Clinical laboratories produce test results that support the diagnosis, prognosis, and patient treatment. Test results must be relevant, accurate, and reliable for patient care. International bibliographic data estimate that approximately 62.0% of the errors made in clinical laboratories are due to errors during the pre-analytical stage. This chapter presents a failure modes and effects analysis (FMEA) to analyze potential failure risks within the pre-analytical phase and classify them according to severity and likelihood. FMEA allows molecular laboratories to lower costs and drive better outcomes through high-quality nucleic acid extraction, sensitive detection, and accurate quantification. RT-PCR technology continues to be the gold standard for the clinical detection of SARS-CoV-2 RNA in individuals suspected of COVID-19. It is essential to use highly sensitive assays to detect active infections and reduce the likelihood of false-negative results.
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Clinical laboratories produce test results that support diagnosis, prognosis and patient treatment. Test results must be relevant, accurate and reliable for patient care. Laboratory testing of patient samples, beginning from test order to the final interpretation of results by the clinicians, is a complex process. Every step in the total testing process must be correctly performed, thus ensuring valuable decision making and effective patient care.
Clinical laboratories have consistently been implementing quality procedures in their analytical processes, and the practices of quality assessment programs have been a routine in laboratory diagnostics. Automation innovations have also contributed to a significant improvement in laboratory science, but errors can still be translated to inappropriate patient care decisions despite all the automation. These errors are classified as preanalytical, analytical, and post-analytical. For a patient-centered approach, there is the need to assure that every step of the entire testing process is correctly performed, that eventual weaknesses are recognized, and that corrective and preventive actions are designed and implemented (Lao, García, Figuerola, Moreno, &Paraire, 2017; Lippi, Sciacovelli, Simundic, &Plebani, 2017; Roy and Das, 2019).
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was identified in Wuhan, China, in December 2019 and since then has spread all over the world, affecting millions of people.Although the disease caused by SARS-CoV-2 in mostcases occurs with mild, influenza-like symptoms, in 10 to 15% of cases may progress to severe pneumonia, acute respiratory distress syndromeand death. The most vulnerable population groups are the elderly and patients with comorbidities, such as diabetes mellitus, obesity, hypertension, cardiovascular disease and renal disorders (Sanyaolu et al., 2020; Wyperet al., 2020). SARS-CoV-2 is a single-stranded positive (+) polarity RNA virus, with an RNA genome size of 30.000 bases and a viral particle size between 70 and 90 nm. It is transmitted using large respiratory droplets, generated by coughing or sneezing, and hands, touching contaminated objects and surfaces (Coronaviridae Study Group, 2020).
In some cases, aerosol transmission is also possibleusingexposure to elevated aerosol concentrations within closed spaces, such as COVID-19 patient rooms or closed and narrow laboratory areas (Lippi et al., 2020). Consequently, the coronavirus outbreak may be especially hazardous to healthcare personnel, including laboratory professionals.World Health Organization provides biosafety guidance to laboratories and other stakeholders involved in diagnostics for SARS-CoV-2. According to WHO, clinical laboratories must adhere to appropriate biosafety practices. Any testing for the presence of SARS-CoV-2 or clinical specimens from suspected cases must be performed by staff trained in the relevant technical and safety procedures. Moreover, each laboratory should conduct arisk assessment to ensure that it iscompetent to perform the comparative tests (WHO, 2021).