Gwent Healthcare NHS Trust

Owner: Quality Manager

Directorate of Pathology

Q-Pulse No. QP0002

Edition No. 10
Printed copy is controlled document only on date last printed 10/07/2008

Pathology
Quality Manual
Gwent Healthcare NHS Trust

Status: Operational
Issue Date: 07/07/2008
Review Date: 07/07/2010
Page 1 of 34

Gwent Healthcare NHS Trust

Owner: Quality Manager
Directorate of Pathology

Q-Pulse No. QP0002

Edition No. 10
Printed copy is controlled document only on date last printed 10/07/2008

PATHOLOGY QUALITY MANUAL

Q-Pulse Number QP0002
EDITION No:

Ten

OPERATIVE DATE:

7th July 2008

REVIEW DATE:

7th July 2010

REPLACES:

Edition Nine

LOCATION:

Q-Pulse, Quality Documents, Quality Manual

AUTHOR:
Signature:
Date:
AUTHORISED BY:
Signature:
Date:

Tim Von Pokorny

Edition No
9.

Operative
Date
01/11/07

10.

07/07/2008

Neil Carbarns

DOCUMENT HISTORY
Comment
Amendments to reflect changes in laboratory reconfiguration and CPA
standards. Hyperlinks added to relevant referenced documents.
Amendments made to reflect new CPA standards (Version 2.00) and
up date changes in staffing.

11.
12.
13.
14.
15.
16.

This document, together with specified procedure manuals, represents the Quality Management
System of the Pathology Directorate, Gwent Healthcare NHS Trust. It has been compiled to meet the
requirements of the Clinical Pathology Accreditation (UK) Ltd. (CPA) system and appropriate national
and international standards. All procedures specified herein are mandatory within the Pathology
Directorate.

Status: Operational
Issue Date: 07/07/2008
Review Date: 07/07/2010
Page 2 of 34

Gwent Healthcare NHS Trust

Owner: Quality Manager
Directorate of Pathology

Q-Pulse No. QP0002

Edition No. 10
Printed copy is controlled document only on date last printed 10/07/2008

CONTENTS
QUALITY MANUAL.............................................................................................................................. 1
GENERAL INFORMATION .................................................................................................................. 4
PATHOLOGY DIRECTORATE .....................................................................................................4
QUALITY POLICY STATEMENT....................................................................................................... 10
ORGANISATION, RESPONSIBILITIES AND AUTHORITIES .......................................................... 11
RELATIONSHIP TO THE HOST ORGANISATION ..........................................................................11
ORGANISATION AND RESPONSIBILITIES WITHIN THE PATHOLOGY DIRECTORATE .......................11
ORGANISATION AND QUALITY MANAGEMENT SYSTEM ........................................................... 17
PERSONNEL ...................................................................................................................................... 20
PREMISES AND ENVIRONMENT ..................................................................................................... 24
EQUIPMENT, INFORMATION SYSTEMS AND REAGENTS ........................................................... 26
PRE-EXAMINATION PROCESS........................................................................................................ 28
EXAMINATION PROCESS ................................................................................................................ 31
POST-EXAMINATION PROCESS ..................................................................................................... 31
EVALUATION AND QUALITY ASSURANCE ................................................................................... 32

Status: Operational
Issue Date: 07/07/2008
Review Date: 07/07/2010
Page 3 of 34

Gwent Healthcare NHS Trust

Owner: Quality Manager
Directorate of Pathology

Q-Pulse No. QP0002

Edition No. 10
Printed copy is controlled document only on date last printed 10/07/2008

GENERAL INFORMATION
Pathology Directorate
There are four Divisions within Gwent Healthcare NHS Trust; Acute services division, Diagnostics,
Therapies, Pharmacy/Facilities and Support Services division, Mental Health, Learning Disabilities
and Community division and Women, Child and Family Services division.
The Pathology Directorate forms part of the Division of Diagnostics, Therapies, Pharmacy/Facilities
and Support Services.
The Trusts Pathology laboratories operate as a network and are based on three hospital sites within
Gwent (see map below).
Nevill Hall
Hospital

Caerphilly
District Miners
Hospital
Royal
Gwent

The postal address is:-

Pathology Directorate
Gwent Healthcare NHS Trust
Block 3
Royal Gwent Hospital
Newport
NP20 2UB

Tel
Fax

01633 238855
01873 733059
01873 732469

Information on the services provided and contact telephone numbers are available in a series of
publications and on the hospital website. www.gwent-tr.wales.nhs.uk

Status: Operational
Issue Date: 07/07/2008
Review Date: 07/07/2010
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Gwent Healthcare NHS Trust

Owner: Quality Manager
Directorate of Pathology

Q-Pulse No. QP0002

Edition No. 10
Printed copy is controlled document only on date last printed 10/07/2008

There are five departments within the Pathology Directorate providing routine and emergency
services across the Trust, outlying Community Hospitals, GP services and other primary care services
as illustrated in the matrix below.
Pathology services provided across the Trust

Discipline
Combined Blood Sciences
with
Biochemistry &
Haematology
Sub-specialisation

Nevill Hall
Hospital

Royal Gwent
Hospital

Cytology Gynaecological

Cytology
Non-Gynaecological

(Reporting only)

Histopathology
Including Mortuary with PM
facilities

(Reporting only
for Histology)

Microbiology

Caerphilly
District Miners
Hospital

The Pathology Department also provides the following Tertiary services:

Angiotensin Converting Enzymes (RGH, NHH)
Arginine vasopressin (RGH)
Atrial natriuretic peptide (RGH)
Beta 2 glycoprotein (RGH)
Breast histopathology for Breast Test Wales (RGH)
Progesterone and Oestrogen receptor status for Velindre Hospital (RGH, NHH)
Occasional referral of histology cases for consultation (RGH, NHH)
The Pathology Department uses a range of Tertiary services appropriate to the need, with the majority
being sent to the University Hospital of Wales in Cardiff.
a) Combined Blood Sciences with Haematology and Blood Transfusion sub-specialisation
This section of the Combined Blood Sciences department provides a comprehensive analytical and
interpretative service to the hospital and GP patient community in Gwent. The department is located
on 3 sites namely the Royal Gwent, Nevill Hall and Caerphilly Miners Hospitals. The laboratory works
closely with the clinical Haematology Directorate and supports daily haematology clinics and
haematology wards at the Royal Gwent and Nevill Hall. The department has subsections of Routine
Haematology, Blood Transfusion, Coagulation and Immunology. The Royal Gwent laboratory
undertakes the more specialist tests in Coagulation and Immunology for the Trust. The Immunology
Status: Operational
Issue Date: 07/07/2008
Review Date: 07/07/2010
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Gwent Healthcare NHS Trust

Owner: Quality Manager
Directorate of Pathology

Q-Pulse No. QP0002

Edition No. 10
Printed copy is controlled document only on date last printed 10/07/2008

service is overseen by Dr Paul Williams as part of the Welsh Immunology Laboratories Group and the
department runs computerised dosing for warfarin therapy with a team of anticoagulant nurse
practitioners.
b) Combined Blood Sciences with Clinical Biochemistry sub-specialisation
This section of the Combined Blood Sciences Department provides a comprehensive analytical,
advisory service to Gwent Healthcare NHS Trust. The Department provides a referral service for five
Local Health Boards and is a very busy Department, with a high and rising primary care workload.
The Department processes over 3 million tests per annum. The appropriateness, precision and
speed of provision of the biochemical tests used for diagnosis, prognosis or in treatment monitoring
influences the duration of the clinical intervention and its outcome.
Staff employed in laboratories across the Trust provide the vital scientific expertise to aid Clinicians
and other health care professionals in the interpretation of laboratory investigations, in addition there
is a major role in supporting research and development, teaching, training and audit of procedures.
The Department is also responsible for selection, maintenance and control of all extra laboratory
equipment within the Trust.
c) Microbiology
The department provides a routine and emergency diagnostic service for hospital and GP surgeries
within the Gwent area. The department is located on two sites, namely Royal Gwent Hospital and
Nevill Hall Hospital. The laboratories routinely process patients specimens such as swabs, urine,
blood and other body fluids, within the two Bacteriology laboratories and further work involving TB
culture, and routine serology for Ante-natal, Occupational Health and GUM Clinics are processed at
the Royal Gwent site. A microbiology Biomedical Scientist attends two outlying GUM clinics (Cordell
Centre and Cwmbran GUM clinic) where microscopy is performed and plates inoculated before being
returned to the Royal Gwent site. The total laboratory samples processed is in excess of 500,000
samples per annum. Medical Microbiologists give advice on the investigation and management of
infectious diseases, antibiotic usage and surveillance of disease in the hospital and in the community.
Clinical and infection control advice is given at the bedside during ward/department visits or via the
telephone.
Staff working within the Microbiology laboratories throughout the Trust are professional in their work
and aim to provide an accurate quality assessment and examination of patients samples and provide
a timely turnaround time on generating and issuing reports to the users of the service.
d) Histopathology and Mortuary services
Histopathology is based on two sites, Royal Gwent Hospital, Newport and Nevill Hall Hospital,
Abergavenny. The Royal Gwent site has the larger laboratory supported by five dedicated consultant
Histopathologists and operates a centralised tissue processing service. The Nevill Hall site operates
as a satellite laboratory and is supported by three dedicated consultant Histopathologists and
maintains a limited processing capacity for very urgent requests. Histopathology requests from
Caerphilly District Miners Hospital are diagnosed on the Nevill Hall site. Histology samples, tissue
blocks and microscope slides are transferred between the three hospitals on dedicated transport
running several times during each week day.
Histopathology provides routine services to Primary Care Surgeries, Hospital Based Clinicians (both
physicians and surgeons) and other Trusts in the region. Histopathology serves a combined
catchment area population in excess of 600,000 and handles in excess of 24,000 surgical requests
and over 900 post mortems per annum, the latter including coroners and hospital cases. The
Histopathology department supports other Directorates in their audit activities and MDT meetings and
also offers a non-gynaecological cytology service to its users. The department is also responsible for
the management of the mortuaries, which are public mortuaries used by HM Coroner for Gwent.
The department deals with a variety of surgical specimens including dermatology, breast surgery,
gastrointestinal surgery, urology, gynaecology and lymphoma etc. but excludes thoracic and
neurosurgery, which are not performed within this Trust.
There is a wide repertoire of
immunocytochemistry covering all specialities. Frozen sections are provided for intra-operative

Status: Operational
Issue Date: 07/07/2008
Review Date: 07/07/2010
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Gwent Healthcare NHS Trust

Owner: Quality Manager
Directorate of Pathology

Q-Pulse No. QP0002

Edition No. 10
Printed copy is controlled document only on date last printed 10/07/2008

diagnosis. There is sub-specialisation of consultant histopathologists within the department to provide

expert opinions.
e) Cytology
The cytolopathology department at the Royal Gwent Hospital receives approximately 37,000
gynaecological and 5,500 diagnostic (non-gynaecological) samples per year. The department
provides centralised processing and screening services for Gwent and some areas of Powys.
Colposcopy and gynaecological samples are received from the Royal Gwent, Nevill Hall, Caerphilly
District Miners and Brecon War Memorial Hospital sites. Cervical cytology services are commissioned
by Cervical Screening Wales which is managed by Velindre NHS Trust. All gynaecological samples
are processed using Liquid Based Cytology.
A centralised processing and screening service is provided for diagnostic cytology at the Royal Gwent
site, supporting bronchoscopy, ENT and other specialist fields. Attended FNAs (at RGHl) can be
arranged through contact with the laboratory. Diagnostic samples are transported from Nevill Hall to
the Royal Gwent, via a dedicated transport system. The samples are processed and screened at the
Royal Gwent and pre-screened slides are returned to Nevill Hall for reporting by the Consultant
Histo/Cytopathologists. Diagnostic samples from Caerphilly District Miners Hospital are transferred to
the Royal Gwent Hospital where samples are processed, screened and reported on site by the Royal
Gwent Histo/Cytopathologists. The Cytopathology service is committed to service improvement
through new technology and the majority of diagnostic samples are processed using Liquid Based
techniques. Cytopathology also provides support for various MDT meetings (both gynaecological and
diagnostic cytology).
f) Caerphilly District Miners Hospital
The laboratory comprises a Consultant led service in Biochemistry, Haematology and Transfusion. It
provides a service to Caerphilly District Miners' Hospital, Ystrad Mynach Hospital, Aberbargoed
Hospital and Redwood Memorial Hospital. In addition a service is provided to all General Practitioners
in the catchment which essentially are those within the Caerphilly borough. There is also a
phlebotomy service which provides wards and outpatients with a weekday service. The laboratory
does not have Microbiology, Immunology or Cellular Pathology departments as these are based at
the Royal Gwent Hospital, Newport and Nevill Hall Hospital Abergavenny. There are also significant
networking arrangements with neighbouring Trusts with regard to various aspects of service provision
across disciplines. Examples of this are Clinical Haematology and some Histopathology/Cytology.

Haematology and Blood Transfusion

Clinical input for this department is currently provided by a neighbouring Trust. The department
supports a Haematology Outpatient clinic at Caerphilly District Miners Hospital and manages an
anticoagulant clinic on three days a week. The repertoire contains basic Haematology, coagulation
and transfusion testing with samples being referred to other sites, mainly at the Royal Gwent Hospital
in Newport for those tests not included in the repertoire.

Biochemistry

As with Haematology the department has a limited repertoire which comprises all commonly
requested tests and refers samples to the Royal Gwent Hospital in Newport for those tests not offered
on site. The department supports in addition to all other routine clinics, a Lipid Outpatient Clinic and
an evening Young Persons Diabetic Clinic
There is a Trustwide Control of Infection department, which is under the management of the
Microbiology department.

Status: Operational
Issue Date: 07/07/2008
Review Date: 07/07/2010
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Gwent Healthcare NHS Trust

Owner: Quality Manager
Directorate of Pathology

Q-Pulse No. QP0002

Edition No. 10
Printed copy is controlled document only on date last printed 10/07/2008

Gwent Healthcare NHS Pathology Matrix Structure - 2008

General Management

Gwent Healthcare NHS

Trust Medical Director
Grant Robinson

Gwent Healthcare NHS

Trust Chief Executive
Martin Turner (Andrew
Cottom acting)

Gwent Healthcare NHS

Trust Chief of Staff
Neil Carbarns

Division of Diagnostics &

Therapies General Manger
Jamie Marchant

Directorate /
Modernisation Manager
Mike Redman

Departmental Management

Quality Manager
Facility Manager (North)
T&D Lead
H&S Lead
Tim von Pokorny
Clinical Lead
Microbiology
Dr E Kubiak

Microbiology
Lead
Dave Williams
Micro 2008.ppt

Clinical Lead
Histology
Dr M Rashid

Histology
Lead
Ann Screen
Histology
2008.doc

Clinical Lead
Cytology
Dr N Dallimore

Cytology
Lead
Sonia Sloan
Cytology
2008.doc
Clinical Lead
Haematology RGH
& NHH
Dr E Moffat/ Dr N
Parry-Jones
CDMH
Dr A Goringe

Clinical Lead
Blood Sciences
Dr M Penney

Clinical Lead
Biochemistry
Dr M Penney /
J Tovey
(Rotation)
Status: Operational
Issue Date: 07/07/2008
Review Date: 07/07/2010
Page 8 of 34

Clinical accountability
Blood Science
Lead
Alison Hunt
Blood Science
North 08.doc

Clinical Lead
Immunology
Dr P Williams
(UHW)

Key:

Managerial accountability
Functional accountability
Line of communication

Blood Science
Lead
South & CDMH
Mario Minoli
BS South &
CMH 08.doc

IT Lead
Facility Manager (South)
Information Mgt Lead
Stuart Thomas

Gwent Healthcare NHS Trust

Owner: Quality Manager
Directorate of Pathology

Q-Pulse No. QP0002

Edition No. 10
Printed copy is controlled document only on date last printed 10/07/2008

The Quality Manual

This Quality Manual describes the Quality Management System of the Pathology Directorate.
Throughout the text there are references to CPA (UK) Ltd. Standards (in brackets) and to
procedures/policies [indicated by square brackets], written in fulfilment of these standards.
This Quality Manual (A6) fulfils two functions. It describes the Quality Management System for the
benefit of the laboratorys 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 CPA (UK) Ltd. Standards {see table below}. Under the title of each standard
there is a brief description of the way in which the Pathology Directorate seeks to comply with the
particular standard and references are given to appropriate procedures.
The sections of the standards relate to each other in the following manner. Section A describes the
organisation of a laboratory and its quality management system, which uses resources (Sections B, C
and D) to undertake pre examination, examination and post examination processes (Sections E, F
and G). The quality management system and the examination processes are continually evaluated
and quality assured (Section H). The results feed back to maintain / improve the quality management
process where required and to ensure that the needs and requirements of users are met.
Section of CPA Standards

Paragraph in the
Quality Manual
4

A Organization and quality management system

B Personnel

C Premises and environment

D Equipment, materials and reagents

E Pre-examination process

F Examination process

10

G Post-examination process

11

H Quality assurance and evaluation

Status: Operational
Issue Date: 07/07/2008
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Gwent Healthcare NHS Trust

Owner: Quality Manager
Directorate of Pathology

Q-Pulse No. QP0002

Edition No. 10
Printed copy is controlled document only on date last printed 10/07/2008

Statement of Quality Policy

The scope of service provided by the Pathology Directorate is an in house routine diagnostic service
for Haematology/Blood Transfusion, Biochemistry, Microbiology (supplemented by an emergency 24
hour on-call facility) and Cellular Pathology (Histology/Cytology). The department also provides
mortuary and post mortem facilities serving the Trusts hospitals as well as for the coroner acting as a
public mortuary.
The Pathology Directorate is committed to providing a service of the highest quality and shall be
aware and take into consideration the needs and requirements of its users.
In order to ensure that the needs and requirements of users are met, the Pathology Directorate will:

Operate a quality management system to integrate the organisation, procedures, processes and
resources. (A4)
Set quality objectives and plans in order to implement this quality policy. (A5)
[PATHOLOGY QUALITY POLICY 6th Ed.doc]
Ensure that all personnel are familiar with this quality policy to ensure user satisfaction. (A3.1c)
Ensure that personnel are familiar with the contents of the quality manual and all procedures
relevant to their work. (A3.1d)
Commit to the health, safety and welfare of all its staff. (C5)
Ensure that visitors to the department will be treated with respect and due consideration will be
given to their safety while on site. (C3 & C5)
Uphold professional values and be committed to good professional practice and conduct. (A3.1e)
To keep advised of and to implement, where applicable, all current legislation relating to the
Health and Safety of staff and visitors.
Commit to comply with all the relevant environmental legislation.
Conform to confidentiality in accordance with The Data Protection Act and Caldicott Guidelines.
The Pathology laboratory will comply with standards set by the CPA (UK) Ltd. accreditation system,
The Blood Safety and Quality Regulations, The Human Tissue Authority and is committed to:

Staff recruitment, training, development and retention at all levels to provide a full and effective
service to its users. (B2, B7, B9)
The proper procurement and maintenance of the equipment and other resources needed for the
provision of the service. (D1)
The collection, transport and handling of all specimens in such a way as to ensure the correct
performance of laboratory examinations. (E3)
The use of examination procedures that will ensure the highest achievable quality of all tests
performed. (F2)
Reporting results of examinations in ways which are timely, confidential, accurate and clinically
useful. (G1)
The assessment of user satisfaction (H2), in addition to internal audit (H3 & H4), external quality
assessment (H5), benchmarking and identification and control of non-conformities (H7) in order to
produce continual quality improvement. (H6).

Signed on behalf of the

Directorate of Pathology

Dr Neil Carbarns
Pathology Chief of Staff
Date 02nd June 2008

Status: Operational
Issue Date: 07/07/2008
Review Date: 07/07/2010
Page 10 of 34

Gwent Healthcare NHS Trust

Owner: Quality Manager
Directorate of Pathology

Q-Pulse No. QP0002

Edition No. 10
Printed copy is controlled document only on date last printed 10/07/2008

ORGANISATION, RESPONSIBILITIES AND AUTHORITIES

Relationship to the Host Organisation (A1.4a)
There are four Divisions within Gwent Healthcare NHS Trust; Acute Services division, Diagnostics,
Therapies, Pharmacy/Facilities and Support Services division, Mental Health, Learning Disabilities
and Community division and Women, Child and Family Services division. Each is led by a General
Manager and one or more Chiefs of Staff.
The Pathology Directorate forms part of the Division of Diagnostics, Therapies, Pharmacy/Facilities
and Support Services.
The Pathology Directorate is also associated with the following external organisations:
Clinical Pathology Accreditation (UK) Ltd
Medicines and Healthcare Products Regulatory Agency
Human Tissue Authority
Welsh Blood Service
United Kingdom National External Quality Assessment service
Wales External Quality Assessment scheme
HM Coroner
Cervical Screening Wales
Breast Test Wales
National Public Health Service Wales
South East Wales Cancer Network
The Directorate / Modernisation Manager (Mike Redman) is responsible to The Chief of Staff (Dr Neil
Carbarns) for clinical matters and to the General Manager (Jamie Marchant) for non clinical matters.
The General Manager is accountable to the Chief Executive of the Trust (Martin Turner - Andrew
Cottom acting CEO). The Chief of Staff is accountable to the Medical Director (Dr Grant Robinson)
and is responsible for directing the overall clinical, quality and financial performance of the
Directorate. As a member of the Trusts Executive Management Group, the Chief of staff contributes
to and shares responsibility for corporate strategy and the management and performance of the Trust.
Organisation and Responsibilities within the Pathology Directorate
The roles and responsibilities of laboratory management are:
Chief of Staff
The Chief of Staff, together with the Divisional General Manager, will be responsible and accountable
for the performance of the Pathology Directorate. The Chief of Staff plays a critical role in managing
the medical staff of the directorate, ensuring quality and other governance targets are met, and future
plans for service provision and development accord with evidence as to best and most cost-effective
practice. The Chief of Staff forms part of a group of senior medical staff providing co-ordination of
medical services and communication with medical colleagues in primary care and elsewhere. They
share responsibility for the development and agreement of future plans and strategies for specific
clinical services and play an instrumental role in identifying and securing resources necessary to
deliver agreed service levels and future plans.
Key roles and responsibilities:
strategic, directorate and individual influencing, supporting, motivating and empowering
others to lead

Implementing the standards for better health at directorate level:

ensuring processes are in place for monitoring and improving quality
contribution to delivering the Healthcare Standards
setting priorities, planning and developing innovation

Status: Operational
Issue Date: 07/07/2008
Review Date: 07/07/2010
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Gwent Healthcare NHS Trust

Owner: Quality Manager
Directorate of Pathology

Q-Pulse No. QP0002

Edition No. 10
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addressing key issues and challenges

Performance management and managing budgets:

contribution to clinical and organisational quality and performance measures
managing budgets, issues and practicalities

Managing risk and improving patient safety:

ensuring patient safety is a top priority in your directorate
ensuring directorate risk assessment is undertaken, and ensuring clinicians report incidents
linking patient safety measures to improved patient outcomes

Dealing with colleagues and supporting doctors:

managing performance and supporting doctors in difficulty

Effective consultant and team job planning:

implementing job planning in the directorate
coordinating job planning across the team

Appraising the directorate:

undertaking appraisal of clinical directors in the directorate
tackling performance issues that can arise within the appraisal

Clinical Leads
Operational Responsibilities for managing the medical workforce including the development and
implementation of workforce plans, recruitment and retention plans, training and development plans,
and (including both medical and non-medical staff) initiatives to improve workforce effectiveness, in
order to continually improve the quality of agreed service levels. To implement delegated staff
appraisal. To develop and agree future plans and strategies for specific clinical services. To agree
levels and models of service delivery with the involvement of clinicians to form the basis of
commissioning arrangements with clinical services to ensure the delivery of timely, clinically
appropriate and effective services. To monitor performance against targets and objectives with the
support of directorate management. To implement the pillars of clinical governance within the
pathology sub-section and provide analysis of performance thereof through the directorate structure,
particularly managing risk and improving patient safety.
Directorate/Modernisation Manager, (DMM) Pathology
The DMM has Trust wide responsibility for the operational management and modernisation of
Pathology services within the Trust. The DMM works with the Chief of Clinical Staff, Divisional
General Manager and Discipline Team leads to develop and implement the planning and performance
management agenda for Pathology across the Trust. The DMM provides operational management
leadership to the Directorate including working with the Discipline Management Teams to ensure
effective budget management & monitoring, workforce management & planning and ensuring
effective use of resources and equipment. The DMM plays a lead role in modernisation of the service
in line with local and National strategies. This involves all aspects of the planning and preparation for
the delivery of services in a Clinical Futures/Designed for Life framework.
Quality Manager
The Quality Manager ensures, on behalf of laboratory management, that the Directorate of
Pathologys quality management system functions correctly and has a defined role for:
Ensuring a quality management system is implemented and maintained
Reporting to laboratory management on the functioning and effectiveness of the quality
management system
Status: Operational
Issue Date: 07/07/2008
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Gwent Healthcare NHS Trust

Owner: Quality Manager
Directorate of Pathology

Q-Pulse No. QP0002

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Coordinating the awareness of the needs and requirements of users

Acting as clinical governance lead on behalf of the Chief of Staff
Acting as Training and Development lead for the Directorate
Acting as Health and Safety Lead for the Directorate
Acting as complaints coordinator for the Directorate
Management of the Pathology facility at Nevill Hall Hospital
The quality and budgetary issues relevant to the Pathology facility at Nevill Hall Hospital

Lead Biomedical Scientists

There is a Lead Biomedical Scientist for each Pathology Discipline having responsibility for technical,
quality and budgetary issues. With the support of the Clinical Head of Department, they provide
strategic leadership and day to day operational management of the non-clinical workforce within their
discipline across the Trust. The position has a lead role in managerial, educational, professional and
technical issues within the department and/or discipline, in conjunction with the Clinical Head of
Department. This includes:

responsibility for the Technical development of the service in close collaboration with the Head of
Department.
Development and promotion of Trust-wide working and standardisation of operational policies,
procedures and practices within the discipline and within the appropriate Pathology Directorate
Management team.
Working together with the designated Clinical Lead to provide team leadership for the Trust-wide
discipline. This involves contributing to the Pathology Management Team to develop and
implement the planning and performance management agenda for Pathology across the Trust.
Taking a lead role in the implementation of new techniques and facilitate research and
development in collaboration with the Clinical Head of Department.

Pathology Operations / Information Technology Manager

To act as the lead BMS for Trust wide Information Technology and information management
To be responsible for management of the Pathology facilities and support services at RGH
To be responsible for the IT development of the service and direct the assessment of new
software and hardware for the provision of effective IT solutions for the Trust wide Pathology
service
To produce timely and accurate management and performance information as required by
General Manager, Directorate Manager, members of the Pathology Management Team and
users of the service
To develop systems to enhance the financial management of the directorate such as clinical
budgeting and the establishment of Service Level Agreements with users of the service
To manage the Trust wide Pathology and Radiology GP electronic reporting system
To manage all Trust wide IT systems in use in Pathology

Each site has a Facility Manager:

Mario Minoli (CDMH)
Stuart Thomas (RGH)
Tim von Pokorny (NHH)
Each Facility Manager is responsible to the Chief of Staff for Clinical matters and to the Directorate
Modernisation Manager for non-clinical modernisation matters and Quality Manager for Governance
matters.
Each of the disciplines have a lead Biomedical Scientist, with a Consultant in over all charge. (B1)
For non clinical matters, the Lead Biomedical Scientists and Quality/Governance manager are
responsible to the Modernisation Manager (Mike Redman) who is responsible to The Divisional
General Manager (Jamie Marchant) who is responsible to the Trusts Chief Executive (Martin Turner
Andrew Cottom acting CEO). For clinical matters, the Quality/Governance manager is responsible to
Status: Operational
Issue Date: 07/07/2008
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Gwent Healthcare NHS Trust

Owner: Quality Manager
Directorate of Pathology

Q-Pulse No. QP0002

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the Chief of Staff, whilst the Lead Biomedical Scientists are responsible to their Discipline Consultant
Lead who is responsible to the Chief of Staff who is responsible to the Medical Director (Dr Grant
Robinson). (A1.4b)
Pathology Directorate (A1.5)
The Pathology Directorate meetings are scheduled to meet five times per year.
Minutes:
[H:\Shares\Sage_Varley\ADMIN\MEETINGS\Directorate Meetings]
Function
The Directorate meeting is the focus of management within the Directorate. It oversees the
governance of the Directorate, and receives reports on Quality, I.T., Site and discipline reports, Health
& Safety, and training.
Membership
Chairman Dr Neil Carbarns (Chief of Staff)
Secretary Tanya Bendon
Divisional General Manager Jamie Marchant
Modernisation Manager Mike Redman
Quality / Governance Manager Tim von Pokorny
Audit Lead Helen Jackson
Discipline Clinical and Scientific Leads
Directorate Consultants and Clinical Scientists
Site Facility Managers
Directorate meetings are open to other members of the Directorate and General Practitioners within
catchment.
Clinical Audit Group
This group is scheduled to meet five times per year to co-ordinate with the Directorate meetings
Function
The group seeks to improve patient care and outcomes through systematic review of pathology
related clinical activity against predetermined criteria and the implementation of change. Where
indicated, changes are implemented at a discipline or service level and further monitoring is used to
confirm improvement in healthcare delivery. The group aims for Pathology to perform at least one
discipline specific audit and one pan-discipline audit per year and ensures that the audit activity is fed
into the Trusts clinical audit programme.
Membership

Chairman Helen Jackson

Secretary Katherine Price
Dr Neil Carbarns (Chief of Staff)
Divisional General Manager Jamie Marchant
Modernisation Manager Mike Redman
Quality / Governance Manager Tim von Pokorny
Discipline Clinical and Scientific Leads
Directorate Consultants and Clinical Scientists
Site Facility Managers
The audit meetings are open to other members of Trust clinical and scientific staff as appropriate.
Pathology Finance and Performance Group
The PFPG are scheduled to meet monthly.
Minutes: [H:\Shares\Sage_Varley\ADMIN\MEETINGS\P F P G]
Function
To monitor the financial and workload activity of the Directorate, and prepare the Directorate
submission to the Divisional Quarterly Performance Review for the Trust. To plan modernisation of
Status: Operational
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the Directorate and the organisation of workshops / working groups to develop solutions in identified
areas.
Membership
Chairman -Jamie Marchant - Divisional General Manager
Secretary Tanya Bendon
Mike Redman Directorate Modernisation Manager
Quality / Governance Manager -Tim von Pokorny
Dr Neil Carbarns -Chief of Staff
Site Facility Managers
Finance Manager
Discipline Clinical / Scientific Leads.
Pathology IT Development Group
This group meets on an ad hoc basis as select smaller groups discussing specific IT issues.
Communication with the whole group by group email
(pathology_it_development.group@gwent.wales.nhs.uk)
The groups chair (Stuart Thomas) reports to the PFPG and Pathology Directorate.
Function
Ensure a consistent approach to all IT related matters.
Ensure standardisation across all laboratories (coding etc.)
To make sure that all relevant personnel are kept informed of any changes made to any IT
system across the Trust.
To monitor access levels assigned to IT systems.
Ensure that changes made to any IT system that affect other systems are coordinated and
controlled.
Discipline Management Teams (A1.5)
The DMTs for each discipline are scheduled to meet quarterly.
Function
Integration of a standardised service across the Trust to include test requesting, specimen
containers, report formats, level of service, reference ranges protocols.
Development of working relationships outside the Trust, particularly within SE Wales.
Performance, including budget control, workload/ workforce monitoring, quality control and
assessment of new technologies.
Governance, including review of quality standards (Microbiology and Histopathology have
separate quality committee meetings), liaison with user clinical teams, trust wide audit, risk
management and maintenance of clear lines of responsibility within the discipline.
Membership
Each Disciplines DMT consists of the Clinical and Scientific Leads, Consultants and other key
members of staff for each of the following departments:
Biochemistry
Haematology
Blood Sciences
Histopathology
Cytology
Microbiology
Departmental Staff Meetings
Departmental meetings are scheduled to meet at least four times per year open to all staff within the
relevant department.
Function
Discuss IQA and EQA performance
Discuss departmental procedural / developmental issues
Discuss departmental health & safety issues
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Discuss departmental equipment requirements

Discuss departmental staffing issues

Site Level Health & Safety Advisory Group

The group is scheduled to meet at least six times per year.
Function
Identifies site specific H&S issues
Site H&S decision making
Pass on new H&S legislation to departments at site level
Receives H&S reports from departmental lab meetings
Membership
Chairman H&S Site Lead
Secretary Site specific
Departmental H&S Leads
The pan-Pathology Health and Safety Advisory Group (C5)
This group is scheduled to meet on a quarterly basis
Minutes: [H:\Shares\Sage_Varley\ADMIN\MEETINGS\H&S Pan Path Group\Meetings]
Function
Receives site discipline H&S reports with a view to planning and coordinating the provision of
a safe environment in the laboratory for staff, patents and visitors.
Pan-Pathology H&S decision making
Pass on H&S issues to the Pathology Directorate.
Pass on Pathology H&S action to Discipline Management Teams
Membership
Chairman Tim von Pokorny(Pan-pathology H&S lead)
Secretary Tanya Bendon
Site H&S Leads
Trust Infection Control Lead/Consultant Microbiologist Dr Neil Carbarns
Microbiology Health and Safety committee
Microbiology also has its own Trust wide Health and Safety committee meeting.
Meetings are scheduled to be held bi-monthly.
Function
Monitor compliance with relevant Health & Safety legislation
Discuss/address laboratory based H&S issues
Plan/act on H&S audits
Review accidents / clinical incidents
Review risk assessments
Membership
A consultant Microbiologist should always attend each meeting.
Chairman Dave Williams (NHH)
Lead BMS Vacant (RGH)
BMS 3 Lisa Chichester (RGH)
BMS 1 Richard Hopkins (RGH)
Health & Safety Rep. Sheila Giles (NHH)

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The Training & Development Committee (B9)

This group is scheduled to meet quarterly
Minutes:
[H:\Shares\Sage_Varley\ADMIN\MEETINGS\Training & Development Commitee\Meetings]
Function
Ensures that appropriate national education and training legislation and regulations are
maintained. (B9.1a)
Discuss and provide direction to the process of staff education and training so that the
demands of the service can be met. (B9.1b, B9.2, 3, 4, 5)
Monitors each disciplines training and education programme including CPD activity.
Ensures that appropriate resources for staff training and education are available. (B9.3)
Membership
T&D Lead/Chair Tim von Pokorny
Secretary Tanya Bendon
Directorate Departmental Training Officers
Quality Officers Meetings
This group is scheduled to meet quarterly
Minutes: [H:\Shares\Sage_Varley\ADMIN\MEETINGS\Quality officers meetings etc\Meetings]
Function
Instigates quality improvement
Receives reports on level of compliance to CPA Standards and other quality standards
Identifies audit requirements and takes reports from audit activity
Plans user surveys
Feeds Directorate management with high level quality/governance issues
Monitors Quality Assurance performance
Monitors departmental error logging
Monitors and drives Directorate and Discipline Quality Improvement Plans.
Membership
Chairman Tim von Pokorny (Quality Manager)
Secretary Tanya Bendon
Departmental Quality Officers
SECTION A
Organisation and Quality Management System
Organisation and management (A1)
The organisation and management of the Pathology Directorate is detailed in section 3 of this quality
manual
Needs and requirements of users (A2)
The needs of the users are kept under constant review. This is achieved by:
Providing workload measurement to Local Health Boards.
Collaboration on Clinical Governance issues with local G.Ps.
GP News Letter.
[H:\Shares\Sage_Varley\ADMIN\MEETINGS\GP2\GP news letters Mario]
Involving G.Ps as pilot sites for service developments such as testing protocols,
interpretive reporting and electronic links for access to Pathology reports.
Provision of a Pathology handbook containing user guidelines.
[PATH HANDBOOK Dec 2007 QPulse Ver.DOC]
Biochemistry helpdesk based at RGH.
User satisfaction surveys.

Status: Operational
Issue Date: 07/07/2008
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Maintenance and analysis of complaints / suggestions logs leading to change /

improvements with quality of service delivered where necessary.

The needs of the users are translated into requirements, which form the focus of objective setting and
planning (A5) within in the quality management system. Assessment of user satisfaction and
complaints (H1) is conducted on a regular basis and consideration of the findings form part of the
annual management review (A11).
Quality policy (A3)
The Quality policy [QP0001] of the Pathology Directorate is detailed on page 10 of this quality manual.
Quality management system (A4)
The components and relationship within the Quality management system are described in section 4 of
this Quality Manual and under CPA standards (A5 to A11)
Quality objectives and plans (A5)
The quality objectives for the Directorate are discussed, agreed and documented at the annual
service review meeting between the Trust executive Team and the senior management team in
Pathology.
[Pathology service review Oct 25 2007.doc].
[SR Pathology Plan from review meeting Oct 2007.doc]
The Laboratory Management Team defines the quality objectives (A5.1) of the laboratory in
consultation with the individual departments and is responsible for ensuring that plans are made to
meet these objectives. Discipline management reviews {see A11below}, which are undertaken on an
annual basis, determine whether the objectives have been successfully completed and provides an
opportunity for revising such objectives and plans and the functioning of the quality management
system. (A5.2)
The quality objectives of each discipline are documented in their Quality Improvement Plan in
accordance with the Directorates continual quality improvement policy.
[PATHOLOGY CONTINUAL QUALITY IMPROVEMENT POLICY 2nd ed.DOC]
Quality manual (A6)
This standard is fulfilled by the production of this Quality Manual [QP0002].
Quality manager (A7)
The Quality Manager for the Pathology Directorate is Tim von Pokorny (A7.1) who works with the
Laboratory Management Committee/Team to ensure the proper running of the Quality Management
System. (A7.2, A7.3)

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Document control (A8)

The Directorate is using Q-pulse software as its procedure for document control (See Document
Control Policy) [QP0004 Document control policy (5).doc](A8.1).
An outline of the structure of the documentation used in the quality management system is as follows:
+

AUDIT

- by discipline

- Quality Manual

CLINICAL PROCEDURES

- Quality Policy

- by discipline

- Quality Procedures

FORMS

- by discipline
+

QUALITY DOCUMENTS

STANDARD OPERATIONAL PROCEDURES

- by discipline

MANAGEMENT PROCEDURES
- by discipline

MEETING MINUTES
- by discipline

Control of process and quality records (A9)

Each discipline have established procedures for controlling process records and quality records
(A9.1) in accordance with the Directorates policy Retention and Storage of Pathological Samples
and Archives in Pathology Laboratories, Gwent Healthcare NHS Trust
[QP0009 Storage and archiving of Samples and records2007.doc]
these procedures include:
a) Identification and indexing.
b) Security.
c) Retention.
d) Storage and retrieval.
e) Disposal.
f)

Compliance with WHC (2005) 066 Blood safety and quality regulations.

[WHC_2005_066.pdf]
Control of clinical material (A10)
Laboratory Management have established procedures for controlling clinical material (A10.1)
[QP0009 Storage and archiving of Samples and records2007.doc]
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Management review (A11)

The Laboratory management participates in an annual service review with the Trusts Executive team,
which provides a mechanism to review the following items:

User satisfaction surveys and complaints (H2)

Clinical incidents and near misses

Laboratory and clinical audit (H3, H4)

National benchmarking data (A11.1f)

Internal and external quality assurance (H5)

The Laboratory management team within each discipline conducts an annual review, the content of
which is detailed in the Directorates annual management review policy:
[ANNUAL MANAGEMENT REVIEW POLICY.DOC]
Records are kept and key objectives for subsequent years defined and plans formulated for their
implementation.
SECTION B
Personnel
Professional direction (B1)
a)

Dr Neil Carbarns {Chief of Staff} professionally leads the Directorate. A Consultant

professionally directs each discipline (B1.1), they are:
Histopathology Majid Rashid
Cytology Nick Dallimore
Biochemistry Mike Penney
Haematology Sarah Lewis (Haematology laboratory lead) / Nilma Parry-Jones (Clinical
Haematology Lead)
Microbiology Elizabeth Kubiak
- Neil Carbarns (Infection Control Lead)

Staffing (B2)
Staff records are available from the appropriate Technical/Scientific head within each department.
The Departmental Technical Heads hold appropriate professional qualifications and work closely with
Consultant Heads of Department.
The Pathology Directorate Management ensures that there are appropriate numbers of staff, with the
required education and training to meet the demands of the service and appropriate national
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legislation/regulations (B2.1). Registration of staff is in accordance with current national legislation

and regulations (B2.2).
Staffing includes one or more individuals with the following roles (B2.3):
a) Quality Manager (Tim von Pokorny) (A7)
b) Discipline and site specific quality officers

Histopathology (Rachel Darch- RGH/NHH)

Biochemistry (Philip Waters-RGH, Annette Walker-NHH, Maria Davies-CDMH )

Haematology (Lesley Newton-RGH, Jill Green-NHH, Graham Oakes/ -CDMH)

Microbiology (Lisa Chichester-RGH, Dave Sanders-NHH),

Cytology (Sonia Sloan)

c) Discipline and site specific training officers (B9)

d)

Histopathology (Becky Osborne and Julie Tomlin)

Biochemistry (Pat Newbury-RGH, Annette Williams-Walker/Graham Talbot-PaineNHH, Graham Oakes/Maria Davies-CDMH )

Haematology (John Edmunds-RGH, Nicola Prosser-NHH, Graham Oakes/Linda

Turner-CDMH)

Microbiology (Stephen Curnow/Sally Gray-RGH, Frances Edwards-NHH )

Cytology (Helen Buchanan-RGH)

Discipline and specific Health & Safety Officers (C5)

Histopathology (Annette Gaona-RGH & NHH)

Biochemistry (Brian Massingham-RGH,

Oakes/Maria Davies -CDMH)

Haematology (Robert Martin-RGH, Alison Hunt-NHH, Graham Oakes -CDMH )

Microbiology (Dave Williams NHH, Lisa Chichester RGH)

Cytology (Christine Hodges)

Graham

Talbot-Payne-NHH,

Graham

Personnel management (B3)

The Directorate has a Personnel Officer (Jeff Connolly), assigned by the Trust, to assist with
Personnel issues. The Directorate complies with all Human Resources Policies laid down by the
Trust. The Trust reviews these policies regularly and the Directorate can contribute and influence
these policies by representation on Trust working groups. The Pathology Directorate Management
through the Trusts Personnel department have procedures for:

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a)

Q-Pulse No. QP0002

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Recruitment and Selection (B3.1a)

[http://howis.wales.nhs.uk/sites3/Documents/79/0006295.pdf]
b)

Staff orientation and Induction (B4)

[Gwent Healthcare NHS Trust | Policy Documents]

[http://howis.wales.nhs.uk/sites3/Documents/79/0005012.pdf]
The general staff induction policy is accessed via the Trust Intranet. Local guidelines for specific
induction issues within the Directorate not covered in the induction manual can be found in individual
departments. All new staff are invited to attend a Trust induction day which is additional to local
induction within the Pathology Directorate. Induction records are filed in individual personal records,
which are held in the Head Biomedical Scientists office.
c)

Job description and contracts (B5)

All staff job descriptions should be produced using the Directorates agreed format in
accordance with their policy:
[Policy for Job Descriptions and Contracts.doc]
These are reviewed annually at appraisal and records are kept in individual personal records.
All staff are issued with a contract of employment on entering service and copies are kept
centrally in the Trust Personnel department as well as in the personal records held by the
Head Biomedical Scientist of the department.

d)

Personal files and staff records. (B6)

Each member of staff has a local personal file and maintains staff records in accordance with
Directorate policy:
[Policy for maintenance of accurate staff records.doc]

e)

Individual Performance Review and personal development plans for staff (B7)
There is a Trust policy on annual appraisal and personal development planning, which is
followed by the Directorate.
[http://howis.wales.nhs.uk/sites3/Documents/79/0004788.pdf]
The Directorate operates a cascade system of appraisal, individuals being appraised by the
next manager or scientist in line above the appraisee. The standard Trust documentation is
used at these meetings or, where possible, reviewers are adopting the use of the e-KSF online tool kit for staff annual joint review. It is the future aim of the Directorate to perform all
staff appraisals through use of the e-KSF online tool kit.

f)

Staff meetings and communication (B8)

Communications between the Trust and the Directorate are maintained by the following
mechanisms:

Trust information bulletin.

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Chief Executives report. [ Gwent Healthcare NHS Trust | Document Search ]

The Trust Intranet. [http://intranet.gwent.wales.nhs.uk/]

E-mail.

The Clinical Governance Group. [Gwent Healthcare NHS Trust | Clinical Governance
Home Page]

Trust Health and Safety Committee

Trust Information Executive Committee [Gwent Healthcare NHS Trust | Trust Information
Executive (TIE)]

Trust Financial Management Group

Local communications between the Directorate and all departments are made through
regular, Directorate and staff meetings.
g)

Staff training and education (B9)

Staff have access to education and training commensurate with their needs and position in
the organisation. Training plans are identified at annual appraisal and as part of the personal
development plan. All BMS training staff are supported by a designated mentor within the
department and follow the guidelines set out in the Institute of Biomedical Sciences training
portfolio. The Directorate has dedicated resources to provide education and continual
professional development for training and trained staff. There are comprehensive library
facilities within the Trust, and staff have access to the Internet for scientific information.
Training records are kept in personal files within the departments. CPD activities of the BMS
staff and Consultant staff are maintained individually. Each department within the Directorate
has an Education and Training Officer.

h)

Grievance procedures and staff disciplinary action. (B3.1h)

The Directorate follows the process as is laid down in the Trust policy.
[http://howis.wales.nhs.uk/sites3/Documents/79/0006054.pdf]

Staff orientation and induction (B4)

Records of staff orientation and induction are kept in individual staff personal records held in the Head
Biomedical/Clinical Scientists office. The induction process includes information in accordance with
the Directorates policy on staff orientation and induction:
[Staff orientation & induction policy.doc]
Job descriptions and contracts (B5)
Each member of staff has a job description prepared using the Directorates agreed format, which
includes information in accordance with the Directorates policy on job descriptions and contracts:
[Policy for Job Descriptions and Contracts.doc]

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Staff records (B6)

All staff records are confidential and abide by Trust guidelines and national legislation. Staff records
include information in accordance with the Directorates policy on staff records:
[Policy for maintenance of accurate staff records.doc]
Staff annual joint review (B7)
Laboratory management ensures that all staff in the Directorate participate in annual Individual
Performance Review (B7.1) in accordance with the Directorates policy on annual joint review:
[STAFF ANNUAL JOINT REVIEW.DOC]
All staff performing Individual Performance Review have received appropriate training and all staff
participating have full explanation of the process (B7.2).
Staff meetings and communication (B8)
There are regular discipline and site specific meetings open to all staff providing the opportunity for
exchange of information (B8.1). Minutes of these meetings are kept and made available to staff
(B8.2).
Staff training and education (B9)
Each discipline ensures that there is a training and education programme for all members of staff
(B9.1) which:
a) Is in accordance with guidelines from the relevant professional and registration bodies.
b) Provides the opportunity for further education and training in relation to the needs of the service
and their professional development.
All trainee staff have a designated supervisor (B9.2) and access to resources for training and
education including library and I.T. services, a quiet room for private study, attendance at meetings
and conferences and financial support (B9.3). Records are kept of all training and education activities
(B6).
SECTION C
Premises and environment (C1)
The laboratory provides accommodation and conditions for staff conducive to the proper performance
of their respective duties in accordance with the Pathology Premises and Environment Policy
[Pathology Premises and Environment policy.doc]
Health and safety (C5)
It is the Directorates policy to provide and maintain a healthy and safe working environment for all our
employees and visitors to the laboratory. The term visitors includes staff of the Trust undertaking
their normal duties, those delivering goods, contractors, company representatives, other visiting
professional groups, patients bringing samples, having samples taken or visiting Consultants. The
Directorate
complies
with
the
Trust
Health
and
Safety
policy:
[http://howis.wales.nhs.uk/sites3/Documents/79/0006050.pdf]
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and also has its own local Health and Safety policy:
[MP0009 Pathology H&S policy 4th Ed.doc].
Staff are made aware of their responsibilities for Health and Safety (C5.2) in:

Contract of employment.

Induction training.

Job descriptions.

The Directorate has Health and Safety procedures in each department (C5.3) that cover:

Action in the event of fire.

Risk assessment and reporting.

Disinfection.

Decontamination of equipment.

COSHH and chemical handling.

Storage and disposal of waste.

Specimen collection handling.

Incident reporting.

Laboratory containment facilities conform to the requirements of the ACDP guidelines on the
containment of hazardous pathogens and agents and regulations on radioactivity (C5.4). The
department will:

Provide and maintain healthy and safe working conditions in accordance with the statutory
requirements.

Provide safety training as part of job induction together with special training where
appropriate. Records will be kept of training.

Provide safety equipment, protective devices and protective clothing as necessary and will
ensure that they are used in an appropriate manner.

Investigate all accidents and possible health hazards, taking appropriate action where
necessary.

Set an example of safe behaviour in all activities.

Stimulate an interest among all our staff in all aspects of safe working practices and
procedures.

Ensure risk assessments are undertaken and necessary actions are taken to establish safe
and proper working practice.

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When instrumentation or methodology is changed ensure that the risk assessments are
updated.

Ensure visitors are escorted at all times.

Ensure in the event of evacuation, visitors are under the care of a member of staff.

In the event of illness visitors are seen by a member of the laboratorys medical staff and if
need be, referred to the A & E department via the ambulance service.

If any accidents or incidents occur, they are reported and fully investigated.

Each department is subject to local Health and Safety inspection managed by the laboratory Health
and Safety group. Inspection includes standards of cleanliness and house keeping.
Occupational health
The Trust provides on site occupational health facilities for staff [Gwent Healthcare NHS Trust |
Occupational Health - Home Page]. It is the policy of the department for staff to have free access to
these facilities.
SECTION D
Equipment, Information Systems and reagents
Management of equipment (D1)
The Directorate has an annual plan that identifies the new and replacement equipment requirements,
ensuring quality and capacity is addressed (D1.2).
[Mastercapital Plan.xls]
The Directorate complies with national guidelines and the Trust policy on purchase, installation,
training and safe disposal of all equipment
[http://howis.wales.nhs.uk/sites3/Documents/79/GHT%200065%20The%20Management%20of%20M
edical%20Equipment%20and%20Devices%20Policy%20%2D%20Issue%201%20Rev%201.pdf]
The Directorate complies with the Trusts policy for Standing Orders, Tendering and Contract
Procedures, Standing Financial Instructions which includes compliance with national legislation for:

Fair competitive tendering.

Value for money.

Suitability and ease of use.

[http://howis.wales.nhs.uk/sites3/Documents/79/0007254.pdf]

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Laboratory staff shall only be permitted to use a particular item of equipment unsupervised when the
appropriate senior member of staff has established that they are confident to do so. This shall then
be documented accordingly in the individuals training record. An inventory of equipment (D1.3) is
held by the technical head of department on each site and includes:

The asset number of equipment (over 5k in value).

Location of the equipment

Serial number.

Date of purchase and disposal.

Record of maintenance.

Electrical safety checks are carried out on a regular basis by the Trust maintenance staff and all
equipment is marked, identifying the last inspection date and when the next inspection is due. Where
appropriate, equipment shall be regularly maintained by hospital engineers or through a maintenance
contract with outside engineers. Where it is necessary for new equipment to be commissioned and/or
calibrated prior to use, this shall be carried out either in-house or through the relevant body as
appropriate. Manufacturers operating and maintenance manuals are held in the relevant section of
the laboratory. Where necessary the manufacturers manuals are supplemented by documented inhouse methods with information pertaining to the operation, maintenance and calibration of such
equipment. These can be found within procedure manuals located within the individual departments.
The head biomedical scientist of each department holds maintenance records for equipment on
service contracts. The head biomedical scientist of each department holds records and certificates
pertaining to the calibration of equipment.
Management of data and information (D2)
Data and information is controlled and managed within the Directorate under the Guidance of the
Trust finance and information service. The Directorate operates in accordance with the Trusts control
measures for:

Data security.

[http://howis.wales.nhs.uk/sites3/Documents/79/GHT%200024%20Information%20Security%
20Policy%20%2D%20Issue%203%20%28Extended%29.pdf]

Electronic passage for data to remote user.

[http://howis.wales.nhs.uk/sites3/Documents/79/0006020.pdf]

Storage, archive and retrieval of records.

[http://howis.wales.nhs.uk/sites3/Documents/79/GHT%200024%20Information%20Security%
20Policy%20%2D%20Issue%203%20%28Extended%29.pdf]
[Storage and archiving of Samples and records2007.doc]

Safe disposal.
[http://howis.wales.nhs.uk/sites3/Documents/79/0007402.pdf]

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Access to electronic data is controlled and restricted through individual password security and
assigned privilege rights. All electronic data is backed up by The Trusts IT department and stored in a
remote location to all the Pathology sites (D2.2).
The Directorate complies with current national legislation and regulations in relation to data protection
including The Freedom of Information Act and Caldecott guidelines. (D2.3)

Management of reagents, calibration and quality control material (D3)

The Directorate ensures the funding and availability of adequate and suitable materials required
providing a quality service to users (D3.1, 2, 3). The Directorate operates in accordance with the
Trusts financial procedures for:

The selection, purchasing and ordering of materials.

Assessment of suitability of materials.

Receipt of goods.

Safe storage and issue of records.

Safe disposal.

[Gwent Healthcare NHS Trust | Financial Control Policies and Procedures]

Materials in use are identified with date of receipt, date of first use, lot numbers and expiry dates
(D3.3).
Reagents and chemicals in use are COSHH assessed in accordance with Trust guidance.
[http://howis.wales.nhs.uk/sites3/Documents/79/0009028.pdf]
[COSHH risk assessment request form.doc]

SECTION E
PRE-EXAMINATION PROCESS
Information for users and patients (E1)
Information for users of the service is available in the pathology users handbook, which is updated
regularly (E1.1). Information to users includes all information reasonably required to access and use
the laboratories effectively.
[PATH HANDBOOK Dec 2007 QPulse Ver.DOC]
Available patient information leaflets include:

An explanation of any preparation required before attending (E1.4b).

An explanation of the procedure (E1.4a).

The expected duration time of the investigation.

Status: Operational
Issue Date: 07/07/2008
Review Date: 07/07/2010
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Gwent Healthcare NHS Trust

Owner: Quality Manager
Directorate of Pathology

Q-Pulse No. QP0002

Edition No. 10
Printed copy is controlled document only on date last printed 10/07/2008

Request form (E2)

Request forms (E2) are designed to provide all relevant information required to provide a safe and
meaningful report including clinical advice and to satisfy internal audit requirements. Haematology
and Clinical Biochemistry have a combined request form, whereas Microbiology and Histopathology /
non-gynaecological cytology and Blood Bank have separate request forms for use. A universal Welsh
request form, issued by Cervical Screening Wales, is used for all cervical cytology tests from GPs,
community hospitals and hospital sources.
Specimen collection and handling (E3)
There are departmental procedures laid down for specimen collection and handling.
[transport labelling reception of specimens policy ed 3.doc]
The guidelines for which are given to service users in the pathology handbook.
[PATH HANDBOOK Dec 2007 QPulse Ver.DOC]
Specimen transportation (E4)
Internal Hospital Transportation
Where possible, samples are sent to the laboratory for haematology and chemistry by the airtube
system. Additional to this system, arrangements are made for portering services to collect the
samples and deliver them to the laboratory. Large volume samples such as 24-hour urine collections
will be transported manually.
Histology
For reasons of health and safety, specimens in formalin fixative must NOT BE SENT via the hospitals
airtube system. Specimens in the pre-filled 60-ml pots should be transported in plastic transport bags
with their accompanying request card. The sender must ensure that the specimen containers are
tightly capped and will not leak fixative during transportation. Multiple specimens must be transported
to the department in proper sealed specimen containers, which comply with rules of health and safety.
Larger volume specimens sent to the department from the hospital theatres must be transported in
proper contained specimen carriers which comply with health and safety rules. The specimen carrier
must be properly sealed and leak proof so that the contents do not escape during transport. The
request cards accompanying the specimens must not become contaminated in any way.
Microbiology
Microbiological specimens are labile and therefore should be delivered to the laboratory as soon as
possible, especially those for which transport media cannot be used. Blood Culture bottles must not
be sent via the airtube system.
All microbiological specimens should be taken with care to avoid contamination and placed in the
transit bag in such a way that the specimens are kept separated from the request form.
They should be labelled with a "High Risk" sticker in cases of the following:
known or suspected Tuberculosis, Brucellosis, Typhoid, Paratyphoid, Q fever, Psittacosis, Diphtheria,
Viral hepatitis, HIV, Viral Haemorrhagic Fever (see pages 88 - 89) or Creutzfeldt-Jakob disease.

Status: Operational
Issue Date: 07/07/2008
Review Date: 07/07/2010
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Gwent Healthcare NHS Trust

Owner: Quality Manager
Directorate of Pathology

Q-Pulse No. QP0002

Edition No. 10
Printed copy is controlled document only on date last printed 10/07/2008

External Hospital Transportation

Specimens regarded as external may come from local GP surgeries, dental surgeries and outlying
hospital clinics. A dedicated courier service {Health Courier Service} run by the Ambulance Trust,
calls at GP surgeries and outlying hospitals throughout the working day. Histology specimens sent in
pre-filled 60-ml specimen pots should be enclosed in plastic transport bags with their accompanying
request card. The sender must ensure that the specimen containers are tightly capped and will not
leak fixative during transportation. These specimens must be transported to the department in proper
specimen carriers, which comply with the rules of health and safety.
[transport labelling reception of specimens policy ed 3.doc]
[Welsh Ambulance Procedures for the Carriage of Diagnostic Specimens 2nd Ed.doc]
Histology specimens should be kept separate from all other specimen types to minimise the risk of
contamination by formalin.
Specimen reception (E5)
The departments have procedures to ensure:

Specimens and requests are accurately identified and matched.

Test requirements are accurately booked into the IT system.

Account is taken of urgency.

Documented monitoring of sample arrival times against the time samples are registered on
the LIMS.

Blood science samples and Microbiology samples arrive into pathology at a central point. Histology
samples are delivered directly to the Histology laboratory specimen reception area for registration
onto the LIMS. Microbiology samples are separated from the blood science samples and sent to the
Microbiology laboratory specimen reception area for registration on the LIMS. Strict rules apply to the
checking of data on request forms and their accompanying specimens. Only when all is deemed
satisfactory is the request accepted. Senior biomedical staff who will ensure that all is correct before
accepting (E5.1e) acts upon discrepancies and/or mistakes. All specimens identified as high risk
must not under any circumstances be opened by the reception staff. They will be dealt with according
to the rules of each department.
Urgent Specimens (E5.1d)
It is the policy of the Directorate to process all urgent specimens as soon as they arrive in the
laboratory. These specimens shall take priority and will be processed and reported upon as soon as
possible. Ward and outpatient areas have electronic means of accessing results. There are also
specific departmental policies relating to telephoning results where necessary. In the case of
histopathology, turnaround time for urgent requests depends on a number of limiting factors. It is
advisable for the requesting clinician to telephone the department for information regarding
turnaround times for urgent histology requests. Urgent specimen requests arriving without notice may
not be treated urgently but will be given priority. Merely marking the request card urgent will not
guarantee that the specimen is treated urgently.
If at any time the suitability of the sample for testing is in doubt, or where the sample does not
conform to the description provided, a senior member of staff shall consult with the user for further
instructions, before proceeding / disposal.
Status: Operational
Issue Date: 07/07/2008
Review Date: 07/07/2010
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Gwent Healthcare NHS Trust

Owner: Quality Manager
Directorate of Pathology

Q-Pulse No. QP0002

Edition No. 10
Printed copy is controlled document only on date last printed 10/07/2008

Each department has criteria for rejection of samples, the recording of rejected samples and
notification to the user of rejected samples (E5.2).
Referrals to Other Laboratories (E6)
The disciplines make every effort to use other laboratory services that meet CPA standards and have
procedures for:

Recording the tests referred.

Documenting in the database, the results of referrals.

A record of all laboratories used in the referral of samples.

[External Laboratories for Work Referral.doc]

Each Discipline periodically review, via the Clinical Pathology Accreditation (UK) Ltd website [CPA
Website], the CPA status of the laboratories they routinely refer samples for analysis, their EQA
performance and periodically monitor turnaround times to ensure that requirements continue to be
met.
SECTION F
EXAMINATION PROCESS
The Directorate of Pathology selects and validates its examination procedures in accordance with its
policy for examination processes.
[POLICY FOR EXAMINATION PROCESSES.DOC]
SECTION G
POST-EXAMINATION PROCESS
Reporting results (G1)
The Directorate has written procedures for reporting results, which include:

The report. [Results Reporting policy.doc]

Telephoned reports.[..\Draft\Policy Telephoned Report.doc]

Amended reports.[..\Draft\Policy Amended Report.doc]

Clinical advice and interpretation (G5)

[CLINICAL ADVICE AND INTERPRETIVE COMMENTS POLICY ED1.DOC]

Clinical advice and interpretation (G5)
The Directorate ensures that advice on investigations and the interpretation of results meets the
needs of the users and patients. The Directorate ensures that users have access to laboratory advice
at all times. The Directorate ensures that all comments are clear, succinct, unambiguous and relevant
to the user in the treatment of the patient.

Status: Operational
Issue Date: 07/07/2008
Review Date: 07/07/2010
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Gwent Healthcare NHS Trust

Owner: Quality Manager
Directorate of Pathology

Q-Pulse No. QP0002

Edition No. 10
Printed copy is controlled document only on date last printed 10/07/2008

The Directorate ensures that there is systematic communication between laboratory staff and clinical
staff to promote effective utilisation of laboratory services and to consult on scientific and logistic
matters. Where appropriate, records are kept of such meetings.
Clinical comments and advice is given only by suitably qualified medical or scientific staff in
accordance with the Directorates policy MP0057:
[CLINICAL ADVICE AND INTERPRETIVE COMMENTS POLICY ED1.DOC]
SECTION H
EVALUATION AND QUALITY ASSURANCE
Evaluation and improvement processes (H1)
Ongoing evaluation and improvement processes are essential to ensure that the service provided by
the Directorate meets the needs and requirements of our users. Recording, analysis and
interpretation of this evaluation data are important parts of the Directorates management process and
as such form part of discipline annual management reviews (A11, H1.3).
Assessment of user satisfaction and complaints (H2).
The Directorate is committed to assessing user satisfaction and monitoring complaints so that the
service provided by the laboratory meets the needs and requirements of users. This is achieved by
listening to and seeking information from users of the service through:

User questionnaires.

Meetings with users, both internal and external to the Trust.

The Directorate has a procedure for assessment of user satisfaction detailed in the Pathology
continual quality improvement policy and complaints policy:
[PATHOLOGY CONTINUAL QUALITY IMPROVEMENT POLICY 2nd ed.DOC]
[Compalints Policy ed 3.doc]
The laboratories investigate all complaints received from clients or other parties and any anomalies
identified relating to the laboratorys accredited activities in accordance with the Trusts complaints
procedure (H2.1a):
[http://howis.wales.nhs.uk/sites3/Documents/79/0008721.pdf].
A record is maintained of any such complaints or anomalies and of any actions taken by the
laboratory.
The Directorate strives to meet performance targets such as turnaround times in all areas (H2.1b).
The Directorate assesses the clinical relevance of laboratory investigations performed and the
reliability of interpretative reports in conjunction with its users (H2.1c).
The Directorate participates in the evaluation of clinical effectiveness, audit and risk management
activities of the Trust and relevant external bodies (H2.1d).

Status: Operational
Issue Date: 07/07/2008
Review Date: 07/07/2010
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Gwent Healthcare NHS Trust

Owner: Quality Manager
Directorate of Pathology

Q-Pulse No. QP0002

Edition No. 10
Printed copy is controlled document only on date last printed 10/07/2008

Internal audit of quality management systems (H3).

The Directorate uses internal audit to provide evidence that the quality management system is
effective, implemented and maintained across the Directorate. The Directorates audit process is
detailed in the policy and procedures for Internal Quality Management System Audits.
[Policies and Procedures for internal quality management system audits 2nd ed.doc]
Internal audit of examination process (H4).
Each Discipline within Pathology operates in accordance with the Directorates policy for examination
processes and audit their compliance to the requirements of this policy using the appropriate audit
form.
[POLICY FOR EXAMINATION PROCESSES.DOC]
[Audit Form: CPA F Examination process.doc]
External quality assessment (H5).
Each Discipline within Pathology participate in approved external quality assessment schemes
appropriate to the examinations and interpretations provided (H5.1). Records of performance in these
schemes are maintained (H5.2), reviewed and communicated to staff by the individual disciplines.
Where decisions are taken by disciplines in relation to their performance, these are recorded,
monitored and acted upon (H5.3). In instances where an appropriate external quality assessment
scheme does not exist and no other formal inter-laboratory comparison programme is available,
disciplines develop a mechanism for determining the acceptability of these procedures which are not
otherwise externally evaluated (H5.4).
Additionally the Directorate receive reports and act on information from a broad range of external
quality assessments including those from:

Health Service Bulletins

MDA reports

National Service Frameworks

National Institute of Clinical Excellence Guidelines

Health and Safety Executive

Institute of Biomedical Sciences

Clinical Pathology Accreditation (UK) Ltd

Medicines and Healthcare products Regulatory Agency

Human Tissue Authority

Annual benchmarking.

Status: Operational
Issue Date: 07/07/2008
Review Date: 07/07/2010
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Gwent Healthcare NHS Trust

Owner: Quality Manager
Directorate of Pathology

Q-Pulse No. QP0002

Edition No. 10
Printed copy is controlled document only on date last printed 10/07/2008

Quality Improvement (H6).

The Directorate has a process for continual quality improvement as detailed in its policy for continual
quality improvement. This includes remedial, corrective, preventative action, monitoring of quality
indicators and improvement processes where necessary (H6.1):
[PATHOLOGY CONTINUAL QUALITY IMPROVEMENT POLICY 2nd ed.DOC]
The results of audit and improvement processes are made available to staff through staff meetings,
Directorate meetings, meetings between the Directorate and the Trust, Discipline annual management
review and to users as required (H1.2).

Identification and control of non-conformities (H7)

The Directorate has a process to ensure that non-conformities in pre examination, examination and
post examination processes are effectively managed to minimise any risks to users. To achieve this
each discipline operates in accordance with the directorates continual quality improvement policy:
[PATHOLOGY CONTINUAL QUALITY IMPROVEMENT POLICY 2nd ed.DOC]
and the policy and procedures for internal quality management system audits:
[Policies and Procedures for internal quality management system audits 2nd ed.doc].

Status: Operational
Issue Date: 07/07/2008
Review Date: 07/07/2010
Page 34 of 34