Outbreak Management it takes a village. November 20, 2014 Linda Stein Marge Gribogiannis

Outbreak Management it takes a village. November 20, 2014 Linda Stein Marge Gribogiannis

Objectives Identification of an outbreak To be able to perform the outbreak management process 1. 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 Cycle 1. ID Team and Resources 10. Maintain surveillance 2. Establish existence of outbreak 9. Communicate 3. Verify diagnosis 8. Implement control and prevention measures 4. Develop case definition 7. Evaluate hypothesis/conduct additional studies 5. Case finding and line listing 6. Descriptive epidemiology/develop hypothesis 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 education CDC 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) Radiology Laboratory Nursing Intubation Station And Anesthesia Cart Daily, discharge cleaning O2 regulator, Suction regulator High dusting Green Cord Organizer Cover C arm exterior & High dusting monitor screens Phones,Chairs, Trash cans Exterior of sharps containers, Windowsills* Suction compartment on floor near ERBE machine Bumper guards, Top of supply cabinet Countertops (Gi lab to remove books, etc.) Floor: wet mop w/ H25 daily in evening Daily or when visibly soiled C arm and ESP-Cine, Instruments, cables Technician table, RBE cautery cart Lead aprons After each use or when visibly soiled Microscope stage; adjustment knobs; objectives; revolving nosepiece; arm Plastic cover over Microscope when not in use After each use or when visibly soiled Endo cart** Nurse Serve supply cart Blood pressure cuffs Daily Keyboards, Massimo leads, IV poles After each use or when visibly soiled Work station area Alaris IV pump; Propofol Infusion pump Weekly Data Ohmeda monitor and cords Exterior of cart including wheels Environmental Services Radiology Tech Histology tech Nursing 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 patient A 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 studies Inside elevator platform Actions 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 Collection NON-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 Letter Name 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 List MRN/Name ADDRESS PHONE GI MD INPT/OUT PCP MD Notification Requested Screening date Notification date Results

CRE Positive Screen Letter Name 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 Letter Insert 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 associates MEMORANDUM Friday, TO: FROM: SUBJECT: All Associates Barb Weber, Interim President, COO, Advocate Lutheran General Hospital 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 2014 Prevention 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 GI Lab Lloyd Hendrick Last know procedure using HLD was on 10/08/13 that resulted in positive result. 10/7/13 Monday 10/8/13 Tuesday ETO sterilization Process began:: 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 Add scope serial # to CPD tracking system Monthly culturing 4/1/14 Process began: 2/25/14 Monthly culture (2) per scope. Elevator in up & down position. Any positive results should be communicated to infection prevention. 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

Other HCF/ECF Hospital Administration Risk Management Data Mining Services Public Relations/Media Nursing Units ID Physicians Our Village Regulatory/CCDPH/I DPH/CDC/FDA IP Outbreak Resources Village Environmental Services Medical Records/Information services Laboratory Services Central Processing/Sterilizati on Professional Associations Quality Management Biomedical Engineering Vendors/Manufactur ers Materials Management

Acknowledgments to our Village Lidia Raslau/Norah Connelly/Dr. Dean Silas Dusanka Bjelan/Evangheline Feldiorean GI Lab Chad Calabria Patient Registration GI Lab Beth Hickey Finance Lynn Guibourdanche, Sinead Forkan Kelly Joanna Werling/Victoria Marriott Infection Prevention Valarie Diaz/Beth Quinones Outpatient Dept 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 Pamela Hyziak Clinical Excellence Drs. Lauren Epstein/Jennifer Hunter/Alice Guh Trent Knanishu Environmental Services Joyce Welton IDPH CDC 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