John Mallon Technical Services Manager NHS GG&C Microbiology

1. Vitek2 Antimicrobial Susceptibility Testing on All Urine Isolates - WASPLaband Removal of UF1000 Automated Urine Microscopy John Mallon Technical Services Manager NHS GG&C Microbiology

2. INTRODUCTION • GG&C Microbiology consolidated onto 2 sites on 15th January 2018 • WASPLab technology introduced in 2018 – delivered in May (GRI) and Sept (QEUH) • GG&C Microbiology receive 270,000 urines per annum – 120,000 GRI & 150,000 QEUH • Funded for a 6 month pilot study in October 2018 to test ALL urine isolates on Vitek2 • Pilot was to examine service improvements by testing all isolates with Vitek 2

3. PREVIOUS METHODOLOGY • All urines screened by UF1000 (Day 0) • Microscopy positive specimens cultured onto CUTI • Disc Testing done on positive isolates (Day 1) • Vitek 2 testing done on some clinical categories (Day 1) and on resistant disc testing isolates (Day 2) • Full ESBL confirmation tests done on suspect organisms (Day 2) if screen positive on disc testing • Resistant organisms requiring Vitek 2 taking at least 3 days for a report to go out • Organism identification only done on isolates sent to the Vitek 2

4. PREVIOUS METHODOLOGY • Advantages: • Good turnaround times for negative samples • Ability to quickly report sensitive isolates to the standard urine antibiotics • Inexpensive • Targeting of additional expense on predominantly more resistant isolates

5. PREVIOUS METHODOLOGY • Disadvantages: • Poor turnaround times for positive samples with more complex resistance patterns • Isolates with disc testing only present a choice of a maximum of 5 antibiotics to the Consultants • Identification not performed on all isolates • Vitek “expert rules” not applied to detect intrinsic and inferred resistance patterns for ALL isolates • Inequality of service provision on urine reports to clinicians

6. URINE VITEK 2 PILOT • Vitek 2 Susceptibility to be performed on ALL urinary isolates • Full ESBL disc testing and Aztreonam / Mecillinamdisc testing to be done as well as Vitek 2 • All organisms to be identified to species level on Vitek MS • Introduction of full electronic reporting and removal of paper worksheets

7. URINE VITEK 2 PILOT - AIMS • Improved Antibiotic Stewardship – reduction of reporting of “non cdiffogenic” antibiotics (Cipro and Amoxy-clav) • Improved turnaround times – 13% of GP and 20% of inpatient have discs and Vitek 2 – 1 day delay • Quicker TAT will assist the inpatient areas with patient flow and potentially release beds sooner • Antimicrobial resistance monitoring – accurate resistance rates not fully known • Spending in laboratory will reduce prescribing costs • Examine accuracy of VitekESBL testing vs Mast Discs

8. URINE VITEK 2 PILOT - ISOLATES

9. URINE VITEK 2 PILOT – VITEK CARDS • Additional Vitek 2 Card Usage for 6 month pilot

10. URINE VITEK 2 PILOT – TAT RESULTS • Turnaround Times – 95% Authorised Pre and Post Pilot

11. URINE VITEK 2 PILOT - RESULTS • Turnaround Times – 95% Authorised

12. VITEK 2 ESBL vs DISC TESTING Correlation between Vitek2 and Mast ESBL disk reporting of ESBL production was evaluated:

13. VITEK 2 ESBL – STATISTICS • Calculation of Sensitivity, Specificity, Positive Predictive Value (PPV) and Negative Predictive Value (NPV):

14. VITEK 2 ESBL STATISTICAL ANALYSIS • Focus on the common ESBLsat the urinebench • For urinary enterobacteriacaea isolates, the detection of ESBLs by the Vitek 2 appears Sensitive and Specific • Viteksusceptibility pattern is effective at eliminating False Negative isolates • False-negatives may be due to poor antibiotic responses within the test or AmpC-masking of ESBLs • The Vitekovercalls ESBL producers for complex resistance patterns. • The clinical outcomes are unlikely to be severely affected by these false positive results

15. VITEK 2 ESBL – CLINICAL ANALYSIS • Evaluation of 263 urinary Enterobacteriaceae isolates found discrepant reporting of ESBL production in 3.8% of cases • Due to interpretation of the full antibiogram this is unlikely to have affected patient management. • For non-sterile sites, it is reasonable to report ESBL production as per Vitek2results • In severe cases, and in sterile sites, ESBL disk testing will continue as a failsafe in the serious clinical cases

16. URINE VITEK 2 PILOT CONCLUSIONS • Improved Turnaround Times • Better antibiotic stewardship with more antibiotics reported clinically e.g. Amoxycillin and more resistant organisms released • ESBL disc testing not routinely required – Vitek 2 Fine • Aztreonam disc testing no longer required • Significant additional cost to fund extension of pilot • More work for BMS staff as setting up disc testing and Vitek 2 more work than previous methodology

17. Urine Microscopy – UF 1000 • GG&C Microbiology performed urine microscopy on ALL specimens on UF 1000 instruments • 270,000 requests per year with 4 instruments at QEUH (150,000) and 3 instruments at GRI (120,000) • Urine microscopy used as a screening method and negative microscopy reported out as final • Approximately 30% of urine samples were microscopy negative and authorised on the same day (Day 0) • Urine microscopy for Red Blood Cells was “switched off” due to the inaccurate results obtained • Specimens requiring mandatory culture manually identified and culture set up manually

18. SIGN Guidelines - Adults • SIGN guidelines recommend urine specimen are Cultured • Guidelines indicated that Microscopy alone lacks Sensitivity • Microscopy indicated in: • Patients who are post renal transplant • Patients with Glomerulonephritis-

19. NICE Guidelines - Paediatrics • Urine microscopy in children is indicated in the following: • Children under 3 years of age – Easy for the lab to triage • Children aged 3 or over - on dipstick testing if leucocyte esterase is positive and nitrite is negative, then a urine specimen should be sent for microscopy and culture - requires the clinical users to contact the lab

20. Culturing All Urines • Blind Culture has been performed before as a result of UF 1000 unavailability • Culturing ALL urine specimens is a similar amount of work for CSW staff • Culturing all urine specimens creates additional work for the BMS staff as there are 30% more CUTI plates to be read the following day • The majority of the additional plates set up with blind culture are culture negative

21. WASPLab • Moving to Blind Culture is less work for CSW staff as UF 1000 is not used and WASPLab loaded directly • WASPLab able to blind culture all specimens with throughput and capacity not an issue • Ability to use WASPLab for rapid screening of negative results no significant increase in BMS work for the additional CUTI plates • Additional plates are contained in WASPlab with negative plates automatically discarded

22. Service Benefits: Urines Vitek 2 • Improving urine culture turnaround times especially for complex resistant isolates • Greater range of antibiotics reported and less reporting of Cdiffogenic antibiotics in over 65’s • Able to report less broad spectrum antibiotics in sensitive isolates • Better epidemiology and information on local resistance patterns and trends • Equityof service for the patient and requestors.

23. Service Benefits Urine Microscopy Change • All specimens cultured and compliant with SIGN and NICE guidelines • Manual Microscopy performed on approximately 3% of specimens • Costs involved in overall service improvement identified from existing budget • Use of WASPLab for blind culture minimises additional work for BMS and CSW staff.

24. CONCLUSION • GG&C Microbiology to perform urine susceptibility testing on Vitek 2 on ALL urine isolates • Urine microscopy service reviewed to ensure microscopy offered as appropriate – evidence based practise • WASPLab technology employed to assist the laboratory to make the change • Financial impact contained within existing budget • Improved Antibiotic stewardship and urine specimen TAT to support better and faster patient care

25. QUESTIONS