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

Samuel, Rana Rana.Samuel at VA.GOV
Tue Jul 12 19:25:04 UTC 2016


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





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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