JACO Officially listed i-STATs as a Blood Analyzer
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See new standard below:
We are planning on using our Cal/Ver data, which we perform on every i-STAT biannually, and compare them against each other. Then do our method comparisons on a subset of meters. For us this would show the devices compare against each other and that the subset compares against the other methods. How is everyone satisfying this new requirement from JACO?
New Blood Analyzer Requirement from CMS for Laboratories
We are planning on using our Cal/Ver data, which we perform on every i-STAT biannually, and compare them against each other. Then do our method comparisons on a subset of meters. For us this would show the devices compare against each other and that the subset compares against the other methods. How is everyone satisfying this new requirement from JACO?
New Blood Analyzer Requirement from CMS for Laboratories
Joint Commission recently received notification from the US Centers for Medicare & Medicaid Services (CMS) about the classification of the Abbott i-STAT system, which includes the i-STAT 1 blood analyzer device and testing cartridges. Effective immediately, Joint Commission–accredited laboratories must incorporate the i-STAT 1 device into their correlation process every six months, in accordance with Quality System Assessment for Nonwaived Testing (QSA) standard QSA.02.08.01. This includes correlation between all i-STAT 1 devices within each Clinical Laboratory Improvement Amendments certificate.
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. However, based on the most current information available, the i-STAT 1 device is categorized as a blood analyzer, not a reader.
Joint Commission surveyors will evaluate compliance with this requirement during your next survey.
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We have been looking at this change from all angles and were told by TJC that we also need to re-evaluate our IQCP and perform monthly QC on every device. Now that they are considered chemistry analyzers, we have to treat them as such in every way. We have been considering using our monthly data to complete our 6 month correlations.
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