Clinitest and TJC standards
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For those of you that are TJC accredited and use the Clinitest for urine pregnancy:
How do you record internal QC for each test cassette?
The Clinitek only gives a test result if the internal QC on the cassette is valid, otherwise it advises the user to repeat the test or contact support. There is no explicit interpretation of internal QC. TJC requires internal QC results to be recorded. How do you marry the two? Is it as simple as recording "QC Pass" with every valid test result?
Thank you,
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We are TJC accredited for waived testing. We do not document internal QC if the internal QC 'lockout' prevent the device from reporting a result, if the internal QC fails (eg PT INR, Clinitek). Since you are concerned specifically with TJC and the EP is interpreted as 'required', my suggestion is to contact TJC specifically on the EP you feel is 'required'. That way you get it straight from TJC as to how they'd inspect this at their visit.
I can say we never had an issue, never had a question on this from TJC survey team coming through but that may not be the case for you (someone else).
Would be interested in hearing the wording you receive back! Peggy
I would agree with Peggy's feedback, Stephen. We are also TJC accredited for waived testing. We use the Clinitek Status+ for both urinalysis and Clinitest testing. Because the Clinitek will not supply results for a Clinitest cassette without recognizing valid R and C lines, we do not require the information to be recorded anywhere.
Are your Clinitek analyzers interfaced?
We currently do not use Clinitest. We were thinking about bringing it in because we already use the Clinitek for UA. I have reached out to TJC through their standards interpretations page. Thank you so much Peggy and Mickayla!