IBMS, LabMed and RCPath have collaborated to set out a shared position on how UK laboratories can improve oversight, clarify accountability and take a whole-system approach to managing assay performance.
Diagnostic assays underpin modern healthcare - guiding clinical decisions, supporting patient outcomes and informing safe, timely care. Their reliability is essential. When performance concerns arise, laboratories must be equipped to respond effectively and transparently.
The new document, 'Guidance for Laboratories: Investigating and Communicating Assay Performance Issues', sets out a coordinated, system-level approach to assay performance management across UK diagnostic laboratories. Developed jointly by the Association for Laboratory Medicine (LabMed), the Institute of Biomedical Science (IBMS) and The Royal College of Pathologists (RCPath), it highlights the need for stronger national oversight, better-aligned reporting requirements, and shared accountability across clinical, regulatory and industry partners.
To support implementation, the guidance provides clear recommendations on how laboratories can identify, investigate and respond to assay performance concerns. It outlines practical actions across triage, risk assessment, communication, and contingency planning – ensuring that laboratories are equipped to maintain service quality and protect patient care when performance issues arise.
The document proposes:
- National and system-level considerations
- retain and deploy specialists who can provide timely guidance and oversight
- national oversight bodies and health systems must play a proactive role in resolving incidents resolving incidents - particularly where performance issues affect multiple laboratory providers
- exploring whether a mandated national framework is needed beyond current guidance
- aligning reporting requirements of bodies such as the United Kingdom Accreditation Service (UKAS) and the Medicines and Healthcare products Regulatory Agency (MHRA)
- Oversight and regulatory considerations
- a clear, consistent framework of rigorous safety and clinical performance standards to ensure that patient care is not compromised
- collaboration between laboratories, regulatory bodies and national health systems to identify and resolve assay performance issues early
- contracts between laboratories and suppliers to clearly define expectations for performance monitoring, issue reporting and corrective action.
- strengthening assurance mechanisms and consistency in performance monitoring by working to International standards, such as ISO 15189.
The full document can be downloaded at Guidance for Laboratories: Investigating and Communicating Assay Performance Issues