Public Board of Directors papers 260123

1. Safe

1.4 – Learning - Patient Safety Incidents

Agreed learning and revised severity outcome following executive reviews up to December 2022 Ref Description Root cause Learning

Outcome

• AAU line manager and matron to reiterate need for full MH assessment on each patient

Patient had an unwitnessed fall in the ensuite bathroom of side room 8, Palatine ward, sustaining an injury to her head.

Unpreventable fall. Patient assessed as independently mobile pre and post fall.

Minor

W71425

• Unit manager and Lead Nurse to cascade the requirement to repeat assessment to all staff

1. Safe

• Findings to be highlighted with the trial sponsor for the sponsor to determine its processes for ensuring consistency between documentation • To disseminate importance of review of trial related forms to sense check for consistency between forms and identify areas for improvement • To disseminate the importance of ensuring appropriate rigor is applied to the review of eligibility criteria. • Ensure robust process in place for the appropriate involvement and engagement of PIs (or appropriately delegated personnel) in addressing clinical related queries.

Patient was not eligible for randomisation into the SHAPE trial (15_DOG13_01) at the time of her treatment in 2017, confirmed with the Sponsor of the trial that this was a protocol violation of the trial

Communication failure with the principle investigator about eligibility

TBC

W73109

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