5.0 Structural and Governance Requirements

The Microbiology Departments are part of the acute services division of NHS Greater Glasgow & Clyde (GG&C). The departments provide a comprehensive and efficient analytical, clinical advisory and educational service of the highest quality to the division hospitals, other hospitals and Primary Care services within and beyond the Greater Glasgow area. The Laboratory is encompassed under the Directorate of Diagnostics (Clinical Microbiology), which offers diagnostic services and clinical liaison including infection control to Greater Glasgow & Clyde and other Health Boards and commercial organisations.

North Glasgow Hospital Division of GG&C Health Board is the organisation legally responsible for the Glasgow Royal Infirmary Laboratory. The South Glasgow Hospital Division of GG&C Health Board is the organisation legally responsible for the Queen Elizabeth University Hospital Laboratory.

Microbiology Management Team (MMT) – Greater Glasgow & Clyde

Head of Service (HoS), General Manager (GM), Clinical Services Manager (CSM), Clinical Lead Microbiologists (CL), Technical Services Manager (HOTS), Service Manager (SM), Quality & Compliance Manager (QCM) & Operational Managers (OM)

Senior Staff – Greater Glasgow & Clyde

Head of Service (HoS), Clinical Lead Microbiologists (CL), Consultant Microbiologists, Technical Services Manager (HOTS), Service Manager (SM), Quality & Compliance Manager (QCM), Operational Manager (OM)

GGC Microbiology: Laboratory Director

• Dr Abhijit Bal MBBS, MD, DNB, MNAMS, FRCP, FRCPath, FISAC, FRAS, Dip Med Mycol is a consultant medical microbiologist, is Head of Service for Microbiology & Virology and is the Laboratory Director
• As per 5.2 of ISO 15189:2022 standard, the Laboratory Director is responsible for the implementation of the management system including the application of risk management to all aspects of the laboratory operations so that risks to patient care and opportunities to improve are identified. This is delegated to the Head of Technical Services (appendix 1 illustrates roles and interrelationships). Competence as Laboratory Director is demonstrated by
• Participation in Continuing Professional Development (CPD) and evidence of continuing practice in the speciality
• Membership of the Royal College of Pathologists & General Medical Council
• Recorded attendance at regular departmental meetings to review service issues and to set quality objectives

The Laboratory Director can delegate responsibilities on an operational level to clinical leads on each laboratory site when required. The Laboratory Director & Clinical Leads undergo annual joint review and have a job plan.

The Lab Director, Clinical Leads, Head of Technical Services, Service Manager, Quality & Compliance Manager & the Operational Manager represent the organisation at Microbiology management team meetings.

Day to day control of the laboratory is under the direction of the Head of Technical Services, co-ordinated by the Operational Manager

Laboratory investigation procedures are documented in corresponding Standard Operating Procedures, Management Procedures and Quality Procedures or Laboratory instructions. Documentation is held within laboratory QMS and also includes Sandyford site procedures. GGC Microbiology website and laboratory user manuals contain information on examinations offered, sample type requirements, and sample acceptability criteria.

Advisory Activities

Laboratory clinical team provide appropriate laboratory advice and interpretation for samples received and individual patients and users needs.

The GGC website and user manual contain information on examinations provided, including type of sample, turnaround times and limitations.  Microbiology clinical team also provide professional judgments on the interpretation of the results and promote the effective use of laboratory examinations i.e. demand managements and appropriateness of test request.

The Clinical Laboratory is part of the Diagnostics Directorate of the Acute Division of NHS Greater Glasgow and Clyde. The organisational relationships are shown below

NHS GG&C Microbiology Management Structure

5.4.2 Quality Management

Evidence illustrating our established of a quality management system includes: our Quality Manual, Quality Policy, appointment of a Quality Manager and the implementation of a quality management system.

The key documentation that demonstrates this includes

QP503           Quality Manual

QP500           Quality Policy

QP506           Annual Management Review

QP516           Internal Audit and Audit Training

QP511           Document control

MP513           Control of process & quality records

MP512           Control of clinical material

The Quality Management System is subject to planned and scheduled internal audit processes, against agreed criteria, by personnel trained in internal audit. The records of internal audit include: the activities, areas or items audited, any nonconformities or deficiencies found and the 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.

The Quality Manager, in liaison with the compliance-operational team are responsible for:

• Implementation, maintenance and improvement of the management system
• Identification of deviations from the management system or from the procedures for performing laboratory activities
• Initiation of actions to prevent or minimise errors/deviations
• Reporting on the performance of the management system and any need for improvement
• Ensuring the effectiveness of laboratory activities

Procedure QP506 describes this process. The management team define the quality objectives of the service in consultation with the laboratory 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.

A quality policy (QP500) is published as a separate controlled document and displayed on the quality notice board. The purpose of the quality policy is to set down, for the information of staff, patient and users, the course of action and measures that the Clinical Laboratory has taken in order to provide a service of the highest quality.

Quality indicators are established by the management team prior to implementation. The objectives, methodology and duration of measurement are detailed in the grid in QP515. Quality indicators are also reviewed periodically by the management team and discussed at the annual management review.

We aim to establish business continuity in order to fulfil responsibilities under the overall objective of providing a safe environment for patients, staff and visitors as well as to comply with relevant legislative requirements. This requires contingency planning by management and is detailed in QP513 – Risk Management – Business Continuity. The service holds and maintains a Risk Register: a virtual document which quantifies and prioritises risks which threaten the achievement of the organisation’s objectives. The Risk Register is reviewed by the management team on a monthly basis and is an agenda item at H&S and management meetings.

A risk based approach is taken to laboratory audit schedule and non-conforming investigations.  Annual audit schedule is constructed based on identification of possible i.e. IQC failures, H&S incidents, EQA/IQA discrepancies or increase number of non-conformances. Risk is also factored into all laboratory processes and procedures, with appropriate risk and COSHH assessment carried out for appropriate area of investigation. Risk is also incorporated into laboratory non-conformances to ensure risks are mitigated and to identify opportunity for improvement, more detail can be found within QP510. Risks/clinical risks are also considered during review of laboratory examination procedures and captured in QF632.