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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