Ensuring Patient Safety: Reducing Health Care-Associated Infections,

Domestically and Abroad

Daniel Gallardo, MPHTisha Johnson, MD, MPH

Presenters

Dale Hu, MD, MPHModerator

Learning Objectives

• Understand the burden and impact of health care-associated infections (HAI) in the United States.

• Learn about the HHS efforts to measure, control, prevent, and reduce HAIs through existing policy and program levers.

• Understand the global burden and impact of HAIs. • Identify opportunities to leverage Federal

strategies and techniques by translating principles to Global opportunities.

Overview

• Burden of HAI – United States• HAI Action Plan• Surveillance – United States• Progress in the Reduction of HAIs• Burden of HAIs Globally• Surveillance – Developing Countries• Adaptable Interventions• Lessons Learned

HAI: UNITED STATESDaniel Gallardo, MPH

Health Care-Associated Infections (HAI) Definition

Health Care-Associated Infections are infection that people acquire while they are receiving treatment for another condition in healthcare settings: • Inpatient Hospitals • Ambulatory settings• Long-term care facilities• Any healthcare setting where

people receive care

At any given time, 1 in 20 U.S. hospital patients has a health care-associated infection.

SOURCE: http://www.cdc.gov/HAI/burden.html

$33 billion in potentially preventable health care costs annually.

Impact of Health Care-Associated Infections in the U.S.

The HAI Burden

100,000 lives lost every year in the United States alone

The HAI BurdenPublic Health Issue Deaths Per Year

HAIs 100,000

Motor Vehicle Traffic 42,031*

Breast Cancer 40,598ŧ

HIV / AIDS 17,489†

SOURCES:

* National Vital Statistics Reports. Final Data for 2007; vol. 58(19). Atlanta (GA): Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Health Statistics.

ŧUnited States Cancer Statistics: 1999–2007 Incidence and Mortality Web-based Report. Atlanta (GA):

Department of Health and Human Services, Centers for Disease Control and Prevention, and National Cancer Institute; 2010.†HIV Surveillance - - - United States, 1981 – 2008. MMWR 2011; 60(21); 689-693. Centers for Disease Control and Prevention.

The HAI Burden

• “Implementing what we know for prevention can lead up to a 70% or more reduction in HAIs”

SOURCE: Scott RD. The direct medical costs of healthcare-associated infections in US hospitals and the benefits of prevention. Atlanta: Centers for Disease Control and Prevention; 2009.

• Improve central coordination of HHS-supported prevention and surveillance strategies

• Identify priorities among CDC guidelines to:– Promote implementation of

high priority practices

• Establish greater consistency and compatibility of the HAI-related data across HHS systems to:– Increase reliable national

estimates of HAIs

Recommendations for HHS:

Cross-Federal Collaboration U.S. Department of Health & Human

Services̶� Administration for Community Living (ACL)̶� Agency for Healthcare Research & Quality (AHRQ)̶� Centers for Disease Control & Prevention (CDC)̶� Centers for Medicare & Medicaid Services (CMS)̶� Food and Drug Administration (FDA)̶� Health Resources & Services Administration (HRSA)̶� Indian Health Services (IHS)̶� National Institutes of Health (NIH)̶� Office of the Secretary (OS)

U.S. Department of Defense (DoD) U.S. Department of Labor (DoL) U.S. Department of Veterans Affairs (VA)

Phase One

• Acute Care Hospitals

Phase Two

• Outpatient Settings

Phase Three

• Long-Term Care Facilities

HAI Action Plan: Measurable Goals

Central line-associated

bloodstream infections

Catheter-associated urinary

tract infections

Methicillin-resistant

Staphylococcus aureus

Clostridium difficile infections

Surgical site infections

Surveillance – United States

National HAI Data

Hospitals

Dialysis centers

Long-term care

Surveillance – Public Reporting

• National Healthcare Safety Network (NHSN)• Active Bacterial Core surveillance (ABCs),

Emerging Infections Program (EIP)• Nationwide Inpatient Sample (NIS), Healthcare

Cost Utilization Project (HCUP)• U.S. Renal Data System

Standardized Infection Ratios

• The SIR is a measure that compares the number of infections reported to NHSN to the number of infections that would be predicted based on national baseline data

NOTES: *Healthy People 2020 objectives HAI-1 and HAI-2 17

Progress Toward the National Action Plan Targets: Elimination of HAIs in Acute Care Hospitals

2006-08 2009 2010 2011 20120.00

0.25

0.50

0.75

1.00

Central Line-Associated Bloodstream Infections

SOURCE: National Healthcare Safety Network (NHSN), CDC/NCEZID.

NOTES: I = 95% confidence interval. The Standardized Infection Ratio compares the observed number of HAI cases during a reporting period with the 2006-08 baseline number of HAI cases.

Standardized Infection Ratio

Obj. HAI-1 Decrease desired

HP2020

Target: 0.25

0

Progress on Additional HAIs

2009 2010 2011 20120.7

0.75

0.8

0.85

0.9

0.95

1

SSICAUTIC. Diff

Source: CDC, 2013

Multiple Levers to Reduce HAIs

Federal Non-Federal

1. Measurementa. Investment in resources for

improved surveillance2. Research

a. Knowledge developmentb. Pilot testing of prevention

bundles3. Policy

a. Information transparencyb. Incentive programsc. Financial penaltiesd. Regulation

4. Education and Outreacha. Disseminationb. Training

1. Partnerships1. Recognition programs2. Information dissemination

2. Outreach/Advocacy1. Patient-family engagement2. Consumer groups

Programs and Initiatives

• Comprehensive Unit-based Safety Project (CUSP)

• CUSP for Safe Surgery (SUSP)• Surgical Care Improvement Project (SCIP)• Hand Hygiene

CLABSI: United States Successes

• Actual Changes in Clinical Practice are Required– Engagement of all frontline professionals – Requires a change in culture too

• Comprehensive Unit-based Safety Program– Developed at Johns Hopkins Medical Center– Large scale test by Keystone Project in Michigan

CUSP & CLABSI Interventions

1. Educate on the science of safety

2. Identify defects3. Assign executive to adopt

unit4. Learn from Defects5. Implement teamwork

& communication tools

CUSP CLABSI

1. Wash Hands Prior to Procedure

2. Use Maximal Barrier Precautions

3. Clean skin with Chlorhexidine

4. Avoid Femoral Lines5. Remove Unnecessary

Lines

Building on Success

• Because the method works– CLABSI rates in Michigan dropped to less than 1 per

thousand and remained at this level for an extended period

• Launched On the CUSP: Stop CLABSI nationally– Reduced the rate of bloodstream infections in ICUs

by 40 percent– Saved more than 500 lives and prevented more

than 2,000 bloodstream infections– Averted $34 million in health care costs

SSI: CUSP for Safe Surgery (SUSP)

• Surgical safety program – National Project Team• Johns Hopkins University Armstrong Institute for

Patient Safety and Quality• American College of Surgeons• University of Pennsylvania• World Health Organization

– 200 participating hospitals in US and Puerto Rico

SUSP: Surgical Safety Strategy

• Engage front-line clinicians and hospital leaders

• Utilize performance measures clinicians believe are valid

• Adapt methods based on local context • Implement a process to improve culture and

teamwork

SUSP: Johns Hopkins Hospital

• Initial focus on colorectal surgery• Reduced SSI in colorectal procedures by 33%• Success attributed to:– Use of simple safety checklists– Urging caregivers to speak up

SUSP: Limited Data

• Insufficient data to draw conclusion about SSI rates

• Ethnographic research data available – 12 hospitals in 4 states– Sites: academic, critical access, and community

hospitals– 100 individual and group interviews– Interviews are currently being transcribed– Coding data and analyzing

SSI: SCIP

• Surgical Care Improvement Project – Implemented 2006– Quality Improvement Organizations provide technical

assistance to hospitals• Process Measures– Antibiotic within 1 hour before incision– Prophylactic antibiotics consistent with recommendations – Antibiotics discontinued within 24 hours of surgery end

time– Appropriate hair removal

SCIP National ProgressFY 2008 – 2012

FY 2008

FY 2009

FY 2010

FY 2011

FY 2012

80%

82%

84%

86%

88%

90%

92%

94%

96%

98%

100%

SCIP Inf 1: Abx within 1 Hr Be-fore Incision (3Q2006)

SCIP Inf 2: Received Prophy-lactic Abx Consistent with Recommendations (1Q2007)

SCIP Inf 3: Prophylactic Abx Discontinued within 24 Hrs of Surgery End Time (3Q2006)

SCIP Inf 4: Controlled 6 AM Postoperative Serum Glucose - Cardiac Surgery (1Q2008)

HAND HYGIENE

• Health care providers– Podcasts– Clean Hands Save Lives campaign

• Patients and hospital visitors– Hand Hygiene Saves Lives campaign– Partnering to Heal interactive training video– Do the WAVE

Challenges with C. difficile hospitalization

• An Environmental Disinfection Intervention to Control C. difficile (AHRQ)

• Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings, 2007 (CDC)

• Guideline for Environmental Infection Control in Health-Care Facilities, 2003 (CDC)

• HCUP discharge data shows an increase in rate• Varies by regions and states• Opportunities for improvement include effective antimicrobial

use and environmental decontamination

Challenges with CAUTI

• National Implementation of CUSP to Reduce CAUTI (AHRQ)

• Guideline for Prevention of CAUTI, 2009 (CDC)

• Small reduction from baseline in 2011• Increase in reporting facilities and locations in

2012– Possible explanation for increase to 1.02 SIR

HAI: GLOBALLYTisha Johnson, MD, MPH

Impact of Health Care-Associated Infections in the EU

SOURCE: European Centre for Disease Prevention and Control. Annual Epidemiological Report 2013. Reporting on 2011 surveillance data and 2012 epidemic intelligence data. Stockholm: ECDC; 2013.

In comparison, 1 in 18 EU hospital patients has a health care-associated infection.

Global Burden: Incidence

SOURCES:1. Klevens, R. M., Edwards, J. R., Richards, C. L., Horan, T. C., Gaynes, R. P., Pollock, D. A., & Cardo, D. M. (2007). Estimating health care-associated infections and deaths in U.S. hospitals, 2002. Public Health Reports, 122, 160-166.2. Allegranzi, B., Nejad, S. B., Combescure, C., Graafmans, W., Attar, H., Donaldson, L., & Pittet, D. (2011). Burden of endemic health-care-associated infection in developing countries: Systematic review and meta-analysis. Lancet, 377, 228-241.

United States Developing Countries0

10

20

30

40

50

60

Overall Incidence per 100 PatientsICU HAI per 1000 Patient-Days

Global Burden: Prevalence

European Union Developing Countries0

5

10

15

20

25

30

35

Hospital

Intensive Care Unit

%HAI

SOURCES:1. World Health Organization. (2011) . Report on the Burden of Endemic Health Care-Associated Infection Worldwide: Clean Care is Safer Care. Retrieved from http://whqlibdoc.who.int/publications/2011/9789241501507_eng.pdf 2. Allegranzi, B., Nejad, S. B., Combescure, C., Graafmans, W., Attar, H., Donaldson, L., & Pittet, D. (2011). Burden of endemic health-care-associated infection in developing countries: Systematic review and meta-analysis. Lancet, 377, 228-241.3. European Centre for Disease Prevention and Control. Annual Epidemiological Report 2013. Reporting on 2011 surveillance data and 2012 epidemic intelligence data. Stockholm: ECDC; 2013.

Frequency of HAI by TypeDeveloping Countries HAI

% by Type

Surgical Site InfectionUrinary Tract InfectionBloodstream InfectionHealth Care-Associated PneumoniaOther

EU Countries HAI % by Type

Surgical Site InfectionUrinary Tract InfectionBloodstream InfectionRespiratory Tract InfectionGastrointestinal Infection

SOURCES: 1. Allegranzi, B., Nejad, S. B., Combescure, C., Graafmans, W., Attar, H., Donaldson, L., & Pittet, D. (2011). Burden of endemic health-care-associated infection in developing countries: Systematic review and meta-analysis. Lancet, 377, 228-241.2. European Centre for Disease Prevention and Control. Annual Epidemiological Report 2013. Reporting on 2011 surveillance data and 2012 epidemic intelligence data. Stockholm: ECDC; 2013.

Selected CLABSI Rates Internationally

INICC, 18 Developing Countries, 2002-2007

INICC, 25 Countries, 2003-2008

INICC, 36 Countries, 2004-2009

Turkey, 1999-2005

Argentina, 1998-2004

Meta-analysis Developing Countries

Germany, 2004-2009

United States, 2006-2008

0 5 10 15 20 25 30

Catheter Related Bloodstream Infection in Adult Intensive Care Units

Catheter Re-lated Blood-stream Infec-tion

Infection Episodes per 1000 Device-DaysSOURCES: 1. Allegranzi, B., Nejad, S. B., Combescure, C., Graafmans, W., Attar, H., Donaldson, L., & Pittet, D. (2011). Burden of endemic health-care-associated infection in developing countries: Systematic review and meta-analysis. Lancet, 377, 228-241.2. Rosenthal et. Al. (2012). International Nosocomial Infection Control Consortium (INICC) report, data summary of 36 countries for 2004-2009. American Journal of Infection Control, 40, 396-407.

Estimated International SSI Rates

SOURCES: 1. Allegranzi, B., Nejad, S. B., Combescure, C., Graafmans, W., Attar, H., Donaldson, L., & Pittet, D. (2011). Burden of endemic health-care-associated infection in developing countries: Systematic review and meta-analysis. Lancet, 377, 228-241.2. Gastmeier, P., Geffers, C., Brandt, C., Zuschneid, I., Sohr, D., Schwab, F., Behnke, Ml, Daschner, F., & Rϋden, H. (2006). Effectiveness of a nationwide nosocomial infection surveillance system for reducing nosocomial infections. J Hosp Infect, 64, 16-22.3. Gaynes, R. P., Culver, D. H., Horan, T. C., Edwards, J. R., Richards, C., & Tolson, J. S. (2001). Surgical site infection (SSI) rates in the United States, 1992-1998: the National Nosocomial Infections Surveillance System basic SSI risk index. Clin Infect Dis, 33(suppl 2), S69-77.

Developing Countries

European Countries

United States

0 1 2 3 4 5 6

Pooled Cumulative Incidence Surgical Site Infections

Pooled Cumulative Inci-dence Surgical Site Infec-tions

Surveillance – Developing Countries

• National Surveillance System in 15.6%– Burden is greatly underestimated

• Limited resources– Expertise

• knowledge of diagnosis • use of standardized definitions

– Finances• dollars to invest in monitoring – electronic patient records

– Time • competing priorities

• Limited generalizabilitySOURCES: 1. World Health Organization. (2010). The burden of health care-associated infection worldwide: A summary. Retrieved from http://www.who.int/gpsc/country_work/summary_20100430_en.pdf 2. World Health Organization. (2011). Report on the Burden of Endemic Health Care-Associated Infection Worldwide: Clean Care is Safer Care. Retrieved from http://whqlibdoc.who.int/publications/2011/9789241501507_eng.pdf

Surveillance – Developing Countries

• Types - passive, active, retrospective, prospective

• Passive surveillance best option when limited resources– Less sensitive– Requires electronic health records

SOURCE: World Health Organization. (2011). Report on the Burden of Endemic Health Care-Associated Infection Worldwide: Clean Care is Safer Care. Retrieved from http://whqlibdoc.who.int/publications/2011/9789241501507_eng.pdf

International HAI Burden

• Health care-associated infections can be prevented and reduced by as much as 50% in developing countries.

• Device-associated health care-associated infections can be decreased by as much as 30%.

SOURCES:1. World Health Organization. (2011). Report on the Burden of Endemic Health Care-Associated Infection Worldwide: Clean Care is Safer Care. Retrieved from http://whqlibdoc.who.int/publications/2011/9789241501507_eng.pdf 2. Rosenthal et. Al. (2012). International Nosocomial Infection Control Consortium (INICC) report, data summary of 36 countries for 2004-2009. American Journal of Infection Control, 40, 396-407.

Additional Factors in Developing Countries

• Poor hygiene and sanitation• Limited basic equipment• Insufficient infrastructure• Poor nutrition• Other infection and/or disease not present in

developed countries• Cultural and social differences

SOURCE: World Health Organization. (2011). Report on the Burden of Endemic Health Care-Associated Infection Worldwide: Clean Care is Safer Care. Retrieved from http://whqlibdoc.who.int/publications/2011/9789241501507_eng.pdf

Commitment to Improving HAI• WHO Patient Safety First Global Patient Safety

Challenge: Clean Care is Safer Care– Between October 2005 and April 2012• 127 Ministries of Health pledged to address HAIs• Over 40 countries began hand hygiene campaigns

• International Nosocomial Infection Control Consortium (INICC)– Established in Argentina 1998– 46 countries on 4 continents

SOURCES: 1. World Health Organization. Clean Care is Safer Care: About SAVE LIVES: Clean Your Hands. Retrieved from http://www.who.int/gpsc/5may/background/en/2. Rosenthal et. Al. (2012). International Nosocomial Infection Control Consortium (INICC) report, data summary of 36 countries for 2004-2009. American Journal of Infection Control, 40, 396-407.3. INICC. (2013). Retrieved from http://inicc.org/english/

CLABSI• INICC– 15 countries studied with improved• Hand hygiene • Consistent use of maximal sterile barriers at catheter

insertion • Chlorhexidine at insertion • Prompt removal of unnecessary catheters

– CLABSI rates and mortality reduced • Similar To CUSP interventions

SOURCE: Rosenthal et. al. (2010). Impact of International Nosocomial Infection Control Consortium (INICC) strategy on central line-associated bloodstream infection rates in the intensive care units of 15 developing countries. Infection Control and Hospital Epidemiology, 31(12), 1264-1272.

SSI

• INICC– Process surveillance– Disinfection and sterilization of supplies program– Adequate use of therapeutic and presurgical

prophylactic antibiotics program

SOURCE: INICC. (2013). Programs and services. Retrieved from http://inicc.org/english/programs_services.php

SSI

• National Project Team for CUSP for Safe Surgery partnered with WHO to implement SUSP– Engaged five hospitals in Africa– SUSP protocol and tools will be adapted for

settings with limited resources– Harare, Zimbabwe August 2013• Finalize project tools and toolkits • Kick off TBD

Hand Hygiene

• Low compliance • WHO – First international guidelines

• WHO multimodal hand hygiene strategy– Implemented in many countries

SOURCES: 1. Rosenthal et. Al. (2012). International Nosocomial Infection Control Consortium (INICC) report, data summary of 36 countries for 2004-2009. American Journal of Infection Control, 40, 396-407. 2. World Health Organization. Clean Care is Safer Care: Background to Clean Care is Safer Care. Retrieved from http://www.who.int/gpsc/background/en/3. Allegranzi, B., Gayet-Ageron, A., Damani, N., Bengaly, L., McLaws, M. L., Moro, M. L., Memish, Z., Urroz, O., Richet, H., Storr, J., Donaldson, L., & Pittet, D. (2013). Global implementation of WHO’s multimodal strategy for improvement of hand hygiene: a quasi-experimental study. Lancet, 13, 843-851.

Clostridium difficile

• More needs to be done to reduce C. difficile in US

• UK Guidance– All health care providers staff should take personal

responsibility for good infection control practices– Hand Hygiene – Prevention through isolation– Restrictive antibiotic guidelines

• 35% reduction in elderly >65 yearsSOURCE: Department of Health. 2008. Clostridium difficile infection: How to deal with the problem. London.

CDI Rates in UK

SOURCE: Public Health England July 2013. Summary Points on Clostridium Infections (CDI).

Lessons Learned

• The Adaptive Work of Culture Change is Challenging

• Strategies or approach to safety varies by hospital

• Teams want flexibility within a defined program structure

• Willingness to Accept and Motivated to Implement when valued as part of the project

For More Information

• Contact– Daniel.Gallardo@hhs.gov– Tisha.Johnson@hhs.gov

• National Action Plan to Prevent Health Care-Associated Infections: Road Map to Elimination– http://www.health.gov/hai/prevent_hai.asp

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