CAP letter

To all, Here is the CAP letter that I received about the ISTAT issue. the letterhead did not transfer, but I vouch that it is real.

Let me know if you have any questions. Deanna Bogner 210-297-9657

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