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Superseded Version Number and Date: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Out of date documents must not be relied upon and should be destroyed.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 13

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 13

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

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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.

PURPOSE
The purpose of this Standard Operating Procedure (SOP) is to set out the procedure
for Universitys 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

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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

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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 PIs 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 13

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:

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 13

CU/11/HTA 09/3.0

Page 8 of 13

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 9 of 13

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

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PROJECT 1
List of Documentation/evidence required to be maintained
Note: a nil return should be made if applicable.
Type of Documentation

Paperwork

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

Comments

Sample consent forms and

evidence of consent if
samples are collected by a
third party
General tissue records inc
receipt

Complianc
e

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

CU/11/HTA 09/3.0

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Traceability

Complianc
e

Comments

Complianc
e

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

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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

Complianc
e

Comments

Page 13 of 13