the value of the clinical microbiology lab in today’s
TRANSCRIPT
The Value of the Clinical
Microbiology Lab in Today’s Changing Healthcare Environment
Karen Kaul, M.D., Ph.D.
Chair, Pathology/ Lab Medicine NorthShore University HealthSystem
Clinical Professor of Pathology University of Chicago Pritzker School of Medicine
New Financial Realities in Healthcare
• US government funds > 50% of our nation’s $3.8 trillion healthcare expenditures
• Lab testing: >$80 billion – 3% of health care cost (1.5% of Medicare) – dictates 70% of downstream spend
• Lab must reduce cost, increase quality and speed, improve overall outcome and cost
Quality
Cost
Value =
New Government Regulations: PAMA – Protecting Access to Medicare Act
• New ‘market-based’ payment rates for lab tests
• Data collection from labs • 10% decreases to Lab Fee
Schedule year over year for 3 years with another 15% decrease years 4-6
• Commercial payer following suit
• Will move labs from revenue center to cost center
Lab’s role in Care Transformation
• Reduce waste, unneeded testing • Use of appropriate testing • Faster, more valuable results • Coordinate lab tests across spectrum of care
– Inpatient, outpatient, outreach • Be more integrated, more available to care team • Create IT solutions in physician workflow
Labs are well-positioned to influence cost and quality
Increasing Lab Value
• Appropriate Laboratory Utilization • Laboratory Consultation • Automation/lab efficiency • New approaches to diagnosis • Integration into hospital quality programs • Integration / use of IT and EMR • Track contributions: value based system
Lab utilization improvement • Right test at the right time
– Clinician understanding of 50-100 tests – Strongest predictor of lab order patterns is residency
• Nomenclature confusing • Technology evolving quickly • Tests over-ordered? under-ordered? Who orders? • The curse of the order sets! • Interpretive guidance (today’s docs are less prepared
to use the lab properly)
Utilization issue in Microbiology
• Blood cultures – >2 sets, fill volume
• Urine Cultures – Reflex from UAs? – Asymptomatic bacteruria
• Stool – O&Ps – Cdiff on formed stool
• CSF workups – Auto-ordering of large infectious panels
9
Clinical case rounds in micro lab: team consultation
Grand rounds, teaching rounds, diagnostic management teams…
Increasing consultation and communication
• Clinicians live in electronic medical record • Electronic communications prevail • Information at fingertips
• Clinicians
– Don’t know lab – Don’t know Pathologists – Don’t take time/don’t have time – Life measured in clicks – Now working in systems
MyPathologist
• Purpose • "MyPathologist" provides a
direct connection between clinicians, and Pathologists and Lab Scientists to answer questions such as: – Should a test be ordered? – Which test should be
ordered? – How should this test result
be interpreted? – Is follow-up testing needed? – I need clarification of a report
• Location
Generates Electronic Message Message is prepopulated to lead user through the process of receiving help. Text page to CP resident (smart phone)
Theparee et al, Academic Pathology 2018.
Technologic advances (faster, better, cheaper?)
• Dramatic advances in microbiology! • Specialized media • Automation • Molecular • MALDI • The need for speed • Appreciation of infection control needs
Diagnosis of infection and antimicrobial resistance
H1N1
H3N2
Swine-derived Pandemic
no templa
te
Kaul et al, J Molecular Diagnostics, 2010
Real time PCR
Conventional
Molecular and MALDI
Molecular diagnosis of MRSA sepsis Impact on Time to Result/Report and Antibiotic Use
1.9 h (report to Pharmacist)
1.9 h (total 10-17h)
24.9 h
8-15 h
Colony /PCR/ Liquid culture/PCR
15.7 h (total 58.2h)
42.5 h Colony/ Culture susceptibility
Time from Report to Antibiotic Change
Time to Susceptibility Report Specimen/Test / Method
Earlier diagnosis -> better outcomes, improved antibiotic use!
Rapid panels and POC PCR
16
Benirschke, McElvania, Thomson, Kaul and Das. Clinical Impact of Rapid POC PCR Influenza testing in the urgent care setting. JCM 57: e01281-18, January 2019.
Value of new technologies/automation
• Increased reproducibility • Aids workforce issues • Continuous work schedule, efficiency • May lower cost • Faster results
– Continual incubation – Molecular and MALDI detection – Faster diagnosis and treatment – Better clinical outcomes!
New Technology v Conventional Methods
Collection Incubation 1st “Read” 2nd “Read” Inoculation Identification 80% Identification 20% Antimicrobial Result
0 2 3 16-18 18-20 42 44 h
Collection Incubation 1st Image Inoculation Identification 100% Antimicrobial Result
0 1.5 2 10 11h 30 h
23 | AAU Study Highlights | NorthShore | April 21, 2010
Significant impact on TAT, LOS Time to ID cut by ~5 hours (23%) (now 8 h) $250K impact on cost outside lab (LOS) Tests performed/FTE increased 14% 6 FTEs ~$500K annual savings Better clinical outcomes!!
- 6% of 35 million annual admissions (2.1 million patients) develop HAI - 4th leading cause of death in U.S.; 103,000 died in the year 2000 - Most are preventable - Spending on infection control saves lives and reduces hospital stays Healthcare-Associated Infection, 2002
Treat infection, or prevent it?
Carriage of resistant organisms • MRSA, C difficile, VRE,
KPC, MDRO • Screen to identify carriers • Implement precautions
– Prevent spread • Decontamination
– Prevent infection • Improve clinical outcomes • Reduce unreimbursed cost
25
Medical and Economic Outcome • Excess expense of MRSA infection (compared
to no infection) = $24,000 • Cost of lab program under $150,000/yr • The first 10 years of NorthShore MRSA
containment program prevented 1,000 infections – Net direct benefit from medical expense reduction is
over $20 million ($2M/Year) – Number of deaths avoided = 180 (18/Year)
LR Peterson. JCM 48:683-9, 2010 LR Peterson et al. Jt Comm J Qual Patient Saf 33:732-8, 2007 RM Klevens et al. JAMA 298:1763-71, 2007
Rate of MRSA Nosocomial Infection
LR Peterson and DM Schora J Clin Micro 54:2647-2654, 2016
Total infections per 10,000 patient days
MRSA Screening Begins
EMR embedded tools
• Automatic ordering of screening PCR • Positives get isolation cart auto-sent to floor • Flag on positive patient chart in EMR • EMR-embedded risk tool since 2012
• Admission screening for C diff • Extended screening for MDROs in ICUs
Predictive Modeling for Risk-Based Testing • Our admission MRSA prevalence dropped
from 10-12 % to <2% over 10 years. • NS developed an EMR-embedded prediction
rule that reduces need for testing • Age, history, home vs nursing home, clinical
problems, other factors • Developed and validated in 25K cohorts • Reduced MRSA admission screening by half (Get credit for the $ saved!)
A Robicsek et al. ICHE 32:9-19, 2011
New Focus: Nursing home partners
• Long-term care facilities harbor MDROs! • Outbreak of KPC-producing
enterobacteriaceae in Chicago in 2010 • Developed PCR screening test for rectal
swabs (KPC, CTXm, NDM, IMP, VIM) – JCM 51:3423-25, 2013
• 70% of long-term care patients colonized – PCR more sensitive and faster than chromogenic – JCM 50:2596-2600, 2012
• Reach out to partner with nursing homes! (episodes of care, readmission rates)
Antibiotic stewardship
• 50% of inpatients get antimicrobials – Half don’t need it
• Cost, collateral issues • Increasing antimicrobial resistance • No new drugs in pipeline • CDC, WHO, IDSA on board • Mandate from JCAHO January 2017 • CMS mandate
Antibiotic stewardship: team effort
• Education of prescribers, nurses, patients • Monitoring and reporting of antibiotic use • At NS, ID docs review all new antibiotic
orders daily – EMR list generated chart review – Place recommendation in chart or page doc
• Also correlating lab results with antibiotic choice
Antibiotic stewardship - RESULTS
• 25% recommend antibiotics be cancelled • 25% recommend antibiotics be changed • 85% of recommendations accepted • Monitor actions, Rx days/1000 patients • Improved quality and outcomes • Reduced expenditures, cost
Lab is primary source of medical information
• All patients get lab tests • 70% of data in EMR is lab-derived • What to do with that data?
EMR/IT and lab partnership: Put data in hands of physicians!
• Mountains of data in EMR! • Need to move from “its in there
somewhere” to “just in time” (data at point of need)
Lab-driven predictive analytics Electronic Cardiac Arrest Risk Triage (eCART)
Age, years Number of ICU stays Respiratory rate, bpm
Heart rate, bpm Systolic bp, mm Hg Diastolic bp, mm Hg
Temperature, degrees C Pulse pressure index Oxygen saturation, % Mental status (AVPU)
Sodium, mEq/L Potassium, mEq/L
Alkaline phosphatase, U/L
Multicenter Development and Validation of a Risk Stratification Tool for Ward Patients Churpek MM, Yuen TC, Winslow C, et al. Am J Resp Crit Care Med 2014;190:649-55
Bicarbonate, mEq/L Anion gap, mEq/L
BUN, mg/dL Creatinine, mg/dL
BUN-creatinine ratio Glucose, mg/dL Calcium, mg/L
WBC, K/μL Hemoglobin, g/dL
Platelets, K/μL Total protein, g/dL
Albumin, g/dL Total bilirubin, mg/dL
AST, U/L
Exis
ting
Med
ical
risk
indi
cato
rs
The future of precision medicine: the Microbiome
• Complex host/ microbiome/ environmental interactions • Normal microbiome important in health and infection • Microbiome important in disease risk
– Inflammatory bowel disease – Diabetes – Obesity – Cancer – Preterm labor – Cancer treatment response
• Studied by deep NGS sequencing of 16S, other genes
42s
43
Maturation of the gut microbiome and risk of asthma in childhood Stokholm et al, Nature Comm. 2018 DOI:10.1038/s41467-017-02573-2
Asthma risk increases: - Caesarian section - Intrapartum antibiotics - Antibiotics in 1st year - Maternal history Newborn gut microbiome: - Matures - Different organisms - Diversity matters! - Composition of gut microbiome at 1 yr predicts asthma
Maturation of the gut microbiome and risk of asthma in childhood
Stokholm et al, Nature Comm. 2018 DOI:10.1038/s41467-017-02573-2
44