East Kent Hospital University Foundation NHS Trust:
DIR-MAN-Q001
Department of Laboratory Medicine
Edition 8.0
QUALITY MANUAL This document together with specified procedure manuals represents the Quality Management System of the Department of Laboratory Medicine of the East Kent Hospital University NHS Foundation Trust.
It has been compiled to meet the requirements of the
Clinical Laboratory Medicine Accreditation (UK) Ltd (CPA) system incorporating ISO 15189:2012 and other appropriate national and international standards. All procedures specified herein are mandatory within the Department of Laboratory Medicine
EDITION No
8.0
DATE OF ISSUE
May 2014
REVIEW INTERVAL
Annual
AUTHORISED BY
Director of LM
AUTHOR
A Bunkall
LOCATION OF COPIES
Q-Pulse
PERSONNEL WHO SHOULD READ THIS DOCUMENT All grades of staff should ensure they have read the appropriate sections of this document before proceeding with any task.
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East Kent Hospital University Foundation NHS Trust:
DIR-MAN-Q001
Department of Laboratory Medicine
Edition 8.0
CONTENTS PERSONNEL WHO SHOULD READ THIS DOCUMENT…………………………………………2 1
GENERAL INFORMATION 1.1 LABORATORY MEDICINE AT EAST KENT ............................................................................ 6 1.2 THE DISCIPLINE OF CLINICAL BIOCHEMISTRY .................................................................... 7 1.3 The Discipline of Haematology & Blood Transfusion
8
1.4 The Discipline of Haemostasis & Thrombosis
9
1.5 The Discipline of Cellular Pathology
11
1.6 The Discipline of Microbiology
13
1.7 The Quality Manual ...................................................................................................... 15 1.8 QUALITY POLICY....................................................................................................... 18 2 ORGANISATION, RESPONSIBILITIES AND AUTHORITIES ........................................ 20 2.1 Relationship to the Host Organisation .......................................................................... 20 2.2 Organisation, Accountabilities and Responsibilities ..................................................... 20 2.3 Organisational Charts ................................................................................................. 24 2.4 Organisation & Responsibilities within Laboratory Medicine
28
3
34
ORGANISATION & MANAGEMENT RESPONSIBILITY
3.1 Organisation
34
3.2 Ethical conduct
34
3.3 Director of Laboratory Medicine
34
3.4 Designated Individual
34
3.5 License Holder- Licensed Mortuary activity……………………………………………….. 35 4 QUALITY MANAGEMENT SYSTEM .............................................................................. 34 4.1 Needs and requirements of users ................................................................................ 35 4.2 Quality Policy(Reference section 1.8)
35
4.3 Quality Management System
36
4.3.1 Quality Objectives & Plans
36
4.3.2 Quality Manual
36
4.3.3 Quality Manager Document number:DIR-NO-Q001 Author: A. Bunkall Approved by: LMPB/ Clinical Director
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Edition 8.0
4.3.4 Document Control & control of Process and Quality records
37
4.3.5 Control of Clinical Material
37
4.3.6 Management Review
38
5 PERSONNEL .................................................................................................................. 38 5.1 Laboratory Director
39
5.2 Staffing
39
5.3 Personnel Management
39
5.4 Staff Orientation & Induction
40
5.5 Job Descriptions and Contracts
40
5.6 Staff Records
41
5.7 Staff Annual Joint Review
41
5.8 Staff Meetings & Communication
42
5.9 Staff Training & Education
43
6 PREMISES AND ENVIRONMENT .................................................................................. 44 6.1 Premises and Environment
45
6.2 Facilities for Staff
45
6.3 Facilities for Patients
46
6.4 Facilities for Storage
46
6.5 Health & Safety
47
7 EQUIPMENT, INFORMATION SYSTEMS AND REAGENTS ......................................... 47 7.1 Procurement & management of Equipment
48
7.1.2 External Services & Supplies
49
7.2 Management of Data & Information
49
7.3 Management of Reagents, consumables, calibration & Quality Control material
49
8 PRE- EXAMINATION PROCESSES ............................................................................... 50 8.1 Information for Users & Patients
50
8.2 Request Form Information
51
8.3 Primary Specimen Collection & Handling
51
8.3.1 Informed Consent
52
8.4 Specimen Transportation
52
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DIR-MAN-Q001
Department of Laboratory Medicine
Edition 8.0
8.5 Specimen Reception
53
8.6 Referral to Other Laboratories
53
9 EXAMINATION PROCESSES/ PROCEUDRES.............................................................. 54 9.1 Selection & Validation of Examination Procedures
54
9.1.2 Validation & Verification of Procedures
54
9.1.3 Measurement Uncertainty of Measured Quality Values
54
9.1.4 Biological Reference Limits or Clinical Decision Values
55
9.2 Examination Procedures
55
9.3 Assuring the quality of Examination
55
9.3.1 Quality Control
55
9.3.2 Interlaboratory Comparisons
56
9.3.3 Comparability of Examination Results
57
10 POST- EXAMINATION PROCESS................................................................................ 56 10.1 Review of Results
57
10.2 Storage Retention & Disposal of Clinical Samples
57
10.3 Reporting Results
57
10.4 The Report
58
10.5 Release of Results
59
10.6 Automated Selection & Reporting of Results
59
10.7 Revised Reports
59
10.8 Clinical Advice & Interpretation
59
10.9 Laboratory Information Management
60
10.10 Authorities and Responsibilities
60
11 EVALUATION AND QUALITY ASSURANCE ............................................................... 60 11.1 Evaluation & Audit
60
11.1.2 Periodic Review of Requests & Suitability of Procedures & Sample requirements
61
11.2 Assessment of User Satisfaction & Complaints
61
11.2.1 Staff Suggestions
62
11.3 Internal Audit of Quality Management System
62
11.3.1 Internal Audit of Examination Processes
63
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Edition 8.0
11.4 External Quality Assessment
63
12 QUALITY IMPROVEMENT............................................................................................ 64 12.1 Quality Improvement
64
13 IDENTIFICATION AND CONTROL OF NON CONFORMITITES .................................. 65 13.1 Identification and control of non conformities
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East Kent Hospital University Foundation NHS Trust:
DIR-MAN-Q001
Department of Laboratory Medicine
Edition 8.0
1. GENERAL INFORMATION
1.1
Laboratory Medicine at East Kent
The Department of Laboratory Medicine is part of Clinical Support Services Division of the EAST KENT HOSPITAL UNIVERSITY NHS FOUNDATION TRUST (EKHUFT). The Trust provides
services to a population of over 720,000 from it’s three main hospital sites and two community Hospitals.
The hospitals covered by the Trust are:
Buckland Hospital Coombe Valley Road, Dover Kent CT1 3LP Tel: 01304 201624
Kent and Canterbury Hospital (KCH) Ethelbert Road Canterbury Kent CT1 3NG Tel: 01227 766877
Queen Elizabeth the Queen Mother Hospital (QEQM), St Peters Road, Margate Kent CT9 4AN Tel: 01843 225544
Royal Victoria Hospital Radnor Park Avenue, Folkestone Kent CT19 5BN Tel: 01303 850202
William Harvey Hospital (WHH) Kennington Road, Willesborough, Ashford Kent TN24 0LZ Tel:01233 633331
The Hospital sites provide a variety of services, the provision of which depends upon local service needs. Pathology laboratories are located on the sites of KCH, QEQM and WHH, with the main laboratory at WHH. The smaller community hospitals have phlebotomy services only.
Over the past 12 months the Dept. of Laboratory medicine at EKHUFT has been moving towards partnership with Maidstone and Tonbridge Wells NHS Trust. The initiative is known as Kent Pathology Partnership (KPP).
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East Kent Hospital University Foundation NHS Trust:
DIR-MAN-Q001
Department of Laboratory Medicine
Edition 8.0
1.2
The Discipline of Clinical Biochemistry
The Discipline of Clinical Biochemistry is part of Laboratory Medicine within EKHUFT. The department is located at WHH with smaller blood science laboratories at KCH and QEQM.
The postal address is:-
Discipline of Clinical Biochemistry William Harvey Hospital Kennington Road, Willesborough Ashford, Kent TN24 0LZ
Tel: 01233 633331 Ext: 74464
Information on the services provided and contact telephone numbers are available on the hospital website http://www.ekhuft.nhs.uk’
The services provided by the Discipline of Clinical Biochemistry are described below. The discipline is spilt into two sections, General Biochemistry and Immunology and allergy testing. The discipline also supports a multi-disciplinary Point of Care Testing (PoCT) team. General Biochemistry
This section is primarily concerned with testing of routine and urgent samples for metabolic testing, paediatric biochemistry, protein & lipid biochemistry, tumour markers and toxicological investigations.
Immunology & Allergy testing
Clinical biochemistry is responsible for the provision of the autoimmune serology service within the trust and also provides a laboratory immunology service for other hospitals within the region. Interpretive advice is available form senior staff within the laboratory and also through a service level agreement with the Protein Reference unit at St Georges Hospital Tooting.
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Department of Laboratory Medicine
Edition 8.0
There is also an active research programme focusing on renal disease markers and clinical aspects of protein and lipid biochemistry, often collaborating with external research and academic partners. Any work is published in peer reviewed journals and are widely disseminated at national and international meetings.
Information on the services provided by Clinical Biochemistry can be obtained from the following sources:
The laboratory medicine pages of SharePoint at http://sharepoint.ekhuft.nhs.uk
Dr Edmund Lamb, Consultant Clinical Scientist, Head of Clinical Biochemistry
[email protected]
Mr Edward Kearney, Consultant Clinical Scientist
[email protected]
Dr Joanna Sheldon, visiting Consultant Immunologist x86716
Duty Biochemist, tel:01233 616287
Mr Ian Rafferty, Head Biomedical Scientist,
[email protected]
1.3
The Discipline of Haematology & Blood Transfusion
The services provided by the Discipline of Haematology & Blood transfusion are described below.
The haematology and blood transfusion discipline have laboratories on all 3 hospital sites within the trust, WHH, KCH & QEQM.
Haematology
The Haematology laboratory provides a diagnostic service to EKHUFT, GP’s, hospices and local independent sector hospitals. They function as part of the Cancer, Clinical Haematology and Haemophilia Directorate and provide a consultant led service for both in patients and out patients suffering from a range of haematological disorders. Document number:DIR-NO-Q001 Author: A. Bunkall Approved by: LMPB/ Clinical Director
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The laboratory services are divided into routine and specialist services, those include routine full blood counts, and on the KCH site Leucocyte Immunophenotyping, and on the QEQM site Heamoglobinopathy screening.
Blood Transfusion
This service is supported by transfusion practitioners on all three acute sites. The practitioners ensure that the service delivered for blood transfusion is a safe, auditable and timely service that meets both local and national guidelines for good transfusion practice.
Information on the services provided by Haematology and Blood Transfusion can be obtained from the following sources:
1.4
The laboratory medicine pages of SharePoint at http://sharepoint.ekhuft.nhs.uk
Dr Kamiran Saied MRCP, FRCPath, Head of Service;
[email protected]
Dr Chris Pocock Consultant Haematologist,
[email protected]
Dr V. S. Ratnayake Consultant Haematologist,
[email protected]
Dr Jindriska Lindsay Consultant Haematologist,
[email protected]
Mr Kevin Read, Head Biomedical Scientist,
[email protected]
Ms Angela Green, Transfusion Coordinator,
[email protected]
The Discipline of Haemostasis and Thrombosis
The Discipline of Haemostasis and Thrombosis is part of Laboratory Medicine within EKHUFT. The Specialist Haemostasis and Thrombosis Service is located at KCH with routine coagulation services available on all three hospital sites across the Trust; WHH, QEQM and KCH.
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East Kent Hospital University Foundation NHS Trust:
DIR-MAN-Q001
Department of Laboratory Medicine
Edition 8.0
The postal address is:
Discipline of Haemostasis and Thrombosis Haemophilia and Thrombosis Laboratory Kent & Canterbury Hospital Tel: 01227 766877 Ethelbert Road, Ext: 74938 Canterbury Kent CT1 3NG
Information on the services provided and contact telephone numbers are available on the hospital website http://www.ekhuft.nhs.uk
The services provided by the Haemostasis and Thrombosis Laboratory are described below.
The Haemostasis and Thrombosis Laboratory is located within the Haemophilia and Thrombosis Centre based at Kent and Canterbury Hospital (KCH). The Centre is one of twenty six Comprehensive Care Centres nationally for the diagnosis and treatment of haemostasis disorders.
The Laboratory provides the specialist coagulation services for the whole of the East Kent Hospitals Trust. It offers a full range of specialist investigations for patients with inherited and acquired disorders of haemostasis and thrombosis using state of the art analysers, molecular genetics and manual techniques where required. The Laboratory also operates an anticoagulant monitoring service and provides training and scientific support for point of care INR testing across the Trust. In addition the laboratory has been successful in repatriating specialist coagulation work from other hospitals in the Kent and Medway region and from hospitals in Sussex.
A 24/7 routine coagulation screening service is provided by the Blood Science Laboratories on all three acute sites across the Trust under the scientific direction of the Haemostasis and Thrombosis Laboratory and using the same state of the art analysers. The Haemophilia and Thrombosis Laboratory provides scientific, technical and training support for the routine coagulation service.
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East Kent Hospital University Foundation NHS Trust:
DIR-MAN-Q001
Department of Laboratory Medicine
Edition 8.0
Information on the services provided by the Haemostasis and Thrombosis Laboratory can be obtained from the following sources:
The Laboratory Medicine pages of SharePoint at http://sharepoint.ekhuft.nhs.uk
Dr Gillian Evans, MRCP, FRCPath, Head of Service and Director of the Haemophilia and Thrombosis Centre
[email protected]
1.5
Dr Kim Elliott Consultant, MRCP, FRCPath,
[email protected]
Ms Joanna Nightingale, Head Biomedical Scientist
[email protected]
The Discipline of Cellular pathology
The Discipline of Cellular Pathology is part of Laboratory Medicine within EKHUFT. The department is located at WHH with one stop Breast clinics at KCH and QEQM, there is also a Mohs clinic located at KCH.
The main Andrology service is provided from WHH, but a limited service is provided at QEQM
The postal address is:-
Discipline of Cellular Pathology William Harvey Hospital Kennington Road, Willesborough Ashford, Kent TN24 0LZ
Tel: 01233 633331 Ext: . 86016
Information on the services provided and contact telephone numbers are available on the hospital website http://www.ekhuft.nhs.uk or internally via SharePoint.
The services provided by the Discipline of Cellular Pathology laboratory include Histology, NonGynaecological Cytology, Gynaecological Cytology, Andrology and Mortuary.
Processing and reporting services are all provided from a single centralised facility located at the William Harvey Hospital by appropriately qualified staff. Document number:DIR-NO-Q001 Author: A. Bunkall Approved by: LMPB/ Clinical Director
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Edition 8.0
Histology
Biopsies and resections of human tissues are processed, sectioned and stained to allow examination under a
microscope to provide a definitive diagnosis: often the presence or
absence of cancer. Cytology/LBC
Liquid Based Cytology - This is used as a screening tool to detect pre-cancerous lesions, and prevent cervical cancer.
Cytopathology is also commonly used to investigate diseases involving sterile body cavities (peritoneal, pleural, and cerebrospinal), and a wide range of other body sites. It is usually used to aid in the diagnosis of cancer, but also helps in the diagnosis of certain infectious diseases and other inflammatory conditions.
Andrology
Investigation of male infertility and vasectomy service. Mortuary Service
The department provides a hospital and public mortuary service to HM Coroners in East Kent at three of our hospital sites. The Kent and Canterbury Hospital with a body storage facility at the Queen Elizabeth the Queen Mother Hospital and the William Harvey Hospital with both body storage and autopsy facilities.
Information on the services provided by Cellular Pathology can be obtained from the following sources:
The laboratory medicine pages of SharePoint at http://sharepoint.ekhuft.nhs.uk
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DIR-MAN-Q001
Department of Laboratory Medicine
Edition 8.0
Dr Miklos Perenyei, Head of Service;
[email protected] , 01233 616183 (Ext: 86183)
Mr Paul Williams, Head Biomedical Scientist,
[email protected] ;01233 616129 (Ext: 86129)
Mr Brian Murphy, Chief Biomedical Scientist for Histology
[email protected] ; 01233 616253 (Ext: 86253)
Mrs Shirley Moses, Chief Biomedical Scientist for Cytology
[email protected] ; 01233 616016 (Ext 84233)
Mr Adam Berry, Lead Anatomical Pathology Technician
[email protected] ; 01233 616606 (Ext: 86606)
1.6
The Discipline of Microbiology
The Discipline of Microbiology is part of Laboratory Medicine within EKHUFT, the department being located at WHH
The postal address is:
Discipline of Microbiology William Harvey Hospital Kennington Road, Willesborough Ashford, Kent TN24 0LZ
Tel: 01233 633331 Ext:
Information on the services provided and contact telephone numbers are available on the hospital website http://www.ekhuft.nhs.uk
The services provided by the Discipline of Microbiology are described below.
The services provided by Microbiology are divided into sections; General Microbiology, Mycology and Virology. There is also a small environmental laboratory. The laboratory is part of the UK Clinical Mycology Network.
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East Kent Hospital University Foundation NHS Trust:
DIR-MAN-Q001
Department of Laboratory Medicine
Edition 8.0
General Microbiology
This section of the discipline is primarily concerned with the isolation, identification and susceptibility testing of bacterial, fungal and parasitic infections. Methods used include microscopy culture and molecular methods.
The Environmental and water laboratory provides services local environmental services from the WHH site.
Virology
Virology is primarily concerned with the serological detection of antibody or antigen to determine infection or protective immunity. Molecular testing for Chlamydia and Gonococcal infections is also part of this sections service.
The Discipline provides reference serology services to other pathology services within the local vicinity. The Laboratory is part of the Clinical Virology Network and also designated as a Specialist Virology centre.
The Microbiology service is consultant led and the discipline has an active research programme and has forged links with the Biomedical Sciences department in the University of Kent.
Information on the services provided by Microbiology can be obtained from the following sources:
The laboratory medicine pages of SharePoint at http://sharepoint.ekhuft.nhs.uk
Dr Matthew Strutt, Head of Service, Consultant Microbiologist,
[email protected]
Dr James Nash MB, Consultant microbiologist,
[email protected]
Mr Marcus Coales, Head Biomedical Scientist,
[email protected]
Mrs Angela Stear, Environmental Technical Manager,
[email protected]
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East Kent Hospital University Foundation NHS Trust:
DIR-MAN-Q001
Department of Laboratory Medicine
Edition 8.0
1.7
The Quality Manual
This Quality Manual describes the Quality Management System of the Department of Laboratory Medicine Throughout the text there are references to CPA (UK) Ltd Standards& UKAS ISO 15189:2012 standards (in brackets CPA followed by ISO) and to procedures written in fulfilment of these standards.
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 can be regarded as the index volume to separate volumes of management, laboratory, clinical and quality procedures. The sections of the Quality Manual are arranged so that they equate with the CPA (UK) Ltd Standards & UKAS ISO 15189:2012 standards (see Table 1 below), other bodies may be listed including Human Tissue Authority (HTA), Health & Safety Executive (HSE) and MHRA (BSQR- (regulatory)) -The Medicines and Healthcare products Regulatory Agency ('The Blood Safety and Quality Regulations 2005'). Under the title of each standard there is a brief description of the way in which the Department of Laboratory Medicine seeks to comply with the particular standard and references are given to appropriate procedures. The sections of the standards should be seen to relate to each other in the following manner. CPA (UK) Ltd section A & UKAS ISO sections 4.1, 4.15,4.4, 4.2, 4.3, 4.13 describe the organisation of a laboratory and its quality management system which uses resources (CPA (UK) Ltd Sections B, C and D, UKAS ISO sections 5.1, 5.2, 5.3, 4.5, 5.9) to undertake pre examination, examination and post examination processes (CPA (UK) Ltd sections E, F and G & UKAS ISO sections 4.5, 5.4, 5.5, 5.6, 4.7, 5.7, 5.8).
The quality management system and the examination processes are continually evaluated and quality assured (CPA (UK) Ltd section F & UKAS ISO sections 5.5, and 5.6 in part). 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 (see Figure 1 below). Document number:DIR-NO-Q001 Author: A. Bunkall Approved by: LMPB/ Clinical Director
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Edition 8.0
2.
Document number:DIR-NO-Q001 Author: A. Bunkall Approved by: LMPB/ Clinical Director
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DIR-MAN-Q001
Department of Laboratory Medicine
Edition 8.0
Figure 1 & 2: Inter-relationship of CPA (UK) Ltd & ISO 15189:2012 Standards Paragraph in the
Section of CPA Standards
ISO 15189:2012 Standard
Quality Manual 4
A Organization and QMS
4.1 organisation and management, 4.2 QMS, 4.3 Document control, 4.4 Service agreements
5
B Personnel
5.1 Personnel
6
C Premises and environment
5.2 Accommodation & environmental conditions, 5.3 Laboratory equipment 5.9 Information systems
7
D Equipment, materials and reagents
4.6 External services and supplies, 5.3 Laboratory equipment
8
E Pre-examination process
4.5 Examination by referral laboratories, 4.7 Advisory services ,5.4 Pre-examination procedures
9
F Examination process
5.5 Examination procedures, 5.6 Assuring the quality of examination processes
10
G Post-examination process
5.8 Reporting of results
11
H Quality assurance and evaluation
4 Management, 4.14 internal Audits, 4.9 Identification of non-conformities, 4.10 Corrective action ,4.11 Preventative action, 4.12 Continual improvement, 5.6 assuring the quality of examination processes,
Table 1 Section of Quality Manual and equation with CPA (UK) Ltd & ISO 15189:2012 Standards
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Edition 8.0
1.8
QUALITY POLICY
The Quality Policy (A3, 4.2.2.2) of the Department of Laboratory Medicine is given below and published as a separate controlled document Laboratory Medicine Quality Policy [DIR-MP-Q100] and is displayed within the Department. Policy: The East Kent Hospitals University NHS Foundation Trust Department of Laboratory Medicine provides a comprehensive diagnostic service. It is committed to providing a service of the highest quality and shall be aware and take into consideration the needs and requirements of its users.
The scope of the service comprises of:
Blood Sciences, which consist of Clinical Biochemistry (including Immunology), Haematology (including Blood Transfusion), and Haemostasis; Cellular Pathology, which includes Andrology, Cytology, Histology and Mortuary; and Microbiology, consisting of Bacteriology, Mycology and Virology. In order to ensure that the needs and requirements of users are met, the Pathology Directorate will: Operate a quality management system to integrate the organisation, procedures, processes, and resources. Set quality objectives and plans in order to implement this quality policy, and seek to achieve continual quality improvement. Ensure that all personnel are familiar with the quality manual and all procedures relevant to their work. Commit to the health, safety, and welfare of its entire staff. Visitors to the department will be treated with respect and due consideration will be given to their safety while on site. Uphold professional values and be committed to good professional practice and conduct. Create and nurture a quality ethos based on continual improvement. Ensure that its activities have calculated and limited impact on the environment and comply with relevant environmental legislation. Document number:DIR-NO-Q001 Author: A. Bunkall Approved by: LMPB/ Clinical Director
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Ensure the suitability and effectiveness of this policy is reviewed as part of the annual management review. The Department of Laboratory Medicine will comply with standards set by CPA (UK) Ltd, ISO 15189:2012, the Human Tissue Authority and the Medicines and Healthcare products Regulatory Agency, and is committed to: Staff recruitment, training, development and retention at all levels to provide a full and effective service to its users Appropriate procurement and maintenance of such equipment and other resources as are needed for the provision of the service The assessment of user satisfaction, in addition to internal audit and external quality assessment, in order to produce continual quality improvement. Ensure that examinations and process are designed and implemented with the focus on user and patient requirements, and applying performance monitoring to assure they deliver the required outcomes. The collection, transport and handling of all specimens in such a way as to ensure the correct performance of laboratory examinations Undertake consistent analytical work so that systematic and random errors do not exceed specified limits; and these limits are in-keeping with those considered as best laboratory practice. Report results of examinations in ways which are timely, confidential, accurate, and clinically useful. Providing a secure controlled archive for the storage of records and clinical material.
Signed:
Friedrich Muhlschlegel Clinical director, Laboratory Medicine
The intent of the Quality Policy is to define the QMS and ensure that it is communicated to all staff. It is reviewed annually and signed by the Director of Laboratory Medicine. All staff are required to read and acknowledge understanding of the policy. Document number:DIR-NO-Q001 Author: A. Bunkall Approved by: LMPB/ Clinical Director
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2
ORGANISATION, RESPONSIBILITIES AND AUTHORITIES
2.1
Relationship to the Host Organisation
The Trust is led by the Trust board, comprising Chairman, non-executive Directors, Chief Executive, and the Executive Directors.
The Department of Laboratory Medicine is part of the Division of Clinical Support Services of EKHUFT. The Executive structure within the Trust is shown below in Figure 3. (A1.4, 4.1). There is a Clinical Director for the Department of Laboratory Medicine who is a member of the Clinical Management Board which is responsible via the Chief Executive to the trust Board for strategic and Policy planning.
The Director is also responsible to the Divisional Director of Clinical Support Services, who in turn reports to the Chief Nurse and Director of Quality and Operations, who report to the Chief Executive.
The Director of Laboratory Medicine is also the professional accountable to the Divisional Medical Director who reports via the Trust Medical Director to the Chief Executive officer. (B1, 5.1). The high level reporting structure is shown in Figure 4.
2.2
Organisation, Accountabilities and Responsibilities within Laboratory Medicine
Laboratory Medicine is divided into 5 disciplines, Haematology/Blood transfusion, Cellular pathology (including Cytology and Andrology), Microbiology, Haemostasis and Thrombosis and Clinical Biochemistry, and also includes Mortuary and Phlebotomy services. Services are found across three hospital sites, although not all services are available on all sites (see below) Document number:DIR-NO-Q001 Author: A. Bunkall Approved by: LMPB/ Clinical Director
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Hospital Site
Services available
William Harvey Ashford
Microbiology Haematology/ Blood transfusion Clinical Biochemistry Cellular pathology Mortuary Phlebotomy
Kent & Canterbury
Haematology/ Blood transfusion Haemostasis and Thrombosis Clinical Biochemistry Moh’s Clinic & One stop breast clinic Mortuary (body store only) Phlebotomy
Queen Elizabeth the Queen Mother Hospital
Haematology /Blood transfusion
Margate
Clinical Biochemistry (Andrology service) One stop Breast clinic Mortuary Phlebotomy
Clinical consultants form the leads for Microbiology, Haematology/Blood transfusion, Cellular Pathology, Clinical Biochemistry and Haemostasis and Thrombosis. Other Consultant staff within each discipline report to their lead consultant. The lead consultants are professionally accountable through the divisional clinical director to the Medical Director and are managerially accountable to the departmental general manager.
The Designated Individual (DI) can be a head of department, clinician, scientist or manager, appointed to lead the mortuary services. The DI reports to the Medical Director.
The General Manager of Laboratory Medicine is accountable to the Divisional Director and has responsibility for overall management of Laboratory Medicine.
Document number:DIR-NO-Q001 Author: A. Bunkall Approved by: LMPB/ Clinical Director
WARNING: this is a controlled document
Page 21 of 64 Date of Issue: 4/7/2013 Revision:8.0
East Kent Hospital University Foundation NHS Trust:
DIR-MAN-Q001
Department of Laboratory Medicine
Edition 8.0
Each discipline has a Head Biomedical Scientist (BMS) who report to their appropriate Clinical Lead for discipline specific issues and are accountable to the pathology General Manager These relationships are illustrated in Figure 5.
There is a Laboratory Medicine Operations Manager, an Information Technology Manager and a Head of Quality, Clinical Governance and Risk Management, all of which are accountable to the Laboratory General Manager,
The Head of Quality for Laboratory Medicine is responsible for overseeing the implementation and maintenance of the Quality Management system across the department. There are Quality Leads in each discipline to assist. The Quality Manager has associated lines of communication to the Head BMS’s, Clinical Leads and Laboratory Medicine Clinical Director.
The Head of Quality also has responsibility to co-ordinate and oversee risk management for Laboratory Medicine, including management of Laboratory Medicine risks and including Clinical Governance issues overseeing incidents and patient related complaints and compliments.
The Pathology IT Manager oversees the Departmental Laboratory Information System.
The Operations Manager co-ordinates complaints and compliments, and also deals with staff welfare and HR issues.
The Laboratory General Manager is budget holder for the Laboratory Medicine directorate. Each Service Manager is the responsible budget manager for their discipline.
Document number:DIR-NO-Q001 Author: A. Bunkall Approved by: LMPB/ Clinical Director
WARNING: this is a controlled document
Page 22 of 64 Date of Issue: 4/7/2013 Revision:8.0
East Kent Hospital University Foundation NHS Trust:
MAN- -xxx-Q001
CPA Number: xxxx Department of Laboratory Medicine
2.3
Edition x
Organisational Charts
Figure 3 Trust Executive Structure Chart (Accessed via Trust Intranet http://www.ekhuft.nhs.uk/patients-and-visitors/about-us/documents-andpublications/structure-charts/) If this document is not in its specified location it is only valid on date printed
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East Kent Hospital University Foundation NHS Trust:
MAN- -xxx-Q001
CPA Number: xxxx Department of Laboratory Medicine
Edition x
Trust Chairman
Trust Chief Executive Officer
Medical Director & Deputy Chief Executive
Chief Nurse & Director of Quality & Operation
Director of Finance & Performance Management
Director of Strategic Development & Capital Planning
Director of Human Resources & Corporate Affairs
Divisional Director Surgical Services Divisional Director Urgent Care & Long Term Divisional Director Specialist Services Divisional Medial Director
Divisional Director Clinical Support
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Figure 4: High level reporting structure.
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CPA Number: xxxx Department of Laboratory Medicine
Edition x
Figure 5 Organisational accountability/ operational management within Laboratory Medicine Director of Laboratory Medicine
Clinical Lead for Haemostasis and Thrombosis, Haematology/BT, Biochemistry, Cellular pathology, Microbiology
General Manager of Laboratory Medicine Head of Quality, Clinical Governance & Risk Management
Operations Manager & IT manager
Blood Transfusion Coordinator
Point of Care Testing Coordinator
General Manager of Laboratory Medicine Blood transfusion Practitioners
Head Biomedical Scientists Haemostasis and Thrombosis, Haematology/BT, Biochemistry, Cellular pathology, Microbiology
Discipline of Biochemistry
Discipline of Haematology & Blood transfusion
Discipline of Haemostasis & Thrombosis
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Discipline of Microbiology
Point of Care testing Practitioners
Discipline of Cellular pathology
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East Kent Hospitals University NHS Foundation Trust: Number: xxxx
CPA
Department of Laboratory Medicine
MAN-DIR-xxx-Q001 Edition x
The Director of Laboratory Medicine (4.1.1.4) has overall responsibility for the Laboratory Medicine Service and is accountable to the General Manager for the Division of Clinical support Services The Director of Laboratory Medicine is responsible for the efficient and effective management of the operational activity ensuring a patient focused service, and is responsible for the managerial direction and associated provision of all Laboratory Medicine services, having managerial responsibility for the Department of Laboratory Medicine’s compliance with CPA (UK) Ltd standards /ISO 15189:2012 and any other relevant regulatory compliance.
The Department of Laboratory Medicine is divided into disciplines. There is a Clinical lead and a Head Biomedical Scientist (BMS) for each discipline. The Clinical Lead for each Department has executive accountability and the overall responsibility for the service provided (B1, 5.1). The responsibilities of the clinical lead include, scientific, professional, consultative, advisory, organisational, administrative and educational activities, relevant to the Laboratory Medicine service provided at EKHUFT. Selected duties and/or responsibilities are delegated to individuals with appropriate competence, but the ultimate accountability for the overall operation, direction and regulatory compliance of the service lies with the clinical lead. The Consultants in each discipline report to their departmental Clinical Lead and are accountable through the Clinical Director for Laboratory Medicine to the Medical Director of the East Kent Hospitals University NHS Foundation Trust. The medical secretaries within each discipline are accountable to their individual departmental consultants.
The Head BMS for each discipline reports to the Director of Laboratory Medicine and is responsible for the managerial direction and associated provision of the relevant Laboratory Medicine service having managerial responsibility for the discipline’s compliance with CPA (UK) Ltd standards/ISO 15189:2012 and any other relevant regulatory compliance. The Head of Quality reports to the Departmental General Manager and Clinical Director and ensures, on behalf of laboratory management, that the quality management system is implemented, maintained and functions correctly. The quality manager is responsible for coordinating the awareness of the needs and requirements of users and coordinates the Department of Laboratory
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East Kent Hospitals University NHS Foundation Trust: Number: xxxx Department of Laboratory Medicine
CPA
MAN-DIR-xxx-Q001 Edition x
Medicine’s compliance with CPA (UK) Ltd and ISO 15189:2012 standards and any other relevant regulatory compliance. The Point of Care Coordinator reports to the Divisional General Manager and is responsible for the day to day planning and implementation of policies, procedures and guidance relating to Point of Care (PoCT) equipment and services across the Trust and associated sites. The PoCT Coordinator is responsible for ensuring user compliance with appropriate SOPs which reflect local and national standards of work practice e.g. CPA and ISO standards. The General Manager of Laboratory Medicine has overall budgetary control for the department and each Head BMS acts as budget manager for their respective discipline. A finance manager from the Finance Directorate is assigned to Laboratory Medicine to assist and oversee the budget of the department. The Human Resources directorate assigns a specific individual from their department to lead the Personnel requirements of the Department of Laboratory Medicine.
2.4
Organisation and Responsibilities within Laboratory Medicine Disciplines
Along with the above managerial and operational structures each discipline is led by a Clinical Lead (Consultant) and a Chief Biomedical Scientist. The following charts show the organizational structures within disciplines.
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CPA
Department of Laboratory Medicine
MAN-DIR-xxx-Q001 Edition x
Figure 6 – Organisational Chart for the Department of Microbiology
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East Kent Hospitals University NHS Foundation Trust: Number: xxxx Department of Laboratory Medicine
CPA
MAN-DIR-xxx-Q001 Edition x
Figure 7 – Organisational Chart for the Department of Cellular pathology
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East Kent Hospitals University NHS Foundation Trust: Number: xxxx Department of Laboratory Medicine
CPA
MAN-DIR-xxx-Q001 Edition x
Figure 8 – Organisational Chart for the Department of Haematology and Blood Transfusion
Blood Transfusion Coordinator & 3x Practitioners
Head Biomedical Scientist Clinical Biochemistry & Automated Haematology Ian Rafferty
Head Biomedical Scientist Haematology & Blood Transfusion Kevin Read
Automated Section Chief Biomedical Scientists Blood Transfusion
Chief Biomedical Scientists Haematology
Catherine Almond Robert Goddard Susan Mitchell
Alistair Mitchelhill Steven Rew
Senior Biomedical Scientists Ben Rayner Jennifer Sedgewick Simon Hughes Ian Roberts Sharon Harding Elizabeth Jackson Jennifer Jeffries Michael King Trevor Godwin Darren Rookes
Biomedical Scientists Bands 5 and 6 x 21.8 wte
Healthcare Scientists x 25.8 wte and Phlebotomists x 30.8 wte
Trainee Biomedical Scientists
(Bands 2, 3 & 4)
x 2.0 wte
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East Kent Hospitals University NHS Foundation Trust: Number: xxxx
CPA
MAN-DIR-xxx-Q001
Department of Laboratory Medicine
Edition x
Figure 9 – Organisational Chart for the Department of Biochemistry
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East Kent Hospitals University NHS Foundation Trust:
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Department of Laboratory Medicine
Edition 1.0
Director of the Haemophilia and Thrombosis Centre Dr Gillian Evans
Head BMS Haematology Laboratory
Head BMS Haemostasis &Thrombosis Laboratory Scientific Director NHS South of England, Directorate Education & Training Lead Joanna Nightingale
Chief BMS Quality Lead, Health & Safety Supervisor Sarah Clarke
Kevin Read
Routine Coagulation KCH
Routine Coagulation QEQMH
Routine Coagulation WHH
Senior BMS x2 Training Lead
Karen Godwin
Molecular Genetics Lead
Kevin Gregory
BMS x2 IT Lead
Celia Waddilove
Health & Safety Deputy
Jane Barnes
Assistant Healthcare Scientist
Figure 10: Organisational Chart for the Haemostasis & Thrombosis Laboratory
Thomas Davis
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Edition 1.0
3
Organisation and Management Responsibility (A1, ISO 4.1.)
3.1
Organisation (A1, 4.1.1)
The organisation of the Department of Laboratory Medicine is detailed in section 2 of this quality manual.
3.2
Ethical Conduct (A1.3, 4.1.1.3)
The ethical conduct expected of staff is outlined in the Staff Handbook, and Equality and Diversity training is mandatory for all staff (Available via Trust Intranet)
3.3
Director of Laboratory Medicine (B1, 4.1.1.4)
Competence of the Director is assured by the General Medical Council licence to practice and Membership of the Royal College of Pathologists. Their responsibilities include clinical, scientific, professional, consultative, advisory, organisational, administrative and educational activities relevant to the services provided to ensure compliance with CPA and ISO and other standards as applicable. Some duties and responsibilities are delegated to the Clinical leads, although ultimate accountability for the overall operation and direction of the service remains with Laboratory Medicine Director. The duties of the Laboratory Medicine Director and Clinical Leads are documented in their job descriptions.
3.4
Designated Individual (HTA)
A Designated Individual, appointed from the Consultant Histopathology team and a practicing anatomical pathologist, supervises the licensed activity of the mortuary service. The designated individual has primary (legal) responsibility to ensure that activities are conducted properly, by people who are suitable to carry out those activities, and that all the necessary requirements are complied with. The designated individual must complete the HTA accredited training.
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Edition 1.0
3.5
Licence Holder - Licensed Mortuary activity (HTA)
The license holder for the licensed mortuary activity is the EKHUF Trust and the contact is the Medical Director. The license holder has the right to apply to the HTA to vary the license.
4
QUALITY MANAGEMENT SYSTEM
4.1
Needs and requirements of users (A2, 4.14.3)
The needs of the users are kept under constant review. This is performed by reacting to outcomes of meetings under the Clinical Governance structure, including adherence to the Care Quality Commission Essential Standards of Quality and Safety, which have arisen out of the Government’s sustained emphasis on the concepts of quality and safety in the working of health care organisations. Laboratory Medicine assesses compliance against these and other appropriate standards. The Department of Laboratory Medicine responds positively to compliments and complaints from users. Assessment by user satisfaction surveys, are translated into requirements, which form the focus of objective setting and planning (A5, 4.1.2.4) within the quality management system. Assessment of user satisfaction and complaints (H1, 4.14.3, 4.8), DIR-SOP-Q123 Procedure for measurement of user satisfaction, is conducted on a regular basis and consideration of the findings form part of the annual management review (A11, 4.15).
Where a discipline enters into a formal agreement to provide medical laboratory services, there is a documented procedure in compliance with standard A2.4, ISO 4.4, DIR-MP-Q200 Establishment and Review of Formal Agreements to Provide Medical Laboratory Services. 4.2
Quality policy (A3, 4.1.2.3)
The Quality policy of the Department of Laboratory Medicine is detailed in section 1.0 of this quality manual, and is available as a separate document, DIR-MP-Q100.
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4.3
Quality management system (A4-A11, 4.2)
The components and relationship within the Quality management system are described in section 4 of this Quality Manual 4.3.1
Quality objectives and plans (A5, 4.1.2.4)
The Department of Laboratory Medicine Management Teams define the quality objectives of the disciplines and is responsible for ensuring that plans are made to meet these objectives.
The
management review (see A11, ISO 4.15) which is undertaken on an annual basis determines whether the objectives have been successfully completed and provides an opportunity for revising such objectives and plans and the functioning of the quality management system. (Discipline specific AMR reports). 4.3.2
Quality manual (A6, 4.2.2.2)
This standard is fulfilled by the production of this Quality Manual DIR-MAN-Q001.
4.3.3
Quality manager (A7, 4.1.2.7)
The Head of Quality for the Department of Laboratory Medicine works with the Laboratory Medicine Management Team to ensure the proper running of the Quality Management System. The Head of Quality advises the discipline Quality leads on the management of appropriate quality systems including its implementation, maintenance and improvements. The operational responsibility, however, lies with the Head BMS for each discipline.
The Head of Quality also ensures that there is awareness of the QMS throughout Laboratory Medicine; the job also includes a GP liaison role which promotes the requirements and needs of users throughout the department.
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4.3.4
Document control (A8, 4.3) & Control of process and quality records (A9)
A commercial document control system Q-Pulse has been purchased by the department and is currently under development by the Head of quality and Quality Leads of each discipline Within the Q-Pulse document system written procedures describing working processes, external documents, forms and notices, policies and management documents are uploaded. The system ensures a robust QMS of documentation, each having a unique identification number, a review audit trail and also a defined review date. It also provides an electronic record of all staff who have read and acknowledged documents in the system. Use of the document module within Q-Pulse is described in procedure DIR-MP-Q002 Q-Pulse Creating drafts, activating, distributing, reviewing and revision. Description of the procedure for the control of process and quality records is found in document DIR-MP-Q001- The Management and Control of Documents Including Process and Quality Records 4.3.5
Control of clinical material (A10, 5.7.2)
This standard is fulfilled by procedures within each discipline and across Laboratory Medicine as follows:
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Department of Laboratory Medicine
Edition 1.0
4.3.6
Management review (A11, 4.15)
The Laboratory management team conduct an annual review of the laboratory’s quality management system (including the quality policy and objectives) and all its services to ensure its continuing suitability, adequacy and effectiveness and support of patient care. The review considers the following information:
a) assessment of user satisfaction and complaints (H2, 4.14.3, 4.8)) b) internal audit (H3, H4, 4.41.5) c) Risk management (H2, 4.14.6) d) external quality assessment reports (H5) e)
reports of assessments by outside bodies
f)
status of preventive, corrective and improvement actions (H6, 4.10, 4.11)
g) Identification and control of non-conformities (H7, 4.9) h) Report of quality indicators/KPI’s (4.14.7) i)
Performance of suppliers (D3, 4.6)
j)
quality indicators that monitor the laboratory’s contribution to patient care
k) major changes in organisation and management, resource (including staffing) or process l)
follow up of previous management reviews.
Records are kept and key objectives for the subsequent year are defined and plans formulated for their implementation.
A copy of the executive summary of the Laboratory Medicine Annual Management Review is sent to CPA(UK) Ltd / UKAS, together with the annual re-registration forms for each department.
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Department of Laboratory Medicine
Edition 1.0
5
PERSONNEL
5.1
Laboratory director (B1, ISO 4.1.1.4)
The Laboratory Director for Laboratory Medicine has executive accountability and the overall responsibility for the service provided. Their responsibilities include, scientific, professional, consultative, advisory, organisational, administrative and educational activities, relevant to the Laboratory Medicine service provided at EKHUFT. Selected duties and/or responsibilities are delegated to individuals with appropriate competence, such as discipline specific clinical leads, but the ultimate accountability for the overall operation, direction and regulatory compliance of the service lies with the Laboratory Director.
The Disciplines of Laboratory Medicine are under the professional direction of clinical leads (appropriate consultants), who are in possession of the FRCPath qualification. (ISO 4.1.2.5)
5.2
Staffing (B2, ISO 5.1)
The Department employs staff with the appropriate level of qualifications, training and experience relevant to the post held. Staff holding technical posts such as Biomedical Scientists (BMSs) are registered with the Health Care Professions Council (HCPC) in accordance with national legislation. The Head BMS’s of the Disciplines check the retention certificates. HCPC registered staff participate in Continuing Professional Development (CPD)
5.3
Personnel management (B3, ISO 5.1)
This standard is fulfilled by the Laboratory Medicine document DIR-MP-Q104 Personnel and Site Management.
There are Trust employment policies defined by the Human Resources Department. These are available to all staff on the Trust intranet via SharePoint.
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5.4
Staff orientation and induction (B4, ISO 5.1.4)
There is a Trust policy on staff induction, which is referred to in the Laboratory Medicine document DIR-MP-Q104. In addition to the Trust Induction all new staff also undertake a general induction to Laboratory Medicine, including basic Health & Safety and Manual Handling instructions. Discipline specific issues are handled at local level. Records of staff orientation and induction are kept in the individual’s personnel file (B4.1, ISO 5.1.4) including information on:
a) The Laboratory. b) Terms and conditions of employment c) Patient confidentiality and data protection. d) Health and safety. e) Occupational health services. f)
Job description including an organizational chart.
g) Salaries and wages. h) Staff facilities. i) 5.5
Quality Management Job descriptions and contracts (B5, ISO 5.1.3)
All Staff are issued with a job description and a person specification, on application for a post. Job descriptions may be subsequently amended after consultation.
Job Descriptions include description of:
a) job role b) the location within the organization c) accountability d) the main purpose of the job
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e) the main duties and responsibilities f)
a requirement for participation in staff annual joint review.
All staff have contracts of employment that provide clear terms and conditions of service.
5.6
Staff records (B6, ISO 5.1.9)
Each member of staff has a personnel file, kept securely in an appropriate discipline office, which includes: a) personal details b) job description c) Copy of certificate of registration where applicable d) a record of staff induction & orientation, and completion of fire training e) a record of education, training and competency including continuing professional development f)
a record of competency assessments, current role training
g) relevant educational and professional qualifications h) accident & absence records i)
a record of staff annual joint reviews [NOTE 2]
j)
a record of disciplinary action.
k) occupational health record including immunisation status when relevant
5.7
Staff annual joint review (B7, ISO 5.1.7)
Staff reviews (appraisals) are conducted in accordance with the Trust guidelines and Trust appraisal training sessions, and follow the procedures laid out in the Knowledge and Skills Framework (KSF). Annual appraisals are held to discuss the needs of the laboratory and of the individual in order to maintain and improve quality of service and encourage productive working relationships. The appraisal format includes consideration of the following:
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a) stated objectives and plans (A5, ISO 4.1.2.4) of the laboratory b) job description of the staff member c) service & personal objectives d) training and development needs of the staff member.
Staff appraisal records are kept in their personnel files, and copies supplied to the individual.
5.8
Staff meetings and communication (B8, ISO 4.1.2.6)
Each department has regular senior staff and staff meetings, to communicate information to all staff, as detailed below. The information discussed at staff meetings covers all aspects of the laboratory service and in particular the effectiveness of the quality management system.
Laboratory Medicine Policy Board (LMPB) meets once a month.
The Chair is the Head of
Laboratory Medicine; the minutes are taken by his Personal Assistant (PA). The meeting is attended by The General Manager of the Directorate, and the Clinical Director. All departments are represented by their Consultants and by their Managers including the Quality Manager, the Point of Care Coordinator and the Manager of Mortuary services. Quality Forum meets once a month. The Chair is the Head of Quality for Laboratory Medicine; who also takes the minutes. The meeting is attended by the Laboratory Quality Leads
Laboratory Medicine Senior Ops meeting meets once a month and is attended by the General manager, Operations manager, Quality manager, IT manager and Chief of each Discipline. The aim is to discuss operational issues along with innovation, training and improvement across the Department.
Laboratory Medicine Governance sub groups:
The Health and Safety subgroup meets once a month. It is chaired by the Health and safety lead for lab medicine. Each discipline is represented by their Laboratory Manager or a deputy, the Quality
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Manager, the Point of Care Coordinator, the Manager of Mortuary services and the chair of the Health and Safety Officers group attend.
The Training and Education subgroup aims to meet on a bi-monthly basis. The meetings are chaired by one of the departmental Training Officers. Each department is represented by their Training Officer, the Point of Care Coordinator and one or more of the Mortuary APTs attend.
Marketing Group aims to meet quarterly or as necessary and is chaired by the Marketing lead for Laboratory Medicine. Each department is represented and the Point of Care Coordinator also attends.
Terms of Reference are agreed and published for all Laboratory Medicine meetings and committees/ groups. DISCIPLINE SPECIFIC MEETINGS Quality Health and safety Senior meetings Team Briefs (Staff meetings) Huddles Diary meeting (Cellular Pathology) Minutes of meetings are e-mailed to all relevant staff and are loaded onto Q-Pulse. Global e-mails are used to distribute Trust news and information to all Trust staff.
5.9
Staff training and education (B9, ISO5.1.5)
All staff have access to the Hospital libraries, the internet, intranet and Q-Pulse. The Trust intranet provides a range of e-learning tools, including mandatory training modules. The courses currently available are listed on the staff zone of the Trust web site.
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DIR-MP-600 The education and Training Policy describes the Laboratory Medicine training protocol. In Addition there are discipline specific training manuals/ protocols which describe the training of BMS/ AHCS staff and covers all areas of the specific laboratory.
Each Department has a designated training officer who coordinates the training and education of all staff, including mandatory Trust courses. Records of attendance are kept by the discipline specific training officers.
The Department of Laboratory Medicine is committed to the training, education and development of all grades of staff, with reference to appropriate training programs which include the following:
a) b) c) d)
assigned work processes and procedures the quality management system applicable computer system(s) health and safety, including the prevention or containment of the effects of adverse incidents; e) the ethics and confidentiality of information.
Competency to perform assigned tasks (B9.3, ISO 5.1.6) is assessed following training and periodically thereafter. Retraining and reassessment occurs when necessary. Records of competency assessments are kept in staff records (Section 5.6). Competency is assessed using a variety of approaches including; direct observation, assessment of problem solving, observation of equipment use, monitoring of records and re-examination of samples. The training officer’s co-ordinate the training of all trainee Biomedical Scientists, including laboratory based training and the following of appropriate portfolios.
(ISO 5.1.8) All staff are encouraged to participate in continuous professional development (CPD), and this is periodically reviewed at staff appraisal. Funds for training are identified in the Laboratory Medicine budget.
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6
PREMISES AND ENVIRONMENT
6.1
Premises and environment (C1, ISO 5.2, 5.3)
Access to Laboratory Medicine is restricted to authorised personnel only via a FOB &/or coded locking system on the doors leading into the department. Staff issued with a FOB are recorded and limited to only those requiring entry; porters have access as appropriate. Doors leading to main reception are not locked and are accessible by all persons. The blood transfusion fridges are accessed via code/FOB accessed doors. Relevant staff are given FOB access as necessary.
All visitors are required to contact Laboratory Medicine reception to gain entry. All non Trust visitors to the department are required to complete a visitor record book and must wear a visitor badge at all times whilst in the department. A coded and FOB access lock is fitted to all pathology outer doors leading to main laboratory access.
(ISO 5.2.2) The premises are designed to ensure there is sufficient space to guarantee the quality, safety and efficiency of the services provided to the users and for the health and safety of laboratory personnel. The environment also ensures that access to areas affecting quality of work are controlled, environmental monitoring of conditions is carried out to safeguard correct performance of examinations, and safety equipment is readily available and regularly maintained. 6.2
Facilities for staff (C2, ISO 5.2.4)
Facilities for staff are provided by the department and include: Male and female toilets, secure lockers for storage of personal items; rest room with drinking water; facilities for making hot drinks and a wash-up area.
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6.3
Facilities for patients (C3, ISO 5.2.5)
No facilities are required for patients within Laboratory Medicine, although private space can be made available if confidential information needs to be shared i.e. Andrology sample drop off. Phlebotomy at EKHUFT is under the management of Laboratory Medicine. Suitable space has been provided for each phlebotomy clinic within their designated areas, at pathology entrance in both KCH and QEQMH, and in the Out Patients Department at WHH. There is provision to maintain privacy for patients with sufficient clinical support if required. 6.4
Facilities for Storage (C4, ISO 5.2.3)
The provision of sufficient storage space, under the correct conditions, is important in maintaining the integrity of samples, reagents and records. All storage facilities are in keeping with national legislation, regulations and guidelines. The following documents describe the procedures throughout Laboratory Medicine for storage of samples, reagents, blood products etc:
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6.5
Health and safety (C5, ISO 5.2, 5.7)
The Department of Laboratory Medicine ensures that there is a safe working environment in accordance with current safety guidelines and legislation. The Trust Health and Safety Policies are on the Trust Intranet available via SharePoint.
A Laboratory Medicine health & safety handbook is in place to ensure a safe environment for staff, patients and visitors. LP-DIR-105a Health & Safety Handbook
The Laboratory Manager has responsibility for Departmental Health and Safety.
Day to day
management of Health and Safety issues is delegated to a Health and Safety Advisor within the disciplines.
Procedures for spillages and decontamination are documented throughout the department as follows:
Chemicals are handled in accordance with each individual relevant SOP.
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Risk assessments are performed on all activities and procedures performed in the department. Each test method and activity has a statement on health and safety aspects in the technical Standard Operating Procedure (SOP) for that procedure. The reporting of any incident, for which there are specific triggers, is through the Trusts’ Incidence Reporting System (DATIX). The Laboratory Medicine document DIR-QP-Q122 Procedure for Reporting Adverse Incidents describes the protocol for reporting adverse incidents by use of electronic DATIX forms. This record is visible to the DATIX coordinator for the trust and anyone who is allocated as part of the report or investigation team.
7
EQUIPMENT, INFORMATION SYSTEMS AND REAGENTS
7.1
Procurement and management of equipment (D1, ISO 4.6, 5.3)
The Laboratory Medicine document DIR-MP-Q106 Procurement and Management of Equipment is in accordance with CPA standard D1 and Trust policies.
There is an asset register/equipment list (D1.3, ISO 5.3.1.7) of all analytical equipment used within each discipline which includes: a) b) c) d) e) f) g)
name of manufacturer serial number date of purchase or acquisition manufacturer’s instructions current location, where appropriate record of contracted maintenance record of equipment breakdowns.
All instrumentation is regularly serviced and maintained as directed by the manufacturer and records of all such maintenance is logged in the Instrument logs which also contain records of analytical breakdowns, downtime and service reports, as well as additional information specific to the analyser. Prior to any analyser being maintained or removed it will be decontaminated as appropriate and logged on a decontamination certificate DIR-FO-038.
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The Estates Department conducts electrical safety testing of all electrical equipment within the department prior to instalment and periodically thereafter, (the repeat testing interval is risk assessment based, where annual re-testing is not practicable). 7.1.2
External services and supplies
The procedure for the selection and purchasing of external services, equipment, reagents and consumables is documented in the document DIR-MP-200 Review of Service Level Agreement (SLA) Between EKHUFT & NHS, Private and Independent Hospitals 7.2
Management of data and information (D2, ISO 5.10)
The proper management of data and information in the laboratory is essential for the provision of the service.
The department is committed to meeting its information security obligations to meet the needs of users, clients, patients and staff with respect to confidentiality, integrity and availability, which are defined as follows:
confidentiality: protecting information from unauthorised disclosure integrity:
safeguarding the accuracy and completeness of information and software
availability:
ensuring information and vital services are available to users when required
DIR-MP-Q107 The Management of Data and Information describes the department’s adherence to this standard. 7.3
Management of reagents, consumables, calibration and quality control material (D3, ISO 5.3.2)
It is essential to have proper management of all the materials used in the provision of the service to ensure a service that meets the needs and requirements of our users.
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The department ensures that an adequate supply of consumables, reagents, calibration and quality control (QC) materials are available for all analysis which is performed. These are received, stored, used and disposed of as stated in DIR-MP-Q108. The management of reagents and Quality Control materials.
Specific instructions for acceptance testing and storage, use and disposal can be found in the relevant SOP’s and QC logs.
Quality control, verification and assurance is also documented within disciplines as required including the following documents: MIC-MP-002 QA Manual (Microbiology) MIC-QP-006 Quality systems, stock control in Serology BIO-LP-431 QC policy HPA-LP-177 Assuarnce of quality in Haemophilia laboratory
Any incident that is directly due to any reagent or equipment will be reported as described in the relevant SOP’s and the directorate H&S handbook.
8
PRE-EXAMINATION PROCESSES
8.1
Information for users and patients (E1, ISO 5.4)
Patient and external user (GP) information required to fulfil E1, ISO 5.4.2 is available on the trust website in the GP and patients & visitors zones at: http://www.ekhuft.nhs.uk/patients-andvisitors/services/a-z-of-services/laboratory-medicine/.
There is information for giving instructions to patients, such as fasting instructions, pre semen analysis preparation and Phlebotomy opening hours on site and for outreach clinics. Other details include user guides and contact details, there is also a link for Lab tests on line, where patients can view test information if they wish (E1.3).
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In the staff zone of the trust website http://www.ekhuft.nhs.uk/staff/clinical/laboratory-medicine/ there is further information including handbooks and user guides, giving detail about sample requirements for various departmental test repertoires and out of hours clinical guidelines (where appropriate). 8.2
Request form information (E2, ISO 5.4.3)
There are three types of request form,
EKHUFT generates Patient Administration System (PAS/ward order entry) request forms for inpatient/ hospital use. GP surgeries have use of an electronic ordering system DART OCM. There are manual paper request forms available where either PAS or DART OCM are not in use. The forms are designed with scanning and OCR (optical character recognition) in mind, with a request for capital letters, black ink and asterisk marked mandatory fields, with a guide for thick horizontal line fill, to aid in scanning.
In addition, the nationally approved gynaecological cytology request forms and appropriate forms for blood transfusion are also used and patient books for haemostasis clinics.
All request forms are designed to meet the appropriate standards and description for acceptance criteria is found in DIR-LP-113a Specimen and request form acceptance.
Any requests received verbally are logged via a verbal request log form and added to electronic requests. Document DIR-IP-252 Apex Laboratory Computer: Inputting requests…, describes the process of adding additional test requests. 8.3
Primary Specimen collection and handling (E3, ISO 5.4.4)
All disciplines have handbooks/ user guides which are available via the Trust website which contain all the information necessary for specimen collection, handling, storage and packing. All information and safety considerations can also be found in the Laboratory Medicine H&S Handbook. These documents are reviewed regularly. These can be found at http://www.ekhuft.nhs.uk/patients-and-
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visitors/services/a-z-of-services/laboratory-medicine/.
and
http://www.ekhuft.nhs.uk/staff/clinical/laboratory-medicine/
DIR-LP-112a Specimen postal regulations and transport procedures is a standard operating procedure which incorporates transportation by Porters, the dedicated Laboratory Medicine porter, Phlebotomists, Couriers and the pneumatic tube system which is also the subject of a specific SOP DIR-LP-Q510 Pneumatic Tube System Operation
8.3.1
All procedures require informed consent (ISO 5.4.4.1).
When a patient presents to a GP surgery or clinic and submits to a collecting procedure, consent is inferred. The Trust policy;
Policy Patient Information and Consent to Examination or Treatment Version 1 2011 is available via the staff zone of the intranet, and for patients there is a web link to the DoH web site regarding medical consent. 8.4
Specimen transportation (E4, ISO 5.4.5)
Transportation of samples within the Hospital is dealt with under E3 above by information on the Trust intranet concerning “Collection & transportation of samples” (within the H&S handbook) subsection Transportation of samples and are transported either by the Hospital portering system, or from the acute sites, by the Aerocom (UK) pneumatic tube system.
There is a Network inter-trust transport system, which is timetabled, whereby samples are sent between network Trusts.
External samples from GP surgeries and community clinics are collected and brought to the laboratory via courier service.
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8.5
Specimen reception (E5, ISO 5.4.6)
There is a centralised reception area on each site for all Laboratory Medicine samples, under the Management of Clinical Biochemistry. As samples are received into Laboratory Medicine they are sorted into the various sections and sent to the relevant disciplines for processing.
Within the WHH site there is a further reception area for both histology and microbiology where samples are further sorted once received from central reception. The documents available which cover all sample receipt processes are as follows: DIR-LP-113a Specimen and request form acceptance policy DIR-LP-113c Procedure for handling & distribution of specimens within blood sciences reception DIR-LP-113d Receipt, handling and distribution of samples arriving at pathology reception DIR-LP-114 Procedure for receipt, handling and distribution of urgent samples CEL-LP-102 Histology specimen reception MIC-LP-028 Microbiology reception and referral guidelines.
8.6
Referral to other laboratories (E6, ISO 4.5)
Procedure for referring samples to other laboratories is detailed in the following procedures: HAE-LP-138 Referring samples to specialist laboratories BLT-LP-006 Referral of samples to STBTS CEl-LP-038 Direct referrals CEL-LP-030 HER2 referral CEL-LP-301a Referral of BCS for external opinion HAe-LP-138 Referral of samples to specialist laboratories for analysis MIC-LP-028 Microbiology reception and referral guidelines.
All referral laboratories are listed within discipline specific handbooks and their ability to meet our quality standards i.e. is the service accredited, is checked on a regular basis.
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For procedures on selection of service see section 7.1.2
9
EXAMINATION PROCESS/ PROCEDURES
9.1
Selection and validation of examination procedures (F1, ISO 5.5)
The Department of Laboratory Medicine uses appropriate methods and procedures for all tests, including specimen handling, storage and preparation for testing. All technical procedures used are documented in internal Standard Operating Procedures (SOPs).
The selection of examination procedures is based on discussion between senior medical and technical staff with due consideration to the requirements of the users of Laboratory Medicine services.
9.1.2
Validation and Verification of procedures (ISO 5.5.1.2, 5.5.1.3)
The documents DIR-MP-Q106 Procedure for the Procurement and Management of Equipment and DIR-SOP-Q008 Laboratory Medicine Validation Strategy, Procedure and Documentation with Particular Reference to Blood Transfusion describe the validation and implementation of new equipment and methodologies into the department.
Documents for verification of methods are also available as below:
9.1.3
Measurement uncertainty of measured quality values ( F3.3, F3.4, ISO 5.5.1.4)
Measurement of uncertainty is addressed in each procedural SOP as necessary. Documentation for determination of uncertainty are available as follows:
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9.1.4
Biological reference limits or clinical decision values (ISO 5.5.2)
Biological reference limits are referenced within all relevant procedural SOP’s and are reviewed as necessary by clinical staff. All issued reports either paper or electronic display reference limits for the tests.
9.2
Examination procedures (F2, ISO 5.5.3)
Examination procedures are fully documented in internal technical Standard Operating Procedures. Technical SOPs conform to the same general layout, and contain all essential criteria as detailed in DIR-MP-Q001 The Management and Control of Documents Including Process and Quality Records. All documents are loaded onto the QM system Q-Pulse, controlled and reviewed on a regular basis. All documents include reference to relevant risk assessments and COSHH assessments.
9.3
Assuring the quality of examinations (F3, ISO 5.6)
9.3.1
Quality Control (ISO 5.6.2.2, 5.6.2.3)
To ensure the quality and reproducibility of results procedures are clearly defined for pre, post and examination processes within SOP’s which define the conditions for performing the examination. All results are documented as described.
Documents describing QC include:
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In order to confirm the performance of laboratory procedures, all disciplines subscribe to all available and relevant External Quality Assurance Schemes (EQAS) Samples received under these schemes are tested in accordance with the relevant internal SOPs and the results obtained compared to the expected results reported by the Scheme organisers. Any exceptions received are fully investigated and logged as non-conformances as described in DIR-MP-Q130 Identification and control of Nonconformities and Quality Improvement.
9.3.2
Interlaboratory Comparisons (ISO 5.6.3)
The disciplines take part in external quality control where they exist and monitor all results of performance. In areas where no such external schemes exist the laboratories partake in interlaboratory comparison where appropriate. Performance is monitored and in the event of an unsatisfactory or erroneous result a non- conformity is raised.
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Procedures for participation of comparison are described in the following documents: MIC-LP-124 Hain Fluorocycler HSV PCR procedure BIO-LP-246 Separation of the isoenzymes of alkaline phosphatase.
9.3.3
Comparability of examination results (F3.5, ISO 5.6.4)
The mechanisms in place for ensuring comparability of results from different sites or equipment are described in the appropriate SOP’s or by comparison of EQA data.
10
POST- EXAMINATION PROCESS
10.1
Review of results (CPA G, ISO 5.7.1)
Results for all examinations are reviewed by appropriately authorised personnel as per procedure SOP’s throughout Laboratory Medicine. Any results which are auto validated are selected for validation against reviewed and clinically agreed criteria.
10.2
Storage, retention and disposal of clinical samples (A10, ISO 5.7.2)
This standard is fulfilled by documented procedures referenced in section 4.3.5 of this manual.
10.3
Reporting results (G1, ISO 5.8.1)
All disciplines within Laboratory Medicine recognise the importance of correct, timely, unambiguous and clinically useful results. Results are authorised in accordance with procedural documents and are electronically generated. Any delay or error in reporting is communicated to the appropriate individual and a non- conformance is raised within the department.
Turnaround times for samples are published via the Discipline specific handbooks/ user guides which can be accessed via the Trust internet/ intranet. These times are monitored on a monthly basis as part of Laboratory Medicine quality indicators. The Procedures for resulting results is described in the following documents:
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10.4
The report (G2, G5, ISO 5.8.2, 5.8.3)
All reports are computer generated. Printed reports for EKHUFT are sent via the internal transport system and all other printed reports are sent via the Trust mailing system, as described in the document DIR-LP-300 Daily routine operation of Pathology ‘clean’ reception. Electronic reports are available for all GPs via DART. Results can be viewed electronically within the hospital using DART, PAS and/or VitalPak.
All reports contain the required data that includes unequivocal identification of the patient, date and type of sample and results with relevant comment. All reports fulfil the criteria required for standard G2, ISO 5.8.3.
There are processes in place to ensure addition of appropriate clinical comments and interpretive comments from clinical scientists and consultants within Laboratory Medicine. Processes include specific technical SOP’s as referenced in section 10.2 of this manual.
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10.5
Release of results (G3, ISO 5.9.1)
All reports/ results are released and controlled as stated in procedures in section 10.2 of this manual. Results for release at a provisional level are issued as per DIR-LP-Q117 Issuing provisional reports, any reports to be released via telephone or fax are done so following procedure DIR-LP-Q118 Telephoning and faxing of results. Any samples with critical results are released following procedure DIR-LP-Q119 Procedure for critical results communication. More specific criteria for discipline specific release of results can be found in local protocols.
10.6
Automated selection and reporting of results (ISO 5.9.2)
Some results may be authorised automatically, as determined by rules written into the software. Rules for auto validation are defined in specific technical procedures. Critical levels are checked and reviewed on a regular basis and any samples falling outside the normal ranges will not be auto validated.
10.7
Revised reports (G4, ISO 5.9.3)
Amended reports may be issued under certain circumstances as described in the following protocols:
Any amendment made to a report is recorded and reported as a non-conformity if directly affecting the results issued. If the amendment is of critical significance then a DATIX incident may be raised.
10.8
Clinical advice and interpretation (G5, ISO 5.4.2)
Clinical advice is available as required. Clinical biochemistry and Microbiology run duty desks which are available throughout working hours to give clinical advice within half an hour. Out of routine hours
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there is an on call doctor available via phone. Haematology have an on call haematologist available for clinical advice and interpretation as necessary. Histologists in Cellular Pathology are available throughout working hours to give clinical advice. See section 10.2, 10.3
10.9
Laboratory information management (ISO 5.10.1)
Refer to section 7.2 of this manual. 10.10 Authorities and responsibilities (ISO 5.10.2)
The EKHUFT has a Caldicott Guardian, a Freedom of information lead and an Information Governance Manager. Laboratory Medicine has a Freedom of Information lead and an Information Technology Manager. An individual’s access rights to the Laboratory Medicine LIMS are determined by each discipline according to the requirements of the individual service and the individual’s role as is documented in the discipline specific procedures. All other management of the IT systems is described in DIR-MP-Q107 Management of data and information. Contingency in cases of IT down time is described in document DIR-IP-Q650 Contingency for loss of IT systems.
11
EVALUATION AND QUALITY ASSURANCE
11.1
Evaluation and audit (H1, ISO 4.14)
The department ensures that the service it provides meets the requirements of its users, by means of on-going evaluation by quality audit of these services.
Results of the evaluation processes are discussed at the monthly Laboratory Medicine Policy Board (LMPB) and Laboratory Medicine Quality Forum meetings in addition to the Clinical Governance Subgroup Meetings and discipline specific Meetings.
Evaluation and on-going quality is assured using a number of processes including internal audit, internal and external quality assurance, internal quality control, assessment of user feedback
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including complaints and compliments, discipline specific and Departmental quality indicators, risk assessment, review of non-conformities and continual quality improvement.
Outcomes of the evaluation and improvement processes are reviewed as part of the annual management review of the quality system and form the basis of the departmental objectives for the coming year.
11.1.2
Periodic review of requests & suitability of procedures and sample requirements (E3.3, ISO 4.14.2)
There is a formal regular review of the examinations provided and the sample volume, collection device and preservative requirements on review of the user handbook/ user guides found on the trust internet/ intranet. (Ref section 8.3 of this manual). Ad hoc reviews arising from user feedback, staff suggestions or quality improvements, may be conducted at Laboratory management meetings.
New examination procedures may be introduced after discussion and approval at laboratory meetings. Protocols are introduced as required, following the Process of validation / verification and change control. (DIR-SOP-Q008, BLT-LP-087)
11.2
Assessment of user satisfaction and complaints (H2, ISO 4.14.3)
In order to establish that the service provided by the laboratory meets the needs and requirements of users, the Department of Laboratory Medicine assess user satisfaction by the use of customer satisfaction surveys (via Survey Monkey) conducted by the Head of Quality on a regular basis. Results are collated and reported back at AMR for review and incorporation of relevant actions into appropriate discipline AMR’s for the coming year. Complaints are monitored, responded to and reported at LMPB meetings on a monthly basis, these procedures are described in the Laboratory Medicine documents DIR-QP-Q002 Policy and procedure for compliments and complaints, DIR-QPQ123 Procedure for the Measurement of User Satisfaction and Effectiveness of Service Delivery.
Any quality improvements that are identified from surveys or complaints are raised as quality improvement records in Q-Pulse and managed as described in DIR-QP-Q130 Procedure for the
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management of non-conformances and the delivery of quality improvement.
Compliments are also recorded and fed back at LMPB meetings.
11.2.1 Staff Suggestions 4.14.4
Staff suggestions may take several forms;
Change requests may be raised against documents (documented via QPulse). Raising change requests is encouraged, as it shows documented processes are being read and practice reflected on. All change requests must be reviewed and a reason must be given if not implemented. A message will be sent to the individual who made the request informing them that their request has been rejected, or accepted and subsequently implemented.
Quality Improvements (QIs) may be raised directly by the individual or may arise from suggestions made at departmental meetings or from informal staff discussions. QIs are managed as described in DIR-QP-Q130
11.3
Internal audit of quality management system (H3, ISO 4.14.5)
All disciplines throughout Laboratory Medicine have an audit calendar incorporating quality management system audits. Any non-compliance is documented and the appropriate remedial and corrective actions implemented within defined timescales, with stated individuals being responsible for these actions. Audits are recorded on the Q-Pulse audit module and any non –conformances are raised as CAPA reports within the system. The results of these audits provide evidence to demonstrate that the quality management system has been effectively established, implemented and maintained. DIR-MP-Q003 Q-pulse CAPA module, DIR-MP-Q006 Use of the Audit Module
Audit data is monitored by review and discussion at the Laboratory Medicine Quality forum, and discipline specific quality meetings.
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11.3.1 Internal audit of examination processes (H4, ISO 4.14.5)
Internal audit of pre examination, examination and post examination processes ensures that they are being conducted according to agreed procedures; these audits are also incorporated into the discipline specific audit calendars. Ad hoc audits are also carried out as necessary and added to the audit calendar.
The process for planning, conducting, evaluating, monitoring and reviewing the audit are described in the procedure DIR-QP-Q125 Internal audit. Any non-compliance is documented and the appropriate remedial and corrective actions implemented within defined timescales, with stated individuals being responsible for these actions. Any quality improvements made from audit findings are recorded as QI’s within Q-Pulse.
Audit data is monitored by review and discussion at the Laboratory Medicine Quality forum, and discipline specific quality meetings. 11.4
External quality assessment (H5,ISO 5.6.3)
The department currently participates in the all relevant and appropriate external QA schemes where they exist and in the event of no such scheme interlaboratory exchange is undertaken. Ref section 9.3.2 of this manual.
Any performance issues are recorded as non conformance on Q-Pulse and appropriate actions taken.
EQA performance is monitored on a monthly basis at Laboratory Medicine quality forum and discipline specific quality meetings.
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12
QUALITY IMPROVEMENT
12.1
Quality improvement (H6, ISO 4.10, 4.11, 4.12)
Continual quality improvement is an essential part of maintaining and improving laboratory services. The Department of Laboratory Medicine employs a continuous quality improvement system, which involves the continual assessment, evaluation and evolution of the service. The Laboratory Medicine procedure DIR-QP-Q130 Procedure for management of non-conformities and delivery of quality improvement, describe the department’s process for continual quality improvement, which includes documented remedial action, corrective action (H6.2, ISOI 4.10) and preventive action (H6.3, ISO 4.11), monitoring of quality indicators and improvement processes.
The department establishes quality indicators to monitor and evaluate performance throughout critical aspects of pre-examination, examination and post-examination processes and their relationship to effective patient care. The objectives of quality indicators, their methodology and duration of measurement, are established for existing procedures and prior to implementation of new procedures.
Each discipline within Laboratory Medicine sets quality objectives. The use of quality indicators can aid in the monitoring of the success of these objectives.
The results of the quality improvement program forms part of the development, training and education of all staff. This is achieved through staff appraisal, departmental meetings and inclusion of quality improvement into staff training protocols. Evidence of staff involvement in this process can be demonstrated by minutes of meetings, training records etc.
The evaluation of the process ensures that the patient is at the heart of the service and processes are streamlined by eliminating non-value adding steps, staff skills are utilized appropriately and the service maximizes the use of technology.
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13
IDENTIFICATION AND CONTROL OF NONCONFORMITIES
13.1
Identification and control of nonconformities (H7, ISO 4.9)
There is a documented procedure DIR-QP-Q130 Procedure for management of non-conformities and delivery of quality improvement in place to ensure that non conformities in pre examination, examination and post examination processes are effectively managed to minimise the risks to users.
There is a process in place for the creation, monitoring and completion of all nonconformities, including the circumstances and mechanism for halting examinations as necessary, all nonconformities are recorded on Q-Pulse. Following root cause analysis, corrective actions and preventative action are identified. The numbers and status discipline specific non-conformities is monitored and reported at discipline specific quality meetings and the Laboratory Medicine Quality forum. The status of non-conformities, together with the status of corrective and preventive actions is also reviewed at the Annual Management review.
The documents describing these processes are as follows: DIR-MP-Q003 Creating and completing CAPA on Q-pulse, and DIR-QP-Q130 Procedure for management of non-conformities and delivery of quality improvement
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