ISO/CD 20364

A draft is being reviewed by the committee.

Abstract

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.