Clinitek QC

Cindy, are these Cliniteks operated under a limited service (CLIA waived) permit at that location?  Is the QC cycle for test strips or for hCG cassettes?  If the QC is for test strips, does each Clinitek have it's own vial of strips?

Operating a CLIA waived instrument like the Clinitek, and under a CLIA waived testing permit, the purpose of urinalysis quality control is to ensure test strip integrity before the vial of strips is used for patient testing, not to check instrument performance. The Clinitek is CLIA waived because the instrument system checks strip integrity and performs instrument diagnostics without needing additional technical service.  If a CLIA waived instrument is operated under a full service CLIA moderately/high complex permit, you may need to do an IQCP to perform QC on test strips when opening a vial and then by the periodicity your lab director indicates is necessary -  and not q24 hours which is required for moderately and high complex instruments.

Per the package insert from Siemens, MultiStix 10SG negative and a positive control only needs to be performed when opening a new vial of strips.  The CLIA waived POCT program I run also performs a negative and positive control on the open test strip vial weekly to ensure continued test strip integrity. 30 days is a stretch in my opinion because of the sensitivity the strips can have to humidity contamination. Urinalysis QC does not QC the Clinitek itself.  The Clinitek performs internal checks on the optical eye and checks the white QC pad for strip integrity each test and will give an error code if there is anything wrong.  So, I do not think you need to do QC on all 3 instruments - unless each instrument has it's own vial of strips assigned to it.  You did not specify if so.  

The Clinitek QC schedule will go out of sync if an operator performs QC after the programmed day.  Our program is scheduled to request QC every 7 days to check open test strip integrity.  I have not seen an instance on any of the 55 Cliniteks in my program going off QC schedule if QC is performed before the scheduled day, only if QC is performed after the scheduled day and then QC resets to that new day.  So, either there was a holiday that threw off the QC schedule or the location is not performing QC on the schedule set by your POCT policy.  The only way to re-synch the Clinitek QC schedule is to go physically to the instrument(s) on the day that the office wants QC done and move the QC time by whatever increment that works - which will reset the QC schedule for that preferred date.  You will have to perform QC to unlock patient testing after resetting the QC time on the Clinitek.  The program I oversee does QC on the Clinitest hCG cassettes when a new kit is opened and every 30 days on stored kits per Siemens instructions.  Hope this info helps.

Karen - would you mind sharing the CLIA guidelines that specify that a CLIA-waived device like a Clinitek may be required to be covered by an IQCP program simply because the CLIA license under which testing is performed is moderate/high complexity?  It has always been my understanding that a CLIA-waived test is a CLIA-waived test, no matter where it is performed and that as long as the minimum of a CLIA Certificate of Waiver, or higher, is in place, the laboratory applies only waived testing guidelines to the device, which for QC would be, to follow manufacturer's instructions.  I am not seeing how having simultaneous mod/high complexity testing in the same laboratory changes the CLIA guidelines around a waived test.  Appreciate anything you can share!