Transcript Slide 1

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?
Death
Cancer
Skin Burns
Cataract
Infertility
Genetic 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 effects
death, skin burns, cataract,
infertility
Stochastic effects
cancer, genetic effects
EFFECT
Stochastic effects
Deterministic effects
cataract
infertility
erythema
epilation
DOSE
500 mSv cataract
150 mSv for sterility (temporary-males)
2500 mSv for ovarian
OBJECTIVES OF RADIATION
PROTECTION
 PREVENTION
of deterministic
effect
 LIMITING the probability of
stochastic 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?
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•
•
•
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
ICRP
The International Commission of
Radiological Protection (ICRP) makes
recommendations relating to radiation
protection
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
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•
•
•
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
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•
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
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•
– 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
RADIATION
TISSUE
• 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
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:
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Ingestion
Inhalation
Absorption
Committed effective dose
• Dose delivered due to deposition of radionuclide in the body
Reg 11: Dose Limits for nonclassified 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 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
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Radiotherapy:
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Nuclear Medicine:
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Typically less than 0.3 mSv/month
This equates to less than 4 mSv/yr
Lower than legal limit of 6 mSv/yr
Dental:
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Typically less than 0.3 mSv/month
This equates to less than 4 mSv/yr
Lower than legal limit of 6 mSv/yr
Radiology:
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Typically less than 0.1 mSv/month
This equates to less than 1 mSv/yr
Much lower than legal limit of 6 mSv/yr
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:
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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
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Contingency plan required for
‘reasonably foreseeable’ accident
Radiotherapy:
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In Brachytherapy if the source fails to
retract during treatment:
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Emergency stop buttons
Nuclear Medicine:
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Take out applicators and place in lead
pot
Wire cutters may be needed in some
instances!
Radiology:
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•
Emergency stop buttons
Spills and contamination
Plan must be documented in Local
Rules
Must be rehearsed at appropriate
intervals dependent on:
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Potential severity
Likely doses
Complexity of plan
Number of people involved
Involvement of emergency services
What is Contingency Plan for a
Major Spill?
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Major Spill =
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Prevent other persons from walking over spill
Contact RPS
Check whether anyone has become contaminated
Wear appropriate clothing
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1 MBq I-131
400 MBq Tc99m
500 MBq Tl201
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
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•
Employer must consult RPA on the following matters:
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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:
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Must be certified by HSE approved body
Risk assessment
Designation of controlled areas
Conduct of investigations
Drawing up of contingency plans
QA programmes
In this Trust:
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–
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
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•
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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
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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
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•
Legal requirement to monitor dose
rates around controlled area at
commissioning
Monitoring at appropriate
frequencies
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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
16 April 2004
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."
Consultant Nuclear Cardiologist
fined for not wearing dose badge
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•
•
•
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
ALARP
• With economic and social factors taken
into account
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
– Variation
of 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 2009
Controls transport of radioactive materials
by road
– driver training
– Packaging
– labelling - packages and vehicles
– consignment notes
– QA.
fin