Radiation Protection Refresher for Bone Densitometry

Dr. Craig MooreMedical Physicist & Radiation Protection Adviser

Radiation Physics ServiceCHH Oncology

THE PATIENT IS NOT RADIOACTIVE AFTER THEY

HAVE HAD AN X-RAY

Medical X-ray Equipment

• Discovered X-rays on 8th November 1895

• 1896 - X-ray Department set at Glasgow Royal Infirmary

• Produced many remarkable radiographs

• In 1896 medical x-ray diagnosis was also started.

Frau Roentgen’s hand, 1895

Colles’ fracture 1896

First Dental Radiograph

• Otto Walkhoff (Dentist - Braunschweig, Germany)• Jan.1896 (<2 weeks after Roentgen announced discovery of X-rays)• 25 minute exposure.

1 Feb 1896

• Walter Konig (physicist, Germany)

• 9 min. exposure

• Elihu Thomson – He immediately saw the dangers of the new radiation but was in a minority.

•Deliberately exposed a finger for several days to prove the point.

Edison’s assistant - hair fell out & scalp became inflamed & ulcerated

• Was a medical missionary student and photographer who became one of the most prominent pioneering radiologists of the time.

• By 1898 he had become an American citizen

Mihran Kassabian (1870-1910)Mihran Kassabian (1870-1910)

Mihran Kassabian (1870-1910) Mihran Kassabian (1870-1910) • In 1898 he joined the Hospital Corps of the regular army, gaining much experience in x-ray technique, and paid the price

•In 1900 he describes the damage to his hands.

•He attributed the damage to holding the tube and putting his hands in the beam to reassure the patient.

In 1903 he urged his colleagues to discuss ways of avoiding the damage that could be caused.

1898, started work as radiographer in Cologne - held nervous patients & children with unprotected hands

After 6 months cancer of hand - arm amputated

1915 severe difficulties of breathing - extensive shadow on the left side of her thorax - large wound on her whole front- and back-side

Died on 22nd October 1916.

What is Radiation?• Wave – an electric part, and a magnetic part• ELECTROMAGNETIC RADIATION

•EM radiations spread like waves, over space.

HOWEVER, RADIATION IS NOT ABSORBED LIKE A WAVE, SO WE HAVE TO DESCRIBE RADIATION AS DESCREET PARTICLES OF ENERGY

•Photon – a particle

•Absorption of energy occurs in well-defined chunks of energy, known as wave packets or more correctly photons.

+

-

-

-

- -

-

• An inner Nucleus made up of Protons (+’vly charged) and Neutrons (0 - zero charge), jointly known as Nucleons.

Outer Electrons (- ‘vly charged) orbiting the nucleus.

Some Basic Physics – Some Basic Physics – The AtomThe Atom

Ionising Radiation

• Ionising radiations – have the ability to separate electrons from atoms to produce “ions”

+

-

Why is it

dangerous?

X-ray passes straight

through cell

No change to cell

X-ray causes a

chemical reaction in cell, but no damage

done or damage repaired by cell

No change to cell

DNA damaged in a“fatal” way”

Cell killed

DNA damaged,causing cell to

reproduceuncontrollably

Cancer?

• 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 from the x ray exposure

• THIS IS THE OVERALL DOSE TO THE WHOLE BODY

RADIATION TISSUE

Effective dose• Dose “averaged” over whole body• Risk of inducing cancer is proportional to effective

dose, e.g.– LD(50,30) = 4 Sv– UK background = 2.3 mSv per year– Legal dose limit for staff working with DEXA = 6 mSv a

year.– Dose Investigation Level for DEXA workers = 1.2 mSv/yr

(or 0.1 mSv/month)– Never go above 1 mSv/yr– Usually record zero on dose badge

• Adult Exposure (per 1 mSv)– Fatal cancer (all types) 1 in 20,000– Fatal leukaemia 1 in 200,000– Non fatal cancer 1 in 100,000– Heritable effects 1 in 80,000

• Childhood exposure– Fatal cancer 1 in 10,000

• Foetal exposure– Fatal cancer to 15 years 1 in 33,000– All cancers to 15 years 1 in 17,000– Heritable effects 1 in 42,000

Risks from Bone Densitometry Exposures

Prodigy Patient Risks• Patient entrance skin dose

– AP spine 0.75mA thin = 12 μGy– AP spine 3mA standard = 47 μGy– AP spine 3mA thick = 105 μGy

• Effective dose = 0.01 mSv– Risk of radiation induced cancer = 1 in 2 million (i.e. negligible)

• REMEMBER – RISK OF GETTING CANCER IN OUR LIFETIME IS 1 IN 3

• So – RADIATION CANCER INDUCED RISKS ARE RELATIVELY SMALL

• NEVERTHELESS:– All exposures must be JUSTIFIED– Doses to patients, and staff, must be As Low As Reasonably

Practicable (ALARP principle) .

Prodigy Staff Risks• 3 mA

– Edge of couch < 24 μSv/h– 1m from couch < 3 μGy/h

• Patient entrance skin dose– AP spine 0.75mA thin = 12 μGy– AP spine 3mA standard = 47 μGy– AP spine 3mA thick = 105 μGy

Prodigy Staff Risks

• Use dose constraint of 0.3 mSv a year– Scatter 1m from couch < 3 μGy/h– Scans about 1 minute each– 2500 patients a year– So dose < 3 μGy/h x 2500 x 1/60 = 125μGy =

0.125 mSv• So

– Controlled area of 1m from couch OK– No lead glass screen needed.

Pixi

• Beam on for 2.5 secs at 50kV then 80kV• Dose at 50cm from unit < 40 μSv/h• Dose to heel ≈ 200 μGy

Pixi Staff Risks

• Use dose constraint of 0.3 mSv a year– Scatter 50 cm from couch < 40 μGy/h– Scans about 2.5 seconds each– < 30 exposures a day, – So dose < 40 μGy/h x 30/d x 2.5/3600 x = 0.8

μGy/day < 170 μGy/year =0.17 mSv• So

– Controlled area of 50 cm from Pixi OK– No lead glass screen needed.

Calscan• 0.5m controlled area• Heel entrance dose ≈ 240 μGy• Effective dose to patient = 0.2 μSv

Metriscan

• Scatter dose < 0.50 μGy per exam at edge of machine• Patient Skin dose < 120 μGy

Recent dose results

• 1 milli-sievert (1 mSv) = annual public dose limit= patient dose from abdomen X-ray= 1 in 20,000 risk of fatal cancer

• Risk of dying on UK road = 1 in 20,000 per year

• Risk from chest X-ray = 1 in 1,000,000• Risk of meteorite killing 1/4 of world

population = 1 in 500,000

• Effective dose from natural background radiation in the UK is approximately 2.2 mSv

– SO WE ALL RECEIVE 2.2 mSv EVERY YEAR FROM NATURAL SOURCES AND WE CAN’T DO ANYTHING ABOUT IT

• This natural radiation comes from cosmic rays, rocks and soil, food, human body & radon.

Stochastic (Random effects)

– Probability of an effect depends upon total dose received

– Severity of effect is independent of the dose

– Assumed there is no threshold (i.e. there is no dose below which effects do not occur)

– Examples are cancer and genetic defects

0%

10%

20%

30%

40%

50%

0 500 1000 1500

mSv

%

37

i.e. a bit like crossing the road - the more times you cross the more likely you are to be run over, but probably never will.

Deterministic Effects (Certain)

– Effects are certain to occur if sufficient radiation dose is received

– Severity will depend upon the dose received

– There are threshold doses threshold doses for deterministic effects

• Skin ‘burn’ (or erythema) is 3 to 5 Gy

• Common in radiotherapy and occasionally in interventional procedures

– Examples are radiation sickness, erythema, infertility, cataract.

Example of Radiation Injury in CardiologyExample of Radiation Injury in Cardiology

•40 year old male•coronary angiography•coronary angioplasty•second angiography procedure due to complications•coronary artery by-pass graft•all on 29 March 1990

Fig. A6-8 weeks after multiple coronary angiography and angioplasty procedures

Fig. B16 to 21 weeks after procedure, with small ulcerated area present

Fig. C18-21 months after procedure, evidencing tissue necrosis

Fig. DClose up of lession in Fig. C

From injury, dose probably in excess of 20 Gy .

Fig. EAppearance after skin grafting procedure .

45

Hair loss from CT scan

• 53-year-old woman with subarachnoid hemorrhage• 4 CT perfusion scans and two angiographies of the head performed within

first 15 days of admission • Bandage-shaped hair loss seen 37 days after first CT and lasted lasted for

51 days• (Imanishi et al 2005)

5000

3500

3000

2500

2000

500 500

150

0

1000

2000

3000

4000

5000

6000

Cataracts

Perm

. male

sterility

Temp.

epilation

Female

sterility

Transienterythem

a

Detectable

opacities(lens)

Supression of

bone marrow

Temp. m

alesterility

mill

i-sie

vert

s

Staff doses never this big

There are three principles of radiation protection:There are three principles of radiation protection:

• Justification– All exposures to ionising radiations must be clinically justified

– benefit must outweigh detriment

• Optimisation– Once exposure has been justified it must be optimised i.e.

lowest possible dose for acceptable image quality

• Limitation– Radiation workers are subject dose limits by law

X-ray Tube

Primary Beam

Scattered Radiation Staff

Patient

The real risk to staffThe real risk to staff

Time

Distance

Shielding

In air, x-rays obey the Inverse Square Law.

I∞1/d2

•Double distance = 1/4 dose

•Triple distance = 1/9th dose.

Distance

• Operator B receives only a quarter of the radiation received by Operator A if she is standing twice the distance from the source

• Operator B receives only one ninth of the radiation received by Operator A is she is standing 3 times the distance from the source

ShieldingShielding

ShieldingShielding

• AAs

• LLow

• AAs

• RReasonably

• PPracticableracticableThe ALARPALARP Principle

And And rememberremember

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

the following effects:– Tissue damage such as skin burns and

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

such as:• 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

– The mSv (milli-sievert) is a measure of radiation dose

• Staff receive radiation doses from X-rays that scatter from the 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– Publicfrom ionising radiation

(such as X-rays)

Authorisation• The IRR99 are enforced by the Health and Safety

Executive in the UK

Structure of IRR99

• Legislation• Approved code of

Practice & HSE Guidance (approx 170 pages)

• Medical & Dental Guidance Notes (approx 230 pages)

So what’s included in IRR99 (relevant to DEXA)

• 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

• Duties of Employees– All of us have duties under these regulations

Reg 11: Staff and public dose limits

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

Staff Public

Whole body dose

6 1

Lens of eye 45 15

Skin 150 50

Hands, legs etc 150 50

Possibly changing to 15 mSv/yr in 2014

Whole body dose limit is low because this is aimed at minimising staff cancer

risks from radiation exposure

Other dose limits are higher because they are aimed at ensuring no member

of staff receives tissue damage, i.e. skin burns of cataract

Reg 7: Prior Risk Assessment• Must be undertaken before

work commences with ionising radiations (X-rays)– 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

DEXA Radiation Risk Assessments

• Radiation Risk Assessments have been produced and are constantly reviewed for staff working in DEXA

• The Trust Radiation Protection Adviser produces the risk assessment in conjunction with the Radiation Protection Supervisor

• Radiation dose to the body, extremities and eyes are assessed.

• Any Personal Protective Equipment (PPE such as lead aprons) required are advised

• Pregnant staff:– By law the Trust Radiation Protection Adviser MUST

carry out a radiation risk assessment for unborn child

Risk Assessments

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 (when the RPA

is planning the design of X-ray Rooms)

• 1 mSv to foetus during declared term• Formal Investigation levels of staff

dose

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 X rays the risk to the foetus from X rays, 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• 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

• Over many years, experience tells us that these dose levels probably won’t be reached by staff in DEXA, assuming Local Rules are followed

• Individual risk assessment must be carried out

Reg 9: Personal Protective Equipment

• Should be provided where necessary, i.e. if the risk assessments recommends the use of PPE

• Should comply with PPE regulations 1992

• 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!!!• Radiology will check them annually to

make sure there are no hidden cracks• But if visibly damaged, ask Radiology to

check them.• IT IS VERY IMPORTANT THAT

APRONS ARE WORN CORRECTLY AND RETURNED TO THEIR HANGER – YOU ARE AT RISK OF PROSECUTION BY THE HSE FOR NOT MAINTAINING PPE

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 As Low As Reasonably Practicable (ALARP)

• If you are issued with a badge, please ensure you

– wear it under your lead apron during all procedures with X-rays

– Return it promptly at the end of the month

• A consultant radiologist was recently prosecuted under the IRR99 regulations for not wearing his dose badge (not at this Trust)

Dose monitoring results for DEXA

• Whole body – typically less than 0.1

mSv/month (usually records a ‘zero’)

– This equates to less than 1 mSv/yr

– Much lower than legal limit of 6 mSv/yr

– Under reg 8 we have to set local dose investigation level:

– 0.10mSv/month for DEXA – see local rules

Exemptions 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– Usually a family member or friend

• What about the other?• Persons undergoing medical exposure, i.e.

the patient

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 (inc DEXA):

– 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

• For HEY:– Dr. Craig Moore– Mr. 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 (mush more physics)!!!!!

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 – DEXA

• Prodigy:– 1m from couch

• Cacscan/Pixi/Metriscan– 50cm from unit

50cm

50cm

1m

1m

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

• You MUST work in accordance to these local rules

Reg 17: Local Rules• Local rules must be provided for controlled areas

Reg 17: Radiation Protection Supervisor (RPS)

• Local staff member to ensure local rules are being followed

• Must have a knowledge of regulations and Local Rules

• Ability to command respect• Understanding of

precautions required and extent to which these will restrict exposures

• Ann Goodby for DEXARPS must be adequately

trained

Reg 18: Additional requirements for designated areas

• Must have 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

• We also have to monitoring at appropriate frequencies– We usually do this by

sticking dose badges up around X-rays rooms from time to time

• Monitoring recorded and reviewed

• Results kept for two years by qualified person

• Monitoring equipment maintained and tested at regular intervals

Reg 31:Duties of Manufacturers• Manufacturers MUST design &

construct X-ray units to restrict exposure & ALARP

• The manufacturer MUST provide proper instructions on proper use, testing and maintenance of X-ray equipment

• Installer of X-ray equipment MUST perform critical examination upon installation

• Safety features• RPA MUST be consulted on

results of crit ex

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

• Users test the performance on a frequent basis

• Medical Physicists test the safety features, radiation dose and image quality aspects of all X-ray systems annually.

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 X-ray someone to carry out tests on the

equipment• 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 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

• THE HSE HAVE PROSECUTED INDIVIDUALS IN THE UK FOR NOT COMPLYING WITH THIS REGULATION

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

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, lasers 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)

IRMER 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

IRMER 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• Examples:

– Radiographers– Technicians– Physicists

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

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 IRMER Operator: Optimisation

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

regulations• In DEXA:

– Techs DO NOT justify the exposure– Techs authorise under justification protocols (written

by Consultant – Dr Aye)– Consultant justifies ALL exposures ‘by proxy’ for

DEXA– Justification AND Authorisation are required under

regulations 6(1a) and 6(1b)

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

Case Study 2• A GP sends a patient for

a CT scan• The details are checked

by a radiologist and the patient is scanned by a Radiographer. The Radiologist evaluates the images.

• Who is the:• Referrer?• GP• Practitioner?• Radiologist• Operator?• Radiographer &

Radiologist (evaluating an image is an operator function)

Case Study 3• A Cardiology Specialist

Registrar refers a patient for angioplasty

• The Consultant Cardiologist countersigns the referral

• The procedure is carried out in a Cath Lab under the direction of a Cardiologist Specialist Registrar

• The Cardiology Radiographer exposes the patient to X-ray during the procedure

• Who is the:• Referrer?• Consultant

Cardiologist• Practitioner?• Registrar• Operator?• Registrar• Radiographer

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

Summary

• You must ensure you are following local rules and procedures

• If you are not it is likely you are not complying with IRR99 or IRMER

• You may be personally liable!!!• Ann Goodby is the custodian of all your

radiation protection documentation

Contacts• Radiation Protection Advisers:

– Mr. John Saunderson (461329)– Dr. Craig Moore (461385)

• Radiation Protection Specialists:– Dr. Tim Wood (461332)– Mr. Andrew Davis (461330)– Mr. Dave Strain (461331)

• Radiation Protection Supervisor:– Ann Goodby

• Our website www.hullrad.org.uk• New RP Trust Policy in the near future