Revised clinical incident reporting – standard operating procedure
Version 1.4, 26 July 2022
2. Purpose of this guidance
4. Classification of adverse incidents
5. Managing adverse clinical incidents
6. Escalation pathways
7. Summary of reporting requirements
See the main PDF document for all appendices:
The vaccine programme is a fast changing, complex national programme. With over 130 million doses delivered, and with a better understanding of the programme’s impact and safety profile, it is timely to review the arrangements for reporting clinical incidents and other safety issues.
A clinical incident is defined as any unintended or unexpected event that could have, or did, lead to harm for one or more people receiving healthcare.
This SOP is intended to clarify responsibilities and arrangements for identifying and managing such incidents, to support sites and Regions to deliver safe care and enable the national team to respond appropriately when needed and influence national change quickly should the need arise.
2. Purpose of this guidance
This document summarises the responsibilities for managing and reporting clinical incidents at site, System, Regional and National Level. It summarises what type of clinical incidents to escalate, how they should be escalated and how quickly. It is intended to:
- Describe responsibilities for clinical incident management and reporting.
- Minimise any unnecessary workload for people reporting such incidents.
- Ensure that when clinical incidents are escalated, they contain sufficient information to enable a timely, informed and proportionate response.
- Ensure that colleagues working at national level can focus on clinical incidents that need a national response (whether through direct action, coordination or national guidance).
Arrangements for managing non-clinical or non-vaccination incidents are not covered in this document. Guidance on how to report such incidents can be found as follows:
- Faulty equipment and non-vaccine supply queries: sites need to raise via usual SVOC>RVOC>NVOC routes. We also have a page of key escalation info here: Key escalation points of contact for vaccination sites – COVID-19 Vaccination Programme – FutureNHS Collaboration Platform
- Medical records, Tech and Data enquiries: contact 119 and ask for the Data Resolution Team.
- IT (hardware) issues: contact Covid Vaccs Help Desk at email@example.com or call 0300 200 1000 (06:00 – 22:00 Mon to Sun).
- Mutual aid issues where vaccine viability is not affected: handled by Regions/Regional Pharmacy Team +/- escalation NVOC as determined by Region
Links to further guidance are provided in Appendix 6.
Staff involved in the vaccine programme should make all reasonable efforts to ensure that patients are cared for safely and effectively. This includes maintaining skills and knowledge up to date, complying with policies and procedures, and reporting any situations that could, and actual incidents that do, lead to unacceptable risk or harm.
If an adverse incident occurs, staff should provide immediate care within their competency, escalate as necessary to senior colleagues for assistance, and report the incident promptly using local incident reporting systems. Staff should also follow the principles of the “Duty of Candour” so that patients and/or relatives are informed about what has happened.
Sites should adopt a “just culture” approach when investigating incidents and ensure that there are suitable mechanisms in place to support staff following an event, for example using a hot debrief or after-action review.
3.2 Vaccination sites and System Vaccination Operating Centres (SVOC)
All sites providing Covid vaccination must have a published policy for managing and reporting adverse incidents and all staff providing care must be familiar with it. Sites should have arrangements in place to review adverse incidents, ensure that they have been appropriately managed and shared with others and, when needed, escalated via SVOC to regional colleagues.
Details of all adverse incidents related to the vaccination programme must be shared with the local System Vaccination Operating Centre (SVOC). Every site should have arrangements in place to review adverse clinical incidents and safety in general on a regular basis, and ensure that lessons learnt are shared with all appropriate staff SVOCs must ensure that they have sight of all adverse incidents and other safety concerns, provide advice on local management as appropriate and ensure that, when needed, they are escalated to Regions in a timely fashion. SVOCs must also ensure that investigations into more serious adverse incidents are completed and closed, with any lessons learned shared appropriately.
Regions are responsible for ensuring that providers deliver the vaccine programme safely and effectively. They must assure that sites within their area meet published standards including having effective and robust systems in place to report and manage clinical incidents, with access to relevant networks to investigate and share lessons learned from incidents.
Regions should ensure that sites and SVOCs are aware of which incidents need to be escalated to them, how quickly and via which route. They are responsible for escalating incidents nationally as described in this SOP and for ensuring that summary reports of lower severity incidents are reported to the National Vaccination Operating Centre (NVOC) on a weekly basis. They should also check that, when indicated, external reporting to MHRA, UKHSA and NRLS has been completed.
Regions should have suitable governance arrangements in place for receiving reports of adverse clinical incidents and for their immediate management. They must have in place a Clinical Risk Management Group (or similar) with appropriate membership that oversees the clinical incident reporting system, ensures that it is operating effectively, and that more serious incidents have been managed and closed in a timely fashion. The group should meet on a regular basis.
Regions may choose to use staff employed within their Regional Vaccine Operations Centre (RVOC) and/or Clinical Advice & Response Service (CARS) to fulfil these roles, as appropriate to local circumstances. Responsibilities must be clearly defined.
3.4 National Vaccine Programme
The National Covid-19 Vaccination Programme Clinical Workstream is responsible for oversight of the programme, liaison and coordination with other national bodies and DHSC, and for ensuring that national policies and guidance are reflected across the programme. It is not responsible for overseeing the safety of the vaccines themselves.
The Clinical Workstream within the national team responds directly to enquiries about clinical matters and to incidents that are identified as being critical or significant risk as described in detail in this SOP. Such enquiries and incidents should be escalated by RVOCs as soon as possible (and at least on the same day) to NVOC by email at firstname.lastname@example.org. NVOC will then triage and forward issues to the relevant member of the workstream.
The Clinical Workstream will liaise with regional teams and with UKHSA, MHRA, other subject matter specialists and key stakeholders to obtain further information as needed. Responses will be copied to and logged by NVOC. If required, significant incidents will be escalated to the Strategic Incident Director of the Day (SIDD).
The Clinical Risk and Safety Group (CRSG) within the Clinical Workstream meets monthly. It is responsible for overseeing the clinical safety of the vaccination programme in England by reviewing and quantifying clinical risks, identifying who is responsible for managing them, ensuring that actions are taken to clarify and/or mitigate them, and monitoring progress to reduce risks to an acceptable level. CRSG is not responsible for managing clinical incidents but it does take an overview of incidents reported to the programme, those submitted to the NRLS, themes identified by the Customer Contact Centre, and issues raised by Regions, MHRA, UKHSA and other stakeholders.
CRSG reports to the national programme Clinical Reference Committee that in turn reports to Programme Board. The national programme Assurance Committee is responsible for ensuring that all parts of the vaccination programme fulfil their responsibilities.
4. Classification of adverse incidents
All clinical incidents should be categorised into one of four categories as indicated below.
5. Managing adverse clinical incidents
5.1 Local management
Sites must have a systematic approach to recording, managing and tracking adverse clinical incidents. Larger organisations typically use a Local Risk Management System (LRMS) such as Datix or Ulysses. In the absence of an LRMS, sites should have an equivalent process that provides a clear audit trail and accountability for clinical risk management.
Unexpected poor outcomes potentially linked to COVID-19 vaccination may be identified days or weeks after vaccination, including when someone presents at another NHS organisation or service, such as an acute Trust or GP practice. In these circumstances, the organisation or service providing care should report the incident as set out below and discuss the case with their lead commissioners. If the person has not been in contact with other services since vaccination, the commissioner is responsible for ensuring that these reporting requirements are met.
The initial review and, if needed, any subsequent investigation should be led by the organisation that delivered the vaccine, in line with the Serious Incident Framework, 2015 (SIF) or its successor, and the insights shared with all relevant stakeholders. The relevant commissioner may be required to coordinate activity including reporting the incident on StEIS and working with relevant providers to ensure that Duty of Candour requirements are satisfied.
Given the nature of vaccination processes, there may be limited information about an individual’s care, so the review should seek to ensure that the delivery of the programme is meeting expected standards, and to identify any areas for improvement at a local, regional or national level which will then need to be shared.
If an incident has been reported on StEIS but no further investigation is needed, it can be removed from StEIS through the de-escalation process. A record of the rationale for de-escalation and the decision-making process should be retained by the reporting organisation.
In the unlikely event that another aspect of the individual’s care or treatment in the reporting organisation is also the subject of an SI investigation, the organisation and commissioner should work together to produce one single investigation report, incorporating details of both the SI investigation and vaccination pathway review wherever this is possible and appropriate.
All sites delivering vaccines must have a systematic approach to recording, managing and tracking adverse clinical incidents. Vaccination related clinical incidents must be routinely shared as follows:
- SVOC and Regions: all incidents must be shared with the local SVOC on a regular and timely basis. Sites and SVOCs should provide weekly summaries of all incidents to their Region using the template in Appendix 4.
- National Reporting & Learning System (NRLS): Local risk management systems (LRMS) such as Ulysses and Datix automatically upload details of all adverse clinical incidents to the NRLS. In the absence of an LRMS, staff/sites must complete the NRLS “Learn From Patient Safety Events” (LFPSE) form. When submitting a report, the free text description of the incident should be started with the term “COVIDVACC” to enable it to be easily identified.
Covid vaccination related incidents are forwarded from NRLS to the national Clinical Workstream on a weekly basis for further analysis and presented to the monthly Clinical Risk and Safety Group (CRSG).
- Strategic Executive Information System (StEIS): All incidents considered to meet the threshold for Serious Incidents should be reported to the StEIS or its successor. Where an individual has died in the care of an organisation in which a Medical Examiner Service is available, the death should also be reviewed through this process and appropriate follow up undertaken.
- MHRA: Use the Yellow Card scheme to report any actual or suspected adverse reaction to Covid-19 vaccines or incidents relating to defective vaccines or vaccine delivery devices eg: syringes. If an error in vaccine administration has occurred which led to a reaction, reporting can be done via NRLS or Yellow Card. It is not necessary to report via both routes. If the reaction is minor and a known side effect, no other action is needed.
- UKHSA: Regional CARS teams will inform and/or request advice from the National Immunisation Team at UKHSA for significant incidents eg: deaths and other serious adverse events, cold chain incidents where more than 500 doses of vaccine need to be discarded, incidents involving large numbers of people and other incidents likely to create media interest.
- HSE, CQC: Depending on the nature and severity of the incident, other existing reporting obligations may apply, eg: Health and Safety Executive, CQC etc.
Actual or potential incidents should be notified to the local SVOC which will agree with the reporting site whether to escalate further, as described below.
The following categories of incidents must be escalated by Regional teams via email to the National Programme team (email address: email@example.com) as soon as possible, and not more than 24 hours after an incident occurs:
- Incidents leading to actual or potential reputational damage to the programme, likely to significantly affect public confidence eg:
- Significant adverse reactions not currently known to be a side-effect to a Covid vaccine.
- Adverse reaction / allergy where the person affected was known to be allergic to the vaccine/component.
- Deaths that occur at a vaccination site (these must also be reported to the Care Quality Commission)
- Patient death(s) that may be related to the vaccine if the underlying cause is not already recognised by MHRA as a possible side-effect of the vaccine used (a Yellow Card must always be completed for any death that may be related to vaccination)
- Significant incidents or risks where staff or volunteers were undertaking roles outside their competency or qualifications.
- Operational issues with clinical cause or impact eg:
- Significant or new concerns regarding potential defective vaccine(s) or products
- Incidents which may impact the ability of the affected site to continue operating
- Any other incident considered to have a significant or critical impact on the public, staff or the programme including incidents with clinical implications that involve actual or potential fraud.
After risk assessment by local teams, the MHRA should be notified immediately if an adverse event, suspected vaccine-induced Adverse Drug Reaction (ADR) or a programmatic error occurs that:
- Is serious and requires rapid response (if not, report suspected ADRs via Yellow Card)
- Relates to a suspected batch/quality issue
- Relates to admin errors that could be mitigated by regulatory action (eg: labelling, packaging, communications)
- Is a programmatic event, such as a local cluster/mass psychogenic episode
- May generate local concern/ media attention around a safety issue
If unsure, the local Screening and Immunisation team should contact UKHSA and MHRA for guidance.
Limited and Moderate Severity incidents don’t usually need escalation. These should be shared with the national team as a Summary Report on a weekly basis.
However, certain types of Moderate Severity incidents should be escalated:
- Any incident associated with a newly introduced vaccine (within first 6 weeks of deployment) or with recent changes in, or extension of, the vaccine programme
- Any incident that is likely to lead to a change to national policy or where there is a need to share lessons widely across the system.
This reporting mechanism is not intended to undermine local and regional responsibilities for managing incidents. Its purpose is to quickly gain national situational awareness of an incident and to provide timely support when needed.
6. Escalation pathways
6.1 Critical and significant clinical incidents
The escalation pathway is described below and summarised in the flow chart (full size version in Appendix 2).
Regional colleagues should agree in advance which types of incidents need to be escalated to them from sites/SVOC, in line with the categorisation of incidents described earlier.
Decisions to escalate an incident to NVOC should be made and actioned at Region level by the Regional Vaccination Operations Centre (RVOC) and/or CARS and sent via email to firstname.lastname@example.org. They must allocate a unique reference number to the report and this should be quoted in all subsequent correspondence. If MHRA and/or UKHSA have already been notified, the relevant reference numbers should also be included.
Incidents should not be escalated to multiple organisations simultaneously to avoid:
- The incident being investigated by different groups simultaneously with the risk that inconsistent advice is provided.
- The incident being double-counted, leading to confusion as to whether it has been managed and closed, or remains open.
If an incident needs an urgent response, the subject line must begin “URGENT – ACTION REQUIRED”.
Escalations should be sent directly to NVOC by RVOC. which logs and records them via the national EPRR tasking system. NVOC will identify clinical incidents and notify the NHS England Clinical Workstream accordingly.
6.2 Incidents affecting product viability (including cold chain failures)
Incidents which compromise vaccine viability include temperature excursions due to site errors or power failures, incorrect storage or handling during transport and incorrect storage or vials being dropped on site. Sites, Systems and Regions are responsible for minimising vaccine waste and must review wastage data to investigate and identify improvements that can be made to reduce this wherever possible.
For these types of incidents, the UKHSA Vaccine Incident Guidance: Responding to errors in vaccine storage, handling and administration should be followed (summarised in flow chart below and in Appendix 3):
- Vaccines should be quarantined, whilst maintaining correct storage conditions, and must not be disposed of until the incident has been discussed with the Region. The following information should be provided:
- Vaccine type
- Batch number
- Number of vials affected
- Temperature logs (if relevant)
- Expiry date (fridge and frozen)
- Transport time where known, especially if in relation to provision of mutual aid
- Current condition and location of vaccine
- Region will liaise with the Regional Pharmacy Teams and/or Regional Quality Assurance Pharmacists for support.
- Regional Pharmacy and QA Pharmacy teams, where appropriate, will contact the manufacturer for specific advice about their products.
- Region will inform the System and Site of the outcome of the review:
- If the vaccine is deemed suitable for use (including off-label), the affected vials can be removed from quarantine. It must remain clear which vials were impacted by a storage breach as further breaches may render the product unviable – affected vials should therefore be labelled as per UKHSA Vaccine Incident Guidance.
- If the vaccine is deemed unviable, the site must dispose of the affected vials using either the Trust’s waste management procedure or the Specialist Pharmacy Service’s ‘Disposing of damaged, unused or expired COVID-19 Vaccine’ procedures). The Site team must record the waste on Foundry (Stock Site Manager) so that the stock record remains accurate.
Although authorisation to dispose of non-viable vials of vaccine is the responsibility of Regions and their Regional Pharmacy colleagues, if more than 1000 vaccine doses need to be destroyed, the Region must escalate to NVOC via email@example.com on the same day for information.
If the incident involves any quantity of vaccine inappropriately stored or transported by wholesalers or delivery teams, escalate to NVOC to inform EECL (Supplies Team: Estates, Equipment, Consumables and Logistics).
The above process can take significant amounts of time. If this is likely to affect the ability to continue running a clinic, sites should liaise with local system colleagues to identify alternative vaccine supplies.
Regions must include details of all incidents relating to wasted vaccines via the weekly summary report (as detailed in Section 6.3). Information should include the type of vaccine, the number of vials wasted, the root cause of the incident and mitigating actions.
Questions regarding whether to revaccinate people who have received doses of expired vaccines should be directed to the Regional CARS team who may escalate to UKHSA.
6.3 Moderate and limited severity incidents
Regions must send summary reports of moderate and limited severity incidents to NVOC by Close of Play each Wednesday including details of all incidents from the preceding Monday to Sunday using the template in Appendix 4 and available here. The reports should indicate clearly whether the cases are being managed and closed regionally, whether they have already been escalated to NVOC, and whether this was “For Information”, “Being Managed” or “For Action”.
The Clinical Workstream routinely and regularly reviews summary reports to identify any trends or themes that require further attention.
6.4 Information needed
When escalating an Incident, please make it clear that it is not an Enquiry. You must include the following information in your initial report:
1. Incident details (only one incident per report, otherwise each incident is difficult to track):
- Reference number. If MHRA/UKHSA already notified of the incident, include their reference numbers as well.
- Reporter name and contact details
- Time and date
- Sufficient information about the events that caused the incident (bullet form is fine) plus any actions taken. This helps NOVC/Clinical Workstream assess severity, significance and what additional actions are needed.
2. Severity and Priority: cases must be graded as Critical (Red), Significant (Orange), Moderate (Yellow) or Limited severity (Green) and escalated accordingly as summarised earlier and in Appendices 1 and 2 (Limited and Moderate Severity incidents don’t usually need escalation nationally).
3. Purpose: Indicate clearly whether the escalation is “For Information”; “Being Managed” by Regional or System teams; or “For Action”. If it is not clear whether you need the national team to take action rather than them just being kept informed, then veer on the side of caution and label the escalation as “For action”. If an urgent response is needed, the subject line must begin “URGENT – ACTION REQUIRED”.
7. Summary of reporting requirements
Regions are asked to provide the following reports to the national team:
- Same day: Critical & Significant severity incidents via SPOC/NOVC to the national Clinical Workstream as described in this SOP.
- Weekly: Summary of Moderate and Low severity incidents to NVOC using the reporting proforma in Appendix 4.
- Monthly: Regional report of key risks, safety issues and significant incident reports & themes to the national Clinical Risk & Safety Group
Clinical incidents do not need to be reported via daily SitReps or other routes.