Controle de Qualidade: Interpretação das Regras Múltiplas

Controle de Qualidade: Interpretação das Regras Múltiplas

James O. Westgard
Um dos nossos objetivos em descrever “Um gráfico Shewhart de Regras Múltiplas para Controle de Qualidade em Bioquímica” [1] foi padronizar a interpretação dos resultados de controle. Todos no laboratório precisam ser capazes de exercer a mesma decisão quando for liberar ou não os resultados dos pacientes. Isto pode ser simples para analistas experientes que podem observar um padrão de resultados de controle e rapidamente chegar a uma decisão válida, entretanto, novos analistas precisam de um direcionamento para saber o que olhar nos dados de controle se o laboratório deseja manter um nível consistente de qualidade. O propósito deste artigo é ilustrar como interpretar resultados de CQ de Regras Múltiplas quando dois materiais de controle distintos estão sendo analisados. Lembre-se que são necessários dois materiais de controle distintos de acordo com a regulação da USA CLIA, sendo assim este artigo é particularmente relevante para aplicações CQ nos EUA.

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Certified Reference Material Producer

Accredited by Coordenação-Geral de Acreditação do Inmetro

Controllab has been accredited as a Certified Reference Material (CRM) Producer since 2016 by Cgcre, under number PMR 0009. The conformity assessment is carried out in accordance with the requirements established in ABNT NBR ISO 17034 and Inmetro standards, ensuring competence for the production of CRMs, as defined in the Scope of Accreditation.

This accreditation attests to Controllab’s technical competence in producing CRMs according to international requirements and enables it to be recognized in other countries, under mutual recognition agreements, thereby reducing technical barriers between Brazil and other countries across continents.

Materiais de Referência Certificados - PMR 0009 - ABNT NBR ISO 17034-Controllab
Cgcre is signatory to the Mutual Recognition Arrangements of the International Laboratory Accreditation Cooperation (ILAC) and Interamerican Accreditation Cooperation (IAAC).

CAL 0214

Calibration Laboratory

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In December 2002, the Calibration Laboratory was accredited by Cgcre. With this recognition, it became part of the Brazilian network of accredited laboratories, under number 214. Since then, it has been periodically evaluated for the maintenance and/or extension of its accreditation.

The Inmetro seal attests to Controllab’s technical competence, credibility, and operational capability for calibration services, in accordance with the requirements of ABNT NBR ISO/IEC 17025.

Calibração de Instrumentos - CAL 0214 - ABNT NBR ISO/IEC 17025 - Controllab
Cgcre is signatory to the Mutual Recognition Arrangements of the International Laboratory Accreditation Cooperation (ILAC) and Interamerican Accreditation Cooperation (IAAC).

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In September 2011, Controllab was accredited by Cgcre as a proficiency test provider, under nº PEP0003. Initially as part of a pilot project by Inmetro, this accreditation was based on ILAC G13: 2007 and included several clinical and hemotherapy tests. In the periodic evaluations of this accreditation, new segments and tests are included and the evaluation is now conducted according to ABNT NBR ISO/IEC 17043.

This accreditation attests to Controllab’s technical competence to develop and conduct proficiency tests in accordance with international requirements and enables it to be recognized in other countries, in accordance with mutual recognition agreements signed by Brazil in Mercosur, the Americas and Europe.

PEP 0003 - ABNT NBR ISO-IEC 17043 - Controllab

Cgcre is signatory to the Mutual Recognition Arrangements of the International Laboratory Accreditation Cooperation (ILAC) and Interamerican Accreditation Cooperation (IAAC).