[Histonet] Equipment Validation

Patti Loykasek ploykasek <@t> phenopath.com
Wed Sep 1 13:21:32 CDT 2004

I'm not familiar with the JCAO requirements, but I know a little about the
GLP requirements. Usually these requirements are mainly intended for
instruments that are reporting data. In anatomic path, the pathlogists are
the "instrument". I do think it is smart to test any new equipment that
comes into the lab to ensure it does what it is supposed to do.

Patti Loykasek
PhenoPath Laboratories
Seattle, WA

> 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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