4.0 Management requirements

The organisation and management of the Microbiology Departments are detailed below. The laboratory accepts its responsibility to meet the requirements of ISO15189 & ISO17025 when carrying out work at its permanent facilities. The service shares a single Management and Quality Management Structure.

The Microbiology Departments are part of the acute services division of NHS Greater Glasgow & Clyde (GG&C). The Department provides 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), Head of Technical Services (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, Head of Technical Services (HoTS), Service Manager (SM), Quality & Compliance Manager (QCM), Operational Manager (OM)

NHSGG&C Standing Financial Instructions and Fraud Policy 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.

Conduct of individual staff is governed by their Contract of Employment, Professional bodies (General Medical Council, Health and Care Professions Council, the Staff Code of Conduct, Standing Financial Instructions, Caldicott report & the Data Protection Act.

Staff are made aware of this information at induction and on an ongoing basis as part of the Competence Programme monitored by the training managers using TRI539. All staff participate through LearnPro to fulfil all the Statutory Mandatory Training by GG&C.

The NHS GGC Policies can be accessed via StaffNet links below:

• http://www.staffnet.ggc.scot.nhs.uk/Corporate%20Services/Finance/Pages/FinancialGovernance-New!.aspx
• http://www.staffnet.ggc.scot.nhs.uk/Corporate%20Services/Finance/Pages/Standing%20Financial%20Instructions%20and%20Procedures.aspx
• http://www.staffnet.ggc.scot.nhs.uk/Corporate%20Services/Finance/Pages/CodeofConductforStaffandDeclarationsofInterest,GiftsandHospitality.aspx

Please note: StaffNet pages can only be accessed from an NHS device on the NHS network

The Environmental Laboratory does not undertake other activities, which would result in a conflict of interest. All staff are bound by GGC contract and policies as for the Clinical Laboratory Service. An impartiality register is maintained for staff working in the Environmental Testing Laboratory at the GRI site.  

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 4.1.1.4 of ISO 15189:2012 standard, the Laboratory Director is responsible for regulatory compliance.  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.

Resilience

The Departments do not sub-contract entire investigations to any other laboratory or organisation unless in the unlikely event of catastrophic occurrence. 

In the unlikely event of either laboratory being unable to fulfil the requirements of its UKAS accreditation due to major equipment breakdown or other catastrophic occurrence, the work would be transferred between the sites.

This is detailed with QP513 Risk Management Procedure.

Alternative arrangements for processing samples would be as follows:

1. Inform client(s) affected by telephone at the earliest opportunity
2. Inform the other GG&C Laboratory that samples are to be referred
3. Triage of all samples by the Clinical Leads & Operations Manager for each laboratory section (or a nominated deputy), to ensure that all diagnostic samples are prioritised and sent based on need to the correct alternative location
4. Arrange transport of the samples by laboratory van, or courier as soon as possible
5. Depending on number of samples etc the receiving Laboratory would PID and issue reports if required due to being on the same LIMS system

If the nature of the catastrophic event is such that the current laboratory building is unusable, clients will be advised to send samples directly to the nominated alternative GG&C Microbiology Laboratory. Staff would transfer to carry out the work at the appropriate site where required. 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 if this is possible.

Management have shown commitment to the development & implementation of the QMS and to continually improving its effectiveness by:-

1. 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
2. Establishing a quality policy. The Quality Policy is reviewed at the AMR
3. Establishing quality objectives & plans. This is updated at the AMR. P&O’s are discussion & reviewed at the compliance operational meetings. Management ensures the setting of Plans & Objectives by following QP506 – Annual Management Review Procedure
4. Responsibilities, authorities & inter-relationships of all personnel are defined under section 4.1.2.5
5. Communication processes are described under section 4.1.2.6
6. Appointment of a Quality Manger as per 4.1.2.7
7. An annual management review is held in January for the preceding year. This will be a joint AMR in person, if facilities are available, or via video conferencing/Teams
8. Competency assessment is a key component of our training programme. It is assessed & reviewed according to criteria set down in TRP500- Training Policy
9. Management ensure adequate resources are available by careful selection, induction and training of appropriately qualified staff. Accommodation is a state-of-the-art laboratory within the New Lister Building, Glasgow Royal Infirmary & the Laboratories and Facilities Management Building, Queen Elizabeth University Hospital. Equipment & consumables are procured & maintained using the Directorate purchasing procedure. Examination processes are verified & validated before use. Processes are continuously monitored by using IQC and EQA checks

There is daily interaction at medical level with service users through ward visits and 24hr access to clinical advice. Surveys or open events are held occasionally and outcomes acted upon. This is a commitment in our Quality Policy. Needs and requirements of users forms part of the annual management review. Information for users is contained in the user manuals accessible on the GG&C Intranet page/website. Medical, senior scientific & BMS staff are in daily contact with users to provide support and advice.

The Needs & requirements of users procedure is defined in QP509, with user needs kept under constant review. In practice, this is can be achieved by user-satisfaction questionnaires, meetings with specific key users and by individual contact between the Director, Clinical Leads, Head of Technical Services, Service Manager, Quality & Compliance Manager, Operational  Manager, Quality Managers, Technical Managers, Microbiology Consultants, Medical Consultants, Clinical Scientists 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 senior management team. Where surveys cannot be performed, a target approach to user interaction and improvement will be taken. Recommendations arising from these exercises are translated into requirements which form the focus of objective setting and planning within the quality management system; consideration of the findings can form part of the annual management review.

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 and users, the course of action and measures that the Clinical Laboratory has taken in order to provide a service of the highest quality.

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.

Refer to Annex 1

Meeting Minutes form the principle means to communicate, Meeting Minutes, inclusive of Action Points are communicated to staff via: other meetings; by email; and, upload to QPulse. The communication & committee of internal communications is shown below.

Microbiology Management Team Meeting (MMT)

Every 4-6 weeks. Chaired by: Head of Service

Attended by: General Manager/HoS/Clinical Service Manager/CL/HoTS/SM/QCM/OM

This is a GG&C wide meeting forum to discuss all aspects of the clinical service. Minutes are held in Qpulse – MF500

Senior Management Meeting (SMT)

Every 4-6 weeks. Chaired by HoS/HoTS

Attended by: HoS/CL/Microbiology Consultants/HoTS/SM/QCM/OM

This is a GG&C wide meeting to discuss the clinical service and laboratory interface including operational and compliance matters.

Minutes and Action Trackers are held in Qpulse – MF501

Compliance & Operation Team Meeting (Com/Op)

Every 4-6 weeks. Chaired by HoTS

Attended by: HoTS/SM/QCM/OMs

This is a GG&C wide meeting to discuss all compliance & operational aspects of the laboratory service. Minutes &/or Action Trackers are held in Qpulse – MF512

Technical Manager Meeting

Every 4-6 weeks. Chaired by OM

Attended by: OM/TM’s/QM/HoTS or SM/QCM   

This is a departmental meeting involving senior staff to discuss all sections of the laboratory, including operational and compliance issues.

North Minutes &/or Action Trackers are held in Qpulse – MF503

South Minutes &/or Action Trackers are held in Qpulse – MF504

All Staff Meeting

This is a weekly meeting for all staff (or weekly update via meeting notes if meetings are unable to take place).

Chaired by OM

Attended by: All Laboratory Staff/Departmental Consultant staff

This is a departmental meeting to discuss all sections of the laboratory & inform all staff of information from other meeting that take place.

Minutes are held in Qpulse – North sector MF513& South sector MF514

Departmental Health and Safety Committee

Four times a year. Chaired by OM/QM

Attended by a representative of each of the grade of staff as required:-

OM/QM/HoTS or SM/QCM/TM (for H&S/CL3)/Staff Side Representative/BMS & CSW Representation

This is a departmental H&S meeting for implementation of H&S policy.  

Minutes are held in Qpulse – North sector MF534& South sector MF510

Building Health and Safety Committee

Four times a year. Chaired by senior staff as per agreement of group (usually on a rotational basis)

Attended by a representative of each of the following for each discipline as required:-

HoTS or SM/OM/QCM/QM/TM (for H&S/CL3)/Staff Side Representative/BMS & CSW Representation

This is a multi disciplinary H&S meeting to discuss shared issues relating to the building; decisions are ratified at local H&S meeting and escalated to MMT where required. Minutes are held in Qpulse – North sector MF511& South sector MF507

The NHSGGC Corporate Communications Strategy (accessed via StaffNet) serves to ensure that NHSGGC communication activities are effectively and efficiently channelled to support the delivery of the organisation's goals and priorities. Key principles include the essential communication of NHSGGC Strategy, inclusive of service and or organisational change, via Staff Newsletters, and GG&C Team/ Core Briefs. Corporate Communications are sent to all staff via email and can be found at the link below.

http://www.staffnet.ggc.scot.nhs.uk/Corporate%20Services/Communications/Briefs/Pages/BriefsList.aspx

Please note: StaffNet pages can only be accessed from an NHS device on the NHS network

The QCM is the appointed quality manager with delegated responsibility for establishing, implementing and maintaining a quality management system and reporting to management on its performance and needs for improvement.  

Each sector has a dedicated quality manager for day to day operation of the QMS, including audits, non-conforming work and to monitor the effectiveness of any actions taken. Further detail on the job role of the QCM and QM are held in appendix 1.

As UKAS accredited clinical laboratories we inform our clients through our intranet site/website of our accreditation status, rather than using the UKAS log as per ED570 regulations.

The following statement is displayed on our individual homepage before clients access the user handbook: ‘a UKAS accredited medical laboratory. No 8078’.

Additionally, all clinical reports from specimens and investigations covered within our UKAS scope contain the following comment: ‘tests included in UKAS accreditation (8078) scope’

As a UKAS accredited testing laboratory for water testing, we inform our clients through a statement on our printed reports as per ED570. 

Printed reports state ‘A UKAS accredited testing laboratory no. 4211’

There is a hyperlink on our Staffnet page and web page to take users to the UKAS website displaying the scope of tests covered by our accreditation to both standards.

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.

Staff are introduced to the Quality Manual at induction and acknowledge the document in Q-pulse. Production of this Quality Manual shows compliance with this standard.

We aim to control our documents, because of the need for traceability, using Q-Pulse software. All documentation is properly controlled and SOPs, forms, worksheets and external documents have a unique identifying code, review date, version number, pagination and name of authoriser (owner), which correctly identifies the type, number and version of the document. This is managed through the Q-Pulse software system. Only active documents are at workstations with obsolete or inactive documents removed and stored indefinitely in the Obsolete Document area of Qpulse only. Refer to QP511 Document Control Policy.

MP503 - Establishing a Service Level Agreement details the method for this and the review process.

MP517 – Review of requests, tenders and contracts details the procedure of contract review for the Environmental testing Service. It ensures that:

1. The requirements are defined
2. The laboratory has the capability and resource requirements
3. Appropriate methods are selected and meet the customers requirement

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. This process is described in QP518 Review of Referral Laboratories.

We aim to provide accurate results for our users by ensuring that our procedures state that we are responsible for providing the results.

MP511 Use of LIMS Procedure details reporting of results.

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

• Quality of service
• Professionalism
• Costs
• Contractual obligation
• Recent performance
• Availability of stock
• Time to delivery
• Partnership

Refer to Managed Service Contract and MP514 - Procurement & Management of Equipment. The laboratory ensures that only suitable externally provided products and services that affect the laboratory activities are used. The laboratory evaluates and reviews suppliers. Refer to QP520 - Management & QC of Media, Reagents & Materials for more detail.

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 Director, Head of Technical Services, Service Manager, Quality & Compliance Manager, Quality Manager, Operational  Manager, Quality Managers, Section Managers, Microbiology Consultants, Medical Consultants, Clinical Scientists and others who use the service. Refer to QP509 – Needs & Requirements of Users.

The Environmental Testing Laboratory is willing to cooperate with customers or their representatives to clarify the client's request and to monitor the laboratory's performance in relation to the tests or work performed for the client, whilst ensuring confidentiality of other clients. The client may have reasonable access to relevant areas of the laboratory to witness tests performed for the provision of test items required by the client for verification purposes.

Communication with the client and service users is maintained regularly to ensure that advice and guidance in technical matters and interpretations and opinions based on results are always clear and relevant to the client’s situation. The laboratory would always inform the client of any delays or major deviations in the performance of tests performed for the client. The laboratory encourages feedback both positive and negative from clients or other parties and records communication with clients in Qpulse. The feedback is used to improve the quality system and also the testing activities of the laboratory and its client/advisory service.

Refer to MP516 Complaints Procedure. 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. All complaints will be logged within the CAPA module in QPulse. Our Complaints Process encompasses the following:

1. To take all complaints seriously
2. To deal with the client in a courteous manner ensuring that any staff member involved in the
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
7. To ensure that the outcomes to be communicated to the complainant shall be made by, or reviewed and approved by, individual(s) not involved in the original laboratory activities in question.

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 QP510 – Accessing & Use of Qpulse. Non-conformity reports are submitted to the quality manager as they arise, and cumulative data forms part of the annual management review. With each non-conformance a root cause analysis is performed. The process is described in QP525 – Root Cause Analysis. RCA is trended and monitored through the quality manager meeting.

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). Identification & control of non-conformances is described in QP510. 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

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
• Integration of risks and opportunities within the QMS so these are captured, addressed and monitored

Proactive approaches to preventive action include audit, identifying risk and opportunity from non-conforming work, feedback, staff suggestions, feedback from external organisations and complaints.

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

• Assessment of user satisfaction – QP509
• Regular discussion with users of the service to discuss service needs
• Participation in clinical meetings
• Internal audit of the quality management system  - QP516
• External quality assessment
• A process for quality improvement – QP515
• Identification and control of nonconformities – QP510

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.

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 MP513. Records & specimens are stored in accordance with RCPath & IBMS guidelines. Quality records are available in QPulse or from the QCM. Process records are stored at workstations or are archived.

The laboratory ensures that all technical records are maintained as per the retention policy and per technical SOP’s. All technical records are signed by the appropriate staff member for work carried out by recording date/initial. Any amended record can be tracked to the previous version. Original copies and any other additional copies are retained by the laboratory either through the filing in place or by electronic record.

All procedures are reviewed periodically as per the Document Control SOP QP511. Appropriateness of specimens/sample containers etc are examined during audit.

User surveys can be performed periodically and reports held in Qpulse. Targeted Quality Improvements as a result of discussions between the laboratory and users can also be initiated. The consultants hold regular meetings and include feedback as an agenda/discussion item to capture any feedback they have received either from hospital or GP users. Feedback is then passed on to the Quality Manager for recording in QPulse and relayed to staff through the meeting schedule.

All staff are encouraged to participate in suggestions for improvements to the department and service. These can be done via QPulse as per QP510 or at staff meetings where suggestions are part of the agenda.

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 as per QP516.

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 QP514. The audit schedules are held in QPulse.

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.

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.

Any non conformity raised externally are followed up immediately/or by required timeframe by management and recorded in the monthly compliance reports. Further details if required can be logged in the CAPA module in QPulse as per QP510. Microbiology Laboratories are assessed by UKAS on a yearly basis. A full assessment report is generated and made available to all staff. The Health & Safety Executive also reviews all clinical laboratories and produce reports of any findings/suggestions.

Multisite Accreditation

For GGC Microbiology, the laboratories are accredited under a single UKAS number and operate under a single management structure.

Each site has a comparable volume of work and carries out almost identical tests. Some services are only offered on one location and these are specified with the laboratory user manuals and are clear on the UKAS schedule. Where a test is only offered on one site this is detailed in the risk continuity SOP with mitigation and contingency detailed.

For all tests that carried out on both sites the SOP’s are identical as is the equipment, reagents and training.

As detailed in the resilience section each site has the capacity to take work from one site to the other in times of emergency. Staff may be asked to transfer with work in times of contingency. If this were to be put in place familiarisation and a mini induction would be carried out for all staff transferring between sites. All areas of GEN 1 have been considered and are in place to enable the laboratories to be set up for multisite accreditation.

UKAS GEN 1 - General Principles for the Assessment of Conformity Assessment Bodies by the United Kingdom Accreditation Service provides guidance on the assessment and accreditation of multi-site laboratories and describes how UKAS will assess and make reference to multi-site laboratory accreditations.

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

The Lab Director, Clinical Leads, HoTS, SM, QCM, OM/ QM/ TM’s / Consultants participate in an annual  review that considers the following items of information based upon reports produced by managerial and supervisory personnel:-

Records are kept and key objectives for subsequent years defined and plans formulated for their implementation as defined in QP506 – Annual Management Review Procedure. Senior staff submit end of year reports for their areas of responsibility. Objectives for the forthcoming year are determined at the AMR and are documented in QF551, installed in Q-Pulse and communicated to staff.