The KHIT Blog: ASQ webinar on Covid19 assay QA

Monday, May 18, 2020

ASQ webinar on Covid19 assay QA

Better late than never. These new coronavirus tests have been rife with error.

PROGRAM OVERVIEW

Testing is dominating our conversation during the current Covid-19 crisis as we think about reopening our economy. FDA has rapidly authorized nearly 100 different tests for emergency use to help detect, diagnose, and treat the infection caused by the novel coronavirus. There is widespread concern about the quality and reliability of these tests because of the perception that the FDA has relaxed the normally stringent requirements for performance validation.

In this webinar, the focus will be on recently authorized serology tests for the detection of antibodies and review their reported performance. The presenter will discuss how we can assess the level of uncertainty and risk when these tests are used for population serological surveys. Finally, the presenter will share thoughts on current misconceptions about testing and how Quality professionals can help facilitate a more informed public conversation and awareness.

Free, but name and email address registration required. I signed up to attend. From the email notice, it's obviously available to all ASQ members, but whether registration extends to the public at large is not clear.

I've been harping on the testing validation issues for more than two months. See here as well. My ASQ (in particular the BioMed Division) has been MIA up to now.

UPDATE FROM SCIENCE-BASED MEDICINE

COVID-19 Testing
Currently available tests for COVID-19 are imperfect but useful if used properly, with rapidly evolving research on new tests underway.

As states are beginning to phase out total lockdown in the US, there is much discussion about how best to do it, minimizing the chance of causing a resurgence in COVID-19 cases. Just about every expert questioned about this topic focuses on testing – we have to do lots of testing in order to track people who have the disease, trace their contacts, and isolate them. At its core the idea is simple – instead of isolated everyone, we isolate those who have the virus, but in order to do that we have to know who has it and who doesn’t. Symptoms are one guide, but you can have the virus and pass it on without displaying symptoms. Therefore testing is critical. Some experts estimate we will need to do millions of tests per day to safely open up.

What is the state of our testing technology, and how reliable is it? There is a lot of work in this area, so this is a rapidly moving target, but some recent reviews help put things into perspective…

BTW, the Wiki has a nice, detailed entry on Covid-19 assay technologies, methodologies, and issues.

POST-WEBINAR UPDATE

It was good, notwithanding the CusterFluck Webex interface login and recurrent bandwidth issues.

Niec presentation deck.

I would say, in deference to his Copyright, contact the author for the slide deck. He has lots of good stuff on his site. Attendees all got pdf access to it, but I don't want to usurp his show.

All good information, but nothing much I'd not already addressed in detail. I was looking for useful particulars on assay tech/methodology R&D QA and SARS-CoV-2 screening deployment workflow QA. They remain substantive concerns.

_____________

More to come...

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Brave New Health

Commonwell Health Alliance

Another important read (pdf)

I love this kind of stuff. It sustains and humbles me. "As politicians, advertisers, salesmen, and propagandists for various political, economic, moral, religious, psychic, environmental, dietary, and artistic doctrinaire positions know only too well, fallible human minds are easily tricked, by clever verbiage... Common language—or at least, the English language—has an almost universal tendency to disguise epistemological statements by putting them into a grammatical form which suggests to the unwary an ontological statement. A major source of error in current probability theory arises from an unthinking failure to perceive this."

Quotes

"An economist is a person who sees something that works in practice and tries to figure out whether it will work in theory."

- J.D. Kleinke, medical economist
___

"The only person who enjoys change is a baby with a wet diaper."

"Every misspent dollar in our health care system is part of somebody's paycheck.

- Brent James, M.D., M.Stat

“We could do healthcare, at markedly higher quality, for everyone in this country, without rationing or denying anybody the care that they need, without having the government dictate how doctors practice or whether hospitals could expand, at half the cost we do it now.”

- Health Care Futurist Joe Flower

Most of the sciences, unlike parts of medical science, are not concerned with the impossible. There is not complementary and alternative physics, or chemistry, or biochemistry, or engineering. These disciplines compare their ideas against reality, and, if the ideas are found wanting, abandoned."

- Mark A. Crislip, MD

"Q: How much alcohol is too much?
A: More than your doctor drinks."

- a physician I once heard speak during a CME presentation

“Just because science doesn’t know everything, doesn’t mean you get to fill in the gaps with whatever fairy tale most appeals to you.”

- Dara O’Briain

'[I]t is one small step from using the computer for "helping" doctors to monitoring them, judging them, dictating to them what to do, and withdrawing payment for computer non-compliance. The use of computer data is a multi-edged sword. It can be used for the "good," facilitating diagnosis and treatment and making it more accurate and up-to-date, and for “evil,” invading privacy, inviting security breechs, and making decisions based on the opinions of remote authorities rather than those present at the patient-doctor encounter.'

- Richard Reece, MD

“[T]here ARE statistics which are non-political. Just because The Washington Post/Fox News reports the temperature is 75 degrees doesn’t mean it’s really snowing and sunscreen is a liberal/conservative plot. Even if you earn a living being ideological.”

- Michael L. Millenson

"It is a generally a fairly convincing argument that people shouldn’t have to be subsidized to undertake a change which is in their best interest.

The reconciliation seems to be that EHR is not supposed to make a doctor’s practice more efficient and higher quality. It is supposed to make the system of care more efficient and higher quality, which is not the same thing. Those of you who took calc recall that maximizing the total of variables is not achieved by maximizing any one variable and this is a perfect example of that.

Those of you have served in combat certainly noticed that too — if everyone works as a team the unit takes fewer casualties. If you try to save your own hide, you might, but at the expense of more casualties overall."

- Al Lewis

"There are two ideas to keep in mind about Bayesian reasoning and how we tend to mess it up. The first is that base rates matter, even in the presence of evidence about the case at hand. This is often not intuitively obvious. The second is that intuitive impressions of the diagnosticity of evidence are often exaggerated."

- Daniel Kahneman, "Thinking, Fast and Slow"

"Physicians apply advanced scientific knowledge, but they must do so without the favorable conditions that experimental scientists create for themselves. Multitasking is forced on physicians, often in chaotic environments and under severe time and resource constraints."

- Lawrence and Lincoln Weed, "Medicine in Denial"

"It’s time to stop the whining about Obama care and acknowledge we already have universal health care. We just pay for it in the stupidest way possible that ensures problems are that much more disastrous and complicated when they’re finally treated."

- Mark Hoofnagle, MD, PhD

"Every act of conscious learning requires the willingness to suffer an injury to one's self-esteem. That is why young children, before they are aware of their own self-importance, learn so easily."

- Thomas Szasz, MD
___

"Of course, one reason that process metrics* are so popular is that processes are much easier to define and measure than outcomes."

- The Skeptical Scalpel
___

"There is an “illusion of validity” for any random data point, a seductive sense that is colored by what we hope will be true. Mountains of pharmaceutical claims are often made from mere molehills of data."

- Danielle Ofri, MD
___

"Joy empowers people. It is a source of energy that enables people to hope and plan and change their lives for the better. Spend some time around someone who is relentlessly negative and how do you feel–drained, right? More and more research shows that joy is not something that just happens to you, like a bolt of lightening out of the blue. Joy is, instead, a habit to cultivate. Negative thinking and despair are the crabgrass of our souls–weeds that take root and spread, sometimes to all areas of life. Joy, in contrast, is a soul’s rose–hardy when cared for, able to put down roots over time and withstand disease and extremes. Like a rose, however, your joy can become blighted from neglect or harsh conditions. We all need to tend to our joy–to prune away the badness, and to know that, even though it may look like a prickly bare root, if you invest time in a joyous outlook, gorgeous things will bloom, even in the harshest conditions."

- Dr. Jan Gurley
___

"'Solutions' exist only in mathematics."

- Karen Martin
___

"The issue of how to regulate clinical software is, in the long run, indistinguishable from the issue of how to regulate medicine. The only difference is that medicine is practiced in the open, without secrecy, subject to peer review, and under a merit-based state license."

- Adrian Gropper, MD
___

"Economist, rope, tree: some assembly required."

- Source unknown

DISCLAIMER:

I write this blog wholly on my own time and my own dime. The views proffered are expressly my own as a concerned and active citizen/taxpayer (in addition to being the result of my substantive experience in the various IT fields), and in no way reflect any policy views of my former employer, notwithstanding that some of the thinking has indeed obviously been spurred by the implications of the work with which I have been doing for them.

FAIR USE POLICY
I cite a ton of news and web sources spanning the breadth of relevant technical and policy domains, sometimes at substantial length. I believe I remain well within the bounds of "Fair Use," as [1] I am not doing any of this for profit, [2] I always provide attribution and links -- which, [3] far from negatively impacting any copyright holders' commercial interests, might actually increase traffic to and interest in their offerings.

Nonetheless, should I post anything of yours regarding which you have any objection, just let me know and I will remove it forthwith.

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Monday, May 18, 2020

ASQ webinar on Covid19 assay QA

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