TJC Email iSTAT Correlation Change
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Hello. I am a fairly new POCT coordinator for a growing system that includes 4 hospitals and numerous outpatient clinics. We have well over 20 iSTATs spread over the 4 hospitals and several clinics. Two of the hospitals are TJC accredited and the other two are CLIA compliance; some of the clinics are TJC and two are CLIA compliance. We just received the message below from TJC regarding CMS classification of the iSTAT as a blood analyzer. There is one other POCT coordinator for our system. Our current process for correlation covers the hospitals only, to correlate cartridges to chemistry analyzers, using iSTATs that stay in the POC office.
This new development appears to require that all iSTATs within each CLIA be correlated to one another at 6 month intervals, and then to the chemistry analyzer if within one of the hospitals. Am I interpreting this correctly? How is everyone else accomplishing this? We cannot collect all the iSTATS and perform this task in the POC office. I'm open to ideas, as our TJC window opens this summer. I'm also looking for a mentor who can share their expertise with me on all things POC, especially related to tracking thousands of users across a system, and improving efficiency. Even with two full-time coordinators, it's a lot. Thank you in advance!
"Dear Colleague:
Joint Commission recently received notification from the U.S. Centers for Medicare and Medicaid Services (CMS) about the classification of the Abbott i-STAT system . . . Historically, only the testing cartridges were subject to correlation every six months to evaluate the results of the same test performed with different methodologies or instruments or at different locations, under the CMS Conditions of Participation-level D5400 (42 CFR 493.1250) and at the Standard level of D5775 (42 CFR 493.1281). Laboratories accredited by Joint Commission did not have to meet the same requirements for the i-STAT 1 device.
However, based on the most current information available, the i-STAT 1 device is categorized as a blood analyzer, not a reader.
Effective immediately, Joint Commission-accredited laboratories must incorporate the i-STAT 1 device into their correlation process every six months, in accordance with the requirements at QSA.02.08.01. This includes correlation between all i-STAT 1 devices within each CLIA certificate. Joint Commission surveyors will evaluate compliance with this requirement during your next survey."
This new development appears to require that all iSTATs within each CLIA be correlated to one another at 6 month intervals, and then to the chemistry analyzer if within one of the hospitals. Am I interpreting this correctly? How is everyone else accomplishing this? We cannot collect all the iSTATS and perform this task in the POC office. I'm open to ideas, as our TJC window opens this summer. I'm also looking for a mentor who can share their expertise with me on all things POC, especially related to tracking thousands of users across a system, and improving efficiency. Even with two full-time coordinators, it's a lot. Thank you in advance!
"Dear Colleague:
Joint Commission recently received notification from the U.S. Centers for Medicare and Medicaid Services (CMS) about the classification of the Abbott i-STAT system . . . Historically, only the testing cartridges were subject to correlation every six months to evaluate the results of the same test performed with different methodologies or instruments or at different locations, under the CMS Conditions of Participation-level D5400 (42 CFR 493.1250) and at the Standard level of D5775 (42 CFR 493.1281). Laboratories accredited by Joint Commission did not have to meet the same requirements for the i-STAT 1 device.
However, based on the most current information available, the i-STAT 1 device is categorized as a blood analyzer, not a reader.
Effective immediately, Joint Commission-accredited laboratories must incorporate the i-STAT 1 device into their correlation process every six months, in accordance with the requirements at QSA.02.08.01. This includes correlation between all i-STAT 1 devices within each CLIA certificate. Joint Commission surveyors will evaluate compliance with this requirement during your next survey."
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We designate one device as primary and use that to compare to the lab methodologies, depending on the cartridge type. That ties them all together. For ACT on the i-STAT, we do QC on all devices and use that to compare the devices to each other. Since the lab does not perform ACT, we don't have to do a comparison. This is the same as what we do with other multiple POC devices, like blood gas devices. We compare them to each other with cal ver material, PVP, etc. then designate one as primary and compare that to lab.
I hope this helps.
For method comparisons, we use patient samples and run on iSTAT, Werfen GEM 5000, Sysmex and Roche Chem. Typically we run 3 patients every 6 months for method comparison but CAP might require even less than 3 now...I'd have to check.