Improvements to the evaluation process for diagnostic quality in laboratories using the SUMA technology
Abstract
The Immunoassay Center (CIE) is a Cuban institution dedicated to develop the SUMA (Ultra Micro Analytical System), a diagnostic system currently applied in programs of prenatal and neonatal screening, epidemiological surveillance, and certification of donated blood, organs and placentas. In order to guarantee the quality of diagnosis with this technology, CIE has implemented a system of quality assessment for SUMA laboratories that is continuously improved and refined. The present work describes the currently implemented quality assessment system and how it solves the limitations of conventional quality control schemes in immunoassay laboratories. This objective was met by incorporating the reliability index and index of coefficients of variation, in an effort to provide a more rounded analysis that combines the examination of different types of quality controls (internal and external). These analyses were incorporated into the automated quality evaluation software currently employed by SUMA technology laboratories (Quality Assurance System; SAC 2.0), yielding measurable improvements to the quality evaluation process.
