Guidance for procurement of in vitro diagnostics and related laboratory items and equipment

Overview

Testing programmes strive to procure products that are appropriate for the intended setting of use at the most reasonable price to ensure that testing is accessible for all who need it. When procurement is not conducted in accordance with documented best practices, the products procured may not be appropriate for use by the intended user or for the intended setting. Therefore, the quality of procurement practices have a direct impact on the effectiveness of programme funding for testing services, for example, when analysers are purchased that require more highly trained staff or when rapid diagnostic tests (RDTs) are procured that are not validated for capillary whole blood specimens. Poorly conducted procurement has a huge programmatic impact if stability of products and allowable shelf life for labile reagents are not foreseen as part of the procurement process. Currently, many testing programmes procure their annual needs to avoid repeating an often long and complex procurement process. This guidance aims to highlight the necessary factors to consider when procuring in vitro diagnostic medical devices (IVDs) and other laboratory items.