Re: [IHCRG] What is considered high complexity testing


when I was inspected by CLIA a couple of years ago, the inspector considered
IHC a HCT.  She tried to give me a hard time about it until I started
explaining IHC. I guess I talked over her head because she never gave any
more trouble the rest of the week. I must add that she was a MT.  As far as
ISH, since it is part of the QIHC exam, there shouldn't be any questions.
    My experience with the CLIA inspector was an eye opener.  She didn't
have a checklist per se as the CAP does.  During the outbriefing, I asked
her where did her questions come from.  She really didn't give a straight
answer because 'till this day, I still don't understand the answer.  But,
CLIA did give us 30 days to report and correct any descrepancies.
    I say this inspector is barking up the wrong tree.

Joe Nocito, BS, HT (ASCP) QIHC
Histology Manager
Pathology Reference Lab
San Antonio, Texas
----- Original Message -----
From: "rueggp" 
To: "HistoNet Server" ; "ihcrg list serv"

Sent: Monday, June 24, 2002 12:21 PM
Subject: [IHCRG] What is considered high complexity testing

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> Folks,
> I had an interesting inquiry.  This technician is being inspected by
> CLIA.  They listed ISH for HPV as one of the tests done in histology.
> They were told that ISH was a "High Compexity Test" and that histotechs
> are not qualified to be doing this.  They said that a test like this
> should be performed by a MedTech type, unless they could demonstrate
> that they had been "High Complexity Tests" before 1995.  The question
> is:  Is IHC considered HCT?  Can someone clear up this issue for me, I
> was not sure how to advise this person?  Is this another issue like
> "grossing" where it can be done by histotechs as long as they are
> trained and supervised by a pathologists type, since we do not interpret
> the results we just do the methods and then give the slides to a
> pathologists to use in making the report.?
> Patsy
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