One of my passions over the last
35 years has been laboratory proficiency testing (PT aka External Quality
Assessment or EQA).
PT/EQA is a requirement for
all laboratories that are accredited to CLIA requirements, mainly in the United
States and ISO15189:2012 almost everywhere else. This is because PT/EQA programs provide
objective, measurable, and reportable information on the Quality, Competence
and Performance of laboratories in all disciplines. In this broader context PT/EQA addresses the
need of laboratories including but cerrtainly not limited to water and food
testing, ore sampling, cement composition and compression, and industrial dyes,
and ship steel.
That laboratory workers are
required by regulation and standard is interesting. I suspect they are the largest group of
workers in the world of whom it is required to have regular quality assessment testing
in order to demonstrate performance competence.
There are few other groups that are monitored in this way, such as
airline pilots, police (gun practice), and I think, bus drivers. It is interesting and I think significant
that physicians, nurses, teachers, lawyers, judges, dentists, and car
mechanics, and scientists have no such requirement. Once they finish their final training
examination, there are no more required objective measures unless they choose
to take a new course, or do a refresher course.
ISO/IEC17043:2010 the Quality
and competence standard for proficiency testing providers, it is interesting to
me that there is the following: “The need for ongoing confidence in laboratory
performance is not only essential for laboratories and their customers but also
for other interested parties, such as regulators, laboratory accreditation
bodies and other organizations that specify requirements for laboratories”.
So my point is that
while PT/EQA may be performed by the laboratory, an essential reason that happens is so that their customers and interested
parties can be confident they take Quality seriously.
A number of years ago during a
laboratory conference I raised some questions about what laboratories do with
our Annual Certificate of Participation from our CMPT proficiency testing (PT/EQA)
program. Without going into details, the
collective opinion was that (a) the Certificates were important to the
laboratories and (b) most laboratories (I was surprised about this!) posted
their certificates, usually framed, usually in a common area within the
laboratory confines, where technologists and pathologists and scientists could
view the certificates. A small number of
laboratories posted the certificates in public areas, such as the Patient
Waiting Room.
While for the most part, these
were results better than I expected, I also saw this as an example of opportunity
lost, because most of the laboratories were missing the opportunity to promote their
Quality monitoring to a critical audience.
While it is nice that laboratory staff can see the affirmation they need
about their Quality focus, the public, in most facilities gets no exposure or
awareness to the information.
In the “olden days” laboratory
competence and quality was self-assured on little information. (Of course we are a quality laboratory. Our
laboratory is run by the finest scientists.
They would never make a mistake.
TRUST me!, trust ME!). Today we
appreciate how empty and self-serving that was.
In today’s reality “trust me” doesn’t cut it. Put up or shut up.
Today, laboratory tests have
become increasingly more sophisticated, and often critical decisions are made
solely on the basis of test results.
Often there are no correlating physical signs to support or reject the
test result, until it is too late. (think
antimicrobial resistance or tumor drug resistance).
If the laboratory gets it
wrong, there can be consequences that ripple through the patient, the
physician, the community and the public.
So Proficiency Testing
Providers primary function is to DEMONSTRATE or ASSURE the community and all interested
parties that the laboratory can be trusted to be proficient and competent, not
based on inappropriate trust, but on OBJECTIVE, MEASURABLE, REPORTABLE EVIDENCE.
PT/EQA Providers should be much
more active in advising / informing the public that they provide their services
as a way to advise laboratories when their assays are not properly, as a way to
protect the public. I am not saying that
PT/EQA providers can or should be public whistle-blowers or be in the business
of pointing fingers at laboratories that are not fulfilling their professional
duty, but the public does need to know that their confidence in the health
care is supported by objective measurable evidence.
Laboratories are better off
when they can say “of course we are a quality laboratory. Our laboratory is run
by the finest scientists, all of whom are closely monitored for their
performance and competency on a regular and repeated basis. You can have confidence because we have
confidence and we have the evidence to back that confidence up.”
And that brings be back to my
story of several years ago, and let me suggest that laboratories these days could
go a long way to better strengthen their trust and credibility, I understand
that this is a very small part of the exercise, but instead of putting their Quality
Assessment certificates where they can be seen only by laboratory staff, but
rather where they can be seen by patients, physicians, and administration.
And PT/EQA providers need to make a
much bigger issue of their role in protecting the integrity of the
laboratory in specific and healthcare in general. We need to remind ourselves up front that
laboratories’ clients are our customers too. Yes we are science guys, but we are also Public Guardians.
And perhaps the time is coming
that physicians and nurses and lawyers and teachers and scientists need to step up to the
plate of regular Quality Assessment for continual improvement.
It has to be better than TRUST
me, Trust ME!!