Outbreak Managementit takes a village….

November 20, 2014 | Linda Stein

Marge Gribogiannis

Objectives • Identification of an outbreak

• To be able to perform the outbreak management process1. Identify investigation team and resources

2. Establish existence of outbreak

3. Verify diagnosis

4. Develop case definition

5. Case finding and line listing

6. Descriptive epidemiology/develop hypothesis

7. Evaluate hypothesis/conduct additional studies

8. Implement control and prevention measures

9. Communicate findings

10.Maintain surveillance

Outbreak Investigation

Principles

- Be systematic

- Re-assess

- Coordinate with partners

Outbreak Management Cycle1. ID Team and

Resources

2. Establish existence of outbreak

3. Verify diagnosis

4. Develop case definition

5. Case finding and line listing

6. Descriptive epidemiology/develop

hypothesis

7. Evaluate hypothesis/Conduct

additional studies

8. Implement control and prevention

measures

9. Communicate

10. Maintain surveillance

Outbreak Investigations. The 10 Step Approach. Zack Moore.MD. https://epi.publichealth.nc.gov/cd/lhds/manuals/cd/training/Module_1_1.6_ppt_OutbreakInvestigation.pdf

1. IP Team & Resources

• 638 bed Academic Teaching Center

• Located in the NW suburbs of Chicago

• Infection Prevention Program:

– 5 FTE (including manager position)

– Infection Prevention Physician Chair

– Data-mining software System

2. Establish existence of outbreak

What made this an outbreak?

Over the course of one month:

• 3 readmissions with CRE

• Specimen source varied

• Organism metallo beta-lactamase positive

• Confirmed strain as NDM-1(Epidemiologically

important pathogen)

• Eventually PFGE same

3. Verify the Diagnosis• Background

– Diagnosis

– Not lab error

– Commonality

• Possible cause

• Source spread of disease

4. Develop case definition

• Person, place & time

• Clinical information: characteristics,

location, time

Case finding:

Any patient identified with specimens

positive for Enterobacteriaceae metallo

beta lactamase and/or a readmission

history of GI procedure.

5. Case finding & line listing• Identification, clinical info, time, demographics,

location, risk factors, possible causes– Patient

– Sex

– Age

– Admit diagnosis

– Admit date

– Patient location

– Previous admissions and room locations

– Medical history (surgery, immuno-compromised)

– Risk Factors (e.g. prior nursing home stay, roommate of other CRE patient,

procedure, equipment)

– Culture and date of collection

– Treatment

– Discharge status

6. Descriptive epidemiology/develop hypothesis

• Three patients were identified with specimens

(e.g. ,urine, sputum,) positive for E. coli, New

Delhi metallo beta-lactamase and history of

GI lab procedure.

• Could this be related to specific procedure?

ERCP?

6. Descriptive Epidemiology/Timeline

IP and CCDPH Epi Review• Patient :88 years old female from Niles IL

• History of travel outside of the United States: None

• Potential Risk factors: Dementia, multiple antibiotic treatments due to

frequent UTI s

• Transmission source: No roommates during ALGH admissions

Location In Date Out Date Comment

Nursing home A 3/30/2013 Present Contact Precautions

ALGH Unit 15 W 3/26/2013 3/30/2013 Discharged to Nursing home A

ALGH Unit ER admit from home

2/25/2013 3/26/2013 Admit with UTI ,E.coli MBL

Nursing home A 2/22/2013 2/25/2013 UTI with VRE

ALGH 5 TWR (Admit from home /had 24 hr caregiver)

1/28/2013 2/2/2013 Admit for UTI

Epi-linked surveillance• Point prevalence surveillance for unrecognized

CRE cases and ongoing transmission.

• Conduct AST of patients with epidemiologic links to

a patient with CRE infection (i.e. patients in the

same unit).

• Partner with:

– Risk management

– Clinical unit

– Physicians

– Patient educationCDC Guidance for Control of Carbapenem-Resistant Enterobacteriaceae (CRE) 2012 CRE

Toolkit.

Evaluating the hypothesis

Step 8. Infection prevention measures:

• Review department policy & procedure

• Observation practice

- ERCP procedure (pre & post)

- High level disinfection

• Bring in equipment manufacturers

• Review & observe Environmental Services procedure

• Environmental surveillance (transmission source)

• Education

• Epi-linked surveillance (unit-based surveillance)

Cleaning and disinfection of Procedure Rooms: Including but not limited CATEGORY EQUIPMENT/ITEMS and FREQUENCY OF CLEANING PERSON WHO CLEANS

EQUIPMENT

Environment (items that do not touch the patient)

Daily, discharge cleaningO2 regulator, Suction regulatorHigh dusting Green Cord Organizer CoverC arm exterior & High dusting monitor screensPhones ,Chairs, Trash cansExterior of sharps containers, Windowsills*Suction compartment on floor near ERBE machineBumper guards, Top of supply cabinet Countertops (Gi lab to remove books, etc.)Floor: wet mop w/ H25 daily in evening

Environmental Services

Radiology Daily or when visibly soiledC arm and ESP-Cine, Instruments, cablesTechnician table, RBE cautery cartLead aprons

Radiology Tech

Laboratory After each use or when visibly soiledMicroscope stage; adjustment knobs; objectives; revolving nosepiece; armPlastic cover over Microscope when not in use

Histology tech

Nursing After each use or when visibly soiledEndo cart** Nurse Serve supply cartBlood pressure cuffsDaily Keyboards , Massimo leads, IV poles

Nursing

Intubation StationAnd Anesthesia Cart

After each use or when visibly soiledWork station areaAlaris IV pump; Propofol Infusion pumpWeeklyData Ohmeda monitor and cordsExterior of cart including wheels

Anesthesia

Epi-linked Active Surveillance Testing

• Develop ―detect and protect‖ screening

protocol– Engage your IP partners.(i.e. Nursing, IS, Physicians)-

– Conduct bed-trace of patients

– Provide education on CRE to both physicians and healthcare

associates including specimen collection.

– Provide patient education (SHEA MDRO FAQ)

– Connect with Laboratory about testing

– Follow up for any positive CRE screen results

– Performed on various nursing units, & Epi-link ECF

CRE Active Screening (AST)

Informing the patientA patient on the same unit you have been on has recently received diagnoses

of a very rare bacterial infection. The bacteria that caused this type of infection

have been seen in only 4% of US Hospitals. It is unclear at this time how this

individual became infected but we believe that this individual already had the

bacteria when they came into the hospital. Since this bacteria is resistant to

many antibiotics, we have notified the Illinois Department of Public Health.

Normally we would not do anything further but to better understand this rare

organism and for the safety of our patients, The Illinois Department of Public

Health has instructed the hospital to conduct a screening test on selected

patients. The screening test consists of an external swabbing of the rectum

using a QTip. The screening test will be done at no cost to you or your

insurance company. The results of the screening test will be shared with the

Illinois Department of Public Health and your physician.

Unit based AST• Conducted over various time frames of the

investigation:

– March , April, May, July

– All hospital epi-linked cultures were reported as

negative for CRE.

Environmental Surveillance• Vital part of investigation.

• Partner with laboratory

• Challenge of collecting cultures from various

surfaces, mechanical parts, liquids.

• Used E-swab, brush tips, sponge stick, TSB

Laboratory-Clinical Microbiology• Follow Clinical and Laboratory

Standards Institute guidelines

for susceptibility testing.

• Establish a protocol for detection of carbapenemase

production (e.g. modified Hodge test)

• Use e-swab for collection. Lab will place swab in TSB

broth with ertapenem and plate onto chromagar with

meropenem. This will identify any CRE. Additional

identification required to determine if CRE isolates are

NDM-1 strain.

• Establish system to ensure prompt notification of IP staff

of all CREs.CDC Vital Signs. Making Health Care Safer. Stop Infections from Lethal CRE Germs Now. March 2013.

Environmental Areas Sampled

7.Evaluate hypothesis & conduct additional studies

• Environmental culture found positive for

E.coli,NDM-1 (ERCP Scope, specifically at the

elevator platform)

• Epi-linked AST – negative (No unit based

transmission)

• Additional studies identified ―rugged‖ surface

inside ERCP scope elevator platform.

New Hypothesis*(4) NDM and (3) KPC patient cases were

identified from varied specimens (e.g. blood,

urine, sputum, wound)

and readmission history of GI lab procedure,

specifically same ERCP scope.

*Elevator section with possible platform defect.

8. (R) Implement control & prevention measures

• Re-reviewed department policies

-ERCP procedure

- High level disinfection

• Review manufacturer recommendations.

• Repeat audit of Environmental Services cleaning

process

• Engage manufacturers to audit associates performing

process.

• Additional environment culture ( Clean room & Storage

unit)

• Epi-linked AST

• Education

Additional studiesInside elevator platformActions taken:

• Scope A removed from service

• ALGH filed complaint with the FDA (SMDA)

• Initiated EPI-AID from the CCDPH/IDPH

• CDC arrival-August 2013

• Scope manufacturer notified of potential ―defect‖

• Scope A sent to CDC for investigation

• CDC partnering with(FDA)for guidance &recommendation

• Complete high level disinfection process reviewed.

• Retrospective review and direct observation of endoscope reprocessing did

not identify lapses in protocol.

Prevention steps taken:

New scope purchased to replace scope A

Next steps:

Continue investigation- how & why related to the scope

CDC Partners • Initial CDC findings:

PFGE results of Cluster : genetically related.

• Suggesting that Hospital 1 was the source of

transmission for many of the patients with

subsequent transmission at ECF between

two roommates.

• Scope A sent to CDC for further analysis and

was confirmed as positive for NDM isolate.

ERCP Specimen CollectionNON-DESTRUCTIVE RECOVERY OF ENTERIC BACTERIA FROM DUODENOSCOPE

Equipment Materials and Reagents

ERCP scope, post ETO sterilization Sterile gloves

E-swab (green top)

Plastic specimen transport bag

Method

Note: Due to the length of the device, it is recommended that this sampling procedure be performed by

two persons, with one holding the endoscope steady while the other manipulates it.

• Don sterile gloves.

• Using the endoscope controls, manipulate the last 1.5-2 inches of the tip several times.

• Swab the endoscope channel tip, and the elevator channel repeatedly with the E-swab, moving

back and forth 15 times.

• Place swab in E-swab container. Label container accordingly.

• Complete lab requisition.

• Transport in plastic bag to laboratory. Hand-off to Microbiology Tech.

•

Elevator mechanism - distal tip

PFGE results

9. Communication

• Patient Notification of all who had ERCP

procedures with Scope A

• IP Resources: Administration, Risk

Management, Public Relations,

CCDPH,IDPH, CDC

– Weekly conference calls

• Deliver consistent message to public

• Ensure any patients screened positive are

informed, verbally and in writing.

Patient Notification LetterName

Address

Chicago, IL

Dear (Insert Patient Name):

Advocate Lutheran General Hospital values the trust you place in us to provide you with the safest and highest quality of care. As a healing ministry, we want

you to know that the safety of our patients and the communities we serve is our top priority. As a valued patient, you are receiving this letter because you

underwent a procedure at the hospital between (x and x timeframe) and we want you to be aware of a potential concern we are investigating.

Your procedure involved the use of a piece of medical equipment called an endoscope. We recently learned that microscopic bacteria may have been present

on the endoscope used during your procedure. It is out of an abundance of caution we are requesting that you schedule an appointment to come in for a free

screening in our outpatient clinic to ensure that you were not exposed.

Please call our GI Lab at (847) 723-6800 between the hours of 8 a.m. and 4 p.m., Monday through Friday to schedule your screening at a time that is

convenient for you.

We recognize that this may be upsetting to you and cause you some concern. Should you have any immediate questions that you would like answered prior to

your screening, please dial the same GI Lab number above and ask to leave a message for Dr. Dean Silas who serves as Medical Director of our GI Lab. He

will respond to your inquiry within 24 hours.

Sincerely,

President

President, Medical Staff

Patient Notification Line ListMRN/Name

ADDRESS PHONE GI MD INPT/OUT PCP

MD

Notification

Requested

Screening

date

Notification

date Results

CRE Positive Screen LetterName

Address

City

Dear ________,

This letter is in follow-up to the recent phone conversation regarding your test results.

The results of your screening test indicate that you have been identified as having a positive carbapenem-resistant Enterobacteriaceae (CRE)

screen result. This positive CRE screening result means that you have been colonized with the CRE germ. CRE colonization means that the

organism can be found on the body but may not cause any symptoms or disease.

If you have already granted us approval to share these results with your Primary Care Physician, a copy of these results will be mailed to your \

doctor’s office. If you so choose, you may want to discuss these results with your physician. If you have additional questions, please feel free to

contact Manager of Infectious Disease Prevention at (847) 723-6353 or, Director, Division of

Infectious Diseases at (847) 723-7638.

Advocate Lutheran General Hospital values the trust you place in us to provide you with the safest and highest quality of care. As a healing

ministry, we want you to know that the safety of our patients and the communities we serve is our top priority.

Sincerely,

Chief Operating Officer Director, Division of Infectious Disease

Negative Screen LetterInsert Date

Insert Name

Address

City, State Zip

Dear ___________,

The purpose of this letter is to inform you of your results from your recent screening test at Advocate Lutheran General Hospital.

The results of your screening test indicate that you have a negative carbapenem-resistant Enterobacteriaceae (CRE) screen

result. This means that the CRE germ was not present at the time of screening. At this time there is no further action you need to

take.

We apologize for any inconvenience and anxiety this may have caused you. At Advocate Lutheran General Hospital we value the

trust you place in us to provide you with the safest and highest quality of care. As a healing ministry, we want you to know that the

safety of our patients and the communities we serve is our top priority.

Sincerely,

Chief Operating Officer Director, Division of Infectious Disease

Public Relations• Lutheran General has recently been investigating a cluster of patients who have presented to ALGH with an

organism of significance (New Delhi Metallo Beta-Lactamase) or NDM-1.

• It falls under the class of CRE, which stands for Carbapenem-resistant Enterobacteriaceae, which are part (or

subgroup) of Enterobacteriaceae that are difficult to treat because they are resistant to commonly used antibiotics.

Occasionally CRE are completely resistant to all available antibiotics. CRE are an important threat to public health.

• I am not sure if it would get any media attention, but since some of our area skilled nursing facilities are also

working with the Health Department, I wanted to make sure you were aware of the situation. I have also notified

Donna Currie & Dr. Malow (Oakbrook Support Center-Patient Safety/Infection Prevention)

• Talking bullets:

• Identified several cases of New Delhi Metallo Beta-Lactamase (CRE- E.Coli) from the community

• Working with the Cook County Health Department & the Illinois Dept of Public Health

• Implemented all health dept recommendations, as well as the CDC recommendations ( CRE Tool kit)

http://www.cdc.gov/hai/organisms/cre/cre-toolkit/

• No evidence of hospital transmission identified

• The weblink above may also have media related Q&A.

• Any additional questions please feel free to contact me

Community Outreach

• Transparency

• Contacting patients/outreach to patients in

ECFs

• IP resources included Post Acute Network,

CCDPH to follow up on screening patients

discharged to LTCFs.

• Additional mailings to patients who did not

respond with first letter sent by certified mail.

Reaching out to associatesMEMORANDUM

Friday,

TO: All Associates

FROM: Barb Weber, Interim President, COO, Advocate Lutheran General Hospital

SUBJECT: Patient Safety

As an associate of Advocate Lutheran General Hospital, you know that providing the safest and highest quality care to those we are privileged to serve is our top priority.

Regrettably, I’m writing to inform you about an issue that affected a small number of our patients.

These patients were exposed to carbapenem-resistant Enterobacteriaceae (CRE), while undergoing a specific endoscopic procedure here at our hospital. CRE are a family of

germs that are highly-resistant to antibiotic treatment and are most likely to affect people with compromised immune systems.

Out of an abundance of caution, we decided to notify every patient who underwent this endoscopic procedure here at the hospital between January and September of this year to

ask that they return to the hospital for a free screening to test for the presence of the bacteria.

While we understand the anxiety this may cause patients, our number one goal is to ensure the well-being of those who have entrusted us with their care.

As part of our investigation into this incident, we have been working closely with the Centers for Disease Control and Prevention (CDC), the Federal Drug Administration (FDA),

the Illinois Department of Public Health (IDPH) and Cook County’s Department of Public Health. With their partnership and guidance, we feel confident that we have taken the

appropriate steps to ensure no other patients are at risk and that this does not happen again.

Given our ongoing commitment to building a strong culture of patient safety and transparency in care, we have decided to proactively share our story with the local media. We

hope that the lessons we have learned and the steps we have taken to remedy this matter can serve as a learning opportunity for other hospital care settings.

We have established a hotline to handle any calls regarding this matter, should you receive any calls, please direct them to our Infection Prevention Department at 847.723.6353.

And as always, should you have any additional questions, please do not hesitate to contact a member of our senior leadership team.

Findings: Patient Screening • Patient screening indentified link to additional

ERCP scopes.

• CDC confirmed their Environmental

Surveillance cultures were negative.

• Additional Epi-linked surveillance was negative

(no unit based transmission identified)

Evaluate hypothesis*• A patient who had an ERCP with scope ―C‖ had a positive culture

for E.coli MBL (metallo beta lactamase). This was the second case

identified with the same source scope.

• There was a one month period of no discernible transmission

between cluster 1 associated with scope ―A‖ and cluster 2

associated with scope ―B‖.

* New Hypothesis:We have a repeated instance of another new scope associated with

E.coli MBL, this would imply the source of the biofilm may be located

within the integral components of the AER (automated endoscope

reprocessor) which functions to wash and disinfect the scopes.

Epi Curve- Scopes

NewDelhi Metallo-β-Lactamase–Producing Carbapenem-Resistant Escherichia coli ssociated With Exposure to Duodenoscopes. Lauren Epstein ,MD., et al. JAMA. 2014;312(14):1447-1455.

8. (R)Infection Control Measures• Manufacturer product evaluation of our AER equipment.

• Review manufactures recommendation of products (detergent,

disinfectant)

• AER bay’s were bleached.

• Detergent and alcohol lines bleached.

• Performed environmental surveillance cultures of AER reservoir

holding tanks and filters.

• Patient notification for those who had ERCP with Scope C.

• Moved from HLD to sterilization with ETO (ethylene oxide).

• ERCP scopes post sterilization were cultured.

• Repeat audit of ERCP patient procedure (pre, during and post)

• Repeat audit of Environmental Services protocol.

• Prior to ERCP procedure, conduct AST CRE screening.

Findings:

• Scope B identified as Epi-link to an infected

patient per CDC review.

• Hospital filed additional SDMA forms for

Scopes B and C.

• Patient notification-expanded to include all

patients that received ERCP during defined

timeframe.

• Environmental cultures negative.

• No AER deficits identified.

CRE Network Diagram

NewDelhi Metallo-β-Lactamase–Producing Carbapenem-Resistant Escherichia coli Associated With Exposure to Duodenoscopes. Lauren Epstein ,MD., et al. JAMA. 2014;312(14):1447-1455

Final Hypothesis*

• Inability to effectively High Level Disinfect

ERCP scopes.

• Challenges of equipment design

impacting the cleaning and disinfection process.

Service, maintenance, length of time device kept

in service.

• Options for alternative methodologies to ensure

equipment is safe for patients.

10. Maintain Surveillance• Surveillance –(CRE alert using data mining system)

• Quality Control Plan: GI Lab

– On a monthly basis, each ERCP endoscope will be cultured

specifically for CRE

– Follow the method described in obtaining samples for

culture using the E-swab.

– (2) swabs from each ERCP & EUS scope (Elevator up &

down position)

– GI lab to maintain record of results

GI Lab IP Plan 2014Prevention Strategies Action Item

(time line)

Accountable Person(s) Intervention

evaluation

(supporting data)

Date of Completed

Screening process 8/7/13 - ongoing Linda Stein Send certified letter to all remaining

unscreened patients.

2/15/14

Sterilization

Follow-up recommendations:Monthly CRE cultures

CDC did not give a recommendation for ongoing environmental or scope culturing

Surveillance cultures of ERCP scopes

GI Lab

Lloyd Hendrick

GI Lab

Last know procedure using HLD was on 10/08/13 that resulted in positive result.

ETO sterilization Process began::

Add scope serial # to CPD tracking system

Monthly culturing

Monthly culture (2) per scope. Elevator in up & down position. Any positive results should be communicated to infection prevention.

10/7/13 Monday

10/8/13 Tuesday

4/1/14

Process began: 2/25/14

On-going

No positives to date 4/23/14

Misc items: Process moving

forward

1. Portable phone

2. Outpatient #365 screening

3. Open financial accts

Recommend closing cluster

investigation

Beth Quinones(Outpatient)

Chad Calabria (Pt intake)

Cori Taylor(Communications)

Presented at Infection

Prevention Committee

Close all open accounts

Return phone to

communications

4/10/14

Cluster investigation officially

closed

4/23/14

All open accts will be closed.

Lessons Learned

• Keep a log/diary of investigation (timeline)

• Senior leadership is essential (resource allocation)

• Challenges in using sterilization as a method to ensure

safety of scopes

• Become familiar with endoscopic design (e.g. ERCP,

EUS).

• Annual competency & education

• System-wide standardization of products versus

manufacturer recommendations

• Renewed respect for associates dedicated to doing this

job, every day.

Looking towards the future• Review and update of current guidelines for

cleaning and disinfection of endoscopes

• More options from manufacturers

• Is sterilization the way?

• Biofilm and in-vitro interaction with equipment

IP Outbreak Resources “Village”

Hospital Administration

Risk Management

Nursing Units

ID Physicians

Environmental Services

Laboratory Services

Professional Associations

Biomedical Engineering

Materials Management

Vendors/Manufacturers

Quality Management

Central Processing/Sterilizati

on

Medical Records/Information

services

Regulatory/CCDPH/IDPH/CDC/FDA

Data Mining Services

Public Relations/Media

Other HCF/ECF

Our “Village”

Acknowledgments to our “Village”

Lidia Raslau/Norah Connelly/Dr. Dean Silas

GI Lab Chad Calabria Patient Registration

Dusanka Bjelan/Evangheline Feldiorean

GI Lab Beth Hickey Finance

Lynn Guibourdanche, Sinead Forkan Kelly

Infection Prevention Valarie Diaz/Beth Quinones Outpatient Dept

Joanna Werling/Victoria Marriott

Administrative assistance

Michael Wiegel Risk Management

Dr. Robert Citronberg Infectious Disease Marcel Trutza Biomedical Engineering

Dr. Leo Kelly VP Medical Management (EMT)

Michael Costello/Janet Havel ACL Lab

Barb Weber COO (EMT) Michael Vernon/Mabel Frias CCDPH

Cindy Mahal-VanBrenk Director ,Surgery Allison Arwady/Judy Conway/Craig Conover

IDPH

Pamela Hyziak Clinical Excellence Drs. Lauren Epstein/Jennifer Hunter/Alice Guh

CDC

Trent Knanishu Environmental Services

Joyce Welton Supply Chain Management

JAMA October 8, 2014 Volume 312, Number 14

References• Brief report: Early identification and control of carbapenemase-producing Klebsiella

pneumoniae, originating from contaminated endoscopic equipment. Sally F. Alrabaa

MD, et. al, American Journal of Infection Control 41 (2013): 562-4.

• CDC Guidance for Control of Carbapenem-Resistant Enterobacteriaceae (CRE) 2012

CRE Toolkit.

• CDC Vital Signs. Making Health Care Safer. Stop Infections from Lethal CRE Germs

Now. March 2013.

• EIS Conference Abstract. Cluster of New Delhi Metallo-β-Lactamase-Producing

Carbapenem-Resistant Enterobacteriaceae at a Hospital — Illinois, 2013. April, 2014

• Notes from the Field: Hospital Outbreak of Carbapenem-Resistant Klebsiella

pneumoniae Producing New Delhi Metallo-Beta-Lactamase- Denver, Colorado, 2012.

MMWR, February 15,2013, vol. 62, no.6, p. 108.

• Notes from the Field: New Delhi Metallo-β-Lactamase–Producing Escherichia coli

Associated with Endoscopic Retrograde Cholangiopancreatography — Illinois, 2013.

MMWR, January 3, 2014, vol 62, no. 51, p.1051-1051.

• Outbreak Investigations. The 10 Step Approach. Zack Moore.MD.

https://epi.publichealth.nc.gov/cd/lhds/manuals/cd/training/Module_1_1.6_ppt_Outbre

akInvestigation.pdf

Questions?

• Linda.Stein@advocatehealth.com

• Marge.Gribogiannis@advocatehealth.com