SCARBOROUGH HOSPITAL PATHOLOGY LABORATORY
QUALITY MANUAL
This document together with specified procedure manuals represents the Quality
Management System of the Pathology Laboratory Scarborough and N E Yorkshire 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 Laboratory.
DATE OF ISSUE
SEPTEMBER 2012
REVIEW INTERVAL
Annual Review
AUTHORISED BY :
P. Sudworth
Directorate Manager
AUTHOR
Electronic versions are sent
to :
H E Price Quality Manager
Chief Executive Officer.
Medical Director
Director of Operations
Directorate managers for:
This document is available
on:
Trust’s Intranet website as a
PDF file

Surgery & critical care

Medicine

Women & Children
The Pathology website
Printed Copies are available
in:
Pathology :
Biochemistry
Haematology
Blood Transfusion
Histology
Microbiology
Pathology Office
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Note: This manual is under continuing review following the merger between the York and
Scarborough Trusts on the 1st July 2012.
See update list below.
Date
Update
1st July 2012
Directorate Manager post
Agreed corrections to quality policy following annual
management review meeting
1st September 2012
Change HBMS titles at Scarborough to Operation
Managers (OM)
Update the Clinical Heads appointments in each
department.
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CONTENTS
Page
1
GENERAL INFORMATION
4
1.1
1.2
1.2.1
Pathology Site
Pathology Service
Haematology and Blood Transfusion
1.2.2 Clinical Biochemistry
1.2.3
Microbiology
1.2.4
Histopathology
1.2.5
Mortuary Services
1.2.6
Infection Control
1.2.7
Phlebotomy
1.2.8
Pathology Office and Stores.
1.3
Pathology Security.
1.4.
User Groups and Meetings
1.5
Complaints procedure
1.6
Pathology transport
2
QUALITY COMMITMENT
2.1
The Quality Manual
2.2
Quality Policy Statement
3
ORGANISATION, RESPONSIBILITIES AND AUTHORITIES
11
3.1
3.2
Relationship to the Host Organisation
Organisation and Responsibilities within the Pathology Laboratory
12
4
THE STANDARDS
14
9
A Organisation and quality management system
B Personnel
C Premises and environment
D Equipment, information systems and reagents
E Pre examination process
F
Examination process
G The post examination phase
H Evaluation and quality assurance
All material associated with this document is held in a document control package EQMS
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1.0 GENERAL INFORMATION
1.1
Pathology Site
The Pathology Laboratory is part of Scarborough and NE Yorkshire NHS Trust.
The postal address
is:-
Pathology Laboratory
Scarborough Hospital
Woodlands Drive, Scarborough
North Yorkshire YO126QL
Tel: 01723 342356
Fax: 01723 500446
Information on the services provided and contact telephone numbers are available in a
series of publications and on the pathology website.
http://www.scarbo-rough.nhs.uk/pathology
There are 4 main departments:
Clinical Biochemistry
Haematology with Blood Transfusion
Histology with Mortuary
Medical Microbiology
These are supported by infection control team, mortuary services, phlebotomy services,
Pathology Office and stores.
1.2
Pathology Service
A comprehensive pathology service is provided from the Scarborough site. Served by
iSOFT (Telepath) laboratory data manager (LDM) it has 36 GP surgeries (including 2
GP access centres) electronically linked to receive pathology reports. The acute
service has access to electronic reports via the ICE 3 Desktop service.
3 of the 4 departments are accredited with Clinical Pathology Accreditation CPA (UK)
Ltd and undergo review in accordance with its standards. The Histology Department
holds conditional accreditation and will have a follow up inspection in October 2012.
Scarborough is an accredited training laboratory for Biomedical Scientists and fully
supports continuing medical and professional development.
The service operates out of a purpose built two-story building adjacent to the Accident &
Emergency Department. The laboratory testing equipment is modern with an active
replacement program in operation. All major analytical systems are bi-directionally
interfaced to the LDM.
All analytical equipment is used and maintained in accordance with manufacturer’s
recommendations and good laboratory practice and is appropriately serviced and
maintained by either the Trust or by the supplier/ independent contractor with whom
formal maintenance agreements exist.
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All areas are supported by a dedicated general office, stores and ancillary staff.
A GP specimen collection service, ward phlebotomy and an out reach GP Phlebotomy
blood collection service operate out of the laboratory.
1.2.1 Haematology and Blood Transfusion
Both Haematology and the Blood transfusion depts. Has a Lead Clinician, Operational
Managers (OM) and are supported by a clinical Haematology team led by consultant
haematologists from Hull and E. Yorkshire NHS Trust under a formal Service Level
Agreement. The SLA is between Scarborough NE. Yorkshire NHS Trust and Hull and E.
Yorkshire NHS Trust. The service provided covers:

A full Haematology service with routine diagnostic full blood counts, coagulation
screens, plasma viscosity and associated investigations.

An oral anticoagulation dosing service (DAWN) to general Practitioners

Transfusion service
The transfusion dept satisfies the MHRA good management practice standards in
accordance with the Blood Safety and Quality regulations 2005/50
The Hospital Transfusion Committee is chaired by the Medical Director and supported
by the Hull and E Yorkshire Haematology team, the lead consultant in the Emergency
Dept, directorate manager, Operational Manager (blood transfusion), Transfusion
Practitioner, quality manager as well as the NHS Blood and transplant hospital liaison
officer and Trust Consultants/ appropriate staff.
1.2.2 Clinical Biochemistry
Led by a Consultant Biochemist, a comprehensive service is provided including
specialties of therapeutic & drugs of abuse monitoring, catecholamine quantitation and
a wide range of hormone testing services. The analytical platform is very modern using
the most up to date methodology and electronic decision-making software to enable test
cascading rather than using a blanket approach to testing in the main.
1.2.3 Microbiology
There is a formal agreement with York Foundation Trust to provide consultant
microbiologist cover for clinical microbiology and control of infection offering a
comprehensive quality routine service that encompasses automated serology, some
virology and mycology. There are, at present 3 consultants in post providing a single
clinical service over the two sites. The Infection Control Committee covers both acute
and primary services.
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1.2.1 Histopathology
There is a Lead Clinician Based at York and three Consultant Histopathologists at
Scarborough, who support a full range of diagnostic histopathology including
immunohistochemistry, non-gynae cytology and andrology screening. Coroner’s post
mortem mortuary facilities are provided, overseen by this discipline. Each pathologist at
Scarborough has two areas of special interest, Dr R. Morgan covers Respiratory and
Urological Pathology, Dr M. Musa covers Gynae and Colorectal Pathology and Dr E.
Elhag covers Skin and Breast Pathology.
1.2.2 Mortuary Services
Scarborough Hospital is licensed with the Human Tissue Authority as a satellite location
under the York Trust license. The designated individual (DI) responsible for overseeing
compliance with the Human Tissue Act 2004 is The HBMS in Histology for York and
Scarborough Hospitals.
The mortuary facilities are covered by specific policies [Consent Policy CP07; Policy
for Bereavement care CP35] and standard operating procedures including
[procedures for the mortuary CID 3771] and [Porters’ duties in the Mortuary CID
5107] which govern this service
H.M Coroner post mortems, within the Scarborough catchment area, are carried out at
Scarborough Hospital under the coroners’ direction. All records relating to coroners post
mortems lie with H.M. Coroner.
At present the hospital post mortem service is suspended following a review of this
service. Coroners post mortems are continuing.
Separate office facilities exist in the mortuary for use by the consultants, coroners officer
and MTO staff
1.2.3 Infection Control
The Infection Control Team, overseen by the Director of Infection, Prevention and
Control, has primary responsibility for all aspects of surveillance, prevention and control
of infection in the acute Trust 24 hours per day.
The infection control committee reports to the Clinical Governance and Trust Board who
monitor the quality of the service.
The acute infection control team strive to maintain links with primary care via liaison with
the Consultant in Communicable Disease Control, the community Infection control
nurse and the environmental health officers.
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1.2.4 Phlebotomy
There is a phlebotomy service available to participating general practitioner surgeries in
the Scarborugh area where (in house) trained phlebotomists see patients in the surgery,
thus avoiding the need for them to visit the hospital for their blood tests.
A list of participating surgeries is available from the phlebotomy manager
There is a phlebotomy service for patients attending out patients clinics (OPD) for
investigations.
There is a daily (morning) blood collection service to all wards (except ITU and
Children’s) at Scarborough Hospital.
The phlebotomy manager conducts regular phlebotomy training sessions.
1.2.5 Pathology Office and Stores.
There are designated sites for specimen reception;

For bulk receipt – separate secure room at the entrance to Pathology

Specimen reception area adjacent to the working laboratories on the
ground floor
There is a separate main Laboratory store with its own staff entrance and separate
goods reception.
All materials used in the analytical process are kept in appropriate secure storage
conditions as recommended by the supplier(s), good stock control and stock rotation is
followed.
1.3
Pathology Security.
All perimeter doors have digital coded locks. Main access doors in the laboratories (on
both floors) are controlled by electronic fob lock access.
All blood (issue) banks at Scarborough, Bridlington Malton, and Whitby Hospitals are
kept locked with limited, documented key access.
All staff members have small secure lockers for personal effects. All staff is issued with,
and must wear, personal I.D. badges which bear photographs. All staff is issued with an
electronic fob to activate the security doors within pathology
All visitors to pathology must both sign in and out at the main office reception. They are
issued with a visitors badge whilst on the premises. All visitors are accompanied to the
relevant staff member if they have to enter the main laboratory area.
1.4
User Groups and Meetings.
Visits to G.P surgeries can be organised in association with the directorate manager
and are usually undertaken by the appropriate senior staff as required. Communications
are maintained by the quality manager as required to discuss issues of interest to the
practice and inform them of proposed change and development of laboratory service.
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When invited the directorate manager, quality manager and other head biomedical
scientists go to the GP group meetings and practice managers meetings.
Meetings with medical and surgical consultants and senior managers take place
throughout the year. Feedback is obtained from specific user and patient forum groups
as relevant.
There is a laboratory webpage for general laboratory information.
http://www.scarborough.nhs.uk/pathology
1.5
Complaints procedure
All written formal complaints received, either directly or from the Trust’s risk
management group or Patient Advice and Liaison Service (PALS) are forwarded to the
directorate manager who will either respond directly or delegate the issue to the
appropriate department operational managers. Full documentation is held on file
(manual and electronic) and responses are formulated as quickly as possible in line with
Trust requirements. All due investigations made are communicated to those relevant
staff in each case.
A file of received “Incident” reporting sheets is held by the quality manager with
attached correspondence/ notes as applicable.
Incident reporting forms for staff use are available outside the quality manager’s office.
However a new electronic format is being rolled out to eventually replace the paper
format All staff is aware of the need to report all incidents / accidents regardless of
severity, grade of staff, time of incident.
A record of complaints, issues and letters of thanks is kept by the quality manager.
1.6
Pathology transport
Paper (hard copy) reports are delivered to wards via the internal messenger service.
There is a daily transport service delivering paper reports and consumables to other
hospitals and GP surgeries.
Transport times are available from the laboratory office and are listed on the pathology
website http://www.scarborough.nhs.uk/pathology
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2
QUALITY COMMITMENT
2.1 The Quality Manual
This quality manual describes the Quality Management System (QMS) of the pathology
laboratory and it provides information for users and for inspection/accreditation bodies.
The format of the quality manual allows correlation with latest version of CPA (UK)
Standards and lists specific documents required by these standards. These standards
relate to each other in the following manner Section A describes the organisation of the
laboratory and its quality management system which uses resources (Sections B and
D) to undertake patient sample 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, and, where required, improve the quality management
process and to ensure that the needs and requirements of users are met.
Paragraph 4 in the
Quality Manual
Section of CPA Standards
Section A
Organisation and quality management system
Section B
Personnel
Section C
Premises and environment
Section D
Equipment, materials and reagents
Section E
Pre-examination process
Section F
Examination process
Section G
Post-examination process
Section H
Quality assurance and evaluation Staff development
and education
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2.2. Quality Policy
The Quality Statement of the Scarborough Pathology Laboratory is given below. This
statement forms part of a Trust Policy Document and is published on the pathology
website. A copy signed by the Clinical Head of Services is displayed in the laboratory
PATHOLOGY QUALITY POLICY STATMENT
The Quality Statement of the Pathology Laboratory, Scarborough Hospital
A comprehensive pathology service is provided from the Scarborough site incorporating 4 main
departments of Clinical Biochemistry, Haematology with blood transfusion, Histology with mortuary
facilities for coroners post mortem and Medical Microbiology.
The Laboratory is committed to providing a 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 Laboratory will:

operate a quality management system integrating the organisation, procedures, processes
and resources, which shall be reviewed annually to improve the service by continuing
evaluation.

Set quality objectives and plans in order to implement this quality policy.

Ensure that all personnel are familiar with this quality policy and quality manual and all
procedures relevant to their work to ensure user satisfaction.

Commit to the health, safety and welfare of its entire staff, who will comply with relevant H&S
legislation. Visitors to the laboratory will be treated with respect and due consideration will be
given to their safety while on site.
 Uphold professional values and commit to good professional practice and conduct.
The Laboratory is committed to:

staff recruitment, training, development and retention at all levels to provide a full and effective
service to its users

the proper procurement and maintenance of such equipment and other resources as
are needed for the provision of the service including qualification and validation of tests, kits
and equipment.

the collection, transport and handling of all specimens in such a way as to ensure the correct
performance of laboratory examinations

Upholding all data quality and data protection regulations.

ensure compliance with appropriate environmental legislation in accordance with trust policy

the use of examination procedures that will ensure the highest achievable quality of all tests
performed

Reporting results of examinations in ways which are timely, confidential, accurate and
clinically useful.

Maintain and continually update the electronic user handbook.

Assess user satisfaction, in addition to internal audit and external quality assessment, in order
to produce continual quality improvement.

Continuing compliance with CPA (UK)Ltd accreditation standards
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Signed on behalf of the Laboratory:
….……………..…………………………………….Clinical Director
Date……………………
3 ORGANISATION, RESPONSIBILITIES AND AUTHORITIES
3.1 Relationship to the Host Organisation
The Pathology Laboratory is part of the Scarborough and NE Yorkshire NHS Trust. The
organisational relationships within are shown below:
Scarborough and NE Yorkshire Trust Management structure
Note. Scarborough and North East NHS Trust underwent acquisition with York Teaching
Hospital NHS Foundation Trust in July 2012 and consequently all organization and staff
structures are under review, and will be updated as the new structures are released.
Chairman of the
Board
Non
executive
Director
Non
executive
Director
Medical
Director
CEO
Director
Of
Director of
Operations
Director of
Finance and
Procurement
Nursing
Director of
Facilities
Integration
Lead
& patient
Administration
Non
executive
Director
Non
executive
Director
Division of
Emergency
Care
Non
executive
Director
Division of Clinical
Support
Division of
Women &
Children
Division of
Elective
Care
Pathology
Laboratory
Awaiting New Structure following merger on the 1st July 2012
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Division
of Critical
Care
SCARBOROUGH HOSPITAL PATHOLOGY LABORATORY
3.2
Organisation and Responsibilities within the Pathology Laboratory
The Clinical Director for Pathology acts across the 2 sites and is responsible to the
Trust Medical Director for the quality and scope of the service provided by the pathology
laboratory, its consultant pathologists and Biochemist.
The Directorate Manager for Pathology acts across the 2 sites and is responsible for all
staff and aspects of service provision and organisation and is also the budget holder.
The Quality Manager is responsible for the implementation and coordination of the
quality management system. The quality manager has defined authority for coordinating
awareness of the needs and requirements of the users. The quality manager also sits
on the clinical governance board for the Trust and represents pathology at the clinical
support division board meeting.
Each department has a designated quality control officer who coordinates the QC
programs and analyses results to identify trends and potential non conformance. Any
and all anomalies are reported to the quality manager.
The Training Forum is responsible for coordination of training programs for all staff and
students. Each department has a training coordinator to facilitate the training programs.
There are regular meetings held to evaluate training needs and requirements.
The laboratory is divided into 4 departments. A medical consultant or scientist of
equivalent standing is in clinical charge of each department. The Operational manager
(OM) of the department is responsible for its operational organisation. OM’s have a
professional responsibility to their respective clinical head of department for the quality
and scope of the analytical work performed in their department.
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Pathology Management & Organisational Structure & Staff Levels
CEO
Medical Director
Director of
Operations
Clinical Head of
Pathology
Clinical Support Divisional
Manager
(Clinical lead)
(Technical Lead)
Microbiology
Haematology
Histology
&
& Blood
transfusion
& Mortuary
COI
Support
Biochemistry
Services
Quality Manger
Consultants 3*
OM
SBMS
1
3
BMS (6)
5.23
BMS (5)
2
AMLA (3)
2
MLA
4.02
IC nurse
4.6
Consultant team
(Hull)
OM
2
SBMS
2.8
BMS
6
MLA
3.8
TP Nurse
0.4
Consultants 3
OM
1
SBMS
1.6
BMS
2.0
MLA
3.5
MTO
1
Porter Staff for
mortuary duties
only
Consultant 1
Office Manager
1
Biochemist 1
HC0
1
OM
1
CO
2
SBMS
3
Phlebotomy Manger 1
BMS (6)
5.53
Phlebotomists
BMS (5)
3
Store man/ /MTO
1
MLA (2)
6.92
Storeman
1
Quality/ IT manager
1
Awaiting New Structure following Trust merger on the 1st July 2012
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11
SCARBOROUGH HOSPITAL PATHOLOGY LABORATORY
4 THE STANDARDS
Section A: ORGANISATION AND QUALITY MANAGEMENT SYSTEM
A1
Organisation and management
The organisation and management structure is detailed in section 3 of this manual
A2 Needs and requirements of users
Laboratory management aims to keep the needs of the users under constant review;
this is done through a communication link between the quality manager and all G.P
surgeries, and various meetings and communications between the laboratory service
manager and user groups both in the acute and primary care service, meetings
between department heads and their consultant peers.
A3 Quality policy
The quality policy of Scarborough Pathology Laboratory is detailed in section 2 of this
manual
A4 Quality management system
The components and relationship with the quality management system are outlined
under standards A5 to A11. Roles and responsibilities for the laboratory management
are clearly defined in section 3.2. Monthly pathology business meetings and the annual
management review meeting are pivotal in ensuring the quality management system
for pathology is maintained in accordance with standards and users requirements’. The
quality manager maintains communications with the general practices and the quality
manager, business manager and clinical head of service sit on trust committees
relating to strategic and governance issues. There is an electronic document control
package. The audit program for the quality management system covers CPA standards
A, B, C, D, and H and also allows for audit of any potential non conformity as they
arise.
A5 Quality objectives and plans [Quality Objectives CID 2101]
Laboratory management defines the quality objectives in consultation with users and
other departments and is responsible for developing plans to meet these objectives.
The management review is undertaken to determine if objectives have been
successfully completed and provides an opportunity for revision of these plans and
development of the function of the quality management system.
A6 Quality manual [CID 1811]
This manual is maintained by the quality manager, who is responsible for ensuring that
it is kept up to date and available to laboratory users. The manual contains the quality
policy and an outline of quality management system, a description of the
documentation used, organisation charts and indicated the correlation between the
quality management system and CPA standards
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A7 Quality manager
The quality manager for Scarborough Pathology Laboratory is: Ms H. E. Price. The
quality manager works with senior laboratory management to design, implement and
maintain the quality management system. The quality manager works with respective
department leads to ensure the proper operation of the QMS within each department.
The quality manager has defined authority for coordinating awareness of the needs and
requirements of users.
A8 Document control
Scarborough laboratory uses an electronic document control system (EQMS) to ensure
all documents are controlled and the processes for control are detailed in the document
[Procedure for document management and production in EQMS CID 1806] which
is in accordance with this standard.
A9 Control of process and quality records
Policy and procedure are in place [Policy for the management of pathology records
and material CID 1832 and the procedure for the management and disposal of
clinical material and pathology records CID 1922] to ensure the appropriate control
and process of documents which have been developed to ensure national and CPA
guidelines. These procedures ensure documents are identified, recorded and retrieved
and achieved in accordance with these guidelines.
A10 Control of clinical material
There is a policy in place ( see above) [CID 1832] to ensure the all clinical material is
appropriately identified, recorded, stored and disposed of in accordance with national
and CPA guidelines.
A11 Management review
Laboratory management conducts an annual management review [Management
Review CID 3604] to monitor the on going effectiveness of the quality management
system and to develop key objectives, training and development programs for the
Laboratory to satisfy users’ needs and requirements.
An executive summery is sent to CPA (UK) Ltd annually after the review meeting.
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Section B: PERSONNEL
B1
Laboratory Director:
Scarborough Pathology laboratory is professionally directed by the Clinical Head of
Service. This post is held by the Consultant Clinical Biochemist who is also the clinical
director for the clinical support division.
The Consultants staffing covering Scarborough is
One Clinical Biochemist
Haematology team led by the consultant haematologist from Hull & E. Yorkshire NHS
Trust
Three Clinical Microbiologists covering both Scarborough and York
Three Clinical Histopathologists
B2 Staffing
Laboratory management ensure that staffing levels, with the required education and
training are appropriate for the demands of the service. The staffing structure is
demonstrated in section 3.2 of this manual.
All qualified biomedical scientists are state registered with the Health Professions
Council (HPC) and registration is checked against the HP data base.
To comply with CPA standards the staffing includes individuals with the following roles
a)
quality manager (A7)
HE Price
b)
training and education (B9)
Laboratory training forum*
c)
health and safety (C5)
Laboratory H&S forum*
*The forums are made up of representatives from each department and is headed up
by one of the group on a rotational basis
B3 Personnel management
This is supported by trust policies and laboratory management procedures (listed
below) ensuring CPA standards are maintained.
B4 Staff Orientation and induction
Laboratory management ensures that all staff participates in the Scarborough Trust
staff induction programme, which is supported by a specific pathology induction
package [Laboratory induction procedure CID 99] and completion of the trust
induction check list. A record is kept of participation in the induction programme in
staff personnel records
B5 Job descriptions and contracts
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Each staff member has a job description, post outline profile and contract of
employment which is in compliance with current legislation and provides clear terms
and conditions of service.
B6 Staff records
All staff records are held either in the laboratory office or by trust’s human resources
department in a secure environment. The contents of personnel files are maintained in
accordance with trust and CPA standards. Personnel files are accessible to directorate
manager, heads of dept, quality manger and the individual only, on written application.
B7 Staff annual joint review [AfC]
Laboratory management ensures that all staff participates in an annual development
review in accordance with KSF guidelines and CPA requirements covering
performance, training needs and goals and the plans and objectives of the laboratory.
All staff conducting annual joint review is trained and staff participating is given a full
explanation of the process. Records are kept in staff personnel records.
B8 Staff Meetings.
Regular management and staff meetings are conducted to maintain good
communications and to disseminate information on all aspects of laboratory service
Minutes of these meetings are kept and are available to all staff in an electronic format
Clinical Support Division Board Meeting
Head BMS/
QM Group
Health and
Safety Forum
Departmental
meetings
.
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Training and
Development
MANAGEMENT REVIEW AND PATHOLOGY
OBJECTIVES
Pathology Business Meeting
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SCARBOROUGH HOSPITAL PATHOLOGY LABORATORY
Pathology Business Meeting
Chaired by the directorate manager and held monthly.
The pathologists, quality manager, heads of departments attend.
Dept Lead/ QM Group
Monthly, chaired by the quality manager with the heads of departments and invited
individuals.
Health and safety Forum
Quarterly (or as required); representative from each department and quality manager.
3 yearly rotation lead
Hospital Transfusion Team
Operational Manager blood transfusion, directorate manager, transfusion practitioner
and quality manager, invited individuals
The Training & Development Forum
Bi yearly: Department training officers.
Laboratory Departmental Meetings
Monthly: All department staff
Management Review and Pathology Objectives Meeting
Annually (May and October): chaired by quality manager. The directorate manager, all
pathologists, department heads and specialist leads including control of infection,
finance, training, H&S. Representatives of user groups are invited.
Joint laboratory Strategic Board:
Monthly or as required: Directorate Managers, Clinical leads, HBMS and OM from Both
Scarborough and York
Strategic Committees: Note: All these meeting are under review and will be modified as part
of the York & Scarborough Trust merge
The needs and requirements of users is also monitored by the following, with
appropriate Pathology representation.

Performance management group – Directorate Manager

Clinical Directors meeting – Pathology Clinical Lead

Executive meetings - Pathology Clinical Lead

Performance Meeting – Directorate Manger and Clinical Lead

Risk Management Group – Quality Manager

Mortality Review group - Directorate Manager or assistant manager
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
CCMG (Corporate Clinical Management group) – Directorate Manager

Medical Staff Committee – All Consultant Pathologists

Clinical / other audit – Senior staff as appropriate

Trust Health and Safety Committee – Lead H&S Forum

Trust Communications Group (review). - Office Manager.
Strategic Meetings with Pathology representation

Lessons learn group – Quality manager

Medical Equipment replacement Group – Directorate Manger
B9 Staff training and education
All trainee biomedical scientists are following the prescribed course of study to achieve
state registration as defined by the Health Professions Council (HPC). A designated
training officer oversees all staff training under the responsibility of the directorate
manager.
The department is a recognised training laboratory for biomedical scientists as
designated by the Institute of Biomedical Scientists (IBMS) and the Health Professions
Council (HPC)
Completed and signed induction log sheets are held in personal staff records in the
Manager’s Office. The Trust HR department also keep computerised (Prism) staff
training records. Both sets of records can be viewed by the relevant staff member upon
request.
Immunisation records and health records are kept by the occupational health
department on behalf of the trust.
There are training and education programs for all staff members in accordance with
guidelines from the relevant professional and registration bodies and all staff are given
the opportunity for further education and training in relation to the needs of the service
and their professional development.
Each department has a training officer and all trainee staff has a designated supervisor.
Facilities are available for access to reference material and information services (Post
Graduate Medical Centre Internet and Intranet facilities in each pathology department
and an Internet café for staff use). Records are kept of all training and education in
personal folders and logged by the department training officers.
Section C: PREMISES AND ENVIRONMENT
C1 Premises
The Laboratory is a purpose built building which provides a working environment in
which staff can perform required functions in accordance with national legislation and
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guidelines. Access to the laboratory is restricted to authorised personnel using coded
locks and electronic security doors
C2 Facilities for staff
The premises have staff facilities that are readily accessible and include toilet, changing
and secure storage areas for personal effects. There is a rest area with basic catering
facilities. There are two dedicated rooms for secure overnight accommodation, as
required, situated in the main hospital building.
C3 Facilities for patients
There is a waiting/reception area with separate toilet facilities and access for disabled
persons, a phlebotomy area which offers privacy and recovery facilities and facilities for
specimen collection.
There are notices advising patients and visitors of health and safety precautions and a
leaflets containing information relating to pathology, test procedures and PALS;
C4 Facilities for storage
There are separate storage facilities as required by CPA standards and in accordance
with national guidelines and regulations, for records, clinical material, blood and blood
products, hazardous substances, drugs and reagents and waste material.
C5 Health and safety
The Trust has overall responsibility for the health & safety of all staff, visitors and
patients. The Trust employs a health, safety and security officer, and the laboratory has
a health & safety forum with links to the Trust H&S board. The laboratory maintains a
Health & Safety Manual [Health and Safety Information and Training Guide CID
3388] which contains procedures to meet all CPA specified requirements. All laboratory
staff is aware of and trained to meet their responsibilities relating the Health and Safety.
All laboratory containment areas conform to ACDP guidelines. There is a Trust wide
waste management policy and all staff attends mandatory training in handling and
lifting, fire awareness and control of infection. As the laboratory working area is small
good working practice ensure the work area is clean, uncluttered and well maintained.
Section D: EQUIPMENT, INFORMATION SYSTEMS AND REAGENTS
D1 Management of equipment
Laboratory management ensures equipment is sufficient and appropriate to provide the
service required. There is a document [Management of equipment, procedures for
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procurement, receipt, installation and maintenance CID 1809] which is written to
satisfy CPA standards and The Trust equipment policy.
An inventory of equipment (asset register) is maintained by the Medical Engineering
department and all electrical equipment is checked by the facilities department and
records are kept of safety compliance.
D2 Management of data and information
Data and information are available to provide a service that meets the requirements of
users. There is a procedure [Procedure for the management of data and
information CID 3389].The laboratory uses a document control package for all internal
and external data, procedures, manuals and records. The document control package,
webpage and electronic results service are controlled and coordinated by the quality
manager. Laboratory management ensures compliance with current national legislation
and regulations in relation to data protection.
D3 Management of materials
Laboratory management ensures the availability of reagents, calibration and quality
control material required to provide a service which meets the needs and requirements
of users. [The procedure for the management of reagents, calibration and quality
control material CID 3390] addresses these CPA specifications.
Section E: PRE EXAMINATION PROCESS
E1 Information for users and patients
Information for users is available from the Pathology website
www.scarborough.nhs.uk/pathology Web pages are stored on EQMS in document
[CID 2136]. The Trust website http://www.scarborough.nhs.uk/ has information relating
to the whole trust. This was prepared in consultation with users and complies with the
CPA requirements. Information for patients can also be obtained from the PALS points
and information available, where necessary, in the Laboratory waiting area
The Trust is at present introducing electronic requesting for pathology services. This
program is being piloted in 2 GP surgeries, rolling out to all GP surgeries in 2011.
Electronic requesting (Order Comms) within the acute service is also planned to roll out
in 2011
E2 Request form
The request form has been designed to include all information require to conduct the
appropriate tests in accordance with CPA specification Laboratory management
encourages the proper completion of the form and further information can be found in
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the user handbook. This form will be replaced by the new electronic request form as
the new system rolls out.
E3 Specimen collection and handling
Laboratory management has procedures including [Procedure for Handling Clinical
Samples Including High Risk Samples CID 79] for specimen collection and handling
that complies with CPA standards. These procedures are available to users of the
service and those who are responsible for specimen collection and handling. Further
information regarding specimen collection and handling is available on the user
website.
E4 Specimen transportation
The Laboratory has a procedure [Transport of specimens to the laboratory CID 78]
dealing with the transportation of specimens, which ensures the safety of the courier,
the general public and receiving laboratory by stipulating the correct packaging and
labeling of the samples to prevent their deterioration. This procedure ensures all
regulatory requirements are met and couriers work in accordance with model rules for
specimen transportation
E5 Specimen reception
Laboratory management has procedures for specimen reception including [specimen
reception CID 569] which details specimen reception procedures in all areas of the
laboratory including linking the samples to the form, recording all relevant information
including date and time received and ensuring staff safety especially when handling
urgent of high risk samples.
There is also a procedure for specimen rejection [Procedure for Sample rejection
CID 2425] which clearly states the criteria for rejection, how this information is recorded
and notified to the users concerned
E6 Referral to other laboratories
Some samples require specialist investigations which involves referring them to other
(reference) laboratories. The laboratory has a procedure [The Procedure for Dispatch
of Postal Samples CID 19] for referral. A list of laboratories used is held by the quality
manager and published on the website. Information relating to their accreditation status
and turn round times is obtained by questionnaire.
Section F. EXAMINATION PROCESS
F1 Selection and validation of examination procedures
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All examination procedures are validated prior to introduction. Such validation
incorporates the requirements of users and any change in procedures is notified to
users prior to introduction. Validation records are held in the relevant departments.
F 2 Examination Procedures
Laboratory procedures (SOPs) for the conduct of all examinations are prepared in
accordance with the procedure [Procedure for document management and
production in EQMS CID 1806] this document defines the format and content of all
procedures to ensure CPA requirements are
One formal hard copy of all procedures is available in the appropriate departments and
sections of the laboratory. These documents are held in a document control package to
ensure an audit trail of all modifications is maintained and they are subject to formal
review.
F3 Assuring the quality of examinations
All departments within the laboratory have procedures for internal quality control of all
examinations which verify that the intended quality is achieved. The management of
this is part of the QMS [Procedure for the management of internal quality control
CID 3393]. Records for IQC are maintained which include information regarding IQC
material, appropriate statistical procedures and, where needed, acceptance criteria for
the results obtained. These records are evaluated and any subsequent corrective and
or preventative actions taken are recorded
Section G: THE POST EXAMINATION PHASE
G 1 Reporting results
It is the intent of Laboratory management to produce results and reports which are
correct, timely, unambiguous and clinically useful. There is a procedure [procedure for
the reporting of pathology results CID 3394] which includes information on, the final
report, processes for telephoning and amending reports and the availability of clinical
advice.
G2 The report
The Laboratory produces reports in hard copy and electronic format. The report format
complies with the requirements of users and CPA standards and contains sufficient
information to ensure the user can interpret the result. Clinical advice and interpretation
is available.
Where results have come from referring laboratories such information is relayed to the
users with any and all supporting information.
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All reports are handling and transmitted in such a manner to ensure confidentiality is
maintained
G3 The telephoned report
It is not normal practice to telephone reports however it cases when it is considered
necessary the procedure [Telephone (and fax) Procedures CID 18] outlines the
laboratories protocol which complies with the CPA requirements the circumstances in
which reports may be given.
G 4 The amended report
Occasionally it is necessary to amend reports the [Procedure for resolving report
error CID 21] outlines the circumstances and reasons for issuing an amended report
including a check list to ensure all corrective and /or preventative actions have been
taken
G 5 Clinical advice and interpretation
Interpretation of results and clinical advice is available from the Laboratory. All clinical
comments and interpretation is authorised by appropriate medical or consultant clinical
staff.
Section H: EVALUATION AND QUALITY ASSURANCE
H1 Evaluation and improvement processes
To ensure the services provided by the Laboratory meets the needs and requirements
of the users’ laboratory management has procedures to satisfy the requirements of this
standard as outlined below in sections H2 to H7. A full evaluation takes place annually
at the management review meeting.
The outcome of these evaluation and improvement processes are made known to staff
at departmental staff meetings. Any service improvements of modifications are made
know to users by letter, the Intranet (acute service) and the Pathology website prior to
modifications to allow comment and discussion. Change control documentation
[Procedure for change control CID 1810] is used for all service modification.
H2 Assessment of user satisfaction and complaints
Laboratory management assesses user satisfaction by conducing management review,
developing objectives to improve service and establish processes for obtaining and
monitoring data on user satisfaction and complaints. Users’ comments are recorded,
reviewed and acted upon. Performance targets information is available. Laboratory
staff participates in the evaluation of clinical effectiveness, audit and risk management.
The document [Process for assessing User Satisfaction and Complaints CID 3569]
defines this process. The Trust complaints procedure is followed for all formal
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complaints received. Customer user surveys are also conducted to determine user
satisfaction.
H3 Internal audit of quality management system
There is an annual program of Internal audit of the quality management system which
provides evidence that it (the QMS) has been effectively established, implemented and
maintained. Audit is conducted according to the program against agreed criteria and
carried out by staff trained in internal audit. Audit programs, reports and action plans
are held on the pathology computer system. Audit is evaluated and reviewed to ensure
improvement of service and systems
H4 Internal audit of examination processes
The pre-examination, examination and post examination processed are audited in
accordance with the audit schedule and against agreed criteria. The [procedure for
the management of Quality Control [CID 3393] outlines the processes used.
Records are maintained and any corrective and /or preventative actions acted upon
and recorded. Audit is evaluated and reviewed and improvement and modification
action taken.
H5 External quality assessment
All departments within the laboratory participate in approved external quality
assessment (EQA) schemes. Performance is reviewed and communicated to all staff.
Current documentation is displayed in the departments and performance is reviewed at
annual management review. Fluctuations in performance are investigated and action
plans for improvement developed if required.
H6 Quality improvement
Continual quality improvement including corrective and preventative actions as
documented in document [Procedure for quality improvement CID 3471] to ensure
the quality of the service is evaluated and improvement documented. Procedures are
in place in accordance with CPA standards and such actions are monitored and
reviewed at Management Review. The outcome of this review forms the quality
improvement program for the laboratory and forms part of the development, training
and education of all staff. Quality indicators are in place to monitor quality
improvement and include training records (professional; and trust core subjects)
compliance with national standards (including Care quality commission, Hygiene Code,
NHSLA), communications with users (medical and patient) turn round times and
performance against external monitoring schemes
All procedures and reference documents are available on written request from the
quality manager.
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H7 Identification and control of nonconformities
The Procedure identified above outlines the steps to be taken to ensure remedial action
is taken and documented and plans developed to correct, monitor and evaluate the non
conformity in accordance with CPA standards. The authority to handle a non conformity
is defined and any and all actions are recorded and communicated to the user as
required. The outcome of any non conformity is reviewed to detect any possible trends
and therefore initiate corrective action.
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