OXFORD MUSCULOSKELETAL BIOBANK - WebLearn · OMB Serial No: OMB-M 001 Controlled document. Do not photocopy. 19/10/10 Final Version 1.0 Page 5 of 38 3 OUTLINE This document together

OMB Serial No: OMB-M 001 Controlled document. Do not photocopy.

19/10/10 Final Version 1.0 Page 1 of 38

OXFORD MUSCULOSKELETAL

BIOBANK

A RESOURCE FOR RESEARCH INTO THE PATHOBIOLOGY OF

BONE, JOINT AND SOFT TISSUE DISEASES

HTA Designated Individual: Professor Andrew Carr

HTA Licence Number: 12500

Chief Investigator: Professor Andrew Carr

OXREC C/NRES Number: 09/H0606/11

OMB MANUAL

QUALITY MANUAL

Serial Number – OMB-M 0001

Version 1.0

Version Date 19/10/10



1 TABLE OF CONTENTS

1 TABLE OF CONTENTS ................................................................................................................................ 2

2 DOCUMENT INFORMATION AND REVIEW ................................................................................................ 4

2.1 DOCUMENT INFORMATION ............................................................................................................................ 4 2.2 DOCUMENT REVIEW ..................................................................................................................................... 4

3 OUTLINE ................................................................................................................................................... 5

4 GENERAL INFORMATION .......................................................................................................................... 5

4.1 THE OXFORD MUSCULOSKELETAL BIOBANK FACILITY ............................................................................ 5 4.2 THE QUALITY MANUAL............................................................................................................................ 7

5 HUMAN TISSUE ACT 2004 ........................................................................................................................ 8

5.1 HUMAN TISSUE AUTHORITY (HTA) .......................................................................................................... 9 5.2 HTA LICENCE ........................................................................................................................................... 9 5.3 DESIGNATED INDIVIDUAL ....................................................................................................................... 9 5.4 HTA CODES OF PRACTICE ............................................................................................................................ 10

6 RESEARCH ETHICS .................................................................................................................................. 10

7 QUALITY POLICY ..................................................................................................................................... 12

7.1 OMB QUALITY POLICY ............................................................................................................................... 12

8 ORGANISATION, RESPOSIBILITIES AND AUTHORITIES ............................................................................ 14

8.1 RELATIONSHIP TO THE HOST ORGANISATIONS ..................................................................................... 14 8.2 ORGANISATION AND RESPONSIBILITIES WITHIN THE FACILITY ............................................................. 14 8.3 REGULAR MEETINGS INVOLVING THE OMB FACILITY ........................................................................... 15

9 GOVERNANCE AND QUALITY SYSTEMS (GQ) .......................................................................................... 17

9.1 GQ1 - ALL ASPECTS OF THE ESTABLISHMENTS WORK ARE SUPPORTED BY RATIFIEDDOCUMENTED

POLICIES AND PROCEDURESAS PART OF THE OVERALL GOVERNANCE PROCESS. ............................................ 17 9.2 GQ2 - THERE IS A DOCUMENTED SYSTEM OF QUALITY MANAGEMENT AND AUDIT. ............................ 18 9.3 GQ3 - STAFF ARE APPROPRIATELY QUALIFIED AND TRAINED IN TECHNIQUESRELEVANT TO THEIR

WORK AND ARE CONTINUOUSLY UPDATING THEIR SKILLS ............................................................................... 19 9.4 GQ4 - THERE IS A SYSTEMIC AND PLANNED APPROACH TO THE MANAGEMENT OF RECORDS............. 19 9.5 GQ5 - THERE ARE DOCUMENTED PROCEDURES FOR DISTRIBUTION OF BODY PARTS, TISSUES AND

CELLS. 20 9.6 GQ6 - A CODING AND RECORDS SYSTEM FACILITATES TRACEABILITY OF BODIES, BODY PARTS, TISSUES

AND CELLS, ENSURING A ROBUST AUDIT TRAIL. ............................................................................................... 20 9.7 GQ7 - THERE ARE SYSTEMS TO ENSURE THAT ALL ADVERSE EVENTS ARE INVESTIGATED PROMPTLY. . 21 9.8 GQ8 - RISK ASSESSMENTS OF THE ESTABLISHEMENTS PRACTICES AND PROCESSES ARE COMPLETED

REGULARLY AND ARE RECORDED AND MONITORED APPROPRIATELY. ............................................................ 22

10 PREMISES, FACILITIES & EQUIPMENT (PFE) ........................................................................................ 22

10.1 PFE1 THE PREMISES ARE FIT FOR PURPOSE ........................................................................................... 22 10.2 PFE2 ENVIRONMENTAL CONTROLS ARE IN PLACE TO AVOID POTENTIAL CONTAMINATION ............... 23 10.3 PFE3 THERE ARE APPROPRIATE FACILITIES FOR THE STORAGE OF BODY PARTS, TISSUES, CELLS, CONSUMABLES AND RECORDS. ........................................................................................................................ 23 10.4 PFE4 SYSTEMS ARE IN PLACE TO PROTECT THE QUALITY AND INTEGRITY OF BODY PARTS, TISSUES AND

CELLS DURING TRANSPORT AND DELIVERY TO A DESTINATION ....................................................................... 24 10.5 PFE5 EQUIPMENT IS APPROPRIATE FOR USE, MAINTAINED, QUALITY ASSURED, VALIDATED AND

WHERE APPROPRIATE MONITORED. ................................................................................................................ 24

11 CONSENT (C) ....................................................................................................................................... 25

11.1 C1 CONSENT IS OBTAINED IN ACCORDANCE WITH THE REQUIREMENTS OF THE HT ACT 2004 AND AS

SET OUT IN THE CODE OF PRACTICE. ................................................................................................................. 25 11.2 C2 INFORMATION ABOUT THE CONSENT PROCESS IS PROVIDED IN A VARIETY OF FORMATS. ............. 26



11.3 C3 STAFF INVOLVED IN SEEKING CONSENT RECEIVE TRAINING AND SUPPORT IN THE IMPLICATIONS

AND ESSENTIAL REQUIREMENTS OFTAKING CONSENT .................................................................................... 27

12 SAMPLE COLLECTION (SC) ................................................................................................................... 27

13 SAMPLE PROCESSING (SP) .................................................................................................................. 27

14 HISTOLOGY SERVICES (HS) .................................................................................................................. 28

15 DISPOSAL (D) ...................................................................................................................................... 28

15.1 D1 THERE IS A CLEAR AND SENSITIVE POLICY FOR DISPOSING OF HUMAN BODY PARTS AND TISSUES. 28 15.2 D2 THE REASONS FOR DISPOSAL AND THE METHODS USED ARE CAREFULLY DOCUMENTED. ............. 29

16 APPENDIX A: OMB MANAGEMENT STRUCTURE ................................................................................ 30

17 APPENDIX B: OMB COMPOSITION ...................................................................................................... 31

17.1 OMB CORE TEAM .................................................................................................................................. 31 17.2 OMB APPROVED CLINICIANS................................................................................................................. 32 17.3 OMB ACCESS AND DEVELOPMENT COMMITTEE ................................................................................... 32 17.4 BIOMEDICAL RESEARCH UNIT (BRU) ..................................................................................................... 33 17.5 OMB MANAGEMENT COMMITTEE ....................................................................................................... 33 17.6 OMB ANNUAL REVIEW .......................................................................................................................... 33

18 APPENDIX C: SUPPLEMENTARY LIST OF MATERIALS ........................................................................... 34

INDEX OF STANDARD OPERATING PROCEDURES (OMB-SOP), POLICIES (OMB-P), FORMS (OMB-F) AND OTHER RELATED DOCUMENTS ....................................................................................................................... 38

APPENDIX C: STAFF RECORD OF DOCUMENT ACKNOWLEDGEMENT AND CONTENTS FORM ......................... 38



2 DOCUMENT INFORMATION AND REVIEW

2.1 DOCUMENT INFORMATION

2.2 DOCUMENT REVIEW

Review

Date

Altered Y/N

(Reason for change)

Version

number

No. of

pages

Signed Next

review

19/04/10 New Document. Draft version. V0.1 38

19/10/10 Final version of new document. After

review by HTA.

V1.0 38 18/10/11

YOU ARE INSTRUCTED TO READ THE FOLLOWING THOROUGHLY BEFORE

PROCEEDING TO UNDERTAKE THE METHODS DESCRIBED.

UNDER NO CIRCUMSTANCES ARE THESE INSTRUCTIONS TO BE AMENDED

OR ALTERED IN ANY WAY OTHER THAN BY THE AUTHOR / SIGNATORY.

Document: OMB Quality Manual

Document serial number: OMB-M 001 Area of application: All areas of OMB

activity

Prepared by: Karolina Kliskey Authorised by: Professor Andrew Carr

Original issue date: 19/04/10 Reviewed by: Stefanie Garden, Matthew

Burgess

Number & location of copies: Hard copy held in master folder in OMB office. Electronic

version held in: M:\OMB Documents\Authorised\Manuals and published in WebLearn

system.

Personnel requirement: All OMB associated staff



3 OUTLINE

This document together with specified procedures represents the Quality Management

System of the Oxford Musculoskeletal BioBank (OMB). It has been compiled to meet the

requirements of the Human Tissue Act (2004) and appropriate national and international

standards. All procedures specified herein are mandatory within the OMB Facility.

4 GENERAL INFORMATION

4.1 THE OXFORD MUSCULOSKELETAL BIOBANK FACILITY

The Oxford Musculoskeletal BioBank (OMB) is located within the Nuffield Department of

Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS) which is itself

housed in the Nuffield Orthopaedic Centre (NOC). The Nuffield Orthopaedic Centre NHS

Trust makes a significant contribution to the teaching of orthopaedics and trauma to clinical

students as well as postgraduate teaching and research. In April 2008, the National Institute

for Health and Research (NIHR) created the Musculoskeletal Biomedical Research Unit

(BRU) in Oxford. This is a partnership between the Nuffield Orthopaedic Centre and the

University of Oxford and is at the forefront of a drive to prevent, diagnose and treat ill health.

The postal address is:-

Oxford Musculoskeletal BioBank

Nuffield Department of Orthopaedics,

Rheumatology and Musculoskeletal

Sciences.

Nuffield Orthopaedic Centre NHS Trust

Windmill Road

Headington

Oxford OX3 7LD

Tel: 01865 - 737418

Fax: 01865 - 737640

Information on the Trust’s services and contact telephone numbers are available on the

Nuffield Orthopaedic Centre NHS Trust website www.noc.nhs.uk

Information about the research interests of the NDORMS can be found on the NDORMS

website: www.ndorms.ox.ac.uk

The Oxford Musculoskeletal BioBank (OMB) is a service and facility that has been

developed to provide a resource to research groups that are studying neoplastic and non-

neoplastic disorders of bone, joint and soft tissue. Primarily, this resource is aimed at research

http://www.noc.nhs.uk/

http://www.ndorms.ox.ac.uk/



groups working within the Botnar Research Centre and the Nuffield Orthopaedic Centre. In

future we would like to promote this resource nationally to external collaborators and

research groups from external institutions.

In order to study these disease processes, human tissue is required, and through close

collaboration with the Nuffield Orthopaedic Centre, the OMB collects samples and associated

data from operations performed there. Most orthopaedic research units share a similar

symbiotic relationship with their local hospital.

All samples obtained are tissues that are either normally disposed of at the time of surgery:

cartilage, bone, synovium, synovial fluid, bone marrow, and tendon; or are surplus to

diagnostic requirements: tumour samples, normal tissue samples. In both cases the patients

care remains the same and their diagnosis is in no way compromised.

In addition to samples obtained during surgical procedures the OMB also routinely collects

samples of blood and urine, and patient information which will enable the OMB to

supplement the data held for each donor. Only appropriately consented patients are to be

entered into the OMB.

In the early stages of the OMB's development the majority of tissue collected will be for

specific projects rather than to create a "stockpile" for future use. Having said that, the

consent that is obtained permits long term storage and future use of the samples if the sample

size allows for this. In time this will enable the OMB to become a resource not only for

internal research groups but also for external research establishments.

All research groups that wish to use the OMB must apply through the OMB Access and

Development Committee. Only projects that are covered by the scope of the NRES approved

Research Protocol will be authorised.

The OMB has the authority to provide tissue to external research groups who do not hold

their own NRES approval. The release of tissue samples and associated data is strictly

regulated.

In addition to the collection, processing and storage of samples and data, the OMB also

provides a histology service to the local research community. The OMB Laboratory has

facilities for fixation, processing and embedding of samples as well as microtomy, routine

histochemical staining and immunohistochemistry.

The OMB is holds a Human Tissue Authority (HTA) license (License number: 12500) and is

also approved by NRES (REC reference: 09/H0606/11).



The OMB itself works to strict guidelines and has developed a series of policies to which

researchers must comply. These policies have been put in place to ensure HTA compliance.

The HTA provides guidance to licensed facilities by issuing standards to which facilities

must ensure compliance to. These standards fall into four categories:

Consent,

Governance and Quality Systems,

Premises, Facilities and Equipment and

Disposal.

In addition to the HTA standards, the OMB has also developed a series of supplementary

standards. The OMB Standards fall into the following categories:

Personnel,

Sample Collection,

Sample Processing, and

Histology Services.

There is a certain degree of overlap between the HTA and OMB standards but the inclusion

of the OMB standards is necessary to ensure all aspects of the facility are covered.

4.2 THE QUALITY MANUAL

This Quality Manual describes the Quality Management System of the Oxford

Musculoskeletal BioBank. Throughout the text there are references to Human Tissue

Authority (HTA) Standards (in brackets), to OMB Standards (in brackets) and to policies or

procedures [indicated by square brackets] written in fulfilment of these standards. A

comprehensive list of policies, procedures and other documents and their associated HTA

Standards are shown in Appendix B.

This Quality Manual (GQ2) fulfils two functions. It describes the Quality Management

System for the benefit of the OMB’s own management and staff, and it provides information

for users and for inspection/accreditation bodies.

This Quality Manual can be regarded as the index volume to separate volumes of

Management, Laboratory, Clinical and Quality Procedures. The sections of the Quality

Manual are arranged so that they equate with the HTA Standards and OMB standards (see

table below). Under the title of each standard there is a brief description of the way in which



the OMB seeks to comply with the particular standard and references are given to appropriate

procedures.

Sections 4 - 9 concern themselves with general information regarding the OMB facility.

Sections 9 - 15 relate to the specific HTA and OMB standards. The standards and the relevant

sections of the manual are tabulated below for easy reference.

Section in the Quality

Manual

Section of HTA Standards/OMB Standards

6, 7, 8, 9 GQ - Governance and Quality

10 PFE - Premises, Facilities and Equipment

11 C - Consent

12 SC - Sample Collection

13 SP - Sample Processing

14 H - Histology Services

15 D - Disposal

5 HUMAN TISSUE ACT 2004

The Human Tissue Act came into force on the 1st September 2006. It replaces existing laws

by setting an updated legislative framework for regulating body donation, and the removal,

storage and use of human tissues.

The Act is intended to provide a consistent legislative framework for matters relating to body

donation and the removal, storage and use of human organs and tissue. It applies to ‘relevant

material’ from living persons. This is defined as “material, other than gametes which consists

of or includes human cells”. Blood is included whereas hair and nails are excluded. A

complete list relevant material can be found in Appendix C.

Building on best practice, the Human Tissue Act makes consent the fundamental principle

underpinning the lawful removal, use and storage of human tissue. The Act sets out detailed

requirements for obtaining consent in various situations including obtaining consent from

children, from adults who lack the capacity to consent and from deceased people.



The Act makes the removal, storage and use of human tissue without consent and the taking

and testing of DNA without consent illegal. Organ trafficking is also illegal. The penalties for

these offences range from a fine to three years imprisonment, or both.

5.1 HUMAN TISSUE AUTHORITY (HTA)

An overarching authority – the Human Tissue Authority – was set up to oversee the Act and

regulate activities through licensing. The purpose of licensing is intended to restore public

confidence in the proper use of human organs and tissue by ensuring compliance with the

provisions of the Act. The Authority was formally established on 1st April 2005.

The Authority licenses and regulates the removal, storage, use, import, export and disposal of

human bodies, organs and tissue. It has the power to issue, revoke, review and suspend

licenses as well as stipulate the conditions that apply to individual licenses. It is responsible

to ensure compliance with the Act; monitor developments and advise the Secretary of State.

It also has the powers of inspection, entry, search and seizure.

5.2 HTA LICENCE

The storage of human tissue and cells for human application (therapeutic use) has needed a

license from 7th

April 2006, in order to comply with the requirements of the EU Tissue and

Cells Directive. Licenses for other practices including the storage of human tissue for

research purposes became necessary as from 1st September 2006.

Medical research, education and training at the University of Oxford depend on the donation

and the removal, use and storage of human tissue and organs. In order to comply with its

obligations under the law and to enable the continuation of such research and education the

Nuffield Department of Orthopaedic Surgery has submitted one licence application with the

University of Oxford as the corporate licence holder. A full HTA licence has been issued for

Research.

Anyone carrying out a licensable activity without an HTA licence is now operating

unlawfully. Researchers receiving tissue for end-use should also assure themselves that it has

been obtained from a HTA licensed establishment

5.3 DESIGNATED INDIVIDUAL

The Act introduces the concept of an individual who will be responsible for licensed

activities and who will supervise compliance with the licensing arrangements under the Act –

the Designated Individual (DI). The DI must be identified in the licence and has a statutory



duty to secure compliance with the licence conditions. The Act also refers to the Licence

Holder (LH) who will normally be different from the DI. The LH can be a corporate entity.

5.4 HTA CODES OF PRACTICE

In order to provide practical guidance on the letter of the law and attempt to diminish the

uncertainties of its interpretation, the HTA have issued 9 Codes of Practice. These have been

approved by the Department of Health and Parliament and relate to the removal, storage, use

and disposal of human tissue and organs.

The Codes of Practice are as follows:

Code of Practice 1: Consent

Code of Practice 2: Donation of organs, tissue and cells for transplantation.

Code of Practice 3: Post mortem examination.

Code of Practice 4: Anatomical examination.

Code of Practice 5: Removal, storage and disposal of human organs and tissue.

Code of Practice 6: Donation of allergenic bone marrow and peripheral blood stem cells for

transplantation.

Code of Practice 7: Public display guidance.

Code of Practice 8: Import and export of human bodies, body parts and tissue.

Code of Practice 9: Research

Researchers are advised to consult and be familiar with the relevant Code of Practice

applicable to their field of work. For human tissue research, the relevant codes are codes 1, 5,

8 and 9.

6 RESEARCH ETHICS

The Oxford Musculoskeletal BioBank has approval from the NRES recognised Research

Ethics Committee (REC), Oxford REC C. Approval was first granted in March 2009 and a

subsequent amendment was approved by the same committee (Oxford REC C) in February

2010. The OMB has REC approval until March 2014. Approval extends to a programme of

study and associated documents including the Patient Information Sheet [OMB-PI 001] and

Consent Form [OMB - F002].



Full details of the approved programme of study can be found in the Oxford Musculoskeletal

BioBank Management Protocol [PROT/NDORMS/01].

Professor Andrew Carr is the Principle Investigator with ultimate responsibility for the ethical

conduct of the OMB.



7 QUALITY POLICY

The Quality Policy (GQ1) [OMB-P 005] of the Oxford Musculoskeletal BioBank is given

below and published as separate controlled document that is displayed within the OMB

Facility.

7.1 OMB QUALITY POLICY

The scope of the OMB is to provide a comprehensive tissue banking and histology service to

research groups and individual researchers both within the NDORMS and external

collaborators and independent research groups. The OMB service centralises the fundamental

processes of patient recruitment & consent, sample processing & storage and research

governance & documentation. This approach ensures a streamlined and manageable system

that benefits both patients and researchers alike.

It is committed to providing a high quality, timely and cost effective service which takes into

consideration the needs and requirements of its users.

The department operates a quality management system which provides the integration of

organisational structure, processes, procedures and resources within the department and is

committed to:-

Staff recruitment, training, development and retention at all levels to ensure a full and

effective service to its users.

Correct procurement and maintenance of equipment, resources and consumables to ensure the

provision of a full high quality service.

In setting quality objectives, monitoring the needs, requirements and service satisfaction of its

users and regularly reviewing the quality management system through internal audits and

external quality assessment, the department is able to achieve continual quality improvement.

Treating all human tissue with respect. Ensuring appropriate collection, transport and

handling of specimens to ensure the highest quality testing possible and timely, accurate,

confidential and relevant reporting.

Compliance with the Human Tissues Act (2004) and current legislation in respect of storage,

retention and disposal of human tissue.

Promoting and supporting ethical and novel research activities.

Personnel are notified of the need for commitment to good professional practice, health,

safety and welfare of both staff and visitors and compliance with all relevant environmental



legislation and are familiar with the contents of the quality manual and all procedures

relevant to their work.

Visitors to the department will be treated with respect and due consideration will be given to

their safety at all times whilst within the department.

The OMB is committed to being compliant with the standards as set by the Human Tissues

Act (2004)

Signed on behalf of the Oxford Musculoskeletal BioBank

...................................................................................................Date:

Prof. Andrew Carr (OMB PI, HTA DI and Head of Department)

……………………………………………………………………… Date:

Ms Karolina Kliskey (OMB Coordinator, BMS2)



8 ORGANISATION, RESPOSIBILITIES AND AUTHORITIES

8.1 RELATIONSHIP TO THE HOST ORGANISATIONS

The OMB is a facility within the Nuffield Department of Orthopaedics, Rheumatology &

Musculoskeletal Sciences, which is the academic department of Orthopaedic Surgery for the

University of Oxford within the Medical Sciences Division. The NDORMS is housed on site

at the Nuffield Orthopaedic Centre, both within the hospital and also in the Botnar Research

Centre. In April 2008, the National Institute for Health and Research (NIHR) created the

Musculoskeletal Biomedical Research Unit (BRU) in Oxford. This is a partnership between

the Nuffield Orthopaedic Centre and the University of Oxford and is at the forefront of a

drive to prevent, diagnose and treat ill health. The OMB is an integral part of the Oxford

BRU. The organisational relationships within are highlighted and shown in Appendix A.

8.2 ORGANISATION AND RESPONSIBILITIES WITHIN THE FACILITY

The Head of the NDORMS Department is Nuffield Professor of Orthopaedic Surgery,

Professor Andrew Carr. Professor Carr, in addition to his duties as Head of Department, is

also the Designated Individual on the HTA Licence and the Principle Investigator with

regards to Research Ethics for the OMB. Professor Carr is professionally accountable to

Professor Buchan, the Dean of the Medical Sciences Division. With regards to the HTA

Licence, Professor Carr is named as Designated Individual on the HTA Licence and reports

to Professor David Bryan who acts as the Corporate Licence Holder for the University of

Oxford.

Within the OMB there are a number of levels of management and responsibility. The

management structure and composition of the OMB can be found in Appendix A and B.

http://www.medsci.ox.ac.uk/



8.3 REGULAR MEETINGS INVOLVING THE OMB FACILITY

Meeting Frequency Membership Main agenda items

OMB

Operational

Group

At least

every 2

weeks

OMB Coordinator

OMB Biomedical Scientists

OMB Nurses

OMB Physiotherapists

OMB Associated theatre

staff

Development & Access meeting

brief

Administrative issues

Clinical issues

Quality

Health + Safety

HTA Update

Items from attendees

OMB Access

and

Development

Committee

At least

every 2

months

OMB Designated Individual

OMB Persons Designated

Clinical issues

Quality

Project Applications/approvals

OMB

Management

Committee

Meets 3 x

per year

All members of staff

involved in the management

of the OMB and it’s users.

Reports from managerial and

supervisory personnel

Assessment of user satisfaction

and complaints



OMB Annual

Review

Annually This is annual update on

OMB activities which is

open to all members of

Nuffield Orthopaedic Centre

and associated University of

Oxford staff.

Internal Audit of quality

management system

Internal audit of recruitment and

collection processes

Reports of assessments by outside

bodies

Status of preventative, corrective

and improvement actions

Major changes in organisation

and management resource

(including staffing) or process

Follow-up of previous

management review

OMB quality objectives and plans

All meetings include an agenda and chairperson. Minutes, are recorded and made available to

all staff members. The procedure ‘Staff Meetings and Communication’ [OMB – M/SOP

005] describes meetings within the department.



9 GOVERNANCE AND QUALITY SYSTEMS (GQ)

9.1 GQ1 - ALL ASPECTS OF THE ESTABLISHMENTS WORK ARE SUPPORTED

BY RATIFIEDDOCUMENTED POLICIES AND PROCEDURESAS PART OF

THE OVERALL GOVERNANCE PROCESS.

The majority of procedures practiced by OMB staff are covered by version controlled

Standard Operating Procedures (SOPs). The OMB will review current SOPs and develop new

ones where a need is identified to ensure full compliance. All OMB documents are subject to

version control and copy control. A computerised document control system is in place. This

records the current status of every document used by the OMB. In addition, it also documents

the change history of all documents and records the distribution of any documents.

This standard is fulfilled by procedures:

Section Document Title & (Number)

Management Procedure

OMB Document control procedure [OMB-M/SOP 001]


Generation, Issue and Control of SOPs [OMB-M/SOP 002]


Retention and storage of Quality Management Records and Documents [OMB-M/SOP 003]


OMB procedures for the production and amendment of the Quality Manual [OMB-M/SOP 004]

In keeping with the OMB Health and Safety Policy [OMB-P 002], University of Oxford

Health and Safety Policy [OMB-ED 048] and the NOC Trust Risk Management Policy

[OMB-ED 027] a risk and/or Control of Substances Hazardous to Health (COSHH)

assessment is made for all work involving the handling of blood, blood products and other

human tissues. Each risk assessment is specific for the procedures involved and takes into

account the nature and source of the samples to be handled. These are reviewed by designated

laboratory safety representatives.




OMB Risk Assessments [OMB-M/SOP 015]

Policy OMB Health and Safety Policy [OMB-P 002]

The overall management of the OMB is described in the OMB Management Protocol

[PROT/NDORMS/01] which has been approved by a Research Ethics Committee.



9.2 GQ2 - THERE IS A DOCUMENTED SYSTEM OF QUALITY MANAGEMENT

AND AUDIT.

Regular safety inspections (at least annual) are carried out and a record of the inspection is

sent to the University Safety Office as part of the department's system for managing health

and safety and conforming to the overarching University policy.



Policy OMB Health and Safety Policy [OMB-P 002]

The OMB has comprehensive audit programme. Internal audit is performed to a pre

established schedule and includes vertical, horizontal and examination audits. In addition, the

OMB conducts an annual audit of research groups that make use of the OMB facility.


Section SOP Title & (Number)


OMB Internal Audit [OMB-M/SOP 008]


Performing an Internal Audit [OMB-M/SOP 010]

OMB Form Internal Human Tissue Audit [OMB-F 020]

OMB Form OMB Audit Report Form [OMB-F 021]

OMB Form OMB Audit Schedule [OMB-F 024]

There is a system in place for staff to report non-conformities and to suggest quality

improvements or highlight potential non-conformities.




OMB Quality Improvement [OMB-M/SOP 007]


OMB Identification and control of nonconformities [OMB-M/SOP 014]


Error notification in the event of mishandling/transportation issues of samples [OMB-M/SOP 022]

OMB Form Notification of Sample Handling Error [OMB-F 012]

OMB Form Quality Improvement Note [OMB-F 019]

OMB Form Non-conformity note [OMB-F 034]



9.3 GQ3 - STAFF ARE APPROPRIATELY QUALIFIED AND TRAINED IN

TECHNIQUESRELEVANT TO THEIR WORK AND ARE CONTINUOUSLY

UPDATING THEIR SKILLS

All new members of staff receive induction training on Health and Safety - this is recorded as

part of Departmental procedures (University Policy Statement S9/01). Members of staff are

made aware of the University Policy and the whereabouts of all safety reference guidance

information in the department e.g. all University Policy Statements (UPS) and Memoranda.

A copy of the general statement is issued to all employees with their contract of employment.

UPS S1/95 is used as the main reference document. All members of staff attend NOC NHS

Trust Mandatory Training in accordance with the NOC Trust Policy - NOC Mandatory and

Statutory Training Policy [OMB-ED 064]. All members of staff attend a general induction

course.

New members of staff working for the OMB participate in the OMB Training Programme. In

addition, a schedule of refresher training will be implemented. Members of staff attending

University Safety Office-provided training courses and or Trust courses are provided with

records of attendance. Records of all training will be kept by the OMB. Before research and

clinical staff are authorised to undertake particular tasks, they receive appropriate training

and are signed off to do these tasks. Documentation of training programmes is held for all

members of staff.



OMB Manual OMB Staff Induction Manual and Training Log Book [OMB-M

004]

Policy OMB Training Policy [OMB-P 003]


OMB induction and training procedure [OMB-M/SOP 006]

9.4 GQ4 - THERE IS A SYSTEMIC AND PLANNED APPROACH TO THE

MANAGEMENT OF RECORDS

All OMB records, including donor records and OMB documents are subject to strict

procedures governing their destruction. Specific time limits are attributed to different types of

documents/records. A back-up/recovery system is in place for all documents held in the

NDORMS Department.




OMB Retention and storage of quality management records and documents [OMB-M/SOP 003]



In addition to electronic records, there is a comprehensive filing system which stores all

paper copies of consent forms and other associated data.

9.5 GQ5 - THERE ARE DOCUMENTED PROCEDURES FOR DISTRIBUTION OF

BODY PARTS, TISSUES AND CELLS.

A system of review is in place to ensure that samples being sent to collaborative groups and

institutions are used appropriately and in studies that are covered by appropriate ethical

approval. The location of released samples is documented on the tissue inventory system.

In order for tissue to be released to any researcher, an initial application must be made to the

OMB Access and Development Committee. Once a project is registered, any samples

released are documented on the OMB Sample Transfer Register [OMB-F 014] as well as on

the Inventory database.

Research Groups using OMB human Tissue samples must provide annual reports describing

the status of any samples allocated.



Policy OMB Access Policy [OMB-P 006]


External applications for human tissue [OMB-M/SOP 017]

Laboratory Procedure

Allocation of human tissue samples to approved projects. [OMB-L/SOP 010]

OMB Form OMB Project Application (Internal) [OMB-F 42]

OMB Form Application for Access to OMB Material (External) [OMB-F

046]

OMB Form OMB Annual Project Report [OMB-F 022]

Material transfer agreements are in place with all of the organisations to which we release for

research.

9.6 GQ6 - A CODING AND RECORDS SYSTEM FACILITATES TRACEABILITY

OF BODIES, BODY PARTS, TISSUES AND CELLS, ENSURING A ROBUST

AUDIT TRAIL.

An electronic inventory database is used which links patient/medical data to samples, their

storage and to their eventual use in ethically approved studies or disposal. The system is

stored on a secure server and is backed up regularly. Each sample is allocated a unique

sample number and this is the identification that the end-point researcher has access to. The

link to the donor is maintained by the OMB through the use of a separate system that records



information about all patients’ consented even if they do not donate any samples. All patients

that consent to donate human tissue samples and/or data are allocated an OMB number.




Processing Consent forms and patient data [OMB-M/SOP 019]


Recording patient and specimen information onto the inventory system (Pro-Curo-2) [OMB-L/SOP 005]

Released tissue to external establishments is linked to a Material Transfer Agreement and a

project which is covered by Research Ethics Committee approval. The date on which the

tissue is released and to whom it is released is also documented. Samples released to

NDORMS researchers are anonymised prior to allocation and transfer is documented on the

OMB Sample Transfer Register [OMB-F 014] as well as on the Inventory database.

9.7 GQ7 - THERE ARE SYSTEMS TO ENSURE THAT ALL ADVERSE EVENTS

ARE INVESTIGATED PROMPTLY.

All episodes of non-conformity will be documented and recorded. These records will be

reviewed at regular specified intervals by OMB management to detect trends and initiate

corrective action. Root cause analysis is performed on all non-conformities. The outcome of

this will determine the resolution/closure timescale and the level of personnel required to

authorise the closure. It will also determine the management level at which the non-

conformity should be reviewed and discussed.

Serious adverse events are reported to both the University and the NOC Trust, and if

appropriate to the Human Tissue Authority.



OMB Manual Health and Safety Manual [OMB-M 002]


OMB Identification and control of nonconformities [OMB-M/SOP 014]

Form Non-conformity note [OMB-F 034]

External Document

NOC Incident/Event Policy [OMB-ED 050]

External Document

Oxford University Accident and Incident reporting [OMB-ED 012]

Quality improvements can be suggested by staff using the Quality Improvement Note form

[OMB-F 019]. Quality improvement suggestions will reviewed and considered, with the

result fed back via the Quality Improvement Note and at departmental and management

meetings as appropriate. Suggestions will be treated in confidence as appropriate.






Quality Improvement [OMB-M/SOP 007]

9.8 GQ8 - RISK ASSESSMENTS OF THE ESTABLISHEMENTS PRACTICES AND

PROCESSES ARE COMPLETED REGULARLY AND ARE RECORDED AND

MONITORED APPROPRIATELY.

Risk assessments for all procedures practiced by OMB staff must be written prior to the

procedure being practiced. Risk assessments are reviewed by the NDORMS Health and

Safety representative as required and also annually during the Health and Safety Inspection

conducted by the University of Oxford Health and Safety Department.





OMB Risk Assessments [OMB-M/SOP 015]

External Document

NOC Risk Management Policy [OMB-ED 027]

10 PREMISES, FACILITIES & EQUIPMENT (PFE)

10.1 PFE1 THE PREMISES ARE FIT FOR PURPOSE

The premises are maintained in line with University Safety Policy S2/02 ‘Workplace (Health,

Safety & Welfare) Regulations 1992’. Risk assessment of the premises and facilities are the

responsibility of the Departmental Safety Officers who carry out annual health and safety

inspections of the department and report findings to the head of department and the

University Safety Office. If relevant, the Safety Office will report these findings to the

University Occupational Health Service.

All of the OMB’s records and computers holding data are located within secure areas (digital

locks or swipe-card entry).

The premises and equipment are regularly maintained. A non-site engineer oversees the unit

and all items of equipment have service contracts. This ensures the safety of staff and

visitors and the quality of samples stored within the OMB.



All members of staff working in the NDORMS and the NOC Trust are informed about the

importance of confidentiality and must abide by the confidentiality policy of both

organisations.

10.2 PFE2 ENVIRONMENTAL CONTROLS ARE IN PLACE TO AVOID

POTENTIAL CONTAMINATION

Appropriate health and safety controls are in place and are covered by current University and

Trust safety policies. Monitoring is carried out by inspection on behalf of the Departmental

Safety Committees.

There are documented procedures for cleaning and decontamination of equipment used.

Regulations for transporting human tissue are met and a service level agreement is in place

with the courier used.

Members of staff wear protective clothing and use personal protective equipment where

appropriate. All laboratory staff members have appropriate immunisation and full records are

held by the Occupational Health Department.





OMB Laboratory Disinfection [OMB-L/SOP 023]

OMB Form Laboratory disinfecting and cleaning log [OMB-F 018]

External Document

NOC Decontamination Policy [OMB-ED 045]

10.3 PFE3 THERE ARE APPROPRIATE FACILITIES FOR THE STORAGE OF

BODY PARTS, TISSUES, CELLS, CONSUMABLES AND RECORDS.

Samples and records are stored in a suitable and secure environment. Contingency plans are

in place in case of storage system failure but some are informally agreed. Fridge and freezer

temperatures are electronically recorded. The records are checked on a weekly basis. In

addition the ULT freezers are monitored by a temperature sensitive alarm that will initiate a

call out system out of normal working hours. There is a on-call rota that all OMB staff

participate in.

The electronic inventory system is in use for the logging of all samples entered into the

OMB. This will ensure all data is stored in a secure environment and access will be limited to

appropriately trained personnel.

Paraffin wax material is stored in purpose-built boxes in a secure area.



Access to both the OMB Office and Laboratory is by swipe-card. In addition the laboratory is

locked by key out of office hours.

Contact details for the DI and OMB Coordinator are held at the main reception. Members of

security staff survey the unit out of hours and they have access to the department in case of an

emergency. The records of the stored tissues are held on a hard copy but also on a secure

network drive on a computer which is password protected. The network drive is regulary

backed up.




Refrigerator and freezer temperature monitoring [OMB-L/SOP 026]


Maintenance of New Brunswick -80 Freezers [OMB-L/SOP 039]


Testing of alarm system on the New Brunswick -80 Freezer [OMB-L/SOP 040]


Responding to the Laboratory out-of-hours call out system [OMB-L/SOP 045]

OMB Form Temperature Log Adverse Event Report Form [OMB-F 047]

10.4 PFE4 SYSTEMS ARE IN PLACE TO PROTECT THE QUALITY AND

INTEGRITY OF BODY PARTS, TISSUES AND CELLS DURING TRANSPORT

AND DELIVERY TO A DESTINATION

Advice on transportation of samples and training is provided by Safety Officers, designated

personnel and specialist courier services. The University has a policy for transport of

samples, appropriate to the type of sample and whether it is classed as dangerous goods. A

service level agreement is place between the OMB and any courier employed to transfer

human tissue.

Movement of samples within the OMB is recorded on the inventory database.

All transfers outside of the University Establishment are governed by an MTA. Copies of all

MTAs are held by the OMB.

10.5 PFE5 EQUIPMENT IS APPROPRIATE FOR USE, MAINTAINED, QUALITY

ASSURED, VALIDATED AND WHERE APPROPRIATE MONITORED.

Equipment is purchased and maintained under the ‘Provision and Use of Work Equipment

Regulations 1998’. Equipment is serviced regularly and records are maintained by the OMB

and NDORMS. Instruction manuals are available for equipment. Staff induction training

includes use of equipment and the location of instruction manuals, if available. Departmental

arrangements are in place for reporting equipment problems and failures. Contingency plans



for equipment failure are in place but will be formalised and subjected to review to ensure

compliance.

Service Level Agreements are in place for equipment outside of its warranty period.

Directions for the use of all the equipment which exists are in SOP format and are kept in the

appropriate working areas. New members of staff are instructed on the use and maintenance

of equipment before being signed off to use it.




Refrigerator and freezer temperature monitoring [OMB-L/SOP 026]


Maintenance of New Brunswick -80 Freezers [OMB-L/SOP 039]


Testing of alarm system on the New Brunswick -80 Freezer [OMB-L/SOP 040]


Responding to the Laboratory out-of-hours call out system [OMB-L/SOP 045]

OMB Form Temperature Log Adverse Event Report Form [OMB-F 047]


004]

11 CONSENT (C)

11.1 C1 CONSENT IS OBTAINED IN ACCORDANCE WITH THE REQUIREMENTS

OF THE HT ACT 2004 AND AS SET OUT IN THE CODE OF PRACTICE.

The OMB will operate under the guidance of a suitable research ethics committee to assure

compliance with current best ethical practice. Our underlying principle is that donors should

give informed consent for the use of their tissue and data in medical research. Samples will

be received as a donation to medical research. Donors must be willing for their tissue and

data to be used in any ethically approved project. The donor will retain no rights to the

samples after acquisition other than the ability to withdraw consent for further storage and

use.

Consent to use human tissue and data in research is obtained via a generic OMB consent form

and Patient Information Sheet. The consent form is in addition to the NHS Trust “Consent to

Investigation or Medical Procedure Form”.

All patients referred to the Nuffield Orthopaedic Centre for medical treatment or a surgical

procedure will be invited to take part in this project. A patient information sheet and sample

consent form will be routinely included in the patients' information/appointment pack. The



patient information sheet includes contact details (telephone, postal and email) for members

of staff trained to provide patient information. The patient will have at least 24 hours to

consider the information given to them. When the patient arrives at the Nuffield Orthopaedic

Centre for their clinic appointment they will be introduced to a dedicated member of the

OMB Team who will be able to answer any further questions that the patient may have. The

patient’s ability to comprehend the information provided in the Patient Information Sheet will

be assessed and if it is understood that they are sufficiently informed they will be asked to

initial and sign the consent form. The consent form is specific to the Oxford Musculoskeletal

BioBank but is broad and enduring. The patient is asked to consent to their samples and data

being stored indefinitely and used in future projects that have not yet been planned. The

consent form is signed and dated by both the patient and the member of OMB staff taking

consent. A copy of the consent form is given to the patient, a copy is retained in the patient's

medical notes and a final copy is held securely by the Oxford Musculoskeletal Bank.



OMB Policy OMB Consent Policy [OMB-P 001]

Patient Information

The Oxford Musculoskeletal BioBank Patient Information Sheet [OMB-PI 001]

OMB Form The Oxford Musculoskeletal BioBank Consent Form [OMB-F

002]




Withdrawal of Donor Consent [OMB-M/SOP 024]

Clinic Procedure Informed Consent [OMB-C/SOP 002]


004]

11.2 C2 INFORMATION ABOUT THE CONSENT PROCESS IS PROVIDED IN A

VARIETY OF FORMATS.

All patient information sheets and consent forms used are ethically approved and have been

developed in line with NRES guidance; it has been deemed suitable for use in written format.

Research staff who obtain informed consent liaise with NHS staff at all times to ensure that it

is appropriate to approach the patient and that the patient will be able to comprehend the

information being communicated, both verbally and in writing. The information is not

currently available in other languages or Braille.



Patients that do not speak English or for any other reason cannot understand the information

given to them will not be recruited.

11.3 C3 STAFF INVOLVED IN SEEKING CONSENT RECEIVE TRAINING AND

SUPPORT IN THE IMPLICATIONS AND ESSENTIAL REQUIREMENTS

OFTAKING CONSENT

All members of OMB staff involved in the consent process must have completed their GCP

Training. In addition, they will also complete the relevant sections of the OMB Training

Programme. They will be supervised and assessed before they are signed off to practice

independently.



OMB Policy OMB Consent Policy [OMB-P 001]




004]

12 SAMPLE COLLECTION (SC)

Samples are collected in one of two ways. If the sample is of no diagnostic importance, it is

retrieved directly from theatres. An OMB approved clinician must sign or co-sign the OMB

sample collection form to qualify its use in research. A member of the OMB team will then

collect the sample/s from theatres and transport it to the OMB Laboratory where it will be

logged, anonymised and stored or distributed.

Alternatively, if the sample requires histopathological analysis it must be sent to the

Histopathology Laboratory where it will be assessed by the consultant pathologist. If there is

residual tissue not required for diagnosis, the consultant pathologist can release tissue for

research by signing the Pathology Surplus – Sample Collection Form. A member of the OMB

Team will collect the sample and transport it to the OMB Laboratory where it will be logged,

anonymised and stored or distributed.

13 SAMPLE PROCESSING (SP)

The processing of human tissue samples includes the anonymisation and logging of any

human tissue samples received. When a human tissue sample is received, it is first matched

up with its consent form and OMB Number. The sample is stripped of all personal identifiers



and logged on the Pro-Curo Inventory database. The link is maintained by the use of the

OMB number which must be referenced at all times.

The OMB will routinely snap freeze tissue and store at -80 and if there is enough material, a

representative sample will be formalin fixed and paraffin embedded.

The OMB will accept requests to process samples by alternative methods if the request is

made in advance and standard operating procedures are provided/already in place.

14 HISTOLOGY SERVICES (HS)

Under development.

15 DISPOSAL (D)

15.1 D1 THERE IS A CLEAR AND SENSITIVE POLICY FOR DISPOSING OF

HUMAN BODY PARTS AND TISSUES.

In the event that a patient withdraws consent for the long-term storage and use of their

sample, a record is made within the inventory control database and the sample is disposed of

in accordance with University and/or NOC NHS Trust policy. There is no time limit within

which a patient must log their withdrawal of consent but they will be made aware that their

sample and/or data may have already been used for research. The disposal of these samples is

in accordance with the University of Oxford Safety Guidance UPS S1/95, UPS S4/97,

Memos M8/05 and M9/05. The disposal of samples no longer required for research is

covered by the same policies. The University of Oxford is also drafting an institutional policy

dealing with the disposal of human tissue. All laboratory clinical and sharps bin waste is

collected from the laboratories for incineration according to arrangements made by the NOC

NHS Trust.

An SOP exists covering the disposal of residual diagnostic tissue. There are arrangements to

cover the release of tissue to official representatives so that material can be disposed of as

required by different cultures. A policy about disposal of tissue is not available to the public.

The Trust Chaplin provides support to families and interaction with members of various

religious/cultures with respect to disposal of body parts. Required standards for health and

safety are met with respect to disposal of tissue. For example, there is no identity on the

samples; all tissue is fixed before it is disposed of; a written record of cases and dates on

which disposals are performed is kept securely; all samples are sent for incineration in sealed

clinical waste bags labelled "For incineration only".



15.2 D2 THE REASONS FOR DISPOSAL AND THE METHODS USED ARE

CAREFULLY DOCUMENTED.

In the event that a patient withdraws consent for the long-term storage and use of their sample

and/or data, a record is made within the inventory control database and the sample is disposed

of in accordance with University and/or NOC NHS Trust policy. This inventory control

database will be implemented for all repositories within this licence application. An SOP for

disposing of the samples and/or data and tracking that disposal is currently under

development.



16 APPENDIX A: OMB MANAGEMENT STRUCTURE

OMB Management

Committee Meets 3 times a year

OMB ANNUAL REVIEW

OMB Access & Development

Committee

Meets monthly

OMB Operational

Group OMB Core Team

Meets twice per month

NOC R&D Monthly

BRU Monthly

OMB Approved

Clinicians



17 APPENDIX B: OMB COMPOSITION

17.1 OMB CORE TEAM

Name and Job Title Authorised responsibilities

Karolina Kliskey, OMB Coordinator Consent, collection, processing, storage, allocation.

Matthew Burgess, Biomedical Scientist Collection, processing, storage, allocation

Chethan Jayadev, Clinical Research Fellow Consent, collection, processing, storage.

Geraint Thomas, Clinical Research Fellow Consent, collection, processing, storage.

Richard Murphy, Clinical Research Fellow Consent, collection, processing, storage.

Vicky Flanagan, Theatre Nurse Consent, collection, processing, storage.

Varun Manhas, Biomedical Scientist Collection, processing, storage.

Stefanie Garden, Research Nurse Consent, collection.

Jessica Paul, Research Physiotherapist Consent, collection.

Kim Wheway, Research Nurse Consent, collection.

Bridgett Watkins, Research Nurse Consent, collection.

Cushla Cooper, Research Nurse Consent, collection.

Cathy Jenkins, Research Physiotherapist Consent, collection.



17.2 OMB APPROVED CLINICIANS

Professor Andrew Carr DI, PI of OMB, Head of department. Nuffield

Professor of Orthopaedic Surgery.

Special Interests: shoulder and elbow surgery

Mr Andrew Price Consultant Orthopaedic Surgeon

Specialty: Knee Surgery

Reader in Musculoskeletal Medicine

Mr Sion Glyn Jones Lecturer and Locum Consultant Orthopaedic Surgeon

Speciality: Hip and knee primary and revision surgery

Mr Jonathon Rees Consultant Orthopaedic Surgeon

Specialty: Shoulder surgery, teaching, education and

research.

Mr William Jackson Clinical Research Fellow in Orthopaedics

Consultant Orthopaedic Surgeon

Special Interests: Knee Surgery

Professor Nick Athanasou Consultant Pathologist

Professor of Musculoskeletal Pathology

17.3 OMB ACCESS AND DEVELOPMENT COMMITTEE

Professor Andrew Carr DI, PI of OMB, Head of department. Nuffield

Professor of Orthopaedic Surgery.

Special Interests: shoulder and elbow surgery

Professor Nigel Arden Reader in Musculosketal Sciences

Consultant Rheumatologist

Mr Andrew Price Consultant Orthopaedic Surgeon

Specialty: Knee Surgery

Reader in Musculoskeletal Medicine

Mr Sion Glyn Jones Lecturer and Locum Consultant Orthopaedic Surgeon

Speciality: Hip and knee primary and revision surgery

Mrs Stefanie Garden Research Nurse

Ms Karolina Kliskey OMB Coordinator



17.4 BIOMEDICAL RESEARCH UNIT (BRU)

Trust Medical Director (Chair)*

Director of BMRU**

Trust Non-executive director*

Representative, Medical Sciences Division of University of Oxford**

Trust Director of Finance*

Clinical Director, Musculoskeletal Services*

Director, Botnar Research Centre**

Chair, NOC Medical Staff Committee***

Chair, NOC Network***

Chair, Patient and Research Engagement Forum***

*Trust representation

**University representation

***Patient, public and medical staff representation

17.5 OMB MANAGEMENT COMMITTEE

All members of staff involved in the management of the OMB and it’s users.

17.6 OMB ANNUAL REVIEW

This is annual update on OMB activities which is open to all members of Nuffield

Orthopaedic Centre and associated University of Oxford staff.



18 APPENDIX C: SUPPLEMENTARY LIST OF MATERIALS

This list is intended to provide supplementary guidance to the HTA’s broader policy

framework on ‘relevant material’.

The list is not intended as exhaustive or exclusive, but is intended to provide guidance to

stakeholders in respect of a number of materials that guidance on the status of, as relevant

material or otherwise, has previously been sought. The HTA will review and update the list

periodically.

The list currently refers solely to which human body parts, tissues and cells are defined as

‘relevant materials’ for the purposes of the Human Tissue Act 2004, in line with the statutory

definition above. The HTA intends to expand the list in the future to also provide guidance to

the human application sector on which ‘tissues and cells’ are regulated under the Human

Tissue (Quality and Safety for Human Application) Regulations 2007.

Where a material is not included within the following list stakeholders should refer to the

policy framework to formulate their own assessment of the material’s status in line with the

guidance provided in the framework.

Materials classified in the following list as relevant material are done so subject to the

following general caveat that they are relevant material except where:

They have divided or been created outside the human body

They have been treated, processed or lysed through a process intended to render them

acellular. This would include the freezing or thawing of cells only where that process

is intended to render the material acellular.

Material

Relevant Materials for

the purposes of the

Human Tissue Act 2004?

Antibodies No

Artificially created stem cells* No

Bile Yes

Blood Yes

Bone marrow Yes

Bones/skeletons Yes



Brain Yes

Breast Milk*** Yes

Breath condensates and exhaled gases No

Buffy coat layer (interface layer between plasma and blood cells when blood

is separated)

Yes

Cell lines** No

Cells that have divided in culture No

CSF (Cerebrospinal fluid) Yes

Cystic fluid Yes

DNA No

Eggs* No

Embryonic stem cells (cells derived from an embryo)** No

Embryos (outside the body)* No

Extracted material from cells, e.g. nucleic acids, cytoplasmic fractions, cell

lysates, organelles, proteins, carbohydrates and lipids. No

Faeces Yes

Fetal tissue Yes

Fluid from cystic lesions Yes

Gametes* No

Hair (from deceased person) Yes

Hair (from living person) No

Joint aspirates Yes

Lysed cells No

Mucus Yes

Nail (from deceased person) Yes



Nail (from living person) No

Nasal and bronchial lavage Yes

Non blood derived stem cells (i.e. derived from the body.) Yes

Non fetal products of conception ( i.e. the amniotic fluid, umbilical cord,

placenta and membranes) Yes

Organs Yes

Pericardial fluid Yes

Plasma (Please note: Depending on how plasma is prepared and processed, it

may contain small numbers of platelets and other blood cells. If any of these

cells are present then the plasma must be regarded as relevant material.)

No

Platelets Yes

Pleural fluid Yes

Primary cell cultures (whole explant/biopsy present) Yes

Pus Yes

RNA No

Saliva Yes

Serum No

Skin Yes

Sperm* No

Sputum (or phlegm) Yes

Stomach contents Yes

Teeth Yes

Tumour tissue samples Yes

Umbilical cord blood stem cells Yes

Urine Yes



* While outside the definition of relevant material for the purposes of the HT Act, these

materials fall under the remit of the Human Fertilisation and Embryology Act 1990, and are

regulated by the Human Fertilisation and Embryology Authority (HFEA).

** Cell lines and embryonic stem cell lines fall within the regulatory remit of the HTA by

virtue of the Human Tissue (Quality and Safety for Human Application) Regulations 2007,

which regulates the processing, storage and distribution of stem cell lines for human

application. Both the HFEA and the

Medicines and Healthcare products Regulatory Agency (MHRA) also have a regulatory remit

in respect of cell lines and embryonic stem cell lines. A joint position statement issued by the

HTA, HFEA and MHRA provides guidance on the relevant regulatory remits.

*** Breast milk does not constitute tissue or cells for human application under the (Quality

and Safety for Human Application) Regulations 2007, but is classified as relevant material

for the purposes of the Human Tissue Act 2004 where stored or used for a scheduled

purposes.



INDEX OF STANDARD OPERATING PROCEDURES (OMB-SOP),

POLICIES (OMB-P), FORMS (OMB-F) AND OTHER RELATED

DOCUMENTS

Under development.

APPENDIX C: STAFF RECORD OF DOCUMENT

ACKNOWLEDGEMENT AND CONTENTS FORM

I have read the following document: OMB Quality Manual, OMB-M 001, V1.0

I understand the contents and I am happy that I have received appropriate training to be able

to follow the procedure to the best of my ability.

Name Position Signature Date Name of Trainer