[Histonet] Xylene sensitivity

McMahon, Loralee A Loralee_Mcmahon <@t> URMC.Rochester.edu
Tue Sep 27 12:09:50 CDT 2011


Well actually yes.  We do a trend analysis and have proven that according to the accepted rates their Her2 positivity was declining (went from 14%- 6%).  Meaning that some patients did not get the correct therapy.  I would have to say poor patient!!

And maybe it wasn't the xylene but if I was a lawyer and I got ahold of the data sheet and found out that my client didn't get herceptin because the hospital decided it would be better to not expose their employees to a chemical that if used handled properly is perfectly fine to use......and then found out that the hospital running the test on those tissue knew that they were not using xylene....as you can see it can get out of hand.

I am sure that there are arguments for both sides.  The Data from Dako was using thousands of cases.  I cannot process that many cases differently to validate it my way.   I am simply using the guidelines that they have established.    Maybe five or so years down the road there will be another company out there that can validate there antibody without using xyelene and get it FDA approved.  But they haven't yet.

And my boss is on the ASCOCAP taskforce, so I really can't argue with him.

Using Xylene on one processor that is ventilated and enclosed is really not exposing every employee to xylene.  If they use it properly they exposure rate is very small.  I would worry more about formalin or DAB.


Loralee McMahon, HTL (ASCP)
Immunohistochemistry Supervisor
Strong Memorial Hospital
Department of Surgical Pathology
(585) 275-7210

________________________________
From: Rene J Buesa [rjbuesa <@t> yahoo.com]
Sent: Tuesday, September 27, 2011 11:35 AM
To: Histonet Listserv (E-mail); ShelleyD'Attilio; McMahon, Loralee A
Subject: RE: [Histonet] Xylene sensitivity

Loralee:
Poor people in your sister hospital! You are affecting their health. I would have approached a different way and never done that.
DAKO cannot dictate how I process my samples. I would have gotten involved my legal department to handle that.
I would have requested the experimental data from DAKO. They obtained approval from FDA using their process. They submitted that process that unfortunately included using xylene but that in no way invalidates the Herpset Tests results.
Are you going to tell me that the results of your sister hospital were wrong while using something other than xylene? I would have interchanged pieces of tissue and evaluate the results.
I would have demonstrated that there were no differences and I say this because that is what I did when processing with mineral oil at my hospital. The whole process was validated and we also did Hercept test from DAKO.
Do they also require using ethanol? Does it matter if you use 2-propanol?
Why limiting the process to just about xylene and not about the dehydrating agent?
Do they also try to determine the lenght of the process?
I think that accepting DAKO protocol without challenging it and forcing your sister hospital to expose their employees to xylene was absolutely wrong!
Forgive me to say this, but you took the "easy way" instead of challenging the whole issue and demonstrate that their requirement from the technical point of view absolutely baseless.
René J.

--- On Tue, 9/27/11, McMahon, Loralee A <Loralee_Mcmahon <@t> URMC.Rochester.edu> wrote:

From: McMahon, Loralee A <Loralee_Mcmahon <@t> URMC.Rochester.edu>
Subject: RE: [Histonet] Xylene sensitivity
To: "Rene J Buesa" <rjbuesa <@t> yahoo.com>, "Histonet Listserv (E-mail)" <histonet <@t> lists.utsouthwestern.edu>, "ShelleyD'Attilio" <SDattili <@t> stormontvail.org>
Date: Tuesday, September 27, 2011, 10:57 AM

The Hercept Test from Dako specifies  xylene in the breast tissue processing section.  The Er/Pr Pharm DX kit may also, but I haven't check that out.   I know this because we just fought with a sister hospital to get them to change their processors to xylene.


Loralee McMahon, HTL (ASCP)
Immunohistochemistry Supervisor
Strong Memorial Hospital
Department of Surgical Pathology
(585) 275-7210

________________________________
From: Rene J Buesa [rjbuesa <@t> yahoo.com]
Sent: Tuesday, September 27, 2011 9:54 AM
To: Histonet Listserv (E-mail); ShelleyD'Attilio; McMahon, Loralee A
Subject: RE: [Histonet] Xylene sensitivity

Loralee:
Please enlighten me! As far as I know FDA requirements extend to fixation time and NBF is required by some kit FDA approved, but not to how the tissues are processed.
Even there are studies that show that xylene has extracting effects over some epitopes.
I know that you cannot argue with FDA, but you can always validate any changes in your procedure.
René J.

--- On Tue, 9/27/11, McMahon, Loralee A <Loralee_Mcmahon <@t> URMC.Rochester.edu> wrote:

From: McMahon, Loralee A <Loralee_Mcmahon <@t> URMC.Rochester.edu>
Subject: RE: [Histonet] Xylene sensitivity
To: "Rene J Buesa" <rjbuesa <@t> yahoo.com>, "Histonet Listserv (E-mail)" <histonet <@t> lists.utsouthwestern.edu>, "ShelleyD'Attilio" <SDattili <@t> stormontvail.org>
Date: Tuesday, September 27, 2011, 9:40 AM

Rene,

I understand the desire to remove Xylene from the lab completely.  But what if you are running FDA approved kits that are only FDA approved if the tissue is processed in Xylene?

Loralee McMahon, HTL (ASCP)
Immunohistochemistry Supervisor
Strong Memorial Hospital
Department of Surgical Pathology
(585) 275-7210
________________________________________
From: histonet-bounces <@t> lists.utsouthwestern.edu<http://us.mc657.mail.yahoo.com/mc/compose?to=histonet-bounces@lists.utsouthwestern.edu> [histonet-bounces <@t> lists.utsouthwestern.edu<http://us.mc657.mail.yahoo.com/mc/compose?to=histonet-bounces@lists.utsouthwestern.edu>] On Behalf Of Rene J Buesa [rjbuesa <@t> yahoo.com<http://us.mc657.mail.yahoo.com/mc/compose?to=rjbuesa@yahoo.com>]
Sent: Tuesday, September 27, 2011 9:33 AM
To: Histonet Listserv (E-mail); ShelleyD'Attilio
Subject: Re: [Histonet] Xylene sensitivity

Shelley:
As you correctly think this employee is most likely sensitive to xylene. Having a filtration system is the wrong solution.
Is like having a pain when you use your arm and immobilizing it to prevent the pain.
Your long term and complete solution is to eliminate xylene from your lab and I mean from ALL tasks using it now.
Under separate cover I am sending 2 publications explaining how to do that.
René J.

--- On Tue, 9/27/11, D'Attilio, Shelley <SDattili <@t> stormontvail.org<http://us.mc657.mail.yahoo.com/mc/compose?to=SDattili@stormontvail.org>> wrote:


From: D'Attilio, Shelley <SDattili <@t> stormontvail.org<http://us.mc657.mail.yahoo.com/mc/compose?to=SDattili@stormontvail.org>>
Subject: [Histonet] Xylene sensitivity
To: "Histonet Listserv (E-mail)" <histonet <@t> lists.utsouthwestern.edu<http://us.mc657.mail.yahoo.com/mc/compose?to=histonet@lists.utsouthwestern.edu>>
Date: Tuesday, September 27, 2011, 9:27 AM


Hi all,
I have a new employee who is developing a scratchy, painful throat and some difficulty breathing when exposed to xylene (for instance, when the cover is raised on the coverslipper).  This is her first job in a lab of any sort.  We are investigating all the usual culprits--air handling system, hoods, allergies or virus unrelated to histology, etc.  Right now she is wearing a PAPR to work, which is obviously not a long-term solution.  Ultimately, I think we will conclude that this employee has a sensitivity to xylene and possibly other chemicals in the histology lab, as other employees are not complaining about symptoms related to chemicals.

Does anyone have any experience with activated charcoal air cleaners?  I am looking at a portable unit that sits on casters and provides 4 air exchanges per hour.  It's not cheap at $1000, but well worth it if it will provide relief for this employee and allow her to continue her employment.  Our lab is approximately 800-1000 sq. ft in size with 8 foot ceilings.  We have 1 standard bio-hood for processing cytology fluids and 2 wall-mounted "air suckers" above our processors.  I am open to any suggestions.

Thanks,

Shelley D'Attilio MT(ASCP)
Manager, Chemistry, Cytology and Histology
Dept. of Pathology and Laboratory Medicine
Stormont-Vail HealthCare
Topeka, Kansas




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