Understanding
the Laboratory Proficiency Testing Cycle
(External Quality Assessment – EQA)
This
presentation is part 4 of a series highlighting
Proficiency Testing as a Laboratory Quality Partner.
This series is put together by
Dr. Michael A Noble BA MD FRCP the material founder and now retired chair of
CMPT – Canadian (formerly Clinical) Microbiology Proficiency Testing
Program. It is based on his national and
international experience and expertise in Proficiency Testing (PT/EQA). Dr Noble continues on the advisory committee
of CMPT and collaborates with other EQA programs including Oneworld Accuracy
In the previous missive (https://www.medicallaboratoryquality.com/2022/10/understanding-laboratory-proficiency.html) I
introduced my version of the PT/EQA cycle and the Teams that work through the
cycle, talked about the importance of starting and closing every cycle and
event with Quality. It is hard for PT/EQA
providers to promote laboratory quality if they are not prepared to run their own
Quality-Committed-Program (QCP).
For this reason it made sense
to designate the Quality Team as Team 1. But let
it be clear this is first in sequence, in the creation of an effective PT/EQA program ALL the teams are of equal and first priority. A failure in any step along the way results in a failure for all.
This entry is on Team 2: the
Organizer, the Planner, the Research and Development and Production team, which
I think is the most fun. Team 2 is all
about planning and introducing new and changing challenges that are of high
quality and relevant to what is happening today... and tomorrow!
Medical laboratories change
all the time. New analytes get
introduced as do new equipment and reagents.
When Sunderman was looking at laboratories he created challenges for Glucose,
Calcium, Salt, Urea, Protein and Hemoglobin.
Today the battery of tests is in the hundreds. To ensure that laboratories are performing
all these tests correctly PT/EQA has be change and adopt all the time.
Consider for the moment just
one analyte that has consumed medical laboratories, everywhere in the world…
looking for laboratory diagnostic evidence for carriage or infection with COVID
19. In the last 3 years there have been
billions of tests performed, with millions near every month. I suspect that no other laboratory test has exploded onto the world stage in as short a time ever before.
As the demand for test results rapidly increased, the number of laboratories testing for COVID around the world rapidly expanded, with many of the laboratories having little prior experience. Laboratories performing assays at super-human capacity, all over-stretched
and exhausted. The chance that all the
tests results were correct and accurate was zero.
What was so interesting was how rapidly people at large just accepted getting their COVID
test done and assumed that is was always right. The number of positive tests was reported on a daily basis through television and internet. Companies and institutions and governments predicated all sorts of decisions based on the results they
received. With little or no consideration about accuracy or relevance.
For those interested, here is
a short presentation on what happens when tests get introduced too quickly,
before sufficient training can be implemented.
https://cmpt.ca/covid-19-proficiency-testing-one-year-later/
Fortunately many countries appreciated that quality assessment of performance was essential if anything constructive was
going to come from the testing. The
PT/EQA providers need to generate new ways to measure testing performance. They needed to get access of COVID RNA or
COVID spike protein, and other materials.
They needed to figure out how much material was needed for each sample, dilutions,
how long the material would be stable, whether the samples should be pure or
were essential additives required. Would
the samples travel, how long would the last, and many more questions. And they needed to do that all in a very
short time in order to reduce the impact of poor performance. Research and Development in PT/EQA was the
cornerstone of protecting laboratories, patients, families, friends, and the
community.
Putting that together requires
a team of laboratory folk; the ones who see and envision the challenge, those
who plan the strategy to keep relevant and move forward, the scientists who
work through the R&D details, and the ones to take the products of R&D
and create it into a program challenge production. That is the group that I call Team 2.
Personally I love being part
of that team; without it the PT/EQA program loses its relevance and performance falls apart; and worse, without relevant monitoring of
performance, the whole of the laboratory exercise goes will slip back to what Sunderman
was railing against 80 years ago.
More on Team 3 next.
