Drug screen cup positives for confirmation

Hello Robert,

Yes, if it is stated in the manufacturer's package insert, then they must send to the main lab for confirmation.  The POC urine drug screen is only presumptive positive.  I had to do some re-education with our offices regarding this exact issue.

I am from an organization that is CLIA inspected and if any testing is performed differently than the package insert states, then it is considered "off-label testing" and automatically makes that testing highly complex and outside the scope of their CLIA license.

I hope this helps!

Raychel

Thank you . The POL is trying to fight that ruling by saying they are expecting that positive. The POL argues that they should be allowed to note in the emr that it is consistent and not send it out. Unfortunately, the insert does not go into that detail.

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Hello,

If we report the result as "Presumptive Positive" in the HIS does that cover us?  I believe we have some that do not get sent out for confirmation if the patient admits using.

Pam

Have you tried contacting the vendor directly?  Maybe they have more literature that may offer more insight.

I requested more documents from our vendor and found the reason for the requirement for confirmation testing is due to the lack of sensitivity and specificity of the POC urine drug screens.  There POC methods are only capable of detecting certain metabolites of the drugs and at much higher concentrations than GC/mass spec, which can potentially cause false pos/neg results.  Some other medications (other than drugs of abuse) can also cause interferences with testing.

This information is specific to each type of POC urine drug cup but definitely worth looking into :)

Hi Pamela! We too have a comment that indicates it is only presumptive results

What is the reasoning that you don’t have to send it out for confirmation if the patient is prescribed or known to take it ?

May I ask which cup you use? We use Discover

Thanks Pam!

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We also put a comment that the results are presumptive, and that confirmatory testing is advised. The clinician ordering the test should have the option to confirm or not, depending on clinical indications. Forcing a confirmation where it's not needed clinically seems draconian. Also, a charge to the patient (or loss to the facility) that would not be welcome.