WoSSVC
MAN-Q-001 v8.1
Authorised by: S. Hughes
Author: J. McOwan
Issued 15/10/15
West of Scotland Specialist Virology Centre
Title: QUALITY MANUAL
NUMBER / VERSION
MAN-Q-001v8.1
DATE OF ISSUE
15/10/2015
REVIEW INTERVAL
2 Years
AUTHORISED BY
S. Hughes
AUTHOR
J. McOwan
COPY
1
LOCATION OF COPY
Master copy in Q-Pulse
Technical Services Manager’s Office
DOCUMENT REVIEW HISTORY
All review / revision details are available in Q-Pulse
Date
Amendment
Purpose and scope
Responsibility
Definitions
Documentation
Quality Manual
Initials
The purpose and scope of this document is to
describe the quality management system within the
West of Scotland Specialist Virology Centre
(hereafter referred to as the WoSSVC).
Laboratory Management is responsible for ensuring
the implementation of the quality management
system in the West of Scotland Specialist Virology
Centre.
The responsible manager: Management Group&
Quality Manager.
The Quality Manual must be read by all staff.
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WoSSVC
MAN-Q-001 v8.1
Authorised by: S. Hughes
Author: J. McOwan
Issued 15/10/15
CONTENTS
Section
in
the Page
Quality Manual
Topic
1.0
3
Introduction
2.0
3
General information about the department
3.0
3
Introduction to the quality manual
Related Section of ISO15189:2012 Standard
4.0
4
Management requirements
4.1
4
Organisation & management responsibility
4.2
14
Quality Management System
4.3
15
Document control
4.4
16
Service agreements
4.5
16
Examination by referral laboratories
4.6
16
External services & supplies
4.7
17
Advisory services
4.8
17
Resolution of complaints
4.9
17
Identification & control of non-conformities
4.10
18
Corrective action
4.11
18
Preventive action
4.12
18
Continual improvement
4.13
19
Control of records
4.14
19
Evaluation & audits
4.15
20
Management review
5.0
21
Technical requirements
5.1
21
Personnel
5.2
24
Accommodation & environmental conditions
5.3
26
Laboratory equipment, reagents and consumables
5.4
28
Pre-examination processes
5.5
30
Examination processes
5.6
31
Ensuring quality of examination results
5.7
32
Post-examination processes
5.8
33
Reporting of results
5.9
34
Release of results
5.10
34
Laboratory information management
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WoSSVC
MAN-Q-001 v8.1
Authorised by: S. Hughes
Author: J. McOwan
Issued 15/10/15
1.0
Introduction
Our aim is to provide a service to users and patients which is of the highest quality. In order to achieve this,
we have established a quality management system to ensure that our service is of consistent quality and
meets user requirements.
The Quality Management system in the WoSSVC has established a quality policy and quality objectives
and is designed to achieve those objectives.
This is done through a process of quality planning which is the part of quality management focused on
setting quality objectives and specifying necessary operational processes and related resources to fulfil
quality objectives.
The Quality Management system ensures that:
 Laboratory management establishes written quality objectives, which are consistent with the quality
policy and are regularly reviewed.

This quality manual is reviewed regularly, updated as required and any changes communicated to all
personnel concerned.

There is a quality manager who has responsibility for the implementation and maintenance of the
quality management system.

There is a process of document control.

The control of process and quality records is according to current legislation, regulations and
guidelines.

The control of clinical material is according to current legislation, regulations and guidelines.

Laboratory management conducts an annual review of the laboratory’s quality management system
and all its services.
This Quality Manual is cross-referenced to the procedures and forms used by the WoSSVC.
The layout of this Quality Manual follows that of the ISO 15189:2012 Standard for Medical Laboratories.
It was reviewed at the Annual Management Review of 2014 and will be reviewed at the Annual
Management Review of 2015.
2.0 General information
The West of Scotland Specialist Virology Centre (WoSSVC)
The West of Scotland Specialist Virology Centre is part of the Department of Laboratory Medicine
within NHS Greater Glasgow and Clyde Health Board.
Contact details:West of Scotland Specialist Virology Centre
Level 5, New Lister Building
Glasgow Royal Infirmary
10 – 16 Alexandra Parade
Glasgow
G31 2ER
Tel: +44 (0)141 201 8722
Fax: +44 (0)141 201 8723
Email: christine.ritchie@ggc.scot.nhs.uk
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MAN-Q-001 v8.1
Authorised by: S. Hughes
Author: J. McOwan
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Information on the services provided and contact telephone numbers are available through the NHS
Greater Glasgow & Clyde website:http://www.nhsggc.org.uk/virology
Core working hours are:
08:45- 17.00 Monday - Friday
09:00 - 12:30 Saturday
10:00 – 14:00 Sunday
At all other times the “on call” virologist or virology BMS (for transplant specimens) can be contacted
via the hospital switchboard (0141 211 4000).
Advice on all aspects of clinical virology is available 24 hours a day, 7 days a week.
The West of Scotland Specialist Virology Centre at Glasgow Royal Infirmary:
provides routine diagnostic services to patients with viral illnesses in the West of Scotland, and
specialist testing facilities for patients outside this area.

provides a wide range of molecular diagnostic tests using automated extraction procedures, a full
serology service and specialist virus detection systems.

provides sequencing for genotypic resistance markers, viral typing and molecular epidemiology.

has been fully computerised since 1993.

is the national surveillance laboratory for viral respiratory infections for Scotland.

is a Health Protection Scotland (HPS) specialist testing laboratory for blood borne viruses.
3.0
Introduction to the Quality Manual.
This Quality Manual describes the Quality Management System of the WoSSVC.
This Quality Manual fulfils two functions. It describes the Quality Management System for the benefit of
the laboratory’s own management and staff, and it provides information for users and for
inspection/accreditation bodies.
This Quality Manual may be regarded as the index volume to the WoSSVC management, laboratory,
clinical and quality procedures. Subsequent sections of this Quality Manual are arranged so that they
equate with sections of ISO 15189:2012. There is a brief description of the way in which the WoSSVC
seeks to comply with the particular section of the standard and references are given to appropriate
procedures.
The quality management system and the examination processes are continually evaluated and quality
assured. The results feed back to maintain and, where required, improve the quality management process
and to ensure that the needs and requirements of users are met.
Knowledge of the quality manual is checked and reinforced by e-mail prompting, at staff meetings, at
the annual joint review, at KSF sessions and by using a staff quiz. The current version of the quality
quiz is available in Q-Pulse (MAN-F-230). The quality manual is reviewed during the AMR.
4.0 Management requirements
4.1 Organisation and management responsibility
4.1.1.1 General
The organisation and management of theWoSSVC is detailed below. The laboratory accepts its
responsibility to meet the requirements of ISO15189:2012 when carrying out work at its permanent facility
at the New Lister Building, Glasgow Royal Infirmary.
4.1.1.2 Legal entity
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MAN-Q-001 v8.1
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The WoSSVC is part of NHS Greater Glasgow & Clyde, which is the entity that can be held legally
responsible for its activities.
Relationship to the Host Organisation
Laboratory services Glasgow-wide have been reorganised within NHS Greater Glasgow& Clyde.
West of Scotland Specialist Virology Centre (WoSSVC) is part of Microbiology.
The Microbiology Operational Management Team consists of a Lead Clinician from microbiology
laboratories from the north sector, the south sector, Argyll & Clyde sector,the Microbiology Technical
Services Manager and the WoSSVC Head of Department and Technical Services Manager.
Microbiology, together with 5 other laboratory disciplines,is part of the Department of Laboratory
Medicine. The Diagnostics Directorate is formed from Laboratory Medicine and Diagnostic
Imaging.
NHSGGC Management Team
Board Chief Executive – Robert Calderwood
Acute Division
Chief Operating Officer – Jane Grant
Diagnostics Directorate
Director – Aileen MacLennan
Department of Laboratory Medicine
Diagnostic Imaging
General Manager – Isobel Neil
Clinical Director – Dr. Ann Cruickshank
Assistant General Manager – Bernadette Findlay
HoS
Biochemistry
HoS
Genetics
Head of Service
Microbiology
Prof. Brian Jones
HoS
Immunology
HoS
Haematology
West of Scotland Specialist Virology Centre
Head of Department – Dr. Celia Aitken
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HoS
Pathology
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MAN-Q-001 v8.1
Authorised by: S. Hughes
Author: J. McOwan
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Organisation and Responsibilities within the West of Scotland Specialist Virology Centre
Management Group
Consultant Dr.Eleri
Wilson-Davies
1wte
Consultant
Clinical Scientist
Dr. Rory Gunson 1wte
Clinical Scientist
3.0 wte
Consultant 0.2 wte
(Vacancy)
Research Scientist
1.0 wte
Consultant
Dr. Celia Aitken
Head of
Department
0.8 wte
Quality Manager
Ms. Jane McOwan
0.5wte
Specialist Registrar
4.0 wte
Technical Services Manager
Mr. Stephen Hughes
1 wte
Data
Analyst
0.68 wte
BMS
Senior Specialist
BMS7.0 wte
BMS Site Lead
Ms. Ann Hawthorn 1wte
Support
Admin & Clerical
CSW
19.0 wte
A&C Band 5
1.0 wte
Office manager
Specialist BMS
24.8 wte
Ref Labs
A&C Band 4
2.0 wte
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Virology
A&C Band 4
1.0 wte
Band 3
3.6 wte
Band 2
1.0 wte
Microbiology
A&C Band 4 (fulltime x3, part-time
x3).
Band 3 (full-time
x1, part-time x1).
WoSSVC
MAN-Q-001 v8.1
Authorised by: S. Hughes
Author: J. McOwan
Issued 15/10/15
The Laboratory has five teams and a medical consultant, or scientist of equivalent standing, who is
responsible for the clinical management of each team.
1. MID (Molecular Isolation and Detection)
2. VS (Virus Serology-Blood Borne Virus and other virus serology, BBV molecular)
3. Specialist testing
4. Office
5. Laboratory Support
The Consultants’ and Technical Services Manager’s time is allocated as required.
MID Team
Consultant Head of Department
(0.8wte)
Clinical Reporting
Specialist Registrar
Clinical Scientist
Technical Services Manager
Senior Specialist BMS (Site Lead)
Senior Specialist BMS 3.0 wte
Specialist BMS11.8 wte
CSW 8.0 wte
VS Team
Consultant Clinical Virologist
(BBV)
Technical Services Manager
Senior specialist BMS
(Site Lead)
Clinical Reporting
Senior Specialist BMS 3.0 wte
Specialist Registrar
Clinical Scientist
Specialist BMS 10.9
wte
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Specialist Testing Team
Consultant Clinical Scientist
Consultant Head of
Department
Technical Services Manager
Clinical Scientist
3.0 wte
Research Scientist
1.0 wte
Senior specialist BMS
1.0 wte
CSW 1.0 wte
LABORATORY SUPPORT
OFFICE Team
Team
Consultant Head of Department
Technical Services Manager
Senior Specialist BMS
(Site lead)
A & C Band 5 Office Manager
A & C Band 4
1.0 wte (Vacancy)
A & C Band 3
3.6 wte
Consultant Head of Department
Technical Services Manager
Senior Specialist BMS (Site lead)
Specialist BMS
2.1 wte
Quality Manager
0.5 wte
Data Analyst
0.68 wte
CSW
2.0 wte
A & C Band 2
1.0 wte
The Microbiology Operational Management Team consists of a Lead Clinician from microbiology
laboratories from the north sector, the south sector and Clyde sectors, the Microbiology Technical
Services Manager and the WoSSVC Head of Department and Technical Services Manager.
They meet once a month; also in attendance are the General Manager, Clinical Director and
Operations Support Manager for Laboratory Medicine. All issues relating to Microbiology Glasgowwide are discussed.
There is a single Senior Staff Committee which includes representatives from Level 4 and Level 5 of
the NewListerBuilding (Microbiology, West of Scotland Specialist Virology Centre and the Scottish
Microbiology Reference Laboratories). It meets monthly and is chaired on rotation by the respective
heads of department.
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The following are the main committees/groups within the West of Scotland Specialist Virology
Centre:
The Virology Sector Group This is held as needed. This is a minuted group that meets to allow
discussion of ongoing or urgent matters relating to service delivery. Set agenda items are discussed,
staffing (including training), operational issues (e.g. fabric of the building), quality and
development/ongoing projects.
Issues raised at the monthly Microbiology Operational Management Meeting are reported back to this
group.
The Health and Safety Committee is a unified group representing Level 4 and level 5 of the New
Lister Building. It meets quarterly and is chaired on rotation by one of the TSMs. A representative
from each grade of staff of the laboratory attends. The meeting is minuted. Staff may ask a committee
member to raise a concern at the next meeting. All safety issues are considered, including accidents
(and near misses) and audits of the premises. Issues raised are passed to the relevant Technical
Services Manager for action, or discussed at the Microbiological Operational Management Group, as
appropriate. Copies of the minutes are available to all staff and are also sent to the Safety Advisor for
the Directorate.
Quarterly Health and Safety updates are given to all staff at the Friday morning update meeting. Fire
training is provided as yearly on-line “LearnPro” tutorials and Trust wide Statutory and mandatory
training every three years – this includes moving and handling, Health and Safety and infection
control.
Staff Meetings
Senior Staff Meetings NLB.
This is a shared meeting for senior staff from levels 4 and 5 (Microbiology, Reference Labs, Glasgow
and WoSSVC ) and are minuted. These meetings are chaired (alternatively by head of Departments
for Microbiology – North / Ref Labs and WoSSVC. This group act as a channel for informing staff of
proposed changes, or other relevant information that may affect management structure or laboratory
procedures that may effect both floors. It is also an opportunity for staff side and all staff to raise
issues or complaints relevant to the efficient running of both floors.
Full staff meetings are held weekly and are minuted. These meetings are chaired by the Technical
Services Manager or Site Lead, and act as a channel for informing staff of proposed changes, or other
relevant information that may affect management structure or laboratory procedures. It is also an
opportunity for staff side and all staff to raise issues or complaints relevant to the efficient running of
the laboratory. On the first Thursday of each month the TSM holds a joint meeting with all WoSSVC
and Scottish Microbiology Reference Laboratory staff.
The Clinical Group meets once per week and is un-minuted. It is chaired by a Senior Registrar and is
attended by all staff involved with clinical reporting, the Technical Services Manager and any visiting
trainee medical / scientific staff. All clinical issues are discussed. A short, daily meeting occurs (at
13.45) when ongoing clinical issues are discussed with relevant reporting staff, and consultant staff are
present to give advice.
Compliance Meeting is held quarterly and minuted. It is chaired by the Technical Services Manager
and is attended by Site Manager, Quality Manager, Training Officer and Health and Safety Officer.
Compliance reports are reviewed. Any issues e.g. non-conformances, Datix, Health and Safety Issues,
User queries, EQA results are discussed.
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MAN-Q-001 v8.1
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Senior Scientist’s meeting is held monthly and is minuted. It is chaired by the Technical Services
Manager and is attended by team leaders (BMS, Clinical Scientist and clerical staff) and the Quality
Manager. All operational issues are discussed. Where appropriate, information from the Management
Group will be discussed by the TechnicalServices Manager, and any issues raised here can be
discussed at the relevant meeting, e.g. Clinical Group. Information from this meeting is cascaded to
individual team members at regular informal meetings within each section.
Ongoing training and development plus quality and accreditation issues are discussed at both the
Clinical Group and the Senior Scientists Meeting.
IT meeting is held fortnightly and is minuted. It is chaired by the Technical Services Manager and is
attended by Site Manager, Quality Manager, Laboratory IT Manager and deputy. An update is given
by the IT manager including discussion of any IT issues within the department e.g. LIMS, Analyser
interfaces etc. These are logged on the IT tracker database stored in the Common File. Progress of
these issues are followed up.
Molecular Development Group. This is held as needed and is chaired by the Consultant Clinical
Scientist in charge of molecular development. Clinical Scientist and BMS staff involved in the
development of molecular assays, together with the BMS in charge of that section, attend this meeting.
The TechnicalServices Manager and other interested staff are encouraged to attend. The primary remit
of this group is to assess new molecular tests, either “in-house” or commercial, for possible
implementation in the laboratory as part of the continual improvement procedure.
Its main roles are:

Discussion of protocols for retrospective and prospective testing using molecular assays

To discuss the results of the above and make recommendations to the Virology Sector Group
for implementation of either a new or modified assay. These assays may either be previously
published or developed by WoSSVC staff. If more than a month remains before this meeting,
the assay can be authorised, in the interim, by the Management Group.
Once an assay has been implemented and is part of the routine service the ongoing quality assurance
of that assay will be discussed at the Senior Scientists’meeting. Issues not able to be resolved by this
group will be referred to the Molecular Development Group for investigation.
4.1.1.3 Ethical conduct
NHSGG&C Standing Financial Instructions and Fraud Policy [external documents ED-13 &ED-14
in Q-Pulse] ensure that work quality is not affected by external pressure, that users’ confidential
information is protected and that the department cannot undertake activity that would diminish
confidence in its impartiality.
Users’ confidential information is also governed by our procedure MAN-SOP-024 ‘Management
of data & information’ and by NHSGG&C I.T. Policy. For report confidentiality, see MAN-SOP001 and MAN-Q-033 (the telephoned report).
Activity that would diminish confidence in impartiality or integrity is also prohibited by the Health
& Care Professions Council code of conduct.
4.1.1.4 Laboratory director
The West of Scotland Specialist Virology Centre is under the professional direction of Head of
Department Dr. Celia Aitken, MBBS, MSc, MRCP, FRCPath.
Competence is demonstrated in the following ways:

Participation in Continuing Professional Development (CPD).

Membership of the Royal College of Pathologists

Appointment as a consultant by an Advisory Appointments Committee
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
Evidence of continuing practice in the specialty

Recorded attendance at regular departmental meetings to review service issues and to set
quality objectives
Functions are delegated to members of the Management Group, with the Head of Department being
chair of this group. All non-clinical organisational and administrative duties relevant to the services
provided are delegated to Stephen Hughes, the TechnicalServices Manager, and clinical responsibility
for the BBV service is delegated to Dr Eleri Wilson-Davies, Consultant Clinical Virologist.
4.1.1.4 Clinical advice and interpretation
Advice on examinations and the interpretation of results is available to users every day of the year.
Clinical advice and interpretative comments on reports are clear, succinct and unambiguous, and are
only authorised by the appropriate Medical Consultant or Consultant Clinical Scientist.
4.1.1.4 Suppliers
We aim to select the highest standard of external services, equipment, reagents & consumable
supplies in order to maintain the highest quality service to our users.
The SOP for reviewing & monitoring suppliers is MAN-SOP-025.
4.1.1.4 Contingency plan for emergency situations (resilience)
There is a plan to ensure that essential services are available during emergency situations or other
conditions when laboratory services are limited or unavailable. See MAN-SOP-023 Risk
Management (Business continuity) for details.
4.1.2.1 Management commitment
Management have shown commitment to the development & implementation of the QMS and to
continually improving its effectiveness by:a) Ensuring laboratory personnel are aware of the importance of meeting the needs &
requirements of users as well as regulatory requirements by having these as standing agenda
items at management meetings, staff meetings and by using CPD accredited quizzes.
b) Establishing a quality policy. See page 13 of this manual. An original copy signed by the
director is displayed at the specimen reception desk. The Quality Policy is reviewed at the
AMR (see minutes).
c) Establishing quality objectives & plans. See MAN-F-216 for the current version, which was
updated at the AMR of 2014. QOPs are also a standing agenda item at the monthly Senior
Scientist meetings. Management ensures the setting of Plans & Objectives by following the
Quality Procedure [MAN-Q-065].
d) Responsibilities, authorities & inter-relationships of all personnel are defined on pages 6-8.
e) Communication processes are described on page 9.
f) A new quality manager was appointed in 2015, shared on a 50:50 basis with the Scottish
Microbiology Reference Laboratories (Glasgow).
g) There is an annual management review, conducted in January of the next calendar year.
Review is also an integral part of the committee structure. MAN-Q-067 defines the conduct of
the annual management review.
h) Competency assessment is a key component of our training programme. It is assessed &
reviewed according to criteria set down inMAN-SOP-032.
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i)
Management ensure adequate resources are available by careful selection, induction and
training of appropriately qualified staff. There is no requirement for WoSSVC to provide
information for patients.
j)
Examination processes are verified & validated before use. Processes are continuously
monitored by using IQC and EQA checks.
Management ensure adequate resources are available by careful selection, induction and training of
appropriately qualified staff. Accommodation is a recently completed state-of-the-art laboratory in the
New Lister Building. Equipment & consumables are procured & maintained using the Managed
Service Contract. Pre-examination information for users is contained in the department’s web page
http://www.nhsggc.org.uk/virology
The Head of department undergoes annual joint review and has a job plan. The responsibilities
of the HoD are defined in the quality manual (MAN-Q-001).
The Head of department, TSM & the Site Lead represent the organisation at Microbiology
management team meetings. The WoSSVC is currently CPA accredited, and will undergo ISO
15189:2012 assessment by UKAS within the period April 2016 - October 2016.
4.1.2.2 Needs of users
This is a commitment in our Quality Policy (MAN-Q-002). Needs & requirements of users forms
part of the annual management review.
Information for users, including turnaround times, is contained in the user manual accessible via the
department’s NHS Greater Glasgow & Clyde website:- http://www.nhsggc.org.uk/virology
Medical, senior scientific & BMS staff are in daily contact with users to provide support and
advice.
The most recent feedback questionnaire was distributed in February 2014.There was a 46%
response, with positive scores for each aspect of the service. Another is planned for late 2015. User
survey feedback is shown to the staff.
Needs & requirements of users is a standing agenda item at management meetings. The procedure
is defined in ‘Needs & requirements of users’ (MAN-Q-068).
The needs of the users are kept under constant review. In practice, this is achieved by user-satisfaction
questionnaires, meetings with specific key users and by individual contact between the Head of
department, TSM, Site Lead, Medical Consultants and others who use the service. Assessment of user
satisfaction and complaints is conducted on a regular basis and consideration of the findings is made
between the Head of department, TSM, Site Lead &Medical Consultants.
Recommendations arising from these exercises are translated into requirements which form the focus
of objective setting and planning within the quality management system, and consideration of the
findings form part of the annual management review.
Meetings are held at least on a six monthly basis between microbiology consultants who refer samples
to the laboratory and the consultant staff of the West of Scotland Specialist Virology Centre. Frequent
meetings are also held with consultants of various clinical specialities e.g. ITU units, Transplant units
(renal, bone marrow and cardiac), infectious disease and respiratory units. Consultant staff or their
deputies attend weekly ward rounds. These visits are translated into requirements which form the
focus of objective setting and planning within the quality management system. Assessment of user
comments and complaints is conducted on a regular basis and is reported to the Virology Sector
Group.
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4.1.2.3 Quality Policy
The Quality Policy of the West of Scotland Specialist Virology Centre is given below and published as
a separate controlled document (MAN-Q-002) which is displayed at the laboratory entrance. The
purpose of the quality policy is to set down, for the information of staff and users, the course of action
and measures that the WoSSVC has taken in order to provide a service of the highest quality.
The Quality Policy of the West of Scotland Specialist Virology Centre (WoSSVC),
New Lister Building, Glasgow Royal Infirmary, Glasgow G31 2ER.
The WoSSVC is committed to providing a comprehensive diagnostic and specialist virology
service of the highest quality and shall be aware of, 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 WoSSVC will:
 Operate a Quality Management System to integrate the organisation, management
procedures, processes practices and resources.
 Set quality objectives and plans in order to implement this Quality Policy and establish
appropriate communication regarding the effectiveness of the system towards
continuous quality improvement.
 Ensure that all personnel are familiar with the Quality Policy, Quality Manual and the
management system and are aware of the importance and relevance of their activities
and procedures and how they contribute to achieving management objectives.
 Ensure the integrity of the management system is maintained even during periods of
change.
 Ensure the health, safety and welfare of all staff and visitors to the department and a
commitment to comply with relevant environmental legislation.
 Uphold professional values and be committed to good professional practice and
conduct.
The WoSSVC will continue to comply with UKAS / ISO15189 accreditation standards and
is committed to:
 Staff recruitment, training, education and development and retention at all levels to
provide a full and effective service to its users that is delivered by well trained
competent staff.
 The proper procurement and maintenance of such equipment, reagents and other
resources as are required for the provision of the service.
 Advising on the collection, transport and handling of all specimens so as to ensure the
correct performance of laboratory examinations.
 The appropriate use of stated laboratory procedures in order to achieve the highest
quality of all tests performed.
 Reporting results of examinations in ways which are timely, confidential, accurate and
clinically relevant.
 The evaluation of user satisfaction, in addition to internal audit and external quality
assessment, in order to produce continual quality improvement.
Signed on behalf of the Virology Sector Group of the WoSSVC:
Date 15.10.15
Dr. Celia Aitken, Head of Department.
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4.1.2.4 Quality objectives and planning
The Laboratory Management Group defines the quality objectives of the laboratory
and is responsible for ensuring that plans are made to meet these objectives. The
management review, which is undertaken on an annual basis, determines whether the
objectives have been successfully completed and provides an opportunity for revising
objectives and plans and the functioning of the quality management system. See
MAN-Q-065 (setting plans & objectives) and MAN-F-216 (Quality plans &
objectives for 2015).
4.1.2.6
Communication – see page 9.
4.1.2.7
Quality Manager
The Quality Manager post is shared on a 50:50 basis with the Scottish Microbiology
Reference Laboratories. Quality Management within NHS GG&C Microbiology has
been re-structured to provide quality manager support for each laboratory site. This is
to ensure the underpinning of quality values within the service, solve recruitment and
retention issues and to provide future succession planning in a Quality Management
career structure. The Quality Manager reports directly to the Technical Services
Manager.
4.2
Quality management system.
Laboratory management demonstrates its commitment to fulfilling the needs &
requirements of its users by clearly defining the way in which the laboratory is
organised & managed.
Evidence that we have established a quality management system includes:Our Quality Manual, Quality Policy, the appointment of a quality manager and
the implementation of a quality management system.
The QMS processes & application, criteria & methods, availability of resources
and its monitoring for improvement action are set down in almost 500 documents
held in Q-Pulse.
The key ones are:MAN-Q-001‘Quality Manual.’
Job descriptions & Quality Policy.
MAN-F-216 ‘Quality Objectives &Plans for 2015.’
MAN-Q-003 ‘Document control& review.’
MAN-Q-036 ‘control of clinical material.’
MAN-Q-067 ‘Annual Management review.’
The WoSSVC Quality Management System is subject to planned and scheduled
internal audit processes, against agreed criteria, by personnel trained in internal audit
[MAN-Q-073].
The records of internal audit include:
 The activities, areas or items audited.

Any nonconformities or deficiencies found.

Recommendations and time scale for corrective and preventive actions.
The results of internal audit are regularly evaluated and decisions taken documented,
monitored, reviewed and acted upon.
Audit findings are communicated to appropriate personnel.
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4.2.2.2
Quality Manual
This standard is fulfilled by the production of this Quality Manual (MAN-Q-001) by
Laboratory Management. It is the responsibility of the Quality Manager to ensure the
implementation and monitoring of the quality management system, and it is the
responsibility of Laboratory Management to ensure that the correct resources are in
place to allow implementation and continuation of the quality management system.
4.3
Document control.
This standard is fulfilled by the Document Control System SOP (MAN-Q-003).
PROCEDURE FOR DOCUMENT PREPARATION AND CONTROL
Definitions of the document hierarchy:A Policy is:- a course or principle of action adopted by an organization.
Objectives & Plans are:- specific results to be achieved within a set time frame, and the ways that
will be done.
Processes are:- The actions taken to achieve the objectives.
Procedures are:- The official way of carrying out a process.
Records are:- Evidence of actions taken when following procedures.
Hierarchy of documentation:
POLICIES
OBJECTIVES & PLANS
PROCESSES
PROCEDURES
RECORDS
New documents
For new documents a template exists for writing SOPs, which has the correct margins, front page,
header and footer. For existing documents it is sufficient to update by replacing the front page and
completing it as below.
Document Control Prefix codes:
The documents are divided into laboratory sections as follows:
ED
EQP
LS
MAN
MD
Quality Manual
External documents (e.g. ISO standards, product inserts etc)
Equipment for all sections
Laboratory Support
Management (including quality and policy documents)
Molecular Development and Typing
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MID
OFF
VS
Molecular Isolation and Detection
Office
Virus Serology (including BBV and non-BBV (SER) serology)
Each section is further sub divided into:
SOP
Standard Operating Procedure (or EOP for equipment)
WI
Work Instructions
F
Forms
Examples:
A quality procedure would read MAN-Q-003
A molecular ID laboratory form would be MID-F-125.
4.4
Service agreements
Formal Service Level Agreements are in place between the WoSSVC and Health
Protection Scotland (HPS) for the provision of specialist Blood-Borne Virus work
and community acquired respiratory virus surveillance work.
At present these contracts require the laboratory to submit 6 monthly reports for both
the testing and financial status of the work involved. Regular meetings occur between
the Head of department /Consultant Clinical Scientist and HPS to discuss the
specialist testing service and to review testing protocols/new developments etc. No
specimens are sent to third parties. For details see MAN-SOP-034.
4.5
Examination by referral laboratories.
4.5.1
Selecting & evaluating referral laboratories & consultants
We aim to carefully select which referral centres we use, for the benefit of our users.
This will ensure that the quality of our service is not compromised by the actions of a
third party. Specimens are referred to other laboratories according to LS-SOP-022.
4.5.2
Provision of examination results.
We aim to provide accurate results for our users by ensuring that our procedures state
that we, as the referring laboratory, are responsible for ensuring the results from the
referral laboratory are delivered to the person making the request.
See MAN-SOP-001 (Reporting results).
4.6
Quality Manual
External services & supplies
We aim to continually improve the quality of our service by carefully selecting
suppliers, and by regularly reviewing their performance.
An annual review is made as the end of the financial year approaches and in due time
for raising standing orders for the new financial year. Services & supplies are
procured via a Managed Service Contract.
Consideration is taken of:
 Quality of service
 Professionalism
 Costs
 Contractual obligation
 Recent performance
 Availability of stock
 Time to delivery
 Partnership
Due consideration is afforded any material, kit or reagent before trial/demonstration
etc are commenced. Results are collated, users’ opinions sought and resource
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implications gathered before a decision is made with the service to the patient in
mind. See MAN-SOP-009 (Management of materials & reagents) for more detail.
4.7
Advisory services.
We aim to maintain close contact with our users in order to ensure that the service
meets their needs & requirements.
Communication with users is kept under constant review. In practice, this is achieved
by user-satisfaction questionnaires, meetings with specific key users and by
individual contact between the Head of department, TSM, Site Lead, Medical
Consultants and others who use the service. The Head of department, TSM, Site
Lead & Consultant Clinical Scientist ensure that users are aware how to obtain advice
about choice of examinations, clinical cases, interpretation of results, how to make
best use of the service and how to ensure specimens meet our acceptance criteria.
See MAN-Q-068 for more detail.
4.8
Resolution of complaints.
We aim to continually improve the quality of our service by building confidence in
our users that complaints will be thoroughly investigated and corrective action taken.
Assessment & resolution of user satisfaction & complaints is described in MAN-Q014 (Complaints procedure). The process is:1.
2.
3.
4.
5.
6.
4.9
To take all complaints seriously.
To deal with the client in a courteous manner.
To try to resolve the issue immediately at a local level.
To inform the client about the progress of the complaint.
To make corrective action as soon as possible.
To investigate root cause analysis to prevent recurrence.
Identification and control of non-conformities
We aim to ensure that nonconformities are effectively managed in order to build
confidence in our users and to continually improve our service. Non-conformity
reports are submitted to the quality manager as they arise, and cumulative data forms
part of the annual management review.
The pre-examination, examination and post-examination processes are particularly
important with respect to non-conformances. These are investigated by the Technical
Manager of each section who will take appropriate corrective action, co-ordinated by
the Quality Manager (MAN-Q-006 error logs).
Non-conformances are discussed with the Technical Services Manager, or another
member of the Virology Sector Group.
The identification and control of non-conformances is described in MAN-Q-032
document. Non-conformances are brought to the attention of the Technical Services
Manager.
Root cause analysis (RCA)
Removing the root cause of a problem is true corrective action (preventing
recurrence). This can be the most rewarding of quality tools but should be performed
by those trained in root cause analysis.
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RCA tools include:
Brainstorming
Brainwriting
Fishbone diagram
Barrier analysis
4.10
Corrective action.
We aim to investigate and, where possible, remove the root cause of nonconformities.
There is a process for continual quality improvement, which includes corrective action,
preventive action and improvement processes [MAN-Q-069, Quality Improvement &Root
cause analysis].
Identification & control of non-conformances is described in MAN-Q-032.

Corrective action for the identification and elimination of the causes of nonconformities
includes:
Investigation of nonconformities and recording of results.

Determination of, and responsibility for, corrective action.

Implementation of corrective action within an agreed time scale.

Monitoring of corrective action taken.
4.11

Preventive action.
We aim to take preventive action in order to reduce nonconformities and this includes:
Investigation of the causes of nonconformities and recording of results.

Determination of and responsibility for preventive action.

Implementation of preventive action within an agreed time scale.

Ensuring the action taken is effective, recorded and submitted for management review.
Evidence of corrective and preventive actions carried out resulting from internal audit
for the previous 12 months can be found in the Q-Pulse CA / PA record.
See MAN-Q-032 and MAN-Q-069 for details.
4.12

Continual improvement
We aim to ensure that the service provided by the WoSSVC meets the needs and
requirements of our users by having evaluation and improvement processes in place which
include:
Assessment of user satisfaction (MAN-Q-068).

A procedure for dealing with complaints (MAN-Q-014).

Regular discussion with users of the service to discuss service needs.

Participation in clinical meetings.

Internal audit of examination processes (MAN-Q-066).

Internal audit of the quality management system.

External quality assessment.

A process for quality improvement (MAN-Q-069).

Identification and control of non-conformances (MAN-Q-032).
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The results of these evaluation and improvement processes are available to staff and users as
required. Analysis, recording and interpretation of the data forms part of the annual review.
The results of the quality improvement programme form part of the development, training and
education of all staff. See also laboratory IQC & EQA procedures.
MAN-Q-069 describes measure used to ensure quality improvement is a continuous process.
Quality objectives (MAN-F-216) are set at the beginning of each year, after completion of the
Annual Management Review. They are regularly reviewed by the laboratory management
team.
Error logs, assessment reports and complaints are presented by the Quality Manager to
monthly senior scientific staff meetings as well as to the Annual Management Review.
Outstanding non-conformances are investigated by the Quality Manager/Technical Services
Manager, with timescales set for corrective action.
EQA/IQA and audits monitor quality indicators. Performance in EQA schemes are analysed
by the Technical Manager of the appropriate section and then summarised at the meetings.
Corrective action is taken as appropriate.
The Quality Manager will monitor that both remedial and corrective actions have been taken
and recorded.
User surveys, complaints and training are discussed by the Virology Sector Group and
information is disseminated to the staff during full staff meetings and Senior Scientists’
meeting.
Staff suggestions are encouraged by using a quality improvement note (MAN-F-227) which
can be returned anonymously if preferred by using the Suggestion Box. Staff
feedback/concerns are voiced at the full staff meetings.
4.13
Control of records.
We aim to adhere to the rules governing record control, in order to ensure accuracy &
availability of all aspects of our service. The process is defined in MAN-Q-003
(Document control & review). Records & specimens are stored in accordance with
RCPath & IBMS guidelines (see ED-9 in Q-Pulse). Quality records are available in QPulse or from the quality manager. Process records are stored at workstations or are
archived.Also see laboratory IQC procedures.
Reports of evaluations, quality assurance, external quality assessment, user satisfaction and
quality improvement are documented, indexed and stored.
Disposal of these records is in accordance with the NHSGG&C policy on confidential waste.
4.14
Evaluation & audits.
We aim to continuously interrogate our service by a system of audits, in order to detect
weaknesses before they cause an error. There is planned and scheduled internal audit of the
pre-examination, examination and post-examination processes against agreed criteria, by
personnel trained in internal audit.
The records of internal audit include:
 The activities, areas or items audited.

Any nonconformities or deficiencies found.

Recommendations and time scale for corrective and preventive actions.
The results of internal audit are regularly evaluated and decisions taken are documented,
monitored, reviewed and acted upon.
Audit findings are communicated to appropriate personnel. In addition audit records are
available for scrutiny within Q-Pulse.
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User satisfaction is assessed formally using a ‘user questionnaire’ which is distributed to
general practices and hospital departments. The data gathered is analysed, and areas for
improvement identified. Any further action will be implemented through the Virology Sector
Group. Informal meetings with microbiology users is undertaken by virology staff in person
during visits, or by telephone and e-mail interactions.
Procedures are in place for evaluating external quality assurance schemes (MAN-Q-004), and
the data are retained by the Quality Manager.
There is a procedure for logging errors in the laboratory (MAN-Q-006). These errors are
discussed at the Virology Sector Group. A record of corrective action is kept by the Quality
Manager which is reported to senior staff in a monthly report.
Quality/Service objectives are agreed at the Annual Management Review.
At the AMR, results of audits are presented by the Quality Manager. This report will highlight
any non-conformances identified and what mechanisms have been put in place to resolve
these issues.
4.14.3
Assessment of user feedback
A questionnaire is sent regularly to the main users of the service. Consultant staff attend
clinical meetings at a number of departments, for example the Princess Royal Maternity
Hospital and Bone Marrow unit.
The department is committed to meeting its quality specifications and performance targets in
all areas. Turnaround times are monitored on a monthly basis.
In conjunction with the users, the department assesses the clinical relevance of the laboratory
investigations performed, and the reliability of interpretive reports. There is full participation
in the evaluation of clinical governance, clinical effectiveness, audit and risk management
activities of NHS Greater Glasgow and Clyde.
User complaints are dealt with according to the Clinical Adverse Patient Incident Reporting
Policy, and the WoSSVC error log (MAN-Q-006). These are fed back to the staff either at
weekly meetings or via the Senior Scientist’s monthly meeting.
4.14.5
Internal audit
An internal audit program for the quality management system is established within the
laboratory (MAN-Q-066). This is a planned scheduled internal audit program using a set of
predetermined criteria, performed by trained auditors. The audit in undertaken by members of
staff trained in internal audit and who are ideally not working in the section under evaluation.
Any non conformities are identified and a time frame given for their correction. The audit
findings (non-conformances identified and corrective action taken) are presented by the
Quality Manager at the Annual Management Review.
4.15
Management review
We aim to regularly review our quality management system, in order to ensure its continued
suitability, adequacy & effectiveness in support of patient care.
4.15.2
Review input
The Laboratory management team conduct an annual review which considers the following
items of information (see MAN-Q-067)
a) the periodic review of requests & suitability of procedures & sample requirements
b) assessment of user feedback
c) staff suggestions
d) internal audits
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e) risk management
f) use of quality indicators
g) reviews by external organisations
h) results of participation in inter-laboratory comparison programmes
i) monitoring & resolution of complaints
j) performance of suppliers
k) identification & control of non-conformities
l) Results of continual improvement including current status of CA/PA
m) follow up actions from previous management reviews
n) changes in the volume & scope of work, personnel & premises that could affect the
quality management system
o) recommendations for improvement, including technical requirements.
Records are kept and key quality objectives for the subsequent year are defined and plans
formulated for their implementation.
5.0
Technical requirements
5.1
Personnel.
5.1.1
General
The staff are the most important asset in any laboratory. We aim to ensure that the WoSSVC
has sufficient appropriately educated and trained staff to meet the requirements of the service.
Staff records
The Human Resources Department of the Diagnostic Directorate of the Acute
Division of NHS Greater Glasgow and Clyde holds the complete staff record. The
Occupational Health Department holds vaccination records and the Pay Department
holds records of payments.
In addition, confidential staff records are kept by the Site Lead, see section 5.1.9 of
this Manual (page 24).
5.1.2
Personnel qualifications
Staffing numbers and qualifications are reviewed as part of the department planning process.
Training requirements are established as part of the process of e-KSF PDP and annual joint
review. Each member of staff has a copy of their own competencies (also kept electronically
by the department ) as part of their own record of training/continual development.
The WoSSVC has on its staff a named Quality Manager (Jane McOwan), a Training Coordinator (Alison Devanney) and a Safety Officer (Stephen Hughes).
The West of Scotland Specialist Virology Centre is staffed with the following grades
Head of Department
Medical Staff
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BMS Staff
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All Clinical Scientists and Biomedical Scientists staff are registered with the Health & Care
Professions Council. Medical staff are registered with the Royal College of Pathologists.
The following personnel have designated roles within the WoSSVC:Staff member
Dr. Celia Aitken
Dr. Rory Gunson
Mrs. Alison Devanney
Mr. Stephen Hughes
Ms. Jane McOwan
Mr. Graeme Gillespie
Mr Anthony Bimpson
5.1.3
Designated rôle
1) Head of department.
2) Training Co-ordinator
(medical staff).
Training Co-ordinator
(clinical scientist staff).
Training Co-ordinator
(BMS and MLA staff).
1) Technical Services Manager.
2) Safety Officer.
3) Training Officer(BMS and
MLA staff).
Quality Manager.
Deputy
Dr. E. Wilson-Davies.
1) I.T. Support.
2) Staff Side Representative.
Health & Safety Co-ordinator.
Ms Eileen Campbell
Dr. Amanda Bradley-Wilson
Mrs. Elaine Murray
Ms. Ann Hawthorn – Site Lead
Ms. Ann Hawthorn – Site Lead
Ms. Jane McOwan
Job descriptions
To allow each member of staff to know their duties, responsibilities and rights, they
are given a written job description. These include: Job title
 The location within the organisation
 Accountability
 Main purpose of the job
 Main duties and responsibilities
 Staff annual joint review
5.1.4
Personnel introduction to the organisational environment
This standard is fulfilled by compliance with procedures from the Human Resources
Department of NHS Greater Glasgow and Clyde.
The following procedures are included:
 Staff recruitment and selection (MAN-SOP-014)
 Staff orientation & induction, job descriptions & contracts (MAN-SOP-033)
 Staff records (Confidential records are held by the Site Lead).
 Staff annual joint review (MAN-SOP-011)
 Staff meetings and communication (See page 9 of this Quality Manual)
 Staff training and education (MAN-SOP-015 & MAN-SOP-022).
Staff orientation and induction
Records of staff orientation and induction are kept using the GG&C induction
template which is held in the staff record folder. A statutory and mandatory core
training day is also organised by NHS GG&C for all members of staff.
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5.1.5
Training
Trainee BMS staff participate in the Postgraduate Certificate and Diploma courses at
Glasgow Caledonian University according to the requirements set by the IBMS for
eligibility for HCPC registration. Trainee BMS staff are required to complete the IBMS
Competency Portfolio to enable them to become registered. Registrant BMS staff are then
required to complete the IBMS Specialist Portfolio in Virology. They are also actively
encouraged to participate in MSc courses. All trainee scientists and medical staff will
follow the appropriate training manual and maintain the log book. All trainees will be
reviewed on a regular basis on completion of each training section and in the annual
review.
Professional development of all staff is encouraged. A professional development system is
available via the Institute of Biomedical Science, and BMS staff are encouraged to
participate in this scheme. It is mandatory for all HCPC registered staff to demonstrate
continued professional development. The Royal College of Pathologists has a CPD scheme
for all College members in career grade posts (consultant and non-consultant); nonmedical and Clinical Scientists grades C and B are eligible to register. All specialist
registrars holding a CST may also participate. The scheme is open to non-members on a
fee-paying basis.
Rotation through the laboratory for less qualified staff is an essential element of training
for HCPC registration purposes. Qualified staff may also be expected to rotate as required
for the efficient running of the laboratory.
Training and Education Resources
a) There is good access to computers throughout the department. All staff have access to
the Internet, e-mail and library facilities through NHSGG&C IT. There is also access
to the University network and Library facilities. The laboratory subscribes to several
journals.
b) Staff are encouraged to attend and present data at meetings and conferences. There
are various interdepartmental meetings and journal clubs e.g. with the GUM and ID
units. The WoSSVC participates in the interdepartmental meetings (“grand rounds”)
at the Queen Elizabeth University Hospital. We also target meetings such as the
Scottish Diagnostic Virology Group and send as many delegates as possible. Staff
regularly attend diagnostic company user groups and update meetings.
c) There is limited funding available from the Directorate. Training would normally be
funded by any company providing new equipment or technology. We would also
expect to present the results of assay evaluations.
d) All training information is displayed on a designated notice board.
5.1.6
Competence assessments are saved in the computer ‘Common’ file, and records of
competency are held by the individual staff member.
5.1.7
Staff annual joint review is carried out in accordance with health board policy.
All staff participate in an annual joint review (e-KSF PDP) which includes
consideration of:
 e-KSF outline for the job role.
 The quality objectives and plans of the laboratory.
 The current job content.
 Documentation of training needs and agreed personal objectives with the
appraiser.
 Evidence that management has recognised the agreed development needs of
individual staff members.
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All staff performing e-KSF PDPs have been trained and records of all staff PDPs are
kept.
5.1.8
5.1.9
CPD
It should be noted that all of the WoSSVC groups/committees have a training element
and should be attended by trainees where possible.
Staff are encouraged to read the article in situ or take the article to a reading area and
return it on the same day, or they may photocopy it if it is required for reference.
Journals are available in the hospital library and on-line.
Each staff member should keep a record of all activities in a log book or equivalent.
Departmentally organised activities should be recorded on the Common file
(H:drive).
Personnel records are held in a locked file within the office of the Site Lead. These
files may be inspected by individuals at any time, but a witness must be present to
ensure the confidentiality of these files. Included in these files will be: Personal details.
 Employment details.
 Job description.
 Terms and conditions of employment.
 A record of staff induction and orientation.
 A record of attendance at fire lectures.
 A record of attendance at manual handling courses.
 A record of education and training.
 Relevant educational and professional qualifications.
 Certificate of registration with the Health & Care Professions Council
(HCPC).
 Occupational health record.
 A record of disciplinary action.
Records of competency will be held in the Common Folder.
Records of attendance will be held in the Common Folder in a password protected
folder.
Record of annual joint review will be available on e-KSF
Accident record will be recorded on Datix.
5.2
Accommodation & environmental conditions.
A laboratory requires sufficient space to ensure that work is performed safely & efficiently. We
aim to ensure that the WoSSVC provides a working environment in which staff can perform
required functions in accordance with national legislation and guidelines. The premises are a
state-of-the-art building which meets all current regulations for medical laboratory
accommodation.
The premises have space for:
 Specimen reception.

The functioning and use of all equipment.

Separation of incompatible activities (e.g. Office and laboratory).

Storage facilities.
Access to the premises is by swipe card entry via locked doors.
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The premises
The laboratory is housed in a modern refurbished floor on level 5 of the New Lister Building,
Glasgow Royal Infirmary. Visitors must be accompanied during their stay.
All equipment is sited according to manufacturer’s recommendations.
Specimen reception is sited at the entrance to the laboratory. Access to the laboratory for
visitors is controlled by specimen reception, with the aid of the CCTV “EnterLink” system.
Work is carried out in restricted areas, for example the Containment Level 3 (CL3) laboratory
on Level 4 of the building (controlled by swipe card entry and the CCTV “EnterLink”
system). The main office and senior staff offices are located in non white coat areas.
Health and Safety
All new staff must undergo an orientation and induction within the laboratory and attend
Statutory and Mandatory Core Training day. If new Clinical Support worker the GG&C
Induction handbook must be completed within three months of start date. They are directed to
read the Laboratory Safety Manual (MAN-SOP-013). There are Health & Safety updates for
all members of staff via weekly staff meetings and from the minuted health & safety
committee meetings.
Safety notices are displayed on noticeboards in the laboratory.
A Directorate Health & Safety Management Manual has been issued to record all health and
safety issues, including defects in the fabric of the building. This Manual is audited by the
Directorate Risk Management safety advisor.
Protective clothing (including white coats, gowns and gloves) and eye protection is provided
to each staff member.
Eye wash, spillage kits, first aid kits and a shower facility are available.
The Technical Services Manager is the Safety Officer and holder of the Health & Safety
Management Manual.
There is a New Lister Building health & safety committee which meets every three months,
and various safety audits are carried out during the year. A laboratory safety document is
given to all staff and visitors which must be signed and kept in their staff records.
The laboratory has consultant staff representation on the Glasgow Area Control of Infection
Committee. The laboratory reports regularly to public health and Health Protection Scotland
(HPS).
All health and safety procedures for the laboratory are in the Laboratory Safety Manual
(MAN-SOP-013).
The safety manual and H&S audits by staff help ensure a safe working environment.
The safety manual is supported by a full range of procedural & equipment SOPs, with
accompanying risk assessments. Staff are directed to read the safety manual at the time
of recruitment, and following any revision.






The following examples of procedures exist in the Health and Safety Manual:
Action in the event of a fire.
Personal safety.
Action in the event of a major spillage of dangerous chemical or clinical material.
Recording of accidents (Datix web based reporting).
Disposal procedures.
Microbiological hazards and precautions.
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 Specimen processing and handling.
 Control measures for blood borne viruses (BBV).
 Disinfection procedures.
 Management of sharps.
 Handling equipment.
Laboratory containment facilities conform to the requirements of the ACDP guidelines.
There is a procedure for performing COSHH /Risk assessments (MAN-SOP-026).
Safety notices for the benefit of staff and visitors to the WoSSVC are displayed.
Staff maintain clean, uncluttered work areas in keeping with good housekeeping practices.
A regular H&S quiz is held to reinforce the details.
CL2 & CL3 accommodation is provided. The Containment Level 3 suite is on Level 4 of the
building. The CL3 suite is maintained under contract by Crowthorne Ltd.
There is a joint Level 4 & 5 New Lister Building H&S committee which meets quarterly.
Occupational health monitoring is used where appropriate.
Communication systems include the LIMS, office telephone enquiry and contact details on the
GG&C website.
Chemical handling & waste disposal is described in the safety manual (MAN-SOP-013).
Spillage kits are provided. Safety rules for specimen collection & handling etc are contained in
LS-SOP-009 and specialist details are found in the user manual.
Reporting & monitoring of accidents & incidents is via DATIX & Q-Pulse, see MAN-Q-006.
Risk assessments & COSHH are dealt with in a combined format. The procedure is described
inMAN-SOP-026. Disinfection processes are described in the safety manual.
5.2.3
Facilities for storage
Dry storage facilities are located beside the Level 4 specimen reception area.
A walk-in cold room (4oC) is used for storage of diagnostic kits and reagents.
Flammable material is kept in appropriate bins (see Safety Manual MAN-SOP-013)
Freezer storage of reagents, biological material and clinical specimens is within the freezer
room and also in the laboratory areas.
Separate storage is available for process and quality records (MAN-Q-003, Document control
& review).
5.2.4
Staff facilities
A staff room (with adjacent kitchen) is provided for use by all staff and a cooled water
dispenser is provided.
Small personal lockers have been provided for all staff.
Toilet facilities sufficient for the number of staff are adjacent to the locker room. They
include a separate shower/changing area and specially designed toilets for disabled access.
There is a linen cupboard for clean white coats and gowns.
Staff do not require overnight accommodation.
5.2.5
Patient sample collection facilities
Patient facilities are not required within the laboratory.
5.3
Laboratory equipment, reagents & consumables.
We aim to ensure that sufficient & appropriate equipment is available so that service quality
is at the highest level. A commitment to this effect is included in the quality manual and in
document MAN-SOP-009. This includes rules for equipment procurement.
See the equipment inventory & laboratory equipment records for further details.
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Management of reagents, calibration and quality control material
Laboratory management ensures the availability of the reagents, calibration material and
quality control material required to provide a service which meets the needs and requirements
of users.
A procedure (MAN-SOP-009) is established for the management of reagents, calibration
material and quality control material that includes:
 Selection, purchasing and ordering.
 Assessment of suppliers.
 Receipt and verification of identity and condition.
 Issue and inventory management.
 Safe disposal.
The SOP for reviewing suppliers is MAN-SOP-025.
Materials in use are correctly identified with date of receipt, lot numbers and expiry.
5.3.1
Management of equipment
There is a programme of preventive maintenance, calibration & monitoring of equipment
(MAN-SOP-010).
The procedure contains instructions for:



Decontamination of equipment.
Recording instrument failure and corrective action.
Disposal of equipment in compliance with WEEE regulations.
Planned replacement.
An Inventory of equipment is maintained in Q-Pulse, which includes:
 Manufacturer’s name.
 Serial number.
 Date of purchase or acquisition.
 Maintenance contract.
The Estates department performs electrical safety testing (PAT) on a regular basis.
A decontamination certificate is issued before an engineer is allowed to work on the
appropriate item of equipment (EQP-F-068).
Equipment purchase and maintenance is arranged by ABBOTT Ltd via a Managed Service
Contract. Requirement for new equipment is highlighted to the Management Group via the
Laboratory Manager’s Group.
A business case is put forward to the Directorate for all new equipment, including upgrading
of existing equipment. Selection of appropriate equipment is based on laboratory
requirements and cost. Quotations/tenders are obtained from suppliers/manufacturers. A
safety assessment is carried out for the positioning of the equipment in the laboratory, and any
special requirements noted.
For all items over £5000, completion of a Capital Equipment Request Form is required.
For all items under £5000 (including IT equipment), the appropriate forms are submitted to
the Directorate for approval. A centrally held budget is available for equipment within this
category.
Training is directed by the supplier/manufacturer of the equipment, and where appropriate
both off-site and on-site training are given.
Maintenance agreements form part of the managed service contract, and scheduled service
visits are arranged with the Technical Services Manager.
Service and breakdown reports, and corrective action taken, are held in the Site Manager’s
office or filed in the equipment folders that accompany each piece of equipment.
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User, maintenance and decontamination procedures are described in equipment SOPs (EOPs).
Disposal of redundant/ broken equipment is arranged through the managed service contract,
and the equipment removed from the asset register.
Adverse incident reporting is through the GG&C IntraNet (DATIX).
5.3.2
Reagents & consumables
This is described in the management document MAN-SOP-009.
Laboratory management ensures the availability of reagents, calibrators, and quality control
material required to provide a service that meets the needs and requirements of users.
Purchasing of all materials is through approved suppliers. Materials are selected following
evaluation of their suitability by the laboratory. Orders are placed electronically onto the
supplies PECOS system or the MSC system as appropriate and, dependant on the value, are
authorised by appropriate staff. Orders up to £1500 can be authorised by the Technical
Services Manager and deputy, and orders are e-mailed to suppliers via the PECOS system.
Yearly Orders are placed with suppliers to ensure that appropriate stock levels are kept and
deliveries are received in a timely manner.
Reagents within the Abbott Managed Service Contract are ordered directly from Abbott by
authorised personnel via an electronic link:- the Abbott Reagent Management Software
(RMS). E-mail confirmation is received by the Technical Services Manager.
All other materials, either “stock” (i.e. NHS supplied), or non-stock items are ordered
electronically through the PECOS system by generating a unique order number, identified as
a WoSSVC order.
Materials are received in the laboratory at specimen reception. Deliveries are logged and
given a unique number. This number is also logged onto the delivery note. Goods are checked
for damage and to ensure that details are correct. Any discrepancies are brought to the
attention of the Technical Services Manager, and the supplier contacted. All materials are then
dated, and stored appropriately in accordance to the manufacturer’s instructions, and recorded
on stock control forms. When materials are in use they are removed from the stock control
forms, and are dated. Lot numbers are recorded on worksheets, as described in the
corresponding SOPs.
The SOPs also contain COSHH references and describe the appropriate handling precautions
and safe disposal of all materials. Materials in use are correctly identified with the date of
receipt, lot numbers, first use and expiry date.
5.4
Pre-examination processes.
We aim to ensure that our users are fully aware of our service in order that they can make the
best use of it. The information includes how to contact us, how to correctly send specimens
for analysis, and how to obtain clinical advice.
5.4.2
Information for users and patients
NHS Greater Glasgow and Clyde Health Board is the largest in Scotland. It provides a
comprehensive range of services from community-based care through the full range of
general hospital services to regional and national specialist services. General information for
patients regarding hospital services is available through the Greater Glasgow and Clyde
website www.nhsggc.co.uk
The WoSSVC is located on Level 5 of the New Lister Building, Glasgow Royal Infirmary.
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A specific user guide for virology is available via the NHS Greater Glasgow & Clyde
website:http://www.nhsggc.org.uk/virology
It contains the following information:
1.
2.
3.
4.
5.
6.
Contact details for the laboratory and key members of staff
Opening times and on call service
Guidance on test requests and specimen types according to disease presentation
Transportation of specimens
Trouble shooting
Quality control
Regular meetings are held with the users to discuss any issues or problems they may have and
as far as possible the service is tailored to meet their requirements. As this laboratory serves
other Scottish Regional Microbiology Departments, there is frequent dialogue between the
laboratories.
Yearly meetings are held with Commissioners from National Services Division Scotland.
No specific information for patients is required.
5.4.3
Request form information
Request forms are received from all over the West of Scotland. All forms should record the
following:
1. Unique patient identifier, name/number and date of birth
2. Identification and location of person requesting the test
3. Type of specimen
4. Collection date
5. Relevant clinical details
6. Investigations required
Within Greater Glasgow and Clyde all Hospital requests are electronic via the Trakcare
ordering system and GP requests are electronic via GP ICE ordering system.
Samples received from other Health Boards are not electronically ordered but are received
with written request forms.
When forms are incomplete, the source is contacted either by telephone, or by printed report,
outlining details required.
An urgent form for use in the laboratory is completed if a specimen requires urgent testing.
This urgent request normally originates from a telephone call to the laboratory. All other
request forms accompany the specimen.
5.4.4
Primary sample collection and handling
Specimen collection is undertaken by our users, guidance on appropriate specimens is
provided in the Virology user guidehttp://www.nhsggc.org.uk/virologyand is also available
directly from the laboratory.
Advice on specimen collection and handling is available from the laboratory on application.
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On introduction of a new procedure or a change to an existing procedure, the laboratory will
review sample volume requirements to ensure that neither insufficient nor excessive amounts
of sample are collected.
5.4.5
Sample transportation
Samples arrive in the laboratory by one of the following routes:

Pneumatic pod system: delivery from within Glasgow Royal infirmary

Porters: local delivery within Glasgow Royal Infirmary (urgent and routine),
including mail from the hospital mail room (including DX). Ward staff may also
deliver urgent specimens.
Van: Hospitals (Glasgow and surrounding regions), Health centres, and courier
deliveries
Taxis: Urgent samples (by arrangement).
Out of hours samples are sent to a secure storage container adjacent to the
GRI/Queen Elizabeth building security room. The on call BMS is responsible for
picking up the specimen from there.



Specimens are transported according to the NHS Greater Glasgow Specimen Transport Policy
(ED-15).
Specimens that are sent via the mail (or DX) comply with ADR 2005 regulations.
5.4.6
Sample reception
On arrival in reception, specimens are sorted and processed according to the Specimen
Reception Manual (LS-SOP-009).
This SOP includes procedures for identification of specimen and the processing of specimens
pre-testing. A bar coded label containing the unique laboratory number is attached to the
primary tube, the request card, and any other secondary container that the specimen is
separated into, either for archiving or processing.
If specimens are unsuitable the source is informed either by telephone or printed report.A
specimen acceptance/rejection policy is also available (MAN-Q-031).
CSW staff will sort specimens into their different groups (e.g.Chlamydia, Hepatitis, MID,
each with their own number stream). CSW staff will refer to designated Biomedical Scientist
staff for advice. Coding is performed both by BMS and / or clinical staff depending on the
investigation(s) required.
5.5
Examination processes.
We aim to use procedures that are selected to meet the needs and requirements of the users, in
order to make them confident that our test repertoire is designed for the maximum benefit of
their patients.
5.5.1
Selection, verification and validation of examination procedures
Prior to introduction, all examination procedures are validated for their intended use and the
methods used and results obtained are recorded.
When examination procedures are changed so that results or their interpretation may be
significantly different, the changes are explained to users prior to the introduction of the new
procedure.
The tests currently in use reflect the requirements of the users. Clinical algorithms have been
produced for various clinical areas of the hospital to guide test selection. All assays are
performed according to the relevant SOP and manufacturers guidelines (where relevant).
Assay performance is assessed on a run-to-run basis by including the relevant controls
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(positive, negative and internal). In-house assays are only implemented after full evaluation
which includes testing of known positive, negative and clinical specimens.
Assays are only changed after a full comparison of the new method with the old is made. The
new assay is only used if it offers clear advantages to the user and the laboratory, and is only
implemented after the results have been discussed at the audit and evaluation group, and
ratified by the Virology Sector Group. Validation & evaluation of test procedures is governed
by management document MAN-SOP-027.
The introduction of new in-house assays is based on published literature and internal
validation using known positive and negative controls. Clinical samples are also tested as part
of the evaluation before the assay is implemented. Assay performance using clinical samples
is then kept under review. All evaluation data is recorded.
If there is a major change to a test procedure where that change would significantly alter
interpretation of the results, then the users are notified in advance.
5.5.3
Examination procedures
Trained BMS staff, Clinical Scientists and medical staff are responsible for test selection and
coding. Selection is based on clinical details and user request. Users are contacted directly if
the case is complicated or it is unclear what tests are required.
The standard operating procedures (SOPs) for the conduct of all examinations are prepared
according to the Document Preparation and Control procedure (MAN-Q-003).
Procedures for the conduct of all examinations include the following:
 The purpose and scope of the examination.
 Responsibility.
 Definitions.
 Documentation (e.g. cross reference to).
 Safety considerations.
 Procedure (including limitations and QC).
 References.
 Appendices (where necessary).
Test SOPs are available as hard copy in the relevant laboratory in addition to the master copy
held electronically in Q-Pulse.
See MAN-SOP-027 for details of ‘Validation & Evaluation.’
For determination of uncertainty, see MAN-Q-070. This quality activity is also dealt with
in pre-examination checks, staff training, and IQC.
The SOPs are divided into each section, and are prefixed with that sections name (e.g. MID,
SER, MD, BBV). The SOPs are found in each relevant section, and a master copy held in QPulse.
Technical authorisation (qualified staff or trainees under supervision). After an assay has
been validated the report is released for authorisation. This provides an opportunity to assess
the clinical relevance of the result. For those assays where sequential samples are likely to
have been received, previous results are compared with those of the current assay.
Clinical authorisation (qualified staff or trainees under supervision). All interpretation of
results and finalising of reports are carried out according to the clinical algorithms.
5.6
Ensuring the quality of examination results.
We aim to use a wide range of procedures in order to detect errors and prevent release of
erroneous results. The WoSSVC has a comprehensive range of procedures for internal quality
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control (IQC) of all examinations, which verify that the intended quality is achieved. These
include:
 Records of date, source and storage of IQC material.
 A process for validation of IQC material prior to use.
 Appropriate statistical methods.
 Acceptance criteria for results with IQC material (e.g. Assay control parameters).
 Evaluation of IQC results with corrective/preventive actions taken and recorded.
Evaluation & quality assurance:- Ongoing evaluation & improvement processes are essential
to ensure that the service provided by the laboratory meets the needs & requirements of its
users. The quality of results is maintained by a system of internal quality control and external
quality assessment.
Run controls are available for BBV serology performed on the Abbott Architect, and data is
recorded in the Analyser QC package
In house molecular assays are monitored by firstly testing 20 times any new batch of controls,
setting +3/-3 SDs from the mean, and then comparing the positive control Ct value of each
run against these values.
MID-SOP-120 describes the Westgard rules for control of molecular tests.
All SOPs contain validation criteria for each assay.
5.6.3
Inter-laboratory comparisons
The West of Scotland Specialist Virology Centre participates in the National External Quality
Assurance Scheme (NEQAS) appropriate to the tests performed in the laboratory. The
Laboratory also takes part in Quality Control Molecular Diagnostics (QCMD) distributions
for molecular assays.
All results are communicated to staff at the Senior Scientists’meeting. When anomalies are
noted, this will be investigated by the Quality Manager/ Technical Manager of each section.
Preventive or corrective action will be taken as appropriate. Results obtained from the QCMD
distributions maybe referred to the Molecular Development Group for discussion and further
investigation, to eliminate the causes of potential non-conformances.
The operating procedure MAN-Q-004 details the testing, reporting and communicating of the
results to staff and dealing with anomalies.
The laboratory also participates in other schemes (HIV Resistance, HPE, Porton Down;
Influenza A H5, HPE, Colindale; Influenza A WHO, Hong Kong), and collaborates with
other laboratories for the exchange of positive control material etc. The laboratory also acts as
a pre-distribution testing centre for some QCMD panels (including the development of new
schemes), and has enrolled on pilot schemes run by QCMD.
5.7
Post-examination processes.
Review of results
We aim to ensure that authorised personnel review the results of our examinations in order to
ensure that patient safety is not compromised. The process is described in MAN-SOP-001
(reporting results).
5.7.2
Storage, retention & disposal of clinical samples
We aim to comply with all regulations concerning this aspect of our service, in order to
ensure that samples which must be stored are correctly handled, and samples which are
marked for disposal are dealt with in accordance with the relevant legislation.
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Storage, retention & disposal of clinical samples are described in procedure MAN-Q-036.
All specimens are given a unique number at reception. The patient and clinical information on
the request card are logged in the Laboratory TelePath computer system using the same
unique number.
Specimens are processed and stored according to SOPs available in the reception area.
All refrigerators, cold storage, freezer & ambient temperatures are checked and recorded on a
daily basis.
All specimens are disposed of according to the waste disposal policy, MAN-SOP-019.
All specimens are kept at 4˚C or -80˚C as appropriate. Selected specimens are stored
indefinitely (see MAN-Q-036). Extracted nucleic acid is stored for one month.
All clinical material is stored at the appropriate temperature to ensure validity of repeat
examination.
5.8
Reporting of results.
The report
We aim to produce reports which are clear and unambiguous and which contain sufficient
information to enable our users to interpret the results for accurate treatment of their patients.
MAN-SOP-001 describes the way in which reporting is conducted.
The WoSSVC issues reports of examinations on hard copy which include the following
information:
 The laboratory name and contact phone number.
 The name, date of birth and CHI number of the patient.
 The requesting individual and the source to which reports are returned.
 The specimen type and date of collection.
 Date of report.
 Examination result and reason if not carried out.
 Interpretive comments as appropriate.
 Highlighting of abnormal results.
Each of the SOPs has a specific section dealing with the recording and reporting of results,
which includes how to put the results into the TelePath system and their release for
authorisation. Details of clinical authorisation including verbal, faxed and urgent reports are
contained in the clinical algorithms. Users would be contacted directly (either by email or
telephone) in cases where delays could compromise patient care.
Turnaround times (TRTs) are reviewed weekly to reflect clinical need and laboratory
performance. TRTs are immediately checked as a ‘snapshot’ exercise in the event of concern
being expressed about a particular test.
5.8.3
Report content
The report exists in both an electronic and paper copy format. A final authorised version is
printed. TelePath records all changes made to a patient record, and the final report includes
the identification of the person authorising and issuing the report. A dedicated printer in the
department is used to print the paper reports. Clerical staff are responsible for sending the
reports out on a daily basis.
The electronic reports are viewable at certain sites within Greater Glasgow and a number of
the Microbiology departments outside the health board.
Referred reports are scanned into DART Viewer and scanned onto Clinical Portal whenever
possible. The original report from the referring laboratory is issued to the user.
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5.9
Release of results.
We aim to have procedures in place to ensure that the results of our tests are accurate and are
reviewed by authorized staff before release, in order to prevent any patient being endangered.
5.9.1
The telephoned report
Telephoned reports are issued by nominated staff according to the WoSSVC telephone
protocol. Details of telephone conversations are recorded on the TelePath “Notepad” screen.
The WoSSVC procedure MAN-Q-033 for issuing results by telephone includes:
 The circumstances in which reports may be given.
 The individuals who may issue results.
 The individuals who may receive results.
 A method of mutual identification of the patient between reporter and receiver.
 Confirmation of correct transmission.
 The mechanism for recording the event.
 Maintaining confidentiality.
 The process for sending a follow up report.
Clinical advice and interpretation
Clinical advice is given by senior members of medical and scientific staff or more junior
members under supervision. A series of comment codes are available to aid standardisation of
clinical reporting along with free text for more complicated interpretation. Clinical advice is
available 24 hours a day either in the laboratory (working hours) or via the hospital
switchboard.
Any changes to technical or clinical reporting are discussed within each section, and the
information is disseminated via the relevant meeting (Senior Scientist’s meeting, Clinical
Group, Molecular Development Group), and by memo.
5.9.3
Revised reports
Amended reports are issued when a problem with an assay has been identified. The procedure
is outlined in the relevant SOP/Clinical Manual. These incidents are recorded in the error log
along with the corrective measures implemented to prevent the error happening again.
Amended reports are only issued by a senior member of staff. Where more information is
required, an accompanying letter is sent outlining the course of action taken to rectify the
problem.
The WoSSVC procedure MAN-SOP-001for issuing an amended report includes:
 The criteria for issuing amended reports.
 Authorisation level of staff able to amend reports.
 The identification of amended reports to the user.
 A process of recording the issue of an amended report.
 The reason for issuing an amended report.
 Instigation of corrective and/or preventive action, if required.
 A process for archiving amended results.
5.10
Laboratory information management.
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We aim to ensure that our data storage ensures accurate records are maintained in a form that
is only accessible to authorised staff & users, in order to protect patient confidentiality.
The laboratory information system is TelePath, supported by other IT equipment for
specialised tasks and it is accessed by CSW, Biomedical Scientist, Clinical Scientist, Medical
and Administrative staff. Each group has its own privilege level. They are supported by the IT
Department of NHSGG&C.
I.T. security is governed by the Data Protection Act, NHSGG&C I.T. Policy, and local SOP
MAN-SOP-024 ‘Management of data & information’. Data and information are available to
provide a service that meets the needs and requirements of users.
The procedure MAN-SOP-024 for the management of data and information includes:






Security.
Access is password protected,
Confidentiality and data protection.
Back-up systems.
Storage, archive and retrieval.
Organised by NHS GG&C H. I.& T.
Safe disposal.
Elaine McCormick is the Microbiology IT Manager, and is supported in the WoSSVC by Mr.
Graeme Gillespie.
Most patient data is received in electronic format. Patient and specimen details are imported to
an electronic database (iSoft TelePath Microbiology module) by office / BMS staff. The entry
of these details sets the work patterns for the sections of the laboratory. The results are entered
either manually or via bi-directional analyser interfaces and reports generated.
The database is accessed via the GG&CIntraNet from PCs.
External access is also available for larger users.
Electronic downloading of reports occurs for our GUM users (Sandyford), and the antenatal
reports to the PNBS database.
Specimens from outwith NHS GG&C come with written request forms. Details are entered
manually into TelePath.
a)
Security of the network is provided by a firewall run by the IT department and personal
security passwords.
b)
Access to the database is password protected. Passwords are issued individually to staff
using the database within the laboratory and to larger external users for whom firewall
protected Internet access has been authorised.
c)
Confidentiality and data protection is afforded via the password protection system.
Within the database privilege levels can be set for each user, to limit access to specimens
and results.
d)
Database and system images are kept up to date so that the system could be re-created on
a new server if required. The laboratory system has been transferred to a central server
with in-built resilience - disk mirroring of the two servers.
e)
Data is backed up to two offsite servers daily, weekly and monthly. Retrieval of data
from both the “live” and “archive” systems is in real time via enquiry menus of the
database.
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f)
Disposal of patient information both in hardcopy and any discarded magnetic media is
via the Hospital’s confidential waste system.
Compliance with current national legislation and regulations for laboratories is considered by
the Directorate IT group. All relevant policies pertaining to confidentiality, security and data
protection can be found on the NHSGG&C IntraNet site.
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