Is it acceptable to release results from an analyzer with flags or alarms if a pathologist sends an email instructing to do so, even if the manufacturer’s instructions state that results with flags or alarms should be verified by another method before reporting?

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If turnaround time is a concern, the pathologist should consider reporting only the valid parts of the automated test as a preliminary result and following up with a manual differential.

1. Graden KC, Bennett SA, Delaney SR, Gill HE, Willrich MAV. A high-level overview of the regulations surrounding a clinical laboratory and upcoming regulatory challenges for laboratory developed tests. Lab Med. 2021;52(4):315–328.

Chad M. McCall, MD, PhD
Hematopathologist
Clinical Pathologist
Carolinas Pathology Group
Charlotte, NC
Member, CAP Hematology Committee

Editor: Frederick L. Kiechle, MD, PhD
Published: October 2022

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