RE: [Histonet] New CAP question ANP.22760

[Morken, Tim]

Thomas and Daniel both make good points.

While clinical labs do run measurable (quantitative) tests they are also 
running completely closed systems in which all reagents are from a certain 
vendor. All the reagents are validated by a vendor and all reagents are 
validated and calibrated for that system.


Running qualitative tests is only different at the interpretive stage. All 
other stages should be standardized and validated to ensure the system works as 
intended every day, every test.

IHC, of course, is a whole different ballgame. There probably is not a single 
lab out there that uses only one vendor and uses only one system to do IHC 
testing. Even if you use one automated staining system you may use antibodies 
from a different vendor, or you may do something outside the system that is 
very different than other labs use. There is such disparity between testing in 
different labs that it is difficult to compare results and even techniques 
between labs. That is the crux of the issue and what CAP and others are trying 
to address by tightening the validation screws. In the near future labs will 
need to have very robust validation and documentation for all antibodies in 
order to prove they are doing things correctly. That scenario is already here 
for the breast markers. It will come for the others as well.

Right now the instances in which solid validation methods are absolutely 
necessary is when validating the breast markers ER, PR and HER2, which all are 
used as stand-alone tests to determine treatment, and for ASR's. If you use a 
vendor kit with all reagents supplied you must still prove it works in your lab 
as intended ("verify outside data." The "outside data" is the claim that it 
stains in a certain way). You must run cases of various expressions and show 
your lab gets the proper results. Third party verification is very helpful, 
that is, comparing your results to that of other labs on the same material (CAP 
surveys, or set up a partnership with another lab).

If you use only the antibody for one of those markers, or mix and match 
components outside a FDA-approved kit, then you are responsible for performing 
a comprehensive validation of the test.

Its worth noting that every news article I've seen about pathology/histology 
labs in the last several years has been about failures to do the breast panel 
tests correctly. We are under a microscope these days and it will pay off to 
make sure you are doing the tests well!

Most other markers in IHC are ancillary tests that are run in conjunction with 
other tests to determine a diagnosis. Those antibodies still need to be 
validated in your system but don't require a large sample of cases. They have 
been validated as IVD's by the vendor so just need to be shown they work as 
intended with your lab's methods and instruments. But I still think it is 
worthwhile to do a validation that includes a range of expressions along with 
irrelevant tissue (negative). That will help calibrate your expectations about 
how the antibody works and give you a baseline to refer to if problems arise. 
Running one or two slides to make sure it "works" is not really satisfactory.

Tim Morken
Supervisor, Histology / IPOX
UCSF Medical Center
San Francisco, CA

-Original Message-
From: histonet-boun...@lists.utsouthwestern.edu 
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Thomas Jasper
Sent: Saturday, June 26, 2010 1:45 PM
To: Daniel
Cc: histonet@lists.utsouthwestern.edu
Subject: RE: [Histonet] New CAP question ANP.22760

Daniel,

I think your observations are very good.  Which brings me again to a
point I was trying to make earlier.  Anatomic Pathology is not the same
as the General Clinical Lab or it's close counterparts.  It almost seems
like this is overblown re: validation.  As you've pointed out, the
interpretation is up to the pathologist.  Patients (prostate, i.e.) will
correlate with other tests.  When known positives demonstrate properly
you're valid.  Even automated systems can use algorithms to score
strength of positivity...which varies yet will show as positive (valid).
You receive a new batch of Ab you run it on a known positive, that's the
bottom line.

It seems somehow CAP or clinical lab (trained) folks want more than
that.  And again (as you pointed out) the appreciation for the
differences in how we operate as laboratorians seems to fall by the
wayside.  As you mention pushing 20, 50, 100 is not feasible (and
frankly unnecessary).  I don't know where the answer lies in making
everyone happy here.  I do know that some thinking outside the box and
trying understand AP is required.  We all want good patient care, but
one size does not fit all.

Thanks,
tj

-Original Message-
From: histonet-boun...@lists.utsouthwestern.edu
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Daniel
Sent: Saturday, June 26, 201

RE: [Histonet] New CAP question ANP.22760

[Thomas Jasper]

Daniel,

I think your observations are very good.  Which brings me again to a
point I was trying to make earlier.  Anatomic Pathology is not the same
as the General Clinical Lab or it's close counterparts.  It almost seems
like this is overblown re: validation.  As you've pointed out, the
interpretation is up to the pathologist.  Patients (prostate, i.e.) will
correlate with other tests.  When known positives demonstrate properly
you're valid.  Even automated systems can use algorithms to score
strength of positivity...which varies yet will show as positive (valid).
You receive a new batch of Ab you run it on a known positive, that's the
bottom line.

It seems somehow CAP or clinical lab (trained) folks want more than
that.  And again (as you pointed out) the appreciation for the
differences in how we operate as laboratorians seems to fall by the
wayside.  As you mention pushing 20, 50, 100 is not feasible (and
frankly unnecessary).  I don't know where the answer lies in making
everyone happy here.  I do know that some thinking outside the box and
trying understand AP is required.  We all want good patient care, but
one size does not fit all.

Thanks,
tj 

-Original Message-
From: histonet-boun...@lists.utsouthwestern.edu
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Daniel
Sent: Saturday, June 26, 2010 11:08 AM
To: histonet@lists.utsouthwestern.edu
Subject: RE: [Histonet] New CAP question ANP.22760

One question I think a lot of you are not considering is that the
clinical laboratory usually tests for analytes present in most patients.
This allows the clinical lab to more easily run validations with
hundreds of patients, using statistical tools to analyze the precision,
specificity and sensitivity of the test.  What most of those concerned
with this new CAP standard (and I count among them) is that our testing
often targets a very rare population of patients.  As such, an extensive
validation is much more difficult to establish.  It then makes the
statistical models used in clinical tests much less valuble since the
accuracy of these formulas decrease with smaller sample sizes.

Additionally, the pathology of the clinical tests are reported as a
measurement which does not have an intrinsic value.  It must be
interpreted by a clinician to give value to the patient.  For example,
the Blood Urea Nitrogen test value range usually is between 7-20 mg/dL
while values above 50 are considered a marker of poor kidney function.
Elevated values, however, do not mean that kidney functions are impaired
but instead may be due to other pathologies such as congestive heart
failure, gi bleeding, certain steroids and even diet.

For histopathology even relatively common antibodies such as pan-T cell
marker CD3 usually only stain 75% of T cell neoplasms.  A negative
result for that minority does not indicate that the tumor does not have
a T cell lineage.  It relies instead on the pathologist interpreting the
result much as the clinician looks at the BUN value in relation to other
factors in the patient's presentation.  When we validate this kind of
antibody, do we perform testing then on T cells and B cells (give me a
good tonsil), on malignant samples or some combination of the two?  What
is a reasonable number of tests to run then?

If I choose 10 normal lymphatic tissue blocks for my routine T/B cell
marking (it can't be as extensive as ER/PR can it?) how many samples
should I choose for my malignant population?  If I use another 10 anyone
with a background in statistics will tell you that the sample size is
too small to interpret accuracy.  If I push it up to 20, 50 or 100 I
would be certain that many laboratories would not be able to afford the
cost of the validation.  This would then push many good laboratories out
of the business of IHC with the unintended result of delaying diagnoses
and increasing patient costs by driving testing to fewer and fewer
testing outlets.

CAP's new path with ER/PR seems to be trying to achieve a noble end of
improving quality in the laboratory but without an understanding of the
complexities and consequences of the method they are implementing.

Dan

-Original Message-
>From: Jesus Ellin 
>Sent: Jun 26, 2010 6:28 AM
>To: "Morken, Tim" , 
>histonet@lists.utsouthwestern.edu
>Subject: RE: [Histonet] New CAP question ANP.22760
>
>I have been reading the post to this question and it seems to me that
there are different standards depending on the lab that is operating the
methodology.  I do agree that the core lab for years have had the
instruction and training in the performance of validation.  One thing
that comes to mind as well is why has histology not had this training?
Why are we not getting this from our certification agency, our
professional societies and biggest reason where is our standardization.
It seems to me that with all these regualtions in plac for so long, why
were we miss

RE: [Histonet] New CAP question ANP.22760

[Daniel]

One question I think a lot of you are not considering is that the clinical 
laboratory usually tests for analytes present in most patients.  This allows 
the clinical lab to more easily run validations with hundreds of patients, 
using statistical tools to analyze the precision, specificity and sensitivity 
of the test.  What most of those concerned with this new CAP standard (and I 
count among them) is that our testing often targets a very rare population of 
patients.  As such, an extensive validation is much more difficult to 
establish.  It then makes the statistical models used in clinical tests much 
less valuble since the accuracy of these formulas decrease with smaller sample 
sizes.

Additionally, the pathology of the clinical tests are reported as a measurement 
which does not have an intrinsic value.  It must be interpreted by a clinician 
to give value to the patient.  For example, the Blood Urea Nitrogen test value 
range usually is between 7-20 mg/dL while values above 50 are considered a 
marker of poor kidney function.  Elevated values, however, do not mean that 
kidney functions are impaired but instead may be due to other pathologies such 
as congestive heart failure, gi bleeding, certain steroids and even diet.

For histopathology even relatively common antibodies such as pan-T cell marker 
CD3 usually only stain 75% of T cell neoplasms.  A negative result for that 
minority does not indicate that the tumor does not have a T cell lineage.  It 
relies instead on the pathologist interpreting the result much as the clinician 
looks at the BUN value in relation to other factors in the patient's 
presentation.  When we validate this kind of antibody, do we perform testing 
then on T cells and B cells (give me a good tonsil), on malignant samples or 
some combination of the two?  What is a reasonable number of tests to run then?

If I choose 10 normal lymphatic tissue blocks for my routine T/B cell marking 
(it can't be as extensive as ER/PR can it?) how many samples should I choose 
for my malignant population?  If I use another 10 anyone with a background in 
statistics will tell you that the sample size is too small to interpret 
accuracy.  If I push it up to 20, 50 or 100 I would be certain that many 
laboratories would not be able to afford the cost of the validation.  This 
would then push many good laboratories out of the business of IHC with the 
unintended result of delaying diagnoses and increasing patient costs by driving 
testing to fewer and fewer testing outlets.

CAP's new path with ER/PR seems to be trying to achieve a noble end of 
improving quality in the laboratory but without an understanding of the 
complexities and consequences of the method they are implementing.

Dan

-Original Message-
>From: Jesus Ellin 
>Sent: Jun 26, 2010 6:28 AM
>To: "Morken, Tim" , 
>histonet@lists.utsouthwestern.edu
>Subject: RE: [Histonet] New CAP question ANP.22760
>
>I have been reading the post to this question and it seems to me that there 
>are different standards depending on the lab that is operating the 
>methodology.  I do agree that the core lab for years have had the instruction 
>and training in the performance of validation.  One thing that comes to mind 
>as well is why has histology not had this training?  Why are we not getting 
>this from our certification agency, our professional societies and biggest 
>reason where is our standardization.  It seems to me that with all these 
>regualtions in plac for so long, why were we missed.  Is it because when 
>inspected through CAP we are being inspected by a pathologist rather than a 
>histo tech?  These are some of the questions at hand.  I to see new standards 
>within the CAP checklist as well as other regulatory organizations that will 
>affect the future of the Anatomic Pathology community.  But I think we need is 
>to provide a underlying architecture for our peers, so that we can begin the 
>transition to the future.  This is only the beginning, there is still Digital 
>Image Analysis and Telepathology.  It funny we are looking to become a hybrid 
>of radiology and the core lab, but with the best of both worlds.  Tim great 
>structure for the validation study.  
>
>
>-Original Message-
>From: histonet-boun...@lists.utsouthwestern.edu on behalf of Morken, Tim
>Sent: Wed 6/23/2010 9:48 AM
>To: histonet@lists.utsouthwestern.edu
>Subject: RE: [Histonet] New CAP question ANP.22760
> 
>Joe,
>
>You wrote : The folks in the 'clinical' lab have been performing more 
>comprehensive and complex validation procedures for a very long time ..."
>
>Those were my thoughts exactly. While the person replying may or may not have 
>specific histology experience she will have clinical lab experience (however, 
>my guess is that she is exposed to histology regularly at CAP). Clin

RE: [Histonet] New CAP question ANP.22760

[Jesus Ellin]

I have been reading the post to this question and it seems to me that there are 
different standards depending on the lab that is operating the methodology.  I 
do agree that the core lab for years have had the instruction and training in 
the performance of validation.  One thing that comes to mind as well is why has 
histology not had this training?  Why are we not getting this from our 
certification agency, our professional societies and biggest reason where is 
our standardization.  It seems to me that with all these regualtions in plac 
for so long, why were we missed.  Is it because when inspected through CAP we 
are being inspected by a pathologist rather than a histo tech?  These are some 
of the questions at hand.  I to see new standards within the CAP checklist as 
well as other regulatory organizations that will affect the future of the 
Anatomic Pathology community.  But I think we need is to provide a underlying 
architecture for our peers, so that we can begin the transition to the future.  
This is only the beginning, there is still Digital Image Analysis and 
Telepathology.  It funny we are looking to become a hybrid of radiology and the 
core lab, but with the best of both worlds.  Tim great structure for the 
validation study.  


-Original Message-
From: histonet-boun...@lists.utsouthwestern.edu on behalf of Morken, Tim
Sent: Wed 6/23/2010 9:48 AM
To: histonet@lists.utsouthwestern.edu
Subject: RE: [Histonet] New CAP question ANP.22760
 
Joe,

You wrote : The folks in the 'clinical' lab have been performing more 
comprehensive and complex validation procedures for a very long time ..."

Those were my thoughts exactly. While the person replying may or may not have 
specific histology experience she will have clinical lab experience (however, 
my guess is that she is exposed to histology regularly at CAP). Clinical labs 
have a bit of an easier time, actually, because they validate primarily to 
known concentration controls - analytical controls manufactured at a range of 
known concentrations for instance. The institution then adds in their normal 
controls for validation.

As far as the current question about validating a new lot of reagent the best 
practice is to run parallel tests on the same machine. If that is not easily 
possible on a particular manufacturer's instrument then the question should be 
asked of them: Why not? If this is a requirement the manufacturer should 
provide an easy path to meeting the requirement. However, if that is not the 
case then the institution simply writes a procedure to get around the 
inadequacies of the instrument (Maybe the vendor can help with that). Then 
follow the procedure. That should satisfy inspectors.

An "...appropriate panel of tissues..." is whatever the institution deems 
appropriate for the given antibody or reagent. This is a perfect place for 
tissue arrays. You can make your own or buy them.

IHC must meet CLIA validation guidelines but since IHC is generally qualitative 
the requirements must be understood and methods adapted to a qualitative 
scenario. Several IHC and Histotechnology books discuss the subject at length 
(Taylor, Dabbs, Bancroft for instance).

Below is a brief overview of how to do that. (for more in-depth info this was 
covered in an NSH teleconference I gave last year - PowerPoint, audio and 
references available from NSH-, and will be covered in a similar workshop at 
NSH in Seattle this year).


1)
CAP General Validation
CAP GEN.42020-42163 Test Method Validation Follows CLIA CFR Sec 493.1253 Does 
not apply well to IHC (IHC is usually qualitative)

But the general principle applies:
The laboratory must have data on each test's accuracy, precision, analytic 
sensitivity, interferences and reportable range.

Unmodified FDA-cleared or approved tests:  the lab may use manufacturer 
information or published reports but lab must verify outside data.

Non-FDA cleared: Lab MUST verify or establish analytic accuracy, precision, 
sensitivity, specificity and reportable range.

2) Validation includes:
Accuracy:
Compare results with New antibody to a previously validated antibody
on the same tissues

Precision:
Test samples with varying antigen expression
Intra-run, Inter-run tests, 10 slides each (reproducibility)

Sensitivity:
True Positive vs False Negative (higher % FN = less sensitive)

Interferences [Specificity]:
True Negative vs False Positive (Higher % FP = less specific)
Delineate what could interfere to give a false positive or false
negative result.

Reportable Range
Establish a scoring system
Provide the definition of a positive result

3)Sensitivity

Analytic Sensitivity:
Lowest amount of substance detectable by the test
Can only be done with controls of known concentration

Diagnostic Sensitivity:
Ability of the test to determine true diagnostic positive v

RE: [Histonet] New CAP question ANP.22760

[Morken, Tim]

Joe,

You wrote : The folks in the 'clinical' lab have been performing more 
comprehensive and complex validation procedures for a very long time ..."

Those were my thoughts exactly. While the person replying may or may not have 
specific histology experience she will have clinical lab experience (however, 
my guess is that she is exposed to histology regularly at CAP). Clinical labs 
have a bit of an easier time, actually, because they validate primarily to 
known concentration controls - analytical controls manufactured at a range of 
known concentrations for instance. The institution then adds in their normal 
controls for validation.

As far as the current question about validating a new lot of reagent the best 
practice is to run parallel tests on the same machine. If that is not easily 
possible on a particular manufacturer's instrument then the question should be 
asked of them: Why not? If this is a requirement the manufacturer should 
provide an easy path to meeting the requirement. However, if that is not the 
case then the institution simply writes a procedure to get around the 
inadequacies of the instrument (Maybe the vendor can help with that). Then 
follow the procedure. That should satisfy inspectors.

An "...appropriate panel of tissues..." is whatever the institution deems 
appropriate for the given antibody or reagent. This is a perfect place for 
tissue arrays. You can make your own or buy them.

IHC must meet CLIA validation guidelines but since IHC is generally qualitative 
the requirements must be understood and methods adapted to a qualitative 
scenario. Several IHC and Histotechnology books discuss the subject at length 
(Taylor, Dabbs, Bancroft for instance).

Below is a brief overview of how to do that. (for more in-depth info this was 
covered in an NSH teleconference I gave last year - PowerPoint, audio and 
references available from NSH-, and will be covered in a similar workshop at 
NSH in Seattle this year).


1)
CAP General Validation
CAP GEN.42020-42163 Test Method Validation Follows CLIA CFR Sec 493.1253 Does 
not apply well to IHC (IHC is usually qualitative)

But the general principle applies:
The laboratory must have data on each test's accuracy, precision, analytic 
sensitivity, interferences and reportable range.

Unmodified FDA-cleared or approved tests:  the lab may use manufacturer 
information or published reports but lab must verify outside data.

Non-FDA cleared: Lab MUST verify or establish analytic accuracy, precision, 
sensitivity, specificity and reportable range.

2) Validation includes:
Accuracy:
Compare results with New antibody to a previously validated antibody
on the same tissues

Precision:
Test samples with varying antigen expression
Intra-run, Inter-run tests, 10 slides each (reproducibility)

Sensitivity:
True Positive vs False Negative (higher % FN = less sensitive)

Interferences [Specificity]:
True Negative vs False Positive (Higher % FP = less specific)
Delineate what could interfere to give a false positive or false
negative result.

Reportable Range
Establish a scoring system
Provide the definition of a positive result

3)Sensitivity

Analytic Sensitivity:
Lowest amount of substance detectable by the test
Can only be done with controls of known concentration

Diagnostic Sensitivity:
Ability of the test to determine true diagnostic positive verses false  
negative (higher % FN = less sensitive)
Requires comparison to a previously validated antibody

IHC Sensitivity:
Extent to which an antibody can be diluted and still achieve target 
recognition. NOTE: This is determined by antibody AND detection system!



4) Specificity:

Analytic Specificity
Accuracy on tests of known positive and negative controls
Controls of known concentration
Determine what could "Interfere" to confound the result


Diagnostic Specificity
Ability of a test to determine true diagnostic negative verses false
positives (Higher % FP = less specific)
Requires comparison to a previously validated antibody


IHC Specificity
Ability of an antibody to bind exclusively to its particular antigen
in the absence of staining of other molecules
Or, staining of other structures in addition to target  structures/cells

(Sensitivity and Specificity adapted from: Theoretical and Practical Aspects of 
Test Performance, in Immunomicroscopy, Taylor & Cote, 2005)

Tim Morken
Supervisor, Histology / IPOX
UCSF Medical Center
San Francisco, CA


-Original Message-
From: histonet-boun...@lists.utsouthwestern.edu 
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of jmye...@aol.com
Sent: Tuesday, June 22, 2010 6:51 PM
To: tjas...@copc.net
Cc: histonet@lists.utsouthwestern.edu
Subject: RE: [Histonet] New CAP question ANP.22760

Tom:

As 

RE: [Histonet] New CAP question ANP.22760

[JMyers1]

Tom:
 
As much as I agree with your acknowledgment that its seems a bit odd for 
the CAP to have a blood-banker responding to AP-related issue, I'm actually 
not surprised.  The folks in the 'clinical' lab have been performing more 
comprehensive and complex validation procedures for a very long time, and they 
wonder why IHC isn't expected to follow the same requirements as chemistry, 
immunology, etc. -- IHC is, after all, an awful lot like ELISA.  And 
rightfully so, because IHC is, under CLIA (which supersedes CAP), considered 
highly-complex, non-waived testing -- and is, therefore, subject to the same 
Quality Systems regulations (in particular, 42CFR493.1252-1256, 1273, and 1281) 
as 
the testing performed in other areas of the lab.
 
Could it be that, because AP produces qualitative results that are 
interpreted by a pathologist and CP produces quantitative results that are 
interpreted by an analyzer, we somehow think that CLIA rules don't apply to 
IHC?  I 
certainly don't have the answer to that, but it make me wonder what the 
future holds.  As witnessed by some of the newest CAP 'standards' (including 
the 
question in question...no pun intended), e.g. ER/PR, where a minimum of 20 
positive and 20 negative specimens must be tested, and where 10 of the 
positives must be weakly positive -- an acknowledgment that validation 
specimens 
must be carefully selected in order to obtain appropriate results), it 
certainly doesn't appear that the regulation of IHC testing is going to become 
more relaxed.
 
Joe Myers, M.S., CT(ASCP)
 
--

Message: 12
Date: Fri, 18 Jun 2010 12:38:07 -0700
From: "Thomas Jasper" 
Subject: RE: [Histonet] New CAP question ANP.22760
To: "Mark Tarango" 
Cc: _histo...@lists.utsouthwestern.edu_ 
(mailto:histonet@lists.utsouthwestern.edu) 

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 
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RE: [Histonet] New CAP question ANP.22760 - continued......

[Laurie Colbert]

Nancy,

If you email CAP and get a response, please post it for all of us to
see.  Thanks!
Laurie

-Original Message-
From: histonet-boun...@lists.utsouthwestern.edu
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Dana
Settembre
Sent: Monday, June 21, 2010 11:39 AM
To: histonet@lists.utsouthwestern.edu; Nancy Schmitt
Subject: Re: [Histonet] New CAP question ANP.22760 - continued..

Nancy,
Pose that question to CAP @ 
acc...@cap.org 
They are very good at returning email questions and
you'll have it from them and in writing.
 

Dana Settembre, HT ASCP
Immunohistochemistry Lab
UMDNJ - University Hospital
Newark, NJUSA


>>> Nancy Schmitt  06/21/10 2:16 PM >>>
Hi to all-
I hate to kick this dog any more than it already has been, but I still
would like to know what is considered an
appropriate panel of control tissues - and is it in a microarray or
sausage? What do you stain to test your detection systems?
Thanks much-
Nancy Schmitt HT(ASCP)MLT(CSMLS)
Histology Coordinator
Dubuque, IA


NOTICE: This email may contain legally privileged information. The
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that you have received it in error and then delete it along with any
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Re: [Histonet] New CAP question ANP.22760 - continued......

[Dana Settembre]

Nancy,
Pose that question to CAP @ 
acc...@cap.org 
They are very good at returning email questions and
you'll have it from them and in writing.
 

Dana Settembre, HT ASCP
Immunohistochemistry Lab
UMDNJ - University Hospital
Newark, NJUSA


>>> Nancy Schmitt  06/21/10 2:16 PM >>>
Hi to all-
I hate to kick this dog any more than it already has been, but I still
would like to know what is considered an
appropriate panel of control tissues - and is it in a microarray or
sausage? What do you stain to test your detection systems?
Thanks much-
Nancy Schmitt HT(ASCP)MLT(CSMLS)
Histology Coordinator
Dubuque, IA


NOTICE: This email may contain legally privileged information. The
information
is for the use of only the intended recipient(s) even if addressed
incorrectly. If you are not the intended recipient, please notify the
sender
that you have received it in error and then delete it along with any
attachments. Thank you.


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RE: [Histonet] New CAP question ANP.22760

[Horn, Hazel V]

So CAP answered the pathology question with a person who is a med tech
with a specialty in blood banking...

Hazel Horn
Hazel Horn, HT/HTL (ASCP)
Supervisor of Histology
Arkansas Children's Hospital
1 Children's WaySlot 820
Little Rock, AR   72202
 
phone   501.364.4240
fax501.364.3155
 
visit us on the web at:www.archildrens.org
 

-Original Message-
From: histonet-boun...@lists.utsouthwestern.edu
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Mark
Tarango
Sent: Friday, June 18, 2010 1:47 PM
To: McMahon, Loralee A
Cc: histonet@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:  **kpas...@cap.org* 



On Fri, Jun 18, 2010 at 10:47 AM, McMahon, Loralee A <
loralee_mcma...@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-boun...@lists.utsouthwestern.edu [
> histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Mike Pence [
> mpe...@grhs.net]
> Sent: Friday, June 18, 2010 12:41 PM
> To: Ellen Yee; Laurie Colbert
>  Cc: histonet@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-boun...@lists.utsouthwestern.edu
> [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Ellen
> Yee
> Sent: Thursday, June 17, 2010 7:21 PM
> To: Laurie Colbert
> Cc: histonet@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.colb...@huntingtonhospital.com]
> To: Ellen Yee [mailto:e...@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-boun...@lists.utsouthwestern.edu
> [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Ellen
> Yee
&

RE: [Histonet] New CAP question ANP.22760

[Mary Abosso]

One thing I noticed was:
 
"*Kathy Passarelli, MT(ASCP)SBB*

*Technical Specialist*

*Laboratory Accreditation Program*

*College** of American** Pathologists*

and then everything else became clear.
 
Mary Abosso
Denver, CO



From: histonet-boun...@lists.utsouthwestern.edu on behalf of Mike Pence
Sent: Fri 6/18/2010 2:12 PM
To: Thomas Jasper; Mark Tarango
Cc: histonet@lists.utsouthwestern.edu
Subject: RE: [Histonet] New CAP question ANP.22760



Tom

I did notice that too and wondered just how long this person had been
"out" of the working lab setting. This was something that was done back
when IHC was done all manually.  I think I will just take my chances
with what I am doing now as acceptable and wait and see what the CAP
inspector thinks or at least how they are dealing with this question!

Mike

-Original Message-
From: histonet-boun...@lists.utsouthwestern.edu
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Thomas
Jasper
Sent: Friday, June 18, 2010 2:38 PM
To: Mark Tarango
Cc: histonet@lists.utsouthwestern.edu
Subject: RE: [Histonet] New CAP question ANP.22760


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-boun...@lists.utsouthwestern.edu
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Mark
Tarango
Sent: Friday, June 18, 2010 11:47 AM
To: McMahon, Loralee A
Cc: histonet@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:  **kpas...@cap.org* 



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

> I think that CAP means t

Re: [Histonet] New CAP question ANP.22760

[Paula Pierce]

http://www.thefreedictionary.com/contemporaneously





From: "anni...@gmail.com" 
To: Mark Tarango ; Histonet 

Sent: Fri, June 18, 2010 3:38:01 PM
Subject: Re: [Histonet] New CAP question ANP.22760

Am following this IHC/CAP thread with great interest, but I have to ask...what 
is the origin of the word 'contemporaneously'?
English is my mother tongue but this word is new to me- simultaneous and 
contemporary make sense but this 'amalgamation' is an abomination!
Annie.
Anyone?
Empower your Business with BlackBerry® and Mobile Solutions from Etisalat

-Original Message-
From: Mark Tarango 
Sender: histonet-boun...@lists.utsouthwestern.edu
Date: Fri, 18 Jun 2010 11:46:53 
To: McMahon, Loralee A
Cc: histonet@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:  **kpas...@cap.org* 



On Fri, Jun 18, 2010 at 10:47 AM, McMahon, Loralee A <
loralee_mcma...@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-boun...@lists.utsouthwestern.edu [
> histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Mike Pence [
> mpe...@grhs.net]
> Sent: Friday, June 18, 2010 12:41 PM
> To: Ellen Yee; Laurie Colbert
>  Cc: histonet@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-boun...@lists.utsouthwestern.edu
> [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Ellen
> Yee
> Sent: Thursday, June 17, 2010 7:21 PM
> To: Laurie Colbert
> Cc: histonet@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.colb...@huntingtonhospital.com]
> To: Ellen Yee [mailto:e...@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 

RE: [Histonet] New CAP question ANP.22760

[sgoebel]

   They're  taking  lessons  from  our former president of the United St   
ates!!  =)

   Sarah Goebel, B.A., HT (ASCP)

   <= /em>

   Histotechnicia= n

   XBiotech USA Inc.

   <= div>8201 East Riverside Dr. B= ldg 4 Suite 100

   Austin, Texas  78744

   <= div>

   (512)= 386-5107

    Original Message ----
   Subject: Re: [Histonet] New CAP question ANP.22760
   From: [1]anni...@gmail.com
   Date: Fri, June 18, 2010 1:38 pm
   To: "Mark Tarango" <[2]marktaran= g...@gmail.com>, "Histonet"
   <[3]histo...@lists.u= tsouthwestern.edu>
   Am  following  this  IHC/CAP thread with great interest, but I have to
   ask...w= hat is the origin of the word 'contemporaneously'?
   English  is  my mother tongue but this word is new to me- simultaneous
   and   co=   ntemporary  make  sense  but  this  'amalgamation'  is  an
   abomination!
   Annie.
   Anyone?
   Empower  your Business with BlackBerry® and Mobile Solutions from
   Etisa= lat
   -Original Message-
   From: Mark Tarango <[4]marktaran= g...@gmail.com>
   Sender: [5]hist= onet-boun...@lists.utsouthwestern.edu
   Date: Fri, 18 Jun 2010 11:46:53
   To: McMahon, Loralee A<[6]loralee_mcma...@urmc.rochester.edu>
   Cc: [7]histo...@lists.u   
tsouthwestern.edu<[8]histo...@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
   lette= r
   that  I  got  from the CAP about this. I tried to argue with them, but
   this i= s
   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<=  br>  all  other  variables,  such  as variations in the lot of
   detection  reagent  or<=  br> instrument function, are eliminated from
   consideration when the slides are<= br> 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 int= o
   service, is *required* for all accredited laboratories.
   To  answer the last question, the key is to order the new reagent well
   befor= e
   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<=  br> 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<= br> 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: [9]**kpas...@cap.org* <= ;[10]kpas...@cap.org>
   On Fri, Jun 18, 2010 at 10:47 AM, McMahon, Loralee A <
   [11]loralee_mcma...@urm= c.rochester.edu> wrote:
   >  I think that CAP means that you need to save the slide that you ran
   fr= om
   >  the  previous lot and compare it to the slide that you have stained
   wit= h the
   >  new  lot  number. To see if they are sufficient diagnostic quality.
   No= t put
   >  both  lot  numbers on the machine at the same time and then compare
   the<= br> > slides? We run Dako machines and it would be tricky to put
   both numb= ers 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: [12]h= istonet-boun...@lists.utsouthwestern.edu [
   >  [13]histone=  t-boun...@lists.utsouthwestern.edu] On Behalf Of Mike
   Pence [
   > [14]mpe...@grhs.net]
   > Sent: Friday, June 18, 2010 12:41 PM
   > To: Ellen Yee; Laurie Colbert
   > Cc: [15]histo...@l= ists.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
   i= n
   > "parallel&

Re: [Histonet] New CAP question ANP.22760

[Mark Tarango]

Hi Tom,

I did notice.  In my original question, I had said something like "is it
possible that the Pathologists that gave the teleconference are somewhat out
of touch with the realities of doing this in the lab?"  Instead of the
speakers writing back, I got her response.

I was just glad that she did say it was acceptable (but not best
practice) to compare against a previosly stained slide.  In the
teleconference he was very clear that he wanted the slides to be stained
side-by-side.

Mark


On Fri, Jun 18, 2010 at 12:38 PM, Thomas Jasper  wrote:

> 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-boun...@lists.utsouthwestern.edu
> [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Mark
> Tarango
> Sent: Friday, June 18, 2010 11:47 AM
> To: McMahon, Loralee A
> Cc: histonet@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:  **kpas...@cap.org* 
>
>
>
> On Fri, Jun 18, 2010 at 10:47 AM, McMahon, Loralee A <
> loralee_mcma...@urmc.rochester.edu> wrote:
>
> > I think that CAP means that you need to save the slide that you ran
> > from the

Re: [Histonet] New CAP question ANP.22760

[annigyg]

Am following this IHC/CAP thread with great interest, but I have to ask...what 
is the origin of the word 'contemporaneously'?
English is my mother tongue but this word is new to me- simultaneous and 
contemporary make sense but this 'amalgamation' is an abomination!
Annie.
Anyone?
Empower your Business with BlackBerry® and Mobile Solutions from Etisalat

-Original Message-
From: Mark Tarango 
Sender: histonet-boun...@lists.utsouthwestern.edu
Date: Fri, 18 Jun 2010 11:46:53 
To: McMahon, Loralee A
Cc: histonet@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:  **kpas...@cap.org* 



On Fri, Jun 18, 2010 at 10:47 AM, McMahon, Loralee A <
loralee_mcma...@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-boun...@lists.utsouthwestern.edu [
> histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Mike Pence [
> mpe...@grhs.net]
> Sent: Friday, June 18, 2010 12:41 PM
> To: Ellen Yee; Laurie Colbert
>  Cc: histonet@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-boun...@lists.utsouthwestern.edu
> [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Ellen
> Yee
> Sent: Thursday, June 17, 2010 7:21 PM
> To: Laurie Colbert
> Cc: histonet@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.colb...@huntingtonhospital.com]
> To: Ellen Yee [mailto:e...@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-boun...@lists.utsouthwestern.edu
> [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Ellen
> Yee
> Sent: Wednesday, June 16, 2010 10:10 PM
> To: histone

RE: [Histonet] New CAP question ANP.22760

[Mike Pence]

Tom

I did notice that too and wondered just how long this person had been
"out" of the working lab setting. This was something that was done back
when IHC was done all manually.  I think I will just take my chances
with what I am doing now as acceptable and wait and see what the CAP
inspector thinks or at least how they are dealing with this question!

Mike

-Original Message-
From: histonet-boun...@lists.utsouthwestern.edu
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Thomas
Jasper
Sent: Friday, June 18, 2010 2:38 PM
To: Mark Tarango
Cc: histonet@lists.utsouthwestern.edu
Subject: RE: [Histonet] New CAP question ANP.22760


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-boun...@lists.utsouthwestern.edu
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Mark
Tarango
Sent: Friday, June 18, 2010 11:47 AM
To: McMahon, Loralee A
Cc: histonet@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:  **kpas...@cap.org* 



On Fri, Jun 18, 2010 at 10:47 AM, McMahon, Loralee A <
loralee_mcma...@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 M

RE: [Histonet] New CAP question ANP.22760

[Thomas Jasper]

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-boun...@lists.utsouthwestern.edu
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Mark
Tarango
Sent: Friday, June 18, 2010 11:47 AM
To: McMahon, Loralee A
Cc: histonet@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:  **kpas...@cap.org* 



On Fri, Jun 18, 2010 at 10:47 AM, McMahon, Loralee A <
loralee_mcma...@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-boun...@lists.utsouthwestern.edu [ 
> histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Mike Pence [ 
> mpe...@grhs.net]
> Sent: Friday, June 18, 2010 12:41 PM
> To: Ellen Yee; Laurie Colbert
>  Cc: histonet@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 &qu

RE: [Histonet] New CAP question ANP.22760

[Mike Pence]

As I have found over the years the opinions and interpretation of CAP
intent is differing. Everyone has how they see the question and think it
to best be answered. I am not sure why it is not acceptable for the lab
to run a control on the new lot and make sure it works and that is the
QC/QA. The pathologist is the one that determines if the stain is
acceptable for diagnosis. Some of the suggestions would be very time
consuming and costly to do each new lot#.

-Original Message-
From: Vickroy, Jim [mailto:vickroy@mhsil.com] 
Sent: Friday, June 18, 2010 1:06 PM
To: Mark Tarango; Mike Pence
Cc: histonet@lists.utsouthwestern.edu
Subject: RE: [Histonet] New CAP question ANP.22760


I'm kind of getting in on the middle of this but is anybody else doing
this with prep kit stickers?  I have not seen the new question but has
anyone talked to CAP to get a clarification of what they mean on this
question?

James Vickroy BS, HT(ASCP)

Surgical  and Autopsy Pathology Technical Supervisor
Memorial Medical Center
217-788-4046


-Original Message-
From: histonet-boun...@lists.utsouthwestern.edu
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Mark
Tarango
Sent: Friday, June 18, 2010 12:27 PM
To: Mike Pence
Cc: histonet@lists.utsouthwestern.edu
Subject: Re: [Histonet] New CAP question ANP.22760

You'll have to use prep kit stickers and duplicate protocols to do it,
but it is possible.  You just need to copy the protocol and save it as
another number, then change the primary antibody to a prep kit sticker
save again and then put that sticker on the dispenser.  Then you need to
print stickers for both protocols and stick them on two controls slides
and run.

I admit its a little bit of a pain.

Mark

On Fri, Jun 18, 2010 at 9:41 AM, Mike Pence  wrote:

>
> 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-boun...@lists.utsouthwestern.edu
> [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Ellen 
> Yee
> Sent: Thursday, June 17, 2010 7:21 PM
> To: Laurie Colbert
>  Cc: histonet@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.colb...@huntingtonhospital.com]
> To: Ellen Yee [mailto:e...@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-boun...@lists.utsouthwestern.edu
> [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Ellen 
> Yee
> Sent: Wednesday, June 16, 2010 10:10 PM
> To: histonet@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
>
> ___
> Histonet mailing list
> Histonet@lists.utsouthwestern.edu 
> http://lists.utsouthwestern.edu/mailman/listinfo/histonet
>
>
>
> ___
> Histonet mailing list
> Histonet@lists.utsouthwestern.edu 
> http://lists.utsouthwestern.edu/mailman/listinfo/histonet
>
>
>
> ___
> Histonet mailing list
> Histonet@lists.utsouthwestern.edu 
> http://lists.utsouthwestern.edu/mailman/listinfo/histonet
>
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This message (including any attachments) contains confidential
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Re: [Histonet] New CAP question ANP.22760

[Mark Tarango]

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:  **kpas...@cap.org* 



On Fri, Jun 18, 2010 at 10:47 AM, McMahon, Loralee A <
loralee_mcma...@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-boun...@lists.utsouthwestern.edu [
> histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Mike Pence [
> mpe...@grhs.net]
> Sent: Friday, June 18, 2010 12:41 PM
> To: Ellen Yee; Laurie Colbert
>  Cc: histonet@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-boun...@lists.utsouthwestern.edu
> [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Ellen
> Yee
> Sent: Thursday, June 17, 2010 7:21 PM
> To: Laurie Colbert
> Cc: histonet@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.colb...@huntingtonhospital.com]
> To: Ellen Yee [mailto:e...@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-boun...@lists.utsouthwestern.edu
> [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Ellen
> Yee
> Sent: Wednesday, June 16, 2010 10:10 PM
> To: histonet@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
>
> ___
> Histonet mailing list
> Histonet@lists.utsouthwestern.edu
> http://lists.utsouthwestern.edu/mailman/listinfo/histonet
>
>
>
> ___
> Histonet mailing list
&

RE: [Histonet] New CAP question ANP.22760

[BSullivan]

Regarding this question. This is my take on this. You always have to check
Lot to Lot antibodies and make sure you have consistent results. We have a
ledger where our new lots are recorded when received into the lab. There is
also a place for all the necessary information about the antibody, the lot
number , open date, Q.C. date and the antibody's expiration date. Once the
antibody is opened it is Q.C'd on tissue that we have used in the past for
control material. The control is checked and it is noted if the results are
favorable or not. If there are favorable results it is put into production.

Beatrice Sullivan, HT(A.S.C.P.) HTL , AAS, CLSP(N.C.A.)
AP Supervisor
Shore Memorial Hospital
609-653-3590


   
 "McMahon, Loralee 
 A"
 , Ellen 
 u>Yee , Laurie  
 Sent by:  Colbert 
 histonet-bounces@ 
 ern.educc 
   "histonet@lists.utsouthwestern.edu" 

 06/18/2010 01:47  Subject 
         PM            RE: [Histonet] New CAP question 
       ANP.22760   
   
   
   
   
   
   




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-boun...@lists.utsouthwestern.edu
[histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Mike Pence
[mpe...@grhs.net]
Sent: Friday, June 18, 2010 12:41 PM
To: Ellen Yee; Laurie Colbert
Cc: histonet@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-boun...@lists.utsouthwestern.edu
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Ellen
Yee
Sent: Thursday, June 17, 2010 7:21 PM
To: Laurie Colbert
Cc: histonet@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.colb...@huntingtonhospital.com]
To: Ellen Yee [mailto:e...@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-boun...@lists.utsouthwestern.edu
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Ellen
Yee
Sent: Wednesday, June 16, 2010 10:10 PM
To: histonet@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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__

RE: [Histonet] New CAP question ANP.22760

[Vickroy, Jim]

I'm kind of getting in on the middle of this but is anybody else doing this 
with prep kit stickers?  I have not seen the new question but has anyone talked 
to CAP to get a clarification of what they mean on this question?

James Vickroy BS, HT(ASCP)

Surgical  and Autopsy Pathology Technical Supervisor
Memorial Medical Center
217-788-4046


-Original Message-
From: histonet-boun...@lists.utsouthwestern.edu 
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Mark Tarango
Sent: Friday, June 18, 2010 12:27 PM
To: Mike Pence
Cc: histonet@lists.utsouthwestern.edu
Subject: Re: [Histonet] New CAP question ANP.22760

You'll have to use prep kit stickers and duplicate protocols to do it, but
it is possible.  You just need to copy the protocol and save it as another
number, then change the primary antibody to a prep kit sticker save again
and then put that sticker on the dispenser.  Then you need to print stickers
for both protocols and stick them on two controls slides and run.

I admit its a little bit of a pain.

Mark

On Fri, Jun 18, 2010 at 9:41 AM, Mike Pence  wrote:

>
> 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-boun...@lists.utsouthwestern.edu
> [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Ellen
> Yee
> Sent: Thursday, June 17, 2010 7:21 PM
> To: Laurie Colbert
>  Cc: histonet@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.colb...@huntingtonhospital.com]
> To: Ellen Yee [mailto:e...@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-boun...@lists.utsouthwestern.edu
> [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Ellen
> Yee
> Sent: Wednesday, June 16, 2010 10:10 PM
> To: histonet@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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RE: [Histonet] New CAP question ANP.22760

[McMahon, Loralee A]

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-boun...@lists.utsouthwestern.edu 
[histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Mike Pence 
[mpe...@grhs.net]
Sent: Friday, June 18, 2010 12:41 PM
To: Ellen Yee; Laurie Colbert
Cc: histonet@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-boun...@lists.utsouthwestern.edu
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Ellen
Yee
Sent: Thursday, June 17, 2010 7:21 PM
To: Laurie Colbert
Cc: histonet@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.colb...@huntingtonhospital.com]
To: Ellen Yee [mailto:e...@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-boun...@lists.utsouthwestern.edu
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Ellen
Yee
Sent: Wednesday, June 16, 2010 10:10 PM
To: histonet@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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Re: [Histonet] New CAP question ANP.22760

[Mark Tarango]

You'll have to use prep kit stickers and duplicate protocols to do it, but
it is possible.  You just need to copy the protocol and save it as another
number, then change the primary antibody to a prep kit sticker save again
and then put that sticker on the dispenser.  Then you need to print stickers
for both protocols and stick them on two controls slides and run.

I admit its a little bit of a pain.

Mark

On Fri, Jun 18, 2010 at 9:41 AM, Mike Pence  wrote:

>
> 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-boun...@lists.utsouthwestern.edu
> [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Ellen
> Yee
> Sent: Thursday, June 17, 2010 7:21 PM
> To: Laurie Colbert
>  Cc: histonet@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.colb...@huntingtonhospital.com]
> To: Ellen Yee [mailto:e...@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-boun...@lists.utsouthwestern.edu
> [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Ellen
> Yee
> Sent: Wednesday, June 16, 2010 10:10 PM
> To: histonet@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
>
> ___
> Histonet mailing list
> Histonet@lists.utsouthwestern.edu
> http://lists.utsouthwestern.edu/mailman/listinfo/histonet
>
>
>
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RE: [Histonet] New CAP question ANP.22760

[Cynthia Robinson]

I do this but it has to be separate runs or wait until the kit is just running 
out. I also keep the slides from the initial QC run and compare it with the new 
lot to assure same intensity staining is obtained when changing lots.

Cindi Robinson HT(ASCP)
Mercy Medical Center
Dunes Medical Laboratories
350 W Anchor Dr
Dakota Dunes SD 57049
phone-712-279-2768
robin...@mercyhealth.com


>>> "Mike Pence"  6/18/2010 11:41 AM >>>

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-boun...@lists.utsouthwestern.edu 
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Ellen
Yee
Sent: Thursday, June 17, 2010 7:21 PM
To: Laurie Colbert
Cc: histonet@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.colb...@huntingtonhospital.com] 
To: Ellen Yee [mailto:e...@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-boun...@lists.utsouthwestern.edu 
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Ellen
Yee
Sent: Wednesday, June 16, 2010 10:10 PM
To: histonet@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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RE: [Histonet] New CAP question ANP.22760

[Mike Pence]

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-boun...@lists.utsouthwestern.edu
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Ellen
Yee
Sent: Thursday, June 17, 2010 7:21 PM
To: Laurie Colbert
Cc: histonet@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.colb...@huntingtonhospital.com]
To: Ellen Yee [mailto:e...@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-boun...@lists.utsouthwestern.edu
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Ellen
Yee
Sent: Wednesday, June 16, 2010 10:10 PM
To: histonet@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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RE: [Histonet] New CAP question ANP.22760

[Rathborne, Toni]

Should these slides be retained? If so, how long? Or is it enough just to have 
the documentation?

-Original Message-
From: histonet-boun...@lists.utsouthwestern.edu
[mailto:histonet-boun...@lists.utsouthwestern.edu]on Behalf Of Ellen Yee
Sent: Thursday, June 17, 2010 8:21 PM
To: Laurie Colbert
Cc: histonet@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.colb...@huntingtonhospital.com]
To: Ellen Yee [mailto:e...@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-boun...@lists.utsouthwestern.edu
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Ellen
Yee
Sent: Wednesday, June 16, 2010 10:10 PM
To: histonet@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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RE: [Histonet] New CAP question ANP.22760

[Ellen Yee]

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.colb...@huntingtonhospital.com]
To: Ellen Yee [mailto:e...@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-boun...@lists.utsouthwestern.edu
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Ellen
Yee
Sent: Wednesday, June 16, 2010 10:10 PM
To: histonet@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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