Point of Care Testing: Elements of a Quality Framework

Ensuring the quality of point-of-care testing (POCT) has proved challenging in many institutions and settings. The lack of a quality framework and defined legislative regulation or mandatory requirements for managing POCT in Australia leaves a gap which can potentially compromise patient safety and the quality of testing. This document presents a quality framework to support organisations intending to provide POCT. The framework also addresses accreditation requirements and provides a structured approach to creating and maintaining processes and procedures for implementing a quality system in a POCT service.

Main sections:

� Organisation

� Customer focus and resolution of complaints

� Facilities and safety

� Personnel

� Purchasing and inventory

� POCT equipment

� Testing method (assay)

� Process management

� Documents and records management

� Information management

� Non-conforming event (NCE) management

� Audits and assessments

� Continual improvement