Investigation for CAP Survey
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Dear team,
Our QA department has requested a follow-up investigation of the AVOX Total Hemoglobin CAP survey results because, over the past three survey events, all specimen results have fallen on the same side of the peer-group mean.
Our QA department has requested a follow-up investigation of the AVOX Total Hemoglobin CAP survey results because, over the past three survey events, all specimen results have fallen on the same side of the peer-group mean.
I have two concerns and would appreciate your guidance:
- All three CAP surveys passed the CAP acceptance criteria, and the results were very close to the peer-group mean, with SDIs within 1.0. Given the small magnitude of the observed bias, is a formal bias investigation necessary?
- The AVOX calibration curve is established by the manufacturer, and POCT is unable to independently recalibrate or adjust the calibration curve to correct a small systematic difference from the peer-group mean. If an investigation confirms a minor positive bias but QC, calibration verification, and CAP performance remain acceptable, what meaningful corrective action could we take to improve the performance?
I would appreciate your advice on how you recommend we respond to the QA request and what level of investigation would be appropriate.
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