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Home > Archive > Medicine laboratory > July 2006 > CLIA-88 and its impact on LIMS implementation
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CLIA-88 and its impact on LIMS implementation
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| guavafan@gmail.com 2006-07-24, 4:26 pm |
| I work in a lab that self-developed their LIMS (LIS) application. I am
trying to figure out if there are any CLIA specific requirements for
validating our LIMS application. For example, do we have to document
our software test plan?
Thanks,
Todd
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| John Gentile 2006-07-24, 9:26 pm |
| On 2006-07-24 15:03:56 -0400, "guavafan@gmail.com" <guavafan@gmail.com> said:
> I work in a lab that self-developed their LIMS (LIS) application. I am
> trying to figure out if there are any CLIA specific requirements for
> validating our LIMS application. For example, do we have to document
> our software test plan?
>
> Thanks,
>
> Todd
There are several CAP inspection questions on the General Laboratory
checklist for LIS. They include things like documenting the system
itself - controlled access, environmental controls, secure backups,
power controls, contingency plans. There is also some reporting things
to look at - the medical director has to approve all the types of
reports that can be produced, you have to document any calculations
that the system performs, document any interfaces between your system
and your instruments or your system and a larger HIS if there is one.
In short you have to document everything!
--
John Gentile, MS M(ASCP)
Laboratory Information Manager
Providence, VAMC
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