Monday, May 30, 2016

Innovation and the Modern Medical Laboratory 2016

A number of years ago I was invited to give a presentation on Quality practices for the research laboratory.  I recommended at good practices would include (1) adherence to established standards (2) Calibrate your equipment regularly (2) strict adherence to quality control (3) ensure that graduate students are properly trained and competency assessed before performing assays (4) where feasible work with a partner laboratory or participate in existing applicable proficiency testing programs to ensure that your procedures are working properly and (5) on a regular basis arrange for some form of external assessment.  

A senior person at the presentation said that he was very successful in funding awards, and never did any of those steps.  

Is it any wonder that only about 10-30 percent of published research is reproducible (see: August 2013).

I raise this story because it relates to a recent threat on LinkedIn by the ASQ “What Do you think? Is Quality shifting to be the Driver of Innovation? .  I have previously commented that Quality is not so much the driver of Innovation, but may be making Innovation better.

Medical laboratories are largely populated by folks who are creative by nature, and always ready to try out something new.  Sometimes it resembles innovation by distraction by the shiny bauble.  But most of the time it is about a self-driven desire to tweak existing processes, as in “if I do this”, I bet I can make this assay easier, or faster, or better.  


The reality is that usually, the assay is not improved, and sometimes it is made worse.  At the very least what happens all too often is that even critical basics of accountable change do NOT occur.  There is little or no verification that the changes result in consistent values, or validation that changes don’t have unsuspected impacts due to age, gender, medications, or geography.  A few studies get done, some basic statistics are generated, and off we go.  We have another new Laboratory Developed Test (LDT) that gets presented as an abstract at a meeting, or gets published in a journal, and everyone is happy, except maybe the clinician who gets a wrong test interpretation, or the patient that gets put on a wrong treatment track.  


Stories come to mind.  The first is the tragic story of misinterpreted test results for her2 (breast tumor responsiveness to the drug Herceptin) that resulted in patient mistreatment and death and led to the hugely expensive and public Cameron Commission in Newfoundland.  


Over recent years, medical laboratories have been galloping forward creating new tests to find new information, largely based on new molecular (i.e. DNA based) assays in the disciplines of genetics, and detection of microbial pathogens of all sorts.  


New laboratory ideas are being generated on a daily basis and new procedures are being created almost as quickly, most commonly using DNA strands that are created in-house.  Laboratories often do a side-by-side comparison of the information generated by the “standard” test, and if the new assay is pretty much in line with the standard assay, then the transition is made.  And if there was not previous assay, but the test worked for other targets, and it seems to work well here, then that is good enough evidence to go forward. The result of this is more tests, more results, new knowledge, and better and faster patient information. And some of the information is very good and very helpful. 

The problem of course is that sometimes results don’t quite go as planned. 


In our Quality course we talk about Quality Partners helping laboratories advance their Quality improvement.  But we point out that the impact of the partners on laboratory performance pales in comparison to the power of an unhappy public who gets fatigued with new ideas bad outcomes and demands something with a lot more rigor.  Today it is the US Food and Drug Administration (FDA) that has made it really clear that the day of free-reign LDTs is over, at least in the US.  The sheriff is going to be laying down some new rules.  If laboratories are not going to discipline themselves, the gov’ment is going to do it for them. 

Needless to say lots of laboratories are unhappy.  Definitions are being made that may or may not work well.  Restrictions are being imposed, and delays are inevitable. 

Gee whiz.  What did they think was going to happen?  When you upset the public enough, you have little control over what happens next.  

But just to be clear, medical laboratories are not the only organizations that have fallen into the rush to innovation trap.  Think Theranos. 

Without going too far into the story (you can read it everywhere and anywhere) this was a new-tech company that figured they could revolutionize all blood sample testing; less blood, easy collection, faster results, simpler testing, better than the best sliced bread.  Going to revolutionize and take over the laboratory industry.

If only it had worked, which it turns out it did not.  And now there are enough bad outcomes to bring in the gov’ment and the lawyers.  It is going to be a very ugly summer for Theranos.


There are tons of opportunity and need for research and improvement and innovation in the medical laboratory arena. But there are some basics (PDSA and basic quality management come to mind) that would increase the odds for success.  

There is always a need for new ideas and improvement, and some basic application of Quality Management would go a long way to move the needle in the right direction.



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