Proposta para a implantação, implementação e avaliação de um programa de gestão da qualidade nos laboratórios de referência para a vigilância epidemiológica da FIOCRUZ

The Public Health Laboratory is one of the main columns of Health Surveillance, in its three major components: a) sanitary surveillance; b) environmental health risk monitoring; and c) epidemiological surveillance and disease control. Laboratories belonging to different Fiocruz Units hold formal attributions as international references or within the National System of Public Health Laboratories. Confidence in analytical results is an ethical compromise and a worldwide requirement in order to fulfill this role. A summary of the historical contribution of quality management to the goal of assurance of analytical results worldwide and in Brazil is presented. The methodology used to achieve the goals of the present dissertation has been based in the diagnosis of the actual situation of the Fiocruz’ reference laboratories in epidemiological surveillance relative to the degree of implementation of quality management requisites, according to the NIT-DICLA-083 standard of April, 2001, a the proposition of an Action Plan for the establishment, implementation and evaluation of the actions necessary to solve probable found deficiencies. Seventeen laboratories, acting as national and/or regional reference in 22 laboratorial actions aimed at Epidemiological Surveillance, were interviewed, representing 81% of all laboratories and 85% of all Fiocruz’ diagnostic reference actions in Epidemiological Surveillance. Only 36% of adherence to 156 requisites was found, when considered the laboratories altogether. For 66 managerial requirements 25% of adherence was registered, while adherence to the 90 technical requirements was estimated in 44%. Based in these results, a plan of corporate actions is described, including promotion and support to the development and implementation of quality management systems for each of the epidemiological surveillance reference laboratories of Fiocruz, within the scope of VPSRA.