Office for Nuclear Regulation

NHS Lothian Radiopharmacy, compliance inspection

Executive summary

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), the Ionising Radiations Regulations 2017 (IRR17) and the Radiation (Emergency Preparedness and Public Information) Regulations 2019 (REPPIR19). CDG refers to the European Agreement concerning the International Carriage of Dangerous Goods by Road (ADR) and ONR used ADR 2019 during this inspection (www.unece.org).

Purpose of Intervention

The purpose of the inspection was to review NHS Lothian Radiopharmacy’s arrangements associated with the road transport of radioactive material. ONR carried out this inspection remotely (via Microsoft Teams) on 19 January 2021.

Interventions Carried Out by ONR

The chosen inspection sample included:

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

The inspector sampled the arrangements deployed by NHS Lothian 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: appropriate registration; appropriate Radiation Protection Adviser and Dangerous Goods Safety Adviser appointments; having RRA’s and contingency plans for emergencies, testing of contingency plans and producing a Dangerous Goods Safety Adviser annual report.

A number of minor contraventions of specific administrative requirements against legislation were identified and discussed during the inspection, which included holding certificates of compliance for packages used, ensuring consignor duties are met for packages transported where third party carriers are used and elements of the RRA and contingency arrangements requiring update.

Conclusion of Intervention

NHS Lothian Radiopharmacy demonstrated that for aspects of its operations it met the requirements of CDG, ADR and IRR17.

Based on the inspection sample, the inspector identified six minor contraventions of administrative requirements against legislation. ONR discussed these non-compliances during the inspection and NHS Lothian Radiopharmacy gave a commitment to address them.

ONR gave NHS Lothian Radiopharmacy until 5 March 2021 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 overall IIS Rating of GREEN was given to reflect that legal duties are complied with, although there were minor contraventions of specific administrative requirements. 

The identified contraventions will be managed through ONR’s Issues Management arrangements.