[Histonet] Equipment Validation

Wed Sep 1 11:10:09 CDT 2004

Joyce,

Thanks for your  reply. I think it is a good idea for the vendor to supply
start-up reagents. I was wondering if you had a copy of the specific
questions that the inspectors ask for with regard to validation. If so
could you fax or e-mail a copy to me? Sure does sound like a lot of work
especially with regards to immuno staining.

Thank You

Best regards,

Mark

Mark Lewis
Product Specialist
Anatomical Pathology
Clinical Diagnostics
Thermo Electron Corporation
Phone (412) 747-4013
Fax     (412) 788-6557
E-mail: mark.lewis <@t> thermo.com

                      "Rush, Joyce"                                                                                                                 
                      <Joyce.Rush <@t> sjmcmn.org>               To:       <Histonet <@t> lists.utsouthwestern.edu>                                           
                      Sent by:                              cc:                                                                                     
                      histonet-bounces <@t> lists.utsouth        Subject:  [Histonet] Equipment Validation                                               
                      western.edu                                                                                                                   

                      09/01/2004 09:36 AM                                                                                                           

Mark,

In the clinical lab our expectation is that the instrument vendor will
perform the validation on our site.  They run our specimens on their
machine using reagents at no cost to us and crunch the data.  For a
processor it was not our expectation that the vendor run the parallels
since the pathologists judge the final outcome.  We compared every special
stain, immuno, etc on tissue run on both old and new processors.  I guess
we could have required that the vendor pay for reagents for the crossover
but I guess we did not think of it, darn it!  It surely is painful but
required as far as I know.

Joyce

-----Original Message-----
From: histonet-bounces <@t> lists.utsouthwestern.edu
[mailto:histonet-bounces <@t> lists.utsouthwestern.edu]On Behalf Of
mark.lewis <@t> thermo.com
Sent: Wednesday, September 01, 2004 08:04
To: Histonet <@t> lists.utsouthwestern.edu
Subject: [Histonet] Equipment Validation

Good morning everyone.

I have a question concerning equipment validation.

We recently had a customer that said they were cited during an inspection
for not having a record of their new equipment being validated.
I am assume that the validation of the equipment means that they should
have run a parallel test with the new and "old" piece of equipment to
verify that it indeed performs as it should. The customer felt it was our
responsibility to do the validation testing in their lab for the equipment.
Does anyone have some more insight or protocols as to  what equipment
validation documentation is required of inspecting agencies like Joint
Commission ?

I appreciate your input.

Have a Blessed Day !

Best regards,

Mark

Mark Lewis
Product Specialist
Anatomical Pathology
Clinical Diagnostics
Thermo Electron Corporation
(412) 747-4013
(412) 788-1097
E-mail: mark.lewis <@t> thermo.com

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