National Public Health Service for Wales / MICROBIOLOGY SWANSEA

Quality Manual

QUALITY MANUAL.

This document together with specified procedure manuals represents the Quality Management system of the NPHS Microbiology Swansea. 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 NPHS Microbiology Swansea Laboratory.

Contents. Page.

Section 1:General Information 3

1.1Title of Laboratory 3

1.2The Quality Manual. 6

Section 2:Quality Policy 7

Section 3:Organisation Responsibilities and Authorities9

Section 4:Organisation and Quality Management System. (A1-A11).13

Section 5:Personnel. (B1-B9).16

Section 6:Premises and Environment (C1-C5).21

Section 7.Equipment, Information systems and reagents. (D1-D3)24

Section 8:Pre-examination process. (E1-E5).27

Section 9:Examination process.(F1-F3).30

Section 10:Post-examination process. (G1-G10).32

Section 11:Evaluation and quality assurance. (H1-H6).34

1.GENERAL INFORMATION

NATIONAL PUBLIC HEALTH SERVICE MICROBIOLOGY SWANSEA

The National Public Health Service Microbiology Swansea is located on Swansea NHS Trust property and is responsible to the Welsh Assembly Government through its parent body the National Public Health Service for Wales (Infection and Communicable Disease Service ICDS), which is part of Velindre NHS Trust.

The postal address is: -

NPHS Microbiology Swansea Tel.No: 01792-285055

Pathology Laboratory. Fax: 01792-202320

Swansea NHS trust.

SingletonHospital

Swansea

SA2 8QA.

Information on the services provided and contact telephone numbers are available in the Swansea NHS Trust Pathology Pointers handbook on the trust intranet site:

and on the ICDS intranet site:

The National Public Health Service, Microbiology, Swansea, consists of two clinical departments, Bacteriology and Virology and three reference units, Cryptosporidium, Molecular Diagnostics and Toxoplasma. The main services of all units are described below.

  1. Bacteriology Department

This department provides a full clinical bacteriology service to the Swansea NHS Trust, which incorporates Singleton and MorristonHospitals, to Neath/Port TalbotHospital (which is part of Bro Morgannwg NHS Trust) and local general practitioners.

Specimens examined include urines for culture and pregnancy testing, all types of wound swabs, respiratory samples, genital, enteric and blood cultures. Antibiotic profiles are provided, together with clinical notes for organisms considered to be clinically significant. An assay service for commonly used aminoglycocides and glycopeptides is provided, and where antibiotic levels are required for lesser-used antibiotics, these are sent to CPA Accredited laboratories for analysis. Within Bacteriology, a range of mycology services are provided which include the dermatophytes, and respiratory fungi. PCR tests are performed off-site, and forwarded to relevant CPA Accredited laboratories e.g. N.meningitidis and Mycobacterium tuberculosis.

  1. Cryptosporidium Reference Unit

The Cryptosporidium Reference Unit provides a comprehensive range of specialist and reference services to NPHS, NHS, and HPA laboratories throughout England and Wales, and private hospital laboratories within the UK

Core Reference Services include:

Confirmation of referred isolates of Cryptosporidium

Specialist testing of samples further to the scope of local laboratory diagnoses

Typing of referred isolates to support outbreak/cluster investigations and for epidemiological surveillance

Evaluation of new laboratory methods for Cryptosporidium

Provision of positive control and training materials

Consultation advice on diagnostic methods and management of cryptosporidiosis

Advice on the investigation, epidemiology, control and prevention of Cryptosporidium

R & D activities in relation to our reference functions

  1. Molecular Diagnostics Unit

The Molecular Diagnostics Unit provides, on behalf of Swansea NHS Trust, the facilities, technical back-up, supervision and management for on-site HIV viral load testing, outsourcing of HIV antiretroviral resistance testing, and a range of haematological molecular investigations. All such testing is carried out by Swansea NHS Trust staff.

  1. Toxoplasma Reference Unit

The Toxoplasma Reference Unit provides a comprehensive range of specialist and reference services to NPHS, NHS, and HPA laboratories throughout England and Wales, and private hospital laboratories within the UK and elsewhere within the EU. These services include serological and molecular assays and direct culture from clinical specimens for the diagnosis and characterization of toxoplasma infection. The Unit also provides advice on patient management strategies including appropriate laboratory investigation, interpretation of results in a clinical context, and advice on treatment. The Unit also co-organises the NEQAS toxoplasma serology scheme and has produced, in collaboration with the UK National Institute of Biological standards and Control, the international standard preparation for Toxoplasma IgG on behalf of the World Health Organisation.The unit has an ongoing R&D programme aimed at reducing the health impact of toxoplasmainfection.

e.Virology Department

The virology department offers a comprehensive service to the Swansea NHS Trust, Bro Morgannwg, Dyfed Powys and Ceredigion Trusts. The department handles ante-natal serology testing on an automated platform interfaced to the pathology LIMS. A rapid hepatitis, HIV serology service is provided by an interfaced random access analyser. A rapid respiratory virus service is provided to paediatric units. Both molecular and ELISA technologies are available for chlamydia diagnosis. Conventional serology tests such as CFTs are carried out as well as IgM assays for early diagnosis. Virus isolation in tissue culture is available. Where work needs referral, there are close links with other accredited laboratories. The department provides advice on clinical interpretation of results and patient management.

1.2 The Quality Manual

The Quality Manual has been compiled by the Quality Manager with wide input from the CPA Quality Manual Template and the staff of the laboratory. The Quality Manager is responsible for authorisation, issue and control of the document, which is fully endorsed by the Laboratory Director.

This Quality Manual outlines the general form of the Quality System in operation in the Laboratory, identifying the arrangements for ensuring that the quality policy is adhered to by staff in all departments at all times. The Quality Manual can be regarded as the index to separate volumes of management, laboratory, clinical and quality procedures. The sections of the Quality manual are organised in the same way as the CPA (UK) Ltd Standards.

  1. Organisational and quality management system.
  2. Personnel.
  3. Premises and Environment.
  4. Equipment, materials and reagents.
  5. Pre- examination process.
  6. Examination process
  7. Post-examination process.
  8. Quality assurance and evaluation.

2.Quality Policy

The Quality policy of the NPHS Microbiology Swansea is given below and published as a separate controlled document to be displayed within the laboratory.

2.1The NPHS Microbiology Swansea Laboratory is committed to providing a service of the highest quality and shall be aware and take into consideration the needs and requirements of its users.

In order to ensure that the needs and requirements of users are met, the laboratory 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.
  • Ensure that all personnel are familiar with this quality policy to ensure user satisfaction.
  • 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 whilst on site.
  • Uphold professional values and is committed to good professional practice and conduct.
  • Comply with all environmental legislation.

2.2The Laboratory will comply with standards set by CPA (UK) Ltd and 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
  • The collection, transport and handling of all specimens in such a way as to ensure the correct performance of laboratory examinations.
  • The use of examination procedures that will ensure the highest achievable quality of all tests performed.
  • Reporting results of examinations in ways that are timely, confidential, accurate and clinically useful.
  • The assessment of user satisfaction, in addition to internal audit and external quality assessment, in order to produce continual quality improvement.

Issued By: -

Ian Thomas - Laboratory & Quality Manager

Authorised By: -

Dr. Khalid El Bouri, Director, NPHS Microbiology Swansea.

3.Organisation Responsibilities and Authorities

3.1Relationship to the host Organisation

The National Public Health Service Microbiology Swansea is located on Swansea NHS Trust property though is responsible to the Welsh Assembly Government through its parent body the National Public Health Service.

Dr. Khalid El Bouri, Laboratory Director is responsible to Dr. A.J. Howard, Director of the Infection and Communicable Disease Service and through him toDr. Cerilan Rogers, Director of the NPHS.

Appendix 1 - Organisational Chart Describing the Relationships of the Component arms of the Infection and Communicable Disease Service within The National Public Health Service

Version: SM/QUALMAN 3.2 / Page 1 of 37
National Public Health Service for Wales / MICROBIOLOGY SWANSEA

3.2Organisation and Responsibilities within the NPHS Microbiology Swansea Laboratory

The Laboratory is divided into two departments with a medical consultant in charge, and three reference units with a medical consultant or consultant clinical scientist in charge.

Appendix 2 - ICDS SwanseaSenior Management Structure

Appendix 3 - Technical Staff Structure

Version: SM/QUALMAN 3.2 / Page 1 of 37
National Public Health Service for Wales / MICROBIOLOGY SWANSEA

The management of the NPHS Microbiology Swansea laboratory ensures that there is continuous monitoring and improvement of all aspects of the laboratory’s function through the following committees:

The NPHS Management Executive – this Committee meets once a month. Its membership is as follows:

ChairDr. Khalid El Bouri Laboratory Director/ Consultant Microbiologist

SecretaryMrs Lynne Ray Laboratory Administrator

Dr. Ann LewisConsultant Microbiologist

Dr Nidhika BerryConsultant Microbiologist

Professor Deitrich Mack Professor of MicrobiologyUniversitySwansea

Dr Angharad DaviesSenior Lecturer University Swansea

Mr Ian ThomasLaboratory Manager/Quality Manager.

Dr. Rachel Chalmers Head of Cryptosporidium Reference Unit.

Dr. Edward GuyHead Toxoplasma Reference Unit.

Dr. Michael IsaacDeputy Laboratory Manager/ BMS 3 Virology.

Mrs Janet FrancisBMS3 Toxoplasma Reference Unit.

.

Mr Eugene Rees BMS 3 Bacteriology / Training Officer

Ms Catherine ShepherdBMS3 Microbiology / Audit Officer

The NPHS Microbiology Swansea Management Annual Review - this Committee meets once a year. It formally discusses all audit reviews and complaints. Its membership is the same as that of the NPHS Management Executive.

The NPHS Microbiology Swansea Health and Safety - this Committee meets every 3 months. Its membership is as follows:

ChairMr.Brian WestwoodLaboratory Safety Officer

SecretaryMrs.Lynne RayLaboratory Administrator

Mr Ian Thomas Laboratory Manager / Quality Manager

Ms Heather AldersonAmicus Health and Safety Representative

Dr Kristin ElwinClinical Scientist grade B (Cryptosporidium

Reference Unit).

Dr. Michael IsaacDeputy Laboratory Manager/ BMS 3 Virology

Mr Eugene ReesBMS 3 Bacteriology./ Training Officer

Mrs Sharon PoyntonBMS 2 Bacteriology / Deputy Laboratory Safety Officer

The NPHS Microbiology Swansea Quality Assurance - this Committee meets every 2 months. Its membership is as follows:

ChairDr. Khalid El Bouri Laboratory Director/ Consultant Microbiologist

SecretaryMrs Lynne RayLaboratory Administrator

Dr Anne LewisConsultant Microbiologist

Dr Nidhika BerryConsultant Microbiologist

Mr Ian ThomasLaboratory Manager/Quality Manager.

Dr Rachel Chalmers Head of Cryptosporidium Reference Unit.

Dr. Edward GuyHead Toxoplasma Reference Unit.

Dr. Michael IsaacDeputy Laboratory Manager/ BMS 3 Virology.

Mrs Janet FrancisBMS 3 Toxoplasma Reference Unit.

Mr Eugene ReesBMS3 Bacteriology / Training Officer

Mrs. Catherine ShepherdBMS 3 Bacteriology / Audit Training

Mrs Kim MeadBMS 2 Bacteriology

Mrs Sharon PoyntonBMS 2 Bacteriology

Mr Stuart JohnstonBMS 2 Bacteriology

Ms Gayle BowenBMS 2 Bacteriology

Mrs Rachel RoperBMS 2 Bacteriology

Mr Brian WestwoodBMS 2 Virology

Mr Kevin StuartBMS 2 Toxoplasma

Ms Katy RobertsClinical Scientist B Toxoplasma Reference Unit

Mrs Anne ThomasBMS 2 Cryptosporidium Reference Unit / Audit Officer.

The NPHS Microbiology Swansea Training and Development – this Committee meets twice a year. Its membership is as follows:

ChairMr.Eugene ReesTraining Officer

SecretaryMrs. Lynne RayLaboratory Administrator

Dr Nidhika BerryConsultant Microbiologist.

Dr. Edward GuyActing Head Toxoplasma Reference Unit

Mr. Ian ThomasLaboratory Manager/Quality Manager

Dr. Michael IsaacBMS 3 Virology/Deputy Laboratory Manager

Mr. Stuart JohnstonBMS 2 Bacteriology/NVQ Co-ordinator

4.Organisation and Quality Management System

A1 Organisation and Management

The organisation and management of the NPHS Microbiology Swansea Laboratory is detailed in section 3 of this quality manual.

A2 Needs and requirement of users

The needs of the users are kept under constant review. NPHS Microbiology Swansea organises a yearly customer satisfaction survey involving a pre-visit questionnaire coupled with information on current issues. These questionnaires are sent to hospital users and followed up with a visit to each user by a senior member of the microbiology staff. Issues are discussed and action agreed within the scope of the surveyor and a report produced for the host trust.

A similar format of customer satisfaction survey is issued by the Reference Units to users outside the host trust.

A monthly report is presented to the NPHS Microbiology Swansea management executive to discuss any incidents/complaints and these are reviewed at the annual management review along with any non-compliance highlighted by the NPHS Microbiology Swansea audit programme.

The needs of the users are also reviewed, for example by membership on various committees (GP liaison group, Pathology Management Executive) and the provision of “alert organism” and mandatory surveillance data to the Trust’s infection control team.

A3 Quality policy

The quality policy of the NPHS Microbiology Swansea Laboratory is detailed in section 2.0 of this quality manual.

A4 Quality management system

The components and relationship within the Quality management system are described in section 4 of this Quality Manual and fulfil standards A5 to A10

A5 Quality Objectives and Plans

The Laboratory Management committee defines the quality objectives of the laboratory and is responsible for ensuring that plans are made to meet these objectives. The management review, which is undertaken on an annual basis, determines whether the objectives have been successfully completed and provides an opportunity for revising such objectives and plans and the functioning of the quality system.

A6 Quality Manual

This standard is fulfilled by the production of this quality manual.

A7 Quality Manager

The Laboratory Manager (Mr I.G.Thomas) has overall responsibility for the technical operation of the Clinical Laboratory, and for ensuring that the CPA requirements are met in full. He also acts as the Quality Manager for the laboratory.

The departmental heads Dr. Michael Isaac, Virology, Ms Catherine Shepherd, Mr. Eugene Rees, Bacteriology, Dr Edward Guy Toxoplasma Reference Unit and Dr Rachel Chalmers Cryptosporidium Reference Unit have responsibility for ensuring that the requirements of the CPA standards are met on a day-to-day basis in within the department for which they have responsibility. The Quality Manager is directly responsible to the Laboratory Director, but also has direct access to the Director of the Infection and Communicable Disease Service of the NPHS if quality issues cannot be resolved locally.

A8 Document Control

This standard is fulfilled by document control procedure: - (MS/DOCUMENT CONTROL)

Through the document control system the laboratory management will ensure that all documents are current authorised versions, regularly revised and readily available to all appropriate staff in electronic form and as printed documents.

A9Control of process and quality records

This standard is fulfilled by the control of process and quality records procedure: (MS/CONTRQUALREC)

Through Control of process and quality records, the laboratory management will ensure that all process records are: identified, filed, stored and accessed appropriately with regard to current legislation and that all quality records are identified, filed, stored and are easily retrieved.

All records should be disposed of complying with current legislation.

A10 Control of clinical material

This standard is fulfilled by control of clinical material procedure:

(MS/CONTRLCLINMAT)

The laboratory management ensures that all clinical material is identified, stored and disposed of appropriately complying with current legislation.

A11Management Review

The laboratory management team conducts an annual review, which considers the following items of information.

  1. Reports from managerial and supervisory personnel
  2. Assessments of user satisfaction and complaints (H2)
  3. Internal audit and quality management system (H3)
  4. Internal audit and examination processes (H4)
  5. External quality assessments reports (H5)
  6. Reports of assessments by outside bodies.
  7. Status of preventative, corrective and improvement actions (H6)
  8. Major changes in organisation and management, resource (including staffing or process).
  9. Progress in relation to the business plans of both the NPHS Microbiology Swansea and NPHS Wales.

Records are kept and key objectives for subsequent years defined and plans formulated for their implementation.

5. Personnel.

B1Professional direction

The NPHS Microbiology Swansea is professionally directed by Dr A.M. Lewis Acting Laboratory Director, two consultant microbiologists and Reference Unit facilities by two consultant grade Clinical Scientists.

B2 Staffing

Laboratory management regularly review the repertoire, workload and staffing levels of the department. Steps are taken in accordance with Velindre Trust recruitment and selection, training and development policies to ensure that there are appropriate numbers of staff with the required skills to meet the demands of the service. All staff who are required to be registered in accordance with current national legislation and regulations must provide proof of their registration on a yearly basis. It is the responsibility of the Laboratory Manager to ensure this is recorded.