Evaluation, Procurement and Rollout of Enteric PCR in Wales

1. Evaluation, Procurement and Rollout of Enteric PCR in Wales Michael Perry – Clinical Scientist Higher Specialist Scientist Trainee Public Health Wales Microbiology UK Anaerobe Reference Unit 23rd May 2019

2. Public Health Wales Microbiology • Several public health organisations including Microbiology Services (also Screening, Health Protection, Health and Wellbeing…) • Wales wide network of Microbiology laboratories - protecting the public from harm • Several UK microbiology reference units sit within this structure including the Anaerobe Reference Unit (UKARU) Michael Perry - UKARU

3. Clinical Microbiology ‘Questions of the Soul’ …and our answers! Michael Perry - UKARU Q1: Are you satisfied with your current CDI/enteric testing assays/algorithms? A1: No Q2: Do you get too many false positive and false negative results? A2: Yes Q3: Are you missing cases of infectious diarrhoea? A3: Yes Q4: So what are you going to do about it? A4: Now there’s a good question!

4. Where should I start? History Olympics 2012 Newport NATO 2014 Welsh Government ETTF 2016 CardiffChampion’s League Final 2017 Welsh Government Innovation Fund 2017 Commercial assay development & evaluation 2012 - 2017 Procurement exercise, planning and implementation 2017 - 2018 Michael Perry - UKARU

5. Conventional Enteric Testing Challenges • Slow TATs • Suboptimal sensitivity • Limited pathogen coverage • Labour intensive & skill-rich processes • Requirement for multiple samples/sample separation • Numerous, fragmented & confusing laboratory workflows Michael Perry - UKARU

6. Molecular Enteric Testing Benefits • Improved TATs • Increased sensitivity • Broader pathogen coverage • Lean and labour efficient processes • Results with augmented clinical relevance • Syndromic testing enabled with multiplex methods Michael Perry - UKARU

7. Conventional vs. Molecular Summary • Increased accuracy in detection of gastrointestinal pathogens • Increased testing for key pathogens of public health importance Michael Perry - UKARU Improved sensitivity Reduced turnaround times Less time consuming and technically demanding A single sample pathway

8. Molecular Enteric Testing Benefits • All targets •  detection rate •  NPV • C. difficile •  sensitivity + specificity •  access • Norovirus •  sensitivity •  access Michael Perry - UKARU

9. Development & evaluation 2012-2016 Cryptosporidium Reference Unit (CRU) Anaerobe Reference Unit (ARU) Michael Perry - UKARU

10. Molecular Enteric Testing 2012-2016 • PCR Microarray-based • Validated at Public Health Wales • and compared with Luminex GPP • Fully automated • EPP validated at Public Health Wales • EBP compared with Luminex GPP Michael Perry - UKARU

11. Molecular Enteric Testing 2012-2016 • Semi-automated • Custom panel being developed in collaboration with Public Health Wales • Semi-automated • Panel to be validated at Public Health Wales Michael Perry - UKARU

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14. In the beginning… Governance Michael Perry - UKARU Establish project team with clear scope and lines of reporting and responsibility Be selective! Not too little but not too big Broad skills and range of experience Agree primary and secondary project objectives and make them SMART Don’t over-promise Beware of healthcare economics

15. Pre-procurement Inform yourself Michael Perry - UKARU Explore market Evaluate assays Attend meetings Discuss internally Perform options appraisal Official market engagement Produce tender specification

16. Pre-procurement Network Michael Perry - UKARU Engage early with all stakeholders Consider requirements: • Different labs – one size fits all? • Different clinical oversight • Different Health Boards • Different Health Protection teams • Involve different teams in market engagement • Consider ‘critical friends’ • Recruit enthusiastic and diligent colleagues from across the network • Manage expectations from the start!

17. Procurement Fun Michael Perry - UKARU Don’t underestimate costs/price – your procurement may not be as economically ‘successful’ as you anticipate It’s not just about the money (pre-procurement really)!

18. Implementation and beyond Post-procurement Michael Perry - UKARU Plan achievable validations/verifications • Don’t duplicate effort unnecessarily Be flexible, but firm Be fair and even-handed Maintain your enthusiasm/optimism through the tough times Manage communication at all levels Allow time for service to embed but reinforce expectations Start thinking of the next procurement!

19. External engagement Multiplied by… • Infection prevention & control • Welsh Government • Shared services • Informatics • Old uncle Tom Cobley & all! • Health Protection • Health Boards • Local authorities • National/local ref labs • Public Health England Michael Perry - UKARU

20. Lessons learned For next time… Michael Perry - UKARU Communication/engagement lines may be poor/non-existent! Try not to over-underestimate timescales but be optimistic – you’ll get places faster Just because it works in one location doesn’t mean it will in another!

21. Lessons learned For next time… Michael Perry - UKARU Anticipated benefits may not be realised in all sites Canvas opinion before making changes – or advise local amendments to SOPs worksheets etc. LIMS/interfacing is always the bottleneck! It will take more of your time than you think!

22. And finally… No regrets Michael Perry - UKARU Think UKAS from the start! Be considerate of people (hopefully for altruistic reasons) but either way… Don’t underestimate the positive effect it will have, even on staff that aren’t directly involved!

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24. Acknowledgements Diolch Michael Perry - UKARU Fatima Downing (Project Manager) Trefor Morris and UKARU colleagues All Wales Microbiology employees (including ref labs) All other Public Health Wales employees Industry partners Clare Jenkins (GBRU, Colindale)