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 clincial 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:

• Clinical safety case report
• Clinical safety hazard log

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, cinical 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.

Local hazard mitigations

Within [Healthcare organisation]‘s CSHL there are a number of mitigations that are the the responsibility of [Healthcare organisation] to implement. These local mitigations are summarised below:

Hazard: Usual Concentric digital consent process is not possible due to technical or device unavailability

Cause: Concentric cloud deployment is down

• A paper consent fallback process is in place to ensure that care is not delayed due to the Concentric cloud deployment being down.

If demographics integration:

Cause: Integration between Concentric and the healthcare organisation’s patient demographics is down or not functioning properly

• (If using Concentric connector for demographics integration) We run more than 1 Concentric connector running for demographics to ensure redundancy. The connectors will then automatically failover where there is an issue with a connection.
• We have a Business Continuity Plan in place for the circumstance that the demographics integration is down.

If document integration and that integration is used as part of routine operations (in document management system (EDMS) or electronic health record (EHR):

Cause: Integration between Concentric and the healthcare organisation’s document management system is down or not functioning properly

• (If using Concentric connector for document integration) We run more than 1 Concentric connector running for demographics to ensure redundancy. The connectors will then automatically failover where there is an issue with a connection.
• We have a Business Continuity Plan in place for the circumstance that the demographics integration is down
• (If there are elements of document integration that are beyond Concentric’s visibility) There is appropriate monitoring and alerting on any processes that are outside Concentric’s visibility on the path from Concentric to EHR/EDMS.

If single sign-on / active directory integration:

Cause: The healthcare organisation’s single sign-on (active directory) provider is down or not functioning properly

• We have a Business Continuity Plan in place for the circumstance that the single sign-on provider is down.

If clinicians are not allowed to use own devices as part of normal operations:

Cause: Deploying organisation network internet connection / WiFi becomes unavailable

• We have a Business Continuity Plan in place for the circumstance that the network internet connection / WiFi becomes unavailable. System is available on the public internet (4G etc) so can be accessed despite deploying organisation’s network / WIFI being unavailable on the device.

If clinicians are not allowed to use own devices as part of normal operations:

Cause: Assigned devices are not available

• We have a Business Continuity Plan in place for the circumstance that no assigned devices are available. System is available on any device - mobile / tablet / desktop - and therefore an assigned device does not have to be used.

Hazard: Concentric provides incorrect clinical information to patient

Cause: Concentric content templates are of poor quality or incomplete, and do not represent best practice

• We have documented in our consent policy the organisation’s approach to the use of Concentric content templates, any requirement for local validation, the process for requesting template updates, and clinician responsibilities.

Cause: Clinician does not modify the Concentric content template appropriately for the individual patient

• We will provide training and onboarding information to clinical staff on the appropriate use of the platform, reminding individuals that they maintain clinical responsibility for the consent interaction and the appropriateness of consent information being documented and shared.
• We will document in our consent policy the organisation’s approach to the use of Concentric content templates, any requirement for local validation, the process for requesting template updates, and clinician responsibilities.

Hazard: External to Concentric signposted resources may contain incorrect information or not be relevant to the individual

Cause: Signposted resources may be from sources that are non-reputable or are out of date and no longer represents best practice.

• We have considered and implemented the exclusion of signposted resources sources we wish to exclude.

Cause: Inappropriate signposted resources may be selected to be shared, by the clinician, in error

• Signposted resources selected for sharing are presented within the clinician view prior to sharing with the patient, and can be edited and removed prior to sending. We have ensure that training and onboarding information includes the importance of ensuring the appropriateness of consent information being shared for the individual.

If Concentric is being used to host local resources:

Cause: Out of date information may be shared with patient if Concentric is not informed of a new version of the local resource

• We have a process in place to inform Concentric of any updates to local resources so that the latest version can be shared.

Hazard: Information presented is difficult for a patient to access, engage with, or understand

Cause: Language presented is not appropriate for a lay audience

• Information provided within Concentric should be consistent with, and supplementary to a consent conversation between clinician and patient. We will ensure that training and onboarding includes the importance of having a consent conversation with the patient and that sharing Concentric information must not be seen as a replacement for a consent conversation.

Cause: Patient may not have access to a device with the capability of accessing the Concentric patient application, or may not have the the technical skills required to do so

• All information shared within Concentric can be printed and shared with the patient by the clinician. The documentation of consent being given remains digital, with the patient completing an electronic signature on the clinician’s device. We will ensure that clinician training and onboarding includes the importance of sharing printed consent information with patients when digital access is not possible.

Cause: By default information is presented to patients in English, which may not be a language that the patient can read

• We will ensure that training and onboarding includes the importance of using professional interpretation services to facilitate the consent conversation (i.e translated Concentric information can be used alongside, but should not be used instead of an interpreter).

Hazard: Local unauthorised user gains access to Concentric

Cause: Clinician leaves Concentric logged in and another individual is able to use the system despite not having their own credentials

• We will ensure that training and onboarding includes the importance of logging out following clinical use.

Cause: Clinician shares access credentials with another individual inappropriately

• We will provide advice to clinicians stating that access credentials are not to be shared, and to remind users that all interactions are associated with their name and therefore clinical practice registration.

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

Cause: Contact details within Concentric - via integration or manual entry by patient or clinician - are incorrect

• (If contact details auto-populated via demographics integration) We will ensure there is an appropriate data validation process in place for contact details that can be pre-populated via integration.
• We will ensure that training and onboarding includes the importance of ensuring accurate data entry for any manual entry of patient contact details.

Hazard: Incorrect clinician is associated with a change or consultation

Cause: Clinician does not log out and session is continued by a different individual

• We will ensure that training and onboarding includes the importance of logging out following clinical use.

Cause: The clinician creating the consent episode assigns incorrect responsible clinician or inappropriately assigns themself as the responsible clinician

• We will ensure training and onboarding covers what a responsible clinician is, and the importance of assigning the correct responsible clinician.

If no patient demographics integration:

Hazard: Incorrect patient demographics are entered for a patient

Cause: Clinician mis-enters demographic details on creating a patient record

• We will ensure training and onboarding covers the importance of ensuring accurate entry of patient demographic details on creating a patient record.

Hazard: Clinician chooses to use paper consent process outside of Business Continuity Plan scenario

Cause: Clinician prefers to use paper consent process or is hesitant to change to digital consent process.

• We will ensure that training and onboarding includes the necessary information to support all clinicians to transition to digital consent (including video guides, test patient details etc), the required human support is offered in supporting clinicians, and the clinical safety and process efficiency importance of avoiding a mix of paper and digital consent processes is highlighted.

Hazard: Communication to the patient is not successfully received

Cause: Contact details within Concentric - via integration or manual entry by patient or clinician - are incorrect

• We will ensure there is an appropriate data validation process in place for contact details that can be pre-populated via integration.
• We will ensure that training and onboarding includes the importance of ensuring accurate data entry for any manual entry of patient contact details.

If no document integration:

Hazard: Completed consent documentation is not visible within the main electronic health record / document management system

Cause: Document integration not in place so consent documentation is only visible within Concentric.

• We will ensure there is appropriate visibility across the organisation that Concentric is being used for digital consent and that there is no integration for documents with the EHR/EDMS and that therefore consent documentation from go-live date will only be present in Concentric.

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.