HAZARD: Reminder function could fail to alert a user to a scheduled event

[pacharanero]

Description

Reminders can be set in the patient-facing Albert app in order to remind the user to take medication or commence their enteral nutrition feeds. The functionality is intended to be an adjunct to rather than a replacement for standard methods of scheduling medication and feeding. However, given there is a feature, which could fail, it is important it is appropriately considered as a clinical risk

Cause

If the reminder feature was set by the user (patient) but did not alert appropriately, then user would not receive an alert.

Effect

Without the alert/reminder, the medication may not be taken at the correct time.

Hazard

If medication or feeding was missed this could cause harm to the patient.

Harm

Missing enteral feeds or medication could have a deleterious effect on the health of the patient, although for most imaginable situations, the missed feeds or doses would have to be prolonged and repeated in order to cause harm.

There would also have to be failure of other more traditional modes of reminding the patient of these feeds/doses, such as the patient knowing when they take their medication (bearing in mind the reminders are set by the patient in the first place).

In general, the responsibility for managing one's medication is assumed to be safely delegated to the patient (in contrast to inpatient situations when the clinical staff administer the medication). For those patients who are unable to manage these responsibilities independently, it is almost certain that there would be additional help in place to enable them to manage their other activities of daily living.

The presence of the reminder feature does not replace more traditional mechanisms for timing interventions such as feeds and medications.

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Assignment: Assign this Hazard to its Owner. Default owner is the Clinical Safety Officer @pacharanero Labelling: Add labels according to Severity. Likelihood and Risk Level Project: Add to the Project 'Clinical Risk Management'

• Subsequent discussion can be used to mitigate the Hazard, reducing the likelihood (or less commonly reducing the severity) of the Harm.
• If Harm is reduced then you can change the labels to reflect this and reclassify the Risk Score.
• Issues can be linked to: Issues describing specific software changes, Pull Requests or Commits fixing Issues, external links, and much more supporting documentation. Aim for a comprehensive, well-evidenced, public and open discussion on risk and safety.

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[pacharanero]

Hazard Review

On the basis of the above Hazard description I have assigned Likelihood: Low and Severity: Minor because it seems exceedingly unlikely that someone would be relying on the reminder function so much that a failure of the feature would result in them not being fed and/or not taking medications for long enough to have a physical clinical impact (days to weeks), without seeking other advice, being reminded in some other way (hunger?, symptoms?) or intervention by some other agency (carers?)

Mitigation

Mitigation at this stage is not mandatory but we can further reduce the risk by ensuring that a suitable unit and integration test suite is in place around the reminder functionality.

[pacharanero]

@ensargunesdogdu if you can confirm satisfactory test suites surround this feature that would help to detect failures then we don't need to further consider this Hazard.