Atualização do panorama das acreditações e certificações laboratoriais no Brasil

Abstract

The implementation of a Quality System in clinical laboratories is essential for the quality assurance of results. Programs of accreditation and certification for clinical laboratories have been introduced by management organizations in the clinical analysis area. These programs establish guidelines and quality Standards including the Clinical Laboratory Accreditation Program, National Accreditation System – Department of Inspection and Quality Control, National Accreditation Organization, College of American Pathologists (CAP) and the International Organization for Standardization 9001 and 15189. Brazil lacks a database or compilation of updated information that provides an overview of laboratory accreditations by the main management organizations. This study aims to survey the accreditation/certification overview of clinical laboratories in Brazil. A data survey was carried out on the official websites of the accreditation/certification management organizations to list all accredited/certified clinical laboratories. It was observed that 922 Brazilian clinical laboratories have some certification/accreditation, of which 48.92% of these are located in the Southeast region, followed by the South (24.95%), Northeast (13.12%), Midwest (9.54%) and North (3.47%). Only 5% are exclusively public management. The predominant accreditation in Brazil is DICQ (48.70%). Only 10 clinical laboratories have CAP certification. The distribution of accredited/certified clinical laboratories in Brazil is concentrated in the Southeast region. This survey highlights the need to increase the adhesion of Brazilian laboratories, mainly from other regions, to accreditation and certification systems. This survey also reveals the need to implement more robust quality management systems in the field of public health.