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LIS downtime validation


simret

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  • 4 years later...

This is a bit of an old post; we did not have any instrumentation that required a revalidation plan for scheduled LIS downtimes.  IT handled any interface checks that were necessary.  We simply retransmitted results directly from the analyzers (and hand entered anything that was a manual entry). If the retransmission didn't work, we knew there was an issue and we called IT immediately to have it fixed.  All testing done during downtime was printed or the results written on a downtime form and tubed to the ordering department/floor. We saved all of the paperwork and printouts for the same amount of time as patient testing.  Lead techs would double check to ensure the results went to the patient side of the LIS correctly (since lab checked to ensure the correct numbers were released). 

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Usually you don't have to revalidate after a scheduled downtime unless you had some changes made, especially if it involves any automation you are using.

However, if you have an unscheduled downtime you will need a validation plan - to make certain your truth tables are still intact.   I've had these in the past but I no longer have a BBIS .

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