ScottishMicrobiology Reference Laboratories(Glasgow) / Date of issue 18/12/14
QUALITY MANUAL
NUMBER / VERSION / 4.6
DATE OF ISSUE / 18/12/2014
REVIEW INTERVAL / 2 Years
AUTHORISED BY / Professor J. E. Coia
AUTHOR / J. Roud
COPY / Master File in Q-Pulse
LOCATION OF COPY / Refer to Master File in Q-Pulse
DOCUMENT REVIEW HISTORY
All review / revision details are available in Q-Pulse
Date / Amendment / Initials
CONTENTS
Section in theQuality Manual / Page / Topic
1.0 / Introduction
2.0 / General information about the department
3.0 / Introduction to the quality manual
Related Section of ISO15189:2012 Standard
4.1 / Management requirements
4.1 / Organisation & management responsibility
4.2 / Quality Management System
4.3 / Document control
4.4 / Service agreements
4.5 / Examination by referral laboratories
4.6 / External services & supplies
4.7 / Advisory services
4.8 / Resolution of complaints
4.9 / Identification & control of non-conformities
4.10 / Corrective action
4.11 / Preventive action
4.12 / Continual improvement
4.13 / Control of records
4.14 / Evaluation & audits
4.15 / Management review
5.0 / Technical requirements
5.1 / Personnel
5.2 / Accommodation & environmental conditions
5.3 / Laboratory equipment, reagents and consumables
5.4 / Pre-examination processes
5.5 / Examination processes
5.6 / Ensuring quality of examination results
5.7 / Post-examination processes
5.8 / Reporting of results
5.9 / Release of results
5.10 / Laboratory information management
1Introduction
Our aim is to provide a service to users and patients which is of the highest quality. In order to achieve this, we have established a quality management system to ensure that our service is of consistent quality and meets user requirements.
The Quality Management system in the SMiRL has established a quality policy and quality objectives and is designed to achieve those objectives.
This is done through a process of quality planning which is the part of quality management focused on setting quality objectives and specifying necessary operational processes and related resources to fulfil quality objectives.
The Quality Management system ensures that:
- Laboratory management establishes written quality objectives, which are consistent with the quality policy and are regularly reviewed.
- This quality manual is reviewed regularly, updated as required and any changes communicated to all personnel concerned.
- There is a quality manager who has responsibility for the implementation and maintenance of the quality management system.
- There is a process of document control.
- The control of process and quality records is according to current legislation, regulations and guidelines.
- The control of clinical material is according to current legislation, regulations and guidelines.
- Laboratory management conducts an annual review of the laboratory’s quality management system and all its services.
This Quality Manual is cross-referenced to the procedures and forms used by the SMiRL.
The layout of this Quality Manual follows that of the ISO 15189:2012 Standard for Medical Laboratories. It will be reviewed at the Annual Management Review of 2014.
In order to achieve an efficient quality management system, there is a structure of documentation which covers all the processes undertaken by the laboratory.
All of this documentation is properly controlled. All have a unique identifying code, review date, version number, number of pages and name of authoriser, which correctly identifies the type, number and version of the procedure or form.
2GENERAL INFORMATION
The Scottish Microbiology Reference Laboratories (Glasgow) are part of the Acute Services Division of NHS Greater Glasgow and Clyde. There are four sections of the department, each offering a different specialist service.
General enquiries:- / Tel:- 0141 201-8663 / Fax:- 0141 201-8729ADDRESS:- / Level 5
New ListerBuilding
10-16 Alexandra Parade
Glasgow Royal Infirmary
GLASGOW
G31 2ER
Individual contact numbers / Scottish Salmonella, Shigella and C.difficile Reference Laboratory (SSSCDRL) / Tel: 0141 201-8670
Fax: 0141 201-8729
Scottish MRSA Reference Laboratory (SMRSARL) / Tel: 0141 201-8671
Fax: 0141 201-8729
Scottish Parasite Diagnostic & Reference Laboratory (SPDRL) / Tel: 0141 201-8667
Fax: 0141 201-8729
Scottish Haemophilus, Legionella, Meningococcus and Pneumococcus Reference Laboratory (SHLMPRL) / Tel: 0141 201-8659
Fax: 0141 201-8729
Contact details, laboratory profiles and request forms can be found on our
NHSGG&C IntraNet page:
Scottish Haemophilus, Legionella, Meningococcus & Pneumococcus Reference Laboratory.
The main services of the SHLMPRLare described below:-
a)Clinical Isolates of N. meningitidis
The laboratory confirms the identity of the isolate culturally and biochemically and employs furthers tests for serogrouping, (by latex agglutination and siaDPCR) subtyping (sequencing of the porA gene) and multi-locus sequence typing (MLST) of seven housekeeping genes. E-test for antimicrobial susceptibility (MIC) is also performed.
b)Detection of Meningococcal DNA in clinical samples
Bacterial DNA is extracted from CSF, whole blood (EDTA), other un-clotted samples or serum for use in the detection of meningococcal ctrA gene, siaD grouping gene and for a non-culture MLST.
c)Clinical Isolates of Haemophilus influenzae
The laboratory confirms the identity, serotypes by slide agglutination and confirms the type by a PCR typing technique. MLST is also performed on all isolates.
d)Detection of Haemophilus influenzae in clinical samples
Bacterial DNA is extracted from clinical samples for use in the detection of the H. influenzae Hel gene. MLST is performed on all positives.
e)Clinical isolates of Streptococcus pneumoniae
The laboratory serotypes (by slide agglutination) the isolate and performs MLST on all invasive isolates. E-test for antimicrobial susceptibility (MIC) is also performed.
f) Detection of Streptococcus pneumoniae in clinical samples
Bacterial DNA is extracted from the samples for use in the detection of the pneumococcal lytA gene. MLST and latex serotyping are performed on all positive samples.
g) Immunofluorescence antibody testing (IFA)
The estimation of antibodies directed against all human associated Legionella species. Antibody levels are determined using the indirect immunofluorescence antibody test (IFAT).
h) Urinary Antigen
This test detects the presence of Legionella pneumophila antigen in the acute phase of Legionnaires’ disease.
i) Detection of Legionella in Clinical Material
The laboratory employs a direct immunofluorescence test using FITC-labelled monoclonal antibodies to detect the presence of Legionella pneumophila. A PCR assay targeting the 5sRNA gene found in all legionellae is also available. The most commonly referred samples are sputum and bronchoalveolar lavage (BAL) although the laboratory will accept any clinical samples for examination. All samples submitted will be cultured to attempt isolation of Legionella.
j) Identification and Typing of Legionella Isolates from Clinical or Environmental Sources
The laboratory welcomes submission of all presumptive Legionella isolates from clinical and environmental sources for confirmation and surveillance purposes. A variety of specialized typing methods is available including monoclonal antibody sub grouping, amplified fragment length polymorphism (AFLP) and Sequence Based Typing (SBT).
k) Environmental Services
The laboratory can offer a service for the isolation of legionellae from environmental waters. SHLMPRL participates in the HPE External Quality Assessment Scheme for Legionella isolation from water.
l) Confirmation and emm typing of invasive Group A Streptococci
The laboratory confirms the identity of invasive Group A Streptococci by Lancefield latex agglutination and genotyping of the M protein.
m) Training
The laboratory offers training in various techniques and methods to visiting technical, scientific and medical staff. Staff training is directed by the laboratory Training Officer and follows the Departmental Training Policy and Training Manual.
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Scottish Parasite Diagnostic & Reference Laboratory
The SPDRL provides a comprehensive reference, diagnostic and advice service for all Microbiology laboratories in Scotland, confirmation and identification of blood parasites for Haematology laboratories in Scotland, direct submitting and results/information service for Infectious Disease units and also provides testing for some Microbiology laboratories in England and Ireland.
The main services of the SPDRL are described below:-
a) Microscopy
SPDRL provides a microscopy identification service for faecal, blood, CSF and tissue parasites.
b) Antigen testing
The detection of parasite-specific antigens is available for Entamoeba histolytica, Giardia species and Plasmodium species.
c) Serology
Parasite serology is offered for a range of parasitic diseases including amoebiasis, cysticercosis, echinococcosis (Hydatid), fascioliasis, filariasis, leishmaniasis, strongyloidiasis, schistosomiasis, toxocariasis, toxoplasmosis and trypanosomiasis.
d) Molecular detection
Assay are available which detect and speciate Cryptsoporidium species, Plasmodium species, Acanthamoeba species and Leishmania species.
e) Outbreak Service
SPDRL assists with the management of Cryptosporidium species outbreaks by offering a molecular genotyping and sub-typing service for clinical & environmental samples.
f) Epidemiology and Enhanced Surveillance
SPDRL submits epidemiological information on the incidence of parasite diseases in Scotlandto Health Protection Scotland (HPS) to assist with analysis of trends. Valuable information is also gathered on imported cases of malaria in Scotland through an enhanced surveillance programme in collaboration with haematology laboratories.
g) Advisory Service
Advice is available for parasitic diseases including the appropriateness of tests, their timing and interpretation together with advice about prophylaxis and treatment.
h) Research and Development
Research and development programmes specifically related to the involvement of parasites in public health issues are performed at SPDRL in addition to the evaluation and validation of new technologies aimed at modernising the diagnostic parasitology service.
i) Teaching and Training
Individual tuition and training programmes are available for Biomedical Scientists, Clinical Scientists and Medical colleagues. SPDRL is also involved in parasitology training as part of the Diploma in Tropical Medicine and Hygiene (DTMH).
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Scottish Salmonella, Shigella & C.difficile Reference Laboratory
The main services of the SSSCDRL are described below:-
Identification and typing
Biochemical identification of Salmonella and Shigella isolates.
Biochemical identification of other members of the Enterobacteriaceae (by arrangement).
Serotyping for Salmonella and Shigella.
‘Phage typing for S.typhimurium and S.enteritidis.
The C.difficile Reference Service for Scotland involves close collaboration with a number of other agencies including Health Protection Scotland (HPS), the Health Protection Agency (HPS), the Anaerobe Reference Laboratory in Cardiff and the ESCMID Study Group for C.difficile. All isolates are screened for resistance to a wide range of clinically relevant & epidemiologically important antimicrobials.
DNA-based typing
A range of DNA-based typing and fingerprinting techniques for Salmonellais utilised. These include plasmid profiling and pulsed-field gel electrophoresis (PFGE) of epidemiologically relevant isolates. Other specific requests for these services should be discussed directly with SSCDRL staff.
All C.difficile isolates are tested by PCR Ribotyping. The laboratory participates in the C.difficile Ribotyping Network England (CDRNE) EQA scheme & will participate in any EQA scheme organized by the ESCMID C.difficile Working Group.
Antibiotic susceptibility testing
All isolates are screened for resistance to a wide range of clinically relevant and epidemiologically important antimicrobials. Information allowing for the detection of changes in trends of resistance or the emergence of resistant clones of salmonellae are passed to Health Protection Scotland on a weekly basis.
Teaching and Training
Facilities are available within SSSCDRL to provide a comprehensive programme of instruction in theoretical and practical aspects of enteric infectious disease. The programme runs on an ad-hoc basis being tailored to the needs of the individual rather than having a formal structure. Further information is available on request. This service is available to visiting technical, scientific and medical staff.
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Scottish MRSA Reference Laboratory
The main services of the Scottish MRSA Reference Laboratoryare described below:-
a) Confirmation of MRSA/MSSA status, antibiotic sensitivity monitoring and epidemiological typing of MRSA/MSSA isolates.
b) Identification to species level and typing of coagulase negative staphylococci (CNS).
c) Screening and confirmation of staphylococci with reduced susceptibility to vancomycin (VISA).
d) Detection of Staphylococcus toxin genes.
e) Provide advice on infection control issues, teaching and training of medical and technical staff and have an ongoing research and development program.
g) Collaborate with HPS to provide data on the national trends in MRSA epidemiology in Scotland.
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3THE QUALITY MANUAL
This Quality Manual describes the Quality Management System of the SMiRL.
This Quality Manual fulfills 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 the SMiRL management, laboratory, clinical and quality procedures. Subsequent sections of this Quality Manual are arranged so that they equate with sections of ISO 15189:2012. There is a brief description of the way in which the SMiRL seeks to comply with the particular section of the standard and references are given to appropriate procedures.
The quality management system and the examination processes are continually evaluated and quality assured. The results feed back to maintain and, where required, improve the quality management process and to ensure that the needs and requirements of users are met.
Knowledge of the quality manual is checked and reinforced by e-mail prompting, at staff meetings, at the annual joint review, at KSF sessions and by using a staff quiz. The current version is available in Q-Pulse [RL_QF_015].The quality manual is reviewed during the AMR.
4 MANAGEMENT REQUIREMENTS
4.1.1.1 General
The organisation and management of the SMiRL is detailed below. The laboratory accepts its responsibility to meet the requirements of ISO15189:2012 when carrying out work at its permanent facility at the New Lister Building, Glasgow Royal Infirmary.
4.1.1.2 Legal entity
The SMiRL is part of NHS Greater Glasgow & Clyde, which is the entity that can be held legally responsible for its activities.
4.1.1.3 Ethical conduct
NHSGG&C Standing Financial Instructions and Fraud Policy [external document ED-12 in Q-Pulse] ensure that work quality is not affected by external pressure, that users’ confidential information is protected and that a department cannot undertake activity that would diminish confidence in its impartiality.
Users’ confidential information is also governed by our procedure RL_MP_010 ‘Management of data & information’ and by NHSGG&C I.T. Policy.For report confidentiality, see RL_MP_003 (Reporting results, in section 3.1) and RL_MP_002 (the telephoned report, section 5.1).
Activity that would diminish confidence in impartiality or integrity is also prohibited by the Health & Care Professions Council code of conduct.
4.1.1.4 Laboratory director
Professor John Coia BSc.,MD.,FRC.Path, FRCP (Ed)directs the SMiRL. Dr. Brian Jones BSc, MB.ChB, FRCPath is a consultant medical microbiologist and is deputy director of the SMiRL.
Competence is demonstrated in the following ways:
- Participation in Continuing Professional Development (CPD).
- Membership of the Royal College of Pathologists
- Appointment as a consultant by an Advisory Appointments Committee
- Evidence of continuing practice in the specialty
- Recorded attendance at regular departmental meetings to review service issues and to set quality objectives
Day to day control of each laboratory is under the direction of the Section Managers, co-ordinated by a Site Manager.
The director undergoes annual joint review and has a job plan.The responsibilities of the director are defined in the quality manual (RL_QMAN_2014).
The Director, TSM & the SiteManager represent the organisation at Microbiology management team meetings. The Reference Laboratories are currently accredited, and underwentISO 15189:2012 assessment by UKAS in October 2014. Staff are working to clear all findings and await a decision from UKAS about accreditation status in 2015.
Clinical advice and interpretation
Advice on examinations and the interpretation of results is available to users every day of the year. Clinical advice and interpretative comments on reports are clear, succinct and unambiguous, and are only authorised by the appropriate Medical Consultant or Consultant Clinical Scientist.
Suppliers
The SOP for reviewing suppliers is RL_QP_019.
Contingency plan for emergency situations
There is a plan to ensure that essential services are available during emergency situations or other conditions when laboratory services are limited or unavailable. See RL_MP_020 [Risk (Business continuity) Management] for details.
Management responsibility / commitment
Management have shown commitment to the development & implementation of the QMS and to continually improving its effectiveness by:-
a)Ensuring laboratory personnel are aware of the importance of meeting the needs & requirements of users as well as regulatory requirements by having these as standing agenda items at management meetings, staff meetings and by using CPD accredited quizzes.
b)Establishing a quality policy, see page 13 of this manual. An original copy signed by the director is displayed at the specimen reception desk.The Quality Policy is reviewed at the AMR (see minutes).
c)Establishing quality objectives & plans. See RL_QF_006 for the 2014 version. This will be updated at the AMR of 2014. QOPs are also a standing agenda item at the monthly Senior Scientist meetings. Management ensures the setting of Plans & Objectives by following the Quality Procedure [RL_QP_016].
See also RL_QF_001 (For Plans & Objectives).
d)Responsibilities, authorities & inter-relationships of all personnel are defined on pages 14-19.
e)Communication processes are described on pages 20-21.
f)A quality manager was appointed in 2009, shared on a 50:50 basis with the West of Scotland Specialist Virology Centre.
g)There is an annual management review, conducted in January of the next calendar year. Review is also an integral part of the committee structure. RL_QP_010 defines the conduct of the annual management review.
h)Competency assessment is a key component of our training programme. It is assessed & reviewed according to criteria set down in RL_MP_025.
i)Management ensure adequate resources are available by careful selection, induction and training of appropriately qualified staff. Accommodation is a recently completed state-of-the-art laboratory in the New Lister Building. Equipment & consumables are procured & maintained using the Directorate purchasing procedure. Pre-examination information for users is contained in the individual laboratory’s web page. There is no requirement for SMiRL to provide information for patients.
j)Examination processes are verified & validated before use. Processes are continuously monitored by using IQC and EQA checks.
Resilience
The Department does not sub-contract entire investigations to any other laboratory or organisation unless in the unlikely event of catastrophic occurrence.