Posted by Sten Westgard
While Dr. Westgard has given a thorough update on the status of EP22 and EP23, as presented at the AACC/ASCLS conference in Washington, DC, and Dr. Jan Krouwer has done the same on his own blog, I thought it worth beating the dead horse on this.
Dr. Jan Krouwer was there at the presentation and asked perhaps the most important question about EP22 since it was created. Is the FDA going to review the Risk information created by manufacturers about their instruments?
I think the answer was somewhat nuanced and subject to interpretation. According to Dr. Krouwer, he heard that the FDA would review EP22 Risk information, but only superficially, and "only egregious problems would be flagged by the FDA."
Basically, I heard the same thing, with a slightly different interpretation: the FDA isn't really going to review the Risk information when the device is first submitted to them. But retrospectively, it might review them very thoroughly. Since the FDA has authority over labeling and branding of medical devices, if it turns out that some of the risk information from a manufacturer is incorrect, inaccurate, or misleading, than the FDA retains the power to sanction the manufacturer.
In other words, manufacturers have the right to remain silent (i.e. don't produce any Risk information, since EP22 is voluntary), and anything they say (i.e. the EP22 Risk information) can be used against them in a court of law.
Call it the Manufacturer's Miranda Risk Rights.
In the absence of a legal mandate, I don't see why any manufacturer would willingly create this Risk information and distribute it to their customers. Any corporate lawyer will be advising against it (liability exposure). Any marketer will argue against it (if our competitors aren't saying they have residual risks, why do we need to do so?). Any executive will oppose it (why are we exposing our weaknesses to our competitors and our customers?). And that's the just the internal opposition this will face.
Certainly, I believe disclosure of Risk is the right thing to do, but the competitive and legal environment are not going to be receptive to it. Unless customers overwhelmingly demand this information, manufacturers will have no incentive - and many disincentives - to produce Risk information.
As Dr. Krouwer laments, there is a lot of good work in the EP22 and EP23 guidelines, but because of the toxic environment, these standards are likely to be stillborn.
Yet another sorry milepost in the story of EQC, AQC and Option 4.
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posted by Sten Westgard
Yes, the Westgard blog is back.
Regular visitors will remember that back in 2006, Westgard QC dipped its toe in the blog water, but after a dozen or so postings, the blog went silent.
It turns out, the technology we were using to run the blog was not that robust or user-friendly. And it was particularly vulnerable to SPAM, with hundreds, if not thousands, of scripts attempting to comment on the blog with links to frightening websites. That forced us to be very strict on comments so we could be certain only genuine comments could go through. The combination of these problems meant that the blog was really not usable for our purpose. We ceased posting but kept it barely alive. The revamping of the blog went on the To-Do list. Unfortunately, that list was so long it took a few years to get done.
Now, we're using a better blog platform, with more capabilities and features than before. This should allow better posting, better commenting, less SPAM, and easier navigation. (Also note, the previous posts from the old blog have been transferred over, so you still have access to the content.)
The blog is always going to me an adjunct to the main westgard website, www.westgard.com. But we'll use this to point to new articles and events, as well as make shorter comments and points about topics of interest to the laboratory community. There are a lot of issues and news stories that warrant a short note, but aren't really worth an entire essay.
In short, we hope that we'll be able to post more stuff and do it faster.
Thanks for your continued readership of the website and the blog. We hope we can continue to improve its offerings.
Don't forget to make your thoughts known in the comments.
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Originally posted on August 8th, 2006
One last report on the AACC/ASCLS conference.
What
do you get when you combine techno music, pulsing neon light, flashing
LED badges, Lance Armstrong-style rubber wristbands, a free buffet, and
five open bars?
Labs Are Vital. The Abbott launch of a truly important initiative.
Jeffrey R. Binder, President of Abbott Diagnostics and Senior Vice
President of Operations for Abbott, announced a new program to address
the biggest problem facing the healthcare laboratory: the coming
shortage of qualified laboratory workers.
In the last 25 years, more than 600 schools and university programs for
medical technology have closed. In 2012 we will need 138,000 laboratory
scientists, but at best there will be 42,000 available. (source)
Why? Low salaries for workers mean less interest in the profession.
Worse still, the schools and programs face high expenses. Providing
instruments and other devices necessary to properly train technologists
is not cheap.
Here's where Labs are Vital comes in. At this event, Abbott announced a
new $1 million dollar donation program - schools and programs can apply
for free instruments, reagents, and service. AACC past president,
Stephen Kahn, PhD and Bernie Bekken, President of ASCLS, were present
to welcome this new effort.
It's good to see that Abbott recognizes a critical reality: While
Abbott may be comfortably profitable, their future profits are in
jeopardy if there aren't enough workers to run their instruments. Not
only do the schools need to be supported, but the profession itself
needs to be supported. Labs and lab workers need some better public
relations - and they need to get out of the basement. In the
increasingly cost-stressed healthcare system, the anonymous role of the
laboratory worker means out of sight, out of compensation. Labs Are
Vital hopes to raise the profile of the laboratory worker and make more
of them.
Abbott noted that the Labs are Vital program would be non-branded and
invited participation by other diagnostic companies. This part is key.
For any real initiative to succeed, it can't simply be a marketing
effort by a single company. It's an easy PR move for a company to make
a donation. But if the initiative is strongly identified with just one
company, there is less incentive for other companies to participate.
How will the other companies react? Will they join the effort? Will they create their own? We'll see.
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Originally posted August 7th, 2006
One of the more significant milestones passed at the AACC/ASCLS
conference was the 30th year of the "Concepts and Practices in the
Evaluation of Laboratory Methods" workshop. This workshop, taught by
Carl Garber, PhD, R. Neill Carey, PhD, and David Koch, PhD, is now the
longest continuously taught workshop at the conference.
An article celebrating this anniversary was in the Monday "Convention Daily" of Clinical Laboratory News
(Title: Workshops Offer Participants New Lab Tools and Skills:
Instructors of 'Evaluation of Laboratory Methods' Mark 30th Year').
Unfortunately, the article is not available online (yet), so I will
quote a short passage where Neill Carey and Carl Garber talk about the
'early years' of the workshop:
"'At the time, what we were suggesting was a fairly new concept,' Carey
recalled. 'Before that point, people hadn't talked much about making
decisions on the acceptability of methods based on measuring errors.'
Garber explains that their workshop has always been intended to provide
practical advice for laboratorians on the use - and the misuse - of
statistics. 'Our focus has consistently been on clinical significance -
where the rubber meets the road,' he said 'Through the years we've
tried to help our colleagues better understand what the clinician
requires in terms of allowable error and variation on a test result.'"
I worked with Carl and Neill and David when they worked at the
University of Wisconsin Hospital and Clinics in Madison. They are
a part of that "Wisconsin mafia" that has helped keep quality and
statistics at the center of laboratory testing. I must also admit I had
a hand in developing this workshop, too. We published a series of
papers in the early 1970s on the "proper use of statistics in
evaluating methods" and presented them in a workshop in 1976 at the
American Society of Medical Technology. The next year, 1977, I was
heading over to Uppsala, Sweden, for a sabbatical (where my interest in
QC would begin and where the "Westgard Rules" would be developed). I
recommended that Carl and Neill take the workshop to the AACC
conference (David Koch would join them in 1982.). And they have taught
that workshop ever since.
Over the years, they have applied continuous improvement to their
Method Evaluation workshop, modifying, updating, and adding material.
The workshop, now part of the new AACC University, is a tightly packed
four hours that includes not only the basic statistical studies for
method validation, but also Six Sigma, CLIA regulations and CLSI
guidelines. There's probably no other workshop that is so stuffed with
information. If you ever get a chance to come to the AACC conference, I
highly recommend attending the workshop. You'll learn a lot - either
something new or something you've forgotten.
What they've accomplished is the long distance marathon of conference
programming. Few people would have the stamina, diligence, and
determination to make a fresh presentation every year on this important
topic. But Carl, Neill, and David have done it and I hope they continue
to do it for decades to come.
So congratulations again.
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