Clinical Governance and Patient Safety

Overview of Clinical Governance

A simple definition of Clinical Governance is the recognition and maintenance of good practice, learning from situations and improving the quality of services delivered to patients. Clinical Governance is also a framework through which NHS organisations are accountable for continually improving the quality of their services and safeguarding high standards of care by creating an environment in which excellence in clinical care will flourish.

It is the responsibility of every member of staff within the organ donation and transplantation pathway not just the remit of a few. Everyone needs to work together to ensure that patients and donor families receive the best possible care. There is no single thing which is clinical governance but there are a series of key elements that aim to:

Identify and pursue opportunities to improve practice
Address areas of clinical concern, identify lessons learned and, where appropriate, implement changes
Share lessons learned amongst the donation, retrieval and transplant community as appropriate
Put systems in place to reduce risks
Ensure continuous improvement
Establishing a supportive, inclusive learning culture

All incidents reported to the Organ Donation and Transplantation (ODT) Directorate that may affect any part of the pathway (which includes not only organ donation but also retrieval, transplantation and activities within transplant support services) are managed by the Clinical Governance Team within ODT.

The team includes:

Assistant Director – Education and Governance
Head of Clinical Governance
Clinical Governance Support Managers

All of the above members have clinical backgrounds and work closely with, and are supported by the Clinical Governance Support Assistant.

The team investigate all incidents that are reported and for oversight the Quality Assurance team review the risk rating and close down all submissions within the Directorate. This provides independent oversight of all incidents reported.

The Clinical Governance Team aim to complete investigations within 90 days, and in many cases sooner. In some cases, this may not be possible however, as a full investigation is required from colleagues in other organisations. Once an incident has been fully reviewed and investigated the individual who reported the incident will always be sent a summary of the outcome and any key actions or learning.

Clinical Governance Improvement Group (GIG)

Alongside designative representatives for retrieval, donation, transplant support services and other expert links, the Clinical Governance Team form the Clinical Governance Improvement Group (GIG). This group are responsible for reviewing and monitoring in detail all incidents reported to ODT including serious adverse events and reactions (SAEARs) reported to the Human Tissue Authority as part of NHS Blood and Transplant (NHSBT)’s assisted function.

GIG’s remit is to:

Have oversight of all incidents and review in detail individual incidents, ensure areas of concern are addressed, learning is shared, and, where appropriate, practice is changed
Identify and review key themes and trends of incidents, and, where appropriate, develop key actions following these reviews
But most importantly to ensure that key learning points are disseminated in a timely way to all stakeholders

Whilst GIG ensures a detailed review of incidents are completed the ODT Clinical Audit, Risk and Effectiveness Group (CARE) has a wider oversight. This group is chaired by the ODT Associate Medical Director and membership includes senior operational, nursing and medical representation, clinical governance, quality assurance and scientists.

ODT Clinical Audit Risk and Effectiveness Group

The ODT CARE group is chaired by the ODT Associate Medical Director and membership includes senior operational, nursing and medical representation, clinical governance, quality assurance and scientists.

It monitors and provides oversight of clinical complaints and legal claims, Clinical Audit, Clinical Risk Register and reviews and, where appropriate approves, clinical policies proposed by the Advisory Groups. It also provides a wider oversight of incidents.

Within NHSBT the ODT CARE Group reports to ODT Senior Management Team (SMT) and the NHSBT CARE Committee which has oversight of Governance across NHSBT. The NHSBT CARE Committee meets every two months and is chaired by the NHSBT Medical Director, this Committee is accountable to the NHSBT Governance and Audit Committee which is chaired by a NHSBT Non-Executive Director and is a sub-group of the NHSBT Board.

Terms of reference

Updated August 2024

1. Purpose

The OTDT CARE Group is responsible for leading clinical governance across the Directorate. The Group reports to the OTDT SMT and to NHSBT Clinical Governance Committee (CGC).

OTDT CARE needs to recognise and be sensitive to the distinct roles and responsibilities of the organisation at different points in the clinical pathway.

The OTDT CARE Group ensures that:

Clinical governance requirements as outlined above are met
Opportunities to improve practice and compliance are identified and pursued
Areas of clinical concern are addressed, learning identified and, where appropriate, shared and changes implemented
Learning is shared amongst the donation, retrieval, and transplant community as appropriate
The regulatory requirements of the Care Quality Commission, the Human Tissue Authority and other regulatory bodies are met

OTDT CARE is also responsible for providing oversight of the management and closure of serious adverse events and reactions (SAEs and SARs) reported, as an assisted function to the HTA under the Quality and Safety of Organs Intended for Transplantation Regulations 2012.

2. Terms of reference

3. Membership

Chief Nurse, Chair
Medical Director, OTDT
Director of Organ and Tissue Donation and Transplantation, OTDT
Assistant Director Strategy Transformation & Business Development
Assistant Director UK Commissioning and Service Development, OTDT
Assistant Director Organ and Tissue Donation, OTDT
Assistant Director Tissue and Eye Services
Lead Nurse, Tissue and Eye Services
Associate Medical Director, Clinical Governance
Consultant in Transfusion Medicine
Consultant, Tissue and Eye Services, NHSBT
Deputy Chief Nurse, OTDT
Scientific Advisor, OTDT
Associate Medical Director, Deceased Organ Donation, OTDT
Head of Service Delivery – Organ Donation, OTDT
Head of Service Delivery, OTDT Hub
Head of Information Governance, NHSBT
Head of Transfusion Microbiology, OTDT
Head of Legal - Clinical (Solicitor)
Clinical Governance Lead, ODT
Clinical Audit Manager, NHSBT
Senior Commissioning Manager, OTDT
Head of Operations, TES
National Quality Manager, OTDT
Clinical Audit Manager, NHSBT

The Group may co-opt other members as appropriate. At least six members are required for a quorum.

4. Meeting frequency

5. Administrative support

6. Reporting

7. Governance

7.1 The OTDT CARE Group will have oversight of all aspects of clinical governance that may affect the donation pathway which includes not only organ and tissue donation, retrieval, and transplantation, but also activities within Information Services and the OTDT Hub.

7.1.1 It is recognised that responsibility for governance of the organ and tissue donation, retrieval, and transplant pathway is complex, with individuals, hospitals, commissioners, Health Departments, regulators, and professional bodies having responsibility and accountability for distinct aspects.

Nonetheless, OTDT CARE has a legitimate interest in any clinical aspect along the organ and tissue donation and retrieval/ transplantation pathway and so must work with stakeholders to ensure that suitable policies and guidelines are in place, available and followed; key processes are audited and all actions arising from incidents, audits, reports, and routine monitoring are appropriately investigated, with development of action plans made and implemented.

7.1.2 Any change and/or change control in relation to consent/ authorisation will be discussed at OTDT CARE. Oversight of such changes and activities must be via the CARE structure.

7.2 Assisted Functions role:
Under the Assisted Function role, OTDT has oversight of the investigation and actions arising from SAEs and SARs and ensuring that investigation and action places arising from incidents outside NHSBT are completed in a timely manner.

7.3 Review of clinical policies:
All policies and protocols developed by the Organ Advisory Groups and National Organ Donation Committee of NHSBT will be reviewed by all Organ Advisory Group Chairs with one designated member of the medical team assigned to sign off. Final sign off is at OTDT CARE.

7.3.1 In clinically urgent situations, the MD or, in their absence, the Chief Nurse may approve changes to policy, for ratification at the next meeting.

7.4 Research projects, service developments and other innovations proposed by those outside OTDT will be reviewed by the Research Operational Feasibility Group which will report to OTDT CARE for information.

7.5 Governance Improvement Group:

All incidents reported to OTDT (including those under the Assisted Function Role) relating to organ donation, organ retrieval, and transplantation will be reviewed by the Governance Improvement Group.

7.5.1 The Terms of Reference are shown below.

7.5.1.1 The group will provide a summary of incidents to OTDT CARE, including details of Patient Safety Incident Investigations (PSII’s), SAEs, and SARs. It will be responsible for ensuring that all action plans, identified because of incidents reported to OTDT under its Assisted Function role, are completed on time and will ensure the HTA are kept informed of all appropriate incidents and actions arising from them as well as any incident that may result in adverse publicity of media attention.

The group is also responsible for ensuring that all action plans, identified because of incidents/near misses reported to OTDT, are completed on time and the learning is shared to prevent any recurrence.

7.6 Audit
The OTDT CARE Group will:

7.6.1 Seek assurance from the Directorate’s functions that practice is evidence-based and supported by a robust process of clinical audit.

7.6.2 Oversee, prioritise, and approve the Directorate clinical audit programme, ensuring that the schedule triangulates themes from risks, incidents, complaints, clinical claims, and patient/donor feedback.

7.6.3 Approve clinical audit proposals for implementation and final reports for dissemination.

7.6.4 Review clinical audit findings, recommendations, and related action plans, ensuring escalation of concerns to the appropriate committees or senior management teams.

7.6.5 Monitor adherence to audit actions' timeframes and ensure that action plans in response to audits are implemented without undue delay, especially where limited assurance is given.

7.6.6 Ensure that learning from both Directorate and other relevant internal and external Clinical Audits is shared with the group and seek assurance that this learning is applied within the Directorate to inform future practice and improvement initiatives.

7.7 Other roles
The OTDT CARE Group will:

7.7.1 Review reports from the Governance Improvement Group together with action plans and proposed further audits.

7.7.2 Ensure transparency by providing high level oversight of all incident reports received, review trends for all incidents and those which have been onward reported to the HTA as SAEARs.

7.7.3 Review all complaints received that are clinically relevant, and, where appropriate, ensure that suitable changes are introduced.

7.7.4 Ensure all learning from Complaints is shared across all relevant teams.

7.7.5 Ensure all Compliments received are shared and celebrated.

7.7.6 Receive and action as necessary a two-monthly report from the Scientific Advisor.

7.7.7 Work with other relevant stakeholders to ensure good governance across the spectrum of the transplant process, including commissioners, Health Departments, relevant professional bodies, Trusts/Boards, regulators, and clinicians.

7.7.8 Caldicott: The MD OTDT has the delegated responsibilities as Caldicott Guardian for OTDT for issues relating to potential or actual organ donors or recipients. Requests will be discussed at OTDT CARE; where there is clinical urgency, the MD or Chief Nurse may make a decision that will be reported at the next OTDT CARE meeting.

7.7.9 PSII's: Review all PSII's and ensure action plans are completed on time (unless these are followed at OTDT SMT).

Appendix

Governance Improvement Group: Terms of Reference

1. Authority

1.1 The Governance Improvement Group (GIG) is authorised by OTDT CARE to:

Lead, support, and report on activities related to incident management, clinical governance, clinical audit, quality, and complaints in all areas across the organ donation and transplantation pathway.
Investigate any activity related to incidents submitted, within its terms of reference. To seek any information it requires that relates to an incident submission from any member of staff both within NHS Blood and Transplant and external stakeholders (Transplant Centres, National Organ Retrieval Service (NORS), Recipient coordination teams).
To monitor complaints and compliments submitted across ODT.

1.2 It is responsible for ensuring complaints meet timescales and key trends are monitored and reported via the appropriate mechanism where required.

1.3 It is responsible for ensuring compliments are shared and celebrated.

2. Purpose

2.1 The Governance Improvement Group is responsible for reviewing and monitoring in detail all incidents reported to ODT and escalating any serious matters within one working day in accordance with NHSBT policies.

2.2 The Governance Improvement Group will:

Have oversight of all incidents and review in detail individual incidents, ensure areas of concern are addressed, learning is shared, and, where appropriate, practice is changed.
Identify and review key themes and trends of incidents, and, where appropriate, develop key actions following these reviews.
Prepare and present this information for discussion and action at OTDT CARE.

3. Process for investigating reported incidents

3.1 The Governance Improvement Group will follow the Incident Management and Complaints Management procedures which include:

Investigate or assign a lead investigator for every occurrence accepted as an incident.
Enlist the expertise of the Designated Representative (defined below) when required.
The Designated Representative will respond to every request as soon as possible, but within two working days and report back within five working days.
Ensure complaints, feedback, and audit findings are reviewed in conjunction with incidents reported if appropriate.
Review the key performance indicators related to governance process and develop actions where needed to improve performance.
Review and manage all complaints and incidents including the investigation, timely closure, lessons learnt, and final response to the reporter.
Prepare and present reports, action plans, and updates for OTDT CARE.

4. Membership

4.1 The membership consists of the individuals listed below:

If a member cannot attend a meeting, subject to the Chair’s advance agreement, a fully briefed deputy may be nominated and attend the meetings.

Chair: Clinical Governance Lead, ODT
Deputy Chair: Deputy Chief Nurse
Chief Nurse, OTDT
Clinical Governance Managers
Associate Medical Director: Clinical Governance
National Quality Manager
Quality Assurance Manager – OTDT
Assistant Quality Assurance Manager
Lead Nurse Recipient Coordination
Innovation and Research Lead, OTDT
Service Lead – Donor Family Care
Senior Commissioning Manager, OTDT
Head of Service Delivery – Organ Donation & Nursing
Head of Service Delivery, OTDT Hub
Head of Health Informatics
Head of Service Delivery - National Referral Centre (NRC), OTDT

Associate Director: Living Donation (enlist expertise when required only, meeting attendance not essential)

5. Review, investigation and monitoring of incidents

The Organ and Tissue Donation pathway is split into 5 main groups: Donation, Retrieval, Transplantation, Information Services, and Quality Assurance. Alongside the Clinical Governance (CG) and Quality Assurance (QA) Team, a ‘group expert’ represents each of these pathways at the Governance Improvement Group. The CG team will monitor incidents, complete investigations utilising various methods to ensure a systems approach, and devise actions plans. The CG and the QA team will conduct any in-depth reviews jointly to ensure appropriate expertise is present and will use the most appropriate methodology to ensure a thorough investigation and review is done. The expertise of the clinical expert will be sought where appropriate and when required. Follow up and closure correspondence will be the responsibility of the CG and QA team.

The CG team will be responsible for the identification and escalation of all reported potential Patient Safety Incident Investigations (PSII”s), as per MPD1735. It is within the remit of the Chief Nurse to ensure PSII’s investigations are conducted in an efficient and transparent manner.

The GIG Group will be responsible for the monitoring of incidents submitted that meet the criteria of reporting to the Human Tissue Authority under NHSBT’s Assisted Function Role as per SOP3842.

5.1 Donation

Responsible Group Expert: Head of Service Delivery – Organ Donation & Nursing

The Donation group relates to the organ and tissue donation pathway, and any aspect of quality and safety for which the Organ Donation Services Team (ODST) is responsible. This can include (but is not exclusive) donor characterisation, post transplantation follow up, management of donor files or any aspects of Information Governance related to Specialist Nurse – Organ Donation (SNOD), Specialist Requestor (SR), or administrative processes.

The Donation responsible group expert will be the operational link between Clinical Governance Team and the operational service.
The group expert for the Donation pathway will work closely with the Clinical Governance Team to ensure that any identified learning, policy development and improvements are shared and incorporated within national guidelines where necessary.

5.2 Retrieval

Responsible Group Expert: Associate Medical Director: Clinical Governance

The Retrieval group related to the retrieval pathway and any aspect of quality and safety relating to the National Organ Retrieval Service (NORS). This can include (but is not exclusive) mobilisation of retrieval team, retrieval and perfusion of organs, or adherence to the NORS Standards for Organ Retrieval from Deceased Donors.

As NHSBT oversees a commissioned service, the group will need to ensure that any concerns are addressed using the processes that have been agreed contractually with providers. In addition, there will need to be a high degree of clarity as to the delineation of responsibilities between NHSBT and the commissioned services.

The Senior Commissioning Manager, OTDT will be the link between Clinical Governance Team for contractual issues reported. Any contractual issues noted will be directed to the commissioning team.
The Senior Commissioning Manager, OTDT will be the link between Clinical Team for all aspects of the Commissioned services.
The Associate Medical Director: Clinical Governance will work closely with the Clinical Governance Team to ensure that lessons learnt, policy development and improvements are shared and incorporated within national guidelines where necessary.

5.3 Transplantation

Responsible Group Expert: Associate Medical Director: Clinical Governance

The Transplantation group related to the transplantation pathway and any aspect of quality and safety relating to transplantation. This can include (but is not exclusive) organ acceptance, potential donor derived diseases or infections, traceability issues and post- transplant care.

The responsible group expert for the transplantation group will be the link between Clinical Governance Team and the transplantation community.
The responsible group expert for the transplantation group will work closely with the Clinical Governance Team to ensure that lessons learnt, policy development and improvements are shared and incorporated within national guidelines where necessary.

5.4 Information Services

Responsible Group Expert: Head of Service Delivery, OTDT Hub

Information Services group related to all aspects of the wider non-clinical support of the donation, retrieval, and transplantation pathway and any aspects of quality and safety relating to this. This can include (but is not exclusive) organ allocation, organ offering, post transplantation follow up, and transplant recipient registration.

The responsible group expert for Information Services will be the link between Clinical Governance Team and the OTDT Hub and Information Services Departments.
The responsible group expert will work closely with the Clinical Governance and Quality Assurance Teams to ensure that lessons learnt, policy development and improvements are shared and incorporated within national guidelines where necessary.

6. Reporting responsibilities

6.1 GIG will report to the OTDT CARE meeting via 2 monthly Clinical reports and minutes.

6.2 Any issues identified that require escalation will be escalated to the Medical Director as soon as we are notified, and preliminary information has been gleaned.

6.3 An annual progress report, outlining activity including key successes and areas for development, will be submitted to the OTDT CARE Group.

7. Quorum

8. Notice of meetings

Unless otherwise agreed, notice of each meeting confirming the venue, time, and date together with an agenda of items to be discussed, shall be forwarded to each member of the committee, and any other person required to attend, to arrive no later than three working days before the date of the meeting. Supporting papers shall be sent to Sub-Committee members and to other attendees as appropriate, at the same time.

9. Records of meetings

10. Monitoring effectiveness

11. Administrative support

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