i-STAT Quality Controls

We perform LQC per shipment, as required by manufacturer and monthly for each lot #.  
Monthly QC was established a long time ago.  I believe at that the manufacturer recommended it.  
We use Abbott's liquid QC products.
The QC results are transferred to RALS, our middleware.  We can pull all the information  you mention from that system.
We do not manually record results.

1. We run QC every new shipment/new lot/new user/Q30-days. New shipment/lot/user is required by MFR and we do Q30-days because we don't run actual patient tests very often (outpatient - CRT only for DI and Chem-8 for IR - very few Chem-8). We did our validation QC every day for 30 days, checking values and then decided that 30-days would work (and Abbott helped with stats).
2. We use Abbott TriControl L1 & 3 (and TriControl CalVer every 6 months). This is what was in use when I started doing POC - haven't had any problems with it so far.
3. In theory, our QC results should go into our Orchard program which could then generate an LJ, but in practice that has never happened that I"ve seen. We are so low on LIS staff and they are so busy with other projects that I haven't pursued making it a reality. I just eyeball everything - our numbers stay very stable and nothing is ever too close to the upper or lover value limits for TriControl.
4. We do manually document QC - I can send you the QC sheets that I have.

~jill

Amanda, 

 

You have to set up IQCP for i-STAT analytes which would help you determine

and prove  the frequency of QC performance  for the i-STAT. 

Based on 3  years  of QC material we had, we determined that we should run QC at least  one a month. Of course you need to do QC  on new lot, and/or new shipment  and when troubleshooting. 

 

We use Eurotrol and we use their recommended ranges .  WE order enough QC for a year. 

 Their products usually expire in May of every year. 

 Since we only do QC once a month, there are only 12-20 data

I-STAT QC - Chem8+ -PMCCLEW 43- rev 11-15-2021.doc

I-STAT QC -CG4+ CLEW 43- Level 1- Rev 11-15-2021.doc

I-STAT QCEG7+ CG8+ 3 levels - Eurotrol lot CLEW 43- Level 1 -11-15-2021.doc

points a year. 

WE calculate our mean, SD, etc but we usually do not change our ranges

  as long as the results we get are close to the recommended mean. 

 

The QC from Eurotrol is labeled for which cartridges those numbers apply. 

They are very clearly labeled on top of each chart. 

Each Level is also clearly marked., each Level has 4 pages. 

Page 1 is usually no designation, page 2 we do not use those cartridges. 

Page 3 is for CG8+, EG7+, etc and CG4+

Page 4 are the ranges for Chem8+ 

 

I attached what I use for manual QC recording. 

I still do comparison of old and new lot. 

I just get a  whole blood sample and run on both old and new lot. 

Acceptable differences are shown on the QC sheets. 

 

Hope this helps. 

Hi Amanda,

MONTHLY REPORT TO PRINT.pdf

These are the Monthly Reports I print in Telcor 

Denver Health Point of Care ACT QC.docx

I use ACT, cTnl and PT/INR. I have the ACT QC document I manually record attached. The PT/INR and troponin are the same with titles changed. QC is run with each new lot and shipment and each month they are in use. I purchase the controls for each cartridge from Abbott directly. Every 6 months I have my staff run the linearity material for the cTnl. ACT and PT don't have these and I don't make them up myself. I also run the external simulator and verify the thermal difference. 

Hi Amanda,
We run liquid QC the first Thursday of every month per our IQCP.  We also run with every new shipment and new lot#.
We use Abbott TriControls. and eVAS for ranges downloaded to RALS.  We use QC lockout
Our results go directly into RALS.  We don't print LJ charts since we would only have 1 point on it.
We do not manually record QC results.

We only use the waived Crea cartridge. QC material is Abbott, we upload the EVAS from Abbott, and everything goes into RALS. 
Our operators run the QC every week... that was the frequency established before my arrival to POC, so after reading that everyone else here is running monthly QC, I'm thinking perhaps we're doing too much? I will need to look into that...