DOCUMENT of COMPLIANCE
with
the Environmental Permitting Regulations 2010
AR0403/BY6001 and BJ5694/BZ9758
issued to the
University College Medical School
Royal Free Campus
Approved by:
UCL Safety Services
Michael Lockyer
9 / 1 / 2012
RWA & Qualified Expert
(UCL-RFH campus)
Deborah Purfield
6 / 1 / 2012
Abbreviations
UCL-RF
RFH
BAT
RAM
RAW
RSG
EPR
RSS
University College Medical School – Royal Free Campus
Royal Free Hampstead NHS Trust
Best Available Techniques
Radioactive Material
Radioactive Waste
Radiation Safety Group of Medical Physics
Environmental Permit Regulations 2010 – superseded RAS95
Radioactive Substances Supervisor (UCL-RF-defined term for staff member responsible for
departmental/laboratory compliance with EPR (analogous to role of RPS under IRR99))
Written by :
D.Purfield
Approved by :
M Lockyer
DocumentWritten
Ref : By UCL-RF
:
EPRv2
Page No. :
Page 1 of 12
Effective from :
Jan12
Next Review date :
Jan13
1. Introduction
On the 6th April 2010, EPR came into force replacing the Radioactive Substances Act 93 (RSA93).
With this change came the automatic amalgamation of the certificates into one Environmental Permit.
Therefore, the certificates for UCL-(Royal Free Campus) (UCL-RF) of Registration of Open Sources
AR0403/BY6001 and Authorisation to accumulate and dispose of radioactive sources BJ5694/BZ9758
under RSA93 are now one Environmental Permit under EPR. The Sealed sources are not included in
this document.
This document demonstrates how the UCL-RF complies with the current Permits for open sources and
disposal of radioactive waste. In addition to this, each UCL-RF department has its own local means of
demonstrating how BAT has been considered via completion of a form for each radionuclide used.
Documented procedures are followed for dealing with all radioactive substances (see appendix 1 for list
of procedures). These cover the decision to use radionuclides, minimising the amount of radionuclides
purchased, control of the material from when it first arrives on the premises up to the point of use,
minimisation in the generation of wastes and subsequent management through to final disposal. The
philosophy is of “cradle to grave” care and control over all pathways for radioactive substances. It
includes adherence to BAT in the planning and design of new facilities as well as the decommissioning
of old facilities.
Radioactivity is used to varying degrees in the following UCL-RF departments :









Haematology
Hepatology
L.E.G
Immunology
Rheumatology
Centre for amyloid and acute phase protein
Centre for molecular cell biology
Neuroscience
Comparative biological unit *
* only generates waste
Radionuclide sources are used mainly for research and QC tests.
1. Management Responsibilities
The organogram below summarises the communication and reporting structures between the RFH and
UCL-RF for the management of radioactive materials at the Royal Free Campus. Each user department
in turn has its own local organogram.
Written by :
D.Purfield
Approved by :
M Lockyer
DocumentWritten
Ref : By UCL-RF
:
EPRv2
Page No. :
Page 2 of 12
Effective from :
Jan12
Next Review date :
Jan13
Written by :
D.Purfield
Approved by :
M Lockyer
DocumentWritten
Ref : By UCL-RF
:
EPRv2
Page No. :
Page 3 of 12
Effective from :
Jan12
Next Review date :
Jan13
2 Responsibilities of Staff
Requirements for staff responsibility are set out below :
Provost UCL
ultimately has the responsibility for the accumulation and disposal of radioactive waste in
the UCL-RF
Radiation Board - Meets every 2 months to ensure that the management and use of ionising radiation within
RFH
the trust and those users on trust premises (eg Royal Free campus of the medical school)
comply with the appropriate legislation, directives and published guidance (eg EPR)
Radiation
Protection
A dvisor
Radioactive
W aste A dvisor
Lab Radiation
Governance
Group (LRGG)
Qualified Expert
Heads of
Departments
and lab managers
RPS / RSS
Staff using
radioactive
materials
Permit Coordinator
(RFH site)
UCL Radiation
Protection
Officer
Provides advice on issues of compliance with the legislation and gives advice on all
aspects of radiation safety for the Medical School at the RFH site.
Makes recommendations which are formally reported via relevant committees and
groups to the RPS/RSS, Heads of Department, Head of Safety (UCL) and the Provost
Provides advice on issues of radiological protection with respect to radioactive waste.
Makes recommendations which are formally reported via relevant committees and
groups to the RPS/RSS, Heads of Department, Head of Safety (UCL) and the Provost
Meets quarterly to ensure compliance with ionising radiation safety legislation within
the laboratories.
Report any recommended actions or escalations to the RFH Radiation Board
Provide information from the Trust board to the users.
Chairs the LRGG
Advises the users of RAMs as to compliance with the Permits
Reports from the LRGG to the Radiation Board
Attends the UCL IRSMC
Carry responsibility for the safe management of radioactive material and waste in their
areas of responsibility, adhering to legislative requirements.
Have to ensure that the RPS/RSS (and deputies, if appointed) has sufficient time and
resources allocated to be able to complete their duties.
Ensure staff are competent in working safely with radioactive materials
determines whether staff are competent in handling radioactive materials but is not
responsible for ensuring competence.
has a supervisory role in the accumulation and disposal of radioactive waste and
compliance with Local Rules
reports any actual or potential breach in their local holding and waste limits as soon as
possible to the Permit Co-ordinator.
Escalates to Local Radiation Governance Group (LRGG) any radiation issues.
have to ensure that they follow the documented procedures (including Local Rules)
when working with radioactive materials.
Complete appropriate records in a timely and legible manner.
Have to report any actual or potential breaches of their local holding and waste limits
as soon as possible to the RPS/RSS.
Responsible for
record keeping,
setting up local limits for users so as to ensure that the Permit limits are not exceeded,
collating monthly holding and waste returns
ensuring the annual pollution inventory is submitted on time to the EA.
Report to the Radiation Board any non-compliance.
Responsible for
Reporting any issues raised at the LRGG to the IRSMC and vice versa.
Reporting any issues raised at the LRGG to UCL health & safety meeting (RF campus)
Raising issues from the IRSMC to the Radiation Board and vice versa
Written by :
D.Purfield
Approved by :
M Lockyer
DocumentWritten
Ref : By UCL-RF
:
EPRv2
Page No. :
Page 4 of 12
Effective from :
Jan12
Next Review date :
Jan13
3 Demonstration of Compliance with Permit to Hold Open Sources – AR0403/BY6001
1
2
3
4
CONDITION
Purposes for
which registered
materials are kept
or used
Maximum
activity of
Registered
material
Supervision of
registered
materials
The keeping and
use of registered
materials
DEMONSTRATION OF COMPLIANCE
When ordering RAM, users have to state what they are
going to use it for. Unless it is for one of the purposes
stated in Schedule 2, the RAM will not be ordered
Local limits are assigned to each department according
to the outcome of their BAT questionnaire and overall
use of the RAM for the UCL-RF. Local limits take
into account higher delivered activities.
Permit limits will not be exceeded as
the total local allocation is kept to within 70%
of it. Any department exceeding their local
limit will still not breech the Permit limit.
Order form includes local limits and total
holdings and this is checked by the RPS and
RSG before an order is placed to ensure that
local limits are not breached. No order is
placed otherwise.
Monthly stock and waste return form provides
a further record that the local limits are not
exceeded for the month. No breach of local
limits implies no breach of Permit limits.
A named person (ie the RPS/RSS) is displayed outside
each designated area where RAMs are stored. These
people have had training and have been deemed
competent by appointment as an RPS/RSS. Training
records are kept with the HoD. RPS/RSS have to
attend up-date training at least once in 3 years. There
is currently a rolling RPS training program for update
training.
The Permit Co-ordinator has the overall responsibility
of ensuring compliance with Permit limits.
No registered material is lent to a person other than to
those registered to use it. A list of all users is kept on
the orders database and updated regularly The
destination of all RAM is known via the order form
before the RAM is on site and good record keeping
when it get to the lab via the stick record sheet traces
its path to the “grave”. Only users who have
completed a “new users” form which has been
approved by RSG will be added to the “approved
users” on the database and only names on this list can
order RAMs.
Written by :
D.Purfield
Approved by :
M Lockyer
DocumentWritten
Ref : By UCL-RF
:
EPRv2
Page No. :
Page 5 of 12
EVIDENCE
Order form (RSGOrderFrm v4) and its
procedure- RSG2a(iii)
BAT v4 form
Excel spreadsheet
“School local Limits”
Order form (RSGOrderFrm v4) and its
procedure- RSG2a(iii)
RSG-WasteRtnFrm v7
Trust Radiation Safety
Policy
Up to date training
records
Med Sch waste and
holding spreadsheet.
Orders database
Order form (RSGOrderFrm v4) and its
procedure- RSG2a(iii)
Stock record sheet
(RSG-stockvial v2)
New user forms (RSGUsrFrm v3)
Effective from :
Jan12
Next Review date :
Jan13
5
a
Loss of material
Procedures for ordering and processing RA material
ensure that loss of sources is negligible when it enters
and leaves Medical Physics
When the RAM is signed over to the user department,
they take ownership. Departments have carried out
risk assessments which cover loss of sources. They
have Local Rules which indicate how RAM should be
kept and dealt with to prevent loss.
b
6
a
b
7
9
a
b
c
10
Risk assessment forms
Local Rules
All RAMs entering the RFH site are signed into
Medical Physics where access is restricted to authorised
users only and accessible only by swipe cards. Delivery
drivers arriving out of normal working hours are
escorted by security staff from the RFH Items are
locked in cages which have been approved by CTSA.
Receipt of radioactive
deliveries
Processing radioactive
deliveries
Restriction of
Access
When items are picked up by the users, they are signed
out and are placed in fridges or storage places which
are lockable.
Local Rules
RAMs stored
safely
All RAMs entering the RFH site are stored in locked in
cages which have been approved by CTSA. There is
CCTV. There are no combustible materials located in
the same area. All items are marked with the word
“Radioactive” when delivered. RAMs are also stored
safety in locked areas when they are taken by the user.
All departments have area security plans which detail
this
BAT forms for each RAM are a requirement of all
users of RAM. The form addresses the issue of
minimisation of RA waste and users have to state how
they will go about doing it. Only minimum activity is
purchased as users have to justify amount purchased to
the RSG before it is approved. Items are monitored and
only those found to be contaminated are disposed as
radioactive.
All new or refurbished premises are inspected by RSG
to ensure that the construction is such that it cannot be
readily contaminated and that it can be easily removed.
Users are required to carry out contamination checks
after every procedure
There are contingency plans in the Local Rules which
deal with what should be done in the event that a source
is lost. All users must sign to say that they have read,
understood and agree to abide by them.
The Trust incident reporting states what must be done
should loss or theft occur. Users are informed of these
documents via the LRGG and training sessions
Minimisation of
RA waste
8
a
b
Receipt of radioactive
deliveries
Processing radioactive
deliveries
Construction of
premises
Loss or Theft of
RAM
Informing Police
and EA
Try and recover
the RAM
Report it in
writing to the EA
Escape of RAM
As for 9
Written by :
D.Purfield
M Lockyer
Department security
plans
BAT v4 form
Local Rules
Local Rules
Local Rules from all
user depts..
Radiation incident
triggers
Radiation incident
flowcharts
Minutes from LRGG.
Training
As for 9
All RAMs entering Medical Physics have their details
Approved by :
Hotlab Local Rules
DocumentWritten
Ref : By UCL-RF
:
EPRv2
Page No. :
Page 6 of 12
RAM track database
Effective from :
Jan12
Next Review date :
Jan13
12
Records
a– c
d- e
recorded onto a database which is backed up daily.
This database stores all the requirements listed in the
Permit (12 a – c)
All departments have to submit a form stating how
much activity they have in their department at the end
of each month. This is put into a spreadsheet and the
total activity for the UCL-RF is known and checked
against the limit each month.
Monthly holding and
waste form (RSGWasteRtnFrm v7)
Med Sch waste and
holding spreadsheet.
Users are required to submit to RSG a monthly check
list stating that they have complied with legislation.
This is collated and presented at the local governance
meeting. 3 non-returns and this is escalated to the
radiation board for further action to be taken.
Manager’s check list
form.
Item on the local
governance agenda
Audits are carried out to ensure that the UCL-RF
complies with requirements.
Audit forms and action
sheets
Written by :
D.Purfield
Approved by :
M Lockyer
DocumentWritten
Ref : By UCL-RF
:
EPRv2
Page No. :
Page 7 of 12
Effective from :
Jan12
Next Review date :
Jan13
4 Demonstration of Compliance with Permit to Dispose of RAW – BJ5694/BZ9758
Conditions
Management
1
Demonstration of Compliance
a
Consultation with
RPA and qualified
expert
b
Written operational
procedures
c
Adequate
supervision of RA
waste
A management system and organisation
structure for UCL-RH is given above. In
addition, each department has its own
organogram
Consultation with the Radioactive waste
advisor and qualified expert is done via the
local radiation governance group (LRGG)
meetings or when needed
Consultation with the RPA is done via the
Radiation board or when needed.
The Radiation Safety Group (RSG) has
written procedures dealing with waste
generation and disposal as well as forms
which together ensure compliance with the
limitation of the permit. Users also have
written procedures to ensure compliance with
local limits.
Supervision of the overall disposal of RAW is
done by the Permit Co-ordinator / RW A . This
person is a Qualified expert. In each
department, the suitable qualified RPS/RSS
takes charge of all waste being disposed from
the department. A unique consecutive
numbering system is in place to ensure that
waste disposed has been checked to ensure
local limits are not breached
Disposal of Radioactive Waste
2
a
Minimise the activity
b
Minimise the volume
c
Minimise
radiological impact
Items are monitored before they are disposed
so that only what is radioactive is disposed as
RAW thus reducing the volume of RAW.
Having a large waste store enables RAW to
be stored for longer periods before it is
disposed off site thereby reducing the out
going activity and volume of RAW. This
reduces the radiological impact.
Aqueous waste is disposed immediately down
designated sinks using the “dilute and
disperse” technique which reduces
radiological impact.
Every user dept is given local limits for
having and disposing of RAMs only after they
have demonstrated BAT.
Written by :
D.Purfield
Approved by :
M Lockyer
DocumentWritten
Ref : By UCL-RF
:
EPRv2
Page No. :
Page 8 of 12
Evidence
See UCL-RF organogram
above
Local organograms available
from each user department.
Terms of reference – LRGG
& Radiation board
Procedures RSG8a – 8g
Order form
Monthly waste return form
Manager’s check list
Stock record sheet
BAT form
Submitting annual pollution
inventory
Manager’s check list
Training
Local Rules
RSG8g-01. Preparing For a
Collection
BAT form
Training
Local limits certs for various
depts.
Effective from :
Jan12
Next Review date :
Jan13
3 & Maintain systems
4
and equipment
To meet (2)
a
For disposal of
b
RAW
Systems are reviewed via audits carried out in
each lab . Issue are raised via the audit report
and feedback via the action sheet and check
list which are discussed at the quarterly
LRGG meeting .
Monitors are calibrated annually to ensure
that figures obtained are accurate to the level
required.
Accumulation of RA waste
5
Prevent Loss of
RAW
Each department has a procedure as to where
to store RAW and how to log it. Accumulated
RAW is logged at all times so that its
whereabouts is always known thus preventing
loss. Waste may be deposited in the waste
store twice a week at set times. Bags have to
be labelled with unique consecutive numbers
so that any loss bags will be easily detected.
a
b
6
Prevent access to
RAW by
unauthorised person
Accumulation of
RAW
RAW and kept in secure places behind locked
doors in the waste store and only authorised
persons have access to it. The security of the
waste store has been approved by the CTSA.
In user depts., waste is kept in the radioactive
area and the area is locked.
RAW is kept in secure places behind locked
doors and only authorised persons have access
to it in the waste store. Waste is logged onto
the database system when it arrives in the
waste store and the consecutive number
checked to ensure nothing goes missing. Solid
waste is then kept is locked containers and the
OLW is placed in non-combustible bins till
they are ready to be disposed off.
Waste in labs is store in Perspex or metal
bins. All RAW is labelled with the
radioactive word and the trefoil sign.
All RAW is always stored away from
flammable items.
Mins of LRGG meeting
Manager’s check list
RSG1 –Instrument calibration
Lab audits and reports
Local Rules
Stock record sheet
RSG8c-01Accepting RAW in
Waste Store
BAT form
New work form
Order form
Physical storage of RAW and
labelling of it in labs and
waste store.
Risk assessments.
Local rules
Manager’s check list
b
Is kept in a suitable
container and stored
7
Premises constructed
and maintained so
that
They do not become
contaminated easily
All new or refurbished premises are inspected
by a qualified expert to ensure that the
construction is such that it cannot be readily
contaminated and that it can be easily cleaned.
Local Rules
Audits
training
Contamination can
easily be removed
Users are required to carry out contamination
checks after every procedure
Contamination monitoring
form
a
b
Written by :
D.Purfield
Approved by :
M Lockyer
DocumentWritten
Ref : By UCL-RF
:
EPRv2
Page No. :
Page 9 of 12
Effective from :
Jan12
Next Review date :
Jan13
Loss of Accumulated RAW
8
a
b
c
Loss or Theft of
RAM
Informing Police and
EA
Try and recover the
RAM
Report it in writing
to the EA
There are contingency plans in the Local
Rules which deal with what should be done in
the event that a source is lost. All users must
sign to say that they have read, understood
and agree to abide by them.
The Trust incident reporting states what must
be done should loss or theft occur. Users are
informed of these documents via the LRGG
and training sessions
Local Rules
Radiation incident triggers
Radiation incident flowcharts
Minutes from LRGG
Training
Escape of Accumulated RAW
9
As for 8
As for 8
Accumulation or Disposal not in Compliance with Permit
10
Records are checked on a monthly basis and
a
Inform the EA
due to allocation of local limits, it is very
unlikely that the Permit limits will be
b
Prevent the further
exceeded. Orders placed are checked first to
accumulation and
ensure that local limits will not be exceeded.
disposal of RAW
The orders database also signals to the person
placing the order if limits will be exceeded.
c
Report to the EA
If they are, users are advised to stop using
RAM and report it to the RWA
Procedures are in place to report noncompliance to the Agency
Records
12
Clear and legible
records on day of
accumulation or
disposal
13
a
Ensure limitations
and conditions are
complied with.
b
c
Retain records from
previous
Authorisations and
predecessor users
Monthly waste return form
Waste database
Orders database
Orders form
Limits database
Radiation incident triggers
Radiation incident flowcharts
Records (in electronic and/or paper forms) are
made and retained for all RAW.
Departments note down on their form what
waste is generated and disposed at the time.
Monthly waste return form
Waste store database
Local Rules
Stock record sheet
The manager’s check list and audits
demonstrate how users comply with this
Permit. Monthly returns of RAMs and RAW
provide the permit co-ordinator with overall
figures which is then compared with the limits
in the Permit to ensure that no limit is
breeched.
Manager’s check list
Monthly waste return forms
Waste store database
Waste record sheets
Order sheets
Monthly waste records from previous
Authorisations and users are kept by the
permit co-ordinator both in hard and soft
copy. All depts. are required to provide a
historical record of all usage of RAMs. This
forms part of the audit. Any lab that no
longer using RAMs will need to provide a
decommissioning report.
Manager’s check list
Monthly waste return forms
Depts. historical records
Decommissioning records
LRGG mins
Audit forms
Written by :
D.Purfield
Approved by :
M Lockyer
DocumentWritten
Ref : By UCL-RF
:
EPRv2
Page No. :
Page 10 of 12
Effective from :
Jan12
Next Review date :
Jan13
14
Original entry
remains clear and
legible if an
amendment occurs
Users who have given erroneous data have it
amended by striking it through and inserting
the appropriate result so that the original can
still be noted. Soft copies have a comment
inserted so that the history can be traced.
16
Retention of records All waste records have been retained and only
disposed of with permission from the EA
Provision of Information
17
The EA have requested that the annual
pollution inventory is returned in electronic
format by a fixed date. The permit coordinator submits this on time every year.
Written by :
D.Purfield
Approved by :
M Lockyer
DocumentWritten
Ref : By UCL-RF
:
EPRv2
Page No. :
Page 11 of 12
Monthly waste return forms
Limits database
Manager’s check list
Monthly waste return forms
Waste store database
Pollution Inventory submission
Effective from :
Jan12
Next Review date :
Jan13
5 Standard documents found within all departments of the UCL-RF using RAMs
Compliance Objective
Document
Control of radioactive material and
ensuring limits are not going to be
breeched
Registration and Authorisation limits,
record keeping
Record keeping, demonstrates training and
BAT compliance and security.
Internal Order form to purchase the radionuclide
Monthly stock and waste return form
New users application form
BAT form
BAT compliance and waste control
BAT compliance, Control of radioactive
material and ensuring limits are not going
to be breeched.
Control of radioactive waste, record
keeping
Control of radioactive waste, ensuring no
loss/theft of RAMs.
New work form
Stock and Vial sheet
Waste labels
Copies of consignment notes received for the daily
delivery of radiopharmaceuticals
Area monitoring records for all areas within the
departments
Record keeping
Contamination control
Personal monitoring records
Staff dose records
Personal/Area contamination incident form
Reporting mechanism
Radiation protection Refresher staff training records
Appropriate use, keeping and disposal of
radioactive materials
Log of waste deposited in departmental store
Control of radioactive waste
Demonstrating the management of RAMs
in that area
Cope of this been given to all user labs so
that they know what they need to comply
with
Demonstrating the management of RAMs
in that area
Demonstrating the management of RAMs
in UCL-RF.
Local Organograms
ERP10 Permit
Manager’s check list
Terms of Reference
Local procedures and forms are held by the department’s RSS and on the UCL web page.
Written by :
D.Purfield
Approved by :
M Lockyer
DocumentWritten
Ref : By UCL-RF
:
EPRv2
Page No. :
Page 12 of 12
Effective from :
Jan12
Next Review date :
Jan13