The Outside Perspective: A remote user of a centralized laboratory

1. The Outside Perspective:A remote user of a centralized laboratory Jeya Nadarajah, MD, MSc, FRCPC Infectious Diseases & Medical Microbiology

2. Objectives • Discuss considerations when moving to a centralized laboratory • Develop and implement a model of shared microbiology services • Recognize the need for local expertise

3. “Laboratory testing impacts up to 70% of our medical decisions, however, diagnostic laboratory services are viewed as having no more clinical relevance in the health care system than the parking garage.”

4. Advantages • Cost Savings • Standardization • Elimination • Single patient record • 24/7 service = Improved Turnaround Times • Implementation of new technology

5. Disadvantages • Delayed specimen processing • Organism viability • Surveillance and Epidemiology • Lack of clinical correlation to patient metrics • Lack of custom reporting • Double Standard • Access to Microbiologists • “Factory”, “ Assembly Line” Processing

6. Initial Considerations • On-site / off-site Testing Menu • Transportation • Specimen Integrity • Optimal turnaround time • Stat testing • Central Laboratory SOPs • Competency in local laboratory

7. On-site Microbiology • Process / Result within 2 hours • Blood cultures • Gram stains of critical specimens • Sterile Fluids, CSF, OR/IR specimens • Pre-analytical quality assurance • Quality indicators • Competency

8. Microbiology at MSH Uxbridge site 41km PHL 26km 28km RCC site 28km SMH 28km HSC 85km HRLMP Gamma-Dynacare

9. Specimen Transport • Pre-inoculate specimens • Aliquoting and storing • Temperature control • # transports / weekday/weekend • Transport Quality Indicators

10. Transport Temperature

11. Blood Cultures • On site / off Site Incubation • On site / off site Gram stain • Inoculation & Transport • Quality indicators • Contamination rates • Positivity rates • Time to positivity • Volume • Single sets

12. YORK REGION HOSPITALS BLOOD CULTURE MODEL Peripheral laboratory Central laboratory 3-18h H#1 H#2 3-18h <1hr Incubation Identification Susceptibility <1h MSH 3-18h

13. Pre-Incubation outside analyzer • 2-5% of positives will go undetected • Strep species, yeasts, NLFs will be missed if pre-incubated at 35-37oC • Stationary phase will not trigger analyzer Janapatla RP JMII 2010; 43:126 Barenfanger J, Am J Clin Path 2008; 130:870 Lemming L, CMI 2004; 10:1089 Mermel LA, Ann Int Med 119:270 Van der Velden LB, JCM 2011 49:275 Klaerner HG, JCM 2000; 38:1036 Seegmuller I, JMM, 2004:53:869

14. Positivity of blood cultures in relation to their pre-analytical time • Delay of >2 h = reduced probability of positive result • Each hour from collection to incubation = decrease of 0.3% in probability of a positive result Venturelli et al, PLOS one Jan 2017

15. Time to Positivity • Wulffen et al. ECCMID • Satellite versus Central laboratory • Blood draw to positive signal longer by7.1h • Final report frequently issued a full day later • Deslandes et al. (EORLA) AMMI 2019 • Blood draw to loading: • Inner city: 3 hours • Distant Sites: 7.6 to 22.7 hours • Time to positivity: • Inner City: 22.5 hours • Distant sites: 25.6-31.8 hours

16. 99 matched pairs of positive blood cultures • Gram Stain TAT < 1h vs > 1h • Crude mortality: 10.1% vs 19.2% (P=0.0389) Barenfanger et al, Am J ClinPathol, 2008; 130:970

17. Early Reporting of Gram = Crucial McCabe WR. Arch Intern Med. 1962; 100:92 Kreger BE. Am J Med. 1980;68:344 Schonheyder HC. APMIS. 1995; 103:37 Weinstein MP, CID 1997; 24:584 Cunney RJ J ClinPathol 1997; 50:1010 Leibovici L. J Intern Med 1998; 244:379 Ibrahim e. Chest. 1999;118:146 Harbarth S. Am J Med 2003; 115:529 Mackenzie AR. Int J. Antimicrobi Agents 2003; 115:529 Mackenzie AR Int J Antimicrob Agents 2003; 22:618 Savinelli T. DiagnMicrobiol Infect Dis. 2004; 48:173 … … … …

18. MSH Blood Culture Quality Indicators

19. IPAC Disadvantages • Surveillance support • Point Prevalence and outbreak specimens • Large bulk volumes = less likely to detect subtle changes • Accommodation of differing IPAC practices • Large volumes = less reflex calling

20. ASP • Antibiotic reporting rules • Antibiograms • Limited due to LIS interface • Minimal benefit from rapid diagnostics • Negotiation of additional testing • Eg. Cefazolin Disk Diffusion

21. Maintenance of Competency • Gram stains by generalists • Concordance rates with Central lab • QC • Validation and Verification • Low volume = loss of competency • Oversight from Central Laboratory

22. Rapid Testing/Molecular Diagnostics • Significant decrease in TATs • ARO, Respiratory Viral Testing, AFBs • PHL = $0 vs On-site = $100s • “Plug ‘n Play” systems • Validation and Verification

23. DIAGNOSTIC STEWARDSHIP CLINICAL DECISION-MAKING PRE-ANALYTICAL POST- ANALYTICAL ANALYTICAL ISO 15189: 9 steps in the performance of any lab test

24. Lessons Learned from a Peripheral User • Centralization is a reality • 7 of 9 steps involved in each lab test are in the hands of the peripheral user • Lack of evidence for true cost effectiveness and clinical impact on LOS, Mortality, Readmission • Local Expertise is a MUST to ensure a quality Test result!