RWA Update Tuesday 22nd May 2018

Manchester Metropolitan University

FINAL PROGRAMME

08.45 – 09.25 Coffee and registration

09.25 – 09.30 Introduction

Chair: Liz Pitcher

09.30 – 09.55 Changes to EPR regulations Kate Griffith, Environment Agency

09.55 – 10.20 Regulatory Update for Scotland Angela Wright, Scottish Environment Protection Agency

10.20 – 10.30 Review of the RWA Certification Scheme Kate Griffith, EA / Angela Wright, SEPA

10.30 – 11.00 Tea/coffee

Chair: Phil Orr

11.00 – 11.30 Office of Nuclear Regulation Update Michael Nettleton, Office for Nuclear Regulation

11.30 – 12.00 Security of Radioactive Materials Martin Ainsworth, Environment Agency

12.00 – 12.20 Draft Radiation (Emergency Preparedness & Public Information) Regulations (REPPIR) 2018 Consultation Andy Brennan, NHS Greater Glasgow and Clyde

12.20 – 12.50 Regulations: Discussion session/Ask the Experts Panel of morning speakers

12.50 – 13.50 Lunch

Chair: Kat Dixon

13.50 – 14.10 What are the Neighbours up to? Experiences of Peer Auditing Ben Johnson, University Hospital Southampton NHS Foundation Trust

14.10 – 14.30 Nuclear Medicine patients and nursing homes: unexpected consequences of IRR17 Jennie Prince, The Christie NHS Foundation Trust

14.30 – 14.50 A matter of half-life and death – experiences of providing advice after the death of patients receiving radionuclide therapy Neil Davis, Royal Free London NHS Foundation Trust

14.50 – 15.05 Recent Experiences of an NHS RWA in North Wales Dr Julian MacDonald, Betsi Cadwaladr University Health Board

15.05 – 15.35 Tea/Coffee

Chair: Liz Pitcher

15.35 – 15.50 Why children should not play in brooks, and other stories Dr Kat Dixon, Poole Hospital NHS Foundation Trust

15.50 – 16.05 Radioactive Drains – When things go wrong Edwina Faulkner, Cambridge University Hospitals NHS Foundation Trust

16.05 – 16.20 Iodine-131 ablation waste disposal – the journey from patient to lift shaft? Dr Tim Watts, The Royal Wolverhampton NHS Trust

16.20 – 16.35 Permit exemption case studies (small quantities of radioactive substances) Hugh Wilkins, University of Exeter

16.35 – 17.00 Discussion and Questions

17.00 Close

Organised by IPEM’s Radiation Protection Special Interest Group Programme subject to change

Changes to the Environmental Permitting Regulations Kate Griffith, Technical Specialist, Environment Agency

The 2013 Basic Safety Standards Directive (BSSD) consolidates existing Euratom radiation safety legislation, implementing developments in standards and recommendations issued by the IAEA and ICRP. It updates the 1996 Basic Safety Standards Directive, together with Directives covering High Activity Sealed Sources (HASS), medical exposures, outside workers and public information. The BSSD is one of the main Directives underpinning the Environmental Permitting Regulations (EPR), through which radioactive substances regulation in England and Wales is undertaken. Whilst the overall regulatory approach under EPR remains broadly the same, some amendments to the legislation have been required in order to comply with the directive. These will come into force on 2 May. This presentation will outline the changes that have been made to the regulations, highlighting those likely to affect the medical sector. These include changes to the HASS definition, the frequency of reporting to the HASS inventory, and also to the exemptions that apply to the accumulation of sealed sources. As a consequence, variations have been made to some permits for sealed sources. A brief update will also be provided on other current Environment Agency issues.

Regulatory Update for Scotland Angela Wright, Scottish Environment Protection Agency

This presentation will discuss the changes to radioactive substances legislation in Scotland. The changes are being made to transpose the requirements of the 2013 Basic Safety Standards Directive as well as incorporating wider changes that are being made as part of Scotland’s Better Regulation programme.

Security of Radioactive Materials Martin Ainsworth, Environment Agency

This presentation, with reference to relevant guidance and standards, will look at why we need to have security measures in place for radioactive materials. It will explain the IAEA Method for Source Categorisation including the concept of danger values, and how this is implemented in the UK. Using example from the medical sector it will show how to work out Source Categorisation and corresponding Security Levels. The presentation will then look at how this is put in to practice, using the principle of Deter, Detect, Delay and Respond. Finally it will also look at appropriate security measures for unsealed sources and radioactive waste.

Draft Radiation (Emergency Preparedness & Public Information) Regulations (REPPIR) 2018 Consultation 1A G Brennan, 2J Thurston, 1Health Physics, DCPB, Glasgow, Scotland 2Royal Marsden Hospital, London, England

REPPIR2018 will come in force in late 2018 (autumn/winter), & will include ACoP & Guidance. ONR will be the enforcing authority, not HSE. Transport is no longer included in REPPIR, & closed session consultation to invitees only is being lead by MoD. The authors will report on the proposed changes, & the possible implications.

What are the Neighbours up to? Experiences of Peer Auditing 1Johnson BP, 2Dixon K, 3Ferrioli C 1Medical Physics, University Hospital Southampton NHS Foundation Trust 1Nuclear Medicine, Poole NHS Foundation Trust 1Medical Physics, Portsmouth Hospitals NHS Trust

Background

As an RWA, continually auditing the same area can lead to blind spots and may result in missing key areas of compliance with permit conditions.

Following the recommendation of our Environment Agency inspector, and with a view to improving both the quality of audit and our auditing skills, the Radioactive Waste Advisers from Poole, Portsmouth and Southampton agreed to audit each other’s sites.

Methods

An audit against permit conditions of the Nuclear Medicine department at each site was undertaken with all three RWAs present. Each audit was limited to a half day. For each centre, a report was created by an RWA from one of the other sites using their own report template and agreed with the other external auditor. All audits were carried out in Summer 2017.

Discussion.

All three auditing styles were different and highlighted different areas of compliance, but generally issues noted by external RWAs were known to the internal RWA. There were several opportunities to learn of good practice at other sites and see alternative management processes in action.

Some examples of good practice found were:

Quick location check of sealed source (Portsmouth)

Centralised staff training records (Poole)

Use of dedicated software for stock/waste tracking (Southampton)

Fire grab packs locations (Portsmouth)

Conclusion.

The experience of being audited by your peers is a daunting one but in a supportive atmosphere it is a positive and constructive process which can improve compliance. Whilst any audit will not discover everything a department does, a fresh pair of (friendly) eyes is helpful to reassure internal auditors of their own findings.

Nuclear Medicine patients and nursing homes: unexpected consequences of IRR17 Prince, J Christie Medical Physics and Engineering, The Christie NHS FT

Following the arrival of IRR17, the publication of the HSE website [1] to “apply to notify, register or get consent” for work with ionising radiation brought an unexpected surprise for many in the nuclear medicine radiation protection community. The registration conditions made it clear that the employer must always appoint an RPA if registration was required. IRR17 itself, and more recently the flowcharts in L121 [2], imply that the levels of radioactivity present in nuclear medicine patients post-procedure mean that nursing homes receiving such patients are required to register with the HSE.

For many, this was a significant departure from their practise under IRR99. Previously, whilst information would have been provided to nursing homes to enable safe working, not all users considered that nursing home employers needed to appoint an RPA or to hold their own radiation risk assessments. There is a strong concern that advising nursing homes of these requirements of IRR17 would mean that nuclear medicine procedures would be significantly delayed or even cancelled, with inevitable consequences for patient care.

For at least some of the HSE inspectorate, the surprise amongst nuclear medicine RP professionals came as a surprise, as the wording of various definitions and regulations was unchanged. This highlighted differences in understanding of the requirements for appointment of RPAs.

This presentation will review the IRR17 requirements for registration, for appointment of RPAs, and for employers to communicate with each other about radiation risk and the requirements of IRR17, as they relate to the nursing home situation. By way of contrast, (and in order to at least mention EPR as this is an RWA update day) the exemption provisions in EPR for medical use of radioactive materials will also be briefly reviewed.

A practical way forward will be proposed, which it is hoped will allow both diagnostic and therapeutic nuclear medicine procedures to be performed without undue delay, whilst the nuclear medicine employer and the nursing home employer both fulfil their obligations under IRR17.

Unanswered questions will be raised, including

Continued concern that nuclear medicine procedures will be delayed, due to requirements which in some cases appear to be disproportionate to the radiation risk

Where on the spectrum of “nursing home – residential care home – sheltered housing – hotel” is the line to be drawn for when staff are “working with ionising radiation” and when are they members of the public included in the radiation risk assessment carried out by the nuclear medicine employer.

Patient confidentiality and data protection as they relate to communication with the nursing home employer.

The possibility of nationally agreed advice to nursing homes, and perhaps national generic risk assessments for nursing patients after e.g. Tc-99m or F-18 procedures.

The possibility of future exemptions under Sch 1 of IRR17, perhaps for limited numbers of diagnostic nuclear medicine patients.

Key references.

[1] https://services.hse.gov.uk/bssd/

[2] L121 (second edition) 2018. Work with ionising radiation: Ionising Radiations Regulations 2017. http://www.hse.gov.uk/pubns/books/l121.htm

A matter of half-life and death – experiences of providing advice after the death of patients receiving radionuclide therapy Neil Davis, Richard Meades, Beverley Holman, Daniel McCool Nuclear Medicine, Royal Free London NHS Foundation Trust

Background

Due to external dose rate and the potential for contamination, patients that die soon after receiving radionuclide therapy present a radiation hazard to their friends, families, various staff groups involved in handling the corpse, and to the environment. Assessment of the associated risks is required to ensure that personal dose limits under IRR17 and environmental discharge limits under EPR16 are not exceeded. Unusually, three patients treated at hospitals to which the Royal Free Nuclear Medicine Department provides scientific support died within a relatively short period of time under different circumstances having received different radionuclide therapies. Here we present our experiences of providing advice and lessons learned during these cases.

Methods

Information about the administration of the radionuclide, the circumstances of the death of the patient and what was likely to happen to the corpse were gathered. The amount of activity likely to be remaining in the body was calculated using the physical half-life and likely biological excretion of the radionuclide. The external dose rate was calculated, and the necessity of any restrictions on duration of close contact with the corpse was considered. The probable location and concentration of any remaining activity in bodily tissues and fluids was determined in order to assess the need for considerations regarding potential contamination and environmental risks.

Results Advice on duration of close contact given to friends, family and staff involved ensured that dose limits were not exceeded. Consideration of the likely locations and concentrations of activity in body tissues and fluids proved vital to inform discussions on timing and practicalities of post mortem exams, embalming procedures and cultural practices. These included the post mortem of a patient who had received a novel alpha emitting therapy agent, and a cultural practice involving family members spending prolonged periods with the corpse and handling bodily fluids.

Discussion and Conclusion

Due to the differing nature of the radionuclides, and of the cultural and post mortem practices, the approaches used and advice given varied widely between each of the three cases. The range of cultural practices encountered underlines the need for the advice to be tailored to the individual situation. A robust contingency plan and clear communication between the groups involved were advantageous in ensuring a satisfactory outcome.

Key references

[1] Radiation Risk Assessment – Deceased Patient Protocol, Julie Robinson, Guy’s and St Thomas’ NHS Foundation Trust, July 2013

[2] Safety Report Series No. 63 – Release of Patients After Radionuclide Therapy, IAEA, 2009

[3] Medical and Dental Guidance Notes, IPEM, 2002

[4] The Ionising Radiations Regulations 2017, HMSO, 2017

Recent Experiences of an NHS RWA in North Wales 1MacDonald J 1North Wales Medical Physics, Betsi Cadwaladr University Health Board, UK.

Background.

This presentation provides some examples of projects and issues faced by an NHS RWA working in North Wales. This includes the impact of methodology changes and historically inaccurate sewage flow-rate assumptions in a recent application to add Ra-223 to an existing permit. It will also discuss issues around the effect of excretion factor changes and evidence provided to allow retention of previous factors.

Methods.

(1) The first piece of work was around the addition of Ra-223 to an existing permit. An environment impact assessment was initially carried out using the Environment Agency’s IRAT tool. This brought to light several issues, including an historical assumption of sewage flow rate which turned out to be significantly higher than the actual value; and limitations in the IRAT tool in respect of inappropriate surrogate radionuclides for generic radionuclide groups. The presentation will describe the communications and calculations that were necessary to resolve these aspects and allow the permit to be varied.

(2) The second piece of work was triggered by the revised values for I-131 excretion factors in 2014 [1]. The change from 30% to 50% to drain resulted in one of our permitted sites coming very close to the permit discharge limits. Our options were to vary the permit, which would have incurred a cost, or to provide sufficient evidence to demonstrate that the original 30% value was more appropriate to our circumstances. This depended on showing that the assumption that patient discharges at home would be treated at the same sewage works as discharges from the hospital was largely incorrect. Work was done on mapping the homes of previous I-131 patients to look at their distribution in relation to sewage treatment works and the general population served by the hospital.

Results.

(1) The existing permit was successfully varied after modifications to the radionuclide groupings were made and specific information was obtained and used to demonstrate that public doses were acceptable.

(2) We were successful in providing convincing evidence to Natural Resources Wales that then allowed us to revert to an excretion factor for I-131 of 30% thus avoiding the variation cost.

Conclusion.

This presentation shares some of the experiences and issues of a RWA working in the NHS.

Key references.

[1] IPEM- “Advice Notice - Excretion Factors: the percentage of administered radioactivity released to sewer for routinely used radiopharmaceuticals.” Feb 2014

Why children should not play in brooks, and other stories 1Dixon K, 1O’Shaughnessy E 1Nuclear Medicine Department, Poole Hospital, UK.

Background. To pre-empt changes to the radionuclide therapies commissioned from Poole Hospital an alteration to its EPR open source permit was required. This opportunity also allowed for a review of the permit limits for other isotopes taking the IPEM advice notice on excretion factors [1] into account. Poole sewage treatment works discharge via a small brook into a large tidal harbour which is a Special Marine Protection Area for a number of bird species; this makes the discharge limits from the hospital somewhat limited and flexibility was therefore required of the EA IRAT spreadsheet [2].

Methods. Several aspects of the discharge pathway were investigated and more detailed knowledge allowed amendments of assumptions made in the IRAT spreadsheet. The most notable of these were a change in the Phosphorous pathway and proof ‘child playing in the brook’ was not a necessary consideration.

Results. When presented with the evidence of investigation the EA approved the new discharge limits from Poole Hospital.

Conclusion. The IRAT spreadsheet is a very good first-point for discharge calculations. It is however not an immovable feast and further investigation of the discharge pathway together with communication with the EA team, allows sensible decisions to be made that not only protect the general public and the environment, but also allow patients to be diagnosed and treated even on the edge of Special Marine Areas.

Key references.

[1] IPEM Advice Notice: Excretion factors: the percentage of administered radioactivity discharge to sewer for routinely used radiopharmaceuticals. Feb 2014.

[2] EA IRAT spreadsheet: Release to sewer. Version 4.0, Dec 2011.

Radioactive Drains – When things go wrong Whish G, Faulkner E East Anglian Regional Radiation Protection Service, Cambridge University Hospitals NHS FT, UK.

Background.

The East Anglian Regional Radiation Protection Service (EARRPS) provides RWA and RPA advice to Addenbrooke’s Hospital, a large acute Trust with an unsealed source EPR permit allowing receipt, accumulation and disposal of waste. A significant proportion of the waste generated is in aqueous form from Nuclear Medicine patients, and contains a wide variety of radionuclides which are disposed of in high volumes from a variety of sources. This creates challenges in terms of ensuring compliance with relevant legislation1,2 and guidance3, managing risks from these disposals and supporting the safe use of an aging drainage system with an increasing capacity burden.

Aim: To provide practical radiation protection and radioactive waste disposal advice following multiple drain incidents, including blockages and any resulting escapes. To develop systems to reduce the probability of, and mitigate the impact from, any reoccurrences.

Methods.

EARRPS have provided support to Addenbrooke’s for 6 relatively significant radioactive drain blockage incidents in recent years, leading to a range of impacts from local contamination to escape of radioactive material. Typical response actions associated with these incidents include the identification of unknown radionuclides, dose rate and contamination monitoring, decontamination of areas, quarantining of equipment and external reporting of incidents where necessary. This has involved cross-departmental working and negotiation, as well as working with departments with no knowledge of working with radioactive materials, such as Estates.

Results.

Key issues identified included a lack of planned preventative maintenance for the drains and an insufficient warning system. Early warning sensors have been installed in some of the drains, and a robust immediate response procedure with detailed actions has been developed for both Estates and Medical Physics use. A long running action plan is used to record lessons learned and improvement points from the incidents which have occurred.

Discussion/Conclusion.

Radiation safety and legislative compliance has been managed through a combination of the introduction of on-going drain maintenance, the deployment of new sensor equipment and the increased engagement and understanding of the Estates team – especially in terms of dedicated equipment and staff training. Key documentation has been developed outlining the immediate actions to be taken and key radiation protection considerations for staff involved.

Although it is not possible to avoid or even predict the failures that might occur, the experiences of EARRPS at Addenbrooke’s can provide an example response system and give an idea of the involvement required by different staff groups.

Key references. 1. Environmental Permitting Regulations (EPR) 2016. 2. Environment Agency (Sep 2012) How to comply with your EPR RSR environmental permit –

open sources and receipt, accumulation and disposal of radioactive waste on non-nuclear sites, Version 2.

3. Environment Agency (Oct 2008) Radioactive Substances Act Guidance (RASAG) Chapter 4 – Generic Issues, Version 3.

Iodine-131 ablation waste disposal – the journey from patient to lift shaft? 1Watts T, 1Cartwright A, 1Foley M, 1Medical Physics and Clinical Engineering, The Royal Wolverhampton NHS Trust, UK.

Background At the Royal Wolverhampton NHS Trust, over 50 in-patient thyroid ablation therapies using Iodine – 131 are performed annually. The disposal route for aqueous radioactive waste from patients is highlighted in the department’s procedure for managing a potential drain blockage. There is also a level alarm to alert staff when there is a blockage in the sewer containing radioactive waste. During a period of heavy rainfall we were alerted to a flood in an area of the basement that was near the drains assigned for radioactive waste, however the designated radioactive waste drainage route was completely clear. The area that had flooded was checked for radioactive contamination and unfortunately contamination was detected. Method Initial action was to block access to any of the areas where contamination was detected. An investigation was then performed to find the blockage, and determine how radioactive waste had ended up in the basement when the plans showed that this shouldn’t have been possible. A major blockage was found a long way downstream of the flooded area but the level alarm had not been triggered. Following a risk assessment to determine risks to staff involved, the blockage was cleared by a specialist company. Much of the aqueous waste then drained away leaving residual macerated waste. Access continued to be restricted to areas that were very rarely accessed in the basement where the waste was left to decay before being cleared. Other areas were cleaned and the waste was washed back down the drain. After clearing the areas of the basement where regular access was required, final contamination checks were performed. Unfortunately, it was then found that approximately 6000 litres of water, contaminated with I-131, had ended up in lift shafts at the top of an incline in the basement near the original contamination incident. There was no clear route that the waste had taken. Samples were taken to determine the concentration of radioactivity. After consultation with the EA, this waste was pumped out of the lift shafts into the designated drain. The dose rate in the lift cars was then reduced to acceptable levels. Investigations were performed to determine how the contamination of the basement was caused and how the lift shaft became compromised with radioactive waste. Results The radioactive drain was found to be connected into a sewer that was connected to open drains in the basement. The blockage had caused a large amount of effluent to flow back up the drains and emerge from the open drains in the basement. Following previous rainwater floods the drainage channels in the basement had sump pumps installed to pump flood water away. However a pump had been fitted incorrectly resulting in water in the drainage channel being pumped into the lift shaft. Conclusion The drains have been surveyed, plans re-drawn and monthly checks of the route are being performed to ensure no blockages develop. The pump in the drainage channel was taken out of use pending correct reconnection.

Permit exemption case studies (small quantities of radioactive substances) Wilkins H University of Exeter, UK.

Background. Regulation 12(3) of the Environmental Permitting Regulations10 (EPR2016) allows exemption under certain circumstances from the requirement for a permit to keep or use radioactive material, or dispose of radioactive waste, on or from premises in England and Wales. This talk outlines relevant legislation, guidance and policy. It is illustrated by case studies in which exemption has been considered for: (i) several sealed sources of Co-57 and Cs-137; (ii) proposed gaseous release to atmosphere of very small quantities of C-14.

Methods. The legislation (EPR2016), and its Schedule 23 (Radioactive substances activities), were studied carefully, and a mini literature review of relevant guidance undertaken. An initial radiological assessment of the prospective dose to a ‘representative person’ from the proposed discharge of gaseous C-14 was performed using published dose per unit release (DPUR) data.

Results. The literature search revealed a substantial body of freely-available relevant guidance on gov.uk and other websites. Applying this guidance led to conclusions that exemption criteria were not met in either case. This is despite the radiological assessment that ‘worst case’ doses to a member of the public from the proposed C-14 gaseous release would be fractions of a µSv.

Discussion. EPR201610, and equivalent legislation in Scotland and Northern Ireland, implement government guidance on exemptions from radioactive substances legislation in the UK1. This is a complex area, as is also the over-arching environmental protection framework. There is undoubtedly a need for guidance for all stakeholders. Fortunately high quality evidence-based authoritative guidance is readily-accessible from various bodies1-9.

Conclusion. Considerable thought has gone into the UK regime which regulates the keeping and use of radioactive substances, and the accumulation and disposal of radioactive waste. Salient guidance to the legislation is available. Radioactive substances regulation is risk-based, and allows the regulators to minimise administrative burdens to regulated businesses whilst protecting the environment. Risks include those arising from societal perceptions of radiation risks as well as purely radiological risks when considering exemptions from permit requirements. References:

1. DEFRA (2011). Guidance on the scope of and exemptions from the radioactive substances legislation in the UK.

2. EA, NIEA, SEPA, FSA, HPA (2012). Principles for the assessment of prospective public doses arising from authorised discharges of radioactive waste to the environment.

3. Environment Agency (2010). Radioactive Substances Regulation: Environmental principles - The principles the Environment Agency uses when regulating and making decisions in relation to radioactive substances.

4. Initial radiological assessment methodology (2006) https://www.gov.uk/government/publications/initial-radiological-assessment-methodology

5. NIEA, SEPA, EA (2011). Exemption guidance: Small amounts of open radioactive sources.

6. NIEA, SEPA, EA (2011). Exemption guidance: Small sealed radioactive sources, etc.

7. NIEA, SEPA, EA (2011). General guidance on the use of exemption provisions.

8. Radioactive substances regulation (RSR) for non-nuclear sites. https://www.gov.uk/government/collections/radioactive-substances-regulation-for-non-nuclear-sites

9. Radioactive substances regulation (RSR): use of exemption provisions. https://www.gov.uk/government/publications/radioactive-substances-regulation-use-of-exemption-provisions

10. The Environmental Permitting (England and Wales) Regulations 2016. S.I. 2016/1154. https://www.legislation.gov.uk/uksi/2016/1154/contents/made