radioactive SUBSTANCES POLICY
(ENVIRONMENTAL PERMITTING REGULATIONS)
Version / 2.0Name of responsible (ratifying) committee / Medical Radiation Committee
Date ratified / Tabled MRC 20th April 2011 – ratified MRC January 2012 re change to Environmental Permitting
Document Manager (job title) / Trust Radiation Protection Adviser
Date issued / 24th April 2011 – Medical Radiation Committee
Review date / 29th March 2015
Electronic location / Management polices
Related Procedural Documents / Appendix I on page 11 of this document
Key Words (to aid with searching) / Radioactive material, source, management, Environment Agency, Certificate, authorisation, radioactive, substance, waste, permitting
CONTENTS
QUICK REFERENCE GUIDE 3
1. INTRODUCTION 3
2. PURPOSE 3
3. SCOPE 3
4. DEFINITIONS 3
5. DUTIES AND RESPONSIBILITIES 3
6. PROCESS 3
7. TRAINING REQUIREMENTS 3
8. REFERENCES AND ASSOCIATED DOCUMENTATION 3
9. MONITORING COMPLIANCE WITH, AND THE EFFECTIVENESS OF, PROCEDURAL DOCUMENTS 3
QUICK REFERENCE GUIDE
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. This corporate policy sets out means of achieving compliance with the Environmental Permitting Regulations for Portsmouth Hospitals use of radioactive materials
2. Devolution of responsibilities through the line management structure and to identified officers with particular responsibilities
3. Framework for providing specialist support, review and reporting
4. Changes to existing radioactive materials inventory and means of obtaining variations to certificates of registration in advance of any such change.
5. Change of use of a facility for radioactive materials, and decommissioning
6. Process for notification of the Environment Agency in the event of breaches that may require this action as a legal duty.
7. Training requirements and means of demonstrating compliance
8. Roles of officers providing specialist support for radioactive materials
9. Related policies and procedures (Appendix I)
1. INTRODUCTION
This policy sets out the means by which Portsmouth Hospitals NHS Trust aims to secure compliance with the Environmental Permitting Regulations as set out in Certificates of Registration and authorisation issued by the Environment Agency.
This covers radioactive substances in all forms (open sources, closed (sealed) sources and all forms of radioactive waste).
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 for managing radioactive materials through their whole life cycle, from the time radioactive substances are acquired through to final disposal
It should be noted that in certain circumstances Certificates of Registration impose a duty on the Trust to notify the Environment Agency of breaches and this policy defines how this is done.
2. PURPOSE
This policy aims to ensure that the management infrastructure is in place, supported by identified duty holders, policy, procedures and specified responsibilities for the range of activities involving work with radioactive substances in Portsmouth Hospitals.
3. SCOPE
This document applies to;
· All staff working with radioactive materials in any form
· Clinical Directors/Heads of Service of departments using radioactive materials in any form
· Trust Management (Chief Executive’s Office and Line Management)
· Director of Estates
· Director of Finance
· Radiation Protection Supervisors
· Radiation Protection Advisers
4. DEFINITIONS
Radioactive Substance:
For the purposes of this policy, 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 and unless separately specified, also radioactive waste in any form.
Radioactive Waste:
Waste that is radioactive as a result of containing a radioactive substance arising from manipulation or administration of an open source, or an open, sealed or closed source that is no longer required or covered by an exemption order. Radioactive waste may be in a gaseous, liquid or solid form.
Certificate of Registration (Authorisation):
Certificate of registration (authorisation) issued by the Environment Agency that sets out minimum conditions that Portsmouth Hospitals is legally obliged to meet for the clinical, scientific or technical use of radioactive materials, and the accumulation and disposal of radioactive waste.
Variation:
Any change to a Certificate of Registration relating to the name of the organisation, address, radionuclide, activity, number of sources, authorised period, nature of material, disposal route or end-point. The process of obtaining an updated Certificate of Registration is referred to as Variation. This usually entails a fee, submission of application, and may take up to 16 weeks from start to finish according to the Category of Certificate of Registration and nature of the change.
Notification:
Mandatory report to a responsible statutory Agency of an event, non-compliance or breach of terms of an authorisation held by the Trust, and of legal responsibilities.
User Department:
The term user department is used to identify departments or services receiving, storing, working with or disposing of radioactive materials.
Category of certificate:
Certificates of registration separately cover open (unsealed) sources, closed (sealed) sources, mobile sources and high activity sealed sources. Certificates of authorization allow storage-accumulation and disposal of radioactive waste.
5. DUTIES AND RESPONSIBILITIES
Portsmouth Hospitals, under the authority of the Chief Executive and support from the Radiation Protection Adviser, secures compliance with the management conditions of Certificates of Authorisation through allocating responsibilities to identified duty holders (Section 3 – Scope) and setting out specific policy/procedures listed in this policy.
Management structure:
Ultimate responsibility for compliance with requirements of Certificates of Registration rests with the Employer represented by the Chief Executive. Responsibility for day to day management and working with radioactive substances is devolved to Clinical Directors/Head of Service of user departments supported by their Radiation Protection Supervisor, Service Managers and staff. Responsibilities are allocated through policies and procedures specific to the Environmental Permitting Regulations.
Financial Provision:
Portsmouth Hospitals is responsible for the final disposal of all radioactive substances, whether by return to supplier, disposal via an approved contractor or decommissioning of facilities where radioactive substances are used or stored. Portsmouth Hospitals NHS Trust makes direct financial provision under the authority of the Director of Finance. In the event of Portsmouth Hospitals NHS Trust being unable to discharge these responsibilities, then the Department of Health underwrites these responsibilities.
Disclosure of information:
Owing to the potential security implications surrounding radioactive materials, no information concerning significant radioactive sources is to be provided by any employee to any third party without prior consent from the Trust Radiation Protection Adviser. The one exception to this is the renewal of an existing supply arrangement with an established supplier and where there is complete confidence that the contact is from the supplier. Any request for information concerning significant sources that is outside of existing supply arrangements must be directed to the Trust RPA. The Trust RPA and Trust Source Custodian will liaise with external bodies on all matters relating to significant sources. A significant source is one that is covered within the sealed sources registration (see section 8) i That is defined as a HASS or source with similar hazard to HASS.
Security arrangements:
All radioactive substances must be kept secure and subject to a rigorous documented “cradle to grave” tracking system. Security measures shall be appropriate to the radioactive substance, radionuclide(s) and aggregated activity at a particular location. Security arrangements shall be specified in local procedures or local rules. High level security requirements shall be explicitly stated on individual source certificates provided to the user department by the Trust Source Custodian.
High-level security requirements are addressed through the HASS Policy within the Site Security Plan. Information concerning the site security plan is available from the Director of Estates, Trust RPA or through the Chief Executive’s Office.
The Director of Estates is responsible for ensuring adequate security arrangements (physical and operational) for radioactive substances. This covers facilities, security personnel and includes details within formal agreements with providers of Facilities Management services to Portsmouth Hospitals by any relevant third party provider.
Clinical Directors/Heads of Service of user departments holding radioactive substances are responsible for ensuring that security arrangements, physical and operational, are suitable, properly maintained and adhered to.
Certificates of Registration:
Certificates of Registration are central to the effective management of radioactive materials (sources and waste). It is essential that copies are kept on display at a suitable location near to a point of use within the user department. For security reasons, the location must not be accessible to members of the public, and preferably within an area accessible to authorised staff only. All staff working with, and with responsibilities for radioactive materials, must be familiar with the requirements stipulated within the certificate and of implications of non-compliance. A copy must also be held in a “departmental radioactive materials folder” at a single accessible location and which contains a master copy of policies, procedures and records. This must be available for inspection and review on demand.
Copies of Certificates of Registration confirming entitlement to receive and hold sealed/closed sources and will be required by suppliers in advance of supply. Owing to security restrictions, copies may only be provided within existing supply agreements. Any new arrangement must be under the direct oversight of the Trust RPA.
Variations to Certificates of Registration (Authorisations):
Changes and additions to the nature and quantity of radioactive materials used, stored or quantities of waste accumulated or disposed of, including changes to end-point, may require variations to Certificates of Registration. The Trust Source Custodian and RPA will be familiar with circumstances requiring variations / alterations to certificates of registration.
No operational change may take place unless the Trust Source Custodian or RPA has assessed the implications and given written approval.
Variations to Certificates of Registration shall only completed by the Trust Source Custodian and under the supervision of the Radiation Protection Adviser. The User Department initiating the change shall meet costs.
The Environment Agency will provide new Certificates of registration to the Chief Executive's Office and cancellation notices for previous versions. The CE’s Office will provide copies to the Trust RPA who will in turn provide copies to user departments, identifying any material changes required to achieve compliance.
Officers with key responsibilities:
Responsibility for securing compliance rests with the Trust as Employer, and is delegated to Clinical Directors/heads of Service of user departments, and through to individual users. Securing compliance is supported by several specialist roles identified in Ionising Radiation legislation and associated Guidance.
The Trust Radiation Protection Adviser has a cooperate role providing advice and support to assist the Trust achieve compliance. The Radiation Protection Supervisor has a local role within a user department assisting the Clinical Director/Head of Service.
The Trust Source Custodian has particular responsibilities in supporting effective implementation and operational oversights of arrangements for radioactive substances. Responsibilities are identified in Appendix II to this policy.
Policies and Procedures:
Policies and procedures will be developed to specify how key responsibilities are to be discharged to secure compliance with Certificates of Registration. Policies and procedures will be developed with the support of the Radiation Protection Adviser and formally endorsed on behalf of the Chief Executive under the authority of the Medical Radiation Committee. A list of these policies and procedures can be found in Appendix 1.
Local procedures are required to demonstrate compliance with specific user department responsibilities. These will be developed and implemented under the authority of the Clinical Director/Head of Service, with support from the RPA, RPS or Trust Source Custodian. Local procedures shall clearly state the step-by-step process to enable compliance with any particular responsibility.
All pollicies and procedures will be supported by records of training and competence by all staff working with radioactive substances, and according to their role and duties.
Policies and procedures will be subject to inspection by the Environment Agency, and periodic audit and review by the RPA or their representative. Deficiencies must be promptly rectified. Non-compliance’s identified through audit or inspection shall be addressed through documented action plans and reports through the Medical Radiation Committee.
Policies and procedures shall be kept at a single accessible location, at the point of use for users, and be available over the Trust’s ICT network.
All policies and procedures shall be periodically reviewed, kept up to date, and changes notified to affected parties. Policies and procedures shall state document identity, version number, implementation/review dates, and page numbers.
Use of Radioactive Materials:
The Trust Source Custodian and/or RPA must be consulted before any new use of radioactive materials, or material change to local management of radioactive material or waste, including any change to facility or equipment.
All use must be covered by local procedures and only be undertaken by staff appropriately trained and competent, or under the direct supervision of an appropriately trained and competent person. Local rules and systems of work shall also be followed.
Work with and storage of radioactive materials may only be within a facility that is suitable for the purpose, it is appropriately designated and identified with appropriate warning signs, and covered by and described within local rules.
Records and inventory:
Comprehensive record keeping of details of the receipt, movements, changes to quantities, disposal or return to supplier is a legal requirement under the Environmental Permitting Regulations for all radioactive substances. This also includes wastes in all forms, and must record form of waste, disposal route, radionuclide and activity, dates. This includes activities excreted by patients.
Records are central to demonstrating compliance with conditions specified in Certificates of Registration and will be reviewed during inspections by the Environment Agency. In addition to annual reporting of waste disposal, the Trust is also required to provide copies of records of replacements of High Activity Sealed Sources.
The Trust Source Custodian maintains central records of inventory of all sealed/closed sources and of radioactive waste disposals. Owing to the regular turnover of open sources used in imaging and some forms of treatment, records of all open sources are kept within user departments.