Prevention of Future Deaths report: Aviva Otte, Oscar Barker and Yousef Al-Kharboush (15 November 2024)

Summary

In 2014 an investigation was commenced into the death of Yousef Al-Kharboush (born 23 May 2014, died 1 June 2014, aged 8 days), Oscar Barker (born 27 May 2014, died 29 June 2014, aged 1 Month) and Aviva Otte (born 10 October 2013, died 2 January 2014, aged 2 months). The investigation concluded at the end of the inquest on 23 October 2023. 

Content

Aviva’s death (January 2014) was in hospital where she had received TPN provided and compounded by the NHS establishment under a section 10 exemption. That TPN had, on balance, been contaminated by Bacillus cereus (subsequently identified as type BC.38). The Trust undertook a root cause analysis together with involving the UKHSA and its own infection and microbiological teams, but no definitive source for the outbreak was found.  

In June 2014 Oscar Barker and Yousef Al-Kharboush received TPN, compounded by a commercial provider, which it turned out was also contaminated by Bacillus cereus (subsequently typed as Bc.44). The compounder having positive finger dab testing for the Bacillus within its laboratory/environmental testing. This outbreak also affected other babies in other Trusts. 

Bacillus cereus is resistant (because it is spore forming) to the spray and wipe cleaning methods used (with alcohol) and sporocides are required to decontaminate the outside of, for example, ampoules containing one of the constituents. 

This was the information and a conclusion that the Trust had reached in early 2014 and therefore prior to the outbreak in May/June 2014. It had not passed on those findings either within other section 10 units compounding TPN or the wider market. Subsequently, the MHRA brought in further advice for the use of sporocides in 2015. 

Matters of concern

• There is no requirement for a section 10 exempt entity to report any of its findings to the MHRA or indeed to other Trusts or the industry in general if an adverse event occurs.
• The current reporting structures (for a section 10 entity) involve reporting to NHSE and the CQC but the threshold or necessity for such reporting appears unclear and, in essence, up to the Trust.
• There may be times when section 10 entities reach conclusions which would assist the wider industry and help to assist both other Trusts and commercial organisations in assessing their own risks and improving the provision of highly specific medication to a group of vulnerable patients.
• The same may also be true of commercial organisations but they have the power of the MHRA controlling and effecting recalls and actions and the wider dissemination of information.

Response from NHS England