IR(ME)R compliance in NHS Dumfries & Galloway By Alison Solley Radiation Protection Supervisor Over the course of this year, NHS Dumfries & Galloway has been liaising with the Health Directorates of the Scottish Government about issues related to compliance with the requirements of the Ionising Radiation (Medical Exposure) regulations 2000. This has resulted in some proposed changes to the way in which we approach these issues, and these will affect all staff who are Duty Holders under the regulations.

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 Read from slide

Radiation protection Risk & 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). Read from slide

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) The principles of Radiation protection are outlined here

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. Read from slide

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 Traditionally the role of organising and Policing Radiation Protection in NHS Dumfries & Galloway has fallen to the X-ray Department staff; and anyone who has ever tried to request an x-ray knows how well the x-ray department staff do this!! . Revising the legislation will set out the requirements more explicitly, and will establish individual and corporate responsibilities throughout the organisation.

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 As stated previously the x-ray Department “runs a very tight ship”, with a robust Radiation Protection Structure in place. EVERY request will be challenged by a specialist team of Radiographers; highly trained to seek out requests which are “NOT JUSTIFIED!”

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 This is the legislation we comply with in NHS Dumfries & Galloway.

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 Why was IRMER introduced.

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 Read from slide

IR(ME)R 2000 There are four distinct roles defined under IR(ME)R: The Employer The Referrer The Practitioner The Operator Read from slide

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. Duty holders under IRMER are outline here

“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 Our employer is NHS Dumfries & Galloway, and the duties are outlined here. 13

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. Read from slide, then e.g. GP’s can refer for plain x-ray imaging, but not CT scans, Orthopaedic surgeons can provide a clinical evaluation of plain x-ray images, but not CT scans etc, etc. 14

(NHS Dumfries & Galloway) 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 This is the framework for Radiation Protection responsibility within NHS Dumfries & Galloway. The Chief executive has responsibility for Health & Safety in the organisation. The Chief Executive has appointed the Director of Human Resources as accountable for the implementation of this policy. The Director of Human Resources has entitled the Medical Director (IRMER lead) to be responsible for ensuring that appropriate structures are in place to fulfil IRMER. A chain of Duty Holders exist within NHS Dumfries & Galloway: from the IRMER lead (medical director) through the Radiation Safety Committee, Clinical Directors of Clinical Specialties (in particular Orthopaedics and Cardiology), the Clinical Director of Radiology and the X-ray Department manager and Superintendent Radiographers. Assess competence Authorised Managers Entitles Practitioners & Operators in that Clinical Specialty Assess competence Referrers (Generic Groups ) Non-Medical Referrers (Individuals ) Radiology Practitioners Operators

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 This is my Role, as Medical Director

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) Read from slide

IRMER Terminology “The Referrer” ‘a registered medical practitioner, dental practitioner or other registered health professional who is entitled in accordance with the employer’s procedures to refer individuals for medical exposure to a practitioner’ Read from slide. We have generic groups of referrers in NHS Dumfries & Galloway i.e. dentists, GP’s, Junior hospital Doctors, and Medical consultants. The scope of entitlement for each generic group of referrers is specific to their job, e.g. Dentists can only refer for dental x-rays, GP’s can only refer for plain x-ray imaging, junior hospital doctors can refer for plain x-ray imaging, BUT not CT scans etc. We also have NON MEDICAL referrers. NEXT SLIDE 18

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 In NHS Dumfries & Galloway we have 2 speech and Language therapists, 7 Radiographers, and 32 nurses who can refer patients for x-ray; and the scope of their entitlement is specific to their job e.g. MRI radiographers can refer patients for x-rays of their orbits prior to MRI scan, to exclude a metallic foreign body; hospital at night nurse practitioners can refer for Chest x-rays, abdominal x-rays and hip / pelvis x-rays. Accident and emergency nurse practitioners each have an individual scope of practice, depending on training and experience.

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 Read from slide

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). Read from slide

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 Read slide 22

Royal College of Radiologists Guidelines 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. The referral Guidelines we work to are the “Royal College of Radiologists Guidelines for making the best use of Clinical Radiology Services”. We also have our own locally adapted NHS Dumfries & Galloway “Radiology Directorate JUSTIFICATION CRITERIA & PROTOCOLS”. “A useful investigation is one in which the result (positive or negative) will alter management and / or add confidence to the clinician’s diagnosis.

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 A PRACTITIONER is a registered clinician, or other health professional who is entitled to take responsibility for an individual medical exposure. Generally Radiologists but also includes Radiographers in certain situations. 24

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 Read from slide 25

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? All of these points have to be considered before a request can be justified. If in doubt ask discuss with a Radiologist! 26

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 Read from slide. THEN : Please note that in certain situations, by agreement, a CLINICAL EVALUATION of the outcome of an x-ray exposure (i.e. a report) is NOT provided by a Radiologist. In these circumstances this becomes an OPERATOR function and the REFERER MUST ensure that a clinical evaluation of the outcome of the medical is made and documented in the patient’s notes e.g. orthopaedic referrals, dental referrals, cardiology procedures and video-fluoroscopy procedures. 27

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 READ FROM SLIDE. Then: Revision of our IRMER documentation is currently taking place, and the purpose of today is to clarify the role of the Duty Holders under IRMER and within the organisation.

(NHS Dumfries & Galloway) 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 As previously stated 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. Assess competence Authorised Managers Entitles Practitioners & Operators in that Clinical Specialty Assess competence Referrers (Generic Groups ) Non-Medical Referrers (Individuals ) Radiology Practitioners Operators

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 Read from slide 30

And finally… Just to recap the principles of radiation protection: a radiological examination should be carried out ONLY after the medical exposure has been JUSTIFIED; each exposure should be OPTIMISED so that all patient doses are kept AS LOW AS REASONABLY PRACTICABLE, consistent with the intended clinical objective. Each medical exposure MUST be CLINICALLY EVALUATED

Don’t forget the benefits Don’t forget the benefits! All methods of medical imaging can bring very real benefits to your patients. The over ridding concern of the person referring a patient for x-ray (that is YOU!!), and the Radiology Department is to ensure that when radiation is used, the benefits from making the right diagnosis, and consequently giving the right treatment, outweigh any small risk involved. THANK YOU.