Role of Quality Management System in Setting up and Sustaining a Molecular Diagnostic Laboratory during COVID-19 Pandemic

Introduction: Coronavirus Disease-2019 (COVID-19), caused by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARSCoV-2) catapulted the need to build, upgrade and expand the number of diagnostic laboratories having molecular capacity. Setting up and sustaining a molecular laboratory especially in the backdrop of a lockdown presented many challenges. The Department of Microbiology, in a tertiary level hospital in Mumbai was one of the first to start the molecular testing laboratory. All other tests performed in the department are accredited as per International Organisation for Standardisation (ISO) 15189:2012 since 2015. However, starting a molecular diagnostic facility for COVID-19 testing presented a unique set of challenges as the organism in question belonged to risk category 2 and had the potential for airborne transmission. Aim: To determine the challenges faced and activities undertaken especially with regards to the role of Quality Management System (QMS) in setting up and sustaining a molecular diagnostic facility during COVID-19 pandemic. Materials and Methods: A retrospective analysis was carried out of experiences and data generated from March 2020 to April 2021 at the Microbiology Department of a tertiary level medical college and hospital in Mumbai, Maharashtra, India. The article included the processes which required and data generated during setting up and sustaining a new molecular testing facility as per the QMS with special reference to the 12 Quality System Essentials (QSE). Quality Indicators (QI) were identified, objectives defined and monitored over the period of the study. It was a descriptive study and statistical analysis was not indicated. Results: All the objectives of the QI were met with. Only 4% staff needed corrective training. Specimen rejection rate pretest and post-test was 0.26% and 0.56%, respectively. Quality control failure was seen in 0.16% runs and Turnaround Time (TAT) deviated beyond 12 hours in 0.52% samples. The run contamination, equipment problems and laboratory associated infections were 0.08%, 0.56% and 0%, respectively. There were no External Quality Assessment (EQAS) failure and negative feedback. Laboratory contamination rate was 1.02%. Definite improvement was observed over time in all identified parameters. Conclusion: Implementation of QMS with specific reference to strengthening QSE is a necessary requirement for achieving quality standards.