LabCoP Cookbook Recipe 5: Quality Management System Considerations and Guidance for COVID-19 Molecular Testing Laboratories

February 8, 2021

Laboratory diagnosis is an essential element of communicable disease surveillance, both for routine confirmation of infections and for the rapid identification of the cause of outbreaks and epidemics. An inaccurate diagnosis can have severe and expensive consequences such as inappropriate treatment or wastage of vaccines and test kits. Implementation of a strong quality management system (QMS) in line with standards for laboratory accreditation is key to improving patient care. In an effort to reduce the risk of laboratory errors and to ensure that laboratories provide accurate and reliable results, implementation of a QMS is important. However, in resource-limited settings, the majority of the laboratories are not accredited to international standards and may be only partially implementing elements of QMS. Quality Assurance (QA) is a part of QMS that focuses on providing confidence for the fulfillment of quality requirements. ASLM and its partners have developed this recipe that describes the critical elements that laboratories should put in place to rapidly identify and minimize the risk of laboratory errors in implementing laboratory testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19, and defines the minimum QA requirements for Nucleic Acid Amplification Testing (NAAT). This recipe covers critical elements of the entire testing cascade from the pre-analytic to the analytic and post-analytic phases. This recipe also covers the key performance indicators to monitor in the routine performance of the whole testing process that should be analyzed and reported on a regular basis. This information is useful and relevant to laboratory professionals, health workers engaged in day-to-day testing of COVID-19, public health experts, members of COVID-19 taskforces, and program personnel involved in the COVID-19 response among others.