Monitoring and evaluation for quality of Thailand SARS-CoV-2 laboratory network: Lesson learnt for policy driven and new guidelines

Abstract

Background: Due to the COVID-19 outbreak, Department of Medical Sciences, Ministry of Public Health has taken responsibility for SARS-CoV-2 laboratories using Real-Time RT-PCR in network accreditation. Monitoring and evaluation are important to ensure the quality of SARS-CoV-2 laboratory networks after receiving accreditation.

Objectives: This study aims to summarize and provide policy proposals and new laboratory guidelines from on-site-assessment key points to elevate lab quality and support laboratory development to meet the international standard, ISO 15189 accreditation.

Materials and methods: The coaching-type-assessment checklist for SARS-CoV-2 laboratory network was prepared by an expert team and contained 44 requirements in Analytical technique and Biological safety. It was then sent to the laboratory network nationwide for self-assessment. The assessor team used this checklist for on-site assessment from May to September 2020.

Results: On-site assessment of 38 SARS-CoV-2 laboratories showed a total of 156 nonconformities (NCs). The top three NCs in the Analytical technique requirements were 1) accommodation and environment condition (27.6%), (involved performing Pre-PCR activities in the same area as Post-PCR and unidirectional workflow), 2) laboratory equipment, reagents, and consumables (13.5%) and 3) post-examination process (13.5%). In Biological safety requirements, personal protective equipment (PPE) was the most frequently found NC with 8.3%, and involved area constraints with no suitable places to put on or remove PPE.

Conclusion: The monitoring and evaluation for the SARS-CoV-2 laboratory network in Thailand has been developed according to the PCR standards both in terms of management and technical including biological safely for improving and developing the quality of SARS-CoV-2 laboratory network response to an emerging situation. To strengthen the quality of laboratory network in Thailand and preparedness to emerging situation, integrated tools are proposed including laboratory's self-assessment (coaching-type checklist), the proficiency testing (PT) programs, re-accreditation, special assessment from particular request and organizing training to disseminate knowledge to all network laboratories. In addition, this system may apply for other emerging diseases in the future and should encourage laboratories to continue for the ISO 15189 accreditation.