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Rush University Medical Center
Diagnostic Stewardship Approaches in the Clinical Microbiology Lab
SCACAM Meeting September 20, 2019
Nicholas Moore, PhD, MLS(ASCP)CM
Assistant Director, Division of Clinical Microbiology Assistant Professor
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I have no financial disclosures related to this activity/topic.
Disclosures
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At the end of this session, the participant will be able to:
Learning Objectiv es
1 Define laboratory utilization and diagnostic
stewardship.
2 Review the importance of diagnostic stewardship in
the clinical microbiology laboratory
3 Discuss different approaches to include in diagnostic
stewardship programs.
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The impact of antibiotics on medicine
CDC. M M WR. 1999 ; 48(29): 621-9.
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Antimicrobial resistance is real! “If you use penicillin,
use enough.”
Clatworthy AE, et a l . Nat Chem Bio l . 2007; 3(9): 541 -8.
• From 2000 to
2015, antibiotic
consumption ↑ 65%
• ↑ use of “last
resort” antibiotics
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Antimicrobial resistant pathogens
• Clostridioides difficile • Carbapenem-resistant
Enterobacteriaceae (CRE)
• CTX-resistant N. gonorrhoeae
• Methicillin-resistant S. aureus
• Vancomycin-resistant Enterococcus spp. (VRE)
• MDR-Mycobacterium tuberculosis
• Candida auris
https ://www.ids oc iety .org/g lobalas s ets /ids a/topic
s -of-in teres t/antim ic robia l -res is tanc e/foar-report-
1-up-fina l -1 .pdf
h ttps ://www.c dc .gov /drugres is tanc e/threat-
report-2013/pdf/ar-threats -2013-508.pdf
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• CMS proposed an amendment to hospital conditions of
participation that required all hospitals create and implement antimicrobial stewardship programs
• Reduce inappropriate antibiotic use
• Lessen risk of C. difficile infections
• Decrease antimicrobial resistance
• Joint Commission added new AS standard effective
January 1, 2017
• Hospitals, critical access hospitals, and nursing care centers
Antimicrobial Stewardship Programs
Federa l Regis ter, Vol . 81, No. 116, 2016
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IDSA Centers of Excellence
• Recognizes institutions that commit to
establishing antimicrobial stewardship programs that foster optimal therapies
• Protect patients from antimicrobial resistant infections
• Safeguarding our vulnerable drug supply
https ://www.ids oc iety .org/c l in ic al -prac tic e/antim ic robial -stewards hip/
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Appropriate antibiotic prescribing
1. Right Diagnosis
2. Right Drug
3. Right Dose
4. Right Duration
5. Deescalate (when appropriate) 5 D’s
Barlam TF, Cl in In fec t Dis 2016; 62: e51 -77
“By 2020, the United States will
reduce by 60% carbapenem-
resistant Enterobacteriaceae infections acquired during
hospitalization compared to
estimates from 2011.”
From the National Strategy:
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• Laboratory testing is the single highest volume activity
that drives medical decision making
• Utilization management or review programs are designed to right size the test
• Right patient
• Right test
• Right time
• Right cost
What is laboratory utilization?
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• Transfusion management guidelines (Blood conservation)
• Transfuse only one 1 unit RBC, only if Hgb <7g/dL
• Restrictions on stool testing in microbiology
• Nikolic D, J Clin Microbiol, 2017; 55(12): 3350
• Clinical decision support to eliminate stool culture and parasitologica l exam in hospitalized inpatients after 3 or more days
• 54% reduction for O&P, 23% reduction in Giardia/Cryptosporidium EIAs,
50% reduction in enteric culture
Examples of Laboratory Utilization Efforts
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What is laboratory stewardship?
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Defining Stewardship
“The careful and responsible
management of something
entrusted to one's care”
https ://www.m erriam -webs ter.c om /
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World Health Organization
“Coordinated guidance and interventions to
improve appropriate use of microbiological diagnostics to guide therapeutic decisions.
It should promote appropriate, timely diagnostic testing, including specimen collection, and pathogen identification and accurate, timely
reporting of results to guide patient treatment.”
World Heal th Organiz ation. (2016). Diagnos tic s tewards hip: a gu ide to im plem entation in antim icrobia l res istanc e
s urv e i l lanc e s i tes . World Heal th Organiz ation. h ttps ://apps .who.in t/i ris /handle/10665/251553
Global Antimicrobial Resistance Surveillance System (GLASS)
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Goals of a diagnostic stewardship program
Improv e the
quality of
patient care
Optimize
resources Reduce waste
1 2 3
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• Ordering laboratory tests is complicated
• Wrong tests ordered
• Tests overused, underused
• Appropriate testing is becoming increasingly more challenging as the number of laboratory tests increases
• Diagnostic stewardship involves modifying the process of ordering, performing, and reporting the results to improve treatment
• Diagnostic-guided therapy
Diagnostic Stewardship
M organ DJ , et a l . J AM A. 2017: 318;(7): 607
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Diagnostic Stewardship and Choosing Wisely
• More than 600 Choosing Wisely
recommendations
• 42 related to microbiology/infectious diseases
• Do not routinely test for community gastrointestinal
stool pathogens in hospitalized patients who develop diarrhea after day 3
• Do not repeat Hepatitis C virus antibody testing in
patients with a previous positive result
https ://www.c hoos ingwis e ly .org/
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Laboratory Testing in the United States
CLIA certificate type No. laboratories No. tests performed
Certificate of Compliance 20,470 3,122,772,023
Certificate of Accreditation 16,829 8,998,058,524
Certificate of Waiver 158,996 477,094,700
Certificate of PPM 38,461 207,777,472
Total 234,756 12,805,702,719
Federal Register, Vol. 79, No. 25, 2014
70% of medical
decision making
3% of U.S.
healthcare costs
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Diagnostic Stewardship Guidelines
• 3 significant causes of patient harm are related
to laboratory services
• Ordering the wrong test
• Failing to retrieve a test result
• Misinterpretation of a test result
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Four basic elements of stewardship
Guidel ines by the National Com m ittee for Laboratory Stewards hip
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Interv entions for diagnostic stewardship
Guidel ines by the National Com m ittee for Laboratory Stewards hip
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8,963,991,903
3,841,710,816
30% of tests
are deemed
medically
unnecessary
1. Overutilization
2. Underutilization 3. Duplicate testing
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• Inappropriate testing likely leads to unnecessary patient
discomfort
• Increases the likelihood of generating false-positive results
• Anxiety, further and unnecessary diagnostic studies
Ov eruse of laboratory tests
Van Walrav en C, et a l . J AM A, 1998;280(6):550 -558.
“Doweknowwhatappropriatelaboratory utilizationis?”
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• Order tests as panels
• Unnecessary repeating of tests
• Lack of test understanding
• Pre-test probability
• Suboptimal method to detect infection
• Patient pressure
• CYA testing
• Training/practice/culture
• CPOE
Why is there ov erutilization of lab tests?
As tion M L. Laboratory Errors and Patient Safety . 2006; 2(4):8-9
Let’s apply Diagnostic Stewardship to a specific example
in the clinical microbiology lab
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1. Most respiratory viral infections are mild and self-limiting
2. Syndromic panel has +20 targets
3. Directed therapy is available only for influenza
4. Proposed guidance that CMS would stop paying for syndromic panels
5. Test was implemented without any guidance on appropriate utilization
Problem: Too many respiratory pathogen panel tests are being ordered
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0
50
100
150
200
250
300
1 3 5 7 9 11 13 15 17 19 21 23 25 27 29 31 33 35 37 39 41 43 45 47 49 51 53
# T
es
ts o
rde
red
an
d r
ep
ort
ed
Week Number (per FY calendar)
Number of RPP tests ordered per week at Rush
FY2017 FY2016
Shaded reg ion s pans typ ica l in fluenz a s eas on (Nov 1 – Apr 30)
Fiscal Year
# Tests performed
FY reagent cost
2016 5382 $694,278
2017 6198 $799,542
2018 7875 $1,015,875
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0100200300400500600700800900
1000
In 2017, only 33% of RP tests were positiv e!
• 6,198 RP tests performed
• 2,053 were positive for any virus
• Influenza: 504 (8%)
• RSV: 268 (4%)
• Adenovirus, Parainfluenza, hMPV: 365 (6%)
• Enterovirus/Rhinovirus, Coronavirus: 916 (15%)
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How does the cost of the test compare to other diagnostic testing?
$1,625 $715 $91
Influenza Common
cold
Bloodstream
Infection
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How can we improv e test utilization?
• Restrict respiratory pathogen testing to
patients most likely to benefit from results
• Narrow assay that tests for influenza and RSV only
• RPP testing available for patients at higher risk for
severe infection due to respiratory viruses other than influenza
• Educate clinicians
• Audit test utilization in real-time via Quality
Management with follow-up to ordering physician
Value
Co
st
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Epic ED Order Set
• No RPP; only Flu/RSV testing for ED
• More rapid test TAT faster diagnosis decrease ED patient wait time increase patient satisfaction
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Inpatient Order Set • Must have negative
Flu/RSV and approved clinical indication for RPP • Must add test in Epic AND • Call Micro Lab
• Exceptions: • BAL fluid: RPP only • Rare immunocompromised
patient
• Real-time auditing of RPP test orders with feedback to ordering and attending physicians planned
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RPP Orders by ED Prov ider
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$-
$5,000
$10,000
$15,000
$20,000
$25,000
$30,000
$35,000
$40,000
$45,000
Cost Avoidance
Cos t - BF Alone Cos t - H ybrid
Implementation of Flu/RSV test for the majority of testing led to a cost avoidance of $321,740
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Comparing RP Testing Year Over Year Week Tested FY 2018 Tested FY 2017 Tested FY 2016
Nov
18 80 95 111
19 136 90 127
20 106 107 102
21 107 116 100
Dec
22 141 81 123
23 153 92 108
24 185 119 117
25 168 136 110
26 221 155 113
Jan
27 307 192 149
28 322 177 113
29 268 159 139
30 289 168 148
Feb
31 318 181 181
32 266 224 174
33 298 247 158
34 253 246 171
Mar
35 192 252 198
36 195 178 187
37 155 181 149
38 189 175 158
Apr
39 166 182 137
40 137 183 120
41 145 185 94
42 131 134 95
43 112 129 78
Total tests performed 5040 4184 3460
• 2017-2018 influenza season was
severe, started earlier
• Nationwide reagent shortages from all vendors in December
• In the 2017-2018 influenza season, we performed ~20% more tests
• Many labs estimate they performed ~30% tests this year compared to
last year – 400 extra tests avoided
– $51,600 additional cost avoidance
CDC. M WWR. 2018; Vol 67/No. 6 .
CAP Today . M arc h 2018.
856(↑20%)
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Seasonal discontinuation
• Discontinued ALL testing in ED locations
• Discontinued Flu/RSV testing
• W ill reactivate Flu/RSV assay in late fall
0
20
40
60
80
100
120
140
160
180
200
Nu
mb
er o
f Te
sts
Respiratory Virus Testing
Spring and Summer 2017-2018
2018 2017
Apri l M ay J une J u ly Aug Sept
Total cost avoidance for RML with new testing and implementing test restrictions and best practices = $373,340 ($321,740 reagent costs alone)
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$ -
$ 5,0 0 0
$ 10 ,0 00
$ 15 ,0 00
$ 20 ,0 00
$ 25 ,0 00
0
5 0
1 0 0
1 5 0
2 0 0
2 5 0
3 0 0
3 5 0
1 3 5 7 9 11 13 15 17 19 21 23 25 27 29 31 33 35 37 39 41 43 45 47 49 51 1 3 5 7 9 11 13 15 17 19 21 23 25 27 29 31 33 35 37 39 41 43 45 47 49 51
Jul Aug Se p Oct Nov Dec Jan Fe b Ma r Apr Ma y Jun Jul Aug Se p Oct Nov Dec Jan Fe b Ma r Apr Ma y Jun
Weekly Flu/RSV and RPP Test Volume
B io Fire Xp ert R P Pan el C ost
Implemented Cepheid assay
Implemented GenMark
ePlex
Deactivated Cepheid
Reactivated Cepheid
2017 2018 2019
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• Still opportunities to reduce overall testing
• Peak flu season, with ILI symptoms: no test, treat empirically
• W orking with ID Fellow to conduct a review of all patients with orders that were Flu/RSV negative that went on to have an RPP performed or had multiple RPP tests
performed
• Opportunities to reduce further unnecessary testing
• Does the selected indication fit the clinical picture?
• How did the RPP result affect patient management?
Next steps on RPP stewardship
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• Form a Diagnostic Stewardship committee
• Identify laboratory champion(s) and clinician champion(s)
• Develop and publish a laboratory formulary
• In-house tests
• Reference tests
• #1 available to all providers
• #2 restricted available only to subspecialty providers
• #3 limited need/high cost (e.g., once in a lifetime tests)
• Reference laboratories – consolidation?
Additional diagnostic stewardship strategies
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• Partner with IT in your institution to optimize CPOE/order
sets
• Remove obsolete tests
• Embed clinical algorithms, decision making tools
• System auto-cancels duplicate testing
• Laboratory reflex testing
• Benchmarking providers against peers
Additional diagnostic stewardship strategies (cont.)
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• Specimen rejection
• Decrease/eliminate testing of low yield specimens
• Consider forming Diagnostic Management Teams (DMTs)
• https://www.dmtconference.com/
• Structured similar to Tumor Boards
• Interdisciplinary teams meet to discuss a complex case, develop
plan
• Communicate!
Additional diagnostic stewardship strategies (cont.)
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Av ailable Resources
• https://www.whitehatcom.com/cardinalhealth
• http://www.choosingwisely.com
• http://www.dmtconference.com
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Summary
1. Diagnostic stewardship is an emerging
hot topic in clinical laboratories
2. As newer, more complicated tests become widely available, laboratory experts are urgently needed to partner with providers
3. Interdisciplinary team-based approach will help to ensure appropriate diagnostic
testing at the right time in order to optimize clinical care
Thank you.
Nicholas Moore, PhD, MLS(ASCP)CM
@nmoore07
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