DCB0160 Clinical Safety Case Report addendum template

Dafydd Loughran
by Dafydd Loughran, CEO

This is a template that can be used and amended by deploying organisation to ensure compliance with DCB0160 standards.

Document details

  • Version:
  • Date issued:
  • Author:
  • Change history:

Executive summary

This document summarises the evidence regarding the clinical safety and documentation compliance for the Concentric digital consent application, as considered by [Deploying Organisation], as laid out in DCB0129 and DCB0160 as required by the NHS Data Coordination Board. The information provided is in addition to the manufacturer’s clinical risk management system and clinical safety case report.

Documentation

This document sits within the deploying organisation’s Clinical Risk Management System, which contains further relevant clinical safety evidence, including the credentials of the named clinical safety officer and details of the organisation’s clinical risk management process.

Reviewed documentation

The following documentation provided by Concentric Health have been reviewed by the deploying organisation:

Maintained documentation

Following review of the documentation provided by Concentric Health a hazard log for the deployment of the Concentric digital consent application is maintained locally. This includes consideration of local factors and details any local controls in place to mitigate the risk as far as is possible.

During live use of the product, the hazard log will be updated to reflect new hazards when identified. Any updates will also be replicated in this document.

A clinical safety incident log is maintained by the deploying organisation and procedures are in place to ensure the appropriate collection of information in recording an incident. Procedures are in place to notify the manufacturer in the case of a clinical safety incident.

Clinical risk analysis, evaluation and control

The local clinical safety hazard log for the deployment of the Concentric digital consent application can be viewed here (deploying organisation to add link, template version available here).

Parallel processes have been followed to ensure information governance and information security best practice is in place.

Summary of hazards

The following is a summary of the remaining hazards:

Note: the risk matrix and description of consequence and likelihood categories can be found in the full hazard log

System is unavailable

  • Potential clinical impact: A clinical interaction may be delayed or a paper process is required to replace the functionality of the system. An operation may be cancelled, prior or following administration of anaesthesia.
  • Consequence: Significant
  • Likelihood: Low
  • Risk: 2

Record is attached to a different patient in error

  • Potential clinical impact: A repeat consent interaction would be required with the appropriate details. An inappropriate clinical decision may be made based on the presence of a false consent interaction for a different patient.
  • Consequence: Considerable
  • Likelihood: Very low
  • Risk: 2

System displays incorrect clinical information to clinician or patient

  • Potential clinical impact: Poor quality or incorrect clinical information may negatively impact a clinical decision, leading to an operation inappropriately being performed, or inappropriately not being performed.
  • Consequence: Minor
  • Likelihood: Low
  • Risk: 1

System does not have coverage of desired procedure

  • Potential clinical impact: A clinical interaction may be delayed as a paper consent form is found.
  • Consequence: Minor
  • Likelihood: Low
  • Risk: 1

Patient information shared may be incorrect or not relevant to the individual

  • Potential clinical impact: Poor quality or incorrect clinical information may negatively impact a clinical decision, leading to an operation inappropriately being performed, or inappropriately not being performed.
  • Consequence: Minor
  • Likelihood: Low
  • Risk: 1

External patient information shared may not be available

  • Potential clinical impact: Patient is less informed about the procedure than they otherwise would have been.
  • Consequence: Minor
  • Likelihood: Low
  • Risk: 1

Information presented is difficult for a patient to understand

  • Potential clinical impact: Patient is unable to engage appropriately in shared decision, potentially leading to an inappropriate clinical decision.
  • Consequence: Minor
  • Likelihood: Low
  • Risk: 1

User without authorisation gains access to the system

  • Potential clinical impact: Patient confidentiality is breached. False consent interactions may be created which may lead to an inappropriate clinical decision being made in future.
  • Consequence: Significant
  • Likelihood: Medium
  • Risk: 2

Communication to the patient is accessed by a different individual to the intended recipient

  • Potential clinical impact: Patient confidentiality is breached. Patient is less informed about the procedure than they otherwise would have been.
  • Consequence: Significant
  • Likelihood: Very low
  • Risk: 1

Document is not stored into healthcare organisation’s electronic health record

  • Potential clinical impact: Medical record may be incomplete with the potential of a difference in clinical decision making.
  • Consequence: Considerable
  • Likelihood: Low
  • Risk: 2

Incorrect clinician is associated with a change or consultation

  • Potential clinical impact: Audit trail for episode is incorrect, with a clinician’s medical registration linked to information not entered by themselves. Confusion for patient as information about clinician at appointment is incorrect.
  • Consequence: Significant
  • Likelihood: Medium
  • Risk: 2

Clinical risk management plan

System overview and intended use

The Concentric digital consent application is a web application that allows treatment information to be shared with patients and consent to be documented. The application’s intended is is throughout the consent pathway, from sharing of consent information in clinic and remotely, documentation of consent, and review of completed consent documentation (for example as part of a surgical safety checklist in theatre). It should be used in parallel to a meaningful consent conversation with a clinician and not in its place.

Clinical risk management procedures

  • Prior to deployment into a live clinical environment a clinical safety case report addendum (this document) will be prepared and approved by the deploying organisation’s clinical safety officer
  • Review of the clinical safety case report in light of any additional hazards identified during deployment and at least yearly (to include consideration of any new functionality added to the application since the previous review)

Clinical risk management responsibilities

  • Local hazard log approval: (add name of deploying organisation’s clinical safety officer)
  • DCB0160 clinical safety case report addendum approval: (add name of deploying organisation’s clinical safety officer)

Local hazard mitigation

Full details of local hazard mitigation can be found in the local clinical safety hazard log. The following are a summary of local controls:

Hazard: System is unavailable

  • Relevant individuals/groups are subscribed to notifications of any planned or unplanned Concentric downtime
  • Automated alerting in place for issues with demographics integration
  • Business continuity process in place to notify users and instruct regarding fallback mechanism (e.g paper consent form availability)

Hazard: Patient information shared may be incorrect or not relevant to the individual


Hazard: User without authorisation gains access to the system

  • Users are reminded; of importance of confidentiality; to log out of system when not in use; and to never share account details, as part of onboarding.