CLIA for In-vivo testing

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Hello fellow POC Colleagues, I have a question and maybe someone might know the answer.  I have a clinic that will be doing
in-vivo allergy testing on the patient’s back, what they want to know, do they need a CLIA license for this testing?


 


Thank you,


 








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John Cuellar, MLT(ASCP) POCS (AACC) |
EXT.  7697

Lab Compliance Liaison, RMF Administration


 


Doctors Hospital at Renaissance
5501 S. MCCOLL RD. EDINBURG, TX 78539
www.dhr-rgv.com 
• (956)
DOCTORS



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tel. (956) 362.7697


mob. (956) 340-3667

fax. (956) 362.7656


ju.cuellar@dhr-rgv.com


 


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They should not need a CLIA for this type of testing because there is no “sample/specimen” to test.


I concur - it is my understanding that CLIA/State BOLs ruling that if it does not involve a sample that can be collected/removed from the patient, it is not a laboratory test.


 

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John Cuellar
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