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

Title:
Survey on critical results management in Brazilian clinical laboratories: Profiling practices through multivariate analysis and a "New Statistics" approach.
Authors:
Dias AC; Sabin Diagnóstico e Saúde, Brasília, DF, Brazil; Quality Committee of the Brazilian Society of Clinical Pathology and Laboratory Medicine (SBPC/ML), Brazil; Reference Intervals Committee of the Brazilian Society of Clinical Pathology and Laboratory Medicine (SBPC/ML), Brazil. Electronic address: alancdias@hotmail.com., de Oliveira D; Promed S.A., Panamá, Brazil; Quality Committee of the Brazilian Society of Clinical Pathology and Laboratory Medicine (SBPC/ML), Brazil; Reference Intervals Committee of the Brazilian Society of Clinical Pathology and Laboratory Medicine (SBPC/ML), Brazil., de Almeida Berlitz F; Siemens Healthineers, Brazil; Indicators Committee of the Brazilian Society of Clinical Pathology and Laboratory Medicine (SBPC/ML), Brazil., Tesser Poloni JA; Controllab, Rio de Janeiro, RJ, Brazil., Shcolnik W; Grupo Fleury, São Paulo, SP, Brazil; Brazilian Society of Clinical Pathology and Laboratory Medicine (SBPC/ML), Brazil., Meira Dias CM; CMeira Qualicare, Brazil; Quality Committee of the Brazilian Society of Clinical Pathology and Laboratory Medicine (SBPC/ML), Brazil; Pre and pos analytics Committee of the Brazilian Society of Clinical Pathology and Laboratory Medicine (SBPC/ML), Brazil., Remor Canalli DG; Laboratório Médico Santa Luzia - Grupo Dasa, Florianópolis, SC, Brazil; Quality Committee of the Brazilian Society of Clinical Pathology and Laboratory Medicine (SBPC/ML), Brazil., Falci Vieira LM; Álvaro Apoio - Grupo Dasa, São Paulo, SP, Brazil; Quality Committee of the Brazilian Society of Clinical Pathology and Laboratory Medicine (SBPC/ML), Brazil., Andreguetto BD; Analiza, Campinas, São Paulo, SP, Brazil; Quality Committee of the Brazilian Society of Clinical Pathology and Laboratory Medicine (SBPC/ML), Brazil., Furtado FM; Sabin Diagnóstico e Saúde, Brasília, DF, Brazil; Hematology Committee of the Brazilian Society of Clinical Pathology and Laboratory Medicine (SBPC/ML), Brazil., Lopes RM; Controllab, Rio de Janeiro, RJ, Brazil., Fernandes AB; Shift, São José do Rio Preto, SP, Brazil; Laboratory Informatics Committee of the Brazilian Society of Clinical Pathology and Laboratory Medicine (SBPC/ML), Brazil., de Souza Vasconcellos L; Federal University of Minas Gerais (UFMG), Brazil; Quality Committee of the Brazilian Society of Clinical Pathology and Laboratory Medicine (SBPC/ML), Brazil; Reference Intervals Committee of the Brazilian Society of Clinical Pathology and Laboratory Medicine (SBPC/ML), Brazil. Electronic address: lsv@ufmg.br.
Source:
Clinica chimica acta; international journal of clinical chemistry [Clin Chim Acta] 2026 Jan 01; Vol. 578, pp. 120566. Date of Electronic Publication: 2025 Aug 20.
Publication Type:
Journal Article
Language:
English
Journal Info:
Publisher: Elsevier Country of Publication: Netherlands NLM ID: 1302422 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1873-3492 (Electronic) Linking ISSN: 00098981 NLM ISO Abbreviation: Clin Chim Acta Subsets: MEDLINE
Imprint Name(s):
Original Publication: Amsterdam, Elsevier.
Contributed Indexing:
Keywords: Critical results; Key performance indicators; Laboratory management; Multivariate analysis; New statistics; Patient safety; Survey
Entry Date(s):
Date Created: 20250822 Date Completed: 20250916 Latest Revision: 20250916
Update Code:
20260130
DOI:
10.1016/j.cca.2025.120566
PMID:
40846166
Database:
MEDLINE

*Further Information*

*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<subscript>Adjusted</subscript>) 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<subscript>McF</subscript><sup>2</sup>) 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<subscript>Adjusted</subscript>: 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<subscript>McF</subscript><sup>2</sup>: 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.
(Copyright © 2025 Elsevier B.V. All rights reserved.)*

*Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.*