Radiation Protection Regulations in the UK

Craig MooreRadiation Protection Adviser

Radiation Physics DepartmentCHH Oncology

But first…..

• What we do in Radiation Protection – We are part of Radiation Physics Service (other half is

Radiotherapy Physics)– Based in Oncology CHH– We provide scientific and technical support in the

fields of • Ionising (x-rays, etc.) and non-ionising (lasers, UV, MRI, etc.)

radiation safety • Diagnostic imaging physics (including equipment quality

assurance)• Radiotherapy metrology, treatment planning, equipment

management • Research & development • Teaching & training

Who are we??

• Radiation Protection Advisers– John Saunderson – x76-1329– Craig Moore – x76-1385

• Rad’n Prot’n Team– Andrew Davis, Dave Strain, Tim Wood – ext. 76-1330

• Radiation Protection website– www.hullrad.org.uk

• Trust Policy CP137

What’s the Point in Legislating?• Ionising radiation such as X-rays can

cause the following effects:– Tissue effects such as skin burns

and loss of hair– Stochastic effects (per 1 mSv)

• 1 in 20,000 risk of fatal cancer• 1 in 100,000 risk of non fatal

cancer• 1 in 77,000 risk of hereditary

effects• Staff receive radiation doses from X-

rays that scatter from the patient and radiation emanating from patient

• Ionising radiation is invisible so you can’t see or smell it, hence it can cause damage without you knowing about it (at first!!!)

The Ionising Radiations Regulations 1999 (IRR99)

• Protection of– Staff– Public

from ionising radiation

Authorisation

• Enforced by the Health and Safety Executive

Structure of IRR99

• 7 ‘Parts’

• 41 Regulations

• 9 Schedules

• Approved Code of Practice - Statutory Guidance (HSE approved)

• Non-statutory guidance (i.e. guidance notes)

Statutory and Non-Statutory Guidance

• Approved code of Practice & HSE Guidance

• Medical & Dental Guidance Notes

So what’s included in IRR99

• General Principles and Procedures– Risk assessment– Dose restriction– Dose limitation

• Arrangements for the Management of Radiation Protection– Radiation Protection Adviser– Radiation Protection Supervisor– Local Rules

• Designated Areas– Controlled Areas

• Classification and Monitoring of Persons– Dose badges

• Control of Radioactive Substances• Duties of Employees

– All of us have duties under these regulations

Reg 7: Prior Risk Assessment• Must be undertaken before

work commences with ionising radiations– Identify hazards– Decide who might be

harmed and how– Evaluate risks and decide

whether existing precautions are adequate or not

– Record findings of risk assessment

– Review and revise it• By Law has to be done (or

approved) by a certified Radiation Protection Adviser

Reg 8: Restriction of Exposure• Doses must be optimised

– As Low As Reasonably Practicable (ALARP)

• Hierarchy of protection measures:

– Engineering controls such as the design of X-ray tubes and shielding

– Systems of work such as local rules

– PPE such as lead aprons

– Dose constraints (planning)

• 1 mSv to foetus during declared term

• Formal Investigation levels of staff dose

Regs 9: Personal Protective Equipment

• Should be provided where necessary

• Should comply with PPE regulations

• Should be properly maintained

Lead Apron Storage

• Always return to hanger• Do not

– fold– dump on floor and run trolleys

over the top of them!!!

• X-ray will check annually• But if visibly damaged, ask

X-ray to check them.

Reg 10: Engineering Controls

• All safety features of an installation must be maintained and tested at suitable intervals

• QA manual should spell out who does what (user, engineer, physics etc)

Reg 11: Staff and public dose limits

BUT FIRST…..

Radiation Dose• Absorbed Dose (Jkg-1)

– Amount of energy deposited per kilogram – Dose to an organ or tissue– Unit is the Gray (Gy)

• DOSE TO A CERTAIN PLACE IN THE BODY

• Effective Dose (Jkg-1)– This is the average dose to whole body– Unit is the Sievert (Sv)– This gives us the risk of contracting cancer of the x ray exposure

• THIS IS THE OVERALL DOSE TO THE WHOLE BODY

RADIATION TISSUE

External and Internal dose

• Dose from external sources– X-ray– Radiation emanating from patient (Nuclear Medicine

and Brachytherapy)– Contamination of work surfaces etc

• Dose from internal sources:– Ingestion– Inhalation– Absorption– Committed effective dose

• Dose delivered due to deposition of radionuclide in the body

Reg 11: Dose Limits for staff & public (mSv) per calendar year

Staff Public

Effective dose 6 1

Lens of eye 45 15

Skin 150 50

Hands, legs etc 150 50

Possibly changing to 6 mSv/yr in a couple of years

Dose Monitoring• Most employees who work

with radiation in a Hospital Trust have radiation monitoring badges.

• These monitor the exposure to radiation of an employee

• Doses received are assessed by the RPA to ensure they are being kept ALARP

• BUT, it is also an RPS duty to monitor results

• Please ensure your staff wear and return it promptly

• There have been recent prosecutions for not doing so under these regulations

Typical Dose Monitoring Results across the Trust

• Physics:– Typically less than 0.1 mSv/month– This equates to less than 1 mSv/yr– Much lower than legal limit of 6 mSv/yr

• Radiotherapy:– Typically less than 0.1 mSv/month– This equates to less than 1 mSv/yr– Much lower than legal limit of 6 mSv/yr

• Nuclear Medicine:– Typically less than 0.3 mSv/month– This equates to less than 4 mSv/yr– Lower than legal limit of 6 mSv/yr

• Radiology:– Typically less than 0.3 mSv/month– This equates to less than 4 mSv/yr– Lower than legal limit of 6 mSv/yr

• Dental:– Typically less than 0.1 mSv/month– This equates to less than 1 mSv/yr– Much lower than legal limit of 6 mSv/yr

• Under reg 8 we have to set dose investigation levels

Dose Investigation Levels

• Physics:– 0.1 mSv/month

• Radiotherapy:– 0.1 mSv/month

• Nuclear Medicine:– 0.5 mSv/month

• Radiology:– 0.35 mSv/month

• Dental:– 0.1 mSv/month

• Breast Screening:– 0.1 mSv/month

Women of reproductive capacity

• Refers to ‘women at work’

• But 1 mSv to foetus during declared term

Exclusions to Dose Limits

• Comforter and Carer– These knowingly and willingly incur an

exposure having been fully advised of the risks

– Not as part of their job

• What about the other?

• Persons undergoing medical exposure

Reg 12: Contingency plans• Contingency plan required for

‘reasonably foreseeable’ accident• Radiotherapy:

– Emergency stop buttons• In Brachytherapy if the source fails to

retract during treatment:– Take out applicators and place in lead

pot– Wire cutters may be needed in some

instances!• Radiology:

– Emergency stop buttons• Nuclear Medicine:

– Spills and contamination• Plan must be documented in Local

Rules• Must be rehearsed at appropriate

intervals dependent on:– Potential severity– Likely doses– Complexity of plan– Number of people involved– Involvement of emergency services

Part 3

Arrangements for the Management of

Radiation Protection

Reg 13: Radiation Protection Adviser

• RPA must be suitably qualified– Must be certified by HSE approved body

• Employer must consult RPA on the following matters:– Implementation of Controlled and Supervised Areas (eg signage)– Prior examination of plans for installations and the acceptance into service of new or

modified sources of radiation in relation to safety and warning features– Regular calibration of equipment provided for monitoring levels of ionising radiation– Regular checking of systems of work provided to restrict exposure to ionising radiation

• In addition, employer should consult RPA on:– Risk assessment– Designation of controlled areas– Conduct of investigations– Drawing up of contingency plans– QA programmes

• In this Trust:– Craig Moore– John Saunderson

Reg 14: Information, Instruction and Training

• Employees must receive adequate training– Risks from ionising

radiations– Precautions to reduce

risk– Importance of

complying with regs• Also need training under

the IRMER regulations (much more physics!!!!!)

Reg 15: Cooperation between employers

• If staff work in controlled areas of other employers (private hospitals for example)– Must be able to

demonstrate that total dose is less than 6 mSv/yr

– Improvement notice has been issued at another Trust recently

• Also needs to be clear which procedures staff members have to follow– HEY Trust or other

employer

Part 5

Designated Areas

Reg 16: Designation of Controlled and Supervised Areas

• Based on risk assessment• Controlled

– ……..if it is necessary to follow special procedures to restrict significant exposure to ionising radiation in that area or prevent or limit the probability and magnitude of radiation accidents of their effects,

– or any person working in that area likely to receive effective dose greater than 6 mSv or 3/10 of any other dose limit (eye, hands etc)

Reg 16: Controlled Areas• External Beam Radiotherapy:

– LINAC treatment room including the maze when the unit is switched on

• Brachytherapy:

– Whole of treatment room whilst the treatment unit is capable of sending source out

• Radiology & BSU:

– Whole room when the unit is switched on

• Nuclear Medicine:

– Radiopharmacy

– Dispensing room

– Waste Store

– Therapy Room

• Dental:

– 1.5m or 2 m from the patient (depending on workload)

Reg 17: Local Rules & Radiation Protection Supervisors

• Local rules must be provided for controlled areas

• RPS’s must be appointed if an area is subject to local rules

Local Rules

• Local Rules must be written and adhered to for every radiation controlled area

• Essential contents of local rules include:– Dose investigation level– Contingency arrangements– Name of radiation protection supervisor & Adviser– Identification of area covered– Working instructions

• Local rules may also contain management and supervision of the work

• Testing of engineering controls• Radiation monitoring• Testing of monitoring equipment• Personal dosimetry• Arrangement for pregnant and breastfeeding staff

Reg 17: Radiation Protection Supervisor

• There to ensure local rules are being followed

• Knowledge of regulations and Local Rules

• Ability to command respect

• Understanding of precautions required and extent to which these will restrict exposures

RPS must be adequately trained

Reg 18: Additional requirements for designated areas

• Physical demarcation of controlled areas

• Warning signs (controlled and supervised)

• Entry restricted to controlled areas

Reg 19: Monitoring of Designated Areas

• Legal requirement to monitor dose rates around controlled area at commissioning

• Monitoring at appropriate frequencies

• Monitoring recorded and reviewed

• Results kept for two years by qualified person

• Monitoring equipment maintained and tested at regular intervals

• Also carry out monitoring with badges stuck on walls every couple of years

Reg 21: Dose assessment and recording

• In this Trust, anyone working in a radiation controlled area must wear a dose badge– Unless the dose to this

employee can be shown to be low by other means

Regs 27 to 30• About control of radioactive substances• Reg 27:

– Sources should be sealed if possible– Containers must be fit for purpose– Suitable leak tests must be carried out

• Reg 28:– Accounting for sources– Must know where all sources are at any time

• Reg 29:– Keeping and moving of sources– Suitable stores– Suitable receptacle for moving

• Reg 30:– Have to notify HSE if radioactive substance is no longer under his

control

Reg 31:Duties of Manufacturers

• Design & construct X-ray units and other articles to restrict exposure & ALARP

• Perform critical examination upon installation

• Safety features

• Consult RPA on crit ex• Provide proper

instructions on proper use, testing and maintenance

Reg 32: Quality Assurance Programme

• A suitable quality assurance programme to be provided ensuring that equipment remains capable of restricting exposure to radiation– Adequate testing before

clinical use– Adequate testing of the

performance throughout lifetime of equipment

– Assessment of representative doses

• Handover procedure(s)– As an engineer you must

ensure that after you have tested the equipment, it is handed back in a clinically fit state

All X Ray Equipment

• Should have a lights on the control panel to show mains switched on

• Fitted with a light/indications that gives a clear indication that an exposure is taking place

• Exposure switches/peddles should only function while continuous pressure is applied

Reg 34: Duties of Employees

• Must not recklessly interfere with sources

• Must not expose themselves unnecessarily

• Report immediately to the RPS/Employer if an incident or accident has occurred

Duties of Employees – DO NOTS

• DO NOT X-ray yourself (even if you think you have broken a bone)

• DO NOT X-ray your colleagues (even if you suspect they have broken a bone)

• DO NOT fail to use lead glass screen properly

• DO NOT fail to wear lead aprons and thyroid collars (if you have a thyroid collar!!)

• DO NOT fail to wear any other PPE correctly

• DO NOT fail to report to your RPS any defects in lead aprons

• DO NOT fail to return lead aprons to their hangers

• DO NOT tamper with dose badges • DO NOT hand badges in late• DO NOT fail to wear badges UNDER your

lead apron• DO NOT fail to inform your RPS if you

believe yourself or someone else has received an overexposure

Notification of Incidents

• Must report to external body when the dose to a patient is ‘much greater than intended’– If it was a machine fault this must be reported

to the HSE– If any other fault (e.g. radiographer) then

inform Care Quality Commission

Exposures much greater than intended

• Diagnostic multiplying factors• HIGH DOSE PROCEDURES

– Barium, angio, NM(>5 mSv), CT• 3 x

• MEDIUM DOSE PROCEDURES– Lumber spine, abdo, pelvis, mammo

• 10 x• LOW DOSE PROCEDURES

– Extremities, skull, dental, chest• 20 x

– Radiotherapy (inc NM therapy)• Whole course x 1.1• One fraction x 1.2

– Also:– Incorrect patient– Incorrect anatomy of the correct patient

Incidents• Any untoward occurrence

that may have resulted in excess radiation to staff or patients must be referred to the RPS and RPA

• The RPA will estimate the dose and inform management, HSE, CQC etc if necessary

• Suspect equipment must be withdrawn from service and labelled accordingly.

Female Staff of Child Bearing Age

• Staff working with radiation are naturally concerned to minimise the risk to a foetus should they become pregnant

• IRR99 places the onus on the employer to provide adequate information and on the employee to inform that they are pregnant

• The employer must:– ensure that the dose to the

foetus does not exceed 1 mSv– Notify female employees

working with radiation the risk to the foetus, and the importance of informing the employer in writing as soon as they are pregnant

Doses and Risk to the Foetus

• Current legal limit to foetus is 1 mSv• For X-ray, this corresponds to around 2 mSv to the

abdomen• Assuming 8 months of declared pregnancy, dose to

abdomen must be kept below 0.25 mSv per month• For X-ray, over many years, experience tells us that

these dose levels are never reached in most areas of Trust, assuming Local Rules are followed

• Only areas that work may need to cease is when using radioactive sources– Dose to abdomen = dose to fetus (e.g. higher energies from

Tc99m)

Conclusions – Staff Pregnancy

• Staff should inform their RPS as soon as they learn that they are pregnant

• RPA must then carry out a risk assessment (if required)

• Usually, provided Local Rules are followed, there are no grounds for amending staff working practice during pregnancy

Compliance with the Regulations

• HSE Inspectorate• Regional specialist

inspectors• Powers of

enforcement– Improvement notice– Prohibition notice– Prosecution

• Unlimited fine• Maximum 2 years in

prison

Ionising Radiation (Medical Exposure) Regulations 2000 -

IRMER

Principles of Radiation Protection

• JUSTIFICATION– Benefit of the radiation exposure must outweigh

risk

• OPTIMISATION– As Low As Reasonably Practicable (ALARP)

• LIMITATION

What is IRMER?• The Ionising Radiation (Medical Exposure) Regulations 2000• The regulations apply to the following medical exposures:

– The exposure of patients as part of their 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

• ‘Medical exposure’ means an exposure to ionising radiation, such as:– Diagnostic X-rays, CT and DEXA– Radiotherapy (including brachytherapy and therapy using unsealed

radioactive sources– Radionuclide imaging (including diagnostic imaging and in vitro

measurements in Nuclear Medicine Dept)• MRI and Ultrasound are not covered by IRMER

IRMER

• IRMER specifically places duties on those professionals responsible for the patient exposure to ionising radiation

Main Duty Holders under IRMER

• Employer

• Referrer

• IRMER Practitioner

• Operator

• Medical Physics Expert (MPE)

Referrer• Registered Healthcare

professional who is entitled in accordance with the with the employer’s procedures to refer individuals for medical exposure to an IRMER Practitioner

• Must have access to referral criteria

• Must supply the IRMER practitioner with sufficient medical data to help him justify exposure. Reg 5(5)

• In HEY, those who are allowed to act as referrers are depends on department – written procedure must be in place

IRMER Practitioner• Registered healthcare professional who is entitled in

accordance with the employer’s procedures to take responsibility for an individual medical exposure

– Must justify exposure– Must authorise exposure (or delegate)– Must be adequately trained – IRMER reg 11– May delegate practical aspects (operator)

In HEY dependent on department and modality – must be a written procedure

IRMER Practitioner

MAIN ROLE IS TO JUSTIFY THE MEDICAL EXPOSURE

BENEFITS OF THE EXPOSURE vs RISKS

Operator• Any person who is entitled, in

accordance with employer’s procedures, to carry out practical aspects of the exposure

• Functions and responsibilities of individual operators must be clearly defined in employer’s procedures

• Need to be adequately trained – IRMER reg 11

• No overarching responsibility allowed

• MUST optimise every exposure

Medical Physics Expert (MPE)• An MPE must be involved in every medical

exposure to which the IRMER regulations apply and shall be:

– Closely involved in every radiotherapeutic practice other than standardised nuclear medicine practices

– Available in standardised therapeutic nuclear medicine practices and in diagnostic nuclear medicine practices

– Involved as appropriate for consultation on optimisation, including patient dosimetry and quality assurance, and to give advice on matters relating to radiation protection concerning medical exposure, as required, in all other radiological practices

• In this Trust, MPEs are:• X-ray

– Craig Moore– John Saunderson

• Radiotherapy– John Saunderson– Andy Beavis– Jenny Marsden– Pete Colley

Duties of employer• 4(1) Written procedures MUST

be in place and adhered to by all IRMER Practitioners and Operators

• 4(2) Written exposure protocols MUST be in place to ensure consistent patient exposure

• 4(3) The employer MUST establish– Referral criteria (these must

be made available to the referrer)

– QA programmes– Diagnostic reference levels– Upper levels of dose for

research exposures and make sure these are adhered to

• Reg 4(4)– Employer shall ensure every practitioner and operator

undertakes continual education and training• Reg 4(5)

– Exposure to ‘much greater than intended’ must be reported

• Reg 4(6)– Take corrective action whenever patient Diagnostic

Reference Levels are consistently exceeded– These are upper levels of patient dose that should not

normally be exceeded

Duties of employer

Duties of IRMER Practitioner and Operator: Optimisation

• Practitioner and operator to keep doses ALARP• Legally obliged to make sure this happens• Possibly the most important aspect of these

regulations• As an X-ray engineer:

– You are an IRMER Operator– Must ensure that an X-ray system is fit for clinical use – Handover procedure?

Case Study 1

• An SHO sends a patient to the X ray dept for chest X ray

• The radiographer checks the request form against justification guidelines written by a radiologist and x rays the patient

• Who is the:• Referrer?• SHO• Operator?• Radiographer• Practitioner?• Radiologist who

writes the written guidelines

Exposures of patients for research purposes

• Must be approved by ethics committee

• Each exposure must be justified by IRMER Practitioner

• Dose constraints must be derived by an MPE

• Dose constraints must be adhered to

• Patient must participate voluntarily

• Patient must be informed of the risks in advance

Image Evaluation

• Clinical Outcome– There MUST be a

record of the outcome of the procedure with radiation

Clinical Audit

• Core component of clinical governance• Must follow national procedures

Equipment

• Inventory of equipment MUST be in place– Name of manufacturer– Model number– Serial number– Year of manufacture– Year of installation

• Avoid unnecessary proliferation – if you have more x ray units than you need, you are breaking the law!!!

Training

• Adequate training must be given– Dependent upon activity– Lots of physics

• Records must be kept

• Continual Professional Development and training

IRMER Legal Requirement under Reg 4(1) & Schedule 1

Employer’s Written Procedures

Employer’s Procedures

• (a) Procedures to identify correctly the individual to be exposed to ionising radiation

• If we X-ray or treat the wrong patient we have to report it to the CQC

Employer’s Procedures

• (b) procedures to identify individuals entitled to act as referrer or practitioner or operator

Employer’s Procedures

• (c) procedures to be observed in the case of medico-legal exposures

Employer’s Procedures

• (d) procedures for making enquiries of females of childbearing age to establish whether the individual is or may be pregnant

Employer’s Procedures

• (e) procedures for ensuring quality assurance programmes are followed

Employer’s Procedures

• (f) procedures for the assessment of patient dose

Employer’s Procedures

• (g) procedures for use of diagnostic reference levels established by the employer for radiographic examinations stating that these are not expected to be exceeded for standard procedures when good or normal practice regarding diagnostic and technical performance applied– DRLs are doses that you shouldn’t consistently

exceed under normal operating conditions– DAPs, DLPs, screening times

Employer’s Procedures

• (h) procedures for the use of dose constraints for research programmes where no direct medical benefit for the individual is expected from the exposure

• (i) procedures for giving information and written instructions to radioactive patients

Employer’s Procedures

• (j) procedures for carrying out and recording of an evaluation for each medical exposure including where appropriate, factors relevant to patient dose

Employer’s Procedures

• (k) procedures to ensure that the probability and magnitude of accidental or unintended dose to patients is reduced as far as reasonably practicable

Enforcing Authority

• Care Quality Commission (CQC)

• Powers of enforcement– Improvement notice– Prohibition notice– Prosecution

• Unlimited fine• Maximum 2 years in

prison

Further information

• HEY Trust Radiation Safety Policy – CP137

• Radiation Physics Department website– www.hullrad.org.uk

Quiz Time!!!!

Question 1

• What is the effective dose limit for a non-classified radiation worker?

Question 2

• What is the dose limit to the eye for a non-classified radiation worker?

Question 3

• What is the public dose limit?

Question 4

• In X-ray, what is the definition of an exposure that is ‘much greater than intended?’

Question 5

• If a patient is exposed to much greater than intended, and it was the operator’s fault; who does this need reporting to– HSE?– CQC?

Question 6

• In this Radiology Department, what staff group acts as IRMER Practitioner?

Question 7

• What are the five elements required by law needed in the local rules?

Question 8

• In this Trust, what function under IRMER do Radiographers perform?

Question 9

• What ‘persons’ are exempt from dose limits under IRR?

Question 10

• For an X-ray room, what three items are required legally to be displayed the controlled area sign?

Question 1

• What is the effective dose limit for a non-classified radiation worker?– 6 mSv/yr

Question 2

• What is the dose limit to the eye for a non-classified radiation worker?– 45 mSv/yr

Question 3

• What is the public dose limit??– 1 mSv/yr

Question 4

• In X-ray, what is the definition of an exposure that is ‘much greater than intended?’– High dose procedures x 3– Medium dose procedures x 10– Low dose procedures x 20

Question 5

• If a patient is exposed to much greater than intended, and it was the operator’s fault; who does this need reporting to– HSE?– CQC?– CQC

Question 6

• In this Radiology Department, what staff group acts as IRMER Practitioner??– Radiologists

Question 7

• What are the five elements required by law needed in the local rules?– RPS– Controlled Area– Systems of work– Contingency plans– Dose investigation levels

Question 8

• In this Trust, what function under IRMER do Radiographers perform??– Operator

Question 9

• What ‘persons’ are exempt from dose limits under IRR?– Comforters and Carers– Patients

Question 10

• For an X-ray room, what are the legal requirements of the controlled area sign? – Trefoil– Controlled area– X rays