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First FRCR Examination in Clinical Radiology Statutory Requirements and Non-Statutory Recommendations Ionising Radiations Regulations 2017 John.

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Presentation on theme: "First FRCR Examination in Clinical Radiology Statutory Requirements and Non-Statutory Recommendations Ionising Radiations Regulations 2017 John."— Presentation transcript:

1 First FRCR Examination in Clinical Radiology Statutory Requirements and Non-Statutory Recommendations Ionising Radiations Regulations John Saunderson Radiation Protection Adviser 2018

2 The route to regulations

3 Relevant Radiation Legislation
Ionising Radiations Regulations 2017 staff, public (IRR17) Ionising Radiation (Medical Exposure) Regs 2017 patients, research subjects (IRMER17) Environmental Permitting Regulations 2016 keeping & disposing of radioactive materials (EPR16) The Carriage of Dangerous Goods and Use of Transportable Pressure Equipment Regulations 2009

4 Guidance Approved Code of Practice (ACOP) Guidance Notes
odd HSE guidance etc. IPEM, NRPB, RCR, BIR, etc. stuff.

5 Ionising Radiations Regulations 2017 (IRR17)
Draft L121 Regs + Approved Code of Practice + HSE guidance (just Google “L121”) 43 regulations, 9 schedules

6 Note, regs changed on 1st January
from IRR99 to IRR17 Mostly the same Numbering of regs changed Regulation IRR 1999 IRR 2017 5 5. Authorisation of practices 5. Notification of certain work 6 6. Notification of specific work 6. Registration of certain practices 7 7. Prior risk assessments 7. Consent to carry out specified practices 8 8. Restriction of exposure 8. Risk assessments 9 9. Personal protective equipment 9. Restriction of exposure etc. up to reg 38 etc. up to reg 39

7 Who’s who “Appropriate authority” Employer Employees
HSE, Health & Safety Executive (GB) HSENI, Health & Safety Executive Northern Ireland (NI) ONR, Office for Nuclear Regulations (transport, nuclear power, and authorised defence site) Employer Is responsible for most of the regulations e.g. NHS Trust, private hospital, private dentist If more than one employer involved, must co-operate and share information Employees Some specific responsibilities e.g. look after PPE (lead aprons), do expose self or others more than necessary, etc.

8 Ionising Radiations Regulations 2017 (IRR17)
Regulation 1 Citation & commencement Came into force 1st January 2018 Regulation 2 Interpretation Defines various terms (e.g. overexposure, dose, controlled area, work with ionising radiation, etc.)

9 Regulation 3(1) Application
Any “practice”, i.e. (a) the production, processing, handling, disposal, use, storage, holding or transport of radioactive substances; or (b) the operation of any electrical equipment emitting ionising radiation and containing components operating at a potential difference of more than 5kV, which can increase the exposure of individuals to ionising radiation; Any work where high concentrations of natural radon gas e.g. nuclear medicine e.g. nursing home where a resident has undergone a nuclear medicine procedure at a hospital e.g. X-rays

10 Regulation 3(2) Application
But, most of the regulations do not apply to person undergoing medical exposure “medical exposure” patients and asymptomatic individuals as part of their own medical diagnosis or treatment; individuals as part of health screening programmes; patients or other persons voluntarily participating in medical or biomedical, diagnostic or therapeutic, research programmes; individuals undergoing non-medical imaging using medical radiological equipment; carers and comforters;

11 The Graded Approach An employer must inform HSE of most types of work with radiation Reg 5 Notification of certain work Reg 6 Registration of specific practices Reg 7 Consent to carry out specific practices

12 Reg 7 Consent to carry out specific practices
Covers nine types of practice Nuclear medicine diagnosis, treatment or research, both medical and veterinary Uranium mines Deliberately adding radioactive substances to products (e.g. radiopharmacy, smoke detector manufacture) Operation of an accelerator > 1MeV (e.g. linac, cyclotron) Industrial radiography Industrial irradiation Use of high-activity sealed source (HASS) Long-term storage or disposal of radioactive waste Discharging significant amounts of radioactive effluent.

13 Reg 7 Consent to carry out specific practices
Consent for one of the nine practices covers all such practices by that employer at all sites e.g. one consent to “operate accelerators” will cover all radiotherapy linacs and proposed cyclotron at CHH Online service - £25 per practice System is mostly yes/no questions All “yeses” and consent almost guaranteed Any “nos” and no consent Also give maximum likely doses to staff and public. Consent may or may not be time limited

14 Reg 6 Registration of specific practices
Covers radiation generators, such as X-ray devices, that are not a specific practice requiring consent, e.g. diagnostic X-ray, superficial X-ray therapy, interventional radiology, use of calibration sources 1000kg or over of artificial or naturally occurring radionuclides (“NORM”) that is above the low end of specific concentration levels under 1000kg of artificial or NORM that is above the medium end of specific concentration levels.

15 Reg 6 Registration of specific practices
A practice subject to “consent” does not need to be “registered” A single registration from an employer covers all their registrable practices at all their sites Online service - £25 per employer A subset of the consent questions Must notify immediately HSE if employer ceases to carry out the practice or material change HSE anticipated around 28,000 employers registering.

16 Reg 5 Notification of certain work
Only for trivial quantities of radioactive materials Reg 5 Notification of certain work Covers Work with ionising radiation which is Not exempt (below schedule 1 limits, e.g. very small amounts of radioactive material) Not registerable Not requiring consent i.e. work with under 1,000kg of artificial or naturally occurring radionuclides that is: between the low and medium end of specific concentration levels above specific quantity levels And work in a radon atmosphere above an annual average of 300Bq.m-3 Online and free.

17 Reg 8 Radiation risk assessments
Prior risk assessment required before new activity involving radiation can start – must be recorded This regulation does not apply to persons undergoing medical exposures

18 Boston Magistrates’ Court heard today that the male staff member working with a CT scanner at the Boston hospital received more than double the annual dose limit for skin exposure in just over three months.

19 Reg 8 Radiation risk assessments
Prior risk assessment required before new activity involving radiation can start – must be recorded Must identify measures required to restrict exposure to staff and others (applied to “comforters & carers” but not patients undergoing medical exposures) Must identify all risks of radiation accidents Must take all reasonable steps to prevent accidents limit consequences Provide employees information, instruction, training & equipment needed to restrict exposure This regulation does not apply to persons undergoing medical exposures

20 Risk Assessments - ACoP
the nature of the sources of ionising radiation to be used, or likely to be present, including accumulation of radon in the working environment; estimated radiation dose rates to which anyone can be exposed; the likelihood of contamination arising and being spread; the results of any previous personal dosimetry or area monitoring relevant to the proposed work; advice from the manufacturer or supplier of equipment about its safe use and maintenance; engineering control measures and design features already in place, or planned; any planned systems of work; estimated levels of airborne and surface contamination likely to be encountered; the effectiveness and the suitability of PPE to be provided; the extent of unrestricted access to working areas where dose rates or contamination levels are likely to be significant; possible accident situations, their likelihood and potential severity; the consequences of possible failures of control measures – such as electrical interlocks, ventilation systems and warning devices – or systems of work; steps to prevent identified accidents, or limit their consequences.

21 Reg 9 Restriction of exposure
Keep doses as low as reasonably practicable (ALARP) Use engineering methods (e.g. lead screens) as far as reasonably practicable then Systems of Work (e.g. local rules) then PPE (e.g. lead aprons), which must be properly used Use dose constraints for planning Formal investigation levels Dose constraints must be in terms of individual effective or equivalent dose Dose to foetus of pregnant worker must be < 1 mSv during declared term, and ALARP This regulation does not apply to persons undergoing medical exposures

22 Must comply with other PPE regs
Appropriate storage must be provided

23 Reg 10 Personal protective equipment Reg 11 Maintenance and examination of engineering controls etc and personal protective equipment Maintain Test safety features and warning devices at regular intervals Appropriate storage must be provided for PPE Examine PPE and keep records for at least 2 years The medical exposures exclusion in r.3(3) does not include regs 10 and 11. However, regs 10 & 11 apply to PPE and controls pursuant to r.9 (ALARP) and r.9 does not apply to persons undergoing medical exposures. So effectively r.10 and r.11 do not apply to persons undergoing medical exposures.

24 This regulation does not apply to persons undergoing medical exposures
Reg 12 Dose limitation Employer must ensure dose limits are not exceeded This regulation does not apply to persons undergoing medical exposures

25 IRR2017 schedule 3 Dose Limits
Type of limit Employee & trainees > 18 Trainee < 18 Others Effective dose 20 mSv/y a 6 mSv/y 1 mSv/y f Equivalent dose Lens of the eye 20 mSv/y b 15 mSv/y Skin c 500 mSv/y 150 mSv/y 50 mSv/y Extremities d a /y = in a calendar year, i.e. 1st January to 31st December b With HSE permission up to 50 mSv/y if total in 5 years < 100 mSv (i.e. average <20mSv/y) c averaged over 1 cm2 d “extremities” means a person’s hands, forearms, feet and ankles e overaged over 5 years, as long as < 50 mSv in every year f if resulting from medical exposure of another, total in 5 years must be < 5mSv This regulation does not apply to persons undergoing medical exposures

26 Here on 24th September 2018 (L4)

27 IRR17 so far (from 24/9/2018 lecture)
Apply to work leading to radiation exposure Mostly does not apply to persons undergoing medical exposures Employer must “Register” with HSE if using X-rays (r.6) Gain HSE “consent” for nuclear medicine and radiotherapy (r.7) Must have risk assessment before new activity starts (r.8) Doses must be As Low As Reasonably Practicable – ALARP (r.9) using Engineering methods Systems of Work PPE Dose to foetus of pregnant employee (r.9) ALARP < 1 mSv during declared term PPE and engineering controls must be maintained, tested and records kept (r.10,11) Annual dose limits must not be exceeded (r.12)

28 IRR2017 schedule 3 Dose Limits
Type of limit Employee & trainees > 18 Trainee < 18 Others Effective dose 20 mSv/y a Equivalent dose Lens of the eye 20 mSv/y b Skin c 500 mSv/y Extremities d a /y = in a calendar year, i.e. 1st January to 31st December b With HSE permission up to 50 mSv/y if total in 5 years < 100 mSv (i.e. average <20mSv/y) c averaged over 1 cm2 d “extremities” means a person’s hands, forearms, feet and ankles e overaged over 5 years, as long as < 50 mSv in every year f if resulting from medical exposure of another, total in 5 years must be < 5mSv This regulation does not apply to persons undergoing medical exposures

29 IRR2017 schedule 3 Dose Limits
Type of limit Employee & trainees > 18 Trainee < 18 Others Effective dose 20 mSv/y a 6 mSv/y Equivalent dose Lens of the eye 20 mSv/y b 15 mSv/y Skin c 500 mSv/y 150 mSv/y Extremities d a /y = in a calendar year, i.e. 1st January to 31st December b With HSE permission up to 50 mSv/y if total in 5 years < 100 mSv (i.e. average <20mSv/y) c averaged over 1 cm2 d “extremities” means a person’s hands, forearms, feet and ankles e overaged over 5 years, as long as < 50 mSv in every year f if resulting from medical exposure of another, total in 5 years must be < 5mSv This regulation does not apply to persons undergoing medical exposures

30 IRR2017 schedule 3 Dose Limits
Type of limit Employee & trainees > 18 Trainee < 18 Others Effective dose 20 mSv/y a 6 mSv/y 1 mSv/y f Equivalent dose Lens of the eye 20 mSv/y b 15 mSv/y Skin c 500 mSv/y 150 mSv/y 50 mSv/y Extremities d a /y = in a calendar year, i.e. 1st January to 31st December b With HSE permission up to 50 mSv/y if total in 5 years < 100 mSv (i.e. average <20mSv/y) c averaged over 1 cm2 d “extremities” means a person’s hands, forearms, feet and ankles e overaged over 5 years, as long as < 50 mSv in every year f if resulting from medical exposure of another, total in 5 years must be < 5mSv This regulation does not apply to persons undergoing medical exposures

31 Reg 13 Contingency plan “Where . . .a radiation accident is reasonably foreseeable the employer must prepare a contingency plan designed to secure, so far as is reasonably practicable, the restriction of exposure to ionising radiation and the health and safety of persons who may be affected by such accident.” r.2 “’radiation accident’ means an accident where immediate action would be required to prevent or reduce the exposure to ionising radiation of employees or any other persons;” r.3 Does apply to persons undergoing medical exposures Train staff. Where appropriate rehearse at suitable intervals. If contingency plans triggered then: (i) Analyse what happened and determine reasonable measures to prevent it happening again; (ii) Record the analysis and kept for at least 2 years, and, (iii) Note on dose record of affected persons if they received extra dose. The medical exposures exclusion in r.3(3) does not include r.13. However, r.13 applies where an r.8 risk assessment shows a accident is reasonably foreseeable and r.9 does not apply to persons undergoing medical exposures. So effectively r.13 does not apply to persons undergoing medical exposures.

32 CONTINGENCY PLANS & ACCIDENTAL OVEREXPOSURE
Example (1) of contingency plans from Interventional Radiology Theatres , HRI CONTINGENCY PLANS & ACCIDENTAL OVEREXPOSURE If the exposure warning light remains on after the footswitch has been released, or any other fault is indicated or suspected, the X-ray set should be immediately isolated from the mains supply by the fastest means possible (emergency off buttons in the x-ray room or control room). It must not be used again clinically until an investigation has resulted in a satisfactory explanation, and remedial work has been carried out. A ‘do not use’ sign must be attached to the unit If anyone enters the room without wearing adequate protection, the footswitch must be released as soon as possible, if this does not adversely affect patient safety. The person must be removed from the controlled area and the RPS/RPA must be contacted. If as a result of malfunction or defect, a patient undergoing a medical exposure may have been exposed to ionising radiation to an extent very much greater than intended, the incident must be investigated immediately. Unless this demonstrates beyond reasonable doubt that no such incident occurred, it must be notified to your Radiation Protection Adviser.

33 Know where the emergency off buttons are located
Example (1) of contingency plans from Interventional Radiology Theatres , HRI CONTINGENCY PLANS & ACCIDENTAL OVEREXPOSURE If the exposure warning light remains on after the footswitch has been released, or any other fault is indicated or suspected, the X-ray set should be immediately isolated from the mains supply by the fastest means possible (emergency off buttons in the x-ray room or control room). It must not be used again clinically until an investigation has resulted in a satisfactory explanation, and remedial work has been carried out. A ‘do not use’ sign must be attached to the unit If anyone enters the room without wearing adequate protection, the footswitch must be released as soon as possible, if this does not adversely affect patient safety. The person must be removed from the controlled area and the RPS/RPA must be contacted. If as a result of malfunction or defect, a patient undergoing a medical exposure may have been exposed to ionising radiation to an extent very much greater than intended, the incident must be investigated immediately. Unless this demonstrates beyond reasonable doubt that no such incident occurred, it must be notified to your Radiation Protection Adviser. Know where the emergency off buttons are located

34 Know where the emergency off buttons are located
Example (1) of contingency plans from Interventional Radiology Theatres , HRI CONTINGENCY PLANS & ACCIDENTAL OVEREXPOSURE If the exposure warning light remains on after the footswitch has been released, or any other fault is indicated or suspected, the X-ray set should be immediately isolated from the mains supply by the fastest means possible (emergency off buttons in the x-ray room or control room). It must not be used again clinically until an investigation has resulted in a satisfactory explanation, and remedial work has been carried out. A ‘do not use’ sign must be attached to the unit If anyone enters the room without wearing adequate protection, the footswitch must be released as soon as possible, if this does not adversely affect patient safety. The person must be removed from the controlled area and the RPS/RPA must be contacted. If as a result of malfunction or defect, a patient undergoing a medical exposure may have been exposed to ionising radiation to an extent very much greater than intended, the incident must be investigated immediately. Unless this demonstrates beyond reasonable doubt that no such incident occurred, it must be notified to your Radiation Protection Adviser. Know where the emergency off buttons are located If this happens a Datix form must be completed

35 Know where the emergency off buttons are located
Example (1) of contingency plans from Interventional Radiology Theatres , HRI CONTINGENCY PLANS & ACCIDENTAL OVEREXPOSURE If the exposure warning light remains on after the footswitch has been released, or any other fault is indicated or suspected, the X-ray set should be immediately isolated from the mains supply by the fastest means possible (emergency off buttons in the x-ray room or control room). It must not be used again clinically until an investigation has resulted in a satisfactory explanation, and remedial work has been carried out. A ‘do not use’ sign must be attached to the unit If anyone enters the room without wearing adequate protection, the footswitch must be released as soon as possible, if this does not adversely affect patient safety. The person must be removed from the controlled area and the RPS/RPA must be contacted. If as a result of malfunction or defect, a patient undergoing a medical exposure may have been exposed to ionising radiation to an extent very much greater than intended, the incident must be investigated immediately. Unless this demonstrates beyond reasonable doubt that no such incident occurred, it must be notified to your Radiation Protection Adviser. Know where the emergency off buttons are located If this happens a Datix form must be completed

36 Example (2) of contingency plans from Nuclear Medicine, HRI & CHH
A lot longer than for X-ray, as risk from liquid radioactive substances, includes Emergency telephone numbers for staff and authorities Spills and contamination Clothing, skin, hair Open would/needlestick Ingestion or inhalation Surfaces Missing, stolen sources Fire Delivery of wrong radioactive material Transport accidents Annual rehearsal

37 Contingency plan HSE Guidance 2017
In particular, the plan should identify: (a) who is responsible for putting the plan into effect; (b) what immediate actions for assessing the seriousness of the situation are necessary, for example the use of suitable radiation and contamination monitors; (c) what immediate mitigating actions are needed, for instance in clearing the accident area and establishing temporary means of preventing access to that area; (d) what emergency equipment is required to deal with identified accidents and where this can be found; (e) other sources of information and guidance, such as equipment manufacturers and contact details; (f) what PPE is needed and where it can be found; (g) what personal dosimetry requirements there are for people involved in controlling the accident; (h) what training is required for employees; (i) how to obtain radiation protection expertise so that proper judgements can be made about the seriousness of the situation and the measures necessary to recover from it; (j) under what circumstances to contact the emergency services and who is responsible for doing this; (k) what dosimetry follow-up is needed so that the people affected by the accident are identified and provision is made for their dose assessment.

38 Reg 14 Radiation Protection Adviser (RPA)
Must have qualification approved by HSE (e.g. RPA2000 certificate) Must be appointed in writing, Must provide RPA with adequate information & facilities Must be consulted on controlled and supervised areas prior examination of plans regular calibration of dose monitoring equipment periodic testing of safety features and warning devices risk assessment of new radiation work incidents where more then 6 mSv has been received critical examination of safety features of new radiation equipment and as necessary for advice on observing IRR17 (Unless schedule 1 work only - i.e. trivial exempt work)

39 Reg 15 Education, training and provision of information
Radiation workers must be adequately trained, including general and specific risks and safety procedures Adequate information to others directly concerned Female workers informed of risk to foetus and importance of informing employer if pregnant/breast feeding Training must be specific to the controlled area they work in Repeat training at suitable intervals and document If HASS used training in specific requirement r.15(1)(b) “other persons who are directly concerned with the work with ionising radiation” – does this applies to persons undergoing medical exposures?

40 Reg 15 & HASS training (2) In addition to the requirements in paragraph (1), every employer who is engaged in work with ionising radiation involving a high-activity sealed source must ensure that the information and training given to employees involved in such work includes— (a) specific requirements for the safe management and control of high-activity sealed sources for the purpose of preparing such employees for any events which may affect their radiation protection; (b) particular emphasis on the necessary safety requirements in connection with high-activity sealed sources; and (c) specific information on the possible consequences of the loss of adequate control of high-activity sealed sources.

41 Reg 16 Cooperation between employers
“Where work with ionising radiation undertaken by one employer is likely to give rise to the exposure to ionising radiation of the employee of another employer, the employers concerned must co-operate by the exchange of information or otherwise to the extent necessary to ensure that each such employer – has access to information on the possible exposure of their employees to ionising radiation; and is enabled to comply with the requirements of these Regulations in so far as their ability to comply depends upon such co-operation.

42 Reg 16 Cooperation between employers
“Where work with ionising radiation undertaken by one employer is likely to give rise to the exposure to ionising radiation of the employee of another employer, the employers concerned must co-operate by the exchange of information or otherwise to the extent necessary to ensure that each such employer – has access to information on the possible exposure of their employees to ionising radiation; and is enabled to comply with the requirements of these Regulations in so far as their ability to comply depends upon such co-operation. e.g. Working in two NHS Trusts Working in private hospital and NHS hospital Company rep helping train in use of or set up new equipment Private cleaners in NHS hospital Note, dose limits, etc. apply to the sum of doses from all work undertaken by an individual person.

43 Reg 16 Cooperation between employers
“Where work with ionising radiation undertaken by one employer is likely to give rise to the exposure to ionising radiation of the employee of another employer, the employers concerned must co-operate by the exchange of information or otherwise to the extent necessary to ensure that each such employer – has access to information on the possible exposure of their employees to ionising radiation; and is enabled to comply with the requirements of these Regulations in so far as their ability to comply depends upon such co-operation.

44 Example for HEY & Spire Staff will adopt the safety policies and procedures of their respective employer upon working on their site Dose monitoring of HEY staff for Spire Healthcare sessions will be carried out through the Spire Healthcare user departments and copies of dose records shall be forwarded to the HEY Radiology Department. Any exposure or potential increase in exposure likely to result in designation of the employee as a classified worker, or other untoward occurrences will be discussed with the health service Radiation Protection Adviser and Spire Healthcare Radiology manager forthwith.

45 Reg 17 Designation of controlled or supervised areas
Controlled Area must be designated for any area where it is necessary to follow special procedures to restrict significant exposure, or any area where it is likely that annual E > 6 mSv, Hlens > 15 mSv, or Hskin> 150 mSv (ACoP gives further advice on where special procedures will be necessary) This regulation does not apply to persons undergoing medical exposures

46 Example – CT scanner room
When CT Scanner switched on at mains electrical supply

47 Example – Dental intraoral X-ray
1.5 m from patient and tube when tube X-ray beam on

48 Examples – mobile X-ray on ward
2 metres around and from the patient/X-ray tube is defined as a Controlled Area when the equipment is energized

49 Example – mobile fluoroscopy in theatre
the operating theatre is the controlled area when the set is energized.

50 Example – nuclear medicine store
Permanent Controlled Area

51 Reg 17 Designation of controlled or supervised areas
where it is necessary to keep the conditions of the area under review to determine whether the area should be designated as a controlled area, or any area where it is likely that annual E > 1 mSv, Hlens > 5 mSv, or Hskin> 50 mSv This regulation does not apply to persons undergoing medical exposures

52 Example Storeroom next to a Controlled Area where low occupancy means low doses and no controls necessary But if the storeroom is turned into an office, high occupancy would lead to too high a dose.

53 This regulation does not apply to persons undergoing medical exposures
Controlled Area Supervised Area Needs special precautions, or Annual doses likely to exceed E > 6 mSv, Hlens > 15 mSv, or Hskin> 150 mSv Needs to be kept under review, or Annual doses likely to exceed E > 1 mSv, Hlens > 5 mSv, or Hskin> 50 mSv This regulation does not apply to persons undergoing medical exposures

54 Reg 18 Local rules & radiation protection supervisors
The employer must have Local Rules for Controlled Areas (and if appropriate Supervised Areas) identify the main working instructions intended to restrict any exposure take reasonable steps to see that they are carried out bring then to the attention of anyone they may affect have a Radiation Protection Supervisor ( RPS) where there are Local Rules. This regulation does not apply to persons undergoing medical exposures

55 Local Rules – HSE Essential Content
How to work safely in that area Must contain Dose investigation levels contingencies for foreseeable accidents RPS (radiation protection supervisor) name describe area covered work instructions for unclassified workers Refer to other working instructions, equipment manuals, etc. as appropriate.

56 For HEY Trust the DIL’s are
26/04/2019

57 26/04/2019 Hull & East Yorkshire Hospitals’ dose investigation levels
Radiation Protection Adviser 26/04/2019

58 Local Rules – HSE Optional Content
Could also contain management and supervision of work testing and maintenance of safety features radiation and contamination monitoring testing of monitors personal dosimetry arrangements for pregnant and breast feeding staff risk assessments programme to review ALARA RPA contact System for information and training.

59 Radiation Protection Supervisor R.P.S.
Must be appointed “for the purpose of securing compliance with these Regulations” in controlled or supervised areas Name must be in Local Rules It is recommended that know & understand regs. and local rules command sufficient authority understand necessary precautions know what to do in an emergency.

60 Reg 19 Additional requirements for designated areas
Controlled and Supervised Areas must be adequately described in Local Rules have suitable & sufficient warning signs be physically demarcated where reasonably practicable, or by some other means This regulation does not apply to persons undergoing medical exposures

61 Reg 19 Additional requirements for designated areas
The employer must not permit a person to enter their Controlled Area unless They are one of their “Classified Persons”, or They are a “classified outside worker” (i.e. another employer’s “Classified Person”) who has been suitably trained, is dose assessed and certified fit to do the job, or enter in accordance with suitable written arrangements (i.e. “Local Rules”) This regulation does not apply to persons undergoing medical exposures

62 Reg 19 Additional requirements for designated areas
The written arrangements must ensure Non-classified persons will not get a dose above a classification trigger level, and Classified persons do not go above dose limits This regulation does not apply to persons undergoing medical exposures

63 Reg 19 Additional requirements for designated areas
Non-classified outside worker must be provided with PPE and training No person can enter Controlled Area unless “personal dose monitoring or other suitable measurements” shown dose limits (or classification levels for unclassified staff) will not be exceeded Results must be kept for at least 2 years Results must be available to those monitored on request This regulation does not apply to persons undergoing medical exposures

64 Reg 19 Additional requirements for designated areas
For “classified outside workers” Arrangement needed for estimating dose When finished dose to go in worker’s radiation passbook This regulation does not apply to persons undergoing medical exposures

65 This regulation does not apply to persons undergoing medical exposures
Reg 19 continued . . . If risk of contamination with radioactive substances, have arrangements to stop this spreading and at least a) the provision of suitable and sufficient washing and changing facilities for persons who enter or leave any controlled or supervised area; (b) the proper maintenance of such washing and changing facilities; (c) the prohibition of eating, drinking or smoking or similar activity likely to result in the ingestion, inhalation or absorption of a radioactive substance by any employee or outside worker in a controlled area; and (d) the means for monitoring contamination — (i) within a controlled area and, where appropriate, in the adjacent area; and (ii) on any person, article or goods leaving a controlled area. This regulation does not apply to persons undergoing medical exposures

66 Reg 20 Monitoring of designated areas
Must adequately monitor levels of radiation in controlled/supervised areas (not just using individual doses) Monitors must be tested before first use then regularly and records kept under the supervision of a qualified person (2) Adequate monitoring …must include — Dose rate measurements for external radiation, Measurements of air activity and surface contamination where appropriate for internal radiation (6) Suitable records of the results of the monitoring … must be checked by a qualified person, kept for at least 2 years and must include - (a) For external radiation, an indication of the nature and quality of the radiation; (b) For internal radiation, an indication, where appropriate, of the nature and physical and chemical states of the radioactive contamination.

67 Reg 21 Designation of classified person
If likely to receive > 6 mSv effective dose > 15 mSv lens of eye dose limit > 150 mSv extremity or skin limit Must be > 18 years old Signed as fit by relevant doctor

68 HEY Hospitals 2017 – Effective Dose
Department Highest Annual Dose (mSv) Average Monthly Dose (mSv) Local Dose Investigation Level (mSv/year) Nuclear Medicine 1.5 0.2 4 CHH Cardiology 0.5 0.02 1 CHH Urology 0.12 0.01 CHH X-ray 0.82 0.1 4.2 CHH BSU HRI X-Ray Maxilla Facial Radiotherapy 0.3 Physics 0.6 DSU3 CHH Ortho Theatres CHH

69 HEY Hospitals 2017 – Finger Dose
Department Highest Annual Finger Dose (mSv) Average Monthly Finger Dose (mSv) Local Dose Investigation Level (mSv/year) Nuclear Medicine - Technologists 47 1.7 84 Nuclear medicine - Physicists 6 0.1 12 Nuclear medicine - Pharmacists 14 0.6 Nuclear medicine - medical 5 Nuclear medicine – aux staff 0.2 CHH Cardiology 32 3 120 CHH X-ray 19 HRI X-Ray 38 4

70 Regulation 22 Dose assessment and recording
Applied to classified persons only Dose monitored and recorded to age 75 and at least for 30 years with an HSE Approved Dosimetry Service - results to HSE Radiation passbook for “outside workers” Adequate (at least yearly) medical surveillance - record to 75 and at least for 30 y

71 Reg 23 Estimated and notional doses and special entries
What to do if classified person’s dose badge lost or damaged is clearly wrong

72 Reg 24 Dosimetry for accidents etc
If accident likely to cause > 6 mSv effective dose > 15 mSv lens of eye dose limit > 150 mSv extremity or skin limit Then Have personal dosemeter read, or if none assess dose Tell person their dose Notify HSE Keep dose record until person would have been 75 years old, and at least 30 years

73 Reg 25 Medical surveillance
Applies to All classified persons Others employees who have exceeded a dose limit Employees working under health restrictions. “.. relevant doctor ..” Keep dose record until person would have been 75 years old, and at least 30 years 28 days to appeal

74 Reg 26 Investigation and notification of overexposure
If dose limit may have been exceeded must investigate immediately If not beyond reasonable doubt that no overexposure then as soon as practicable Notify HSE If outside worker, notify their employer Notify relevant doctor The overexposed person Investigate what went wrong and how to prevent reoccurrence and report to list above. Records 75 age or +30y

75 Reg 27 Dose limitation for overexposed employees
If dose limit of employee exceeded, for the rest of the year must not exceed the equivalent limit for the remaining period e.g. Radiopharmacy worker receives over 500 mSv finger skin dose between 1st January and 30th April. For remaining 8 months of year they must not exceed 8/12 x 500 = 333 mSv skin dose.

76 Reg 28 Sealed sources and articles containing or embodying radioactive substances
Use sealed sources when reasonably practicable Design and maintain them so they don’t leak Undertake suitable leak testing and keep records for at least 2 years after disposal of source or until next leak test

77 Reg 29 Accounting for radioactive substances
Audit sources and keep records for 2 years and at least 2 years after disposal.

78 Reg 30 Keeping and moving of radioactive substances
Keep sources in suitable receptacles in suitable stores when not being moved When being moved, transport in a suitable, labelled receptacle Doesn’t apply if source inside a live body or corpse of a human being

79 Reg 31 Notification of certain occurrences
Notify HSE if spill or release of more than Schedule 7 Part 1 column 5 level (e.g. 10,000 GBq 99Tcm) Notify HSE if lost or stolen more than Schedule 7 Part 1 column 6 level (e.g. 0.1 GBq 99Tcm) Investigate immediately, make report and keep for 50 years (2 years if investigation shows no spill above levels)

80 This regulation does not apply to persons undergoing medical exposures
Reg 32 Duties of manufacturers etc of articles for use in work with ionising radiation Installers must undertake a Critical Examination of safety features and warning devices to ensure they work and are sufficient. They must consult an RPA. articles must be designed to keep doses ALARP Installer must provide adequate info to user on proper use, testing and maintenance. This regulation does not apply to persons undergoing medical exposures

81 Reg 33 Equipment used for medical exposure

82 Reg 34 Misuse of or interference with sources of ionising radiation
“No person may intentionally or recklessly misuse or without reasonable excuse interfere with any radioactive substance or any electrical equipment to which these Regulations apply.” Applies to employees and public, and not just employers.

83 Reg 35 Duties of employees
Employees must not knowingly expose themselves or others to a dose greater than reasonably necessary (does not apply to those undergoing medical exposures) If medical surveillance required, must undergo Report suspected overexposures Employees and outside workers must use PPE provided, report any defects and return after use to accommodation provided This regulation does not apply to persons undergoing medical exposures

84 IRR 1999/2017 Reg 37 Approval of dosimetry services
Now includes emergency dosimetry Reg 37 Defence on contravention No significant changes Reg 38 Exemption certificates No significant changes – at HSE discretion Reg 39 Extension outside Great Britain Same etc.

85 Here on end of 11/10/18 (L5)


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