PURCHASE of radioactive materialS POLICY

(ENVIRONMENTAL PERMITTING REGULATIONS)

Version / 4
Name of responsible (ratifying) committee / Medical Radiation Committee
Date ratified / 14 June 2018
Document Manager (job title) / Trust Radiation Protection Adviser
Date issued / 26 June 2018
Review date / 25 June 2020
Electronic location / Management Policies
Related Procedural Documents / Medical Radiation Policy
Key Words (to aid with searching) / Radioactive material, source, purchase, nuclide

Version Tracking

Version / Date Ratified / Brief Summary of Changes / Author
4 / 14.06.2018 / Update for new regulations / RPA
3.1 / 31/03/2017 / 12-month extension to review date. New regulations due February 2018 / -
3.0 / 14.05.2014 / Minor definition change and review / RPA
2.0 / Jan 2012 / - / -

CONTENTS

QUICK REFERENCE GUIDE

1.INTRODUCTION

2.PURPOSE

3.SCOPE

4.DEFINITIONS

5.DUTIES AND RESPONSIBILITIES

6.PROCESS

7.TRAINING REQUIREMENTS

8.REFERENCES AND ASSOCIATED DOCUMENTATION

9.EQUALITY IMPACT STATEMENT

10.MONITORING COMPLIANCE WITH PROCEDURAL DOCUMENTS

EQUALITY IMPACT SCREENING TOOL

QUICK REFERENCE GUIDE

This policy must be followed in full when developing or reviewing and amending Trust procedural documents.

For quick reference the guide below is a summary of actions required. This does not negate the need for the document author and others involved in the process to be aware of and follow the detail of this policy.

  1. Implementation of procedure in advance of any purchase – section 6
  2. Requirements for purchase of radioactive materials – check if you are a duty holder – section 3 Scope
  3. Responsibilities of Duty holders – section 5 as applies to your role
  4. Preparation for a routine inspection – section 10 monitoring compliance with, and effectiveness of procedural documents

1.INTRODUCTION

This policy set out the requirements and process governing the purchase of radioactive materials (sources). This is essential to ensure that Portsmouth Hospitals fully complies with requirement and limits specified in permitsissued under the Environmental Permitting Regulations by the Environment Agency. The permits held are specific to the Portsmouth Hospitals site and the Category of Source

Exceeding defined limits is highly likely to result in prosecution and severe financial penalties being imposed on the Trust. Central to ensuring compliance, is this policy to manage the purchasing of radioactive materials, and to define the process for making variations to the inventory. It should be noted that in certain circumstances, the permits impose a duty on the Trust to notify breaches to the Environment Agency.

2.PURPOSE

This policy aims to ensure that at no time will any radioactive material arrive on Trust premises and cause authorised limits specified in permits to be exceeded. The policy provides a means of identifying other issues that may affect the Trusts ability to comply with statutory responsibilities. For example; change in Technetium generator may require registration of the generator’s shielding material (depleted Uranium), legally required international cross frontier shipping agreements may be required or varied, final disposal arrangements or return to supplier agreements may be required.

3.SCOPE

This document applies to;

  • Users wishing to purchase or receive radioactive materials/sources
  • Authorised Purchaser
  • Radiation Protection Supervisor
  • Budget Manager
  • Clinical Director/Head of Service
  • Trust Source Custodian
  • Radiation Protection Adviser
  • Radioactive Waste Adviser
  • Chief Executive’s Office

In the event of an infection outbreak, flu pandemic or major incident, the Trust recognises that it may not be possible to adhere to all aspects of this document. In such circumstances, staff should take advice from their manager and all possible action must be taken to maintain ongoing patient and staff safety.

4.DEFINITIONS

Radioactive Material:

For the purposes of this procedure, any radioactive substance in the form of an open or closed (sealed) source, including a source that is built into a device, is being exchanged, replaced or on loan.

Category of Source:

The Category of Source is specified on the Certificate of Registration, a permitbeing required for each category of source for each site. These categories are currently; Sealed Sources (Closed sources) or Open Sources,

Permit:

Permitsissued by the Environment Agency sets out minimum conditions that Portsmouth Hospitals is legally obliged to meet for the clinical, scientific or technical use of radioactive materials. The permit specifies the types and quantities of Radioactive Materials that the Trust may hold on a specified hospital site. The Trust Radioactive Waste Advisorholds a copy on behalf of the Trust. Copies are required to be on display in a departmental location close to where the material is stored, prepared or used. A copy is also kept at an accessible location in each user department.

Variation:

Any increase in inventory of Radioactive Materials on a site must be added to an existing permitbefore receipt of any delivery, and before an order is placed. The process of obtaining an updated permitis referred to as Variation. This usually entails a fee, submission of application, and typically takes 4 to 16 weeks to complete.

Notification:

Mandatory report to a responsible statutory Agency of an event, non-compliance or breach of terms of a permit held by the Trust.

5.DUTIES AND RESPONSIBILITIES

In order for the Trust to fully comply with requirements stipulated in certificates of registration, the following duty holders are required to fully discharge the responsibilities as detailed;

User wishing to purchase or receive radioactive materials/sources:

For routine purchases to replenish stock and replace sources that have been disposed of or returned to supplier, the user must;

  • Not initiate any order for a new sealed source, non-registered radionuclide or open source that is not listed on the permit
  • Not initiate any order that when received may result in any authorised limit being exceeded
  • Only initiate the purchase of radioactive materials under the authority of the Authorised Purchaser

Anyone considering receiving on loan or the purchase of a new radioactive source, new liquid nuclide, new device containing a radioactive source, or new/additional radiation generator, must;

  • Promptly inform the RPS/Service Manager
  • Discuss the proposal with the Trust Source Custodian
  • Provide sufficient detail to enable a risk assessment and implications of the proposed purchase to be considered against requirements of the relevant permitand of any International Shipping Certificates
  • Allow and plan for the time taken to apply for a new permitwhere this is necessary (typically 16 weeks)

Authorised Purchaser:

The authorised purchaser is the person authorised to place an order for radioactive materials, and who must;

  • Only place an order for radioactive materials if authorised to do so and with the prior knowledge of the RPS
  • Purchase radioactive materials from established suppliers and consult the Trust Source Custodian where an alternative supplier is required
  • Understand requirements of permitand implications of non-compliance
  • Have checked that the purchase will not result in breach of terms in the permit
  • Is assured that where applicable any source exchange agreements will operate and that the period where any additional source is on the premises will be within that specified in the permit. Where the purchase is for a new source, or device containing a radioactive source, has obtained prior approval from the Trust Source Custodian and/or Trust RWA before placing an order
  • Consult the Trust Source Custodian or RWA where there is any doubt

Radiation Protection Supervisor:

The Radiation Protection Supervisor for the user department supports the Clinical Director/Head of Service to secure compliance with Ionising Radiations Regulations and has additional responsibilities for matters relating to radioactive materials within their department. The RPS will;

  • Assist with assessing local implications of proposed purchases of radioactive materials, in particular risk assessments, storage requirements, local records, user department procedures, local contingency arrangements
  • Provide local advice and information concerning the management of radioactive materials so as to meet the requirements of permits, local rules and systems of work
  • Locally audit awareness of this policy and records of training
  • Review and contribute to the investigation of incidents and near misses involving radioactive materials, remedial actions and improvements
  • Periodically check the inventory to verify all radioactive materials are accounted for, records are up to date, labelling remains clear and accurate, deficiencies are identified and corrected
  • Consult with the Trust Source Custodian and RWA in cases of doubt and where changes to source inventory are being considered (nuclide, activity, form, use and storage location)
  • Ensure local documentation is complete, up to date and organised in a single accessible location.
  • Arrange for and provide radiation protection training to users of radioactive materials and ensuring that records of training are kept

Budget Manager:

The Budget Manager is the person within the service who authorises orders placed by the Authorised Purchaser. Under this policy, the Budget Manager must;

  • Ensure orders for radioactive materials are only initiated by an ‘Authorised Purchaser’
  • Check to ensure that the purchase is appropriate to the needs of the service
  • Check whether the purchase is for new or additional material and that the relevant approvals have been obtained
  • Where necessary confirm with the Trust Source Custodian that the purchase is within the normal operating levels of the permit
  • Agree prior delegation with another budget manager to cover periods of absence to ensure that the requirements of this policy are met
  • Where there is doubt, consult with the Trust Source Custodian or Radioactive Waste Adviser for advice

Clinical Director / Head of Service (User Department):

The Head of Service has delegated managerial responsibility to ensure that purchases of radioactive material do not result in breaches of Certificates of Registration issued to the Trust and for meeting day to day management conditions as they apply to the service.

The Clinical Director / Head of Service will;

  • Nominate a limited number of staff to be authorised to purchase radioactive materials where there is a routine operational requirement (e.g. to maintain stocks for the effective running of the service)
  • Be responsible for ensuring arrangements are in place to ensure compliance with permitswithin their service, or to confirm that these are covered by the support provided by others, e.g. the Medical Physics Service.
  • Ensuring relevant staff are aware of this policy and the identity of those with responsibilities as Authorised Purchasers and Budget Manager
  • Providing funds for applications and variations arising as a consequence of changes to sources required for the operation of their service.
  • Inform the Trust RWA of any shortfall in control measures or operational change that will affect the requirements of this policy from being met

Trust Source Custodian:

The Trust Source Custodian takes day-to-day responsibility for managing and keeping up to date central Trust inventories of radioactive sources and providing a point of advice and support to user departments. When consulted on proposals to purchase radioactive materials, the Trust Source Custodian will;

  • Establish the details of the radioactive materials, the operational requirement, category of source and compliance issues under the relevant permit
  • Provide advice and authorisation to purchase in accordance with this policy
  • Consult the Trust Radioactive Waste Adviser where variations or new applications may be required
  • Consider secondary issues relating to the proposed purchase, e.g. specifications of the source, shipping agreements, changes to practice imposed by conditions of source supply, delivery or disposal.
  • Liaise with the user department to enable effective introduction of changes to radioactive materials inventory and usage in compliance with requirements of relevant permits
  • Prepare application documents, impact and risk assessments as may be required
  • Liaise with relevant Trust officers and the Environment Agency to establish the implications of requirements for the proposed acquisition of radioactive materials
  • Inform the Trust RWA of any concern over compliance with the permits

Trust Radioactive Waste Adviser (RWA):

The Trust RWAis formally appointed with responsibilities to assist the Trust meet its statutory duties. When consulted on proposals to purchase radioactive materials, the Trust RWA will;

  • Review source purchase requests and provide authorisation to proceed with conditions as may be necessary to the user and the relevant Head of Service. In the absence of the Trust RWA a nominated deputy will advise on behalf of the RWA.
  • Consider implications to the Trust and advise Trust Management accordingly
  • Liaise with Counter Terrorism Security Adviser as may be required for High Activity Sources
  • Maintain a list of ‘authorised purchasers’ and provide copies to responsible officers within this policy
  • Oversee and submit applications to the Environment Agency and other agencies as may be required
  • Review draft permitsand disseminate to relevant Trust officers when issued
  • Assist the Trust by providing representation and support during inspections or investigations by agencies
  • Maintain central records of permitsand documents required under their terms

The Trust RWA is assisted by the RPA, deputy RPA and radiation protection team and who will also provide support, and cover during periods of absence.

Chief Executives Office:

The Chief Executive’s Office will;

  • Receive permitsfrom the Environment Agency and provide copies directly to the Trust RWA
  • Provide prompt notification of any breaches of conditions within permitsto the Environment Agency as advised by the Trust RWA
  • Immediately inform the Trust RWA of any intended inspection by the Environment Agency
  • Endorse and ensure the implementation of policy changes through the line management structure

6.PROCESS

User departments will have copies of permitsfor sources used or held in their department, and will also have access to other permitsfor information. Radioactive material may only be purchased by Authorised purchasers who have been given this responsibility by the Clinical Director/Head of Service (or next-in-line manager where appropriate). For all purchases other than those required to routinely replenish depleted stocks, checks must be made with the Trust Source Custodian to verify the proposed purchase is within the Trusts permits. Variations to existingpermit, or new permits, will be obtained taking into account potential requirements of other departments to avoid incurring unwarranted cost. Individual responsibilities are detailed in Section 5.

The Environment Agency issue new or replacement Certificates of Registration directly to the Chief Executive’s Office, which are sent on to the Trust RWA. The Trust RWA will assess any potential implications of changes to source inventory and provide advice to user departments.

All communications with the Environment Agency are either through the Chief Executive’s Office, the Trust RWA or Trust Source Custodian.

7.TRAINING REQUIREMENTS

Staff working with radioactive materials must know their duties and responsibilities concerning the purchase, loan and use of radioactive material, and be aware of the duties and responsibilities of others. This is to be achieved as part of training and confirmation of competence to undertake this work, which includes the existence of this procedure and how to locate a local copy. This is the responsibility of the Service Manager, supported by the RPS. Training is obligatory for all new staff and should be refreshed annually or when there is any material change to local procedures.

All staff working with, and having local responsibility for radioactive materials must be familiar with the requirements of working within permits and the implications of those requirements not being met, particularly with regard to authorised inventory limits and material management.

The Radiation Protection Supervisor, Service Manager and Clinical Director/Head of Service will be issued with a copy of this procedure and any additional training support provided by the Trust RWAas may be required.

8.REFERENCES AND ASSOCIATED DOCUMENTATION

Environmental Permitting Regulations 2010 - Statutory Instruments 2010 No 675 -

Ionising Radiation Regulations 1999. - Statutory Instruments 1999 No 3232 –

High Activity Sealed Sources (radioactive) – Management and security arrangements, under review June 2009 – Portsmouth Hospitals – Available from Trust RWA

9.EQUALITY IMPACT STATEMENT

Portsmouth Hospitals NHS Trust is committed to ensuring that, as far as is reasonably practicable, the way we provide services to the public and the way we treat our staff reflects their individual needs and does not discriminate against individuals or groups on any grounds.

This policy has been assessed accordingly

Our valuesare the core of what Portsmouth Hospitals NHS Trust is and what we cherish. They are beliefs that manifest in the behaviours our employees display in the workplace.

Our Values were developed after listening to our staff. They bring the Trust closer to its vision to be the best hospital, providing the best care by the best people and ensure that our patients are at the centre of all we do.

We are committed to promoting a culture founded on these values which form the ‘heart’ of our Trust:

Respect and dignity

Quality of care

Working together

Efficiency

This policy should be read and implemented with the Trust Values in mind at all times

Purchase of Radioactive Material Policy

Version: 4

Issue Date: 26 June 2018

Review Date: 25 June 2020 (unless requirements change) Page 1 of 12

10.MONITORING COMPLIANCE WITH PROCEDURAL DOCUMENTS

Minimum requirement to be monitored / Lead / Tool / Frequency of Report of Compliance / Reporting arrangements / Lead(s) for acting on Recommendations
Training records / RPS/Source custodian / Audit / As required / Policy audit report to:
  • Speciality RP group
/ Service manager
Incidents involving ordering or receipt of radioactive material / RPS/Source custodian / DATIX reports / As required / Policy audit report to:
  • Speciality RP group
/ Service manager
Policy audit report to:

This document will be monitored to ensure it is effective and to assure compliance.

This procedure will be required by the Environment Agency during any routine inspection against the conditions defined in one or more of thepermits. This can be expected to be at least once in any 12 month period and will provide the basis for review of acceptability.