Management and use of IVD point of care test devices -DB2010(02)

April 07 2010

The MHRA has revised their advice and guidance on the management and use of point of care testing (POCT) in vitro diagnostic (IVD) devices. They provided a guidance document in 2002 and this is the first time it has been revised.

The MHRA DB2010(02) Feb 2010 documents list the following as the key issues addressed :

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 (SOP's) must be made and reviewed at frequent specified intervals.
Assessment of the service by an extrenal accreditation body is recommended. You should consider the available evidence for the porformance 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.