Framework for reporting, monitoring and escalating adverse events in the COVID-19 immunisation programme

Scottish Flu Vaccine and COVID-19 Vaccine (FVCV) programme (vaccine safety workstream)

Publication date: 14 December 2020

Version 1.3

19

Version history

Version

Date

Summary of changes

1.3

14/12/20

Re-formatted for publication using PHS template

ContentsBackground4Accountability and responsibility5Defining adverse events and when to report6Current reporting systems6Requirements of a system to escalate clinical and programmatic adverse events that arise in the COVID immunisation programme7Proposed operational procedure for reporting and escalation of clinical and programmatic adverse events7Algorithm7The role of the immunisation coordinator7PHS responsibilities and governance structure8Qpulse, MACRO and other web-based, hosted tools8The framework in different vaccine delivery settings9Appendix 1 - Reporting adverse events from board-level to national level11HIS risk categorisation of adverse events11Appendix 2 – examples of clinical and programmatic adverse events that could occur during the COVID-19 immunisation programme and those that would require immediate reporting from board to national-level15Appendix 3 – additional background on extant reporting systems17Datix17Healthcare Improvement Scotland national notification system17Care Inspectorate reporting platform18Yellow card scheme/MHRA18Health Facilities Scotland - Incident Reporting and Investigation Centre (IRIC)19COVID-19 Vaccine Waste Reporting19

Background

Vaccines rarely cause serious adverse events with most side effects being minor and self-limiting or coincidental to vaccination (WHO Vaccine Safety basics, e-learning). This said, monitoring vaccine safety by looking for adverse events that occur following immunisation is a crucial part the COVID-19 immunisation programme as it will highlight and inform any areas requiring further investigation and potential action, and will help sustain public confidence in the immunisation programme. 

Adverse events are broadly categorised as (a) clinical adverse events, e.g. anaphylaxis, breathing difficulties, fainting etc. and (b) non-clinical programmatic adverse events which includes issues and incidents relating to the vaccinator, vaccine, vaccination technique or venue. These relate to any unintended or unexpected events that occur during delivery of the immunisation programme. They may occur immediately before, at the point of vaccination or post-vaccination, or in some instances programmatic adverse events may occur pre-vaccination e.g. an accident when preparing the venue/clinic.

Monitoring adverse events is important as it could highlight an issue that risks the lives or health of the population or an issue that risks the reputation of the immunisation programme, NHS boards or national bodies. This should then trigger a proportionate escalation process to investigate, manage or mitigate a situation, where appropriate and disseminate lessons learned.

There are a number of systems currently in place for monitoring adverse events and these will continue to operate and be utilised where appropriate to add epidemiological intelligence on vaccine safety (e.g. yellow card scheme, local board reporting through Datix, analysis of hospital admissions data (SMR01)). However, there is an opportunity to gather further intelligence and learn early lessons on vaccine safety with the introduction of a tailored monitoring framework that will capture both clinical and programmatic adverse events of interest. Data trends will be interpreted and support clinical governance decision-making. This operational process will also enable the rapid escalation of significant adverse events if required.

This paper proposes an operation process that would allow for reporting and escalation of significant clinical and programmatic adverse events, therefore enabling surveillance and management of these events. This process is intended for use in all vaccine delivery settings established within the health boards, e.g. care homes, GPs, walk through and drive through clinics, pharmacies, and others.

The development of this framework is a key milestone and deliverable in the Vaccine Safety Charter. The final draft of the framework has been developing following extensive consultation with key colleagues working in and relating to Vaccine Safety, Healthcare Improvement Scotland, the Care Inspectorate, Scottish Social Services Council, Scottish National Blood Transfusion Service, Risk Leads in LHBs as referred by colleagues in Healthcare Improvement Scotland, Immunisation Coordinators and members of the Scottish Immunisation Programme Group.

Accountability and responsibility

It is a matter of professional judgement whether to report or escalate an incident working within extant local NHS board procedures. Depending on significance and potential consequences, adverse events can be managed:

at clinic level, with no further action required

and/or reported to health board level (immunisation coordinator)

and/or reported to Public Health Scotland (PHS) where the event would be reviewed and where required communicated to, discussed and actions recommended by:

FVCV Programme Board and/or

Executive Group (Rapid Decisions)

Further details of this clinical governance structure are provided in the ‘Scottish Covid-19 Clinical Governance structure and process’ document and described in Figure 1.

Health and social care providers have a Duty of Candour set out in the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014. The statutory duty of openness and transparency applies to incidents where death, severe and moderate harm or prolonged psychological harm has occurred or could occur. Further information can be found on the Scottish Government website.

As well as the significant outcome for the patient, meeting Duty of Candour requirements would be the responsibility of the health board. Known complications to treatment are not normally Duty of Candour unless the consent has not been performed correctly and the incident is actually the failure to properly inform rather than the outcome, or the issues that occurred could have been avoided (if vaccinee had known contraindications). Consent is very important so individuals are aware of whatever risk (however slight) they are undertaking.

Defining adverse events and when to report

Healthcare Improvement Scotland (HIS) defines an adverse event as an event that could have caused (a near miss), or did result in, harm to people or groups of people. HIS and NHS Scotland have also developed useful categorisation of adverse events and risk matrix that are relevant here. Consideration of the risk categorisation (Appendix 1), risk matrix (Appendix 1, Table 1) and how those relate to each other (Appendix 1, Table 2) from Healthcare Improvement Scotland A national framework for Scotland, December 2019 will provide a guide of which adverse events should be reported from board-level to national level. Those that are described as moderate, major or extreme on the risk matrix and those that, after consideration are thought to be associated with the vaccination, are reportable.

Those events that are significant should be rapidly reported as per the operational procedure outlined in the algorithm (Figure 1). Events that are significant are those that broadly align with the Office of Human Research Protections (OHRP) of the Department of Health and Human Services (DHHS) definition of serious or serious suspected adverse event, e.g. Any adverse event that: results in death; is life threatening, or places the participant at immediate risk of death from the event as it occurred; requires or prolongs hospitalisation; causes persistent or significant disability or incapacity; results in congenital anomalies or birth defects; or is another condition which investigators judge to represent significant hazards. Some vaccine safety-specific examples of adverse events and significant adverse events are provided in Appendix 2.

Current reporting systems

There are a number of local and national reporting systems/frameworks for adverse events however none, in their current states, would be suitable or timely enough for collecting, monitoring and escalating clinical and programmatic adverse events occurring during the COVID-19 immunisation programme, hence the requirement for the proposed framework outlined in this document. Further details of those other reporting systems and frameworks are provided in Appendix 3.

Reporting to those other local and national reporting systems/frameworks should continue as standard and the proposed framework outlined in this document does not replace them, instead it is intended to supplement and enhance these existing processes.

Requirements of a system to escalate clinical and programmatic adverse events that arise in the COVID immunisation programme

The following are important considerations for any reporting system to identify and escalate clinical and programmatic adverse events:

The system must be timely

The system must inform the people who need to know

The system should align with existing systems if possible or duplicate other existing processes

The system must be clear and acceptable to users

The system must be able to collect the required information

The system should not be onerous or time consuming to administer

Proposed operational procedure for reporting and escalation of clinical and programmatic adverse eventsAlgorithm

Figure 1 outlines the proposed operational procedure for managing and monitoring clinical and programmatic adverse events. The purpose of this framework is for learning and prevention purposes and is not about blame or performance.

The role of the immunisation coordinator

It would be the responsibility of the board to assign a local immunisation coordinator. This named person (and deputy) will be the main contact person for clinic staff to contact if there was an adverse event that required rapid escalation. This person(s) will also be responsible for reporting events to PHS on a weekly basis using a template provided. Details of the template, reporting frequency, national phone number and email address to send template to and any other relevant instructions will be shared with the immunisation coordinators as a protocol.

The roles and responsibilities of the board Immunisation Coordinator are well defined and include the requirement to monitor and respond to adverse vaccination related events. The full definition of these roles and responsibilities currently sit with the Scottish Government vaccine transformation programme (VPT) Oversight Committee awaiting distribution to BCEs.

PHS responsibilities and governance structure

PHS will host and manage the adverse events data received from boards on a template and regularly analyse, interpret and report this intelligence to the Executive Group (Rapid Decisions), FVCV Delivery Group and Programme Board, as well as the MHRA and Scottish Government as required. PHS will also provide workforce education materials for training clinic staff and immunisations coordinators on the framework outlined in this paper. PHS will also provide a protocol and template for the immunisations coordinators reporting.

Qpulse, MACRO and other web-based, hosted tools

We have investigated a number of alternative options to an Excel template for the boards to report adverse events to PHS. There are a number of online tools available for electronic data capture that are currently used by the health service including QPulse, MACRO, ServiceNow. These have the benefits that they are quick to input, monitor, run reports, have built in validation processes which means low error rate and a visible audit trail. However, such systems come with a financial cost, require users to have licences, require time to be built, and will require buy-in from each of the boards. While we appreciate that an Excel template is not the more sophisticated approach, we will be able to build in some validation, it is free and easy to use and something boards are familiar with. These would be sent via secure NHS to PHS mailboxes as is done in other programmes. For the reasons mentioned above, and given the short timescales at present, an Excel spreadsheet template is thought to be the more feasible, user-friendly and acceptable approach to report information on adverse events in the boards to PHS. In future, we may re-assess the need and utility of an online reporting platform.

The framework in different vaccine delivery settings

There will be a variety of delivery settings for the COVID immunisation programme including walk-through and drive-through clinics, Care Homes, GP surgeries and others. This framework for reporting, monitoring and escalating adverse events is intended for use in all vaccine delivery settings established within the health boards.

In order to embed this framework firmly within the COVID-19 immunisation programme, the vaccine safety workstream has engaged with Service Delivery to ensure that the framework is included in the manual. The manual sets the requirements of the algorithm and that this should be adapted to fit the delivery setting of each health board. We have also engaged with Workforce education who are developing a range of materials for training clinic staff. This will include a poster or aid memoir for staff on adverse event reporting requirements. This can be implemented in any setting. The Care Inspectorate and SSSC have given feedback on this framework and support its use for the COVID-19 immunisation programme delivered in Care Home settings.

Figure 1 – Algorithm of operational procedure for monitoring, reporting and escalating adverse events

Appendix 1 - Reporting adverse events from board-level to national level

The question of which adverse events to escalate from board-level to national level will require consideration of the risk categorisation and risk matrix impact/consequences definitions from the Healthcare Improvement Scotland (HIS) publication Learning from adverse events through reporting and review. A national framework for Scotland, December 2019.

HIS risk categorisation of adverse events

Every event should be reviewed, but the level of review will be determined from the category of the event and other factors such as the potential for learning. The following categories should be used to group adverse events.

Category 1 – events that may have contributed to or resulted in permanent harm, for example unexpected death, intervention required to sustain life, severe financial loss (£>1m), ongoing national adverse publicity (likely to be graded as major or extreme impact on NHSScotland risk assessment matrix, or Category G, H or I on National Coordinating Council for Medical Error Reporting and Prevention (NCC MERP) index).

Category 2 – events that may have contributed to or resulted in temporary harm, for example initial or prolonged treatment, intervention or monitoring required, temporary loss of service, significant financial loss, adverse local publicity (likely to be graded as minor or moderate impact on NHSScotland risk assessment matrix, or Category E or F on NCC MERP index).

Category 3 – events that had the potential to cause harm but no harm occurred, for example near miss events (by either chance or intervention) or low impact events where an error occurred, but no harm resulted (likely to be graded as minor or negligible on NHSScotland risk matrix or Category A, B, C or D on NCC MERP index)

Table 1: Healthcare Improvement Scotland / NHS Scotland risk matrix impact and consequences definitions

Descriptor

Negligible

Minor

Moderate

Major

Extreme

Patient Experience

Reduced quality of patient experience/clinical outcome not directly related to delivery of clinical care.

Unsatisfactory patient experience/clinical outcome directly related to care provision – readily resolvable.

Unsatisfactory patient experience/clinical outcome; short term effects – expect recovery < 1 wk.

Unsatisfactory patient experience/clinical outcome; long term effects – expect recovery > 1 wk.

Unsatisfactory patient experience/clinical outcome; continued ongoing long term effects.

Objectives/

Project

Barely noticeable reduction in scope, quality or schedule.

Minor reduction in scope, quality or schedule.

Reduction in scope or quality of project; project objectives or schedule.

Significant project over-run.

Inability to meet project objectives; reputation of the organisation seriously damaged.

Injury

(physical and psychological) to patient/visitor/staff

Adverse event leading to minor injury not requiring first aid.

Minor injury or illness, first aid treatment required.

Agency reportable, e.g. Police (violent and aggressive acts).

Significant injury requiring medical treatment and/or counselling.

Major injuries/long term incapacity or disability (loss of limb) requiring medical treatment and/or counselling.

Incident leading to death or major permanent incapacity.

Complaints/Claims

Locally resolved verbal complaint.

Justified written complaint peripheral to clinical care.

Below excess claim.

Justified complaint involving lack of appropriate care.

Claim above excess level.

Multiple justified complaints.

Multiple claims or single major claim.

Complex justified complaint.

Service/Business Interruption

Interruption in a service which does not impact on the delivery of patient care or the ability to continue to provide service.

Short term disruption to service with minor impact on patient care.

Some disruption in service with unacceptable impact on patient care.

Temporary loss of ability to provide service.

Sustained loss of service which has serious impact on delivery of patient care resulting in major contingency plans being invoked.

Permanent loss of core service or facility.

Disruption to facility leading to significant “knock on” effect.

Staffing and Competence

Short term low staffing level temporarily reduces service quality (< 1 day).

Short term low staffing level (>1 day), where there is no disruption to patient care.

Ongoing low staffing level reduces service quality.

Minor error due to ineffective training/implementation of training.

Late delivery of key objectives/service due to lack of staff.

Moderate error due to ineffective training/implementation of training. Ongoing problems with staffing levels.

Uncertain delivery of key objectives/service due to lack of staff.

Major error due to ineffective training/implementation of training.

Non-delivery of key objectives/service due to lack of staff.

Loss of key staff.

Critical error due to ineffective training/implementation of training.

Financial (including damage/loss/fraud)

Negligible organisational/personal financial loss. (£<1k)

(NB. Please adjust for context)

Minor organisational/personal financial loss (£1>10k).

Significant organisational/personal financial loss (£10-100k).

Major organisational/personal financial loss (£100k-1m).

Severe organisational/personal financial loss (£>1m).

Inspection/Audit

Small number of recommendations which focus on minor quality improvement issues.

Recommendations made which can be addressed by low level of management action.

Challenging recommendations that can be addressed with appropriate action plan.

Enforcement action.

Low rating.

Critical report.

Prosecution.

Zero rating.

Severely critical report.

Adverse Publicity/Reputation

Rumours, no media coverage.

Little effect on staff morale.

Local media coverage – short term. Some public embarrassment. Minor effect on staff morale/public attitudes.

Local media – long term adverse publicity.

Significant effect on staff morale and public perception of the organisation.

National media/adverse publicity, less than 3 days.

Public confidence in the organisation undermined.

Use of services affected.

National/international media/adverse publicity, more than 3 days.

MSP/MP concern (Questions in Parliament).

Court Enforcement.

Public Inquiry/FAI.

In general, the risk matrix (Table 1) should align to the categories as described below.

Table 2: Aligning the categories and matrix

Risk Category

Category 3

Category 2

Category 1

Matrix

Negligible

Minor

Moderate

Major

Extreme

Reportable events

Not-reportable

Reportable

Note: We are aware that some boards grade the patient outcome of their adverse event using the Risk Matrix and call these severity levels with 5 being extreme and 1 being negligible, therefore the significant end would be described as severity 3 – 5. Other boards use the Category levels and would describe significant as upper Category 2 and all of Category 1. In addition, some boards have created topic specific descriptions to align with the injury matrix definitions. For example, falls: Extreme would be death, Major would be long bone fracture or severe head injury requiring surgery, moderate would be small fracture (finger/toe), sprains, lacerations, minor requiring just first aid (skin plaster), negligible would be no injury/ slight bruise etc.

Appendix 2 – examples of clinical and programmatic adverse events that could occur during the COVID-19 immunisation programme and those that would require immediate reporting from board to national-level

Adverse event level

Adverse event group 

Examples of adverse events that may occur during the COVID-19 immunisation programme (not exhaustive)

Examples of events requiring immediate escalation (not exhaustive)

Clinical

Clinical symptoms experienced by the vaccinee following vaccination (either in the clinic or once they have left)

Anaphylaxis, Dizziness, Fainting, Excessive bleeding, Rash, Seizure, Shortness of breath / breathing problems, Sudden elevated temperature, Swelling of tongue or throat

Hospitalisation due to symptoms

Multiple occurrences of less severe event

Death of vaccinee

Anaphylaxis

Hospitalisation of vaccinee

Significant disability or incapacity of vaccinee

Programmatic

Issues relating to the vaccination technique

Needle broken in arm

Vaccine syringe not fully emptied

Incorrect administration method

Incorrect vaccine preparation given

Repeated adverse events associated with vaccination method for specific risk groups e.g. IM method for those with bleeding disorders (the unique characteristics of the vaccine may require a specific vaccination method which may have consequences for certain clinical groups)

Programmatic

Issues relating to the vaccinator

Needle-stick injury

Dry-ice exposure (e.g. if ultra-cold storage required)

Repeated inappropriate usage of the multi-dose system by specific category of vaccinators

Programmatic

Issues related to the vaccine

Administration of wrong vaccine

Breakage of vaccine vial

Use of expired vaccine

Vaccine stored at inappropriate temperatures

Cold chain failure

Programmatic

Issues related to the venue, setting or delivery model

Inability to social distance at venue before, during or after vaccination (post vaccination-observation period) - e.g. too small, unsuitable for adverse weather, or groups/queues forming)

Accidents – either for ambulatory vaccines/vaccinators (e.g. trip hazard) or car accident (drive through setting)

Inappropriate invitation sent out

Accidents – either for ambulatory vaccines/vaccinators (e.g. trip hazard) or car accident (drive through setting)

Programmatic

Any other events or issues not mentioned

Appendix 3 – additional background on extant reporting systemsDatix

Currently, all boards (excluding independent GP practices, community pharmacies, etc.) are required to report a wide range of adverse events and near misses and most (all but one board) use the Datix incident management tool for this purpose. Adverse events are generally reported in the local Datix systems within 24 hours of the event. Statistical reports can easily be extracted from the system and exported to e.g. Excel, but all coding for adverse events across Scotland is done locally thus comparisons between boards are difficult.

This lack of consistency in adverse event coding has been a known issue for many years and is currently being looked at by NHS Healthcare Improvement Scotland (HIS). If relying on reporting via Datix, where there is a serious adverse event, clinical or programmatic, the delay in this information being escalated to board-, PHS- and/or SG-level, would potentially be too long. Potential consequences of this delay could be that an opportunity to mitigate an ongoing issue in the population, or negative media attention is missed.

So, while we cannot replace or cut across this existing reporting structure (i.e. reporting via Datix), we are not content that for the more severe adverse events, that it would be suitable for timely management and response.

Healthcare Improvement Scotland national notification system

From 1 January 2020, all significant adverse event reviews commissioned by the NHS boards for a category 1 adverse event should be reported monthly to HIS in alignment with the new national notification system. As these events are based on board-specific Datix codes that are largely not comparable, the monthly report is not currently in a sharable format.

This proposed framework and operating procedure aligns with HIS document National Framework for Scotland - Learning from adverse events through reporting and review.

Care Inspectorate reporting platform

The Care Inspectorate require that all registered care services (except childminding) must notify of any accident (any unforeseen events resulting in harm or injury to a person using the service including a GP visit, a visit or admission to hospital, an injury reportable under Reporting of Injuries, Diseases and Dangerous Occurrences Regulations 1995 (RIDDOR)); or incident (a serious unplanned event that had the potential to cause harm or loss, physical, financial or material) via an ePlatform.

These should be made within 24 hours but there is significant variability in this reporting time between facilities, and in addition, there is also variation regarding which accidents and incidents are reported.

We do not intend to replace this existing reporting structure but do not think that it would be suitable for timely management and response.

Yellow card scheme/MHRA

The Yellow Card scheme is the UK system for collecting and monitoring information on suspected safety concerns or incidents involving medicines and medical devices. The MHRA run the scheme and it currently relies on voluntary reporting of suspected adverse events by health professionals and patients.

The purpose of the scheme is to provide an early warning that the safety of a product may require further investigation. This system will continue to operate as per usual during the COVID immunisation programme and PHS will receive weekly summary reports that will add to the intelligence on adverse events gathered via other routes (e.g. analysis of national data sets, point of vaccination app, framework for collection and monitoring of adverse events).

If in the event of a serious event requiring immediate escalation, again we are not content that the yellow card scheme would provide detailed and timely information for prompt management and response. In addition, since this scheme is voluntary, it cannot be assured that we will capture information on all adverse events of interest.

Health Facilities Scotland - Incident Reporting and Investigation Centre (IRIC)

This is a specialist safety and risk management unit dealing with:

medical devices (e.g. syringes, needles, surgical instruments, defibrillators, physiological monitors, imaging and radiotherapy equipment, active and passive implants, orthoses and prostheses, hospital and community beds, mattresses and overlays, hoists and slings, wheelchairs, walking aids, urine and blood test kits, IUDs, condoms, autoclaves, etc.)

estates & facilities (electrical installations, water supplies, wash hand basins, mixer taps, showers, waste systems, fire detection and protection, lighting, operating lamps, medical gas pipeline systems, windows, points of ligature, laundries, catering equipment, etc.)

social care equipment (shower chairs, commodes, bath boards, bed leavers, gripping aids, rise and recliner chairs, vari-tables, perch stools, swivel-bathers, stair lifts, etc.).

Any adverse incident involving medical devices, social care and facilities equipment should be reported to the IRIC via a reporting webform (Q-Pulse) or by emailing a completed PDF within 24hours.

Adverse events due to syringes and needles will be relevant and data from the IRIC could add important intelligence to the COVID immunisation programme.

COVID-19 Vaccine Waste Reporting

A specific objective given to the Flu Vaccination Covid-19 Vaccine Storage, Cold-Chain and Distribution working group was to “ensure there is a process in place for monitoring of cold-chain failures within the supply chain”. There is currently no established national system for the recording of incidents that lead to wasted vaccines and this working group is therefore considering an online system to support reporting of vaccine wastage.

There are a range of reasons why vaccines may be wasted, for example temperature excursions or mismatches between stock taken out of the freezer/fridge and planned sessions (vaccines have limited stability outside of the cold chain).

The framework for reporting and escalating programmatic adverse events as proposed in this document also includes cold-chain failures but rather than wanting to capture all cold-chain issues and their impact on services delivery and logistics; instead this framework is concerned with capturing information on cold-chain failures where individuals have been or have potentially been vaccinated with an inappropriately stored vaccine. This would still require rapid escalation via our framework.