PROVISIONS OF PCR MASTER MIXES – CLONALITY TESTING

Procurement reference

CAV-DIR (25-26) 99

Procurement description

The All Wales Medical Genomics Service (AWMGS) is awarding a direct contract for the supply of PCR mastermixes and associated reagents required for B and T cell clonality testing. These assays are critical for diagnosing and monitoring haematological malignancies such as lymphoma and must include validated clonal and polyclonal controls, as well as a control gene, to ensure accurate and reproducible results. In addition to product supply, the contract includes technical support to maintain continuity of service. Changing supplier would require extensive revalidation and re-accreditation of all assays, which would be a major undertaking and cause significant disruption to diagnostic services. This would lead to delays in patient testing, risking late or missed diagnoses and potentially endangering patient health and outcomes. The direct award is therefore essential to safeguard patient safety, maintain compliance with UKAS standards, and ensure uninterrupted delivery of critical genomic testing services across Wales.

Cardiff and Vale University Health Board

Invivoscribe Technologies SARL

Procedure type

Direct award

Description of how these justifications apply

The All Wales Medical Genomics Service (AWMGS) requires PCR mastermixes and associated reagents for B and T cell clonality testing, which are critical for diagnosing and monitoring haematological malignancies such as lymphoma. These assays must include validated clonal and polyclonal controls and a control gene to ensure accurate and reproducible results. Changing supplier would necessitate full revalidation and re-accreditation of all existing assays under UKAS ISO 15189:2022 standards—a process that is highly complex, resource-intensive, and time-consuming. This would cause significant disruption to diagnostic services, resulting in delays to patient testing and reporting. Such delays pose a serious risk to patient safety, as timely diagnosis is essential for initiating treatment and improving clinical outcomes. Any interruption could lead to missed or late diagnoses, directly endangering patient health and potentially impacting survival rates. To avoid these unacceptable risks and maintain continuity of service, a direct award is the only viable option, service resilience, and safeguarding patient care across Wales.

Direct award justification

Single suppliers technical reasons

Description of risks to contract performance

The main risks to contract performance include supply chain disruption, single supplier dependency, and potential delays in delivery or technical support. These risks could impact continuity of testing and patient care. Mitigation measures include strict service level agreements, proactive communication requirements, and performance monitoring through AWMGS’s Quality Management System.