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IHI ExpeditionReducing Clostridium difficile Infections Session 2: Rapid Detection and Isolation

July 9, 2014

These presenters have

nothing to disclose

Brian Koll, MDCliff McDonald, MDDiane Jacobsen MPH, CPHQ

Today’s Host2

Morgen Palfrey, Project Coordinator, Institute for

Healthcare Improvement, is the current coordinator for

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Morgen graduated from the University of Florida in

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Public Administration.

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Expedition Director8

Diane Jacobsen, MPH, CPHQ, Director, Institute for Healthcare Improvement (IHI) is currently directing the CDC/IHI Antibiotic Stewardship Initiative, NSLIJ/IHI Reducing Sepsis Mortality Collaborative. Ms. Jacobsen served as IHI content lead and improvement advisor for the California Healthcare-Associated Infection Prevention Initiative (CHAIPI) and directed Expeditions on Antibiotic Stewardship, Preventing CA-UTIs, Reducing C.difficle Infections, Sepsis, Stroke Care and Patient Flow. She served as faculty for IHI’s 100,000 Lives and 5 Million Lives Campaign and directed improvement collaboratives on Sepsis Mortality, Patient Flow, Surgical Complications, Reducing Hospital Mortality Rates (HSMR) and co-directed IHI’s Spread Initiative. She is an epidemiologist with experience in quality improvement, risk management, and infection control in specialty, academic, and community hospitals. A graduate of the University of Wisconsin, she earned her master’s degree in Public Health- Epidemiology.

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Today’s Agenda9

Introductions

Action Period Assignment

Debrief

Rapid Detection & Isolation

Action Period Assignment

Expedition Objectives

At the end of this Expedition, participants will be able to:

Explain the impact of the increasing incidence and

severity of C. difficile on hospitals

Discuss key approaches to preventing the spread of C.

difficile in the hospital setting

Identify and begin improving at least one key process for

impacting C. difficile in their hospital

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Schedule of Calls

Session 1 – Making the Case for Reducing Clostridium difficileInfections (CDI)

Date: Wednesday, June 25, 2:00 – 3:30 PM ET

Session 2 – Rapid Detection and IsolationDate: Wednesday, July 9, 2:00 – 3:00 PM ET

Session 3 – Symptom Recognition, Precautions, and the Role of the EnvironmentDate: Wednesday, July 23, 2:00 – 3:00 PM ET

Session 4 – Antibiotic StewardshipDate: Wednesday, August 6, 2:00 – 3:00 PM ET

Session 5 – The Role of LeadershipDate: Wednesday, August 20, 2:00 – 3:00 PM ET

Session 6 – Transitions and Long- term CareDate: Wednesday, September 3, 2:00 – 3:00 PM ET

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Action Period Assignment Debrief

Assess your current process for identifying patients with C diff. Does it include:

- A flagging system for patients previously hospitalized with C diff?

- Prompt implementation of isolation precautions for patients suspected of C diff, pending laboratory confirmation?

- Prompt notification from the laboratory of results of testing?

“Assess” this process by interviewing a bedside nurse on a unit caring for C diff patient(s)

What did you learn? Insights? Surprises?

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Faculty13

Brian Koll, MD, FACP, FIDSA, Executive Director for Infection Prevention, the Mount Sinai Health System, New York, NY, is a nationally-renowned and award-winning infection prevention expert. He has been featured on CBC Evening News for successful efforts to reduce central line associated bloodstream infections, on World News Tonight for successful efforts to control C. difficile, and in a national public service announcement regarding this disease by the Peggy Lillis Memorial Foundation.

Faculty14

Cliff McDonald, MD, is a former officer in the Epidemic Intelligence Service and is currently the Senior Advisor for Science in the Division of Healthcare Quality Promotion at the CDC. This division seeks to protect patients and healthcare personnel and promotes safety and quality in healthcare delivery systems. Examples of activities include programs for addressing antimicrobial resistance, healthcare-associated infections, and other adverse events affecting patients and healthcare workers. Dr. McDonald is an expert in Clostridium difficile, an antibiotic resistant bacterium.

Dr. McDonald graduated from Northwestern University Medical School in Chicago. He completed his Internal Medicine Residency at Michigan State and an Infectious Diseases Fellowship at the University of South Alabama, following which he completed a fellowship in Medical Microbiology at Duke University. Past positions have included Associate Investigator at the National Health Research Institutes in Taiwan, where he helped develop an island-wide surveillance system for antimicrobial resistance, and Assistant Professor in the Division of Infectious Diseases at the University of Louisville, where he worked as a hospital epidemiologist in infection control. He is the author or co-author of over 100 peer-reviewed publications, is a Fellow of the American College of Physicians and the Society for Healthcare Epidemiology of America, and a member of the Infectious Diseases Society of America and American Society for Microbiology.

Areas of Expertise include: C. Difficile, Drug Resistant Pathogens, and Healthcare Associated Infections

To request an interview, call CDC′s Division of Media Relations at (404) 639-3286, or e-mail us at media@cdc.gov.

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Changing from EIA to

GDH PCR Testing for CDI

Brian Koll, MD, FACP, FIDSA

Executive Director, Infection Control

Mount Sinai Health System

Professor of Medicine

Icahn School of Medicine

Acknowledgements

Research Fellow

• Jennifer Leoniak DO

Data Collection

• Jonathan Martin, MD

• Rie Ueno, MD

• Aaron Etra, MD

Statistical Analysis

• David Lucido, PhD

Microbiologic Data

• William Riley, PhD

Pharmaceutical Data

• Tom Jodlowski, PhD

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BACKGROUND

▶ Clostridium difficile (CDI) is the most commonly

recognized cause of infectious diarrhea in health

care settings and is one of the most common

healthcare associated infections

▶ The goals of testing patients with clinical

significant diarrhea (CSD) are to identify cases

of Clostridium difficile infection.

Cohen, S.H., Gerding, D.N., Johnson, S., Kelly, C.P., Loo, V.G., McDonald, L.C., Pepin, J., Wilcox, M.H.,

Clinical Practice Guidelines for Clostridium difficile Infection in Adults: 2010 Update by the Society for

Healthcare Epidemiology of America (SHEA) and the Infectious Diseases Society of America (IDSA).

Infection Control and Hospital Epidemiology 2010; 31 (5): 431 – 455.

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BACKGROUND: Testing Algorithms

▶ One of the ways hospitals can decrease CDI

incidence and decrease length of stay is through

improved testing protocols, which can decrease

spread of CDI through increased detection and

more rapid implementation of infection control

measures.

▶ Diagnostic testing for CDI has undergone a

paradigm shift in recent years from

immunoassay for toxins A and B, to the newer

molecular assays or combination algorithms

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BACKGROUND: Performance for Testing

Strategies

Performance Characteristics: Results for Different Testing Strategies

Assay(s)Sensitivity

%

Specificity

%

Approx. Cost of Testing

Materials at our Facility

($)

Toxin A/B alone 32-98.7 84-100 5.00

GDH and toxin A/B EIA 41-92 94-100 15.00

GDH/toxin A/B EIA and

molecular68-100 97-100 15.00-30.00

Molecular alone 73-100 91-100 30.00

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GDH assay had lower sensitivities with specimens positive for ribotypes other

than 027

BACKGROUND: FDA APPROVED PCR

Food and Drug Administration-Approved

Polymerase Chain Reaction Assays for

Clostridium difficile

Gene Target (s) Time (min)

tcdB 75-100

tcdB 180-200

tcdB +/-

tcdC

Binary toxin

30-45

tcdB 60-90

tcdA

tcdB

tcdC

110-120

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tdcC gene is found in NAP1/BI/O27 strains and is

associated with increased toxin production

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Stool Sample

GDH Positive Toxin Positive

“TRUE POSITIVE”

GDH Positive Toxin Negative“Possible CDI”

PCR for Toxin

Positive Negative

GDH Negative Toxin Negative

“TRUE

NEGATIVE”

CDI Protocol

• When CDI test ordered, patient automatically

placed on contact precautions

• When patient placed on oral metronidazole or

oral vancomycin, review for need for contact

precautions

• CDI result treated as critical value with results

called to the patient care area

• Education of healthcare providers

– Frequency of testing

– Interpretation of results

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Results of CDI Testing

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Results of CDI Testing

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Results of CDI Testing

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Results of CDI Testing

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New York State DOH

Hospital Acquired Infections Report 2012

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Contact Precautions Traffic Light

PATIENTS ON ISOLATION PRECAUTIONS

March 7, 2013

Patient MR# Room Source Organism Precautions

F 6 5L02A Blood MDR Acinetobacter / VRE Strict Contact

G 7 5L03A Urine / Wound MDR Klebsiella / VRE Strict Contact

H 8 5L03B Blood MDR Acinetobacter / VRE Strict Contact

I 9 5L03C Blood / Nasal MDR Klebsiella / MRSA Strict Contact

J 10 5L04C WoundMDR Klebsiella / MDR Pseudomonas / VRE/ MDR

Acinetobacter Strict Contact

M 13 SICU10 Blood / Wound MRSA Contact

N 14 SICU01 Abscess VRE Contact

O 15 11L16P Wound MRSA / C. difficile Contact

P 16 11L12B Stool MRSA Contact

U 21 5L01B Nasal MRSA Contact

V 22 5L02B Sputum MRSA Contact

W 23 MICU07 C. difficile Contact

X 24 11L12B C. difficile Contact

Y 25 10D05S C. difficile Contact

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Contact Precautions Traffic Light

Patients with Multi-Drug Resistant (MDR) or Pan-Drug Resistant (PDR)

Acinetobacter, Klebsiella, etc. should be on strict contact precautions and

cohorted. Staff caring for these patients should not care for other non-infected

patients. Equipment used on these patients should not be used on non-infected

patients.

Care givers should wear gowns and gloves when entering the room tosee these patients. Masks should be worn if suctioning is necessary.

Rooms must be terminally cleaned after a patient with this organism isdischarged and cleared by Infection Control before a new patient isadmitted.

Patients with Clostridium difficile should be cohorted. Upon discharge,the room must be terminally cleaned using a 1:10 bleach solutionafter initial cleaning with the hospital approved germicide. While apatient is in the hospital a 1:10 bleach solution should be used fordaily cleaning as needed.

CDI Bundle Compliance

Ownership by the Unit

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New York State DOH

Hospital Acquired Infections Report 2012

New York State DOH

Hospital Acquired Infections Report 2012

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Patient Demographics

Patient DemographicEIA

n = 331GDH PCRn = 495

p Value

Age (mean) 64 65 0.663

Female 175 (53) 273 (55) 0.576

Race

White 175 (53) 257 (52) 0.767

Black 56 (17) 94 (19) 0.368

Hispanic 46 (14) 64 (13) 0.542

Asian 30 (9) 35 (7) 0.352

Other 20 (6) 46 (8) 0.331

Charlson Comorbidity Index (mean) 13 (4) 20 (4) 0.689

Prior Hospitalization 113 (34) 173 (35) 0.658

CDI positive patients 31(9) 37(7) 0.3326

Patient Demographics

EIA(n=31)

GDH PCR(n=37)

p Value

Severity in Positive Patients

Mild to Moderate 17 21 0.874

Severe 11 11 0.613

Severe Complicated 3 5 0.625

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TESTINGEIA

(n=331)

GDH PCR

(n=495)p Value

Total Test Cost ($) 10 (5-30) 22 <0.000

Mean Days to

Final Test Result3 (1-13) 2 (1-8) <0.000

EIA

(n=31)

GDH PCR

(n=37)p Value

Total Test Cost ($) 12 41 <0.000

Mean Days to

Final Test Result3 (1-8) 3 (1-6) 0.6493

TESTING (CDI POSITIVE PATIENTS)

Number of Tests Performed

Total EIA Tests Performed

n = 635

Total GDH PCR Performed

n = 604

0

50

100

150

200

1 2 3 4 5 6 7 8 9

Quantity of EIA Tests Ordered During a Single

Episode

050

100150200250300350400450

1 2 3 4

Number of GDH PCR Tests Ordered During a Single

Episode

36

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RESULTS FOR PCR

0

50

100

150

200

250

300

350

400

450

0 1 2 3

Results Number

Positive 26 (45%)

Negative 32 (55%)

58 (12%) out of 495 possible CDI

NUMBER OF PCR TESTS

PERFORMED IN A SINGLE

EPISODE

05

101520

1 2 3 4 5 6 7 8

Number of Hospital Days to PCR Results

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RESULTS FOR ALL PATIENTS

EIA

(n=331)

GDH PCR

(n=495)p Value

Length of Stay (mean) 19 12 <0.000

30d Readmission 86 (26) 134 (27) 0.774

Total Test Costs ($) 10 22 <0.000

Mean CDI Antibiotic Cost ($) 12 6 0.0016

Death within 30d 23 11 0.001

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RESULTS FOR CDI POSITIVE PATIENTS

EIA

(n=31)

GDH PCR

(n=37)p Value

Mean Length of Stay 28 15 <0.014

Escalation of Care 13 6 0.019

Mean Total Test Costs ($) 12 41 <0.000

Mean CD Antibiotic Cost ($) 61 30 0.0741

Recurrence within 30 days 5 2 0.147

Death within 30d 9 2 <0.000

EIA to GDH PCR for CDI

• The amount of CDI detected was not

significantly different between the two testing

methodologies

• 12% required confirmatory testing by PCR

• Decreased time to result by one day

• During time period GDH PCR in place

– Decrease in length of stay

– Decrease in antibiotic costs

– Decrease in escalation of care

– Decrease in all cause 30 day mortality

– Increase in cost of testing

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EIA to GDH PCR for CDI

• During time period GDH PCR in place

– Decrease in length of stay

– Decrease in antibiotic costs

– Increase in cost of testing

• Costs during EIA = $1,705,090

• Costs during GDH PCR = $1,099,440

• Reduction in costs overall = $605,650

Questions/Discussion42

Raise your hand

Use the Chat

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Carolyn Gould, MD, MSCR

L. Clifford McDonald, MD, FACP, SHEA

Division of Healthcare Quality Promotion

Centers for Disease Control and Prevention

Clostridium difficile Infection: Rapid Detection and Isolation

National Center for Emerging and Zoonotic Infectious Diseases

Division of Healthcare Quality Promotion

Vital Signs: 6 Key Components of Prevention

Prescribe and use antibiotics carefully

Focus on an early and reliable diagnosis

Isolate patients immediately

Wear gloves and gowns for all contact with patient

and patient care environment

Assure adequate cleaning of the patient care

environment, augment with EPA-registered C.

difficile sporicidal disinfectant

Notify facilities upon patient transfer

http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6109a3.htm

Rapid detection and isolation

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Components of Rapid Detection and

Isolation

Screen

patients for

new-onset

diarrhea on

admission and

on a regular

basis.

Facilitate early

testing.

Consider

nurse-driven

protocols.

Pair testing with

order for Contact

Precautions.

Use more

sensitive testing

methods.

Optimizing Testing

Enzyme immunoassay (EIA) for toxin sensitivity 48%-

67%

More sensitive tests:

Nucleic-acid amplification tests (NAAT)

• Polymerase chain reaction (PCR)

• Loop-mediated amplification (LAMP)

GDH + toxin testing of positive specimens

• GDH less sensitive (79%-98%) compared to NAAT or toxigenic

culture in a recent meta-analysis

Tenover FC, Novak-Weekley S, Woods CW, et al. J Clin Microbiol 2010; 48:3719–24

Tenover et al. J Mol Diagn 2011;13:573-82

Peterson et al. Clin Infect Dis 2007;45:1152-60

Shetty et al. J Hosp Infect 2011;77:1-6

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Typical Diagnostic Algorithm for Detection of

Toxigenic C. difficile in Stool Specimens

Kufelnicka and Kirn T J Clin Infect Dis. 2011;52:1451-57

FDA-Approved Commercial NAAT Assays

5 currently

4 use PCR to detect toxin B gene (tcdB)

1 uses LAMP to detect toxin A gene (tcdA)

• Only LAMP assay specifically cleared for testing symptomatic

children 1-2 years of age

• Although some C. difficile strains are toxin A negative, vestigial tcdA

sequences still present in such strains are reportedly sufficient to

provide a signal

Tenover et al. J Mol Diagn 2011;13:573-82

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances

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First and Foremost…

• For any testing method, you need a favorable pre-

test probability of disease for optimal performance

– Diagnostic accuracy improves with increasing

prevalence of disease in the population tested

• That means testing appropriately:

– Watery/unformed stool (conforms to shape of

container)

– At least 3 unformed stools in 24 hours

– Avoidance of repeat testing, tests of cure

• Lab stool rejection policies important

Making Early and Accurate Diagnosis a Reality To Realize Benefit of NAAT Need a Rational Testing Strategy

Meta-analysis of 19

studies, 7392 samples

Mean sensitivity: 90%

Mean specificity: 96%

Deshpande et al. Clinical Infectious Diseases 2011;53(7):e81–e90

“…a 15-20% testing prevalence with

a NAAT may be more achievable than

a 8-12% prevalence with an EIA…”

--LC McDonald

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Results of Repeat PCR Tests Following a

Negative Result.

Luo R F and Banaei N J. Clin. Microbiol. 2010;48:3738-41

How Will Use of NAAT Affect CDI Incidence Rates?

Source Change in testing % Increase in

CDI incidence

3 states in CDC’s

Emerging Infections

Program CDI surveillance

EIA → PCR 43% - 67%

Multi-hospital EIA → PCR 56%

Single center EIA → PCR 57%

Single center EIA → PCR 110%

Single center GDH+EIA+CCNA → PCR 50%

Single center EIA → GDH+PCR 97%

Single center GDH+EIA → GDH+EIA+PCR 70%

Gould et al. Clin Infect Dis 2013 Longtin et al. Clin Infect Dis 2012; advanced access

Moehring et al ICHE 2013;34:1051-66 de Jong et al. Eur J Clin Microbiol Infect Dis 2012;31:2219-25

Goldenberg SD. Infect Control Hosp Epidemiol 2011;32:1231-2 Fong et al. Infect Control Hosp Epidemiol 2011;32:932

Williamson et al. Am J Infect Control 2012; in press

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NHSN CDI Risk Adjusted SIR Accounts for

More Sensitive Testing

Factor Description

Intercept

Facility Bed Size > 245

101-245

≤ 100

Teaching Type Major

Graduate

Limited & Non

CDI Test Type NAAT (PCR)

EIA

All Other

Prevalence Continuous

(no CO-HCFA)

Data Sources and Submission

• CDI test type, facility bed size, and

teaching type are collected on the

required Annual Facility Survey.

• The survey is completed after the

end of each year for accuracy in

describing a full year’s worth of data.

Variables from Final Model to be included

for Risk Adjustment in SIR Calculation

Potential Benefits of More Sensitive Testing

Fewer isolation days for negative patients

Fewer repetitive tests performed (46% at one institution

with restriction rules in place)

In theory, earlier treatment initiation, reduced

complications, and improved infection control

Gould et al. CID 2013;57:1304

Moehring et al. ICHE 2013;34:1055-61

Loo VG, Frenette C. Presented at ICAAC 2011. Abstract D-1273

Morgan M, Grein J, Ochner M, Hoang H, Jin A, Murthy R. Presented at ICAAC 2011

Belmares J, Pua H, Schreckenberger P, Parada J. [abstract 150]. Presented at SHEA 2011 Annual Scientific Meeting, 1–4 April, 2011; Dallas, TX

Goldenber g SA et al. ICHE 2011

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Early Detection of CDI: Importance of

Inter-Facility Communication

Hospital Post-acute care Long-term acute care

Nursing home/SNF

Home health

Hospice

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Post Symptomatic CDI Carriage: Particularly Contagious Asymptomatic Carriers?

Sethi AK et al. Infect Control Hosp Epidemiol 2010; 31:21-27

http://www.cdc.gov/HAI/toolkits/InterfacilityTransferCommunicationForm11-2010.pdf

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For more information please contact Centers for Disease Control and

Prevention1600 Clifton Road NE, Atlanta, GA 30333

Telephone, 1-800-CDC-INFO (232-4636)/TTY: 1-888-232-6348

E-mail: cdcinfo@cdc.gov Web: www.cdc.gov

The findings and conclusions in this report are those of the authors and do not necessarily represent the official

position of the Centers for Disease Control and Prevention.

Thank you!

Questions?

National Center for Emerging and Zoonotic Infectious Diseases

Place Descriptor Here

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Questions?61

Raise your hand

Use the Chat

Action Period Assignment

Rapid detection and precautions for C diff – test a process:

To expedite patients being placed on contact precautions when C diff is suspected or confirmed

- Test a flag, prompt, etc. to automatically initiate contact precaution when CDI test is ordered. (one unit, one nurse/unit clerk, refine based on initial test)

- Test a process to review patient placed on oral metronidazole or oral vancomycin, for need for contact precautions (one unit, one pharmacist/nurse, one day on MDR’s – refine based on initial test)

- Test a process to enhance STAT reporting of CDI, ie: critical value(one unit, one week, partner with laboratory – refine based on initial test)

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Expedition Communications

Listserv for session communications:

CdiffExpedition@ls.ihi.org

– To add colleagues, email us at info@ihi.org

– Pose questions, share resources, discuss barriers or successes

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Next Session

Session 3: Symptom Recognition, Precautions, and

the Role of the Environment

Wednesday, July 23rd, 2:00 PM – 3:00 PM ET

Faculty: Brian Koll MD & Cliff McDonald MD

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