Autoverification of the automated blood cell counter (CBC) in a reference laboratory in Bogota, Colombia / Autoverificação do contador de células automatizado de sangue (CBC) em um laboratório de referência em Bogotá, Colômbia

ABSTRACT Introduction: The clinical laboratory is part of the group of actors in health systems that are under increasing pressure by users and administrators to increase their productivity in order to respond efficiently to the increased volume of patients, optimizing costs and professional time. This pressure forced laboratories to perform a full review of their procedures and develop technical, logistical and computational tools to enable excellent response times. Objective: This study aimed to evaluate the implementation of the automated blood cell counter autoverification process and its impact on the safety of patients. Methods: Verification rules were designed in the connectivity software, based on manual validation criteria for laboratory professionals, according to the guidelines of the Clinical and Laboratory Standards Institute (CLSI) Guideline Auto10-A and the International Consensus Group for Hematology Review (ISLH). The autoverification percentage was established, and non-conforming product (NCP) percentages were estimated before and after the procedure. Pilot tests were also performed in different days so as to adjust the process. Results: 53.4% of automated blood cell counters autoverification were achieved, and, subsequently in the audit of 18 months, 60% was reached due to verification adjustments in the delta programmed filter. The NCPs rose from 0.065% to 0.0036% from the beginning to the end of the process. Conclusion: The autoverification process enabled to reduce the variability associated with human intervention, therefore the professional is able to focus on the pathological report analysis, reducing the risk of errors and advocating greater importance on patient safety.

RESUMO Introdução: O laboratório clínico é parte do grupo de atores nos sistemas de saúde, que são cada vez mais pressionados por usuários e administradores para aumentar sua produtividade a fim de responder de forma eficiente ao aumento do volume de pacientes, otimizando custos e tempo dos funcionários. Essa pressão forçou laboratórios para efetuar uma revisão completa de seus procedimentos, bem como desenvolver instrumentos técnicos, logísticos e computacionais para permitir excelentes tempos de resposta. Objetivo: Neste estudo, a implementação do processo automatizado de autoverificação do hemograma e seu impacto sobre a segurança do paciente são avaliados. Métodos: Regras de verificação foram construídas no software de conectividade com base em critérios de validação manual dos profissionais de laboratório, de acordo com as orientações do Clinical and Laboratory Standards Institute (CLSI) de Guideline Auto10-A e do International Consensus Group for Hematology Review (ISLH). A percentagem de autoensaio foi estabelecida e as de produtos não conformes (PNC), estimadas antes e depois do procedimento. Testes piloto foram realizados em dias diferentes para ajustar o processo. Resultados: Cinquenta e três por cento da autoverificação dos hemogramas automatizados foram alcançados e, posteriormente, na auditoria dos 18 meses, foram obtidos 60% devido a ajustes na verificação do filtro delta programado. Os PNCs aumentaram de 0,065% a 0,0036% desde o início até ao final do processo. Conclusão: O processo do autoverificação ajudou a reduzir a variabilidade associada à intervenção humana, portanto o profissional pode concentrar-se na análise de relatórios patológicos, reduzindo o risco de erros e dando maior importância para a segurança do paciente.

Exactitud del test ADN-HPV para la detección de la enfermedad cervical de alto grado (NIC 2+) en mujeres con anormalidades citológicas (ASC-US y LSIL), afiliadas a la seguridad social en Bogotá (Colombia) / Accuracy of HPV-DNA test for detecting high-grade disease (CIN 2+)in women with minor cytological abnormalities (ASC-US and LSIL)

Objetivo: evaluar la exactitud de la prueba ADNHPV en el diagnóstico de lesiones premalignas cervicales de alto grado (HSIL, por sus siglas en inglés) en mujeres con alteraciones citológicas ASC-US (células escamosas atípicas de significado indeterminado) y LSIL (lesión escamosa intraepitelial de bajo grado). Metodología: estudio de validez diagnóstica y de cohorte transversal, realizado en mujeres con diagnóstico citológico de ASC-US o LSIL entre octubre de 2006 y enero de 2008, pertenecientes al Programa de Tamizaje de Cáncer de Cérvix de una aseguradora privada en Bogotá (Colombia). Se comparó el resultado de la colposcopia y de la prueba de ADN-HPV con la patología del cérvix como patrón de oro. Resultados: de las 429 mujeres, 344 (80,2%) presentaron ASC-US y 85 (19,8%) LSIL. Las prevalencias de infección por HPV de alto riesgo fueron 52,9% y 75,7% en pacientes con reporte citológico de ASC-US y LSIL, respectivamente. A las 379 de las 425 pacientes se les practicó biopsia, 24 (6,3%) dieron positivas para HSIL. La sensibilidad de la prueba ADN-HPV para detectar lesiones de alto grado (NIC 2+) en las mujeres con reportes de citología ASC-US y LSIL fue 88% y la especificidad fue 44%. En 21 (87.5%) de los 24 casos de HSIL se detectó la presencia de HPV de alto riesgo. Conclusión: debido a que la prueba ADN-HPV tiene una sensibilidad superior a la citología cervicovaginal (CCV), ésta puede considerarse una alternativa útil para estratificar el riesgo y mejorar la aproximación diagnóstica de lesiones premalignas del cuello uterino en mujeres con reporte de ASC-US.

Objective: evaluating the accuracy of the HPV DNA test as a complementary test for diagnosing highgrade cervical disease (high-grade squamous intra epithelia lesions-HSIL) in women with minor cytological abnormalities (atypical squamous cells of undetermined significance ASC-US) and low-grade squamous intraepithelial lesions (LSIL). Methodology: a diagnostic validity study based on a cross-sectional design was applied to 429 women who had had a cytological report of ASC-US and/or LSIL who were attending a health maintenance organisation’s cervical cancer screening programme in Bogotá, Colombia between January 2006 and October 2008. Colposcopy reports and HPV-DNA testresultswerecomparedwithpathologicalreports which were considered the gold standard. Results: 344 (80.2%) of the 429 women had a cytological report of ASC-US and 85 (19.8%) of them one for LSIL. High-risk HPV infection prevalence was 52.9% and 75.7% in patients having an ASC-US and LSIL report, respectively. A biopsy specimen was obtained in 379 of the 429 participants and 24 high-grade cases (6.3%) were diagnosed. DNA-HPV test sensitivity was 88% and specificity was 44% for detecting high-grade disease (CIN 2+) in women having an ASC-US and LSIL cytology report . The presence of high-risk HPV virus was detected in 21 of the 24 HSIL cases (87.5%). Conclusion: the DNA-HPV test’s higher sensitivity compared to the PAP smear (due to high NPV) means that it could be considered a useful tool for stratifying risk and improving the diagnostic approach to premalignant lesions of the uterine cervix in patients having a cytological report of ASC-US.