Standards Development

Scope

This document provides guidance and considerations for healthcare organizations to deliver diagnostic tests timely and accurately in a pandemic by leveraging innovative approaches to overcome the limitations of laboratory capacity as follows:

– mitigating threats encountered in providing diagnostic services during a pandemic;

– consideration for quality assurance of diagnostic service provision in a pandemic context; and

– 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

Diagnostic testing is an important service in contact tracing, effective triaging, and informed treatment decision making processes. In a pandemic situation, there is a need to extensively increase the above processes which in turn increased the demand for diagnostic services. There were many instances where the surged diagnostic demand was not met due to the lack of skilled laboratory personnel and shortage of diagnostic equipment [1, 2]. The World Health Organization (WHO) also stated that diagnostic testing is an essential element for the comprehensive COVID-19 pandemic response strategy [3]. The demand for diagnostic testing become even higher during the later stage of the pandemic where a large scale testing of asymptomatic population is needed for reopening of economies and businesses [2].

However, the expansion of organizations' molecular testing capabilities was not an easy task because of the problems related to securing competent staff as well as the hardship of establishing a reliable testing practice within a short time, not to mention the challenges of getting enough supply for diagnostic and personal protective equipment. The lack of legally approved commercial in vitro diagnostic (IVD) medical devices, and unpredictable nature of a pandemic progression are some of the critical challenges that health organizations have to overcome. Moreover, the turn-around time (TAT) of the testing results for both pandemic and non-pandemic related tests are prolonged due to the surge in diagnostic demand [4]. The prolonged TAT can impact on all the subsequent healthcare process for the individual patients in emergency department (ED), intensive care units (ICU), and other in-patients. It may delay the operation starting time of a critically ill patient who needs emergency operation [5, 6]. It can also prolong the length of hospital stay when a negative diagnostic test is required for discharge [6]. These challenges are indicating that they cannot be solved in the laboratory alone, rather, healthcare organizations as a whole, need to find alternative solutions to address the surging diagnostic demand by optimizing available resources and overcoming the limitations set by laboratory capacity.

This document aims to strengthen global capabilities for surging diagnostic demand for upcoming pandemics based on the experience of different countries including the lessons learned, and innovative approaches. For instance, there were some practical efforts to gather collective intelligence from a collaborative network approach like a public-private partnership for an effective response to the pandemic of COVID-19 [7]. Health organizations, both public and private, can form networks in order to maximize the diagnostic testing capacities in response to the pandemic. This kind of approach can contribute to maintaining hospital functions and to ensure healthcare service delivery to all the patients in need.

A standardized framework for healthcare organizations to follow during a pandemic can facilitate a consistent strategy globally, leading to better coordination and more effective response. Besides, having an international standard for diagnostic surge would improve the public trust and confidence in healthcare organizations’ response to the pandemic.