DCB0160 Clinical Safety Case Report addendum template
Executive summary
This document summarises the evidence regarding the DCB0129 and DCB0160 clinical safety and documentation compliance for the Concentric digital consent application, as considered by [Healthcare organisation]. The information provided is in addition to Concentric Health’s clinical safety case report.
Overview and intended use
Concentric is a digital consent to treatment web application for managing the preparation and sharing of consent information, and the documentation of consent for treatment. This includes consent for any treatment where written consent is considered best practice, including operations, procedures, and medical treatments.
All consent form scenarios are managed within Concentric:
- Patient agreement to investigation or treatment (AKA consent form 1 and consent form 3)
- Parental (or person with parental responsibility) agreement to investigation or treatment for a child or young person (AKA consent form 2)
- Treatment in best interests for an adult who lacks the capacity to consent to investigation or treatment (AKA consent form 4)
Procedures and responsibilities
- Prior to deployment into a live clinical environment a clinical safety hazard log and clinical safety case report addendum (this document) will be prepared and approved by [Healthcare organisation]‘s clinical safety officer.
- Annual review of [Healthcare organisation]‘s Concentric clinical safety hazard log and clinical safety case report addendum is undertaken, including review of any updates to Concentric Health’s own clinical safety hazard log and clinical safety case report.
Documentation
This clinical safety case report (CSCR) addendum sits within [Healthcare 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:
Maintained documentation
Following review of the documentation provided by Concentric Health a clinical safety hazard log (CSHL) for the use of Concentric is maintained locally. This includes consideration of local factors, details any local controls in place to mitigate clinical safety risk, and includes an assessment of residual risk.
During live use of the product, the CSHL will be updated to reflect new hazards when identified. Any updates will also be replicated in this DCB0160 clinical safety case report addendum.
A clinical safety incident log is maintained by [Healthcare organisation] and procedures are in place to ensure the appropriate collection of information in recording an incident. Procedures are in place to notify Concentric Health in the case of a clinical safety incident.
Clinical safety analysis
This section describes the people involved in clinical safety analysis, the methodology followed, and the evaluated safety profile.
Team and competency
Clinical safety activities relating to Concentric are led by [Healthcare Organisation’s CSO], a registered clinician and trained Clinical Safety Officer (CSO). In addition to the CSO, clinical safety activities involve a multidisciplinary team (MDT) who all understand the product and how it is used in the clinical setting.
Methodology
Clinical safety hazard analysis is undertaken at least annually by the MDT to identify new hazards and re-evaluate known hazards, consider causes and existing controls, and identify any controls that should be introduced.
The output from the hazard analysis is documented in [Healthcare organisation]‘s Concentric CSHL and can be viewed here (deploying organisation to add link, modified from Concentric’s CSHL, including an evaluation of the clinical safety risk of each hazard based on the hazard’s severity and likelihood of patient harm given the presence of existing controls. The risk matrix used is shown within the ‘Risk Matrix’ tab of the CSHL.
Clinical safety hazard profile
The following is a summary of the detail within the CSHL.
| Clinical risk category | Number of hazards |
|---|---|
| Very high | 0 |
| High | 0 |
| Significant | 0 |
| Moderate | 6 |
| Low | 9 |
Hazards:
Usual Concentric digital consent process is not possible due to technical or device unavailability.
- Consent documentation is attached to a different patient record in error.
- Concentric provides incorrect clinical information to patient.
External to Concentric signposted resources may contain incorrect information or not be relevant to the individual.
- External to Concentric signposted resources may not be available.
- Information presented is difficult for a patient to access, engage with, or understand.
- Local unauthorised user gains access to Concentric.
Communication to the patient is accessed by a different individual to the intended recipient.
- Incorrect clinician is associated with a change or consultation.
(If no patient demographics integration) Incorrect patient demographics are entered for a patient.
Clinician chooses to use paper consent process outside of Business Continuity Plan scenario.
- Unauthorised user gains access to Concentric via cyber attack.
- Communication to the patient is not successfully received.
(If no document integration) Completed consent documentation is not visible within the main electronic health record / document management system.
- A theatre list takes place with consent forms in a mix of locations
All hazards are deemed to be acceptable (risk: low) or tolerable (risk: medium) and therefore no further mitigation is required at this time.
Local hazard mitigations
Within [Healthcare organisation]‘s CSHL there are a number of mitigations that are the responsibility of [Healthcare organisation] to implement. These local mitigations are summarised below:
[This is a filtered view of DCB0160 controls from the Concentric hazard log. This can be used to populate this section.]
Conclusion
This clinical safety case report outlines the evidence that the Concentric digital consent application is appropriate for clinical use as per the outlined intended use at [Healthcare organisation], and is compliant with the DCB0129 and DCB0160 standards.