Download ST HELENS + KNOWSLEY NHS TEACHING HOSPITAL TRUST

ST HELENS + KNOWSLEY NHS TEACHING
HOSPITAL TRUST
Specification for Radiation
Protection Advisor (RPA)
Services.
OCTOBER 2014
Contents
Page
1. Legal requirements
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2. Radiation protection advice
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3. New Installations
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4. Training
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5. Quality Assurance
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6. Dosimetry
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7. Unintended or Accidental Doses
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8. Dose Audit
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9. Radiation Safety Surveys
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10. Breast screening
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11. Nuclear medicine
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12. Radio-pharmacy
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13. Non-ionising Radiation
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 Magnetic resonance imaging
 Ultrasound
 Medical Lasers
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14. Equipment Performance Checks
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1. Legal Requirements
The RPA is expected to be able to provide radiation safety advice and the
appropriate scientific and technical support necessary to enable full
compliance with the statutory requirements relating to work with ionising
radiation. This will include:
1.1 IRR(99)
The Ionising Radiation Regulations (IRR 99) statutory instrument 1999 No.
3232, state that every radiation employer shall consult such suitable radiation
protection advisors (RPA’s) as are necessary for the purpose of advising the
radiation as to the observance of the regulations and the matters which are
set out in them.
The radiation employer shall appoint the RPA in writing and shall include in
that appointment the scope of the advice which the RPA is required to give.
Requirements set out in IRR (99) include:
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Prior risk assessment before commencing any new work involving
ionising radiation i.e. installation of new x ray equipment.
Restriction of exposure and dose limitation.
Contingency plans in the event of adverse incidents.
Instruction and training of staff.
Production of local rules.
Designation and monitoring of classified persons.
Investigation of overexposure.
Arrangements for the control of radioactive substances, articles and
equipment.
Medical Physics Expert.
1.2 IR(ME)R 2000
The Ionising Radiation (Medical Exposure) Regulations 2000, statutory
instrument 2000 No. 1059 include:
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Justification, optimisation and auditing of medical exposures.
Access to expert medical physics advice regarding dose optimisation,
dosimetry and quality assurance services.
1.3 IPEM 88
In addition the Institute of Physics and Engineering in Medicine – Report 88 –
Guidance on the establishment and Use of Diagnostic Reference Levels for
Medical X Ray Examinations requires the regular auditing of patient doses to
ensure compliance with National DRLs.
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2. Radiation Protection Advice
Advice and assistance must be available by telephone or e-mail at any time
during normal working hours. The RPA must keep the Trust updated on the
contact details of all relevant staff and provide regular updates on their work
and services to Trust users.
The RPA must send a representative to the Annual Radiation Safety
committee meeting and produce a written report on their work for the Trust on
an annual basis.
The RPA must be able to provide personnel on site at short notice as and
when required to assist in the continuity of the business of the radiology
department and the utilization of capacity.
The RPA service will be required to cover all radiation equipment owned /
loaned / leased or within an mes arrangement by the Trust whether on site or
mobile units and any new equipment purchased / loaned / leased by the Trust
after the commencement of the contract.
Examples of the type of advice which may be required shall include:
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Legal requirements and their interpretation.
Quality assurance and dose audit.
Production of local rules, radiation safety polices and other documents.
Equipment installation and maintenance.
Radiation risk assessments.
Appointment and training of radiation protection supervisors and other
staff affected by work with ionising radiation
Personnel dose monitoring.
Environmental monitoring
Advice regarding unintended or accidental doses or any other adverse
incidents involving ionising radiation.
Assessment of foetal doses for patients subsequently found to be
pregnant after a radiological examination.
Drawing up of contingency plans.
Advice on the consequences of future radiation legislation
Advice on compliance with HSE requirements, meeting with the HSE to
discuss specific and general protection problems and liaison with the
DoH over equipment failure problems
The performance of critical examinations, with the agreement of both
the supplier and customer
Prior examination of plans for new equipment, installations and
processes, and also any subsequent modification having radiation
safety implications.
Medical Physics Expert.
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3. New Installations
The RPA will be expected to advise on the design of new installations and the
modification of existing facilities, including:
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Ensuring equipment used for medical purposes is designed and
installed so as to be capable of restricting as far as is reasonable, the
radiation exposure to the patient.
The prior examination of plans and proposals, including relevant
aspects of building design.
Advice on equipment specifications and evaluation of new equipment.
Surveys of new and modified installations to test conformity with
design.
4. Training
The RPA must provide a formal training course for at least two people on an
annual basis to enable key staff to be able to fulfil the requirements of the
Radiation Protection Supervisor role, and also regular updates for these staff.
There is also a need to provide training in the safe use of medical lasers.
There is also a requirement for at least one days training per year on relevant
aspects of radiation safety to any number of Trust staff at a time and site
specified by the radiology department.
The RPA must also be available to provide initial and ongoing training and
support in the use of any new radiation safety systems or equipment as
required.
5. Quality Assurance
All equipment using ionising radiation for medical imaging purposes is
required to have regular quality assurance checks with regard to tube output,
limitation of field size and quality of image display.
The RPA needs to give guidance as to which specific tests are required for
each piece of equipment and at what frequency, the purchasing of specialist
equipment required for performing the tests and the tolerance limits for the
results of any such tests. The RPA should also provide a calibration service
for any QA equipment used.
The RPA will advise and assist the Trust in establishing in-house quality
assurance programmes, which may incorporate the following elements:
 Reject analysis
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 Simplified X-ray tube and generator performance checks
 Simplified X-ray image intensifier – TV system performance checks
 Radiographic image quality checks when problems arise
 Automatic exposure control checks
 X-ray beam size and collimation checks
 CR processor monitoring.
 Digital Acquisition Systems (DR)
 PACS Display Components
 Ultrasound imaging equipment performance
 Patient dose audit
 Link with equipment providers and Radiology Information System to
extract dose data
The RPA also needs to provide an electronic system for the recording of all
QA data with initial and on going training in the use of the system for all
relevant staff.
The Trust currently uses an electronic Quality Assurance and Dose Data
System (QADDS). QADDS enables the Trust to undertake patient dose audits
from any computer with an internet connection, improving accuracy and
saving time in the department. Performance indicators, such as x-ray tube
outputs and mean patient doses are easily viewable through the bespoke
database and charting functionality. QADDS is ISO-compliant to the TickIT
standard for software development. It is essential that this system is retained
or a suitable substitute system with identical functionality be offered.
The functionality of any systems offered must be detailed in the tender
response. Any such system offered must be itemised and shown as a fully
costed option in the response (This includes any hardware requirements, if
required, installation and training and on going support). This will ensure all
tenders provide comparably offers and hence will allow the Trust to make a
like for like comparison of the core services. The Trust can then also opt to
include or exclude these electronic systems.
6. Dosimetry
Provision of a comprehensive dose monitoring service for the environment,
staff and patient escorts to enable Trust compliance with current legislation to
include:
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Advice on the extent and frequency to which personnel monitoring and
environmental surveys are required.
Provision of a comprehensive monitoring service to enable the Trust to
demonstrate compliance with Regulation 8[1] and 18[2] of Ionising
Regulations 1999
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Advise on the provision, maintenance and testing of safety features
and personal protective clothing.
Maintenance of relevant records, including individual dose records, on
behalf of the Trust in accordance with IRR 99, to include annual
summaries.
To provide the HSE with relevant summaries of dose records.
Assisting in the assessment of doses where dosimetry equipment is
lost or destroyed.
Where appropriate the RPA will provide advice and assistance in
monitoring intakes of radioactive material by staff and patients of the
Trust, by means of the whole body monitor, whenever practicable in a
manner approved by HSE.
Where appropriate, the results of such monitoring will be included in
individual dose records in accordance with statutory requirements and
the conditions described earlier.
To alert the Trust to any abnormally high dose readings, or
overexposure of staff and to advise and assist in the investigation of
these.
Investigation of any annual cumulative staff dose which exceeds an
effective dose of 6.0 mSv or of any equivalent dose limit.
Investigation when doses received by staff are believed to be much
greater or less than that recorded on individual dose meters
Investigation when the results of any environmental dose monitoring
indicates unsatisfactory conditions and when appropriate, liaison with
manufactures representatives.
7. Unintended or Accidental Doses
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Estimation of foetal doses for patients subsequently found to be
pregnant following radiological investigation and the potential impact of
these, to include deterministic effects of foetal irradiation of increased
lifetime cancer risk. These reports should be available within two
working days of notification by Trust.
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Estimation of patient dose because of suspected equipment faults or
operator error and the potential impact of these to include increased
lifetime cancer risk. These reports should be available within two
working days of notification by Trust.
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Advice regarding notification to the Care Quality Commission or other
organisation following unintended or accidental doses.
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Advice to prevent re-occurrence of any unintended or accidental dose.
8. Dose Audit
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Provision of a dose audit service for those examinations which have
national DRLs, using data sent electronically to the RPA from the
radiology information system (RIS).
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Comparison of results between national DRLs and actual exposures;
and the establishment of local and regional DRLs by comparison with
RIS data from other Trusts.
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Advice and support regarding collection of dose data and interpretation
of any results.
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Provision of other data and information regarding aspects of radiation
safety using information as recorded on the RIS.
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The RPA will be pro-active in providing advice/input into changing
examination protocols and techniques, for example the transition from
barium enema to CT colonography.
9. Radiation Safety Surveys
The RPA will be expected to ensure that all hospital departments where
ionising radiations are used routinely are visited at least annually, in order to
review, in consultation with heads of departments (or their nominees), the
protection measures laid down.
A radiation survey of the working environment and review of protection
measures should be carried out, in consultation with the Radiation Protection
Supervisor (RPS) at specified intervals. The results of all surveys, together
with any recommendations will be submitted in writing to the RPS, which
should draw attention to any aspect of the equipment or other radiation safety
provisions which fail to comply with relevant radiation safety legislation, codes
of practice, guidance notes or British standards.
Surveys should be performed in accordance with a routine programme. In
addition all new installations and any equipment which has undergone major
modification should be surveyed and inspected before coming into routine use
with patients.
Radiation safety checks and status checks of equipment should be carried out
by arrangement with the department Leads / Operational Manager for each
area at specified periods.
The RPA will undertake to supply reports on periodic assessment checks to
the RPS within one month from the end of the survey. However, any x-ray
equipment, which at the time of the survey, fails testing procedures, or has
radiation safety implications associated with it will be brought to the attention
of the radiographer in charge at the time of the survey.
The RPA will also as part of the radiation safety survey advise on any
radiation safety documentation, policies and procedures and record keeping
and make suggestions for improvement as required.
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10. Breast Screening
Regulation 9 of IR(ME)R 2000 requires a Medical Physics Expert to provide
advice and support on the optimisation of radiation dose and image quality in
line with relevant NHSBSP and other professional guidance.
Performance testing of mammographic x-ray systems and associated
equipment is required by Regulation 32 of IRR 99 and in compliance with
recommended IPEM and NHSBSP standards.
The RPA will provide advice on the selection of equipment for breast
screening. This includes all radiographic and ultrasound items and
instruments used for performing quality control tests. This includes the
purchase of new equipment, relocation of existing equipment, the need to
replace existing equipment and the timing of such replacements.
Acceptance and commissioning tests will be performed on all new equipment
before use, including those used for screening, assessment and stereotactic
localisation attachments.
Performance testing of mammographic equipment will be undertaken twice
yearly. All tests will be performed according to agreed regional protocols that
conform to Commissioning and Routine Testing of Mammography X-Ray
Systems (currently IPEM 89) and Commissioning and Routine Testing of Full
Field Digital Mammography Systems (currently NHSBSP Equipment Report
0604).
Relevant tests will also be performed following replacement of the x-ray tube
or AEC, or after major breakdowns. These will be done before the unit reenters clinical service.
Acceptance and commissioning tests will be performed on all new ultrasound
equipment before use. Performance tests will be undertaken twice yearly.
All tests will be performed according to agreed regional protocols that conform
to Further Revisions to Guidance Notes for Ultrasound Scanners in the
Examination of the Breast, with Protocol for Quality Testing (MDA 98/52).
Relevant tests will also be performed following replacement of the transducer,
or after major breakdowns. These will be done before the unit re-enters
clinical service.
A written report will be submitted to the director of the Breast screening unit
and a copy to the Principal Radiographer within 4 weeks of the survey date.
11. Nuclear Medicine
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The RPA will provide advice and support to the Nuclear medicine Department.
The working environment, where necessary, to be surveyed together with a
staff survey of clothing and parts of the body at least biennially in all
diagnostic X-ray departments
Applications by staff of the Trust are sent to the RPA for approval prior to
going to the Administration of Radioactive Substances Advisory Committee of
the Department of Health.
The allocated RPA will advise the Trust in obtaining from the Environment
Agency Inspectorate as and when required, appropriate registration to keep
and use radioactive substances and for the authorisation to dispose of
radioactive waste and to advise the Trust on the most appropriate manner of
compliance with such registration/authorisations.
The RPA will maintain central records summarising waste disposal and check
at least annually that departments are complying with the conditions of the
authorisations or exemption orders.
12. Radio pharmacy (Where applicable)
The RPA will also provide advice and support to the radio-pharmacy
department to include monitoring or personnel and the environment as
detailed in section 6. There will be radiation safety surveys on a monthly
basis in this area and advice and support in any emergency situations.
13. Non-ionising Radiation
Radiation safety surveys and advice are also required in relation to work with
non-ionising radiations e.g. magnetic resonance, ultrasound and medical
lasers.
Magnetic Resonance Imaging
The RPA will provide advice regarding the methods of complying with the
requirements of any relevant statutory provisions and codes of practice
together with any other aspects of radiation safety which are considered
necessary by the Trust. Examples include:
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Assessment of levels of exposure to patients in order to check that
these are within national guidelines.
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Assessment of levels of exposure in the working environment in order
to check that these are within national guidelines.
Assessment of imaging performance on acceptance and annually
thereafter.
Setting up QA tests and training local staff in the performance and
interpretation of the tests.
Advice and guidance on the safe operation of MR units and
collaboration with local staff in the preparation and regular review of
local rules.
The interpretation and significance of exposures
Prior consideration of proposals for new installations and any relevant
matters raised by HSE inspectors.
Ultrasound
The RPA should provide services to enable the Trust to comply with advice
and requirements form regulatory and advisory bodies e.g. DOH, HSE;
including scientific and technical support on all aspects of the use of
ultrasound. The schedule of work to be undertaken is detailed in the
appendices.
The service provision will include:
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Advice on the procurement of ultrasound systems and related
peripheral equipment, including preparation of specifications, the
appraisal of tenders and advice on the disposal of equipment.
Performance testing of equipment.
Advice on the safety of ultrasound techniques.
Assistance with in-house quality assurance programme.
Medical Lasers
The RPA must provide advice and scientific and technical support to enable
the Trust to comply with current legislative requirements. The schedule of
work required is detailed in the appendices.
Service provision is expected to include:
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Advice on the purchase and installation of laser equipment
Advice on safe use of laser equipment
Hazard assessment of laser installations
Assistance in writing local rules
Advice and assistance to the local Laser Protection Supervisor
Advice on maintenance
The Company will provide the Trust with suitably qualified and
experienced Laser Protection Advisers (LPA’s) who shall have the
following duties and responsibilities in all departments where work is
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undertaken with laser equipment in classes 3b or 4 which gives rise to
a significant radiation hazard.
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The LPA will provide advice regarding the methods of complying with
the requirements of any relevant statutory provisions and codes of
practice together with any other aspects of radiation safety which are
considered necessary by the Trust.
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The LPA will provide advice and assistance in identifying those
departments where a significant hazard from laser radiation exists and
will ensure that all such departments are visited in order to review in
consultation with heads of departments (or their nominees), the
protective measures laid down.
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The LPA will provide advice and assistance with regard to the provision
of appropriate arrangements for the working environment to be
inspected and for the equipment to be surveyed on installation of a new
source of laser radiation which entails a significant hazard, prior to the
source coming into regular use and at least annually thereafter.
The annual check of the performance of laser equipment in classes 3b and 4
will include:
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Checking that the equipment incorporates the radiation safety features
specified in relevant DOH guidance notes and British Standards
Checking that the maximum power output of the aiming beam is within
the limits specified by British Standards
Checking that the level of laser radiation is within 20% of that indicated
by the meter readings or equipment settings as required in BS EN
60825
The Company will submit reports of inspections of medical lasers and
laser controlled areas to the particular Laser Safety Officer with a copy
to the Laser Protection Supervisor and the Medical Engineering
Manager.
The LPA will also advise and assist the Trust with regard to:
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The interpretation and significance of exposures
Drawing up local rules, where appropriate
Prior consideration of proposals for new installations having safety
implications
The provision, maintenance and testing of safety features and the
requirements for testing personal protective equipment, where
appropriate
Verification of the supplied protective eyewear specification in
accordance with BS EN 207
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Any relevant mailers raised by HSE inspectors
The appointment of departmental Laser Protection Supervisors
The identification of laser controlled areas
The Company shall assist the Trust in the registration and inspection of nonNHS premises using lasers, as required in relevant Health Circulars. With
regard to this service the Company shall be entitled to charge an additional
fee per inspection. The Company will assist the Trust to maintain the following
records on behalf of the Trust:
 Details of all sources of non-ionising radiation identified which may
constitute a significant hazard.
 Reports of all surveys, inspections and investigations carried out.
The Company will submit annual reports to the Chief Executive of the Trust,
or his nominee, of work undertaken by the Company in relation to non ionising
radiation.
14. Equipment Performance Checks
As part of the equipment survey as detailed above the RPA will ensure
suitably qualified staff carry out the following safety and performance checks
on those items of radio diagnostic and dental X-ray equipment specified
below:
X-ray tube and generators
Miscellaneous checks of general radiation safety features
X-ray output – Consistency and reproducibility
Variation with kV setting
Linearity with change in mA setting
Linearity with change in exposure time setting
Output waveform
Screening doses to patients
X-Ray tube filtration
Exposure timer accuracy and consistency
Accuracy of tube voltage settings
X-ray beam filtration and half value thickness
Alignment of X-ray field, light field and image receptor area
Perpendicularity of X-ray beam to image receptor area
Focal spot size
X-ray tube and diaphragm leakage
DR Detector based systems
TOMOSYNTHESIS
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Image intensifier – television systems
Automatic brightness control – dose rate settings
Field size and distortion
TV grey scale test
Limiting resolution – high contrast
Low contrast imaging performance
Overall imaging performance
Conversion factor – if necessary
Contrast ratio – if necessary
Photo-fluorographic camera systems/digital units
All the checks described above for the intensifier – TV System
Fluorographic speed
Field size and distortion
Limiting resolution – high contrast
Low contrast imaging performance
Overall imaging performance
Imaging performance in rapid sequence operation
Flat panel detectors
Automatic exposure control systems
Reproducibility of radiographic density levels
Check radiographic density levels are within acceptable range
Consistency with change in control chamber
Consistency with change in kV
Consistency with change in mA (where applicable)
Consistency with change in patient thickness
Conventional tomographic systems
Cut height calibration
Cut height increment/decrement calibration
Consistency of movement and radiation output
Accuracy of angle of swing and symmetry
DR tomosynthesis
Mammographic systems
All checks described above for x ray tubes, generators and
AECs where applicable.
Measurement of patient dose
Assessment of image quality
Dental X-ray machines
Miscellaneous checks on general safety features
Field size measurement
Minimum focus–skin distance
Accuracy and consistency of exposure timer
Check on performance of Auto Technic control systems
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X-ray output -Consistency
Linearity V. time, auto-technique
Magnitude
Scatter measurements – upon request
Patient dose
Accuracy of tube kilo voltage
Adequacy of mains supply
X-ray beam filtration and half value thickness
CT Scanners
X-ray tube output
Focal spot size
Accuracy of tube kilo voltage
Image noise
Pixel size
Spatial resolution
Slice width
Patient dose – Single scan profile Multi-slice
Spatial Non-uniformity – Low atomic number materials
High atomic number materials
Structured noise
Linearity of CT values
Accuracy of patient positioning devices
Alignment of scanner geometry
Geometric image distortion
Ultrasound imaging units
Simple general checks of equipment condition and function
Inspection of transducer condition
Check optimisation of display settings
Record Imaged Acoustic Range
Check low contrast penetration for each transducer/dynamic
focus
Check high contrast penetration for each transducer/dynamic
focus
Check caliper accuracy
Check accuracy of area calculation
Measure the Dead Zone for each transducer/dynamic focus
Measure the Lateral Imaged Beam Profile for each T/DF
Measure slice thicknesses for each T/DF
Check function of individual elements in linear array transducers
The RPA will maintain records of all the equipment performance
measurements on behalf of the Trust. The RPA will submit reports of the
results of these measurements together with any relevant recommendations
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to the Chief Executive of the Trust (or his nominee), the head of department
and the Radiation Protection Supervisor.
The RPA will submit an annual report through the Radiation Protection
Committee summarising this work to the Chief Executive of the Trust (or his
nominee).
Radiation Protection Reports
Reports should be sent via email to a designated Radiology Management
Group for ease of electronic storage. A paper copy to also be sent. It will be
expected that these will be received within 5 working days.
Any urgent deficiencies or advice should be emailed to the Radiology
Management Group
All faults/errors/inconsistencies in equipment
highlighted on the front page or in a conclusion.
performance
should
be
An action plan for resolution of these faults should be provided.
Length of Contract/Pricing Structure
It is envisaged that the minimum time for this contract would be 5 years to
allow 2 bi-annual survey cycles to be completed with an option to extend for 2
years.
To provide a 5 year pricing structure.
To provide prices on a site specific basis eg Whiston, St Helens, Newton etc.
To provide options with or without ultrasound surveys.
To provide a mechanism for expansion of our service / equipment in the future
eg acquisition of a new nuclear medicine scanner and possible acquisition of
community dental services.
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