Manual:
Laboratory
Chapter:
Quality System Assessment for Nonwaived Testing QSA
Topic:
Moderate Complexity i-STAT cartridge - FDA Warning Letter November 2022
Can organizations continue to use the Abbott cTnI moderate complexity i-STAT cartridge based on the warning letter issued by the FDA in November 2022?
Any examples are for illustrative purposes only.
The Joint Commission, as an accrediting agency, will follow the guidance from the FDA, CMS and CLIA regarding this issue. CMS/CLIA has updated their FAQ on this topic and they have stated that facilities can continue to use the Abbott cTnI moderate complexity i-STAT cartridge.
Here is the link to the CMS/CLIA FAQ: Frequently Asked Questions (FAQ), Abbott iSTAT updated as of 12/8/2022.
The Joint Commission suggests that your organization continue to work with your CLIA laboratory director, risk manager and legal team to determine your further course of action. We also recommend that you frequently check the FDA website which assigns complexity to tests.
The Joint Commission, as an accrediting agency, will follow the guidance from the FDA, CMS and CLIA regarding this issue. CMS/CLIA has updated their FAQ on this topic and they have stated that facilities can continue to use the Abbott cTnI moderate complexity i-STAT cartridge.
Here is the link to the CMS/CLIA FAQ: Frequently Asked Questions (FAQ), Abbott iSTAT updated as of 12/8/2022.
The Joint Commission suggests that your organization continue to work with your CLIA laboratory director, risk manager and legal team to determine your further course of action. We also recommend that you frequently check the FDA website which assigns complexity to tests.
Last updated on December 25, 2022
with update notes of: Reflects new or updated requirements
Last Reviewed Date: December 25, 2022
Last Major Update: December 25, 2022