CARDIFF UNIVERSITY
STANDARD OPERATING PROCEDURE FOR THE USE OR
STORAGE OF HUMAN TISSUE FOR THE PURPOSES OF
RESEARCH OR EDUCATION
RISK MANAGEMENT AND CONTINGENCY PLANNING- CARRYING
OUT A RISK ASSESSMENT
SOP Number: CU/11/ HTA 10/3.0
Version Number & Date: 3.0 Jan 2013
Superseded Version Number and Date:
Effective Date:
09 Jan 2013
Review Date:
09 Jan 2014
CU/11/ HTA 10/2.0
July 2011
Author:
Position:
Carina Hibbs
HTA Governance
Officer, GOVRN
____________________
Sarah Woods
Graduate Assistant,
GOVRN
____________________
Sharon Orton
HTA Co-ordinator,
GOVRN
Approved by:
____________________
Signature
Date
Position:
Professor Jonathan Bisson DI – Licence No 12422 ____________________
Signature
Date
Disclaimer
When using this document, please ensure that the version you are using is the most up to
date either by checking on the GOVRN/HTA website for any new versions or contact the
HTA Governance Officer to confirm the current version.
Out of date documents must not be relied upon.
CU/11/HTA 10/3.0
Page 1 of 15
Version
Number
1.0
2.0
Changes to Document
Changes
authored by
Version 1.0 was started in 2009 but never Carina Hibbs
fully approved.
Changes were made to version 1.0
including a modified Risk Assessment
Guidance Notes that are now more
relevant to HTA RAs (Appendix B) and
alteration of text order and formatting.
Contact information updated
Carina Hibbs
CU/11/HTA 10/3.0
Date Approved
14/06/2011
09/01/2013
Page 2 of 15
CONTENTS PAGE
1.
2.
3.
4.
5.
Background
Purpose
Responsible Personnel
Definitions
Procedure
5.1 Risk Assessments
5.2 Monitoring Risks
5.3 Contingency Planning
5.4 Adverse Events
6. References
7. Referenced SOPs
8. Contacts
Appendix A – Cardiff University HTA Risk Assessment Form
Appendix B – Cardiff University HTA Risk Assessment Guidance
Notes
CU/11/HTA 10/3.0
Page 3 of 15
1
BACKGROUND
The Human Tissue Act 2004 (HT Act) came fully in to force on 1 September 2006.
The aim of the HT Act is to provide a legal framework regulating the storage and use
of human tissue from the living and the removal storage and use of tissue from the
deceased. It introduces regulation of other activities like post mortem examinations,
and the storage of human material for education, training and research. It is intended
to achieve a balance between the rights and expectations of individuals and families,
and broader considerations, such as the importance of research, education, training,
pathology and public health surveillance to the population as a whole.
In order to comply with the conditions of the Licence issued by the Human Tissue
Authority, the University is required to ensure that risk assessments of practices and
processes in relation to licensable activities are completed regularly, and that the
assessments are recorded and monitored appropriately by trained staff.
2
PURPOSE
The purpose of this Standard Operating Procedure (SOP) is to set out the processes
and procedures for carrying out a risk assessment, including risk monitoring and
contingency planning. Risk management, as detailed in this SOP, refers to risk to
human tissue. Generic risk assessments from Occupational, Safety, Health and
Environment Unit (OSHEU) should also be completed detailing risks to the health
and safety of individuals, facilities and equipment.
3
RESPONSIBLE PERSONNEL
This SOP applies to all Cardiff University and UHB Staff who are responsible for
collecting, using or storing human tissue for research or teaching purposes.
Persons Designate (PD) are responsible for ensuring that risk assessments for
each practice and process are recorded and monitored appropriately by trained and
experienced staff.
Principal Investigators (PI), or equivalent, are responsible for conducting risk
assessments for each practice and process associated with human tissue.
Governance and Compliance Division (GOVRN), in association with
Occupational, Safety, Health and Environment Unit (OSHEU) is responsible for
providing guidance and ensuring that this SOP remains fit for purpose.
4
DEFINITIONS
Designated Individual (DI) – the person who is authorised and who supervises
activities under a licence issued by the Human Tissue Authority.
Human Tissue – Any and all constituent parts of the human body formed by cells.
The Human Tissue Authority has issued a Supplementary List of Materials which
contains additional information.
Human Tissue Authority (HTA) – The governing body set up to regulate activities
that come under the HT Act. The HTA is a watchdog that supports public confidence
by licensing organisations that store and use human tissue for purposes such as
research, patient treatment, post-mortem examination, teaching, and public
exhibitions.
CU/11/HTA 10/3.0
Page 4 of 15
Person Designate – A person to whom the licence applies and to whom the
authority conferred by the licence extends. Each School operating under an HTA
Licence should have at least one Person Designate.
Principal Investigator (PI) – The appropriately qualified individual at each project
site who has responsibility for the conduct of the project at that site.
Standard Operating Procedure (SOP) – Detailed, written instructions to achieve
uniformity of performance of a specific function.
5
PROCEDURES
Risk management is a systematic way of identifying and analysing potential risks/
hazards and deciding on an appropriate course of action to minimise risks through
the use of risk assessments, risk monitoring and contingency planning.
Risk management, as detailed in this SOP, refers to the risk to human tissue such as
fridge/freezer failure or damage during transport. Generic risk assessments from
Occupational, Safety, Health and Environment Unit (OSHEU) should be followed
regarding risks to the health and safety of individuals, facilities and equipment.
5.1
Risk Assessments
A risk assessment should be completed for each practice and process involving
human tissue, including transportation, use, storage and disposal, before the activity
commences.
5.1.1
Completing the Risk Assessment Form
The risk assessment must be completed by the PI for the project using the Cardiff
University Human Tissue Risk Assessment form (see Appendix A) and the Cardiff
University Human Tissue Risk Assessment Guidance Notes (see Appendix B).
Forms and Guidance Notes can also be found on the Cardiff University Human
Tissue website.
Once completed, a copy of the risk assessment must be sent to the HTA Coordinator and relevant PD, in addition to being held locally.
5.1.2
Reviewing the Risk Assessment Form
Reviews of risk assessments must be carried out in line with the timescales detailed
in the Cardiff University Human Tissue Risk Assessment Guidance Notes. If there
are any changes to the risk assessment all old copies must be replaced with the new
copy, including those held by the HTA Co-ordinator and relevant PD.
If there is a significant change in practice/procedure before the review date, or if any
serious adverse event has occurred, the risk assessment should be revisited and
reassessed to identify any further potential hazards or reduce the risk rating of
hazards previously identified.
Following the modification of a risk assessment, the PI must send an up-to-date
version to the HTA Co-ordinator and relevant PD.
CU/11/HTA 10/3.0
Page 5 of 15
5.1.3
Staff and the Risk Assessment
All staff involved with the transportation, use, storage or disposal of human tissue
must be aware of the potential risks to the tissue. A copy of the risk assessment must
be given to every individual carrying out the activity and each copy must be
countersigned by the holder.
5.1.4
Record Keeping
All risk assessments must be kept locally by the PI and up-to-date copies sent to the
HTA Co-ordinator and relevant PD. See the Cardiff University HTA Standard
Operating Procedure for the Management of Records for further information.
5.2
Monitoring Risks
The identification of risks should not end once the risk assessment form has been
completed. The risk assessment should be considered an active document that can
be used for frequent reference. It is important that the risks and hazards identified on
the form are continually monitored.
5.3
Contingency Planning
Contingency planning is required to limit the extent of the risk arising from an
accident or emergency and for regaining control of the area as quickly as possible.
In addition to including a brief contingency plan within the risk assessment form, the
PI should also feed their HTA related contingency plans into the local School/ Unit
contingency plan.
The establishment must have contingency arrangements in place should there be an
emergency situation that renders the premises unusable for the storage of human
tissue for research.
5.4
Adverse Events
Any adverse events involving human tissue must be reported to the HTA Coordinator and the procedures detailed in the Cardiff University HTA Standard
Operating Procedure for Adverse Event Reporting must be followed.
Following an adverse event all relevant risk assessments must be reviewed and
updated if necessary.
6
REFERENCES


7
Cardiff University HTA website: risk assessment forms and guidance
http://www.cardiff.ac.uk/govrn/cocom/humantissueact/risk/riskindex.html
Cardiff University Occupational, Safety, Health and Environment Unit
(OSHEU): risk assessment forms and guidance
http://www.cardiff.ac.uk/osheu/complete_risk_assessment/index.html
REFERENCED SOPS


Cardiff University HTA Standard Operating Procedure for the Management of
Records [CU/09/HTA06/3.0]
Cardiff University HTA Standard Operating Procedure for Adverse Event
Reporting [CU/11/HTA08/3.0]
CU/11/HTA 10/3.0
Page 6 of 15
8
CONTACTS
8.1
DI and PDs
Name
School/
UHB
Coverage
Email
Tel
Prof Jonathan Bisson
DI
CU/UHB
All areas
BissonJI@cf.ac.uk
(207)43742
ARUK
BBC
BIOSI
LongmanAJ1@cf.ac.uk
EdwardsWD@cf.ac.uk
(208)75419
(208)75136
DENTL
DENTL
DENTL
DENTL
StephensP@cf.ac.uk
ChadwickBL@cf.ac.uk
WhiteFS@cf.ac.uk
Gilmour@cf.ac.uk
(207)42529
(207)46569
(207)42546
(207)42617
PATHY
AML and
HAEMY
Jasani@cf.ac.uk
(207)42700
WhitePC@cf.ac.uk
(207)44524
PowellNG@cf.ac.uk
(207)44742
IdziaszczykSA1@cf.ac.uk
(206)87859
Bowden@cf.ac.uk
GregoryC1@cf.ac.uk
MantripragadaKK@cf.ac.uk
Topley@cf.ac.uk
(206)87302
(206)87221
(206)87063
(207)43770
ITIME
MOLEX
HanzelK@cf.ac.uk
DayanCM@cf.ac.uk
(207)42050
(207)42182
MOLEX
SURGY
Tenovus
Building
OPTOM
PHRMY
Med Gen
PowellW1@cf.ac.uk
MartinTA1@cf.ac.uk
(207)48497
(207)46536
WangEC@cf.ac.uk
AlbonJ@cf.ac.uk
BirchallJC@cf.ac.uk
Ian.Frayling@wales.nhs.uk
(206)87318
(208)75427
(208)75815
(207) 44203
Dr Andrea Longman
Mr Bill Edwards
Prof Bharat Jasani
BIOSI PD
BIOSI PD
DENTL
Lead PD
DENTL PD
DENTL PD
DENTL PD
MEDIC
Lead PD
Dr Paul White
MEDIC PD
Dr Ned Powell
MEDIC PD
Prof Phil Stephens
Prof Barbara Chadwick
Dr Fiona Gagg
Dr Alan Gilmour
Mrs Shelley Idziaszczyk MEDIC PD
Dr Paul Bowden
Dr Clive Gregory
Dr Kiran Mantripragada
Prof Nick Topley
Dr Wendy Powell
Dr Tracey Martin
MEDIC PD
MEDIC PD
MEDIC PD
MEDIC PD
MEDIC PD
(assistant)
MEDIC PD
MEDIC PD
(assistant)
MEDIC
Dr Eddie Wang
Dr Julie Albon
Dr James Birchall
Dr Ian Frayling
MEDIC PD
OPTOM PD
PHRMY PD
UHB
Mr Karl Hanzel
Prof Colin Dayan
8.2
ICAGE/
GYNON
ICAGE/
MGENE
INIIM in
HWB
IPCPH
IPMCN
ITIME
Additional Contacts
Name
Division
Position
Email
Tel
Mrs Sharon Orton
GOVRN
HTA Co-ordinator
HTA@cf.ac.uk
(208)74888
Dr Carina Hibbs
GOVRN
Governance Officer HTA@cf.ac.uk
(208)70231
Mrs Pat Tamplin
Dr Rachel
Coombe
UHB
Governance Officer Pat.Tamplin@wales.nhs.uk
Assistant Director –
Scientific Safety
CoombeRA@cf.ac.uk
(207)45879
OSHEU
CU/11/HTA 10/3.0
(208)70785
Page 7 of 15
Appendix A
Human Tissue Risk Assessment Form
IMPORTANT: Before carrying out the assessment, read the Human Tissue Guidance
Notes provided on the website.
Department
Building
Room No
Name of
Assessor
Date of
Original
Assessment
ID No
[optional*]
* You may wish to use an ID No. if you want to have a unique identifier of the risk assessments within
your Department
Brief Description of Procedure/Activity and its Location: [Guidance note 2]
Note: Should no potential hazard be identified as associated with the
procedure/activity in this location, you may stop the risk assessment at this point
[See Guidance note 2]
CU/11/HTA 10/3.0
Page 8 of 15
Hazards Involved: [Guidance note 3-5]
Substance/Item of
equipment/procedure or
physical location
CU/11/HTA 10/3.0
Associated
hazards
Existing Control Measures
Page 9 of 15
Severity
Likelihood
Risk
Tissue Potentially at Risk: (Include all tissue potentially at risk)
Additional Control Measures which will need to be applied to reduce the
risk to an acceptable level (Guidance note 4)
Control measure
Date of
Implemented
Implementation by:
Remaining
Level of
Risk
Action Taken Following Adverse Event (Guidance note 7)
Arrangements for Monitoring Effectiveness of Control:
(Guidance note 8)
CU/11/ HTA 10/1.1
Page 10 of 15
Receipt of the Risk Assessment: (Guidance note 9)
This assessment has been issued to and read by:
Name of
Recipient:
Date of Receipt
Signature
Name of
Recipient:
Date of Receipt
Signature
Name of
Recipient:
Date of Receipt
Signature
Name of
Recipient:
Date of Receipt
Signature
Name of
Recipient:
Date of Receipt
Signature
Name of
Recipient:
Date of Receipt
Signature
Name of
Recipient:
Date of Receipt
Signature
Name of
Recipient:
Date of Receipt
Signature
CU/11/ HTA 10/1.1
Page 11 of 15
Review of the Risk Assessment: (Guidance note 10)
Have the control measures been effective in controlling the risk?
Yes
No
Have there been any changes in the procedure or in information
available which affect the estimated level of risk from the listed
substances?
Yes
No
What changes to the control measures are required?
Date of
Review:
Date of Next
Review
CU/11/ HTA 10/1.1
Name of
Reviewer
Signature:
Page 12 of 15
Appendix B
Guidance Notes for Human Tissue Risk Assessment Form
IMPORTANT - These guidance notes refer to completing a risk assessment form for
risks to human tissue; additional generic forms from Occupational Safety, Health and
Environment Unit (OSHEU) need to be completed for risks to individuals, facilities and
equipment.
1. Prior to carrying out the risk assessment, write out the procedure in the form of a
method statement or safe operating procedure or refer to an appropriate existing
procedure [e.g. standard manual] to ensure that you have included and
considered all of its components.
2. Under the provisions of the Human Tissue Authority Licence Regulations risk
assessments must be carried out for all practices and processes in relation to
licensable activities. This can initially be a simple consideration of the
activity/procedure in order to identify potential hazards to human tissue. Should
none be identified, no further action is required. If a potential hazard or hazards
are detected, then you must carry out a full assessment using this form.
3. Remember to consider all potential hazards from procurement to use and
storage. Things to consider include package failure, delay or loss in transit,
malfunction of storage facilities, unauthorised access to tissue samples, incorrect
procedures being carried out, untrained personnel handling the tissue and any
other hazards that result in tissue loss.
4. The hierarchy of control measures employed should primarily be aimed at
eliminating or reducing the hazards in a procedure, followed by early detection of
risks and contingency planning. One example of a hierarchy of control measures
is regular maintenance of storage facilities to prevent failure; followed by
installation of an early warning system to detect changes in storage temperature;
and finally alternative on-site storage facilities in the event of storage failure.
Other examples of control measures include appropriate training, written
procedures [Standard Operating Procedures, Method Statement] and supervision
by an appropriate person. The level of supervision must always be appropriate to
the competence of the individuals involved in the work activity.
Any special training required to ensure that persons involved in the work activity
can operate safely should be detailed. This is particularly important so that
persons can understand and comply effectively with a Standard Operating
Procedure (SOP), Scheme of Work, or Method Statement, where this has been
formulated.
You should record when each control measure has been implemented and the
new numerical risk rating following its implementation. The aim should be to
achieve a progressive reduction down to a final risk rating of 6 or less.
5. Risk should be calculated for an existing activity taking into account any control
measures in place. This is estimated by considering both the likelihood of
exposure to a risk and the severity of the consequences of such an exposure.
The calculation of risk should be done as follows:
CU/11/ HTA 10/1.1
Page 13 of 15
Select an appropriate number for both Likelihood and Severity from the bottom of
the table and multiply them together. Cross reference your score on the coloured
part of the table and this is your risk rating.
5
4
3
2
1
Likelihood
Almost
Certain
Very Likely
Likely
Unlikely
Very
Unlikely
5
10
15
20
25
4
3
2
1
8
6
4
2
12
9
6
3
16
12
8
4
20
15
10
5
No tissue
Minor tissue
Severity damage/loss damage/loss
1
2
Significant
tissue
damage/loss
3
Tissue
Tissue
destroyed
destroyed
but
and
replaceable irreplaceable
4
5
Score Action to be taken:
0-5
Low Risk:
No further action needed.
6-9
Medium Risk : Appropriate additional control measures should be implemented
10-25 High Risk: Work should not be started or should cease until appropriate
additional control measures are implemented.
6. Include all tissue potentially at risk.
7. Contingency planning is required to limit the extent of the risk arising from an
adverse event and for regaining control of the area as quickly as possible.
8. Appropriate arrangements for monitoring the efficacy and continued employment
of the control measures must be put in place. This may include regular
inspections and maintenance checks, and reviewing documentation and training
needs.
9. A copy of the risk assessment must be given to every individual carrying out the
activity and each copy must be countersigned by the holder. Copies of the risk
assessment must be sent to the relevant School/Unit PD and held on site by the
PI.
10. The risk assessment must be reviewed at regular intervals. There is no specified
interval in Safety Law, but, we recommend the following simple guide depending
on the estimated level of risk:
0-5 – every 3 years
6-10 – every 2 years
12-25 – every year
You must also review the assessment whenever there has been a significant
change in the procedure or work circumstances or there is any reason to suspect
that the original assessment is no longer valid. Examples would include new
CU/11/ HTA 10/1.1
Page 14 of 15
information on the hazard indicating a higher or lower level of risk, personnel
changes, changes in equipment or substances used, change of location, following
an accident or incident.
.
WARNING! Completion of the assessment is not an end in itself, merely the beginning.
You must consider it as an active document for frequent reference, particularly when
preparing associated method statements, safe operating procedures and training.
CU/11/ HTA 10/1.1
Page 15 of 15