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QUALITY MANUAL
This document together with referenced documents represents the Quality Management
System of the Histocompatibility & Immunogenetics Laboratories (H&I Lab) of Anthony
Nolan. It has been compiled to meet the requirements of the Clinical Pathology Accreditation
(UK) Ltd (CPA) system, The United Kingdom Accreditation Services (UKAS, ISO 15189
Medical Laboratories Accreditation) the European Federation for Immunogenetics (EFI) and
the Care Quality Commission (CQC) standards. All procedures specified herein are
mandatory within the H&I Lab.

Accreditation CPA UKAS EFI CQC

Body / Regulator
Number: 1517 8630 03-GB-005- 1-
995 240372502

VERSION No. Version 008

AUTHORISED BY See Q-pulse Document Record

REVIEWED BY See Q-pulse Document Record

LOCATION OF COPIES 1. Master in Q pulse

DOCUMENT REVIEW HISTORY

See Q-pulse document record for full details

Changes in this version

Updated the document with the changes that have taken place in the H&I Lab with regards to
the teams (TGS and Services) and changes in roles in the H&I Lab management team.
Removed information which is duplicated from other QMS documents such as the IT back up
and disposal. Formatting changes made to the entire document along with amendments to
the footer with new logo and details removed from the first page which can be found in Q-
pulse.

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CONTENTS

1 GENERAL INFORMATION

2 QUALITY POLICY

3 ORGANISATION, RESPONSIBILITIES AND AUTHORITIES

4 QUALITY MANAGEMENT SYSTEM

5 PERSONNEL

6 PREMISES AND ENVIRONMENT

7 EQUIPMENT, INFORMATION SYSTEMS AND REAGENTS

8 PRE-EXAMINATION PROCESS

9 EXAMINATION PROCESS

10 POST-EXAMINATION PROCESS

11 EVALUATIONS AND PROFICIENCY TESTING

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1 GENERAL INFORMATION

1.1 Histocompatibility & Immunogenetics (H&I) Laboratories

The H&I Lab is part of Anthony Nolan, a charity that was established in 1974 as the world’s
first volunteer unrelated Haemopoietic Stem Cell (HSC) donor register. The H&I Lab provides
a histocompatibility and immunogenetics service to the Anthony Nolan Register and
haemopoietic stem cell transplant (HSCT) centres throughout the world. In addition, the
laboratories also provide a histocompatibility and immunogenetics service to the renal and
liver transplant units of the Royal Free Hospital.

The postal address is: Anthony Nolan Histocompatibility Laboratories

Royal Free Hospital
Pond Street
London NW3 2QG

Tel: +44 20 7284 8348

Fax: +44 20 7284 8301

Information on the services provided and contact telephone numbers are available in the
users’ guide entitled ‘Anthony Nolan H&I Laboratories Service User Guide’ available on the
charity’s website and document controlled through the Q-Pulse system (DOC455).

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The H&I Lab of Anthony Nolan are able to provide the following genetic testing and
typing services to the defined ‘users’.

Service User
Haematopoietic stem cell transplantation  
HLA-A, -B, -C, -DRB1, -DQA1,-DQB1 –DPA1 and -DPB1 typing of potential Anthony Nolan Registry (Operations
unrelated HSC donors Division)
Maternal & Cord Blood ABO RhD blood group typing Anthony Nolan Cord Programme
HLA-A, -B, -C, -DRB1, -DRB3, -DRB4, -DRB5, -DQA1, -DQB1, -DPA1 and Anthony Nolan Registry
-DPB1 confirmatory typing of potential unrelated HSC donors External Registers
Transplant Centres
HLA typing on stored frozen potential unrelated donor DNA Transplant Centres
HLA-A, -B, -C, -DRB1, -DRB3, -DRB4, -DRB5,-DQA1, -DQB1, DPA1 and Transplant Centres
-DPB1 typing of patients and potential related HSC donors
HLA-A, -B, -C, -DRB1, -DRB3, -DRB4, -DRB5-, -DQA1, -DQB1, -DPA1 and Transplant Centres
-DPB1 typing of non-ANT HSC donors for patients within the U.K.
ABO RhD blood group typing of HSC donors and patients Transplant Centres
Virology screening (CMV, HIV, HBsAg, HCV) of potential HSC donors and Transplant Centres
patients
Antibody screening of recipients where a transplant with either a haplo-identical Transplant Centres
related donor, a mismatched unrelated donor or cord donation is intended.
Solid organ transplantation  
HLA-A, -B, -C, -DRB1,-DRB3, -DRB4, -DRB5, -DQA1, -DQB1and  -DPB1 Transplant and Specialist Services
typing of liver and renal potential transplant recipients Division, Royal Free Hospital
HLA-A, -B, -C, -DRB1, -DRB3, -DRB4, -DRB5, -DQA1, -DQB1 and  -DPB1 Transplant and Specialist Services
typing of cadaver liver and kidney donors Division, Royal Free Hospital, United
Kingdom Transplant
Organ Donation and Transplantation,
NHS Blood and Transplant
HLA-A, -B, -C, -DRB1,-DRB3, -DRB4, -DRB5, -DQA1, -DQB1 and –DPB1 Transplant and Specialist Services
typing of living kidney donors Division, Royal Free Hospital
HLA alloantibody screening and definition for patients awaiting renal transplant Transplant and Specialist Services
Division, Royal Free Hospital
Crossmatching of liver, renal and islet cell transplant recipients and donors Transplant and Specialist Services
Division, Royal Free Hospital
24 hour, 7 day / week on-call HLA typing and crossmatching service for liver, Transplant and Specialist Services
renal and islet cell transplantation Division, Royal Free Hospital
Non-transplantation services  
HLA disease associations Transplant and Specialist Services
Division, Royal Free Hospital
HLA-A, -B, -C, -DRB1, -DRB3, -DRB4, -DRB5, -DQA1, -DQB1, -DPA1 and – Commercial and non-commercial
DPB1 typing for non-transplantation projects organisations
Haemochromatosis gene (HFE) mutation typing Centre for Hepatology, Royal Free
Hospital, and other requesting
centres.
HLA-B*57:01 screening for Abacavir drug resistance Royal Free Hospital and other related
organisations

There are 5 ‘teams of scientists’ in the laboratories (listed below). This division is based on
the services provided to users and methods utilised.
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Lab Management Team

 
This team is responsible for turning a spit or blood sample into a DNA sample.  This includes
sample reception, DNA extraction using the Tecan machine, quantification and normalisation
and preparation of the final blocks of DNA samples ready for HLA typing.  This team also
makes sure the whole Laboratory runs smoothly and efficiently through managing stock,
equipment, maintenance and calibrations.
 
TGS Team
 
This team performs HLA class I and class II allelic level high resolution typing on all samples
requiring ‘6 loci’ typing, using the Third Generation Sequencing (TGS) technique. 
 
Services Team
 
This team uses Sequence Specific Primers (PCR-SSP) and/or PCR-Sequence Based Typing
(PCR-SBT) methods to HLA type samples which don’t require the ‘6 loci’ typing that TGS
provides.  This includes requests from other registries through EMDIS (European Marrow
Donor Information System), urgent samples such as 24-hour cords, and samples that don’t
contain enough cells to be processed through TGS.  This team also completes commercial
work including disease associations and B57 typing, alongside serology, virology screens
(e.g. CMV, Hep B, Hep C and HIV) and ABO blood grouping.
 
Client Team
 
This team supports interactions with service users and is the first point of contact for queries
relating to the services provided by the Laboratories.  The team ensures HSCT clinical
service users are prioritised; focusing on reporting and maintaining regular communication,
and also works with external customers who utilise the disease association and commercial
testing services. This team also works closely with the Registry Development Team and the
Anthony Nolan Cell Therapy Centre.
 
Solid Organ Group
 
This team performs HLA typing by serological and molecular techniques (PCR-SSP) at an
intermediate level of resolution to support Solid Organ Transplantation at the RFH and UCLH
facilities. These programs include renal, liver and islet transplantation.  The team also
provides pre-transplant crossmatching using flow cytometry and complement-dependant
cytotoxicity as well as HLA antibody screening and identification.  A 24-hour, 7-day week on-
call service is provided, lead by a consultant Clinical Scientist.
 

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1.2 QUALITY MANUAL

This document describes the Quality Management System of Anthony Nolan H&I Lab.
Throughout the text there are references to CPA (UK) Ltd Standards (in brackets), to the
UKAS, ISO 15189 Medical Laboratories Accreditation standards <in brackets>, to EFI
Standards {in brackets} and to documents written in fulfilment of these standards [in
brackets].

This Quality Manual (A6) <4.2.2.2> fulfils two functions:

i) It describes the Quality Management System for the benefit of the laboratory’s
own management and staff
ii) 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 and quality procedures. Under the title of each section there is a
brief description of the way in which the H&I Lab seek to comply with the relevant standards
and references are given to appropriate procedures.

The sections of the Quality Manual should be seen to relate to each other in the following
manner. Sections 3 and 4 describe the organisation of the laboratory and it’s Quality
Management System, which uses resources (Sections 5, 6 and 7) to undertake pre-
examination, examination and post-examination processes (Sections 8, 9 and 10). The
Quality Management System and the examination processes are continually evaluated and
quality assured (Sections 10 and 11). Safe working environment is maintained by
implementing relevant Health and Safety (H&S) procedures (Section 6).

The results of evaluations are fed back through laboratory management reviews, to maintain
and, where required, improve the quality management process and to ensure that the needs
and requirements of users are met.

2 QUALITY POLICY

2.1 INTRODUCTION

A quality policy provides the basis for running a laboratory in a manner that will fulfil the
needs and requirements of its users.

2.2 QUALITY POLICY STATEMENT

It is the policy of H&I Lab to provide a high standard of quality with regard to all aspects of
the clinical service that it provides.

2.3 QUALITY POLICY

The Quality Policy (A3) <4.1.2.3> of H&I Lab is given below and the master copy is available
as a controlled document on Q-Pulse DOC611. It is also displayed on the Quality Board
opposite room G02 in the laboratory.

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The Quality Policy of Anthony Nolan Histocompatibility Laboratories

The Laboratory is committed to providing a service of the highest quality and has developed
a Quality Management System (QMS) which has gained and held full accreditation.
The purpose of the QMS is to provide a framework for directing and managing activities
carried out by laboratory staff that are essential to providing high quality service that meets
the needs and requirements of our users.
The laboratories are committed to provide Histocompatibility, Immunogenetics, Virology
Screening and ABO and RhD Blood Grouping services.

The department management are committed to:

 Continually improve the Quality Management System

The department management has a continuing commitment to:

 Ensure that needs and expectations of users are determined and fulfilled with the aim of
achieving increasing user satisfaction
 Communicate throughout the department the importance of meeting user needs and all
relevant statuary and regulatory requirements
 Establish the Quality Policy and its objectives. Ensure the Quality Policy is regularly
reviewed in order to assess its continuing suitability. The Quality Policy is made available to
all members of staff
 Ensure that all staff are familiar with the Quality Manual and all procedures relevant to
their work
 Ensure that the Management Reviews set and review the quality objectives and report on
the internal audit results as a means of monitoring and measuring the processes and the
effectiveness of the QMS
 Ensure the department constantly monitors its quality performance and implements
improvements where appropriate
 Ensure the protection of the health, safety and welfare of its entire staff. Visitors to the
department will be treated with respect, and due consideration will be given to their safety
while on site. A departmental commitment will be given to comply with relevant
environmental legislation
 Ensure all staff adhere to mechanisms in place for the protection of patient confidentiality
at all times, and comply with Anthony Nolan policies
 Ensure that all staff uphold their professional values and are committed to good
professional practice and conduct

The Laboratory will comply with the standards set by Clinical Pathology Accreditation
(CPA, UK) Ltd, the Care Quality Commission (CQC), ISO 15189 Medical Laboratories
Accreditation Standards, UKAS and the European Federation for Immunogenetics
(EFI) and is committed to:

 Staff recruitment, training, development and retention

 Procurement and maintenance of equipment resources
 Examination procedures that will ensure the highest achievable quality of all tests
performed on a 24 hour basis
 Reporting results in timely, confidential, accurate and clinically useful ways
 Assessment of user satisfaction, internal audit and external quality assessment
 The collection, transport and handling of all specimens in such a way as to ensure the
correct performance of laboratory examinations
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2.4 QUALITY POLICY RESPONSIBILITIES <4.1.2.5>

The laboratory senior management must provide the users at all times with an analytical and
consulting service complying with the relevant CPA (UK) Ltd, ISO15189, CQC and EFI
Standards.

All staff must be familiar with the content of the Quality Manual and comply with the policies
and procedures described in the Manual and related documentation.

The quality team have overall responsibility for implementing the quality policy in the
laboratory.

The Head of Quality has overall responsibility for the control of quality management systems
(QMS) and shall monitor and give guidance on all aspects of quality management in the H&I
Lab.

3 ORGANISATION, RESPONSIBILITIES, AUTHORITIES

3.1 RELATIONSHIP TO THE HOST ORGANISATION <4.1.2.5>

The H&I Lab is part of Anthony Nolan.

Dr Katy Latham is the Laboratory Director and the Laboratory Co-Director is Professor
Steven Marsh, a role he fulfils alongside his position as Director of Bioinformatics & Deputy
Director of Research. Professor J.A Madrigal is the Research and Scientific Director and acts
as a Scientific Consultant, for the H&I Lab.
Dr Katy Latham, Professor Steven Marsh and Professor J.A Madrigal are part of the
organisations Senior Management Team (SMT) and are responsible to the Chief Executive
of Anthony Nolan; Mrs Henny Braund, who in turn is responsible to the Trustees and Chair;
Mr Simon Dyson.

Other departments, which exist in Anthony Nolan, include the following:

 Anthony Nolan Research Institute  Marketing & Communications

 Operations Division (Registry)  Fundraising
 Information Technology (IT)  Cord Blood Bank (ANCTC)
 Finance and Administration  Commercial

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3.2 ORGANISATION AND RESPONSIBILITIES WITHIN THE

HISTOCOMPATIBILITY LABORATORIES

The H&I Lab is a single department represented in the departmental organogram DOC447
(A1) <4.1>

3.2.1 Supervisory Staff

The senior team meet weekly to discuss laboratory activities and other issues as required.
The supervisory staff of the H&I Lab consist of:

Director of H&I (Consultant Clinical Scientist) Dr Katy Latham

Co-Director of H&I Prof S.G. E Marsh
Laboratory Manager Justine Reader
Head of TGS (Principal Clinical Scientist) Franco Tavarozzi
Head of Services (Principal Clinical Scientist) Finnuala Fowles
Head of Client Team Dr Vivien Hanson
(Principal Clinical Scientist)
Consultant Clinical Scientist (solid organ) Dr Henry Stephens
Senior BMS (solid organ) Joyce Grant
Laboratory Supervisors (Senior Clinical Sandra Frater
Scientists) Michael Hoddinott
Shem Wallis-Jones
Reetinder Grewal
Dr Sharon Vivers
Health and Safety Manager Hazel Forde
Head of Quality Salmah Mahmood
Quality & Training Supervisor Josefina Gil-Moya
Training Manager Shem Wallis-Jones

The H&I Lab organogram is available on Q-Pulse as a controlled document DOC447. It is

also displayed on the Quality management board opposite room G02.

3.2.2 Roles and Responsibilities of Laboratory Management

Directors
The Laboratory Director(s) are primarily responsible for the clinical direction and
management of the Histocompatibility services provided, research and development work
and ensuring that the Laboratory’s activities fulfil the requirements of Clinical Pathology
Accreditation (UK) Limited, United Kingdom Accreditation Service (UKAS) and European
Federation for Immunogenetics (EFI) accreditation. Dr Katy Latham is the ‘Nominated
Individual’ for the Care Quality Commission for Diagnostic and Screening activity. The
Director roles also extend to ensuring the H&I Lab’s involvement with appropriate external
proficiency testing schemes.

The Directors assess current and potential future scientific and medical developments that
may influence the services provided by the laboratories and to adapt the services provided
appropriately. Furthermore, they assess the technical demands of the services provided,
assess new technology and introduce as appropriate while continually liaising with clinical

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colleagues regarding services provided. They also perform a myriad of other roles and
responsibilities as outlined in the appropriate job descriptions. As per CPA standard B1.3
and ISO 15189 4.1.1.4: The Laboratory Director delegates selected duties and/or
responsibilities to persons with appropriate competence. These duties are itemised in
individual job descriptions.

Laboratory Manager

The Laboratory Manager is primarily responsible for the day to day running of the
laboratory, reviewing and advising the Laboratory Director on operational practice and
ensures that the laboratory is running efficiently. As the Laboratory Manager is not from a
scientific background there are formal links with the Head of the Client Team and the
Research Laboratory Manger to support in the continuing assessment of technical
demands of the services. The Laboratory Manager with an appropriate project team
supports the implementation of new technology and oversees introducing them.

The post holder ensures standards appropriate to Good Laboratory Practice and relevant
external bodies (e.g. CPA, EFI, UKAS, ISO 15189, and CQC) are achieved and upheld by
working closely with the Quality Team, Client Team and Research Laboratory Manager.

Day to day the Laboratory Manager is a point of contact within the Laboratory for all teams
if they are having any operational issues, they review and develop the overall budget
ensuring best value for money is factored in decision making. They work closely with
internal departments to ensure continuous improvement in interdepartmental
communications. Furthermore, the post holder performs other duties as outlined within the
associated post job description.

Head of Quality
The Head of Quality is responsible for the design, implementation and management of a
Quality Management System for Anthony Nolan on behalf of the Divisional Directors and
deals with all related issues. The post holder reports directly to the Chief Executive.
The Head of Quality is tasked with achieving continuous quality improvement in the 3 core
departments (H&I Laboratory, Operations, Cord Programme) of Anthony Nolan, ensuring
that the organisation becomes progressively more effective in quality terms and maintains
standards compliant with both regulatory and accreditation requirements. The post holder
is the Registered Manager for the CQC registration and performs other duties as outlined
within the associated post job description. The Head of Quality is supported by a team of 3
Quality of Training Supervisors, 1 in each of the departments.

Head of Services and Head of TGS

These two senior managers of the H&I Lab are responsible for the management of the day
to day running of the Services and TGS Teams respectively and that all quality procedures
governing the laboratories are followed. Both of these individuals report directly to the
Laboratory Director.

Head of Client Team

The Head of Client Team is responsible for leading the effective design and delivery of the
Client Team within the H&I Lab that supports HSCT and interactions with the users of
Anthony Nolan’s Histocompatibility services. The post holder reports to the Laboratory
Director.
This post holder is responsible for ensuring that the service provided by the H&I Lab
achieves the highest quality standards and meets regulatory and other best practice

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frameworks, and for developing and promoting the clinical Histocompatibility service to
respond to the needs of the customers in all operational matters in the HSCT and HLA
typing provision setting. This requires fostering good relations within Anthony Nolan with the
Operations Division, and Cord Blood Programme and externally with Transplant Centres
and various hospitals respectively, and involves effective communication and information
sharing back to the H&I Lab’s senior managers. The individual also has responsibility for
achieving targets set in respect of both quality and quantity of work undertaken and agreed
turnaround times.

Consultant Clinical Scientist- Solid Organ Group

Dr Henry Stephens is the lead for the Solid Organ Group, supported by Dr Katy Latham,
and is responsible for clinical decisions relating to this area, leading the team, ensuring that
the laboratory adheres to correct guidelines and procedures and providing Consultant
Scientific cover for the on-call service. This position is a substantive NHS post within the
Royal Free NHS Foundation Trust and reports into both the Laboratory Director and the
Transplant Programme Lead within the Royal Free.

3.2.3 The Anthony Nolan Health & Safety Committee

The committee meets four times a year and consists of the Health and Safety Manager,
Finance Director, Human Resources Manager, Radiological Protection Officer, Employee
Safety Representatives from H&I Lab, Research, Heathgate, Cord Programme, Regional &
Home based. The committee covers all aspects and locations of the charities’ operations
and acts as a body to consult, review, update and inform on health and safety matters.  The
minutes of the meeting are circulated widely and the committee report directly to the Senior
Management team and to the Chief Executive. The Chief Executive assumes ultimate
responsibility for Health and Safety at Anthony Nolan.
 
The Royal Free Hospital Health & Safety Executive review any accidents or incidents that
occur within the charity on an on going basis.
Should the need arise; an emergency meeting of the group can be called.  In addition, any
health issues of laboratory staff are overseen by a contracted Occupational Health
specialist organisation. 

3.2.4 The Training & Development Group for H&I Lab

The group provides oversight for the training programme the H&I Lab offers to staff. The
group reviews and provides guidance on the British Society for Histocompatibility and
Immunogenetics (BSHI) diploma, IBMS training and any other relevant training courses for
e.g. MSc or RCPath. The group meets once a month (training managers meeting) which is
chaired by the Training Manager and its membership is as follows:

Lead Training Manager (Labs) Shem Wallis-Jones

Director of H&I Labs Dr Katy Latham
BSHI Training Managers Dr Sharon Vivers
Aliyye Karasu
Dr Raymond Fernando

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4 QUALITY MANAGEMENT SYSTEM

4.1 Introduction

A quality management system (QMS) provides the integration of organisational structure,

procedures, processes and resources needed to fulfil a quality policy, and thus meet the
needs and requirements of users. The aim of the QMS is to fulfil the requirements of the
relevant standards from CPA, EFI, ISO15189 and CQC. QMS documents are stored on Q-
Pulse in the documents module; this manages the document control aspects such as
assigning unique document identifier numbers, review dates, version numbers, recording
document acknowledgement along with a few other details all described in the Document
Control SOP DOC122.

4.2 Needs and requirements of uses (A2) <4.4.1>

The needs of the H&I Lab service users are under constant review. The feedback from
users is translated into requirements, which form the focus of objective setting and planning
within in the QMS. Assessment of user satisfaction is conducted on a regular basis through
meetings with the users and consideration of the findings form part of the annual
management review.

4.3 Quality objectives and plans (A5) <4.1.2.4>

The H&I Lab management team defines the quality objectives in consultation with the
individual team supervisors, and is responsible for ensuring that plans are made to meet
these objectives. During the annual management review the H&I Lab management team
determines whether the objectives have been successfully completed, and provides an
opportunity for revising such objectives and plans. Objectives and plans are detailed in the
Annual Management Review documents on Q-Pulse DOC647 for the calendar year of 2013
and DOC3385 for the calendar year of 2014.

4.4 Control of process and quality records, and clinical material (A9 and
A10) <4.3>

Control of process and quality records is described in the laboratories Control of Laboratory
Processes, Sample Tracking, Records Storage & Retention document DOC119 and
Control of clinical material DOC120.

4.5 Management review (A11) <4.15>

An annual management review is held to review the H& Lab’s activity for all services, user
feedback, external proficiency testing and the QMS.
The findings of the management review are documented and actions taken recorded, this
document is then distributed to all laboratory staff.
The document includes:
 Follow-up on actions from the previous management review
 Results from external audits (e.g. EFI inspections, CPA inspections)
 Reports from Managerial and Supervisory Personnel
 Staff Changes, annual leave and sickness

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 Mandatory Training, CPD and Educational Courses Attended

 Assessments of User Satisfaction and Complaints
 Internal Audit of Quality Management System and Examination Processes
 External Quality Assessments
 Review of complaints received, discrepancies and corrective action taken
 Report on any changes to activities of laboratories in terms of service provision,
staffing etc.

The current Annual Management Review documents can be found in Q-Pulse DOC647 for
the calendar year of 2013 and DOC3385 for the calendar year of 2014.

5 PERSONNEL
5.1 Staffing (B2) <5.1>

The H&I Lab employs the following staff:

 Clinical Scientists
 Biomedical Scientists
 Laboratory Scientists
 Clinical Assistants
 Administrator / Receptionist

Staff registered with the HCPC participate in the British Society for Histocompatibility and
Immunogenetics, IBMS or the Royal College of Pathologists CPD scheme. All scientific
staff log their training in the appropriate format for their CPD scheme or in-house training
records and participate in the competency training programme relevant to their roles.

5.2 PERSONNEL MANAGEMENT (B3) <5.1>

5.2.1 Staff recruitment and selection <5.1.2>

All staff recruitment is performed in liaison with Anthony Nolan Human Resources (HR)
department either through the budgeting process or completion & submission of a specific
form. A request to recruit form (G:\HR\Forms\Request to Recruit Form) can be completed
and sent to Human Resources for approval. After approval, an advertisement is made in the
appropriate media. The interview panel will consist of a minimum of one supervisory staff,
plus other additional staff as required for the vacancy.

5.2.2 Staff orientation and induction (B4) <5.1.4>

On the first day of employment, new employees are given orientation and a tour of the
laboratories. All new staff are also given Q-Pulse access. The procedure for laboratory
induction is given in the laboratory staff induction booklet DOC675. All new staff are also
invited to participate in an Anthony Nolan induction day. This event is generic, organised
by Human Resources. Records of laboratory inductions are kept by individual staff
members on their record of activities document.

Staff are issued with the Anthony Nolan staff handbook which is available on the intranet
and managed by HR (http://heagrv01/intranet/category/resources/staff-handbook/).
The handbook includes details of the following:

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 Anthony Nolan as a charity

 Standard Terms and Conditions
 Policies and Procedures
 Benefits
 Important Information
 High level organisational chart for Anthony Nolan

5.2.3 Job descriptions and contracts (B5) <5.1.3>

Each member of staff has a job description and a contract of employment issued by the
charity’s Human Resources Department. Job descriptions are reviewed annually at the
Anthony Nolan Review of Performance meetings. Anthony Nolan staff involved in the
support solid organ service (histocompatibility and immunogenetics service to the
renal and liver transplant units of the Royal Free Hospital) also hold honorary
contracts with the Royal Free Hospital. Similarly Royal Free staff based in Anthony
Nolan have visitor contracts with Anthony Nolan.

5.2.4 Staff records (B6) <5.1.9>

All primary staff records are maintained by the Human Resources Department.

5.2.5 Staff annual review (B7) <5.1.7>

Review of performance is coordinated by the Human Resources department with the aim
for all staff to have at a minimum a review on or close to the anniversary of their start date.
All reviews are maintained on the Human Resources personnel software system.

5.2.6 Staff meetings and communication (B8) <4.1.2.6>

All staff should participate in regular team meetings organised by the supervisory staff.
Anthony Nolan also has a staff consultation programme including a staff forum group which
ahs representatives from all areas of the organisation for discussion of the charity’s
activities and plans, and also an opportunity to raise staff suggestions.

5.2.7 Staff training and education (B9) <5.1.5 and 5.18>

The charity’s policy on staff training and education is given in the staff handbook. All staff
maintain their individual training records (made up at least of a record of activities:
DOC1177).
Individual staff training folders can be found here: G:\Labs\QM\Training
Records\Training\Lab Training Records. Staff training and competency is regularly
assessed and updated where staff keep and maintain individual records of techniques
trained in and this is documented in DOC136, H&I Training and Competency.
Furthermore, registration and Specialist Biomedical and Clinical Scientist training pathways
are open to selected staff and are governed by the ‘Clinical & Biomedical Scientist Training’
document DOC469.

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6 PREMISES AND ENVIRONMENT

6.1 Staff and laboratory facilities <5.2.2>

Review of the laboratory premises and environment including storage and staff facilities is
included within the annual management review and routine H&S checks. Patients are not
required to attend the laboratories as part of their treatment (C3).

The laboratories and office areas are compliant with national health and safety guidelines
and are subject to assessment by local H&S inspectorates and outside bodies - CPA, CQC,
ISO 15189 and EFI inspectors. Sufficient space is provided for the use of equipment,
specimen reception, separation of ‘incompatible’ work areas (e.g. pre and post PCR), and
storage of equipment and paperwork (C4) <5.2.2>.

The following staff facilities are available on site (C2) <5.2.2>

 Toilets
 Rest Area
 Basic catering facilities and supply of drinking water
 Changing area and personal lockers
 Storage for laboratory coats
 Safe and secure working arrangements

6.2 HEALTH AND SAFETY (C5)

6.2.1 Introduction

According to the Management of Health and Safety at Work Regulations 1999, every
employer must make and give effect to the arrangements for the effective planning,
organisation, control, monitoring and review of the preventive and protective measures.

The following text briefly describing the procedures established in our laboratories to meet
this requirement.

6.2.3 Related documents

All documents relating to Health & Safety are located in the ‘Health and Safety manual’ type
folder of the Q-Pulse documents module.

6.2.4 New Starters

All new members of staff undergo an induction briefing, tour of the building and are given a
copy of the laboratory staff induction booklet (DOC675). The line manager for the new
individual (or designee) also creates a tailored brief training plan so that the new starter is
exposed to all teams of the Laboratory, not long after they commence employment.

The issued induction booklet covers aspects of Health & Safety, laboratories security, data
protection and confidentiality, absence procedure, daily attendance monitoring and
meetings with key staff members.

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At the end of the induction the inductee and the inductor sign and date all the relevant
sections of the induction booklet. The inductee then keeps this as the laboratories induction
record.

6.2.5 Training

H&S issues, e.g. fire and spillage of dangerous chemicals, form an integral part of the
annual training and assessment period.

The following training courses are provided as determined by the Health & Safety Manager:
 Biological Safety in Laboratories
 Display Screen Equipment (DSE) Assessors Course
 Fire Safety Lectures
 Fire Prevention and Protection
 First Aid at Work
 First aid at Work Refresher
 Back Care Awareness Training Programme

6.2.6 Security

ID badges are issued to all new members of staff, and are provided by HR.
Access is restricted to the laboratory by alpha numeric key code access.
Members of staff are allocated lockers for their clothing and valuables.
All visitors must sign the visitor’s book when arriving and leaving the building.
All visitors are required to read the model Health & Safety rules (DOC629) which is
displayed by main reception.

6.2.7 Fire

The location of fire call points, fire exits, fire fighting equipment and fire evacuation routes
are explained to new arrivals at induction.
All staff are required to undertake an annual fire safety course once a year as organised by
the Health & Safety manager.
Members of staff who have attended the fire lectures sign and date an attendance form and
additionally record the fact in their record of activities.
The fire alarm is tested weekly on Tuesday by the Works Department staff from the Royal
Free Hospital.
A fire drill with full evacuation of building is carried out once a year.
The Royal Free Hospital provides further fire training if required, and fire equipment
checking and maintenance.

6.2.8 Needle stick / inoculation injuries

The Royal Free Hospital Occupational H & S Unit provides a 24-hour Needle stick hotline.
This telephone number is found throughout the building, and also in the Departmental
Safety Codes of Practice Handbook. Also, all needle sticks must be reported as per SOP
K16 (‘Reporting Laboratory Accident & Incidents’: Q pulse DOC112).

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6.4.9 Spillages

‘Dealing with Spillages’: Q pulse DOC108 deals with how to handle chemical and biological
spillages.

6.4.10 COSHH

Completed COSHH assessment forms for the various procedures carried out throughout
the laboratories are located on Q pulse in documents module.

6.4.11 Reporting laboratory accidents and incidents

This is detailed in Reporting laboratory accidents and incidents DOC112

6.2.12 The Laboratories Health and Safety group

For details refer to the section 3 of this manual - Organisation, Responsibilities and
Authorities.

6.2.13 Waste Disposal

Disposal of laboratory waste products is described in ‘Disposal of Laboratory Waste

Products’ DOC104.

7 EQUIPMENT, INFORMATION SYSTEMS AND REAGENTS

7.1 Procurement and management of equipment (D1) <5.3.1>

The H&I Lab has established procedures which explain how the H&I Lab manages the
procurement (& disposal), management of equipment and validation.
Validation Procedures for New Technologies & Equipment’ DOC123
Procedure for Selection and Procuring External Goods and/or Services DOC3041

7.1.2 Laboratory management shall establish a procedure(s) for the

management of data and information that includes: (D2.2) <5.10>

a) Security

The IT Services provided are secured according to best practices and the service is
provided by an in-house IT department. Encryption is utilized where appropriate and
system logs are created and used. In particular the network has been configured to isolate
the H&I Lab from the rest of the organisation. Appropriate communications are permitted for
approved processes/users.

b) Access

System User IDs are only created when approved by the appropriate signatory. User
access forms are stored for future reference.

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Access to Services and data is controlled by both physical and electronic mechanisms.
User/3rd Party access is controlled and permissions given are appropriate to the individual
and/or group role.
3rd Party organizations are supervised when they are on-site and remote access is only
granted in exceptional circumstances.

c) Confidentiality, Data Protection and Backup

Anthony Nolan has a duty of care obligation to ensure that confidential data held is not
released in an unauthorized or accidental manner. The charity complies with the Data
Protection Act and has a Data Protection Officer, IT Director. Access to data stored on IT
systems is controlled via File, Group and User password access permissions. All staff
undergo data protection training and are issued with Anthony Nolan’s data protection policy
which is on the intranet.
Full system backups are taken on a daily basis using industry standard mechanisms. There
is an IT Backup policy DOC2357 which describes the full details of this process.
d)
8 PRE-EXAMINATION PROCESS
8.1 Information for users and patients (E1) <5.4.2>

The H&I Lab publish a user guide which is available on the Anthony Nolan website and
document controlled on Q-pulse, H&I Laboratories Service User Guide DOC455.

8.2 Request forms (E2) <5.4.3>

Specific Request forms are issued for the following:

HLA Histocompatibility Testing Request form DOC2857

Solid organ transplantation (kidney, liver and islet cell) (Appendix 1 of DOC189)
Disease association studies (DOC1277)
Hemochromatosis Mutation Testing Request (DOC479)

All forms are distributed to appropriate users and can be obtained by contacting the
laboratory. This information is given in the user guide and on the website.

8.3 Specimen collection, handling and transportation (E3, E4) <5.4.4>

Procedures describing specimen collection, handling and transportation are given in the
following SOPs:

Acceptance and rejection of blood samples (Q pulse DOC4)

Collection of blood samples from the Royal Free Hospital (Q pulse DOC6)
Transport of blood, cells or DNA to other laboratories (Q pulse DOC7)
Processing known ‘high-risk’ samples (Q pulse DOC8)

8.4 SPECIMEN RECEPTION (E5) <5.4.6>

Procedures describing specimen reception are given in the following SOPs (in addition to
those described in 8.3):

Booking-in blood samples received for testing

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(new donors - Q pulse DOC2)

Booking-in clinical services samples (Q pulse DOC3)
Receiving clinical services samples on SOLAR (Q pulse DOC5)
Booking-in and receiving samples for disease association studies (Q-Pulse DOC9)
Organisation of samples received by the solid organ team (Q-Pulse DOC189)

8.5 Referral to other laboratories (E6) <4.5>

The H&I Lab does utilise the services of other accredited Laboratories for some services.
For HLA typing, The Histogenetics Laboratory in Ossining is used. This laboratory has the
relevant accreditation from American Society for Histocompatibility and Immunogenetics
(ASHI).
For the blood grouping and virology testing any equivocal test result is referred to the
department of blood transfusion and virology (respectively) in the Royal Free Hospital.
Both departments are CPA accredited.

9 EXAMINATION PROCESS
9.1 Selection and validation of examination procedures (F1) <5.5.1>

All testing/examination and certain pre-examination procedures undertaken in the H&I Lab
have undergone rigorous validation or verification testing prior to the tests being used
routinely. Validation/ verification reports are stored on Q pulse.

9.2 Examination procedures (F2) <5.5.1>

All examination procedures are described within method SOPs. The master volumes of
SOPs are located within Q pulse.

SOPs are prepared by the laboratory staff and updated regularly to ensure that the contents
remain accurate.

Full details regarding the preparation, use of, and review of SOPs is given in; ‘Preparation,
Reviewing, Use of & Updating SOPs’ (DOC100).
Quality Management Systems software called Q pulse acts as a document controlling
database, and each SOP within the QMS has elements of:
 SOP Name
 SOP Number
 SOP Date for Review
 Q pulse number (e.g. DOC123)
 Name of staff member responsible for review and approval

Document Owners are notified by flagging and email generated notifications when
documents are due for review or approval rejection in the system.
Also, all SOPs are reviewed annually by the allocated ‘owner’ through Q pulse workflow.

9.3 Assuring the quality of examinations (F3) <5.6>

Internal quality controls for various procedures are described within the SOP for that
procedure. In addition, all staff within the H&I Lab participate in competency testing
(Internal Quality Control Exercise / Competency Testing’ Q pulse DOC136).

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10 POST-EXAMINATION PHASE <5.7>

10.1 Reporting results (G1, G2, G3, G4, G5) <5.8>

Procedures describing reporting results are given in the following SOPs: The procedures
also cover the production of amended reports and the description of comments for clinical
advice that can be given on the report. All haemopoietic stem cell transplantation related
reports are checked by HCPC registered Clinical Scientists before release. Solid organ
transplantation related reports are final checked by the Senior Supervisor for the Solid
Organ Group Consultant Clinical Scientist.
The following SOPs describe the reporting process of the H&I Lab;

Preparation of Clinical Services reports I (DOC90)

Preparation of Clinical Services reports II (DOC91)
Sending results by fax, email or telephone (DOC95)
Reporting HFE results (DOC165)
Preparation and checking solid organ HLA typing reports (DOC196)
On-call procedure (DOC191)
Checking and authorising Luminex results (DOC211)
Checking and authorising blood grouping results (DOC78)
Checking and authorising virology test results (DOC79)

These procedures include:

 The criteria for issuing amended reports.
 The authorisation of staff able to amend reports.
 The identification to the user of amended reports.
 A process for recording the issue of amended reports.
 The reason for issuing an amended report.
 The instigation of preventative action, if required.
 A process for archiving amended reports.

Procedures are also in place for dealing with discrepant results:

Identifying and processing discrepant typing results. Laboratory and Operations

Processes DOC2206
Procedure for dealing with virology and blood group typing discrepancies DOC96

11 EVALUATION AND PROFICIENCY TESTING

11.1.2 Internal Audit of the H&I Lab (H3) <4.14.5>

Internal audit of the H&I Lab provides evidence that there are procedures which have been
effectively established, implemented and maintained which enable the H&I Lab to achieve
compliance.
Systems of internal audit of the H&I Lab have been established and audits are conducted
according to a pre-determined schedule and against agreed criteria. The audits module of
Q pulse is used to record and communicate the findings of all audits. Audits are performed
by individuals with appropriate training and if possible by those who are independent of the
work being audited. Details of any actions, improvement suggestions and good practise
are logged on the audit module. The results of all internal audits are regularly evaluated
and any decisions taken to alter/improve the H&I Lab procedures are documented and are
monitored and review.

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Example of an audit schedule view in Q-pulse:

11.1.3 External quality assessment (H5) <4.18.8>

The H&I Lab participate in external proficiency testing programmes for all aspects of testing
performed:
United Kingdom National External Quality Assurance Schemes (UK NEQAS) for
Histocompatibility and Immunogenetics:
Scheme 1A HLA Phenotyping
Scheme 1B HLA-B27 Testing
Scheme 2A Cytotoxic Crossmatch
Scheme 2B Crossmatching by Flow Cytometry
Scheme 3 HLA Antibody Specificity Analysis/ Educational Scheme
Scheme 4A1 DNA HLA Typing at 1st Field Resolution
Scheme 4A2 DNA HLA Typing at 2nd Field Resolution
Scheme 5 Haemochromatosis Candidate Gene Mutations
Scheme 6 “HLA” Antibody Detection
Scheme 7 HLA-B*57:01 Typing for Drug Hypersensitivity

UK NEQAS for Microbiology

Immunity Screen (CMV testing)
Blood Borne Virus Scheme (Hepatitis B, Hepatitis C and HIV serology)
UK NEQAS for Blood Transfusion Laboratory Practice
ABO RhD Blood Group Typing
University of California at Los Angeles (UCLA) International Cell and DNA Extract
Exchange
Results from all schemes are posted on the laboratory notice board and presented at
supervisors meetings.

11.1.4 Quality Improvements (H6) <4.12> & The Identification of

Nonconformities (H7) <4.9>

The H&I Lab has a process for continual quality improvement which includes corrective
action, preventative action and improvement processes, these are all referred to as
‘Actions’ within the H&I Lab. <4.10><4.12>

Corrective action for identification and the elimination of the causes of non-conformities
includes:

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 Investigation of non-conformities and recording of results.

 Determination of, and responsibility for, corrective action.
 Implementation of corrective action within an agreed time scale.
 Root cause investigation and attempted fix.
 Monitoring of corrective action taken.

All errors, discrepancies and complaints are documented together with assigned corrective
action. All errors / discrepancies are reviewed by relevant senior staff and discussed with
staff at lab meetings. These activities are governed and implemented by application of the
following SOPs:

Reporting and Investigating Events DOC148

Actions DOC145
H&I Complaints, Comments and Compliments Procedure DOC146

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