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Medical Radiation Policy _Radiation Safety Policy_ by liwenting

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									                             MEDICAL RADIATION POLICY (Radiation Safety Policy)




Reference Number                                 3.55

Version                                          1
                                                 Medical Radiation Committee to Trust Quality and
Name of responsible (ratifying) committee
                                                 Governance
Date ratified                                    28th March 2010
                                                 Graeme Zaki – Medical Director
Document Manager (job title)
                                                 Mike Holubinka – Trust Radiation Protection Adviser
Date issued                                      29.03.2010

Review date                                      30.06.2010

Electronic location                              Corporate Policies

Related Procedural Documents                     See section 8 on page 9 of this policy
                                                 Radiation safety; IRR1999; IRMER; ionising radiation;
                                                 x-rays; radionuclides; diagnosis; radiotherapy; referrer;
Key Words (to aid with searching)                practitioner; operator; radiation protection adviser;
                                                 radiation protection supervisor; local rules; radioactive
                                                 materials




Medical Radiation Policy. Issue 1. (Review date: 30.06.2010)                                 Page 1 of 20
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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)




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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. 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




Medical Radiation Policy. Issue 1. (Review date: 30.06.2010)                                Page 3 of 20
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 1. 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) and 2006 Amendment                (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.


 2. 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.


 3. 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.

Medical Radiation Policy. Issue 1. (Review date: 30.06.2010)                                 Page 4 of 20
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 4. 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:
      Certificate of authorisation 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.

      License:
      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 licenses are issued by the
      HPA Administration of Radioactive Substances Advisory Committee and are time limited.

      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.




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      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”.


 5. 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.




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      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 health 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 License 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 license. 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.
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6. 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.




Policy and procedures are developed at Trust level for overarching policy and procedures, where
these apply across all clinical radiation procedures. Specialties will develop their IRMER
procedures to cover specialty clinical radiation procedures and supporting activities and own
Local Rules and systems of work for working with ionising radiation. In developing specialty
procedures, appropriate support shall be sought from radiation practitioners, experts and
specialists (see duty holders and responsibilities).

Specialty or Departmental “Radiation Files” are central to demonstrating compliance on matters
relating to ionising radiation safety, considerably simplify implementation and preparation for
inspection by regulators.

Duty Holders and responsibilities – summary list of roles identified in ionising radiations legislation;

                        Employer (Radiation Employer)
                        Employees
                        Referrer
                        Practitioner
                        Operator
                        Medical Physics Expert
                        ARSAC license holder
                        Radiation Protection Advisor
                        Radiation Protection Supervisor



Medical Radiation Policy. Issue 1. (Review date: 30.06.2010)                                 Page 8 of 20
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7. TRAINING
     All staff working with ionising radiation must be trained in radiation safety practices and be trained
     to act at the level commensurate with their role, under supervision or independently according to
     training and competence.
     The extent and depth of training depends on role, particularly for duty holders and where there is
     a requirement to demonstrate competence. Continuous education and professional development
     includes keeping up to date with developments within own sphere of practice and responsibility,
     and radiation protection.
     Staff must be familiar with local rules, standard operating procedures, local departmental
     procedures, and procedures specific to the work undertaken.
     All staff undertaking a role as operator or practitioner must be able to demonstrate knowledge
     and training in topics identified in IRMER Schedule 2. This is particularly important for staff
     appointed from outside the traditional qualifying routes for a specialism.
     Training in new techniques, methods, procedures and safety requirements is particularly
     important when a practice is carried out for the first time.
     Records of training must be kept at departmental level, be kept up to date and available for
     review.
     Shortfalls in training are to be identified by the individual staff member and brought to the
     attention of the clinical supervisor, immediate supervisor or line manager. Review of training is an
     implicit requirement of APDR reviews. Training and development plans must include specialist
     radiation training according to the clinical discipline.
     It is the responsibility of managers and the RPS to monitor the work with radiation to ensure that
     training is reinforced by safe practice.
     Training matrices should be in place to support identification of training needs, the recording of
     training, competence and level, including eligibility to train others. Training requirements should
     also be informed by the findings of risk assessments.


8.    REFERENCES AND ASSOCIATED DOCUMENTATION

       1)   Ionising Radiation Regulations 1999. Statutory Instruments 1999 No 3232 –
            http://www.opsi.gov.uk/si/si1999/19993232.htm
       2)   Ionising (Medical Exposures) Regulations 2000. Statutory Instruments 2000 No 1059 –
            http://www.opsi.gov.uk/si/si2000/20001059.htm
       3)   IRMER – Ionising Radiation (Medical Exposures) Amendment Regulations 2006
            http://www.opsi.gov.uk/si/si2006/uksi_20062523_en.pdf
       4)   Essential standards of quality and safety – Guidance about compliance. December 2009. Care Quality
            Commission. http://www.cqc.org.uk/publications.cfm?fde_id=13512
       5)    Medicines Administration of Radioactive Substances Regulations 1978. Statutory Instruments 1978 No 1006
            – and subsequent amendments.
       6)   The Medicines (Administration of Radioactive Substances) Amendment Regulations 1995. Statutory
            Instrument 1995 No. 2147 – http://www.opsi.gov.uk/si/si1995(uksi_19952147_en_1.htm
       7)   The Medicines (Administration of Radioactive Substances) Amendment Regulations 2006. Statutory
            Instrument 2006 No. 2806 – http://www.opsi.gov.uk/si/si2006/20062806.htm

      Contd.




Medical Radiation Policy. Issue 1. (Review date: 30.06.2010)                                         Page 9 of 20
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      REFERENCES AND ASSOCIATED DOCUMENTATION contd.

      8)    Notes for Guidance on the Clinical Administration of Radiopharmaceuticals and Use of Sealed Radioactive
            Sources. Health Protection Agency. March 2006 –
            http://www.arsac.org.uk/notes_for_guidance/docs/arsac_nfg.pdf
      9)    Administration of Radioactive Substances as part of diagnosis, treatment or research policy – Portsmouth
            Hospitals NHS Trust – working draft
      10)   Medical and Dental Guidance Notes. A Good Practice Guide on all Aspects of Ionising Radiation
            Protection in the Clinical Environment. Institute of Physics and Engineering in Medicine, York: IPEM
      11)   HSE guidance note PM77 (3rd edition) – Equipment used for Medical Exposure – March 2006 -
            http://www.hse.gov.uk/pubns/guidance/pm77.pdf


 9. MONITORING COMPLIANCE WITH, AND THE EFFECTIVENESS OF,
    PROCEDURAL DOCUMENTS
      Specialties must have in place regular programmes of review of matters affecting radiation
      safety of patients, staff and the public. Periodically, Radiation Protection Supervisors should
      carry out selective internal audits. The Radiation Protection Adviser, Medical Physics Experts
      and Radiation Protection staff of the Medical Physics department will provide support and
      undertake period audits and reviews.
      Risks require careful assessment and mitigation through safe working practices, being vigilant
      to identify errors, effective procedures and protocols, the monitoring, commissioning,
      optimisation, calibration, maintenance, performance and safety assessment of equipment.
      Monitoring of radiation doses to staff and patients is an implicit part of compliance and safety
      assurance. This is supported by identification and review of doses above reference or
      investigation levels. Improvements in procedures and practices, optimization of techniques
      should in the majority of cases restore doses to expected levels. In exceptional cases, justifying
      and accepting higher doses may be necessary where the cost or other implications are
      disproportionate to the level expected reductions.
      Internal audits, incidents and near misses must be actively reviewed and action plans
      developed to implement improvements. Learning from incidents and near misses is implicit to
      maintaining high levels of safety and practice and must be actively disseminated. Full use
      should be made of multi-disciplinary team meetings, departmental and professional audit and
      development meetings.
      Published reports into incidents at other hospitals must be reviewed to learn from causes and
      recommendations. Similarly recommendations of Peer Review external audits and inspections.
      Implementation of change arising from such reports should be structured and managed,
      documenting the work undertaken to be available for the assurance of patients, the Trust and
      external bodies, for example demonstrating outcomes to the Car Quality Commission and other
      interested statutory regulatory bodies such as the HSE or DoH.




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APPENDIX 1: Duties and Responsibilities in more detail

This appendix details the duties and responsibilities under Ionising Radiations Legislation (IRR99 and
IRMER, referred to in Section 5 of this policy.

AP 1.1 Chief Executive:

       The Chief Executive represents the radiation employer and has ultimate responsibility for
       compliance with legislation for the use of ionising radiation within the Trust, and will ensure that:
       -
            The Executive Team understands and accepts its responsibilities and accountabilities for
             the implementation and monitoring of the Health and Safety Policy and Medical Radiation
             Policy
            The requirements of ionising radiation legislation are applied
            The Trust‟s Policies and Codes of practice are observed
            That appropriate resources are made available to meet these requirements
       The framework which identifies the levels of management responsible for implementing and
       monitoring health and safety within the Trust is depicted in section 6 above and in section 6 of
       The Trust‟s Health and Safety Policy. In addition for clinical aspects as set out below.

AP 1.2 Lead Executive Director:

       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
            Bringing to the attention of Referrers and Practitioners responsibilities for achieving
             compliance with clinical radiation requirements in regulations, codes of practice and
             guidance and with their co-operation making arrangements for the introduction and
             implementation of these
            Being the Lead Executive for the implementation of the relevant requirements under the
             terms of Registration and as set out in CQC Essential standards for quality and safety.
            Ensuring the provision of an appropriate Governance framework for medical radiation
             practice for the Trust and its staff

AP 1.3 Clinical Directors and Heads of Service:

       Clinical Directors/Heads of Service shall with the support of their operational management
       structure, ensure that work clinical radiation procedures and supporting activities undertaken
       within their specialty are undertaken in compliance with ionising radiation legislation. To
       achieve this they will;
            Ensure the existence of a governance framework that specifically addresses ionising
             radiation requirements within their specialism and/or to ensure participation and
             representation in other groups within the framework to achieve the same objectives
            Ensure that referral criteria for others referring patients to the specialty for diagnosis or
             treatment are defined and made available, including specific restriction or entitlements
             (e.g. Consultant referral only) and that the referral process is robust
            Make available to their staff, and ensure adherence to, Trust policies, procedures and
             local rules applicable to medical radiation practice and supporting activities
            Identify duty holders within their service, including one or more Radiation Protection
             Supervisors, and clinical IRMER lead if necessary. To understand and make use of the
             contribution of other duty holders in assisting towards achieving compliance.
            Through a process of audit and review, particularly in response to incidents and near
             misses, ensure a process of continuous improvement and learning. Ensure this is
             supported by action plans that are actively reviewed and updated
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          Ensure individual roles, entitlements and responsibilities are identified and allocated
           through job descriptions, local records and procedures. Ensure this is supported by a
           structured approach to training and recognition of competence
         Identify the need for specialty specific procedures and ensure that the are developed and
           implemented so as to ensure the Trust meets its obligations under ionising radiations
           legislation
         Ensure that documentation is subject to a quality assurance process, and organised so as
           to be available to the Medical Director in support of CQC inspection under the system of
           Registration, for internal audit and review and any external inspection (HSE, DoH).
AP 1.4 Referrer:

       A registered medical or dental practitioner, or other health professional who is entitled to refer
       individuals for medical exposure to a practitioner in accordance with the Specialty guidelines.
       This may include specific criteria and entitlements, for example; Consultant referral only, care
       pathways, extended entitlements for non-medical referrers. Referrers are required to;
          Pay due regard to referral criteria and requirements, and for non-medical referrals act
           solely within defined agreements
         Provide all relevant clinical information to enable the decision to undertake the appropriate
           clinical radiation procedure
         Provide accurate and complete information to enable correct identification of the patient,
           screening participant or research volunteer.
         Provide sufficient information to enable special circumstances to be identified to minimise
           unnecessary and avoidable dose, e.g. previous clinical radiation procedures, pregnancy
           status, underlying reasons for procedures in relation to screening, employment or for
           medico-legal purposes
         To not request repeated procedures without taking into account other procedures that are
           in progress or outstanding and highlight this on any additional referral.
AP 1.5 Practitioners:

       All references to practitioner in this document mean IRMER Practitioner as set out in IRMER
       regulations. A practitioner will have received specialist training in a medical radiation discipline
       enabling them to undertake IRMER duties as an Oncologist, Radiologist, Nuclear Medicine
       Physician, Cardiologist or Dentist. Others may undertake the practitioner role through local
       agreements with the radiation specialty IRMER Group or the Medical Radiation Committee.
       Practitioners are responsible for;
            Providing to Referrers information for referrals to their services, in terms of clinical
             appropriateness, required information and any restrictions on entitlements according to
             level of clinical expertise (e.g. consultant referral only). Referral criteria must be readily
             available and kept current.
            Justifying individual procedures taking into account the clinical objectives and specific
             characteristics and/or circumstances of the patient with a view to optimising dose, and
             providing to operators any specific instructions to undertake the procedure appropriately.
                 - specific objectives of the exposure and the characteristics of the individual
                 - total potential diagnostic or therapeutic benefits (personal health and societal)
                 - individual detriment the exposure may cause
                 - the efficacy, benefit and risk of alternative techniques
                 - urgency of the exposure where pregnancy cannot be excluded
                 - urgency of the exposure for breastfeeding mothers having isotope procedures
            Provide operators with written guidelines for authorising individual exposures where these
             are delegated by the practitioner



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            For the purpose of optimisation, to pay special attention to doses to children, high dose
             procedures, doses from health screening, and to keep doses from medico-legal
             exposures as low as reasonably practicable
            Adhering to IRMER requirements for research and setting dose limits where appropriate
            Identifying the appropriate person for the receipt of information and instruction on behalf of
             an incapacitated patient undergoing radionuclide treatment where there is no identifiable
             legal „guardian‟
            Undertaking continuing education and training commensurate with their role

AP 1.6 Operators:

       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,
       prescribing a treatment dose, outlining a treatment volume, administering a
       radiopharmaceutical, performing a calibration.
       Certain professional groups are by virtue of their training and qualifications entitled to act as
       operators under IRMER, e.g. radiologists, radiographers, medical (radiation) scientists and
       technical officers, Others may need limited additional training, e.g. cardiologists. Operator roles
       and entitlements to take responsibility must be defined locally and supported by records of
       training and competence.
       Operators are responsible for;

            Applying, and complying with, Portsmouth Hospitals and Specialty IRMER procedures
            Authorise individual exposure according to Practitioner guidelines where delegated
            Carry out exposures in accordance with written protocols and training
            Contribute to the continuous development and improvement of protocols and procedures
            Apply professional judgment within limits of training and experience, and referring to
             others in cases of doubt
            Challenge inappropriate procedures and seek to correct inadequate or insufficient
             information
            Undertake essential checks to verify appropriate procedures are undertaken on the
             correct patient and without inadvertently exposing others (identification checks, pregnancy
             status checks, if infants or carers could be exposed following radionuclide diagnostic or
             therapy procedures etc)
            Ensure radiation doses are kept as low as reasonably practicable consistent with the
             intended diagnostic purpose (consistent with their involvement in that exposure) taking
             into account in particular;
                 - the use of appropriate equipment and methods
                 - results from quality assurance
                 - the results of dose assessments
                 - dose reference levels
            Pay special attention to the following for the purpose of optimisation;
                 - doses to children
                 - high dose procedures
                 - medico-legal exposures
                 - exposure of the unborn child and the needs of the mother
            Report incidents and near misses and actively engage in positive learning from such
             events




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AP 1.7       Medical Physics Experts (MPE):

      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.
      Entitlements will be further defined within each of these fields according to knowledge and
      experience, will be defined in job descriptions and records kept within the Medical Physics
      Department. The roles of MPE and the degree to which an MPE must be involved with
      individual patient procedures varies according to radiation discipline as specified within
      published IRMER guidance and the Medical & Dental Guidance Notes.

      In summary, MPEs are responsible for;
             Actively supporting the safe introduction of new facilities, technologies and techniques to
              maximise therapeutic and diagnostic benefits at optimal doses
             Working alongside lead clinicians, the development of techniques and protocols to ensure
              that diagnosis and treatment are undertaken with minimal risk to the patient
             Prospective and retrospective dosimetry, dose monitoring, audit and review
             Developing scientific and technical quality assurance, quality control and calibration
              programmes for equipment employed in diagnosis and therapy. Taking responsibility for
              accuracy and precision for dosimetry.
             Scientific and technical evaluation and selection of medical radiation equipment. In
              conjunction with lead clinical staff the commissioning of equipment into clinical use, risk
              assessing system performance and function so as to eliminate, reduce and control
              untoward exposures to those undergoing examination and treatment, including accidents
              and emergencies.
             Radiation dosimetry in therapeutic procedures, optimising dose distributions to diseased
              and healthy tissues and maximising the extraction of useful clinical information
             In partnership with senior clinical staff, comprehensive data and image analysis in pursuit
              of optimal treatment and diagnosis and development of software in support of these
              activities
             Taking responsibility for scientific and technical standards in support of licensing,
              authorisation and accreditation
             Providing patient specific advice and information concerning risks taking into account
              particular circumstances, e.g. pregnancy, breastfeeding.
             Undertaking audit in pursuit of maintaining and improving diagnosis and treatment at
              appropriate dose levels.
             Supporting the development of procedures and protocols, their application within
              disciplines, and adhering to Trust procedures.
             Providing advice to practitioners and operators on matters affecting the effectiveness and
              safety of techniques and procedures on individual patients, groups of patients, and others
              that may undergo a diagnostic or therapeutic procedure.
             Training and assessing competence of other scientists and technologists involved in
              delivery of scientific and technical support activities to diagnosis and treatment.
              Supporting the training and development of practitioners and operators.




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 AP 1.8 ARSAC License Holders:

       Administration of radiopharmaceuticals and the use of radioactive sources in diagnosis,
       treatment and research is governed by the Medicines (Administration of Radioactive
       Substances) Regulations(6) and the 1995 amendment(7) colloquially known as the MARS
       regulations. These activities can only be undertaken by medically qualified staff who possess
       an ARSAC license, or under supervision through a formally delegated entitlement from the
       ARSAC license holder. ARSAC licenses are specific to the individual, listed procedures, site
       and facilities (equipment and staff support) at that site and are time limited subject to renewal.
       The role of the ARSAC license holder for administration of radioactive medicinal products and
       sources is analogous to the IRMER Practitioner. ARSAC license holders are required to comply
       with IRMER requirements for practitioners and operators and those laid down in ARSAC Notes
       for Guidance(8). Roles and responsibilities are detailed in a separate policy - Administration of
       Radioactive Substances as part of diagnosis, treatment or research policy(9) – Portsmouth
       Hospitals NHS Trust

AP 1.9 Radiation Protection Advisor (RPA):

       One or more Radiation Protection Advisors (RPA) must be appointed by the Trust as radiation
       employer as a statutory requirement under IRR1999. RPAs have an advisory and supporting
       role in assisting the radiation employer to undertake their work in compliance with ionising
       radiations legislation RPAs must possess certificates defining sphere of knowledge and
       expertise and issued by a body recognised by the Health and Safety Executive. Certificates are
       time limited subject to renewal.
       The role and responsibilities of the RPA are laid down in ionising radiation legislation,
       associated Medical and Dental Guidance Notes(10), and topic specific guidance such as HSE
       Guidance Note PM77 – equipment used in connection with medical exposure(11).
       The RPA has responsibilities according to the role statement endorsed by the Chief Executive,
       to provide advice and support on all matters relating to the use of ionising radiation within the
       defined sphere of responsibility.

       Responsibilities of the RPA include:
            Advising on the practical implementation of new legislation and guidance to enable the
             Trust to work with ionising radiation to the benefit of patient care whilst assuring the safety
             of staff, patients and members of the public. Development of policy to achieve these
             objectives.
            Providing advice on the planning and development of new and modified radiation facilities
             to meet the requirement of optimal control of dose, through engineering controls and
             operational safety measures that are compatible with clinical needs and are cost-effective.
             Designation of work areas.
            Pre-use inspection, testing and commissioning of radiation facilities, associated safety
             systems, design and oversight of monitoring and inspection programmes and of the
             testing and calibration of monitoring equipment. Design, development and review of
             quality assurance programmes.
            Undertaking risk assessments for the effective management and control of radiation dose
             and risks arising from the use of medical radiation equipment, sources and nuclides.
             Using risk assessment to design and inform appropriate system of work and operational
             safety procedures – Local Rules.
            Advice on the appointment of appropriate Radiation Protection Supervisors (RPS) and
             their training. Working with RPSs and Heads of Service to achieve compliance within
             individual areas of responsibility.
            Individual risk assessments and incident investigations involving potential exposures and
             those much greater than intended. Providing recommendations and reports for
             appropriate methods of dose control, improvement and mitigation of consequences.

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            Supporting the occupational health of staff through appropriate monitoring programmes,
             special attention to vulnerable groups (including pregnancy), availability of protective
             equipment and systems for dose control. Setting and review of dose investigation levels
             and exceptional doses.
            Providing advice to the Chief Executive concerning statutory notifications to regulatory
             agencies where required as a consequence of adverse incidents involving exposures
             greater than intended and uncontrolled release or loss of radioactive materials.
            Ensuring licenses and authorisations are in place and that responsibility arising from
             conditions for compliance is delegated.
            Overseeing the management of records required by regulations and to assist with
             demonstrating compliance with ionising radiation legislation.
            Audits and reviews of compliance and ensuring reporting through line management and
             governance structures.
            Emergency and contingency planning

AP1.10 Radiation Protection Supervisor (RPS):

       One or more Radiation Protection Supervisors (RPS) must be appointed by the Trust as
       radiation employer as a statutory requirement under IRR1999. RPSs are appointed within a
       specialty or department with a description of responsibilities for a defined area of work. RPSs
       have a supporting role to assist the Head of Service to implement radiation protection
       requirements within the service.
       The RPS should be in a senior position and be able to appropriately assert their authority on
       matters concerning radiation safety within their discipline and sphere of responsibility. The RPS
       will have appreciable experience of work with radiation within their service, a working
       knowledge of the relevant regulatory requirements, and have received training as an RPS. A
       principal requirement is to ensure that work is carried out in accordance with local rules and
       systems of work.
       In supporting the Head of Service to meet requirements for radiation safety, the RPS will have
       responsibilities that include:
            Assist the Head of Service to achieve compliance and bring to their attention any areas
             that require improvement, to do so immediately where there are significant safety
             concerns.
            Undertake risk assessments, and/or contribute to risk assessments carried out with the
             support of the Radiation Protection physicist. Ensure any modifications that are required
             as a result of the risk assessment are incorporated into local rules, systems of work and
             procedures and that any changes are brought to the attention of staff affected by them.
            Oversee the work carried out within the department and areas for which they are
             appointed so that work may be carried out in accordance with local rules and policy as
             applicable to that locality
            Assist with the development and implementation of procedures and protocols and that
             these are available at the point of use. Manage documentation through the departmental
             “Radiation File”
            Act as a point of reference and local expertise on matters of radiation safety within their
             sphere of responsibility
            Issue local rules and procedures to staff, to review these procedures to ensure that they
             remain practical and detail practices that keep doses as low as reasonably practicable
             (ALARP)
            Ensure that staff are appropriately trained, have access to training and that records of
             training are kept, including also of familiarisation with procedures, monitoring equipment
             and safety devices



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            Ensure that an effective QA programme is in place, that it operates effectively, results are
             available and used to inform practice, and that reports are provided through the
             Governance structure
            Supervise the issue and collection of personal dosimeters as may be required, to keep
             records of results and make results available to the wearers
            Investigate, in collaboration with the RPA and Head of Service, instances of excess dose
             to staff or patients from dose monitoring or where there is suspicion that an overexposure
             may have occurred
            Oversee procedures carried out within the area of responsibility to ensure that these are
             carried out in a manner which ensures doses are kept ALARP and provide appropriate
             advice to staff
            Review use of equipment, workload and environment to ensure that the radiation
             designation of that area remains correct and that doses to patients, staff and members of
             the public are kept ALARP
            Liaise with the RPA on arrangements for introducing new equipment, techniques or
             planning new facilities using radiation equipment or sources
            Assist with carrying out risk assessments for new activities and in cases where staff
             working with radiation have become pregnant
            Ensure safety and monitoring equipment is available where required, is in sound condition
             and is tested and calibrated at the required intervals, including personal protective
             equipment
            Keep records of radiation equipment, quality assurance, maintenance, training etc
            Participate in reviews of radiation safety, undertake and support audits and inspections
            Oversee the action arising from recommendations in Medical Physics reports and from the
             RPA
            Advise the Medical Physics Department of new equipment, sources and facilities, and
             changes that may require testing before use on patients, e.g. new X-ray tubes, AEC
             devices, dose monitoring devices etc.
        
AP1.11 Employees:

       All employees are required to follow to safe working practices and discharge their
       responsibilities to ensure the safety of patients according to their role as referrer, practitioner
       and/or operator under IRMER. Additionally and at all times, to take care of their safety and the
       safety of others as required by IRR99. In so doing, all employees must;
            Undertake training and ensure sufficient training has been received according to role
            ensure personal doses and doses to others are kept to a minimum at all times
            adhere to local rules, systems of work, standard operating procedures and written
             procedures covering any work involving ionising radiation
            make full and proper use personal protective equipment, take care of and correctly store
             personal protective equipment.
            notify the RPS of defect any personal protective equipment
            Wear dosimeters as issued and return promptly at the end of each period to ensure
             accuracy
            Propose improvements to working procedures and rules to ensure that they remain
             practical, relevant and continuously improving
            Inform the RPS and Head of Service of any suspected or known incident involving excess
             exposure



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APPENDIX 2

IRMER Schedule 2 – Minimum training requirements for non-radiation disciplines
undertaking IRMER roles (excludes referrers)
                                       SCHEDULE 2 - Adequate Training
Practitioners and operators shall have successfully completed training, including theoretical
knowledge and practical experience, in:-
    (i) such of the subjects detailed in section A as are relevant to their functions as
        practitioner or operator; and
    (ii) such of the subjects detailed in section B as are relevant to their specific area of
         practice.

   A. Radiation production, radiation protection and statutory obligations relating to ionising radiations
        1.      Fundamental Physics of Radiation
        1.1     Properties of Radiation
                       Attenuation of ionising radiation
                       Scattering and absorption
        1.2     Radiation Hazards and Dosimetry
                       Biological effects of radiation
                       Risks/benefits of radiation
                       Dose optimisation
                       Absorbed dose, dose equivalent, effective dose and their units
        1.3     Special Attention Areas
                       Pregnancy and potential pregnancy
                       Infants and children
                       Medical and biomedical research
                       Health screening
                       High dose techniques
        2.      Management and Radiation Protection of the Patient
        2.1     Patient Selection
                        Justification of the individual exposure
                        Patient identification and consent
                        Use of existing appropriate radiological information
                        Alternative techniques
                        Clinical evaluation of outcome
                        Medico-legal issues
        2.2     Radiation Protection
                       General radiation protection
                       Use of radiation protection devices
                       -      patient
                       -      personal
                       -      Procedures for incidents involving overexposure to ionising radiation
        3.      Statutory Requirements and Advisory Aspects
        3.1     Statutory Requirements and Non-Statutory Recommendations
                       Regulations
                       Local rules and procedures
                       Individual responsibilities relating to medical exposures
                       Responsibility for radiation safety
                       Routine inspection and testing of equipment
                       Notification of faults and Health Department hazard warnings
                       Clinical audit

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      B.        Diagnostic radiology, radiotherapy and nuclear medicine

        4.      Diagnostic Radiology

        4.1     General
                      Fundamentals of radiological anatomy
                      Fundamentals of radiological techniques
                      Production of X-rays
                      Equipment selection and use
                      Factors affecting radiation dose
                      Dosimetry
                      Quality assurance and quality control
        4.2     Specialised Techniques
                       Image intensification/fluoroscopy
                       Digital Fluoroscopy
                       Computed Tomography Scanning
                       Interventional procedures
                       Vascular imaging
        4.3     Fundamentals of Image Acquisition etc.
                      Image quality v. radiation dose
                      Conventional film processing
                      Additional image formats, acquisition, storage and display
        4.4     Contrast Media
                       Non-ionic and ionic
                       Use and preparation
                       Contra-indications to the use of contrast media
                       Use of automatic injection devices

        5.      Radiotherapy

        5.1     General
                      Production of ionising radiations
                      Use of radiotherapy
                         - benign disease
                         - malignant disease
                         - external beam
                         - brachytherapy
        5.2     Radiobiological Aspects for Radiotherapy
                      Fractionation
                      Dose rate
                      Radiosensitisation
                      Target volumes
                5.3     Practical Aspects for Radiotherapy
                        Equipment
                        Treatment planning
        5.4     Radiation Protection Specific to Radiotherapy
                       Side-effects – early and late
                       Toxicity
                       Assessment of efficacy
        6.      Nuclear Medicine

        6.1     General
                      Atomic structure and radioactivity
                      Radioactive decay
                      The tracer principle
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                        Fundamentals of diagnostic use
                        Fundamentals of therapeutic use
                           - dose rate
                           - fractionation
                           - radiobiology aspects
        6.2     Principles of Radiation Detection, Instrumentation and Equipment
                        Types of systems
                        Image acquisition, storage and display
                        Quality assurance and quality control
        6.3     Radiopharmaceuticals
                      Calibration
                      Working practices in the radiopharmacy
                      Preparation of individual doses
                      Documentation
        6.4     Radiation Protection Specific to Nuclear Medicine
                       Conception, pregnancy and breastfeeding
                       Arrangements for radioactive patients
                       Disposal procedures for radioactive waste




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