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