ODT CARE GROUP Clinical Audit, Risk and Effectiveness
Terms of Reference
The ODT CARE Group is responsible for leading clinical governance across the Directorate. The Group reports to the ODT SMT and to NHSBT CARE. ODT CARE needs to recognise and be sensitive to the different roles and responsibilities of the organisation at different points in the clinical pathway.
The ODT 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 and lessons learned, identified and, where appropriate, shared and changes implemented;
Lessons learned are 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.ODT CARE is also responsible for providing oversight of the management and closure of serious adverse events and reactions (SAE's and SARs) reported, as an assisted function to the HTA under the Quality and Safety of Organs Intended for Transplantation Regulations 2012.
2. The ODT CARE Terms of Reference will largely follow the generic NHSBT Care Comittee Terms of Reference.
Associate Medical Director, ODT - (Chair)
Assistant Director – Education and Governance (Deputy Chair)
Director of Organ Donation and Transplantation, ODT
Assistant Director of Support Services, ODT
Assistant Director - UK Commissioning, ODT
Assistant Director - Organ Donation and Nursing, ODT
Scientific Advisor, ODT
National Clinical Lead for Governance
National Clinical Lead for Organ Donation
National Clinical Lead for Organ Retrieval
Clinical Quality and Compliance Manager
Chair of the Clinical Microbiology Sub-group
Head of Clinical Governance
Clinical Audit Manager, NHSBT
National Quality Manager, ODT
The Group may co-opt other members as appropriate.
At least six members are required for a quorum.
4. Meeting Frequency
The ODT CARE Group will meet at least every two months. Meetings will be timed to occur two weeks before the ODT SMT meeting. The Chair and Deputy may call for extra-ordinary meetings.
5. Administration Support
Administration and financial support will be provided by ODT. The Clinical Governance Support Manager will be responsible to the chair for agreeing the agenda, reviewing minutes and ensuring these are sent to ODT SMT and preparing the report for NHSBT CARE Committee Meeting.
Escalation of and accountability for the majority of clinical governance issues will follow a similar route as for other NHSBT Directorates which is to the Directorate Senior Management Team and the NHSBT CARE Committee, according to current NHSBT Guidance.
7.1 The ODT CARE Group will have oversight of all aspects of clinical governance that may affect the pathway which includes not only organ donation, retrieval and transplantation but also activities within transplant support services.
7.1.1 It is recognized that responsibility for governance of the donation, retrieval and transplant pathway is complex, with individuals, hospitals, commissioners, Health Departments, regulators and professional bodies having responsibility and accountability for some aspects. Nonetheless, ODT CARE will have a legitimate interest in any clinical aspect along the donation/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.
7.2 Assisted Functions role:
Under the Assisted Function Role, ODT has oversight of the investigation and actions arising from SAEs and SARs and ensuring that investigation and action plans 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 the ODT CARE. Once approved by ODTCARE, those policies affecting patient and donor selection and organ allocation will be referred to the Transplant Policy Review Committee (which acts on behalf of the Board) before implementation.
7.3.1. In clinically urgent situations, the AMD or, in his absence, the Assistant Director for Education and Governance may approve changes to policy for ratification at the next meeting.
7.4 Research projects, service developments and other innovations proposed by those outside ODT will be reviewed by the Research, Innovations and Novel Technologies Advisory Group which will report to ODT CARE for information.
7.5 Governance Improvement Group:
All incidents reported to ODT (including those under the Assisted Function Role) relating to organ donation and transplantation will be reviewed by the Governance Improvement Group.
7.5.1 The Terms of reference are shown in the Appendix.
The group will provide a summary of incidents to ODT CARE, with details of Serious incidents (SIs), including SUIs,SAEs and SARs. It will be responsible for ensuring that all action plans, identified as a result of incidents reported to ODT 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 or media attention.
7.6.1 ODT CARE will work with the NHSBT Audit Department to agree audits for the forthcoming year, review reports, action plans and outcomes.
7.6.2 Review appropriate elements of Regulatory and Quality Audits performed within ODT.
7.7 Other roles.
The ODT CARE Group will:
7.7.1 Review the report 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 Receive and action as necessary a two-monthly report from the Scientific Advisor.
7.7.5 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.
7.7.6 Caldicott: The AMD ODT has the delegated responsibilities as Caldicott Guardian for ODT for issues, relating to potential or actual organ donors or recipients. Requests will be discussed at ODT CARE; where there is clinical urgency, the AMD or AD Education and Excellence may make a decision that will be reported at the next ODT CARE meeting.
7.7.7 SI: Review all SIs and ensure action plans are completed on time (unless these are followed at ODT SMT).
Governance Improvement Group
Terms of Reference
1.1 The Governance Improvement Group (GIG) is authorised by ODT 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 submitted across ODT.
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 keys themes and trends of incidents, and, where appropriate, develop key actions following these reviews.
- Prepare and present this information for discussion and action at ODT CARE.
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 ODT CARE.
4.1 The membership consists of the individuals listed below.
In the event that 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: Assistant Director – Education and Governance
Deputy Chair: Head of Clinical Governance
Clinical Governance Support Manager
National Clinical Lead for Governance
National Quality Manager
Quality Assurance Manager – ODT
Assistant Quality Assurance Manager
National Clinical Lead for Organ Donation
Associate National Clinical Lead for Organ Retrieval
Lead Nurse Service Delivery
Lead Nurse Recipient Coordination
Head of Health Informatics
Lead Nurse for Living Donation (enlist expertise when required only, meeting attendance not essential)
5.0 Review, Investigation and Monitoring of Incidents
The Organ Donation pathway is split into 4 main groups: Donation, Retrieval, Transplantation and Transplantation Support Services. Alongside the Clinical Governance (CG) and Quality Assurance (QA) Team, a ‘Designated Representative’ (DR) represents each of these pathways at the Governance Improvement Group. The CG and QA team will monitor incidents, complete investigations and formal root cause analysis, and devise action plans. The expertise of the DR 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 and QA team will be responsible for the identification and escalation of all serious incidents requiring investigation (SIs), as per MPD772. It is within their remit to arrange SIRI teleconferences, take minutes and ensure investigations are carried out 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.
Designated Representative (DR); Lead Nurse Service Delivery
The donation group relates to the 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) or Administrative processes.
- The DR for the Donation group will be the operational link between Clinical Governance and Quality Assurance Team and the operational service.
- The DR for the Donation group will work closely with the Clinical Governance and Quality Assurance Team to ensure that lessons learnt, policy development and improvements are shared and incorporated within national guidelines where necessary.
Designated Representative (DR); Associate National Clinical Lead for Organ Retrieval
The Retrieval group relates 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 DR for the retrieval group will be the link between Clinical Governance and Quality Assurance Team for contractual issues reported. Any contractual issues noted will be directed to the commissioning team.
- The Associate National Clinical Lead for Organ Retrieval DR will be the link between Clinical Governance and Quality Assurance Team for all clinical aspects of the Commissioned services.
- The Associate National Clinical Lead for the retrieval group will work closely with the Clinical Governance and Quality Assurance Team to ensure that lessons learnt, policy development and improvements are shared and incorporated within national guidelines where necessary.
Designated Representative (DR); National Clinical Lead for Governance
The Transplantation group relates 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 DR for the transplantation group will be the link between Clinical Governance and Quality Assurance Team and the transplantation community.
- The DR for the transplantation group will work closely with the Clinical Governance and Quality Assurance Team to ensure that lessons learnt, policy development and improvements are shared and incorporated within national guidelines where necessary.
Designated Representative (DR); Head of Health Informatics
The TSS group relates to all aspect of the wider support of the donation and transplantation pathway and any aspects of quality and safety relating to this. This can include (but is not exclusive), organ allocation, organ offering, Organ Donor Register related events, post transplantation follow up, and transplant recipient registration.
- The DR for the transplantation support services group will be the link between Clinical Governance and Quality Assurance Team and the Transplant Support Service Departments (TSS).
- The DR for the TSS group will work closely with the Clinical Governance and Quality Assurance Team to ensure that lessons learnt, policy development and improvements are shared and incorporated within national guidelines where necessary.
6.1 GIG will report to the ODT CARE meeting via 2 monthly Clinical reports and minutes.
6.2 Any issues identified that require escalation, will be escalated to the Associate Medical Director as soon as we are notified and preliminary information has been gleaned.
6.2 An annual progress report, outlining activity including key successes and areas for development, will be submitted to the ODT CARE group.
7.1 The Quorum necessary for the transaction of business shall be 4 members.
A duly convened meeting of the Committee at which a quorum is present shall be competent to exercise all or any of the authorities, powers and discretions vested in or exercisable by the Committee.
8.0 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.
9.0 Minutes of Meetings
The Organ Donation Governance Support Assistant shall minute the proceedings of all meetings of the committee, including recording the names of those present and in attendance.
Minutes of meetings shall be circulated promptly to all members of the Sub-Committee.
10.0 Monitoring Effectiveness
10.1 The membership, terms of reference and progress of the committee shall be reviewed annually.
10.2 At least once a year, the Committee will review its own performance and terms of reference to ensure it is operating at maximum effectiveness and recommend any changes it considers necessary to the ODT CARE Group for approval.
11.0 Administrative Support
11.1 Administrative and secretarial support will be provided from Organ Donation Governance Support Assistant.
Next section: Reports on Incidents