Regular monitoring of sites is crucial for ensuring the quality and efficacy of point-of-care EID implementation.
This guidance and associated checklists are useful instruments for routinely monitoring the quality of POC EID implementation in both hub-and-spoke and stand-alone testing sites.
“Standalone” sites contain a POC EID platform, but do not have spoke sites providing samples.
Regular assessments of the competency of POC EID device operators are crucial for ensuring the quality of the testing procedure at an individual level, and can also serve as a key component of a POC EID quality assurance scheme.
This guidance provides practical step-by-step guidance on enrolling a POC EID site including pre-installation orientation and planning; installation, training, and start up; and post-installation monitoring and follow-up.
This document contains important information about each POC EID product currently on the market.
This guidance note provides consolidated information related to POC EID products as well as some suggestions and considerations related to facility upgrades and sample transportation between spokes and hubs.
Selecting the most appropriate EID and VL products and sites for piloting and scaling up EID and VL point of care testing.
Regular monitoring of POC EID implementation sites is crucial for ensuring the quality and efficacy of site-level operations throughout the project. Site monitoring visits will provide essential insights into site-level issues related to human resources, patient flow, platform functioning, end user performance, specimen transport, data, data quality, and capacity building needs of site level staff.
Post-market surveillance aims to ensure that IVDs continue to meet the same quality, safety and performance requirements as when they were initially placed on the market. WHO has developed normative guidance on post-market surveillance of in vitro diagnostics, emphasizing the importance of both reactive post-market surveillance and proactive post-market surveillance activities.
Reactive post-market surveillance refers to activities undertaken after an issue has occurred related to the IVD test (e.g., complaint reporting/monitoring; end user quality control programs, etc.), whereas proactive post-market surveillance refers to scans for potential issues related to the IVD (e.g., pre- and/or post-distribution lot testing). Lot testing involves testing samples from a manufacturing lot to ensure performance meets an acceptable standard.
For additional information on post-market surveillance, including sample reporting forms, see http://www.who.int/diagnostics_laboratory/postmarket/en/
Regular assessments of the competency of POC EID device operators are crucial for ensuring the quality of the testing procedure at an individual level, and can also serve as a key component of a POC EID quality assurance (QA) scheme.