Re: [IHCRG] What is considered high complexity testing

From:Manju Kaushal

I think we are at a stage to start defining QA/QC & compliance &
regulatory issues in IHC.
IHC can be done by a histotech - with either good science background (
demonstrated by educational degrees & diplomas ) or with higher aptitude
for science ( demonstrated by experience & publications etc ).
We have such shortage of skilled histotechs & we have to narrow that by
additional qualifications.So we tend to tell ourselves that all
histotechs can do IHC. Which is not true.
A good IHC tech is the one with sound histology background & science
degree or aptitude.
In my true opinion - to be a med tech is true science but to be a HT or
IHC tech is science with skill.
Med tech - Science 100%
Histology - 75% skill + 25% science.
IHC - 75% science +25% skill.
Yes it is similar issue like they should be trained and supervised by a
pathologists type to then give the slides to a pathologists to use in
making the report.?
But how many of these pathologist can really train a IHC tech ?.
ISH in a step further IHC. Yes it is highly complex test - Should be
performed by  HT trained in IHC & ISH.because basic of Slide handling
are similar.But any regulatory agency telling us that - I m not aware of

It brings me back to start talking about regulatory procedures in IHC.
Its been 10 years I have been in IHC & till date we are debating where
does IHC belong - immunonogy,histology, research lab,med tech?
It has become an integral part of diagnosis for surgical pathologist.?
But no one has started the debate on issues of IHC regulatory
May be it is time..............

> rueggp  06/24/02 01:21PM >>>
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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
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
the results we just do the methods and then give the slides to a
pathologists to use in making the report.?

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Manju Kaushal
Senior Manager
Immunopathology Service
Johns Hopkins Medical System
Weinberg Building - Rm 2323
401 North Broadway
Baltimore MD 21287
PH 410 614 6650
Fax 410 502 1732

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