CHEM8 and CG4 Blue cartridge

January 15, 2020

Dear CAP-accredited laboratory,

Abbott sent an urgent notice to all i-STAT® users January 15, 2020 regarding the use of CHEM8+ and CG4+ cartridges. We are providing guidance for CAP-accredited laboratories concerning the required actions that must be taken to address this issue.

A few years ago, Abbott changed the cartridges for many of its tests and did not get FDA approval for these changes. The FDA informed Abbott that they are not approved. This removes their waived status and converts these cartridges to high-complexity laboratory developed tests (LDT). The following checklist requirements will now apply to all laboratories using these cartridges:

1) COM.40350: Revise waived and/or nonwaived verification studies to a full validation study. Laboratories can use historical data for help in these areas. Please note that Abbott is stating that all laboratories should discontinue the use of these with capillary specimens all together - laboratories would need to evaluate these specimen types thoroughly. a. Analytical accuracy

b. Analytical precision

c. Reportable range

d. Analytical sensitivity (lower detection limit)

e. Analytical specificity

f. Any other performance characteristic required to ensure analytical test performance

2) COM.40475: New validation summary that must include evaluation information of each instrument (I-STAT).

3) COM.04250 and COM.04300: Instrument comparisons; COM.30450: New lot/shipment verification (for the CHEM8+ cartridges, previously were waived but now is an LDT and must include acceptability criteria.

4) CHM.13600, POC.08600 or LSV.40610: AMR verification for the CHEM8+ cartridge.

5) COM.40830 Add these tests to the LDT/Modified test list.

6) COM.40850: Add LDT disclaimer to testing as there is no evidence of FDA clearance or approval.

7) GEN.55500 and GEN.54750: All waived cartridges now will require a full competency assessment including all six elements. Staff will need to be evaluated to ensure they qualify as high-complexity testing personnel.

8) COM.40800: Laboratories must notify clinicians of this urgent recall/change.

9) COM.50200 - COM.50600: If the laboratory will not be doing external QC daily, the laboratory must develop an IQCP. This can be accomplished through historical data; CHM.13900 & CHM.34400 or POC.07300 & POC.09035 OR LSV.41650 & LSV.37078: Otherwise daily QC is required for the CHEM8+ or every eight hours for the CG4+ as this is a blood gas.

10) Laboratories that choose to switch to an alternative cartridge will have to discuss with their laboratory director how they will validate/verify those alternatives.

This is not an all-inclusive list and the laboratory director must evaluate their laboratory activities based on the CAP checklist requirements and CLIA's State Operations Manual Appendix C - Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services. If the laboratory has a Certificate of Waiver for this testing, that laboratory's certificate would no longer be applicable to this situation and they need to apply for a new CLIA Certificate at:

https://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/Downloads/CMS116.pdf

For additional assistance, please email accred@cap.org and we will triage your questions and follow up by email and/or phone.

Sincerely,

CAP Accreditation

I expected that this letter from CAP was coming sooner or later, so we decided to discontinue the use of these two cartridges effective this Friday. In the meantime we are brainstorming ideas on how to support our emergency departments with a test that is not only reliable, but most importantly approved by the FDA.  

I think the validation of these two cartridges as high complexity tests is to cumbersome and not worth the efforts of ensuring and maintaining the regulatory compliance.

I just received clarification that the Blue G3+ cartridge is also not FDA approved. Assuming this will need to fall under the aforementioned CAP recommendations for validating a LDT.

To provide a rapid solution (at least in the interim), we are considering immediately validating and transitioning our affected departments to the CG8+ cartridge, as this contains the majority of desired analytes and is also FDA approved for use on capillary specimens (white cartridge, never was redesigned). It isn't a complete fix, but at least our most fragile patients (neonates) can continue to have blood gases, ionized calcium, H/H, etc., available.

Surprisingly, this was not proposed or brought up by Abbott as a potential, alternative solution to halting the usage of G3/CG4/CHEM8..

For any Certificate of Waiver sites what is your plan? Find another waived instrument (Picollo?) or discontinue testing all together and send to a lab.

Thanks,

Anastasia

We use the CG4+ in ER as part of the sepsis protocol. For those in the group that were able to get the cartridges removed from the ER. Was there any push back from physicians to keep the cartridges? How did you present the issue?

Sent via Groupsite Mobile.

Sent via Groupsite Mobile.

Caroline, we are also using the CG8 as the replacement as we already carry these. I believe this wasn’t suggested by Abbott because the reps are not being allowed to suggest or market a new product type to you as they go through this. And also, I think there’s some fear that production of the CG8 and the other cartridges that are still usable may not keep up with demand.

I will be interested to hear the plans that everyone comes up with moving forward and any other testing or instrumentation changes.

Sent via Groupsite Mobile.

We told them there was a recall and we had no choice. We didn’t like it either but again we had no choice. Our ER Medical Director was awesome about it. In fact, everyone has been awesome about it. Very understanding and pulmonary even helped round up cartridges.

Jeremy Williford, PBT(ASCP)CM
Laboratory Services Coordinator
Laboratory

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South Georgia Medical Center
2501 North Patterson Street
Valdosta, Georgia 31602
229-433-4804 (O) | 229-563-2292 (M)
jeremy.williford@SGMC.ORG | sgmc.org

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________________________________
From: Yeline Alvarez via POCT Listserv (Groupsite)
Sent: Wednesday, January 15, 2020 10:03:19 PM
To: Williford, Samuel 'Jeremy'
Subject: [POCT Listserv] Re: CHEM8 and CG4 Blue cartridge

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I was thinking of looking at NOVA StatStrip Lactate as a replacement in our ED.  Any suggestions for those using alternate methods?

Sylvia Lowery, was this letter from CAP sent just to you or did they sent a letter to all members?

Thanks,