Harmonizing sample collection quality indicator monitoring via an informatics platform in a regional medical...

This study aimed to develop and implement an integrated informatics platform to harmonize sample collection quality indicators (QIs) monitoring across a regional medical laboratory center (RMLC), and to systematically characterize the frequency and distribution of four key pre-analytical QIs using platform-generated data.

A standardized dictionary of rejection types and reasons was configured into the laboratory information system sample rejection menu. The web-based QIs management system (iLab system) was developed with key functions including automated data collection, QI calculation, visual analytics, and a corrective action implementation module. A 24-month retrospective analysis was performed on four sample rejection QIs.

The iLab QIs management system was successfully implemented across the RMLC network. In total, 7,437,716 biological samples were received, with 4,208 (0.057%) rejected based on four QI criteria. Clotted samples (43.37% of total rejections) and incorrect sample volume (24.50%) were the leading causes, with "inadequate mixing" accounting for 62.25% of clotting incidents. Primary sample volume issues included insufficient volume in urine and empty tubes in stool. Nasopharyngeal swabs, urine, and secretion samples collectively represented over 50% of incorrect container incidents, while sputum incorrectly collected as stool or urine was a common sample type error. P-control charts were utilized for continuous rejection rate monitoring, and electronic forms for process automation supported collaborative non-conformity rectification.

The iLab platform successfully harmonized pre-analytical QI monitoring, demonstrating that an integrated informatics framework enables standardized, automated data capture and precise, network-wide root cause attribution for sample rejection.