What is a “medical exposure”

1. First FRCR Examination in Clinical RadiologyStatutory Requirements and Non-Statutory Recommendations(b) Ionising Radiation (Medical Exposure) Regulations 2000John SaundersonRadiation Protection Adviser

2. the exposure of patients as part of their own medical diagnosis or treatment including any exposure of an asymptomatic individual; What is a “medical exposure”

3. “…exposure of an asymptomatic individual” Committee on Medical Aspects of Radiation in the Environment (COMARE) (2007).  Twelfth Report. The impact of personally initiated X-ray computed tomography scanning for the health assessment of asymptomatic individuals. Health Protection Agency, December 2007. http://www.comare.org.uk/documents/COMARE12thReport.pdf Recommendation 7 Current evidence suggests that there is no benefit to be derived from CT scanning of the lung in asymptomatic individuals. Further research is required in this area but, until this is available, CT scanning of the asymptomatic individual cannot be justified for the lung and should not be made available.

4. the exposure of patients as part of their own medical diagnosis or treatment including any exposure of an asymptomatic individual; • the exposure of individuals as part of occupational health surveillance; What is a “medical exposure” "OCCUPATIONAL HEALTH SURVEILLANCE" means medical surveillance for workers;

5. the exposure of patients as part of their own medical diagnosis or treatment including any exposure of an asymptomatic individual; • the exposure of individuals as part of occupational health surveillance; • the exposure of individuals as part of health screening programmes; What is a “medical exposure” "HEALTH SCREENING" means a procedure using ionising radiation for early diagnosis in population groups at risk; e.g. NHS Breast Screening Programme screening for breast cancer

6. the exposure of patients as part of their own medical diagnosis or treatment including any exposure of an asymptomatic individual; • the exposure of individuals as part of occupational health surveillance; • the exposure of individuals as part of health screening programmes; • the exposure of patients or other persons voluntarily participating in medical or biomedical, diagnostic or therapeutic, research programmes; What is a “medical exposure”

7. the exposure of patients as part of their own medical diagnosis or treatment including any exposure of an asymptomatic individual; • the exposure of individuals as part of occupational health surveillance; • the exposure of individuals as part of health screening programmes; • the exposure of patients or other persons voluntarily participating in medical or biomedical, diagnostic or therapeutic, research programmes; • the exposure of individuals as part of medico-legal procedures. What is a “medical exposure” "MEDICO-LEGAL PROCEDURE" means a procedure performed for insurance or legal purposes without a medical indication;

9. Basic Principles • Roles & Responsibilities (employers, referrers, practitioners, operators, MP experts) • Procedures & Protocols • Adequate training & Audit . Justification Optimisation

10. Function with associated duties • employer • referrer • practitioner • operator • medical physics expert .

11. Employer (1) • Write procedures for all medical exposures .

12. IRMER SCHEDULE 1Employer’s Procedures • patient identification • identification of competent staff for specific tasks • medico-legal • identifying pregnant patients • QA programmes • assessing patient dose.

13. IRMER SCHEDULE 1Employer’s Procedures patient identification ; identification of competent staff for specific tasks; medico-legal ; identifying pregnant patients ; QA programmes ; assessing patient dose • diagnostic reference levels • dose constraints in research • instructions to nuclear medicine patient on dose to others • evaluating each medical exposure • ensure chances of overdose are A.L.A.R.P.

16. Employer (2) • Write procedures for all medical exposures • Write protocols for every standard radiological practice for each equipment • e.g. for X-ray room 29, PAchest: 120 kV, 2mAs. For pre-programmed units i.e. with a chest button, a record should be kept of what the programmed values are. For nuclear medicine, document amount administered for each routine examination and treatment .

17. Employer (3) • Establish • referral criteria and make available to referrers • a QA programme • diagnostic reference levels • dose constraints fo medical research where no benefit to “exposee” • Decide who is a practitioner or operator, and establish training records. • For “sub-contractor operators” stipulate in contract adequate training .

18. Employer (4) • Ensure that they are undergoing continuing education & training • Investigate all incidents and report all significant overdoses to DoH • Review when diagnostic reference levels consistently exceeded and take appropriate action. • Ensure a clinical evaluation of outcome of every exposure is carried out and recorded (including dose/activity) .

19. Employer (5) • Clinical audit in accordance with national procedures must be performed • Ensure a medical physics expert in areas specified • Keep an equipment inventory • Limit the amount of equipment ---oooOOOooo---.

20. Referrer • Must supply sufficient medical info’ to practitioner so that they can decide if justified • (i.e. not “Give this guy a bone scan” but “Please give this guy a bone scan because . . . . . . . . ” • Must be a “registered healthcare professional” .

22. Practitioner • Must comply with employers procedures. • Responsible for justifying exposure - must be a net benefit (practical aspects can be delegated but not responsibility) • Must be a “registered healthcare professional” - not necessarily a medic - could be a radiographer if specified in procedures • Must cooperate with other specialists and staff involved in the exposure.

23. Operator • Responsible for the “practical aspects” they carry out. • Must cooperate with other specialists and staff involved in the exposure • Undergo continuing education & training • In fluoroscopy, ensure AEC used unless other method justified.

24. Medical Physics Expert • Hold a science degree • Be experienced in the application of physics to the diagnostic and therapeutic uses of ionising radiation • Closely involved in radiotherapy • Available in nuclear medicine • Involved as appropriate in optimisation for other radiological practices .

25. Here on 5 Nov 2013

26. Justification • No medical exposure can take place unless authorised by a practitioner - must be net benefit • No medical or biomedical research unless approved by Local Research Ethics Committee.

27. Optimisation (1) • For diagnostic exposures (P & O) • A.L.A.R.P. • For therapeutic exposures (P) • exposures to target volumes to be individually planned • Doses to non-target volumes A.L.A.R.P. • For medical or biomedical research (P) • volunteers only • volunteer aware in advance of the risk • if no medical benefit, adhere to dose constraints • if medical benefit, plan individual target dose levels.

28. Medical or biomedical research • NRES have issued guidance • http://www.nres.nhs.uk/EasySiteWeb/GatewayLink.aspx?alId=18531 • 2.4 The research provisions of IRMER apply to any research exposure involving ionising radiation, not only to exposures that are additional to routine care. • 2.5 In this guidance, a “research exposure” is defined as any exposure required by the research protocol following initial consent from the participant. It includes all exposures carried out on the participant as determined by the protocol, including those which would otherwise be part of routine clinical care for patients treated outside the research setting. • 2.7 Research exposures include any exposure required by the screening procedures for the research.

29. Medical or biomedical research – Lead site • Lead Clinical Radiation Expert (lead CRE) • assesses whether the protocol could involve additional radiation exposure at any site in the study and • advises the Chief Investigator (CI) and the main Research Ethics Committee (REC) on the suitability and ethical acceptability of additional exposures. • take into account variations in practice at other centres • reviews the information sheet for participants and ensure that it contains accurate and appropriate advice on radiation exposure, in particular that: • Where there is no direct benefit to the participant, this is made clear. • The risks are realistic and not over- or under-stated. • The information is comprehensible to participants. • It is sensitive to cohort prognosis by taking into account the population and illness under study. • “Raw‟ numerical risks are not quoted without reference to reasonable comparators, and terminology is harmonised by reference to tables such as the HPA table in their patient information leaflet concerning x-rays, available at: http://www.hpa.org.uk/webc/HPAwebFile/HPAweb_C/1194947388410

30. X-RaysHow safe are they? NRPB#, May 2001 http://www.hpa.org.uk/webc/HPAwebFile/HPAweb_C/1194947388410 #National Radiological Protection Board was absorbed by the Health Protection Agency (HPA) in 2005, In 2013 the HPA was itself absorbed by Public Health England (PHE). This document still available from the PHE web site.

31. Medical or biomedical research – Lead site • Lead Clinical Radiation Expert (lead CRE) • assesses whether the protocol could involve additional radiation exposure at any site in the study and • advises the Chief Investigator (CI) and the main Research Ethics Committee (REC) on the suitability and ethical acceptability of additional exposures. • take into account variations in practice at other centres • reviews the information sheet for participants and ensure that it contains accurate and appropriate advice on radiation exposure, in particular that: • Where there is no direct benefit to the participant, this is made clear. • The risks are realistic and not over- or under-stated. • The information is comprehensible to participants. • It is sensitive to cohort prognosis by taking into account the population and illness under study. • “Raw‟ numerical risks are not quoted without reference to reasonable comparators, and terminology is harmonised by reference to tables such as the HPA table in their patient information leaflet concerning x-rays, available at: http://www.hpa.org.uk/webc/HPAwebFile/HPAweb_C/1194947388410 • Lead Medical Physics Expert (lead MPE) • Assess dose and dose related risk for the application form in IRAS. The assessment should include all research exposures, including those that might be received as part of normal clinical care at some or all sites. • establish the dose constraint or target dose level.

32. Medical or biomedical research – Local site • IRMER Practitioner • The principal investigator (PI) should identify a suitable individual within the care organisation who is entitled to act as the Practitioner for the site. • The Practitioner should review the protocol and main REC application and confirm in writing to the PI and the R&D office that: • The site can adhere to the protocol. • Where local patients would receive additional exposure, this has been identified in the REC application and has been ethically approved by the main REC. • Any additional exposure is justified having regard to IRMER. • Local Medical Physics Expert (local MPE) • review the protocol and the REC application form and confirm to the PI that the protocol can be performed at the site within the estimated range of dose made by the lead MPE for the research • A local dose constraint or target dose should be established under IRMER. This should be in line with the Total Research Protocol Dose estimated in the REC application • In the case of research involving administration of radioactive substances, the local MPE will usually advise on whether a research ARSAC certificate is required and may assist with the application

33. Optimisation (2) • For nuclear medicine (E) • instructions to patients to minimise risk to others (where appropriate) • or to other appropriate person • Special attention to • A.L.A.R.P. for medico-legal exposures • children • screening programmes • high dose procedures • abdomen of the potentially pregnant • breastfeeding females (NM).

34. Doses much greater than intended • For doses “much greater than intended” not caused by equipment • Report to Care Quality Commission (CQC)

35. 1.5 (2012 change) 1.5

36. “IRMER Incidents”(Note – local Hull procedure, not specific regulations) • Incident is report to line management and DATIX • RPA is informed - he assess whether “reportable” Incident Reporting

38. intranet A-Z R Radiation Physics (intranet) Radiation, laser, etc incidents

39. CQC 2012 IRMER Report

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