[Histonet] IHC negative controls

[Patsy Ruegg]

So true!

Patsy Ruegg, HT(ASCP)QIHC
Ruegg IHC Consulting, LLC
40864 Arkansas Ave
Bennett, CO 80102
Phone: 303-644-4538
Fax: 720-859-4110
pruegg <@t> ihctech.net

-----Original Message-----
From: Morken, Timothy [mailto:Timothy.Morken <@t> ucsfmedctr.org] 
Sent: Monday, November 05, 2012 2:10 PM
To: Patsy Ruegg; 'Glen Dawson'; 'histonet'
Subject: RE: [Histonet] IHC negative controls

Could be, but my point, maybe not clear in my answer, is that you should
check with your accrediting agency before an inspection and not assume that
they will follow what CAP has said it will do.

Tim

-----Original Message-----
From: histonet-bounces <@t> lists.utsouthwestern.edu
[mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of Patsy Ruegg
Sent: Monday, November 05, 2012 12:56 PM
To: Morken, Timothy; 'Glen Dawson'; 'histonet'
Subject: RE: [Histonet] IHC negative controls

The thing is in my opinion that having the backing of CAP on this issue is a
good argument to make to CLIA for why you are not doing negatives for
polymer based detection IHC work, at least you will have some documentation
to cover your decision.

Patsy Ruegg, HT(ASCP)QIHC
Ruegg IHC Consulting, LLC
40864 Arkansas Ave
Bennett, CO 80102
Phone: 303-644-4538
Fax: 720-859-4110
pruegg <@t> ihctech.net
-----Original Message-----
From: histonet-bounces <@t> lists.utsouthwestern.edu
[mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of Morken,
Timothy
Sent: Friday, October 26, 2012 9:45 AM
To: Glen Dawson; histonet
Subject: RE: [Histonet] IHC negative controls

" Can anyone tell me if JHACO & CLIA are deferring to CAP's judgment that a
negative control is not needed when utilizing a polymer detection?
 
I assume that this is the case, but I'd like to be sure."


Short answer: 

Don't bet the farm on it. Each enforces CLIA regulations but have different
methods of doing so. There is no reason to think that  JC or CAP will defer
to the other in any particular situation. They really don't have anything to
do with one another. My experience is that CAP is more lab-method oriented
while JC is more total-process (patient admission to final result )
oriented.  

Long answer: 

Let's clarify this. CLIA is the law administered by the Centers for Medicare
and Medicaid Services (CMS). The Joint Commission and CAP are two different,
independent accrediting agencies deemed by CMS to enforce the CLIA
regulations. CMS/ CLIA does not "defer" to CAP or JC, rather CMS deems JC
and CAP to be their agent to accredit laboratories according to the CLIA
law.  CAP and JC cannot enforce anything without CMS/CLIA approval. The fact
that CAP allows labs to leave out negative controls in certain situations
may be approved by CMS/ CLIA regulators, but it does not follow that CLIA or
JC inspectors will follow the same rational. JC is totally independent and
can make their own interpretation of the CLIA regulations, which CMS can
approve, even if they are different than what CAP allows, as long as it is
within the scope of the CLIA regulations. JC can simply interpret it
differently and require negative controls (I don't know if that is the case;
I haven't yet looked over the new checklist this year).  

Tim Morken
Department of Pathology
UC San Francisco Medical Center


-----Original Message-----
From: histonet-bounces <@t> lists.utsouthwestern.edu
[mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of Glen Dawson
Sent: Friday, October 26, 2012 6:45 AM
To: histonet
Subject: [Histonet] IHC negative controls


All,
 
Can anyone tell me if JHACO & CLIA are deferring to CAP's judgement that a
negative control is not needed when utilizing a polymer detection?
 
I assume that this is the case, but I'd like to be sure.
 
Thank-you in advance,
 
Glen Dawson  BS, HT(ASCP), QIHC
Histology Technical Specialist
Janesville, WI
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