Antifungal Susceptibility Testing Data 2018

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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.


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


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/


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


What is laboratory stewardship?


Defining Stewardship

“The careful and responsible

management of something

entrusted to one's care”

https ://www.m erriam -webs ter.c om /


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


• 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/


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


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


Four basic elements of stewardship

Guidel ines by the National Com m ittee for Laboratory Stewards hip


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


• 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?”


• 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


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


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%)


How does the cost of the test compare to other diagnostic testing?

$1,625 $715 $91

Influenza Common

cold

Bloodstream

Infection


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


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


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


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


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%)


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)


$ -

$ 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


• 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


• 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.)


• 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.)


Av ailable Resources

• https://www.whitehatcom.com/cardinalhealth

• http://www.choosingwisely.com

• http://www.dmtconference.com


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

[email protected]

@nmoore07

https://www.dmtconference.com/

https://www.dmtconference.com/

https://www.whitehatcom.com/cardinalhealth

https://www.whitehatcom.com/cardinalhealth

http://www.choosingwisely.com/

http://www.dmtconference.com/

Antifungal Susceptibility Testing Data 2018

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