Sunday, November 8, 2015

The State of North America Laboratory Quality 2015

The State of North America Laboratory Quality 2015

Earlier this week I was invited to participate in the 2015 edition of Robert Michel’s and Dark Daily’s annual Laboratory Quality Confab held in New Orleans.  I was the third speaker in a symposium on the challenges facing US laboratories.  The lead speaker was Ellen Gabler, a journalist with the Milwaukee Journal Sentinel who had written a number of articles on the questionable quality of what the Commission on Medicaid and Medicare Services (CMS) and the Clinical Laboratory Improvement Act (CLIA) refer to as unwaived tests, i.e. tests that are so easy to perform correctly they require no quality assessment, and on the state of laboratory inspection (accreditation).  [in a nutshell… big glaring problems abound with both].   

The next speaker was Elissa Passiment, the Executive Vice President for the American Society for Clinical Laboratory Science and importantly the head (former) of the Clinical Laboratory Improvement Advisory Committee (CLIAC), the body that reviews activities associated with CLIA and reports to Congress.  Elissa talked about the challenges that CLIA has posed, and continues to pose to US laboratories.  And as she put it CLIA has become a driver to the bottom rather than an inspiration to excellence (Those aren’t quite Elissa’s words, but certainly the sentiment!).

I talked about Quality Partners (a favorite subject of mine) [see: ] , emphasising both their strengths and weaknesses and how laboratories need to progress through the development of Quality Progress Plans, basically a page out of the newly published crown document of organizational quality, ISO9001:2015. 

I thought the symposium went well, although my guess is that it was way over the heads of most of the audience.  While I give them all points for wanting to be at a laboratory quality conference, for 80 percent of the audience this was their first time attending.  More importantly, and without putting too much importance on show of hand displays during conference presentations,  when I asked how many worked in laboratories where they regularly performed internal audits or if they maintained an Opportunities For Improvement list, for both questions I got about a 10-15 percent response.  So their notions about quality are not really yet on the foundations of quality improvement.

Of interest to me, following my presentation, Robert Michel asked me in front of the audience with microphone in hand, how I felt about Canada being a country with provincial control over laboratory quality and would we do better if we had CLIA. 

My response was that it is a tragedy that in Canada our federal government has never engaged in a process, voluntary or mandatory to insist on an across-the-country approach to laboratory Quality, leaving a true hodgepodge mess.  But on the other hand I thank my lucky stars that we do not have to put up with the tired and obsolete mess that the US Congress has made with CLIA.  

 If there is a true and singular tragedy it is that in 1967 the US Congress create a ground breaking approach through the creation of a quality concept, but over time, with the introduction of lobby power over quality power, and political expedience over any interest in patient care, CLIA has fallen from being a force for quality to one of the exact and very opposite.  CLIA today almost guarantees Quality-by-luck rather than Quality-by-design.

Even a quick look at CLIA rules today points to the absence of quality assessment for the vast majority of tests, the absence of any semblance of clinical appropriateness requirements, test acceptability tolerances that one could drive a Mack truck through, and a series of silly regulations about who you can and cannot talk too, or how many times you can or cannot test a proficiency testing sample as if any of that is monitorable or has anything to do with Quality.  What it speaks to is how poor regulations lead to gaming rather than improvement.  

Tired, broken, lack of innovation.  Not at ringing endorsement.

Given the choice, between Canadian hodgepodge and American tired-obsolete, I think if I really needed to have a laboratory test performed today, I would have far greater confidence on the accuracy, quality, and interpretability of the test performed in a Canadian laboratory.

Today we have a new government in Canada with a 4-5 year majority mandate (in other countries we would call that a benevolent dictatorship), and perhaps a new opportunity for a new beginning.  Perhaps this is the right new time to start communicating with my federal government contacts.


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