Search the KHIT Blog

Friday, March 6, 2020

HIMSS20 and SXSW bug out. Is COVID-19 a "Force Majeure?"

Ouch. Wonder if they're insured, and if Force Majeure indemnity comes into play?

HIMSS is a roughly $100 million a year "non-profit" business (501c6), according to their latest available IRS 990. The annual conference is the Really Big Show in terms of their yearly gross revenue. This stand-down was a real shot below the waterline. One of many to come across the world economy and societies.
I am the ASQ 2020 Baltimore Science Fair volunteer lead. It may well have to be canceled or postponed.
I was fortunate to get press comps to cover the HIMSS events for a half-dozen years, ending in 2016. Great fun.

They had no choice here but to cancel. It was increasingly problematic.

Now Trump won't get to hold his little taxpayer-funded MAGA Rally "Keynote" on Monday. Small silver lining.

Hopkins COVID-19 link

Buckle up, folks.



Joyce White Vance is a well-known law professor at Alabama and former federal prosecutor. She's a frequent MSNBC panel contributor. I dig her, but she's way out of her lane here.

I cut my white-collar teeth in a forensic-level radioanalytical / mixed-waste lab (pdf) in Oak Ridge in the '80s, serving as a technical programmer and quality control (QC) analyst.
From January of 1986 through about May of 1991 I served under a series of personal services contracts with a laboratory owned by a major environmental engineering and remediation firm. We performed environmental and health physics support analyses for clients with radiation and mixed waste contamination and exposure problems (mixed waste is that which is composed of conventional chemical toxins and radionuclides). Since much of our work involved litigation support, we were trained to—and continually reminded of the need to—perform to forensic standards (i.e., to a quality level sufficient for our analytical results to stand up as viable evidence in court).

It was my job to develop, install, and maintain custom, procedure-specific software for use by the technicians in calculating radionuclide concentrations and dose exposures. I also worked on statistical quality control applications, applied research toward development of analytical correction factors, and helped write and subsequently administer our Software Quality Assurance procedure. While at this complex I worked amid much of the very same analytical technology (e.g., High Performance Liquid Chromatography, Gas Chromatography/Mass Spectrometry) also employed by drug testing labs, as much of our specimen workload consisted of urine samples suspected of contamination. I also learned just how difficult it can be to substantiate analytical results. We underwent frequent adversarial lab audits that would be the envy of a Spanish Inquisitor. I have been audited right down to my rounding algorithms…
Alluded to this work in my 1998 grad thesis. to wit:

While I am long since out to pasture, a lot of this standard QA/QC process knowledge is durable.

"Mass testing" for coronavirus is not "logical, sensible, & doable."

I'm reviewing the CDC tech specs and guidelines at the moment.

Stay tuned.

For now, consider a couple of items.

Lots to unpack there.


From another of my rants, this time on "Total Information Awareness."
While the relative "accuracy" (sensitivity & specificity) levels of many clinical methods that estimate disease probabilities (or any type of  experimental assay with anterior empirical underpinnings using Bayesian statistical methods [see below] ) are tolerably well-defined (and uniformly well below 99.9%), those pertaining to a TIA program are wholly speculative at this point, and will not clarify for years (if ever). One daunting limitation will come in the form of pervasively inaccurate and/or incomplete data pouring in from the myriad public and private sources. Another will owe to the relative recency and transience of the phenomenon. As Robert Levy of the Cato Institute observes: "Never mind that Pentagon computer scientists believe that terrorists could easily avoid detection, leaving bureaucrats with about 200 million dossiers on totally innocent Americans — instant access to e-mail, web surfing, and phone records, credit-card and banking transactions, prescription-drug purchases, travel data, and court records." (see I could not agree more. While the innocent will more or less simply go on with their customary daily life transactions, our terrorist enemies will undoubtedly take evasive measures. What shall we do? Outlaw, among other things, all anonymous cash transactions? If we don't (and we cannot) the very utility of a TIA database will be fatally compromised at the outset.

Given that no test is infallible, there are inescapable trade-offs in terms of relative false-positive/false negative levels associated with any assessment. For example, where routine workplace drug tests are concerned, labs seek to limit false positives (and the lawsuits they spawn), while they are far less troubled by false negatives (recreational drug users who slip through the screenings). With respect to terrorism, on the other hand, authorities will necessarily fret principally over false negatives -- actual terrorists who go undetected. Should you wrongly end up on a Homeland Security "No-Fly List" or be uselessly visited by a couple of FBI agents in the wake of a false positive TIA "hit", you will likely be met with bureaucratic indifference at best should you protest. At worst, you could be wrongly arrested, have your assets seized, lose your job, or otherwise have your reputation ruined.
For now, suffice it to assert that, if you are asymptomatic for COVID-19, you don't want to risk the severe personal upshot of turning up false positive.

Criteria to Guide Evaluation of PUI (Patient Under Investigation) for COVID-19

"…Clinicians should use their judgment to determine if a patient has signs and symptoms compatible with COVID-19 and whether the patient should be tested. Decisions on which patients receive testing should be based on the local epidemiology of COVID-19, as well as the clinical course of illness. Most patients with confirmed COVID-19 have developed fever1 and/or symptoms of acute respiratory illness (e.g., cough, difficulty breathing). Clinicians are strongly encouraged to test for other causes of respiratory illness, including infections such as influenza.

Epidemiologic factors that may help guide decisions on whether to test include: any persons, including healthcare workers, who have had close contact with a laboratory-confirmed COVID-19 patient within 14 days of symptom onset, or a history of travel from affected geographic areas within 14 days of symptom onset…

Close contact is defined as—

a) being within approximately 6 feet (2 meters) of a COVID-19 case for a prolonged period of time; close contact can occur while caring for, living with, visiting, or sharing a healthcare waiting area or room with a COVID-19 case
– or –
b) having direct contact with infectious secretions of a COVID-19 case (e.g., being coughed on)

If such contact occurs while not wearing recommended personal protective equipment or PPE (e.g., gowns, gloves, NIOSH-certified disposable N95 respirator, eye protection), criteria for PUI consideration are met…"
Couple of quick observations here. First, the CDC guidelines are episodically updated, so they are (inescapably) in flux. Second, (inter-subjective albeit informed) "clinical judgment" will have to contend with mostly uninformed "political judgment" (read alarmist pandering).

So, right at the outset we have potential for individual and population results variability--the enemy of assay accuracy. More shortly.

Specimen Type and Priority
For initial diagnostic testing for COVID-19, CDC recommends collecting and testing upper respiratory (nasopharyngeal AND oropharyngeal swabs), and lower respiratory (sputum, if possible) for those patients with productive coughs. Induction of sputum is not recommended. Specimens should be collected as soon as possible once a PUI is identified, regardless of the time of symptom onset…
Earlier there was a reference to "serum" (blood samples), but that is not now on the CDC page. I'd be wanting to see stratified data minimally on relative sensitivity and specificity for both upper respiratory specimen types and the lower respiratory (sputum). Probably as yet to soon to get solid numbers there.

Consistency of specimen collection and handling will also be very important. For one thing, the risks of cross-contamination during collection, handling/shipment, and at the lab bench will require constant mitigation vigilance.
What of the manufacturing QA documentation of the test kits themselves? 'eh? After all, Trump never met a regulatory standard he didn't want to eliminate.
Once we get to the actual test kit production analyses (pdf), all the myriad QC risks (and documentation requirements) that apply to lab work generally most certainly apply here. These are not Playskool chemistry kit litmus paper tests.


These CDC tests are "qualitative," yielding simply either "positive" or "negative" findings. No quantitative estimate of "severity," i.e. "viral load." By contrast, if you test "positive" for illegal drugs via a workplace EMIT screen, it must be confirmed by a more accurate quantitative GC/MS lab technology. Warranted, in light of the adverse consequences of a positive finding.

Well, should you test positive on a COVID19 screen, you will be remanded to quarantine custody. absent any further confirmatory clinical assays. And probably on your own dime. What are you gonna do, sue?

Calls among antsy politicians are increasing for (vaguely specified) "mass testing." Bad idea.
Epidemic mortality rates are properly derived as "deaths / confirmed cases." You can disingenuously deflate the apparent rate by summarily changing the denominator to "PUIs tested" in the wake of mandating indiscriminate mass testing without pre-screening judgment criteria. Don't tell Trump.

President Trump at the CDC, prattling on in his 2020 re-election campaign "KAG" cap, and humbling praising himself for his scientific public health acumen (inherited from his late "great super genius" MIT physics professor uncle).

More to come...

No comments:

Post a Comment