[Histonet] Validation help

[Moumita Kundu via Histonet]

Hi Pam,

I know you have connections in histoworld. Can you please connect me to someone 
I can ask about IHC antibodies validations on ultra Benchmarks in a brand new 
hospital set up.



Thanks and Regard

Moumita Kundu

2167980697

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[Histonet] Validation of new G2 Coverslipper

[Eileen Akemi Allison via Histonet]

Good Morning Histo Peeps:

We just purchased a new Sakura G2 Coverslipper for our IHC Lab.  The engineer 
will be coming Monday to make sure all adjustments are in alignment and fine 
tune anything which might have gotten out of alignment due to shipping. 

I have never validated a new Coverslipper in any of the labs I have managed.  I 
searched the internet and was not able to find any information or instructions 
pertaining to Coverslipper Validation.  I am of course going to run several 
test slides prior to running any actual cases on it.  I will instruct my staff 
to date and provide test information on the slides to accompany the paperwork 
Sakura provides for the set-up of the equipment, but I am not sure that will be 
sufficient. 

Since we our a research facility, my IHC Director does not feel we need to 
validate our new Coverslipper to comply to GLP.  I just want to make sure for 
my own assurance.  I would greatly appreciate any guidelines for validation you 
may want to share with me.

Best Regards,
Akemi

Eileen (Akemi) Allison, BS, HT/HTL (ASCP)
IHC Manager
HistoTox Labs, Inc.
2108 55th St. Suite 120
Boulder, CO 80301
Cell: (408) 335-9994
Office: 303-633-5401
Email: ealli...@histotoxlabs.com 
www.histotoxlabs.com 
 
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[Histonet] Validation of Tissue Processor

[Michael S Pence via Histonet]

When I am looking for answers I go to the experts.

Who has written a procedure for validation of a new tissue processor and would 
be willing to share? I just want to make sure I have not overlooked something.

Thanks for the help,

Michael S. Pence | Supervisor of Laboratory Services
Great River Health Systems
1221 S. Gear Ave. | West Burlington, IA 52655
Office 319-768-4546 | Main 319-768-4525 | Fax 319-768-4557
mpe...@grhs.net | 
www.greatrivermedical.org.
www.Facebook.com/GreatRiverHealthSystems
 | www.Twitter/GreatRiverMed


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Re: [Histonet] validation

[Fulton Regan via Histonet]

Hello Nancy, 
 
Given your interest in best practices for validations,  I’d like to offer some 
recent literature references that may be of some use.
 
Your use of 20 positives and 20 negatives exceeds the minimum standard, from 
CAP Guidance. For purely diagnostic markers. (10+ and 10- are suggested in such 
cases), while 20+ and 20- are suggested as a minimum for predictive markers, 
such as ER, PR, etc… Your practice exceeds the minimum, but is certainly an 
excellent approach for better control of your assays!  
 
Patrick, L. F., Linda, A. B., Lisa, A. F., Alsabeh, R., Regan, S. F., Jeffrey, 
D. G., … Swanson, P. E. (2014). Principles of analytic validation of 
immunohistochemical assays: Guideline from the College of American Pathologists 
Pathology and Laboratory Quality Center. Archives of Pathology and Laboratory 
Medicine, 138(11), 1432–1443. https://doi.org/10.5858/arpa.2013-0610-CP
 
With respect to negative controls, there is another good reference, below:
 
Torlakovic, E. E., Francis, G., Garratt, J., Gilks, B., Hyjek, E., Ibrahim, M., 
… Vyberg, M. (2014). Standardization of Negative Controls in Diagnostic 
Immunohistochemistry. Applied Immunohistochemistry & Molecular Morphology, 
22(4), 241–252. https://doi.org/10.1097/PAI.0069
 
Internal negative control elements can definitely be part of the validation 
plan and can be used in specificity calculations.  Of course, it is important 
to confirm that these internal negatives are in fact negative!  However, it is 
also best practice to design validations as “fit for purpose”. That is,  does 
the assay reliably distinguish among the differential diagnostic  
considerations?  So, for specificity, a collection of “pertinent negatives” 
should also be included in the validation.  As an example: in the case of 
Beta-catenin for the diagnosis of fibromatosis, one should include some cases 
that resemble fibromatosis.  These might include, GIST, SCHWANNOMA, LEIOMYOMA, 
NEUROFIBROMA, and others, as your question clearly anticipated. 
 
I hope this of some use to you. 
 
Feel free to contact me if I can be of any further help. 
 
Regan



Regan Fulton, MD/PhD
 
CEO
Array Science, LLC
Tissue Microarray Technologies
475 Gate 5 Road, #102
Sausalito, CA 94965

ful...@arrayscience.com

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Re: [Histonet] validation

[Tony Henwood (SCHN) via Histonet]

Immunohistochemistry validation is much more than simply 20 positives and 20 
negative cases, though this will allow you to meet most accreditation 
requirements.

Validation is a multi step process:
1.  Optimisation: following a thorough literature review (what should and 
should not stain, clones used (any difference), recommended assay conditions 
(eg antigen retrieval type), choose an appropriate control to confirm staining 
conditions and perform an optimum titre.
2.  Validation: based on the literature review, choose appropriate known 
(or expected) positives and negative cases that the pathologists would 
entertain in the differential diagnosis that should be negative.

Take Prostate Specific Antigen as an example, include known prostatic 
carcinomas with a mix of well, moderately and poorly differentiated prostatic 
carcinomas and include negative tumours that should not express PSA (eg 
melanomas, lymphomas, colonic and lung carcinomas).

This is a scientific approach that inspires confidence in the usefulness of the 
test.

3.  Another task that we find extremely useful is on-going Verification, 
where we compare staining results with final diagnosis of cases immunostained 
for the marker.

Food for thought?

Regards 
Tony Henwood JP, MSc, BAppSc, GradDipSysAnalys, CT(ASC), FFSc(RCPA) 
Principal Scientist, the Children's Hospital at Westmead
Adjunct Fellow, School of Medicine, University of Western Sydney 
Tel: 612 9845 3306 
Fax: 612 9845 3318 
Pathology Department
the children's hospital at westmead
Cnr Hawkesbury Road and Hainsworth Street, Westmead
Locked Bag 4001, Westmead NSW 2145, AUSTRALIA 

-Original Message-
From: Nancy Schmitt via Histonet [mailto:histonet@lists.utsouthwestern.edu] 
Sent: Wednesday, 25 October 2017 4:16 AM
To: 'histonet@lists.utsouthwestern.edu'
Subject: [Histonet] validation

Good Day!
When performing validation on IHC, we use 20 positives and 20 negative cases.

When testing for negative, can the normal tissue surrounding the tumor be 
counted as negative?

Does the negative tissue need to be tumor that is negative for the AB or just 
normal tissue?

Thank you for your consideration,

Nancy
Dubuque, IA
Ph. 563-589-9810



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[Histonet] validation inquiry regarding negative tissue

[Eddie Martin via Histonet]

Hi Nancy,

The use of negative internal control tissue on your antibody testing for 
negative cases would have to be determined by your medical director/chief 
pathologist as acceptable. 

You may also use Lipoma tissue as a negative control tissue. It works as a 
negative control for just about every antibody I can think about. There may 
also be a few antibodies that would have false positive staining with a lipoma, 
but a pathologist could read through that stuff. 

Hope this helps!

Kind regards,
Eddie M.

Edward M. Martin, HTL, HT(ASCP), QIHC(ASCP)
Lead Hematopathology Medical Technologist
The National Institutes of Health
and
IHC Histotechnologist III
The Joint Pathology Center
Walter Reed NMMC
Bethesda, MD


> On Oct 24, 2017, at 1:16 PM, Nancy Schmitt  wrote:
> 
> Good Day!
> When performing validation on IHC, we use 20 positives and 20 negative cases.
> 
> When testing for negative, can the normal tissue surrounding the tumor be 
> counted as negative?
> 
> Does the negative tissue need to be tumor that is negative for the AB or just 
> normal tissue?
> 
> Thank you for your consideration,
> 
> Nancy
> Dubuque, IA
> Ph. 563-589-9810
> 
> 
> 
> 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.
> 
> 
> 
> 
> 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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[Histonet] validation

[Nancy Schmitt via Histonet]

Good Day!
When performing validation on IHC, we use 20 positives and 20 negative cases.

When testing for negative, can the normal tissue surrounding the tumor be 
counted as negative?

Does the negative tissue need to be tumor that is negative for the AB or just 
normal tissue?

Thank you for your consideration,

Nancy
Dubuque, IA
Ph. 563-589-9810



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incorrectly. If you are not the intended recipient, please notify the sender
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attachments. Thank you.




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[Histonet] validation for special stains

[Nancy Schmitt via Histonet]

Good Morning-

What is everyone doing for validation on special stains?  We have a new Artisan 
but I am struggling with finding exact validation specifications.  It will be 
difficult to find 10-20 cases on some of these stains.

Thoughts and Thank you!

Nancy
Pathology Support Services Manager
United Clinical Laboratories

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[Histonet] Validation Process or Procedure for the Shandon Cytospin 4 and the Sorvall ST 8 Centrifuge

[ian bernard via Histonet]

Does anyone have a validation protocol to share?

 

Mr B

 

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[Histonet] Validation

[Erskine Husbands via Histonet]

Does anyone in Histoland have any information on validation of H.pylori 
immunohistochemical staining,
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RE: [Histonet] Validation of IHC

[Pathology-Histology Sr. Supervisor]

Dear Jamal,
Please see 
Principles of Analytic Validation of Immunohistochemistry Assays
Published : Archives of Pathology and Laboratory Medicine
March 19, 2014
cap.org
Later on I will send you template of IHC Validation, which we are using in 
SKMCHRC.
Regards
Muhammad Tahseen
Senior Supervisor Histopathology
SKMCHRC
Lahore, Pakistan


-Original Message-
From: histonet-boun...@lists.utsouthwestern.edu 
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Jamal
Sent: Saturday, July 19, 2014 3:42 PM
To: Histonet edu
Subject: [Histonet] Validation of IHC

Dear colleagues

We purchased Ventana GX from Rosh for IHC

I reviewed the resent CAP check list 2013 for validation of IHC but I got 
confused.

I am using ready to use prediluted antibodies from Ventana and I want to 
validate the antibodies before use according to CAP requirements.

Can I have the validation plane and procedure for IHC antibodies.

 

 

 

Best Regards,

 

 

Jamal M. Al Rowaihi  Anatomic Pathology Supervisor   | Al Borg
Medical Laboratories |  Mobile +966 503629832| 
mailto:j.rowa...@alborglaboratories.com j.rowa...@alborglaboratories.com 

Palestine St, Al Rajhi Building, P.O. Box 52817, Jeddah 21573, KSA|
Phone: +966 12 670 0099   | Fax: +966 12 676 4984 |
http://www.alborglaboratories.com/ www.alborglaboratories.com

 

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[Histonet] Validation of IHC

[Jamal]

Dear colleagues

We purchased Ventana GX from Rosh for IHC

I reviewed the resent CAP check list 2013 for validation of IHC but I got
confused.

I am using ready to use prediluted antibodies from Ventana and I want to
validate the antibodies before use according to CAP requirements.

Can I have the validation plane and procedure for IHC antibodies.

 

 

 

Best Regards,

 

 

Jamal M. Al Rowaihi  Anatomic Pathology Supervisor   | Al Borg
Medical Laboratories |  Mobile +966 503629832|
mailto:j.rowa...@alborglaboratories.com j.rowa...@alborglaboratories.com 

Palestine St, Al Rajhi Building, P.O. Box 52817, Jeddah 21573, KSA|
Phone: +966 12 670 0099   | Fax: +966 12 676 4984 |
http://www.alborglaboratories.com/ www.alborglaboratories.com

 

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[Histonet] Validation of cryostat

[Gloria Tharp]

Could anyone tell me how you are handling the new CAP ANP.23045 question on
function and verification of equipment regarding a cryostat.

 

 

Gloria Tharp, BA, HTL(ASCP)

PCA Southeast Laboratory

Director of Operations

gth...@pcasoutheast.com

931-490-1005

931-619-5149 cell

 

 

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[Histonet] Validation

[Herring, Colleen]

We are getting the new Ventana Nexus in next month and I would like any input. 
After I optimize all the stains what is the amount of positive controls do I 
run on each to validate? Thanks in advance


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[Histonet] Validation Sign off

[Laurie Colbert]

When validating IHC antibodies and detection kits (either initially or with new 
lots), does a pathologist have to sign off on the validation , or can it be 
his/her designee (such as a PhD) that signs off?  The pathologist will be 
signing the IHC procedures.

Laurie Colbert, HT (ASCP)

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RE: [Histonet] Validation Sign off

[tapiarita]

“Based on FDA’s ruling on class reagents in IHC, the legal responsibility for 
validation and knowing the relevant parameters is put squarely on the shoulders 
of the lab director.” True, the legal responsibility rests with the lab 
director..


Sent from my Samsung Galaxy S®4

 Original message 
From: Laurie Colbert lcolb...@pathmdlabs.com 
Date: 09/11/2013  10:45 AM  (GMT-07:00) 
To: Histonet Post (histonet@lists.utsouthwestern.edu) 
histonet@lists.utsouthwestern.edu 
Subject: [Histonet] Validation Sign off 
 
When validating IHC antibodies and detection kits (either initially or with new 
lots), does a pathologist have to sign off on the validation , or can it be 
his/her designee (such as a PhD) that signs off?  The pathologist will be 
signing the IHC procedures.

Laurie Colbert, HT (ASCP)

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[Histonet] Validation Protocols

[Matthew Roark]

Would anybody be willing to share their protocol/policy for the validation
of a new IHC stainer and/or tissue processor?
 
Thanks!!
 
 
 
 
Matthew Roark- HT/HTL(ASCP)CM
Histology Specialist
Saint Francis Medical Center
211 Saint Francis Drive
Cape Girardeau, MO 63703
573-331-5267
 mailto:mro...@sfmc.net mro...@sfmc.net
 http://www.sfmc.net http://www.sfmc.net
 
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RE: [Histonet] Validation Protocols (ANP.23120)

[Andrew Horvath]

The following is a copy of validation protocol I received from CAP...




Dear Andrew,

 

Here is the information for ANP.23120:

 

To validate a new processing schedule the user should run tissue samples
in duplicate. Side by side samples of the tissue that have been fixed
for the same amount of time and are of the same size and thickness.
Reagents on the processor should be of the same age and quality, i.e.
all fresh reagents. Process, embed cut and stain slides (at the same
time). The quality of the blocks should be evaluated on tissue quality
I.e. Firmness, ease of cutting etc. The slides can be blind evaluated
with the pathologist not knowing which processing schedule was used.
Grade on quality of section and staining quality. The new process
schedule must be of equal or better quality before put into use. 
This method can also be used when using the same processing schedule but
setting up a new processor of the same model or when setting up a new
brand of processor.
Multiple common tissue types should be evaluated. Fake biopsies can be
created so that patient tissues are not compromised. 

 

If you are changing a specific program on a single processor, like you
are adjusting the ties or reagents on a breast tissue program. You run
the first set of samples on the processor using the routine program and
the run the duplicate set of tissues on the same processor using the new
program to be validated. 

When validating programs for a new processor (especially when the new
processor is a new brand or different model) you run the first set of
tissues on the routine program on the old processor and the second set
using the same program on the new processor.




I hope this information has been helpful.

 

Sincerely,

 

Arlene Clancy MBA MT(ASCP)SC

Technical Team, CAP Accreditation Programs

College of American Pathologists


 
 
 
Andrew Horvath, MBA, MA
Interim Operations Manager
303-770-4848 (O)
303-770-6641 (fax)
 
Colorado GI Pathology
7346 S. Alton Way
Suite 10E
Centennial, CO 80112
 
 
-Original Message-
From: histonet-boun...@lists.utsouthwestern.edu
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Matthew
Roark
Sent: Thursday, June 20, 2013 9:25 AM
To: histonet@lists.utsouthwestern.edu
Subject: [Histonet] Validation Protocols

Would anybody be willing to share their protocol/policy for the
validation
of a new IHC stainer and/or tissue processor?
 
Thanks!!
 
 
 
 
Matthew Roark- HT/HTL(ASCP)CM
Histology Specialist
Saint Francis Medical Center
211 Saint Francis Drive
Cape Girardeau, MO 63703
573-331-5267
 mailto:mro...@sfmc.net mro...@sfmc.net
 http://www.sfmc.net http://www.sfmc.net
 
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[Histonet] Validation Method for Auto HE stainer

[Ian R Bernard]

I'm looking for a benchmark or researched protocol.

IB

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RE: [Histonet] Validation of Her2

[Troutman, Kenneth A]

Hi Jim,

The way I understand this guideline, you will need to send it to a lab that 
uses the same Ventana clone and instrument that you use.

Regards,

Ashley Troutman BS, HT(ASCP) QIHC
Immunohistochemistry Supervisor
Vanderbilt University Histopathology
1301 Medical Center Drive TVC 4531
Nashville, TN  37232
ashley.trout...@vanderbilt.edumailto:ashley.trout...@vanderbilt.edu

Message: 5
Date: Tue, 19 Mar 2013 17:33:03 -0500
From: Vickroy, Jim vickroy@mhsil.commailto:vickroy@mhsil.com
Subject: [Histonet] Validation of Her2
To: 
histonet@lists.utsouthwestern.edumailto:histonet@lists.utsouthwestern.edu

histonet@lists.utsouthwestern.edumailto:histonet@lists.utsouthwestern.edu
Message-ID:

bb0b9f1a8373f14fa2974e8cb24bf9cf2adfb...@mmc-mail.ad.mhsil.commailto:bb0b9f1a8373f14fa2974e8cb24bf9cf2adfb...@mmc-mail.ad.mhsil.com
Content-Type: text/plain; charset=us-ascii


We are working on validating HER 2 testing in our laboratory.  I see that the 
guidelines state that we should use 25 - 100 cases to complete our validation.
In the past we sent our Her2 IHC testing to Clarient and they performed the 
technical testing and then our pathologists would do the scoring.  So for 
validation we used 25 of the cases we sent to Clarient and then did them in 
house to compare.   Our comparison was nearly 100%.  Here is my question:

Clarient uses the DAKO method while we are using Ventana's antibody Pathway 
(4B5).   The validation guidelines state parallel by identical method in 
another lab with the same validated assay is also acceptable.  Can I assume 
that this means comparison with another lab for IHC HER2 testing and does not 
have to be using the same clone (DAKO vs Ventana)?

Jim

James Vickroy BS, HT(ASCP)

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

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[Histonet] Validation of Her2

[Vickroy, Jim]

We are working on validating HER 2 testing in our laboratory.  I see that the 
guidelines state that we should use 25 - 100 cases to complete our validation.
In the past we sent our Her2 IHC testing to Clarient and they performed the 
technical testing and then our pathologists would do the scoring.  So for 
validation we used 25 of the cases we sent to Clarient and then did them in 
house to compare.   Our comparison was nearly 100%.  Here is my question:

Clarient uses the DAKO method while we are using Ventana's antibody Pathway 
(4B5).   The validation guidelines state parallel by identical method in 
another lab with the same validated assay is also acceptable.  Can I assume 
that this means comparison with another lab for IHC HER2 testing and does not 
have to be using the same clone (DAKO vs Ventana)?

Jim

James Vickroy BS, HT(ASCP)

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



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Re: [Histonet] Validation of Her2

[Jesus Ellin]

What did you do to evaluate your system and algorithms.   Also the cases of ER 
and PR. Negative vs Postive concordance. 

Sent from my iPad

On Mar 19, 2013, at 4:57 PM, Vickroy, Jim vickroy@mhsil.com wrote:

 
 We are working on validating HER 2 testing in our laboratory.  I see that the 
 guidelines state that we should use 25 - 100 cases to complete our validation.
 In the past we sent our Her2 IHC testing to Clarient and they performed the 
 technical testing and then our pathologists would do the scoring.  So for 
 validation we used 25 of the cases we sent to Clarient and then did them in 
 house to compare.   Our comparison was nearly 100%.  Here is my question:
 
 Clarient uses the DAKO method while we are using Ventana's antibody Pathway 
 (4B5).   The validation guidelines state parallel by identical method in 
 another lab with the same validated assay is also acceptable.  Can I assume 
 that this means comparison with another lab for IHC HER2 testing and does not 
 have to be using the same clone (DAKO vs Ventana)?
 
 Jim
 
 James Vickroy BS, HT(ASCP)
 
 Surgical  and Autopsy Pathology Technical Supervisor
 Memorial Medical Center
 217-788-4046
 
 
 
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 you are not the intended recipient, you should delete this message. Any 
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Re: [Histonet] Validation of a new tissue processor

[Rene J Buesa]

Absolutely agree with Tim's comments. 
I would even add that if the new tissue processor uses the standard 
heat/agitation/vacuum/pressue sequences as the old one, the validation 
objective is mainly directed to have some documentation that the facility's 
attorneys can have in case something goes wrong and the plaintiff's attorney 
asks: Was the instrument validated? avoiding that a judge, also ignorant of 
our methods, rules against our lab.
The validation is really necessary if the processing technology goes from the 
conventional to the microwave technology where the times are so different and 
the development of new quality protocols are of paramount importance. 
The one who has to decide about the validation test is the pathologist and his 
acceptance has to go to the QC file, and that's it!
René J. 

From: Morken, Timothy timothy.mor...@ucsfmedctr.org
To: 'histonet@lists.utsouthwestern.edu' histonet@lists.utsouthwestern.edu 
Sent: Wednesday, November 28, 2012 5:10 PM
Subject: RE: [Histonet] Validation of a new tissue processor

I don't think it is necessary to test every single stain or antibody you do to 
validate a new tissue processor. Most of the time the only thing changing is 
the machine, not the chemicals you use. The point of validation is to prove 
that the system gives you the same results as the old instrument. Using a 
representative sample of types of stains and antibodies will give you 
confidence that it works fine and save a huge amount of money and time. 

Think about it from this perspective: We get paraffin slides and blocks from 
consult cases from all over the place, processed on many different machines 
with infinitely variable time and chemical protocols. Yet virtually all the 
cases work fine in our immuno staining system. It is rare to find cases that do 
not. That alone tells you that massive validation is not really necessary.

The point of a validation procedure is to plan one that you feel will give you 
confidence that the new instrument gives you the same results as the old one. 
If you do insist on testing all your antibodies (we have over 200 here) then 
tissue arrays or multiple tissue blocks will save a lot of time and money. 

Of course, if you go to a new processor that uses totally different  types of 
chemicals and methods then validation of every antibody may be necessary. Even 
then, however, representative markers of various types may suffice. 

Tim Morken
Department of Pathology
UC San Francisco Medical Center


-Original Message-
From: histonet-boun...@lists.utsouthwestern.edu 
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Helen Fedor
Sent: Wednesday, November 28, 2012 1:51 PM
To: 'Rene J Buesa'; Howe, Helena; 'histonet@lists.utsouthwestern.edu'
Subject: RE: [Histonet] Validation of a new tissue processor

You will also need to validate all of the IHC stains and special stains that 
you do on these tissues. You can take samples from each tissue type and run 
them in parallel on both machines. Then test all of your special stains and 
antibodies that you have in your inventory.

:)
Helen

-Original Message-
From: histonet-boun...@lists.utsouthwestern.edu 
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Rene J Buesa
Sent: Wednesday, November 28, 2012 4:47 PM
To: Howe, Helena; 'histonet@lists.utsouthwestern.edu'
Subject: Re: [Histonet] Validation of a new tissue processor

Using at least 25 different types of tissues, prepare parallel almost identical 
pairs of slices for each tissue and process them simultaneously in your new 
tissue processor and in the old one.
Prepare HE sections and give them to the pathologists concealing the used 
tissue processor. The pathologists should decide if there are differences 
between the pairs of sections.
The pathologist's opinion should be registered in the QC file and that will be 
your validation.
René J.

From: Howe, Helena helena.h...@promedica.org
To: 'histonet@lists.utsouthwestern.edu' histonet@lists.utsouthwestern.edu 
Sent: Wednesday, November 28, 2012 2:57 PM
Subject: [Histonet] Validation of a new tissue processor

Does anyone know what the CAP is requiring to validate a new tissue processor?
Thank You
Helena Howe
ProMedica Laboratories
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

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[Histonet] Validation of a new tissue processor

[Howe, Helena]

Does anyone know what the CAP is requiring to validate a new tissue processor?
Thank You
Helena Howe
ProMedica Laboratories
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

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RE: [Histonet] Validation of a new tissue processor

[Helen Fedor]

You will also need to validate all of the IHC stains and special stains that 
you do on these tissues. You can take samples from each tissue type and run 
them in parallel on both machines. Then test all of your special stains and 
antibodies that you have in your inventory.

:)
Helen

-Original Message-
From: histonet-boun...@lists.utsouthwestern.edu 
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Rene J Buesa
Sent: Wednesday, November 28, 2012 4:47 PM
To: Howe, Helena; 'histonet@lists.utsouthwestern.edu'
Subject: Re: [Histonet] Validation of a new tissue processor

Using at least 25 different types of tissues, prepare parallel almost identical 
pairs of slices for each tissue and process them simultaneously in your new 
tissue processor and in the old one.
Prepare HE sections and give them to the pathologists concealing the used 
tissue processor. The pathologists should decide if there are differences 
between the pairs of sections.
The pathologist's opinion should be registered in the QC file and that will be 
your validation.
René J.

From: Howe, Helena helena.h...@promedica.org
To: 'histonet@lists.utsouthwestern.edu' histonet@lists.utsouthwestern.edu 
Sent: Wednesday, November 28, 2012 2:57 PM
Subject: [Histonet] Validation of a new tissue processor

Does anyone know what the CAP is requiring to validate a new tissue processor?
Thank You
Helena Howe
ProMedica Laboratories
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

EMAIL CONFIDENTIALITY NOTICE 
This Email message, and any attachments, may contain confidential patient 
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RE: [Histonet] Validation of a new tissue processor

[Morken, Timothy]

I don't think it is necessary to test every single stain or antibody you do to 
validate a new tissue processor. Most of the time the only thing changing is 
the machine, not the chemicals you use. The point of validation is to prove 
that the system gives you the same results as the old instrument. Using a 
representative sample of types of stains and antibodies will give you 
confidence that it works fine and save a huge amount of money and time. 

Think about it from this perspective: We get paraffin slides and blocks from 
consult cases from all over the place, processed on many different machines 
with infinitely variable time and chemical protocols. Yet virtually all the 
cases work fine in our immuno staining system. It is rare to find cases that do 
not. That alone tells you that massive validation is not really necessary.

The point of a validation procedure is to plan one that you feel will give you 
confidence that the new instrument gives you the same results as the old one. 
If you do insist on testing all your antibodies (we have over 200 here) then 
tissue arrays or multiple tissue blocks will save a lot of time and money. 

Of course, if you go to a new processor that uses totally different  types of 
chemicals and methods then validation of every antibody may be necessary. Even 
then, however, representative markers of various types may suffice. 

Tim Morken
Department of Pathology
UC San Francisco Medical Center


-Original Message-
From: histonet-boun...@lists.utsouthwestern.edu 
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Helen Fedor
Sent: Wednesday, November 28, 2012 1:51 PM
To: 'Rene J Buesa'; Howe, Helena; 'histonet@lists.utsouthwestern.edu'
Subject: RE: [Histonet] Validation of a new tissue processor

You will also need to validate all of the IHC stains and special stains that 
you do on these tissues. You can take samples from each tissue type and run 
them in parallel on both machines. Then test all of your special stains and 
antibodies that you have in your inventory.

:)
Helen

-Original Message-
From: histonet-boun...@lists.utsouthwestern.edu 
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Rene J Buesa
Sent: Wednesday, November 28, 2012 4:47 PM
To: Howe, Helena; 'histonet@lists.utsouthwestern.edu'
Subject: Re: [Histonet] Validation of a new tissue processor

Using at least 25 different types of tissues, prepare parallel almost identical 
pairs of slices for each tissue and process them simultaneously in your new 
tissue processor and in the old one.
Prepare HE sections and give them to the pathologists concealing the used 
tissue processor. The pathologists should decide if there are differences 
between the pairs of sections.
The pathologist's opinion should be registered in the QC file and that will be 
your validation.
René J.

From: Howe, Helena helena.h...@promedica.org
To: 'histonet@lists.utsouthwestern.edu' histonet@lists.utsouthwestern.edu 
Sent: Wednesday, November 28, 2012 2:57 PM
Subject: [Histonet] Validation of a new tissue processor

Does anyone know what the CAP is requiring to validate a new tissue processor?
Thank You
Helena Howe
ProMedica Laboratories
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

EMAIL CONFIDENTIALITY NOTICE 
This Email message, and any attachments, may contain confidential patient 
health information that is legally protected. This information is intended only 
for the use of the individual or entity named above. The authorized recipient 
of this information is prohibited from disclosing this information to any other 
party unless required to do so by law or regulation and is required to destroy 
the information after its stated need has been fulfilled. If you are not the 
intended recipient, you are hereby notified that any disclosure, copying, 
distribution, or action taken in reliance on the contents of this message is 
strictly prohibited. 

If you have received this information in error, please notify the sender 
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RE: [Histonet] validation runs

[Sebree Linda A]

In our opinion, yes. 

-Original Message-
From: histonet-boun...@lists.utsouthwestern.edu 
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Melissa Whitaker
Sent: Tuesday, October 23, 2012 9:07 PM
To: histonet@lists.utsouthwestern.edu
Subject: [Histonet] validation runs

Hi everyone in IHC, are controls needed when performing antibody validation 
runs?

Thanks all!
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Re: [Histonet] validation runs

[Rene J Buesa]

When you are validating an antibody the only way you can do that is by using 
(+) controls.
René J.



From: Sebree Linda A lseb...@uwhealth.org
To: 'Melissa Whitaker' mwhitak...@gmail.com; 
histonet@lists.utsouthwestern.edu histonet@lists.utsouthwestern.edu 
Sent: Wednesday, October 24, 2012 11:04 AM
Subject: RE: [Histonet] validation runs

In our opinion, yes. 

-Original Message-
From: histonet-boun...@lists.utsouthwestern.edu 
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Melissa Whitaker
Sent: Tuesday, October 23, 2012 9:07 PM
To: histonet@lists.utsouthwestern.edu
Subject: [Histonet] validation runs

Hi everyone in IHC, are controls needed when performing antibody validation 
runs?

Thanks all!
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RE: [Histonet] validation runs

[Bea DeBrosse-Serra]

Yes

Beatrice DeBrosse-Serra HT(ASCP)QIHC
Isis Pharmaceuticals
Antisense Drug Discovery
2855 Gazelle Ct.
Carlsbad, CA 92010
760-603-2371



-Original Message-
From: histonet-boun...@lists.utsouthwestern.edu 
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Melissa Whitaker
Sent: Tuesday, October 23, 2012 7:07 PM
To: histonet@lists.utsouthwestern.edu
Subject: [Histonet] validation runs

Hi everyone in IHC, are controls needed when performing antibody validation 
runs?

Thanks all!
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[Histonet] validation runs

[Melissa Whitaker]

Hi everyone in IHC, are controls needed when performing antibody validation
runs?

Thanks all!
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[Histonet] validation Form

[tahseen]

Good Morning Histoland,
I was wondering if anyone has a instument and antibody validation Form
they would be
willing to share?

Thanks,
Tahseen



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Re: [Histonet] Validation of new equipment

[Rene J Buesa]

Your client and immediate supervisor is the pathologists, and s/he is also the 
one who has to answer directly to your inspecting authority, be it CAP or any 
other.
Therefore, is s/he is satisfied with the way the tissues you process in a new 
tissue processor turn out, that is sufficient.
Any discrepancy of methodology with the inspecting authority let him/her to 
deal it with.
René J.

--- On Thu, 3/15/12, lau...@blufrogpath.com lau...@blufrogpath.com wrote:


From: lau...@blufrogpath.com lau...@blufrogpath.com
Subject: [Histonet] Validation of new equipment
To: Histonet post histonet@lists.utsouthwestern.edu
Date: Thursday, March 15, 2012, 5:15 PM



   If  I  am  validating  a new tissue processor, can I just process a 
v   ariety  of  tissues  and  have  the pathologist sign off that they are
   acce=  ptable,  or  do  I  need to do a parallel run with tissue on an
   established pro= cessor and compare the results?

   




   


   Laurie
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[Histonet] Validation of new equipment

[Laurie]

   If  I  am  validating  a new tissue processor, can I just process a v   
ariety  of  tissues  and  have  the pathologist sign off that they are
   acce=  ptable,  or  do  I  need to do a parallel run with tissue on an
   established pro= cessor and compare the results?

   




   


   Laurie
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[Histonet] validation

[Amos Brooks]

Hi,
I would say no, and if any inspector disagreed you would be well within
your rights to give him a good cuff upside the head. The point in having a
negative mouse and rabbit is to run them at the same concentration as
whatever primary you are running. That would mean you would need to
validate it at every conceivable dilution you could ever have a primary
antibody at. Kinda silly if you think about it. Any good validation for a
primary antibody should include a proper isotype negative control anyway,
but that is a separate can o' worms.

Amos


On Tue, Nov 29, 2011 at 1:01 PM,
histonet-requ...@lists.utsouthwestern.eduwrote:

 Message: 5
 Date: Mon, 28 Nov 2011 20:00:03 +
 From: Amber McKenzie amber.mcken...@gastrodocs.net
 Subject: [Histonet] validation
 To: histonet@lists.utsouthwestern.edu
histonet@lists.utsouthwestern.edu
 Message-ID: 5a33c952bb67f4468af1f36d739212bc064...@jerry.gia.com
 Content-Type: text/plain; charset=us-ascii

 Do you have to validate the neg mouse and rabbit?

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[Histonet] validation

[Amber McKenzie]

Do you have to validate the neg mouse and rabbit?


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Re: [Histonet] validation

[Rene J Buesa]

I have been thinking about your question and it seems to me that it is similar 
to proving a negative or a non existent situation or entity. Proving the 
non-existence of something is impossible the same as proving the existence of 
something non-existent.
On the other hand, you may have a protocol so off that you could have a heavy 
background in a supposedly non reacting section, and you could try to adjust it 
to make sure that the non-reactive tissue should just be that, negative.
You could run your negative through the whole protocol and compare its 
negativity against a section that has NOT been run through your protocol, 
just hematoxylin stained, and see if both are equal.
Other than that I do not think validating a negative is worth much thought or 
effort.
I never did it, and I do not see the advantage of doing it, although I may be 
wrong (as in many an occasion).
René J.

--- On Mon, 11/28/11, Amber McKenzie amber.mcken...@gastrodocs.net wrote:


From: Amber McKenzie amber.mcken...@gastrodocs.net
Subject: [Histonet] validation
To: histonet@lists.utsouthwestern.edu histonet@lists.utsouthwestern.edu
Date: Monday, November 28, 2011, 3:00 PM


Do you have to validate the neg mouse and rabbit?


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[Histonet] Validation

[Amber McKenzie]

Just wondering what y'alls opinion is on validation:  I don't really understand 
why optimization isn't enough.  At that point, the pathologist has said what he 
wanted the stain to look like, so why do 3-10 positive slides on the new 
instrument to compare to previous slides from another instrument?  Thanks!

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RE: [Histonet] Validation

[joelle weaver]

Here is a link to a CAP  presentation from their website, maybe this will help 
out.  http://www.cap.org/apps/docs/education/lapaudio/pdf/051910_pres.pdf 

Joelle Weaver MAOM, BA, (HTL) ASCP
 
http://www.linkedin.com/in/joelleweaver

  From: amber.mcken...@gastrodocs.net
 To: histonet@lists.utsouthwestern.edu
 Date: Wed, 16 Nov 2011 18:20:31 +
 Subject: [Histonet] Validation
 
 
 Just wondering what y'alls opinion is on validation:  I don't really 
 understand why optimization isn't enough.  At that point, the pathologist has 
 said what he wanted the stain to look like, so why do 3-10 positive slides on 
 the new instrument to compare to previous slides from another instrument?  
 Thanks!
 
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Re: [Histonet] Validation

[Cynthia Robinson]

Amber,

Optimizing the antibody is the first step of validation. Running the new 
protocol against previously stained cases is the second step and shows you are 
getting results as good as, if not better, with the new vs the old.



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


 Amber McKenzie amber.mcken...@gastrodocs.net 11/16/2011 12:20 PM 

Just wondering what y'alls opinion is on validation:  I don't really understand 
why optimization isn't enough.  At that point, the pathologist has said what he 
wanted the stain to look like, so why do 3-10 positive slides on the new 
instrument to compare to previous slides from another instrument?  Thanks!

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[Histonet] VALIDATION

[Sara Baldwin/mhhcc.org]

Thanks for all of those who replied I have enough samples and I hope I 
forwarded them to all wanted a sample!!

Thanks
Pathology Supervisor
S. Kathy Baldwin, SCT (ASCP)
Memorial Hospital and Health Care Center
sbald...@mhhcc.org
Ph 812-996-0210, 0216,  Fax 812-996-0232, 
Pager 812-481-0897, Cell 812-887-3357
Confidential information, Authorized use only.
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[Histonet] VALIDATION SHEET

[Sara Baldwin/mhhcc.org]

 
Hi Histonetters
Does anyone have a sample validation sheet for immuno's like ER/PR etc??
Thanks
Pathology Supervisor
S. Kathy Baldwin, SCT (ASCP)
Memorial Hospital and Health Care Center
sbald...@mhhcc.org
Ph 812-482-0210, 0216,  Fax 812-482-0232, 
Pager 812-481-0897, Cell 812-887-3357
Confidential information, Authorized use only.
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[Histonet] validation sheet

[Cynthia Pyse]

Happy Friday Histonetters

Does anyone have a validation log sheet they have used for the validation of
a recycler. Someone spilled xylene on our copy then proceeded to discard it
without coping the sheet first. I would appreciate it if anyone would share
the log sheet they have used, it would save me some time. Thanks in advance.

 

Cindy Pyse, CLT, HT (ASCP)

Laboratory/Histology Supervisor

X-Cell Laboratories

e-mail cp...@x-celllab.com

 

 

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[Histonet] VALIDATION of a new clone

[Vickroy, Jim]

I am wondering what others  are doing when they validate a new clone of a 
antibody that you have used in the lab for quite sometime.  When we introduce a 
new antibody obviously we go through a pretty extensive validation process 
including sampling of around 20 - 30 specimens, some presumed positive cases 
and some presumed negative cases.   We also try to include in the positive 
cases some that are strongly positive and others that are weakly positive.

Lately several of our regular antibodies are now no longer available in the 
same clone.  I am interested in how different labs would validate the new clone 
to be used in the lab.  It would seem to me that the validation process would 
not have to be as extensive since we have already established that the antibody 
works well in our laboratory.   I know if it was the same clone but a different 
lot we would just do a comparison of the old lot with the new lot, but what 
about a different clone?   I realize that the methods are going to be diverse 
but I would appreciate hearing from others.


James Vickroy BS, HT(ASCP)

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



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RE: [Histonet] VALIDATION of a new clone

[Liz Chlipala]

If it's a different clone then it's essentially a different antibody you
would have to go through the same process as you did initially.

LIz

Elizabeth A. Chlipala, BS, HTL(ASCP)QIHC
Manager
Premier Laboratory, LLC
PO Box 18592
Boulder, Colorado 80308
office (303) 682-3949 
fax (303) 682-9060
www.premierlab.com
 
 
Ship to Address:
1567 Skyway Drive, Unit E
Longmont, Colorado 80504

-Original Message-
From: histonet-boun...@lists.utsouthwestern.edu
[mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Vickroy,
Jim
Sent: Monday, March 14, 2011 12:17 PM
To: histonet@lists.utsouthwestern.edu
Subject: [Histonet] VALIDATION of a new clone

I am wondering what others  are doing when they validate a new clone of
a antibody that you have used in the lab for quite sometime.  When we
introduce a new antibody obviously we go through a pretty extensive
validation process including sampling of around 20 - 30 specimens, some
presumed positive cases and some presumed negative cases.   We also try
to include in the positive cases some that are strongly positive and
others that are weakly positive.

Lately several of our regular antibodies are now no longer available in
the same clone.  I am interested in how different labs would validate
the new clone to be used in the lab.  It would seem to me that the
validation process would not have to be as extensive since we have
already established that the antibody works well in our laboratory.   I
know if it was the same clone but a different lot we would just do a
comparison of the old lot with the new lot, but what about a different
clone?   I realize that the methods are going to be diverse but I would
appreciate hearing from others.


James Vickroy BS, HT(ASCP)

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



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Re: [Histonet] VALIDATION of a new clone

[Mark Tarango]

Hi Jim,

If it's a new clone then a new valiation should be performed.  I know of
many instances where one clone stains something that another doesn't.

If this is regarding Ventana not selling certains clones, those clones are
still available from Cell Marque directly.

Mark

On Mon, Mar 14, 2011 at 11:16 AM, Vickroy, Jim vickroy@mhsil.comwrote:

 I am wondering what others  are doing when they validate a new clone of a
 antibody that you have used in the lab for quite sometime.  When we
 introduce a new antibody obviously we go through a pretty extensive
 validation process including sampling of around 20 - 30 specimens, some
 presumed positive cases and some presumed negative cases.   We also try to
 include in the positive cases some that are strongly positive and others
 that are weakly positive.

 Lately several of our regular antibodies are now no longer available in the
 same clone.  I am interested in how different labs would validate the new
 clone to be used in the lab.  It would seem to me that the validation
 process would not have to be as extensive since we have already established
 that the antibody works well in our laboratory.   I know if it was the same
 clone but a different lot we would just do a comparison of the old lot with
 the new lot, but what about a different clone?   I realize that the methods
 are going to be diverse but I would appreciate hearing from others.


 James Vickroy BS, HT(ASCP)

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


 
 This message (including any attachments) contains confidential information
 intended for a specific individual and purpose, and is protected by law. If
 you are not the intended recipient, you should delete this message. Any
 disclosure, copying, or distribution of this message, or the taking of any
 action based on it, is strictly prohibited.
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[Histonet] validation of tissue processor

[Inman, Anna]

Hello Histoland 

1.  I am just curious what process is followed for validating a new
tissue processor? 
2.  Do you validate every IHC stain again or can you simply
re-validate a representative sample of IHC and be ok?   

 

Thank you as always for your wealth of knowledge

 

Anna

SMH Pathology

anna.in...@stmarygj.org

 

 

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Re: [Histonet] Validation of IHC

[Rene J Buesa]

If you go to HistoNet archives you will find detailed answers to your questions 
posted about 2 months ago.
Every time you change anything in any protocol, that change has to be validated.
René J.

--- On Wed, 10/14/09, Jason McGough jmcgo...@clinlab.com wrote:


From: Jason McGough jmcgo...@clinlab.com
Subject: [Histonet] Validation of IHC
To: histonet@lists.utsouthwestern.edu
Date: Wednesday, October 14, 2009, 5:51 PM


Our lab is inquiring about how other labs are validating their IHC stains. We 
currently are processing specimens both in a microwave and conventional 
processors. Are labs validating every type of program on the conventional and 
microwave processors? (i.e. small biopsies vs. larger tissue samples)Or just 
microwave vs. conventional processing? Also how many blocks of each tissue 
control are you testing? Thanks in advance for your replies.


Jason McGough HT(ASCP)
Account Representative-Anatomic Pathology
Clinical Laboratory of the Black Hills
2805 5th Street Suite 210
Rapid City, SD 57701
605-343-2267
jmcgo...@clinlab.com



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[Histonet] Validation of IHC

[Jason McGough]

Our lab is inquiring about how other labs are validating their IHC  
stains. We currently are processing specimens both in a microwave and  
conventional processors. Are labs validating every type of program on  
the conventional and microwave processors? (i.e. small biopsies vs.  
larger tissue samples)Or just microwave vs. conventional processing?  
Also how many blocks of each tissue control are you testing? Thanks in  
advance for your replies.



Jason McGough HT(ASCP)
Account Representative-Anatomic Pathology
Clinical Laboratory of the Black Hills
2805 5th Street Suite 210
Rapid City, SD 57701
605-343-2267
jmcgo...@clinlab.com



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[Histonet] VALIDATION FOR FIXATIVES

[Phyllis Thaxton]

Does anyone out there know any reference labs that do egfr, her2 fish, k ras 
gene mutation, etc. that have performed validation testing for tissues fixed in 
anything other than 10% NBF?
 Phyllis Thaxton HT(ASCP)QIHC
DCH Regional Medical Center
Tuscaloosa, AL 



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Re: [Histonet] validation documentation for processors

[Michael LaFriniere]

Rene,
 
I agree with your process as to validation, however, could you help me
understand where does the CAP state (what check off list item)
concerning validation requirements when changing out processors or
processing technologies. My staff is currently performing the validation
process with a large microwave processor. If CAP does have a
recommendation I would appreciate seeing it. I have a (1) out of (12)
pathologists that (I think is going overboard) who would like my
Pathology Manager to perform over 100 tissue samples for validation
process to include IHC/FISH/special staining as we make the switch from
conventional to microwave processing.
 
Thanks!
 
Michael

 
 
Michael R. LaFriniere
Executive Director
Cytology Services of Maryland (CSM)
301-206-2555 ext 27  301-206-2595 fax
michael.lafrini...@csmlab.com


 On 3/10/2009 at 5:23 PM, Rene J Buesa rjbu...@yahoo.com wrote:
As all validations, you will have to process at least 25 pieces (CAP
requires from 25 to 100) of tissue using your old and your new processor
simultaneously. Make slides and later prepare HE and some HC and  IHC
procedures using both sets of slides and give them to as many
pathologists as you can so they can select, without knowing which
section comes from which processor, with only two options: either one
section is better than the other, or both are equivalent for diagnostic
purposes.
Later your data should be analyzed statistically with the chi-square
test or you could obviate the test if almost (more than 90%) of all the
pairs are qualified as equivalent.
René J.

--- On Tue, 3/10/09, Joseph Fear fe...@bronsonhg.org wrote:

From: Joseph Fear fe...@bronsonhg.org
Subject: [Histonet] validation documentation for processors
To: histonet@lists.utsouthwestern.edu
Date: Tuesday, March 10, 2009, 4:45 PM

A question came up in our lab about validation documentation for our
new
processor. 
Does anyone have any creative feedback on how your lab documents
validation of
machines like processors and stainers? 

See below

Joseph Fear 03/01/09
I'll post the question at histonet and see what i can find out about
how
other histo labs document validation of thier machines. 

I think with the peloris we ran test cases and Dr.Pearson checked the
HE
slides, but you're right that we don't have documentation of what
cases
were run and with JP's signiture for approval of validation. I can work
on a
general 'machine validation form' in excel and get back with you.

-Joseph

 Virginia Rupert 02/20/09 3:44 PM 
In your searches, or past experience, do you know or can you find out
how new
instruments are validated? I don't think we have adequate documentation
for
the Peloris, with test cases, etc. But I also haven't found a document
to
use as a template for our purposes. Any ideas?
Thanks





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Re: [Histonet] validation documentation for processors

[Rene J Buesa]

As all validations, you will have to process at least 25 pieces (CAP requires 
from 25 to 100) of tissue using your old and your new processor simultaneously. 
Make slides and later prepare HE and some HC and  IHC procedures using both 
sets of slides and give them to as many pathologists as you can so they can 
select, without knowing which section comes from which processor, with only two 
options: either one section is better than the other, or both are equivalent 
for diagnostic purposes.
Later your data should be analyzed statistically with the chi-square test or 
you could obviate the test if almost (more than 90%) of all the pairs are 
qualified as equivalent.
René J.

--- On Tue, 3/10/09, Joseph Fear fe...@bronsonhg.org wrote:

From: Joseph Fear fe...@bronsonhg.org
Subject: [Histonet] validation documentation for processors
To: histonet@lists.utsouthwestern.edu
Date: Tuesday, March 10, 2009, 4:45 PM

A question came up in our lab about validation documentation for our new
processor. 
Does anyone have any creative feedback on how your lab documents validation of
machines like processors and stainers? 

See below

Joseph Fear 03/01/09
I'll post the question at histonet and see what i can find out about how
other histo labs document validation of thier machines. 

I think with the peloris we ran test cases and Dr.Pearson checked the HE
slides, but you're right that we don't have documentation of what cases
were run and with JP's signiture for approval of validation. I can work on a
general 'machine validation form' in excel and get back with you.

-Joseph

 Virginia Rupert 02/20/09 3:44 PM 
In your searches, or past experience, do you know or can you find out how new
instruments are validated? I don't think we have adequate documentation for
the Peloris, with test cases, etc. But I also haven't found a document to
use as a template for our purposes. Any ideas?
Thanks

 

 

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[Histonet] Validation

[Karla Arrington]

Fellow HT's:

I am putting together a DAKO IHC instrument for performing IHC's.  I would like 
any information or examples of antibody validation forms that others are using 
to validate their antibodies. Examples would be greatly appreciated or a link 
to where I can get a sample to look at and tweek. 

Thanks!!
Karla Arrington, HT(ASCP)



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[Histonet] validation

[Webb, Dorothy L]

Is it better to use a lab's own tissue for validation in a microarray
for Ihc purposes or would it be passable to use TMA's from another
source??  Thanks for your opinions!!

Dorothy Webb, HT (ASCP)
Histology Technical Supervisor 
Regions Hospital, Pathology Department 
640 Jackson Street, Saint Paul, MN 55101-2595 
Phone: 651-254-2962
Fax: 651-254-2741 
Regions Hospital is part of the HealthPartners family of care

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Re: [Histonet] validation

[Rene J Buesa]

Dorothy:
At the end you are going to use tissues from your laboratory to do the tests, 
and you do not know how other labs processed their tissues. Although it is not 
absolutely clear how the processing steps (other than fixation) can affect the 
reactivity of a tissue, it is always better not to introduce more variables 
than necessary, so I would use tissues from my own laboratory.
René J.

--- On Mon, 10/6/08, Webb, Dorothy L [EMAIL PROTECTED] wrote:

From: Webb, Dorothy L [EMAIL PROTECTED]
Subject: [Histonet] validation
To: histonet@lists.utsouthwestern.edu
Date: Monday, October 6, 2008, 10:16 AM

Is it better to use a lab's own tissue for validation in a microarray
for Ihc purposes or would it be passable to use TMA's from another
source??  Thanks for your opinions!!

Dorothy Webb, HT (ASCP)
Histology Technical Supervisor 
Regions Hospital, Pathology Department 
640 Jackson Street, Saint Paul, MN 55101-2595 
Phone: 651-254-2962
Fax: 651-254-2741 
Regions Hospital is part of the HealthPartners family of care

This e-mail and any files transmitted with it are confidential and are intended
solely for the use of the individual or entity to whom they are addressed. If
you are not the intended recipient or the individual responsible for delivering
the e-mail to the intended recipient, please be advised that you have received
this e-mail in error and that any use, dissemination, forwarding, printing, or
copying of this e-mail is strictly prohibited.
 
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