Assessment of best practices for quality assurance in laboratories in Portuguese-speaking countries

Laboratories (labs) play a fundamental role in screening, diagnosis, prognosis, and treatment of diseases. For a laboratory result to be useful, it must have guaranteed quality. In this context, there is no informative data on the best practices adopted by labs in Portuguese-speaking countries (PSC). This information is essential for formulating policies and educational strategies intended for this target audience.

To identify and assess adherence to laboratory best practices by clinical analysis labs in Portuguese-speaking countries.

A digital questionnaire consisting of 47 questions on laboratory best practices and quality management was sent to participants in the National Program for External Quality Assessment of Portugal and other labs involved in the Laboratory Quality Improvement Project for PSC-ProMeQuaLab, except from Brazil. Data were collected anonymously between July 7 and September 30, 2024 and analysed with descriptive statistics.

59 labs (ambulatory and hospital) participated in the study, but 5 institutions did not consent to the disclosure of their data, even if anonymously. Of the 54 included labs, most were from Portugal (39; 72%), followed by Cabo Verde (9; 16%), Guinea-Bissau (4; 7%), São Tomé and Príncipe (1; 2%), and 1 lab did not specify its country of origin. 57% of the labs have an implemented management system, and half of them are certified. Most labs belong to public services (63%), have a professional responsible for the management system (85%), conduct an annual training plan (85%), use quality indicators for the pre-analytical (87%) and post-analytical (83%) phases, and perform internal (70%) and external (89%) quality control. Opportunities for improvement were identified, as only 59% of labs record the causes of rejection of control sample results, 65% develop a competency matrix, 66% construct control charts, and 72% use quality specifications to assess analytical performance.

Portuguese labs contributed the most to these results. Laboratory best practices are implemented, but there are opportunities for improvement. Conducting training and involving more labs from PSC will contribute to the implementation and harmonization of laboratory best practices, which can contribute to ensuring the quality of results and patient safety.