Clinical governance is vital for delivering safe, high-quality healthcare. In Point-of-Care Testing (POCT), it ensures bedside and near-patient tests produce accurate results and are used safely by clinical teams. For POCT leads, ward managers, and healthcare staff, good governance means managing risks, maintaining quality, and ensuring staff are trained and supported.
POCT services must meet strict regulatory and quality standards. These include:
- NHS England POCT Guidance
- ISO 15189:2022 – International Standard for Medical Laboratories
- MHRA Medical Device Regulations (UK)
- EU In Vitro Diagnostic Regulation (IVDR)
- FDA In Vitro Diagnostics Oversight (USA)
- WHO Diagnostics and Laboratory Standards
- CQC Regulations for service providers and managers
Following these frameworks helps organisations achieve quality assurance, maintain regulatory compliance, and protect patient safety. It also supports accreditation (such as UKAS in the UK) and improves trust in POCT results across clinical teams and patients alike.
Strong clinical governance is not just about compliance — it builds a culture of safety, empowers clinical staff, and ensures POCT services support effective, reliable patient care every day.
