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VALIDITY TESTING
AS OF NOVEMBER 2004

Provided by Dr. Daniel C. Drew

Nationwide Medical Review

IMPORTANT  FACTS  FOR  EMPLOYERS  AND  TPA'S

  • As with "quants," the lab and the MRO handle all the calculations and technical parts of this process. 
  • There are no new rules or mathematics you need to learn.
  • Although there is some confusing language in the new regs, there has been no new requirement for a second collection on dilute specimens except for very rare cases where the MRO will report this requirement case by case.

ALL  THE  NEW  CHANGES  ARE  IN  THE  PINK  ROWS  BELOW !

IF

Creatinine

AND

Specific
Gravity

THEN

LAB
Reports

AND

MRO
Reports

AND

RULES
APPLY

 

>20
(above 20)

 

NOT
measured

 

NOT
mentioned

 

NOT
mentioned

 

NO
CHANGES

 

Between
5 & 20

 

Above 1.003

 

NOT
mentioned

 

NOT
mentioned

 

NO
CHANGES

 

Between
2 & 20

 

Between
1.001 & 1.003

 

DILUTE

 

DILUTE

 

NO
CHANGES

 

Between
2 & 20

 

< 1.0010
(below 1.001)

 

INVALID
WITH #'S
SCUDO *

 

CANCELED
INVALID
SCUDO *

 

NEW
40.67

 

Between
2 & 5

 

Below 1.001
or Above 1.020

 

INVALID
WITH #S
SCUDO *

 

CANCELED
INVALID
SCUDO *

 

NEW
40.67

 

< 2
(below 2)

 

1.0011 - 1.0199
"normal"

 

INVALID
WITH #'S
SCUDO *

 

CANCELED
INVALID
SCUDO *

 

NO
CHANGES

 

< 2
(below 2)

 

Below 1.001
or Above 1.020

 

SUBSTITUTED

 

SUBSTITUTED

 

NO
CHANGES

* Medtox "language" for these categories is: "invalid."  Their certifying scientist defines it (correctly) as a new category of invalid.

DILUTE SCUDO   is language I invented.  It actually means dilute and requiring a
 
     Second Collection Under Direct Observation.

The lab will actually report this to the MRO using nomenclature they are still debating about; and reporting the actual creatinine level and specific gravity reading. The new "regs" indicate they will use the term "negative dilute" ...but Medtox has decided to use the term "invalid" for this new category of validity results.  This "result" will be very rare and we will always include the DER/Employer's instructions in the assertion part of our reports.

NEW ¶ 40.67 (a) (3)   [A directly observed collection is conducted if] The laboratory reported to the MRO that the specimen was negative-dilute with a creatinine concentration greater than or equal to 2 mg/dL but less than or equal to 5 mg/dL, and the MRO reported the specimen to you as negative-dilute and that a second collection must take place under direct observation.

NOTE   that for years we have reported our tests which are both dilute and negative (for drugs) as "DILUTE NEGATIVE" as opposed to "NEGATIVE DILUTE."  The primary reason for this has been the ability to quickly identify them visually in the tabular displays.  As luck would have it, the new terminology of "negative dilute" provided in the new rules will NOT be a conflict; although I do not think it's a good choice of language by the DOT.  For this reason, I plan to use the words "Dilute SCUDO" until someone in a high place tells me it is just too silly.  Although very rare, all these specimens are actually "super-dilute" or "unbelievably dilute" or "invalidly dilute" ...any of which would have been better terms than "negative dilute" which is a term we already use all the time.  These specimens were all called "substituted" in times past; but, unfortunately, newer research shows that we just CAN'T PROVE IT with 100% certainty with creatinines between 2 & 5.

WHAT'S GOING ON HERE?  These rules changes have occurred to accommodate the RHUBARB that was caused regarding the definition of a substituted specimen.  All the specimens in the new "category" used to be called "substuted" and most of them probably do indicate an attempt to cheat on a drug test.  Because it has been shown to be a rare possibility for a human to produce urine with creatinine between 2 and 5 and specific gravity as shown above, the new rules give a "second chance"  to donors whose specimens meet those criteria.
 


Daniel C. Drew, M.D. ~~~ Nationwide Medical Review
 
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