[Histonet] Equipment Validation

[Rush, Joyce]

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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