MEDICAL RADIATION POLICY (Radiation Safety Policy)
Version / 2Name of responsible (ratifying) committee / Medical Radiation Committee
Date ratified / 14th May 2014
Document Manager (job title) / Trust Radiation Protection Adviser
Date issued / 25th June 2014
Review date / 24th June 2017
Electronic location / Corporate Policies
Related Procedural Documents / See section 8 on page 9 of this policy
Key Words (to aid with searching) / Radiation safety; IRR1999; IRMER; ionising radiation; x-rays; radionuclides; diagnosis; radiotherapy; referrer; practitioner; operator; radiation protection adviser; radiation protection supervisor; local rules; radioactive materials
Version Tracking
Version / Date Ratified / Brief Summary of Changes / Author1.0 / 19/2/12 / Review and minor definition changes / RPA
CONTENTS
QUICK REFERENCE GUIDE ……………………………………………………..……….3
1. INTRODUCTION ……………………………………………………………………………….4
2. PURPOSE …………………………………………………………………………………….4
3. SCOPE ……………………………………………………………………………………….4
4. DEFINITIONS ………………………………………………………………………………….5
5. DUTIES AND RESPONSIBILITIES ………………………………………………………...6
6. PROCESS ……………………………………………………………………………………...8
7. TRAINING ……………………………………………………………………………………...9
8. REFERENCES AND ASSOCIATED DOCUMENTATION ………………………………9
9. MONITORING COMPLIANCE AND EFFECTIVENESS ………………………………10
APPENDICES:
Appendix 1: Duties and responsibilities in more detail
Appendix 2: IRMER Schedule 2 – Minimum training requirements for non-radiation disciplines undertaking IRMER roles (excludes referrers)
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. The quick reference can take the form of a list or a flow chart, if the latter would more easily explain the key issues within the body of the document
1. 1. This document details means by which statutory responsibilities under Ionising Radiation legislation are implemented within Portsmouth Hospitals.
2. Clinical Directors/Heads of Service of disciplines using ionising radiation as part of, and in support of, clinical diagnosis and therapy, need to;
- identify the relevant duty holders and understand their roles
- ensure that roles and responsibilities within the service are defined
- have in place written departmental protocols, procedures and safety rules
- ensure all staff are, according to their roles, adequately trained in the specific requirements for working with radiation
- have in place monitoring arrangements are with systematic review and audit
- adverse events are identified and reported according to local rules
- have in place effective quality assurance programmes
- ensure a programme for regular review is in place within the specialty and reporting through to the Medical Radiation Committee
- The radiation environment, medical radiation equipment and personal protective equipment are suitable and well maintained
INTRODUCTION
This policy sets out the means by which Portsmouth Hospitals Trust (PHT) implements, oversees, and monitors compliance with Ionising Radiation legislation as it applies to clinical diagnostic and therapeutic activities undertaken within the Trust. Through application of this policy and of individual duty holders discharging their roles and responsibilities, Portsmouth Hospitals aim to effectively utilise ionising radiation to the benefit of patients in a manner that meets legal duties and maintains the confidence of regulatory agencies and of the public.
The Ionising Radiations Regulations 1999(1) – [hereafter IRR99] applies to the safe use of ionising radiation in the workplace for the protection of employees and members of the public. It also stipulates responsibilities with respect to the operation of medical radiation equipment.
The Ionising Radiation (Medical Exposure) Regulations 2000(2), 2006 and 2011 Amendments (3) – [hereafter IRMER] applies to the use of ionising radiation procedures in;
· Medical examination and treatment of patients
· Health screening
· Occupational health surveillance
· Medico-legal examinations
· Research
PHT is Registered under the Care Quality Commission (Registration) Regulations 2009 and is duty bound to meet the Essential standards for Quality and Safety (4). This policy covers these and other requirements relating to the clinical use of ionising radiation of interest to the Care Quality Commission.
1. PURPOSE
This policy aims to ensure the effective implementation of statutory responsibilities that rest with the Trust as employer (radiation employer), and individual duty holders according to the roles identified within ionising radiations legislation. These roles and responsibilities are summarised in section 5.
Central to achieving this aim, is the delegation of responsibilities through line management, policy development and of monitoring and review through the assurance framework provided by the radiation protection structure. The Trust, and where applicable individual duty holders, will hold authorisations, licenses or certificates that set out conditions of compliance, and confer and recognise entitlements to undertake identified roles and functions. Where necessary, reference is made to other policies that clarify specific requirements.
Fundamental to all use of ionising radiation involving the exposure of patients, staff or the public is the requirement for Justification, Optimisation and Limitation. Routine application of these principles is central to sound radiation protection practice. These principles apply to the protection of employees and the public to whom statutory dose limits apply.
Compliance is assessed and enforced through a combination of internal audits and external inspection by regulatory and standards agencies.
2. SCOPE
The policy applies to the duty holders identified within this policy and all staff utilising ionising radiation as part of, and in support of, clinical diagnosis and therapy. This includes those with entitlements to refer patients for diagnosis and treatment using ionising radiation.
As with any aspect of safety in the workplace and clinical environment, corporate commitment in fostering a culture of safety, high standards and of continuous improvement is central to ensuring duty holders are able to effectively discharge their responsibilities at all levels. The policy hence has wider relevance.
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.
3. DEFINITIONS
Ionising Radiation:
X-rays, electron beams, emissions from radioactive materials (gamma rays, beta particles), neutrons that are produced from machines or emitted from radioactive sources. Excludes lasers, other radiofrequency radiation (microwaves, MRI-RF).
Diagnosis:
Process of reaching a clinical decision concerning a patient, screening participant or research volunteer directly supported by undertaking a clinical radiation procedure. Includes X-ray interventional procedures and the use of X-rays to assess position in radiation therapy.
Therapy:
Process of delivering treatment to a patient exploiting the tissue dose response effects of ionising radiation (excludes surgical interventions using X-ray imaging).
Justification:
Decision to undertake a clinical radiation procedure to determine or affect the clinical management of a patient, screening participant or research volunteer taking into account the benefit of the procedure and potential detriment including specific aspects such as age, gender and pregnancy status. Includes procedures undertaken for non-medical purposes (e.g. non-accidental injury, employment, medico legal etc).
Optimisation:
Process of ensuring that the procedure dose is appropriate to the intended clinical purpose for the equipment and technique employed, taking into account the capabilities of the equipment to control dose and of standards and guidance.
Limitation:
Process of ensuring doses are restricted to defined levels within regulations, associated guidance and published by recognised national institutions.
Authorisation or Permit:
Certificate of authorization or permit issued by a regulatory body (e.g. Health and Safety Executive, Environment Agency) that sets out minimum conditions that Portsmouth Hospitals is legally obliged to meet for the clinical use of ionising radiation.
ARSAC Certificate:
Permit issued to a named individual at a specific site that entitles them to undertake particular clinical radiation procedures using radioactive substances and sources according to the intended clinical purpose (diagnosis, treatment or research). ARSAC certificates are issued by the HPA Administration of Radioactive Substances Advisory Committee and are time limited.
Specalist Certificate:
Document issued by a nationally recognised body that confirms that through application and evaluation of qualifications, experience and evidence provided, that the named individual has met the criteria for certification according to the stated role, assessing body rules and criteria. Certificates may be time limited.
Duty Holder:
Person undertaking a role identified where ionising radiations regulations stipulate specific responsibilities. The role may be generic according to function, e.g. referrer, practitioner, operator. Alternatively, a specifically identified role to enable and assist the radiation employer (Portsmouth Hospitals) to meet statutory responsibilities, e.g. Radiation Protection Adviser, Medical Physics Expert, Radiation Protection Supervisor. Duty Holders under ionising radiation legislation are defined in section 5.
IRMER procedure:
Written procedure or instruction setting out the requirements to undertake an identified activity or function in a manner that aims to meet legal obligations under IRMER regulations. The status of the written procedure or instruction that links it with IRMER is identified on the document, or in the preceding text. Wherever practicable “IRMER procedure” shall be incorporated into the document header.
Local Rules:
Written document setting out requirements for working safely with ionising radiation in the workplace for the protection of staff, patients and the public under IRR99. This includes any system of work for working in radiation controlled areas and description of the designation of radiation work areas. Documents are specifically identified as “Local Rules”.
4. DUTIES AND RESPONSIBILITIES
Under ionising radiation legislation, statutory responsibilities rest primarily with the ‘radiation employer’. However in the case of IRMER, specific duty holders also carry personal legal responsibility for compliance.
Anyone performing an IRMER function as an operator hence has a personal legal responsibility for his or her actions. Duty holders specifically identified in ionising radiation legislation are identified below in bold.
To aid understanding, the relevant regulations are referred to in the summary responsibilities of duty holders below. Responsibilities are provided in more detail in Appendix 1.
Radiation Employer – Portsmouth Hospitals NHS Trust
Chief Executive: [IRR99 and IRMER]
The Chief Executive represents the radiation employer and has ultimate responsibility for compliance with legislation for the use of ionising radiation within the Trust.
Lead Executive Director: [IRR99 and IRMER]
The lead Executive Director is the Medical Director and is responsible for the effective co-ordination of all medical radiation compliance matters in the Trust and the provision of a framework for compliance.
Clinical Directors and Heads of Service: [IRR99 and IRMER]
Clinical Directors/Heads of Service are through the delegated line management structure responsible for operational implementation of the requirements of IRR99 and IRMER within their specialty. This extends beyond the organisation to cover arrangements for duty holders for patients undergoing medical exposure within their service, e.g. GP referrers.
Employees: [IRR1999 and IRMER)
All employees undertaking any work with ionising radiation and in any capacity (e.g. as practitioner, operator, radiation worker, MPE etc) are responsible for their own safety and the safety of others, and are required to adhere to Trust policies, Local Rules and procedures that set down methods of working with radiation sources and procedures that affect the safe use of those sources of radiation.
Referrer: [IRMER]
Referrers, as medical or dental practitioner, or other registered healthcare professional who is entitled to refer individuals for medical exposure to a Practitioner in accordance with the Specialty guidelines. Referrals must enable the appropriate procedure to be undertaken on the correct individual, taking account of any patient dependent factors, e.g. pregnancy, breastfeeding.
Practitioner: [IRMER]
IRMER Practitioners are radiation trained clinical specialists entitled to undertake IRMER duties as an Oncologist, Radiologist, Nuclear Medicine Physician, Cardiologist or Dentist. Practitioners are responsible for justifying medical radiation procedures and for all clinical aspects that influence the dose received by the person undergoing examination or treatment.
Operators: [IRMER]
Any person undertaking a practical task associated with a medical exposure does so as an operator, e.g. delivering a radiotherapy dose, taking an X-ray, authorising (approving) a referral, performing a calibration. Operators are responsible for the radiation dose delivered to the patient and undertaking all tasks that affect that dose correctly and in adherence to the employer’s procedures.
Medical Physics Expert (MPE): [IRMER]
Medical Physics Experts must be appointed by the Trust as radiation employer as a statutory requirement under IRMER. Medical Physicists that have achieved the required post qualification knowledge and expertise may be entitled to undertake the role of MPE within a specified field of radiation science, i.e. Radiotherapy, Nuclear Medicine, Radiology. MPE’s are responsible for providing expert support to ensure that the clinical radiation dosage, quality and safety requirements can be met.
ARSAC Certificate Holder: [Medicines Administration of Radioactive Substances Regs] (5)
Administration or any radiopharmaceutical or radioactive substance as part or diagnosis, treatment or research can only be carried out under the authority of a Practitioner who possesses an ARSAC certificate. The ARSAC Practitioner has all the responsibilities of the IRMER practitioner, plus additional requirements as set out under the terms of the license.
Radiation Protection Advisor (RPA): [IRR1999]
The radiation employer is required by IRR99 to appoint one or more Radiation Protection Advisors (RPA) to provide advice and a supporting role in assisting the radiation employer to undertake their work in compliance with ionising radiations legislation. RPAs must be certified via an HSE accredited scheme for a defined field of knowledge and expertise. The RPA has responsibilities according to the role statement endorsed by the Chief Executive.
Radiation Protection Supervisor (RPS): [IRR1999]
One or more Radiation Protection Supervisors (RPS) must be appointed by the Trust as radiation employer as a statutory requirement under IRR1999. A RPS is appointed within a specialty or department to assist the Head of Service to implement radiation protection requirements and locally supervise work with ionising radiation. A RPS will have a written description of responsibilities for a defined area of work. More than one RPS may be appointed according to the scope and extend of work.
5. PROCESS
Compliance is achieved through the delegation of responsibilities to duty holders directly and through the line management structure, through policy, IRMER procedures, and Local Rules. Advice on implementation and the monitoring and review process is supported by the Trust Radiation Protection Adviser and Specialty Radiation Protection Advisor(s). The Governance framework provides assurance, a mechanism to record, review and improve, mechanism for approval of policy and procedures, acknowledging entitlements, for reviewing incidents and where necessary their oversight.