[Histonet] Xylene/substitutes & Validation/verification

[Stephanie Rodriguez]

Liz,

You are correct. If you bring in an FDA-approved test with NO
modifications, all that is required is verification; you simply have to
verify that the test works in your lab when you follow the recommended
procedure.  Validation, which is required for laboratory-developed tests
as well as laboratory-modified FDA-approved tests, is, indeed, a much
lengthier process.

Stephanie Rodriguez, HTL(ASCP), QIHC
Lead Molecular Technologist-FISH
IHC Technologist III
Phenopath Laboratories
Seattle, WA
(206) 374-9000 



On 9/27/11 9:49 AM, "histonet-request <@t> lists.utsouthwestern.edu"
<histonet-request <@t> lists.utsouthwestern.edu> wrote:

>Message: 8
>Date: Tue, 27 Sep 2011 10:32:07 -0600
>From: Elizabeth Chlipala <liz <@t> premierlab.com>
>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>, Loralee AMcMahon
>	<Loralee_Mcmahon <@t> URMC.Rochester.edu>
>Message-ID:
>	<14E2C6176416974295479C64A11CB9AE1DECBA0A63 <@t> SBS2K8.premierlab.local>
>Content-Type: text/plain; charset="iso-8859-1"
>
>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
>PO Box 18592
>Boulder, CO 80308-1592
>(303) 682-3949 office
>(303) 682-9060 fax
>(303) 881-0763 cell
>www.premierlab.com
>
>Ship to address:
>
>1567 Skyway Drive, Unit E
>Longmont, CO 80504




This e-mail message, including any attachments, is for the sole use of the 
intended recipients and may contain privileged information. Any unauthorized 
review, use, disclosure or distribution is prohibited. If you are not the intended 
recipient, please contact the sender by e-mail and destroy all copies of the 
original message, or you may call PhenoPath Laboratories, Seattle, WA U.S.A. 
at (206) 374-9000.