Louro PY, Pérez PI, Tudela CM, Concepción ÁA, Acosta ST

Language: Spanish
References: 20
Page: 1-21
PDF size: 440.12 Kb.

ABSTRACT

Introduction: During the stage of confrontation with the coronavirus disease 2019 also named COVID-19 and as part of the Cuban strategy for the control of the disease in Cuba, the National Center for Medical Genetics created the conditions to carry out the diagnosis of Severe infection. Acute Respiratory Syndrome coronavirus 2 known as SARS-CoV-2, through molecular biology studies with the real-time PCR technique. It was necessary to obtain accurate and reliable results, so ensuring quality was considered as important as the diagnosis of the disease.
Objective: To design a strategy to ensure the quality of the results in the COVID-19 diagnostic laboratory.
Methods: A descriptive study was conducted including different parameters such as training of all personnel, work organization, analytical processing, biosafety management and quality controls of the COVID-19 diagnostic process, in the period from August 2020 to October 2021.
Results: The strategy designed included the training of all personnel, the organization of the work flow and the establishment of procedures in the 3 stages of the laboratory associated with the diagnosis of COVID-19: pre-analytical, analytical and post-analytical. Risk management processes and biosafety guarantees, policies for retesting and process quality controls, as well as for equipment maintenance and calibration were implemented.
Conclusions: The designed strategy allowed to organize the processes identifying the critical points. Ensured the quality of the results of the center's COVID-19 diagnostic laboratory, as well as contributed to increasing customer satisfaction.

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