Monday, November 5, 2012

CMPT at the crossroads.

In many ways health care is only recently awakening to the notion of Quality Management.  For reasons interesting, despite many false starts, the publication of the Institute of Medicine’s To Err is Human, finally struck an accord that sparked the whole of the Patient Safety movement, and with it, increasingly active awareness in Quality as a backbone structure of health organizations.  

That is not to say that Quality was absent from all aspects of health; indeed there were some early pockets of success.  Medical laboratory Quality Control and Quality Assurance has a long but hushed history going back through the 1930s and forties with the creation of Levey-Jennings Quality Control charting (llearned from Shewhart), and the development of proficiency testing, having grown from the ground breaking studies published by Belk and Sunderman in 1947, and followed by the introduction of accreditation by the College of American Pathologists a few years later.
Over the past 60 years we have seen a lot of changes in structure and process in the Quality instruments.  Take proficiency testing (PT/EQA) as an example.  In his early studies, Sunderman demonstrated a sad and embarrassing lack of laboratory testing consistency, although to be fair, the materials that they were using for challenges was pretty iffy.  The group of colleagues created samples for interlaboratory testing using serum or water and whole blood but with no regard for production or transport or standardization.  

That is not said as fault.  What we know now was spawned from studies that followed these early days.  Had the group in Philadelphia not started, we would not know what we know today.  

Since those days, the breadth and depth and science and technology of PT/EQA has grown by leaps and bounds.  As laboratory recognition, mainly by accreditation, became the norm, the number of laboratories requiring PT/EQA samples grew dramatically, as did the number of programs.  From my perspective this was generally not a competitive program versus program exercise.  In Canada all the programs worked pretty much together, sharing technology and ideas.  

For about 20 years we saw more surveys with more sophisticated challenge materials.  As one of my colleagues has said, you may not ever get rich from EQA, but you will always be interested in what you are doing.

Change started in the mid-1990s as laboratory closure and consolidation started to appear.  At first as a trickle, and then as a flood, the number of laboratories shrunk dramatically, in some areas by as much as 75 percent.

To give a positive spin, the last 15 years or so created a huge opportunity for creative and innovative thought.  How do you continue to meet the needs of the consolidated larger laboratories, knowing that the point of consolidation was to reduce budgets, and continue to keep the programs viable.  

Some groups have successfully expanded their outreach internationally, others have changed their own funding model.  And others, decided that it was time to find other activities to get involved in, and the PT/EQA component stopped.

For CMPT we went through a complete transformation exercise.  First and foremost we adopted a better organizational model through Quality Management and certification to ISO9001.  With that in place it became easier for us to set annual goals and objective for planned revision.   We worked a lot at communicating with our participants to get their input (Call that Customer Satisfaction).  We worked with new challenge targets to expand the breadth of our service and we focused a lot of energy on becoming more adept at making highly stable multi-purpose clinically simulating challenge materials, not only for our own program, but also for others.  We focused a lot of attention at building up a library of materials, and a reputation for solid educational materials.  We got into developing training programs for PT/EQA programs in other countries so that we could have a network for collaboration.  

Now it seems that the authorities’ need to consolidate has reduced, at least for the moment, and some of the pressure may be off.  

But now 30 years CMPT is a stronger and more effective and confident member of the PT/EQA community.   Our Quality Management infrastructure will remain in place, with increasing focus on Quality and Service and Excellence.  We will continue to focus on innovation (and perhaps some dimension of invention).  We will be making some bold moves toward more and stronger laboratory participant participation. 

What will the laboratory Quality field look like as we go forward; less conventional testing, more Point-of-Care, more outside-of-mainstream testing, more home-brew rapid change assays?  Will PT/EQA be a part of this, or will we devolve into a runt program serving a diminishing infrastructure.  Only time will tell. 

For the best answer, put in your calendar to check my blog in 2042.

But in the meantime, to look at where we are now and what we are doing now, please visit us at:

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