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The aim of this document is to provide advice and guidance on the management and use of point of care testing (POCT) in vitro diagnostic (IVD) devices. It is a revised edition of the version first published in 2002 as DB 2002(03).
The key issues addressed in this guidance include:
- A clinical need must be identified before the implementation of a POCT service.
- Consider involving the local hospital laboratory in the management of POCT services.
- Lines of accountability for POCT management must be clear.
- Managers of POCT services must be aware of their responsibilities under clinical governance.
- Arrangements for training, management, quality assurance (QA) and quality control (QC), health and safety policy and the use of standard operating procedures (SOPs) must be made and reviewed at frequent specified intervals.
- Assessment of the service by an external accreditation body is recommended. You should consider the available evidence for the performance of the test.
- Adverse incidents must be reported to the MHRA.
- Clear, comprehensive record keeping and documentation is vital.
- Everyone involved in POCT should know what to do in the event of any abnormal result or unsatisfactory QC result.
March 2010: Amendment to page 4, paragraph 3.
Management and use of IVD POCT devices - DB 2010(02) 
