Using experience during the COVID-19 pandemic to ensure the quality of PCR studies.

Abstract

The issues of laboratory diagnostics have been relevant since the first days of the SARS-CoV-2 pandemic and play a key role in the fight against the spread of a new coronavirus infection. A direct method for the etiological diagnosis of the causative agent of COVID-19 is the detection of SARS-CoV-2 RNA using the nucleic acid amplification method. In the context of a pandemic and the mass appeal of patients for medical care, the issues of ensuring the quality of ongoing molecular biological studies at all stages (preanalytical, analytical, postanalytical) become the most relevant. the results and timing of the study not only affect the diagnosis and treatment tactics of a particular patient, but are also the basis for the introduction of anti-epidemic measures, the adoption of organizational measures. The study is to summarize the experience in creating an effective and reliable system for managing the quality of molecular biological research in a pandemic using the example of a federal budgetary healthcare institution. The experience of the laboratory of a federal healthcare institution in the context of the COVID-19 pandemic was analyzed, errors were analyzed at the preanalytical, analytical and postanalytical stages of PCR studies with the identification of quality criteria, the impact on which significantly leads to quality improvement. The quality control system for PCR studies is based on the development of regulatory documents and instructions for the patient and laboratory staff, registration of all documents in a single information system with access to information from all structural divisions, with the possibility of uploading data to the patient's personal account on the institution's website. Quality indicators of all stages of PCR studies and measures that significantly affect the quality of laboratory studies were identified; Measures have been identified to reduce the turnaround time of a PCR test: distribution of biomaterial flows, optimization of operators' work, purchase of additional equipment, a patient feedback system, and an infection control information system. The obtained results make it possible to create a reliable quality control system, minimize the risk of obtaining erroneous research results, optimizing the work of the clinical diagnostic laboratory and increasing its productivity.