, but most of them get killed or lost because of process.  Usually they come from the hands and heads of bench technologists who see ways to improve the “official” SOP.  Sometimes these “a-ha” moments can lead to major improvements, but more times than not they get stifled.  Usually they don’t tell anyone because they know they will be ignored or worse.  Usually the improvements stay underground until someone finds out that they are not following the SOP. The problem all too often is poor laboratory communication that only goes top-down.  

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