[EXTERNAL] [IMPROVEDX] Diagnosis gone awry: A flawed drug test could be sending thousands of innocent people to jail each year

Grubenhoff, Joe Joe.Grubenhoff at CHILDRENSCOLORADO.ORG
Tue Jul 12 20:32:06 UTC 2016


I would venture further to say that in many instances, providers don’t take into consideration bell-shaped curves of test results, selection of cut points and fluid differences.

Our facility’s urine tox screen includes EtOH but provides an actual quantification in mg/dL rather than the remainder of the substances which are listed as either POS or NEG. The cut-point for negative is <10 mg/dL. Often, the test gives a reading of 11 mg/dL. If I understand correctly (and I am certainly open to correction) this lab test where there is a specific value given has a measurement error associated with it. So 11 is flagged as abnormal and 10 mg/dL is flagged by the computer/testing machine as normal but both are really telling the same story.

Why this is important (outside of legal realms) is that clinicians then jump to the assumption that positive is positive whether it’s 11 or 111. This then triggers all sorts of nonsense like invoking our hospital policy that kids in the ED with + EtOH screens be seen by psych (luckily clinicians can override). Also, in this case where a child was clinically intoxicated but now is clinically sober but with a urine EtOH of 200 mg/dL, then the psych folks won’t see him until he’s “serum concentration sober” meaning waiting 6 hours invoking the 20 mg/dL/hr drop rate.

Tests are great if they are interpreted correctly which requires an understanding not only of the stats around the test but also the methodology/measurement parameters and basic physiology. If clinicians have a hard time understanding these concepts, how can a patrol officer whose medical knowledge is limited to BLS???

Truly scary

Joe Grubenhoff, MD, MSCS| Associate Professor of Pediatrics
Section of Emergency Medicine | University of Colorado
Children's Hospital Colorado
13123 East 16th Avenue, Box 251  |  Anschutz Medical Campus  |  Aurora, CO 80045 | Phone: (303) 724-2581 | Fax: (720) 777-7317
joe.grubenhoff at childrenscolorado.org<mailto:joe.grubenhoff at childrenscolorado.org>

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From: Samuel, Rana [mailto:Rana.Samuel at VA.GOV]
Sent: Tuesday, July 12, 2016 1:25 PM
To: IMPROVEDX at LIST.IMPROVEDIAGNOSIS.ORG
Subject: Re: [IMPROVEDX] [EXTERNAL] [IMPROVEDX] Diagnosis gone awry: A flawed drug test could be sending thousands of innocent people to jail each year

This is use of a test for legal purposes. To my knowledge, none of the regulations and standards (like CLIA 88) that govern the performance of tests for clinical decision making apply to legal testing, even though the consequences of diagnostic error can be as consequential as they are in the field of Medicine.

In the medical world point of care tests (POCT -tests performed at the patients side, and not in a clinical laboratory) offer a trade-off between speed and convenience versus accuracy. A risk benefit analysis is always needed prior to implementing a POCT, but in my experience is never performed unless a pathologist is involved in the decision making (and sadly, not all pathologists are as competent in clinical pathology as they usually are in anatomic pathology).

The sales reps pitching the test to the ED physician or Specialty clinic certainly never discuss false positives and false negatives. The product insert for the POCTs mention sensitivity and specificity, but I would venture to guess that the number of clinicians who bother to read these is extremely low, and the number who critically evaluate how the sensitivity and specificity data were obtained is probably multiple decimal points on the wrong side of one!

Now translate the above factors to point-of-use tests in the legal world, and you can easily see how test accuracy can drop off the radar.

Rana

Rana Samuel, MD, FCAP
Chief, Pathology and Laboratory Medicine Service (PALMS, 113)
Lead pathologist – VISN 2
VA western New York Healthcare System (VAWNYHS)
3495 Bailey Avenue, Buffalo, NY 14215
Ph:    716-862-8701
Fax:  716-862-7824
Rana.samuel at va.gov<mailto:Rana.samuel at va.gov>





From: Mark Graber [mailto:graber.mark at GMAIL.COM]
Sent: Tuesday, July 12, 2016 2:09 PM
To: IMPROVEDX at LIST.IMPROVEDIAGNOSIS.ORG<mailto:IMPROVEDX at LIST.IMPROVEDIAGNOSIS.ORG>
Subject: [EXTERNAL] [IMPROVEDX] Diagnosis gone awry: A flawed drug test could be sending thousands of innocent people to jail each year

This is a disturbing article in this week’s NY Times magazine on the roadside tests police use to detect narcotics.  People are being jailed for narcotics possession based on tests that have high, and unknown, rates of false positive results.

http://tinyurl.com/zhqm44o

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