Standards Development

Scope

This document provides guidance and considerations for a healthcare organization to deliver medical tests timely and accurately in a pandemic as follows:

a) threats encountered in providing diagnostic services during a pandemic;

b) general consideration to deliver a quality diagnostic service of the healthcare organization in a pandemic context;

c) recommendations for ensuring the quality assurance thru a collaborative network approach with the help of the advisory committee; and

d) possible response measures to the surge in diagnostic demand.

This document does not apply to the details for providing pandemic response medical tests such as the specimen collection protocols in the specimen collection units or screening stations (e.g., Walk-through or Drive-through), experiment procedures, and quality management systems of medical laboratories. Also, this document omits the pandemic responses related to the medical treatment of infected patients in the care units (e.g., emergency unit, in-patient unit) and transferring of confirmed patients in the healthcare organization during a pandemic.

Purpose

COVID-19, characterized as a pandemic by the World Health Organization (WHO) in March 2020, served as a lesson to society. This lesson taught us that aggressive and large-scale testing to confirm positive cases is an effective and practical measure in flattening the curve regarding the spread of disease prior to vaccine availability. The WHO noted that timely and accurate diagnostic testing for SARS-CoV-2 is essential for comprehensive COVID-19 response strategy. In response to the need for increased accessibility of testing, countries have implemented both decentralized testing at subnational levels and testing at a national level and have deployed antigen rapid diagnostic tests (RDTs). Furthermore, the WHO pointed out that it is critical to maintain and expand molecular testing capacities as well as continue strengthening laboratory networks and systems to identify SARS-CoV-2 variants.

Enhancing accessibility is one of the crucial factors for effective medical testing response in pandemics, and health organizations have an advantage in their geographic locations. Health organizations provide diagnostic services, including medical laboratory tests, to serve their customers (primarily patients). Moreover, it is crucial to maintain the critical care capability of the organizations--- even during the pandemic waves---to protect the public's health. In other words, health organizations, whether they be in the private or public sector, should contribute to slowing the spread of disease by leveraging their diagnostic ability, which will lead to maintaining their ability to provide critical care.

From the perspective of providing pandemic response testing services, the lack of legally approved commercial in vitro diagnostic (IVD) medical devices and unpredictability in a pandemic progression are critical challenges that health organizations have to overcome. In the initial stages of the COVID-19 pandemic, health organizations confronted the surging demand for molecular tests all around the world. However, the expansion of organizations' molecular testing capabilities was not an easy feat because of the problems related to securing competent staff as well as the hardship of establishing a reliable testing practice within a short time.

There are published documents from ISO (ISO 5798:2022) or CLSI (CLSI EP43-Ed1) to ensure the quality of the examination process for medical tests during a pandemic including COVID-19. They are focusing on the examination practice in a medical laboratory. However, we are reaching a consensus that the efforts should not limit within the medical laboratory to succeed in a battle with a pandemic. Also, there were efforts to gather collective intelligence from a collaborative network approach like a public-private partnership or private partnership for an effective response to the pandemic of COVID19, and those approaches are practical.

This document was developed based on practical experience with the pandemic responses of South Korea. Health organizations, both public and private, formed networks in order to maximize the molecular testing capacities of the country in retaliation to the pandemic. It prevented the serious overloading of the intensive care capacity of the country's hospitals and minimized excess mortalities related to COVID-19 in the country during several global pandemic waves. This document defines the potential considerations for healthcare organization networks for the response to the surging diagnostic demands, regardless of test methods (e.g., molecular or antigen tests) provided in pandemics.

Footnotes:

1. ISO/TS 5798:2022, In vitro diagnostic test systems — Requirements and recommendations for detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by nucleic acid amplification methods 2. CLSI EP43-Ed1:2021, Implementing a Laboratory Test Under Emergency Use Conditions, 1st Edition