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Explore the challenges and advantages when transitioning to a centralized laboratory, focusing on shared microbiology services, local expertise, and considerations for optimal testing processes. Learn about the impact on medical decisions, advantages such as cost savings and standardization, and the need for local competency. Discover the initial considerations, on-site microbiology processes, specimen transport, blood culture models, time to positivity, and the importance of rapid testing. Gain insights on maintaining competency, implementing rapid testing, and navigating diagnostic stewardship. Lessons from a peripheral user shed light on the realities of centralization.
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The Outside Perspective:A remote user of a centralized laboratory Jeya Nadarajah, MD, MSc, FRCPC Infectious Diseases & Medical Microbiology
Objectives • Discuss considerations when moving to a centralized laboratory • Develop and implement a model of shared microbiology services • Recognize the need for local expertise
“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.”
Advantages • Cost Savings • Standardization • Elimination • Single patient record • 24/7 service = Improved Turnaround Times • Implementation of new technology
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
Initial Considerations • On-site / off-site Testing Menu • Transportation • Specimen Integrity • Optimal turnaround time • Stat testing • Central Laboratory SOPs • Competency in local laboratory
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
Microbiology at MSH Uxbridge site 41km PHL 26km 28km RCC site 28km SMH 28km HSC 85km HRLMP Gamma-Dynacare
Specimen Transport • Pre-inoculate specimens • Aliquoting and storing • Temperature control • # transports / weekday/weekend • Transport Quality Indicators
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
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
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
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
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
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
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 … … … …
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
ASP • Antibiotic reporting rules • Antibiograms • Limited due to LIS interface • Minimal benefit from rapid diagnostics • Negotiation of additional testing • Eg. Cefazolin Disk Diffusion
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
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
DIAGNOSTIC STEWARDSHIP CLINICAL DECISION-MAKING PRE-ANALYTICAL POST- ANALYTICAL ANALYTICAL ISO 15189: 9 steps in the performance of any lab test
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!