RE: [Histonet] RE: [IHCRG] IHC antibody expiration question for CAP. .

From:"Lee & Peggy Wenk"



In addition, ruling is from Department of Health and Human Services (DHHS),
Center for Medicaid and Medicare Services (CMS), 42 CFR 493.1252(c)
http://edocket.access.gpo.gov/cfr_2006/octqtr/pdf/42cfr493.1253.pdf

So it's bigger than CAP. It's the US government.

Peggy A. Wenk, HTL(ASCP)SLS
Beaumont Hospitals
Royal Oak, MI 48073

-----Original Message-----
From: histonet-bounces@lists.utsouthwestern.edu
[mailto:histonet-bounces@lists.utsouthwestern.edu] On Behalf Of Morken, Tim
Sent: Friday, October 10, 2008 7:16 PM
To: 'Histonet'
Cc: 'ihcrg Group (E-mail)'
Subject: [Histonet] RE: [IHCRG] IHC antibody expiration question for CAP. .


Unfortunately, "Expiration Date" is required by FDA/IVD and European CE/IVD
mark. No one is going to touch that one due to liabilities to a laboratory
of re-validating "expired" reagents.

Tim Morken
Technical Support Manager
Lab Vision Products
Anatomical Pathology
ThermoFisher Scientific

-----Original Message-----
From: ihcrg@googlegroups.com [mailto:ihcrg@googlegroups.com] On Behalf Of
Richard Cartun
Sent: Friday, October 10, 2008 3:10 PM
To: Jackie.O'Connor@abbott.com; pruegg@ihctech.net; Histonet
Cc: 'ihcrg Group (E-mail)'; ancillarypath@mac.com; charlene.henry@stjude.org
Subject: [IHCRG] IHC antibody expiration question for CAP. .


I have antibodies that work great 10-20 years after their expiration date.
Once again, I propose that the manufactures eliminate the "expiration date"
and use a "stability guarantee date".  If the antibody is used after that
date then the user would be responsible for validating its performance.

Richard

Richard W. Cartun, Ph.D.
Director, Histology & Immunopathology
Assistant Director, Anatomic Pathology
Hartford Hospital
80 Seymour Street
Hartford, CT  06102
(860) 545-1596
(860) 545-0174 Fax

>>> Jackie M O'Connor  10/10/08 3:12 PM
>>>
When I was making and testing antibodies for a manufacturer, we had retest
dates on all the lots.   As each lot reached or was past it's
expiration
date, we would test it against a fresh antibody lot - if it still met the
exact same standard, we would extend the expiration date 3 or 6 months.

Most antibodies stored at 40C I tested were still good 6 months past
expiration.  ALL antibodies were still good 30 days past expiration,
regardless of the storage conditions.     There was a strict rule about

thawing frozen aliquots  - no more than 3x freeze-thaw cycles, as this did
damage the antibody.
Throwing away frozen aliquots because they have expired is nuts.   If
your
results are still meeting standards, it's a waste.

Jackie O'



"Patsy Ruegg" 
Sent by: ihcrg@googlegroups.com
10/10/2008 02:00 PM
Please respond to
pruegg@ihctech.net


To
, , "'ihcrg Group
\(E-mail\)'"  cc

Subject
[IHCRG] Re: IHC antibody expiration question for CAP.    .






Charlene,

This is new to me as well.  Hadi can you give us the rule where it says

you can use expired abs if you freeze aliquots before they expire?
Folks, do not throw away expired antibodies.  The IHCRG has a reagent bank,
you can send them to me.  We will even provide you with a fedex act.
No to use to ship the reagents.  I have a refrigerator full of these
reagents labs being CAP inspected have sent me.  We use them in research and
for teaching purposes.  If any of you members of the IHCRG want to

check something out we have in the bank, perhaps before you purchase it

for a research project, you can do that.  Just send me a message asking if I
have what you need.

Patsy

Patsy Ruegg, HT(ASCP)QIHC
IHCtech
12635 Montview Blvd. #215
Aurora, CO 80045
720-859-4060
fax 720-859-4110
pruegg@ihctech.net
www.ihctech.net
www.ihcrg.org



From: ihcrg@googlegroups.com [mailto:ihcrg@googlegroups.com] On Behalf Of
Henry, Charlene
Sent: Friday, October 10, 2008 12:48 PM
To: 'ancillarypath@mac.com'; ihcrg Group (E-mail)
Subject: [IHCRG] Re: IHC antibody expiration question for CAP. .

What do you do when the antibody data sheet states "do not freeze" and if
freezing the antibody is accepted by CAP wouldn't the CAP Checklist state
that this practice is acceptable? Also I have been to a couple CAP workshops
and this question was ask. The CAP instructors stated that the antibody
cannot be used past the expiration date regardless if it is frozen or stored
at -20C.

Charlene Henry HT (ASCP), QIHC
Anatomic Pathology Section Head
Department of Pathology
St. Jude Children's Research Hospital
901-495-3191
fax 901-495-3100



From: ihcrg@googlegroups.com [mailto:ihcrg@googlegroups.com] On Behalf Of
Hadi Yaziji
Sent: Friday, October 10, 2008 1:28 PM
To: ihcrg Group (E-mail)
Subject: [IHCRG] Re: IHC antibody expiration question for CAP. .
You need to educate the inspectors that it's accepted by the CAP. Most

inspectors don't even know about this, because it hardly ever comes up.


==========================3D======
Hadi Yaziji, M.D., Medical Director
Vitro Molecular Laboratories
President,
Ancillary Pathways
7000 62nd Avenue, PH-C
Miami, FL 33143
T 305-740-4440
F. 786-513-0175
www.vitromolecular.com
www.ancillarypath.com



On Oct 10, 2008, at 1:55 PM, Mark Tarango wrote:


I'm a little skeptical too, but if this isn't allowed then it should be.
On Fri, Oct 10, 2008 at 9:22 AM, Sebree Linda A. 

wrote:
Call me skeptical but I've never heard of CAP accepting this method of

shelf-life extension.


Linda A. Sebree
University of Wisconsin Hospital & Clinics IHC/ISH Laboratory
DB1-223 VAH
600 Highland Ave.
Madison, WI 53792
(608)265-6596
-----Original Message-----
From: ihcrg@googlegroups.com [mailto:ihcrg@googlegroups.com] On Behalf Of
ancillarypath@mac.com
Sent: Friday, October 10, 2008 11:19 AM
To: ihcrg Group (E-mail)
Subject: [IHCRG] Re: IHC antibody expiration question for CAP


There is a CAP-accepted way of working around this...


If you aliquot the antibody before its expiration date and store it in -20
freezer, the clock is in effect "frozen" too. For example, if there are
6
months left before the antibody expires and you freeze the aliquots for
5
years, then if you thaw one of the frozen aliquots, the thawed aliquot

will still be good for 6 months.


Just make sure you don't thaw and re-freeze the aliquot.


Hadi


==========================3D======
Hadi Yaziji, M.D., Medical Director
Vitro Molecular Laboratories
President,
Ancillary Pathways
7000 62nd Avenue, PH-C
Miami, FL 33143
T 305-740-4440
F. 786-513-0175
www.vitromolecular.com
www.ancillarypath.com


On Oct 10, 2008, at 12:15 PM, Swain, Frances L wrote:

Hey everyone.  I use outdated antibodies I work in a research service
laboratory.  The reason CAP has these rules is because of patient
protection.  If you use an outdated antibody and the specimen comes back
negative and later it was discovered that the patient had the problem that
the antibody was suppose to identify.  Maybe the patient dies or is
permanently ill for the rest of their lives. Can you live with that?
CAP
is suppose to make sure that all of the labs (clinical only right now) are
working under the same guidelines.  They are not making these rules to

make you spend more money but to protect the patient and make sure the

diagnosis is as correct as can be. I agree that it is unfair to destroy

antibodies that are used only once or twice before they expire.  Maybe the
companies preparing these antibodies should extend their expiration times?
Just thought I would put my two cents worth in.


Frances L. Swain HT(ASCP) A. A. S.
Special Procedures Technician
Department of Orthopaedic Surgery
Center for Orthopaedic Research
Barton Research Building 2R28
4301 West Markham Street
Little Rock AR 72205
(501) 686-8739 PHONE
(501) 686-8987 FAX
swainfrancesl@uams.edu email

From: ihcrg@googlegroups.com [mailto:ihcrg@googlegroups.com] On Behalf Of
Mark Tarango
Sent: Friday, October 10, 2008 11:10 AM
To: themagoos@rushmore.com
Cc: ihcrg@googlegroups.com
Subject: [IHCRG] Re: IHC antibody expiration question for CAP


The rules are the rules.  We need to change them back.


Mark
On Fri, Oct 10, 2008 at 8:41 AM, Jason and Heather  wrote:

CAP question ANP.22432 states: Are all immunohistochemical reagents used
within their indicated expiration dates?

I am wondering what labs across the country are doing to answer this
question. IHC antibodies are very expensive and can be validated on every
run that is made. Some of these concentrated antibodies are diluted out so
far that only a very small portion of them are used before they expire.

Are some labs still using outdated antibodies? If so how do you get away
with it when you are inspected by CAP? Or are you paying the high prices to
throw out the majority of your antibodies so you can answer this question
yes?

I thank you in advance to your response.

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 Ext 127
605-718-3779 (Fax)
jmcgough@clinlab.com









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