Concentric - Clinical safety hazard log


1	Concentric digital consent application
2	Clinical safety hazard log
3
4	Owner	Dr Dafydd Loughran
5	Authors	Dr Dafydd Loughran, CEO and Clinical Safety Officer Dr Edward St John, Chief Medical Officer Mr Martyn Loughran, Chief Technical Officer
6	Approver(s) required for each update	Dr Dafydd Loughran, CEO and Clinical Safety Officer
7	Version	1.7
8	Last updated	8 Apr 2025
9	Target review date	Earliest of one year from issue date or at time of significant change
10
11	Version history
12	Version	Date	Summary of changes
13	1.7	8 Apr 2025	Following a technical review, the recommendation – for organisations that run a Concentric connector – to run more than one connector was dropped (controls 1.02.02 and 1.06.02). The recommendation was in place to increase redundancy, but a multidisciplinary decision was made that, with several years of experience, the connection stability seen does not warrant the cost and complexity of running additional infrastructure.
14	1.6	13 Feb 2025	Annual review, including the following changes: - Availability SLO to 99.95% from 99.9% - Add PIF-tick reference into control 3.01.01 - Addition of control 3.01.05 regarding not replacing the need for a consent conversation between patient and clinician. - Addition of cause 3.04 regarding quality of consent episodes from blank or from custom templates. - Addition of control 7.03.04 regarding guidance for using interpreters shown in UI. - Closed cause 11.03 (When using NHSmail Single Sign On, the login flow does not display the name of the user logging in if there is already a user logged in to NHSmail in the browser) as the ‘select_account’ flow is now also used for NHSmail. - Drop ‘Template DCB0160 controls’ sheet as these are best viewed within the main hazard log so that context is not lost.
15	1.5	29 Nov 2023	Annual review. Addition of hazard Haz-17 and associated causes and controls. Addition of causes 1.07, 3.03, 5.05, 13.02, and 15.02, with associated controls. Addition of controls 8.01.03, 11.01.03, 12.01.02, 14.01.02, and 15.01.03, to existing causes7
16	1.4	16 Aug 2022	Annual review
17	1.3	17 Dec 2021	User authentication controls update
18	1.2	2 Jun 2021	Annual review
19	1.1	31 Jan 2020	Updates following pre-live MDT clinical safety review
20	1	18 Aug 2019	Initial release
21	0.1	14 Aug 2019	Initial draft


1	No.	Hazard Name	Potential Clinical Impact(s)	Cause ID	Possible Causes	Control ID	Existing Controls	Tags	Consequence	Likelihood	Risk

2	Haz-01	Usual Concentric digital consent process is not possible due to technical or device unavailability	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. The medical record within the EHR/EDMS may not be complete when reviewed in future.	1.01	Concentric cloud deployment is down.	1.01.01	Service level objective of 99.95% uptime. Near-zero downtime deployments of new application code.		Significant	Low	2
3						1.01.02	If document integration and that integration is used as part of routine operations (in document management system (EDMS) or electronic health record (EHR): Where a consent episode has been completed in Concentric, for example, following confirmation of consent, then the completed consent form PDF should be in the EHR store and can continue to be used as normal by ward and theatre teams.
4						1.01.03	The deploying organisation is advised to ensure that there is a paper consent fallback process (see example at https://concentric.health/implementation/business-continuity-plan/#paper-consent-fallback-process ) in place to ensure that care is not delayed due to the Concentric cloud deployment being down.	DCB0160
5				1.02	If demographics integration: Integration between Concentric and the healthcare organisation's patient demographics is down or not functioning properly.	1.02.01	Connection between system and critical integration services are monitored in real-time. Alert sent to Concentric support team in the event of loss of connection.
6				1.02		1.02.03	The deploying organisation is advised to have a Business Continuity Plan in place for the circumstance that the demographics integration is down (see example at https://concentric.health/implementation/business-continuity-plan/#demographic-integration-down ).	DCB0160
7				1.06	If document integration and that integration is used as part of routine operations (in document management system (EDMS) or electronic health record (EHR): Integration between Concentric and the healthcare organisation's document management system is down or not functioning properly.	1.06.01	Connection between system and critical integration services are monitored in real-time. Alert sent to Concentric support team in the event of loss of connection.
8						1.06.03	The deploying organisation is advised to have a Business Continuity Plan in place for the circumstance that the documents integration is down (see example at https://concentric.health/implementation/business-continuity-plan/#document-integration-down ).	DCB0160
9						1.06.04	If using Concentric connector for document integration: When consent documents fail to reach the Concentric connector these will be re-sent once the connection is functioning again.
10						1.06.05	If there are elements of document integration that are beyond Concentric's visibility: The deploying organisation is advised to ensure there is appropriate monitoring and alerting on any processes that are outside Concentric's visibility on the path from Concentric to EHR/EDMS.	DCB0160
11				1.03	If single sign-on / active directory integration: The healthcare organisation's single sign-on (active directory) provider is down or not functioning properly.	1.03.01	The deploying organisation is advised to ensure there is a Business Continuity Plan in place for the circumstance that the single sign-on provider is down.	DCB0160
12				1.04	If clinicians are not allowed to use own devices as part of normal operations: Deploying organisation network internet connection / WiFi becomes unavailable	1.04.01	The deploying organisation is advised to ensure there is 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.	DCB0160
13				1.05	If clinicians are not allowed to use own devices as part of normal operations: Assigned devices are not available	1.05.01	The deploying organisation is advised to ensure there is a Business Continuity Plan in place for the circumstance that no assigned devices are available. Concentric is available on any device - mobile / tablet / desktop - and therefore an assigned device does not have to be used.	DCB0160
14				1.07	Clinician tries to access Concentric on an unsupported browser.	1.07.01	The deploying organisation is advised to ensure that all devices have a supported browser that clinicians can use to access Concentric. The Concentric browser support policy is at: https://concentric.health/standards-policies/browser-support-policy/	DCB0160
15	Haz-02	Consent documentation is attached to a different patient record in error	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.	2.01	Incorrect patient number is entered and error is not identified by clinician.	2.01.01	Patient bar is designed in line with best practice, ensuring that the format of the patient bar will be familiar to clinicians, increasing the likelihood that an error is noticed.		Considerable	Very Low	2
16						2.01.02	Patient bar is always visible within the view, throughout all interactions with the patient episode, increasing the likelihood that an error is noticed, by either clinician or patient user.
17						2.01.03	There is the ability to delete consent interactions where they have been created in error, with full audit trail of these activities to ensure this feature is not used maliciously.
18				2.03	If using launch in context integration: Launch in context integration could take clinician to incorrect patient record.	2.03.01	Patient bar is designed in line with best practice, ensuring that the format of the patient bar will be familiar to clinicians, increasing the likelihood that an error is noticed.
19						2.03.02	Patient bar is always visible within the view, throughout all interactions with the patient episode, increasing the likelihood that an error is noticed, by either clinician or patient user.
20						2.03.03	There is the ability to delete consent interactions where they have been created in error, with full audit trail of these activities to ensure this feature is not used maliciously.
21	Haz-03	Concentric provides incorrect clinical information to patient	Poor quality or incorrect clinical information may negatively impact a clinical decision, leading to an operation inappropriately being performed, or inappropriately not being performed.	3.01	Concentric content templates are of poor quality or incomplete, and do not represent best practice.	3.01.01	Prior to release of any clinical content to the healthcare organisation's production environment a PIF-tick certified validation process is followed, by appropriately trained GMC-registered Concentric Health employees.		Considerable	Low	2
22						3.01.02	Best available evidence is used to develop clinical content, and where appropriate the source of the information is documented.
23						3.01.04	The deploying organisation is advised to document in their 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.	DCB0160
24						3.01.05	The deploying organisation is advised to document in their consent policy and Concentric onboarding information that information shared as part of the Concentric process sits alongside but does not replace the need for a consent conversation.	DCB0160
25				3.02	Clinician does not modify the Concentric content template appropriately for the individual patient.	3.02.01	The deploying organisation is advised to 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.	DCB0160
26				3.02		3.02.02	The deploying organisation is advised to document in their 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.	DCB0160
27				3.03	Clinician submits a template request that is of poor quality or incomplete, and does not represent best practice.	3.03.01	The deploying organisation is advised to document in their SOP the governance process for content requests.	DCB0160
28				3.04	Clinician creates a consent episode from blank, or using a custom template, that is incomplete or of poor quality.	3.04.01	Episodes created from blank or from a custom template have the same validation placed in terms of elements that are 'required for consent', and clinician view has the same access to Concentric concepts such as indications, anaesthetic information and risk descriptions.
29				3.04		3.04.02	The deploying organisation is advised to document in their consent policy and Concentric onboarding information information regarding standards expected for content created outside of a Concentric content template.	DCB0160
30	Haz-04	(Archived)
31	Haz-05	External to Concentric signposted resources may contain incorrect information or not be relevant to the individual	Poor quality or incorrect clinical information may negatively impact a clinical decision (leading to an operation inappropriately being performed, or inappropriately not being performed) or cause patient confusion due to information that is contradictory to that shared within Concentric.	5.01	Signposted resources may be from sources that are non-reputable or are out of date and no longer represents best practice.	5.01.01	All signposted resource sources are verified to be from trusted sources (e.g. established healthcare organisation, Royal College, specialty association).		Minor	Low	1
32						5.01.02	The deploying organisation can choose to exclude signposted resources from specific sources should they wish.	DCB0160
33						5.01.03	On visiting a signposted resource from the Concentric patient application a disclaimer is shown to advise patients that this is additional information and should not be considered as part of the core consent information.
34				5.03	Inappropriate signposted resources may be selected to be shared, by the clinician, in error.	5.03.01	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. The deploying organisation is advised to ensure that training and onboarding information includes the importance of ensuring the appropriateness of consent information being shared for the individual.	DCB0160
35				5.04	If sharing local resources: Out of date information may be shared with patient if Concentric is not informed of a new version of the local resource (this applies to local resources that are hosted by Concentric, and local resources that are accessible at a historic URL).	5.04.01	The deploying organisation is advised to have a process in place to inform Concentric of any updates to local resources so that the latest version can be shared.	DCB0160
36				5.05	If sharing local resources: Link may be shared to resources that have been deleted.	5.05.01	The deploying organisation is advised to have a process in place to inform Concentric of any local resources that are deleted, so that the link can be removed from Concentric.	DCB0160
37	Haz-06	External to Concentric signposted resources may not be available	Patient is less informed about the treatment than they otherwise would have been.	6.01	The signposted resource's page is down.	6.01.01	The page will fail to load or a 404 failure message is displayed to the user.		Minor	Low	1
38	Haz-06			6.02	The signposted resource's current url is different to what is recorded within Concentric.	6.02.01	A routine, regular check is run on all linked information to identify any broken or redirected links so that these can be rectified.		Minor	Low	1
39	Haz-07	Information presented is difficult for a patient to access, engage with, or understand	Patient is unable to engage appropriately in shared decision, potentially leading to an inappropriate clinical decision.	7.01	Language presented is not appropriate for a lay audience.	7.01.01	All patient-facing information within Concentric is aimed at a lay audience following the principles set out in the NHS content style guide (https://service-manual.nhs.uk/content).		Minor	Low	1
40				7.01	Language presented is not appropriate for a lay audience.	7.01.02	Information provided within Concentric should be consistent with, and supplementary to a consent conversation between clinician and patient. Deploying organisations are advised to 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.	DCB0160
41				7.02	Patient may not have the the technical skills required to access and/or use Concentric.	7.02.01	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. Deploying organisations are advised to ensure that clinician training and onboarding includes the importance of sharing printed consent information with patients when digital access is not possible.	DCB0160
42				7.03	By default information is presented to patients in English, which may not be a language that the patient can read.	7.03.01	Automated in-browser translation can be used in all modern browsers.
43						7.03.02	Browser based text-to-speech functionality can be used in all modern browsers.
44						7.03.03	Deploying organisations are advised to 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).	DCB0160
45						7.03.04	Guidance for using intrepreters, including considerations when using non-professional interpreters, is shown to clinician users at the appropriate point in the Concentric UI.
46				7.04	The patient may have accessibility needs (e.g visual impairment) which prevents them from being able to access the information with the Concentric patient application.	7.04.01	Best practice is followed with regards to accessibility allowing users to manually edit text size and colour contrast, navigate through the information using the keyboard, and use screen readers (text-to-speech software).
47	Haz-08	Local unauthorised user gains access to Concentric	Patient confidentiality is breached which may cause psychological distress. False consent interactions may be created which may lead to an inappropriate clinical decision being made in future.	8.01	Clinician leaves Concentric logged in and another individual is able to use the system despite not having their own credentials.	8.01.01	A 'logout' button is accessible within the account menu to minimise friction to logout at the end of an interaction with the system.		Significant	Medium	2
48						8.01.02	The deploying organisation is advised to ensure that training and onboarding includes the importance of logging out following clinical use.	DCB0160
49						8.01.03	Concentric has an inactivity timeout, the length of which is configurable by the deploying organisation.	DCB0160
50				8.02	Clinician shares access credentials with another individual inappropriately.	8.02.01	The deploying organisation is advised to 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.	DCB0160
51	Haz-09	Communication to the patient is accessed by a different individual to the intended recipient	Patient confidentiality is breached.	9.01	Contact details within Concentric - via integration or manual entry by patient or clinician - are incorrect.	9.01.02	No special category (medical information) data is shared within the message sent, with the requirement to additionally enter the correct date of birth to access special category data.		Minor	Low	1
52						9.01.03	A date of birth check, with a lock-out after 10 incorrect attempts, is presented on following the link.
53						9.01.04	If contact details auto-populated via demographics integration: The healthcare organisation is advised to ensure there is an appropriate data validation process in place for contact details that can be pre-populated via integration.	DCB0160
54						9.01.05	The healthcare organisation is advised to ensure that training and onboarding includes the importance of ensuring accurate data entry for any manual entry of patient contact details.	DCB0160
55				9.02	The url for the patient information is entered despite not being shared the link by the system.	9.02.01	The url is in an unguessable format, with over 10^16 combinations, plus a check digit, and date of birth check, which makes accessing a valid consent via url trawling implausible.
56	Haz-10	(Archived)
57	Haz-11	Incorrect clinician is associated with a change or consultation	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.	11.01	Clinician does not log out and session is continued by a different individual.	11.01.01	Initials of clinician logged are shown in the header, with clinician name and option to logout shown in the account menu.		Minor	Low	1
58						11.01.02	The deploying organisation is advised to ensure that training and onboarding includes the importance of logging out following clinical use.	DCB0160
59						11.01.03	Concentric has an inactivity timeout, the length of which is configurable by the deploying organisation.	DCB0160
60				11.02	The clinician creating the consent episode assigns incorrect responsible clinician or inappropriately assigns themself as the responsible clinician.	11.02.01	Responsible clinician name shown prior to signing consent in clinician view, as well as on the post-consent summary page and consent form PDF.
61				11.02		11.02.02	The healthcare organisation is advised to ensure training and onboarding covers what a responsible clinician is, and the importance of assigning the correct responsible clinician.	DCB0160
62	Haz-12	If no patient demographics integration: Incorrect patient demographics are entered for a patient	Patient record may not be able to be found in future, or treatment may be delayed due to discrepancy being noted during pre-treatment checks (e.g. in the operating theatre).	12.01	Clinician mis-enters demographic details on creating a patient record.	12.01.01	The healthcare organisation is advised to ensure training and onboarding covers the importance of ensuring accurate entry of patient demographic details on creating a patient record.	DCB0160	Minor	Low	1
63	Haz-12			12.01		12.01.02	Concentric requires that a valid date of birth and NHS number (if applicable) are entered when creating a patient record.		Minor	Low	1
64	Haz-13	Paper consent process is used outside of Business Continuity Plan scenario	Confusion may ensue due to uncertainty regarding the location of consent information, and patient does not benefit from the Concentric information.	13.01	Clinician prefers to use paper consent process or is hesitant to change to digital consent process.	13.01.01	The healthcare organisation is advised to 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.	DCB0160	Minor	Medium	2
65	Haz-13			13.02	Patient refuses to use digital consent process.	13.02.01	The healthcare organisation is advised to have a documented process around how to manage this, for example how to ensure that the paper consent form is stored in the Electronic Health Record (if applicable).	DCB0160	Minor	Medium	2
66	Haz-14	Unauthorised user gains access to Concentric via cyber attack	Patient confidentiality is breached which may cause psychological distress. False consent interactions may be created which may lead to an inappropriate clinical decision being made in future.	14.01	Cyber attack penetrates system to gain access to personal identifiable data.	14.01.01	Independent CREST-approved penetration testing is undertaken annually to ensure that there are no known vulnerabilities that could lead to the leak of personal identifiable data via a malicous cyber attack. Episode details are encrypted at rest and in transit.		Considerable	Very Low	2
67	Haz-14			14.01		14.01.02	Concentric is certified to meet Cyber Essentials and Cyber Essentials Plus standards for Cyber Security, reviewed annually.		Considerable	Very Low	2
68	Haz-15	Patient is not able to access their treatment information	Patient is less informed about the treatment than they otherwise would have been.	15.01	Contact details within Concentric - via integration or manual entry by patient or clinician - are incorrect.	15.01.01	If contact details auto-populated via demographics integration: The healthcare organisation is advised to ensure there is an appropriate data validation process in place for contact details that can be pre-populated via integration.	DCB0160	Minor	Low	1
69						15.01.02	The healthcare organisation is advised to ensure that training and onboarding includes the importance of ensuring accurate data entry for any manual entry of patient contact details.	DCB0160
70						15.01.03	Concentric validates the structure of email address and mobile number (e.g. prevents a landline number being entered) when sharing information with patients.
71				15.02	Patient may not have access to a device with the capability of accessing the Concentric patient application.	15.02.01	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. Deploying organisations are advised to ensure that clinician training and onboarding includes the importance of sharing printed consent information with patients when digital access is not possible.	DCB0160
72	Haz-16	If no document integration: Completed consent documentation is not visible within the main electronic health record / document management system	Future review of medical record may seem incomplete if a clinician is expecting to see a consent form in the EHR/EDMS, or an incorrect assumption may be made that a patient has not had a certain operation due to the absence of a completed consent form to that effect.	16.01	Document integration not in place so consent documentation is only visible within Concentric.	16.01.01	The healthcare organisation is advised to 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.	DCB0160	Minor	Low	1
73	Haz-17	A theatre list takes place with consent forms in a mix of locations	Consent forms are difficult for staff to find, and looking for them may contribute to day-of-treatment delays.	17.01	During rollout of Concentric, not all clinicians within a department or not all departments transition to digital consent at the same time.	17.01.01	If paper consent forms are being used after Concentric go-live, the deploying organisation is advised to have a documented policy around how this is to be managed. This can include having 'EHR consent' lists where paper consent forms are scanned, stored and accessed digitally on the day of treatment.	DCB0160	Minor	Low	1
74	Haz-17			17.02	Clinician prefers to use paper consent process or is hesitant to change to digital consent process.	17.02.01	The healthcare organisation is advised to 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.	DCB0160	Minor	Low	1


1
2	Likelihood	Very High	3	4	4	5	5	Severity Classification	Interpretation	Number of Patients Affected
3		High	2	3	3	4	5	Severity Classification		Number of Patients Affected
4		Medium	2	2	3	3	4	Catastrophic	Death	Multiple
5		Low	1	2	2	3	4		Permanent life-changing incapacity and any condition for which the prognosis is death or permanent life-changing incapacity; severe injury or severe incapacity from which recovery is not expected in the short term	Multiple
6		Very Low	1	1	2	2	3			Multiple
7			Minor	Significant	Considerable	Major	Catastrophic	Major	Death	Single
8			Severity						Permanent life-changing incapacity and any condition for which the prognosis is death or permanent life-changing incapacity; severe injury or severe incapacity from which recovery is not expected in the short term	Single
9										Single
10		Likelihood Category	Interpretation						Severe injury or severe incapacity from which recovery is expected in the short term	Multiple
11		Very high	Certain or almost certain; highly likely to occur						Severe psychological trauma	Multiple
12		High	Not certain but very possible; reasonably expected to occur in the majority of cases					Considerable	Severe injury or severe incapacity from which recovery is expected in the short term	Single
13		Medium	Possible						Severe psychological trauma	Single
14		Low	Could occur but in the great majority of occasions will not						Minor injury or injuries from which recovery is not expected in the short term	Multiple
15		Very low	Negligible or nearly negligible possibility of occurring						Significant psychological trauma	Multiple
16								Significant	Minor injury or injuries from which recovery is not expected in the short term	Single
17									Significant psychological trauma	Single
18		5 Very High	Unacceptable level of risk. Mandatory elimination or control to reduce risk to an acceptable level.						Minor injury from which recovery is expected in the short term	Multiple
19		4 High	Unacceptable level of risk. Mandatory elimination or control to reduce risk to an acceptable level.						Minor psychological upset; inconvenience	Multiple
20		3 Significant	Undesirable level of risk. Attempts should be made to eliminate or control to reduce risk to an acceptable level. Shall only be acceptable when further risk reduction is impractical or impossible without introducing alternative risks.					Minor	Minor injury from which recovery is expected in the short term; minor psychological upset; inconvenience; any negligible consequence	Single
21		2 Moderate	Tolerable where further risk reduction is not practical or is impossible without introducing alternative risks.
22		1 Low	Acceptable, no further action required.