Survey on critical results management in Brazilian clinical laboratories: Profiling practices through multivariate analysis and a "New Statistics" approach.

BACKGROUND AND OBJECTIVE

Effective communication of critical laboratory results is crucial for patient safety, yet practices vary widely across clinical laboratories. This study aimed to profile critical results management practices in Brazil and identify features independently associated with laboratory accreditation.

METHODS

A nationwide web-based survey was distributed to clinical laboratories, collecting data on 59 binary features related to critical result management. Data were processed and analyzed using multivariate logistic regression with LASSO feature selection. Effect sizes and statistical uncertainty were interpreted according to the "New Statistics" framework, with adjusted odds ratios (OR) and corresponding confidence intervals (CI) estimated. Predictive model performance was internally validated by stratified 5-fold cross-validation, using area under the Receiver Operating Characteristic Curve (AUC-ROC); and McFadden's pseudo R-squared (R) as metrics.

RESULTS

This study analyzed critical results management in 369 Brazilian laboratories. Most had formalized lists (87.5 %), written procedures (82.4 %), and periodic reviews (83.7 %). Communication times varied, with 30.9 % setting a 30-minute maximum and 53.4 % within one hour. The main communication methods were telephone with recorded confirmation (61.5 %). Performance indicators were used by 59.6 % of laboratories, 94.4 % of which were PALC-accredited. Only the use of key performance indicators (KPI) as robustly and independently associated with accreditation status (OR: 4.08; 95 % CI: 3.06-5.44; p < 0.001). The model showed acceptable discriminatory performance (AUC-ROC: 78.5 %; 95 % CI: 75.0 %-82.0 %) and adequate fit (R: 0.287; 95 % CI: 0.241-0.333).

CONCLUSIONS

This first nationwide survey provides a comprehensive profile of critical results management in Brazilian laboratories, revealing marked variability in protocols and communication strategies. These findings underscore the central role of KPI and support the development of national guidelines to standardize practices and enhance patient safety.