Thanks to everyone that has responded to my question.
We specifically interested in the procedure for this CAP question:
COM.40350 Validation of Test Performance Specifications - Modified FDA-cleared/
approved Tests and LDTs
Prior to clinical use of each modified FDA-cleared or approved test
We are working on IHC antibody validations and I want to know if there is a
minimum number of slides you must run to demonstrate precision? I have not
been able to find a definitive number or procedure. What is everyone doing
for this?
Thanks in advance for everyone's help.
Martha Ward
It was brought to my attention that we had significant washing on 3 of 8 bone
marrow clot sections the other day; this is not the first time so we would like
to get to the bottom of this. We use positively charged slides and all 8
cases were cut and run the same morning but allowed to air
Our heme path docs are interested in this antibody and I wondered if anyone has
a protocol they can share?We have the Leica Bond 3 as our staining
platform/detection system.
Thanks in advance for your help.
Martha Ward MT(ASCP) QIHC
Manager, Molecular Diagnostics Lab
Atrium Health Wake
Thank you for the information. I will look into your antibody source.
Martha
-Original Message-
From: Cartun, Richard
Sent: Tuesday, June 15, 2021 3:26 PM
To: Martha Ward-Pathology
Cc: histonet@lists.utsouthwestern.edu
Subject: [EXTERNAL] RE: HSV1 and HSV2
Hi Martha:
We are using
We have always offered these two antibodies separately but recently we have
begun having issues with our HSV2. In researching a new source I am seeing
that some places do some sort of cocktail mixture of the two. What are others
out there doing for this?
Thanks in advance for your help.
I am posting this question for our Histology manager:
Does anyone dry coverslipped slides in an oven before filing and if so how long
and at what temperature. We are having issues with filed slides sticking
together.
Thanks in advance for your help with her question.
Martha Ward, MT ASCP
When doing an initial antibody validation CAP requires at least 90% concordance
between the new test and the comparator test or expected values.Are there
specified requirements for sensitivity, specificity and accuracy?
Thanks in advance for any help provided!
Martha Ward, Manager,
We are in the process of switching to AP Beaker and in the midst of the build.
My question involves how others are handling outside consult surgical and/or
cytology cases. Do you assign them an unique number that identifies them as a
consult as opposed to an inside case - SO20- verses
I am posting this question for a colleague in our Cytology department. How
often do you see floaters on surgical or cytology specimens?Obviously we
would never want to see any type of carryover but is there a standard rate
published somewhere that he can reference?
Thanks in advance
I am posting this question for my colleague in the Histology lab. She is
working on a plan for a new tissue processor validation, including special
stains, and would like to get input from anyone that has already gone through
it.This is the first time anyone here has ever been involved in
Hello all,
After a very long time our histology department is getting a new tissue
processor, and hopefully several more in the near future. Of course for IHC
that means a revalidation/reverification of our IHC stains. Since I have not
had to do this before I wanted to get some guidance on
This may be an odd request but I am hoping someone out there can help us with
this problem. Our institution is purchasing new digital scanners (Olympus
200) to scan all our pathology case slides. It has come to our attention
that the mounting media we have all been using for cover
Our department is looking at safety issues and one suggestion from our CLIA
director is that everyone in the lab (our lab performs IHC only) should wear
gloves, a gown and eye or face protection at all times and requiring it for
anyone that enters the lab. We have task specific PPE
We are looking for IVD antibodies for C1q and C4d for use on frozen tissues
(renal). What vendors are folks using for these direct immunofluorescence
stains?
Thanks in advance for your help.
Martha Ward
Wake Forest Baptist Health
Winston-Salem, NC 27157
I am having trouble locating a distributor for the Zeus Wash solution (cat#103)
that we use to wash our skin and renal biopsies.Cardinal and Fisher do not
seem to carry it and we do not have Zeus Scientific in our system as a vendor
we can use. Any help would be appreciated!
Thanks,
Am I the only one that finds it odd and frustrating that some vendors are
closed on Presidents Day? I just tried to call the technical service number
for Dako about a problem and the message said to call back tomorrow!
Hospital labs don't close and I would have thought they would at least
My medical director and I are working on our procedure for reproducibility in
our IHC validations and would like to know how others are handling this.
How many slides do you run and over how many days/runs?If someone would
share their procedure with us that would be wonderful.
Thanks in
Hello,
My billing group wanted me to ask if anyone is seeing denials for reimbursement
for HPV testing on male Medicare patients when it is performed on ffpe for head
and neck tumors? We have seen a few denials recently and they wanted to see
how everyone is handling the coding. This is
I am posting this for our Histology lab manager:
Is anyone recycling formalin and if so, exactly what are you using the recycled
formalin for?Putting it on processors, adding to specimens, etc?
Apparently our EHS department is pushing this.
Also thank everyone for their help with our
I am posting this question for our Histology manager.For prostate needle
biopsies how many levels and unstained slides are people cutting and also how
long after the case is signed out is everyone keeping the unstained slides that
have been cut?
Thanks in advance for everyone's help.
"They" aren't the ones that will have to use it.therein lies the rub! I
have not heard many positive things about AP Beaker.
Martha Ward, MT (ASCP) QIHC
Manager
Molecular Diagnostics Lab
Medical Center Boulevard \ Winston-Salem, NC 27157
p 336.716.2109 \ f 336.716.5890
Hello everyone,
I am trying to find someone who can share a C4d ffpe control block with us.
Ours is almost gone and I don't have access to any suitable tissues in house.
If anyone has a block they are willing to share please contact me. I can try
to help out with any controls that you may
Good morning,
I have had a request for this antibody but I am having trouble locating a
vendor for it.If anyone has any information on vendor, etc. , I would
appreciate it. We have Leica Bond 3s.
Thank you in advance for your help.
Martha Ward
Wake Forest Baptist Health
How is everyone handling new instrument validation processes? We are looking
at getting a new immunostainer.Beyond the varication process that the
installers do what are our responsibilities from a lab stand point? We have a
large menu of antibodies.Would it be sufficient to run one
Does anyone have a specific form that they use to indicate that a particular
instrument is functioning as expected after service repairs or PMs? We need
to document this information and I would like a simple form to fill out and
include with the service reports.Just trying to not have to
We just installed a new Dako Link Autostainer and have started using the
Herceptest Link kit. We had been using two drop zones with our other, older
instrument but that was applying only 100 uL in the 2 drop zones. With this
new program we set it up to apply two zones of 200 uL but
I have been asked to look into offering PLA2R on our renal biopsies and in
doing some research on the subject I find that some people are staining frozen
tissue via an indirect IMF procedure and some are staining ffpe tissues, also
using an indirect IMF procedure.I would prefer to do this
I agreethe delete button is very easy to use.
-Original Message-
From: Jennifer MacDonald via Histonet
[mailto:histonet@lists.utsouthwestern.edu]
Sent: Thursday, April 14, 2016 12:16 PM
To: Rene J Buesa
Cc: histonet@lists.utsouthwestern.edu
Subject: Re: [Histonet] Blog Post Not
Yes that is how we do it as well.
Martha Ward, MT (ASCP) QIHC
Manager
Molecular Diagnostics Lab
Medical Center Boulevard \ Winston-Salem, NC 27157
p 336.716.2109 \ f 336.716.5890
mw...@wakehealth.edu
-Original Message-
From: Vickroy, James
That's what we do as well.
Martha Ward
Wake Forest Baptist Health
From: Weems, Joyce K. [joyce.we...@emoryhealthcare.org]
Sent: Friday, May 01, 2015 9:13 AM
To: 'Cartun, Richard'; histonet@lists.utsouthwestern.edu
Subject: Re: [Histonet] IHC billing
We have not been charging for the negative control, assuming that it was just a
cost of doing business. I would be interested to hear if anyone has been
charging for their negative controls as well.
Martha Ward, MT (ASCP) QIHC
Manager
Molecular Diagnostics Lab
Medical Center Boulevard \
In advance of preparing for our CAP inspection window, I am working on our
validation write-up for our Her2 IHC and was looking for some data concerning
the correlation rates.We compared our IHC staining to FISH Her2 results on
the same case. Is there a minimum correlation rate? I have
We dilute ours 1:5 from the predilute and run it on the Bond 3. It works very
well.
Martha Ward, MT (ASCP) QIHC
Manager
Molecular Diagnostics Lab
Medical Center Boulevard \ Winston-Salem, NC 27157
p 336.716.2109 \ f 336.716.5890
mw...@wakehealth.edu
-Original Message-
I just need a moment to ventis it just me or is everyone seeing more and
more back order issues with their various vendors? It is not specific to any
one particular vendor, product or even category of product, but lately I am
being told more and more often that an item is not
for the inconvenience.
Argg
-Original Message-
From: Marcum, Pamela A [mailto:pamar...@uams.edu]
Sent: Tuesday, December 02, 2014 10:59 AM
To: Martha Ward-Pathology; histonet@lists.utsouthwestern.edu
Subject: RE: back orders from various vendors
Happens every year at this time with various
...@lists.utsouthwestern.edu
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Martha
Ward-Pathology
Sent: Monday, December 01, 2014 2:21 PM
To: histonet@lists.utsouthwestern.edu
Subject: [Histonet] EDTA decalcification solution
I am asking this question for our Histology Lab. They are being asked about
I am asking this question for our Histology Lab. They are being asked about
using EDTA as a decal solution for bone and wondered if anyone else is using
this?Is this available as a ready to use? Or do you have to make it up?
What vendors are you using and could you provide a procedure
Sounds like we are all working at the same place! LOL
I hear exactly the same questions.is it something they teach to all
pathology residents
Martha Ward, MT (ASCP) QIHC
Manager
Molecular Diagnostics Lab
Medical Center Boulevard \ Winston-Salem, NC 27157
p 336.716.2109 \ f
We do the same thing on our lab. It isn't necessary for them to rollwe
just catch them and fold them up and put them in the tube.
Martha Ward, MT (ASCP) QIHC
Manager
Molecular Diagnostics Lab
Medical Center Boulevard \ Winston-Salem, NC 27157
p 336.716.2109 \ f 336.716.5890
So do we.
Martha Ward, MT (ASCP) QIHC
Manager
Molecular Diagnostics Lab
Medical Center Boulevard \ Winston-Salem, NC 27157
p 336.716.2109 \ f 336.716.5890
mw...@wakehealth.edu
-Original Message-
From: histonet-boun...@lists.utsouthwestern.edu
Hello all,
I have been reading through the most recent revisions and want to see how
others are handling this question. The explanation states that it is for new
and existing assays and that if your validation does not meet current standards
that you must supplement and bring it into
I'm with you. There really appears to be no value to this particular
requirement.I would only be concerned with it if I had just purchased it,
or moved it into our lab from another location.
Martha Ward, MT (ASCP) QIHC
Manager
Molecular Diagnostics Lab
Medical Center Boulevard \
We discontinued them over a year ago.
Martha Ward, MT (ASCP) QIHC
Manager
Molecular Diagnostics Lab
Medical Center Boulevard \ Winston-Salem, NC 27157
p 336.716.2109 \ f 336.716.5890
mw...@wakehealth.edu
-Original Message-
From: histonet-boun...@lists.utsouthwestern.edu
on our PCR testing as those are batched.
More of an editorial comment that anything else
Martha
From: Rene J Buesa [mailto:rjbu...@yahoo.com]
Sent: Monday, February 03, 2014 4:38 PM
To: Martha Ward-Pathology; Dawn Bugge; histonet@lists.utsouthwestern.edu
Subject: Re: [Histonet] Turn Around Time
While I recognize the need for a quick result in some cases, I also subscribe
to the theory that speed kills. I'm not sure that these quick TATs are
always medically necessary, but rather more of a convenience.However that
is another discussion altogether. That said, our institution
That is an interesting observation, as we have seen something of the same thing
and we use the Dako Herceptest.I would be interested in hearing others
responses as well. Thank you for asking the question.
Martha Ward, MT (ASCP) QIHC
Manager
Molecular Diagnostics Lab
Medical Center
I am looking for a vendor for FITC labeled IgG1, IgG2 IgG3 and IgG4 antibodies
for use in our immunofluorescence panels when staining renal biopsies. We
get most of our FITC antibodies for our panel from Dako but I didn't see these
others. Any suggestions are appreciated. Thanks in
We have something of a mystery here and I am hoping someone can help. My
cytopath docs are saying that our B72.3 (TAG-72) antibody is not working well
in cell blocks created from fluids (plural), etc. and that this is a fairly
recent development (over the past 5-6 weeks or so).The
the same doctor/clinic and
see if they are doing anything different.
Martha
-Original Message-
From: Tom McNemar [mailto:tmcne...@lmhealth.org]
Sent: Thursday, October 31, 2013 9:17 AM
To: Martha Ward-Pathology; histonet@lists.utsouthwestern.edu
Subject: RE: cell block staining issues
We have
I have had the same problem over the past few months...
Martha Ward, MT (ASCP) QIHC
Manager
Molecular Diagnostics Lab
Medical Center Boulevard \ Winston-Salem, NC 27157
p 336.716.2109 \ f 336.716.5890
mw...@wakehealth.edu
-Original Message-
From:
Is there a minimum number of cells that should be present when testing for ER,
PR and Her2? I have looked on the CAP website but cannot see anything about
this. We are constantly getting these small biopsies or FNAs for testing and I
sometimes wonder what the lowest threshold is for
Thanks everyone
From: Rene J Buesa [mailto:rjbu...@yahoo.com]
Sent: Thursday, September 12, 2013 10:56 AM
To: Martha Ward-Pathology; histonet@lists.utsouthwestern.edu
Subject: Re: [Histonet] Minimum sample size for breast markers
No, there are no written instructions on the subject. You just
Thanks to everyone that responded to my question. It has encouraged a nice
discussion and I have learned from it.
Martha Ward, MT (ASCP) QIHC
Manager
Molecular Diagnostics Lab
Medical Center Boulevard \ Winston-Salem, NC 27157
p 336.716.2109 \ f 336.716.5890
mw...@wakehealth.edu
I would be interested in any information as well. We do not plan to
implement for a year or more but one of our hospitals is working on Beaker now
and finding that it does not adapt to AP as well as it does CP.
Martha Ward, MT (ASCP) QIHC
Manager
Molecular Diagnostics Lab
Medical Center
We do quite a number of renal biopsies and sometimes the frozen tissue is not
sufficient for the immunofluorescent panel and we have to use paraffin sections
for our fluorescence staining. It has never really worked all that well and
so we are looking for alternative methods.
We get all
We are looking at ways to improve our work processes, save time and labor and
reduce costs, all while maintaining patient quality...as we all are of course.
During our conversations the subject of cutting unstained slides has come up
and we are looking for bench marking data to see if we are
I have been asked by a new pathologist to look into a DAB enhancer for use on
our Bond III instruments. Are many of you using this on the Bond, or any
other staining platform and what are the pros and cons of its use?
Thanks!
Martha Ward, MT (ASCP) QIHC
Manager
Molecular Diagnostics Lab
Sorry but I cannot get my messages to go through to the Histonet so I am
piggybacking onto a previous message:
I have been asked by a new pathologist to look into a DAB enhancer for use on
our Bond III instruments. Are many of you using this on the Bond, or any
other staining platform and
At our institution the hospital bills the technical and the pathologist bills
the professional.
Martha Ward, MT (ASCP) QIHC
Manager
Molecular Diagnostics Lab
Medical Center Boulevard \ Winston-Salem, NC 27157
p 336.716.2109 \ f 336.716.5890
mw...@wakehealth.edu
-Original
I am having trouble posting to the histonet for some reason. I am looking for
condition and incubation times for p16 on the Bond. Our new pathologist says
our p16 looks overstained to him and not at all what he is accustomed to seeing
and I am trying to get the staining more to his liking,
We eliminated them on August 1st, except in cases where they are specifically
requested. So far we have run 10 negative slides.
Martha Ward, MT (ASCP) QIHC
Manager
Molecular Diagnostics Lab
Medical Center Boulevard \ Winston-Salem, NC 27157
p 336.716.2109 \ f 336.716.5890
What wonderful news
Martha Ward, MT (ASCP) QIHC
Manager
Molecular Diagnostics Lab
Medical Center Boulevard \ Winston-Salem, NC 27157
p 336.716.2109 \ f 336.716.5890
mw...@wakehealth.edu
-Original Message-
From: histonet-boun...@lists.utsouthwestern.edu
Again, we would be interested in any replies as well. Our institution is
going live with Epic this fall but the labs will not be using Beaker until
later on. We are still trying to figure out how all this will work and
welcome all information.
Paula, how soon will Duke be up and using
Mihalik [mailto:m...@pathview.com]
Sent: Friday, July 13, 2012 2:03 PM
To: Martha Ward-Pathology; 'Paula Sicurello'; 'HistoNet';
microsc...@microscopy.com
Subject: RE: [Histonet] Beaker module in EPIC
I'm curious. Are ANY labs using Epic for their APLIS? The last I heard
was a sales
We would interested in any replies as well.
Martha Ward, MT (ASCP) QIHC
Manager
Molecular Diagnostics Lab
Medical Center Boulevard \ Winston-Salem, NC 27157
p 336.716.2109 \ f 336.716.5890
mw...@wakehealth.edu
-Original Message-
From:
Hello. I was wondering if anyone had used the NapsinA from BioCare on the
Bond III and if so, would you mind sharing your protocol?
Thanks in advance for any advice you can give.
Martha Ward, MT (ASCP) QIHC
Manager, Molecular Diagnostics Lab
Dept. of Pathology
Wake Forest University Baptist
From what we understand from the new policy the cocktailed antibodies, such as
PIN4, are not to be charged separately.
Martha Ward, MT (ASCP) QIHC
Manager, Molecular Diagnostics Lab
Dept. of Pathology
Wake Forest University Baptist Medical Center
Winston-Salem, NC 27157
336-716-2104
I would also be interested in any replies concerning EPIC-beaker.
Martha Ward, MT (ASCP) QIHC
Manager, Molecular Diagnostics Lab
Dept. of Pathology
Wake Forest University Baptist Medical Center
Winston-Salem, NC 27157
336-716-2104
-Original Message-
From:
Oh yes, we are very aware and quite upset at the change!
Martha Ward, MT (ASCP) QIHC
Manager, Molecular Diagnostics Lab
Dept. of Pathology
Wake Forest University Baptist Medical Center
Winston-Salem, NC 27157
336-716-2104
-Original Message-
From:
We are interested in finding out what type of positive control tissue everyone
is using when performing C4d immunofluorescence on heart biopsies. Thanks in
advance for any and all responses.
Martha Ward, MT (ASCP) QIHC
Manager, Molecular Diagnostics Lab
Dept. of Pathology
Wake Forest
Hello all,
I am still hunting for a source for the PAX 2 antibody.Is this antibody
currently available? I have heard in the past that there was a manufacturing
issue.
Martha Ward, MT (ASCP) QIHC
Manager, Molecular Diagnostics Lab
Dept. of Pathology
Wake Forest University Baptist Medical
Thank you to the people who responded to my inquiry about the IDH1 antibody.
I think we have found one to try.
I have also have a request for the MHC-Class 1 antibody for muscle biopsies.
Could anyone performing this suggest a vendor. So far I am coming up with
antibodies for frozen
Hello all,
I have had a request from our neuropathologists to bring these antibodies in
house but I am having some trouble finding vendors for them. I would
appreciate any information.
Thanks!
Martha Ward, MT (ASCP) QIHC
Manager, Molecular Diagnostics Lab
Dept. of Pathology
Wake Forest
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