[Histonet] New CAP question ANP.22760

Fri Jun 18 14:38:07 CDT 2010

Mark,

Did you notice the credentials from this CAP representative? MT with a
Blood Bank specialty I believe.  What I glean from that is...more than
likely this person does not grasp the logistics of "contemporaneously"
staining identical Abs from separate lots.  She also likely does not
understand the logistical application for detection and automation
either.

I'm not trying to be overly critical of this person.  I'm sure she is
quite intelligent and would not have the MT/SBB if she wasn't
intelligent.  It comes down to a lack of understanding Anatomic
Pathology testing application re: automated IHC.  I believe this is a
common problem in and out of CAP. Many lab directors and other folks in
positions of authority without AP/Histology/Cytology backgrounds seem to
believe that broad clinical lab modalities apply to Anatomic Path
scenarios.  I used to refer to this in my former position as - "Trying
to put the yoke of clinical lab onto anatomic path."  We are
laboratorians, but in many instances do not fit the general clinical lab
mold.

It's unfortunate that CAP has put this person in the position to
respond.  It is apparent to me that she's not grasping the particulars
here.  She probably never will unless she decides to go into a working,
automated IHC "tissue" lab and take the time to ask questions and
understand (learn) what we're all about.

Thanks,
Tom Jasper

Thomas Jasper HT (ASCP) BAS
Histology Supervisor
Central Oregon Regional Pathology Services
Bend, OR 97701 

-----Original Message-----
From: histonet-bounces <@t> lists.utsouthwestern.edu
[mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of Mark
Tarango
Sent: Friday, June 18, 2010 11:47 AM
To: McMahon, Loralee A
Cc: histonet <@t> lists.utsouthwestern.edu
Subject: Re: [Histonet] New CAP question ANP.22760

That's what I thought at first too.  It might be helpful to post this
letter that I got from the CAP about this.  I tried to argue with them,
but this is the answer I got.

Dear Mark,

Your questions were forwarded to me for response.

During the Audio-conference, the idea of comparing a previously stained
slide (that had used the "old" lot) to one stained with the new lot was
deemed acceptable, but not optimal. Doing a simultaneous staining using
old and new lots, better demonstrates the performance characteristics of
the reagent.  The reason parallel staining is considered best practice
is that all other variables, such as variations in the lot of detection
reagent or instrument function, are eliminated from consideration when
the slides are stained contemporaneously.

The antibody "getting weak over time" should not happen to a significant
degree if the antibody is used within its expiration date.  If the lab
is having this kind of trouble, it should look carefully at its storage
conditions.

Demonstrating acceptable performance of the new lot, before being place
into service, is *required* for all accredited laboratories.

To answer the last question, the key is to order the new reagent well
before you run out of the old lot so that the parallel stain can be
performed before the old lot is consumed. One multi-tissue slide control
slide would suffice to evaluate a primary antibody lot in most cases,
which helps to minimize the impact on the lab.

I hope that this information is helpful.  Thank you for your
participation in the Laboratory Accreditation Program.

Sincerely,

*Kathy Passarelli, MT(ASCP)SBB*

*Technical Specialist*

*Laboratory Accreditation Program*

*College** of American** Pathologists*

*Phone: 1-(800)-323-4040 ext 7486*

*e-mail:  **kpassar <@t> cap.org* <kpassar <@t> cap.org>

On Fri, Jun 18, 2010 at 10:47 AM, McMahon, Loralee A <
Loralee_Mcmahon <@t> urmc.rochester.edu> wrote:

> I think that CAP means that you need to save the slide that you ran 
> from the previous lot and compare it to the slide that you have 
> stained with the new lot number.  To see if they are sufficient 
> diagnostic quality.  Not put both lot numbers on the machine at the
same time and then compare the
> slides?   We run Dako machines and it would be tricky to put both
numbers on
> the same machine.
>
> Although this is my interpretation.
>
> Loralee McMahon, HTL (ASCP)
> Immunohistochemistry Supervisor
> Strong Memorial Hospital
> Department of Surgical Pathology
> (585) 275-7210
> ________________________________________
> From: histonet-bounces <@t> lists.utsouthwestern.edu [ 
> histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of Mike Pence [ 
> mpence <@t> grhs.net]
> Sent: Friday, June 18, 2010 12:41 PM
> To: Ellen Yee; Laurie Colbert
>  Cc: histonet <@t> lists.utsouthwestern.edu
> Subject: RE: [Histonet] New CAP question ANP.22760
>
> I don't think I can do this with the automated system we are currently

> using. Ventana. Does any other Ventana users know if you can do this 
> in "parallel"
>
> Mike
> -----Original Message-----
> From: histonet-bounces <@t> lists.utsouthwestern.edu
> [mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of Ellen 
> Yee
> Sent: Thursday, June 17, 2010 7:21 PM
> To: Laurie Colbert
> Cc: histonet <@t> lists.utsouthwestern.edu
> Subject: RE: [Histonet] New CAP question ANP.22760
>
>
> Sorry, I should have included it.
>
> ANP.22760  Are new lots of antibody and detection system reagents 
> tested in parallel with old lots?  (NOTE: New lots of primary antibody

> and detection system reagents must be compared to the previous lot 
> using an appropriate panel of control tissues.)
>
> Ellen Yee
>      _____
>
>  From: Laurie Colbert [mailto:laurie.colbert <@t> huntingtonhospital.com]
> To: Ellen Yee [mailto:eyee <@t> dpmginc.com]
> Sent: Thu, 17 Jun 2010 08:47:38 -0700
> Subject: RE: [Histonet] New CAP question ANP.22760
>
> Can you give us the wording of that question/checklist item? Laurie
>
> -----Original Message-----
> From: histonet-bounces <@t> lists.utsouthwestern.edu
> [mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of Ellen 
> Yee
> Sent: Wednesday, June 16, 2010 10:10 PM
> To: histonet <@t> lists.utsouthwestern.edu
> Subject: [Histonet] New CAP question ANP.22760
>
> How are IHC labs complying with this question? What is considered an 
> appropriate panel of control tissues? What do you stain to test your 
> detection systems?
>
> Ellen Yee
>
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