CoagSense

Great questions!
The second question is related to how you set up your clinic in the first question.

For the first question, you and your team that oversee this testing can really set it up how it is best for you.  IF you set it up under your main lab's CLIA and that CLIA is a certificate of accreditation with CAP as the accreditor, then yes, your Coag Clinic would also fall under CAP. Then the answer to your second question would be that you must follow the CAP guidelines for all testing under that CLIA number, including your Coag Clinic testing.

Alternatively, you could put in a CLIA application for a waived certificate for your coag clinic that is separate than your main lab.  At this point, it could now be excluded from CAP inspections because it is under a separate CLIA number.  Now you only need to follow CLIA waived standards for this testing.  I have many locations set up like this.

Does that help? 
Mary Hammel

Yes, thank you so much! There is so much information to take it in!

Hi Jennifer, I just want to confirm what Mary said.  I have 8 ACS (Anticoagulation Service) clinics that use the CoagSense meter.  Our Lab method is Stago.  I implemented them at clinics after the 2019 FDA approval.  Our ACS clinics are under their own CLIA certificate of waiver permit for New York State and are permitted separately from the clinical lab.  The ACS clinics here follow CLIA waived testing requirements:  initial and annual competency assessment and test strip QC is each new lot/shipment and each new operator.  Our CoagSense meters are also wirelessly interfaced to Epic via RALS - which was a quirky process to do.  If you have any CoagSense questions, please feel free to reach out karen.updegraff@guthrie.org

Mary is correct!!  I would suggest applying for a separate CLIA certificate of waiver.