Ionising Radiations Safety Policy - nuhrise.org

IONISING RADIATIONS SAFETY POLICY

Reference HS/SP/009
Date approved 21 October 2011
Approving body Directors’ Group
Implementation date 21 October 2011
Version 3
Supersedes NUH Version 2 (July 2009)
Consultation undertaken Radiation Safety Committee
Organisational Risk Committee
Date of Completion of Staff in departments using ionising radiation
Equality Impact 10 March 2011
Assessment
Date of Completion of 10 March 2011
We Are Here for You
Assessment 10 March 2011
Date of Environmental
Impact Assessment (if Heads of Service and staff in departments where
applicable) there is a radiation facility including Theatres
Target audience October 2013
Medical Director
Review Date Derek Pearson, Radiation Protection Adviser
Lead Executive(s)
Author(s) / Lead Radiation Protection Advisers
Manager(s) Risk Management Adviser
Further
Guidance/Information

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CONTENTS

Section Title Page
1 Introduction 4

2 Policy Statement 4

3 Definitions 5
4 Delivering the Ionising Radiations Safety Policy 5
5 Incident Reporting 9
6 External Audit and Inspection 9
7 Audit 9
8 Research Exposures 9
9 Training 10
10 Environmental Impact Assessment 10
11 Equality & Diversity Statement 10
12 We are here for you 10
Appendix A List of Associated Procedures 12
Appendix B Terms of Reference, Radiation Safety Committee 13
Appendix C Procedure for Optimising Medical Exposures 16
Appendix D Procedure for personal and environmental dose 22
monitoring
Appendix E 34
Procedure for the protection of pregnant or
Appendix F breastfeeding staff 41
Procedure for the Appointment of Qualified Experts in
Appendix G radiation protection, diagnostic radiology, nuclear 42
Appendix H medicine and radiotherapy physics 49

Appendix I Procedure for the control of Radioactive Substances 51

Appendix J Procedure for the reporting and investigation of 52
Appendix K radiation incidents 56
Appendix L 60
Training Requirements for Radiation Users and those
with Radiation Protection Responsibilities

Procedure for control of diagnostic X-ray machines
Equality Impact Assessment
Certification of Employee Awareness

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1 Introduction

1.1 The Trust uses ionising radiations from X-ray and Radiotherapy
equipment, and radioactive substances. It does so in order to benefit
patients directly through diagnostic X-ray tests, Nuclear Medicine and
Radiotherapy services, and indirectly in the maintenance and calibration
of associated equipment, and research and development.

1.2 The general principles by which the Trust manages risk are set out in
the Trust’s “Risk Management Strategy”. The “Ionising Radiations
Safety Policy” (IRSP) supports, supplements and clarifies those
principles in relation to the use of ionising radiations. It is supported by
a number of procedures1 that give detailed instruction on the means
whereby ionising radiation risks are managed.

2 Policy statement

2.1 The Trust Board is committed to minimising risks to patients, staff,
visitors and contractors from any of the Trust’s uses of ionising
radiations.

2.2 To this end the Board will ensure that structures and systems and
processes are in place, and regularly reviewed, in order that:

only justified practices involving ionising radiations are undertaken (i.e.
the benefits to the patient or society outweigh the associated risk);

all radiation sources are used appropriately and safely and that the
Trust complies with current legislation and best practice

radiation doses to staff, contractors and members of the public arising
out of work activities are restricted to as low as is reasonably
practicable, and within dose limits;

medical exposures are individually justified and optimised (i.e. a
medical exposure will be of net benefit to the individual or society, as
appropriate, and the dose will be the minimum required to achieve the
intended outcome);

there is an appropriate exchange of information with other radiation
employers.

2.3 The Trust operates X-ray and radiotherapy equipment under generic
authorisation certificates for the use of X-ray machines and accelerators
issued by the Health & Safety Executive (HSE). Prior authorisation for

1 a list of the current supporting procedures is given in Appendix A. Page 4 of 60

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the use of such equipment must be obtained from the HSE where the
conditions of these authorisations cannot be met.

2.4 The Trust stores and uses radioactive material, and accumulates and
disposes of radioactive waste under Registrations and Authorisations
from the Environment Agency. In undertaking these activities the Trust
will use best practicable means to minimise the activity, volume and
radiological effects on the environment and members of the public, of
any disposal.

3 Definitions

3.1 Terms defined in the Risk Management Strategy have the same
meaning in the Ionising Radiations Safety Policy.

3.2 Ionising radiations are:

X-rays generated by electrical means i.e. diagnostic X-ray machines or
radiotherapy linear accelerators;

atomic or sub-atomic particles generated by particle accelerators (e.g.
electron beams from linear accelerators);

the radiations from radioactive substances.
3.3 The term “radiation” may be used within this policy to refer to all ionising

radiations.

3.4 This policy DOES NOT APPLY to non-ionising radiations, which include:

lasers, ultraviolet, visible and infra red light;

ultrasound;

microwaves;

electromagnetic fields including the fields associated with magnetic
resonance imaging (MRI) scanners.

4 Delivering the Ionising Radiations Safety Policy

4.1 Radiation exposure is a hazard associated with the Trust’s activities
and as such will be managed according to its Risk Management
Strategy (RMS).

4.2 Those groups and individuals at corporate, divisional and directorate /
department level who are charged with the management of risk will take
responsibility for the clinical and non-clinical risks posed by the use of
ionising radiations within their areas as described within the RMS

Roles and responsibilities

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4.3 Although the Chief Executive retains overall responsibility for ensuring
that systems are in place to manage risks arising out of the use of
radiations, he discharges this responsibility through designated
individuals.

4.4 Within this framework an executive director, the Responsible Manager,
has delegated executive responsibility for the preparation and
implementation of the Ionising Radiations Safety Policy and the
associated procedures, structures and processes.

4.5 The Responsible Manager is the Medical Director.

The Responsible Manager

4.6 The Responsible Manager will appoint Radiation Protection Advisers
(RPAs) who advise him on all aspects of radiation safety. The suitability
of RPA appointments will be ensured by seeking the advice of the Head
of Medical Physics & Clinical Engineering and by, where appropriate,
utilising appropriate assessment on appointment (see Appendix F).

4.7 The Responsible Manager has arranged for services in support of
radiation safety to be available through the RPAs, who can call upon
resources within Medical Physics & Clinical Engineering.

4.8 The Responsible Manager will ensure that Heads of Service in
departments where there is a radiation facility have been authorised to
sign off employer procedures under this policy.

4.9 The Responsible Manager is advised on the health of workers exposed
to radiation by the Occupational Health Medical Adviser.

Heads of Service

4.10 Control of radiation facilities: Heads of Service in departments where
there is a radiation facility are responsible for ensuring that safety and
protection measures are carried out. Detailed requirements for the
management of radiation facilities are published in supporting
procedures (see Appendix A). Their responsibilities include ensuring
that:

Explicit provision for the risk management of radiation and/or
radioactive materials is made within the directorate’s / department’s
governance arrangements.

Risk assessment is carried out before the introduction of any new
practice involving ionising radiation or before the modification of an
existing one. Risk assessments are reviewed regularly.

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Systems for radiation safety, including up-to-date Local Rules and
procedures, and appropriate equipment and security measures, are in
place.

Systems are in place to ensure the safety of carers, visitors and the
control of contractors.

There is appropriate cooperation between employers in circumstances
where Trust employees may undertake radiation work at other
establishments or there are radiation workers visiting the Trust.

The advice of the appropriate RPA is sought when updating systems,
procedures and Local Rules and planning new or modified facilities.

A suitably trained and experienced person is appointed as Radiation
Protection Supervisor (RPS), with the advice of the RPA. A copy of the
appointment letter must be sent to the RPA. The RPS must also receive
update training (Appendix I).

New, replacement, or re-sited radiation equipment undergoes a critical
examination and commissioning tests prior to first clinical use.

Areas in which radioactive substances are used meet the requirements

of the Trust procedures for the control of radioactive substances as part
of the Trust’s implementation of “best practicable means” for the

minimisation of radioactive waste disposal.

Suitably trained and updated individuals are appointed to undertake the

supervision of compliance with the use of radioactive substances as
required by the Trust’s Registrations and Authorisations.

Written procedures are in place for medical exposures, including

ensuring that Trust R&D procedures for the exposure of research study
participants are followed, and that such participants’ exposures comply

with the requirements of IRMER.

Staff who take responsibility for, or undertake medical exposures are
identified, authorised, adequately trained and updated and an up-to-
date list of their names and their scope of practice is maintained.

An ARSAC certificate holder takes responsibility for every
administration of a radioactive substance to a human for medical
purposes.

An inventory of radiation equipment is maintained.

A programme of audit is carried out.

Staff are adequately trained and updated to carry out their duties under
this policy and their radiation duties are given in their job descriptions.

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4.11 Heads of Service who have significant responsibility for radiation
facilities, medical exposures or the use of radioactive substances:

must appoint one or more individuals to take an operational lead with
respect to radiation issues if it is inappropriate for the Head of Service
to do so personally because of the commitment required;

notify the names of lead individuals to the RPAs as points of contact for
management issues within relevant areas.

4.12 The Head of Medical Physics & Clinical Engineering must ensure that
the Trust has, during normal working hours, Medical Physics Experts:
on-site and available for Radiotherapy; available for Nuclear Medicine;
and, available as appropriate for Diagnostic Radiology.

4.13 Heads of Service in all departments must cooperate with the managers
of radiation facilities in implementing the Trust’s Ionising Radiations
Safety Policy and associated procedures; this will apply particularly in
respect of medical exposures and to staff working away from their main
area of employment in the vicinity of radiation facilities.

All staff

4.14 Staff are required to co-operate with the Trust in implementing this
policy. All staff must carry out only activities involving radiation and
radioactivity for which they have had appropriate training and only
undertake the responsibilities for radiation work outlined in their job
descriptions.

Radiation Safety Committee

4.15 As part of its Risk Management Strategy the Trust has convened a
group of relevant specialist advisers and representatives of ionising
radiation users as a sub-committee of the Organisational Risk
Committee (ORC). This Radiation Safety Committee (RSC) has the
remit of drafting Trust documentation, advising the ORC, monitoring
compliance with Trust policies and procedures in relation to ionising
radiations, and granting certain authorisations with the agreement of
ORC.

4.16 Detailed Terms of Reference of the RSC are attached at Appendix B.

Documentation and supporting procedures

4.17 All written procedures relating to radiation work must be controlled
documentation within an appropriate quality system, with a version,
issue date and authorising signature on them. For high risk areas
external accreditation of the quality system is desirable (e.g. inter-
departmental audit, ISO9001:2000). All written procedures relating to

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radiation work must be audited at least once every 3 years, and the
results of the audit recorded and reviewed.

4.18 Implementation of the Ionising Radiations Safety Policy is supported by
detailed Trust wide procedures. Appropriate procedures will be
developed under the direction of the Radiation Safety Committee and
will be ratified by ORC.

5 Incident Reporting

5.1 Incidents must be reported according to the Trust Incident Reporting
Policy. Radiation incidents must also be reported to the RPA as soon as
possible, who will advise the Trust on the need for external reporting.

5.2 The loss or uncontrolled release of radioactive substances may require
prompt reporting to the Police and the Environment Agency. Users of
radioactive substances must ensure that they are aware of and follow
supplementary procedures in their Local Rules for these circumstances.

6 External Audit and Inspection

6.1 External audits and inspections by the Healthcare Commission, the
Health & Safety Inspectorate and the Environment Agency must be
managed according to the Managing Visits, Audits, Inspections,
Assessments And Accreditations By Bodies External To The Trust
Policy GM/CM/023

7 Audit

7.1 Heads of Service are responsible for ensuring that clinical audit is
undertaken to confirm that good standards of radiological and
therapeutic practice are demonstrated and to improve the quality and
outcome of patient care.

7.2 There will be an annual RPA audit of radiation departments that will
include the RPS and management representatives and will include a
review of the outcome of audit.

7.3 The outcome of audit will be reported to the Trust Radiation Safety
Committee.

8 Research Exposures

8.1 Exposures carried out for the purposes of research studies require the
authorisation of a Medical Physics Expert, prior to the study starting. It
is the responsibility of the Chief or Principal Investigator to obtain such
authorisation.

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8.2 Procedures for the governance of radiation within research are held by
the R&D Department. Chief and Principal Investigators are responsible
for ensuring that these procedures are followed.

9 Training

9.1 All new members of staff must receive appropriate instruction on
radiation protection and safety procedures as part of their induction
training.

9.2 Staff working in designated radiation areas are required to sign a
statement that they have read and understood the Local Rules.

9.3 All staff using radiation or with responsibility for radiation protection
shall receive appropriate training prior to undertaking such work, and
shall receive regular update training. This training is defined in
Appendix I. It is the responsibility of relevant Heads of Service to ensure
staff receive such training.

10 Environmental Impact Assessments
10.1 The Trust’s use of radioactive material has an impact on the

environment through the release of radioactive waste. The
management of this environmental impact is given in Appendix G.

11 Equality & Diversity Statement

11.1 All patients, employees and members of the public should be treated
fairly and with respect, regardless of age, disability, gender, marital
status, membership or non-membership of a trade union, race, religion,
domestic circumstances, sexual orientation, ethnic or national origin,
social & employment status, HIV status, or gender re-assignment.

11.2 IRR99 requires the Trust to have special arrangements in place for
those employees under the age of 18. Where employees under the age
of 18 are required to work in radiation facility the Head of Service
should ensure that appropriate arrangements are documented in the
Local Rules.

11.3 IRR99 requires the Trust to have special arrangements in place for
pregnant and breast feeding employees. These are given in Appendix E

12 We Are Here For You

12.1 This Trust is committed to providing the highest quality of care to our
patients, so we can pledge to them that ‘we are here for you’. This Trust
supports a patient centred culture of continuous improvement delivered
by our staff. The Trust established the Values and Behaviours

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programme to enable Nottingham University Hospitals to continue to
improve patient safety, outcomes and experiences. The set of twelve
agreed values and behaviours explicitly describe to employees the
required way of working and behaving, both to patients and each other,
which would enable patients to have clear expectations as to their
experience of our services

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APPENDIX A

Ionising Radiation Safety Policy Supporting Procedures

Title Author Location
Matt Dunn Appendix C
Procedure for Optimisation
(including setting Diagnostic Matt Dunn Appendix D
Reference Levels (DRLs)) Nick Dudley Appendix E

Procedure for personal and Derek Pearson Appendix F
environmental dose monitoring
David Pye Appendix G
Procedure for the protection of Andy Rogers Appendix H
female, pregnant or breastfeeding Andy Rogers Appendix I
staff Matt Dunn Appendix J

Procedure for the appointment of
Qualified Experts in radiation
protection and diagnostic radiology

Procedure for the control of
radioactive substances

Radiation Incident Reporting &
Investigation

Training requirements for Radiation
Users

Procedure for control of
diagnostic X-ray machines

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APPENDIX B

IONISING RADIATION SAFETY COMMITTEE
TERMS OF REFERENCE

Membership

Ionising Radiation Safety Representative on the Organisational Risk
Committee (Chair)
Representative of each service or departments where there is a radiation
facility
Trust Radiation Protection Advisers
Society of Radiographers Union, Health and Safety Representative
RCN Health and Safety Representative
University Representative

Representatives of other external agencies, other Site Users and/or internal
Departments / functions may also be invited to attend, as required.

Chairman

Radiation Safety Representative on the Organisational Risk Committee or his
nominated deputy will chair the committee.

Quorum

Attendance will be monitored at each meeting and reported to the
Organisational Risk Committee.

No business shall be conducted unless the Radiation Safety Committee is
quorate. The quorum is seven members, provided that this includes;

the chair or deputy chair

at least one member from the Diagnostic Imaging Directorate, either:
the Clinical Lead, or Radiology Services Manager

at least one member from the Oncology/Radiotherapy service

a Radiation Protection Adviser

Frequency

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Reporting
A secretarial support will be provided from the Medical Physics and Clinical
Engineering Directorate.

A summary of key discussion points will be provided after each meeting to the
Organisational Risk Committee.

The Chair of the Committee shall draw to the attention of the Organisational
Risk Committee (ORC) and the Directors’ Group any issues that require
disclosure to the full Board, or require executive action.

Duties

1. To advise the Trust on the implementation of legislation and guidelines on
issues of radiation safety

2. To monitor the Trust’s radiation protection performance by:
a. receiving reports from the RPAs’ Committee on issues of radiation
safety including the outcome of audit visits

b. receiving reports from Directorates and Departments on radiation
safety risk assessments, Ionising Radiation (Medical
Exposures)Regulations 2000 compliance, training, reports on
incidents and associated action plans, internal and external audits
and inspections, issues of cooperation between employers and other
radiation safety issues

3. To review and develop the Trust Radiation Safety Policy

4. To draft and review Trust level procedures in support of the
implementation of the Radiation Safety Policy

5. To monitor the implementation of all radiation safety related policies and
procedures

6. To monitor the identification and management of radiation risks

7. To ensure that the relevant CQC Outcomes are being managed and
provide any additional monitoring in areas of low compliance

8. To review the Committee’s Terms of Reference on an annual basis and if
necessary make recommendations for amendment to ORC.

9. To facilitate a close working relationships between the management of
radiation safety and other areas of risk management.

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Organisational Risk Committee
Health & Safety Committee
Emergency Preparedness Committee (NAIR Coordinator)

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Date of Next Review

November 2012
Date of Approval by the Organisational Risk Committee
December 2010
Version
Version 3.0- RSC

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APPENDIX C

Ionising Radiations Safety Policy

Procedure for Optimising Medical Exposures

Flow chart Annually RSC will
Set local DRL’s
MPE assists selection
Review patient dose of low dose
equipment
reports
New radiodiagnostic
Review optimisation equipment or
priorities set by MPE’s
techniques introduced.
Dose audit undertaken
at required frequency MPE/operator and
supplier involved in
MPE advises on dose initial protocols

reduction Optimisation/dose
audit within 1 year
opportunities post commissioning

Yes reducto Key
MPE – medical physics expert
Doses below DRL RSC – radiation safety
committee
No DRL – diagnostic reference
level
Report to next RSC.
Corrective action by the
relevant department

Dose optimisaNtion

carried out by Dept and
MPE.

Introduction

The Ionising Radiation (Medical Exposure) Regulations 2000 (IRMER) [1]
require the Employer to optimise medical radiation exposures to ensure
they are kept as low as reasonably practicable consistent with the
intended purpose. This procedure aims to set out the Trust actions that
will ensure this requirement is met. In addition the IR(ME)R 2000 require
that Diagnostic Reference Levels (DRLs) for radiodiagnostic examinations
are set and periodically reviewed. These DRLs are designed to ensure

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that patient doses are optimised when compared with European and
national dose levels [2]. Generally doses above these DRLs would be
considered bad practice and could not be justified solely on the grounds of
the use of poor equipment and/or techniques, irrespective of the
appropriateness of the examination. DRLs are part of the overall
framework for protection of the patient along with the other requirements
of IRMER 2000 and of Regulation 32 of IRR 99 [3]. The Department of
Health expect that levels at which the DRLs are set will be reviewed
annually. This will be done by the RSC. This review is intended to provide
a formal mechanism for revision of DRL values that may follow from
revised or new guidance. Where local examination protocols have been
changed, revision of locally adopted DRLs should be considered.

1. Diagnostic Radiology (X-ray)

In the first instance the Trust wide DRLs are set at the values provided in
NRPB publication–W14 [2]. Departments should adopt these values as
DRLs. Regulation 32 of IRR 99 requires that a quality assurance
programme be undertaken which includes periodic measurements of
representative radiation doses to samples of average size patients. The
basis of a suitable quality assurance programme for X-rays is outlined in
IPEM Report 91 [4]. This states that measurements for the most common
examinations should be made at least every 3 years on each piece of
equipment or whenever changes are made to equipment or procedures
that are likely to significantly affect patient dose. These periodic patient
dose assessments can usefully be used to determine whether DRLs are
being consistently exceeded. Where a DRL is consistently exceeded, the
employer must instigate a review of local practice to establish reasons and
implement corrective action, where appropriate. Local DRLs will be set for
the Trust at the RSC based on advice from the MPEs.

2. Nuclear Medicine

The Administration of Radioactive Substances Advisory Committee
(ARSAC) recommends maximum usual administered activities (MUAs).
These activities should only be exceeded in individual patients in whom
particular clinical circumstances make it necessary (e.g. very much
overweight, or in severe bone pain). The national DRLs for nuclear
medicine should be taken from the current MUA guidance issued by
ARSAC. The levels of administered activity should be measured prior to
administration so additional measurements are not required. Local DRL’s
for nuclear medicine should be set by the Head of Nuclear Medicine in
conjunction with the ARSAC licence holders and MPEs. These levels

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should be included in the departments IR(ME)R documentation, be
reviewed annually and reported to the Radiation Safety Committee.

3. Radiotherapy
Exposures in Radiotherapy are optimised during the treatment planning
stage. All treatment plans are optimised for each patient within the
constraints of the prescribed radiation dose and the technology/equipment
in clinical use at the time the treatment plan is formulated.

4. Specific Responsibilities

4.1 Radiation Safety Committee is responsible for:

Setting and periodically reviewing the Trust wide DRLs following
advice from the relevant Medical Physics Experts (MPEs). This must
be done at least annually.
Reviewing all patient dose audits on an annual basis including any
corrective actions recommended by the MPEs.
Reviewing the optimisation priorities for the coming year as advised
by the MPEs.
Monitoring action plans when a DRL is exceeded or a dose
reduction opportunity is recommended by an MPE.

4.2 Clinical Leads/Heads of Service are responsible for ensuring that:

the dose monitoring as required by IRR 99 is carried out;
procedures are in place for the use of DRL’s within their area of
responsibility;
the comparison of average doses against DRLs, is carried out; and
any resulting actions as a result of doses exceeding DRLs are
carried out.
Informing and taking into consideration the advice of an MPE when
procuring new equipment for medical exposure or introducing new
techniques
Acting on dose reduction opportunities recommended by an MPE.

4.3 Medical Physics Experts (MPE) are responsible for:
providing advice to the Radiation Safety Committee on setting and
reviewing Trust wide DRLs;
Preparing a programme of dose optimisation on an annual basis.

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Providing advice to departments on optimisation as part of the
procurement process for new equipment.
Assisting departments to optimise their equipment when first used
and post commissioning (within 1 year where appropriate).
Assisting departments to optimise exposures when new techniques
are introduced.
Advising on dose reduction opportunities following any dose audit.
Informing RSC of any doses that are above the relevant DRL.
Assisting departments to optimise doses above the relevant DRL

4.4 Radiation Protection Advisers (RPA) are responsible for:
providing advice on suitable patient dose measurements as part of a
quality assurance programme.

N.B. a list of RPAs and MPEs is available from the Head of Radiation
Physics, Medical Physics and Clinical Engineering.

5 References
[1] The Ionising Radiations (Medical Exposure) regulations 2000
[2] Doses to patients from medical x-ray examinations in the UK – 2000
review NRPB-W14
[3] The Ionising Radiations Regulations 1999
[4] Recommended standards for the routine performance testing of
diagnostic x-ray equipment IPEM Report 91, 2005

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Table 1. Recommended Diagnostic Reference Levels (DRLs) for
radiodiagnostic examinations.

Radiograph ESD per DAP per
radiograph radiograph
Skull AP/PA
Skull LAT (mGy) (Gy cm2)
Chest PA -
Chest LAT 3 -
Thoracic spine AP 1.5
Thoracic spine LAT 0.2 0.12
Lumbar spine AP 1.0 -
Lumbar spine LAT 3.5 -
Lumbar spine LSJ 10 -
Abdomen AP 6
Pelvis AP 14 1.6
26 3
6 3
4 3
3

Complete DAP (Gy cm2) Fluoroscopy
Examinations screening time
11
Barium swallow* 13 (mins)
Barium meal 14 2.3
Barium follow through 31 2.3
Barium enema* 50 2.2
Small bowel enema 54 2.7
Biliary 10.7
drainage/intervention 33 17
Femoral angiogram 4
Hickman line 4 5
Hysterosalpinogram 16 2.2
IVU 17 1.0
MCU 13
Nephrostogram 19 -
Nephrostomy 13 2.7
Retrograde 4.6
pyelogram 1.6 8.8
Sialogram 10 3.0
T-tube cholangiogram 5
Venogram (leg) 1.6
2.0
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Coronary angiogram 36 5.6

Oesophageal dilation 16 5.5

Pacemaker insertion 27 10.7

*Includes water

soluble

ESD = entrance surface dose (including backscatter).

DAP = dose area product.

Paediatric Standard age DAP (Gy cm2)
complete
examinations

MCU 0 0.4
1 1.0
5 1.0
10 2.1
15 4.7

Barium meal 0 0.7
1 2.0
5 2.0
10 4.5
15 7.2

Barium swallow 0 0.8
1 1.5
5 1.5
10 2.7
15 4.6

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Appendix D

Ionising Radiations Safety Policy

Procedure for personal and environmental dose monitoring

This procedure forms a part of the Trust Ionising Radiations Safety Policy.

1.Aims

To ensure that an appropriate dose monitoring programme for ionising
radiations is carried out, and that significant findings of the programme are
acted upon.

2. Introduction

2.1 Employers have a legal duty to ensure a safe working environment for
employees, patients and visitors. Part of this duty is, where staff are working
with ionising radiation, to ensure that the doses received by staff are as low
as reasonably achievable and do not exceed any legal limits. (“Staff” is taken
to mean employees of the Trust and other personnel working on the site). In
addition, employers have a legal duty to set investigation levels, which if
exceeded, require the employer to carry out a formal investigation. The
employer, in conjunction with the RPA, should carry out the investigation
immediately whenever the recorded doses for an individual exceed the
specified dose level. To that end a programme of personal monitoring to
ascertain radiation doses is undertaken. The monitors and administration are
provided by the Department of Medical Physics and Clinical Engineering (the
‘Radiation Monitoring Service’). In addition employers have a legal duty to
ensure (other than by assessment of doses to individuals) that the levels of
ionising radiation are adequately monitored in and around radiation areas.
This document describes the principles that are used to decide how, where
and when such monitoring is undertaken, along with a schedule of monitoring
and the dose levels that trigger a formal investigation.

2.2 Within a given directorate or department the various duties related to
personal monitoring may be assigned amongst a variety of people. Therefore,
this protocol does not in general seek to specify who will carry out which task
within a directorate/department. It is the responsibility of the Department
Clinical Lead or Head of Service to ensure that the required duties are
undertaken and that details of the relevant individuals are passed to the Head
of Radiation Physics, Medical Physics and Clinical Engineering, to facilitate
communications.

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3. Responsibilities

3.1 The Head of Medical and Clinical Engineering will ensure that a suitable
Radiation Protection Adviser:
Advises on the appropriate monitoring regime for each staff group and
radiation area.
Provides advice as required by this procedure.
Produces an annual report to the Trust Radiation Safety Committee
(Section 11).

Will recommend to the Clinical Lead or Head of Service, when appropriate,
that employees be designated as “classified persons”.

3.2 The Department Clinical Lead or Head of Service will:

Ensure that:
Staff for whom they are responsible comply with the procedures given
in Section 4.
Their duties relating to “classified persons” are undertaken (Section 5).
Incidents, lost or damaged dosemeters are investigated (Section 6).
Pregnant staff are appropriately monitored (Section 7).
Environmental monitoring of the doses in the vicinity of sources of
ionising radiation is undertaken (Section 8).
Monitoring results are reviewed and acted upon (Section 9).
Appropriate records are kept (Section 10).

They will also, with reference to the procedures in the relevant sections of this
protocol:

Ensure that compliance with these procedures is monitored.
Report to an RPA their arrangements for implementing and monitoring
these procedures.

NB. Implementation will require that the Department Clinical Lead or Head
of Service identifies key workers to carry out particular tasks but, as
discussed later, some of the tasks will be undertaken by the Radiation
Protection Supervisors (RPSs’).

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4. Procedure for staff personal dose monitoring

4.1 The relevant investigation levels are given in Table 1 and the monitoring
regimes for particular staff groups are in Table 2. Dosemeters are to be
provided by a dosimetry service (ADS) approved as such by the HSE. The
provision of dose meters will be organised through the Radiation Monitoring
Service.

4.2 Records are to be kept by a dosimetry service (ADS) approved for such
record keeping by the HSE, and organised through the Radiation Monitoring
Service.

4.3 Personal dose monitoring must be considered for all staff groups who
work with ionising radiation. An RPA is responsible for determining whether
monitoring is necessary for a particular staff group. Usually, monitoring will be
required for staff routinely entering controlled or supervised areas. Monitoring
may be carried out simply to reassure staff, if this is deemed appropriate.

4.4 If new work is undertaken, or there are changes to working practice or
there is a significant change in workload, then an RPA must be consulted (the
RPS will bring the changes to the notice of the RPA). The RPA is responsible
for determining whether personal monitoring for staff who undertake this work
should be commenced or changed. Also a change in legislation may result in
changes in personal monitoring for some staff groups.

4.5 The relevant RPS will monitor compliance with the advised dose
monitoring regime and report any significant non-compliance, either by
individuals or groups, to the relevant line manager and notify the RPA. It is
expected that for each monitoring group i.e. identified by a separate site code
the percentage of monitors are returned as follows:

at least 80% returned within two weeks following the end of the
relevant monitoring period
at least 90% returned within 1 month following the end of the
relevant monitoring period.

4.6 Monitoring will normally be carried out (as shown in Table 2):

Continuously – for groups who are likely to receive greater than 1/10th of
any relevant dose limit and/or spend a significant proportion of their working
time within a Controlled Area; or

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On a sample basis (for example for one month each year) – for low risk
groups who only need occasional confirmation of continued acceptable
working practice; or

On an ad hoc basis to assess doses in a particular situation, or for
reassurance.

The RPA may vary the actual monitoring regime where appropriate.

4.7 A single dosemeter worn to represent whole body dose (whole body
monitoring) will be adequate to assess radiation dose for most staff. The
relevant RPA may require that additional monitoring is carried out if, in his
opinion, the nature of the work warrants it. Whole body monitoring will be
carried out using film badges or thermoluminescent dosimeters (TLD’s) worn
at waist height, under a lead apron if used. If required, dose to the fingers will
be assessed using appropriate TLD’s. Doses to the index fingers of both
hands will be measured unless indicated otherwise. If required, dose to the
eyes will be assessed either using a suitably positioned film badge or
appropriate TLD.

4.8 After personal monitoring has taken place the Radiation Monitoring
Service will notify the results to key staff (nominated by the Departmental
Clinical Lead or Head of Service) and to the relevant RPA (see Section 9 for
review procedure).

4.9 Staff who work in more than one establishment may be monitored
separately at each establishment. The Radiation Protection Service will
ensure that an appropriate monitoring and merging of data is undertaken and
that the relevant RPA for each establishment is aware of such staff's total
radiation dose.

4.10 Instruction and training in the use and care of dosemeters must be given
to all users. An appropriate record must be kept of this training. However, this
training may form part of a broader training package in which case there is no
need to record the training separately.

5. The designation and surveillance of classified persons.

5.1 The Ionising Radiations Regulations 1999 (IRR99) Reg. 20 requires that
an employer “shall designate as classified persons those of his employees

who are likely to receive an effective dose in excess of 6mSv per year or an
equivalent dose which exceeds 3/10ths of any relevant dose limit”.

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5.2 When appropriate a Radiation Protection Adviser will recommend to a
Departmental Clinical Lead or Head of Service that an employee be
designated as classified, according to the criteria in paragraph 5.3 and taking
into account the results of any review undertaken. He will also notify the
Radiation Safety Committee and the Trust director with responsibility for
health and safety.

An employer has a legal duty to ensure that classified workers have:
their designation as classified immediately notified to them;
adequate medical surveillance, which will consist of at least pre-
classification and annual medicals carried out by an HSE Appointed
Doctor; and
dose monitoring and record keeping undertaken by an ADS.
appropriate access to their to their personal dose records.

5.3 A worker must be designated as classified if:

A radiation risk assessment indicates the likelihood that the threshold referred
to in IRR99 will be exceeded, either during routine work or as a result of a
reasonably foreseeable incident;

or

(for staff who are routinely monitored) his annual accumulated effective
(whole body) dose is 4mSv or more, or accumulated equivalent dose is
2/10ths or more of any relevant dose limit (see Table 3) (on the presumption
that at this level of recorded dose, there is the strong potential for the levels
referred to by IRR99 to be exceeded); unless it is clearly demonstrated upon
investigation that the recorded dose, or a significant part of it, was not actually
received by the individual concerned; or was the result of planned work (i.e.
not an incident) which has now ceased or will cease within the relevant
calendar year.

Before an employee is designated as classified on the basis of historical
dose, the relevant risk assessments and working practices must be reviewed
to ensure that doses are as low as reasonably practicable. A written summary
of the findings of any such investigation or review must be sent to the Head of
Radiation Physics.
If a classified person, as part of their employment by the Trust, works in the
controlled area of another employer, then the classified person is considered
to be an “Outside Worker” to whom special dose assessment provisions
apply (IRR99 Regulation 21). If a classified person may potentially work in the
controlled area of another employer advice must be taken from the relevant
RPA on the required action.

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Table 1. Investigation levels

Monitor Method Staff Group Investigation Level

Position (mSv)

Annual Wear

Period

Whole Body Film Nuclear medicine -2 0.5
(inside apron) badge
Radiopharmacy only.

All other whole body wearers. 1 0.5

Eye/Thyroid Film All wearers 10 5

(outside badge Laboratory Workers 2 0.5
All other extremity wearers 20 5
apron)

Extremity TLD

e.g. feet and

ankles etc.

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Table 2. Monitoring Regime Monitoring Whole Eye/ Extremity
period Body
Staff group Activity Quarterly ✔

Monthly ✔ Thyroid

Cardiac Cardiac Interventional --

Technician

Cardiologist Interventional ✔ ✔fingers
and ankles

Nurse Interventional Monthly ✔ ✔ -
Imaging ✔ - -
Diagnostic assistant X-ray QA Quarterly ✔ -
Radiology Assistant -
practitioner ✔ -
General, Quarterly ✔ ✔ -
Helper radiography, ✔ ✔
Nurse mobile Quarterly ✔ ✔ -
Radio- radiography, Monthly ✔ - -
grapher theatres. ✔ ✔
Assisting in -
Radiologist X-ray rooms -
Interventional ✔
(monitor
Interventional Monthly ankles if
not using
Fluoroscopy Quarterly lead
drapes or
Others Quarterly other Pb
screens)
Interventional Monthly -
-
Fluoroscopy Monthly ✔ ✔
✔ ✔ ✔
Endoscopy Physician Endoscopy Quarterly ✔ ✔ -
✔ -
Medical Nurse Endoscopy Quarterly
Physics ✔ -
Clinical Radio Monthly
scientists pharmacy (TLD)
technicians Other Monthly
and radio- (TLD)
grapher

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Staff group Activity Monitoring Whole Eye/ Extremity
period Body Thyroid ✔
Radiotherapy All staff Preparing or For -
Physics and dispensing remainder ✔
clinical I131 of monthly
oncology thyrotoxicosis monitoring
staff treatments. period once
Handling I192 used for
implants. treatment.
Involved with
All staff unsealed Thyroid monitoring with calibrated gamma
source
therapies. P- camera. Monitoring to be performed once per
32,Sr-89, Y-
90, I-131 year following administration of radioactive
MIBG, I-131
inpatient only. isotopes of iodine.
Involved with
Other unsealed Monthly ✔ - -
Surgeons source
Theatres therapies. Quarterly ✔ ✔ ✔
Other
Quarterly ✔ ✔ -
Hand surgery
Quarterly ✔ ✔ ✔
Spinal
Radiotherapy Radio- surgery Monthly ✔ - -
grapher Vascular
Assistant surgery
practitioner All

All Monthly ✔ - -

The above monitoring regime must be followed unless advised by an RPA.

N.B Where a member of staff carries out more than one activity the most
frequent monitoring regime will prevail.

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Table 3. Dose Limits (Ionising Radiations Regulations 1999)

Annual Limit Employees 2/10th of dose
(aged 18+) limit
4mSv
Effective dose 20mSv
(whole body) 30mSv

Equivalent dose to 150mSv 100mSv
the lens of the eye.
100mSv
Equivalent dose to 500mSv
hands, forearms,
feet and ankles.

Equivalent dose to 500mSv

the skin averaged
over 1cm2.

N.B. different dose limits apply to the following groups
Trainees aged under 18
Pregnant employees
Women of reproductive capacity
Members of the public
Comforters and carers.

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6. Incidents, lost or damaged dosemeters

6.1 Following a real or suspected incident (e.g. an accidental exposure)
dosemeters may need to be returned to the approved dosimetry service for
immediate readout. All radiation incidents must be reported according to the
Trust Incident Reporting Procedure and notified to the relevant RPA who will
advise on the most appropriate course of action to be taken.

6.2 Should any member of staff lose or damage their dosemeter they must
report the fact to the relevant RPS as documented in the Local Rules. Where
possible a replacement dosemeter should be assigned immediately to the
member of staff. A record must be kept of the action taken and the Radiation
Monitoring Service informed.

6.3 Should a classified person lose or damage their dosemeter an
investigation into the circumstances of the loss etc must be carried out by the
RPS in consultation with the relevant RPA. The RPA will advise the ADS on
the appropriate entry to be made in the dose records (copied to Radiation
Monitoring Service) and will bring the incident to the attention of the Radiation
Safety Committee, if appropriate.

7. Pregnant staff

7.1 Pregnant staff will have their monitoring needs decided at their individual
risk assessment carried out by the appropriate line manager in consultation
with the relevant RPA. See the Trust document - Procedure for the protection
of pregnant or breastfeeding staff.

8. Environmental Monitoring

8.1 Environmental monitoring will be carried out in order to determine the
radiation levels in the vicinity of sources of ionising radiation. As advised by
the relevant RPA, the monitoring will be carried out periodically for existing
areas and within an appropriate period following commissioning for new or
modified facilities. The results will be reviewed by the RPA and reported to
the appropriate manager along with any recommendations.

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9. Review of Monitoring Results

9.1 A review of the monitoring results must be carried out to ensure that any
doses exceeding the investigation levels or any unusual doses are brought to
the attention of the relevant RPA. On receipt of the monitoring results the
following actions must be taken:

Compare the individual doses reported with the record of
dosemeters returned to ensure that a report has been received from
the ADS for each dosemeter.

Report to the relevant RPA all doses exceeding the relevant
investigation levels for the wear period, the accumulated annual
doses (see 9.2) or any statutory dose limits (see 9.3).

Report to the relevant RPA any doses that appear unusual or were
unexpected.

9.2 If an annual investigation level is exceeded (see Table 1):
It must be reported as soon as reasonably practicable to an RPA and
the relevant Department Clinical Lead or Head of Service.
A Trust incident report must be completed.
The RPA will carry out an investigation and recommend further action
as necessary.
The RPA will copy the investigation report to the Radiation Safety
Committee and other relevant persons.

9.3 If a statutory dose limit is exceeded (see Table 3):

It must be reported immediately to an RPA and the relevant Department
Clinical Leads or Heads of Service, and as soon as is reasonably
practicable to the divisional operations director, the Trust director with
responsibility for health and safety and the Risk Management Adviser.
The person concerned must be withdrawn from relevant work with
ionising radiation as soon as is reasonably practicable, consistent with
the proper treatment of patients who may require radiological
examination or intervention.

A Trust incident report must be completed.
An RPA will carry out an investigation and recommend further action as
necessary including any requirement to notify externally. The RPA will
copy the investigation report to the Radiation Safety Committee and
other relevant persons.

10. Record keeping

10.1 Proper record keeping is important in order to demonstrate that an

adequate and effective system of personal monitoring is undertaken.

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10.2 Up to date records of the issue, return and dispatch of all dosemeters
must be maintained. The loss or damage of any dosemeter must also be
recorded and notified to the Radiation Monitoring Service.

10.3 Classified workers must be formally issued with their dosemeters and an
appropriate record kept of the issue.

10.4 The results of all monitoring must be retained for a minimum of two
years. In addition the ADS approved for record keeping will maintain the
statutory records for classified workers.

10.5 Staff members must be provided with the results of their personal
monitoring on request. The monitoring coordinator must provide the records
to the staff member.

11. Annual review

11.1 The Head of Radiation Physics will ensure that a summary report is
produced on the dose levels measured, the level of compliance with the
monitoring programme and any recommended actions required by the Trust
to ensure compliance with the regulations, to the Radiation Safety Committee
(normally at the April RSC meeting).

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Appendix E
Ionising Radiations Safety Policy

Procedure for the protection of pregnant or breastfeeding staff

This protocol forms a part of the Trust Ionising Radiations Safety Policy. It
should be read in conjunction with other Trust family-centred employment
guidance and in particular the Trust “New and Expectant Mothers at Work
Procedure”.

Summary Flowchart

Information for female staff Employee notifies manager of
Risks pregnancy or breastfeeding
Need to inform manager
when pregnant
Confidentiality

Work details Manager ensures risk
Likely doses (area risk assessment carried out and HSE
assessment) guidance document issued
Measured doses

Manager consults RPA re.
potential dose, restrictions and
monitoring arrangements

RPS supervises activities of Manager informs employee and
employee RPS of restrictions

Manager reviews monitoring
results on receipt and informs
RPA of unexpected dose levels

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1. Aims

To ensure that instruction and training are given to pregnant or breastfeeding
staff, and action is taken to appropriately control their exposure to ionising
radiation.

2. Introduction

Employers have a legal duty to ensure a safe working environment for
employees, patients and visitors ensuring that the dose from ionising
radiations to the fetus or baby of an employee is as low as reasonably
practicable. The working conditions for females of childbearing capacity
should ensure that any fetal dose received is not significant in the time
before a pregnancy can be confirmed and is then appropriately controlled
for the remainder of the pregnancy within a limit of 1mSv. Breast-feeding
mothers who work with radioactive substances may need to have their
work restricted.

The phrase “ionising radiation(s)” refers to X-rays and radiations from
radioactive substances.

3. Responsibilities

3.1 Clinical Leads/Heads of Service (managers)

Managers must ensure that:

this procedure is implemented, where relevant, in their directorate or
department;
all female employees who work with ionising radiations are given
information as detailed in section 4;
pregnant or breast feeding employees have an individual risk
assessment carried out by their line manager or other suitably
qualified person as soon as he is made aware of their situation (see
section 5); and
all actions identified by individual risk assessments are implemented.

3.2 Head of Radiation Physics Section, Medical Physics & Clinical
Engineering

Will ensure that a suitable Radiation Protection Adviser:

provides advice as required by this procedure;

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provides advice and reassurance to individual staff when requested
to do so; and
produces an annual summary report to the Radiation Safety
Committee (section 7).

3.3 Radiation Protection Supervisors (RPSs)

Will (acting on behalf of their manager):

supervise any restrictions to the work of the staff member; and
inform the RPA of any changes in working practices or workload for
any pregnant or, if working with radionuclides, breastfeeding staff.

3.4 All female employees

Must:

notify their line manager in writing as soon as practicable after they
become aware that they are pregnant, intend to breastfeed or
discontinue breastfeeding.

3.5 All relevant members of staff

This section applies particularly to RPSs, RPAs and those involved in dose
monitoring. It will also apply to any person handling information according to
this procedure. They must, within the constraints of carrying out their legal
obligations:

respect the confidentiality of any information given to them under this
procedure;
take all reasonably practicable steps to maintain that confidentiality;
and
respect the wishes of the female staff concerned.

4. Provision of information to all female staff

All female employees engaged in work with ionising radiations (X-rays or
radioactive substances) must be informed:

of the potential risk to the fetus, or to a nursing infant, arising from
exposure to ionising radiation;
of the need to notify their line manager, in writing, as soon as
possible after they become aware of their pregnancy; and
that all reasonably practicable steps will be taken to maintain the
confidentiality of their condition, within the constraints imposed by the
law.

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The information must be given:

in full as part of the induction process for a new employee;
the main points re-iterated at intervals as part of update training; and
the relevant points included in Local Rules.

5. Action required when notification of pregnancy or breastfeeding has
occurred.

5.1 Pregnancy

When notified that an employee is pregnant their manager must ensure that
an individual risk assessment is carried out as soon as practicable and
certainly within 2 weeks of notification. The risk assessment must include the
following information:

details of the type of work the expectant employee carries out
(including out-of-hours on-call and work for other employers);
details of the dose levels likely to be received whilst carrying out the
duties required while pregnant including the potential doses resulting
from accidents (this information will usually be contained within the
original risk assessment for the area); any actions required by the
original risk assessment that have not been completed, should also
be noted;
details of the likelihood of inhalation or ingestion of radioactive
material (this information will usually be contained within the original
risk assessment for the area);
details of potential external personal contamination (this information
will usually be contained within the original risk assessment for the
area);
the results of any measurements of inhaled or ingested activities;
dose levels recorded during personal monitoring of the individual;
dose levels recorded for employees carrying out similar work; and
dose levels measured as part of any other dose monitoring exercise.

Once the above information has been obtained the relevant RPA should be
consulted regarding the potential dose to the fetus, any restrictions required
to the working patterns of the mother and any additional personal monitoring
which may be needed.

5.2 Breastfeeding (only for mothers who work with radioactive
substances)

All employees returning to work following maternity leave should be assumed
to be breastfeeding until a written statement to the contrary is received.

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When notified that an employee is, or intends to be, breastfeeding the
manager must ensure that an individual risk assessment is carried out, which
must include the following information:

details of the type of work the mother carries out (including out-of-
hours on-call and work for other employers);
details of the likelihood of inhalation or ingestion of radioactive
material (this information will usually be contained within the original
risk assessment for the area);
details of potential external personal contamination (this information
will usually be contained within the original risk assessment for the
area); and
the results of any measurements of inhaled or ingested activities.

Once the above information has been obtained the relevant RPA should be
consulted regarding the potential dose to the nursing infant, any restrictions
required to the working patterns of the mother and any additional personal
monitoring which may be needed.

5.3 Restrictions to working practices

The manager should inform the employee of any restrictions to their duties, in
writing. The RPS should also be informed of any restrictions imposed.

Where it is necessary to apply restrictions the manager will follow the
procedure laid out in the Trust “New and Expectant Mothers at Work
Procedure” to determine how the employee’s duties may be redefined.

5.4 Information for pregnant or breastfeeding staff
5.4.1 The leaflet “Working safely with ionising radiation: Guidelines for

expectant or breastfeeding mothers” produced by the HSE should be
issued to all members of staff working with ionising radiation when they
inform the employer that they are pregnant or, if working with
radioactive substances, are or intend to be breastfeeding.

5.4.2 The employee should be informed that complying with the Local Rules
will restrict the dose to the baby and asked to re-familiarise herself with
the contents of the Local Rules. She should be informed of any specific
restrictions following her individual risk assessment.

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5.4.3 The employee should be told that any necessary changes to their
monitoring procedure or working practices might cause their colleagues
to surmise that they are pregnant or breastfeeding. However, the
protection of the employee, fetus or child is paramount.

5.5 Monitoring Arrangements For Pregnant Staff

5.5.1 The manager should ensure that the personal monitoring regime
identified by the individual risk assessment is carried out and notify the
RPA of any further changes to working practices of the pregnant
employee which may affect the monitoring regime. See section 6.

5.5.2 Where staff work in more than one establishment the results of any
monitoring carried out at all sites should be combined to give the total
dose received. If the risk assessment indicates that the employee works
at other sites the manager should make arrangements to obtain the
dose records for that staff member at all sites and provide a copy to the
RPA.

5.5.3 The employee’s manager must ensure that a timely review of the
monitoring results is carried out. The review must ensure that any
doses exceeding the investigation levels or any unusual doses are
brought to the attention of the relevant RPA, when the manager and
RPA should investigate and review the restrictions.

6. Monitoring regime / investigation levels for pregnant staff

6.1 All pregnant staff who are routinely monitored using a whole body badge
should be monitored monthly (whole body) unless:

the staff member only works with X-rays and will not at any time
during their pregnancy be required to enter the unprotected area (i.e.
work outside the protective screen or work wearing a lead apron)
during an exposure when the monitoring regime need not be
changed; or
based on the findings of the individual risk assessment the RPA
advises that a specific monitoring regime is carried out.

N.B. If the person is not advised to wear a whole body monitor routinely then
monitoring during pregnancy is not required. The monitoring of other parts of
the body e.g. hands, eye, thyroid etc may remain the same during pregnancy
although it may be more convenient to issue all the monitors at the same
frequency.

Investigation Level (Whole body, 1 month wear period) 0.2 mSv

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6.2 Staff monitored more often than monthly will have the investigation level
for the wear period determined at their individual risk assessment.

7. Reporting
7.1 The Head of Radiation Physics will ensure that an annual report

summarising actions taken under this protocol is presented to the
Radiation Safety Committee. The report will include any problems
encountered.

8. References
HSE. Working safely with ionising radiation: Guidelines for expectant or
breastfeeding mothers. HSE Books, Sudbury. 2001
(http://www.hse.gov.uk/pubns/indg334.pdf)

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APPENDIX F
IONISING RADIATIONS SAFETY POLICY

Procedure for the Appointment of Qualified Experts in radiation
protection, diagnostic radiology, nuclear medicine and radiotherapy
physics

Nottingham University Hospitals NHS Trust appoints the following qualified
experts in radiation protection, diagnostic radiology, nuclear medicine and
radiotherapy physics:

1. Radiation Protection Advisers to the Trust as required by the Ionising
Radiations Regulations 1999

The Head of Medical Physics and Clinical Engineering will ensure that
staff to be appointed as Radiation Protection Advisers hold an RPA2000
certificate of competence and are assessed as suitable and competent
on appointment to a post within the Trust.

2. Medical Physics Experts to the Trust as required by the Ionising
Radiation (Medical Exposure) Regulations 2000

The Head of Medical Physics and Clinical Engineering will ensure that
staff to be appointed as Medical Physics Experts are assessed as
competent on appointment to a post within the Trust.

3. Qualified Experts to the Trust in the disposal of radioactive waste as
required by an Authorisation under Reg. 13 of the Radioactive
Substances Act

The Head of Medical Physics and Clinical Engineering will ensure that
staff to be appointed as Qualified Experts are assessed as competent on
appointment to a post within the Trust.

4. The Head of Medical Physics and Clinical Engineering will write to the
Medical Director with a list of appointments for the Medical Director to
sign. Once signed, that letter will be issued to staff appointed within this
procedure.

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APPENDIX G

Ionising Radiations Safety

Procedure for the control of radioactive substances

This procedure forms a part of the Trust Ionising Radiations Safety Policy.
1. Summary flow chart

Department Trust

Department identifies requirement to use or Ionising Radiations Safety
handle RaS (including new or changed Policy
practices)

Practice BAT case Radiation prior risk Procedure for the control
assessment1 of radioactive substances

Sign off by senior
Trust management

RaS Lead

RPA review of limits on holding and waste Trust Best Available
disposal; also general requirements for Techniques Case

compliance with EPR10, HASS and IRR991 Annual review
by RSC

Resource implications and
procedures for compliance
agreed with user department

BAT case and risk assessment1 Practice BAT case
signed off by RaS Lead
Notes:
Department appoints Radioactive Protection 1 outside the remit of this document
Supervisor and prepares procedures for BAT = Best Practicable Means
RaS = Radioactive Substance
compliance with EPR10, IRR991 and HASS; as RSC = Radiation Safety Committee
necessary RPA = Radiation Protection Adviser
EPR10, HASS, IRR99
Department maintains records in compliance
with EPR10 Permits = legislation, see section 2.

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2. Aims

To ensure that the Trust has documented management structures and
processes for the control of radioactive substances which meet the
requirements of: the Environmental Permitting Regulations 2010 (EPR10)
and any Environmental Permits granted in accordance with that Act by the
Environment Agency; and, the High-activity Sealed Radioactive Sources and
Orphan Sources Regulations 2005 (HASS).

To support the provisions of the Trust Ionising Radiations Safety Policy in
relation to the control of radioactive substances.

To ensure that a procedural framework exists for the application of Best
Available Techniques to all accumulation and disposal of radioactive waste by
the Trust.

This procedure addresses issues within the remit of EPR10 and HASS only.
Other issues are dealt with as follows.

The health and safety of individuals involved in the handling of
radioactive substances is subject to the Ionising Radiations
Regulations 1999 (IRR99) (see Trust Ionising Radiations Safety
Policy and individual department Local Rules).

The administration of radioactive substances to humans is controlled
by the Medicines (Administration of Radioactive Substances)
Regulations 1978 (amended 1995) (see Trust Procedure for the
Control of Medical Exposures).

The transport of radioactive substances by any means (road, rail, air,
mail, courier) is subject to the Carriage of Dangerous Goods and Use
of Transportable Pressure Equipment Regulations 2009. Transport
includes all related processes: design, manufacture, maintenance
and repair of packaging; preparation, consigning, loading, carriage,
unloading and receipt of material; including storage in transit. No
employee may undertake any transport of radioactive material i.e. the
sending of radioactive substances (including waste) off site by any
means, except in compliance with the relevant legislation and after
consultation with a Radiation Protection Adviser and the Trust
Dangerous Goods Safety Adviser.

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3. Introduction

The Trust uses radioactive substances for medical diagnosis, therapy and
research, both directly on patients and also indirectly (e.g. performing tests on
biological samples or in testing-instruments).

The possession of radioactive sources and the accumulation and disposal of
radioactive waste are controlled by the Environmental Permitting Regulations
2010, through permits issued to users (e.g. the Trust) by the Environment
Agency. The permits impose certain conditions and limitations, included
amongst these are;

the requirement to have “a management system, organisational
structure and resources sufficient to achieve compliance with the
limitations and conditions” of the certificates;

the provision for consultation with a suitable RPA;

the requirement for written operating procedures;

the requirement for adequate supervision by suitably qualified and
experienced persons whose names are published in the locations for
which they have responsibility;

numerical limits on the maximum activities of material which may be
held or disposed of.

The HASS regulations extend the requirements which may be associated
with the above for sealed sources of high activity (as defined by the
regulations).

Best Available Techniques

In using and disposing of radioactive substances the Trust is obliged to
ensure that it applies Best Available Techniques (BAT) to minimise the impact
on the environment and the public. In order to do so the Trust must justify:

its decision to use a technique involving radioactivity;
its choice of radionuclide and amount of radioactivity;
the way it is used and disposed of.
All reasonably available alternatives must be considered.

Best Available Techniques also implies adequate control.

The Trust must document the way in which it ensures that BAT is practised
as well as the BAT justifications for specific practices. This Best Available
Techniques Case must be available for inspection by the Environment
Agency, on request.

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4. Definitions
For the purposes of this procedure–

4.1 Radioactive substances are those substances subject to control under
EPR10 or HASS and including those which are controlled by Exemption
Orders.

4.2 The “use” of radioactive substances includes their involvement as part of
any activity, the possession of radioactive sources and their storage, and
the accumulation and disposal of radioactive waste.

5. Strategy for control

The Trust will control the use of radioactive substances by ensuring that there
is in place:

5.1 A procedure (this document) which has been authorised by senior Trust
management and which details a transparent and robust framework for
the control of radioactive substances within Nottingham University
Hospitals NHS Trust.

5.2 An identified individual within the Trust, the Radioactive Substances
Lead (RaS Lead), who will coordinate the control of radioactive
substances within the Trust. The RaS Lead is the Head of Medical
Physics & Clinical Engineering

5.3 A written statement justifying each practice of holding or use of
radioactive sources, or accumulation or disposal of radioactive waste.

5.4 One or more individuals appointed in each department using radioactive
substances who has a defined scope of responsibility for the supervision
of activities subject to a permit under EPR10.

5.5 The requirement to report and investigate incidents involving radioactive
substances.

5.6 The requirement to establish a mechanism for maintaining accurate
records of holding and disposals of radioactive substances and for those
records to be audited.

5.7 Regular audit of users procedures and practice by a Radiation Protection
Adviser.

5.8 The monitoring of compliance with the Control of Radioactive
Substances Procedure by the Radiation Safety Committee.

5.9 Guidance for managing sealed radioactive sources available from the
RaS Lead

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6. Procedures and responsibilities

The general control of ionising radiations takes place within the Trust’s
organisational structure for risk management. The relevant parts of this
structure and associated management responsibilities may be found in the
Trust “Ionising Radiations Safety Policy”. The following paragraphs define
additional specific requirements associated with the control of radioactive
substances.

6.1 The Responsible Manager

6.1.1 It is the responsibility of the Responsible Manager, as part of this
procedure, to identify and authorise an individual who will be the Trust
Radioactive Substances Lead (Appendix 1)

6.2 The Radiation Safety Committee

6.2.1 The RSC will monitor compliance with this procedure, by:

reviewing relevant incident reports;
receiving an annual compliance report from the RaS Lead;
periodically reviewing the Trust Best Available Techniques case.

6.3 Trust Radioactive Substances Lead
6.3.1 The RaS Lead will undertake duties as defined within this procedure.
6.3.2 The RaS Lead will collate and hold the Trust Best Available Techniques

case.
6.3.3 The RaS Lead will present an annual report on compliance with this

procedure to the RPC.
6.3.4 The RaS Lead will be responsible for ensuring that the annual statutory

return on radioactive waste disposal is prepared and presented to the
Environment Agency, as they require.
6.3.5 The RaS Lead will approve BAT justifications submitted by departments
for new or varied practices using radioactive substances.
6.3.6 The RaS Lead will set sub-limits for each department proposing to use
radioactive substances, which are within the numerical limits set in the
relevant certificates and which when summed together do not exceed
the certificate limits. He will monitor compliance with them on a regular
basis.

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6.4 Radiation Protection Advisers

6.4.1 RPAs will carry out reviews of new BAT cases and prior risk
assessments on behalf of the RaS Lead, as required.

6.4.2 RPAs will audit departmental use of radioactive substances as part of
their routine audit programme.

6.5 Clinical Leads/Heads of Service

6.5.1 The Clinical Lead/Head of Service of each department which wishes to
use radioactive substances must submit a statement justifying his
proposal as the “best available technique”. Submissions must be made
to the Trust RaS Lead for review and approval, prior to commencing the
proposed practice.

6.5.2 A department proposing a change to its working practices which would
lead to any of its limits for RaS use being exceeded, must prepare a
new BAT justification for approval as in 6.3.1.

Note: significant changes to holdings or disposals of radioactive
substances may necessitate variations to Registrations or
Authorisations. The need to prepare documentation and obtain
revised certificates from the Environment Agency can be a lengthy
process, partially outside our control. Users are advised to make a
draft proposal at the earliest opportunity, in anticipation that obtaining
the necessary variations, if required, may take several months. A
charge may be made by the Environment Agency [currently between
£600 and £2500] which must be met by the user department.

6.5.3 A copy of approved proposals will be held as part of the overall Trust
BAT case.

6.5.4 Prior to commencing any work with ionising radiation, or any change in
practice, the head of department must ensure that a radiation prior risk
assessment has been carried out and submitted for review to the RaS
Lead along with the BAT case. The prior risk assessment is a
requirement of IRR99.

6.5.5 The Clinical Lead/Head of Service will appoint, in writing, one or more
individuals to be Radioactive Protection Supervisors (RPS) with
responsibility for the safe use of RaS within a service. They will ensure
compliance with the requirements of the EPR10 permits and Trust
procedures.

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6.6 User departments must:

display copies of the Trust’s EPR10 permits along with the name(s) of
their RPS (s);
prepare written procedures for their procurement, secure holding and
use of radioactive sources, and their accumulation and disposal of
radioactive waste, including record keeping, which will ensure
compliance with the EPR10 permits, HASS and Trust procedures;
prepare written procedures for the reporting of incidents in
accordance with the requirements of the certificates;
comply with their departmental limits for activity of radioactive
substances which they use;
present periodic returns indicating their current holdings of radioactive
sources and waste disposals in the previous period, to the RaS Lead;
and
ensure that relevant staff have appropriate training and that up-to-
date training records are maintained.

Follow the guidance on the management of sealed radioactive
sources available from the RaS Lead.

6.7 Director of Estates & Facilities

6.7.1 Estates & Facilities are responsible for the collection of solid radioactive
waste from user departments and its transfer to a contractor for
incineration. The Director of Estates & Facilities will appoint a suitable
person for each site (Queen’s Medical Centre Campus and City
Hospital Campus) to supervise this activity.

6.7.2 Any proposal to change arrangements for collection or disposal
(including change of contractor) must be notified to the RaS Lead well
in advance as it will require notification to the Environment Agency and
potentially a formal application for a variation to the Trust Authorisation.

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APPENDIX H
IONISING RADIATIONS SAFETY POLICY

Procedure for the reporting and investigation of incidents involving
radiation

1. All staff should report all incidents and near misses to their Line
Manager as soon as possible following the incident or near miss as per their
departmental procedure.

2. If radiation is involved in the incident or near miss then the Line
Manager should inform the relevant Radiation Protection Supervisor (RPS) as
soon as possible.

3. The RPS must instigate an immediate investigation to clarify that an
incident has occurred and where there is no firm evidence that no such
incident has occurred must seek advice from a Radiation Protection Adviser
(RPA) immediately.

4. The RPA must log the incident on the Radiation Safety Committee
(RSC) spreadsheet. They will advise on requirement to report to external
agencies & will aid the investigation as appropriate.

5. The Head of Service (HoS) is responsible for ensuring that an
appropriate action plan is developed (with RPA advice). This action plan must
be copied to the RPA.

6. The HoS must provide the RSC with regular updates on progress
against the action plan.

7. The RSC monitors progress against action plans, raises any concerns
regarding progress with HoS and, if concerns not allayed, raises the issue
with ORC.

Reporting Timescales

Initial report of incident same/next working day after discovery
If radiation involved, RPS informed within 2 working days after discovery
RPA informed within 3 working days

If external reporting is required, the RPA informs;
HSE if suspected overexposure, or patient mgti within 1 working day
HCC within 5 working days
EA within 5 working days unless lost source (immediately)

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For all externally reportable incidents, RPA informs the Chief Executive,
Medical Director, the relevant Clinical Lead and HoS following report to
external agency

Records

HoS responsible for keeping suitable records of all action plans and for
providing update reports to RSC

RPA responsible for updating RSC incident log spreadsheet

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