Siemens DCA Replacement Validation Protocol
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We need to set up a replacement DCA for one of our outpatient clinics. DCA HA1cs as a new platform were initially validated over 10 years ago and included extensive validation testing (accuracy, precision, comparison, linearity). Given that the DCA HA1c is a waived test and we are regulated by CLIA/CAP, do you have any recommendations for replacement instrument validation protocols? We contacted the manufacturer and they said to follow our internal regulatory protocol (which would be...us).
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for new or replacement waived test instruments we have a validation summary page we use for all our devices with device info, serial number, date device was checked and tagged by Biomed, and that initial QC was performed and passed. It includes operator signature performing QC and CLIA Lab Director signature. I can share template if you email me kimberly.arnesen@providence.org