Evaluation and application of automated quality control in clinical coagulation testing

Internal quality control (IQC) is indispensable for ensuring the accuracy of clinical laboratory testing. While fully automated track systems have enabled standardized IQC for clinical chemistry and hematology, coagulation assays-despite their diagnostic importance-still depend on manual handling. Variability during critical preparatory steps such as rewarming, thawing, mixing, and aliquoting of control materials often leads to QC instability and misinterpretation.

The aim of this study was to evaluate the clinical applicability of automated internal quality control (auto-QC) detection using a fully automated sample processing system.

To analyze the performance of auto-QC in coagulation testing, the stability, detection efficiency, and QC completion time of the auto-QC and concurrently acquired manual QC (immediate reconstitution) methods were compared at the Department of Laboratory Medicine at Suining Central Hospital (October 2024 to February 2025) and at Ordos Central Hospital (November 2024 to February 2025).

At Suining Central Hospital, auto-QC yielded lower coefficients of variation (CVs) than manual QC for activated partial thromboplastin time (aPTT), prothrombin time (PT), and multiple levels of D-dimer (DD), as well as low and high levels of fibrin degradation product (FDP), but had a higher CV for FDPs at the middle level (2.63% vs 2.46%). For thrombin time (TT), auto-QC had a lower CV at the normal level (1.00% vs 1.56%) but a higher CV at the abnormal level (1.96% vs 1.80%). For fibrinogen (FIB), auto-QC had a higher CV at the normal level (3.43% vs 3.14%) but a lower CV at the abnormal level (2.31% vs 2.56%). At Ordos Central Hospital, auto-QC yielded lower CVs than manual QC for APTT, TT, FIB, DD, and FDP at both levels, and for PT at the normal level; for PT at the abnormal level, auto-QC had a marginally higher CV (3.37% vs 3.26%). Wilcoxon signed-rank test showed significantly higher σ values for auto-QC (P < .05 for both centers). Regarding daily workflow, auto-QC was completed approximately 1.5 to 2.5 hours faster than manual QC. In routine coagulation testing, auto-QC reduced materials consumption by 16.5% to 38.1% compared with manual QC.

The fully automated sample processing system's QC detection meets laboratory quality requirements, significantly shortens processing time, reduces workload, and improves work efficiency.