POC

Site Monitoring Guidance and Checklists for POC EID

 

Site Monitoring Guidance and Checklists for POC EID

 

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.

Site Enrollment Guidance

 

Site Enrollment Guidance

 

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.

Author: EGPAF

Year: 2016

Site Monitoring Guidance and Checklists

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.

Author: EGPAF

Year: 2017

Post-Market Surveillance

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/