IR(ME)R compliance in NHS Dumfries & Galloway

1. IR(ME)R compliance in NHS Dumfries & Galloway By Alison Solley Radiation Protection Supervisor

2. Why legislate? • Radiation is harmful • Medicine is the highest source of radiation that patients receive • Current research (dose-response models) indicate that there is a risk of harm associated with all doses of radiation • Some radiological procedures deliver high doses of radiation

3. Radiation protectionRisk & Benefit Framework • …….the primary aim of radiological protection is to provide an appropriate standard of protection for man without unduly limiting the beneficial practices giving rise to radiation exposure. This aim cannot be achieved on the basis of scientific concepts alone. All those concerned with radiological protection have to make value judgments about the relative importance of different kinds of risks and about the balancing of risks and benefits (ICRP, 1991, p. 3).

4. PRINCIPLES OF RADIATION PROTECTION Justification The examination should be of sufficient benefit to the patient to justify the radiation dose (risk : benefit ratio) Optimisation Keep all doses As Low As Reasonably Practicable (ALARP) Dose Limitation Keep to dose limits and Record (dose reference levels)

5. Radiation Regulations • Radiation Regulations exist to reduce unnecessary dose to the patient (and staff) • This is a shared responsibility between the employer and staff, through a series of delegated entitlements, to carry out specified duties.

6. The organisation of RADIATION PROTECTION in NHS Dumfries & Galloway RPA – Radiation Protection Advisers Policies and Procedures (Employers procedures and local rules) Employee Responsibilities (all staff) Responsible Persons – (Radiation Protection Supervisor) Staff training Dose Monitoring – Audit, Dose Reference Levels, personnel monitoring

7. DOSE REDUCTION Good Department Radiation Protection Structure Only image where necessary Challenge requests! Use old reports / images on PACS Good maintenance QA Effective staff – CPD and best practice Reduction in views and careful technique Local Comparisons Good use of equipment – pulse fluoroscopy

8. Legislation • Ionising Radiations Regulations 1999 (IRR99) • Safety of staff and the general public • Ionising Radiation (Medical Exposures) Regulations 2000 (IRMER) • Safety of patients • Radioactive Substances Act 1993 (RSA93) • Holding and disposal of radioactive material

9. IRMER 2000 • Why was it introduced? • The government pledged to modernise the health service by making it: • More accessible to the needs of the patient • Increasing the flexibility amongst health care professionals • Focus on specific duties rather than the professional background of the individual health care professional

10. IRMER 2000 • Aims to ensure that all radiation exposures of patients: • are of net benefit to the patient or society • are carried out by trained individuals • and all radiation doses are as low as reasonable practicable for the intended purpose

11. IR(ME)R 2000 There are four distinct roles defined under IR(ME)R: The Employer The Referrer The Practitioner The Operator

12. IRMER 2000 The Employer – who must provide a framework under which medical exposures may take place; The Referrer – who must provide adequate and relevant clinical information to enable the practitioner to justify the exposure; The Practitioner – who decides the appropriate imaging and justifies any exposure to radiation; The Operator – who authorises and undertakes the exposure with regard to dose optimisation, or carries out other practical aspects.

13. “The Employer” NHS Dumfries & Galloway The Employer must provide: • Written procedures for medical exposures as set out in the regulations (the ‘Employers Procedures’) • referral criteria for medical exposures, including radiation doses, and shall ensure that these are available to the referrer • Must ensure that written protocols are in place for every type of examination • Ensure that all practitioners and operators are trained (including check registration documents) • Entitle duty holders

14. ENTITLEMENT AND SCOPE IRMER requires that all duty holders be ‘entitled’ and to have the scope of their entitlement defined. The duty holder needs the agreement of their employer that this duty can be part of their role. Having been entitled to perform a duty by a previous employer does not automatically mean entitlement by another employer This entitlement to act as a duty holder would also specify the scope of the duties: that is, for example the types or range of examinations for which referrals can be made; or the range of examinations which a practitioner can justify, or the specific tasks an operator can perform.

15. Chief Executive (NHS Dumfries & Galloway) Director of Human Resources NHS D&G Health & Safety Policy IRMER Lead Medical Director Radiation Safety Committee Entitles Clinical Director of Clinical Specialties Clinical Director of Radiology Approves Entitles Assess competence & entitles Assess competence & entitles Assess competence Authorised Managers Entitles Practitioners & Operators in that Clinical Specialty Assess competence Referrers (Generic Groups ) Non-Medical Referrers (Individuals ) Radiology Practitioners Operators

16. IRMER Lead Responsible for ensuring that appropriate structures are in place to fulfil IRMER Include mechanisms for the entitlement of Duty Holders Establish agreed qualifications and experience required for individuals to be entitled as Duty Holders

17. IRMER Lead • Entitles Referrers (general) • Authorise in writing the appropriate Clinical Director to entitle duty holders within their respective work areas • Practitioners • Operators • Referrers (within directorate)

18. IRMER Terminology “The Referrer” ‘a registered medical practitioner, dental practitioner or other registered healthprofessional who is entitled in accordance with the employer’s procedures to refer individuals for medical exposure to a practitioner’

19. WHAT ARE THE ADDITIONAL IMPLICATIONS? Non-medical personnel may be ‘referrers’ under these Regulations, Provided they have the competence (conferred by training and experience) to provide the medical data required to enable the practitioner to justify the examination

20. WHAT IS COMPETENCE? Before entitling referrer status will be necessary to show evidence of training and competence in Basic principles of radiation safety IR(ME)R 2000 Process of referral and audit Clinical skills in patient examination Written policy and procedures for each examination region (SCOPE OF ENTITLEMENT) Documentary evidence from lead clinician of individual clinical competence Evidence of qualifications, experience and registration Training Records

21. IRMER Terminology “The Referrer” The referrer shall supply the practitioner with sufficient medical data (such as previous diagnostic information or medical records) relevant to the medical exposure requested by the referrer to enable the practitioner to decide on whether there is a sufficient net benefit as required by regulation 6(1)(a).

22. IRMER Terminology “The Referrer” The referrer has a particular responsibility to ensure the completeness and accuracy of data relating to the patient's condition. It is incumbent, therefore, upon the referrer, wherever possible, to be fully informed about patient history, the presenting complaint, the relevant past history and previous radiation exposure relevant to the condition being investigated. The relevance of physical findings as indicators for a medical exposure are also requirements. Failure to provide such information might result in an inappropriate exposure being performed or an exposure not being performed because of lack of relevant information. (RCR) guidelines 22

23. Royal College of RadiologistsGuidelines for making the best use of Clinical Radiology Services A useful investigation is one in which the result (positive or negative) will alter management and/ or add confidence to the clinician’s diagnosis.

24. IRMER Terminology “The Practitioner” A Practitioner is a registered healthcare professional who is entitled to take responsibility for an individual exposure (within the SCOPE of their clinical expertise). The primary function of the Practitioner is to undertake the justification of medical exposures, taking into account the risks and benefits while considering alternative investigations or procedures. For example, Radiologist, Radiographers, Dentists, Cardiologists and Surgeons

25. IRMER Terminology “Justification” Regulation 6(1)(a) requires that exposures can only be carried out when justified by the practitioner. Strictly speaking, the referrer is requesting a clinical opinion from the practitioner rather than an x-ray examination. The practitioner is responsible for the justification of each individual medical exposure. This should be based on his/her knowledge of the hazard associated with the exposure and the clinical information supplied by the referrer

26. IRMER Terminology “Justification” Appropriateness of the request (correlation with clinical details) Best use of imaging modality available Risk V benefit Urgency of exposure – if patient is pregnant can the procedure be delayed until after delivery?

27. IRMER Terminology “Operator” An operator is anyone who carries out a practical aspect e.g. Performing procedures, issuing a report etc. The operator can authorise the request following set criteria (general radiography) The operator is responsible in selecting the equipment and methods to ensure that the dose is kept ALARP Operator must be appropriately trained For example, Radiographers, Radiologists, , Assistant Practitioners, Medical and Dental Practitioners and Dental Nurses

28. HOW DO WE DO THIS? Employers procedures Training and Education Clinical Radiation awareness Entitlement, Scope and Competency Framework Continuous Professional Development and Audit Individual Responsibilities and Accountability Annual Reviews Clinical Governance

29. Chief Executive (NHS Dumfries & Galloway) Director of Human Resources NHS D&G Health & Safety Policy IRMER Lead Medical Director Radiation Safety Committee Entitles Clinical Director of Clinical Specialties Clinical Director of Radiology Approves Entitles Assess competence & entitles Assess competence & entitles Assess competence Authorised Managers Entitles Practitioners & Operators in that Clinical Specialty Assess competence Referrers (Generic Groups ) Non-Medical Referrers (Individuals ) Radiology Practitioners Operators

30. SUMMARY Revised procedures will set out requirements more explicitly Aimed at ensuring that staff members are trained and competent Entitlement establishes individual and corporate responsibilities Records of training for staff acting as duty holders must be available and current. These should be held by the individual and by the CD/authorised manager who has conferred entitlement

31. And finally…