RESUMO Este estudo apresenta as principais não conformidades às normas sanitárias encontradas em laboratórios de análises clínicas (LAC) intra-hospitalares públicos localizados no município do Rio de Janeiro (RJ) no período de novembro de 2016 a novembro de 2017. A avaliação de não conformidades sanitárias é fundamental para garantir metas na melhoria do controle da qualidade, aumento da confiabilidade dos resultados gerados e diminuição de riscos em saúde. Por meio da avaliação de 20 laboratórios públicos, federais e municipais, foi possível analisar as principais não conformidades sanitárias nas diferentes fases laboratoriais (pré-analítica, analítica e pós-analítica), avaliando a frequência e a tendência da distribuição através do teste exato de Fisher. Os resultados evidenciaram que 100% dos LAC analisados apresentaram ao menos uma não conformidade; entre aquelas com maiores frequências de não conformidades sanitárias estão as relacionadas com inexistência de procedimentos operacionais padrão (POPs), apresentando 45,5% em LAC de hospitais federais e 66,7% em LAC de hospitais municipais, além de falhas nos processos de limpeza, desinfecção e esterilização, nos equipamentos e na presença do responsável técnico (TM) durante todo o horário de trabalho. As ações de fiscalização sanitária buscam a prestação de serviços em saúde à população que esteja de acordo com padrões de qualidade estabelecidos, ainda que a identificação de não conformidades subsidie a adoção de ações corretivas pelo estabelecimento de saúde.

ABSTRACT The study presents the main nonconformities related to the sanitary regulations found in clinical laboratory analysis (CLA) attached to a public hospital in the city of Rio de Janeiro (RJ) from November 2016 to November 2017. The evaluation of the nonconformities related to sanitary conditions is fundamental to ensure the goals in improving quality control, increasing the reliability of the results generated and reducing health risks. Through the evaluation of 20 federal and municipal public health laboratories, it was possible to analyze the main sanitary nonconformities in the different laboratories phases (pre-analytical, analytical and post-analytical), evaluating, through Fisher's exact test, the frequency and trend distribution of reported nonconformities. One hundred percent (100%) of the clinical analysis laboratories presented at least, one nonconformity. Among those with the highest frequencies of nonconformity related to sanitary conditions are those related to the lack of standard operating procedures (SOPs), presenting 45.5% in clinical analysis laboratories of federal hospitals and 66.7% in clinical analysis laboratories of municipal hospitals. Moreover flaws in the cleaning, disinfection and sterilization processes, in equipments and in the presence of the technical manager (TM) throughout the working hours. Sanitary surveillance actions seek to provide health services to the population that comply with established quality standards, even though the identification of nonconformities subsidizes the adoption of corrective actions by the health establishment.

A non-controlled longitudinal study was conducted to evaluate the combined vaccine against measles, mumps and rubella (MMR) immunogenicity in 150 children vaccinated in the routine of three health units in the city of Rio de Janeiro, Brazil, 2008-2009, without other vaccines administered during the period from 30 days before to 30 days after vaccination. A previous study conducted in Brazil in 2007, in 1,769 children ranging from 12-15 months of age vaccinated against yellow fever and MMR simultaneously or at intervals of 30 days or more between doses, had shown low seroconversion for mumps regardless of the interval between administration of the two vaccines. The current study showed 89.5% (95% confidence interval: 83.3; 94.0) seroconversion rate for mumps. All children seroconverted for measles and rubella. After revaccination, high antibody titres and seroconversion rates were achieved against mumps. The results of this study and others suggest that two MMR doses confer optimal immunoresponses for all three antigens and the possible need for additional doses should be studied taking into account not only serological, but also epidemiological data, as there is no serological correlate of protection for mumps.

OBJECTIVES: To analyze postvaccination serological status in pregnant women inadvertently vaccinated against rubella in the state of Rio de Janeiro, Brazil. METHODS: This was a cross-sectional study of pregnant women 15 to 29 years old, vaccinated against rubella and measles from November 2001 to March 2002, who were unaware of their pregnancy at the time of vaccination or who became pregnant within 30 days thereafter. They were tested for rubella-specific immunoglobulin M (IgM) and G (IgG) and classified as immune (IgM-negative, IgG-positive, tested within 30 days after vaccination), susceptible (IgM-positive after vaccination) or indeterminate (IgM-negative, IgG-positive, vaccination- serological testing interval greater than 30 days). RESULTS: Of 2 292 women, 288 (12.6%) were susceptible, 316 (13.8%) immune, 1 576 (68.8%) indeterminate, 8 (0.3%) ineligible, and 104 (4.5%) lost to follow-up. IgM seropositivity by vaccination-serological testing interval was 16.1% (d" 30 days), 15.4% (30-60 days), and 14.2% (61-90 days). Considering the campaign's target age, the 20-to-24-year age group had the largest proportion of individuals susceptible to rubella (14.8%) and represented 42.4% (122/288) of all susceptible women. In 75% of susceptible pregnant women, gestational age was 5 weeks or less at the time of vaccination. CONCLUSIONS: Mass immunization of childbearing-age women was justified on the basis of epidemiological and serological data. Follow-up of vaccinated pregnant women revealed no cases of congenital rubella syndrome due to rubella vaccination. However, the observed rate of congenital infection supports the recommendation to avoid vaccinating pregnant women, and to avoid conception for up to 1 month following rubella vaccination.

OBJETIVOS: Analizar el estado serológico de mujeres embarazadas tras haber recibido inadvertidamente la vacuna antirrubeólica, en el estado de Rio de Janeiro, Brasil. MÉTODOS: Se realizó un estudio transversal de mujeres embarazadas de 15 a 29 años de edad que fueron vacunadas contra la rubéola y el sarampión entre noviembre de 2001 y marzo de 2002 y que no sabían que estaban embarazadas en ese momento o que concibieron en el transcurso de los siguientes 30 días. Se les aplicaron las pruebas detectoras de inmunoglobulina M (IgM) e inmunoglobulina G (IgG) contra el virus de la rubéola y se les clasificó de inmunes si se obtenían resultados negativos a IgM y positivos a IgG al aplicar las pruebas en un lapso no mayor de 30 días después de la vacunación; de susceptibles si se obtenía un resultado positivo a IgM después de la vacunación, o indefinido si se obtenían resultados negativos a IgM y positivos a IgG tras un intervalo mayor de 30 días entre la vacunación y la aplicación de las pruebas serológicas. RESULTADOS: De 2 292 mujeres, 288 (12,6%) se mostraron susceptibles; 316 (13,8%) se mostraron inmunes; 1 576 (68,8%) tuvieron resultados indefinidos; 8 (0,3%) tuvieron resultados ilegibles y 104 (4,5%) no tuvieron seguimiento. La seropositividad a IgM, según el intervalo transcurrido entre la vacunación y la aplicación de las pruebas serológicas, fue de 16,1% (< 30 días), 15,4% (31-60 días), y 14,2% (61-90 días). En lo respectivo a la edad de las personas a las que se dirigió la campaña, se encontró que el grupo de 20 a 24 años tenía la mayor proporción de personas susceptibles a la rubéola (14,8%) y representaba a 42,4% (122/288) de todas las mujeres susceptibles. En 75% de las embarazadas susceptibles, la edad gestacional fue de 5 semanas o menos en el momento de la vacunación. CONCLUSIONES: Se justificó la vacunación poblacional de todas las mujeres en edad fecunda sobre la base de datos epidemiológicos y serológicos. Durante el seguimiento de las embarazadas no se observó ningún caso de síndrome de rubéola congénita ocasionado por la vacuna antirrubeólica. No obstante, el porcentaje de infección congénita observado refuerza la recomendación de que se evite vacunar a mujeres embarazadas y de que estas procuren no concebir durante un mes como mínimo después de la vacunación antirrubeólica.