UK Regulation and Nuclear Cardiology

Dr. Craig Moore

Medical Physicist & Radiation Protection Adviser

Radiation Physics Service

CHH Oncology

Do we need radiation protection in nuclear medicine?

What can radiation do?

DeathCancerSkin BurnsCataractInfertilityGenetic effects

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

– Roughly, patient would receive approx 1 mSv radiation dose from a permanent pacemaker repositioning at this Trust

– From abdo x-ray– Thyroid imaging with Tc99m

• 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!!!)

What can radiation do?

Deterministic effectsdeath, skin burns, cataract, infertility

Stochastic effectscancer, genetic effects

Deterministic effects

cataract infertilityerythema

epilation

CancerGeneticProb dose

500 mSv cataract 150 mSv for sterility (temporary-males)2500 mSv for ovarian

Stochastic effects

DOSE

EFFECT

OBJECTIVES OF RADIATION PROTECTION

PREVENTIONPREVENTION of deterministic of deterministic effecteffect

LIMITINGLIMITING the probability of the probability of stochastic effectstochastic effect

The need for protection applies to all dose levels

• It is generally assumed that even very small doses of ionizing radiation can potentially be harmful (linear no threshold hypothesis)

• Therefore, persons must be protected from ionizing radiation at all dose levels

Who should be protected in nuclear medicine?

• Patient

• Members of his/her family

• Worker

• General public

How should the people be protected?

• Optimize protection

• Justify the exposure

• Dose limitations

This is the system of radiological protection as

defined by the ICRP (International Commission on

Radiological Protection)

What is the ICRP?

A non-governmental

professional organization

established in 1928 by the

International Congress of

Radiology

The International Commission of The International Commission of Radiological ProtectionRadiological Protection (ICRP) makes (ICRP) makes recommendations relating to radiation recommendations relating to radiation protectionprotection

ICRP

Recommendations of the ICRP

• Prepared typically by a task group which includes other experts

• Approved by the full commission

• Published in the journal “Annals of the ICRP”

• Have no legal status themselves - however, are typically the foundation onto which national legislation is built

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)

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

Structure of IRR99

• Legislation• Approved code of

Practice & HSE Guidance (approx 170 pages)

• Medical & Dental Guidance Notes (approx 230 pages)

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:• Containment and local

shielding• Ease of cleaning of floors,

work tops etc• Sufficient space

– 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

Reg 10: Engineering Controls

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

can be used to check the continuing suitability of easy clean surfaces/floors

– Visual inspections of lead windows etc

• 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 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 non-classified staff & public (mSv) per

calendar yearStaff Public

Effective dose 6 1

Lens of eye 45 15

Skin 150 50

Hands, legs etc 150 50

Possibly changing to 15 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

• 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• Radiotherapy:

– 0.1 mSv/month• Nuclear Medicine:

– Technologist:• Whole body = 0.35 mSv/month (averaged over three months)• Finger = 5 mSv/month

– Others:• Whole body = 0.2 mSv/month• Fingers = 3 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’

• 1 mSv to foetus• This is roughly 1.3

mSv to abdomen during declared term

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 NM, this corresponds to around 1.3 mSv to the

abdomen• Assuming 8 months of declared pregnancy, dose to

abdomen must be kept below 0.16 mSv per month• Individual risk assessment MUST be carried out• Possible areas that work may need to cease are:

– Dealing with spills– Using aerosols– Imaging very ill patients– Preparing radionuclide therapy doses– PET?

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

What is Contingency Plan for a Major Spill?

• Major Spill =– 1 MBq I-131– 400 MBq Tc99m– 500 MBq Tl201

• Prevent other persons from walking over spill• Contact RPS• Check whether anyone has become contaminated• Wear appropriate clothing

– Gloves– Overshoes– Lab coat– Plastic apron or gown may also be worn

• Use paper towels or moistened tissues and work inwards from the outside• Monitor to ensure radioactive material has been removed• If this is unsuccessful use detergent but avoid vigorous scrubbing• Put waste in a yellow bag and label with trefoil• Report incident• Rehearsal????????

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:– 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 (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– Identification of area covered– Working instructions

• Protective clothing• Wear Monitoring badge• No eating, drinking or smoking• All manipulations must be carried out over drip trays and

behind lead window

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

• Who are NM RPSs?– Kat– Alison– Sallyann RPS must be adequately

trained

Reg 18: Additional requirements for designated areas

• Physical demarcation of controlled areas

– Must have:• Trefoil (radiation symbol)• Controlled area• Nature of radiation

• Warning signs (controlled and supervised)

• Entry restricted to controlled areas• If significant risk of spread of

contamination:– Washing and changing facilities at

the entrance/exit– Maintenance of washing facilities– No eating, drinking or smoking– Contamination monitoring at exit

Reg 19: Monitoring of Designated Areas

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

• Monitoring at appropriate frequencies

– Check that areas have been and continue to be correctly designated

– Determine measures for ALARP– Detect breakdowns

• 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 & construction of articles to

restrict exposure & ALARP– The manufacturer, supplier or

importer of any article embodying of containing a radioactive substance, including a sealed source, should ensure that suitable leak tests are carried out as soon as practicable after manufacture or importation.

• Perform critical examination upon installation

• Safety features• Any article containing radioactive

substances

• 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

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 screens and other local shielding properly

• DO NOT fail to wear any PPE correctly

• DO NOT fail to report to your RPS any defects in PPE

• DO NOT tamper with dose badges • DO NOT hand badges in late• 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/technician) then inform Care Quality Commission

Exposures much greater than intended

• Diagnostic multiplying factors• HIGH DOSE PROCEDURES

– Barium, angio, NM(>5 mSv), CT• 1.5 x

• MEDIUM DOSE PROCEDURES– Lumber spine, abdo, pelvis, mammo, NM(<5 mSv but > 0.5 mSv),

• 10 x• LOW DOSE PROCEDURES

– Extremities, skull, dental, chest, NM< 0.5 mSv)• 20 x

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

• Also:– Incorrect patient

Compliance with the Regulations

• HSE Inspectorate• Regional specialist

inspectors• Powers of

enforcement– Improvement notice– Prohibition notice– Prosecution

• Unlimited fine• Maximum 2 years in

prison

NHS Trust fined £45000 The Royal Free Hampstead NHS Trust was today fined a total of £45,000 at City of London Magistrates Court for breaches of health and safety at work legislation and of the Radioactive Substances Act 1993. The Trust pleaded guilty to seven separate offences. On top of the fine, the Trust were also ordered to pay the full costs of £45,619.

Investigations by the Health and Safety Executive and the Environment Agency revealed a catalogue of failings in the management of a radioactive source, caesium 137. The investigation by HSE revealed serious deficiencies in the Trust’s handling and storage of the caesium, as well as weaknesses in the training and supervision of staff and the procedures for tracking the source. These failings resulted in the loss of the source, which has never been found, and in the risk of exposure to radiation of staff and members of the public. Adequate control over the source could have been achieved very easily by the Trust.

The caesium was used inside a patient’s body to treat a tumour in March 2001. After use it was presumed returned to the locked store but in fact was not, as discovered in May 2001. The caesium could not be found despite searching at the hospital and waste disposal sites.

HSE inspector Emmie Galilee said: “This serves as a reminder to other employers who use radioactive materials that they should ensure that their control systems are in accordance with the Ionising Radiations 1999 Regulations - and give their staff, patients and members of the public the level of protection and reassurance they deserve.”

Environment Agency officer Adrian Bush said: "Those ientrusted with radioactive material have a great responsibility to manage and dispose of such potentially harmful substances appropriately. This case highlighted the Trust's failure to protect its own staff, and this court action could have been avoided had management implemented a proper training and handling regime.”

"The Environment Agency [and the HSE] will seek to control the proper use of radioactive sources."

16 April 2004

Consultant Nuclear Cardiologist fined for not wearing dose badge

• Royal Free Hospital• April 2010• Consultant very rarely wore badge• When he did he rarely returned it at all (or on

time if he did)• HSE successfully prosecuted • Consultant got fined approx £4,000• Trust got fined approx £20,000 for not enforcing

badge wearing or having sufficient procedures

The Ionising Radiation (Medical Exposure) Regulations in Nuclear

Medicine

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

– 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

Justification

Benefit of the radiation exposure must outweigh the risk of exposure

vs

Optimisation

• All exposures and radiation doses must be kept – As – Low – As– Reasonably – Practicable

• With economic and social factors taken into account

ALARP

Principles of Radiation Protection

• JUSTIFICATION–Benefit v risk

• OPTIMISATION–ALARP

• LIMITATION–Staff & public dose limits

IR(ME)R Terminology

• IR(ME)R specifically places duties on those professionals responsible for the patient exposure

Duty Holders under IR(ME)R

• Employer

• Referrer

• Practitioner

• Operator

• Medical Physics Expert (MPE)

Duties of employer

• 4(1) Written procedures• 4(2) Written standard operating

procedures• 4(3) Establish

– Referral criteria for referrers– Procedural QA programmes – Diagnostic reference levels (DRLs)– Dose constraints for research– Ensure adequate training

Referral Criteria

SOPs

Referrer• Registered Healthcare

professional who is allowed to refer individuals for medical exposure to an IR(ME)R Practitioner

• Must have access to referral criteria

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

• Do not need specific radiation training

Who is allowed to be a referrer in HEYH Nuclear Medicine Dept??

• Any UK registered medical practitioner

• Other state registered group (such as nurses or radiographers) under protocol– MUST be authorised by ARSAC holder

IR(ME)R Practitioner• Registered healthcare

professional who takes responsibility for an individual medical exposure

• Must justify exposure• Must authorise exposure

(or delegate)• Must be adequately

trained• May delegate practical

aspects (operator)

IR(ME)R Practitioner in nuclear Medicine

• MUST hold a current valid ARSAC certificate for any of the sites covered by HEYH NM Dept

• Only for procedures stated on certificate

• Only for hospital sites covered on certificate

ARSAC?

• The Administration of Radioactive Substances Advisory Committee

• Any doctor or dentist who wishes to administer radioactive materials to humans for diagnosis or treatment can only do so if he/she holds a certificate issued by Health Ministers

• ARSAC set up to advise government on:– Grant– Renewal– suspension– Revocation– Variationof certificates

IRMER Practitioner

MAIN ROLE IS TO JUSTIFY THE MEDICAL EXPOSURE

BENEFITS OF THE EXPOSURE VS RISKS

Authorisation

• After justification has been performed, the exposure must be authorised

• This is demonstrating that justification has been carried out

• ARSAC certificate holders MUST authorise NM exposures, OR:

• Other NM staff authorise NM investigations under strict written protocols

• Current list of persons allowed to authorise exposures, and what they are allowed to authorise is held on departmental shared drive– E009 – Persons Permitted to Authorise Nuclear Medicine

Exposures

Operator

• Any person who is allowed to carry out practical aspects of the exposure– Patient set up– Pressing the button– Evaluating images– Processing images– Tc99m elution– Injecting patient– Authorising exposure

• Need to be adequately trained• No overarching responsibility

allowed• Must optimise exposure – if not

breaking the law• Personally liable in court

Operators in NM Dept?

• Any Tech employed by NM in Hull Hospitals who have received adequate training

• Any Clinical Scientist employed in Hull Hospitals who have received adequate training in specific procedure– Rad Physics Staff testing Hawkeye

• Any registered medical practitioner• Pharmacists employed by Hull Hospitals

qualified to work in aseptic pharmaceutical units who have undergone training in radiation protection

Other Aspects of IR(ME)R

• As well as the written policies, IR(ME)R also places other statutory obligations on the employer (and employees!!)

– Optimisation

– Clinical Audit

– Expert Physics Advice

– Inventory of Equipment

– Training

– Diagnostic Reference Levels:

• Upper level of patient dose

• Must be an investigation if consistently exceeded

• Exposure much greater than intended must be reported • Barium, Angio, NM, CT x 1.5

• Mammo, pelvis, lumbar spine, abdo x 10

• Extremities, skull, dental chest x 20

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, Nuclear Medicine MPEs are:– Dr. Graham Wright– Dr. Glyn Davies

Regulation 4(1) – Employer’s Procedures (E000’s)

• These are the written procedures that must be in place

• Legally, you must follow these

• If you can’t prove you have – personally liable under the regs

• Available on Nuclear Medicine shared drive

E001 – Patient Identification

• Correct following of procedure rests with the operator undertaking the administration/imaging

• Procedure:– Ask patient their name, DOB and adress– Check that details given by patient match that on

request card– At time of imaging make sure patient details match

that on acquisition computer– Sign request card (demonstrating authorisation)– DO NOT proceed unless positive ID is given

E002 – Diagnostic Reference Levels

• Upper level of activity (Bq) allowed to administer to patient

• Guidance very descriptive and provided by ARSAC

• Allowed ± 10% from ARSAC guidance

• If go above MUST be justified by ARSAC certificate holder

E011 – Patient Pregnancy with Diagnostic Examinations

• Current guidance stipulates no risk to conceptus following irradiation during first 10 days of menstrual cycle

• However, time between this and next cycle there is a finite (but small) risk for high dose procedures– > 10 mGy to fetus

E011 – Patient Pregnancy with Diagnostic Examinations

‘High Dose’ Exams

• Uterine dose > 10 mGy

E003 – Breast Feeding Patients

• Procedure:– Ask patient if she is breast feeding– Record result– If ‘no’ carry on with exam– If ‘yes’ decision to carry on with exam depends on

radiopharmaceutical• Consult individual SOPs• May be able to carry on breast feeding• May need to cease altogether• Patient should have been informed prior to attending NM

dept

E004 – Assessment of administered activity

• Procedure:– Immediately before administration, check radiopharmaceutical on label

agrees with that on request card– Note activity and reference time on label– Decay correct to calculate activity at time of administration– Check this is within DRL– For Tc99m check approx activity with dose checking monitor– Record details of radiopharmaceutical and activity just

measured/calculated on request card– Sign to show you have verified these details– Syringe and label must be passed to the injector– Following administration, the operator who performed the injection must

sign request card and details must be entered into RadCentre.– For Hawkeye procedures, operator must enter DLP and scanned body

area onto RadCentre in comments field.

E005 – Medico-legal Exposures

• Procedure:– Insurance and court cases etc– Usually no direct health benefit to patient– Request must be sent with solicitor letter– Only ARSAC holder can justify/authorise

exposure

E007 & E008 – Authorisation Criteria

• Defines who is allowed to authorise an exposure• Ensure that the card is correctly completed with the details of the patient and referrer. As a

minimum, the card must have the name, address and date of birth of the patient; the clinical question to be answered and enough clinical history to justify the procedure. The referrer must have signed the request; this can be an electronic signature if the request is made using the Trust’s Order Comms system.

• Check the referrer is entitled to refer to the department, as specified at http://www.heynm.org.uk/referralcriteria/

• On paper requests, if the referrer has not printed their name and job title but you recognise the signature and the person is a valid referrer, print the name of the referrer next to the signature and add your initials. If the signature is not recognised, the validity of the request can be confirmed by telephone conversation with the patient’s consultant (or another member of the medical staff with responsibility for the patient). If this is done, you must sign the request and become co-referrer. Please note: the signature of the referrer is to be included on the card for clinical audit purposes only; it is not the responsibility of the authorising signatory to ensure that the signature is genuine.

• If all the above is satisfied and the exposure is justifiable given the referral information, the request may be authorised. On A4 general Nuclear medicine requests, initial the box marked “Auth Signature”. On the old Nuclear Medicine A5 requests initial the box marked “ARMP Cert. holder”. On the old Nuclear Cardiology request cards, write your initials next to the part marked “Justification Signature”. If necessary, indicate the protocol to be followed (e.g. whole body or three phase bone scan)

• For MPS studies, follow the procedure Determination of Mode of Stress for MPS to determine to which stream to allocate the patient

E012 – Evaluation of Exposures

• All exposures to ionising radiation MUST be evaluated and reported

• This procedure documents who is responsible– Radiologists– Cardiologists– NM Physicists

E018 – QA of Procedures

• Must have QA of all documentation– New procedures– Reviewing current procedures– Approving procedures

E013 – Minimising Accidental Exposures

Case Study 1

• A registered medical practitioner requests renal MAG3 scan

• The technician checks clinical information on the request card against written protocol (E007) and authorises the procedure

• Physicist prepares individual dose for administration

• Tech injects MAG3 and scans the patient

• NM Physicist AND Radiologist evaluates the images

• Who is the:• IR(ME)R Referrer?• Medical Practitioner• IR(ME)R Operator?• Technician, Physicist &

Radiologist• IR(ME)R Practitioner?• ARSAC certificate holder for

this specific procedure• Any other IR(ME)R Operator?• Radiopharmacist

(manufactured Tc99m at HRI)

Case Study 2

• Registrar requests sentinel lymph node localisation prior to surgery

• Physicist checks clinical details on request card and authorises exposure

• Tech A injects patient with Tc99m nanocolloid

• Tech B scans the patient post administration

• Physicist checks images post scan and sends them to PACS

• Who is the:• IR(ME)R Referrer?• Registrar• IR(ME)R Practitioner?• ARSAC certificate holder• IR(ME)R Operator?• Physicist• Tech A• Tech B• Registrar performing operation• Nurses measuring radiation

uptake in node whilst in theatre• Pathology staff

Enforcement

• IRMER is enforced by the Care Quality Commission (CQC) in England and Wales

PRACTICAL EXAMPLES AND CONSEQUENCES UNDER IRMER

MISADMINISTRATION (wrong patient)

• Patient A received 500 MBq Tc99m for a bone scan and returned to waiting room

• Patient B was scheduled to receive 400 MBq I-131 for hyperthyroidism and already seated in waiting room

• Tech prepared Patient B’s activity of I-131 and called Patient B, but Patient A responded

• Tech administered the activity• Patient A questions the Tech and it becomes obvious

wrong patient had been given I-131

What went wrong here?

• Patient responded to another patient’s name• Tech DID NOT follow patient ID procedure• Broken reg 5(1) of IR(ME)R:

– The practitioner and operator shall comply with employer’s procedures

• Broken reg 6(1b) of IR(ME)R:– No exposure shall be carried out unless authorised by

operator• Be careful as IR(ME)R operators are personably

liable in a court of law – no overarching responsibility– IRMER reg 5(4)

Misadministration (wrong activity)

• Patient was to be administered 260 MBq I-131• Radiopharmaceutical was in form of TWO 130

MBq capsules– Usually administered as ONE capsule

• When vial was inverted, one of the capsules got stuck in vial without techs knowledge

• Tech assumed full dose in single capsule• Much later capsule was found so patient only

received 50% of prescribed dose

What are the consequences here?

• Absence of cross check of vial label with respect to full dose and number of capsules

• Tech did not measure activity before administration?

• Or if they did is the activity meter calibrated?• Broken reg 5(1) of IR(ME)R:

– The practitioner and operator shall comply with employer’s procedures

Activity meter

Correct settings?

Misadministration(wrong radiopharmaceutical)

• Tech injected patient with what he believed to be a radiopharmaceutical for a bone scan

• Upon scanning, no bone uptake was observed

• Patient appeared to be injected with radiopharmaceutical for brain imaging

What went wrong?

• Improper labelling?– Whoever dispensed radiopharmaceutical into syringe

made a mistake• Correct labelling?

– Injecting tech has made the mistake by not adequately checking label

• Broken reg 5(1) of IR(ME)R:– The practitioner and operator shall comply with

employer’s procedures• Broken reg 5(4) of IR(ME)R:

– Operator shall be responsible for every practical aspect he/she carries out

Misadministration(pregnant women)

• Female patient scheduled for thyroid scan (Tc99m)

• She called department in the morning to tell them she was trying for a baby, but no evidence yet that she was pregnant

• Tech ensured the patient that she should still have the scan

• Later it appeared that patient was pregnant (early stage) and she had a miscarriage

What went wrong?

• Tech not following pregnancy procedure?– In this case pregnancy cannot be excluded,

so tech MUST ask LMP– Scan was with Tc99m, so low dose (< 10

mGy to fetus)– If patient ‘s LMP is not overdue tech can

proceed with examination, and record result on request card/RadCentre

– If LMP is overdue, MUST contact ARSAC holder

MISADMINISTRATION – Breast Feeding Mother

• Nursing mother given 180 MBq I-131

• Resulted in absorbed doses to infant of 300 Gy to thyroid, and 170 mSv effective dose

• Only detected when patient returned to hospital for a scan

• Infant will need thyroid hormone medication for rest of life

Reason?

• Tech forgot to ask standard questions• Almost certain litigation action would be taken by

the mother• Tech would have no chance in court• Broken reg 5(1) of IR(ME)R:

– The practitioner and operator shall comply with employer’s procedures

• Broken reg 5(4) of IR(ME)R:– Operator shall be responsible for every practical

aspect he/she carries out

MISADMINISTRATION(causes)

• Communication problems• Busy environment, distraction• Procedures not known• No training in emergency situations• Not clearly defined responsibilities• No efficient quality assurance

How to avoid accidents and misadministrations

• Safety culture• Safety assessment to define critical procedures and emergency situations• Reporting system (When? Where? Why?)• Education and training: initial, continuing

Investigation of accidental medical exposure

• Inform responsible nuclear medicine physician• Inform patient and referring physician• Calculate dose• Indicate corrective measures• Implement measures• Submit report to RPC and Regulatory Authority

YOU MUST ENSURE THAT YOU ARE FOLLOWING ALL IR(ME)R

PROCEDURES RELEVANT TO YOU

IF YOU ARE NOT THEN YOU ARE LIABLE FOR PROSECUTION IF

ANYTHING UNTOWARD HAPPENS

PLEASE COVER YOUR BACK

CQC Improvement Notice

• The CQC has just issued an improvement notice for breach of IRMER to an NHS Trust– HiLo trial– Dr requested low dose– Operator gave higher dose– Lack of procedure evident– Lack of training– Lazyness of operator???

Other Relevant UK legislation

•Medicines (Administration of Radioactive Substances) Regulations 1978 (see www.arsac.org.uk)

•Environmental Permitting Regulations 2010 (Amended 2011)

•The Carriage of Dangerous Goods and Use of Transportable Pressure Equipment Regulations 2009.

Medicines (Administration of Radioactive Substances) Regs 1978

(“ARSAC”)• “No person shall administer to a human being

(otherwise than to himself) any radioactive medicinal product unless he is doctor or dentist holding a certificate issued by the Health Minister for the purposes of section 60 of the Act in respect of radioactive medicinal products (hereinafter referred to as a “certificate”) or a person acting in accordance with the directions of such a doctor or dentist.” .

Covers• Nuclear medicine scanning• Nuclear medicine therapy• Some pathology tests, e.g.

– C-14 urea breath test– Co-57 Schilling test

• Brachytherapy– interstitial– intracavity– surface applicators– neutron activation.

Certificates are specific to• Specific to

– Practitioner– Site (i.e. hospital)

– Radio-pharmaceutical and proposed use

• Valid for 5 years (or maybe less for research)

• Information must be provided on– equipment– facilities– scientific support

• Applicants assessed against “core curriculum”.

Environmental Permitting Regulations 2010 “EPR10” (Amended 2011)

Replaces Radioactive Substances Act 1993“RSA93”

Unless exempt, must have PERMIT to

• keep or use radioactive material

• dispose of radioactive waste

• accumulate radioactive waste

Permits are issued by the Environment Agency.

Source Registration

• Limits activity and number of sources

• Requires– supervision– labelling– security– report losses to Police & EA– Records .

Waste Authorisation• Limits activities, disposal routes, accumulation times• Requires

– security– report losses to Police & EA– Records & annual summaries to EA

• Disposal routes may be– aqueous to drain– incinerate solid– transfer solid to others– gaseous discharge.

Exemptions to the Requirement for a Permit

• Exemptions are governed by EPR11

• Smaller amounts of activities (such as schools and nursing homes)

• No requirement for a permit but must keep adequate records etc to comply with exemptions regulation

The Carriage of Dangerous Goods and Use of Transportable Pressure Equipment

Regulations 2009“It does what it says on the packet”

• Controls transport of radioactive materials (and other dangerous goods) – driver training– packaging

Typical packages

The Carriage of Dangerous Goods and Use of Transportable Pressure Equipment

Regulations 2009Controls transport of radioactive materials

by road– driver training– Packaging– labelling - packages and vehicles

– consignment notes– QA.

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