IQCP

Abbott has an excellent resource called "Guiding the Development of an Individualized Quality Control Plan (IQCP)". It gave me the framework on which I built our IQCP.

Hello everyone, I was wondering if any I-Stat users have had a CLIA inspection?  If so what was said about the IQCP's?  When I developed my IQCP's I pulled information from numerous I-Stats but did an IQCP for each cartridge type, G4, ACTk, CG8+ and cTnI.  Even though I had years of QC performed on every i-Stat every 30 days I still went back and had 30 days of QC run on each cartridge type.  Now I am being told by a compliance team that I must have an IQCP for every i-Stat device for every type cartridge we run on it.  So my 7 ER i-Stats would need 7 IQCPs for G4 and cTnI cartridges with a total of  14 IQCPs.  Also, they are requiring 30 consecutive days of QC every time an i-Stat is replaced and a new IQCP has to be written.  This is all being requested in case we have a CLIA inspection.  We have been inspected by CAP 3 times since the IQCPs were developed with no deficiencies.

We have had CLIA inspections in areas that have i-STATs. I don't believe that what your compliance team is telling you is correct. Our IQCPs are by device.Then we list the similar cartridges. So, we have ACT and Troponin separate since they have different requirements. Within the one IQCP we have them listed by unit, since they might differ in one of the risk areas (environment or personnel, for example). The initial IQCP (for each CLIA/CAP) has the LQC vs. EQC study, and we don't repeat it when we get replacement i-STATs. We would only do that if we put an i-STAT under a new CLIA/CAP, or if there was a reason to adjust the IQCP, maybe a different cartridge type in use. You shouldn't need a separate IQCP for each i-STAT, since you are testing the system. Also, neither CAP nor CLIA lists a specific number of days to do the LQC/EQC study. We do 20 days, based on our medical director guidance, only for a brand-new i-STAT where there was not one before. Additional i-STATs to that area are covered under the initial risk assessment/QC Plan.

I would ask your compliance team to show you the regulations they are using to tell you what needs to be done, or to explain why they are asking this. We are continually having "friendly" debates with the non-POCT technical people, who think that POCT devices should be handled exactly like the core lab. It doesn't make sense, and even though the regulatory agencies need to catch up with POCT technology and make regulations that are relevant, we have had success when we explain the differences.

NO, NO, NO....that is way overkill and doesn't even make sense!  You validate each new handheld of course, but you have already done the risk assessments for each cartridge type and/or location.  CLIA states that if the environment or any part of an I-STAT process is different enough to change the risks, then you need a new IQCP.  It doesn't matter if you have one I-STAT or 30 that do the same testing with the same risks.  The handheld itself is not a risk if it have been validated.

I also think your compliance team doesn't understand what an IQCP is nor how point of care testing is different than lab testing.  Stand your ground!

I am late to this party, but I wanted to ask a follow up question.  I agree with the additional comments that it is only necessary to have one IQCP per cartridge/test that you run.  One per analyzer is too many, as the analyzer is actually just a reader (the test cartridge being the actual analyzer).

On our most recent Joint Commission survey we were told to add a signature section to each of the three subdivisions of our IQCP plans.  So the pathologist and lab director sign each of the three sections.  My question is, as you update these sections (an IQCP plan changes as necessary), do they re-sign these sections?  if I should post a picture to clarify, let me know.  I do have a chart for review signatures-maybe that's all I need to update.

These plans have been in place about two years-there was always a signature on the first page (the approval) and on the last sheet.  I guess these extra signatures seem a bit excessive, but I am curious to hear what others think.

Thanks!

We do at least an annual review of our IQCP's and have the medical director and lab administrative director sign them.  We added a piece to this for that says: By the laboratory medical director signing below, they have reviewed and approved IQCP Risk Assessment, Quality Control Plan, and Quality Assessment Plan.  We use this instead of re-signing every section each time.

We were just TJC inspected September 9-13. I got cited for this but she marked it 'fixed on site' as I had it fixed by end of day. I did not have the QC Plan and QA Plan separated from the risk assessment as I thought it was all part of the software package I had. My bad...  I did point out where the information was, she agreed but said all 3 parts needed signed by the medical director on the CLIA license. She suggested I just hand write in the plans and add the signature /date to the last page. As some of you know I am a little anal retentive so I wrote up a separate QC Plan and QA plan, pulling out the info from my IQ, put it on one sheet of paper and put the signature/date at the bottom. This was fine with her.

Another twist.... I had separate IQCPs for the 3 different locations of EPOC as they used them in different ways and QC was performed at different intervals. For my ACT (Signature Elites) I had one IQCP because it was used the same way in all 6 areas. She said I needed one for each area and suggested that I copy the one I had for each area.  I reprinted 5 more copies and added the locations to the front page. Added a Location field to my new QC/QA Plan forms and printed 5 more of those. She did not cite me for this.

FYI - unrelated to this but maybe helpful for others awaiting inspection the only other thing I was cited for was not having the reportable range of instrument listed in the EPOC and ABL 80 procedures. I had it in my ACT because they will get ranges > 400 seconds so they need to know that. The other 2 tests are multiple tests and the reportable range is not compatible with life so I left it out of the nursing procedure as they won't read them if they are too long. Yep, it's in there now. :)

Overall, she was very fair, very thorough and for the first time in 8 inspections I felt like someone actually looked at everything I had done. Also the first time anyone has spent 8 hours in POC. Did I mention they were 2 weeks late again this time? :)

Lois

lois.snider@stclair.org

We had our first TJC inspection last Summer.  First inspection with TJC is more of a "getting to know your lab"  so I can't wait  next year.  We got more recommendations than citations. POC no citation. The whole lab did real well though. We have always been CAP until last year. TJC is very thorough. TJC looked at everything.  Not just one day inspection- but 3-4 days. My philosophy with inspection and I don't care who is inspecting, if you are doing what you are supposed to be doing everyday, every week, monthly, - they can come any day.  Make  a checklist according to the standards and check daily. The inspector will tell you what you missed. Fix it then.

All agencies based their inspection on the CLIA regulations. Know your CLIA regs well.  

On the IQCP,  the inspector wanted the 3 sections separated and a signature page for each section. Not just on the first page.  The IQCP has to be reviewed and signed every year. CLIA, CAP and TJC require that there are separate IQCP for each cartridge for each location not the I-STAT meter.  The test happens in the cartridge.  The I-STAT is just a reader. So if you have I-STAT G3+ in Nursery, Surgery, ICU, etc.  you can just use the same IQCP but revise the environment, operator  and whatever factor may be different for each location. If Surgery use I-STAT  CG8+ and I-STAT ACT, you will need separate IQCP for those cartridges in the Surgery IQCP binder. My lab director is getting cramps in his arms just signing those paperwork.  It is not his favorite task.

The TJC inspector also told us  that Siemens RapidPoint 500 for ABG does not require IQCP.

  TJC does not require Calibration Verification  for I-STAT every 6 months  per QSA.02.03.01 since calibration does not change.  They are factory set.  You have to do calibration only for  initial verification.  TJC saved us a lot of money and time.  

For new and replacement I-STATs,  we follow what Abbott had in their Technical Bulletin 720619  : System Performance Verification Protocol  ( page 8 of 10). 1)  Run Low, Mid and High Linearity material in triplicate for Reportable range; 2) For Accuracy, run one or more patients ( we do  5 ) on both the new and a previously verified handheld. Calculate the level of agreement required for CLIA to see if acceptable.3) For Precision, run  Controls Low and High in duplicate  for 2 days for each of the new handheld. 4) For Reference Range- use the current reference range for I-STAT.   

PManiquis@primeheatlhcare.com

Thank you for the input!  I plan on utilizing all advice.