A number of years ago I was
invited to give a presentation on Quality practices for the research laboratory. I recommended at good practices would include
(1) adherence to established standards (2) Calibrate your equipment regularly
(2) strict adherence to quality control (3) ensure that graduate students are
properly trained and competency assessed before performing assays (4) where
feasible work with a partner laboratory or participate in existing applicable
proficiency testing programs to ensure that your procedures are working
properly and (5) on a regular basis arrange for some form of external assessment.
A senior person at the
presentation said that he was very successful in funding awards, and never did
any of those steps.
Is it any wonder that only
about 10-30 percent of published research is reproducible (see: www.jove.com August 2013).
I
raise this story because it relates to a recent threat on LinkedIn by the ASQ “What
Do you think? Is Quality shifting to be the Driver of Innovation? . I have previously commented that Quality is
not so much the driver of Innovation, but may be making Innovation better.
Medical
laboratories are largely populated by folks who are creative by nature, and
always ready to try out something new.
Sometimes it resembles innovation by distraction by the shiny
bauble. But most of the time it is about
a self-driven desire to tweak existing processes, as in “if I do “this”, I bet I can make this assay easier, or faster, or
better.
The
reality is that usually, the assay is not improved, and sometimes it is made
worse. At the very least what happens
all too often is that even critical basics of accountable change do NOT
occur. There is little or no verification
that the changes result in consistent values, or validation that changes don’t
have unsuspected impacts due to age, gender, medications, or geography. A few studies get done, some basic statistics
are generated, and off we go. We have
another new Laboratory Developed Test (LDT) that gets presented as an abstract
at a meeting, or gets published in a journal, and everyone is happy, except
maybe the clinician who gets a wrong test interpretation, or the patient that
gets put on a wrong treatment track.
Stories
come to mind. The first is the tragic
story of misinterpreted test results for her2 (breast tumor responsiveness to
the drug Herceptin) that resulted in patient mistreatment and death and led to
the hugely expensive and public Cameron Commission in Newfoundland.
Over
recent years, medical laboratories have been galloping forward creating new
tests to find new information, largely based on new molecular (i.e. DNA based)
assays in the disciplines of genetics, and detection of microbial pathogens of
all sorts.
New
laboratory ideas are being generated on a daily basis and new procedures are
being created almost as quickly, most commonly using DNA strands that are
created in-house. Laboratories often do
a side-by-side comparison of the information generated by the “standard” test,
and if the new assay is pretty much in line with the standard assay, then the
transition is made. And if there was not
previous assay, but the test worked for other targets, and it seems to work
well here, then that is good enough evidence to go forward. The result of this
is more tests, more results, new knowledge, and better and faster patient
information. And some of the information is very good and very helpful.
The
problem of course is that sometimes results don’t quite go as planned.
In
our Quality course we talk about Quality Partners helping laboratories advance
their Quality improvement. But we point
out that the impact of the partners on laboratory performance pales in
comparison to the power of an unhappy public who gets fatigued with new ideas bad
outcomes and demands something with a lot more rigor. Today it is the US Food and Drug
Administration (FDA) that has made it really clear that the day of free-reign LDTs
is over, at least in the US. The sheriff
is going to be laying down some new rules. If laboratories are not going to discipline
themselves, the gov’ment is going to do it for them.
Needless
to say lots of laboratories are unhappy.
Definitions are being made that may or may not work well. Restrictions are being imposed, and delays
are inevitable.
Gee
whiz. What did they think was going to
happen? When you upset the public enough, you have little control over what happens next.
But
just to be clear, medical laboratories are not the only organizations that have
fallen into the rush to innovation
trap. Think Theranos.
Without
going too far into the story (you can read it everywhere and anywhere) this was
a new-tech company that figured they could revolutionize all blood sample
testing; less blood, easy collection, faster results, simpler testing, better
than the best sliced bread. Going to
revolutionize and take over the laboratory industry.
If
only it had worked, which it turns out it did not. And now there are enough bad outcomes to
bring in the gov’ment and the lawyers.
It is going to be a very ugly summer for Theranos.
There
are tons of opportunity and need for research and improvement and innovation in
the medical laboratory arena. But there are some basics (PDSA and basic quality
management come to mind) that would increase the odds for success.
There is always a need for new ideas and improvement, and some basic application of Quality Management would go a long way to move the
needle in the right direction.
