Ensuring Robust Assay Performance in Laboratory Medicine

Introduction

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.

This 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.

National and System-Level Considerations

The expertise of laboratory staff, quality assurance programmes, accrediting organisations and regulatory bodies across the four nations is essential to addressing complex, cross-disciplinary pathology issues. These organisations must retain and deploy specialists who can provide timely guidance and oversight when assay performance concerns arise.

National oversight bodies and health systems must play a proactive role in resolving incidents — particularly where performance issues affect multiple laboratory providers. Coordinated responses to widespread concerns are essential to timely resolution and minimal disruption to patient care.

Given the complexity of managing assay performance issues, there is a case for exploring whether a mandated national framework is needed beyond current guidance. Standardised protocols would support consistency across laboratories, improve investigation processes and help ensure that patient safety remains the top priority.

There should also be alignment between the reporting requirements of bodies such as the United Kingdom Accreditation Service (UKAS) and the Medicines and Healthcare products Regulatory Agency (MHRA). Streamlined processes would reduce the administrative burden on laboratories while ensuring that regulators receive timely, accurate information to support effective decision-making.

Industry bodies — including the British In Vitro Diagnostics Association (BIVDA) and the Association of British Healthcare Industries (ABHI) — have a key role in post-implementation performance monitoring. Individual manufacturers, suppliers and procurement leads should be included in this collaboration to support a whole-system approach to identifying and resolving emerging performance issues.

Oversight and Regulatory Considerations

Maintaining high standards in diagnostic assays requires stronger oversight. A clear, consistent framework gives laboratories the confidence that new assays meet rigorous safety and clinical performance standards. Without this, there is a risk that patient care is compromised.

Collaboration between laboratories, regulatory bodies and national health systems is essential to identify and resolve assay performance issues early. Working together enables a responsive system that protects public health and sustains confidence in laboratory medicine.

A key consideration is whether CE or UKCA marking provides sufficient assurance of regulatory compliance and patient safety. Laboratories must assess whether these certifications reflect reliable assay performance in clinical settings.

Another important factor is the contractual relationship between laboratories and suppliers. Contracts should clearly define expectations for performance monitoring, issue reporting and corrective action. Embedding these provisions in procurement agreements helps ensure supplier accountability and proactive support when performance concerns arise.

International standards, such as ISO 15189, provide a useful foundation for laboratories seeking to align their internal practices with globally recognised quality benchmarks. These standards can strengthen assurance mechanisms and support consistency in performance monitoring, particularly in the context of supplier contracts and regulatory compliance.

Conclusion

The Association for Laboratory Medicine, the Institute of Biomedical Science and the Royal College of Pathologists are united in their commitment to upholding the highest standards in laboratory medicine. By fostering collaboration between laboratories, regulators and industry partners, this guidance document supports a system that can identify and address assay performance issues proactively.

It offers a shared framework to ensure that diagnostic assays remain reliable, accurate and safe for patients. Through coordinated action and sustained commitment, the profession can continue to strengthen the foundations of laboratory medicine and deliver high-quality diagnostic services to those who rely on them.


Issued by:

• Institute of Biomedical Science (IBMS)
• The Royal College of Pathologists (RCPath)
• Association for Laboratory Medicine (LabMed)