Hemochron Signature Elite ACT-LR IQCP
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Good Afternoon,
We are a COLA inspected lab. Does the Hemochron Signature Elite ACT-LR require IQCP if you follow the manufacturer recommended QC frequency (monthly or new lots)? I know it has the internal electronic control but I am not sure if that negates the need for IQCP since external QC isn't done daily.
Thank you,
Carol Brown
We are a COLA inspected lab. Does the Hemochron Signature Elite ACT-LR require IQCP if you follow the manufacturer recommended QC frequency (monthly or new lots)? I know it has the internal electronic control but I am not sure if that negates the need for IQCP since external QC isn't done daily.
Thank you,
Carol Brown
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When it comes to non-waived tests, labs must follow CLIA regulations as well as the manufacturer's recommendations. Per CLIA regulations, each non-waived test must have at least 2 levels of liquid QC per day of use and per every 8 hours for coagulation tests. Labs can choose to do less by means of IQCP (individualized QC plan) after proper risk assessment. I do see your point, but it can only apply to waived tests.