CARDIFF UNIVERSITY
STANDARD OPERATING PROCEDURE FOR THE USE OR
STORAGE OF HUMAN TISSUE FOR THE PURPOSES OF
RESEARCH OR EDUCATION
INTERNAL AUDIT
SOP Number: CU/11/HTA 09/3.0
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Superseded Version Number and Date: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 09/2.0
July 2011
Author:
Position:
Carina Hibbs
HTA Governance Officer, ____________________
GOVRN
Sharon Orton
HTA Co-ordinator,
GOVRN
____________________
Signature
Approved by:
Position:
Professor Jonathan Bisson
DI – Licence No 12422
Date
____________________
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Out of date documents must not be relied upon and should be destroyed.
CU/11/HTA 09/3.0
Page 1 of 12
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.
Minor changes were made to version 1.0
including formatting and the addition of a
‘process’ audit.
Contact information and audit checklist
Carina Hibbs
updated
CU/11/HTA 09/3.0
Date Approved
14/06/2011
09/01/2013
Page 2 of 12
CONTENTS PAGE
1. Background
2. Purpose
3. Responsible Personnel
4. Definitions
5. Procedure
5.1
5.2
Face to Face Audit

Prior to Audit

During Audit

After the Audit
Paper Based Audit
6. References
7. Referenced SOPs
8. Contacts
Appendix A- HTA Audit checklist
CU/11/HTA 09/3.0
Page 3 of 12
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 for the
University to ensure compliance with the HT Act and all HTA Codes of Practice, the
University will conduct internal monitoring to all departments/ units that may hold
human tissue for the purpose of research.
2
PURPOSE
The purpose of this Standard Operating Procedure (SOP) is to set out the procedure
for University’s Governance and Compliance Division, who, together with a PD, will
be conducting an internal audit.
The main aim of the internal audit is to ensure that all activities related to human
tissue, including consent, transportation, storage and disposal are conducted in
accordance with the HTA Codes of Practice and that internal systems for compliance
are effectively in place.
The objectives of the internal audit are to:








determine whether or not the tissue is covered by the license;
ensure the premises and equipment used for the storage of human tissue is
compliant with HTA guidance and requirements;
ensure that essential documentation relating to all aspects of the human
tissue are held by the department/unit;
ensure that SOPs are being followed during the handling/processing of tissue;
ensure that an audit trail is in place from receipt of sample to disposal;
ensure that the health and safety of staff are protected;
identify any problems and suggest solutions;
ensure that those involved are fully trained and experienced and that staff
have received the appropriate level of training.
Further actions may arise which may include additional correspondence between the
PD, Governance and Compliance Division and the School/Unit being inspected. This
could be via telephone, by mail, by electronic mail or facsimile.
3
RESPONSIBLE PERSONNEL
Governance and Compliance Division will carry out the internal audit and
subsequently write a report. Wherever possible the auditor will be accompanied by a
Persons Designate (PD) from another School. This will ensure impartiality and help
to share good practice. It is the responsibility of those carrying out the internal audit
to ensure that they have the relevant experience and/or training to do so.
Persons Designate are responsible for ensuring that a School file of relevant
documentation, as detailed in the HTA Audit Checklist, is held and kept up to date
within their School. This includes ensuring that staff in the School are using the
correct version of any University or School SOP.
CU/11/HTA 09/3.0
Page 4 of 12
Chief Investigators (CI) or Principal Investigators (PI) are responsible for ensuring
that all information and facilities required for inspection are available for a full internal
audit to take place.
Governance and Compliance Division is responsible for ensuring that this SOP
remains fit for purpose.
4
DEFINITIONS
Chief Investigator (CI) – The individual who takes overall responsibility for the
design, conduct and reporting of a study if it is at one site; or if the study involves
researchers at more than one site, the Chief Investigator takes responsibility for the
design, management and reporting of the study, co-ordinating the investigators who
take the lead at each site.
Consent – Process by which an individual confirms his/her willingness to participate
in a particular procedure. The individual must have been informed of all aspects of
the procedure/request that are relevant to the decision to participate. The individual
must be competent to take the particular decision, be acting voluntarily and not be
acting under duress. Informed consent can be documented by means of a written,
signed and dated consent form or may be given non-verbally or orally. In the latter
cases, a note of the consent should be made by the person taking it.
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. They also give approval for organ and bone marrow donations from living
people.
Person Designate (PD) – 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) – is the appropriately qualified individual at each project
site who has responsibility for the conduct of the project at that site.
Records – Information created, received, and maintained as evidence and
information by an organization or person, in pursuance of legal obligations or in the
transaction of business.
Record Keeping System – An information system which captures, manages and
provides access to records.
Standard Operating Procedure (SOP) – Detailed, written instructions to achieve
uniformity of performance of a specific function.
CU/11/HTA 09/3.0
Page 5 of 12
5
PROCEDURE
Internal audits of Schools/research projects are undertaken to confirm that the area
concerned is adhering to the University's Procedures and is compliant with HTA
requirements and regulations. The audit programme will operate on a two-year cycle.
In the first year there will be a face-to-face physical audit; in the second year a paperbased audit return will be made. If this identifies any areas of concern, an inspection
visit will be made. All Cardiff University Standard Operating Procedures should be
consulted prior to an audit.
5.1
Face to Face Audit
The face to face audit schedule comprises a records audit, to ensure records are
accurate, complete and legible; a process audit to ensure staff are adhering to SOPs;
and a traceability audit to ensure that the establishment can trace specimens from
donors consent, or point of receipt if supplied by a third party, to storage, use or
disposal.
Prior to the internal face-to-face audit, the HTA Co-ordinator will:









check documentation at the Governance and Compliance Division to ensure
familiarity with the project and identify if anything is missing;
review any local SOPs that should be followed during the process audit;
identify a selection of projects for which compliance will be audited including
samples stored under the university licence and a random sample of those
stored under NRES approval;
if applicable, review report of the last visit and look at recent telephone/ email
conversations;
check availability of PD and School/Unit to be inspected and also a PD from
another school;
schedule a visit stating time, date, venue, expected duration of visit and
outlining purpose of visit, items for discussion, which samples will be looked
at, any storage facilities that will want to be seen and if any other personnel
including the PI’s need to be present;
send confirmation of this to PD and those who are being audited;
send the HTA Audit Checklist to PD and those who are being audited so that
staff are fully aware of what will be covered;
gather documentation needed for visit- including own audit checklist.
During the visit the HTA Co-ordinator and PD will:








review site file of documentation as set out in the HTA Audit Checklist;
work through the HTA Audit Checklist of documentation to establish what is
held and where there are gaps that could be filled;
discuss adverse event reporting system and any adverse events that have
occurred, including remedial action taken;
inspect storage facilities;
ask a member of staff to demonstrate how the tissue is handled/processed,
ensuring that all relevant SOPs are followed;
conduct a trial of traceability system/record keeping to ensure that tissue
samples can be traced from receipt to disposal and vice versa;
discuss training needs;
interview the PI if necessary to establish:
CU/11/HTA 09/3.0
Page 6 of 12


whether staff involved in human tissue activities have the appropriate
experience and training and whether they are familiar with HT Act and
HTA Codes of Practice;
 if informed consent procedures are followed and records held;
 the record management and retention process;
 whether risk assessments have been carried out;
 if there are any issues/ queries that they would like guidance on.
have a final meeting to discuss findings of audit.
Following the audit, the HTA Co-ordinator will:


5.2
complete the Audit Report within one week of the audit visit and send a copy
to the PD;
provide follow up information and suggest a timescale for implementation of
any recommendations arising from the audit visit.
Paper Based Audit:
Once a School/Unit has had a face to face audit, the second year can be a done via
a paper based audit return. The procedure will be as follows:






6
the HTA Co-ordinator will contact the Department/ Unit to inform them that a
paper based inspection is required;
the HTA Co-ordinator will send the HTA Audit Checklist to the School PD to
be completed;
the School PD will fill in the Audit Checklist and send it back to the HTA-Coordinator. This may involve individual units within the School providing
specific information in relation to their unit;
the School PD should report specifically on implementation of any
recommendations made in the previous inspection visit;
the HTA Co-ordinator and the PD will meet to discuss the paper based audit
return. If there are any issues arising from the return that cannot be resolved
otherwise, a face to face audit will take place;
the face to face audit will take the same format as above.
REFERENCES
No external references
7.
REFERENCED SOPs
All Cardiff University HTA Standard Operating Procedures:
 Obtaining Informed Consent [CU/09/HTA02/3.0]
 Storage of Human Tissue [CU/09/HTA03/3.0]
 Disposal of Human Tissue [CU/09/HTA04/3.0]
 Transportation of Human Tissue [CU/09/HTA05/3.0]
 Management of Records [CU/09/HTA06/3.0]
 Staff Training [CU/09/HTA07/3.0]
 Adverse Event Reporting [CU/11/HTA08/3.0]
 Risk Management and Contingency Planning [CU/11/HTA10/3.0]
 Maintenance and Upkeep of Constant Temperature Storage Facilities
[CU/11/HTA11/3.0]
 Running a Research Tissue Bank [CU/13/HTA12/1.0]
 Import and Export of Human Tissue for Research Purposes
[CU/13/HTA13/1.0]
CU/11/HTA 09/3.0
Page 7 of 12
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
Human Tissue Act Compliance Team
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
UHB
Governance Officer Pat.Tamplin@wales.nhs.uk
(207)45879
CU/11/HTA 09/3.0
Page 8 of 12
APPENDIX A
HUMAN TISSUE ACT AUDIT CHECKLIST
Cardiff University, as part of its compliance with the conditions of the HTA licence,
conducts internal audits of departments/units that hold human tissue for the
purposes of research.
In conducting the internal audit the University seeks to satisfy itself that the terms of
the licence have been complied with. The audit process involves:
 an assessment of the premises and equipment used for the storage of human
tissue to ensure compliance with HTA guidance and requirements;

an assessment of documentation held by the department/unit. The list of
documentation is attached;

an audit trail for a randomly-selected tissue sample, including an assessment
of records of the trail. This would start from receipt of sample to disposal.
For Office use only:
PD
School/Section
Date
Attending
Projects Seen
Paper/Tissue
Storage Rooms
CU/11/HTA 09/3.0
Page 9 of 12
PROJECT 1
List of Documentation/evidence required to be maintained
Note: a nil return should be made if applicable.
Type of Documentation
Paperwork


Sample consent forms and
evidence of consent if
samples are collected by a
third party
General tissue records inc
receipt

Disposal record

Donor and sample ID link
document

Tissue location record

Risk assessments for
individual and tissue

Electronic storage drive

Training records, inc consent
and HTA

Standard Operating
Procedures (SOPs):
University SOPs, Local
SOPs and version control
Quality Manual


Service Level Agreements
(SLAs) or Material Transfer
Agreements (MTAs)

Agreements with third
parties
Note: evidence of ethics
approval if applicable
Inspection report by other
regulators/accreditors

Compliance Comments
CU/11/HTA 09/3.0
Page 10 of 12
Traceability

Compliance Comments
Traceability sample number
and location
Equipment

Storage facilities locked

Storage equipment locked

HTA Licence on display

Alarm systems in place

Back-up facilities available

Equipment Logs including
temperature logs

Maintenance records /
contracts for equipment

Evidence of Equipment
Validation and Calibration

Adverse events / incidents
log(s)

Evidence of corrective and
preventative actions
(CAPAs) for incidents and
quality non-compliances
CU/11/HTA 09/3.0
Compliance Comments
Page 11 of 12
Tissue Banks

Governance committee and
procedures in place

Record of tissue recipients

NRES approval

If non-generic RTB REC
approval, evidence of NRES
or HTA Licence for
recipients
CU/11/HTA 09/3.0
Compliance Comments
Page 12 of 12