Office for Nuclear Regulation

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Alliance Medical Radiopharmacy - Compliance inspection of Transport of Radioactive Materials

Executive summary

Purpose of Intervention

ONR regulates the civil transport of radioactive material by road, rail and inland waterway in Great Britain (GB). The ONR Transport Competent Authority (TCA) is responsible for delivering non-nuclear transport inspection and enforcement activities. This particular inspection forms part of that delivery function with reference to Carriage of Dangerous Goods and Use of Transportable Pressure Equipment Regulations 2009 (CDG) and the Ionising Radiations Regulations 2017 (IRR17). CDG refers to the European Agreement concerning the International Carriage of Dangerous Goods by Road (ADR) and ADR 2019 was used during this inspection (www.unece.org).

Purpose of Intervention

The purpose of the inspection was to review Alliance Medical Radiopharmacy’s arrangements associated with the road transport of radioactive material. ONR carried out this inspection remotely (via Skype and telephone) on 30 June 2020.

Interventions Carried Out by ONR

The chosen inspection sample included:

notification, registration or consent – IRR17 Regulation 5, 6 or 7;

a suitable and sufficient radiation risk assessment (RRA) – IRR17 Regulation 8;

suitable and sufficient measures to restrict exposure – IRR17 Regulation 9;

suitable and sufficient Contingency Planning and/or Emergency Arrangements – IRR17 Regulation 13 and CDG 2009 Regulation 24 & Schedule 2;

adequate information, instruction and training – IRR17 Regulation 15 and ADR 1.3.1;

Key Findings, Inspector's Opinions and Reasons for Judgements Made

The inspector sampled the arrangements deployed by Alliance Medical Radiopharmacy for the safe transport of radioactive materials, including the associated arrangements for protecting workers against the effects of ionising radiations and reducing risks as low as reasonably practicable (ALARP). 

The inspector compared relevant statutory requirements with both prescribed arrangements and actual practice. A number of examples of the duty holder meeting relevant good practice in reducing risk to levels that are ALARP were identified, including contingency planning, local rules, information instruction and training and its management system. A number of non-compliances were identified and discussed during the inspection, which included a suitable and sufficient radiation risk assessment and emergency plans (under CDG 2009).

During the inspection, the inspector also suggested certain improvements to transport practices that would be prudent for Alliance Medical Radiopharmacy to consider.

 Conclusion of Intervention

 Alliance Medical Radiopharmacy demonstrated that for a number of aspects of its operations it met the requirements of CDG, ADR and IRR17. Based on the inspection sample, the inspector identified two non-compliances with relevant legislation and suggested three improvements. These were all discussed during the inspection and a commitment obtained from Alliance Medical Radiopharmacy to address them.

Alliance Medical Radiopharmacy was given until 11 August 2020 to provide ONR either with evidence that the findings have been resolved, or an appropriate resolution plan with timescales for completion.

For this intervention, an IIS Rating of AMBER was given, due to there being some deficiencies identified with its arrangements for compliance with legal requirements. These relate to the two areas of non-compliance identified during the inspection.

The non-compliances will be managed through ONR’s Issues Management arrangements.