rl qman 2014 v4.6cysticercosis, echinococcosis (hydatid), fascioliasis, filariasis, leishmaniasis,...

North Glasgow Microbiology QUALITY MANUAL

Scottish Microbiology Reference Laboratories (Glasgow) Date of issue 18/12/14

Document name: RL_QMAN_2014 Approved by: J E Coia of 44 Controlled Document

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 the Quality 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

1 INTRODUCTION Our aim is to provide a service to users and patients which is of the highest quality. In order to achieve this, we have established a quality management system to ensure that our service is of consistent quality and meets user requirements.

The Quality Management system in the 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.




2 GENERAL 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 201-8729

ADDRESS:-

Level 5

New Lister Building

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: www.nhsggc.org.uk/smrl




Scottish Haemophilus, Legionella, Meningococcus & Pneumococcus Reference Laboratory.

The main services of the SHLMPRL are 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 siaD PCR) 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 Scotland to 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 Salmonella is 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 Laboratory are 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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3 THE 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 Site Manager represent the organisation at Microbiology management team meetings. The Reference Laboratories are currently accredited, and underwent ISO 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.

In the unlikely event of the Scottish Microbiology Reference Laboratories, Glasgow at the Glasgow Royal Infirmary being unable to fulfil the requirements of its UKAS accreditation due to major equipment breakdown or other catastrophic occurrence, the following laboratories have agreed to assist.

PHE Central Public Health Laboratory, Colindale

CDRN, Microbiology, General Infirmary, Leeds)

Liverpool School of Tropical Medicine, Pembroke Place, Liverpool




Each of these laboratories are currently used for referral purposes

See RL_QP_014 (Reviewing referral laboratories).

There are relevant procedures for referral:

• Maintaining a record of referral laboratories and their repertoire.

• Maintaining a record of all samples referred.

• Recording of dispatch dates.

• Monitoring the return of reports from referral laboratories.

• Their UKAS accreditation status.

• Their participation and acceptable performance in appropriate EQA schemes.

• Turn around time of results from referral laboratories.

See RL_MP_009 (Transportation & referral of infectious & diagnostic substances).

See RL_MP_018 (Specimen Reception Procedure)

Alternative arrangements for processing samples would be as follows:

1. Inform client(s) affected by telephone at the earliest opportunity. 2. Inform UKAS accredited laboratory that samples are to be referred. 3. Triage of all samples by the Director of each laboratory section, or their

nominated deputy, to ensure that all diagnostic samples and any isolates to support public health interventions are prioritised.

4. Remove all confidential and commercially sensitive information from the samples.

5. Compile list of samples to be referred and make a copy for our records. 6. Pack samples into cold boxes sufficient for the number of samples with a copy

of the sample list. 7. Arrange transport of the samples by laboratory van, or courier as soon as

possible. 8. Issue reports clearly stating the fact that these samples have been referred to

another UKAS accredited laboratory for testing and add comments where appropriate.

If the nature of the catastrophic event is such that the current laboratory building is unusable, clients will be advised to send samples to the Microbiology Laboratory, Southern General Hospital. Reference Laboratory staff sufficient to carry out the process for referral of samples will transfer to the SGH and steps 3 to 8 of the above procedure will then be undertaken from that site. If the catastrophic event is anticipated to render the laboratory building unusable for a period of greater than 2 months, Greater Glasgow and Clyde Health Board undertake to provide temporary accommodation for the laboratory pending re-provision of permanent substantive premises.




Needs of users

This is a commitment in our Quality Policy (RL_QPOL_2014). Needs & requirements of users forms part of the annual management review.

Information for users is contained in individual user manuals accessible via the laboratories’ NHS Greater Glasgow & Clyde website:- www.nhsggc.org.uk/smrl

Medical, senior scientific & BMS staff are in daily contact with users to provide support and advice. Each specialist laboratory has a section which gives full details of how to use the service. The diagnostics directorate also uses e-surveys periodically.

The most recent Users’ meeting took place on 6th March 2012 and was attended by 73 delegates from around the country. A feedback questionnaire was distributed at the meeting. User surveys, including feedback from the Users’ Day, are fed back to staff and sent to Health Protection Scotland staff.

Needs & requirements of users is a standing agenda item at management meetings. The procedure is defined in ‘Needs & requirements of users’ (RL_QP_003).

The needs of the users are kept under constant review. In practice, this is achieved by user-satisfaction questionnaires, meetings with specific key users and by individual contact between the Director, Site Manager, Section Managers, Microbiology Consultants, Medical Consultants and others who use the service. Assessment of user satisfaction and complaints is conducted on a regular basis and consideration of the findings is made between the Director, Laboratory Managers, Consultant / Principal Clinical Scientists and the Senior Administrative Assistant.

Recommendations arising from these exercises are translated into requirements which form the focus of objective setting and planning within the quality management system, and consideration of the findings form part of the annual management review.

Turnaround times are agreed between the individual reference laboratories (as providers of the service) and Health Protection Scotland (as purchasers of the service). These are normally located within the service level agreement (SLA) for each laboratory, which are updated when contracts are renewed. The turn-around times are monitored by HPS at six-monthly intervals when we submit six-month and annual reports.

For the SLA that was in place until June 2013, HPS commissioned a detailed questionnaire on each reference laboratory service. This was sent to members of the Scottish Medical and Veterinary Network, requesting their views. The results were very favourable. The SLA has been renewed for a further three years, until 31st May 2016.

Quality Policy Shown below also published as a separate controlled document [SMRL_QPOL_2014] displayed at the laboratory specimen reception desk.

The purpose of the quality policy is to set down, for the information of staff and users, the course of action and measures that the SMiRL has taken in order to provide a service of the highest quality.




The Quality Policy of the Scottish Microbiology Reference Laboratories (SMiRL)

New Lister Building, Glasgow Royal Infirmary, Glasgow G31 2ER

The Scottish Microbiology Reference Laboratories (SMiRL) are committed to providing highly

specialised diagnostic and typing services of the highest quality for clinical laboratories across Scotland,

and shall be aware of, and take into consideration, the needs and requirements of their users.

In order to ensure that the needs and requirements of their users are met the SMiRL will:

• Operate a Quality Management System to integrate the organisation, management procedures,

processes practices and resources.

• Set quality objectives and plans in order to implement this Quality Policy and establish appropriate

communication regarding the effectiveness of the system towards continual quality improvement.

• Ensure that all personnel are familiar with the Quality Policy, Quality Manual and the management

system and are aware of the importance and relevance of their activities and procedures and how

they contribute to achieving management objectives.

• Ensure the integrity of the management system is maintained even during periods of change.

• Ensure the health, safety and welfare of all staff and visitors to the department and a commitment to

comply with relevant environmental legislation.

• Uphold professional values and be committed to good professional practice and conduct.

The Scottish Microbiology Reference Laboratories will maintain UKAS accreditation by

complying with the requirements of the ISO15189 International Standard, and are

committed to:-

• Staff recruitment, training, education, development and retention at all levels to provide a full and

effective service to its users that is delivered by well trained competent staff.

• The proper procurement and maintenance of such equipment, reagents and other resources as are

required for the provision of the service.

• Advising on the collection, transport and handling of all specimens so as to ensure the correct

performance of laboratory examinations which are fit for their intended use.

• The appropriate use of stated laboratory procedures in order to achieve the highest quality of all tests

performed.

• Reporting results of examinations in ways which are timely, confidential, accurate and clinically

relevant.

• The evaluation of user satisfaction, in addition to internal audit and external quality assessment, in

order to produce continual quality improvement.

Signed on behalf of the Scottish Microbiology Reference Laboratories:-

………………………………………….. Date……………

Professor John Coia BSc., MD., FRCPath.,FRCP.,(Edin) Director, SMiRL




Quality objectives and planning

Procedure RL_QF_006 describes this process. The Reference Laboratory management team define the quality objectives of the laboratory in consultation with the individual laboratories and are 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 management system. QOP review is also a standing agenda item at monthly TSM meetings.

Responsibility, authority & inter-relationships

The SMiRL is part of the Diagnostics Directorate of the Acute Division of NHS Greater Glasgow and Clyde. The organisational relationships are shown on the next page.

The Medical Director and Lead Consultant, Professor J. Coia, has professional responsibility for the Department. He is directly responsible to Health Protection Scotland for the provision of service but for financial and administrative matters is responsible via the Greater Glasgow & Clyde Health Board Laboratory Directorate structure.




Organisation and Responsibilities within the SMRL:-

ACUTE DIVISION / DIAGNOSTICS DIRECTORATE

LAB MEDICINE DIRECTORATE

GG&C MICROBIOLOGY MANAGEMENT TEAM

DIRECTOR SMRL

REFERENCE LABORATORY STAFF

SCOTTISH HEALTH & EDUCATION DEPARTMENT

NATIONAL SERVICES SCOTLAND

HEALTH PROTECTION SCOTLAND

NHS GREATER GLASGOW & CLYDE




Scottish Haemophilus, Legionella, Meningococcus & Pneumococcus Reference Laboratory

The laboratory is staffed by; One Band 8A Biomedical Scientist (Section Manager), 3 Band 6 Biomedical Scientists (1wte, 1x 0.6wte, 1x 0.5wte), 1 Band 6 Trainee Clinical Scientist, 1 Band 7 Clinical Scientist, 1 Band 8B Principal Clinical Scientist, 3 Band 3 Clinical Support Workers (2 x 1wte, 1 x 0.7wte), 1 Band 4 Administrative Officer / Surveillance coordinator (0.8wte).

The Principal Clinical Scientist, Section Manager and Administrative Officer are responsible to the Director, TSM & Site Manager for Scientific, Technical and Managerial Issues.

The Biomedical Scientists, Clinical Scientists and Clinical Support Workers (CSWs) report directly to the Section Manager for technical and managerial issues, and to the Principal Clinical Scientist for scientific issues.

The Principal Clinical Scientist reports through the Section Manager for all matters relating to service provision, and directly to the Director for research matters.




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Scottish Parasite Diagnostic & Reference laboratory

The laboratory is staffed by one Consultant Clinical Scientist (1wte), one Consultant Medical Microbiologist (0.25 wte), one Section Manager (1 wte), one specialist BMS (0.5 wte), one Trainee Healthcare Scientist (1 wte); one Clinical Support Worker (0.3 wte), one administrative assistant (0.25 wte) and one surveillance co-ordinator (0.25 wte).

Professor John Coia is Medical Director of the SMiRL as well as Head of Service for NHSGG&C microbiology.

The line accountability within the SPDRL has clinical input from Dr. Claire Alexander, Consultant Clinical Scientist, Dr. Brian Jones, Consultant Clinical Microbiologist, deputy director of the SMRL, as well as Clinical Director for laboratory medicine.

Specialist Biomedical Scientist Biomedical

Scientist

Technical Services Manager

Site Manager

Director

Consultant Clinical

Scientist

Consultant

Microbiologist

Quality Manager

CSW / Admin

Surveillance

Co-ordinator




Scottish Salmonella, Shigella & C.difficile Reference Laboratory

Organisational Chart

The laboratory is staffed by: - A medical consultant who is the Director of the department, a medical consultant who is deputy director, 1 Band 8 who is Site Manager as well as Section Manager, 1 Band 8 Clinical Scientist, 1 Band 6 Clinical Scientist, 2 Senior Specialist BMS, 2 Specialist BMS, 1 Healthcare Scientist Practitioner, 0.5 Secretarial Staff.

Senior management & clinical scientists

Healthcare scientists & administration

The Site Manager / Section Manager is responsible to the Clinical Director & TSM.

SITE MANAGER /

SECTION MANAGER

SECRETARIAL STAFF

PHAGE TYPING (SENIOR SPECIALIST BMS)

SEROLOGY ( SENIOR SPECIALIST BMS)

SPECIALIST BMS HEALTHCARE SCIENTIST

PRACTITIONER

DIRECTOR (OR DEPUTY DIRECTOR)

QUALITY MANAGER

SITE MANAGER / SECTION MANAGER

RESEARCH

CLINICAL SCIENTIST

Band 8

CLINICAL SCIENTIST BAND 6

TECHNICAL SERVICES MANAGER




The Band 8 Clinical Scientist is responsible to the Clinical Director for Scientific issues and to the TSM & Site / Section Manager for technical and managerial issues.

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Scottish MRSA Reference Laboratory

Organisational Chart

Director: Prof John Coia

Deputy Director: Dr Nitish Khanna

Section Manager: Bonnie Cosgrove Principal Clinical Scientist: Dr. Elizabeth Dickson

Senior Specialist BMS Section Manager: Loraine Graham

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The Laboratory Director

The Director is a competent individual with responsibility for, and authority over the whole laboratory. The Director is an individual who ensures, on behalf of the laboratory, that all aspects of the laboratory including management organisation and quality, personnel, premises and environment, equipment, information systems, materials and pre- and post- examination processes function correctly. This is achieved in co-ordination with the TSM / Site Manager / Section Manager, Quality Manager and Principal Clinical / Healthcare Scientist.

Site Manager

The Site Manager is the individual who ensures, on behalf of the laboratory, that the management of all aspects of the laboratory including, quality, personnel, premises and environment, equipment, information systems and materials and examination processes both pre and post function correctly. This is achieved in co-ordination with the Laboratory Director, TSM / Quality Manager and Principal Clinical / Healthcare Scientist.

Principal / Clinical Scientist

The Principal / Clinical Scientist is the individual who ensures, on behalf of the laboratory, that the clinical liaison between stakeholders is maintained and the quality improvement processes are monitored including, teaching, research and development. This is achieved in co-ordination with the Laboratory Director / TSM / Site Manager / Section Manager and Quality Manager.

Quality Manager

The Quality Manager is the individual who ensures, on behalf of the laboratory management, that the quality management systems function correctly. This is achieved in co-ordination with the Laboratory Director / TSM / Site Manager & Section Manager.

Key posts are supported by named deputies as detailed:

Post Name Deputy

Director - Reference Laboratories: Professor John Coia Dr Brian Jones

Technical Service Manager: Stephen Hughes Henry Mather

Lead Manager Ref Labs: Henry Mather Alistair Brown

Quality Manager: Jim Roud Henry Mather

Training Officer: Alistair Brown Fiona Shaw

IT Manager: Michael Coyne Andrew Small

Health & Safety Officer: Dr Diane Lindsay Sharon Paton




Communication

The communication & committee structure of internal & external communications is shown below. The committee structures within Levels 4 and 5 of the New Lister Building have been reviewed with the intention of simplifying & streamlining activity in areas common to all departments.

National Services Division & Health Protection Scotland. Meets annually. This service planning meeting is attended by the SMiRL Director, the Site Manager and relevant Clinical Scientist.

Microbiology Management Team – Greater Glasgow & Clyde Every 4-6 weeks

Attended by Clinical Director, General Manager, Assistant General Manager, Head of Microbiology Services, Lead Microbiologists, Technical Services Managers from North, South, Clyde and Virology Sectors. Meetings are held in “partnership” with staff side representatives.

Glasgow Microbiology Consultants (Every 4-6 weeks)

The New Lister Building Management Committee meets four times a year.

The Reference Laboratories representatives are:-

♦ Prof. J. Coia (Director)

♦ Mr. S. Hughes, (TSM)

♦ Mr. H.Mather (Site Manager & SSSCDRL manager)

♦ Dr. C. Alexander (SPDRL)

♦ Ms E.Quail (SSSCDRL) (Partnership representative)

♦ Mr. J. Roud (Quality Manager)

The New Lister Building Health and Safety Committee meets four times a year.

The Reference Laboratories representatives are:-

♦ Mr. S. Hughes, (TSM)

♦ Mr. H.Mather (Site Manager & SSSCDRL manager)

♦ Dr D.Lindsay (SHLMPRL & safety officer)

♦ Ms E.Quail (SSSCDRL) (Partnership representative)

♦ Ms. Sharon Paton (SSSCDRL)




The Scottish Microbiology Reference Laboratories Senior Scientist Committee meets monthly.

♦ Mr S Hughes (TSM & Chairman)

♦ Mr H Mather (Site Manager & SSSCDRL section manager)

♦ Mr A Brown (SHLMPRL section manager)

♦ Mr D Brown (Clinical scientist, SSSCDRL)

♦ Mr J Roud (Quality manager)

♦ Dr.C.Alexander (Consultant clinical scientist, SPDRL)

♦ Mrs L Graham (Senior BMS, SMRSARL)

♦ Ms E Quail (Senior BMS, SSSCDRL)

♦ Dr E Dickson (Principal clinical scientist, SMRSARL)

♦ Mrs F Shaw (Senior BMS, SSSCDRL)

♦ Ms R Ure (Clinical scientist, SHLMPRL)

♦ Dr A Robb (Clinical scientist, SMRSARL)

♦ Dr D Lindsay (Clinical scientist, SHLMPRL)

User surveys, including results from Users’ days, are fed back to staff and sent to Health Protection Scotland.

Quality manager A quality manager was appointed in 2009, shared on a 50:50 basis with the West of Scotland Specialist Virology Centre. Duties are defined in the quality manual, and in the quality manager’s job description.

4.2 QUALITY MANAGEMENT SYSTEM

Evidence that we have established a quality management system includes:-

Our Quality Manual, Quality Policy, the appointment of a quality manager and the implementation of a quality management system.

The QMS processes & application, criteria & methods, availability of resources and its monitoring for improvement action are set down in almost 500 documents held in Q-Pulse.

The key ones are:-

RL_QMAN_2014 ‘Quality Manual.’ Job descriptions & Quality Policy. RL_QF_006 ‘Quality Plans & Objectives for 2014.’ RL_QP_008 ‘Document control.’ RL_MP_013 ‘Control of process & quality records.’ RL_MP_012 ‘control of clinical material.’

RL_QP_010 ‘Annual Management review.’

The SMiRL Quality Management System is subject to planned and scheduled internal audit processes, against agreed criteria, by personnel trained in internal audit [RL_QP_011].




The records of internal audit include:

• The activities, areas or items audited.

• Any nonconformities or deficiencies found.

• Recommendations and time scale for corrective and preventive actions.

The results of internal audit are regularly evaluated and decisions taken documented, monitored, reviewed and acted upon.

Audit findings are communicated to appropriate personnel. In addition audit records are available for scrutiny within Q-Pulse.

………………………………………………………………

Quality Manual This requirement is fulfilled by the production of this Quality Manual (RL_QMAN_2014)

4.3 DOCUMENT CONTROL

We aim to control our documents, because of the need for traceability, using Q-Pulse software managed by Gael Quality Ltd.

Rules are set out in RL_QP_008 ‘Document control.’ See any procedure for evidence of identifier, review date, revision number, total pages & author’s name.

Definitions of the document hierarchy.

A Policy is:- a course or principle of action adopted by an organization.

Objectives & Plans are:- specific results to be achieved within a set time frame, and the ways that will be done.

Processes are:- The actions taken to achieve the objectives.

Procedures are:- The official way of carrying out a process.

Records are:- Evidence of actions taken when following procedures.

Hierarchy of documentation:

POLICIES

OBJECTIVES & PLANS

PROCESSES

PROCEDURES

RECORDS




New documents

For new documents a template exists for writing SOPs which has the correct margins, front page, header and footer. For existing documents it is sufficient to update by replacing the front page and completing it as below.

Document Control Prefix codes:

The documents are divided into specialist sections as follows:

RL_M MANAGEMENT

RL_Q QUALITY

RL_HS SAFETY

SHLMPRL_ Scottish Haemophilus, Legionella, Meningococcus & Pneumococcus Reference Lab.

SMRSA_ Scottish MRSA Reference Laboratory

SPDRL_ Scottish Parasite Diagnostic & Reference Laboratory

SSRL_ Scottish Salmonella, Shigella & C.difficile Reference Laboratory

Each section is further sub-divided into

RA Risk assessment

LP Laboratory procedure (SOP)

UM User manual

WF Work form.

Examples:

A Scottish Haemophilus, Legionella, Meningococcus & Pneumococcus Reference Laboratory procedure would read SHLMPRL_SOP_001

A Scottish Salmonella, Shigella & C.difficile Reference Laboratory work form would read SSRL_WF_100.

Control of process and quality records

This standard is fulfilled by procedure [RL_MP_013]

Control of clinical material

This standard is fulfilled by procedure [RL_MP_012]

4.4 SERVICE AGREEMENTS

We aim to establish service agreements by discussion with our parent organisation Health Protection Scotland. This benefits the department because it allows planning of resources for the period of the SLA. It benefits users because they are made aware of what services we offer. The mechanism for establishing a SLA is explained in the next section.




Establishment & review of service agreements

Service Level Agreements – National Reference Laboratories

A National Reference Service is established on the basis of the identification of a specific Clinical or Public Health need, either by the Reference Laboratory Working Group (RLWG) or Health Protection Scotland (HPS). If approved by the Scottish Government HPS will authorise a “Service Level Agreement” (SLA) with the specific Health Board to provide the service. This is along the lines of a purchaser / provider agreement; where HPS, part of National Services Scotland (NSS), acts as the purchaser. NHS Greater Glasgow & Clyde acts as the provider.

The service level agreement normally runs for three year periods and will include: -the range of services provided, financial agreements, acceptable levels of service delivery, roles and responsibilities of each parties. The contract contains Key Performance Indicators which will be used by HPS to measure the performance of the service. These will include: - activity, quality objectives and turn-around times for each part of the service provided. NHS Greater Glasgow & Clyde will submit six-month and annual reports as outlined in the SLA and these will be discussed at formal meetings with HPS / NSS at joint twice-yearly meetings.

For the SLA that was in place until June 2013, HPS commissioned a detailed questionnaire on each reference laboratory service. This was sent to members of the Scottish Medical and Veterinary Network, requesting their views. The results were very favourable. The SLA has been renewed for a further three years, until May 2016.

4.5 EXAMINATION BY REFERRAL LABORATORIES

4.5.1 Selecting & evaluating referral laboratories & consultants

We aim to carefully select which referral centres we use, for the benefit of our users. This will ensure that the quality of our service is not compromised by the actions of a third party. In practice, because we are a reference facility, very few samples have to be sent away.

See RL_QP_014 (Reviewing referral laboratories).

See RL_MP_009 (Transportation & referral of infectious & diagnostic substances).

4.5.2 Provision of examination results.

We aim to provide accurate results for our users by ensuring that our procedures state that we, as the referring laboratory, are responsible for providing the results from the referral laboratory are delivered to the person making the request.

See RL_MP_003 (Reporting results).

4.6 EXTERNAL SERVICES & SUPPLIES

We aim to continually improve the quality of our service by carefully selecting suppliers, and by regularly reviewing their performance.

An annual review is made as the end of the financial year approaches and in due time for raising standing orders for the new financial year. Services & supplies are procured via Service Contracts.




Consideration is taken of:

• Quality of service

• Professionalism

• Costs

• Contractual obligation

• Recent performance

• Availability of stock

• Time to delivery

• Partnership Due consideration is afforded any material, kit or reagent before trial/demonstration etc are commenced. Results are collated, users’ opinions sought and resource implications gathered before a decision is made with the service to the patient in mind.

See RL_MP_008 (Management of materials & reagents) for more detail.

4.7 ADVISORY SERVICES

We aim to maintain close contact with our users in order to ensure that the service meets their needs & requirements.

Communication with users is kept under constant review. In practice, this is achieved by user-satisfaction questionnaires, meetings with specific key users and by individual contact between the Director, TSM, Site Manager, Section Managers, Microbiology Consultants, Medical Consultants and others who use the service. The Director, Section Managers, Consultant / Principal Clinical Scientists and the Senior Administrative Assistant ensure that users are aware how to obtain advice about choice of examinations, clinical cases, interpretation of results, how to make best use of the service and how to ensure specimens meet our acceptance criteria.

See RL_QP_003 (needs & requirements of users) and RL_QF_023 (Users’ day feedback questionnaire) for more detail.

4.8 RESOLUTION OF COMPLAINTS

We aim to continually improve the quality of our service by building confidence in our users that complaints will be thoroughly investigated and corrective action taken. Assessment & resolution of user satisfaction & complaints is described in RL_QP_006 (Complaints procedure). The process is:-

1. To take all complaints seriously. 2. To deal with the client in a courteous manner. 3. To try to resolve the issue immediately at a local level. 4. To inform the client about the progress of the complaint. 5. To make corrective action as soon as possible. 6. To investigate root cause analysis to prevent recurrence.




4.9 IDENTIFICATION & CONTROL OF NON-CONFORMITIES

We aim to ensure that nonconformities are effectively managed in order to build confidence in our users and to continually improve our service. The process is described in RL_QP_017 and in RL_QP_007. Non-conformity reports are submitted to the quality manager as they arise, and cumulative data forms part of the annual management review (see RL_QP_010).

Root cause analysis (RCA)

Removing the root cause of a problem is true corrective action (preventing recurrence). This can be the most rewarding of quality tools but should be performed by those trained in root cause analysis.

RCA tools include:

Brainstorming

Brainwriting

Fishbone diagram

Barrier analysis

For full details see RL_QP_012 (Root cause analysis & Quality Improvement).

4.10 CORRECTIVE ACTION

We aim to investigate and, where possible, remove the root cause of nonconformities. Removing the root cause of a problem is true corrective action (preventing recurrence).

There is a process for continual quality improvement, which includes corrective action, preventive action and improvement processes [RL_QP_012, Root cause analysis & Quality Improvement].

Identification & control of non-conformances is described in RL_QP_017.

Corrective action for the identification and elimination of the causes of nonconformities includes:

• Investigation of nonconformities and recording of results.

• Determination of, and responsibility for, corrective action.

• Implementation of corrective action within an agreed time scale.

• Monitoring of corrective action taken.

4.11 PREVENTIVE ACTION

We aim to take preventive action in order to reduce nonconformities and this includes:

• Investigation of the causes of nonconformities and recording of results.




• Determination of and responsibility for preventive action.

• Implementation of preventive action within an agreed time scale.

• Ensuring the action taken is effective, recorded and submitted for management review.

Evidence of Corrective and preventive actions carried out resulting from internal audit for the previous 12 months. This can be found in the Q-Pulse CA / PA record.

4.12 CONTINUAL IMPROVEMENT

We aim to ensure that the service provided by the SMiRL meets the needs and requirements of our users, by having evaluation and improvement processes in place which include:

• Assessment of user satisfaction [RL_QP_003].

• A procedure for dealing with complaints [RL_QP_006].

• Regular discussion with users of the service to discuss service needs.

• Participation in clinical meetings.

• Internal audit of examination processes [RL_QP_009].

• Internal audit of the quality management system [RL_QP_011].

• External quality assessment.

• A process for quality improvement [RL_QP_012].

• Identification and control of nonconformities [RL_QP_017].

The results of these evaluation and improvement processes are available to staff and users as required. Analysis, recording and interpretation of the data forms part of the management review, which is contained in the annual review.

The results of the quality improvement programme forms part of the development, training and education of all staff. RL_QP_013 allows the assessment of employee satisfaction. See also individual laboratory IQC & EQA procedures.

4.13 CONTROL OF RECORDS

We aim to adhere to the rules governing record control, in order to ensure accuracy & availability of all aspects of our service. The process is defined in RL_MP_013. Records & specimens are stored in accordance with RCPath & IBMS guidelines (see ED-1 in Q-Pulse). Quality records are available in Q-Pulse or from the quality manager. Process records are stored at workstations or are archived.

Also see individual laboratory IQC procedures.

4.14 EVALUATION & AUDITS We aim to continuously interrogate our service by a system of audits, in order to detect weaknesses before they cause an error. There is internal audit of the pre-examination,




examination and post-examination processes, which is planned and scheduled, against agreed criteria, by personnel trained in internal audit [RL_QP_009].

The records of internal audit include:

• The activities, areas or items audited.

• Any nonconformities or deficiencies found.

• Recommendations and time scale for corrective and preventive actions.

The results of internal audit are regularly evaluated and decisions taken are documented, monitored, reviewed and acted upon.

Audit findings are communicated to appropriate personnel. In addition audit records are available for scrutiny within Q-Pulse.

Internal audit of the QMS is defined by RL_QP_011. The audit schedule and records are held in a file in the quality manager’s office. Internal audit of examination processes is set out in RL_QP_015 and in individual reference laboratory procedures. RL_QP_013 describes measuring employee satisfaction. RL_QF_002 is an employee suggestion form for improvement ideas. The Q-Pulse ‘improvement ideas’ function is another option.

4.15 MANAGEMENT REVIEW

We aim to regularly review our quality management system, in order to ensure its continued suitability, adequacy & effectiveness in support of patient care.

The Directors, TSM, Site Manager, Quality Manager, Safety Officer, Section Managers and Band 8 Clinical Scientists conduct an annual review that considers the following items of information based upon reports produced by managerial and supervisory personnel:-

a) the periodic review of requests, and suitability of procedures and sample requirements b) assessment of user feedback [RL_QP_003] c) staff suggestions d) internal audits [RL_QP_009] [RL_QP_011]

e) risk management f) use of quality indicators g) reviews by external organizations [UKAS, HSE, HPS, HCPC, IBMS]. h) results of participation in inter-laboratory comparison programmes (PT/EQA) i) monitoring and resolution of complaints j) performance of suppliers k) identification and control of nonconformities l) results of continual improvement including current status of corrective actions and preventive actions [RL_QP_ 007,009,012]

m) follow-up actions from previous management reviews; n) changes in the volume and scope of work, personnel, and premises that could affect the quality management system; o) recommendations for improvement, including technical requirements.

Records are kept and key objectives for subsequent years defined and plans formulated for their implementation. An executive summary of the management review will be sent to UKAS.




5.1 TECHNICAL REQUIREMENTS – PERSONNEL

Staffing

We aim to ensure that the SMiRL has sufficient appropriately educated and trained staff to meet the requirements of the service. Staffing numbers and qualifications are reviewed as part of the department planning process.

Training requirements are established as part of the process of e-KSF PDP and annual joint review. Each member of staff has a Training and Education Development (TED) portfolio in which a record of training/continual development is kept.

A record of each staff member’s training and copies of HCPC Registration certificates are kept in the SMiRL site managers’ office.

The SMiRL has on its staff a named Quality Manager (Jim Roud), a Training Officer (Alistair Brown) and a Health and Safety Officer (Diane Lindsay).

Personnel management

This standard is fulfilled by and ensures the following procedures are included:

• Staff recruitment and selection [RL_MP_016]

• Staff orientation and induction [RL_MP_001]

• Job descriptions and contracts [RL_MP_016]

• Staff records [Confidential records are held by individual section managers]

• Staff annual joint review [RL_MP_021]

• Staff meetings and communication [See section 7 of this Quality Manual]

• Staff training and education [SMRL_TRM_2014]

Staff orientation and induction

The organisation adheres to NHSGG&C personnel policies (defined on StaffNet). Individual managers hold personal records for their employees.

Examples of personnel procedures are:

• RL_MP_016 Staff recruitment & selection.

• RL_MP_001 Induction & training

• RL_MP_004 Information for staff

Induction & training records are kept in personnel files by each manager. For an example of location/accountability/job purpose/duties/AMR see the quality manager JD. Contracts are held by the individual and a copy is retained by the HR department.

See staff list with qualifications (SMRL_MF_004). HCPC / RCPath registration records are in personal files.

Defined duties:-

Quality manager - Jim Roud

Training & education – Alistair Brown

Health & safety officer – Dr. Diane Lindsay




GG&C Health Board has a comprehensive staff orientation and induction programme. An induction pack is issued on or before a new employee's starting date and local induction training is carried out within the SMiRL on the first day of work. This local induction training covers such areas as:

• Department/Division information

• Working environment

• Terms and conditions of employment

• Patient confidentiality and data protection

• Health & Safety

• Job description including an organisational chart

• Salaries and wages

• Staff facilities

• Equality and Diversity

Records of staff orientation and induction are kept.

Job descriptions and contracts

To allow each member of staff to know their duties, responsibilities and rights, they are given a written job description.

Job descriptions include:

• Job title

• The location within the organisation

• Accountability

• Main purpose of the job

• Main duties and responsibilities

• Staff annual joint review

All staff have a contract of employment, which is in compliance with current legislation and provides clear terms and conditions of service.

Staff records

The Human Resources Department of the Diagnostic Directorate of the Acute Division of NHS Greater Glasgow and Clyde holds the complete staff record. The Occupational Health Department holds vaccination records and the Pay Department holds records of payments.

In addition, confidential staff records are kept including:

• Personal details.

• Employment details.

• Job description.

• Terms and conditions of employment.




• A record of staff induction and orientation.

• A record of attendance at fire lectures.

• A record of attendance at manual handling courses.

• A record of education and training.

• Relevant educational and professional qualifications.

• Certificate of registration with the Health & Care Professions Council (HCPC).

• Absence record.

• Accident record.

• Record of annual joint review.

• Occupational health record.

• A record of disciplinary action.

Staff annual joint review

All staff participate in an annual joint review (e-KSF PDP) that includes consideration of:

• e-KSF outline for the job role.

• The quality objectives and plans of the laboratory.

• The current job content.

• Documentation of training needs and agreed personal objectives with the appraiser.

• Evidence that management has recognised the agreed development needs of individual staff members.

All staff performing e-KSF PDPs have had training and records of all staff PDPs are kept.

Staff meetings and communication

Formal staff meetings are held regularly and minutes are posted on the staff notice boards.

The Division has a policy of "Partnership" which invites staff side representation.

Additional material is available from the Trust via the Intranet site and in the form of Staff Bulletins.

Staff training and education

A training and education programme exists for all staff, which is in accordance with guidelines from the relevant professional and registration bodies.

Consultant medical staff are required to successfully participate in the CPD programme of the Royal College of Pathologists.

The designated Training Officer for SMiRL is Alistair Brown and all staff are encouraged to participate in "Continuing Professional Development" (CPD), which is now mandatory for continuing registration with HCPC.




Opportunities for further education and training are available in relation to the requirements of the service and individual personal development. The Department provides resources for such education that includes:

• Access to library and information services.

• Suitable accommodation for private study.

• Opportunity to attend meetings, seminars and conferences.

• Financial support.

Records of training and education are kept for each member of staff.

Although Alistair Brown is the Training Officer, the other BMS staff and Clinical Scientists will assist in delivering the training programme and in assessing competency.

SMRL_TRM_2014 defines training of healthcare scientists within the organisation. We also use quality manager tutorials & questionnaires, IT / TelePath / Q-Pulse training, instructions in H&S manual (SMRL_SMAN). Also H&S tutorials & feedback from H&S committee meetings, NHS code of practice on patient confidentiality & RL_MP_001 Induction & training procedures.

Competency assessments for staff are held in the individual’s portfolio or records held by the line manager. The department is approved by the HCPC as a training laboratory. All staff have access to the NHSGG&C IntraNet & to the InterNet. There is a study room and library. Training records are maintained by the training manager, Alistair Brown.

The procedure for internal audit & audit training is shown in RL_QP_009.

5.2 TECHNICAL REQUIREMENTS – ACCOMMODATION & ENVIRONMENTAL CONDITIONS. We aim to ensure that the SMiRL provides a working environment in which staff can perform required functions in accordance with national legislation and guidelines. The premises are a state-of-the-art building which meets all current regulations for medical laboratory accommodation.

The premises have space for:

• Specimen reception.

• The functioning and use of all equipment.

• Separation of incompatible activities (e.g. Office and laboratory).

• Storage facilities.

Access to the premises is by swipe card entry via locked doors.

Facilities for staff

The SMiRL provides a safe and secure working environment for all staff at all times. Staff have ready access to toilet facilities and a rest room with kitchen / catering. All staff have secure storage for their personal belongings.

Facilities for patients

This is not applicable to the SMiRL.




Facilities for storage

Separate storage facilities exist for:

• Process and quality records

• Clinical material

• Consumables and reagents

• Stationery

• Media

• Hazardous substances

Laboratory management’s safety responsibilities are defined in the SMiRL Health & Safety Manual and in the Division's H&S Policy.

A hard copy of the safety manual is kept in the site manager’s room and electronically in Q-Pulse [SMRL_SMAN].

Dr Diane Lindsay is the designated Safety Officer.

All staff are aware of their responsibilities relating to Health and Safety and complete mandatory annual fire training. This is reinforced by use of a regular quiz on Health & Safety matters.

The safety manual SMRL_SMAN and H&S audits by staff help ensure a safe working environment. The safety manual is supported by a full range of procedural & equipment SOPs, with accompanying risk assessments. Staff are directed to read the safety manual at the time of recruitment, and following any revision.

The following examples of procedures exist in the Health and Safety Manual:

• Action in the event of a fire.

• Personal safety.

• Action in the event of a major spillage of dangerous chemical or clinical material.

• Recording of accidents (Datix web based reporting).

• Disposal procedures.

• Microbiological hazards and precautions.

• Specimen processing and handling.

• Control measures for blood borne viruses (BBV).

• Disinfection procedures.

• Management of sharps.

• Handling equipment.

Laboratory containment facilities conform to the requirements of the ACDP guidelines.

There is a procedure for performing COSHH /Risk assessments [RL_MP_017]

Safety notices for the benefit of staff and visitors to the SMiRL are displayed.

Staff maintain clean, uncluttered work areas in keeping with good housekeeping practices.




A regular H&S quiz is held to reinforce the details.

CL2 & CL3 accommodation is provided. The Containment Level 3 facilities are on Level 4 of the building. The CL3 suite is maintained under contract by Crowthorne Ltd.

There is a joint Level 4 & 5 New Lister Building H&S committee which meets regularly.

Occupational health monitoring is used where appropriate.

Staff are supplied with laboratory coats, protective gloves and other necessary personal protective equipment.

Access to the department is restricted via swipe card entry. Visitors must be accompanied during their stay. Communication systems include the LIMS, office telephone enquiry and contact details on the GG&C website.

Chemical handling & waste disposal is described in the safety manual (SMRL_SMAN). Spillage kits are provided. Safety rules for specimen collection & handling etc are contained in RL_MP_018 and specialist details are found in the individual user manuals.

Reporting & monitoring of accidents & incidents is via DATIX & Q-Pulse, see SOP RL_QP_007.

Risk assessments & COSHH are dealt with in a combined format. For writing this, see RL_MP_017. Disinfection processes are described in the safety manual.

Management of equipment

The equipment within the SMiRL is sufficient and appropriate to provide the service required.

There is a Divisional procedure for the procurement of equipment, which includes:

• Assessment and justification of need.

• Selection.

• Acceptance.

• Training.

• Maintenance, service and repair.

The SMiRL procedure RL_MP_007 contains instructions for :

• Decontamination of equipment

• Recording instrument failure and corrective action

• Disposal of equipment in compliance with WEEE regulations

• Planned replacement

An Inventory of equipment is maintained in Q-Pulse, which includes:

• Manufacturers name.

• Serial number.

• Date of purchase or acquisition.

• Maintenance contract.




The Estates department performs electrical safety testing (PAT) on a regular basis.

Equipment decontamination is described in RL_MP_007. The decontamination certificate is stored in Q-Pulse as SMRL_WF_001.

5.3 LABORATORY EQUIPMENT, REAGENTS & CONSUMABLES. We aim to ensure that sufficient & appropriate equipment is available so that service quality is at the highest level. A commitment to this effect is included in the quality manual and in document RL_MP_007. This includes rules for equipment procurement. See the equipment inventory & individual laboratory equipment records for further details. There is a programme of preventive maintenance, calibration & monitoring of equipment (RL_MP_007).

Management of reagents, calibration and quality control material

Laboratory management ensures the availability of the reagents, calibration material and quality control material required to provide a service which meets the needs and requirements of users.

A procedure is established for the management of reagents, calibration material and quality control material [RL_MP_008] that includes:

• Selection, purchasing and ordering.

• Assessment of suppliers.

• Receipt and verification of identity and condition.

• Issue and inventory management.

• Safe disposal.

The SOP for reviewing suppliers is RL_QP_019.

Material date of receipt, lot numbers, use & expiry are described in RL_MP_008 ‘Management of materials & reagents’.

Control of Substances Hazardous to Health files (Risk Assessment and COSHH sheets) are maintained for all hazardous materials, and manufacturers’ safety data sheets (MSDS) are held where available.

Materials in use are correctly identified with date of receipt, lot numbers and expiry.

5.4 PRE-EXAMINATION PROCESSES

We aim to ensure that our users are fully aware of our service in order that they can make the best use of it. The information includes how to contact us, how to correctly send specimens for analysis, and how to obtain clinical advice.

Information for users and patients

Information for users is contained electronically on the individual laboratory web pages. See

www.nhsggc.org.uk/smrl

The information for users includes:




• Contact details of key staff.

• Location of the laboratory.

• Opening hours.

• Details of the out of hours emergency service.

• Instructions for specimen transport.

• Availability of clinical advice and interpretation.

• The repertoire of tests offered, specimen type required and turnaround time.

• Key factors which are known to affect the validity of results.

Providing information to patients is not a normal function of the SMiRL, however the Director may assist with a patient enquiry.

Request form

SMiRL request forms are available to users from the website (see page 4 of this manual).

The request forms are designed to include:

• Sufficient information to allow unique identification of the patient.

• The source of the request.

• The requesting individual.

• The date and time of specimen collection.

• Specimen type and where appropriate the anatomical site of origin.

• The investigation required.

• Relevant clinical information.

• Location to which report should be sent (including copy report).

• The unique laboratory accession number.

The date & time of receipt at the laboratory is recorded using a date/time electronic stamp and at computer entry (PID).

The department encourages proper completion of the request form.

Specimen collection and handling

The SMiRL have a procedure for this [RL_MP_018], which includes:

• Checking the completion of the request form and confirming the identity of the patient.

• Checking that the specimen container is correctly labelled.

• Ensuring that the specimen is correctly collected.

• Minimising the risk of interchange of samples and sub samples.

• Ensuring that environmental and storage conditions are fulfilled.




• Ensuring the safe disposal of all materials used in specimen collection.

• Ensuring that high risk specimens are identified and processed correctly.

• Ensuring that all spillages and breakages are dealt with correctly.

• Minimising the risk to ensure the safety of the specimen collector, carrier, the general public

and the receiving laboratory.

Information on collection and handling of microbiology specimens is also available by enquiry to the Director or other appropriate member of staff.

The pre-analytical process forms part of the annual audit schedule.

Specimen transportation

The North Glasgow Specimen Transport Policy [ED-61] fulfils this standard. The policy includes:

• Measures to ensure the safety of the courier the general public and the receiving laboratory.

• Measures to ensure the confidentiality of patients' samples whilst in transit.

• Measures to minimise delay in delivery.

• Disinfection protocol following spillage.

• Model rules on the type of outer container used to transport specimens.

This policy is also subject to audit.

Specimen reception

The SMiRL procedure RL_MP_018 for specimen reception includes instructions on:

• Accurate matching of request form and specimen.

• Recording date of receipt.

• Assigning a unique laboratory accession number.

• Handling urgent samples.

• Spillage protocol.

• Staff safety.

The procedure has instructions for the rejection of specimens that includes:

• The criteria for rejection of specimens.

• The recording of rejected samples.

• Notification of the user concerning rejected specimens.

Referral to other laboratories

Very few items are referred to other laboratories. There are procedures for referral

[RL_MP_018 and RL_MP_009] that include:




• Maintaining a record of referral laboratories and their repertoire.

• Maintaining a record of all samples referred.

• Recording of dispatch dates.

• Monitoring the return of reports from referral laboratories.

• Their UKAS accreditation status.

• Their participation and acceptable performance in appropriate EQA schemes.

• Turn around time of results from referral laboratories.

Local rules are described in RL_MP_009 (Transportation & referral of infectious & diagnostic substances).

Turnaround times are agreed between the individual reference laboratories (as providers of the service) and Health Protection Scotland (as purchasers of the service). These are normally located within the service level agreement (SLA) for each laboratory, which are updated when contracts are renewed. The turn-around times are monitored by HPS at six-monthly intervals when we submit six-month and annual reports.

5.5 EXAMINATION PROCESSES

We aim to use procedures that are selected to meet the needs and requirements of the users, in order to make them confident that our test repertoire is designed for the maximum benefit of their patients.

Selection and validation of examination procedures

Prior to introduction, all examination procedures are validated for their intended use and the methods used and results obtained are recorded.

When examination procedures are changed so that results or their interpretation may be significantly different, the changes are explained to users prior to the introduction of the new procedure.

Examination procedures

The standard operating procedures (SOPs) for the conduct of all examinations are prepared

according to the Document Preparation and Control procedure [RL_QP_004].

Procedures for the conduct of all examinations include the following:

• The purpose and scope of the examination.

• Responsibility.

• Definitions.

• Documentation (e.g. cross reference to).

• Safety considerations.

• Procedure (including limitations and QC).

• References.

• Appendices (where necessary).




Test SOPs are available as hard copy in the relevant laboratory in addition to the master copy held electronically in Q-Pulse.

See RL_QP_020 for details of ‘Validation & Evaluation.’

For determination of uncertainty, see RL_QP_018. This quality activity is also dealt with in pre-examination checks, staff training, and IQC.

5.6 ENSURING QUALITY OF EXAMINATION RESULTS We aim to use a wide range of procedures in order to detect errors and prevent release of erroneous results. The SMiRL has a comprehensive range of procedures for internal quality control (IQC) of all examinations, which verify that the intended quality is achieved. These include:

• Records of date, source and storage of IQC material.

• A process for validation of IQC material prior to use.

• The use of recognized control organisms (ATCC & NCTC strains).

• Appropriate statistical methods.

• Acceptance criteria for results with IQC material (e.g. Assay control parameters).

• Evaluation of IQC results with corrective/preventive actions taken and recorded.

EQA

There are very few EQA schemes available to Reference Laboratories. The SMiRL participate fully in the available External Quality Assessment schemes appropriate to the examinations and interpretations provided, as well as being involved in inter-laboratory testing.

A record of results against agreed performance criteria of the EQA scheme is maintained.

The Department has a procedure for dealing with EQA samples [RL_MP_019]

The performance results are reviewed and communicated to staff and decisions taken recorded, monitored and acted upon. See EQA procedures RL_QP_021.

5.7 POST-EXAMINATION PROCESSES

Review of results We aim to ensure that authorised personnel review the results of our examinations in order to ensure that patient safety is not compromised. The process is described in RL_MP_003 (reporting results).

Storage, retention & disposal of clinical samples. We aim to comply with all regulations concerning this aspect of our service, in order to ensure that samples which must be stored are correctly handled, and samples which are marked for disposal are dealt with in accordance with the relevant legislation. Storage, retention & disposal of clinical samples is described in procedure RL_MP_012. 5.8 REPORTING OF RESULTS

The report




We aim to produce reports which are clear and unambiguous and which contain sufficient information to enable our users to interpret the results for accurate treatment of their patients.

The SMiRL issues reports of examinations on hard copy which include the following information:

• The laboratory name and contact phone number.

• The name, date of birth and CHI number of the patient.

• The requesting individual and the source to which reports are returned.

• The specimen type and date of collection.

• Date of report.

• Examination result and reason if not carried out.

• Interpretive comments as appropriate.

• Highlighting of abnormal results.

Procedures for processing results from other reference laboratories are described in RL_MP_003 (Reporting results, in section 5.4). For report confidentiality, see RL_MP_003 (Reporting results, in section 3.1) and RL_MP_002 (the telephoned report, section 5.1). For telephoned reports, see RL_MP_003 (Reporting results, in section 5.4).

The telephoned report

The SMiRL procedure [RL_MP_002] for issuing results by ‘phone includes:

• The circumstances in which reports may be given.

• The individuals who may issue results.

• The individuals who may receive results.

• A method of mutual identification of the patient between reporter and receiver.

• Confirmation of correct transmission.

• The mechanism for recording the event.

• Maintaining confidentiality.

• The process for sending a follow up report.

The amended report

The SMiRL procedure RL_MP_003 for issuing an amended report includes:

• The criteria for issuing amended reports.

• Authorisation level of staff able to amend reports.

• The identification of amended reports to the user.

• A process of recording the issue of an amended report.

• The reason for issuing an amended report.

• Instigation of corrective and/or preventive action, if required.




• A process for archiving amended results.

5.9 RELEASE OF RESULTS We aim to have procedures in place to ensure that the results of our tests are accurate and are reviewed by authorized staff before release, in order to prevent any patient being endangered.

For reporting results of laboratory investigations, the SMiRL have procedures in place for the

report [RL_MP_003 ] the telephoned report [RL_MP_002] and the amended report [RL_MP_003].

5.10 LABORATORY INFORMATION MANAGEMENT We aim to ensure that our data storage ensures accurate records are maintained in a form that is only accessible to authorised staff & users, in order to protect patient confidentiality.

The laboratory information system is TelePath, supported by other IT equipment for specialised tasks and it is accessed by CSW, Biomedical Scientist, Clinical Scientist, Medical and Administrative staff. They are supported by the IT Department of NHSGG&C.

I.T. security is governed by the Data Protection Act, NHSGG&C I.T. Policy, and local SOP RL_MP_010 ‘Management of data & information’. Data and information are available to provide a service that meets the needs and requirements of users.

The procedure RL_MP_010 for the management of data and information includes:

• Security.

• Access is password protected,

• Confidentiality and data protection.

• Back-up systems.

• Storage, archive and retrieval.

• Safe disposal.

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