RESUMO
The Lyon Hospitals Board (HCL) hemostasis laboratory has shifted from a frequentist to a long-term Bayesian approach to IQC results management, using the Hemohub® software of the Werfen corporation, which hosts the requisite Bayesian tools. IQC plans based on supplier specifications proved effective in managing analytic risk in line with the ISO 15189 standard. Long-term Hemohub® control and monitoring has been validated by acceptable feedback from the EQA organization used by the hemostasis community.
Assuntos
Hemostasia , Laboratórios Hospitalares , Humanos , Teorema de Bayes , Controle de QualidadeRESUMO
Laboratories need to set up effective overall management of their internal quality control (IQC) and external quality assessment (EQA) results as key elements in statistical process control. Quality targets need to be defined, with methods to ensure durable control with respect to the relevant specifications. The hemostasis laboratory of the Lyon Hospitals Board (HCL, Lyon, France) uses model 3 from the Milan consensus conference, which is the state of the art in terms of quality targets, and uses a common EQA provider supplying as many real patient samples as possible. Giving priority to adopted methods, the lab optimizes the use of manufacturers' prior data: maximum acceptable inter assay coefficient of variation (CV) and prior IQC target values. Bayesian inference brings the method under control with respect to the manufacturers' prior data without the need for a preliminary phase. It links the IQC and EQA plans by the maximum acceptable CVs defined by the manufacturer.
