1. Using RCA to ensure learning from an error involving the national infant primary immunisation schedule Anita Aindow, David Sharpe, Catrin Barker, Joan Mulvoy, Dr Andrew Riordan, Andrea Gill, Alder Hey Children’s NHS Foundation Trust Dr Daniel Seddon, Michelle Falconer, NHS England

2. May 2013 DoH/PHE/NHS England circulated a letter detailing changes to the national immunisation schedule for MenC vaccination from 1 st June 2013 Removal of 2 nd dose at 4 months of age Introduction of booster at 14 years of age Annex B, page 6 NeisVac-C R and Menjugate R only brands of MenC vaccine suitable for single dosing in infants Background

3. Incident chronology (1) April 2014 – 5 month old, long stay patient given MenC vaccine by a Junior Doctor. Grandmother queried use of Meningitec R brand Pharmacy confirmed this was the brand stocked and that the new schedule recommended a single dose. Grandmother informed local PHE staff of the error - they alerted Alder Hey Pharmacy

4. Incident chronology (2) Pharmacy department identified 33 patients who had been given Meningitec R vaccine at Alder Hey since June 2013 PHE contacted for advice on action required GPs and Child Health Records systems were contacted Status of each patient was identified

5. Incident chronology (3) StatusNumber of patients Patients who had received 2 doses or a 12 month booster 11 Patient who had not received a second dose or a booster Under 12 months of age (15 patients) Over 12 months (6 patients) 21 Died of an unrelated cause1

6. Root Cause Analysis “when incidents.. happen it is important that lessons are learned to prevent the same incident occurring elsewhere. Root Cause Analysis investigation is a well recognised way of doing this. Investigations identify how and why patient safety incidents happen. Analysis is used to identify areas for change and to develop recommendations which deliver safer care for our patients” http://www.nrls.npsa.nhs.uk/

7. Root Cause Analysis – 5 Whys

8. Why did it happen? 1.Information about the need to use specific brands of MenC vaccine for the new schedule was not obvious in the letter from DoH/PHE/NHS England 2.The Alder Hey Chief Pharmacist did not receive this letter via the Chief Pharmacist cascade mechanism 3.National IMM-form did not request those ordering MenC vaccines to specify a particular brand 4.The paper version of the BNFC 2013/14 contained the old schedule for immunisation

9. Why did it happen? 5.The majority of patient immunisations in the Trust are undertaken by junior doctors or nurse specialists who have not undergone training 6.There is not a formal process for dissemination of information about immunisation 7.The Trust process for documenting immunisation is unclear 8.There is no process to alert clinicians if long term patients have missed a scheduled immunisation.

10. “The Trust does not have a Lead for Immunisation or a clear process in place that includes communication, training and documentation for patients requiring immunisations”

11. Recommendations 1.To ensure affected patients do not delay in obtaining their 12 month booster dose and that future patients receive the correct brand of vaccine. 2.To feedback to DoH/PHE/NHSE that their letter did not make all the relevant information obvious 3.To inform Movianto of the changes required to the IMM-form. 4.To request information is distributed through the national Chief Pharmacist cascade system

12. Recommendations 5.To alert clinicians that on-line versions of the BNFC and Green Book must be used as reference documents when prescribing immunisations 6.To agree a Trust lead for Immunisation and develop a Trust policy 7.To develop a formal system for dissemination of relevant information by the pharmacy department. 8.To explore if the Trust EPR system can link directly to the Child Health Record system

13. Conclusion Undertaking a RCA investigation involving the multi-disciplinary team and NHS England identified learning and actions required on a local and national level to ensure safe and effective immunisation for patients