Welcome !!! Please join us via phone for the audio portion of the webinar, you will be connected by the operator when the meeting begins. Conference Line : Line: Code: Please complete the EMR Surveillance Assessment at your convenience :

VAE Surveillance Definition & Electronic Capture Webinar Hosted by Armstrong Institute of Patient Safety and Quality July 31 st & August 2 nd Sean Berenholtz, MD, MPH, FCCM Kathleen Speck, MPH 2

Sponsors and Affiliate Partners 3

Agenda 1:00 pm – 1:10pm - Welcome and Introduction – Sean Berenholtz MD, MHS 1:10 pm - 1:30pm - Surveillance for Ventilator- Associated Events in Adults: A new Approach for the National Healthcare Safety Network (NHSN) – Shelley Magill MD, PhD, 1:30 pm – 1:50pm – Improving Surveillance Definitions for Ventilator- Associated Events: Better Surveillance, Better Care – Michael Klompas, MD, MPH 1:50pm- 2:00pm- Question and Answer Session 4

Learning Objectives To introduce the new surveillance definition of Ventilator Associated Event (VAE) To gain insights into your perceptions about the new VAE definition and existing infrastructure to capture VAE data using Electronic Medical Records (EMR) Armstrong Institute for Patient Safety and Quality 5

Expert Panel & Presenters Dr. Magill will be discussing the new NHSN surveillance definitions. Dr. Klompas will be discussing techniques for implementing electronic surveillance focusing on experience with the CDC’s Epicenters for Excellence group. Armstrong Institute for Patient Safety and Quality 6

Shelley S. Magill, MD, PhD Division of Healthcare Quality Promotion Centers for Disease Control and Prevention Atlanta, GA Surveillance for Ventilator-Associated Events in Adults: A New Approach for the National Healthcare Safety Network (NHSN) National Center for Emerging and Zoonotic Infectious Diseases Division of Healthcare Quality Promotion

The Problem  Ventilator-associated pneumonia (VAP) is an important complication of mechanical ventilation  But other bad things also happen to patients on ventilators  No valid, reliable definition for VAP  Need more accurate diagnostics …  Until those are available, how do we conduct surveillance and track prevention progress?  Commonly used definitions include subjective elements and are neither sensitive nor specific for VAP  Not ideal in an era of public reporting of healthcare-associated infection (HAI) rates, comparisons among facilities, pay-for- performance programs  Need a new approach

Current PNEU Definitions Three sets of criteria Chest x-ray evidence required Signs/symptoms required Lab evidence used if available from acceptable specimen type VAP is a PNEU event that meets the “ventilator- associated” criterion— Endotracheal tube (ETT)/ventilator must have been in place at some time during the 48 hours preceding the onset of PNEU No required amount of time that the ETT/ventilator must have been in place for a PNEU to count as a VAP

Limitations of Current VAP Definitions References include but are not limited to the following: 1 Wunderink R, et al., Chest 1992;101;458-63; 2 Young M, et al., Arch Intern Med 1994;154: ; 3 Fabregas N, et al., Thorax 1999;54:867-73; 4 Kirtland SH, et al., Chest 1997;112:445-57; 5 Berton DC, et al., Cochrane Database Syst Rev 2008; 6 Ruiz M, et al., Am J Respir Crit Care Med 2000;162:

Goals for Modifying Current NHSN Definitions  Achieve face validity/clinical credibility  Improve reliability  Reduce burden

Ventilator-Associated LOwer Respiratory Infection (VALORI) Streamlined VAP (“sVAP”) Ventilator-Associated Events (VAE) Evaluated draft definition in collaboration with the CDC Prevention Epicenters Definition based on work done by Klompas and others 1,2 Received expert feedback during HHS-sponsored meetings Funded Epicenters proposal to evaluate feasibility and preventability of “sVAP” Convened VAP Surveillance Definition Working Group, with Critical Care Societies Collaborative and other society/organization representatives ( ) From VAP to VAE 1 Klompas et al., Infect Control Hosp Epidemiol 2008;29:31-7; 2 Klompas et al., 5th Decennial International Conference on Healthcare- Associated Infections, Atlanta, GA, March 18-22, 2010, abstract #741.

Working Group Members and Participants Society/OrganizationRepresentatives American Association of Critical-Care NursesSuzanne Burns, Beth Hammer American Association for Respiratory CareDean Hess American College of Chest PhysiciansRobert Balk, David Gutterman Association of Professionals in Infection Control and Epidemiology Linda Greene American Thoracic SocietyNicholas Hill, Mitchell Levy Council of State and Territorial EpidemiologistsCarole VanAntwerpen HICPAC Surveillance Working GroupDaniel Diekema Infectious Diseases Society of AmericaEdward Septimus Society of Critical Care MedicineClifford Deutschman, Marin Kollef, Pamela Lipsett Society for Healthcare Epidemiology of AmericaMichael Klompas U.S. Department of Health and Human Services/Office of Healthcare Quality Don Wright National Institutes of HealthDavid Henderson

Working Group Objectives  Critically review CDC’s draft, streamlined VAP surveillance definition for use in adult patients;  Suggest modifications to enhance reliability and credibility within the critical care community;  Propose final adult definition algorithm that will be implemented for use in NHSN for the potential purposes of public reporting, inter-facility comparisons, and federal pay- for-reporting and -performance programs.

Working Group Progress  Kick-off meeting 9/2011, multiple follow up calls  Revised definition algorithm—tiered approach  Definitions suitable for potential use in public reporting: objective, general measures of ventilator-associated conditions and complications Similar definitions evaluated by Klompas et al. identified events associated with longer duration of mechanical ventilation, longer ICU stay, and increased mortality—and were more efficient to apply than current VAP definitions (PLoS One 2011;6:e18062, Crit Care Med 2012; in press)  Internal use definitions: possible and probable VAP, incorporating laboratory evidence  Research agenda items  Mechanism for intensive care unit-level risk adjustment or stratification (to account for differences in severity of illness)  Denominator data collection

VENTILATOR-ASSOCIATED EVENTS (VAE) SURVEILLANCE DEFINITION ALGORITHM ***Note that this is NOT a clinical definition algorithm and is not intended for use in the management of patients.***

Patients Eligible for VAE Surveillance  ≥18 years of age  Inpatients of acute care hospitals, long term acute care hospitals, inpatient rehabilitation facilities  NOTE: Patients receiving high frequency ventilation or extracorporeal life support are excluded from surveillance.

VAE Definition Algorithm Summary

Ventilator-Associated Condition (VAC)

VAE Definition Algorithm Summary

Infection-related Ventilator-Associated Complication (IVAC)

VAE Definition Algorithm Summary

Possible VAP

Probable VAP VAC, IVAC plus the following…

Key Operational Details*  In 2013, in-plan surveillance for ventilator-associated PNEU may still be conducted for neonatal and pediatric patients ONLY.  In 2012 and 2013, the PNEU definitions are still available for those units seeking to conduct off-plan PNEU surveillance for mechanically-ventilated adults or non-ventilated adults or children.  Conducting in-plan VAE surveillance means assessing patients for the presence of ALL events included in the algorithm—from VAC to IVAC to Possible and Probable VAP. A unit participating in in-plan VAE surveillance cannot decide, for example, that only surveillance for VAC (and not for IVAC or Possible or Probable VAP) will be performed. *Preliminary and subject to change.

More Key Operational Details*  “New” antimicrobial agent  How to determine whether a new antimicrobial agent has been given for at least 4 days (including in patients with renal insufficiency)  Single doses of vancomycin  Multiple VAEs during a single hospitalization  VAEs in patients who’ve been recently extubated  Pathogens and secondary BSIs  Lung histopathology  Diagnostic tests for viruses and Legionella spp.  Time frame within which VAE criteria must be fulfilled *Preliminary and subject to change.

Next Steps

Options for Tracking VAP/VAE Rates,  Implement VAE early  Forms and protocol  Training  Data management  Continue VAP surveillance into 2013  Will remain available off-plan in NHSN application—but probably only until end of CY 2013  Do both

Acknowledgments  Patients and staff in NNIS and NHSN facilities  VAP Surveillance Definition Working Group  Other subject matter experts  HHS Office of Healthcare Quality  CDC Prevention Epicenters  CDC VALORI/draft sVAP project facilities, Premier, Inc., expert reviewers  CDC/DHQP colleagues The findings and conclusions in this presentation are those of the author and do not necessarily represent the views of the Centers for Disease Control and Prevention.

Thank you! National Center for Emerging and Zoonotic Infectious Diseases Division of Healthcare Quality Promotion For more information please contact Centers for Disease Control and Prevention 1600 Clifton Road NE, Atlanta, GA Telephone, CDC-INFO ( )/TTY: Web: 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.

Expert Panel & Presenters Dr. Magill will be discussing the new NHSN surveillance definitions. Dr. Klompas will be discussing techniques for implementing electronic surveillance focusing on experience with the CDC’s Epicenters for Excellence group. Armstrong Institute for Patient Safety and Quality 32

IMPROVING SURVEILLANCE DEFINITIONS FOR VENTILATOR-ASSOCIATED EVENTS BETTER SURVEILLANCE, BETTER CARE JULY 31, 2012 MICHAEL KLOMPAS MD, MPH, FRCPC HARVARD MEDICAL SCHOOL DEPT OF POPULATION MEDICINE BRIGHAM AND WOMEN’S HOSPITAL, BOSTON, MA

OUTLINE CDC Prevention Epicenters’ studies of objective surveillance Operationalizing the new definitions

CDC PREVENTION EPICENTERS For Kathy: text in this image be included in the alt text.

Multicenter Evaluation Of A Novel Surveillance Paradigm For Complications Of Mechanical Ventilation Retrospective comparison of VAC surveillance versus conventional surveillance in medical and surgical patients ventilated ≥48 hours in 3 university hospitals Brigham and Women’s Hospital (Boston, MA) Ohio State University Medical Center (Columbus, OH) LDS Hospital (Salt Lake City, UT) 597 patients ventilated for 6,347 days

LENGTH OF STAY: VAP VERSUS VAC Model adjusted for vent days prior to event, age, sex, hospital, unit, and co-morbidities Ventilator days ICU days Hospital days VAP VAC Days VAP or VAC positive VAP or VAC negative VAP VAC VAP VAC *** * * PLoS ONE 2011;6: e18062

MORTALITY: VAP VERSUS VAC PLoS ONE 2011;6: e18062 Model adjusted for vent days prior to event, age, sex, hospital, unit, and co-morbidities Odds Ratio VAC VAP

QUALITATIVE ANALYSIS OF CASES Critical care MD blinded to VAC or VAP status Pneumonia Percent of Patients Pulm Edema ARDS Lobar Collapse/ Atelectasis PE Mucous Plug VACVAP 25 Sepsis XRT pneumonitis 30 PLoS ONE 2011;6: e18062

Objective surveillance definitions for ventilator-associated pneumonia Retrospective analysis of all patients on mechanical ventilation in 8 different U.S. hospitals Community, academic, VA hospitals 8,123 patients 8,735 ventilation episodes 50,324 ventilator-days VAC patients matched to non-VAC patients. Regression analyses adjusting for age, sex, comorbidities, APACHE score, unit, hospital, pre-morbid time on ventilator Klompas et al. 2012; Critical Care Medicine; in press

RESULTS VAC versus non-VAC Mortality odds ratio2.4 (95% CI ) Excess ventilator days4.2 days (95% CI ) Excess hospital days3.8 days (95% CI ) Klompas et al. 2012; Critical Care Medicine; in press

SENSITIVITY & PPV OF SURVEILLANCE DEFINITIONS FOR HOSPITAL DEATH Klompas et al. 2012; Critical Care Medicine; in press

VAC SUMMARY Simple and objective measure Captures important complications, most cases due to: Pneumonia Pulmonary edema ARDS Atelectasis Associated with prolonged mechanical ventilation, length of stay, and hospital mortality

VAE SURVEILLANCE IN PRACTICE

Sustained increase in ventilator support after ≥2 days of stable or decreasing settings VAC + (abnormal temp or WBC count) AND new antibiotic for 4 days or more VAC ventilator-associated condition iVAC infection-related ventilator-associated complication VAP possible probable iVAC + positive respiratory culture OR gram stain with ≥25 polys and ≤10 epis iVAC + positive respiratory culture AND gram stain with ≥25 polys and ≤10 epis

HOW ON EARTH DO WE APPLY THESE DEFINITIONS?

BEGIN WITH VAC Criteria ≥2 days of stable or decreasing daily minimum PEEP or FiO2 followed by Rise in daily minimum PEEP by ≥3 cm H 2 O or FiO2 by ≥20 points sustained ≥2 days

OPERATIONALIZING THE DEFINITION CREATE A DAILY LINELIST

CHECK FOR IVAC: ADD TEMP, WBC, & ABX TO THE LINELIST

CHECK FOR VAP: ADD GRAM STAIN & CULTURE RESULTS

TIPS FOR SUCCESS Use the linelist approach Explore your hospital’s IT environment Definitions are amenable to complete automation …but if IT can only offer semi-automation, still a substantial help e.g. automatic linelists with daily vent settings for manual review Linelists of vent settings PLUS temp / wbc / abx / micro Linelists + automatically flag VAE Does respiratory therapy already have an electronic tracking system for vented patients? Vent settings sometimes stored electronically but outside the EMR If not currently tracking vented pts electronically, do they want to start? If automation not possible, ask respiratory therapy and / or nursing for help collecting daily vent settings

Upcoming project: CUSP for VAP –Maryland –Pennsylvania VAP Program Overview –August 7 th at 1 pm –August 8 th at 11 am Complete the EMR Surveillance Assessment Armstrong Institute for Patient Safety and Quality 56 Next steps:

VAE - EMR Surveillance To gain insights into your perceptions about the new VAE definition and existing infrastructure to capture VAE data using Electronic Medical Records (EMR) –EMR Surveillance Assessment Survey Monkey 10 minutes to complete Armstrong Institute for Patient Safety and Quality 57