[Histonet] Xylene sensitivity

Tue Sep 27 11:32:07 CDT 2011

Rene

Rene

Loralee is correct in some aspects and you have addressed this already with mentioning validation.  This basically has to do with the internal validation that is required when you bring these kits into the laboratory.  When you modify a 510K cleared kit or FDA approved kit it becomes a LDT or Laboratory Developed Test there is significant additional validation required because by changing the process you have essentially increased the risk.  Additional validation is required as defined by CLIA.  The manufacturer of the kit has gone through a process that essentially has decreased the laboratory risk when then get a kit FDA cleared or approved, if the lab chooses to modify this kit they essentially have increased their risk significantly and are required to do additional validation, more than would be required if you used the kit as recommended.

I'm thinking that all that is required if you use a cleared or approved kit is verification and not validation, but I may be incorrect. Validation is a more intense process.  Patty from Phenopath or Beth Shepard from Ventana would be able to comment on this process also.

Liz

Elizabeth A. Chlipala, BS, HTL(ASCP)QIHC
Manager
Premier Laboratory, LLC
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-----Original Message-----
From: histonet-bounces <@t> lists.utsouthwestern.edu [mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of Rene J Buesa
Sent: Tuesday, September 27, 2011 7:55 AM
To: Histonet Listserv (E-mail); ShelleyD'Attilio; Loralee AMcMahon
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 [histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of Rene J Buesa [rjbuesa <@t> 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> wrote:

From: D'Attilio, Shelley <SDattili <@t> stormontvail.org>
Subject: [Histonet] Xylene sensitivity
To: "Histonet Listserv (E-mail)" <histonet <@t> 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

NEED A DOCTOR?  Stormont-Vail's Health Connections can help you find a doctor accepting new patients.  Call (785) 354-5225.

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