Biannual requirements - iSTAT

I am not an iSTAT user, but what you described above sound like a new instrument verification.  For semi-annual verification, you don't need accuracy or precision.  
For iSTAT to iSTAT, refer to your institution's policy.  If you don't have one, write one.  You can use as little as two levels.  

If just Bi-annual and not new setup/install then...
 ·         Method to Method: Study between the iSTAT and the Roche Cobas. 
1.  min of 5 patient correct. 

·         Calibration Verification: Using TriControls Cal Ver (L1,3,5) on all 9 istats (both cartridges).
2. You are not testing the ISTATs but the analytes on the cartridge.  I just pick two istats each time I do bi-annual. Try to rotate to different devices each time.
·         AMR Study: Satisfied by Cal Ver because it measures low, mid and high. 
3. Yes

·         Accuracy: Is it satisfied by Cal Ver? It has an established range. 
4. New devices not bi-annual.

·         Precision: Do I need to do a precision run using QC or can I run my 5 patient samples in duplicate when testing method to method? 
5. New devices not bi-annual.

If just Bi-annual and not new setup/install then...
 ·         Method to Method: Study between the iSTAT and the Roche Cobas. 
1.  min of 5 patient correct. 

·         Calibration Verification: Using TriControls Cal Ver (L1,3,5) on all 9 istats (both cartridges).
2. You are not testing the ISTATs but the analytes on the cartridge.  I just pick two istats each time I do bi-annual. Try to rotate to different devices each time.
·         AMR Study: Satisfied by Cal Ver because it measures low, mid and high. 
3. Yes

·         Accuracy: Is it satisfied by Cal Ver? It has an established range. 
4. New devices not bi-annual.

·         Precision: Do I need to do a precision run using QC or can I run my 5 patient samples in duplicate when testing method to method? 
5. New devices not bi-annual.

If just Bi-annual and not new setup/install then...
 ·         Method to Method: Study between the iSTAT and the Roche Cobas. 
1.  min of 5 patient correct. 

·         Calibration Verification: Using TriControls Cal Ver (L1,3,5) on all 9 istats (both cartridges).
2. You are not testing the ISTATs but the analytes on the cartridge.  I just pick two istats each time I do bi-annual. Try to rotate to different devices each time.
·         AMR Study: Satisfied by Cal Ver because it measures low, mid and high. 
3. Yes

·         Accuracy: Is it satisfied by Cal Ver? It has an established range. 
4. New devices not bi-annual.

·         Precision: Do I need to do a precision run using QC or can I run my 5 patient samples in duplicate when testing method to method? 
5. New devices not bi-annual.

If just Bi-annual and not new setup/install then...
 ·         Method to Method: Study between the iSTAT and the Roche Cobas. 
1.  min of 5 patient correct. 

·         Calibration Verification: Using TriControls Cal Ver (L1,3,5) on all 9 istats (both cartridges).
2. You are not testing the ISTATs but the analytes on the cartridge.  I just pick two istats each time I do bi-annual. Try to rotate to different devices each time.
·         AMR Study: Satisfied by Cal Ver because it measures low, mid and high. 
3. Yes

·         Accuracy: Is it satisfied by Cal Ver? It has an established range. 
4. New devices not bi-annual.

·         Precision: Do I need to do a precision run using QC or can I run my 5 patient samples in duplicate when testing method to method? 
5. New devices not bi-annual.

If just Bi-annual and not new setup/install then...
 ·         Method to Method: Study between the iSTAT and the Roche Cobas. 
1.  min of 5 patient correct. 

·         Calibration Verification: Using TriControls Cal Ver (L1,3,5) on all 9 istats (both cartridges).
2. You are not testing the ISTATs but the analytes on the cartridge.  I just pick two istats each time I do bi-annual. Try to rotate to different devices each time.
·         AMR Study: Satisfied by Cal Ver because it measures low, mid and high. 
3. Yes

·         Accuracy: Is it satisfied by Cal Ver? It has an established range. 
4. New devices not bi-annual.

·         Precision: Do I need to do a precision run using QC or can I run my 5 patient samples in duplicate when testing method to method? 
5. New devices not bi-annual.

For 6 months you dont have to do Accuracy and Precision. 
For instrument to Instrument there is no required number. Most people do 5 because EP evaluator requires a minimum of 5 points for calculation. I have inspected lab that have done 1 to 5. As long as it is done. As Don said write a policy and follow it.
I usually do the thermal Probe check at this time.

Every 6 months you are required to do the Calibration Verification.  Accuracy is measure using the CVM by the results coming in the acceptable range of the material. (manufacturer's range)  I also verify my AMR using the CVM.  The correlation between any instruments reporting the same analyte and under the same CLIA number, also needs to be completed.  There is no requirement on how many specimens you use.  You must follow any written procedures your institution has, but CLIA does not say how many specimens you must use.  We use 3.  Precision only needs done for new instrument validation.

Thank you all! I greatly appreciate help. 

For comparison between our I-stat devices we use the CAP quality cross check AQIQ that comes every 6 months and contains three samples for testing on three different devices. Our program is on a different CLIA number than the main lab so we do not perform the i-STAT to Roche comparison.

Ashley, 
What you have to do bi annually on your i-STAT depends on who inspects you. 
CAP require, calibration, AMR, method comparison, and meter to meter. Precision is not required biannually, It is required for new meters or new analyte. 

Joint Commission DO NOT require Calibration or linearity biannually. They do not require meter to meter either. They only require comparison  of the i-STAT with the main lab ( method to method  comparison).  They also want to see that  you perform thermal probe every 6-months and internal simulation readings. 

You seem to be doing what is required biannually, if you are CAP inspected. 

I get data from my middleware  for Method comparison.  Sometimes I find duplicates and I collect those data. Sometimes they perform Troponin and Chem8+ in ER and then turn around and order  Troponin and  Comp Panel.   I try to collect as many as 10 minimum for my comparison. Doing this saves i-STAT cartridges which can be expensive. 

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