Quality and Competence in Point-of-Care Testing: A Technical Guide to CSA Z316.7-12 (R2017)

1. Scope and General Overview

CSA Z316.7-12 (R2017) — Point-of-care testing (POCT) — Requirements for quality and competence — is the Canadian national adoption of the international standard ISO 22870:2006. Reaffirmed in 2017, this standard specifies mandatory requirements for quality and competence specific to point-of-care testing. It is designed to be applied in conjunction with the general laboratory medicine standard CSA Z15189-12 (adoption of ISO 15189:2012).

The standard applies to all POCT performed by healthcare professionals under the direction of a central clinical laboratory or a healthcare organization. It covers testing conducted in hospital wards, operating rooms, intensive care units, outpatient clinics, physician offices, and ambulatory care facilities, but explicitly excludes self-testing or home-use tests performed directly by patients.

A fundamental principle of CSA Z316.7-12 is that POCT must achieve a quality of results equivalent to that of the central laboratory. The standard provides the framework to bridge the gap between the rigorous regulated environment of a central lab and the inherently more variable setting of bedside testing.

2. Core Technical Requirements

CSA Z316.7-12 is built upon several key technical pillars: Quality Management, Equipment and Materials Control, Pre-Examination, Examination, Post-Examination Processes, and Personnel Competence.

2.1 Quality Management System (QMS)

The standard requires a formal POCT Coordinator role and a POCT Committee to oversee governance. The QMS must include:

• Document Control: Policies, procedures, and standard operating procedures (SOPs) must be controlled, versioned, and readily available at the point of care.
• Agreements and Service Level Agreements (
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